I 
108TH CONGRESS 
1ST SESSION H. R. 3547
To amend the Federal Meat Inspection Act, the Poultry Products Inspection 
Act, and the Federal Food, Drug, and Cosmetic Act to provide for 
improved public health and food safety through enhanced enforcement, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 20, 2003
Ms. DEGETTE (for herself, Ms. DELAURO, Mr. HINCHEY, Mr. STARK, and 
Mr. WAXMAN) introduced the following bill; which was referred to the 
Committee on Agriculture, and in addition to the Committee on Energy 
and Commerce, for a period to be subsequently determined by the Speak-
er, in each case for consideration of such provisions as fall within the ju-
risdiction of the committee concerned 
A BILL 
To amend the Federal Meat Inspection Act, the Poultry 
Products Inspection Act, and the Federal Food, Drug, 
and Cosmetic Act to provide for improved public health 
and food safety through enhanced enforcement, and for 
other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safe And Fair En-
forcement and Recall for Meat, Poultry, and Food Act’’ 
or ‘‘SAFER Meat, Poultry, and Food Act’’. 
SEC. 2. FOOD SAFETY ENFORCEMENT FOR MEAT AND MEAT 
FOOD PRODUCTS. 
(a) IN GENERAL.—The Federal Meat Inspection Act 
(21 U.S.C. 601 et seq.) is amended—
(1) by redesignating section 411 (21 U.S.C. 
680) as section 414; and 
(2) by inserting after section 410 (21 U.S.C. 
679a) the following: 
‘‘SEC. 411. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES. 
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.—
‘‘(1) IN
GENERAL.—A person (other than a 
household consumer) that has reason to believe that 
any carcass, part of a carcass, meat, or meat food 
product of cattle, sheep, swine, goats, horses, mules, 
or other equines (referred to in this section as an 
‘article’) transported, stored, distributed, or other-
wise handled by the person is adulterated or mis-
branded shall, as soon as practicable, notify the Sec-
retary of the identity and location of the article.
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.—
‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means, if 
the Secretary finds that an article is adulterated or 
misbranded and that there is a reasonable prob-
ability that human consumption of the article would 
present a threat to public health (as determined by 
the Secretary), the Secretary shall provide all appro-
priate persons (as determined by the Secretary), 
that transported, stored, distributed, or otherwise 
handled the article with an opportunity—
‘‘(A) to cease distribution of the article; 
‘‘(B) to notify all persons that transport, 
store, distribute, or otherwise handle the article, 
or to which the article has been transported, 
sold, distributed, or otherwise handled, to cease 
immediately distribution of the article; 
‘‘(C) to recall the article; or 
‘‘(D) in consultation with the Secretary, to 
provide notice of the finding of the Secretary to
all consumers to which the article was, or may 
have been, distributed. 
‘‘(2) MANDATORY ACTIONS.—If the appropriate 
person referred to in paragraph (1) does not carry 
out the actions described in that paragraph with re-
spect to an article within the time period and in the 
manner prescribed by the Secretary, the Secretary 
shall, by order, require, as the Secretary determines 
to be necessary, the person—
‘‘(A) to cease immediately distribution of 
the article; and 
‘‘(B) to make immediately the notification 
described in paragraph (1)(B). 
‘‘(3) NOTICE TO CONSUMERS.—The Secretary 
shall, as the Secretary determines to be necessary, 
provide notice of the finding of the Secretary under 
paragraph (1) to consumers to which the article was, 
or may have been, distributed. 
‘‘(4) NONDISTRIBUTION
BY
NOTIFIED
PER-
SONS.—A person that transports, stores, distributes, 
or otherwise handles the article, or to which the arti-
cle has been transported, sold, distributed, or other-
wise handled, and that is notified under paragraph 
(1)(B) or (2)(B) shall cease immediately distribution 
of the article.
‘‘(5) AVAILABILITY
OF
RECORDS
TO
SEC-
RETARY.—Each appropriate person referred to in 
paragraph (1) that transported, stored, distributed, 
or otherwise handled an article shall make available 
to the Secretary information necessary to carry out 
this subsection, as determined by the Secretary, re-
garding—
‘‘(A) persons that transport, store, dis-
tribute, or otherwise handle the article; and 
‘‘(B) persons to which the article has been 
transported, sold, distributed, or otherwise han-
dled. 
‘‘(c) INFORMAL HEARINGS ON ORDERS.—
‘‘(1) IN GENERAL.—The Secretary shall provide 
a person subject to an order under subsection (b) 
with an opportunity for an informal hearing (in ac-
cordance with such rules or regulations as the Sec-
retary shall prescribe) on—
‘‘(A) the actions required by the order; and 
‘‘(B) any reasons why the article that is 
the subject of the order should not be recalled. 
