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ol boy has a helmet that can…
yeah
just watch
the helmet is in the intro to the lecture itself
i like to listen to this guy speak
his voice
his logic
searchin out more of his work now
kinda curious as to why im ignorant of him given the work n all
“christians” or christ likin folk should pay attention to the 36:45 min mark up until 39:00
and the info presented on rauvolfia
then his remarks on synergism
this is one h.a.i.r.y. fella
47:45 is another buena vista!
View Current Issue (Volume 60 Issue 13 September 2009) Advance Access Browse the Archive
The Journal of Experimental Botany publishes high-quality primary research papers in the plant sciences. These papers cover a range of disciplines from molecular and cellular physiology and biochemistry through whole plant physiology to community physiology. Every issue of the Journal contains at least one ‘Perspective’ article. These are most commonly reviews of research areas, which are particularly exciting and important, topical or controversial. Opinion articles are also considered. In addition to 12 regular issues, at least one Special Issue is published each year. These are collections of articles derived from a specialised meeting or conference session. All papers are fully reviewed, and we will endeavour to complete the review process with all speed.
Journal of Experimental Botany named one of the top 100 most influential journals in Biology and Medicine over the last 100 years (DBIO 100)
crackers
negros
and sundry ochre shaded folk
and you know!!!
Weeding out marijuana: Researchers close in on engineering recognizable, drug-free Cannabis plant
http://www.eurekalert.org/pub_releases/2009-09/uom-wom091509.php
U of Minnesota researchers identify genes producing THC
In a first step toward engineering a drug-free Cannabis plant for hemp fiber and oil, University of Minnesota researchers have identified genes producing tetrahydrocannabinol (THC), the psychoactive substance in marijuana. Studying the genes could also lead to new and better drugs for pain, nausea and other conditions.
The finding is published in the September issue of the Journal of Experimental Botany. Lead author is David Marks, a professor of plant biology in the College of Biological Sciences.
The study revealed that the genes are active in tiny hairs covering the flowers of Cannabis plants. In marijuana, the hairs accumulate high amounts of THC, whereas in hemp the hairs have little. Hemp and marijuana are difficult to distinguish apart from differences in THC.
With the genes identified, finding a way to silence them—and thus produce a drug-free plant — comes a step closer to reality. Another desirable step is to make drug-free plants visually recognizable. Since the hairs can be seen with a magnifying glass, this could be accomplished by engineering a hairless Cannabis plant.
The researchers are currently using the methods of the latest study to identify genes that lead to hair growth in hopes of silencing them.
“We are beginning to understand which genes control hair growth in other plants, and the resources created in our study will allow us to look for similar genes in Cannabis sativa,” said Marks.
“Cannabis genetics can contribute to better agriculture, medicine, and drug enforcement,” said George Weiblen, an associate professor of plant biology and a co-author of the study.
As with Dobermans and Dachshunds, marijuana and hemp are different breeds of the same species (Cannabis sativa), but marijuana contains much more THC than hemp, which is a source of industrial fiber and nutritious oil.
Hemp was raised for its fiber — which is similar to cotton but more durable — in the United States until legislation outlawed all Cannabis plants because they contain THC. Today, marijuana contains as much as 25 percent THC, whereas hemp plants contain less than 0.3 percent.
Hemp was once a popular crop in the upper Midwest because it tolerates a cool climate and marginal soils that won’t support other crops but, after drug legislation, hemp fiber was replaced by plastic and other alternatives. Recent popular demand for hemp products has led some states to consider the economic and environmental benefits of hemp. North Dakota legislation aims to reintroduce it as a crop, and Minnesota is considering similar legislation. At the same time, California and other states permit the medicinal use of marijuana.
“I can’t think of a plant so regarded as a menace by some and a miracle by others,” says Weiblen, who is one of the few researchers in the United States permitted to study Cannabis genetics. In 2006, Weiblen and colleagues developed a DNA “fingerprinting” technique capable of distinguishing among Cannabis plants in criminal investigations.
so i’ve really been tryin to empathize with this bill
see if i can find the logic play
and how this is a means to an end
i did some extensive and exhausted web searches and most of what i’m herain and seein is a bunch of left leanin libbys cryin on how mommy and daddy are raisin them
how wrong it is that hey are tellin them what to eat
idk
i really want to slap them and say
“quit bitchin about the paradigm you created!”
“you made the bed, lie in it”
“KARMA”
here’s some of the propaganda i’ve received and come across
http://www.federaljack.com/index.php?s=organic <-where is that first vid from? and how scary are they tryin to be in their bullshit boo!
http://www.change.org/ideas/6133/view_blog/hr_875s_425_farm_to_fork_food_fascism_comes_to_america
http://www.opencongress.org/bill/111-h875/show
http://www.facebook.com/group.php?gid=59474562131
http://www.thenhf.com/press_releases/pr_26_mar_2009.html
http://boards.straightdope.com/sdmb/showthread.php?t=511973
http://www.opednews.com/articles/Response-to-Myths-and-Fac-by-Aaron-Lucich-090315-298.html
http://www.opednews.com/articles/CODEX-is-in-HR-875–learn-by-Abu-Ahmad-090511-625.html
http://www.opednews.com/populum/search.php?mode=AR&pg=30&from=183&to=0&search_requested=hr+875&submit=Site
idk
my utopian fairy tale would be that these folk said
“ok gub’ment”
“but we are responsible for our own life”
“we dont need nor want for you to do for us”
but again it dawns on me
that is a right sided logic
not left
right now the entity that thinks it owns and runs me has already told me what i can and can’t grow in my garden
they just said i was wrong for a garden of beautiful purple flowers last year
there are hundreds of plants/fruits/veggies that this authoritative entity tells me not to grow
so what does one do now?
what will you do?
the entire bill is listed below
but i’ve taken time to pull ou the prohibitive acts section here
i read that it’s not that organic farming is to become illegal like i keep hearin
and it seems to be focused on interstate commerce more so
even in the penalties section it is focused on businesses of people not their private use
but there is the lack of responsibility in the regulation and inspection by the government(although i wonder if that is only for interstate commerce as well
ya
responsibility is the only issue i see
imo
liberal dems fel entitled for someone to do for them and everyone else
in the projected solipsism of my way is the best way
then they bitch when the folk doin for them arent doin it the way they want
a libertarian rep wuld rather do it his way for him and bitch at himself if he does it wrong
SEC. 401. PROHIBITED ACTS.
It is prohibited–
(1) to manufacture, introduce, deliver for introduction, or receive in interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
(2) to adulterate or misbrand any food in interstate commerce;
(3) for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
(4) to refuse to permit access to a food establishment or food production facility for the inspection and copying of a record as required under sections 205(f) and 206(a);
(5) to fail to establish or maintain any record or to make any report as required under sections 205(f) and 206(b);
(6) to refuse to permit entry to or inspection of a food establishment as required under section 205;
(7) to fail to provide to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant under section 205(f)(1)(B);
(8) to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, 206, or 208;
(9) to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any food for commerce, except in compliance with the food safety law;
(10) to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained;
(11) to fail to comply with a recall or other order under section 403; or
(12) to otherwise violate the food safety law.
Text of H.R. 875: Food Safety Modernization Act of 2009
111th CONGRESS
1st Session
H. R. 875
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
February 4, 2009
Ms. DELAURO (for herself, Ms. ESHOO, Ms. DEGETTE, Ms. SCHAKOWSKY, Mr. ENGEL, Ms. CASTOR of Florida, Mr. MURPHY of Connecticut, Ms. SUTTON, Mrs. LOWEY, Ms. SLAUGHTER, Mr. HINCHEY, Mr. MCGOVERN, Ms. WASSERMAN SCHULTZ, Ms. HIRONO, Mr. GRIJALVA, Mr. SCHAUER, Mr. NADLER of New York, Mr. BISHOP of New York, Ms. LINDA T. SANCHEZ of California, Mr. MCDERMOTT, Mr. RYAN of Ohio, Ms. GIFFORDS, Mr. FILNER, Mr. HALL of New York, Ms. LEE of California, Ms. PINGREE of Maine, Ms. KAPTUR, Mr. BISHOP of Georgia, Ms. MOORE of Wisconsin, and Mr. DEFAZIO) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Agriculture, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned
A BILL
To establish the Food Safety Administration within the Department of Health and Human Services to protect the public health by preventing food-borne illness, ensuring the safety of food, improving research on contaminants leading to food-borne illness, and improving security of food from intentional contamination, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the ‘Food Safety Modernization Act of 2009’.
(b) Table of Contents- The table of contents of this Act is as follows:
TITLE I–ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
TITLE II–ADMINISTRATION OF FOOD SAFETY PROGRAM
TITLE III–RESEARCH AND EDUCATION
TITLE IV–ENFORCEMENT
TITLE V–IMPLEMENTATION
SEC. 2. FINDINGS; PURPOSES.
(a) Findings- Congress finds that–
(1) the safety of the food supply of the United States is vital to the public health, to public confidence in the food supply, and to the success of the food sector of the Nation’s economy;
(2) lapses in the protection of the food supply and loss of public confidence in food safety are damaging to consumers and the food industry, and place a burden on interstate commerce and international trade;
(3) recent ongoing events demonstrate that the food safety program at the Food and Drug Administration is not effective in controlling hazards in food coming from farms and factories in the United States and food and food ingredients coming from foreign countries, and these events have adversely affected consumer confidence;
(4) the safety and security of the food supply require a systemwide approach to prevent food-borne illness involving the integrated efforts of Federal, State and local agencies; a thorough, broad-based, and coordinated approach to basic and applied science; and intensive, effective, and efficient management of the Nation’s food safety program;
(5) the task of preserving the safety of the food supply of the United States faces tremendous pressures with regard to–
(A) emerging pathogens and other contaminants and the ability to detect all forms of contamination;
(B) the threat of intentional contamination of the food supply;
(C) a growing number of people at high risk for food-borne illnesses, including an increasing population of aging and immune-compromised consumers, together with infants and children;
(D) an increasing volume of imported food, without adequate monitoring, inspection, and systems for prevention of food safety problems; and
(E) maintenance of rigorous inspection of the domestic food processing and food service industries;
(6) Federal food safety standard setting, inspection, enforcement, and research efforts should be based on the best available science and public health considerations, and food safety resources should be systematically deployed in ways that most effectively prevent food-borne illness;
(7) the Food and Drug Administration, an agency within the Department of Health and Human Services, has regulatory jurisdiction over the safety and labeling of 80 percent of the American food supply, encompassing all foods except meat, poultry, and egg products, as well as drugs, medical devices, and biologics;
(8) rapid technological advance and the expansion and globalization of industries in all areas of Food and Drug Administration jurisdiction present challenges and require leadership beyond the capacity of any one agency or agency head to provide;
(9) in the food safety area, the Food and Drug Administration implements provisions of the Federal Food, Drug, and Cosmetic Act that are 70 years old and that antiquated law limits the Food and Drug Administration’s role largely to reacting to and correcting food safety problems after they occur, rather than working with the food industry to systematically prevent problems;
(10) the Food and Drug Administration’s effectiveness is further impaired by fragmentation of leadership and management within the Administration, as major food safety responsibilities are dispersed across the Administration’s Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, and Office of Regulatory Affairs;
(11) there is no official with the full-time responsibility and budget authority for food safety at the Food and Drug Administration and food safety competes unsuccessfully with the drug and medical device programs for senior agency management attention and resources; and
(12) improving Federal oversight of food safety requires a modern food safety mandate, clear authorities, and a dedicated official within the Department of Health and Human Services with budget authority to manage an integrated organizational structure and report directly to the Secretary.
(b) Purposes- The purposes of this Act are–
(1) to establish an agency within the Department of Health and Human Services to be known as the ‘Food Safety Administration’ to–
(A) regulate food safety and labeling to strengthen the protection of the public health;
(B) ensure that food establishments fulfill their responsibility to process, store, hold, and transport food in a manner that protects the public health of all people in the United States;
(C) lead an integrated, systemwide approach to food safety and to make more effective and efficient use of resources to prevent food-borne illness;
(D) provide a single focal point within the Department of Health and Human Services for food safety leadership, both nationally and internationally; and
(E) provide an integrated food safety research capability, including internally generated, scientifically and statistically valid studies, in cooperation with academic institutions and other scientific entities of the Federal and State governments;
(2) to transfer to the Food Safety Administration the food safety, labeling, inspection, and enforcement functions that, as of the day before the date of the enactment of this Act, are performed by various components of the Food and Drug Administration and the National Oceanic and Atmospheric Administration;
(3) to modernize and strengthen the Federal food safety law to ensure more effective application and efficient management of the laws for the protection and improvement of public health; and
(4) to establish that food establishments have responsibility to ensure that all stages of production, processing, and distribution of their products or products under their control satisfy the requirements of this law.
SEC. 3. DEFINITIONS.
In this Act:
(1) ADMINISTRATION- The term ‘Administration’ means the Food Safety Administration established under section 101(a)(1).
(2) ADMINISTRATOR- The term ‘Administrator’ means the Administrator of Food Safety appointed under section 101(a)(2).
(3) ADULTERATED-
(A) IN GENERAL- The term ‘adulterated’ has the meaning given that term in section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342).
(B) INCLUSION- The term ‘adulterated’ includes bearing or containing a contaminant that causes illness or death among sensitive populations.
(4) AGENCY- The term ‘agency’ has the meaning given that term in section 551 of title 5, United States Code.
(5) CATEGORY 1 FOOD ESTABLISHMENT- The term ‘category 1 food establishment’ means a food establishment (other than a seafood processing establishment) that slaughters, for the purpose of producing food, animals that are not subject to inspection under the Federal Meat Inspection Act or poultry that are not subject to inspection under the Poultry Products Inspection Act.
(6) CATEGORY 2 FOOD ESTABLISHMENT- The term ‘category 2 food establishment’ means a seafood processing establishment or other food establishment (other than a category 1 establishment) not subject to inspection under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act, that processes raw seafood or other raw animal products, whether fresh or frozen, or other products that the Administrator determines by regulation to pose a significant risk of hazardous contamination.
(7) CATEGORY 3 FOOD ESTABLISHMENT- The term ‘category 3 food establishment’ means a food establishment (other than a category 1 or category 2 establishment) that processes cooked, pasteurized, or otherwise ready-to-eat seafood or other animal products, fresh produce in ready-to-eat raw form, or other products that pose a risk of hazardous contamination.
(8) CATEGORY 4 FOOD ESTABLISHMENT- The term ‘category 4 food establishment’ means a food establishment that processes all other categories of food products not described in paragraphs (5) through (7).
(9) CATEGORY 5 FOOD ESTABLISHMENT- The term ‘category 5 food establishment’ means a food establishment that stores, holds, or transports food products prior to delivery for retail sale.
(10) CONTAMINANT- The term ‘contaminant’ includes a bacterium, chemical, natural toxin or manufactured toxicant, virus, parasite, prion, physical hazard, or other human pathogen that when found on or in food can cause human illness, injury, or death.
(11) HAZARDOUS CONTAMINATION- The term ‘hazardous contamination’ refers to the presence of a contaminant in food at levels that pose a risk of human illness, injury, or death or are capable of reaching levels that pose such risk during the shelf life of the product.
(12) FOOD- The term ‘food’ means a product intended to be used for food or drink for a human or an animal and components thereof.
(13) FOOD ESTABLISHMENT-
(A) IN GENERAL- The term ‘food establishment’ means a slaughterhouse (except those regulated under the Federal Meat Inspection Act or the Poultry Products Inspection Act), factory, warehouse, or facility owned or operated by a person located in any State that processes food or a facility that holds, stores, or transports food or food ingredients.
(B) EXCLUSIONS- For the purposes of registration, the term ‘food establishment’ does not include a food production facility as defined in paragraph (14), restaurant, other retail food establishment, nonprofit food establishment in which food is prepared for or served directly to the consumer, or fishing vessel (other than a fishing vessel engaged in processing, as that term is defined in section 123.3 of title 21, Code of Federal Regulations).
(14) FOOD PRODUCTION FACILITY- The term ‘food production facility’ means any farm, ranch, orchard, vineyard, aquaculture facility, or confined animal-feeding operation.
(15) FOOD SAFETY LAW- The term ‘food safety law’ means–
(A) the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) related to and requiring the safety, quality, nutritional composition, labeling, and inspection of food, infant formulas, food additives, pesticide residues, and other substances present in food;
(B) the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 11 seq.) and of any other Acts that are administered by the Center for Veterinary Medicine of the Food and Drug Administration;
(C) the provisions of the Public Health Service Act that relate in any way to studying, surveying, containing, or preventing food-borne illness; and
(D) the provisions of this Act.
(16) FOREIGN FOOD ESTABLISHMENT- The term ‘foreign food establishment’ means any category 1 through 5 food establishment or food production facility located outside the United States that processes or produces food or food ingredients for consumption in the United States.
(17) INTERSTATE COMMERCE- The term ‘interstate commerce’ has the meaning given that term in section 201(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(b)).
(18) MISBRANDED- The term ‘misbranded’ has the meaning given that term in section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343).
(19) PROCESS- The term ‘process’ or ‘processing’ means the commercial slaughter, packing, preparation, or manufacture of food.
(20) STATE- The term ‘State’ means–
(A) a State;
(B) the District of Columbia;
(C) the Commonwealth of Puerto Rico; and
(D) any other territory or possession of the United States.
TITLE I–ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION
SEC. 101. ESTABLISHMENT OF THE FOOD SAFETY ADMINISTRATION.
(a) Establishment-
(1) IN GENERAL- There is established in the Department of Health and Human Services an agency to be known as the ‘Food Safety Administration’.
(2) HEAD OF THE ADMINISTRATION- The Administration shall be headed by the Administrator of Food Safety, who shall be appointed by the President, by and with the advice and consent of the Senate, for a term of 5 years, and who may be reappointed.
(3) DELEGATION- All the authorities and responsibilities assigned to the Secretary of Health and Human Services in the food safety law are hereby assigned to the Administrator.
