I 

111TH CONGRESS 

1ST SESSION H. R. 999 

To amend the Federal Food, Drug, and Cosmetic Act to improve food safety. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 11, 2009 

Mr. ROSKAM (for himself and Mr. KIRK) introduced the following bill; which 

was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

improve food safety. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Keeping America’s 

5 Food Safe Act of 2009’’. 

6 SEC. 2. CERTIFICATION OF PRIVATE LABORATORIES AND 

7 SAMPLING SERVICES. 

8 (a) AMENDMENT.—Chapter IV of the Federal Food, 

9 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend10 ed by adding at the end the following: 


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1 ‘‘SEC. 418. FOOD SAFETY LABORATORIES AND SAMPLING 

2 SERVICES. 

3 ‘‘(a) DEFINITIONS.—In this section: 

4 ‘‘(1) FOOD SAFETY LABORATORY.—The term 

5 ‘food safety laboratory’ means an establishment that 

6 analyzes or tests samples of imported food to ensure 

7 the safety of such food. 

8 ‘‘(2) SAMPLING SERVICE.—The term ‘sampling 

9 service’ means an establishment that collects sam10 ples of an imported food. 

11 ‘‘(b) CERTIFICATION REQUIREMENT.— 

12 ‘‘(1) IN GENERAL.—Any entity that is a food 

13 safety laboratory or a sampling service shall submit 

14 to the Secretary an application for certification. 

15 Upon review, the Secretary may grant or deny cer16 tification to the food safety laboratory or sampling 

17 service. 

18 ‘‘(2) CERTIFICATION STANDARDS.—The Sec19 retary shall establish criteria and methodologies for 

20 the evaluation of an application for certification sub21 mitted under paragraph (1). Such criteria shall in22 clude the requirements that a food safety laboratory 

23 or sampling service— 

24 ‘‘(A) be accredited as being in compliance 

25 with standards set by the International Organi26 zation for Standardization; 


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1 ‘‘(B) agree to permit the Secretary to con2 duct an inspection of the facilities of the food 

3 safety laboratory or sampling service and the 

4 procedures of such facilities before making a 

5 certification determination; 

6 ‘‘(C) agree to permit the Secretary to con7 duct routine audits of the facilities to ensure 

8 ongoing compliance with accreditation and cer9 tification requirements; 

10 ‘‘(D) submit with such application a fee es11 tablished by the Secretary in an amount suffi12 cient to cover the cost of application review, in13 cluding inspection; and 

14 ‘‘(E) agree to submit to the Secretary, in 

15 accordance with the process established, the re16 sults of tests conducted by such food safety lab17 oratory or sampling service on behalf of an im18 porter. 

19 ‘‘(c) SUBMISSION OF TEST RESULTS.—The Sec20 retary shall establish a process by which a food safety lab21 oratory or sampling service certified under this section 

22 shall submit to the Secretary the results of all tests con23 ducted by such food safety laboratory or sampling service 

24 on behalf of an importer. 


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1 ‘‘(d) CERTIFICATION OF IMPORTERS FOR TESTING

2 AND SAMPLING OWN PRODUCTS.—An importer shall not 

3 be federally certified for the purposes of analyzing, testing, 

4 or sampling its own food products for import unless the 

5 Secretary establishes a process under this section by which 

6 an importer can become certified for such purposes.’’. 

7 (b) ENFORCEMENT.—Section 303(f) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)) is 

9 amended— 

10 (1) by redesignating paragraphs (5), (6), and 

11 (7) as paragraphs (7), (8), and (9), respectively; 

12 (2) by inserting after paragraph (4) the fol13 lowing: 

14 ‘‘(5) An importer (as such term is used in section 

15 418) shall be subject to a civil penalty in an amount not 

16 to exceed $1,000,000 if such importer knowingly engages 

17 in the falsification of test results submitted to the Sec18 retary by a food safety laboratory or sampling service cer19 tified under section 418. 

20 ‘‘(6) A food safety laboratory or sampling service cer21 tified under section 418 shall be subject to a civil penalty 

22 in an amount not to exceed $1,000,000 for knowingly sub23 mitting to the Secretary false test results under section 

24 418.’’. 


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1 (3) in paragraph (2)(C), by striking ‘‘paragraph 

2 (5)(A)’’ and inserting ‘‘paragraph (7)(A)’’; 

3 (4) in paragraph (7), as so redesignated, by 

4 striking ‘‘paragraph (1), (2), (3), or (4)’’ each place 

5 it appears and inserting ‘‘paragraph (1), (2), (3), 

6 (4), (5), or (6)’’; 

7 (5) in paragraph (8), as so redesignated, by 

8 striking ‘‘paragraph (5)(A)’’ and inserting ‘‘para9 graph (7)(A)’’; and 

10 (6) in paragraph (9), by striking ‘‘paragraph 

11 (6)’’ each place it appears and inserting ‘‘paragraph 

12 (8)’’. 

