To amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to require that ready-to-eat meat or poultry products that are not produced under a scientifically validated program to address Listeria monocytogenes be required to bear a label advising pregnant women and other at-risk consumers of the recommendations of the Department of Agriculture and Food and Drug Administration regarding consumption of ready-to-eat products, and for other purposes.

June 4, 2003

Mrs. CLINTON introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

To amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to require that ready-to-eat meat or poultry products that are not produced under a scientifically validated program to address Listeria monocytogenes be required to bear a label advising pregnant women and other at-risk consumers of the recommendations of the Department of Agriculture and Food and Drug Administration regarding consumption of ready-to-eat products, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `At-Risk Consumer Protection Through Food Safety Labeling Act'.

SEC. 2. FINDINGS.

Congress finds that--

(1) consumption of food contaminated with microbial pathogens such as bacteria, parasites, viruses, and their toxins causes an estimated 76,000,000 illnesses, 325,000 hospitalizations, and 5,000 deaths each year in the United States;

(2) Government economists estimate that illnesses from Campylobacter, Salmonella, E. coli O157:H7, E. coli non-O157:H7 STEC, Listeria, and Toxoplasma gondii cause $6,900,000,000 in medical costs, lost productivity, and premature death in the United States each year;

(3) in particular, Listeria monocytogenes is the cause of 2,500 illnesses and 500 deaths annually, with economic costs of $2,300,000,000;

(4) people that face relatively higher risks from foodborne illness and associated complications include the very young, the very old, pregnant women, and the immunocompromised, such as persons with AIDS and cancer;

(5) outbreaks of foodborne illness are becoming increasingly widespread in both geographic area and duration, making detection and containment difficult;

(6) in 1998, following a major listeriosis outbreak from deli meats, many ready-to-eat meat and poultry processors established Listeria testing programs, but others have no Listeria testing and control program at all, giving them an unfair advantage in production costs over firms that are taking steps to protect public health;

(7)(A) in 1989, the Secretary of Agriculture established a performance standard allowing zero tolerance for Listeria monocytogenes that prohibits detectable levels of the pathogen in ready-to-eat meat and poultry products; and

(B) a performance standard for Listeria monocytogenes of nondetectable levels in ready-to-eat meat products--

(i) is appropriate to protect at-risk consumers (including pregnant women) (referred to in this section as `at-risk consumers') from severe health consequences or death from exposure to Listeria monocytogenes; and

(ii) is necessary to provide an adequate safety margin for at-risk consumers;

(8) in February 2001, the Secretary of Agriculture proposed regulations establishing performance standards for the production of processed meat and poultry products, including requirements for controlling Listeria monocytogenes, but, in the time since the public comment period closed in September 2001, little progress has been made in finalizing the regulation;

(9) in 2002, an outbreak of foodborne listeriosis linked to ready-to-eat turkey deli meat in Pennsylvania, New York, New Jersey, Delaware, Maryland, Connecticut, and Michigan--

(A) sickened 53 persons;

(B) killed 8 persons; and

(C) caused at least 3 pregnant women to suffer miscarriages or stillbirths;

(10) in a March 21, 2003, speech to the North American Meat Processors, Food Safety and Inspection Service Administrator Dr. Gary McKee said the agency's December 2002 directive outlining Listeria testing procedures for agency inspectors is only an interim measure;

(11) to ensure the safety of at-risk consumers, ready-to-eat meat and poultry products not produced under a scientifically validated program to address Listeria monocytogenes should be required to bear a label advising at-risk consumers of the Government's recommendations not to consume ready-to-eat meat and poultry products without heating the products until steaming hot; and

(12) all data generated through scientifically validated programs to address Listeria monocytogenes should be shared with the Department of Agriculture and used to improve scientific research regarding the safety of ready-to-eat foods.

SEC. 3. READY-TO-EAT MEAT PRODUCTS.

(a) IN GENERAL- Section 7 of the Federal Meat Inspection Act (21 U.S.C. 607) is amended by adding at the end the following:

`(g) READY-TO-EAT MEAT PRODUCTS-

`(1) DEFINITIONS- In this subsection:

`(A) AT-RISK CONSUMER- The term `at-risk consumer' includes a pregnant woman.

`(B) READY-TO-EAT MEAT PRODUCT- The term `ready-to-eat meat product' means a meat product that has been processed so that the meat product may be safely consumed without further preparation by the consumer, that is, without cooking or application of some other lethality treatment to destroy pathogens.