(b) Duties of Administrator- The Administrator shall–
(1) administer and enforce the food safety law;
(2) serve as the food safety leader within the Department of Health and Human Services and coordinator of all Department activities related to ensuring the safety, quality, and proper labeling of the food supply;
(3) represent the United States in relevant international food safety bodies and discussions;
(4) promulgate regulations to ensure the safety and security of the food supply from all forms of contamination, including intentional contamination; and
(5) oversee within the Department of Health and Human Services–
(A) in consultation with the Director of the Centers for Disease Control and Prevention, all activities related to foodborne illness surveillance and investigation of foodborne illness outbreaks;
(B) implementation of food safety inspection, enforcement, and research efforts to protect the public health;
(C) development of consistent and science-based standards for safe food;
(D) coordination and prioritization of food safety research and education programs with other Federal agencies;
(E) prioritization of food safety efforts and deployment of food safety resources to achieve the greatest possible benefit in reducing food-borne illness;
(F) coordination of the response to food-borne illness outbreaks with other Federal and State agencies; and
(G) integration of food safety activities with State and local agencies.
SEC. 102. CONSOLIDATION OF FOOD SAFETY FUNCTIONS.
(a) Transfer of Functions and Resources- For each component of the Department of Health and Human Services or the Department of Commerce specified in subsection (b), there are transferred to the Administration all functions, personnel, and assets (including facilities and financial resources) of those components as of the day before the date of the enactment of this Act (including all related functions of any officer or employee of the component) that relate to administration or enforcement of the food safety law, as determined by the President.
(b) Transferred Functions and Resources- The components referred to in subsection (a) are–
(1) the Center for Food Safety and Applied Nutrition of the Food and Drug Administration;
(2) the Center for Veterinary Medicine of the Food and Drug Administration;
(3) the National Center for Toxicological Research of the Food and Drug Administration;
(4) the personnel and assets of the Office of Regulatory Affairs of the Food and Drug Administration used to administer and conduct inspections of food establishments and imports and conduct laboratory analyses and other investigations relating to food safety and enforcement of the food safety law;
(5) the personnel and assets of the Office of the Commissioner of Food and Drugs used to support–
(A) the Center for Food Safety and Applied Nutrition;
(B) the Center for Veterinary Medicine;
(C) the National Center for Toxicological Research; and
(D) the personnel and assets of the Office of Regulatory Affairs described in paragraph (4); and
(6) the personnel and assets of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration of the Department of Commerce used to administer the seafood inspection program.
(c) Renaming and Reservation of Agency Identity- The Food and Drug Administration in the Department of Health and Human Services is hereby renamed the Federal Drug and Device Administration and may be referred to as ‘FDA’.
(d) Sharing of Facilities and Resources- The Food Safety Administration and the Federal Drug and Device Administration shall enter into such agreements concerning the sharing of facilities and other resources as may be appropriate to make efficient use of such facilities and resources and achieve their respective missions.
SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.
(a) Officers and Employees- The Administrator may–
(1) appoint officers and employees for the Administration in accordance with the provisions of title 5, United States Code, relating to appointment in the competitive service; and
(2) fix the compensation of those officers and employees in accordance with chapter 51 and with subchapter III of chapter 53 of that title, relating to classification and General Schedule pay rates.
(b) Experts and Consultants- The Administrator may–
(1) procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and
(2) pay in connection with those services the travel expenses of the experts and consultants, including transportation and per diem in lieu of subsistence while away from the homes or regular places of business of the individuals, as authorized by section 5703 of that title.
(c) Bureaus, Offices, and Divisions- The Administrator may establish within the Administration such bureaus, offices, and divisions as the Administrator determines are necessary to perform the duties of the Administrator.
(d) Advisory Committees-
(1) IN GENERAL- The Administrator shall establish advisory committees that consist of representatives of scientific expert bodies, academics, industry specialists, and consumers.
(2) DUTIES- The duties of an advisory committee established under paragraph (1) may include developing recommendations with respect to the development of new processes, research, communications, performance standards, and inspection.
TITLE II–ADMINISTRATION OF FOOD SAFETY PROGRAM
SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM.
(a) In General- The Administrator shall–
(1) develop, administer, and annually update a national food safety program (referred to in this section as the ‘program’) to protect public health; and
(2) ensure that persons who produce, process, or distribute food meet their responsibility to prevent or minimize food safety hazards related to their products.
(b) Comprehensive Analysis- The program shall be based on a comprehensive analysis of the hazards associated with different food and with the processing of different food, including the identification and evaluation of–
(1) the severity of the potential health risks;
(2) the sources of potentially hazardous contamination or practices extending from the farm or ranch to the consumer that may increase the risk of food-borne illness;
(3) the potential for persistence, multiplication, or concentration of naturally occurring or added contaminants in food;
(4) the potential for hazardous contamination to have cumulative toxic effects, multigenerational effects, or effects on specific categories of consumers;
(5) opportunities across the food production, processing, distribution, and retail system to reduce potential health risks; and
(6) opportunities for intentional contamination of food or food ingredients.
(c) Program Elements- In carrying out the program, the Administrator shall–
(1) adopt and implement a national system for the registration of food establishments and foreign food establishments, as provided in section 202 of this Act;
(2) adopt and implement a national system for regular unannounced inspection of food establishments;
(3) require and enforce the adoption of preventive process controls in food establishments, based on the best available scientific and public health considerations and best available technologies;
(4) establish and enforce science-based standards for–
(A) potentially hazardous substances that may contaminate food; and
(B) safety and sanitation in the processing and handling of food;
(5) implement a statistically valid sampling program with the stringency and frequency to independently monitor that industry programs and procedures that prevent food contamination are effective on an ongoing basis and that food meets the standards established under this Act;
(6) implement appropriate surveillance procedures and requirements to ensure the safety and security of imported food;
(7) coordinate and collaborate with other agencies and State or local governments in carrying out inspection, enforcement, research, and monitoring;
(8) implement a national system to identify the food products posing the greatest public health risk and to analyze the effectiveness of existing food safety programs, in conjunction with the Centers for Disease Control and Prevention and other Federal agencies;
(9) develop public education, risk communication, and advisory programs;
(10) implement an applied research program to further the purposes of this Act;
(11) coordinate and prioritize food safety research and educational programs with other Federal agencies and with State and local governments; and
(12) provide technical assistance to farmers and food establishments that are small business concerns (meeting the requirements of section 3(a) of the Small Business Act and the regulations promulgated thereunder) to assist with compliance with the requirements of this Act.
SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND FOREIGN FOOD ESTABLISHMENTS.
(a) In General- Any food establishment or foreign food establishment engaged in manufacturing, processing, packing, or holding food for consumption in the United States shall register annually with the Administrator.
(b) Registration Requirements-
(1) IN GENERAL- To be registered under subsection (a), a food establishment shall submit a registration or reregistration to the Administrator.
(2) REGISTRATION- Registration under this section shall begin within 90 days of the enactment of this Act. Each such registration shall be submitted to the Secretary through an electronic portal and shall contain such information as the Secretary, by guidance, determines to be appropriate. Such registration shall contain the following information:
(A) The name, address, and emergency contact information of each domestic food establishment or foreign food establishment that the registrant owns or operates under this Act and all trade names under which the registrant conducts business in the United States relating to food.
(B) The primary purpose and business activity of each domestic food establishment or foreign food establishment, including the dates of operation if the domestic food establishment or foreign food establishment is seasonal.
(C) The types of food processed or sold at each domestic food establishment or, for foreign food establishments selling food for consumption in the United States, the specific food categories of that food as listed under section 170.3(n) of title 21, Code of Federal Regulations, or such other categories as the Administrator may designate in guidance, action level, or regulations for evaluating potential threats to food protection.
(D) The name, address, and 24-hour emergency contact information of the United States distribution agent for each domestic food establishment or foreign food establishment, who shall maintain information on the distribution of food, including lot information, and wholesaler and retailer distribution.
(E) An assurance that the registrant will notify the Administrator of any change in the products, function, or legal status of the domestic food establishment or foreign food establishment (including cessation of business activities) not later than 30 days after such change.
(3) PROCEDURE- Upon receipt of a completed registration described in paragraph (1), the Administrator shall notify the registrant of the receipt of the registration, designate each establishment as a category 1, 2, 3, 4, or 5 food establishment, and assign a registration number to each domestic food establishment and foreign food establishment.
(4) LIST- The Administrator shall annually compile a list of domestic food establishments and a list of foreign food establishments that are registered under this section. The Administrator may establish the manner of and any fees required for reregistration and any circumstances by which either such list may be shared with other governmental authorities. The Administrator may remove from either list the name of any establishment that fails to reregister, and such delisting shall be treated as a suspension.
(5) DISCLOSURE EXEMPTION- The disclosure requirements under section 552 of title 5, United States Code, shall not apply to–
(A) the list compiled under paragraph (4); and
(B) information derived from the list under paragraph (4), to the extent that it discloses the identity or location of a specific person.
(6) SUSPENSION OF REGISTRATION-
(A) IN GENERAL- The Administrator may suspend the registration of a domestic food establishment or foreign food establishment, including the facility of an importer, for violation of a food safety law that is either repeated or could result in serious adverse health consequences or death to humans or animals.
(B) NOTICE AND OPPORTUNITY FOR HEARING- The Administrator shall provide notice of an intent to suspend the registration of an establishment under this paragraph to a registrant and provide the registrant with an opportunity for an administrative hearing within 3 days. The Administrator may issue a written order of suspension following the hearing, if the Administrator finds that a violation described in subparagraph (A) has occurred.
(C) JUDICIAL REVIEW- The issuance of an order of suspension under subparagraph (B) shall be considered to be a final agency action subject to judicial review in accordance with the provisions of chapter 7 of title 5, United States Code.
(7) REINSTATEMENT- A registration that is suspended under this section may be reinstated based on a showing that adequate process controls have been instituted that would prevent future violations and there are assurances from the registrant that the violations will not be repeated.
(c) Transitional Provision- During the 6-month period following the date of the enactment of this Act, a food establishment is deemed to be registered in accordance with this section if the establishment is registered under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d).
(d) Repeal- Effective at the end of the 6-month period following the date of the enactment of this Act, section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is repealed.
SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION OF FOOD.
(a) In General- The Administrator shall, upon the basis of best available public health, scientific, and technological data, promulgate regulations to ensure that food establishments carry out their responsibilities under the food safety law.
(b) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations that require all food establishments, within time frames determined by the Administrator–
(1) to adopt preventive process controls that–
(A) reflect the standards and procedures recognized by relevant authoritative bodies;
(B) are adequate to protect the public health;
(C) meet relevant regulatory and food safety standards;
(D) limit the presence and growth of contaminants in food prepared in a food establishment using the best reasonably available techniques and technologies; and
(E) are tailored to the hazards and processes in particular establishments or environments;
(2) to establish a sanitation plan and program that meets standards set by the Administrator;
(3) to meet performance standards for hazardous contamination established under section 204;
(4) to implement recordkeeping to monitor compliance with regulatory requirements;
(5) to implement recordkeeping and labeling of all food and food ingredients to facilitate their identification and traceability in the event of a recall or market removal;
(6) to implement product and environmental sampling at a frequency and in a manner sufficient to ensure that process controls are effective on an ongoing basis and that regulatory standards are being met;
(7) to label food intended for final processing outside commercial food establishments with instructions for handling and preparation for consumption that will destroy microbial contaminants; and
(8) to provide for agency access to records kept by the food establishments and submission of copies of records to the Administrator, as the Administrator determines appropriate.
(c) Specific Hazard Controls- The Administrator may require any person with responsibility for or control over food or food ingredients to adopt specific hazard controls, if such controls are needed to ensure the protection of the public health.
SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.
(a) In General- To protect the public health, the Administrator shall establish by guidance document, action level, or regulation and enforce performance standards that define, with respect to specific foods and contaminants in food, the level of food safety performance that a person responsible for producing, processing, or selling food shall meet.
(b) Identification of Contaminants; Performance Standards-
(1) LIST OF CONTAMINANTS- Not later than 6 months after the date of the enactment of this Act, the Administrator shall publish in the Federal Register a list of the contaminants in foods that have the greatest adverse impact on public health in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act. Where appropriate, the Administrator shall indicate whether the risk posed by a contaminant is generalized or specific to particular foods or ingredients.
(2) PERFORMANCE STANDARDS-
(A) ESTABLISHMENT- The Administrator shall establish by guidance document, action level, or regulation a performance standard for each contaminant in the list under paragraph (1) at levels appropriate to protect against the potential adverse health effects of the contaminant.
(B) TIMING- The Administrator shall establish a performance standard under subparagraph (A) for each contaminant in the list under paragraph (1)–
(i) as soon as practicable; or
(ii) in the case of a contaminant described in subparagraph (C), by the date described in such subparagraph.
(C) SIGNIFICANT CONTAMINANTS- The list under paragraph (1) (and any revision thereto) shall identify the 5 most significant contaminants in the list (in terms of the number and severity of illnesses and number of deaths associated with foods regulated under this Act). Not later than 3 years after a contaminant is so identified, the Administrator shall promulgate a performance standard under subparagraph (A) for the contaminant.
(3) REVIEW; REVISION- Not less than every 3 years, the Administrator shall review and, if necessary, revise–
(A) the list of contaminants under paragraph (1); and
(B) each performance standard established under paragraph (2).
(c) Performance Standards-
(1) IN GENERAL- The performance standards established under this section may include–
(A) health-based standards that set the level of a contaminant that can safely and lawfully be present in food;
(B) zero tolerances, including any zero tolerance performance standards in effect on the day before the date of the enactment of this Act, when necessary to protect against significant adverse health outcomes;
(C) process standards, such as log reduction criteria for cooked products, when sufficient to ensure the safety of processed food; and
(D) in the absence of data to support a performance standard described in subparagraph (A), (B), or (C), standards that define required performance on the basis of reliable information on the best reasonably achievable performance, using best available technologies, interventions, and practices.
(2) BEST REASONABLY ACHIEVABLE PERFORMANCE STANDARDS- In developing best reasonably achievable performance standards under paragraph (1)(D), the Administrator shall collect, or contract for the collection of, data on current best practices and food safety outcomes related to the contaminants and foods in question, as the Administrator determines necessary.
(3) REVOCATION BY ADMINISTRATOR- All performance standards, tolerances, action levels, or other similar standards in effect on the date of the enactment of this Act shall remain in effect until revised or revoked by the Administrator.
(d) Enforcement-
(1) IN GENERAL- In conjunction with the establishment of a performance standard under this section, the Administrator shall develop a statistically valid sampling program with the stringency and frequency sufficient to independently monitor whether food establishments are complying with the performance standard and implement the program within 1 year of the promulgation of the standard.
(2) INSPECTIONS- If the Administrator determines that a food establishment fails to meet a standard promulgated under this section, the Administrator shall, as appropriate–
(A) detain, seize, or condemn food from the food establishment under section 402;
(B) order a recall of food from the food establishment under section 403;
(C) increase the inspection frequency for the food establishment;
(D) withdraw the mark of inspection from the food establishment, if in use; or
(E) take other appropriate enforcement action concerning the food establishment, including withdrawal of registration.
(e) Newly Identified Contaminants- Notwithstanding any other provision of this section, the Administrator shall establish interim performance standards for newly identified contaminants as necessary to protect the public health.
SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS.
(a) In General- The Administrator shall establish an inspection program, which shall include statistically valid sampling of food and facilities to enforce performance standards. The inspection program shall be designed to determine if each food establishment–
(1) is operated in a sanitary manner;
(2) has continuous preventive control systems, interventions, and processes in place to minimize or eliminate contaminants in food;
(3) is in compliance with applicable performance standards established under section 204, and other regulatory requirements;
(4) is processing food that is not adulterated or misbranded;
(5) maintains records of process control plans under section 203, and other records related to the processing, sampling, and handling of food; and
(6) is otherwise in compliance with the requirements of the food safety law.
(b) Establishment Categories and Inspection Frequencies- The resource plan required under section 209, including the description of resources required to carry out inspections of food establishments, shall be based on the following categories and inspection frequencies, subject to subsections (c), (d), and (e):
(1) CATEGORY 1 FOOD ESTABLISHMENTS- A category 1 food establishment shall be subject to antemortem, postmortem, and continuous inspection of each slaughter line during all operating hours, and other inspection on a daily basis, sufficient to verify that–
(A) diseased animals are not offered for slaughter;
(B) the food establishment has successfully identified and removed from the slaughter line visibly defective or contaminated carcasses, has avoided cross-contamination, and has destroyed or reprocessed such carcasses in a manner acceptable to the Administrator; and
(C) applicable performance standards and other provisions of the food safety law, including those intended to eliminate or reduce pathogens, have been satisfied.
(2) CATEGORY 2 FOOD ESTABLISHMENTS- A category 2 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least weekly.
(3) CATEGORY 3 FOOD ESTABLISHMENTS- A category 3 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least monthly.
(4) CATEGORY 4 FOOD ESTABLISHMENTS- A category 4 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least quarterly.
(5) CATEGORY 5 FOOD ESTABLISHMENTS- A category 5 food establishment shall–
(A) have ongoing verification that its processes are controlled; and
(B) be randomly inspected at least annually.
(c) Establishment of Inspection Procedures- The Administrator shall establish procedures under which inspectors shall take random samples, photographs, and copies of records in food establishments.
(d) Alternative Inspection Frequencies- With respect to a subcategory of food establishment under category 2, 3, 4, or 5, the Administrator may establish alternative increasing or decreasing inspection frequencies for subcategories of food establishments or individual establishments, to foster risk-based allocation of resources. Before establishing an alternative inspection frequency for a subcategory of food establishments or individual establishments, the Administrator shall take into consideration the evidence described in paragraph (2)(D) and the overall record of compliance described in paragraph (2)(E) for such subcategory. In establishing alternative inspection frequencies under this subsection, the Administrator shall comply with the following criteria and procedures:
(1) Subcategories of food establishments and their alternative inspection frequencies shall be defined by regulation, subject to paragraphs (2) and (3).
