https://www.fda.gov/media/142280/download).
10. * FDA Memorandum, ``Methodological Approach to Developing a
Risk-Ranking Model for Food Tracing FSMA Section 204 (21 U.S.C.
2223),'' September 2022.
11. * FDA Memorandum, ``FDA Foodborne Illness Outbreak Data Used to
Inform the `Requirements for Additional Traceability Records for
Certain Foods' Proposed Rule,'' August 2020.
12. * FDA, ``Investigation Report: Factors Potentially Contributing
to the Contamination of Packaged Leafy Greens Implicated in the
Outbreak of Salmonella Typhimurium During the Summer of 2021,''
January 2022 (https://www.fda.gov/media/155402/download).
13. * FDA, ``FDA's Response to External Peer Review--Data Review on
FDA's `Draft Report for Peer Review: Risk-Ranking Model for Product
Tracing as Required by Section 204 of FSMA' (September 2015),''
August 2020 (https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews and
https://www.fda.gov/media/142281/download).
14. * Food and Agriculture Organization of the United Nations and
World Health Organization (FAO/WHO), ``Microbiological Risk
Assessment: Guidance for Food,'' Microbiological Risk Assessment
Series 36, 2021 (https://www.fao.org/policy-support/tools-and-publications/resources-details/en/c/1412247/).
15. * FDA Memorandum, ``Designation of the Food Traceability List
Using the Risk-Ranking Model for Food Tracing,'' October 2022.
16. * FDA, ``Final Regulatory Impact Analysis,'' Docket No. FDA-
2014-N-0053, November 2022.
17. * FDA, ``Risk-Ranking Model for Food Tracing: Web-based tool for
Criteria and Results,'' 2022. (https://cfsanappsexternal.fda.gov/scripts/FDARiskRankingModelforFoodTracingfinalrule/).
18. * FDA, ``New Era of Smarter Food Safety Blueprint,'' July 2020
(https://www.fda.gov/media/139868/download).
19. * FDA Memorandum, ``Food Traceability List for Requirements for
Additional Traceability Records for Certain Foods Final Rule 2022,''
October 2022.
20. Scott, V.N., Y. Chen, T.A. Freier, et al., ``Control of
Salmonella in Low-Moisture Foods I: Minimizing Entry of Salmonella
into a Processing Facility,'' Food Protection Trends, 29:342-353,
2009.
21. Chen, Y., V.N. Scott, T.A. Freier, et al., ``Control of
Salmonella in Low-Moisture Foods II: Hygiene Practices To Minimize
Salmonella Contamination and Growth,'' Food Protection Trends,
29:435-445, 2009.
22. * FDA and Health Canada, ``Joint FDA/Health Canada Quantitative
Assessment of the Risk of Listeriosis from Soft-Ripened Cheese
Consumption in the United States and Canada: Report.,'' July 2015
(https://www.fda.gov/food/cfsan-risk-safety-assessments/joint-fda-health-canada-quantitative-assessment-risk-listeriosis-soft-ripened-cheese-consumption).
23. * FDA, ``Fish and Fishery Products Hazards and Controls Guidance
(June

2022 Edition),'' June 2022 (https://www.fda.gov/media/80637/download).
24. * FDA Memorandum, ``Categorical Exclusion--Requirements for
Additional Traceability Records for Certain Foods,'' Docket No. FDA-
2014-N-0053,'' October 2022.
25. * FDA Memorandum, ``Inclusion of Retail Establishments of All
Sizes Under FSMA Section 204,'' August 13, 2020.
26. * FDA, ``Guidance for Industry: Questions and Answers Regarding
Food Facility Registration (Seventh Edition),'' August 2018 (https://www.fda.gov/media/85043/download).
27. * FDA, ``Draft Guidance for Industry: Classification of
Activities as Harvesting, Packing, Holding, or Manufacturing/
Processing for Farms and Facilities,'' August 2016 (https://www.fda.gov/media/99911/download).
28. * FDA Memorandum, ``Seed Intended for Agricultural Purposes Sold
for Sprouting,'' October 2022.
29. * FDA, ``Guidance for Industry: The Seafood List,'' July 2012
(https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-seafood-list).
30. * FDA, ``Low- or No-Cost Tech-Enabled Traceability Challenge,''
October 19, 2021. (https://precision.fda.gov/challenges/13).
31. * Codex Alimentarius Commission, ``Principles for Traceability/
Product Tracing as a Tool Within a Food Inspection and Certification
System'' (CAC/GL 60-2006) (https://www.fao.org/fao-who-codexalimentarius/sh-proxy/tr/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B60-2006%252FCXG_060e.pdf).
32. * FDA, ``Foreign Supplier Verification Programs for Importers of
Food for Humans and Animals (FSVP) Regulation Records Requirements''
(https://www.fda.gov/media/131229/download).
33. * FDA and National Oceanic and Atmospheric Administration,
``Memorandum of Understanding Between the Food and Drug
Administration, United States Department of Health and Human
Services and the National Oceanic and Atmospheric Administration,
United States Department of Commerce,'' 2009 (https://www.fda.gov/about-fda/domestic-mous/mou-225-09-0008).
34. * Eastern Research Group, ``Traceability Costs and Costs Savings
From Avoiding Overly Broad Recalls,'' 2022.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 is revised to read as follows:

    Authority:  15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c,
350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371,
374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216,
241, 243, 262, 264, 271.

0
2. Add subpart S, consisting of Sec. Sec.  1.1300 through 1.1465, to
read as follows:
Subpart S--Additional Traceability Records for Certain Foods
Sec.

General Provisions

1.1300 Who is subject to this subpart?
1.1305 What foods and persons are exempt from this subpart?
1.1310 What definitions apply to this subpart?

Traceability Plan

1.1315 What traceability plan must I have for foods on the Food
Traceability List that I manufacture, process, pack, or hold?
1.1320 When must I assign traceability lot codes to foods on the
Food Traceability List? Records of Critical Tracking Events
1.1325 What records must I keep and provide when I harvest or cool a
raw agricultural commodity on the Food Traceability List?
1.1330 What records must I keep when I am performing the initial
packing of a raw agricultural commodity (other than a food obtained
from a fishing vessel) on the Food Traceability List?
1.1335 What records must I keep when I am the first land-based
receiver of a food on the Food Traceability List that was obtained
from a fishing vessel?
1.1340 What records must I keep and provide when I ship a food on
the Food Traceability List?
1.1345 What records must I keep when I receive a food on the Food
Traceability List?
1.1350 What records must I keep when I transform a food on the Food
Traceability List?

Procedures for Modified Requirements and Exemptions

1.1360 Under what circumstances will FDA modify the requirements in
this subpart that apply to a food or type of entity or exempt a food
or type of entity from the requirements of this subpart?
1.1365 When will FDA consider whether to adopt modified requirements
or grant an exemption from the requirements of this subpart?
1.1370 What must be included in a petition requesting modified
requirements or an exemption from the requirements?
1.1375 What information submitted in a petition requesting modified
requirements or an exemption, or information in comments on such a
petition, is publicly available?
1.1380 What process applies to a petition requesting modified
requirements or an exemption?
1.1385 What process will FDA follow when adopting modified
requirements or granting an exemption on our own initiative?
1.1390 When will modified requirements that we adopt or an exemption
that we grant become effective?
1.1395 Under what circumstances may FDA revise or revoke modified
requirements or an exemption?
1.1400 What procedures apply if FDA tentatively determines that
modified requirements or an exemption should be revised or revoked?

Waivers

1.1405 Under what circumstances will FDA waive one or more of the
requirements of this subpart for an individual entity or a type of
entity?
1.1410 When will FDA consider whether to waive a requirement of this
subpart?
1.1415 How may I request a waiver for an individual entity?
1.1420 What process applies to a request for a waiver for an
individual entity?
1.1425 What must be included in a petition requesting a waiver for a
type of entity?
1.1430 What information submitted in a petition requesting a waiver
for a type of entity, or information in comments on such a petition,
is publicly available?
1.1435 What process applies to a petition requesting a waiver for a
type of entity?
1.1440 What process will FDA follow when waiving a requirement of
this subpart on our own initiative?
1.1445 Under what circumstances may FDA modify or revoke a waiver?
1.1450 What procedures apply if FDA tentatively determines that a
waiver should be modified or revoked?

Records Maintenance and Availability

1.1455 How must records required by this subpart be maintained and
made available?

Consequences of Failure To Comply

1.1460 What consequences could result from failing to comply with
the requirements of this subpart?

Updating the Food Traceability List

1.1465 How will FDA update the Food Traceability List?

Subpart S--Additional Traceability Records for Certain Foods

General Provisions

Sec.  1.1300   Who is subject to this subpart?

    Except as otherwise specified in this subpart, the requirements in
this subpart apply to persons who manufacture, process, pack, or hold
foods that appear on the list of foods for which additional
traceability records are

required in accordance with section 204(d)(2) of the FDA Food Safety
Modernization Act (Food Traceability List). FDA will publish the Food
Traceability List on its website, www.fda.gov., in accordance with
section 204(d)(2)(B) of the FDA Food Safety Modernization Act.

