Per- and Polyfluoroalkyl Substances in Seafood; Request for Information, 91765-91769 [2024-27070]
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TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued
TABLE 2.—REVISED DRAFT PRODUCT- DEPARTMENT OF HEALTH AND
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Active ingredient(s)
Active Ingredient(s).
Dexamethasone; Neomycin sulfate; Polymyxin b sulfate.
Enfuvirtide.
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Estrogens, conjugated.
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Macitentan; Tadalafil.
Magnesium sulfate; Polyethylene glycol
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Memantine hydrochloride.
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Paclitaxel.
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III. Drug Products for Which Revised
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Available
FDA is announcing the availability of
revised draft product-specific guidances
for industry for drug products
containing the following active
ingredients:
[Docket No. FDA–2024–N–4604]
Tiotropium bromide.
Tramadol hydrochloride.
Per- and Polyfluoroalkyl Substances in
Seafood; Request for Information
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investigational new drugs have been
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V. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27048 Filed 11–19–24; 8:45 am]
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Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice; request for information.
AGENCY:
The Food and Drug
Administration (FDA or we) is
requesting information to help fill data
gaps that remain regarding per- and
polyfluoroalkyl substances (PFAS) in
seafood. The purpose of this request is
to help increase our understanding of
the potential for PFAS exposure from
seafood. We intend to use the
information submitted in response to
this request to help inform future
activities to reduce dietary exposure to
PFAS that may pose a health concern.
DATES: Either electronic or written
comments on the notice must be
submitted by February 18, 2025.
ADDRESSES: You may submit comments
and information as follows. Please note
that late, untimely filed comments will
not be considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 18, 2025. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
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do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
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• For written/paper comments
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Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2024–N–4604 for ‘‘Per- and
Polyfluoroalkyl Substances in Seafood;
Request for Information.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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more information about FDA’s posting
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the information at: https://
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www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Stacey Wiggins, Office of Dairy and
Seafood Safety, Human Foods Program,
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,
240–402–1470; or Alexandra Beliveau
or Jessica Ritsick, Office of Policy,
Regulations, and Information, Human
Foods Program, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
SUPPLEMENTARY INFORMATION:
I. Background
A. PFAS in Food, Generally
PFAS are a diverse group of
thousands of synthetic chemicals—
including perfluorooctanoic acid
(PFOA), perfluorooctane sulfonic acid,
perfluorononanoic acid,
perfluorohexane sulfonic acid, and
perfluorodecanoic acid—that are used
in a wide range of consumer and
industrial products. PFAS do not easily
break down, and some types have been
shown to accumulate in the
environment and in our bodies.
Exposure to certain types of PFAS has
been linked to serious health effects,
including hepatic, cardiovascular,
immune, and developmental effects
(Refs. 1 through 4).
FDA has developed validated
methods for testing for certain PFAS at
very low levels (i.e., in the parts per
trillion) in increasingly diverse types of
foods (Ref. 5). We select specific PFAS
for testing based on, for example,
information from the scientific
literature, the expected PFAS uptake in
foods, and the availability of chemical
standards to accurately detect and
identify the presence of PFAS.
As with other chemical contaminants
for which there are no established
action levels or tolerances, FDA
evaluates PFAS in food on a case-bycase basis. When we detect PFAS in
food, we may conduct a human health
assessment to evaluate whether the
levels detected present a possible
human health concern. We consider the
level of the contaminant in the specific
food, consumption patterns for that
specific food in various sectors of the
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population (by age), and current
toxicological data for the PFAS
chemical(s) detected to determine
whether the concentration of PFAS
found in the food poses a health
concern (see Ref. 5 for additional
information on our approach to human
health assessments, generally).
Addressing potential effects of
Americans’ PFAS exposure is a national
priority and is coordinated across
several Federal Agencies. Through these
interagency collaborations, we are
working to identify routes of PFAS
exposure, understand associated health
risks, and reduce the public’s dietary
exposure to PFAS that may pose health
concern. FDA is a part of the Council on
Environmental Quality-led Interagency
Policy Committee on PFAS, which is
tasked with coordinating the Federal
response to PFAS contamination in the
environment and in products.
Additionally, FDA also participates in
an interagency Strategy Team on PFAS,
focused on research and development.