‘‘(2) TIMING
OF
HEARINGS.—The Secretary 
shall hold a hearing under paragraph (1) as soon as 
practicable, but not later than 2 business days, after 
the date of issuance of the order.
‘‘(d) POST-HEARING RECALL ORDERS.—
‘‘(1) AMENDMENT OF ORDERS.—If, after pro-
viding an opportunity for an informal hearing under 
subsection (c), the Secretary determines that there is 
a reasonable probability that human consumption of 
the article that is the subject of an order under sub-
section (b) presents a threat to public health, the 
Secretary may, as the Secretary determines to be 
necessary—
‘‘(A) amend the order under subsection 
(b)—
‘‘(i) to require recall of the article or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which the recall shall occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; or 
‘‘(C) provide notice of the recall to con-
sumers to which the article was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (c), the Secretary determines that adequate 
grounds do not exist to continue the actions required 
by the order, the Secretary shall vacate the order.
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 412. REFUSAL OR WITHDRAWAL OF INSPECTION OF 
ESTABLISHMENTS. 
‘‘(a) IN GENERAL.—The Secretary may, for such pe-
riod, or indefinitely, as the Secretary considers necessary 
to carry out this Act, refuse to provide or withdraw inspec-
tion under title I with respect to an establishment if the 
Secretary determines, after opportunity for a hearing on 
the record is provided to the applicant for, or recipient 
of, inspection, that the applicant or recipient, or any per-
son responsibly connected with the applicant or recipient 
(within the meaning of section 401), has committed a will-
ful violation or repeated violations of this Act (including 
a regulation promulgated under this Act). 
‘‘(b) DENIAL OR SUSPENSION OF INSPECTION PEND-
ING HEARING.—The Secretary may deny or suspend in-
spection under title I, pending opportunity for an expe-
dited hearing, with respect to an action under subsection 
(a), if the Secretary determines that the denial or suspen-
sion is in the public interest to protect the health or wel-
fare of consumers or to ensure the effective performance 
of an official duty under this Act. 
‘‘(c) JUDICIAL REVIEW.—
‘‘(1) IN GENERAL.—A determination and order 
of the Secretary with respect to the refusal or with-
drawal of inspection under this section shall be final 
unless, not later than 30 days after the effective 
date of the order, the affected applicant for, or re-
cipient of, inspection—
‘‘(A) files a petition for judicial review of 
the order; and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) REFUSAL
OR
WITHDRAWAL
OF
INSPEC-
TION PENDING REVIEW.—Inspection shall be refused 
or withdrawn as of the effective date of the order 
pending any judicial review of the order unless the 
Secretary directs otherwise. 
‘‘(3) VENUE; RECORD.—Judicial review of the 
order shall be—
‘‘(A) in—
‘‘(i) the United States court of ap-
peals for the circuit in which the applicant 
for, or recipient of, inspection resides or 
has its principal place of business; or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and
‘‘(B) on the record on which the deter-
mination and order are based. 
‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 413. CIVIL PENALTIES. 
‘‘(a) IN GENERAL.—
‘‘(1) ASSESSMENT.—The Secretary may assess 
against a person that violates this Act (including a 
regulation promulgated or order issued under this 
Act) a civil penalty for each violation of not more 
than $100,000. 
‘‘(2) SEPARATE
OFFENSES.—Each violation 
and each day during which the violation continues 
shall be considered to be a separate offense. 
‘‘(3) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—The Secretary shall not assess a civil penalty 
under this section against a person unless the person 
is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with sec-
tions 554 and 556 of title 5, United States Code. 
‘‘(4) DETERMINATION
OF
CIVIL
PENALTY 
AMOUNT.—The amount of a civil penalty under this 
section—
‘‘(A) shall be assessed by the Secretary by 
written order, taking into account—
‘‘(i) the gravity of the violation; 
‘‘(ii) the degree of culpability of the 
person; 
‘‘(iii) the size and type of the business 
of the person; and 
‘‘(iv) any history of prior offenses by 
the person under this Act; and 
‘‘(B) shall be reviewed only in accordance 
with subsection (b). 
‘‘(b) JUDICIAL REVIEW.—
‘‘(1) IN GENERAL.—An order assessing a civil 
penalty against a person under subsection (a) shall 
be final unless the person—
‘‘(A) not later than 30 days after the effec-
tive date of the order, files a petition for judi-
cial review of the order in—
‘‘(i) the United States court of ap-
peals for the circuit in which the person re-
sides or has its principal place of business; 
or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) FILING OF COPY OF RECORD.—The Sec-
retary shall promptly file in the court a certified 
copy of the record on which the order was issued. 
‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY 
ASSESSMENT.—
‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 
person fails to pay a civil penalty assessed under 
subsection (a) after the order assessing the civil pen-
alty has become a final order, or after the court of 
appeals has entered final judgment in favor of the 
Secretary, the Secretary shall refer the matter to the 
Attorney General. 
