II

105TH CONGRESS

1ST SESSION S. 1264

To amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to provide for improved public health and food safety through

enhanced enforcement.

IN THE SENATE OF THE UNITED STATES

OCTOBER 7, 1997

Mr. HARKIN (for himself, Mr. DASCHLE, Mr. LEAHY, and Mr. JOHNSON) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To amend the Federal Meat Inspection Act and the Poultry

Products Inspection Act to provide for improved public

health and food safety through enhanced enforcement.

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 ‘‘Food Safety Enforce5 ment Enhancement Act of 1997’’.

6 SEC. 2. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT

7 FOOD PRODUCTS.

8 (a) IN GENERAL.—The Federal Meat Inspection Act

9 (21 U.S.C. 601 et seq.) is amended—
2

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1 (1) by redesignating section 411 (21 U.S.C.

2 681) as section 414; and

3 (2) by inserting after section 410 (21 U.S.C.

4 679a) the following:

5 ‘‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL

6 OF ADULTERATED OR MISBRANDED ARTI7 CLES.

8 ‘‘(a) NOTIFICATION.—A person (other than a house9 hold consumer) that has reason to believe that a carcass,

10 part of a carcass, meat, or meat food product of cattle,

11 sheep, swine, goats, horses, mules, or other equines (re12 ferred to in this section as an ‘article’) transported, stored,

13 distributed, or otherwise handled by the person is adulter14 ated or misbranded shall immediately notify the Secretary,

15 in such manner and by such means as the Secretary may

16 by regulation promulgate, of the identity and location of

17 the article.

18 ‘‘(b) NONDISTRIBUTION AND RECALL.—

19 ‘‘(1) VOLUNTARY ACTIONS.—On receiving the

20 notification under subsection (a) or otherwise, if the

21 Secretary finds that an article is adulterated or mis22 branded and that there is a reasonable probability

23 that human consumption of the article would present

24 a threat to public health, as determined by the Sec25 retary, the Secretary shall provide all appropriate
3

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1 persons, as determined by the Secretary, that trans2 ported, stored, distributed, or otherwise handled the

3 article with an opportunity to—

4 ‘‘(A) cease distribution of the article;

5 ‘‘(B) notify all persons transporting, stor6 ing, distributing, or otherwise handling the arti7 cle, or to which the article has been trans8 ported, sold, distributed, or otherwise handled,

9 to immediately cease distribution of the article;

10 ‘‘(C) recall the article; and

11 ‘‘(D) in consultation with the Secretary,

12 provide notice to consumers to whom the article

13 is, or may have been, distributed.

14 ‘‘(2) MANDATORY ACTIONS.—If the person re15 fuses to or does not voluntarily take the actions de16 scribed in paragraph (1) with respect to an article

17 within the time and in the manner prescribed by the

18 Secretary, the Secretary shall, by order, require the

19 person to immediately—

20 ‘‘(A) cease distribution of the article; and

21 ‘‘(B) notify all persons transporting, stor22 ing, distributing, or otherwise handling the arti23 cle, or to which the article has been trans24 ported, sold, distributed, or otherwise handled,

25 to immediately cease distribution of the article.
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1 ‘‘(3) NOTICE TO CONSUMERS.—The Secretary

2 shall, as the Secretary considers necessary, provide

3 notice to consumers to whom the article was, or may

4 have been, distributed.

5 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER6 SONS.—A person transporting, storing, distributing,

7 or otherwise handling the article, or to which the ar8 ticle has been transported, sold, distributed, or oth9 erwise handled, that is notified under paragraph

10 (1)(B) or (2)(B) shall immediately cease distribution

11 of the article.

12 ‘‘(c) INFORMAL HEARING ON ORDER.—

13 ‘‘(1) IN GENERAL.—The Secretary shall provide

14 a person subject to an order under subsection (b)

15 with an opportunity for an informal hearing (pursu16 ant to such rules or regulations as the Secretary

17 shall prescribe) on the actions required by the order

18 and on why the article that is the subject of the

19 order should not be recalled.

20 ‘‘(2) TIMING.—The Secretary shall hold the in21 formal hearing as soon as practicable, but not later

22 than 2 days, after the issuance of the order.

23 ‘‘(d) RECALL OR OTHER ACTIONS.—

24 ‘‘(1) IN GENERAL.—If, after providing an op25 portunity for an informal hearing under subsection
5

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1 (c), the Secretary determines that there is a reason2 able probability that human consumption of the arti3 cle that is the subject of an order under subsection

4 (b) presents a threat to public health, the Secretary

5 may—

6 ‘‘(A) amend the order to require recall of

7 the article or other appropriate action;

8 ‘‘(B) specify a timetable during which the

9 recall will occur;

10 ‘‘(C) require periodic reports to the Sec11 retary describing the progress of the recall; and

12 ‘‘(D) provide notice to consumers to whom

13 the article is, or may have been, distributed.

