I 
110TH CONGRESS 
1ST SESSION H. R. 2108 
To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
safety of food for humans and pets. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 2, 2007 
Ms. DELAURO (for herself, Ms. DEGETTE, Mr. MORAN of Virginia, Mr. GENE 
GREEN of Texas, Ms. SCHAKOWSKY, Ms. MATSUI, and Mrs. DAVIS of 
California) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act with 
respect to the safety of food for humans and pets. 
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 ‘‘Human and Pet Food 
Safety Act of 2007’’. 
SEC. 2. FOOD SAFETY FOR HUMANS AND PETS. 
(a) ADVERSE EVENTS; INSPECTIONS; RECALL.— 
Chapter IV of the Federal Food, Drug, and Cosmetic Act 
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(21 U.S.C. 341 et seq.) is amended by adding at the end 
the following: 
‘‘SEC. 417. NOTIFICATION AND RECALL. 
‘‘(a) NOTICE TO SECRETARY OF VIOLATION.— 
‘‘(1) IN GENERAL.—A person that has reason 
to believe that any food introduced into or in inter-
state commerce, or held for sale (whether or not the 
first sale) after shipment in interstate commerce, 
may be in violation of this Act shall immediately no-
tify the Secretary of the identity and location of the 
food. 
‘‘(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; VOL-
UNTARY ACTIONS.—If the Secretary determines that food 
is in violation of this Act when introduced into or while 
in interstate commerce or while held for sale (whether or 
not the first sale) after shipment in interstate commerce 
and that there is a reasonable probability that the food, 
if consumed, would present a threat to public health, as 
determined by the Secretary, the Secretary shall give the 
appropriate persons (including the manufacturers, import-
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ers, distributors, or retailers of the food) an opportunity 
to— 
‘‘(1) cease distribution of the food; 
‘‘(2) notify all persons— 
‘‘(A) processing, distributing, or otherwise 
handling the food to immediately cease such ac-
tivities with respect to the food; or 
‘‘(B) to which the food has been distrib-
uted, transported, or sold, to immediately cease 
distribution of the food; 
‘‘(3) recall the food; 
‘‘(4) in conjunction with the Secretary, provide 
notice of the finding of the Secretary— 
‘‘(A) to consumers to whom the food was, 
or may have been, distributed; and 
‘‘(B) to State and local public health offi-
cials; or 
‘‘(5) take any combination of the measures de-
scribed in this paragraph, as determined by the Sec-
retary to be appropriate in the circumstances. 
‘‘(c) CIVIL AND CRIMINAL PENALTIES.— 
‘‘(1) CIVIL SANCTIONS.— 
‘‘(A) CIVIL
PENALTY.—Any person that 
commits an act that violates the notification 
and recall standards under subsection (b) (in-
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cluding a regulation promulgated or order 
issued under this Act) may be assessed a civil 
penalty by the Secretary of not more than 
$10,000 for each such act. 
‘‘(B) SEPARATE OFFENSE.—Each act de-
scribed in subparagraph (A) and each day dur-
ing which that act 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 Secretary by a written order, which shall 
specify the amount of the penalty and the basis 
for the penalty under subparagraph (B) consid-
ered by the Secretary. 
‘‘(B) AMOUNT OF PENALTY.—Subject to 
paragraph (1)(A), the amount of the civil pen-
alty shall be determined by the Secretary, 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 
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‘‘(iv) any history of prior offenses by 
the person under this Act. 
‘‘(C) REVIEW OF ORDER.—The order may 
be reviewed only in accordance with subsection 
(d). 
‘‘(3) EXCEPTION.—No person shall be subject 
to the penalties of this subsection— 
‘‘(A) for having received, proffered, or de-
livered 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 Secretary)— 
‘‘(i) the name, address and contact in-
formation 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 pur-
chased or received the food; and 
‘‘(iii) copies of all documents per-
taining 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 
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in good faith the food, stating that the food is 
not adulterated or misbranded within the mean-
ing of this Act. 
