[Congressional Record Volume 165, Number 108 (Wednesday, June 26, 2019)]
[Senate]
[Pages S4569-S4579]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Mr. MERKLEY:
  S. 1987. A bill to require the Secretary of Health and Human Services 
to establish reference prices for prescription drugs for purposes of 
Federal health programs, and for other purposes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. MERKLEY. Mr. President, the three most important words of our 
Constitution are the first three: ``We the People.'' That is what our 
entire vision of our form of government is about.
  There was a lot of discussion among the Founders about how we make 
sure we don't end up with the equivalent of a King here in the United 
States of America because with a King, you get a government by and for 
the King and the King's circle, the powerful circle at the top, rather 
than the people.
  Unfortunately, that vision in America is being challenged--challenged 
because we have a fundamental concentration of power through dark money 
in campaigns and gerrymandering through voter suppression and 
intimidation. The result is a shredding of the vision of our 
Constitution.
  We have a responsibility in the Senate to fix that, and that is why 
we should be considering the For the People Act that takes on 
gerrymandering, voter suppression, and dark money. If we want evidence 
of just exactly how corrupted the system has become, go no further than 
to look at drug companies gouging Americans on drug prices.
  Today I am introducing the End Price Gouging for Medications Act to 
stop the pharmaceutical companies' greed and give Americans much needed 
relief.
  The average American spends about $1,000 per year on medication. That 
is 11 times what they spent in 1960. More than half of Americans take 
at least one prescription medication--about 60 percent of us. One-
quarter of them say they or family members have not filled a 
prescription or have cut pills in half or have skipped doses because of 
the cost, and those costs just keep going right on up.
  January through June 2018, there were price increases on 4,412 drugs 
and decreases on just 46. That is a ratio that approaches 100 to 1. For 
every 100 drugs that go up in price, 1 comes down a little. We are 
clearly failing to tackle this problem.
  I hear it from my constituents back in Oregon. Bonnie Davis from 
Creswell, who is a senior citizen on a fixed income and has been 
diabetic for 30 years, was prescribed two new kinds of insulin in 
December: BYDUREON, which costs $1,927 for a 3-month supply, and Lantus 
SoloSTAR, which costs $1,952. She will pay more than $5,000 out of 
pocket by the end of the year. In 1972, insulin cost just $1.49 per 
vial. What an incredible difference on a product that has been around 
forever.
  Her two adult children are living in Germany. They thought about 
coming back to the United States of America but decided not to for one 
simple reason: the cost of healthcare in the United States of America 
and specifically the cost of medications.
  I come from Douglas County, a little timber county in Southern 
Oregon. Leslie Rogers comes from that county. She comes from Roseburg, 
a town where I went to first grade. Leslie shared his daughter Gloria's 
story at one of my townhalls. Gloria suffers from a rare genetic 
condition called West syndrome. She lives, therefore, in near constant 
fear of seizures and cystic fibrosis. It is treatable.
  It is treatable with a drug called ACTH. It was invented in the 
1950s. Previously, it cost $40 a vial--$40--but in 8 years, the cost 
has grown to $45,000. Yes, you heard that right--from $40 to $45,000. 
That is more than a thousandfold increase.
  The company that makes the drug bought the rights to and blocked a 
$200 synthetic ACTH treatment used in Canada to prevent it from coming 
to the United States. They are making a lot of money by blocking a 
generic synthetic competitor.
  Leslie Rogers says: ``Hospitalization and treatment drove my family 
to the edge of bankruptcy, and my daughter was left tube fed and 
suction dependent due to treatment delays fighting with insurance over 
the drug price.''
  How would you feel if your daughter or your son were left in a 
situation of being tube fed and suction dependent because you couldn't 
afford the drug because the drug had increased in price 1,000 times?
  The cost of another drug used to treat the disease, Vigabatrin, has 
also skyrocketed after makers saw what the first company was able to 
get away with. It cost about $1,500 a month 3

[[Page S4570]]

years ago, and $1,500 is a lot. How much does it cost today? It costs 
$26,000 per month. That is roughly a twentyfold increase.
  Leslie Rogers notes: ``This price gouging has led to thousands of 
children since we first spoke to suffer the same fate as my daughter--
severe brain damage, cerebral palsy, reliance on tube feedings, and 
many have died.''
  Let's be clear. Price gouging in America isn't just about the 
pocketbook; it is about health, and it is about life or death for many 
people.
  This situation doesn't exist in other countries. The whole entire 
price regime is different. Let's take, as an example, HUMIRA, a common 
drug for rheumatoid arthritis. Here in the United States, it is about 
$2,700 per dose. In the United Kingdom, it is $1,362. Why does it cost 
twice that in the United States of America for this drug, this common 
drug? Then there is CRESTOR, which is used to treat high cholesterol? 
It is $216 in the United States, and it is $32 in France. Crudely, that 
is a sevenfold increase in the United States over France. Why do we pay 
seven times as much as the people in France? There is also HARVONI that 
is used to treat hepatitis C. It cost $13,000 in Japan and $30,000 in 
United States. That is three times as much. Why do we pay three times 
what they pay in Japan for this drug? There is also JANUVIA that is 
used to treat type 2 diabetes. It costs $34 in Australia and $331 in 
the United States of America--a tenfold increase. Why do we pay 10 
times as much as people in Australia?
  There is an answer to the question--the question of why we pay so 
much for HUMIRA, for CRESTOR, for HARVONI, and for JANUVIA. Very 
simply, other governments negotiate the price: If you want to sell it 
in our country, we negotiate the price.
  We don't. Now, what is the reason why we don't? Why don't we pick up 
and do for Americans what the Government of Australia does for 
Australians, or the Government of the United Kingdom does for its 
citizens, or the Government of France does for their citizens? Why 
don't we do it for our citizens--the same good work in negotiating the 
price that other governments do? What is wrong with our government? 
What is wrong with this Chamber?
  It is corruption. It is the absolute corruption of money in 
campaigns.
  So who are we serving here in this Chamber? Are we serving the people 
or are we serving the drug companies? That is the question every Member 
of this Chamber should struggle with.
  In the United States, drug companies set the price, and we don't 
negotiate. In fact, the U.S. Government has set a law saying the U.S. 
Government can't negotiate. Why would we do that? Why would we do that 
to ourselves? Why would we do that to the people of this country who 
cannot afford the drugs because we make them far more expensive than 
anywhere else in the world?
  Well, we shouldn't. That is why I have introduced the End Price 
Gouging for Medications Act. On behalf of the people of America, we 
need to end the drug gouging.
  Now, I do a lot of townhalls. I do one in every county every year. 
There are 36 counties in Oregon. It is open hour for people to ask 
questions. They are blue counties, and they are red counties. Twenty-
two of my 36 are about as red as the reddest counties you will find in 
America.
  I ask the people: How many people here at this townhall like getting 
gouged on drugs? Nobody does. How many people like paying 2 or 5 or 10 
times more than the citizens of other developed countries? No one likes 
it.
  America is united--rural America, urban America, blue America, red 
America, young America, old America. America is united to end this drug 
gouging.
  So why don't we act?
  I challenge my colleagues: Come here and work for the people of the 
United States of America rather than the drug companies' profits. It is 
time to stand up. Stand up against those companies.
  This plan is quite simple. It says you can't sell the drug for more 
than the median price of what you sell it for in Australia, Japan, 
Canada, and the largest European countries. It is that simple. Median 
price in those markets. If you want to raise your prices in America, 
you have to raise your prices in those countries. That way we all get a 
fair deal. This would stop the drug gouging of Americans overnight.
  This is quite simple, but you may ask how is it enforced? How do you 
make sure that this happens?
  Well, it is this. The difference between the reference price, or the 
median price in those countries, and the price the drug company sells 
their product at--if they sell it for more than the median price, the 
penalty is five times the difference. If they sell it for $1,000 more 
per dose over the median price, the penalty is $5,000. That gets 
people's attention. Drug companies don't want to be paying massive 
penalties.
  And where do the fines go? They go to the NIH for drug research and 
development. There is all this myth that we are not going to invest in 
drug development. The basic science is done by NIH, and this would fund 
NIH.
  Americans have been ripped off. Americans have been gouged, and it is 
this Chamber that is allowing it to happen. Who here wants to come and 
say they are for the drug gouging of Americans?
  Well, I can tell you that America is not with you if you are 
supporting the drug gouging of our citizens. So let's have the courage 
to carry the fight for the people, not the powerful.
                                 ______
                                 
      By Mr. DURBIN (for himself, Mr. Blumenthal, Mrs. Feinstein, and 
        Mrs. Gillibrand):
  S. 1995. A bill to establish the Food Safety Administration to 
protect the public health by preventing foodborne illness, ensuring the 
safety of food, improving research on contaminants leading to foodborne 
illness and the chronic health outcomes associated with foodborne 
illnesses, improving the surveillance of foodborne pathogens (including 
foodborne pathogens identified as antibiotic resistant), and improving 
security of food from intentional contamination, and for other 
purposes; to the Committee on Agriculture, Nutrition, and Forestry.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 1995

       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 ``Safe Food 
     Act of 2019''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings; purposes.
Sec. 3. Definitions.

          TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

Sec. 101. Establishment of Food Safety Administration.
Sec. 102. Consolidation of separate food safety and inspection services 
              and agencies.
Sec. 103. Additional duties of the Administration.

            TITLE II--ADMINISTRATION OF FOOD SAFETY PROGRAM

Sec. 201. Administration of national program.
Sec. 202. Registration of food facilities.
Sec. 203. Preventive process controls to reduce adulteration of food.
Sec. 204. Performance standards for contaminants in food.
Sec. 205. Inspections of food facilities.
Sec. 206. Food production establishments.
Sec. 207. Federal and State cooperation.
Sec. 208. Foreign supplier verification program.
Sec. 209. Imports.
Sec. 210. Traceback.
Sec. 211. Food safety technology.

                   TITLE III--RESEARCH AND EDUCATION

Sec. 301. Public health assessment system.
Sec. 302. Public education and advisory system.
Sec. 303. Research.

                         TITLE IV--ENFORCEMENT

Sec. 401. Prohibited acts.
Sec. 402. Mandatory recall authority.
Sec. 403. Injunction proceedings.
Sec. 404. Civil and criminal penalties.
Sec. 405. Presumption.
Sec. 406. Whistleblower protection.
Sec. 407. Administration and enforcement.
Sec. 408. Citizen civil actions.

                        TITLE V--IMPLEMENTATION

Sec. 501. Definition.
Sec. 502. Reorganization plan.
Sec. 503. Transitional authorities.
Sec. 504. Savings provisions.
Sec. 505. Conforming amendments.
Sec. 506. Additional technical and conforming amendments.
Sec. 507. Regulations.
Sec. 508. Authorization of appropriations.
Sec. 509. Limitation on authorization of appropriations.

[[Page S4571]]

  


     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;
       (3) the safety and security of the food supply requires an 
     integrated, systemwide approach to preventing foodborne 
     illness, a thorough and broad-based approach to basic and 
     applied research, and intensive, effective, and efficient 
     management of the Nation's food safety program;
       (4) 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) an aging and immune-compromised population, with a 
     growing number of people at high risk for foodborne 
     illnesses, including infants and children;
       (C) a concern regarding food fraud for economic gain, 
     especially with mislabeling and intentionally misleading 
     claims;
       (D) an increasing volume of imported food, without adequate 
     monitoring and inspection; and
       (E) maintenance of rigorous inspection of the domestic food 
     processing and food service industries;
       (5) 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 foodborne illness;
       (6) the Federal food safety system is fragmented, with at 
     least 15 Federal agencies sharing responsibility for food 
     safety, and operates under laws that do not reflect current 
     conditions in the food system or current scientific knowledge 
     about the cause and prevention of foodborne illness;
       (7) the fragmented Federal food safety system and outdated 
     laws preclude an integrated, systemwide approach to 
     preventing foodborne illness, to the effective and efficient 
     operation of the Nation's food safety program, and to the 
     most beneficial deployment of food safety resources;
       (8) the National Academy of Sciences recommended in the 
     report ``Ensuring Safe Food from Production to Consumption'' 
     that Congress establish by statute a unified and central 
     framework for managing Federal food safety programs, and 
     recommended modifying Federal statutes so that inspection, 
     enforcement, and research efforts are based on scientifically 
     supportable assessments of risks to public health; and
       (9) the lack of a single focal point for food safety 
     leadership in the United States undercuts the ability of the 
     United States to exert food safety leadership 
     internationally, which is detrimental to the public health 
     and the international trade interests of the United States.
       (b) Purposes.--The purposes of this Act are--
       (1) to establish a single agency to be known as the ``Food 
     Safety Administration'' to--
       (A) regulate food safety and related labeling to strengthen 
     the protection of the public health;
       (B) ensure that food facilities fulfill their 
     responsibility to produce 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 foodborne illness;
       (D) provide a single focal point for food safety 
     leadership, both nationally and internationally; and
       (E) provide an integrated food safety research capability, 
     utilizing internally generated, scientifically and 
     statistically valid studies or other food safety initiatives, 
     in cooperation with academic institutions, food safety 
     nonprofit organizations, and other scientific entities of the 
     Federal and State governments, to achieve the continuous 
     improvement of research on foodborne illness and 
     contaminants;
       (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 enactment of this Act, are 
     performed by other Federal agencies; and
       (3) to modernize and strengthen the Federal food safety 
     laws to achieve more effective application and efficient 
     management of the laws for the protection and improvement of 
     public health.

     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)(3).
       (3) Adulterated.--
       (A) In general.--The term ``adulterated'' has the meaning 
     given the term in--
       (i) section 402 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 342) for food regulated under such Act;
       (ii) section 1(m) of the Federal Meat Inspection Act (21 
     U.S.C. 601(m)) for food regulated under such Act;
       (iii) section 4(g) of the Poultry Products Inspection Act 
     (21 U.S.C. 453(g)) for food regulated under such Act; and
       (iv) section 4(a) of the Egg Products Inspection Act (21 
     U.S.C. 1033(a)) for food regulated under such Act.
       (B) Inclusion.--In applying the definitions cited in 
     subparagraph (A), poisonous or deleterious substances in food 
     shall be treated as an added substance if the poisonous or 
     deleterious substances are known to cause serious illness or 
     death in persons, including in sensitive populations.
       (4) Agency.--The term ``agency'' has the meaning given the 
     term in section 551 of title 5, United States Code.
       (5) Category 1 food facility.--The term ``category 1 food 
     facility'' means a facility that slaughters animals for food.
       (6) Category 2 food facility.--The term ``category 2 food 
     facility'' means a facility that processes--
       (A) raw meat, poultry, or seafood in a manner that may 
     reduce but is not validated to destroy contaminants; or
       (B) other products that the Administrator determines by 
     regulation to be at high risk of contamination.
       (7) Category 3 food facility.--The term ``category 3 food 
     facility'' means a facility--
       (A) that processes meat, poultry, or seafood, or other 
     products that the Administrator determines by regulation to 
     be at high risk of contamination; and
       (B) whose processes include one or more steps validated to 
     destroy contaminants.
       (8) Category 4 food facility.--The term ``category 4 food 
     facility'' means a facility that processes food but is not a 
     category 1, 2, or 3 food facility.
       (9) Category 5 food facility.--The term ``category 5 food 
     facility'' means a facility that stores, holds, or transports 
     food prior to delivery for retail sale.
       (10) Contaminant.--The term ``contaminant'' includes 
     biological, chemical, physical, or radiological hazards, 
     natural toxins, pesticides, drug residues, decomposition, 
     parasites, allergens, and unapproved food or color additives.
       (11) Contamination.--The term ``contamination'' refers to a 
     presence of a contaminant in food, which may occur naturally 
     or be introduced into a food.
       (12) Feed facility.--The term ``feed facility'' means a 
     domestic or foreign feed manufacturer, processor, packer, 
     warehouse, or other facility that--
       (A) if operating in the United States, manufactures, 
     slaughters, processes, or holds animal feed or feed 
     ingredients; or
       (B) if operating elsewhere, manufactures, slaughters, 
     processes, or holds animal feed or feed ingredients intended 
     for consumption in the United States.
       (13) Food.--
       (A) In general.--The term ``food'' means a product intended 
     to be used for food or drink for a human or an animal.
       (B) Inclusions.--The term ``food'' includes any product 
     (including a meat food product, as defined in section 1(j) of 
     the Federal Meat Inspection Act (21 U.S.C. 601(j))), capable 
     for use as human and animal food that is made in whole or in 
     part from any animal, including cattle, sheep, swine, goat, 
     or poultry (as defined in section 4 of the Poultry Products 
     Inspection Act (21 U.S.C. 453)), and animal feed.
       (14) Food facility.--
       (A) In general.--The term ``food facility'' means a 
     domestic or foreign food manufacturer, slaughterhouse, 
     processor, packer, warehouse, or other facility that--
       (i) if operating in the United States, manufactures, 
     slaughters, processes, or holds food or food ingredients; or
       (ii) if operating outside the United States, manufactures, 
     slaughters, processes, or holds food intended for consumption 
     in the United States.
       (B) Exclusions.--For the purposes of registration, the term 
     ``food facility'' does not include--
       (i) a farm, restaurant, other retail food establishment, 
     nonprofit food establishment in which food is prepared for or 
     served directly to the consumer; or
       (ii) a fishing vessel (other than a fishing vessel engaged 
     in processing, as that term is defined in section 123.3(k) of 
     title 21, Code of Federal Regulations).
       (15) Food production establishment.--The term ``food 
     production establishment'' means any farm, ranch, orchard, 
     vineyard, aquaculture facility, or confined animal-feeding 
     operation.
       (16) 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, labeling, and inspection of food, infant formulas, 
     food additives, pesticide residues, and other substances 
     present in food under that Act;
       (B) the provisions of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 301 et seq.) and of any other Act that are 
     administered by the Center for Veterinary Medicine of the 
     Food and Drug Administration;
       (C) the Poultry Products Inspection Act (21 U.S.C. 451 et 
     seq.);
       (D) the Federal Meat Inspection Act (21 U.S.C. 601 et 
     seq.);
       (E) the FDA Food Safety Modernization Act (Public Law 111-
     353; 124 Stat. 3885);
       (F) the Egg Products Inspection Act (21 U.S.C. 1031 et 
     seq.);
       (G) chapter 57 of title 49, United States Code (formerly 
     known as the ``Sanitary Food Transportation Act of 1990'');

