H. R. 2751—56 
‘‘SEC. 423. MANDATORY RECALL AUTHORITY. 
‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary determines, 
based on information gathered through the reportable food registry 
under section 417 or through any other means, that there is a 
reasonable probability that an article of food (other than infant 
formula) is adulterated under section 402 or misbranded under 
section 403(w) and the use of or exposure to such article will 
cause serious adverse health consequences or death to humans 
or animals, the Secretary shall provide the responsible party (as 
defined in section 417) with an opportunity to cease distribution 
and recall such article. 
‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION
AND GIVE 
NOTICE.— 
‘‘(1) IN GENERAL.—If the responsible party refuses to or 
does not voluntarily cease distribution or recall such article 
within the time and in the manner prescribed by the Secretary 
(if so prescribed), the Secretary may, by order require, as the 
Secretary deems necessary, such person to— 
‘‘(A) immediately cease distribution of such article; and 
‘‘(B) as applicable, immediately notify all persons— 
‘‘(i) manufacturing, processing, packing, trans-
porting, distributing, receiving, holding, or importing 
and selling such article; and 
‘‘(ii) to which such article has been distributed, 
transported, or sold, to immediately cease distribution 
of such article. 
‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 
‘‘(A) IN GENERAL.—If an article of food covered by a 
recall order issued under paragraph (1)(B) has been distrib-
uted to a warehouse-based third party logistics provider 
without providing such provider sufficient information to 
know or reasonably determine the precise identity of the 
article of food covered by a recall order that is in its 
possession, the notice provided by the responsible party 
subject to the order issued under paragraph (1)(B) shall 
include such information as is necessary for the warehouse- 
based third party logistics provider to identify the food. 
‘‘(B) RULES OF CONSTRUCTION.—Nothing in this para-
graph shall be construed— 
‘‘(i) to exempt a warehouse-based third party logis-
tics provider from the requirements of this Act, 
including the requirements in this section and section 
414; or 
‘‘(ii) to exempt a warehouse-based third party logis-
tics provider from being the subject of a mandatory 
recall order. 
‘‘(3) DETERMINATION TO LIMIT AREAS AFFECTED.—If the Sec-
retary requires a responsible party to cease distribution under 
paragraph (1)(A) of an article of food identified in subsection 
(a), the Secretary may limit the size of the geographic area 
and the markets affected by such cessation if such limitation 
would not compromise the public health. 
‘‘(c) HEARING
ON ORDER.—The Secretary shall provide the 
responsible party subject to an order under subsection (b) with 
an opportunity for an informal hearing, to be held as soon as 
possible, but not later than 2 days after the issuance of the order,
H. R. 2751—57 
on the actions required by the order and on why the article that 
is the subject of the order should not be recalled. 
‘‘(d) POST-HEARING
RECALL
ORDER
AND
MODIFICATION
OF 
ORDER.— 
‘‘(1) AMENDMENT OF ORDER.—If, after providing opportunity 
for an informal hearing under subsection (c), the Secretary 
determines that removal of the article from commerce is nec-
essary, the Secretary shall, as appropriate— 
‘‘(A) amend the order to require recall of such article 
or other appropriate action; 
‘‘(B) specify a timetable in which the recall shall occur; 
‘‘(C) require periodic reports to the Secretary describing 
the progress of the recall; and 
‘‘(D) provide notice to consumers to whom such article 
was, or may have been, distributed. 
‘‘(2) VACATING OF ORDER.—If, after such hearing, the Sec-
retary determines that adequate grounds do not exist to con-
tinue the actions required by the order, or that such actions 
should be modified, the Secretary shall vacate the order or 
modify the order. 
‘‘(e) RULE REGARDING ALCOHOLIC BEVERAGES.—The Secretary 
shall not initiate a mandatory recall or take any other action 
under this section with respect to any alcohol beverage until the 
Secretary has provided the Alcohol and Tobacco Tax and Trade 
Bureau with a reasonable opportunity to cease distribution and 
recall such article under the Alcohol and Tobacco Tax and Trade 
Bureau authority. 
‘‘(f) COOPERATION
AND CONSULTATION.—The Secretary shall 
work with State and local public health officials in carrying out 
this section, as appropriate. 
‘‘(g) PUBLIC NOTIFICATION.—In conducting a recall under this 
section, the Secretary shall— 
‘‘(1) ensure that a press release is published regarding 
the recall, as well as alerts and public notices, as appropriate, 
in order to provide notification— 
‘‘(A) of the recall to consumers and retailers to whom 
such article was, or may have been, distributed; and 
‘‘(B) that includes, at a minimum— 
‘‘(i) the name of the article of food subject to the 
recall; 
‘‘(ii) a description of the risk associated with such 
article; and 
‘‘(iii) to the extent practicable, information for con-
sumers about similar articles of food that are not 
affected by the recall; 
‘‘(2) consult the policies of the Department of Agriculture 
regarding providing to the public a list of retail consignees 
receiving products involved in a Class I recall and shall consider 
providing such a list to the public, as determined appropriate 
by the Secretary; and 
‘‘(3) if available, publish on the Internet Web site of the 
Food and Drug Administration an image of the article that 
is the subject of the press release described in (1). 
‘‘(h) NO DELEGATION.—The authority conferred by this section 
to order a recall or vacate a recall order shall not be delegated 
to any officer or employee other than the Commissioner.