B. PFAS in Seafood
For purposes of this document, we
use the term ‘‘seafood’’ to refer to fresh
or saltwater finfish, crustaceans, other
forms of aquatic animal life (e.g.,
alligator) other than birds or mammals,
and all mollusks, where such animal life
is intended for human consumption,
which is consistent with our definition
of ‘‘fish’’ under 21 CFR 123.3(d). Since
2019, we have been utilizing samples
collected from the Total Diet Study
(TDS) to evaluate the presence of PFAS
in foods, including seafood. The
analysis of TDS samples was a
preliminary step in determining
whether more targeted or larger surveys
of PFAS in foods may be needed. To
date, we have analyzed 810 TDS food
samples, including samples from 7
regional collections and 1 national
collection. PFAS were detected at
relatively low levels in 23 out of 810
TDS food samples. Of those 23 food
samples with PFAS detected, 19 were
seafood samples (Ref. 6). Using human
health assessments, we determined that
none of the TDS seafood samples had
levels of PFAS that would be considered
a human health concern. However,
FDA’s testing indicates that seafood may
be at higher risk for environmental
PFAS contamination compared to other
types of food. This request for
information is one way we are working
to better understand PFAS
contamination in commercial seafood to
reduce dietary exposure to PFAS that
may pose a health concern.
To expand on the results from the
TDS samples and evaluate potential
exposure to PFAS from other seafood
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types, we collected additional seafood
samples for PFAS analysis in 2021 and
2022. The survey targeted the most
commonly consumed seafood in the
United States and consisted of 81
samples comprised of clams, cod, crab,
pollock, salmon, shrimp, tilapia, and
canned tuna—most of which were
imported to the United States. This
work advances our efforts to understand
PFAS levels in commercial seafood and
is also a part of our comprehensive
approach to help ensure the safety of
imported seafood, as outlined in the
‘‘Activities for the Safety of Imported
Seafood’’ report released in March 2023
(Ref. 7). Based on the PFOA
concentrations found in canned clams,
we concluded that consumption of the
canned clams sampled from China were
likely a human health concern. Two
voluntary recalls of processed clams
from China have occurred due to these
findings (Refs. 8 and 9).
Because many potential hazards can
be introduced at the source—in growing
areas, in aquaculture farms, and on
fishing vessels—seafood presents a
unique challenge and opportunity to
prevent contamination. This request for
information is an opportunity for
interested entities (including the
seafood industry, academia, and state
and other Federal Agencies) (you) to
provide information to address the data
gaps that exist. This request is
consistent with FDA’s efforts to increase
our understanding of the potential for
PFAS exposure from seafood and to
reduce dietary exposure to PFAS that
may pose a health concern. The
information submitted in response to
this request for information will help
enhance FDA’s knowledge about the
types of seafood prone to accumulate
PFAS and harvest locations with PFAS
contamination, improve our
comprehensive understanding of the
sources of PFAS in seafood, prioritize
our sampling strategies and seafood
targets for testing, and inform potential
mitigation strategies. Additional
information about existing data and
information on PFAS in seafood will
help us advance our public health
mission and further support the current
Administration’s comprehensive
approach to addressing PFAS and
advancing clean air, water, and food
(Refs. 10 through 12).
II. Request for Information
This request focuses on PFAS in
seafood. We request data and
information in response to specific
questions presented below that fall
under the following categories: (1) PFAS
concentrations in seafood; (2) PFAS
concentrations in the environment; (3)
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PFAS concentrations in processing
water; and (4) mitigation strategies for
PFAS in seafood. When responding,
please identify the question by its
number (e.g., ‘‘1.1’’) so that we can
associate your response with a specific
question. Please be as detailed as
possible in your response.
It is important to know whether
samples were found to contain
detectable PFAS. Information about
samples where no PFAS was detected is
just as important as samples where
PFAS was detected. This information
helps identify where PFAS was
observed and lets us know that it was
undetected, as opposed to simply not
sampled.
When reporting PFAS concentrations
detected (Questions 1–3), please include
information about sample preparations
(e.g., individual samples versus
composites of subsamples) and
analytical methods (e.g., the analytical
method(s) used and associated limits of
detection, limit of quantitation, and
method detection limit (MDL)). Such
information provides context and helps
enable better interpretation of data (e.g.,
determining which datasets can be
compared to other datasets and what
conclusions may be drawn). For
example, if analytical methods with
high MDLs were used and reported nondetectable concentrations, it is possible
that the concentrations may have been
detectable if a more sensitive method
had been used.