13 SEC. 3. FOREIGN CERTIFICATION AND EQUIVALENCY. 

14 (a) AMENDMENT.—Chapter VIII of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 381 et seq.) 

16 is amended by adding at the end the following: 

17 ‘‘SEC. 805. CERTIFICATION OF FOOD IMPORTERS. 

18 ‘‘(a) IN GENERAL.—Not later than 2 years after the 

19 date of enactment of this section, the Secretary shall es20 tablish a certification program in accordance with this sec21 tion to ensure that food imported into the United States 

22 meets the food safety standards applied to food produced 

23 in the United States. 

24 ‘‘(b) CERTIFICATION STANDARD.—A foreign facility 

25 or foreign country requesting a certification to import food 


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1 to the United States shall demonstrate, in a manner deter2 mined appropriate by the Secretary, that food produced 

3 under the supervision of the foreign facility or foreign 

4 country has met standards for food safety, inspection, la5 beling, and consumer protection that are at least equiva6 lent to standards applicable to food produced in the 

7 United States. In determining whether standards are so 

8 equivalent, the Secretary shall consider— 

9 ‘‘(1) the potential for health, sanitary, environ10 mental, or other conditions within the foreign coun11 try involved to adversely affect the safety of food 

12 products exported from such nation; and 

13 ‘‘(2) how well the food safety programs of the 

14 foreign country function to minimize any adverse ef15 fects on such safety. 

16 ‘‘(c) REQUIREMENT OF CERTIFICATION FOR IMPORT17 ING.— 

18 ‘‘(1) IN GENERAL.—Except as provided in para19 graph (2), no food shall be permitted entry into the 

20 United States from a foreign facility in a foreign 

21 country unless there is— 

22 ‘‘(A) a certification for such facility in ef23 fect under subsection (d)(1); or 

24 ‘‘(B) a certification for such country in ef25 fect under subsection (d)(2). 


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1 ‘‘(2) EQUIVALENCY DETERMINATION BY SEC2 RETARY.—Paragraph (1) does not apply if the Sec3 retary determines that the certification process de4 scribed in subsection (d) is not needed for the Sec5 retary’s evaluation of whether the facility’s or coun6 try’s standards for food safety, inspection, labeling, 

7 and consumer protection are at least equivalent to 

8 standards applicable to food produced in the United 

9 States. 

10 ‘‘(d) CERTIFICATION.— 

11 ‘‘(1) FOREIGN FACILITY.—Each foreign facility 

12 seeking to import food into the United States may 

13 obtain a certification by the Secretary stating that 

14 the facility maintains a program using reliable ana15 lytical methods to ensure compliance with all the 

16 food safety standards described in subsection (a) to 

17 import such food. 

18 ‘‘(2) FOREIGN COUNTRY.—A foreign country 

19 may obtain a certification by the Secretary stating 

20 that— 

21 ‘‘(A) the country has in effect and is en22 forcing food safety standards at least as protec23 tive of food safety as the standards applicable 

24 to food in the United States; and 


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1 ‘‘(B) the country has a program in effect 

2 to monitor and enforce its food safety standards 

3 with respect to food being exported from such 

4 country to the United States, ensuring that the 

5 food products intended for export to the United 

6 States are safe for human consumption, and 

7 not adulterated or misbranded. 

8 ‘‘(e) AGREEMENTS WITH FOREIGN NATIONS.—Any 

9 certification of a foreign country under subsection (d)(2) 

10 shall— 

11 ‘‘(1) require the foreign country to promptly no12 tify the Secretary of any violations affecting the 

13 safety of food products exported or intended for ex14 port to the United States; 

15 ‘‘(2) provide for such activities (whether in the 

16 foreign country or at the port of entry during impor17 tation) by the Secretary, including analysis, testing, 

18 and sampling, at such stages in the growth or har19 vest of food, or in the processing or handling of food 

20 products, as the Secretary considers appropriate to 

21 ensure that the foreign country has in effect and is 

22 enforcing food safety standards at least as protective 

23 of food safety as the standards applicable to food in 

24 the United States; and 


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1 ‘‘(3) provide for reciprocity with respect to the 

2 treatment of food imports and exports between the 

3 United States and the foreign country. 

4 ‘‘(f) DOCUMENTATION.—The Secretary shall provide 

5 to the Congress annual documentation demonstrating the 

6 Secretary’s confidence in the standards of any foreign fa7 cility or country for which the Secretary has made a deter8 mination under paragraph (2) of subsection (c). 