(2) In defining subcategories of food establishments and their alternative inspection frequencies under paragraphs (1) and (2), the Administrator shall consider–
(A) the nature of the food products being processed, stored, or transported;
(B) the manner in which food products are processed, stored, or transported;
(C) the inherent likelihood that the products will contribute to the risk of food-borne illness;
(D) the best available evidence concerning reported illnesses associated with the foods processed, stored, held, or transported in the proposed subcategory of establishments; and
(E) the overall record of compliance with food safety law among establishments in the proposed subcategory, including compliance with applicable performance standards and the frequency of recalls.
(3) The Administrator may adopt alternative inspection frequencies for increased or decreased inspection for a specific establishment and shall annually publish a list of establishments subject to alternative inspections.
(4) In adopting alternative inspection frequencies for a specific establishment, the Administrator shall consider–
(A) the criteria in paragraph (2), together with any evidence submitted from the individual food establishment supporting a request for an alternative inspection frequency, including the establishment’s record for implementing effective preventive process control systems;
(B) whether products from the specific establishment have been associated with a case or an outbreak of food-borne illness; and
(C) the establishment’s record of compliance with food safety law, including compliance with applicable performance standards and the frequency of recalls.
(e) Effective Date- The inspection mandates shall go into effect 2 years after the date of the enactment of this Act.
(f) Maintenance and Inspection of Records-
(1) IN GENERAL-
(A) RECORDS- A food establishment shall–
(i) maintain such records as the Administrator shall require by regulation, including all records relating to the processing, distributing, receipt, or importation of any food; and
(ii) permit the Administrator, in addition to any authority transferred to the Administrator pursuant to section 102, upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and copy all records maintained by or on behalf of such food establishment representative in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator–
(I) to determine whether the food is contaminated or not in compliance with the food safety law; or
(II) to track the food in commerce.
(B) REQUIRED DISCLOSURE- A food establishment shall have an affirmative obligation to disclose to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant.
(2) MAINTENANCE OF RECORDS- The records in paragraph (1) shall be maintained for a reasonable period of time, as determined by the Administrator.
(3) REQUIREMENTS- The records in paragraph (1) shall include records describing–
(A) the origin, receipt, delivery, sale, movement, holding, and disposition of food or ingredients;
(B) the identity and quantity of ingredients used in the food;
(C) the processing of the food;
(D) the results of laboratory, sanitation, or other tests performed on the food or in the food establishment;
(E) consumer complaints concerning the food or packaging of the food;
(F) the production codes, open date codes, and locations of food production; and
(G) other matters reasonably related to whether food is adulterated or misbranded, or otherwise fails to meet the requirements of this Act.
(g) Protection of Sensitive Information-
(1) IN GENERAL- The Administrator shall develop and maintain procedures to prevent the unauthorized disclosure of any trade secret or commercially valuable confidential information obtained by the Administrator.
(2) LIMITATION- The requirements under this subsection and subsection (f) do not–
(A) limit the authority of the Administrator to inspect or copy records or to require the establishment or maintenance of records under this Act;
(B) have any legal effect on section 1905 of title 18, United States Code;
(C) extend to any food recipe, financial data, pricing data, or personnel data;
(D) limit the public disclosure of distribution records or other records related to food subject to a voluntary or mandatory recall under section 403; or
(E) limit the authority of the Administrator to promulgate regulations to permit the sharing of data with other governmental authorities.
(h) Bribery of or Gifts to Inspector or Other Officers and Acceptance of Gifts- Any person or agent or employee thereof that gives, pays, or offers, directly or indirectly, to the Administrator or any employee or other designee thereof authorized to perform any duty under the food safety law any money or other thing of value, with intent to influence the discharge of any duty under such law, shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both. Any Administrator, employee, or other designee that solicits or accepts any money or other thing of value from any person, with intent to influence the discharge of any duty under the food safety law, shall be summarily discharged from office and imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.
SEC. 206. FOOD PRODUCTION FACILITIES.
(a) Authorities- In carrying out the duties of the Administrator and the purposes of this Act, the Administrator shall have the authority, with respect to food production facilities, to–
(1) visit and inspect food production facilities in the United States and in foreign countries to determine if they are operating in compliance with the requirements of the food safety law;
(2) review food safety records as required to be kept by the Administrator under section 210 and for other food safety purposes;
(3) set good practice standards to protect the public and animal health and promote food safety;
(4) conduct monitoring and surveillance of animals, plants, products, or the environment, as appropriate; and
(5) collect and maintain information relevant to public health and farm practices.
(b) Inspection of Records- A food production facility shall permit the Administrator upon presentation of appropriate credentials and at reasonable times and in a reasonable manner, to have access to and ability to copy all records maintained by or on behalf of such food production establishment in any format (including paper or electronic) and at any location, that are necessary to assist the Administrator–
(1) to determine whether the food is contaminated, adulterated, or otherwise not in compliance with the food safety law; or
(2) to track the food in commerce.
(c) Regulations- Not later than 1 year after the date of the enactment of this Act, the Administrator, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall promulgate regulations to establish science-based minimum standards for the safe production of food by food production facilities. Such regulations shall–
(1) consider all relevant hazards, including those occurring naturally, and those that may be unintentionally or intentionally introduced;
(2) require each food production facility to have a written food safety plan that describes the likely hazards and preventive controls implemented to address those hazards;
(3) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to fertilizer use, nutrients, hygiene, packaging, temperature controls, animal encroachment, and water;
(4) include, with respect to animals raised for food, minimum standards related to the animal’s health, feed, and environment which bear on the safety of food for human consumption;
(5) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;
(6) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and
(7) include a description of the variance process under subsection (d) and the types of permissible variances which the Administrator may grant under such process.
(d) Variances- States and foreign countries that export produce intended for consumption in the United States may request from the Administrator variances from the requirements of the regulations under subsection (c). A request shall–
(1) be in writing;
(2) describe the reasons the variance is necessary;
(3) describe the procedures, processes, and practices that will be followed under the variance to ensure produce is not adulterated; and
(4) contain any other information required by the Administrator.
(e) Approval or Disapproval of Variances- If the Administrator determines after review of a request under subsection (d) that the requested variance provides equivalent protections to those promulgated under subsection (c), the Administrator may approve the request. The Administrator shall deny a request if it is–
(1) not sufficiently detailed to permit a determination;
(2) fails to cite sufficient grounds for allowing a variance; or
(3) does not provide reasonable assurances that the produce will not be adulterated.
(f) Enforcement- The Administrator may coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.
(g) Imported Produce- Not later than 1 year after the date of the enactment of this Act, the Administrator shall promulgate regulations to ensure that raw agricultural commodities and minimally processed produce imported into the United States can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to such commodities and produce produced in the United States.
SEC. 207. FEDERAL AND STATE COOPERATION.
(a) In General-
(1) AUTHORITY- The Administrator shall strengthen and expand food-borne illness surveillance systems to–
(A) inform and evaluate efforts to prevent food-borne illness; and
(B) enhance the identification and investigation of, and response to, food-borne illness outbreaks.
(2) FOOD-BORNE ILLNESS OUTBREAK- For purposes of this section, the term ‘foodborne illness outbreak’ means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a common food.
(b) Food-Borne Illness Surveillance Systems- The Administrator, in collaboration with the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by–
(1) coordinating food-borne illness surveillance systems, including complaint systems, in order to–
(A) produce better information on illnesses associated with foods, including sources and risk factors for infections by emerging pathogens; and
(B) facilitate sharing of data acquisition and findings on a more timely basis among governmental agencies, including the Food Safety Administration, the Food Safety and Inspection Service, and State and local agencies, and with the public;
(2) augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;
(3) developing improved epidemiological tools for obtaining quality exposure data, microbiological methods for classifying cases and detecting clusters, and improved tracebacks to rapidly and specifically identify contaminated food products;
(4) expanding capacity of such systems for implementation of fingerprinting strategies for food-borne infectious agents, including parasites and hepatitis A, in order to increase pathogen discovery efforts to identify new or rarely documented causes of food-borne illness;
(5) allowing timely public access to de-identified, aggregate surveillance data;
(6) at least annually, publishing current reports on findings from such systems;
(7) exploring establishment of registries for long-term case follow-up to better characterize late complications of food-borne illness;
(8) increasing participation in national networks of public health and food regulatory agencies and laboratories to–
(A) allow public health officials at the Federal, State, and local levels to share and accept laboratory analytic findings; and
(B) identify food-borne illness outbreaks and attribute such outbreaks to specific foods through submission of standardized molecular subtypes (also known as ‘fingerprints’) of food-borne illness pathogens to a centralized database; and
(9) establishing a flexible mechanism for rapidly supporting scientific research by academic centers of excellence, which may include staff representing academic clinical researchers, food microbiologists, animal and plant disease specialists, ecologists, and other allied disciplines.
(c) Improving State Surveillance Capacity- The Administrator, in collaboration with the Director of the Centers for Disease Control and Prevention, shall improve capacity for surveillance in the States by–
(1) supporting outbreak investigations with needed specialty expertise, including epidemiological, microbiological, and environmental expertise, to assist identification of underlying common sources and contributing factors;
(2) identifying, disseminating, and supporting implementation of model practices at the State and local level for–
(A) facilitating rapid shipment of clinical isolates from clinical laboratories to State public health laboratories to avoid delays in testing;
(B) conducting rapid and more standardized interviewing of cases associated with major enteric pathogens, including prior to designation of clusters as food-borne illness outbreaks;
(C) conducting and evaluating rapid and standardized interviews of healthy control persons;
(D) sharing information on a timely basis–
(i) within public health and food regulatory agencies;
(ii) among such agencies;
(iii) with the food industry;
(iv) with healthcare providers; and
(v) with the public;
(3) developing, regularly updating, and disseminating training curricula on food-borne illness surveillance investigations, including standard sampling methods and laboratory procedures;
(4) integrating new molecular diagnostic tools for parasites into web-based consultation services for parasitic infections to accelerate the identification of these food-borne infectious agents;
(5) supporting research to develop and deploy new subtyping methods for salmonella, E. coli, campylobacter, and other pathogens, to increase the speed and accuracy of diagnoses;
(6) determining minimum core competencies for public health laboratories, and developing self-evaluation and proficiency-testing tools for such laboratories;
(7) facilitating regional public health laboratory partnerships to leverage resources, including equipment and physical space, and increase surge capacity;
(8) providing technical assistance, which may include the detailing of officers and employees of the Administrator, to State and local public health and food regulatory agencies;
(9) partnering with the Food Safety Administration to increase communication, coordination, and integration of food-borne illness surveillance and outbreak investigation activities; and
(10) developing and periodically updating response and interview procedures so that such procedures are standardized and tested.
(d) Program Activities- The Administrator shall carry out activities to support core food safety functions of State and local public health laboratories, including–
(1) establishing fellowships, stipends, and scholarships to address critical workforce shortages;
(2) training and coordination of State and local personnel;
(3) establishing partnerships between private and public laboratories to facilitate sharing of positive enteric specimens and improve surge capacity;
(4) strengthening capacity to participate in existing or new food-borne illness surveillance systems; and
(5) purchasing and maintaining data systems hardware and software and laboratory equipment.
(e) Plan To Improve Food Safety Capacity at the State and Local Level-
(1) GOALS- The Administrator shall leverage and enhance the food safety capacity and roles of State and local agencies and integrate State and local agencies as fully as possible into national food safety efforts, in order to achieve the following goals:
(A) Improve food-borne illness outbreak response and containment.
(B) Improve the contribution of food-borne illness surveillance and investigation to the prevention of food-borne illness.
(C) Strengthen oversight of food safety at the retail level.
(D) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards in food processing establishments, as part of a national strategy and plan to provide an adequate level of inspection and achieve compliance with safety standards in such establishments.
(E) Make more effective use of the Nation’s combined food safety resources to reduce the burden of food-borne illness.
(2) SURVEY- In preparation for development of the plan required by paragraph (3), the Administrator shall, not later than 1 year after the date of enactment of this part, complete a survey of State and local capacities, and needs for enhancement, with respect to–
(A) staffing levels and expertise available to perform food safety functions;
(B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;
(C) information systems to support data management and sharing of food safety information among State and local agencies and with counterparts at the Federal level;
(D) legal authorities of State and local agencies to support the roles of such agencies in a national food safety system; and
(E) organizational arrangements for managing and coordinating food safety activities.
(3) PLAN- Taking into account the goals established in paragraph (1), results from the survey required in paragraph (2), and consultations with State and local agencies and other food safety stakeholders, the Administrator shall, not later than 2 years after the date of enactment of this part, develop, publish, and begin implementation of a plan that includes the following elements:
(A) Criteria for assessing the adequacy of State and local capacity to perform food safety functions as part of a national food safety system.
(B) Priorities for enhancing the capacity of State and local agencies.
(C) Action plans for meeting the highest priority capacity needs, including budget requirements and financing plans that take into account Federal, State, and local resources.
(D) Improved coordination and information flow among Federal, State, and local agencies to strengthen food-borne illness surveillance, outbreak response, and investigation and to ensure that agencies at all levels have the information on origins and causes of food-borne illness that such agencies need to plan preventive measures.
(E) Integration of the inspection and compliance programs in food processing establishments of the Food Safety Administration and State and local agencies, including–
(i) joint planning and priority setting to ensure that the collective effort has the greatest possible impact on achieving compliance with food safety standards and reducing food-borne illness;
(ii) elimination of barriers to the free flow of information among the Food Safety Administration and State and local agencies with respect to inspection and compliance programs and integration of State and Federal inspection and laboratory data systems;
(iii) steps to expand, and ensure the vigor and consistency of, State inspection of processing establishments under contract to the Food Safety Administration; and
(iv) reliance by the Food Safety Administration on State inspection and food sample analyses in Federal enforcement activities.
(4) FOOD SAFETY CAPACITY BUILDING GRANTS- The Administrator shall make grants to State and local agencies to enhance State and local food safety capacity and programs and support achievement of the goals established in paragraph (1). In awarding such grants, the Administrator shall take into account the criteria and priorities established by the Administrator under paragraph (3).
(5) REPORT TO CONGRESS- Not later than 1 year after the date of enactment of this part, and on an annual basis thereafter, the Administrator shall submit to Congress a report that describes–
(A) progress made in implementing this section, including any obstacles to such implementation; and
(B) any legislative recommendations or additional resources needed for full implementation.
(f) Service Agreements-
(1) IN GENERAL- The Administrator may, under agreements entered into with Federal, State, or local agencies, use on a reimbursable basis or otherwise the qualified personnel and services of those agencies in carrying out this Act.
(2) TRAINING- Agreements with a State under this subsection shall provide for training of State employees.
(3) MAINTENANCE OF AGREEMENTS- The Administrator shall maintain any agreement described in paragraph (1) that is in effect on the day before the date of the enactment of this Act until the Administrator evaluates such agreement and determines whether to maintain or substitute such agreement.
(4) COMMISSIONING- Where necessary and appropriate to fulfill the provisions of this Act or other food safety law, the Administrator shall, as part of any service agreement, commission qualified State and local regulatory officials and inspectors to assist the Administrator in carrying out the food safety law and accord such commissioned officials and inspectors access to information in possession of the Administrator as if they were Federal employees.
SEC. 208. IMPORTS.
(a) In General- All imported food under this Act shall meet requirements for food safety, inspection, labeling, and consumer protection that are at least equal to those applicable to food grown, manufactured, processed, packed, or held for consumption in the United States.
(b) Certification System- Not later than 2 years after the date of the enactment of this Act, the Administrator shall establish a system under which food products offered for importation into the United States shall be certified by the accredited foreign government in the country of export or by an accredited certifying agent meeting all applicable standards under this section.
(1) Category 1, 2, and 3 food establishments shall secure certification of products from the accredited foreign government in the country where the products are produced and must enter the United States through ports designated by the Administrator.
(2) Category 4 and 5 food establishments shall be certified either by–
(A) the accredited foreign government in the country where the products are produced; or
(B) a certifying agent that has been accredited under subsection (c).
(3) Beginning not later than 5 years after the date of the enactment of this Act, food from category 4 and 5 food establishments that is not certified by an accredited entity described in subsection (c) shall not enter the United States except through ports of entry that are located in a metropolitan area with an accredited food testing laboratory.
(c) Certification Standard-
(1) IN GENERAL- A foreign government or third party agent requesting accreditation to certify food for entry into the United States shall demonstrate, in a manner determined appropriate by the Administrator, that food produced under the supervision of the foreign government or third party agent, respectively, can meet standards for food safety, inspection, labeling, and consumer protection that are at least equal to standards applicable to food produced in the United States.
(2) REQUEST BY FOREIGN GOVERNMENT- Prior to accrediting a foreign government, the Administrator shall–
(A) review and audit the food safety program of the requesting foreign government (including all statutes, regulations, and inspection authority); and
(B) determine that the exporting country–
(i) administers a food control program that requires food exporters to implement hazard control measures for physical, chemical, and biological contaminants;
(ii) ensures sanitary operations of facilities;
(iii) utilizes testing and verification programs; and
(iv) administers an effective enforcement program.
(3) REQUEST BY A CERTIFYING AGENT- Prior to accrediting a certifying agent, the Administrator shall–
(A) review the training and qualifications of auditors and other employees used by the agent;
(B) ensure that any such auditors have completed such training as may be required by the Administrator for the conduct of food safety inspections; and
(C) conduct reviews of internal systems and such other investigation as the Administrator deems necessary to determine that the certifying agent is capable of auditing food establishments–
(i) to assess the adequacy of systems and standards in use; and
(ii) to ensure that food approved by the agent for import to the United States meets the requirements of this Act.