While the questions presented below
are aimed at gathering data and
information on PFAS in seafood that is
most pertinent, we welcome any
additional data and information
regarding PFAS in seafood that may
improve our understanding and advance
our public health mission.
1. PFAS Concentrations in Seafood
FDA is interested in identifying
which specific seafood types are more
prone to PFAS accumulation, as this
could help inform future seafood
sampling plans. We have been analyzing
the most commonly consumed seafood
in the United States for PFAS; however,
there are many other seafood types for
which data are limited. Additionally,
we are interested in the harvest
locations where the seafood samples
were collected. Information about
geographical PFAS contamination and
harvest areas where seafood may be
contaminated with PFAS will help
inform potential mitigation strategies.
For each item below, please provide
the PFAS concentrations for each type
of PFAS detected (including samples
where no PFAS was detected), as well
as any relevant data (e.g., sample
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collection date), evidence, or other
information to support your response.
1.1 Which types of seafood (e.g.,
scientific name, acceptable market
name, common name) have you tested
for PFAS? Please describe the sample
(e.g., individual or composite) and
provide the number of subsamples used
for composite samples. Please answer
the following questions for each type of
seafood tested, providing any data and
evidence to support your response.
1.1.1 Was the seafood sample a
commercial seafood product (i.e., was
the seafood in or intended for interstate
commerce whether collected from
harvest areas, processing stages, or at
retail)? Or was the seafood sample
collected a non-commercial seafood
product?
1.1.2 Was the seafood sample
harvested from fresh water or salt water?
What else is known about the harvest
location of the seafood sample? Please
provide latitude and longitude of
harvest location, if known.
1.1.3 Was the seafood sample raw or
processed? If raw, was the sample fresh
or frozen? If processed, was the sample
frozen, canned, pouched, or other? Was
the processed sample cooked,
eviscerated, smoked, dried, or other?
1.1.4 Was the seafood sample wildcaught or raised via aquaculture?
1.1.5 If the sample was a commercial
seafood product, what was the country
of origin on the seafood label? The
country of origin label indicates the
country where the last substantial
transformation to the seafood product
was made, which may not be the
country where the seafood was
harvested (19 U.S.C. 1304(a) and 19 CFR
part 134; see also Ref. 13).
1.2 Knowing whether the seafood
sample (for commercial or noncommercial seafood) has been tested
whole or separated into parts is
valuable, particularly for informing
potential mitigation strategies (e.g.,
anatomical parts demonstrated to have
higher PFAS concentrations may be
removed as a mitigation strategy for the
remaining parts to be sold for
consumption). For each question below,
please provide any relevant data,
evidence, or other information to
support your response.
1.2.1 How would you characterize
the seafood sample that was tested (e.g.,
whole, muscle, roe, viscera)?
1.2.2 If the seafood was separated
into different tissues, which specific
tissues were used to measure PFAS
concentrations? Why were those
specific tissues chosen for testing?
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2. PFAS Concentrations in the
Environment (e.g., Water and Sediment
in Seafood Harvest Areas)
PFAS can enter seafood through
environmental contamination. FDA is
interested in understanding PFAS
sources and concentrations in the
environment that impact seafood. Such
information can aid in the identification
of harvest areas to avoid. Examples of
PFAS sources in the environment
include water and sediment.
For each item below, please provide
the PFAS concentrations for each type
of PFAS detected (including samples
where no PFAS was detected), as well
as any relevant data (e.g., sample
collection date), evidence, or other
information to support your response.
2.1 In conjunction with testing
PFAS concentrations in seafood, please
describe any environmental samples
(e.g., volume or amount of matrix,
individual or composite) you have
tested from locations where seafood was
grown or harvested, including the
number of subsamples used for
composite samples. Please provide
latitude and longitude of sample
location, if known.
2.1.1 What type of environmental
sample was collected and analyzed for
PFAS (i.e., water, sediment, or another
type of sample (e.g., soil, biosolids))?
Please provide the date of sample
collection, if known.
2.1.2 If water, was the sample fresh
water or salt water? What was the depth
at which the water sample was
collected? What was the salinity of the
salt water?
2.1.3 If sediment, was the sample
mud, sand, or clay? What was the depth
at which the sediment was collected?
2.1.4 If another type of sample,
please provide additional information
about the sample matrix (e.g., whether
the samples were biosolids or soils near
the coast).