Sec.  1.1305   What foods and persons are exempt from this subpart?

    (a) Exemptions for certain small producers. (1) Certain produce
farms. (i) This subpart does not apply to farms or the farm activities
of farm mixed-type facilities with respect to the produce they grow,
when the farm is not a covered farm under part 112 of this chapter in
accordance with Sec.  112.4(a) of this chapter,
    (ii) This subpart does not apply to produce farms when the average
annual sum of the monetary value of their sales of produce and the
market value of produce they manufacture, process, pack, or hold
without sale (e.g., held for a fee) during the previous 3-year period
is no more than $25,000 (on a rolling basis), adjusted for inflation
using 2020 as the baseline year for calculating the adjustment.
    (2) Certain shell egg producers. This subpart does not apply to
shell egg producers with fewer than 3,000 laying hens at a particular
farm, with respect to the shell eggs they produce at that farm.
    (3) Certain other producers of raw agricultural commodities. This
subpart does not apply to producers of raw agricultural commodities
other than produce or shell eggs (e.g., aquaculture operations) when
the average annual sum of the monetary value of their sales of raw
agricultural commodities and the market value of the raw agricultural
commodities they manufacture, process, pack, or hold without sale
(e.g., held for a fee) during the previous 3-year period is no more
than $25,000 (on a rolling basis), adjusted for inflation using 2020 as
the baseline year for calculating the adjustment.
    (b) Exemption for farms when food is sold or donated directly to
consumers. This subpart does not apply to a farm with respect to food
produced on the farm (including food that is also packaged on the farm)
that is sold or donated directly to a consumer by the owner, operator,
or agent in charge of the farm.
    (c) Inapplicability to certain food produced and packaged on a
farm. This subpart does not apply to food produced and packaged on a
farm, provided that:
    (1) The packaging of the food remains in place until the food
reaches the consumer, and such packaging maintains the integrity of the
product and prevents subsequent contamination or alteration of the
product; and
    (2) The labeling of the food that reaches the consumer includes the
name, complete address (street address, town, State, country, and zip
or other postal code for a domestic farm and comparable information for
a foreign farm), and business phone number of the farm on which the
food was produced and packaged. FDA will waive the requirement to
include a business phone number, as appropriate, to accommodate a
religious belief of the individual in charge of the farm.
    (d) Exemptions and partial exemptions for foods that receive
certain types of processing. This subpart does not apply to the
following foods that receive certain types of processing:
    (1) Produce that receives commercial processing that adequately
reduces the presence of microorganisms of public health significance,
provided the conditions set forth in Sec.  112.2(b) of this chapter are
met for the produce;
    (2) Shell eggs when all eggs produced at the particular farm
receive a treatment (as defined in Sec.  118.3 of this chapter) in
accordance with Sec.  118.1(a)(2) of this chapter;
    (3) Food that you subject to a kill step, provided that you
maintain records containing:
    (i) The information specified in Sec.  1.1345 for your receipt of
the food to which you apply the kill step (unless you have entered into
a written agreement concerning your application of a kill step to the
food in accordance with paragraph (d)(6) of this section); and
    (ii) A record of your application of the kill step;
    (4) Food that you change such that the food is no longer on the
Food Traceability List, provided that you maintain records containing
the information specified in Sec.  1.1345 for your receipt of the food
you change;
    (5) Food that you receive that has previously been subjected to a
kill step or that has previously been changed such that the food is no
longer on the Food Traceability List;
    (6) Food that will be subjected to a kill step by an entity other
than a retail food establishment, restaurant, or consumer; or that will
be changed by an entity other than a retail food establishment,
restaurant, or consumer, such that the food will no longer be on the
Food Traceability List, provided that:
    (i) There is a written agreement between the shipper of the food
and the receiver stating that the receiver will apply a kill step to
the food or change the food such that it is no longer on the Food
Traceability List; or
    (ii) There is a written agreement between the shipper of the food
and the receiver stating that an entity in the supply chain subsequent
to the receiver will apply a kill step to the food or change the food
such that it is no longer on the Food Traceability List and that the
receiver will only ship the food to another entity that agrees, in
writing, it will:
    (A) Apply a kill step to the food or change the food such that it
is no longer on the Food Traceability List; or
    (B) Enter into a similar written agreement with a subsequent
receiver stating that a kill step will be applied to the food or that
the food will be changed such that it is no longer on the Food
Traceability List.
    (iii) A written agreement entered into in accordance with paragraph
(d)(6)(i) or (ii) of this section must include the effective date,
printed names and signatures of the persons entering into the
agreement, and the substance of the agreement; and
    (iv) A written agreement entered into in accordance with paragraph
(d)(6)(i) or (ii) must be maintained by both parties for as long as it
is in effect and must be renewed at least once every 3 years.
    (e) Exemption for produce that is rarely consumed raw. This subpart
does not apply to produce that is listed as rarely consumed raw in
Sec.  112.2(a)(1) of this chapter.
    (f) Exemption for raw bivalve molluscan shellfish. This subpart
does not apply to raw bivalve molluscan shellfish that are covered by
the requirements of the National Shellfish Sanitation Program, subject
to the requirements of part 123, subpart C, and Sec.  1240.60 of this
chapter, or covered by a final equivalence determination by FDA for raw
bivalve molluscan shellfish.
    (g) Exemption for persons who manufacture, process, pack, or hold
certain foods subject to regulation by the U.S. Department of
Agriculture (USDA). This subpart does not apply to persons who
manufacture, process, pack, or hold food on the Food Traceability List
during or after the time when the food is within the exclusive
jurisdiction of the USDA under the Federal Meat Inspection Act (21
U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451
et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
    (h) Partial exemption for commingled raw agricultural commodities.
(1) Except as specified in paragraph (h)(3) of this section, this
subpart does not apply to commingled raw agricultural commodities
(which, as defined in