(4) CERTIFICATION TO ACCOMPANY EACH SHIPMENT- As a condition of accrediting any foreign government or certifying agent, such government or agent shall agree to issue a written and electronic certification to accompany each shipment intended for import to the United States from any food establishment which the government or agent certifies, subject to requirements set forth by the Administrator.
(d) Audits; Inspections- Following any accreditation under subsection (c), the Administrator may at any time–
(1) conduct an on-site audit of any food establishment registered under section 202, with or without the certifying agent; or
(2) require a certifying agent to submit an onsite audit report and any other reports or documents which the agent requires as part of the audit process, including documentation that the food establishment is in compliance with registration requirements and prior notice requirements for food imported to the United States.
(e) Limitation- A foreign government or other certifying agent accredited by the Administrator to certify food for import to the United States under this section may certify only the food products or food categories for importation to the United States that are specified in the grant of accreditation.
(f) Withdrawal of Accreditation- The Administrator may withdraw accreditation from a foreign government or certifying agent–
(1) if food approved by the foreign government or certifying agent is linked to an outbreak of human illness;
(2) following an investigation and finding by the Administrator that the programs of the foreign government, or a foreign food establishment certified by the certifying agent, are no longer equal to those applied to food grown, manufactured, processed, packed, or held in the United States; or
(3) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements of this section.
(g) Renewal of Accreditation- The Administrator shall audit foreign governments and certifying agents whenever needed, but no less than once every 3 years, to ensure the continued compliance with the requirements set forth in this section. Renewal of accreditation shall occur following each satisfactory audit.
(h) Required Routine Inspection- The Administrator shall routinely inspect food before or at entry into the United States to ensure ongoing compliance with food safety law and where appropriate, as part of the audit of any certifying entity.
(i) Enforcement- The Administrator may–
(1) deny importation of food from any foreign country if the government of such country does not permit United States officials to enter the foreign country to conduct such audits and inspections as may be necessary to fulfill requirements under this section;
(2) deny importation of food from any foreign country or foreign food establishment that does not consent to a timely investigation by the Administration when food from that foreign country or foreign food establishment is linked to a food-borne illness outbreak or is otherwise found to be adulterated or misbranded;
(3) promulgate regulations to carry out the purposes of this section, including setting terms and conditions for the destruction of products that fail to meet the requirements of this Act; and
(4) establish such fees as are necessary to carry out the implementation of the accreditation and inspection programs required under this section.
(j) Detention and Seizure- Any food imported for consumption in the United States may be detained, seized, or condemned pursuant to section 402 or recalled pursuant to section 403.
(k) Certifying Agents- Entities eligible for accreditation as a certifying agent under subsection (c) may include–
(1) a State or regional food authority; or
(2) a foreign or domestic cooperative that aggregates the products of growers or processors for importation.
(l) Avoiding Conflicts of Interest With Certifying Agents-
(1) IN GENERAL- To be eligible for accreditation under subsection (c), a certifying agent shall–
(A) not be owned, managed, or controlled by any person that owns or operates an establishment whose products are to be certified by such agent;
(B) have procedures to ensure against the use, in carrying out audits of food establishments under this section, of any officer or employee of such agent that has a financial conflict of interest regarding an establishment whose products are to be certified by such agent; and
(C) annually make available to the Secretary, disclosures of the extent to which such agent, and the officers and employees of such agent, have maintained compliance with subparagraphs (A) and (B) relating to financial conflicts of interest.
(2) REGULATIONS- The Secretary shall promulgate regulations not later than 18 months after the date of the enactment of this Act to ensure that there are protections against conflicts of interest between a certifying agent and the establishments whose products are to be certified by such agent. Such regulations shall include–
(A) requiring that domestic audits performed under this section be unannounced;
(B) a structure, including timing and public disclosure, for fees paid by food establishments to certifying agents to decrease the potential for conflicts of interest; and
(C) appropriate limits on financial affiliations between a certifying agent and any person that owns or operates an establishment whose products are to be certified by such agent.
SEC. 209. RESOURCE PLAN.
(a) In General- The Administrator shall prepare and update annually a resource plan describing the resources required, in the best professional judgment of the Administrator, to develop and fully implement the national food safety program established under this Act.
(b) Contents of Plan- The resource plan shall–
(1) describe quantitatively the personnel, financial, and other resources required to carry out the inspection of food establishments under section 205 and other requirements of this Act;
(2) allocate inspection resources in a manner reflecting the distribution of risk and opportunities to reduce risk across the food supply to the extent feasible based on the best available information, and subject to section 205; and
(3) describe the personnel, facilities, equipment, and other resources needed to carry out inspection and other oversight activities, at a total resource level equal to at least 50 percent of the resources required to carry out inspections in food establishments under section 205 and food production facilities under section 206–
(A) in foreign establishments and production facilities; and
(B) at the point of importation.
(c) Grants- The resource plan shall include recommendations for funding to provide grants to States and local governments to carry out food safety activities and inspections of food establishments and food production facilities and include resources to audit such programs.
(d) Submission of Plan- The Administrator shall submit annually to the Committee on Appropriations of the Senate, the Committee on Appropriations of the House of Representatives, and other relevant committees of Congress, the resource plan required under this section.
SEC. 210. TRACEBACK REQUIREMENTS.
(a) In General- The Administrator, in order to protect the public health, shall establish a national traceability system that enables the Administrator to retrieve the history, use, and location of an article of food through all stages of its production, processing, and distribution.
(b) Applicability- Traceability requirements under this section shall apply to food from food production facilities, food establishments, and foreign food establishments.
(c) Requirements-
(1) STANDARDS- The Administrator shall establish standards for the type of information, format, and timeframe for food production facilities and food establishments to submit records to aid the Administrator in effectively retrieving the history, use, and location of an item of food.
(2) RULE OF CONSTRUCTION- Nothing in this section shall be construed as requiring the Administrator to prescribe a specific technology for the maintenance of records or labeling of food to carry out the requirements of this section.
(3) AVAILABILITY OF RECORDS FOR INSPECTION- Any records that are required by the Administrator under this section shall be available for inspection by the Administrator upon oral or written request.
(4) DEMONSTRATION OF ABILITY- The Administrator, during any inspection, may require a food establishment to demonstrate its ability to trace an item of food and submit the information in the format and timeframe required under paragraph (1).
(d) Relationship to Other Requirements-
(1) CONSISTENCY WITH EXISTING STATUTES AND REGULATIONS- To the extent possible, the Administrator should establish the national traceability system under this section to be consistent with existing statutes and regulations that require recordkeeping or labeling for identifying the origin or history of food or food animals.
(2) EXISTING LAWS- For purposes of this subsection, the Administrator should review the following:
(A) Country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).
(B) The Perishable Agricultural Commodities Act of 1930 (7 U.S.C. 499a-t).
(C) Country of origin labeling requirements of section 304 of the Tariff Act of 1930 (19 U.S.C. 1340).
(D) The National Animal Identification System as authorized by the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.).
(3) CERTAIN REQUIREMENTS- Nothing contained in this section prevents or interferes with implementation of the country of origin labeling requirements of subtitle D of the Agricultural Marketing Act of 1946 (7 U.S.C. 1638 et seq.).
SEC. 211. ACCREDITED LABORATORIES.
(a) Establishment of Program- The Administrator shall establish a program for accrediting laboratories to perform sampling and testing for purposes of this Act. Such program shall include–
(1) standards for appropriate sampling and analytical procedures;
(2) training and experience qualification levels for individuals who conduct sampling and analysis;
(3) annual onsite visits to audit the performance of an accredited laboratory; and
(4) such additional requirements as the Administrator determines to be appropriate.
(b) Requirements- To be accredited under this section, a laboratory shall–
(1) prepare and submit an application for accreditation to the Administrator;
(2) meet required tests and standards established by the Administrator; and
(3) comply with such terms and conditions as are determined necessary by the Administrator.
(c) Accrediting Bodies- The Administrator may approve State agencies or private, nonprofit entities as accrediting bodies to act on behalf of the Administrator in accrediting laboratories under this section. The Administrator shall–
(1) in making such approvals–
(A) oversee and review the performance of any accrediting body acting on behalf of the Administrator to ensure that such accrediting body is in compliance with the requirements of this section; and
(B) have the right to obtain from an accrediting body acting on behalf of the Administrator and from any laboratory that may be certified by such a body all records and materials that may be necessary for the oversight and review required by subparagraph (A);
(2) reevaluate accreditation bodies approved under paragraph (1) whenever–
(A) the Administrator determines a laboratory accredited by the accrediting body is no longer in compliance with this section;
(B) the Administrator determines the accrediting body is no longer in compliance with the requirements of this section; or
(C) no less than once every 5 years; and
(3) promptly revoke the approval of any accreditation body found not to be in compliance with the requirements of this section.
(d) Revocation of Accreditation- The Administrator shall revoke the accreditation of any laboratory that fails to meet the requirements this section.
TITLE III–RESEARCH AND EDUCATION
SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM.
(a) In General- The Administrator, acting in coordination with the Director of the Centers for Disease Control and Prevention and with food safety and research programs of the Department of Agriculture, shall–
(1) identify on an ongoing basis the priorities for collection of epidemiological data and for other food safety research and data collection that are most important to implementing the food safety law and reducing the public health burden of food-borne illness;
(2) have full access for purposes of implementing the food safety law to the applicable data and data systems of the Centers for Disease Control and Prevention, including data made available to the Centers by a State;
(3) provide appropriate support and input on the design and implementation by the Centers for Disease Control and Prevention and the States of an active surveillance system that provides information on the incidence and causes of food-borne illness which is timely, detailed, and representative of the population of the United States;
(4) based on data and information obtained from the Centers for Disease Control and Prevention, the States, and other sources, assess the incidence, distribution, public health impact, and causes of human illness in the United States associated with the consumption of food, and conduct research and analysis to devise effective and feasible interventions to reduce food-borne illness;
(5) maintain a state-of-the-art DNA matching system and epidemiological system dedicated to food-borne illness identification, outbreaks, and containment; and
(6) utilize surveillance data created by means of monitoring and statistical studies conducted as part of its own inspection.
(b) Public Health Sampling-
(1) IN GENERAL- Not later than 1 year after the enactment of this Act, the Administrator shall establish guidelines for a sampling system under which the Administrator shall take and analyze samples of food–
(A) to assist the Administrator in carrying out this Act; and
(B) to assess the nature, frequency of occurrence, and quantities of contaminants in food.
(2) REQUIREMENTS- The sampling system described in paragraph (1) shall provide–
(A) statistically valid monitoring, including market-based studies, on the nature, frequency of occurrence, and quantities of contaminants in food available to consumers; and
(B) at the request of the Administrator, such other information, including analysis of monitoring and verification samples, as the Administrator determines may be useful in assessing the occurrence of contaminants in food.
(c) Assessment of Health Hazards-
(1) IN GENERAL- Through the surveillance system and analyses referred to in subsection (a) and the sampling system described in subsection (b), the Administrator shall–
(A) rank food categories based on the hazard to human health presented by the food category and specific chemical and microbiological hazards associated with foods in those categories;
(B) identify appropriate industry and regulatory approaches to minimize hazards in the food supply; and
(C) assess the conditions affecting the likelihood that emerging pathogens and diseases, including zoonosis, will affect the safety of the food supply and possible strategies for minimizing the potential risk to public health associated with emerging pathogens and diseases.
(2) COMPONENTS OF ANALYSIS- The analysis under subsection (b)(1) may include–
(A) a comparison of the safety of commercial processing with the health hazards associated with food that is harvested for recreational or subsistence purposes and prepared noncommercially;
(B) a comparison of the safety of food that is domestically processed with the health hazards associated with food that is processed outside the United States;
(C) a description of contamination originating from handling practices that occur prior to or after the sale of food to consumers; and
(D) use of comparative risk assessments.
SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.
(a) Public Education-
(1) IN GENERAL- The Administrator, in cooperation with private and public organizations, including the cooperative extension services and building on the efforts of appropriate State and local entities, shall establish a national public education program on food safety.
(2) REQUIREMENTS- The program shall provide–
(A) information to the public regarding Federal standards and best practices, and promotion of public awareness and understanding of those standards and practices;
(B) information for health professionals–
(i) to improve diagnosis and treatment of food-related illness; and
(ii) to advise individuals at special risk for food-related illnesses; and
(C) such other information or advice, including on safe food handling practices, to consumers and other persons as the Administrator determines will promote the purposes of this Act.
(b) Health Advisories- The Administrator, in consultation with other Federal departments and agencies as the Administrator determines necessary, shall work with the States and other appropriate entities–
(1) to develop and distribute regional and national advisories concerning food safety;
(2) to develop standardized formats for written and broadcast advisories;
(3) to incorporate State and local advisories into the national public education program established under subsection (a); and
(4) to present prompt, specific information regarding food found to pose a threat to the public health, including by identifying the retailers and food establishments where such food has been sold.
SEC. 303. RESEARCH.
(a) In General- The Administrator shall conduct research to carry out this Act, including studies to–
(1) improve sanitation and food safety practices in the processing of food;
(2) develop improved techniques to monitor and inspect food;
(3) develop efficient, rapid, and sensitive methods to detect contaminants in food;
(4) determine the sources of contamination of contaminated food;
(5) develop food consumption data;
(6) identify ways that animal production techniques could improve the safety of the food supply;
(7) draw upon research and educational programs that exist at the State and local level;
(8) utilize the DNA matching system and other processes to identify and control pathogens;
(9) address common and emerging zoonotic diseases;
(10) develop methods to reduce or destroy harmful pathogens before, during, and after processing;
(11) analyze the incidence of antibiotic resistence as it pertains to the food supply and develop new methods to reduce the transfer of antibiotic resistance to humans; and
(12) conduct other research that supports the purposes of this Act.
(b) Contract Authority- The Administrator may enter into contracts and agreements with any State, university, Federal Government agency, or person to carry out this section.
SEC. 304. WORKING GROUP ON IMPROVING FOODBORNE ILLNESS SURVEILLANCE.
Not later than 180 days after the date of enactment of this Act, the Administrator shall establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, consumer organizations, and academia. Such working group shall provide the Administrator, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of food-borne illness surveillance, including advice and recommendations on–
(1) the priority needs of regulatory agencies, the food industry, and consumers for information and analysis on food-borne illness and its causes that can be used to prevent food-borne illness;
(2) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;
(3) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to food-borne illness surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;
(4) key barriers to improvement in food-borne illness surveillance and its utility for preventing food-borne illness at Federal, State, and local levels; and
(5) specific actions to reduce barriers to such improvement, implement the working group’s recommendations, with measurable objectives and timelines, and identification of resource and staffing needs.
SEC. 305. CAREER-SPANNING TRAINING FOR FOOD INSPECTORS.
(a) In General- The Administrator shall make a grant to an entity described in subsection (c) to provide training to Federal, State, and local food inspectors.
(b) Use of Funds- The Administrator may make a grant under this section to an applicant only if the applicant agrees to use the grant to provide regular, standardized, graduated, career-spanning training, based on a curriculum developed by the Association of Food and Drug Officials, to Federal, State, and local food inspectors.
(c) Eligible Entity- An entity described in this subsection is an entity that–
(1) is described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3));
(2) has the capability to train not less than 1,000 food inspectors per year; and
(3) offers both on-site and off-site training for food inspectors.
SEC. 306. FOOD-BORNE ILLNESS HEALTH REGISTRY.
(a) Purpose- The purpose of the registry under subsection (b) is to stimulate research on the trends, sources, health outcomes, and preventive strategies related to food-borne disease.
(b) Registry- For the purpose described in subsection (a), the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention, shall develop and maintain a registry, to be known as the Food-Borne Illness Health Registry, consisting of data on the trends, sources, health outcomes, and preventive strategies related to food-borne disease.
SEC. 307. STUDY ON FEDERAL RESOURCES.
Not later than one year after the date of the enactment of this Act, the Comptroller General of the United States shall complete a study on the Federal resources being dedicated to food-borne illness and food safety research and submit a report on the results of such study to the Congress.
TITLE IV–ENFORCEMENT
SEC. 401. PROHIBITED ACTS.
It is prohibited–
(1) to manufacture, introduce, deliver for introduction, or receive in interstate commerce any food that is adulterated, misbranded, or otherwise unsafe;
(2) to adulterate or misbrand any food in interstate commerce;
(3) for a food establishment or foreign food establishment to fail to register under section 202, or to operate without a valid registration;
(4) to refuse to permit access to a food establishment or food production facility for the inspection and copying of a record as required under sections 205(f) and 206(a);
(5) to fail to establish or maintain any record or to make any report as required under sections 205(f) and 206(b);
(6) to refuse to permit entry to or inspection of a food establishment as required under section 205;
(7) to fail to provide to the Administrator the results of testing or sampling of food, equipment, or material in contact with food, that is positive for any contaminant under section 205(f)(1)(B);
(8) to fail to comply with a provision, regulation, or order of the Administrator under section 202, 203, 204, 206, or 208;
(9) to slaughter an animal that is capable for use in whole or in part as human food at a food establishment processing any food for commerce, except in compliance with the food safety law;
(10) to transfer food in violation of an administrative detention order under section 402 or to remove or alter a required mark or label identifying the food as detained;
(11) to fail to comply with a recall or other order under section 403; or
(12) to otherwise violate the food safety law.
SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNATION.
(a) Administrative Detention of Food-
(1) EXPANDED AUTHORITY- The Administrator shall have authority under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) to administratively detain and seize any food regulated under this Act that the Administrator has reason to believe is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of the food safety law.
(2) DETENTION AUTHORITY- If, during an inspection conducted in accordance with section 205 or 208, an officer, employee, or agent of the Administration making the inspection has reason to believe that a domestic food, imported food, or food offered for import is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this the food safety law, the officer, employee, or agent may order the food detained.
(3) PERIOD OF DETENTION-
(A) IN GENERAL- A food may be detained under paragraph (1) or (2) for a reasonable period, not to exceed 20 days, unless a longer period, not to exceed 30 days, is necessary for the Administrator to institute a seizure action.