2.2 If known, please provide any
historical data you have about PFAS
sources in the sampling locale and any
information showing a relationship
between PFAS in the environmental
samples and PFAS in the seafood
samples. Such historical information
can help identify whether there are
patterns or trends in PFAS
contamination that may be useful in
predicting potential PFAS
contamination in seafood, which could
inform mitigation efforts.
2.2.1 Are there any factors specific
to this geographic location that play a
role in PFAS accumulation? If yes,
please elaborate.
2.2.2 Is the PFAS contamination in
the geographic location persistent?
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Please provide the rationale for this
conclusion.
2.2.3 What, if anything, has the data
shown about the source of the PFAS
contamination?
3. PFAS Concentration in Processing
Water
PFAS can enter processed seafood
through the use of contaminated
processing water. FDA would like to
know about the occurrence of PFAS
contamination in processing water
intended for use with seafood.
Identification of the source of
contaminated water that was intended
for use as processing water will help
FDA better understand potential and
likely routes of PFAS contamination,
and may help inform mitigation
strategies, such as the need to find
alternative source water for food
processing. It is also helpful to know if
water that was intended for use as
processing water was tested but not
found to contain detectable
concentrations of PFAS.
For each item below, please provide
the PFAS concentrations for each type
of PFAS detected (including samples
where no PFAS was detected), as well
as any relevant data (e.g., sample
collection date), evidence, or other
information to support your response.
3.1 What processing water samples
have been tested for PFAS? At what
stage of processing was the process
water used or intended to be used?
Please describe the sample (e.g.,
individual or composite, volume) and
provide the number of subsamples used
for composite samples.
3.2 What is the source of the
processing water (e.g., municipal,
private, well)? If known, please provide
any historical data you have about PFAS
sources in the sampling locale of the
processing water, and any information
showing a relationship between PFAS
in the processing water samples and
seafood samples. Such information can
help identify whether patterns or trends
are available to aid in mitigation efforts.
4. Mitigation Strategies for PFAS in
Seafood
As PFAS are known to accumulate
and persist in the environment, it is
important to develop mitigation
strategies for reducing PFAS
contamination in seafood. Examples of
mitigation strategies include changing
or closing seafood harvest locations if an
area is contaminated with PFAS or
processing certain tissues of seafood
that have been determined to not
accumulate PFAS. Understanding the
rates of PFAS accumulation and
elimination from seafood can help to
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determine whether natural or controlled
reduction strategies may be effective at
removing PFAS. FDA is interested to
learn about additional mitigation
strategies that may be used to reduce or
prevent PFAS contamination of seafood.
For each item below, please provide any
relevant data, evidence, or other
information to support your response.
4.1 Please describe the PFAS
mitigation strategies that you have used
or of which you are aware to reduce
PFAS in seafood, including any
industry-wide practices. Please provide
details regarding, as applicable, testing
seafood products and/or processing
water for PFAS, changing seafood
harvest areas and/or processing water
sources based on PFAS concentrations,
eviscerating seafood and/or processing
different tissues for consumption, or
depurating (i.e., storing in controlled
conditions to allow for elimination of
impurities) PFAS from seafood.
4.1.1 Which mitigation strategies
have you determined to be successful at
reducing PFAS in seafood? Please
provide details about the strategy,
including your criteria for determining
success and the level to which PFAS
was reduced.
4.1.2 What challenges have you
encountered regarding mitigation
strategies for reducing PFAS
contamination in seafood?
4.2 If any seafood growing areas or
harvest areas have been found to be
contaminated with PFAS, please
describe whether the area has been
placed in a closed or prohibited status,
you have been impacted by growing or
harvest areas being placed in a closed
status, or you have avoided harvesting
in the area. Please describe the
contamination event in as much detail
as possible (e.g., PFAS concentration,
location with latitude and longitude if
known, length of closure or avoidance).
4.3 To what degree is PFAS in
seafood testing being incorporated into
Seafood Hazard Analysis Critical
Control Point (HACCP) plans? If PFAS
was detected in seafood or processing
water, was PFAS added to HACCP
plans? Please provide details, such as
what critical limit is being considered.
III. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. Although FDA
verified the website addresses in this
document, please note that websites are
subject to change over time.
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1. Agency for Toxic Substances and Disease
Registry, ‘‘Toxicological Profile for
Perfluoroalkyls.’’ Accessed June 14,
2024. Available at: https://
www.atsdr.cdc.gov/toxprofiles/
tp200.pdf.
2. U.S. Environmental Protection Agency,
‘‘Human Health Toxicity Assessment for
PFBS.’’ Accessed June 14, 2024.