Sec.  1.1310, do not include types of fruits and vegetables to which
the standards for the growing, harvesting, packing, and holding of
produce for human consumption in part 112 of this chapter apply).
    (2) Except as specified in paragraph (h)(3) of this section, this
subpart does not apply to a raw agricultural commodity that will become
a commingled raw agricultural commodity, provided that:
    (i) There is a written agreement between the shipper of the raw
agricultural commodity and the receiver stating that the receiver will
include the commodity as part of a commingled raw agricultural
commodity; or
    (ii) There is a written agreement between the shipper of the raw
agricultural commodity and the receiver stating that an entity in the
supply chain subsequent to the receiver will include the commodity as
part of a commingled raw agricultural commodity and that the receiver
will only ship the raw agricultural commodity to another entity that
agrees, in writing, it will either:
    (A) Include the raw agricultural commodity as part of a commingled
raw agricultural commodity; or
    (B) Enter into a similar written agreement with a subsequent
receiver stating that the raw agricultural commodity will become part
of a commingled raw agricultural commodity;
    (iii) A written agreement entered into in accordance with paragraph
(h)(2)(i) or (ii) of this section must include the effective date,
printed names and signatures of the persons entering into the
agreement, and the substance of the agreement; and
    (iv) A written agreement entered into in accordance with paragraph
(h)(2)(i) or (ii) must be maintained by both parties for as long as it
is in effect and must be renewed at least once every 3 years;
    (3) With respect to a commingled raw agricultural commodity that
qualifies for either of the exemptions set forth in paragraphs (h)(1)
and (2) of this section, if a person who manufactures, processes,
packs, or holds such commodity is required to register with FDA under
section 415 of the Federal Food, Drug, and Cosmetic Act with respect to
the manufacturing, processing, packing, or holding of the applicable
raw agricultural commodity, such person must maintain records
identifying the immediate previous source of such raw agricultural
commodity and the immediate subsequent recipient of such food in
accordance with Sec. Sec.  1.337 and 1.345. Such records must be
maintained for 2 years.
    (i) Exemption for small retail food establishments and small
restaurants. This subpart does not apply to retail food establishments
and restaurants with an average annual monetary value of food sold or
provided during the previous 3-year period of no more than $250,000 (on
a rolling basis), adjusted for inflation using 2020 as the baseline
year for calculating the adjustment.
    (j) Partial exemption for retail food establishments and
restaurants purchasing directly from a farm. (1) Except as specified in
paragraph (j)(2) of this section, this subpart does not apply to a
retail food establishment or restaurant with respect to a food that is
produced on a farm (including food produced and packaged on the farm)
and both sold and shipped directly to the retail food establishment or
restaurant by the owner, operator, or agent in charge of that farm.
    (2) When a retail food establishment or restaurant purchases a food
directly from a farm in accordance with paragraph (j)(1) of this
section, the retail food establishment or restaurant must maintain a
record documenting the name and address of the farm that was the source
of the food. The retail food establishment or restaurant must maintain
such a record for 180 days.
    (k) Partial exemption for retail food establishments and
restaurants making certain purchases from another retail food
establishment or restaurant. (1) Except as specified in paragraph
(k)(2) of this section, this subpart does not apply to either entity
when a purchase is made by a retail food establishment or restaurant
from another retail food establishment or restaurant, and the purchase
occurs on an ad hoc basis outside of the buyer's usual purchasing
practice (e.g., not pursuant to a contractual agreement to purchase
food from the seller).
    (2) When a retail food establishment or restaurant purchases a food
on the Food Traceability List from another retail food establishment or
restaurant in accordance with paragraph (k)(1) of this section, the
retail food establishment or restaurant that makes the purchase must
maintain a record (e.g., a sales receipt) documenting the name of the
product purchased, the date of purchase, and the name and address of
the place of purchase.
    (l) Partial exemption for farm to school and farm to institution
programs. (1) Except as specified in paragraph (l)(2) of this section,
this subpart does not apply to an institution operating a child
nutrition program authorized under the Richard B. Russell National
School Lunch Act or Section 4 of the Child Nutrition Act of 1966, or
any other entity conducting a farm to school or farm to institution
program, with respect to a food that is produced on a farm (including
food produced and packaged on the farm) and sold or donated to the
school or institution.
    (2) When a school or institution conducting a farm to school or
farm to institution program obtains a food from a farm in accordance
with paragraph (l)(1) of this section, the school food authority or
relevant food procurement entity must maintain a record documenting the
name and address of the farm that was the source of the food. The
school food authority or relevant food procurement entity must maintain
such record for 180 days.
    (m) Partial exemption for owners, operators, or agents in charge of
fishing vessels. (1) Except as specified in paragraph (m)(2) of this
section, with respect to a food that is obtained from a fishing vessel,
this subpart does not apply to the owner, operator, or agent in charge
of the fishing vessel, and this subpart also does not apply to persons
who manufacture, process, pack, or hold the food until such time as the
food is sold by the owner, operator, or agent in charge of the fishing
vessel.
    (2) With respect to any person who receives the partial exemption
set forth in paragraph (m)(1) of this section, if such person is
required to register with FDA under section 415 of the Federal Food,
Drug, and Cosmetic Act with respect to the manufacturing, processing,
packing, or holding of the applicable food, such person must maintain
records identifying the immediate previous source of such food and the
immediate subsequent recipient of such food in accordance with
Sec. Sec.  1.337 and 1.345. Such records must be maintained for 2
years.
    (n) Exemption for transporters. This subpart does not apply to
transporters of food.
    (o) Exemption for nonprofit food establishments. This subpart does
not apply to nonprofit food establishments.
    (p) Exemption for persons who manufacture, process, pack, or hold
food for personal consumption. This subpart does not apply to persons
who manufacture, process, pack, or hold food for personal consumption.
    (q) Exemption for certain persons who hold food on behalf of
individual consumers. This subpart does not apply to persons who hold
food on behalf of specific individual consumers, provided that these
persons:
    (1) Are not parties to the transaction involving the food they
hold; and

    (2) Are not in the business of distributing food.
    (r) Exemption for food for research or evaluation. This subpart
does not apply to food for research or evaluation use, provided that
such food:
    (1) Is not intended for retail sale and is not sold or distributed
to the public; and
    (2) Is accompanied by the statement ``Food for research or
evaluation use.''

Sec.  1.1310  What definitions apply to this subpart?

    The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act apply to such terms when used in this subpart. In
addition, the following definitions apply to words and phrases as they
are used in this subpart:
    Commingled raw agricultural commodity means any commodity that is
combined or mixed after harvesting but before processing, except that
the term ``commingled raw agricultural commodity'' does not include
types of fruits and vegetables that are raw agricultural commodities to
which the standards for the growing, harvesting, packing, and holding
of produce for human consumption in part 112 of this chapter apply. For
the purpose of this definition, a commodity is ``combined or mixed''
only when the combination or mixing involves food from different farms
under different company management; except that for food obtained from
a fishing vessel, a commodity is ``combined or mixed'' only when the
combination or mixing involves food from different landing vessels and
occurs after the vessels have landed. Also, for the purpose of this
definition, the term ``processing'' means operations that alter the
general state of the commodity, such as canning, cooking, freezing,
dehydration, milling, grinding, pasteurization, or homogenization.
    Cooling means active temperature reduction of a raw agricultural
commodity using hydrocooling, icing (except icing of seafood), forced
air cooling, vacuum cooling, or a similar process.
    Critical tracking event means an event in the supply chain of a
food involving the harvesting, cooling (before initial packing),
initial packing of a raw agricultural commodity other than a food
obtained from a fishing vessel, first land-based receiving of a food
obtained from a fishing vessel, shipping, receiving, or transformation
of the food.
    Farm means farm as defined in Sec.  1.328. For producers of shell
eggs, ``farm'' means all poultry houses and grounds immediately
surrounding the poultry houses covered under a single biosecurity
program, as set forth in Sec.  118.3 of this chapter.
    First land-based receiver means the person taking possession of a
food for the first time on land directly from a fishing vessel.
    Fishing vessel means any vessel, boat, ship, or other craft which
is used for, equipped to be used for, or of a type which is normally
used for fishing or aiding or assisting one or more vessels at sea in
the performance of any activity relating to fishing, including, but not
limited to, preparation, supply, storage, refrigeration,
transportation, or processing, as set forth in the Magnuson-Stevens
Fishery Conservation and Management Act (16 U.S.C. 1802(18)).
    Food Traceability List means the list of foods for which additional
traceability records are required to be maintained, as designated in
accordance with section 204(d)(2) of the FDA Food Safety Modernization
Act. The term ``Food Traceability List'' includes both the foods
specifically listed and foods that contain listed foods as ingredients,
provided that the listed food that is used as an ingredient remains in
the same form (e.g., fresh) in which it appears on the list.
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities, or on
processed foods created by drying/dehydrating a raw agricultural
commodity without additional manufacturing/processing, on a farm.
Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural commodity from the crop plant and removing or
trimming part of the raw agricultural commodity (e.g., foliage, husks,
roots, or stems). Examples of harvesting also include cooling, field
coring, filtering, gathering, hulling, shelling, sifting, threshing,
trimming of outer leaves of, and washing raw agricultural commodities
grown on a farm.
    Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food, such as fumigating food
during storage, and drying/dehydrating raw agricultural commodities
when the drying/dehydrating does not create a distinct commodity (such
as drying/dehydrating hay or alfalfa)). Holding also includes
activities performed as a practical necessity for the distribution of
that food (such as blending of the same raw agricultural commodity and
breaking down pallets), but does not include activities that transform
a raw agricultural commodity into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
    Initial packing means packing a raw agricultural commodity (other
than a food obtained from a fishing vessel) for the first time.
    Key data element means information associated with a critical
tracking event for which a record must be maintained and/or provided in
accordance with this subpart.
    Kill step means lethality processing that significantly minimizes
pathogens in a food.
    Location description means key contact information for the location
where a food is handled, specifically the business name, phone number,
physical location address (or geographic coordinates), and city, State,
and zip code for domestic locations and comparable information for
foreign locations, including country.
    Manufacturing/processing means making food from one or more
ingredients, or synthesizing, preparing, treating, modifying, or
manipulating food, including food crops or ingredients. Examples of
manufacturing/processing activities include: Baking, boiling, bottling,
canning, cooking, cooling, cutting, distilling, drying/dehydrating raw
agricultural commodities to create a distinct commodity (such as
drying/dehydrating grapes to produce raisins), evaporating,
eviscerating, extracting juice, formulating, freezing, grinding,
homogenizing, irradiating, labeling, milling, mixing, packaging
(including modified atmosphere packaging), pasteurizing, peeling,
rendering, treating to manipulate ripening, trimming, washing, or
waxing. For farms and farm mixed-type facilities, manufacturing/
processing does not include activities that are part of harvesting,
packing, or holding.
    Mixed-type facility means an establishment that engages in both
activities that are exempt from registration under section 415 of the