[[Page S4572]]

       (H) Public Law 85-765 (commonly known as the ``Humane 
     Methods of Slaughter Act of 1958'') (7 U.S.C. 1901 et seq.);
       (I) this Act; and
       (J) such other provisions of law related to and requiring 
     food safety, labeling, inspection, and enforcement as the 
     President designates by Executive order as appropriate to 
     include within the jurisdiction of the Administration.
       (17) Interstate commerce.--The term ``interstate commerce'' 
     has the meaning given the 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 the term in--
       (A) section 403 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 343) for food regulated under such Act;
       (B) section 1(n) of the Federal Meat Inspection Act (21 
     U.S.C. 601(n)) for food regulated under such Act;
       (C) section 4(h) of the Poultry Products Inspection Act (21 
     U.S.C. 453(h)) for food regulated under such Act; and
       (D) section 4(l) of the Egg Products Inspection Act (21 
     U.S.C. 1033(l)) for food regulated under such Act.
       (19) Process.--The term ``process'' or ``processing'' means 
     the commercial slaughter, packing, preparation, or 
     manufacture of food.
       (20) Safe.--The term ``safe'' refers to human and animal 
     health.
       (21) 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.
       (22) Validation.--The term ``validation'' means the act of 
     obtaining evidence that the process control measure or 
     measures selected to control a contaminant in food is capable 
     of effectively and consistently controlling the contaminant.
       (23) Statistically valid.--The term ``statistically valid'' 
     means evaluated and conducted under standards set by the 
     National Institute of Standards and Technology.

          TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

     SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION.

       (a) Establishment.--
       (1) In general.--There is established in the Executive 
     branch an agency to be known as the ``Food Safety 
     Administration''.
       (2) Status.--The Administration shall be an independent 
     establishment (as defined in section 104 of title 5, United 
     States Code).
       (3) Head of 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.
       (b) Duties of Administrator.--The Administrator shall--
       (1) administer and enforce the food safety law;
       (2) serve as a representative to international food safety 
     bodies and discussions;
       (3) promulgate regulations to ensure the security of the 
     food supply from all forms of contamination, including 
     intentional contamination; and
       (4) oversee--
       (A) implementation of Federal food safety inspection, 
     labeling, enforcement, and research efforts to protect the 
     public health;
       (B) development of consistent and science-based standards 
     for safe food;
       (C) coordination and prioritization of food safety research 
     and education programs with other Federal agencies;
       (D) prioritization of Federal food safety efforts and 
     deployment of Federal food safety resources to achieve the 
     greatest benefit in reducing foodborne illness;
       (E) coordination of the Federal response to foodborne 
     illness outbreaks with other Federal and State agencies; and
       (F) integration of Federal food safety activities with 
     State and local agencies.

     SEC. 102. CONSOLIDATION OF SEPARATE FOOD SAFETY AND 
                   INSPECTION SERVICES AND AGENCIES.

       (a) Transfer of Functions.--For each Federal agency 
     specified in subsection (b), there are transferred to the 
     Administration all functions that the head of the Federal 
     agency exercised on the day before the date of enactment of 
     this Act (including all related functions of any officer or 
     employee of the Federal agency) that relate to administration 
     or enforcement of the food safety law, as determined by the 
     President.
       (b) Transferred Agencies.--The Federal agencies referred to 
     in subsection (a) are--
       (1) the Food Safety and Inspection Service of the 
     Department of Agriculture;
       (2) the Center for Food Safety and Applied Nutrition of the 
     Food and Drug Administration;
       (3) the part of the Agriculture Marketing Service that 
     administers shell egg surveillance services established under 
     the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);
       (4) the resources and facilities of the Office of 
     Regulatory Affairs of the Food and Drug Administration that 
     administer and conduct inspections of food and feed 
     facilities and imports;
       (5) the Center for Veterinary Medicine of the Food and Drug 
     Administration;
       (6) the Office of Food Policy and Response of the Food and 
     Drug Administration;
       (7) the part of the Research, Education, and Economics 
     mission area of the Department of Agriculture related to food 
     and feed safety;
       (8) the part of the National Marine Fisheries Service of 
     the National Oceanic and Atmospheric Administration of the 
     Department of Commerce that administers the seafood 
     inspection program;
       (9) the part of the Animal and Plant Inspection Health 
     Service of the Department of Agriculture related to the 
     management of animals going into the food supply; and
       (10) such other offices, services, or agencies as the 
     President designates by Executive order to carry out this 
     Act.

     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 regulatory 
     science and 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) administer a national food safety program (referred to 
     in this section as the ``program'') to protect public health; 
     and
       (2) ensure that persons who produce or process 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 health risks;
       (2) the sources and specific points of potential 
     contamination extending from the farm or ranch to the 
     consumer that may render food unsafe;
       (3) the potential for persistence, multiplication, or 
     concentration of naturally occurring or added contaminants in 
     food;
       (4) opportunities across the food production, processing, 
     distribution, and retail system to manage and reduce 
     potential health risks; and
       (5) opportunities for intentional contamination.
       (c) Program Elements.--In carrying out the program, the 
     Administrator shall--
       (1) adopt and implement a national system for the 
     registration of food facilities and regular unannounced 
     inspection of food facilities;
       (2) verify and enforce the adoption of preventive process 
     controls in food facilities, based on the best available 
     scientific and public health considerations and best 
     available technologies;
       (3) establish and enforce science-based standards for--
       (A) substances that may contaminate food; and
       (B) safety and sanitation in the processing and handling of 
     food;
       (4) implement a statistically valid sampling program to 
     ensure that industry programs and procedures that prevent 
     food contamination are effective on an ongoing basis and that 
     food meets the performance standards established under this 
     Act;
       (5) implement procedures and requirements to ensure the 
     safety and security of imported food;
       (6) coordinate with other agencies and State or local 
     governments in carrying out inspection, enforcement, 
     research, and monitoring;
       (7) access the surveillance data of the Centers for Disease 
     Control and Prevention, and other Federal Government 
     agencies, in order to develop and implement a national 
     surveillance system to assess the health risks associated 
     with the human consumption of food or to create surveillance 
     data and studies to mitigate food threats (such as antibiotic 
     resistance) or to identify the ways that food

[[Page S4573]]

     contamination spreads through environments;
       (8) partner with relevant agencies to identify and prevent 
     terrorist threats to food;
       (9) establish a process for providing a single point of 
     contact to assist impacted consumers in navigating Federal, 
     State, and local agencies involved in responding to or 
     monitoring a foodborne outbreak;
       (10) develop public education risk communication and 
     advisory programs;
       (11) implement a basic and applied research program to 
     further the purposes of this Act; and
       (12) coordinate and prioritize food safety research and 
     educational programs with other agencies, including State or 
     local agencies.