‘‘(2) ACTION
BY
ATTORNEY
GENERAL.—The 
Attorney General shall bring a civil action to recover 
the amount of the civil penalty in United States dis-
trict court. 
‘‘(3) SCOPE
OF
REVIEW.—In a civil action 
under paragraph (2), the validity and appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to review. 
‘‘(d) REFUSAL
OR WITHDRAWAL
OF INSPECTION 
PENDING PAYMENT.—If a person fails to pay the amount 
of a civil penalty after the order assessing the civil penalty
has become a final order, the Secretary may refuse to pro-
vide or withdraw inspection under title I of the person 
until the civil penalty is paid or until the Secretary directs 
otherwise. 
‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.—
Nothing in this Act requires the Secretary to report for 
prosecution, or for the commencement of an action, any 
violation of this Act in any case in which the Secretary 
believes that the public interest will be adequately served 
by the assessment of a civil penalty under this section. 
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
(b) CONFORMING AMENDMENTS.—
(1) Section 1 of the Federal Meat Inspection 
Act (21 U.S.C. 601) is amended by adding at the 
end the following: 
‘‘(w) PERSON.—The term ‘person’ means any indi-
vidual, partnership, corporation, association, or other busi-
ness unit.’’. 
(2) The Federal Meat Inspection Act (21 
U.S.C. 601 et seq.) is amended—
(A) by striking ‘‘person, firm, or corpora-
tion’’ each place it appears and inserting ‘‘per-
son’’;
(B) by striking ‘‘persons, firms, and cor-
porations’’ each place it appears and inserting 
‘‘persons’’; and 
(C) by striking ‘‘persons, firms, or corpora-
tions’’ each place it appears and inserting ‘‘per-
sons’’. 
SEC. 3. FOOD SAFETY ENFORCEMENT FOR POULTRY AND 
POULTRY FOOD PRODUCTS. 
The Poultry Products Inspection Act (21 U.S.C. 451 
et seq.) is amended—
(1) in the first sentence of section 5(c)(1) (21 
U.S.C. 454(c)(1))—
(A) by striking ‘‘, by thirty days prior to 
the expiration of two years after enactment of 
the Wholesome Poultry Products Act,’’; and 
(B) by striking ‘‘sections 1–4, 6–10, and 
12–22 of this Act’’ and inserting ‘‘sections 1 
through 4, 6 through 10, 12 through 22, and 
31 through 33’’; and 
(2) by adding at the end the following: 
‘‘SEC. 31. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES. 
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.—
‘‘(1) IN
GENERAL.—A person (other than a 
household consumer) that has reason to believe that 
any poultry or poultry product (referred to in this 
section as an ‘article’) transported, stored, distrib-
uted, or otherwise handled by the person is adulter-
ated or misbranded shall, as soon as practicable, no-
tify the Secretary of the identity and location of the 
article. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.—
‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means, if 
the Secretary finds that an article is adulterated or 
misbranded and that there is a reasonable prob-
ability that human consumption of the article would 
present a threat to public health (as determined by 
the Secretary), the Secretary shall provide all appro-
priate persons (as determined by the Secretary), 
that transported, stored, distributed, or otherwise 
handled the article with an opportunity—
‘‘(A) to cease distribution of the article;
‘‘(B) to notify all persons that transport, 
store, distribute, or otherwise handle the article, 
or to which the article has been transported, 
sold, distributed, or otherwise handled, to cease 
immediately distribution of the article; 
‘‘(C) to recall the article; or 
‘‘(D) in consultation with the Secretary, to 
provide notice of the finding of the Secretary to 
all consumers to which the article was, or may 
have been, distributed. 
‘‘(2) MANDATORY ACTIONS.—If the appropriate 
person referred to in paragraph (1) does not carry 
out the actions described in that paragraph with re-
spect to an article within the time period and in the 
manner prescribed by the Secretary, the Secretary 
shall, by order, require, as the Secretary determines 
to be necessary, the person—
‘‘(A) to cease immediately distribution of 
the article; and 
‘‘(B) to make immediately the notification 
described in paragraph (1)(B). 
‘‘(3) NOTICE TO CONSUMERS.—The Secretary 
shall, as the Secretary determines to be necessary, 
provide notice of the finding of the Secretary under
paragraph (1) to consumers to which the article was, 
or may have been, distributed. 
‘‘(4) NONDISTRIBUTION
BY
NOTIFIED
PER-
SONS.—A person that transports, stores, distributes, 
or otherwise handles the article, or to which the arti-
cle has been transported, sold, distributed, or other-
wise handled, and that is notified under paragraph 
(1)(B) or (2)(B) shall cease immediately distribution 
of the article. 