Federal Food, Drug, and Cosmetic Act and activities that require the
establishment to be registered. An example of such a facility is a
``farm mixed-type facility,'' which is an establishment that is a farm,
but also conducts activities outside the farm definition that require
the establishment to be registered.
    Nonprofit food establishment means a charitable entity that
prepares or serves food directly to the consumer or otherwise provides
food or meals for consumption by humans or animals in the United
States. The term includes central food banks, soup kitchens, and
nonprofit food delivery services. To be considered a nonprofit food
establishment, the establishment must meet the terms of section
501(c)(3) of the U.S. Internal Revenue Code (26 U.S.C. 501(c)(3)).
    Packing means placing food into a container other than packaging
the food and also includes re-packing and activities performed
incidental to packing or re-packing a food (e.g., activities performed
for the safe or effective packing or re-packing of that food (such as
sorting, culling, grading, and weighing or conveying incidental to
packing or re-packing)), but does not include activities that transform
a raw agricultural commodity into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
    Person includes an individual, partnership, corporation, and
association.
    Point of contact means an individual having familiarity with an
entity's procedures for traceability, including their name and/or job
title, and their phone number.
    Produce means produce as defined in Sec.  112.3 of this chapter.
    Product description means a description of a food product and
includes the product name (including, if applicable, the brand name,
commodity, and variety), packaging size, and packaging style. For
seafood, the product name may include the species and/or acceptable
market name.
    Raw agricultural commodity means ``raw agricultural commodity'' as
defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act.
    Receiving means an event in a food's supply chain in which a food
is received by someone other than a consumer after being transported
(e.g., by truck or ship) from another location. Receiving includes
receipt of an intracompany shipment of food from one location at a
particular street address of a firm to another location at a different
street address of the firm.
    Reference document means a business transaction document, record,
or message, in electronic or paper form, that may contain some or all
of the key data elements for a critical tracking event in the supply
chain of a food. A reference document may be established by you or
obtained from another person. Reference document types may include, but
are not limited to, bills of lading, purchase orders, advance shipping
notices, work orders, invoices, database records, batch logs,
production logs, field tags, catch certificates, and receipts.
    Reference document number means the identification number assigned
to a specific reference document.
    Restaurant means a facility that prepares and sells food directly
to consumers for immediate consumption. ``Restaurant'' does not include
facilities that provide food to interstate conveyances, central
kitchens, and other similar facilities that do not prepare and serve
food directly to consumers.
    (1) Entities in which food is provided to humans, such as
cafeterias, lunchrooms, cafes, bistros, fast food establishments, food
stands, saloons, taverns, bars, lounges, catering facilities, hospital
kitchens, day care kitchens, and nursing home kitchens are restaurants;
and
    (2) Pet shelters, kennels, and veterinary facilities in which food
is provided to animals are restaurants.
    Retail food establishment means an establishment that sells food
products directly to consumers as its primary function. The term
``retail food establishment'' includes facilities that manufacture,
process, pack, or hold food if the establishment's primary function is
to sell from that establishment food, including food that it
manufactures, processes, packs, or holds, directly to consumers. A
retail food establishment's primary function is to sell food directly
to consumers if the annual monetary value of sales of food products
directly to consumers exceeds the annual monetary value of sales of
food products to all other buyers. The term ``consumers'' does not
include businesses. A ``retail food establishment'' includes grocery
stores, convenience stores, and vending machine locations. A ``retail
food establishment'' also includes certain farm-operated businesses
selling food directly to consumers as their primary function.
    (1) Sale of food directly to consumers from an establishment
located on a farm includes sales by that establishment directly to
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
    (ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a
farmer or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and internet order, including online
farmers' markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
    (2) Sale of food directly to consumers by a farm-operated business
includes the sale of food by that farm-operated business directly to
consumers:
    (i) At a roadside stand (a stand situated on the side of or near a
road or thoroughfare at which a farmer sells food from his or her farm
directly to consumers) or farmers' market (a location where one or more
local farmers assemble to sell food from their farms directly to
consumers);
    (ii) Through a community supported agriculture program. Community
supported agriculture (CSA) program means a program under which a
farmer or group of farmers grows food for a group of shareholders (or
subscribers) who pledge to buy a portion of the farmer's crop(s) for
that season. This includes CSA programs in which a group of farmers
consolidate their crops at a central location for distribution to
shareholders or subscribers; and
    (iii) At other such direct-to-consumer sales platforms, including
door-to-door sales; mail, catalog and internet order, including online
farmers' markets and online grocery delivery; religious or other
organization bazaars; and State and local fairs.
    (3) For the purposes of this definition, ``farm-operated business''
means a business that is managed by one or more farms and conducts
manufacturing/processing not on the farm(s).
    Shipping means an event in a food's supply chain in which a food is
arranged for transport (e.g., by truck or ship) from one location to
another location. Shipping does not include the sale or shipment of a
food directly to a consumer or the donation of surplus food. Shipping
includes sending an

intracompany shipment of food from one location at a particular street
address of a firm to another location at a different street address of
the firm.
    Traceability lot means a batch or lot of food that has been
initially packed (for raw agricultural commodities other than food
obtained from a fishing vessel), received by the first land-based
receiver (for food obtained from a fishing vessel), or transformed.
    Traceability lot code means a descriptor, often alphanumeric, used
to uniquely identify a traceability lot within the records of the
traceability lot code source.
    Traceability lot code source means the place where a food was
assigned a traceability lot code.
    Traceability lot code source reference means an alternative method
for providing FDA with access to the location description for the
traceability lot code source as required under this subpart. Examples
of a traceability lot code source reference include, but are not
limited to, the FDA Food Facility Registration Number for the
traceability lot code source or a web address that provides FDA with
the location description for the traceability lot code source.
    Transformation means an event in a food's supply chain that
involves manufacturing/processing a food or changing a food (e.g., by
commingling, repacking, or relabeling) or its packaging or packing,
when the output is a food on the Food Traceability List. Transformation
does not include the initial packing of a food or activities preceding
that event (e.g., harvesting, cooling).
    Transporter means a person who has possession, custody, or control
of an article of food for the sole purpose of transporting the food,
whether by road, rail, water, or air.
    You means a person subject to this subpart under Sec.  1.1300.

Traceability Plan

Sec.  1.1315   What traceability plan must I have for foods on the Food
Traceability List that I manufacture, process, pack, or hold?

    (a) If you are subject to the requirements in this subpart, you
must establish and maintain a traceability plan containing the
following information:
    (1) A description of the procedures you use to maintain the records
you are required to keep under this subpart, including the format and
location of these records.
    (2) A description of the procedures you use to identify foods on
the Food Traceability List that you manufacture, process, pack, or
hold;
    (3) A description of how you assign traceability lot codes to foods
on the Food Traceability List in accordance with Sec.  1.1320, if
applicable;
    (4) A statement identifying a point of contact for questions
regarding your traceability plan and records; and
    (5) If you grow or raise a food on the Food Traceability List
(other than eggs), a farm map showing the areas in which you grow or
raise such foods.
    (i) Except as specified in paragraph (a)(5)(ii) of this section,
the farm map must show the location and name of each field (or other
growing area) in which you grow a food on the Food Traceability List,
including geographic coordinates and any other information needed to
identify the location of each field or growing area.
    (ii) For aquaculture farms, the farm map must show the location and
name of each container (e.g., pond, pool, tank, cage) in which you
raise seafood on the Food Traceability List, including geographic
coordinates and any other information needed to identify the location
of each container.
    (b) You must update your traceability plan as needed to ensure that
the information provided reflects your current practices and to ensure
that you are in compliance with the requirements of this subpart. You
must retain your previous traceability plan for 2 years after you
update the plan.

Sec.  1.1320   When must I assign traceability lot codes to foods on
the Food Traceability List?

    (a) You must assign a traceability lot code when you do any of the
following: Initially pack a raw agricultural commodity other than a
food obtained from a fishing vessel; perform the first land-based
receiving of a food obtained from a fishing vessel; or transform a
food.
    (b) Except as otherwise specified in this subpart, you must not
establish a new traceability lot code when you conduct other activities
(e.g., shipping) for a food on the Food Traceability List.

Records of Critical Tracking Events

Sec.  1.1325   What records must I keep and provide when I harvest or
cool a raw agricultural commodity on the Food Traceability List?

    (a) Harvesting. (1) For each raw agricultural commodity (not
obtained from a fishing vessel) on the Food Traceability List that you
harvest, you must maintain records containing the following
information:
    (i) The location description for the immediate subsequent recipient
(other than a transporter) of the food;
    (ii) The commodity and, if applicable, variety of the food;
    (iii) The quantity and unit of measure of the food (e.g., 75 bins,
200 pounds);
    (iv) The location description for the farm where the food was
harvested;
    (v) For produce, the name of the field or other growing area from
which the food was harvested (which must correspond to the name used by
the grower), or other information identifying the harvest location at
least as precisely as the field or other growing area name;
    (vi) For aquacultured food, the name of the container (e.g., pond,
pool, tank, cage) from which the food was harvested (which must
correspond to the container name used by the aquaculture farmer) or
other information identifying the harvest location at least as
precisely as the container name;
    (vii) The date of harvesting; and
    (viii) The reference document type and reference document number.
    (2) For each raw agricultural commodity (not obtained from a
fishing vessel) on the Food Traceability List that you harvest, you
must provide (in electronic, paper, or other written form) your
business name, phone number, and the information in paragraphs
(a)(1)(i) through (vii) of this section to the initial packer of the
raw agricultural commodity you harvest, either directly or through the
supply chain.
    (b) Cooling before initial packing. (1) For each raw agricultural
commodity (not obtained from a fishing vessel) on the Food Traceability
List that you cool before it is initially packed, you must maintain
records containing the following information:
    (i) The location description for the immediate subsequent recipient
(other than a transporter) of the food;
    (ii) The commodity and, if applicable, variety of the food;
    (iii) The quantity and unit of measure of the food (e.g., 75 bins,
200 pounds);
    (iv) The location description for where you cooled the food;
    (v) The date of cooling;
    (vi) The location description for the farm where the food was
harvested; and
    (vii) The reference document type and reference document number.
    (2) For each raw agricultural commodity (not obtained from a
fishing vessel) on the Food Traceability List that you cool before it
is initially packed, you must provide (in electronic, paper, or other
written form) the information in paragraphs (b)(1)(i) through (vi) of
this section to the initial packer of the raw agricultural commodity
you cool, either directly or through the supply chain.