`(2) LABELING REQUIREMENT- Except as provided in paragraph (3) or (4), a ready-to-eat

meat product shall bear a label advising consumers that an at-risk consumer--

`(A) should not consume the ready-to-eat meat product unless the ready-to-eat meat product is heated until steaming hot; or

`(B) should follow such other instructions as the Secretary may prescribe in accordance with health guidelines and recommendations published by the Secretary and the Secretary of Health and Human Services.

`(3) EXEMPTIONS FOR PRODUCERS- On the motion of the Secretary or on petition of a producer of a ready-to-eat meat product, the Secretary, after notice and opportunity for a public hearing, shall, by regulation applicable to all producers of the ready-to-eat meat product or by order applicable to a particular producer of the ready-to-eat meat product, provide an exemption from the requirement of paragraph (2) if--

`(A) in the case of a ready-to-eat meat product that the Secretary determines presents a low risk to at-risk consumers, the producer--

`(i) has a scientifically validated program (as determined by the Secretary) to control Listeria monocytogenes; and

`(ii) makes all Listeria control program records (including the results of any testing of plant environment, food-contact surfaces, or meat product) available for inspection by the Secretary; or

`(B) in the case of any ready-to-eat meat product that the Secretary determines presents a greater risk to at-risk consumers, the producer of the ready-to-eat meat product has a scientifically valid program to address Listeria monocytogenes under which the producer--

`(i) tests food-contact surfaces for Listeria monocytogenes--

`(I) at least once every 2 days of production; and

`(II) if a food-contact surface tests positive--

`(aa) at least 3 times per day until the surface tests negative on 3 consecutive days; or

`(bb) in accordance with such other regimen as the Secretary may specify;

`(ii) tests the plant environment in the ready-to-eat meat processing area for the Listeria species--

`(I) at least once every 2 days of production; and

`(II) if any part of the plant environment in the ready-to-eat meat processing area tests positive--

`(aa) at least 3 times per day until the plant environment tests negative on 3 consecutive days; or

`(bb) in accordance with such other regimen as the Secretary may specify;

`(iii)(I) tests final products for Listeria monocytogenes at least 5 times per month to measure the effectiveness of the Listeria control program; and

`(II) if any food-contact surface tests positive, conducts daily testing of the meat product from the line found to be positive until the surface tests negative for 3 days;

`(iv) makes all control program records (including the results of any testing of plant environment, food-contact surfaces, or meat product) available for inspection by the Secretary; and

`(v) meets any other requirement that the Secretary may specify.

`(4) EXEMPTIONS FOR DISTRIBUTORS- On the motion of the Secretary or on petition of a distributor of a ready-to-eat meat product, the Secretary, after notice and opportunity for a public hearing, shall, by regulation applicable to all distributors of the ready-to-eat meat product or by order applicable to a particular distributor of the ready-to-eat meat product, provide an exemption from the requirement of paragraph (2) if--

`(A) the distributor has purchasing specifications incorporating the requirements of paragraph (3); and

`(B) the Secretary determines that the suppliers of the distributor are in compliance with paragraph (3).

`(5) REPORTS BY THE SECRETARY- Not later than 3 years after the date of enactment of this section, and at least triennially thereafter, the Secretary shall compile and disseminate information from records made available under paragraphs (3)(A)(ii), (3)(B)(iv), and (4) to Federal agencies, universities, and other research institutions and other entities, as appropriate (excluding any such proprietary or confidential information as is protected from disclosure), for the purpose of furthering scientific research.

`(6) PERFORMANCE STANDARD- A performance standard of the Secretary that provides zero tolerance for detectable levels of Listeria monocytogenes in ready-to-eat meats--

`(A) shall not be modified to permit any detectable level of Listeria monocytogenes in any ready-to-eat meat product; and

`(B) shall be based on scientifically validated testing methods for the detection of Listeria monocytogenes, as determined by the Secretary.'.

(b) MISBRANDING- Section 1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)) is amended--

(1) in paragraph (11), by striking `or' at the end;

(2) in paragraph (12), by striking the period at the end and inserting `; or'; and

(3) by adding at the end the following:

`(13) if it is a ready-to-eat meat product that is required to bear a label under section 7(g), and it does not bear such a label.'.

SEC. 4. READY-TO-EAT POULTRY PRODUCTS.

(a) IN GENERAL- Section 8 of the Poultry Products Inspection Act (21 U.S.C. 457) is amended by adding at the end the following:

`(e) READY-TO-EAT POULTRY PRODUCTS-

`(1) DEFINITIONS- In this subsection:

`(A) AT-RISK CONSUMER- The term `at-risk consumer' includes a pregnant woman.