14 ‘‘(2) VACATION OF ORDER.—If, after providing

15 an opportunity for an informal hearing under sub16 section (c), the Secretary determines that adequate

17 grounds do not exist to continue the actions required

18 by the order, the Secretary shall vacate the order.

19 ‘‘(e) ADDITIONAL REMEDIES.—The remedies pro20 vided in this section shall be in addition to any other rem21 edies that may be available.

22 ‘‘SEC. 412. REFUSAL OR WITHDRAWAL OF INSPECTION OF

23 ESTABLISHMENTS.

24 ‘‘(a) IN GENERAL.—The Secretary may, for such pe25 riod, or indefinitely, as the Secretary considers necessary
6

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1 to carry out this Act, refuse to provide or withdraw inspec2 tion under title I with respect to an establishment if the

3 Secretary determines, after opportunity for a hearing on

4 the record is provided to the applicant for, or recipient

5 of, inspection, that the applicant or recipient, or any per6 son responsibly connected with the applicant or recipient

7 (within the meaning of section 401), has committed a will8 ful violation or repeated violations of this Act (including

9 a regulation promulgated under this Act).

10 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND11 ING HEARING.—The Secretary may deny or suspend in12 spection under title I, pending opportunity for an expe13 dited hearing, with respect to an action under subsection

14 (a), if the Secretary determines that the denial or suspen15 sion is in the public interest to protect the health or wel16 fare of consumers or to ensure the effective performance

17 of an official duty under this Act.

18 ‘‘(c) JUDICIAL REVIEW.—

19 ‘‘(1) IN GENERAL.—A determination and order

20 of the Secretary with respect to the refusal or with21 drawal of inspection under this section shall be final

22 and conclusive unless, not later than 30 days after

23 the effective date of the order, the affected applicant

24 for, or recipient of, inspection—
7

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1 ‘‘(A) files a petition for judicial review of

2 the order; and

3 ‘‘(B) simultaneously sends a copy of the

4 petition by certified mail to the Secretary.

5 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC6 TION PENDING REVIEW.—Inspection shall be refused

7 or withdrawn as of the effective date of the order

8 pending any judicial review of the order unless the

9 Secretary directs otherwise.

10 ‘‘(3) VENUE; RECORD.—Judicial review of the

11 order shall be—

12 ‘‘(A) in—

13 ‘‘(i) the United States court of ap14 peals for the circuit in which the applicant

15 for, or recipient of, inspection resides or

16 has its principal place of business; or

17 ‘‘(ii) the United States Court of Ap18 peals for the District of Columbia; and

19 ‘‘(B) on the record on which the deter20 mination and order are based.

21 ‘‘(d) ADDITIONAL REMEDIES.—The remedies pro22 vided in this section shall be in addition to any other rem23 edies that may be available.

24 ‘‘SEC. 413. CIVIL PENALTIES.

25 ‘‘(a) IN GENERAL.—
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1 ‘‘(1) ASSESSMENT.—The Secretary may assess

2 a civil penalty against a person that violates this Act

3 (including a regulation promulgated or order issued

4 under this Act) of not more than $100,000 for each

5 violation.

6 ‘‘(2) SEPARATE OFFENSES.—Each violation

7 and each day during which a violation continues

8 shall be a separate offense.

9 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR10 ING.—The Secretary shall not assess a civil penalty

11 under this section against a person unless the person

12 is given notice and opportunity for a hearing on the

13 record before the Secretary in accordance with sec14 tions 554 and 556 of title 5, United States Code.

15 ‘‘(4) AMOUNT.—The amount of a civil penalty

16 under this section shall be—

17 ‘‘(A) assessed by the Secretary by written

18 order, taking into account—

19 ‘‘(i) the gravity of the violation;

20 ‘‘(ii) the degree of culpability;

21 ‘‘(iii) the size and type of the busi22 ness; and

23 ‘‘(iv) any history of prior offenses

24 under this Act; and
9

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1 ‘‘(B) reviewed only in accordance with sub2 section (b).

3 ‘‘(b) JUDICIAL REVIEW.—

4 ‘‘(1) IN GENERAL.—An order assessing a civil

5 penalty against a person under subsection (a) shall

6 be final and conclusive unless the person—

7 ‘‘(A) not later than 30 days after the effec8 tive date of the order, files a petition for judi9 cial review in—

10 ‘‘(i) the United States court of ap11 peals for the circuit in which the person re12 sides or has its principal place of business;

13 or

14 ‘‘(ii) the United States Court of Ap15 peals for the District of Columbia; and

16 ‘‘(B) simultaneously sends a copy of the

17 petition by certified mail to the Secretary.