Sec.  1.1330   What records must I keep when I am performing the
initial packing of a raw agricultural commodity (other than a food
obtained from a fishing vessel) on the Food Traceability List?

    (a) Except as specified in paragraph (c) of this section, for each
traceability lot of a raw agricultural commodity (other than a food
obtained from a fishing vessel) on the Food Traceability List you
initially pack, you must maintain records containing the following
information and linking this information to the traceability lot:
    (1) The commodity and, if applicable, variety of the food received;
    (2) The date you received the food;
    (3) The quantity and unit of measure of the food received (e.g., 75
bins, 200 pounds);
    (4) The location description for the farm where the food was
harvested;
    (5) For produce, the name of the field or other growing area from
which the food was harvested (which must correspond to the name used by
the grower), or other information identifying the harvest location at
least as precisely as the field or other growing area name;
    (6) For aquacultured food, the name of the container (e.g., pond,
pool, tank, cage) from which the food was harvested (which must
correspond to the container name used by the aquaculture farmer) or
other information identifying the harvest location at least as
precisely as the container name;
    (7) The business name and phone number for the harvester of the
food;
    (8) The date of harvesting;
    (9) The location description for where the food was cooled (if
applicable);
    (10) The date of cooling (if applicable);
    (11) The traceability lot code you assigned;
    (12) The product description of the packed food;
    (13) The quantity and unit of measure of the packed food (e.g., 6
cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
    (14) The location description for where you initially packed the
food (i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
    (15) The date of initial packing; and
    (16) The reference document type and reference document number.
    (b) For each traceability lot of sprouts (except soil- or
substrate-grown sprouts harvested without their roots) you initially
pack, you must also maintain records containing the following
information and linking this information to the traceability lot:
    (1) The location description for the grower of seeds for sprouting
and the date of seed harvesting, if either is available;
    (2) The location description for the seed conditioner or processor,
the associated seed lot code, and the date of conditioning or
processing;
    (3) The location description for the seed packinghouse (including
any repackers), the date of packing (and of repacking, if applicable),
and any associated seed lot code assigned by the seed packinghouse;
    (4) The location description for the seed supplier, any seed lot
code assigned by the seed supplier (including the master lot and sub-
lot codes), and any new seed lot code assigned by the sprouter;
    (5) A description of the seeds, including the seed type or
taxonomic name, growing specifications, type of packaging, and (if
applicable) antimicrobial treatment;
    (6) The date of receipt of the seeds by the sprouter; and
    (7) The reference document type and reference document number.
    (c) For each traceability lot of a raw agricultural commodity
(other than a food obtained from a fishing vessel) on the Food
Traceability List you initially pack that you receive from a person to
whom this subpart does not apply, you must maintain records containing
the following information and linking this information to the
traceability lot:
    (1) The commodity and, if applicable, variety of the food received;
    (2) The date you received the food;
    (3) The quantity and unit of measure of the food received (e.g., 75
bins, 200 pounds);
    (4) The location description for the person from whom you received
the food;
    (5) The traceability lot code you assigned;
    (6) The product description of the packed food;
    (7) The quantity and unit of measure of the packed food (e.g., 6
cases, 25 reusable plastic containers, 100 tanks, 200 pounds);
    (8) The location description for where you initially packed the
food (i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
    (9) The date of initial packing; and
    (10) The reference document type and reference document number.

Sec.  1.1335   What records must I keep when I am the first land-based
receiver of a food on the Food Traceability List that was obtained from
a fishing vessel?

    For each traceability lot of a food obtained from a fishing vessel
for which you are the first land-based receiver, you must maintain
records containing the following information and linking this
information to the traceability lot:
    (a) The traceability lot code you assigned;
    (b) The species and/or acceptable market name for unpackaged food,
or the product description for packaged food;
    (c) The quantity and unit of measure of the food (e.g., 300 kg);
    (d) The harvest date range and locations (as identified under the
National Marine Fisheries Service Ocean Geographic Code, the United
Nations Food and Agriculture Organization Major Fishing Area list, or
any other widely recognized geographical location standard) for the
trip during which the food was caught;
    (e) The location description for the first land-based receiver
(i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
    (f) The date the food was landed; and
    (g) The reference document type and reference document number.

Sec.  1.1340   What records must I keep and provide when I ship a food
on the Food Traceability List?

    (a) For each traceability lot of a food on the Food Traceability
List you ship, you must maintain records containing the following
information and linking this information to the traceability lot:
    (1) The traceability lot code for the food;
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25
reusable plastic containers, 100 tanks, 200 pounds);
    (3) The product description for the food;
    (4) The location description for the immediate subsequent recipient
(other than a transporter) of the food;
    (5) The location description for the location from which you
shipped the food;
    (6) The date you shipped the food;
    (7) The location description for the traceability lot code source,
or the traceability lot code source reference; and
    (8) The reference document type and reference document number.
    (b) You must provide (in electronic, paper, or other written form)
the information in paragraphs (a)(1) through (7) of this section to the
immediate subsequent recipient (other than a transporter) of each
traceability lot that you ship.
    (c) This section does not apply to the shipment of a food that
occurs before the food is initially packed (if the food is a raw
agricultural commodity not obtained from a fishing vessel).

Sec.  1.1345   What records must I keep when I receive a food on the
Food Traceability List?

    (a) Except as specified in paragraphs (b) and (c) of this section,
for each traceability lot of a food on the Food Traceability List you
receive, you must maintain records containing the following information
and linking this information to the traceability lot:
    (1) The traceability lot code for the food;
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25
reusable plastic containers, 100 tanks, 200 pounds);
    (3) The product description for the food;
    (4) The location description for the immediate previous source
(other than a transporter) for the food;
    (5) The location description for where the food was received;
    (6) The date you received the food;
    (7) The location description for the traceability lot code source,
or the traceability lot code source reference; and
    (8) The reference document type and reference document number.
    (b) For each traceability lot of a food on the Food Traceability
List you receive from a person to whom this subpart does not apply, you
must maintain records containing the following information and linking
this information to the traceability lot:
    (1) The traceability lot code for the food, which you must assign
if one has not already been assigned (except that this paragraph does
not apply if you are a retail food establishment or restaurant);
    (2) The quantity and unit of measure of the food (e.g., 6 cases, 25
reusable plastic containers, 100 tanks, 200 pounds);
    (3) The product description for the food;
    (4) The location description for the immediate previous source
(other than a transporter) for the food;
    (5) The location description for where the food was received (i.e.,
the traceability lot code source), and (if applicable) the traceability
lot code source reference;
    (6) The date you received the food; and
    (7) The reference document type and reference document number.
    (c) This section does not apply to receipt of a food that occurs
before the food is initially packed (if the food is a raw agricultural
commodity not obtained from a fishing vessel) or to the receipt of a
food by the first land-based receiver (if the food is obtained from a
fishing vessel).

Sec.  1.1350   What records must I keep when I transform a food on the
Food Traceability List?

    (a) Except as specified in paragraphs (b) and (c) of this section,
for each new traceability lot of food you produce through
transformation, you must maintain records containing the following
information and linking this information to the new traceability lot:
    (1) For the food on the Food Traceability List used in
transformation (if applicable), the following information:
    (i) The traceability lot code for the food;
    (ii) The product description for the food to which the traceability
lot code applies; and
    (iii) For each traceability lot used, the quantity and unit of
measure of the food used from that lot.
    (2) For the food produced through transformation, the following
information:
    (i) The new traceability lot code for the food;
    (ii) The location description for where you transformed the food
(i.e., the traceability lot code source), and (if applicable) the
traceability lot code source reference;
    (iii) The date transformation was completed;
    (iv) The product description for the food;
    (v) The quantity and unit of measure of the food (e.g., 6 cases, 25
reusable plastic containers, 100 tanks, 200 pounds); and
    (vi) The reference document type and reference document number for
the transformation event.
    (b) For each traceability lot produced through transformation of a
raw agricultural commodity (other than a food obtained from a fishing
vessel) on the Food Traceability List that was not initially packed
prior to your transformation of the food, you must maintain records
containing the information specified in Sec.  1.1330(a) or (c), and, if
the raw agricultural commodity is sprouts, the information specified in
Sec.  1.1330(b).
    (c) Paragraphs (a) and (b) of this section do not apply to retail
food establishments and restaurants with respect to foods they do not
ship (e.g., foods they sell or send directly to consumers).