     SEC. 202. REGISTRATION OF FOOD FACILITIES.

       (a) In General.--The Administrator shall require that all 
     food and feed facilities register before the facility can 
     operate in the United States or import food, feed, or 
     ingredients into the United States.
       (b) Registration Requirements.--
       (1) In general.--To be registered under subsection (a)--
       (A) all food facilities covered under this Act shall comply 
     with registration requirements in section 415 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 350d);
       (B) for food facilities that have not registered under such 
     section 415 prior to the date of enactment of this Act, the 
     requirement in subparagraph (A) applies beginning on the day 
     that is 180 days after the date of enactment of this Act; and
       (C) for food facilities that have registered under such 
     section 415 prior to the date of enactment of this Act, such 
     facilities shall file an amended registration within 180 days 
     of such date of enactment to deliver the information required 
     by paragraph (2).
       (2) Categories.--In addition to the information required 
     under section 415 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 350d) to be included in registration, a food 
     facility shall--
       (A) list the facility's primary purpose and business 
     activity, including the dates of operation if the food 
     facility is operating seasonally; and
       (B) list the types of food handled at the facility and 
     identify the activities conducted in the facility, that are 
     relevant to determining whether the facility is a category 1, 
     2, 3, 4, or 5 facility.
       (3) Procedure.--Upon receipt of a completed or amended 
     registration described in paragraph (1), the Administrator 
     shall notify the registrant of the receipt of the 
     registration, review the activities identified in the 
     registration, designate the facility as a category 1, 2, 3, 
     4, or 5 food facility for the purposes of inspection, and 
     assign a registration number to each food facility.
       (4) List.--The Administrator--
       (A) shall compile and maintain an up-to-date list of food 
     facilities that are registered under this section, in 
     accordance with section 415(a)(5) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 350d(a)(5)); and
       (B) may establish regulations on how the list may be shared 
     with other governmental authorities.

     SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE ADULTERATION 
                   OF FOOD.

       (a) In General.--The Administrator shall review existing 
     regulations on hazard analysis and process controls and amend 
     existing regulations as appropriate, upon the basis of best 
     available public health, scientific, and technological 
     information, to ensure that those regulations are working 
     effectively to--
       (1) ensure food facilities operate in a sanitary manner so 
     that food is not adulterated;
       (2) limit the presence of contaminants in food;
       (3) meet the performance standards established under 
     section 204;
       (4) ensure fully processed or ready-to-eat foods are 
     processed using reasonably available techniques and 
     technologies to eliminate contaminants;
       (5) label food intended for final processing outside 
     commercial food facilities with instructions for handling and 
     preparation for consumption that will destroy contaminants;
       (6) require sampling and testing at a frequency and in a 
     manner sufficient to ensure that process controls are 
     effective on an ongoing basis and that performance standards 
     are being met; and
       (7) provide for agency access to records kept by food 
     facilities and submission of copies of the records to the 
     Administrator, as the Administrator determines appropriate.
       (b) Processing Controls.--The Administrator may require any 
     person with responsibility for or control over food or food 
     ingredients to adopt process controls, if the process 
     controls are needed to ensure the protection of the public 
     health.

     SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS IN FOOD.

       (a) Performance Standards.--Whenever the Administrator 
     determines that a foodborne contaminant presents the risk of 
     serious adverse health consequences or death to consumers, 
     causes food to be adulterated, or could promote the spread of 
     communicable disease described in section 361 of the Public 
     Health Service Act (42 U.S.C. 264), the Administrator shall 
     issue a performance standard (in the form of guidance, action 
     levels, or regulations) to prevent or control the 
     contaminant.
       (b) Enforcement.--
       (1) In general.--Not later than 1 year after the 
     promulgation of a performance standard under this section, 
     the Administrator shall implement a statistically significant 
     sampling program to determine whether food facilities are 
     complying with the standards promulgated under this section.
       (2) Actions.--If the Administrator determines that a food 
     facility fails to meet a standard promulgated under this 
     section, and such facility fails to take appropriate 
     corrective action as determined by the Administrator, the 
     Administrator shall, as appropriate--
       (A) detain, seize, or condemn food from the food facility 
     under section 209(i);
       (B) order a recall of food from the food facility under 
     section 402;
       (C) increase the inspection frequency for the food 
     facility;
       (D) withdraw the mark of inspection from the food facility, 
     if in use; or
       (E) take other appropriate enforcement action concerning 
     the food facility, including suspension of registration.
       (c) Newly Identified Contaminants.--Notwithstanding any 
     other provision of this section, the Administrator shall 
     promulgate interim performance standards for newly identified 
     contaminants as necessary to protect the public health.
       (d) Revocation by Administrator.--All performance 
     standards, tolerances, action levels, or other similar 
     standards with respect to food in effect on the date of 
     enactment of this Act shall remain in effect until revised or 
     revoked by the Administrator.

     SEC. 205. INSPECTIONS OF FOOD FACILITIES.

       (a) In General.--The Administrator shall establish an 
     inspection program, which shall include sampling and testing 
     of food and food facilities, to determine if each food 
     facility--
       (1) is operating in a sanitary manner;
       (2) has continuous systems, interventions, and processes in 
     place to minimize or eliminate contaminants in food;
       (3) uses validated process controls and ongoing 
     verification;
       (4) is in compliance with applicable performance standards 
     established under section 204, process control regulations, 
     and other requirements;
       (5) is processing food that is safe and not adulterated or 
     misbranded;
       (6) maintains records of process control plans under 
     section 203, and other records related to the processing, 
     sampling, and handling of food; and
       (7) is in compliance with the requirements of the 
     applicable food safety law.
       (b) Facility Categories and Inspection Frequencies.--
     Inspections of food facilities under this Act shall be based 
     on the following categories and inspection frequencies, 
     subject to subsections (c), (d), and (e):
       (1) Category 1 food facilities.--A category 1 food facility 
     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 facility has successfully identified and 
     removed from the slaughter line visibly defective or 
     contaminated carcasses, has avoided cross-contamination, and 
     has destroyed or reprocessed contaminated 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 facilities.--A category 2 food facility 
     shall be randomly inspected at least daily.
       (3) Category 3 food facilities.--A category 3 food facility 
     shall--
       (A) provide documentation to the Administrator on request 
     that ongoing verification shows that its processes are 
     controlled; and
       (B) be randomly inspected at least monthly.
       (4) Category 4 food facilities.--A category 4 food facility 
     shall be randomly inspected at least quarterly.
       (5) Category 5 food facilities.--A category 5 food facility 
     shall be randomly inspected at least annually.
       (c) Establishment of Inspection Procedures.--The 
     Administrator shall establish procedures under which 
     inspectors or safety officers inspect food facilities, which 
     shall allow the taking of random samples, photographs, and 
     copies of records in food facilities.
       (d) Alternative Inspection Frequencies.--
       (1) In general.--With respect to a category 2, 3, 4, or 5 
     food facility, to foster a risk-based allocation of 
     resources, the Administrator may establish, in accordance 
     with this subsection, alternative increased or decreased 
     inspection frequencies for--
       (A) 1 or more subcategories of food facilities under 
     paragraph (2); and
       (B) 1 or more specific food facilities under paragraph (3).
       (2) Determination of subcategories and frequencies.--
       (A) In general.--The Administrator shall define, by 
     regulation, each subcategory of food facilities established 
     under paragraph (1)(A) and the alternative inspection 
     frequency of that subcategory.
       (B) Considerations.--In defining a subcategory of food 
     facilities and the alternative inspection frequency of that 
     subcategory under subparagraph (A), the Administrator shall 
     consider--
       (i) the nature of the foods being processed, stored, or 
     transported;