‘‘(d) JUDICIAL REVIEW.— 
‘‘(1) IN GENERAL.—An order assessing a civil 
penalty under subsection (c) shall be a final order 
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 the United States 
court of appeals for the circuit in which that 
person resides or has its principal place of busi-
ness or the United States Court of Appeals for 
the District of Columbia; and 
‘‘(B) simultaneously serves a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) FILING OF RECORD.—Not later than 45 
days after the service of a copy of the petition under 
paragraph (1)(B), the Secretary 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 Secretary relating to the order shall be set aside 
only if found to be unsupported by substantial evi-
dence on the record as a whole. 
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‘‘(e) COLLECTION ACTIONS FOR FAILURE TO PAY.— 
‘‘(1) IN GENERAL.—If any person fails to pay 
a civil penalty assessed under subsection (c) after 
the order assessing the penalty has become a final 
order, or after the court of appeals described in sub-
section (d) has entered final judgment in favor of 
the Secretary, the Secretary shall refer the matter to 
the Attorney General, who shall institute in a United 
States district court 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 appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to judicial review. 
‘‘(f) PENALTIES PAID INTO ACCOUNT.—The Sec-
retary— 
‘‘(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 in-
spect retail commercial food establishments, 
such as an establishment that holds, stores, or 
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transports food or food ingredients, or other 
food or firms under the jurisdiction of State 
food safety programs. 
‘‘(g) DISCRETION OF THE SECRETARY TO PROS-
ECUTE.—Nothing in this section, section 418, or section 
419 requires the Secretary to report for prosecution, or 
for the commencement of an action, the violation of this 
Act in a case in which the Secretary finds that the public 
interest will be adequately served by the assessment of a 
civil penalty under this section. 
‘‘(h) 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. 418. MANDATORY RECALL ACTION. 
‘‘(a) MANDATORY ACTIONS.—If a person referred to 
in section 417(b) refuses to or does not adequately carry 
out the actions described in that section within the time 
period and in the manner prescribed by the Secretary, the 
Secretary shall— 
‘‘(1) have authority to control and possess the 
food, including ordering the shipment of the food 
from a food establishment, such as an establishment 
that holds, stores, or transports food or food ingredi-
ents, to the Secretary— 
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‘‘(A) at the expense of such food establish-
ment; or 
‘‘(B) in an emergency (as determined by 
the Secretary), at the expense of the Secretary; 
and 
‘‘(2) by order, require, as the Secretary deter-
mines to be necessary, the person to immediately— 
‘‘(A) cease distribution of the food; and 
‘‘(B) notify all persons— 
‘‘(i) processing, distributing, or other-
wise handling the food to immediately 
cease such activities with respect to the 
food; or 
‘‘(ii) if the food has been distributed, 
transported, or sold, to immediately cease 
distribution of the food. 
‘‘(b) NOTIFICATION
TO
CONSUMERS
BY
SEC-
RETARY.—The Secretary shall, as the Secretary deter-
mines to be necessary, provide notice of the finding of the 
Secretary under subsection (a)— 
‘‘(1) to consumers to whom the food was, or 
may have been, distributed; and 
‘‘(2) to State and local public health officials. 
‘‘(c) NONDISTRIBUTION BY NOTIFIED PERSONS.—A 
person that processes, distributes, or otherwise handles 
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the food, or to which the food has been distributed, trans-
ported, or sold, and that is notified under section 
417(b)(2) or subsection (a)(2)(B) of this section shall im-
mediately cease distribution of the food. 
‘‘(d) AVAILABILITY OF RECORDS TO SECRETARY.— 
Each person referred to in section 417 that processed, dis-
tributed, or otherwise handled food shall make available 
to the Secretary information necessary to carry out this 
subsection, as determined by the Secretary, regarding— 
‘‘(1) persons that processed, distributed, or oth-
erwise handled the food; and 
‘‘(2) persons to which the food has been trans-
ported, sold, distributed, or otherwise handled. 