Procedures for Modified Requirements and Exemptions

Sec.  1.1360   Under what circumstances will FDA modify the
requirements in this subpart that apply to a food or type of entity or
exempt a food or type of entity from the requirements of this subpart?

    (a) General. Except as specified in paragraph (b) of this section,
FDA will modify the requirements of this subpart applicable to a food
or type of entity, or exempt a food or type of entity from the
requirements of this subpart, when we determine that application of the
requirements that would otherwise apply to the food or type of entity
is not necessary to protect the public health.
    (b) Registered facilities. If a person to whom modified
requirements or an exemption applies under paragraph (a) of this
section (including a person who manufactures, processes, packs, or
holds a food to which modified requirements or an exemption applies
under paragraph (a) of this section) is required to register with FDA
under section 415 of the Federal Food, Drug, and Cosmetic Act (and in
accordance with the requirements of subpart H of this part) with
respect to the manufacturing, processing, packing, or holding of the
applicable food, such person must maintain records identifying the
immediate previous source of such food and the immediate subsequent
recipient of such food in accordance with Sec. Sec.  1.337 and 1.345.
Such records must be maintained for 2 years.

Sec.  1.1365   When will FDA consider whether to adopt modified
requirements or grant an exemption from the requirements of this
subpart?

    FDA will consider modifying the requirements of this subpart
applicable to a food or type of entity, or exempting a food or type of
entity from the requirements of this subpart, on our own initiative or
in response to a citizen petition submitted under Sec.  10.30 of this
chapter by any interested party.

Sec.  1.1370   What must be included in a petition requesting modified
requirements or an exemption from the requirements?

    In addition to meeting the requirements on the content and format
of a citizen petition in Sec.  10.30 of this chapter, a petition
requesting modified requirements or an exemption from the requirements
of this subpart must:
    (a) Specify the food or type of entity to which the modified
requirements or exemption would apply;
    (b) If the petition requests modified requirements, specify the
proposed modifications to the requirements of this subpart; and

    (c) Present information demonstrating why application of the
requirements requested to be modified or from which exemption is
requested is not necessary to protect the public health.

Sec.  1.1375   What information submitted in a petition requesting
modified requirements or an exemption, or information in comments on
such a petition, is publicly available?

    FDA will presume that information submitted in a petition
requesting modified requirements or an exemption, as well as
information in comments submitted on such a petition, does not contain
information exempt from public disclosure under part 20 of this chapter
and will be made public as part of the docket associated with the
petition.

Sec.  1.1380   What process applies to a petition requesting modified
requirements or an exemption?

    (a) In general, the procedures set forth in Sec.  10.30 of this
chapter govern FDA's response to a petition requesting modified
requirements or an exemption. An interested person may submit comments
on such a petition in accordance with Sec.  10.30(d) of this chapter.
    (b) Under Sec.  10.30(h)(3) of this chapter, FDA will publish a
notice in the Federal Register requesting information and views on a
submitted petition, including information and views from persons who
could be affected by the modified requirements or exemption if we
granted the petition.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the
petitioner in writing, as follows:
    (1) If we grant the petition either in whole or in part, we will
publish a notice in the Federal Register setting forth any modified
requirements or exemptions and the reasons for them.
    (2) If we deny the petition (including a partial denial), our
written response to the petitioner will explain the reasons for the
denial.
    (d) We will make readily accessible to the public, and periodically
update, a list of petitions requesting modified requirements or
exemptions, including the status of each petition (for example,
pending, granted, or denied).

Sec.  1.1385   What process will FDA follow when adopting modified
requirements or granting an exemption on our own initiative?

    (a) If FDA, on our own initiative, determines that adopting
modified requirements or granting an exemption from the requirements
for a food or type of entity is appropriate, we will publish a notice
in the Federal Register setting forth the proposed modified
requirements or exemption and the reasons for the proposal. The notice
will establish a public docket so that interested persons may submit
written comments on the proposal.
    (b) After considering any comments timely submitted, we will
publish a notice in the Federal Register stating whether we are
adopting modified requirements or granting an exemption, and the
reasons for our decision.

Sec.  1.1390   When will modified requirements that we adopt or an
exemption that we grant become effective?

    Any modified requirements that FDA adopts or exemption that we
grant will become effective on the date that notice of the modified
requirements or exemption is published in the Federal Register, unless
otherwise stated in the notice.

Sec.  1.1395   Under what circumstances may FDA revise or revoke
modified requirements or an exemption?

    FDA may revise or revoke modified requirements or an exemption if
we determine that such revision or revocation is necessary to protect
the public health.

Sec.  1.1400   What procedures apply if FDA tentatively determines that
modified requirements or an exemption should be revised or revoked?

    (a) If FDA tentatively determines that we should revise or revoke
modified requirements or an exemption, we will provide the following
notifications:
    (1) We will notify the person that originally requested the
modified requirements or exemption (if we adopted modified requirements
or granted an exemption in response to a petition) in writing at the
address identified in the petition; and
    (2) We will publish a notice in the Federal Register of our
tentative determination that the modified requirements or exemption
should be revised or revoked and the reasons for our tentative
decision. The notice will establish a public docket so that interested
persons may submit written comments on our tentative determination.
    (b) After considering any comments timely submitted, we will
publish a notice in the Federal Register of our decision whether to
revise or revoke the modified requirements or exemption and the reasons
for the decision. If we do revise or revoke the modified requirements
or exemption, the effective date of the decision will be 1 year after
the date of publication of the notice, unless otherwise stated in the
notice.

Waivers

Sec.  1.1405   Under what circumstances will FDA waive one or more of
the requirements of this subpart for an individual entity or a type of
entity?

    FDA will waive one or more of the requirements of this subpart when
we determine that:
    (a) Application of the requirements would result in an economic
hardship for an individual entity or a type of entity, due to the
unique circumstances of the individual entity or type of entity;
    (b) The waiver will not significantly impair our ability to rapidly
and effectively identify recipients of a food to prevent or mitigate a
foodborne illness outbreak or to address credible threats of serious
adverse health consequences or death to humans or animals as a result
of such food being adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act or misbranded under section 403(w) of the
Federal Food, Drug, and Cosmetic Act; and
    (c) The waiver will not otherwise be contrary to the public
interest.

Sec.  1.1410   When will FDA consider whether to waive a requirement of
this subpart?

    FDA will consider whether to waive a requirement of this subpart on
our own initiative or in response to the following:
    (a) A written request for a waiver for an individual entity; or
    (b) A citizen petition requesting a waiver for a type of entity
submitted under Sec.  10.30 of this chapter by any person subject to
the requirements of this subpart.

Sec.  1.1415   How may I request a waiver for an individual entity?

    You may request a waiver of one or more requirements of this
subpart for an individual entity by submitting a written request to the
Food and Drug Administration as described at www.fda.gov. The request
for a waiver must include the following:
    (a) The name, address, and point of contact of the individual
entity to which the waiver would apply;
    (b) The requirements of this subpart to which the waiver would
apply;
    (c) Information demonstrating why application of the requirements
requested to be waived would result in an economic hardship for the
entity, including information about the unique circumstances faced by
the entity that result in unusual economic hardship from the
application of these requirements;
    (d) Information demonstrating why the waiver will not significantly
impair FDA's ability to rapidly and effectively

identify recipients of a food to prevent or mitigate a foodborne
illness outbreak or to address credible threats of serious adverse
health consequences or death to humans or animals as a result of such
food being adulterated under section 402 of the Federal Food, Drug, and
Cosmetic Act or misbranded under section 403(w) of the Federal Food,
Drug, and Cosmetic Act; and
    (e) Information demonstrating why the waiver would not otherwise be
contrary to the public interest.

Sec.  1.1420   What process applies to a request for a waiver for an
individual entity?

    (a) After considering the information submitted in a request for a
waiver for an individual entity, we will respond in writing to the
person that submitted the waiver request stating whether we are
granting the waiver (in whole or in part) and the reasons for the
decision.
    (b) Any waiver for an individual entity that FDA grants will become
effective on the date we issue our response to the waiver request,
unless otherwise stated in the response.

Sec.  1.1425   What must be included in a petition requesting a waiver
for a type of entity?

    In addition to meeting the requirements on the content and format
of a citizen petition in Sec.  10.30 of this chapter, a petition
requesting a waiver for a type of entity must:
    (a) Specify the type of entity to which the waiver would apply and
the requirements of this subpart to which the waiver would apply;
    (b) Present information demonstrating why application of the
requirements requested to be waived would result in an economic
hardship for the type of entity, including information about the unique
circumstances faced by the type of entity that result in unusual
economic hardship from the application of these requirements;
    (c) Present information demonstrating why the waiver will not
significantly impair FDA's ability to rapidly and effectively identify
recipients of a food to prevent or mitigate a foodborne illness
outbreak or to address credible threats of serious adverse health
consequences or death to humans or animals as a result of such food
being adulterated under section 402 of the Federal Food, Drug, and
Cosmetic Act or misbranded under section 403(w) of the Federal Food,
Drug, and Cosmetic Act; and
    (d) Present information demonstrating why the waiver would not
otherwise be contrary to the public interest.