[[Page S4574]]

       (ii) the manner in which foods are processed, stored, or 
     transported;
       (iii) the inherent likelihood that the foods will 
     contribute to the risk of foodborne illness;
       (iv) the best available evidence concerning reported 
     illnesses associated with the foods produced in the proposed 
     subcategory of facilities; and
       (v) the overall record of compliance with the food safety 
     law among facilities in the proposed subcategory, including 
     compliance with applicable performance standards and the 
     frequency of recalls.
       (3) Specific facilities.--
       (A) In general.--The Administrator--
       (i) may establish an alternative inspection frequency for 
     increased or decreased inspection for a specific food 
     facility; and
       (ii) shall annually publish a list of food facilities 
     subject to alternative inspection frequencies under clause 
     (i).
       (B) Considerations.--In establishing an alternative 
     inspection frequency for a specific food facility, the 
     Administrator shall consider--
       (i) the supporting evidence that the specific food facility 
     shall submit to the Administrator relating to whether an 
     alternative inspection frequency should be established for 
     that facility by the Administrator;
       (ii) whether products from the specific food facility have 
     been associated with a case or an outbreak of foodborne 
     illness;
       (iii) the record of the facility of compliance with the 
     food safety law, including compliance with applicable 
     performance standards and the frequency of recalls; and
       (iv) the considerations described in clauses (i) through 
     (iii) of paragraph (2)(B).
       (4) Frequency requirements for categories 2, 3, and 4.--An 
     alternative inspection frequency for a subcategory of food 
     facilities or a specific food facility under this subsection 
     shall be--
       (A) in the case of a category 2 food facility, not less 
     frequently than monthly; and
       (B) in the case of a category 3 or 4 food facility, not 
     less frequently than annually.
       (5) Requirements for decreased frequencies.--Before issuing 
     a regulation or order establishing a decreased alternative 
     inspection frequency for a subcategory of food facilities or 
     an individual food facility under this subsection, the 
     Administrator shall--
       (A) describe, in general terms, the alternative uses of 
     resources of the Administration that would have been required 
     to carry out the inspection activity; and
       (B) determine, based on the best available evidence, that 
     the alternative uses of the resources would make a greater 
     contribution to protecting the public health and reducing the 
     risk of foodborne illness.
       (e) Inspection Transition.--The Administrator shall manage 
     the transition to the inspection system described in this Act 
     as follows:
       (1) Regulations.--The Administrator shall promulgate 
     regulations to implement this section no later than 24 months 
     after the date of enactment of this Act.
       (2) Limit on reduction in inspection frequency.--For any 
     food facility, the Administrator shall not reduce the 
     inspection frequency from the frequency required pursuant to 
     the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the 
     Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.) until the food facility has demonstrated that 
     sufficient changes in facilities, procedures, personnel, or 
     other aspects of the process control system have been made 
     such that the Administrator determines that compliance with 
     the food safety law is achieved.
       (f) Official Mark.--
       (1) In general.--
       (A) Establishment.--Before the completion of the transition 
     process under subsection (e), the Administrator shall by 
     regulation establish an official mark that can be affixed to 
     a food produced in a category 1, 2, or 3 food facility if--
       (i) the facility is in compliance with the food safety law; 
     and
       (ii) has been inspected in accordance with the inspection 
     frequencies under this section.
       (B) Removal of official mark.--The Administrator shall 
     promulgate regulations that provide for the removal of the 
     official mark under this subsection if--
       (i) the Administrator makes a finding that the facility is 
     not in compliance with the food safety law; or
       (ii) the Administrator suspends the registration of the 
     facility.
       (2) Category 1, 2, or 3 food facilities.--In the case of 
     products manufactured, slaughtered, processed, or held in a 
     category 1, 2, or 3 food facility--
       (A) products subject to the Federal Meat Inspection Act (21 
     U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 
     U.S.C. 451 et seq.), the Egg Products Inspection Act (21 
     U.S.C. 1031 et seq.), and the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) as of the date of 
     enactment of this Act shall remain subject to the requirement 
     under those Acts that they bear the mark of inspection 
     pending completion of the transition process under subsection 
     (e);
       (B) the Administrator shall publicly certify on a monthly 
     basis that the inspection frequencies required under this 
     section have been achieved; and
       (C) a product from a facility that has not been inspected 
     in accordance with the required frequencies under this 
     section shall not bear the official mark and shall not be 
     shipped in interstate commerce.
       (3) Category 4 and 5 food facilities.--In the case of a 
     product manufactured, slaughtered, processed, or held in a 
     category 4 or 5 food facility, the Administrator shall 
     provide by regulation for the voluntary use of the official 
     mark established under paragraph (1), subject to--
       (A) such minimum inspection frequencies as determined 
     appropriate by the Administrator;
       (B) compliance with applicable performance standards and 
     other provisions of the food safety law; and
       (C) such other requirements as the Administrator considers 
     appropriate.
       (g) Maintenance and Inspection of Records.--
       (1) In general.--
       (A) Records.--A food facility shall--
       (i) maintain such records as the Administrator requires 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 
     of the food safety agencies in effect on the day before the 
     date of enactment of this Act, 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 facility 
     representative in any format (including paper or electronic) 
     and at any location, that are necessary to assist the 
     Administrator to determine whether the food is contaminated 
     or not in compliance with the food safety law.
       (B) Required disclosure.--A food facility 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 required by 
     paragraph (1) shall be maintained for a reasonable period of 
     time, as determined by the Administrator.
       (3) Requirements.--The records required by 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 facility;
       (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 
     unsafe, is adulterated or misbranded, or otherwise fails to 
     meet the requirements of this Act.
       (h) Protection of Sensitive Information.--
       (1) In general.--The Administrator shall develop and 
     maintain procedures to prevent the unauthorized disclosure of 
     any trade secret or confidential information obtained by the 
     Administrator.
       (2) Limitation.--The requirement under this subsection does 
     not--
       (A) limit the authority of the Administrator to inspect or 
     copy records or to require the facility 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, personnel data, or sales data (other than shipment 
     dates relating to sales);
       (D) limit the public disclosure of distribution records or 
     other records related to food subject to a voluntary or 
     mandatory recall under section 402; or
       (E) limit the authority of the Administrator to promulgate 
     regulations to permit the sharing of data with other 
     governmental authorities.
       (i) Bribery of or Gifts to Inspector or Other Officers and 
     Acceptance of Gifts.--Section 22 of the Federal Meat 
     Inspection Act (21 U.S.C. 622) shall apply under this Act.

     SEC. 206. FOOD PRODUCTION ESTABLISHMENTS.

       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 establishments, 
     to--
       (1) visit and inspect food production establishments in the 
     United States and in foreign countries for food safety 
     purposes;
       (2) review food safety records as needed to carry out 
     traceback and for other food safety purposes;
       (3) set good practice standards to protect the public and 
     promote food safety;
       (4) partner with appropriate agencies to monitor animals, 
     plants, products, or the environment, as appropriate; and
       (5) collect and maintain information relevant to public 
     health and farm practices.

     SEC. 207. FEDERAL AND STATE COOPERATION.

       (a) In General.--The Administrator shall work with the 
     States to carry out activities and programs that create a 
     national food safety program so that Federal and State 
     programs function in a coordinated and cost-effective manner.
       (b) State Action.--The Administrator shall work with States 
     to--
       (1) continue, strengthen, or establish State food safety 
     programs, especially with respect to the regulation of retail 
     commercial food establishments, transportation, harvesting, 
     and fresh markets;

[[Page S4575]]

       (2) continue, strengthen, or establish inspection programs 
     and requirements to ensure that food under the jurisdiction 
     of the State is safe; and
       (3) support recall authorities at the State and local 
     levels.
       (c) Assistance.--To assist in planning, developing, and 
     implementing a food safety program, the Administrator may 
     provide to a State--
       (1) advisory assistance;
       (2) technical and laboratory assistance and training 
     (including necessary materials and equipment); and
       (3) financial assistance, in kind assistance, and other 
     aid.
       (d) 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 personnel and services of 
     those agencies in carrying out this Act.
       (2) Training.--Agreements with a State under this 
     subsection may provide for training of State employees.
       (3) Maintenance of agreements.--The Administrator shall 
     maintain any agreement that is in effect on the day before 
     the date of enactment of this Act until the Administrator 
     evaluates such agreement and determines whether to maintain 
     or substitute such agreement.
       (e) Audits.--
       (1) In general.--The Administrator shall annually conduct a 
     comprehensive review of each State program that provides 
     services to the Administrator in carrying out the 
     responsibilities under this Act, including mandated 
     inspections under section 205.
       (2) Requirements.--The review shall--
       (A) include a determination of the effectiveness of the 
     State program; and
       (B) identify any changes necessary to ensure enforcement of 
     Federal requirements under this Act.
       (f) No Federal Preemption.--Nothing in this Act shall be 
     construed to preempt the enforcement of State food safety 
     laws and standards that are at least as stringent as those 
     under this Act.