18 ‘‘(2) RECORD.—The Secretary shall promptly

19 file in the court a certified copy of the record on

20 which the violation was found and the civil penalty

21 assessed.

22 ‘‘(c) COLLECTION ACTION FOR FAILURE TO PAY AS23 SESSMENT.—

24 ‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a

25 person fails to pay a civil penalty after the order as-
10

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1 sessing the civil penalty has become final and

2 unappealable, the Secretary shall refer the matter to

3 the Attorney General.

4 ‘‘(2) ACTION BY ATTORNEY GENERAL.—The

5 Attorney General shall bring a civil action to recover

6 the amount of the civil penalty in United States dis7 trict court.

8 ‘‘(3) SCOPE OF REVIEW.—In the collection ac9 tion, the validity and appropriateness of the order of

10 the Secretary imposing the civil penalty shall not be

11 subject to review.

12 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

13 PENDING PAYMENT.—If a person fails to pay the amount

14 of a civil penalty after the order assessing the civil penalty

15 becomes final and unappealable, the Secretary may refuse

16 to provide or withdraw inspection under title I of the per17 son until the civil penalty is paid or until the Secretary

18 directs otherwise.

19 ‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.—

20 Nothing in this Act requires the Secretary to report for

21 prosecution, or for the institution of an action, a violation

22 of this Act if the Secretary believes that the public interest

23 will be adequately served by assessment of a civil penalty.
11

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1 ‘‘(f) ADDITIONAL REMEDIES.—The remedies pro2 vided in this section shall be in addition to any other rem3 edies that may be available.’’.

4 (b) CONFORMING AMENDMENTS.—

5 (1) Section 1 of the Federal Meat Inspection

6 Act (21 U.S.C. 601) is amended by adding at the

7 end the following:

8 ‘‘(w) PERSON.—The term ‘person’ means any indi9 vidual, partnership, corporation, association, or other busi10 ness unit.’’.

11 (2) The Federal Meat Inspection Act (21

12 U.S.C. 601 et seq.) is amended—

13 (A) by striking ‘‘person, firm, or corpora14 tion’’ each place it appears and inserting ‘‘per15 son’’;

16 (B) by striking ‘‘persons, firms, and cor17 porations’’ each place it appears and inserting

18 ‘‘persons’’; and

19 (C) by striking ‘‘persons, firms, or corpora20 tions’’ each place it appears and inserting ‘‘per21 sons’’.

22 SEC. 3. FOOD SAFETY ENFORCEMENT FOR POULTRY AND

23 POULTRY FOOD PRODUCTS.

24 The Poultry Products Inspection Act (21 U.S.C. 451

25 et seq.) is amended—
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1 (1) in the first sentence of section 5(c)(1) (21

2 U.S.C. 454(c)(1))—

3 (A) by striking ‘‘, by thirty days prior to

4 the expiration of two years after enactment of

5 the Wholesome Poultry Products Act,’’; and

6 (B) by striking ‘‘sections 1–4, 6–10, and

7 12–22 of this Act’’ and inserting ‘‘sections 1

8 through 4, 6 through 10, 12 through 22, and

9 31 through 33’’; and

10 (2) by adding at the end the following:

11 ‘‘SEC. 31. NOTIFICATION, NONDISTRIBUTION, AND RECALL

12 OF ADULTERATED OR MISBRANDED ARTI13 CLES.

14 ‘‘(a) NOTIFICATION.—A person (other than a house15 hold consumer) that has reason to believe that any poultry

16 or poultry product (referred to in this section as an ‘arti17 cle’) transported, stored, distributed, or otherwise handled

18 by the person is adulterated or misbranded shall imme19 diately notify the Secretary, in such manner and by such

20 means as the Secretary may by regulation promulgate, of

21 the identity and location of the article.

22 ‘‘(b) NONDISTRIBUTION AND RECALL.—

23 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti24 fication under subsection (a) or otherwise, if the

25 Secretary finds that an article is adulterated or mis-
13

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1 branded and that there is a reasonable probability

2 that human consumption of the article would present

3 a threat to public health, as determined by the Sec4 retary, the Secretary shall provide all appropriate

5 persons, as determined by the Secretary, that trans6 ported, stored, distributed, or otherwise handled the

7 article with an opportunity to—

8 ‘‘(A) cease distribution of the article;

9 ‘‘(B) notify all persons transporting, stor10 ing, distributing, or otherwise handling the arti11 cle, or to which the article has been trans12 ported, sold, distributed, or otherwise handled,

13 to immediately cease distribution of the article;

14 ‘‘(C) recall the article; and

15 ‘‘(D) in consultation with the Secretary,

16 provide notice to consumers to whom the article

17 is, or may have been, distributed.