Sec.  1.1430   What information submitted in a petition requesting a
waiver for a type of entity, or information in comments on such a
petition, is publicly available?

    FDA will presume that information submitted in a petition
requesting a waiver for a type of entity, as well as information in
comments submitted on such a petition, does not contain information
exempt from public disclosure under part 20 of this chapter and will be
made public as part of the docket associated with the petition.

Sec.  1.1435   What process applies to a petition requesting a waiver
for a type of entity?

    (a) In general, the procedures set forth in Sec.  10.30 of this
chapter govern FDA's response to a petition requesting a waiver. An
interested person may submit comments on such a petition in accordance
with Sec.  10.30(d) of this chapter.
    (b) Under Sec.  10.30(h)(3) of this chapter, FDA will publish a
notice in the Federal Register requesting information and views on a
submitted petition requesting a waiver for a type of entity, including
information and views from persons who could be affected by the waiver
if we granted the petition.
    (c) Under Sec.  10.30(e)(3) of this chapter, we will respond to the
petitioner in writing, as follows:
    (1) If we grant the petition either in whole or in part, we will
publish a notice in the Federal Register setting forth any requirements
we have waived and the reasons for the waiver.
    (2) If we deny the petition (including a partial denial), our
written response to the petitioner will explain the reasons for the
denial.
    (d) We will make readily accessible to the public, and periodically
update, a list of petitions requesting waivers for types of entities,
including the status of each petition (for example, pending, granted,
or denied).

Sec.  1.1440   What process will FDA follow when waiving a requirement
of this subpart on our own initiative?

    (a) If FDA, on our own initiative, determines that a waiver of one
or more requirements for an individual entity or type of entity is
appropriate, we will publish a notice in the Federal Register setting
forth the proposed waiver and the reasons for such waiver. The notice
will establish a public docket so that interested persons may submit
written comments on the proposal.
    (b) After considering any comments timely submitted, we will
publish a notice in the Federal Register stating whether we are
granting the waiver (in whole or in part) and the reasons for our
decision.
    (c) Any waiver for a type of entity that FDA grants will become
effective on the date that notice of the waiver is published in the
Federal Register, unless otherwise stated in the notice.

Sec.  1.1445   Under what circumstances may FDA modify or revoke a
waiver?

    FDA may modify or revoke a waiver if we determine that:
    (a) Compliance with the waived requirements would no longer impose
a unique economic hardship on the individual entity or type of entity
to which the waiver applies;
    (b) The waiver could significantly impair our ability to rapidly
and effectively identify recipients of a food to prevent or mitigate a
foodborne illness outbreak or to address credible threats of serious
adverse health consequences or death to humans or animals as a result
of such food being adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act or misbranded under section 403(w) of the
Federal Food, Drug, and Cosmetic Act; or
    (c) The waiver is otherwise contrary to the public interest.

Sec.  1.1450   What procedures apply if FDA tentatively determines that
a waiver should be modified or revoked?

    (a) Waiver for an individual entity. (1) If FDA tentatively
determines that we should modify or revoke a waiver for an individual
entity, we will notify the person that had received the waiver in
writing of our tentative determination that the waiver should be
modified or revoked. The notice will provide the waiver recipient 60
days in which to submit information stating why the waiver should not
be modified or revoked.
    (2) Upon consideration of any information submitted by the waiver
recipient, we will respond in writing stating our decision whether to
modify or revoke the waiver and the reasons for the decision. If we
modify or revoke the waiver, the effective date of the decision will be
1 year after the date of our response to the waiver recipient, unless
otherwise stated in the response.
    (b) Waiver for a type of entity. (1) If FDA tentatively determines
that we should modify or revoke a waiver for a type of entity, we will
provide the following notifications:
    (i) We will notify the person that originally requested the waiver
(if we granted the waiver in response to a petition) in writing at the
address identified in the petition.
    (ii) We will publish a notice in the Federal Register of our
tentative determination that the waiver should be

modified or revoked and the reasons for our tentative decision. The
notice will establish a public docket so that interested persons may
submit written comments on our tentative determination.
    (2) After considering any comments timely submitted, we will
publish a notice in the Federal Register of our decision whether to
modify or revoke the waiver and the reasons for the decision. If we do
modify or revoke the waiver, the effective date of the decision will be
1 year after the date of publication of the notice, unless otherwise
stated in the notice.

Records Maintenance and Availability

Sec.  1.1455   How must records required by this subpart be maintained
and made available?

    (a) General requirements for records. (1) You must keep records as
original paper or electronic records or true copies (such as
photocopies, pictures, scanned copies, or other accurate reproductions
of the original records). Electronic records may include valid, working
electronic links to the information required to be maintained under
this subpart.
    (2) All records must be legible and stored to prevent deterioration
or loss.
    (b) Establishment and maintenance of records by another entity. You
may have another entity establish and maintain records required under
this subpart on your behalf, but you are responsible for ensuring that
such records can be retrieved and provided onsite within 24 hours of
request for official review.
    (c) Record availability. (1) You must make all records required
under this subpart available to an authorized FDA representative, upon
request, within 24 hours (or within some reasonable time to which FDA
has agreed) after the request, along with any information needed to
understand these records, such as internal or external coding systems,
glossaries, abbreviations, and a description of how the records you
provide correspond to the information required under this subpart.
    (2) Offsite storage of records is permitted if such records can be
retrieved and provided onsite within 24 hours of request for official
review. Electronic records are considered to be onsite if they are
accessible from an onsite location.
    (3) When necessary to help FDA prevent or mitigate a foodborne
illness outbreak, or to assist in the implementation of a recall, or to
otherwise address a threat to the public health, including but not
limited to situations where FDA has a reasonable belief that an article
of food (and any other article of food that FDA reasonably believes is
likely to be affected in a similar manner) presents a threat of serious
adverse health consequences or death to humans or animals as a result
of the food being adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act or misbranded under section 403(w) of the
Federal Food, Drug, and Cosmetic Act, you must make available, within
24 hours (or within some reasonable time to which FDA has agreed) of a
request made in-person or remotely (e.g., by phone) by an authorized
FDA representative, the information you are required to maintain under
this subpart, for the foods and date ranges or traceability lot codes
specified in the request.
    (i) If FDA's request for the information specified in paragraph
(c)(3) of this section is made by phone, we will also provide the
request to you in writing upon your request; however, you must provide
the requested information within 24 hours (or within some reasonable
time to which FDA has agreed) of the phone request.
    (ii) Except as specified in paragraph (c)(3)(iii) and (iv) of this
section, when the information requested by FDA under paragraph (c)(3)
of this section is information you are required to maintain under
Sec. Sec.  1.1325 through 1.1350, you must provide such information in
an electronic sortable spreadsheet, along with any other information
needed to understand the information in the spreadsheet.
    (iii) You may provide the information requested by FDA under
paragraph (c)(3) of this section in a form other than an electronic
sortable spreadsheet if you are:
    (A) A farm whose average annual sum of the monetary value of their
sales of raw agricultural commodities and the market value of raw
agricultural commodities they manufacture, process, pack, or hold
without sale (e.g., held for a fee) during the previous 3-year period
is no more than $250,000 (on a rolling basis), adjusted for inflation
using 2020 as the baseline year for calculating the adjustment;
    (B) A retail food establishment or restaurant with an average
annual monetary value of food sold or provided during the previous 3-
year period of no more than $1 million (on a rolling basis), adjusted
for inflation using 2020 as the baseline year for calculating the
adjustment; or
    (C) A person (other than a farm, retail food establishment, or
restaurant) whose average annual sum of the monetary value of their
sales of food and the market value of food they manufacture, process,
pack, or hold without sale (e.g., held for a fee) during the previous
3-year period is no more than $1 million (on a rolling basis), adjusted
for inflation using 2020 as the baseline year for calculating the
adjustment.
    (iv) FDA will withdraw a request for an electronic sortable
spreadsheet under paragraph (c)(3)(ii) of this section, as appropriate,
to accommodate a religious belief of a person asked to provide such a
spreadsheet.
    (4) Upon FDA request, you must provide within a reasonable time an
English translation of records required under this subpart maintained
in a language other than English.
    (d) Record retention. Except as specified otherwise in this
subpart, you must maintain records containing the information required
by this subpart for 2 years from the date you created or obtained the
records.
    (e) Electronic records. Records that are established or maintained
to satisfy the requirements of this subpart and that meet the
definition of electronic records in Sec.  11.3(b)(6) of this chapter
are exempt from the requirements of part 11 of this chapter. Records
that satisfy the requirements of this subpart, but that also are
required under other applicable statutory provisions or regulations,
remain subject to part 11 of this chapter, if not otherwise exempt.
    (f) Use of existing records. You do not need to duplicate existing
records you have (e.g., records that you keep in the ordinary course of
business or that you maintain to comply with other Federal, State,
Tribal, territorial, or local regulations) if they contain the
information required by this subpart. You may supplement any such
existing records as necessary to include all of the information
required by this subpart.
    (g) Use of multiple sets of records. You do not have to keep all of
the information required by this subpart in a single set of records.
However, your traceability plan must indicate the format and location
of the records you are required to keep under this subpart, in
accordance with Sec.  1.1315(a)(1).
    (h) Public disclosure. Records obtained by FDA in accordance with
this subpart are subject to the disclosure requirements under part 20
of this chapter.