     SEC. 208. FOREIGN SUPPLIER VERIFICATION PROGRAM.

       (a) In General.--The Administrator shall require that each 
     importer of products from a feed facility, food facility, or 
     food producer establishment be in compliance with the foreign 
     supplier verification program requirements under section 805 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a).
       (b) Rule of Construction.--In applying subsection (a) with 
     respect to products subject to the Federal Meat Inspection 
     Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection 
     Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection 
     Act (21 U.S.C. 1031 et seq.), references in section 805 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) to 
     sections 402, 403(w), 418, and 419 of such Act (21 U.S.C. 
     342, 343(w), 350g, and 350h) shall be construed to be 
     references to the corresponding provisions of the food safety 
     law, if any, that apply to such products, as determined by 
     the Administrator.
       (c) Repeal of Exemptions.--Section 805 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 384a) is amended--
       (1) in subsection (a)(1), by striking ``subsections (e) and 
     (f)'' and inserting ``subsection (e)'';
       (2) by striking subsection (e); and
       (3) by redesignating subsections (f) and (g) as subsections 
     (e) and (f), respectively.

     SEC. 209. IMPORTS.

       (a) In General.--Not later than 2 years after the date of 
     enactment of this Act, the Administrator shall establish a 
     system under which a foreign government seeking to certify 
     food for importation into the United States shall submit a 
     request for accreditation to the Administrator.
       (b) Accreditation Standard.--A foreign government 
     requesting to be accredited to certify food for importation 
     into the United States shall demonstrate, in a manner 
     determined appropriate by the Administrator, that the foreign 
     government (or an agency thereof) is capable of adequately 
     ensuring that eligible entities or foods certified by such 
     government (or agency) meet the requirements of the food 
     safety law.
       (c) Request by Foreign Government.--Prior to granting 
     accreditation to a foreign government under this section, the 
     Administrator shall review and audit the food safety program 
     of the requesting foreign government and certify that such 
     program (including all statutes, regulations, and inspection 
     authority) meets the standard specified in subsection (b).
       (d) Limitations.--Any accreditation of a foreign government 
     under this section shall--
       (1) specify the foods covered by the accreditation; and
       (2) be limited to a period not to exceed 5 years.
       (e) Withdrawal of Accreditation.--The Administrator may 
     withdraw accreditation fully or partially from a foreign 
     government if the Administrator finds that--
       (1) food covered by the accreditation is linked to an 
     outbreak of human illness;
       (2) the programs or procedures of the foreign government no 
     longer meet the standards of the food safety programs and 
     procedures of the United States; or
       (3) the foreign government refuses to allow United States 
     officials to conduct such audits and investigations as may be 
     necessary to fulfill the requirements under this section.
       (f) Renewal of Accreditation.--The Administrator shall 
     audit foreign governments accredited under this section at 
     least every 5 years to ensure the continued compliance by 
     such governments with the standard set forth in subsection 
     (b).
       (g) Required Routine Inspection.--The Administrator shall 
     routinely inspect food or food animals by physical 
     examination before the food or food animals enter the United 
     States to ensure that the food or food animals--
       (1) are safe;
       (2) are labeled as required for food produced in the United 
     States; and
       (3) otherwise meet the requirements of the food safety law.
       (h) Enforcement.--The Administrator may--
       (1) deny importation of food from any country if the 
     country's government does not permit United States officials 
     to enter the country to conduct such audits and inspections 
     as may be necessary to fulfill the requirements under this 
     section;
       (2) deny importation of food from any country or foreign 
     facility that does not consent to an investigation by the 
     Administrator when food from that country or foreign facility 
     is linked to a foodborne illness outbreak or is otherwise 
     found to be adulterated or mislabeled; and
       (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 standards of 
     the food safety law.
       (i) Detention and Seizure.--Any food imported for 
     consumption in the United States that fails to meet the 
     standards of the food safety law may be detained, seized, or 
     condemned.

     SEC. 210. TRACEBACK.

       (a) In General.--The Administrator, in order to protect the 
     public health, shall establish requirements for a national 
     system for tracing food, animals, or ingredients from point 
     of origin to retail sale, subject to subsection (b).
       (b) Applicability.--Traceability requirements shall--
       (1) be established in accordance with regulations and 
     guidelines issued by the Administrator; and
       (2) apply to food production establishments and food 
     facilities.

     SEC. 211. FOOD SAFETY TECHNOLOGY.

       (a) In General.--The Administrator shall establish and 
     implement a program, to be known as the Food Safety 
     Technology Program, to foster innovation in food technologies 
     and foods that have the potential to improve food safety at 
     the point of production, processing, transport, storage, or 
     final preparation.
       (b) Program Described.--The program under this section 
     shall consist of technical guidance to and consultation with 
     technology developers to assist them in meeting requirements 
     for approval of technologies and products described in 
     subsection (a).

                   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 the Deputy Under Secretary of Agriculture for 
     Research, Education, and Economics, shall--
       (1) have access to the applicable data systems of the 
     Centers for Disease Control and Prevention and to the 
     databases made available by a State;
       (2) partner with relevant agencies to maintain or access an 
     active surveillance system of food and epidemiological 
     evidence submitted by States to the Centers for Disease 
     Control and Prevention based on a representative proportion 
     of the population of the United States;
       (3) assess the frequency and sources of human illness in 
     the United States associated with the consumption of food;
       (4) partner with relevant agencies to maintain or access a 
     state-of-the-art partial or full genome sequencing system and 
     epidemiological system dedicated to foodborne illness 
     identification, outbreaks, and containment; and
       (5) have access to the surveillance data created via 
     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 date of 
     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.--Through the surveillance 
     system referred to

[[Page S4576]]

     in subsection (a), the sampling system described in 
     subsection (b), and other available data, the Administrator 
     shall--
       (1) rank food categories based on the hazard to human 
     health presented by the food category;
       (2) identify appropriate industry and regulatory approaches 
     to minimize hazards in the food supply; and
       (3) assess the public health environment for emerging 
     diseases, including zoonosis, for their risk of appearance in 
     the United States food supply.

     SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM.

       (a) Public Education.--The Administrator shall--
       (1) in cooperation with private and public organizations, 
     including the cooperative extension services and building on 
     the efforts of appropriate State and local entities, 
     establish a national public education program on food safety; 
     and
       (2) coordinate with other Federal departments and agencies 
     to integrate food safety messaging into all food-related 
     agricultural, nutrition, and health promotion programs.
       (b) Health Advisories.--The Administrator, in consultation 
     with such 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 foods 
     found to pose a threat to the public health.

     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) determine the food safety education needs of vulnerable 
     populations, including children less than 10 years of age, 
     pregnant women, adults 65 years of age and older, and 
     individuals with compromised immune systems;
       (9) utilize the partial or full genome sequencing system 
     and other processes to identify and control pathogens;
       (10) address common and emerging zoonotic diseases;
       (11) develop methods to reduce or destroy harmful pathogens 
     before, during, and after processing;
       (12) analyze the incidence of antibiotic resistance as it 
     pertains to the food supply and develop new methods to reduce 
     infection by antibiotic resistant bacteria in humans and 
     animals; and
       (13) conduct other research that supports the purposes of 
     this Act.
       (b) Contract Authority.--The Administrator may enter into 
     contracts and agreements with any State, institution of 
     higher education, Federal Government agency, or person to 
     carry out this section.

                         TITLE IV--ENFORCEMENT

     SEC. 401. PROHIBITED ACTS.

