H. R. 2751—48 
(F) minimize the number of different recordkeeping 
requirements for facilities that handle more than 1 type 
of food; 
(G) to the extent practicable, not require a facility 
to change business systems to comply with such require-
ments; 
(H) allow any person subject to this subsection to main-
tain records required under this subsection at a central 
or reasonably accessible location provided that such records 
can be made available to the Secretary not later than 
24 hours after the Secretary requests such records; and 
(I) include a process by which the Secretary may issue 
a waiver of the requirements under this subsection if the 
Secretary determines that such requirements would result 
in an economic hardship for an individual facility or a 
type of facility; 
(J) be commensurate with the known safety risks of 
the designated food; 
(K) take into account international trade obligations; 
(L) not require— 
(i) a full pedigree, or a record of the complete 
previous distribution history of the food from the point 
of origin of such food; 
(ii) records of recipients of a food beyond the imme-
diate subsequent recipient of such food; or 
(iii) product tracking to the case level by persons 
subject to such requirements; and 
(M) include a process by which the Secretary may 
remove a high-risk food designation developed under para-
graph (2) for a food or type of food. 
(2) DESIGNATION OF HIGH-RISK FOODS.— 
(A) IN GENERAL.—Not later than 1 year after the date 
of enactment of this Act, and thereafter as the Secretary 
determines necessary, the Secretary shall designate high- 
risk foods for which the additional recordkeeping require-
ments described in paragraph (1) are appropriate and nec-
essary to protect the public health. Each such designation 
shall be based on— 
(i) the known safety risks of a particular food, 
including the history and severity of foodborne illness 
outbreaks attributed to such food, taking into consider-
ation foodborne illness data collected by the Centers 
for Disease Control and Prevention; 
(ii) the likelihood that a particular food has a 
high potential risk for microbiological or chemical 
contamination or would support the growth of patho-
genic microorganisms due to the nature of the food 
or the processes used to produce such food; 
(iii) the point in the manufacturing process of the 
food where contamination is most likely to occur; 
(iv) the likelihood of contamination and steps taken 
during the manufacturing process to reduce the possi-
bility of contamination; 
(v) the likelihood that consuming a particular food 
will result in a foodborne illness due to contamination 
of the food; and
H. R. 2751—49 
(vi) the likely or known severity, including health 
and economic impacts, of a foodborne illness attributed 
to a particular food. 
(B) LIST OF HIGH-RISK FOODS.—At the time the Sec-
retary promulgates the final rules under paragraph (1), 
the Secretary shall publish the list of the foods designated 
under subparagraph (A) as high-risk foods on the Internet 
website of the Food and Drug Administration. The Sec-
retary may update the list to designate new high-risk foods 
and to remove foods that are no longer deemed to be 
high-risk foods, provided that each such update to the 
list is consistent with the requirements of this subsection 
and notice of such update is published in the Federal 
Register. 
(3) PROTECTION OF SENSITIVE INFORMATION.—In promul-
gating regulations under this subsection, the Secretary shall 
take appropriate measures to ensure that there are effective 
procedures to prevent the unauthorized disclosure of any trade 
secret or confidential information that is obtained by the Sec-
retary pursuant to this section, including periodic risk assess-
ment and planning to prevent unauthorized release and controls 
to— 
(A) prevent unauthorized reproduction of trade secret 
or confidential information; 
(B) prevent unauthorized access to trade secret or con-
fidential information; and 
(C) maintain records with respect to access by any 
person to trade secret or confidential information main-
tained by the agency. 
(4) PUBLIC
INPUT.—During the comment period in the 
notice of proposed rulemaking under paragraph (1), the Sec-
retary shall conduct not less than 3 public meetings in diverse 
geographical areas of the United States to provide persons 
in different regions an opportunity to comment. 
(5) RETENTION OF RECORDS.—Except as otherwise provided 
in this subsection, the Secretary may require that a facility 
retain records under this subsection for not more than 2 years, 
taking into consideration the risk of spoilage, loss of value, 
or loss of palatability of the applicable food when determining 
the appropriate timeframes. 
(6) LIMITATIONS.— 
(A) FARM
TO
SCHOOL
PROGRAMS.—In establishing 
requirements under this subsection, the Secretary shall, 
in consultation with the Secretary of Agriculture, consider 
the impact of requirements on farm to school or farm 
to institution programs of the Department of Agriculture 
and other farm to school and farm to institution programs 
outside such agency, and shall modify the requirements 
under this subsection, as appropriate, with respect to such 
programs so that the requirements do not place undue 
burdens on farm to school or farm to institution programs. 
(B) IDENTITY-PRESERVED
LABELS
WITH
RESPECT
TO 
FARM SALES OF FOOD THAT IS PRODUCED AND PACKAGED 
ON A FARM.—The requirements under this subsection shall 
not apply to a food that is produced and packaged on 
a farm if—
H. R. 2751—50 
(i) the packaging of the food maintains the integ-
rity of the product and prevents subsequent contamina-
tion or alteration of the product; and 
(ii) the labeling of the food includes the name, 
complete address (street address, town, State, country, 
and zip or other postal code), and business phone 
number of the farm, unless the Secretary waives the 
requirement to include a business phone number of 
the farm, as appropriate, in order to accommodate 
a religious belief of the individual in charge of such 
farm. 