‘‘(e) INFORMAL HEARINGS ON ORDERS.— 
‘‘(1) IN GENERAL.—The Secretary shall provide 
any person subject to an order under subsection (a) 
with an opportunity for an informal hearing, to be 
held as soon as practicable but not later than 2 busi-
ness days after the issuance of the order. 
‘‘(2) SCOPE OF THE HEARING.—In a hearing 
under paragraph (1), the Secretary shall consider 
the actions required by the order and any reasons 
why the food that is the subject of the order should 
not be recalled. 
‘‘(f) POST-HEARING RECALL ORDERS.— 
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‘‘(1) AMENDMENT OF ORDER.—If, after pro-
viding an opportunity for an informal hearing under 
subsection (e), the Secretary determines that there 
is a reasonable probability that the food that is the 
subject of an order under subsection (a), if con-
sumed, would present a threat to the public health, 
the Secretary, as the Secretary determines to be nec-
essary, may— 
‘‘(A) amend the order to require recall of 
the food or other appropriate action; 
‘‘(B) specify a timetable in which the recall 
shall occur; 
‘‘(C) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(D) provide notice of the recall to con-
sumers to whom the food was, or may have 
been, distributed. 
‘‘(2) VACATION OF ORDERS.—If, after providing 
an opportunity for an informal hearing under sub-
section (e), the Secretary determines that adequate 
grounds do not exist to continue the actions required 
by the order, the Secretary shall vacate the order. 
‘‘(g) REMEDIES NOT EXCLUSIVE.—The remedies 
provided in this section shall be in addition to, and not 
exclusive of, other remedies that may be available. 
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‘‘SEC. 419. FOREIGN INSPECTIONS; IMPORTS. 
‘‘(a) AUTHORITY TO INSPECT.—The Secretary shall 
have the authority to visit any foreign country that im-
ports to the United States human or pet food. Such a visit 
shall be for the purpose of auditing the food safety or pet 
food programs of such foreign country or to conduct inves-
tigations in the event that a food or ingredient of a food 
is found to violate this Act. 
‘‘(b) IMPORTS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this section, the 
Secretary shall establish a system under which a for-
eign government or foreign manufacturer, importer, 
distributor, or retailer that seeks to import food to 
the United States shall submit a request for certifi-
cation to the Secretary. 
‘‘(2) CERTIFICATION
STANDARD.—A foreign 
government or foreign manufacturer, importer, dis-
tributor, or retailer requesting a certification to im-
port food to the United States shall demonstrate, in 
a manner determined appropriate by the Secretary, 
that food produced under the supervision of a for-
eign government or by the foreign manufacturer, im-
porter, distributor, or retailer has met standards for 
food safety, inspection, labeling, and consumer pro-
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tection that are at least equivalent to standards ap-
plicable to food produced in the United States. 
‘‘(3) CERTIFICATION APPROVAL.— 
‘‘(A) REQUEST
BY
FOREIGN
GOVERN-
MENT.—Prior to granting the certification re-
quest of a foreign government, the Secretary 
shall review, audit, and certify the food safety 
program of a requesting foreign government 
(including all statutes, regulations, and inspec-
tion authority) as at least equivalent to the food 
safety program in the United States, as dem-
onstrated by the foreign government. 
‘‘(B) REQUEST BY FOREIGN ESTABLISH-
MENT.—Prior to granting the certification re-
quest of a foreign manufacturer, importer, dis-
tributor, or retailer that seeks to import food to 
the United States, the Secretary shall certify, 
based on an onsite inspection, the food safety 
programs and procedures of a requesting for-
eign firm as at least equivalent to the food safe-
ty programs and procedures of the United 
States. 
‘‘(4) LIMITATION.—A foreign government or 
foreign manufacturer, importer, distributor, or re-
tailer approved by the Secretary to import food to 
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the United States under this section shall be cer-
tified to export only the approved food products to 
the United States for a period not to exceed 5 years. 