‘‘(5) AVAILABILITY
OF
RECORDS
TO
SEC-
RETARY.—Each appropriate person referred to in 
paragraph (1) that transported, stored, distributed, 
or otherwise handled an article shall make available 
to the Secretary information necessary to carry out 
this subsection, as determined by the Secretary, re-
garding—
‘‘(A) persons that transport, store, dis-
tribute, or otherwise handle the article; and 
‘‘(B) persons to which the article has been 
transported, sold, distributed, or otherwise han-
dled. 
‘‘(c) INFORMAL HEARINGS ON ORDERS.—
‘‘(1) IN GENERAL.—The Secretary shall provide 
a person subject to an order under subsection (b) 
with an opportunity for an informal hearing (in ac-
cordance with such rules or regulations as the Sec-
retary shall prescribe) on—
‘‘(A) the actions required by the order; and 
‘‘(B) any reasons why the article that is 
the subject of the order should not be recalled. 
‘‘(2) TIMING
OF
HEARINGS.—The Secretary 
shall hold a hearing under paragraph (1) as soon as 
practicable, but not later than 2 business days, after 
the date of issuance of the order. 
‘‘(d) POST-HEARING RECALL ORDERS.—
‘‘(1) AMENDMENT OF ORDERS.—If, after pro-
viding an opportunity for an informal hearing under 
subsection (c), the Secretary determines that there is 
a reasonable probability that human consumption of 
the article that is the subject of an order under sub-
section (b) presents a threat to public health, the 
Secretary may, as the Secretary determines to be 
necessary—
‘‘(A) amend the order under subsection 
(b)—
‘‘(i) to require recall of the article or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which the recall shall occur;
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; or 
‘‘(C) provide notice of the recall to con-
sumers to which the article was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (c), the Secretary determines that adequate 
grounds do not exist to continue the actions required 
by the order, the Secretary shall vacate the order. 
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 32. REFUSAL OR WITHDRAWAL OF INSPECTION OF 
ESTABLISHMENTS. 
‘‘(a) IN GENERAL.—The Secretary may, for such pe-
riod, or indefinitely, as the Secretary considers necessary 
to carry out this Act, refuse to provide or withdraw inspec-
tion under this Act with respect to an establishment if the 
Secretary determines, after opportunity for a hearing on 
the record is provided to the applicant for, or recipient 
of, inspection, that the applicant or recipient, or any per-
son responsibly connected with the applicant or recipient 
(within the meaning of section 18(a)), has committed a
pending any judicial review of the order unless the 
Secretary directs otherwise. 
‘‘(3) VENUE; RECORD.—Judicial review of the 
order shall be—
‘‘(A) in—
‘‘(i) the United States court of ap-
peals for the circuit in which the applicant 
for, or recipient of, inspection resides or 
has its principal place of business; or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) on the record on which the deter-
mination and order are based. 
‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 33. CIVIL PENALTIES. 
‘‘(a) IN GENERAL.—
‘‘(1) ASSESSMENT.—The Secretary may assess 
against a person that violates this Act (including a 
regulation promulgated or order issued under this 
Act) a civil penalty for each violation of not more 
than $100,000.
‘‘(2) SEPARATE
OFFENSES.—Each violation 
and each day during which the violation continues 
shall be considered to be a separate offense. 
‘‘(3) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—The Secretary shall not assess a civil penalty 
under this section against a person unless the person 
is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with sec-
tions 554 and 556 of title 5, United States Code. 
‘‘(4) DETERMINATION
OF
CIVIL
PENALTY 
AMOUNT.—The amount of a civil penalty under this 
section—
‘‘(A) shall be assessed by the Secretary by 
written order, taking into account—
‘‘(i) the gravity of the violation; 
‘‘(ii) the degree of culpability of the 
person; 
‘‘(iii) the size and type of the business 
of the person; and 
‘‘(iv) any history of prior offenses by 
the person under this Act; and 
‘‘(B) shall be reviewed only in accordance 
with subsection (b). 
‘‘(b) JUDICIAL REVIEW.—
‘‘(1) AMENDMENT OF ORDERS.—If, after pro-
viding an opportunity for a hearing under subsection 
(c), the Secretary determines that an article of food 
when introduced into or while in interstate com-
merce, or while held for sale (regardless of whether 
the first sale) after shipment in interstate commerce, 
is adulterated or misbranded in a manner that, if 
consumed, may result in illness or injury, the Sec-
retary may, as the Secretary determines to be nec-
essary—
‘‘(A) amend the order under subsection 
(b)—
‘‘(i) to require recall of the article or 
other appropriate action; and 
‘‘(ii) to specify a timetable during 
which the recall shall occur; 
‘‘(B) require periodic reports to the Sec-
retary describing the progress of the recall; or 
‘‘(C) provide notice of the recall to con-
sumers to which the article was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for a hearing under subsection (c), 
the Secretary determines that adequate grounds do