(B) PERISHABLE FOOD- The Administrator shall provide by regulation for procedures to institute a seizure action on an expedited basis with respect to perishable food.
(4) SECURITY OF DETAINED FOOD-
(A) IN GENERAL- A detention order under this subsection–
(i) may require that the food be labeled or marked as detained; and
(ii) shall require that the food be removed to a secure facility, if appropriate.
(B) FOOD SUBJECT TO AN ORDER- A food subject to a detention order under this subsection shall not be transferred by any person from the place at which the food is removed, until released by the Administrator or until the expiration of the detention period applicable under the order, whichever occurs first.
(C) DELIVERY OF FOOD- This subsection does not authorize the delivery of a food in accordance with execution of a bond while the article is subject to the order.
(b) Appeal of Detention Order-
(1) IN GENERAL- A person who would be entitled to be a claimant for a food subject to a detention order under subsection (a) if the food were seized under section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334), may appeal the order to the Administrator.
(2) ACTION BY THE ADMINISTRATOR- Not later than 5 days after an appeal is filed under paragraph (1), the Administrator, after providing an opportunity for an informal hearing, shall confirm, modify, or terminate the order involved.
(3) FINAL AGENCY ACTION- Confirmation, modification, or termination by the Administrator under paragraph (2) shall be considered a final agency action for purposes of section 702 of title 5, United States Code.
(4) TERMINATION- A detention order under subsection (a) shall be considered to be terminated if, after 5 days, the Administrator has failed–
(A) to provide an opportunity for an informal hearing; or
(B) to confirm, modify, or terminate the order.
(5) EFFECT OF INSTITUTING COURT ACTION- If the Administrator initiates an action under section 302 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 332) or section 304(a) of that Act (21 U.S.C. 334(a)) for a food subject to a detention order under subsection (a), the process for the appeal of the detention order with respect to such food shall terminate.
(c) Condemnation of Food-
(1) IN GENERAL- After confirming a detention order, the Administrator may order the food condemned.
(2) DESTRUCTION OF FOOD- Any food condemned shall be destroyed under the supervision of the Administrator.
(3) RELEASE OF FOOD- If the Administrator determines that, through reprocessing, relabeling, or other action, a detained food can be brought into compliance with this Act, the food may be released following a determination by the Administrator that the relabeling or other action as specified by the Administrator has been performed.
(d) Temporary Holds at Ports of Entry-
(1) IN GENERAL- If an officer or qualified employee of the Administration has reason to believe that a food is unsafe, is adulterated or misbranded, or otherwise fails to meet the requirements of this Act, and the officer or qualified employee is unable to inspect, examine, or investigate the food when the food is offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Homeland Security to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, to enable the Administrator to inspect or investigate the food as appropriate.
(2) REMOVAL TO SECURE FACILITY- The Administrator shall work in coordination with the Secretary of Homeland Security to remove a food held in accordance with paragraph (1) to a secure facility as appropriate.
(3) PROHIBITION ON TRANSFER- During the period in which food is held, the food shall not be transferred by any person from the port of entry into the United States, or from the secure facility to which the food has been removed.
(4) DELIVERY IN ACCORDANCE WITH A BOND- The delivery of the food in accordance with the execution of a bond while the food is held is not authorized.
(5) PROHIBITION ON REEXPORT- A food found unfit for human or animal consumption shall be prohibited from reexport without further processing to remove the contamination and reinspection by the Administration.
SEC. 403. NOTIFICATION AND RECALL.
(a) Notice to Administrator of Violation-
(1) IN GENERAL- A person that has reason to believe that any food introduced into or in interstate commerce, or held for sale (whether or not the first sale) after shipment in interstate commerce, may be in violation of the food safety law shall immediately notify the Administrator of the identity and location of the food.
(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Administrator may require by regulation.
(b) Recall and Consumer Notification-
(1) VOLUNTARY ACTIONS- If the Administrator determines that food is in violation of the food safety law when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce and that there is a reasonable probability that the food, if consumed, would present a threat to public health, as determined by the Administrator, the Administrator shall give the appropriate persons (including the manufacturers, importers, distributors, or retailers of the food) an opportunity to–
(A) cease distribution of the food;
(B) notify all persons–
(i) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
(ii) to which the food has been distributed, transported, or sold, to immediately cease distribution of the food;
(C) recall the food;
(D) in conjunction with the Administrator, provide notice of the finding of the Administrator–
(i) to consumers to whom the food was, or may have been, distributed; and
(ii) to State and local public health officials; or
(E) take any combination of the measures described in this paragraph, as determined by the Administrator to be appropriate in the circumstances.
(2) MANDATORY ACTIONS- If a person referred to in paragraph (1) refuses to or does not adequately carry out the actions described in that paragraph within the time period and in the manner prescribed by the Administrator, the Administrator shall–
(A) have authority to control and possess the food, including ordering the shipment of the food from the food establishment to the Administrator–
(i) at the expense of the food establishment; or
(ii) in an emergency (as determined by the Administrator), at the expense of the Administration; and
(B) by order, require, as the Administrator determines to be necessary, the person to immediately–
(i) cease distribution of the food; and
(ii) notify all persons–
(I) processing, distributing, or otherwise handling the food to immediately cease such activities with respect to the food; or
(II) if the food has been distributed, transported, or sold, to immediately cease distribution of the food.
(3) NOTIFICATION TO CONSUMERS BY ADMINISTRATOR- The Administrator shall, as the Administrator determines to be necessary–
(A) provide notice of the finding of the Administrator under paragraph (1)–
(i) to consumers to whom the food was, or may have been, distributed; and
(ii) to State and local public health officials; and
(B) provide notice to the public of the names and addresses of retail locations at which recalled food products were available for sale.
(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that processes, distributes, or otherwise handles the food, or to which the food has been distributed, transported, or sold, and that is notified under paragraph (1)(B) or (2)(B) shall immediately cease distribution of the food.
(5) AVAILABILITY OF RECORDS TO ADMINISTRATOR- Each person referred to in paragraph (1) that processed, distributed, or otherwise handled food shall make available to the Administrator information necessary to carry out this subsection, as determined by the Administrator, regarding–
(A) persons that processed, distributed, or otherwise handled the food; and
(B) persons to which the food has been transported, sold, distributed, or otherwise handled.
(c) Informal Hearings on Orders-
(1) IN GENERAL- The Administrator shall provide any person subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as practicable but not later than 2 business days after the issuance of the order.
(2) SCOPE OF THE HEARING- In a hearing under paragraph (1), the Administrator shall consider the actions required by the order and any reasons why the food that is the subject of the order should not be recalled.
(d) Post-Hearing Recall Orders-
(1) AMENDMENT OF ORDER- If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that there is a reasonable probability that the food that is the subject of an order under subsection (b), if consumed, would present a threat to the public health, the Administrator, as the Administrator determines to be necessary, may–
(A) amend the order to require recall of the food or other appropriate action;
(B) specify a timetable in which the recall shall occur;
(C) require periodic reports to the Administrator describing the progress of the recall; and
(D) provide notice of the recall to consumers to whom the food was, or may have been, distributed.
(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Administrator determines that adequate grounds do not exist to continue the actions required by the order, the Administrator shall vacate the order.
(e) Remedies Not Exclusive- The remedies provided in this section shall be in addition to, and not exclusive of, other remedies that may be available.
SEC. 404. INJUNCTION PROCEEDINGS.
(a) Jurisdiction- The district courts of the United States, and the United States courts of the territories and possessions of the United States, shall have jurisdiction, for cause shown, to restrain a violation of section 202, 203, 204, 208, or 401 (or a regulation promulgated thereunder).
(b) Trial- In a case in which violation of an injunction or restraining order issued under this section also constitutes a violation of the food safety law, trial shall be by the court or, upon demand of the accused, by a jury.
SEC. 405. CIVIL AND CRIMINAL PENALTIES.
(a) Civil Sanctions-
(1) CIVIL PENALTY-
(A) IN GENERAL- Any person that commits an act that violates the food safety law (including a regulation promulgated or order issued under the food safety law) may be assessed a civil penalty by the Administrator of not more than $1,000,000 for each such act.
(B) SEPARATE OFFENSE- Each act described in subparagraph (A) and each day during which that act continues shall be considered a separate offense.
(2) OTHER REQUIREMENTS-
(A) WRITTEN ORDER- The civil penalty described in paragraph (1) shall be assessed by the Administrator by a written order, which shall specify the amount of the penalty and the basis for the penalty under subparagraph (B) considered by the Administrator.
(B) AMOUNT OF PENALTY- Subject to paragraph (1)(A), the amount of the civil penalty shall be determined by the Administrator, after considering–
(i) the gravity of the violation;
(ii) the degree of culpability of the person;
(iii) the size and type of the business of the person; and
(iv) any history of prior offenses by the person under the food safety law.
(C) REVIEW OF ORDER- The order may be reviewed only in accordance with subsection (c).
(b) Criminal Sanctions-
(1) OFFENSE RESULTING IN SERIOUS ILLNESS- Notwithstanding section 303(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)), if a violation of any provision of section 301 of such Act (21 U.S.C. 301) with respect to an adulterated or misbranded food results in serious illness, the person committing the violation shall be imprisoned for not more than 5 years, fined in accordance with title 18, United States Code, or both.
(2) OFFENSE RESULTING IN DEATH- Notwithstanding section 303(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(a)), if a violation of any provision of section 301 of such Act (21 U.S.C. 331) with respect to an adulterated or misbranded food results in death, the person committing the violation shall be imprisoned for not more than 10 years, fined in accordance with title 18, United States Code, or both.
(c) Judicial Review-
(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be a final order unless the person–
(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in the United States court of appeals for the circuit in which that person resides or has its principal place of business or the United States Court of Appeals for the District of Columbia; and
(B) simultaneously serves a copy of the petition by certified mail to the Administrator.
(2) FILING OF RECORD- Not later than 45 days after the service of a copy of the petition under paragraph (1)(B), the Administrator shall file in the court a certified copy of the administrative record upon which the order was issued.
(3) STANDARD OF REVIEW- The findings of the Administrator relating to the order shall be set aside only if found to be unsupported by substantial evidence on the record as a whole.
(d) Collection Actions for Failure To Pay-
(1) IN GENERAL- If any person fails to pay a civil penalty assessed under subsection (a) after the order assessing the penalty has become a final order, or after the court of appeals described in subsection (b) has entered final judgment in favor of the Administrator, the Administrator shall refer the matter to the Attorney General, who shall institute in a United States district court of competent jurisdiction a civil action to recover the amount assessed.
(2) LIMITATION ON REVIEW- In a civil action under paragraph (1), the validity and appropriateness of the order of the Administrator assessing the civil penalty shall not be subject to judicial review.
(e) Penalties Paid Into Account- The Administrator–
(1) shall deposit penalties collected under this section in an account in the Treasury; and
(2) may use the funds in the account, without further appropriation or fiscal year limitation–
(A) to carry out enforcement activities under the food safety law; or
(B) to provide assistance to States to inspect retail commercial food establishments or other food or firms under the jurisdiction of State food safety programs.
(f) Discretion of the Administrator To Prosecute- Nothing in this Act requires the Administrator to report for prosecution, or for the commencement of an action, the violation of the food safety law in a case in which the Administrator finds that the public interest will be adequately served by the assessment of a civil penalty under this section.
(g) Remedies Not Exclusive- The remedies provided in this section are in addition to, and not exclusive of, other remedies that may be available.
SEC. 406. PRESUMPTION.
In any action to enforce the requirements of the food safety law, the connection with interstate commerce required for jurisdiction shall be presumed to exist.
SEC. 407. WHISTLEBLOWER PROTECTION.
(a) In General-
(1) PROHIBITION- No Federal employee, employee of a Federal contractor or subcontractor, or covered individual may be discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against, because of any lawful act done by the employee or covered individual to–
(A) provide information, cause information to be provided, or otherwise assist in an investigation regarding any conduct that the covered individual reasonably believes constitutes a violation of any law, rule, or regulation, or that the covered individual reasonably believes constitutes a threat to the public health, when the information or assistance is provided to, or the investigation is conducted by–
(i) a Federal regulatory or law enforcement agency;
(ii) a Member or committee of Congress; or
(iii) a person with supervisory authority over the covered individual (or such other individual who has the authority to investigate, discover, or terminate misconduct);
(B) file, cause to be filed, testify, participate in, or otherwise assist in a proceeding or action filed or about to be filed relating to a violation of any law, rule, or regulation; or
(C) refused to violate or assist in the violation of any law, rule, or regulation.
(2) DEFINITION- For the purposes of this section, the term ‘covered individual’ means an individual who is an employee of–
(A) a food establishment;
(B) a food production facility;
(C) a restaurant;
(D) a retail food establishment other than a restaurant;
(E) a nonprofit food establishment in which food is prepared for or served directly to the consumer;
(F) a fishing vessel; or
(G) an agent of any of the above.
(b) Enforcement Action-
(1) IN GENERAL- A covered individual who alleges discharge or other discrimination by any person in violation of subsection (a) may seek relief under subsection (c) by filing a complaint with the Secretary of Labor. If the Secretary of Labor has not issued a final decision within 180 days after the date on which the complaint is filed and there is no showing that such delay is due to the bad faith of the claimant, the claimant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which shall have jurisdiction over such an action without regard to the amount in controversy.
(2) PROCEDURE-
(A) IN GENERAL- An action under paragraph (1) shall be governed under the rules and procedures set forth in section 42121(b) of title 49, United States Code.
(B) EXCEPTION- Notification under section 42121(b)(1) of title 49, United States Code, shall be made to the person named in the complaint and to the person’s employer.
(C) BURDENS OF PROOF- An action brought under paragraph (1) shall be governed by the legal burdens of proof set forth in section 42121(b) of title 49, United States Code.
(D) STATUTE OF LIMITATIONS- An action under paragraph (1) shall be commenced not later than 90 days after the date on which the violation occurs.
(c) Remedies-
(1) IN GENERAL- A covered individual prevailing in any action under subsection (b)(1) shall be entitled to all relief necessary to make the covered individual whole.
(2) COMPENSATORY DAMAGES- Relief for any action described in paragraph (1) shall include–
(A) reinstatement with the same seniority status that the covered individual would have had, but for the discrimination;
(B) the amount of any back pay, with interest; and
(C) compensation for any special damages sustained as a result of the discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.
(d) Rights Retained by the Covered Individual- Nothing in this section shall be construed to diminish the rights, privileges, or remedies of any covered individual under any Federal or State law, or under any collective bargaining agreement.
SEC. 408. ADMINISTRATION AND ENFORCEMENT.
(a) In General- For the efficient administration and enforcement of the food safety law, the provisions (including provisions relating to penalties) of sections 6, 8, 9, and 10 of the Federal Trade Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) through (h) of section 6 of that Act), relating to the jurisdiction, powers, and duties of the Federal Trade Commission and the Attorney General to administer and enforce that Act, and to the rights and duties of persons with respect to whom the powers are exercised, shall apply to the jurisdiction, powers, and duties of the Administrator and the Attorney General in administering and enforcing the provisions of the food safety law and to the rights and duties of persons with respect to whom the powers are exercised, respectively.
(b) Inquiries and Actions-
(1) IN GENERAL- The Administrator, in person or by such agents as the Administrator may designate, may prosecute any inquiry necessary to carry out the duties of the Administrator under the food safety law in any part of the United States.
(2) POWERS- The powers conferred by sections 9 and 10 of the Federal Trade Commission Act (15 U.S.C. 49 and 50) on the United States district courts may be exercised for the purposes of this chapter by any United States district court of competent jurisdiction.
SEC. 409. CITIZEN CIVIL ACTIONS.
(a) Civil Actions- A person may commence a civil action against–
(1) a person that violates a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator to ensure the safety of food; or
(2) the Administrator (in his or her capacity as the Administrator), if the Administrator fails to perform an act or duty to ensure the safety of food that is not discretionary under the food safety law.
(b) Court- In an action commenced under this section:
(1) IN GENERAL- The action shall be commenced–
(A) in the case of a civil action against a person, the United States district court for the district in which the defendant resides, is found, or has an agent; and
(B) in the case of a civil action against the Administrator, any United States district court.
(2) JURISDICTION- The court shall have jurisdiction, without regard to the amount in controversy, or the citizenship of the parties, to enforce a regulation (including a regulation establishing a performance standard), order, or other action of the Administrator, or to order the Administrator to perform the act or duty.
(3) DAMAGES- The court may–
(A) award damages, in the amount of damages actually sustained; and
(B) if the court determines it to be in the interest of justice, award the plaintiff the costs of suit, including reasonable attorney’s fees, reasonable expert witness fees, and penalties.
(c) Remedies Not Exclusive- The remedies provided for in this section shall be in addition to, and not exclusive of, other remedies that may be available.
TITLE V–IMPLEMENTATION
SEC. 501. REORGANIZATION PLAN.
(a) Submission of Plan- Not later than 180 days after the enactment of this Act, the President shall transmit to the appropriate congressional committees a reorganization plan regarding the following:
(1) The transfer of agencies, personnel, assets, and obligations to the Administration pursuant to this Act.
(2) Any consolidation, reorganization, or streamlining of agencies transferred to the Administration pursuant to this Act.
(b) Plan Elements- The plan transmitted under subsection (a) shall contain, consistent with this Act, such elements as the President determines appropriate, including the following:
(1) The timetable for transfer and identification of any functions of agencies designated to be transferred to the Administration pursuant to this Act that will not be transferred promptly to the Administration under the plan.
(2) Specification of the steps to be taken by the Administrator to organize the Administration, including the delegation or assignment of functions transferred to the Administration among the officers of the Administration in order to permit the Administration to carry out the functions transferred under the plan.
(3) Specification of the funds available to each agency that will be transferred to the Administration as a result of transfers under the plan.
(4) Specification of the proposed allocations within the Administration of unexpended funds transferred in connection with transfers under the plan.