‘‘(5) WITHDRAWAL
OF
CERTIFICATION.—The 
Secretary may withdraw certification of any food 
from a foreign government or foreign manufacturer, 
importer, distributor, or retailer that seeks to import 
food to the United States— 
‘‘(A) if such food is linked to an outbreak 
of human illness; 
‘‘(B) following an investigation by the Sec-
retary that finds that the food safety programs 
and procedures of the foreign government or 
foreign manufacturer, importer, distributor, or 
retailer are no longer equivalent to the food 
safety programs and procedures in the United 
States; or 
‘‘(C) following a refusal to allow United 
States officials to conduct such audits and in-
vestigations as may be necessary to fulfill the 
requirements under this section. 
‘‘(6) RENEWAL OF CERTIFICATION.—The Sec-
retary shall audit a foreign government and a for-
eign manufacturer, importer, distributor, or retailer 
that seeks to import food to the United States at 
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least every 5 years to ensure the continued compli-
ance with the standards set forth in this section. 
‘‘(7) REQUIRED
ROUTINE
INSPECTION.—The 
Secretary shall routinely inspect food and food ani-
mals (via a physical examination) before it enters 
the United States to ensure that it is— 
‘‘(A) safe; 
‘‘(B) labeled as required for food produced 
in the United States; and 
‘‘(C) otherwise meets requirements under 
this Act. 
‘‘(8) RECORDS INSPECTION.— 
‘‘(A) IN GENERAL.—The responsible party 
or importer shall permit an authorized person 
to have access to records required to be main-
tained under this section during an inspection 
pursuant to section 704. 
‘‘(B) DEFINITIONS.—For purposes of this 
paragraph— 
‘‘(i) the term ‘authorized person’ 
means an officer or employee of the De-
partment of Health and Human Services, 
who has— 
‘‘(I) appropriate credentials, as 
determined by the Secretary; and 
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‘‘(II) been duly designated by the 
Secretary to have access to the 
records required under this section; 
and 
‘‘(ii) the term ‘responsible party’ 
means, with respect to an article of food, 
any person responsible for the manufac-
turing, processing, packaging, or holding 
for such food for consumption in the 
United States. 
‘‘(9) ENFORCEMENT.—The Secretary is author-
ized to— 
‘‘(A) deny importation of food from any 
foreign government that does not permit United 
States officials to enter the foreign country to 
conduct such audits and inspections as may be 
necessary to fulfill the requirements under this 
section; 
‘‘(B) deny importation of food from any 
foreign government or foreign manufacturer, 
importer, distributor, or retailer that does not 
consent to an investigation by the Administra-
tion when food from that foreign country or 
foreign firm is linked to a foodborne illness out-
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break or is otherwise found to be adulterated or 
mislabeled; and 
‘‘(C) promulgate rules and 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 
this Act. 
‘‘(10) DETENTION
AND
SEIZURE.—Any food 
imported for consumption in the United States may 
be detained, seized, or condemned pursuant to sec-
tion 418.’’. 
SEC. 3. ENSURING EFFICIENT AND EFFECTIVE COMMU-
NICATIONS DURING A RECALL. 
The Secretary, during an ongoing recall of human or 
pet food, shall— 
(1) work with companies, relevant professional 
associations, and other organizations to collect and 
aggregate information pertaining to the recall; 
(2) use existing networks of communication in-
cluding electronic forms of information dissemina-
tion to enhance the quality and speed of communica-
tion with the public; and 
(3) post information regarding recalled prod-
ucts on the Internet website of the Food and Drug 
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Administration in a consolidated, searchable form 
that is easily accessed and understood by the public. 
SEC. 4. ENSURING THE SAFETY OF PET FOOD. 
(a) PROCESSING AND INGREDIENT STANDARDS.— 
Not later than 18 months after the date of the enactment 
of this Act, the Secretary of Health and Human Services 
(referred to in this section as the ‘‘Secretary’’), in con-
sultation with the Association of American Feed Control 
Officials, and other relevant stakeholder groups, including 
veterinary medical associations, animal health organiza-
tions, and pet food manufacturers, shall by regulation es-
tablish— 
(1) processing and ingredient standards with 
respect to feed, pet food, animal waste, and ingre-
dient definitions; and 
(2) updated standards for the labeling of pet 
food that includes nutritional information and ingre-
dient information. 