`(B) READY-TO-EAT POULTRY PRODUCT- The term `ready-to-eat poultry product' means a poultry product that has been processed so that the poultry product may be safely consumed without further preparation by the consumer, that is, without cooking or application of some other lethality treatment to destroy pathogens.

`(2) LABELING REQUIREMENT- Except as provided in paragraph (3) or (4), a ready-to-eat poultry product shall bear a label advising consumers that an at-risk consumer--

`(A) should not consume the ready-to-eat poultry product unless the ready-to-eat poultry product is heated until steaming hot; or

`(B) should follow such other instructions as the Secretary may prescribe in accordance with health guidelines and recommendations published by the Secretary and the Secretary of Health and Human Services.

`(3) EXEMPTIONS FOR PRODUCERS- On the motion of the Secretary or on petition of a producer of a ready-to-eat poultry product, the Secretary, after notice and opportunity for a public hearing, shall, by regulation applicable to all producers of the ready-to-eat poultry product or by order applicable to a particular producer of the ready-to-eat poultry product, provide an exemption from the requirement of paragraph (2) if--

`(A) in the case of a ready-to-eat poultry product that the Secretary determines presents a low risk to at-risk consumers, the producer--

`(i) has a scientifically validated program (as determined by the Secretary) to control Listeria monocytogenes; and

`(ii) makes all Listeria control program records (including the results of any testing of plant environment, food-contact surfaces, or poultry product) available for inspection by the Secretary; or

`(B) in the case of any ready-to-eat poultry product that the Secretary determines presents a greater risk to at-risk consumers, the producer of the ready-to-eat poultry product has a scientifically valid program to address Listeria monocytogenes under which the producer--

`(i) tests food-contact surfaces for Listeria monocytogenes--

`(I) at least once every 2 days of production; and

`(II) if a food-contact surface tests positive--

`(aa) at least 3 times per day until the surface tests negative on 3 consecutive days; or

`(bb) in accordance with such other regimen as the Secretary may specify;

`(ii) tests the plant environment in the ready-to-eat poultry processing area for the Listeria species--

`(I) at least once every 2 days of production; and

`(II) if any part of the plant environment in the ready-to-eat poultry processing area tests positive--

`(aa) at least 3 times per day until the plant environment tests negative on 3 consecutive days; or

`(bb) in accordance with such other regimen as the Secretary may specify;

`(iii)(I) tests final products for Listeria monocytogenes at least 5 times per month to measure the effectiveness of the Listeria control program; and

`(II) if any food-contact surface tests positive, conducts daily testing of the poultry product from the line found to be positive until the surface tests negative for 3 days;

`(iv) makes all control program records (including the results of any testing of plant environment, food-contact surfaces, or poultry product) available for inspection by the Secretary; and

`(v) meets any other requirement that the Secretary may specify.

`(4) EXEMPTIONS FOR DISTRIBUTORS- On the motion of the Secretary or on petition of a distributor of a ready-to-eat poultry product, the Secretary, after notice and opportunity for a public hearing, shall, by regulation applicable to all distributors of the ready-to-eat poultry product or by order applicable to a particular distributor of the ready-to-eat poultry product, provide an exemption from the requirement of paragraph (2) if--

`(A) the distributor has purchasing specifications incorporating the requirements of paragraph (3); and

`(B) the Secretary determines that the suppliers of the distributor are in compliance with paragraph (3).

`(5) REPORTS BY THE SECRETARY- Not later than 3 years after the date of enactment of this section, and at least triennially thereafter, the Secretary shall compile and disseminate information from records made available under paragraphs (3)(A)(ii), (3)(B)(iv), and (4) to Federal agencies, universities, and other research institutions and other entities, as appropriate (excluding any such proprietary or confidential information as is protected from disclosure), for the purpose of furthering scientific research.

`(6) PERFORMANCE STANDARD- A performance standard of the Secretary that provides zero tolerance for detectable levels of Listeria monocytogenes in ready-to-eat poultry products--

`(A) shall not be modified to permit any detectable level of Listeria monocytogenes in any ready-to-eat poultry product; and

`(B) shall be based on scientifically validated testing methods for the detection of Listeria monocytogenes, as determined by the Secretary.'.

(b) MISBRANDING- Section 4(h) of the Poultry Products Inspection Act (21 U.S.C. 453(h)) is amended--

(1) in paragraph (11), by striking `or' at the end;

(2) in paragraph (12), by striking the period at the end and inserting `; or'; and

(3) by adding at the end the following:

`(13) if it is a ready-to-eat poultry product that is required to bear a label under section 8(e), and it does not bear such a label.'.

END