(5) Specification of any proposed disposition of property, facilities, contracts, records, and other assets and obligations of agencies transferred under the plan.
(6) Specification of the proposed allocations within the Administration of the functions of the agencies and subdivisions that are not related directly to ensuring the safety of food.
(c) Modification of Plan- The President may, on the basis of consultations with the appropriate congressional committees, modify or revise any part of the plan until that part of the plan becomes effective in accordance with subsection (d).
(d) Effective Date-
(1) IN GENERAL- The reorganization plan described in this section, including any modifications or revisions of the plan under subsection (c), shall become effective for an agency on the earlier of–
(A) the date specified in the plan (or the plan as modified pursuant to subsection (c)), except that such date may not be earlier than 90 days after the date the President has transmitted the reorganization plan to the appropriate congressional committees pursuant to subsection (a); or
(B) the end of the 12-month period beginning on the date of the enactment of this Act.
(2) STATUTORY CONSTRUCTION- Nothing in this subsection may be construed to require the transfer of functions, personnel, records, balances of appropriations, or other assets of an agency on a single date.
(3) SUPERSEDES EXISTING LAW- Paragraph (1) shall apply notwithstanding section 905(b) of title 5, United States Code.
SEC. 502. TRANSITIONAL AUTHORITIES.
(a) Provision of Assistance by Officials- Until the transfer of an agency to the Administration, any official having authority over or function relating to the agency immediately before the date of the enactment of this Act shall provide the Administrator such assistance, including the use of personnel and assets, as the Administrator may request in preparing for the transfer and integration of the agency to the Administration.
(b) Services and Personnel- During the transition period, upon the request of the Administrator, the head of any executive agency may provide services or detail personnel to assist with the transition.
(c) Acting Officials-
(1) IN GENERAL- During the transition period, pending the advice and consent of the Senate to the appointment of an officer required by this Act to be appointed by and with such advice and consent, the President may designate any officer whose appointment was required to be made by and with such advice and consent and who was such an officer immediately before the date of the enactment of this Act (and who continues to be in office) or immediately before such designation, to act in such office until the same is filled as provided in this Act.
(2) COMPENSATION- While acting pursuant to paragraph (1), such officers shall receive compensation at the higher of–
(A) the rates provided by this Act for the respective offices in which they act; or
(B) the rates provided for the offices held at the time of designation.
(3) LIMITATION- Nothing in this Act shall be construed to require the advice and consent of the Senate to the appointment by the President to a position in the Administration of any officer whose agency is transferred to the Administration pursuant to this Act and whose duties following such transfer are germane to those performed before such transfer.
(d) Transfer of Personnel, Assets, Obligations, and Function-
(1) IN GENERAL- Consistent with section 1531 of title 31, United States Code, the personnel, assets, liabilities, contracts, property, records, and unexpended balances of appropriations, authorizations, allocations, and other funds that relate to the functions transferred under subsection (a) from a Federal agency shall be transferred to the Administration.
(2) UNEXPENDED FUNDS- Unexpended funds transferred under this subsection shall be used by the Administration only for the purposes for which the funds were originally authorized and appropriated.
SEC. 503. SAVINGS PROVISIONS.
(a) Completed Administrative Actions- The enactment of this Act or the transfer of functions under this Act shall not affect any order, determination, rule, regulation, tolerance, guidance, permit, personnel action, agreement, grant, contract, certificate, license, registration, user fees, privilege, or other administrative action issued, made, granted, or otherwise in effect or final with respect to that agency on the day before the transfer date with respect to the transferred functions.
(b) Pending Proceedings- Subject to the authority of the Administrator under this Act–
(1) pending proceedings in an agency, including notices of proposed rulemaking, and applications for licenses, permits, certificates, grants, and financial assistance, shall continue notwithstanding the enactment of this Act or the transfer of the agency to the Administration, unless discontinued or modified under the same terms and conditions and to the same extent that such discontinuance or modification could have occurred if such enactment or transfer had not occurred; and
(2) orders issued in such proceedings, and appeals therefrom, and payments made pursuant to such orders, shall issue in the same manner on the same terms as if this Act had not been enacted or the agency had not been transferred, and any such order shall continue in effect until amended, modified, superseded, terminated, set aside, or revoked by an officer of the United States or a court of competent jurisdiction, or by operation of law.
(c) Pending Civil Actions- Subject to the authority of the Administrator under this Act, any civil action commenced with regard to that agency pending before that agency on the day before the transfer date with respect to the transferred functions shall continue notwithstanding the enactment of this Act or the transfer of an agency to the Administration.
(d) References-
(1) IN GENERAL- After the transfer of functions from a Federal agency under this Act, any reference in any other Federal law, Executive order, rule, regulation, directive, document, or other material to that Federal agency or the head of that agency in connection with the administration or enforcement of the food safety law shall be deemed to be a reference to the Administration or the Administrator, respectively.
(2) STATUTORY REPORTING REQUIREMENTS- Statutory reporting requirements that applied in relation to such an agency immediately before the date of the enactment of this Act shall continue to apply following such transfer if they refer to the agency by name.
SEC. 504. CONFORMING AMENDMENTS.
(a) Executive Schedule- Section 5313 of title 5, United States Code, is amended by inserting at the end the following new item: ‘Administrator of Food Safety.’.
SEC. 505. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.
Not later than 60 days after the submission of the reorganization plan under section 501, the President shall prepare and submit proposed legislation to Congress containing necessary and appropriate technical and conforming amendments to the Acts listed in section 3(15) of this Act to reflect the changes made by this Act.
SEC. 506. REGULATIONS.
The Administrator may promulgate such regulations as the Administrator determines are necessary or appropriate to perform the duties of the Administrator.
SEC. 507. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated such sums as are necessary to carry out this Act.
SEC. 508. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.
For the fiscal year that includes the date of the enactment of this Act, the amount authorized to be appropriated to carry out this Act shall not exceed–
(1) the amount appropriated for that fiscal year for the Federal agencies identified in section 102(b) for the purpose of administering or enforcing the food safety law; or
(2) the amount appropriated for those agencies for that purpose for the preceding fiscal year, if, as of the date of the enactment of this Act, appropriations for those agencies for the fiscal year that includes such date have not yet been made.
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Text of S. 425: Food Safety and Tracking Improvement Act
S 425 IS
111th CONGRESS
1st Session
S. 425
To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.
IN THE SENATE OF THE UNITED STATES
February 12, 2009
Mr. BROWN introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a traceability system for food, to amend the Federal Meat Inspection Act, the Poultry Products Inspections Act, the Egg Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act to provide for improved public health and food safety through enhanced enforcement, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the Food Safety and Tracking Improvement Act.
(b) Table of Contents- The table of contents for this Act is as follows:
TITLE II–ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD
TITLE I–TRACEABILITY OF FOOD
SEC. 101. TRACEABILITY OF FOOD.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended–
(1) in section 301, by inserting at the end the following:
‘(oo) The failure to comply with any requirement of section 414A (relating to the traceability of food).’; and
(2) in chapter IV, by inserting after section 414 the following:
‘SEC. 414A. TRACEABILITY OF FOOD.
‘(a) Establishment of System- Not later than 3 years after the date of the enactment of this section, the Secretary shall establish a traceability system described in subsection (b) for all stages of manufacturing, processing, packaging, and distribution of food.
‘(b) Description of System- The traceability system required by subsection (a) shall require each article of food shipped in interstate commerce to be identified in a manner that enables the Secretary to retrieve the history, use, and location of the article through a recordkeeping and audit system, a secure, online database, or registered identification.
‘(c) Records-
‘(1) IN GENERAL- The Secretary may require that each person required to identify an article of food pursuant to subsection (b) maintain accurate records, as prescribed by the Secretary, regarding the purchase, sale, and identification of the article.
‘(2) ACCESS- Each person described in paragraph (1) shall, at all reasonable times, on notice by a duly authorized representative of the Secretary, allow the representative to access each place of business of the person to examine and copy the records described in paragraph (1).
‘(3) DURATION- Each person described in paragraph (1) shall maintain records as required under this subsection for such period of time as the Secretary prescribes.
‘(d) False Information- No person shall falsify or misrepresent to any other person or to the Secretary, any information as to any location at which any article of food was held.
‘(e) Alteration or Destruction of Records- No person shall, without authorization from the Secretary, alter, detach, or destroy any records or other means of identification prescribed by the Secretary for use in determining the location at which any article of food was held.
‘(f) Advisory Committee-
‘(1) IN GENERAL- In order to assist the Secretary in implementing the traceability system under subsection (a), the Secretary shall convene an advisory committee (referred to in this subsection as the ‘Committee’).
‘(2) MEMBERSHIP- The Committee shall consist of 13 members appointed by the Secretary which shall include–
‘(A) an equitable number of food safety and tracking technology experts, representatives of the food industry, and consumer advocates; and
‘(B) officials from the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs of the Food and Drug Administration and the Agriculture Marketing Service of the Department of Agriculture.
‘(3) CHAIRPERSON- The Secretary shall appoint a Chairperson of the Committee.
‘(4) MEETING- The Committee shall convene not later than 180 days after the date of enactment of this section and periodically thereafter at the call of the Chairperson.
‘(5) REPORT OF COMMITTEE-
‘(A) IN GENERAL- Not later than 1 year after the date of enactment of this section, the Committee shall submit to the Secretary and the Office of the Commissioner a report that describes the recommendations regarding the most practicable approach to providing for the traceability of food, including the most efficient means of implementing the traceback of contaminated foods.
‘(B) CONSIDERATIONS- In developing the report under subparagraph (A), the Committee shall consider the following approaches to providing for the traceability of food:
‘(i) A national database or registry operated by the Food and Drug Administration.
‘(ii) Electronic records identifying each prior sale, purchase, or trade of the food and its ingredients, and establishing that the food and its ingredients were grown, prepared, handled, manufactured, processed, distributed, shipped, warehoused, imported, and conveyed under conditions that ensure the safety of the food. The records should include an electronic statement with the date of, and the names and addresses of all parties to, each prior sale, purchase, or trade, and any other information as appropriate.
‘(iii) Standardized tracking numbers on all shipments. These numbers would identify the country of origin, the unique facility registration number, date of production, and lot number (if applicable).
‘(iv) Recall performance standards for each food or commodity type.
‘(v) Safeguards for the combining, repacking, or otherwise mixing of items of food, particularly fresh produce.
‘(vi) Other approaches that enable the reliable tracking of food and food products.
‘(g) Authorization of Appropriations- For the purpose of carrying out this section, there is authorized to be appropriated $40,000,000 for the period of fiscal years 2010 through 2012.’.
TITLE II–ENFORCEMENT AND RECALL FOR MEAT, POULTRY, AND FOOD
SEC. 201. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT FOOD PRODUCTS.
(a) In General- The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended–
(1) by redesignating section 411 (21 U.S.C. 680) as section 414; and
(2) by inserting after section 410 (21 U.S.C. 679a) the following:
‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any carcass, part of a carcass, meat, or meat food product of an amenable species (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity–
‘(A) to cease distribution of the article;
‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local public health officials.
‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.
‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding–
‘(A) persons that transport, store, distribute, or otherwise handle the article; and
‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
‘(c) Informal Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall;
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed; or
‘(D) take any combination of actions described in subparagraphs (A) through (C).
‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 412. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.
‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under title I with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 401), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).
‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under title I, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.
‘(c) Judicial Review-
‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection–
‘(A) files a petition for judicial review of the order; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.
‘(3) VENUE; RECORD- Judicial review of the order shall be–
‘(A) in–
‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) on the record on which the determination and order are based.
‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 413. CIVIL PENALTIES.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 411 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.
‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person under this Act; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under title I of the person until the civil penalty is paid or until the Secretary directs otherwise.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 411 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
(b) Conforming Amendments-
(1) Section 1 of the Federal Meat Inspection Act (21 U.S.C. 601) is amended by adding at the end the following:
‘(x) Person- The term ‘person’ means any individual, partnership, corporation, association, or other business unit.’.
(2) The Federal Meat Inspection Act (21 U.S.C. 601 et seq.) is amended–
(A) by striking ‘person, firm, or corporation’ each place it appears and inserting ‘person’;
(B) by striking ‘persons, firms, and corporations’ each place it appears and inserting ‘persons’; and
(C) by striking ‘persons, firms, or corporations’ each place it appears and inserting ‘persons’.
SEC. 202. FOOD SAFETY ENFORCEMENT FOR POULTRY AND POULTRY FOOD PRODUCTS.
(a) In General- The Poultry Products Inspection Act (21 U.S.C. 451 et seq.) is amended by adding at the end the following:
‘SEC. 32. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any poultry or poultry product (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity–
‘(A) to cease distribution of the article;
‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.
‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.
‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding–
‘(A) persons that transport, store, distribute, or otherwise handle the article; and
‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
‘(c) Informal Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall; or
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 33. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.
‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18(a)), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).
‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.
‘(c) Judicial Review-
‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection–
‘(A) files a petition for judicial review of the order; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.
‘(3) VENUE; RECORD- Judicial review of the order shall be–
‘(A) in–
‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) on the record on which the determination and order are based.
‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 34. CIVIL PENALTIES.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 32 (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.
‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person under this Act; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 32 in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
(b) Conforming Amendments- Section 5(c)(1) of the Poultry Products Inspection Act (21 U.S.C. 454(c)(1)) is amended in the first sentence–
(1) by striking ‘, by thirty days prior to the expiration of two years after enactment of the Wholesome Poultry Products Act,’; and
(2) by striking ‘sections 1-4, 6-10, and 12-22 of this Act’ and inserting ‘sections 1 through 4, 6 through 10, 12 through 22, and 32 through 34’; and
SEC. 203. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.
The Egg Products Inspection Act is amended by inserting after section 20 (21 U.S.C. 1049) the following:
‘SEC. 20A. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED EGGS AND EGG PRODUCTS.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer) that has reason to believe that any egg or egg product (referred to in this section as an ‘article’) transported, stored, distributed, or otherwise handled by the person is adulterated or misbranded shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article is adulterated or misbranded and that there is a reasonable probability that human consumption of the article would present a threat to public health (as determined by the Secretary), the Secretary shall provide all appropriate persons (as determined by the Secretary), that transported, stored, distributed, or otherwise handled the article with an opportunity–
‘(A) to cease distribution of the article;
‘(B) to notify all persons that transport, store, distribute, or otherwise handle the article, or to which the article has been transported, sold, distributed, or otherwise handled, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.
‘(4) NONDISTRIBUTION BY NOTIFIED PERSONS- A person that transports, stores, distributes, or otherwise handles the article, or to which the article has been transported, sold, distributed, or otherwise handled, and that is notified under paragraph (1)(B) or (2)(B) shall cease immediately distribution of the article.
‘(5) AVAILABILITY OF RECORDS TO SECRETARY- Each appropriate person referred to in paragraph (1) that transported, stored, distributed, or otherwise handled an article shall make available to the Secretary information necessary to carry out this subsection, as determined by the Secretary, regarding–
‘(A) persons that transport, store, distribute, or otherwise handle the article; and
‘(B) persons to which the article has been transported, sold, distributed, or otherwise handled.
‘(c) Informal Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for an informal hearing (in accordance with such rules or regulations as the Secretary shall prescribe) on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that there is a reasonable probability that human consumption of the article that is the subject of an order under subsection (b) presents a threat to public health, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall; or
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
‘(2) VACATION OF ORDERS- If, after providing an opportunity for an informal hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 20B. REFUSAL OR WITHDRAWAL OF INSPECTION OF ESTABLISHMENTS.
‘(a) In General- The Secretary may, for such period, or indefinitely, as the Secretary considers necessary to carry out this Act, refuse to provide or withdraw inspection under this Act with respect to an establishment if the Secretary determines, after opportunity for a hearing on the record is provided to the applicant for, or recipient of, inspection, that the applicant or recipient, or any person responsibly connected with the applicant or recipient (within the meaning of section 18), has committed a willful violation or repeated violations of this Act (including a regulation promulgated under this Act).
‘(b) Denial or Suspension of Inspection Pending Hearing- The Secretary may deny or suspend inspection under this Act, pending opportunity for an expedited hearing, with respect to an action under subsection (a), if the Secretary determines that the denial or suspension is in the public interest to protect the health or welfare of consumers or to ensure the effective performance of an official duty under this Act.
‘(c) Judicial Review-
‘(1) IN GENERAL- A determination and order of the Secretary with respect to the refusal or withdrawal of inspection under this section shall be final unless, not later than 30 days after the effective date of the order, the affected applicant for, or recipient of, inspection–
‘(A) files a petition for judicial review of the order; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) REFUSAL OR WITHDRAWAL OF INSPECTION PENDING REVIEW- Inspection shall be refused or withdrawn as of the effective date of the order pending any judicial review of the order unless the Secretary directs otherwise.
‘(3) VENUE; RECORD- Judicial review of the order shall be–
‘(A) in–
‘(i) the United States court of appeals for the circuit in which the applicant for, or recipient of, inspection resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) on the record on which the determination and order are based.
‘(d) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 20C. CIVIL PENALTIES.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that violates section 20A (including a regulation promulgated or order issued under that section) a civil penalty for each violation of not more than $100,000.
‘(2) SEPARATE OFFENSES- Each violation and each day during which the violation continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person under this Act; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary shall refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Refusal or Withdrawal of Inspection Pending Payment- If a person fails to pay the amount of a civil penalty after the order assessing the civil penalty has become a final order, the Secretary may refuse to provide or withdraw inspection under this Act of the person until the civil penalty is paid or until the Secretary directs otherwise.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of an action, any violation of section 20A in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
SEC. 204. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.
(a) Prohibited Acts- Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
‘(pp)(1) The failure to notify the Secretary in violation of section 311(a).
‘(2) The failure to comply with–
‘(A) an order issued under section 311(b) following any hearing requested under section 311(c); or
‘(B) an amended order issued under section 311(d)(1).’.