Consequences of Failure To Comply

Sec.  1.1460   What consequences could result from failing to comply
with the requirements of this subpart?

    (a) Prohibited act. The violation of any recordkeeping requirement
under section 204 of the FDA Food Safety Modernization Act, including
the violation of any requirement of this

subpart, is prohibited under section 301(e) of the Federal Food, Drug,
and Cosmetic Act, except when such violation is committed by a farm.
    (b) Refusal of admission. An article of food is subject to refusal
of admission under section 801(a)(4) of the Federal Food, Drug, and
Cosmetic Act if it appears that the recordkeeping requirements under
section 204 of the FDA Food Safety Modernization Act (other than the
requirements under subsection (f) of that section), including the
requirements of this subpart, have not been complied with regarding
such article.

Updating the Food Traceability List

Sec.  1.1465   How will FDA update the Food Traceability List?

    (a) When FDA tentatively concludes, in accordance with section
204(d)(2) of the FDA Food Safety Modernization Act, that it is
appropriate to revise the Food Traceability List, we will publish a
notice in the Federal Register stating the proposed changes to the list
and the reasons for these changes and requesting information and views
on the proposed changes.
    (b) After considering any information and views submitted on the
proposed changes to the Food Traceability List, FDA will publish a
notice in the Federal Register stating whether we are making any
changes to the list and the reasons for the decision. If FDA revises
the list, we will also publish the revised list on our website.
    (c) When FDA updates the Food Traceability List in accordance with
this section, any deletions from the list will become effective
immediately. Any additions to the list will become effective 2 years
after the date of publication of the Federal Register notice announcing
the revised list, unless otherwise stated in the notice.

    Dated: November 3, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-24417 Filed 11-15-22; 11:15 am]
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[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56469-56470]
[FR Doc No: 2015-23389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3230]

Consumer Comments--Public Posting and Availability of Comments
Submitted to Food and Drug Administration Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is changing
the Agency's long standing practice of not publically posting on http://www.regulations.gov comments submitted by individuals in their
individual capacity. These are generally comments from people who self-
identify as an ``individual consumer'' under the field titled
``Category (Required)'' on the ``Your Information'' page on http://www.regulations.gov. Changing FDA's practice to routinely post these
comments, as we do other comments, will increase the transparency and
public utility of FDA's public dockets. It will better enable our
public dockets to function as intended: To share information and
encourage an open exchange of ideas.

DATES: All comments submitted to any FDA docket on or after October 15,
2015, will be publically posted, unless otherwise determined not to be
subject to posting as described in the SUPPLEMENTARY INFORMATION
section.

FOR FURTHER INFORMATION CONTACT: Kenneth R. Cohen, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3324, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Historically, FDA generally has not publicly posted on http://www.regulations.gov comments submitted by individuals in their
individual capacity (and not on behalf of an organization, corporation,
or other entity). For comments submitted through http://www.regulations.gov, for example, such comments are identified as
``Individual Consumer'' under the field titled ``Category (Required) ''
on the ``Your Information'' page. This non-posting practice has applied
only to individual consumer comments which otherwise would be displayed
on http://www.regulations.gov. These comments have been placed in the
official FDA docket and are publicly available in FDA's Reading Room or
through Freedom of Information Act requests and have been considered by
the Agency in finalizing its regulatory actions.
    FDA is changing this practice and will post such consumer comments
on http://www.regulations.gov, as it posts other comments. FDA has made
this change so that its public dockets better serve their purpose of
promoting transparency and the sharing of information.
    In 1995, FDA explained that it routinely reviewed all comments for
obvious confidential information before placing the comments in the
docket (60 FR 66982), but this practice is no longer feasible given
factors such as the volume of comments FDA receives and the adoption of
a government-wide electronic portal system for submitting and posting
comments at http://www.regulations.gov. FDA developed the practice of
not posting individual consumer comments largely because of concerns
about disclosing personal information of individuals who may not have
realized, when submitting their comments, that their name, address, and
other identifying information would be publicly viewable. This public
viewability became more obvious as the Internet gained popularity and
particularly when FDA dockets system was merged with the government-
wide portal system for submission of all public comments on government
regulatory actions at http://www.regulations.gov in 2007. This practice
has been precautionary because, as FDA has stated previously, ``there
can be no reasonable expectation of confidentiality for information
submitted to a public docket in a rulemaking proceeding.'' \1\ With the
advent of http://www.regulations.gov,

FDA selected ``individual consumer'' comments for non-posting because
of previous concerns raised by individuals and the conclusion that such
commenters may not be as familiar with the regulatory process and the
public nature of dockets as are other entities, such as regulated
industry.
---------------------------------------------------------------------------

    \1\ 60 FR 66981, at 66982 (December 27, 1995).
---------------------------------------------------------------------------

    In recent years, FDA has occasionally made exceptions to this non-
posting practice, typically using the COMMENTS section in a particular
Federal Register document to alert the public that all comments were
subject to public posting. FDA Federal Register documents, requesting
or providing for the submission of comments, published subsequent to
this notice will contain new instructions and information concerning
the posting of comments submitted to that particular docket.
    This change fulfills a recommendation from the 2010 FDA
Transparency Initiative \2\ and aligns with a 2013 recommendation from
the Administrative Conference of the United States that ``[a]gencies
should manage their public rulemaking dockets to achieve maximum public
disclosure'' consistent with legal limitations and other claims of
privilege.\3\ It also furthers an objective in Executive Order
13563,\4\ which directs Agencies to base their regulations on ``public
participation and an open exchange of ideas.''
---------------------------------------------------------------------------

    \2\ ``FDA Transparency Initiative: Draft Proposals for Public
Comment Regarding Disclosure Policies of the U.S. Food and Drug
Administration,'' May 2010, available at www.fda.gov/AboutFDA/Transparency/PublicDisclosure (p. 4).
    \3\ Recommendation No. 2013-4, available at http://www.acus.gov/recommendation/administrative-record-informal-rulemaking.
    \4\ Executive Order 13563, available at http://www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf.
---------------------------------------------------------------------------

II. Consumer Comments and Confidential Information

    The commenter is solely responsible for ensuring that the submitted
comment does not include any confidential information that the
commenter or a third party may not wish to be posted, such as private
medical information, the commenter's or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. If a name, contact information, or other information that
identifies the commenter is included in the body of the submitted
comment, that information will be posted on http://www.regulations.gov.
FDA will post comments, as well as any attachments submitted
electronically, on http://www.regulations.gov, along with the State/
Province and country (if provided), the name of the commenter's
representative (if any), and the category selected to identify the
commenter (e.g., individual, consumer, academic, industry).
    The Agency expects that only in exceptional instances would a
comment need to include private, personal, or confidential information.
If a comment is submitted with confidential information that the
commenter does not wish to be made available to the public, the comment
would be submitted as a written/paper submission and in the manner
detailed in the applicable Federal Register document. For written/paper
comments submitted containing confidential information, FDA will post
the redacted/blacked out version of the comment including any
attachments submitted by the commenter. The unredacted copy will not be
posted, assuming the commenter follows the instructions in the
applicable Federal Register document. Any information marked as
confidential will not be disclosed except in accordance with Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law.
    FDA will include new information and standard instructions for
submitting comments in all Federal Register documents requesting or
providing for the submission of comments. The instructions will explain
how to submit comments to the docket on that particular document via
electronic means and also will explain the process for submission of
comments, in written/paper format, that the commenter wishes to mark as
confidential.

III. Date of Implementation

    All comments submitted electronically through http://www.regulations.gov to any FDA docket, existing or new, after October
15, 2015, will be posted to the applicable docket and publicly viewable
on http://www.regulations.gov. All comments submitted by mail or
delivery to the Division of Dockets Management in written/paper format
to any FDA docket, existing or new, after October 15, 2015, will be
posted to the applicable docket and publicly viewable on http://www.regulations.gov unless submitted under the following conditions:
(1) The written/paper submission is marked as confidential, and (2) the
submitter provides an unredacted and a redacted version; the redacted
version must have the information claimed as confidential redacted/
blacked out. If submitted under these conditions, only the redacted/
blacked out written/paper submission will be posted publicly on http://www.regulations.gov, except as otherwise provided by Sec.  10.20 or
other law.

    Dated: September 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23389 Filed 9-17-15; 8:45 am]
BILLING CODE 4164-01-P