(b) EARLY WARNING SURVEILLANCE SYSTEMS AND 
NOTIFICATION DURING PET FOOD RECALLS.— 
(1) IN
GENERAL.—Not later than 180 days 
after the date of the enactment of this Act, the Sec-
retary shall by regulation establish an early warning 
and surveillance system to identify contaminations of 
the pet food supply and outbreaks of illness from pet 
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food. In establishing such system, the Secretary 
shall— 
(A) use surveillance and monitoring mech-
anisms similar to, or in coordination with, those 
mechanisms used by the Centers for Disease 
Control and Prevention to monitor human 
health, such as the Foodborne Diseases Active 
Surveillance Network (FoodNet) and PulseNet; 
(B) consult with relevant professional asso-
ciations and private sector veterinary hospitals; 
and 
(C) work with Health Alert Networks and 
other notification networks to inform veterinar-
ians and relevant stakeholders during any recall 
of pet food. 
(2) AUTHORIZATION
OF
APPROPRIATIONS.— 
There are authorized to be appropriated to carry out 
paragraph (1) such sums as may be necessary. 
SEC. 5. SENSE OF THE HOUSE OF REPRESENTATIVES. 
(a) FINDINGS.—Congress finds that— 
(1) the safety and integrity of the United 
States food supply is vital to the public health, to 
public confidence in the food supply, and to the suc-
cess of the food sector of the Nation’s economy; 
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(2) illnesses and deaths of individuals and com-
panion pets caused by contaminated food— 
(A) have contributed to a loss of public 
confidence in food safety; and 
(B) have caused significant economic losses 
to manufacturers and producers not responsible 
for contaminated food items; 
(3) the task of preserving the safety of the food 
supply of the United States faces tremendous pres-
sures with regard to— 
(A) emerging pathogens and other con-
taminants and the ability to detect all forms of 
contamination; and 
(B) an increasing volume of imported food, 
without adequate monitoring and inspection; 
(4) the United States is increasing the amount 
of food that it imports such that— 
(A) from 2003 to the present, the value of 
food 
imports 
has 
increased 
from 
$45,600,000,000 to $64,000,000,000; and 
(B) imported food accounts for 13 percent 
of the average Americans diet, including 31 
percent of fruits, juices, and nuts, 9.5 percent 
of red meat, and 78.6 percent of fish and shell-
fish; and 
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(5) the number of full-time equivalent Food and 
Drug Administration employees conducting inspec-
tions has decreased during the period between 2003 
and 2007. 
(b) SENSE OF THE HOUSE OF REPRESENTATIVES.— 
It is the sense of the House of Representatives that— 
(1) it is vital for Congress to provide the Food 
and Drug Administration with additional resources, 
authorities, and direction with respect to ensuring 
the safety of the food supply of the United States; 
(2) additional Food and Drug Administration 
inspectors are required if we are to improve Food 
and Drug Administration’s ability to safeguard the 
food supply of the United States; and 
(3) because of the increasing volume of inter-
national trade in food products the Secretary of 
Health and Human Services should make it a pri-
ority to enter into agreements, including memoranda 
of understanding, with the trading partners of the 
United States with respect to food safety. 
SEC. 6. ANNUAL REPORT TO CONGRESS. 
The Secretary of Health and Human Services shall, 
on an annual basis, submit to the Committee on Energy 
and Commerce and the Committee on Appropriations of 
the House of Representatives and the Committee on 
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Health, Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate a report that in-
cludes, with respect to the preceding 1-year period— 
(1) the number and amount of food products 
imported into the United States, aggregated by 
country and type of food, if any; 
(2) a listing of the number of inspectors of im-
ported food products and the number of inspections 
performed on such products; and 
(3) aggregated data on the findings of such in-
spections, including data related to violations of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
201 et seq.), and enforcement mechanisms used with 
respect to such findings and violations. 
Æ 
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H2108
mstockstill on PROD1PC66 with BILLS