18 ‘‘(2) MANDATORY ACTIONS.—If the person re19 fuses to or does not voluntarily take the actions de20 scribed in paragraph (1) with respect to an article

21 within the time and in the manner prescribed by the

22 Secretary, the Secretary shall, by order, require the

23 person to immediately—

24 ‘‘(A) cease distribution of the article; and
14

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1 ‘‘(B) notify all persons transporting, stor2 ing, distributing, or otherwise handling the arti3 cle, or to which the article has been trans4 ported, sold, distributed, or otherwise handled,

5 to immediately cease distribution of the article.

6 ‘‘(3) NOTICE TO CONSUMERS.—The Secretary

7 shall, as the Secretary considers necessary, provide

8 notice to consumers to whom the article was, or may

9 have been, distributed.

10 ‘‘(4) NONDISTRIBUTION BY NOTIFIED PER11 SONS.—A person transporting, storing, distributing,

12 or otherwise handling the article, or to which the ar13 ticle has been transported, sold, distributed, or oth14 erwise handled, that is notified under paragraph

15 (1)(B) or (2)(B) shall immediately cease distribution

16 of the article.

17 ‘‘(c) INFORMAL HEARING ON ORDER.—

18 ‘‘(1) IN GENERAL.—The Secretary shall provide

19 a person subject to an order under subsection (b)

20 with an opportunity for an informal hearing (pursu21 ant to such rules or regulations as the Secretary

22 shall prescribe) on the actions required by the order

23 and on why the article that is the subject of the

24 order should not be recalled.
15

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1 ‘‘(2) TIMING.—The Secretary shall hold the in2 formal hearing as soon as practicable, but not later

3 than 2 days, after the issuance of the order.

4 ‘‘(d) RECALL OR OTHER ACTIONS.—

5 ‘‘(1) IN GENERAL.—If, after providing an op6 portunity for an informal hearing under subsection

7 (c), the Secretary determines that there is a reason8 able probability that human consumption of the arti9 cle that is the subject of an order under subsection

10 (b) presents a threat to public health, the Secretary

11 may—

12 ‘‘(A) amend the order to require recall of

13 the article or other appropriate action;

14 ‘‘(B) specify a timetable during which the

15 recall will occur;

16 ‘‘(C) require periodic reports to the Sec17 retary describing the progress of the recall; and

18 ‘‘(D) provide notice to consumers to whom

19 the article is, or may have been, distributed.

20 ‘‘(2) VACATION OF ORDER.—If, after providing

21 an opportunity for an informal hearing under sub22 section (c), the Secretary determines that adequate

23 grounds do not exist to continue the actions required

24 by the order, the Secretary shall vacate the order.
16

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1 ‘‘(e) ADDITIONAL REMEDIES.—The remedies pro2 vided in this section shall be in addition to any other rem3 edies that may be available.

4 ‘‘SEC. 32. REFUSAL OR WITHDRAWAL OF INSPECTION OF

5 ESTABLISHMENTS.

6 ‘‘(a) IN GENERAL.—The Secretary may, for such pe7 riod, or indefinitely, as the Secretary considers necessary

8 to carry out this Act, refuse to provide or withdraw inspec9 tion under this Act with respect to an establishment if the

10 Secretary determines, after opportunity for a hearing on

11 the record is provided to the applicant for, or recipient

12 of, inspection, that the applicant or recipient, or any per13 son responsibly connected with the applicant or recipient

14 (within the meaning of section 18(a)), has committed a

15 willful violation or repeated violations of this Act (includ16 ing a regulation promulgated under this Act).

17 ‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND18 ING HEARING.—The Secretary may deny or suspend in19 spection under this Act, pending opportunity for an expe20 dited hearing, with respect to an action under subsection

21 (a), if the Secretary determines that the denial or suspen22 sion is in the public interest to protect the health or wel23 fare of consumers or to ensure the effective performance

24 of an official duty under this Act.

25 ‘‘(c) JUDICIAL REVIEW.—
17

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1 ‘‘(1) IN GENERAL.—A determination and order

2 of the Secretary with respect to the refusal or with3 drawal of inspection under this section shall be final

4 and conclusive unless, not later than 30 days after

5 the effective date of the order, the affected applicant

6 for, or recipient of, inspection—

7 ‘‘(A) files a petition for judicial review of

8 the order; and

9 ‘‘(B) simultaneously sends a copy of the

10 petition by certified mail to the Secretary.