       It shall be unlawful--
       (1) for a person--
       (A) to manufacture, introduce, deliver for introduction, or 
     receive into interstate commerce any food that is 
     adulterated, misbranded, or otherwise unsafe;
       (B) to adulterate or misbrand any food in interstate 
     commerce;
       (C) to refuse to permit access to a food facility for the 
     inspection and copying of a record as required under section 
     205(g);
       (D) to fail to establish or maintain any record or to make 
     any report as required under section 205(g);
       (E) to refuse to permit entry to or inspection of a food 
     facility as required under section 205;
       (F) to fail to provide to the Administrator the results of 
     a testing or sampling of a food, equipment, or material in 
     contact with contaminated food under section 205(g)(1)(B);
       (G) to fail to comply with an applicable provision of, or a 
     regulation or order of the Administrator under, section 202, 
     204, or 208;
       (H) to slaughter an animal that is capable for use in whole 
     or in part as human food at a food facility processing any 
     such food for commerce, except in compliance with the food 
     safety law;
       (I) to fail to comply with a recall or other order under 
     section 402; or
       (J) to otherwise violate the food safety law; and
       (2) for a food facility or foreign food facility to fail to 
     register under section 202, or to operate without a valid 
     registration.

     SEC. 402. MANDATORY RECALL AUTHORITY.

       (a) Voluntary Procedures.--If the Administrator determines 
     that there is a reasonable probability that an article of 
     food (other than infant formula) is adulterated or misbranded 
     and the use of or exposure to such article will cause serious 
     adverse health consequences or death to humans or animals, 
     the Administrator shall provide to the owner, operator, or 
     agent in charge of the facility that created, caused, or was 
     otherwise responsible for that article of food an opportunity 
     to cease distribution and recall that article of food in a 
     manner and within a time period determined by the 
     Administrator.
       (b) Prehearing Order To Cease Distribution and Give 
     Notice.--
       (1) In general.--If the owner, operator, or agent in charge 
     of a facility refuses to, or does not voluntarily, cease 
     distribution or recall an article of food in the manner and 
     within the time period determined by the Administrator under 
     subsection (a), the Administrator may by order require, as 
     the Administrator determines to be necessary--
       (A) that owner, operator, or agent--
       (i) to immediately cease distribution of that article of 
     food; and
       (ii) as applicable, to immediately notify all persons 
     manufacturing, processing, packing, transporting, 
     distributing, receiving, holding, or importing and selling 
     that article of food; and
       (B) any person to which that article of food has been 
     distributed, transported, or sold, to immediately cease 
     distribution of that article of food.
       (2) Required additional information.--
       (A) In general.--If an article of food covered by a recall 
     order issued under paragraph (1) has been distributed to a 
     warehouse-based, third-party logistics provider without 
     providing such provider sufficient information to know or 
     reasonably determine the precise identity of the article of 
     food covered by a recall order that is in its possession, the 
     notice provided by the owner, operator, or agent of a 
     facility under paragraph (1)(A)(ii) shall include such 
     information as is necessary for the warehouse-based, third-
     party logistics provider to identify the article of food.
       (B) Rules of construction.--Nothing in this paragraph shall 
     be construed--
       (i) to exempt a warehouse-based, third-party logistics 
     provider from the requirements of food safety law; or
       (ii) to exempt a warehouse-based, third-party logistics 
     provider from being the subject of a mandatory recall order.
       (3) Determination to limit areas affected.--If the 
     Administrator requires an owner, operator, or agent in charge 
     of the facility to cease distribution under paragraph 
     (1)(A)(i) of an article of food identified under subsection 
     (a), the Administrator may limit the size of the geographic 
     area and the markets affected by such cessation if such 
     limitation would not compromise the public health.
       (c) Hearing on Order.--The Administrator shall provide the 
     owner, operator, or agent in charge of the facility subject 
     to an order under subsection (b) with an opportunity for an 
     informal hearing, to be held as soon as possible, but not 
     later than 2 days after the issuance of the order, on the 
     actions required by the order and on why the article that is 
     the subject of the order should not be recalled.
       (d) Post-Hearing Recall Order and Modification of Order.--
       (1) Amendment of order.--If, after providing opportunity 
     for an informal hearing under subsection (c), the 
     Administrator determines that removal of the applicable 
     article of food from commerce is necessary, the Administrator 
     shall, as appropriate--
       (A) amend the order to require recall of such article 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 to consumers to whom such article was, 
     or may have been, distributed.
       (2) Vacating of order.--If, after an informal hearing under 
     subsection (c), the Administrator determines that adequate 
     grounds do not exist to continue the actions required by the 
     applicable order, or that such actions should be modified, 
     the Administrator shall vacate the order or modify the order, 
     as appropriate.
       (e) Rule Regarding Alcoholic Beverages.--The Administrator 
     shall not initiate a mandatory recall or take any other 
     action under this section with respect to any alcohol 
     beverage until the Administrator has provided the 
     Administrator of the Alcohol and Tobacco Tax and Trade Bureau 
     with a reasonable opportunity to cease distribution and 
     recall the alcohol beverage under the authority of the 
     Administrator of the Alcohol and Tobacco Tax and Trade 
     Bureau.
       (f) Cooperation and Consultation.--The Administrator shall 
     work with State and local public health officials in carrying 
     out this section, as appropriate.
       (g) Public Notification.--In conducting a recall under this 
     section, the Administrator shall--
       (1) ensure that a press release is published regarding the 
     recall, as well as alerts and public notices, as appropriate, 
     in order to provide notification--
       (A) of the recall to consumers and retailers to whom the 
     applicable article of food was, or may have been, 
     distributed; and
       (B) that includes, at a minimum--
       (i) the name of the article of food subject to the recall;
       (ii) a description of the risk associated with such 
     article; and

[[Page S4577]]

       (iii) to the extent practicable, information for consumers 
     about similar articles of food that are not affected by the 
     recall;
       (2) provide to the public a list of retail consignees 
     receiving products for which there is determined to be a 
     reasonable probability that eating the food will cause 
     serious adverse health consequences or death to humans or 
     animals; and
       (3) if available, publish on the Internet website of the 
     Administration an image of the article that is the subject of 
     the press release described in paragraph (1).
       (h) No Delegation.--The authority conferred by this section 
     to order a recall or vacate a recall order shall not be 
     delegated to any officer or employee other than the 
     Administrator.
       (i) Effect.--Nothing in this section shall affect the 
     authority of the Administrator to request or participate in a 
     voluntary recall, or to issue an order to cease distribution 
     or to recall under any other provision of the food safety law 
     or under the Public Health Service Act (42 U.S.C. 201 et 
     seq.).
       (j) Coordinated Communication.--
       (1) In general.--To assist in carrying out the requirements 
     of this subsection, the Administrator shall establish an 
     incident command operation or a similar operation that will 
     operate not later than 24 hours after the initiation of a 
     mandatory recall or the recall of an article of food for 
     which the use of, or exposure to, such article will cause 
     serious adverse health consequences or death to humans or 
     animals.
       (2) Requirements.--To reduce the potential for 
     miscommunication during recalls or regarding investigations 
     of a foodborne illness outbreak associated with a food that 
     is subject to a recall, each incident command operation or 
     similar operation under paragraph (1) shall use regular staff 
     and resources of the Administration to--
       (A) ensure timely and coordinated communication within the 
     Administration, including enhanced communication and 
     coordination between different agencies and organizations 
     within the Administration;
       (B) ensure timely and coordinated communication from the 
     Administration, including public statements, throughout the 
     duration of the investigation and related foodborne illness 
     outbreak;
       (C) identify a single point of contact within the 
     Administration for public inquiries regarding any actions by 
     the Administrator related to a recall;
       (D) coordinate with Federal, State, local, and Tribal 
     authorities, as appropriate, that have responsibilities 
     related to the recall of a food or a foodborne illness 
     outbreak associated with a food that is subject to the 
     recall, including notification of the Secretary of 
     Agriculture and the Secretary of Education in the event such 
     recalled food is a commodity intended for use in a child 
     nutrition program (as defined in section 25(b) of the Richard 
     B. Russell National School Lunch Act (42 U.S.C. 1769f(b))); 
     and
       (E) conclude operations at such time as the Administrator 
     determines appropriate.
       (3) Multiple recalls.--The Administrator may establish 
     multiple or concurrent incident command operations or similar 
     operations in the event of multiple recalls or foodborne 
     illness outbreaks.
       (4) Fees applicable to all facilities.--Fees described in 
     section 743 of Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379j-31) for not complying with a recall order are 
     applicable to all food facilities under this Act as if--
       (A) the term ``responsible party'' means ``owner, operator, 
     or agent in charge of the facility''; and
       (B) references to section 423 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 350l) are references to section 
     402 of this Act.