H. R. 2751—58 
‘‘(i) EFFECT.—Nothing in this section shall affect the authority 
of the Secretary to request or participate in a voluntary recall, 
or to issue an order to cease distribution or to recall under any 
other provision of this Act or under the Public Health Service 
Act. 
‘‘(j) COORDINATED COMMUNICATION.— 
‘‘(1) IN GENERAL.—To assist in carrying out the require-
ments of this subsection, the Secretary shall establish an 
incident command operation or a similar operation within the 
Department of Health and Human Services that will operate 
not later than 24 hours after the initiation of a mandatory 
recall or the recall of an article of food for which the use 
of, or exposure to, such article will cause serious adverse health 
consequences or death to humans or animals. 
‘‘(2) 
REQUIREMENTS.—To 
reduce 
the 
potential 
for 
miscommunication during recalls or regarding investigations 
of a food borne illness outbreak associated with a food that 
is subject to a recall, each incident command operation or 
similar operation under paragraph (1) shall use regular staff 
and resources of the Department of Health and Human Services 
to— 
‘‘(A) ensure timely and coordinated communication 
within the Department, including enhanced communication 
and coordination between different agencies and organiza-
tions within the Department; 
‘‘(B) ensure timely and coordinated communication 
from 
the 
Department, 
including 
public 
statements, 
throughout the duration of the investigation and related 
foodborne illness outbreak; 
‘‘(C) identify a single point of contact within the Depart-
ment for public inquiries regarding any actions by the 
Secretary related to a recall; 
‘‘(D) coordinate with Federal, State, local, and tribal 
authorities, as appropriate, that have responsibilities 
related to the recall of a food or a foodborne illness outbreak 
associated with a food that is subject to the recall, including 
notification of the Secretary of Agriculture and the Sec-
retary of Education in the event such recalled food is a 
commodity intended for use in a child nutrition program 
(as identified in section 25(b) of the Richard B. Russell 
National School Lunch Act (42 U.S.C. 1769f(b))); and 
‘‘(E) conclude operations at such time as the Secretary 
determines appropriate. 
‘‘(3) MULTIPLE RECALLS.—The Secretary may establish mul-
tiple or concurrent incident command operations or similar 
operations in the event of multiple recalls or foodborne illness 
outbreaks necessitating such action by the Department of 
Health and Human Services.’’. 
(b) SEARCH ENGINE.—Not later than 90 days after the date 
of enactment of this Act, the Secretary shall modify the Internet 
Web site of the Food and Drug Administration to include a search 
engine that— 
(1) is consumer-friendly, as determined by the Secretary; 
and 
(2) provides a means by which an individual may locate 
relevant information regarding each article of food subject to 
a recall under section 423 of the Federal Food, Drug, and
H. R. 2751—59 
Cosmetic Act and the status of such recall (such as whether 
a recall is ongoing or has been completed). 
(c) CIVIL PENALTY.—Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) 
is amended by inserting ‘‘or any person who does not comply with 
a recall order under section 423’’ after ‘‘section 402(a)(2)(B)’’. 
(d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 et seq.), 
as amended by section 106, is amended by adding at the end 
the following: 
‘‘(xx) The refusal or failure to follow an order under section 
423.’’. 
(e) GAO REVIEW.— 
(1) IN GENERAL.—Not later than 90 days after the date 
of enactment of this Act, the Comptroller General of the United 
States shall submit to Congress a report that— 
(A) identifies State and local agencies with the 
authority to require the mandatory recall of food, and 
evaluates use of such authority with regard to frequency, 
effectiveness, and appropriateness, including consideration 
of any new or existing mechanisms available to compensate 
persons for general and specific recall-related costs when 
a recall is subsequently determined by the relevant 
authority to have been an error; 
(B) identifies Federal agencies, other than the Depart-
ment of Health and Human Services, with mandatory recall 
authority and examines use of that authority with regard 
to frequency, effectiveness, and appropriateness, including 
any new or existing mechanisms available to compensate 
persons for general and specific recall-related costs when 
a recall is subsequently determined by the relevant agency 
to have been an error; 
(C) considers models for farmer restitution imple-
mented in other nations in cases of erroneous recalls; and 
(D) makes recommendations to the Secretary regarding 
use of the authority under section 423 of the Federal Food, 
Drug, and Cosmetic Act (as added by this section) to protect 
the public health while seeking to minimize unnecessary 
economic costs. 
(2) EFFECT OF REVIEW.—If the Comptroller General of the 
United States finds, after the review conducted under para-
graph (1), that the mechanisms described in such paragraph 
do not exist or are inadequate, then, not later than 90 days 
after the conclusion of such review, the Secretary of Agriculture 
shall conduct a study of the feasibility of implementing a farmer 
indemnification program to provide restitution to agricultural 
producers for losses sustained as a result of a mandatory recall 
of an agricultural commodity by a Federal or State regulatory 
agency that is subsequently determined to be in error. The 
Secretary of Agriculture shall submit to the Committee on 
Agriculture of the House of Representatives and the Committee 
on Agriculture, Nutrition, and Forestry of the Senate a report 
that describes the results of the study, including any rec-
ommendations. 
(f) ANNUAL REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 2 years after the date 
of enactment of this Act and annually thereafter, the Secretary 
of Health and Human Services (referred to in this subsection 
as the ‘‘Secretary’’) shall submit a report to the Committee