(b) Notification, Nondistribution, and Recall of Adulterated or Misbranded Articles of Food; Civil Penalties Relating to Foods- Chapter III of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 et seq.) is amended by adding at the end the following:
‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD.
‘(a) Notification to Secretary of Violation-
‘(1) IN GENERAL- A person (other than a household consumer or other individual who is the intended consumer of an article of food) that has reason to believe that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury shall, as soon as practicable, notify the Secretary of the identity and location of the article.
‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation.
‘(b) Recall and Consumer Notification-
‘(1) VOLUNTARY ACTIONS- On receiving notification under subsection (a) or by other means, if the Secretary finds that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury (as determined by the Secretary), the Secretary shall provide all appropriate persons (including the manufacturer, importer, distributor, or retailer of the article) with an opportunity (as determined by the Secretary)–
‘(A) to cease distribution of the article;
‘(B) to notify all persons–
‘(i) that produce, manufacture, pack, process, prepare, treat, package, distribute, or hold the article, to cease immediately those activities with respect to the article; or
‘(ii) to which the article has been distributed, transported, or sold, to cease immediately distribution of the article;
‘(C) to recall the article;
‘(D) in consultation with the Secretary, to provide notice of the finding of the Secretary to all consumers to which the article was, or may have been, distributed and to appropriate State and local health officials; or
‘(E) to notify State and local public health officials.
‘(2) MANDATORY ACTIONS- If the appropriate person referred to in paragraph (1) does not carry out the actions described in that paragraph with respect to an article within the time period and in the manner prescribed by the Secretary, the Secretary–
‘(A) shall require the person–
‘(i) to immediately cease distribution of the article; and
‘(ii) to immediately make the notification described in paragraph (1)(B); and
‘(B) may take control or possession of the article.
‘(3) NOTICE TO CONSUMERS AND HEALTH OFFICIALS- The Secretary shall, as the Secretary determines to be necessary, provide notice of the finding of the Secretary under paragraph (1) to consumers to which the article was, or may have been, distributed and to appropriate State and local health officials.
‘(c) Hearings on Orders-
‘(1) IN GENERAL- The Secretary shall provide a person subject to an order under subsection (b) with an opportunity for a hearing on–
‘(A) the actions required by the order; and
‘(B) any reasons why the article of food that is the subject of the order should not be recalled.
‘(2) TIMING OF HEARINGS- The Secretary shall hold a hearing under paragraph (1) as soon as practicable, but not later than 2 business days, after the date of issuance of the order.
‘(d) Post-Hearing Recall Orders-
‘(1) AMENDMENT OF ORDERS- If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that, if consumed, may result in illness or injury, the Secretary may, as the Secretary determines to be necessary–
‘(A) amend the order under subsection (b)–
‘(i) to require recall of the article or other appropriate action; and
‘(ii) to specify a timetable during which the recall shall occur;
‘(B) require periodic reports to the Secretary describing the progress of the recall; or
‘(C) provide notice of the recall to consumers to which the article was, or may have been, distributed.
‘(2) VACATION OF ORDERS- If, after providing an opportunity for a hearing under subsection (c), the Secretary determines that adequate grounds do not exist to continue the actions required by the order, the Secretary shall vacate the order.
‘(e) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.
‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS.
‘(a) In General-
‘(1) ASSESSMENT- The Secretary may assess against a person that commits an act prohibited by section 301(pp) a civil penalty for each such act of not more than–
‘(A) $100,000, in the case of an individual; and
‘(B) $500,000, in the case of any other person.
‘(2) SEPARATE OFFENSES- Each prohibited act and each day during which the act continues shall be considered to be a separate offense.
‘(3) NOTICE AND OPPORTUNITY FOR HEARING- The Secretary shall not assess a civil penalty under this section against a person unless the person is given notice and opportunity for a hearing on the record before the Secretary in accordance with sections 554 and 556 of title 5, United States Code.
‘(4) DETERMINATION OF CIVIL PENALTY AMOUNT- The amount of a civil penalty under this section–
‘(A) shall be assessed by the Secretary by written order, taking into account–
‘(i) the gravity of the violation;
‘(ii) the degree of culpability of the person;
‘(iii) the size and type of the business of the person; and
‘(iv) any history of prior offenses by the person; and
‘(B) shall be reviewed only in accordance with subsection (b).
‘(b) Judicial Review-
‘(1) IN GENERAL- An order assessing a civil penalty against a person under subsection (a) shall be final unless the person–
‘(A) not later than 30 days after the effective date of the order, files a petition for judicial review of the order in–
‘(i) the United States court of appeals for the circuit in which the person resides or has its principal place of business; or
‘(ii) the United States Court of Appeals for the District of Columbia Circuit; and
‘(B) simultaneously sends a copy of the petition by certified mail to the Secretary.
‘(2) FILING OF COPY OF RECORD- The Secretary shall promptly file in the court a certified copy of the record on which the order was issued.
‘(3) STANDARD OF REVIEW- The findings of the Secretary relating to the order shall be set aside only if the findings are found to be unsupported by substantial evidence on the record as a whole.
‘(c) Collection Actions for Failure To Pay Assessment-
‘(1) REFERRAL TO ATTORNEY GENERAL- If a person fails to pay a civil penalty assessed under subsection (a) after the order assessing the civil penalty has become a final order, or after the court of appeals has entered final judgment in favor of the Secretary, the Secretary may refer the matter to the Attorney General.
‘(2) ACTION BY ATTORNEY GENERAL- The Attorney General shall bring a civil action to recover the amount of the civil penalty in United States district court.
‘(3) SCOPE OF REVIEW- In a civil action under paragraph (2), the validity and appropriateness of the order of the Secretary assessing the civil penalty shall not be subject to review.
‘(d) Penalties Deposited in Treasury- All amounts collected as civil penalties under this section shall be deposited in the Treasury of the United States.
‘(e) Penalties in Lieu of Other Actions- Nothing in this Act requires the Secretary to report for prosecution, or for the commencement of any libel or injunction proceeding, any violation of section 301(pp) in any case in which the Secretary believes that the public interest will be adequately served by the assessment of a civil penalty under this section.
‘(f) Remedies Not Exclusive- The remedies authorized by this section shall be in addition to any other remedies that may be available.’.
The Pharmacratic Inquisition DVD – Official Online Edition
1:51:19
How deep does the rabbit hole go? Gnostic Media is proud to present the official online edition of The Pharmacratic Inquisition 2007. If you enjoyed “Zeitgeist – The Movie”, you will love this video; the creators of this video are listed as one of the sources for the Zeitgeist Movie. The Pharmacratic Inquisition 2007 is a video version of the book, “Astrotheology & Shamanism” by Jan Irvin & Andrew Rutajit. The painstakingly detailed and heavily footnoted research in the book comes to life in this video and is now available to you for FREE! For further research of the claims made in this video, please read AstroTheology & Shamanism – this book is available to order as a combo with the DVD. Thousands of years ago, in the pre monarchic era, sacred plants and other entheogenic substances where politically correct and highly respected for their ability to bring forth the divine, Yahweh, God, The Great Spirit, etc., by the many cultures who used them. Often the entire tribe or community would partake in the entheogenic rites and rituals. These rites were often used in initiation into adulthood, for healing, to help guide the community in the decision process, and to bring the direct religious experience to anyone seeking it. In the pre literate world, the knowledge of psychedelic sacraments, as well as fertility rites and astronomical knowledge surrounding the sun, stars, and zodiac, known as astrotheology, were anthropomorphized into a character or a deity; consequently, their stories and practices could easily be passed down for generations. Weather changes over millenniums caused environmental changes that altered the available foods and plant sacraments available in the local vicinity. If a tribe lost its shamanic El-der (El – God), all of the tribe’s knowledge of their plant sacraments as well as astronomical knowledge would be lost. The Church’s inquisitions extracted this sacred knowledge from the local Shamans who were then exterminated…It is time to recognize the fact that this Pharmacratic Inquisition is still intact and destroy it.
http://e-cognitive-enhancers.blogspot.com/
Dopaminergics
Dopaminergics are substances that affect the neurotransmitter dopamine or the components of the nervous system that use dopamine. Dopamine is produced in the synthesis of all catecholamine neurotransmitters, and is the rate limiting step for this synthesis. Dopaminergic nootropics include dopamine precursors and cofactors (vitamin C and vitamin B6), and dopamine reuptake inhibitors:
* Mucuna pruriens – Seed powder which contains high concentrations of levodopa (L-dopa),[28] a direct precursor of the neurotransmitter dopamine.
* Tyrosine (requires Vitamin B6 and Vitamin C) – Amino acid. Precursor to dopamine, anti-depressant, sleep reducer.
* Lazabemide – a MAO-B inhibitor and has potent membrane lipid antioxidant activity. The antioxidant effects of lazabemide are attributed to its chemical structure and direct physicochemical interactions with the membrane lipid bilayer. It is a potent antioxidant, even more powerful than selegiline (deprenyl) or vitamin E, and is used to treat Alzheimer’s disease.[29]
* L-dopa – Prescription drug and dietary supplement. Precursor to the neurotransmitter dopamine, anti-depressant.
* Phenylalanine (requires Vitamin B6 and Vitamin C) – Essential amino acid. Precursor to dopamine, anti-depressant, sleep reducer.
* Selegiline – L-deprenyl is an irreversible MAO-B inhibitor, an enzyme that breaks down dopamine. Thus, it is used to treat Parkinson’s disease, and has been tested as a treatment for Alzheimer’s disease.[30] It protects against the genotoxin AraC, provides neuroprotection against growth factor withdrawal in PC12 cells, protects against oxidative stress in mesencephalatic neurons, and delays neuronal cell death in the hippocampus after global ischemia.[31]
* Tolcapone – Inhibits COMT (an enzyme that breaks down the neurotransmitters dopamine, epinephrine, and norepinephrine) and increases performance in tasks depending on working memory in individuals with the val/val and val/met genotype of the val158Met polymorphism of the catechol-O-methyltransferase gene, while decreasing it in presence of the met/met version. Tolcapone presents the risk of deadly side effects.
* Yohimbe – Bark. Aphrodisiac. Boosts dopamine levels,[citation needed] though how it does this is not yet understood. Supplements are likely to have no yohimbe in them.[32] Yohimbe poses some health risks through its side-effects: it is a neuro-paralytic which slows down breathing and induces acidosis, some symptoms of which are malaise, nausea, and vomiting. Contraindicated for users of megadoses of acidic vitamins or nutrients.
* Theanine – Found in tea. Increases serotonin and dopamine levels in the brain. Increases alpha-wave based alert relaxation.
Publicat de health victorro la 04:23 0 comentarii
Etichete: Dopaminergics
Cholinergics
Cholinergics are substances that affect the neurotransmitter acetylcholine or the components of the nervous system that use acetylcholine. Acetylcholine facilitates memory, concentration, focus, and high-order thought processes (abstract thought, calculation, innovation, etc.).[citation needed] Increasing the availability of this neurotransmitter in the brain may improve these functions and increase the duration in which they may be engaged without slowing down or stopping. Oversupplying the brain with acetylcholine may have the opposite effect, temporarily reducing rather than improving mental performance.[citation needed] Cholinergic nootropics include acetylcholine precursors and cofactors, and acetylcholinesterase inhibitors:
Piracetam
Main article: Piracetam
Piracetam (Nootropil) is the original[15] and most commonly taken[16][15] nootropic supplement. It is a cholinergic agent synergistic with DMAE, Centrophenoxine, choline, Alpha-GPC and Hydergine. It increases brain cell metabolism and energy levels,[17][15] and speeds up interhemispheric flow of information (left-right brain hemisphere communication). It increases alertness,[12] improves concentration, and enhances memory. Protects neurons from hypoxia,[15] and stimulates growth of acetylcholine receptors.[citation needed] It may also cause nerves to regenerate.[citation needed] Piracetam markedly decreases the formation of neuronal lipofuscin.[18] It improves posture in elderly people.[19] It is not regulated in the US.[citation needed] It is a pyrrolidone derivative.
Aniracetam
Main article: Aniracetam
Aniracetam is a pyrrolidone derivative drug, analogous of piracetam, and considered more potent[citation needed]. Like piracetam, aniracetam protects against some memory impairing chemicals, such as diethyldithiocarbamate and clonidine.[20] Also like piracetam, aniracetam may enhance memory in aging adults by increasing levels of brain biogenic monoamines, which are beneficial to learning and memory.[13] Both racetams have possible therapeutic use in treating fetal alcohol syndrome.[21] Aniracetam increases vigilance.[12] Aniracetam has shown to positively potentiate AMPA receptors.
Other cholinergics
This section needs additional citations for verification.
Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (December 2007)
* Acetyl-L-carnitine (ALCAR) – Amino acid. Precursor of acetylcholine (donating the acetyl portion to the acetylcholine molecule). It is synergistic with lipoic acid.[22] Inhibits lipofuscin formation.
* Choline – precursor to acetylcholine (an essential component of the acetylcholine molecule).
o Alpha-GPC (L-alpha glycerylphosphorylcholine, Choline alfoscerate) – most effective choline precursor, readily crosses the blood-brain barrier.
o Citicoline – less expensive and similar in effect to Alpha GPC. Appears effective in rats.[23][24]
o Choline bitartrate – precursor of acetylcholine, anti-depressant.
o Choline citrate – precursor of the neurotransmitter acetylcholine, anti-depressant.[citation needed]
* DMAE – approved treatment for ADD/ADHD[citation needed], precursor of acetylcholine, cholinergic agent, removes lipofuscin from the brain, anti-depressant.
* Galantamine – acetylcholinesterase inhibitor made from chemical synthesis or extract from plants such as Red Spider Lily (Lycoris radiata).
* Huperzine A – potent acetylcholinesterase inhibitor derived from Chinese club-moss. Recent Cochrane review concluded that it appears to have beneficial cognitive effects with limited side-effects, but more evidence is needed.[25]
* Ispronicline – recently developed selective α4β2 partial agonist
* Lecithin – contains phosphatidylcholine, precursor of acetylcholine.
* Other pyrrolidone derivatives:
o Etiracetam – It increases vigilance.[12]
o Nefiracetam – Drug. Analog of piracetam, and facilitates hippocampal neurotransmission.[26]
o Oxiracetam – Drug. Analog of piracetam, and 2 to 4 times stronger. Improves memory, concentration, and vigilance. When fed to pregnant rats, the offspring of those rats were more intelligent than the offspring of rats fed a saline solution placebo.
o Pramiracetam – Drug. Analog of piracetam.
o In animal studies, nootropics such as piracetam, oxiracetam and aniracetam are known to facilitate the formation of long term memory traces and to restore object recognition in aging rats.[27] There is evidence that the beneficial effect of racetams may result from an interaction with the central glutamatergic receptor function. [27]
* Vitamin B5 – cofactor in the conversion of choline into acetylcholine, cholinergic agent, increases stamina (including mental stamina).[citation needed]
Excess acetylcholine is considered by many to be potentially harmful; see acetylcholinesterase inhibitor.
Acetylcholinesterase inhibitors
Acetylcholinesterase inhibitors function by inhibiting the cholinesterase enzyme which breaks down the neurotransmitter acetylcholine. They exist in the form of poisons and have been used as weapons, but they are also used to treat Alzheimer’s patients. Donepezil, galantamine, and Huperzine A are notable among these.
Publicat de health victorro la 04:21 0 comentarii
Etichete: Cholinergics
Replenishing and increasing neurotransmitters
As the brain ages, its ability to produce and maintain youthful levels of neurotransmitters declines.[13] There are various reasons for such an insufficiency. For instance, there might be a lack of enzymes involved in the neurotransmitter synthesis. Nevertheless, in many cases, providing the brain with ample raw materials necessary to make neurotransmitters can restore them to more youthful levels and thus help maintain cognitive function at vigorous youthful levels.[citation needed] Furthermore, there are declines in immune and endocrine functioning.[14] Certain nootropics enhance immune and endocrine functioning.
Publicat de health victorro la 04:21 0 comentarii
Etichete: neurotransmitters
Stimulants
Stimulants are often seen as smart drugs. Their effects are non-specific with similar results seen in children and adults with and without ADHD. One finds improved concentration and behavior in all.[6][7][8][9] Due to their non-specific activity, stimulants have been used by writers to increase productivity,[10] as well as by the United States Air Force to improve effectiveness in combat.[11] Some scientists recommend wide spread use (of Ritalin and Adderall) by the general population to increase brain power.[4]
This section needs additional citations for verification.
Please help improve this article by adding reliable references. Unsourced material may be challenged and removed. (January 2008)
* Adrafinil (Olmifon) – Drug.
* Caffeine – Drug. Improves concentration, idea production, but hinders memory encoding. Large amounts produce the jitters. Caffeine is the most widely used psychoactive substance in the world, and may be susceptible to strong levels of tolerance.
* Coffee – Bean. Contains caffeine; brewed coffee is high in antioxidants.
* Nicergoline – Drug. Nicergoline is an ergoloid mesylate derivative used to treat senile dementia. It has also been found to increase mental agility and enhance clarity and perception. It increases vigilance.[12] Increases arterial flow and use of oxygen and glucose in the brain.
* Nicotine – stimulus barrier (aids in concentration). Stimulus barrier rebound effect (an unpleasant side effect).
* Cocaine – Drug. Schedule II. Increase extracellular dopamine and serotonin levels resulting in increased alertness and arousal.
* Methylphenidate (Ritalin) – aids in concentration, focus and stamina. Prescribed for ADHD.
* Dextroamphetamine – (Adderall, Dexedrine) – aids in concentration, focus and stamina. Prescribed for ADHD.
* Modafinil – (Provigil) – Drug.
* Phenibut -
* Theophylline -
* Amphetamines – aids in concentration, focus and stamina. Prescribed for ADHD.