     SEC. 403. 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, 207, or 401 (or a regulation promulgated under that 
     section).
       (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. 404. CIVIL AND CRIMINAL PENALTIES.

       (a) Civil Sanctions.--
       (1) Civil penalty.--
       (A) In general.--Any person that violates section 401 may 
     be assessed a civil penalty by the Administrator of not more 
     than $250,000 for each violation.
       (B) Separate offense.--Each violation described in 
     subparagraph (A) and each day during which that violation 
     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.--A written order under subparagraph 
     (A) may be reviewed only in accordance with subsection (c).
       (b) Criminal Sanctions.--
       (1) In general.--Except as provided in paragraphs (2) and 
     (3), a person that violates subparagraph (A) or (B) of 
     section 401(1) shall be imprisoned for not more than 1 year, 
     fined not more than $10,000, or both.
       (2) Severe violations.--A person that commits a violation 
     described in paragraph (1) after a conviction of that person 
     under this section has become final, or commits such a 
     violation with the intent to defraud or mislead, shall be 
     imprisoned for not more than 3 years, fined not more than 
     $100,000, or both.
       (3) Exception.--No person shall be subject to the penalties 
     of this subsection--
       (A) for having received, proffered, or delivered in 
     interstate commerce any food, if the receipt, proffer, or 
     delivery was made in good faith, unless that person refuses 
     to furnish (on request of an officer or employee designated 
     by the Administrator)--
       (i) the name, address, and contact information of the 
     person from whom that person purchased or received the food;
       (ii) copies of all documents relating to the person from 
     whom that person purchased or received the food; and
       (iii) copies of all documents pertaining to the delivery of 
     the food to that person; or
       (B) if that person establishes a guaranty signed by, and 
     containing the name and address of, the person from whom that 
     person received in good faith the food, stating that the food 
     is not adulterated or misbranded within the meaning of this 
     Act.
       (c) Judicial Review.--
       (1) In general.--An order assessing a civil penalty 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--
       (i) the court of appeals of the United States for the 
     judicial circuit in which that 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 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 (c) has entered final 
     judgment in favor of the Administrator, the Administrator 
     shall refer the matter to the Attorney General, who shall 
     institute in a district court of the United States 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 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 may be in addition to, and not exclusive of, other 
     remedies that may be available.

     SEC. 405. 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. 406. WHISTLEBLOWER PROTECTION.

       Section 1013 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 399d) shall apply with respect to any violation 
     of, or any act or omission an employee reasonably believes to 
     be a violation of, any provision of this Act to the same 
     extent and in the same manner as that section applies with 
     respect to a violation of, or any act or omission an employee 
     reasonably believes to be a violation of, any provision of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
     seq.).

     SEC. 407. ADMINISTRATION AND ENFORCEMENT.

       (a) In General.--For the efficient administration and 
     enforcement of the food safety

[[Page S4578]]

     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 (15 
     U.S.C. 46)), 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, 50) on the 
     United States district courts may be exercised for the 
     purposes of this chapter by any district court of the United 
     States of competent jurisdiction.

     SEC. 408. 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.--
       (1) In general.--The action shall be commenced in the 
     district court of the United States for the judicial district 
     in which the defendant resides, is found, or has an agent.
       (2) Jurisdiction.--The court described in paragraph (1) 
     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 described in paragraph (1) 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. DEFINITION.

       In this title, the term ``transition period'' means the 12-
     month period beginning on the date of enactment of this Act.

     SEC. 502. REORGANIZATION PLAN.

       (a) Submission of Plan.--Not later than 180 days after the 
     date of 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) Identification of any functions of agencies designated 
     to be transferred to the Administration pursuant to this Act 
     that will not be transferred 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 transition period.
       (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) Supercedes existing law.--Paragraph (1) shall apply 
     notwithstanding section 905(b) of title 5, United States 
     Code.

     SEC. 503. 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 on 
     the day before the date of 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, on a reimbursable basis, 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 on the day 
     before the date of 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. 504. 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, 
     permit, personnel action, agreement, grant, contract, 
     certificate, license, registration, 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 could have 
     occurred if such enactment or transfer had not occurred; and
       (2) orders issued in such proceedings, and appeals from 
     those orders, and payments made pursuant to such orders, 
     shall be issued 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, superceded, 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.--

[[Page S4579]]

       (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 laws 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 on 
     the day before the date of enactment of this Act shall 
     continue to apply following such transfer if the reporting 
     requirements refer to the agency by name.

     SEC. 505. CONFORMING AMENDMENTS.

       Section 5313 of title 5, United States Code, is amended by 
     adding at the end the following new item:
       ``Administrator of Food Safety.''.

     SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING AMENDMENTS.

       Not later than 60 days after the submission of the 
     reorganization plan under section 502, the President shall 
     prepare and submit proposed legislation to Congress 
     containing necessary and appropriate technical and conforming 
     amendments to any food safety law to reflect the changes made 
     by this Act.

     SEC. 507. REGULATIONS.

       The Administrator may promulgate such regulations as the 
     Administrator determines are necessary or appropriate to 
     perform the duties of the Administrator.

     SEC. 508. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated such sums as are 
     necessary to carry out this Act.

     SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIATIONS.

       For the fiscal year that includes the date of 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 
     enactment of this Act, appropriations for those agencies for 
     the fiscal year that includes that date of enactment have not 
     yet been made.
                                 ______
                                 
      By Mr. WYDEN (for himself and Mr. Merkley):
  S. 1997. A bill to authorize transitional sheltering assistance for 
individuals who live in areas with unhealthy air quality caused by 
wildfires, and for other purposes; to the Committee on Homeland 
Security and Governmental Affairs.
  Mr. WYDEN. Mr. President, today I am introducing the Wildfire Smoke 
Relief Act of 2019 with the ultimate goal of providing Federal 
emergency assistance to at risk individuals in areas with unhealthy air 
quality caused by wildfire smoke. By actively preparing for the effects 
of wildfire smoke inhalation, this bill attempts to ensure the long 
term health and security of all of those affected by wildfires.
  In 2018, over 2,000 fires burned nearly 900,000 acres in the State of 
Oregon. The result of these fires was weeks and weeks of wildfire 
smoke. In Southern Oregon alone, there were 39 days with unhealthy air 
quality directly caused by smoke from wildfires. People need proper air 
filtration equipment, and in extreme cases, to seek refuge in a 
smokeless area. Communities are being choked by wildfire smoke, and 
each year wildfires are becoming more destructive than the previous.
  Vulnerable populations like children, the elderly, pregnant women, 
and low-income families are disproportionately affected by wildfire 
smoke. Additionally, those with chronic heart or lung conditions are at 
a similarly heightened risk. Symptoms from smoke inhalation can develop 
within a relatively short time of exposure, and according to research, 
is akin to smoking several packs of cigarettes per day. Symptoms vary 
and can include poor development of lungs in children, shortness of 
breath, coughing, chest pain, nausea, reduced lung capacity, 
bronchitis, headaches, and visual impairment.
  The bill would authorize the Federal Emergency Management Agency 
(FEMA) to provide assistance to at risk individuals by providing smoke 
inhalation prevention equipment and low-cost home improvements when air 
quality causes unhealthy air quality levels or three consecutive days. 
Smoke inhalation prevention equipment would include an air filter, a 
face mask or respirator, a portable air filtration unit, and other low 
cost equipment used to keep smoke out of a house.
  In severe cases, the Wildfire Smoke Relief Act would authorize FEMA 
to provide transitional sheltering assistance for at risk individuals. 
In these extreme cases FEMA can arrange alternate, cost-efficient 
housing arranged for at-risk people to escape the smoke.
  Mr. President, I am pleased to be joined by Senator Jeff Merkley in 
introducing the bill today and look forward to working with my 
colleagues toward enactment of the Wildfire Smoke Relief Act in the 
116th Congress.

                          ____________________