9 ‘‘(g) REVOCATION OF CERTIFICATION.—The Sec10 retary may, with respect to a foreign facility or foreign 

11 country, revoke a certification under subsection (d) if— 

12 ‘‘(1) food from the foreign facility or foreign 

13 country is linked to an outbreak of human illness; 

14 ‘‘(2) the Secretary determines that the foreign 

15 facility or foreign country is no longer meeting the 

16 requirements described in subsection (d); or 

17 ‘‘(3) United States officials are not allowed to 

18 conduct such audits and investigations as may be 

19 necessary to carry out this section. 

20 ‘‘(h) DURATION OF CERTIFICATION.—Each certifi21 cation under subsection (d) shall be for a period of not 

22 more than 5 years. 

23 ‘‘(i) INSPECTION; INDEPENDENT AUDITS.— 

24 ‘‘(1) AUTHORIZATION.—In determining whether 

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1 voke a certification under subsection (g), the Sec2 retary is authorized to— 

3 ‘‘(A) inspect foreign facilities to ensure 

4 compliance with the food safety standards de5 scribed in subsection (a); and 

6 ‘‘(B) consider independent audits, product 

7 test data, and other relevant information gen8 erated by the facility, importer, or foreign coun9 try involved. 

10 ‘‘(2) RENEWAL OF CERTIFICATION.—The Sec11 retary shall audit foreign countries and foreign fa12 cilities at least every 5 years to ensure the continued 

13 compliance with the standards set forth in this sec14 tion. 

15 ‘‘(j) ENFORCEMENT.—The Secretary is authorized 

16 to— 

17 ‘‘(1) deny importation of food from any foreign 

18 country that does not permit United States officials 

19 to enter the foreign country to conduct such audits 

20 and inspections as may be necessary to fulfill the re21 quirements of this section; 

22 ‘‘(2) deny importation of food from any foreign 

23 country or foreign facility that does not consent to 

24 an investigation by the Secretary when food from 

25 that foreign country or foreign facility is linked to 


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1 a food-borne illness outbreak or is otherwise found 

2 to be adulterated or mislabeled; and 

3 ‘‘(3) promulgate rules and regulations to carry 

4 out the purposes of this section, including setting 

5 terms and conditions for the destruction of products 

6 that fail to meet the standards of this Act. 

7 ‘‘(k) FOREIGN FACILITY.—In this section, the term 

8 ‘foreign facility’ means a foreign facility (as defined in sec9 tion 415(b)(3)) that is required to be registered under sec10 tion 415.’’. 

11 (b) TRANSITIONAL PROGRAM.—Not later than 180 

12 days after the date of enactment of this Act, the Secretary 

13 shall promulgate regulations to establish a transitional 

14 food safety import review program, with minimal disrup15 tion to commerce, that shall be in effect until the date 

16 of implementation of the food import certification program 

17 under section 805 of the Federal Food, Drug, and Cos18 metic Act, as added by subsection (a) of this section. 

19 SEC. 4. INFORMATION CLEARINGHOUSES. 

20 Chapter IV of the Federal Food, Drug, and Cosmetic 

21 Act (21 U.S.C. 341 et seq.), as amended by section 2 of 

22 this Act, is amended by adding at the end the following: 

23 ‘‘SEC. 419. INFORMATION CLEARINGHOUSES. 

24 ‘‘(a) WEBSITE ON FOOD SAFETY ISSUES.— 


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1 ‘‘(1) IN GENERAL.—The Secretary, in consulta2 tion with the Secretary of Agriculture, shall develop 

3 and maintain a Website with public information 

4 that— 

5 ‘‘(A) provides information on Federal food 

6 standards and best practice requirements for 

7 food preparation; 

8 ‘‘(B) assists health professionals to im9 prove their ability— 

10 ‘‘(i) to diagnose and treat food-related 

11 illness; and 

12 ‘‘(ii) to advise individuals whose 

13 health conditions place them at particular 

14 risk; and 

15 ‘‘(C) promotes the public awareness of food 

16 safety issues. 

17 ‘‘(2) RESOURCES.—The Secretary shall utilize 

18 the resources of the Food and Drug Administration 

19 and the Centers for Disease Control and Prevention 

20 to carry out this subsection. 

21 ‘‘(b) WEBSITE ON SCHOOL CURRICULA REGARDING

22 FOOD SAFETY.—The Secretary, in consultation with the 

23 Secretary of Education, shall develop and maintain a 

24 Website to provide the public with appropriate information 


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1 on developing school curriculum regarding food safety 

2 issues.’’. 

3 SEC. 5. WHISTLEBLOWER PROTECTION. 

4 Chapter IV of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 341 et seq.), as amended by sections 2 

6 and 4 of this Act, is amended by adding at the end the 

7 following: 

8 ‘‘SEC. 420. WHISTLEBLOWER PROTECTION. 