(C) FISHING VESSELS.—The requirements under this 
subsection with respect to a food that is produced through 
the use of a fishing vessel (as defined in section 3(18) 
of the Magnuson-Stevens Fishery Conservation and 
Management Act (16 U.S.C. 1802(18))) shall be limited 
to the requirements under subparagraph (F) until such 
time as the food is sold by the owner, operator, or agent 
in charge of such fishing vessel. 
(D) COMMINGLED RAW AGRICULTURAL COMMODITIES.— 
(i) LIMITATION ON EXTENT OF TRACING.—Record-
keeping requirements under this subsection with 
regard to any commingled raw agricultural commodity 
shall be limited to the requirements under subpara-
graph (F). 
(ii) 
DEFINITIONS.—For 
the 
purposes 
of 
this 
subparagraph— 
(I) the term ‘‘commingled raw agricultural 
commodity’’ means any commodity that is com-
bined or mixed after harvesting, but before proc-
essing; 
(II) the term ‘‘commingled raw agricultural 
commodity’’ shall not include types of fruits and 
vegetables that are raw agricultural commodities 
for which the Secretary has determined that stand-
ards promulgated under section 419 of the Federal 
Food, Drug, and Cosmetic Act (as added by section 
105) would minimize the risk of serious adverse 
health consequences or death; and 
(III) the term ‘‘processing’’ means operations 
that alter the general state of the commodity, such 
as canning, cooking, freezing, dehydration, milling, 
grinding, pasteurization, or homogenization. 
(E) EXEMPTION OF OTHER FOODS.—The Secretary may, 
by notice in the Federal Register, modify the requirements 
under this subsection with respect to, or exempt a food 
or a type of facility from, the requirements of this sub-
section (other than the requirements under subparagraph 
(F), if applicable) if the Secretary determines that product 
tracing requirements for such food (such as bulk or commin-
gled ingredients that are intended to be processed to 
destroy pathogens) or type of facility is not necessary to 
protect the public health. 
(F) RECORDKEEPING REGARDING PREVIOUS SOURCES AND 
SUBSEQUENT RECIPIENTS.—In the case of a person or food 
to which a limitation or exemption under subparagraph 
(C), (D), or (E) applies, if such person, or a person who
H. R. 2751—51 
manufactures, processes, packs, or holds such food, is 
required to register with the Secretary under section 415 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350d) with respect to the manufacturing, processing, 
packing, or holding of the applicable food, the Secretary 
shall require such person to maintain records that identify 
the immediate previous source of such food and the imme-
diate subsequent recipient of such food. 
(G) GROCERY
STORES.—With respect to a sale of a 
food described in subparagraph (H) to a grocery store, 
the Secretary shall not require such grocery store to main-
tain records under this subsection other than records docu-
menting the farm that was the source of such food. The 
Secretary shall not require that such records be kept for 
more than 180 days. 
(H) FARM SALES TO CONSUMERS.—The Secretary shall 
not require a farm to maintain any distribution records 
under this subsection with respect to a sale of a food 
described in subparagraph (I) (including a sale of a food 
that is produced and packaged on such farm), if such 
sale is made by the farm directly to a consumer. 
(I) SALE OF A FOOD.—A sale of a food described in 
this subparagraph is a sale of a food in which— 
(i) the food is produced on a farm; and 
(ii) the sale is made by the owner, operator, or 
agent in charge of such farm directly to a consumer 
or grocery store. 
(7) NO
IMPACT
ON
NON-HIGH-RISK
FOODS.—The record-
keeping requirements established under paragraph (1) shall 
have no effect on foods that are not designated by the Secretary 
under paragraph (2) as high-risk foods. Foods described in 
the preceding sentence shall be subject solely to the record-
keeping requirements under section 414 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350c) and subpart J of 
part 1 of title 21, Code of Federal Regulations (or any successor 
regulations). 
(e) EVALUATION AND RECOMMENDATIONS.— 
(1) REPORT.—Not later than 1 year after the effective date 
of the final rule promulgated under subsection (d)(1), the Comp-
troller General of the United States shall submit to Congress 
a report, taking into consideration the costs of compliance and 
other regulatory burdens on small businesses and Federal, 
State, and local food safety practices and requirements, that 
evaluates the public health benefits and risks, if any, of lim-
iting— 
(A) the product tracing requirements under subsection 
(d) to foods identified under paragraph (2) of such sub-
section, including whether such requirements provide ade-
quate assurance of traceability in the event of intentional 
adulteration, including by acts of terrorism; and 
(B) the participation of restaurants in the record-
keeping requirements. 
(2) DETERMINATION
AND
RECOMMENDATIONS.—In con-
ducting the evaluation and report under paragraph (1), if the 
Comptroller General of the United States determines that the 
limitations described in such paragraph do not adequately pro-
tect the public health, the Comptroller General shall submit