11 ‘‘(2) REFUSAL OR WITHDRAWAL OF INSPEC12 TION PENDING REVIEW.—Inspection shall be refused

13 or withdrawn as of the effective date of the order

14 pending any judicial review of the order unless the

15 Secretary directs otherwise.

16 ‘‘(3) VENUE; RECORD.—Judicial review of the

17 order shall be—

18 ‘‘(A) in—

19 ‘‘(i) the United States court of ap20 peals for the circuit in which the applicant

21 for, or recipient of, inspection resides or

22 has its principal place of business; or

23 ‘‘(ii) the United States Court of Ap24 peals for the District of Columbia; and
18

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1 ‘‘(B) on the record on which the deter2 mination and order are based.

3 ‘‘(d) ADDITIONAL REMEDIES.—The remedies pro4 vided in this section shall be in addition to any other rem5 edies that may be available.

6 ‘‘SEC. 33. CIVIL PENALTIES.

7 ‘‘(a) IN GENERAL.—

8 ‘‘(1) ASSESSMENT.—The Secretary may assess

9 a civil penalty against a person that violates this Act

10 (including a regulation promulgated or order issued

11 under this Act) of not more than $100,000 for each

12 violation.

13 ‘‘(2) SEPARATE OFFENSES.—Each violation

14 and each day during which a violation continues

15 shall be a separate offense.

16 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR17 ING.—The Secretary shall not assess a civil penalty

18 under this section against a person unless the person

19 is given notice and opportunity for a hearing on the

20 record before the Secretary in accordance with sec21 tions 554 and 556 of title 5, United States Code.

22 ‘‘(4) AMOUNT.—The amount of a civil penalty

23 under this section shall be—

24 ‘‘(A) assessed by the Secretary by written

25 order, taking into account—
19

•S 1264 IS

1 ‘‘(i) the gravity of the violation;

2 ‘‘(ii) the degree of culpability;

3 ‘‘(iii) the size and type of the busi4 ness; and

5 ‘‘(iv) any history of prior offenses

6 under this Act; and

7 ‘‘(B) reviewed only in accordance with sub8 section (b).

9 ‘‘(b) JUDICIAL REVIEW.—

10 ‘‘(1) IN GENERAL.—An order assessing a civil

11 penalty against a person under subsection (a) shall

12 be final and conclusive unless the person—

13 ‘‘(A) not later than 30 days after the effec14 tive date of the order, files a petition for judi15 cial review in—

16 ‘‘(i) the United States court of ap17 peals for the circuit in which the person re18 sides or has its principal place of business;

19 or

20 ‘‘(ii) the United States Court of Ap21 peals for the District of Columbia; and

22 ‘‘(B) simultaneously sends a copy of the

23 petition by certified mail to the Secretary.

24 ‘‘(2) RECORD.—The Secretary shall promptly

25 file in the court a certified copy of the record on
20

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1 which the violation was found and the civil penalty

2 assessed.

3 ‘‘(c) COLLECTION ACTION FOR FAILURE TO PAY AS4 SESSMENT.—

5 ‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a

6 person fails to pay a civil penalty after the order as7 sessing the civil penalty has become final and

8 unappealable, the Secretary shall refer the matter to

9 the Attorney General.

10 ‘‘(2) ACTION BY ATTORNEY GENERAL.—The

11 Attorney General shall bring a civil action to recover

12 the amount of the civil penalty in United States dis13 trict court.

14 ‘‘(3) SCOPE OF REVIEW.—In the collection ac15 tion, the validity and appropriateness of the order of

16 the Secretary imposing the civil penalty shall not be

17 subject to review.

18 ‘‘(d) REFUSAL OR WITHDRAWAL OF INSPECTION

19 PENDING PAYMENT.—If a person fails to pay the amount

20 of a civil penalty after the order assessing the civil penalty

21 becomes final and unappealable, the Secretary may refuse

22 to provide or withdraw inspection under this Act of the

23 person until the civil penalty is paid or until the Secretary

24 directs otherwise.
21

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1 ‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.—

2 Nothing in this Act requires the Secretary to report for

3 prosecution, or for the institution of an action, a violation

4 of this Act if the Secretary believes that the public interest

5 will be adequately served by assessment of a civil penalty.

6 ‘‘(f) ADDITIONAL REMEDIES.—The remedies pro7 vided in this section shall be in addition to any other rem8 edies that may be available.’’.

Æ