* Carphedon (Phenotropil) -
Publicat de health victorro la 04:19 0 comentarii
Etichete: cognitive, enhancers, Stimulants
Availability
Currently there are several drugs on the market that improve memory, concentration, planning and reduce impulsive behavior. Many more are in different stages of development.[3] The most commonly used class of drug are the stimulants.[4]
These drugs are used primarily to treat people with cognitive difficulties: Alzheimer’s disease, Parkinson’s disease, ADHD. However, more widespread use is being recommended by some researchers.[5] These drugs have a variety of human enhancement applications as well and are marketed heavily on the World Wide Web. Nevertheless, intense marketing may not correlate with efficacy; while scientific studies support some of the claimed benefits, it is worth noting that many of the claims attributed to most nootropics have not been formally tested.
My Maria don’t you know I’ve come a long, long way
I been longin’ to see her
When she’s around she takes my blues away
Sweet Maria the sunlight surely hurts my eyes
I’m a lonely dreamer on a highway in the skies
Maria, Maria I love you
My Maria there were some blue and sorrow times
Just my thoughts about you bring back my piece of mind
Gypsy lady you’re a mircle work for me
You set my soul free like a ship sailing on the sea
She is the sunlight when skies are grey
She treats me so right lady take me away
My Maria
Maria I love you
My Maria
Maria I love you
My Maria
Maria I love you
http://aiwazzsaying.blogspot.com
aiwazzsaying is an esoteric library blog
Bashar is a multi-dimensional being who speaks through channel Darryl Anka from what we perceive as the future.
Bashar explores a wide-range of subjects with great insight, humor and a profound understanding of how reality creation occurs.
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Bashar is a male member of a 5th dimensional civilization called the Essassani. This is an “informal” concentrated summary by Iasos of some of the core concepts of Bashar, based on his books “Quest for Truth” and “Bashar: Blueprint for Change” and also based on listening to many audio/video recordings of channeled evenings where Bashar responds to questions from the audience. The entire Essassani civilization is based on unconditional love, ecstasy, fun, following your excitement, being totally non-judgemental, and giving validity and equality to each individual in the society. Bashar, as experienced from the tapes of the channelings, is extremely enthusiastic – almost to the point of seeming cartoon-like! And yet he has an incredibly fast mind, an amazing wit, a loving heart, and of course a profound understanding of reality. -http://iasos.com/metaphys/bashar
Meeting With Bashar 1/19/07
I discovered Bashar one late night in December, 2006. I brought all my friends to a private session at Darryl’s house (the guy who channels Bashar) a few weeks later after I was SHOCKED and discovered that he lived in the same city as me, LA. Within 2 months this information had COMPLETELY CHANGED MY LIFE. I gave away all my possessions and tested the powers of reality “selection” (it’s a holographic universe so you don’t actually CREATE anything). Every since that point, my life has expanded in the most amazing ways.
Two films have been made about this progress and they are both pretty special: http://vimeo.com/2434635 & http://vimeo.com/2497823
I love Bashar so much and I find so much inspiration day after day, week after week, year after year from this material. I think it is the most profound information that has ever hit Earth–if you find anything better, PLEASE E-MAIL ME from our website! I tried to tell April from the start that putting videos like this on the internet would be great for spreading the information and getting people into Bashar. I’m glad to see it’s happening! To me, the BEST way to start with Bashar is this summary. I think this is the best explanation of the nature of reality that has ever been created. http://iasos.com/metaphys/bashar And me, I’m Otis Funkmeyer. Check out our website for Bashar-inspired inspiration: SHIVAI!!! (you’ll understand once you get really into Bashar) -Otis Funkmeyer – www.funkmeyers.com
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Bashar 20 yrs ago
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big love to Eddie Bravo for this
Madventures is a Finnish travel show that premiered on the channel Subtv, nowadays Sub, on October 13, 2002. The show concentrates on so called backpacking instead of tourist attractions. It is presented by Riku Rantala (born July 20, 1974, Helsinki, Finland), and Tuomas “Tunna” Milonoff (born February 26, 1974, Helsinki, Finland), the show’s director and cameraman, travel around the world exploring different cultures. The two emphasize that they are on a journey, not on a holiday.
The travel documentary is made on a relatively low budget with no major production crew but rather just the two presenters traveling together with the shooting equipment.
The first two seasons were made in Finnish, but for season three the show was sold to Travel Channel and Fiver and the language was switched to English. The third season began airing in Finland in early April 2009 with each episode being 10 minutes longer than the international version.
season 3 “ayahuasca healing session”
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season 2 “best bits” w/english subtitles
http://media.www.skidmorenews.com
Jason Takahashi
Issue date: 1/30/09
“I believe the mycellial network is a neural network for the Gaian consciousness. I believe we all are partaking and taking steps through different doors and coming to the same realization that we are not separate from this planet…And I think as time goes on, the importance of our being aware of these processes becomes paramount.” – Paul Stamets 1999
Anthropologists and ethnobotanists have generally considered the role of the shaman within indigenous cultures to be one with great responsibility, for it is he or she that possesses the ability to navigate other worlds and other realms safely in order to bring back pertinent information for the community. Access to these dimensions can be found in a multitude of ways from dance to trance to well-studied pharmacological intervention (i.e. hallucinogenic compounds), and it is generally a fairly strict discipline to become initiated into. In almost all cases, however, our Earth provides the initial guidance into the shamanic world.
It is not often that we discuss such matters seriously in this day and age, and over the course of the years I have slowly started to figure out why. To put it simply, our culture hasn’t gotten the memo about serious healing – about finding the roots of problems, both physical and spiritual, and going from there . We make it illegal for citizens to utilize the magic-like power of the plant kingdom, which in the end forces us into greater dependence on the governments and industries and into deeper ignorance about our true environment – this Earth.
Lucky for us though, I think this Earth has got our back. A mycologist (researcher of fungus and mushrooms) by the name of Paul Stamets has developed a novel theory to help explain the benevolence of the plant kingdom and its relation to the human species. What Stamets has found is that the Earth has its own Internet – yes that’s right – and it comes in the form of fungus.
These microscopic nodes run throughout Earth’s soil, connecting at the roots, countless species of plantlife. This in turn creates a vast network in which resources are intelligently transferred and allocated. According to Stamets, the Earth-Internet’s ultimate goal is to support all life on this planet and interestingly – mushrooms springing forth from the ground with enough force to break through asphalt are its fruitbody.
Fungal organisms have existed on Earth for over a billion years, and it is entirely unclear how long the humans have been ingesting hallucinogenic species. Writer and ethnobotanist Terence McKenna goes as far to say that the active compound psilocybin found in such mushrooms was an exceedingly influential factor in the evolution of human consciousness, and while mainstream science would most likely immediately refute this idea – we only have to think about it in more modern, technological terms.
This is a map of the Internet taken in 2005. The Internet runs off of computer hardware and software which was developed in the wake of a psychedelic revolution in the United States of America. Hundreds of innovators and engineers, including Steve Jobs founder of Apple, now confirm their psychedelic debriefing during this time and as Stamets theorizes – the Earth created the Internet through us, for itself – to protect itself, to disseminate as much information as efficiently as possible to support life on this planet and perhaps once again catalyze an evolution in human consciousness.
It is as beautiful a story as any, and it is here and now. Each and every day members of the developed world navigate realms of ‘manipulated light’ which contain ‘information’ and then we in turn can spread it wherever we go. If we wish, we can get online and seek out information for people who may need some help, and while perhaps we won’t go blow tobacco smoke in their face in the jungle like the Shipibo Indians in Peru – we could set up a micro-credit loan and give them a hand while our dollar is still worth something. Regardless, I think this can all serve as proof that there is a point to all of this – and that one of the most beautiful stars in the sky is depending on us.
And as the universe would have it, Paul Stamets will be giving a lecture on bioremediation on February 9th at Skidmore College.
Read Jason’s blog at datda.wordpress.com
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The Online guide to vaporizers
Which vaporizer is correct for me?
Yes, theres a lot of vaporizers out there. They range in price from make your own, to spending $539 on a Volcano unit. What is right for you? Do I even need a vaporizer?
Some reasons for purchasing a vaporizer
Ok, but theres so many to choose from!
What does it come down to?
The important factors when buying a vaporizer.
It’s entirely down to personal preference. There are a range of devices in lot’s of price ranges, styles, colours, heating elements, with different warm up times and warranties… hang out, we’re right back where we’re started…
Maybe it’s time for you to check out the following links:
http://www.gnosticmedia.podomatic.com
Download the Podcast
Today we discuss oo-koo-he, ayahuasca, habit and novelty theory, Terence McKenna, plant communication and the future of psychedelic research. For the last thirty years, Dennis McKenna has pursued the interdisciplinary study of ethnopharmacology and plant hallucinogens. He is co-author, with his brother Terence, of The Invisible Landscape: Mind, Hallucinogens, and the I Ching (Seabury Press, 1975; Citadel Press, 1991), a philosophical and metaphysical exploration of the ontological implications of psychedelic drugs which resulted from the two brothers’ early investigations of Amazonian hallucinogens in 1971. He received his doctorate in 1984 from the University of British Columbia. His doctoral research focused on ethnopharmacological investigations of the botany, chemistry, and pharmacology of ayahuasca and oo-koo-he, two orally-active tryptamine-based hallucinogens used by indigenous peoples in the Northwest Amazon. Following the completion of his doctorate, Dr. McKenna received post-doctoral research fellowships in the Laboratory of Clinical Pharmacology, National Institute of Mental Health, and in the Department of Neurology, Stanford University School of Medicine. In 1990, he joined Shaman Pharmaceuticals as Director of Ethnopharmacology. He joined the Center for Spirituality and Healing at the University of Minnesota in 2001 as a Senior Lecturer and Research Associate. He is a founding board member and Vice-President of the Heffter Research Institute, a non-profit scientific organization dedicated to the investigation of therapeutic applications for psychedelic plants and compounds. He was a primary organizer and key scientific collaborator for the Hoasca Project, an international biomedical study of Hoasca, a psychoactive drink used in ritual contexts by indigenous peoples and syncretic religious groups in Brasil. He has conducted extensive ethnobotanical fieldwork in the Peruvian, Colombian, and Brasilian Amazon. He has served as invited speaker at numerous scientific congresses, seminars, and symposia. Dr. McKenna is author or co-author of over 40 scientific papers in peer-reviewed journals. His publications have appeared in the Journal of Ethnopharmacology, European Journal of Pharmacology, Brain Research, Journal of Neuroscience, Journal of Neurochemistry, Journal of Nervous and Mental Disease, Economic Botany, and elsewhere.
http://www.csh.umn.edu/csh/about/centerstaff/mcKenna/home.html
http://www.sphinxproductions.com
Mushrooms – we put them on our pizza and steaks and in our soups and salads, we marvel at their variety and are sometimes repelled by their grotesque beauty when encountering them in the bush. And yeah, some have even sampled their more exotic possibilities and asked the question: “Do mushrooms come from a far away planet?”
Still, others have asked: “Can mushrooms save the planet?”
The world of fungi and their integral relationship with the health of the planet have only recently been appreciated. The oldest and largest living organisms recorded on Earth are both fungi. And their use by a new, maverick breed of scientists and thinkers has proven vital in the cleansing of sites despoiled by toxins and as a “clean” pesticide among many other environmentally-friendly applications.
Inspired by a chance conversation with fellow filmmaker and mushroom buff Jim Jarmusch, Mann set off to the annual Telluride Mushroom Festival in Colorado. It was there he encountered the unique sub-sub-subculture surrounding fungi that includes an unlikely assortment of nerds, nuts, hipsters, tripsters, artists, chefs, musicians, foodies, foragers, and seekers all paying homage to the mighty mushroom.
KNOW YOUR MUSHROOMS follows uber myco visionaries Gary Lincoff and Larry Evans (two of the more expert and unforgettably mercurial characters in the community) as they lead us on a hunt for the wild mushroom and the deeper cultural experiences attached to the mysterious fungi.
Combining material filmed at the Telluride Mushroom Fest with animation and archival footage along with a neo-psychedelic soundtrack by the Flaming Lips, KNOW YOUR MUSHROOMS opens the doors to perception, takes the audience on a longer, stranger trip and delivers them to a brave new world where the fungi might well guide humanity to a saner, safer place… with extra cheese…
CONSUMER WARNING: Don’t Go Into The Forest Without This Movie!
“Caps off to ‘fun guy’ Ron Mann, who delivers another wildly entertaining, mind-expanding film.”
- Jennie Punter, Film Critic
From the award-winning director of COMIC BOOK CONFIDENTIAL, GRASS, GO FURTHER and a host of paradigm-shifting films reappraising the backwaters of popular culture, Ron Mann investigates the miraculous, near-secret world of fungi with his newest piece of cinema, KNOW YOUR MUSHROOMS.
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Gary Lincoff’s mushroom trip from KNOW YOUR MUSHROOMS, the upcoming documentary by Ron Mann.
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Canadian Director Ron Mann sits down with CBC Radio Q host Jian Ghomeshi to talk about his new film ‘Know Your Mushrooms’.
For former drug interdiction officer Barry Cooper, the media storm is just beginning.
His upcoming reality show, ‘KopBusters,’ a ‘To Catch A Predator’ style crusade against dirty officers, sparked an immediate response after RAW STORY covered a news brief of their first sting.
Cooper has now released footage from the initial episode of ‘KopBusters,’ in which the Odessa, TX police department raids a suspected marijuana grow house, only to discover they played right into the filmmaker’s hands. As surveillance cameras roll, the police slowly figure out they’ve been had, seemingly caught red-handed of illegally overreaching in a first-of-its-kind operation.
On his Web site, KopBusters.com, Cooper describes how the sting took place.
“KopBusters rented a house in Odessa, Texas and began growing two small Christmas trees under a grow light similar to those used for growing marijuana. When faced with a suspected marijuana grow, the police usually use illegal FLIR cameras and/or lie on the search warrant affidavit claiming they have probable cause to raid the house. Instead of conducting a proper investigation which usually leads to no probable cause, the Kops lie on the affidavit claiming a confidential informant saw the plants and/or the police could smell marijuana coming from the suspected house.
“The trap was set and less than 24 hours later, the Odessa narcotics unit raided the house only to find KopBuster’s attorney waiting under a system of complex gadgetry and spy cameras that streamed online to the KopBuster’s secret mobile office nearby.
“The attorney was handcuffed and later released when eleven KopBuster detectives arrived with the media in tow to question the illegal raid. The police refused to give KopBusters the search warrant affidavit which is suspected to contain the lies regarding the probable cause.”
This video is from NeverGetBusted.com, posted Dec. 7, 2008.
NOTE: This is a recently restored version for a show in USA.
Bruce Conner described Looking for Mushrooms in the 1975 Film-Makers’ Cooperative Catalogue as a “[f]amous documentary containing full information. Special effects by Isauro Nava, Rancho del Cura, Huatla de Jimenez, Mexico. Sound by John Liniment and frenz”.
In 1962, Bruce Conner left San Francisco and moved to Mexico, apparently intending to “wait out the impending nuclear holocaust” . He spent about a year in Mexico before running out of cash and patience, and returning to the United States. During his year in Mexico, Conner hosted psychedelic guru Timothy Leary, who he had met on an earlier visit to New York. Conner and Leary occupied themselves with mushroom hunts in the Mexican countryside. It’s not clear whether their hunts were successful. But Conner’s staccato home-movies of their walks – combined with movies of previous mushroom hunts in San Francisco – became his film Looking for Mushrooms. The film rushes through the rustic landscape of rural Mexico, flitting past houses and through a crumbling graveyard. It’s quite a contrast to Valentin de las Sierras (1967), Bruce Baillie’s serene portrait of life in a Mexican village. But the quality of the image is similar, sun-blasted colours bleached to pastel.
Conner cut Looking for Mushrooms down to 100 feet in 1965 in order to fit it into an endless-loop cartridge for continuous projection. In 1967 he added a soundtrack by The Beatles (“Tomorrow Never Knows”). Thirty years later, Conner revisited Looking for Mushrooms, extending it to 15 minutes by repeating each frame five times and adding a new soundtrack – “Poppy Nogood and the Phantom Band” (1968) by Terry Riley. Later, Conner exhibited Looking for Mushrooms as an interactive sculpture, threading a print on a Moviscop viewer for museum patrons to view on their own. -http://arttorrents.blogspot.com/2008/02/bruce-conner-crossroads-and-looking-for.html
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http://gnosticmedia.podomatic.com/en…6_55-08_00.mp3
Griffths-Mystical.pdf (307.4 KB, 0 views)
In May 2006 a Johns Hopkins University study on psilocybin (the active ingredient in Psilocybe varieties of mushrooms) was published stating that the religious experience had been proven through the use of the active ingredient in psilocybe mushrooms. The article by Dr. Roland Griffiths, et al, is titled: ‘Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance’. It found that:
“…when administered to volunteers under supportive conditions, psilocybin occasioned experiences similar to spontaneously occurring mystical experiences and which were evaluated by volunteers as having substantial and sustained personal meaning and spiritual significance.”
A follow-up study by Dr. Griffiths, et al, published in the Journal of Psychopharmacology in July 2008 confirmed the first study’s findings. It found that:
“At the 14-month follow-up, 58% and 67%, respectively, of volunteers rated the psilocybin-occasioned experience as being among the five most personally meaningful and among the five most spiritually significant experiences of their lives; 64% indicated that the experience increased well-being or life satisfaction; 58% met criteria for having had a ‘complete’ mystical experience. Correlation and regression analyses indicated a central role of the mystical experience assessed on the session day in the high ratings of personal meaning and spiritual significance at follow-up. Of the measures of personality, affect, quality of life and spirituality assessed across the study, only a scale measuring mystical experience showed a difference from screening. When administered under supportive conditions, psilocybin occasioned experiences similar to spontaneously occurring mystical experiences that, at 14-month follow-up, were considered by volunteers to be among the most personally meaningful and spiritually significant of their lives.”
I’m happy to present the author of these studies – Professor Roland Griffiths from Johns Hopkins University.