9 ‘‘(a) PROHIBITION.—No employee or other person 

10 may be harassed, prosecuted, held liable, or discriminated 

11 against in any way because that person— 

12 ‘‘(1) has commenced, caused to be commenced, 

13 or is about to commence a proceeding, testified or is 

14 about to testify at a proceeding, or assisted or par15 ticipated or is about to assist or participate in any 

16 manner in such a proceeding or in any other action 

17 to carry out the purposes, functions, or responsibil18 ities of this Act; or 

19 ‘‘(2) is refusing to violate or assist in violation 

20 of this Act. 

21 ‘‘(b) PROCEDURES.—The process and procedures 

22 with respect to prohibited discrimination under subsection 

23 (a) shall be governed by the applicable provisions of sec24 tion 31105 of title 49, United States Code, unless the 

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1 ternative dispute resolution procedures such as mediation 

2 or arbitration. 

3 ‘‘(c) BURDENS OF PROOF.—The legal burdens of 

4 proof with respect to prohibited discrimination under sub5 section (a) shall be governed by the applicable provisions 

6 of sections 1214 and 1221 of title 5, United States 

7 Code.’’. 

8 SEC. 6. REPORTABLE FOOD REGISTRY. 

9 (a) RESPONSIBLE PARTIES.—Paragraph (1) of sec10 tion 417(a) of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 350f(a)) is amended to read as follows: 

12 ‘‘(1) RESPONSIBLE PARTY.—The term ‘respon13 sible party’, with respect to an article of food, means 

14 a person that— 

15 ‘‘(A) submits the registration under section 

16 415(a) for a food facility that is required to 

17 register under section 415(a), at which such ar18 ticle of food is manufactured, processed, 

19 packed, or held; or 

20 ‘‘(B) is an establishment that analyzes or 

21 tests samples of food for consumption in the 

22 United States to ensure the safety of such 

23 food.’’. 

24 (b) INDIVIDUAL ANALYSIS OR TEST.—Subsection (d) 

25 of section 417 of the Federal Food, Drug, and Cosmetic 


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1 Act (21 U.S.C. 350f(d)) is amended by adding at the end 

2 the following: 

3 ‘‘(9) INDIVIDUAL ANALYSIS OR TEST.—If any 

4 individual analysis or test of an article of food by a 

5 responsible party produces a result suggesting that 

6 the article is reportable food, the responsible party 

7 shall send a notice within 24 hours to the Food and 

8 Drug Administration containing the results of such 

9 analysis or test for review consistent with subsection 

10 (b)(2), irrespective of whether the party subse11 quently determines, based on additional analysis or 

12 testing or other factors, that such article is not re13 portable food.’’. 

14 (c) CONFORMING AMENDMENTS.—Section 417 of the 

15 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350f) 

16 is amended— 

17 (1) in subsection (e)(1), by striking ‘‘The reg18 istration’’ and inserting ‘‘In the case of a responsible 

19 party described in subsection (a)(1)(A), the registra20 tion’’; and 

21 (2) in subsection (f)(2)(A), by striking ‘‘not re22 quired to register under section 415’’ and inserting 

23 ‘‘not responsible parties’’. 


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1 SEC. 7. RECALL AUTHORITY. 

2 (a) PROHIBITION.—Section 301 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 331) is amended by 

4 adding at the end the following: 

5 ‘‘(oo) The violation of an order to recall food under 

6 section 417A.’’. 

7 (b) RECALL AUTHORITY.—Chapter IV of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) 

9 is amended by inserting after section 417 the following: 

10 ‘‘SEC. 417A. RECALL AUTHORITY. 

11 ‘‘(a) REQUEST TO INITIATE A RECALL.—The Sec12 retary may request an establishment to initiate a recall 

13 of food when the Secretary makes each of the following 

14 determinations: 

15 ‘‘(1) The food has been distributed and pre16 sents a risk of illness or injury or gross consumer 

17 deception. 

18 ‘‘(2) The establishment has not initiated a re19 call of the food. 

20 ‘‘(3) Action by the Secretary is necessary to 

21 protect the public health. 

22 ‘‘(b) ORDER.—If an establishment subject to a re23 quest under subsection (a) does not initiate a voluntary 

24 recall of the food involved within 24 hours of receiving 

25 such request, the Secretary may issue an order requiring 

26 such establishment to conduct a recall of the food. 


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1 ‘‘(c) DEFINITION.—In this section, term ‘establish2 ment’ means an establishment required to be registered 

3 under section 415.’’. 

4 SEC. 8. AUTHORIZATION OF APPROPRIATIONS. 

5 There are authorized to be appropriated to carry out 

6 this Act and the amendments made by this Act such sums 

7 as may be necessary for each of fiscal years 2010 through 

8 2014. 

Æ 


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