Available at: https://www.epa.gov/
chemical-research/learn-about-humanhealth-toxicity-assessment-pfbs.
3. U.S. Environmental Protection Agency,
‘‘Human Health Toxicity Assessments
for GenX Chemicals.’’ Accessed June 14,
2024. Available at: https://www.epa.gov/
chemical-research/human-healthtoxicity-assessments-genx-chemicals.
4. U.S. Environmental Protection Agency,
‘‘Final IRIS Assessment of
Perfluorobutanoic Acid (PFBA) and
Related Salts.’’ Accessed June 14, 2024.
Available at: https://www.epa.gov/
newsreleases/epa-publishes-irishandbook-and-final-iris-assessmentperfluorobutanoic-acid-pfba-and.
5. U.S. Food and Drug Administration,
‘‘Testing Food for PFAS and Assessing
Dietary Exposure.’’ Accessed June 14,
2024. Available at: https://www.fda.gov/
food/process-contaminants-food/testingfood-pfas-and-assessing-dietaryexposure.
6. U.S. Food and Drug Administration,
‘‘Analytical Results of Testing Food for
PFAS from Environmental
Contamination.’’ Accessed June 14, 2024.
Available at: https://www.fda.gov/food/
process-contaminants-food/analyticalresults-testing-food-pfas-environmentalcontamination.
7. U.S. Food and Drug Administration,
‘‘Activities for the Safety of Imported
Seafood, February 2023.’’ Accessed June
14, 2024. Available at: https://
www.fda.gov/media/165447/download.
8. U.S. Food and Drug Administration, ‘‘FDA
Shares Results on PFAS Testing in
Seafood, July 15, 2022.’’ Accessed June
14, 2024. Available at: https://
www.fda.gov/food/cfsan-constituentupdates/fda-shares-results-pfas-testingseafood.
9. U.S. Food and Drug Administration,
‘‘Crown Prince, Inc. Issues Voluntary
Recall of Smoked Baby Clams in Olive
Oil Due to the Presence of Detectable
Levels of PFAS Chemicals.’’ Accessed
June 14, 2024. Available at: https://
www.fda.gov/safety/recalls-marketwithdrawals-safety-alerts/crown-princeinc-issues-voluntary-recall-smoked-babyclams-olive-oil-due-presence-detectablelevels.
10. The White House, ‘‘Fact Sheet: BidenHarris Administration Launches Plan to
Combat PFAS Pollution, October 2021.’’
Accessed June 14, 2024. Available at:
https://www.whitehouse.gov/briefingroom/statements-releases/2021/10/18/
fact-sheet-biden-harris-administrationlaunches-plan-to-combat-pfas-pollution/
.
11. The White House, ‘‘Fact Sheet: BidenHarris Administration Combatting PFAS
Pollution to Safeguard Clean Drinking
VerDate Sep<11>2014
18:39 Nov 19, 2024
Jkt 265001
Water for All Americans, June 2022.’’
Accessed June 14, 2024. Available at:
https://www.whitehouse.gov/briefingroom/statements-releases/2022/06/15/
fact-sheet-biden-harris-administrationcombatting-pfas-pollution-to-safeguardclean-drinking-water-for-all-americans/.
12. The White House, ‘‘Fact Sheet: BidenHarris Administration Takes New Action
to Protect Communities from PFAS
Pollution, March 2023.’’ Accessed June
14, 2024. Available at: https://
www.whitehouse.gov/briefing-room/
statements-releases/2023/03/14/factsheet-biden-harris-administration-takesnew-action-to-protect-communities-frompfas-pollution/.
13. U.S. Food and Drug Administration,
‘‘CPG Sec. 560.200 Country of Origin
Labeling.’’ Accessed June 14, 2024.
Available at: https://www.fda.gov/media/
71994/download.
Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–27070 Filed 11–19–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA), Office of the
Commissioner (OC), Office of Digital
Transformation (ODT) has modified
their organizational structure. The new
organizational structure was approved
by the Secretary of Health and Human
Services on September 20, 2024.
FOR FURTHER INFORMATION CONTACT:
William Tootle, Director, Office of
Budget; 10903 New Hampshire Avenue,
WO–2, #3313, Silver Spring, MD 20990.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
64 FR 36361, July 6, 1999, 72 FR 50112,
August 30, 2007, 74 FR 41713, August
18, 2009, 76 FR 45270, July 28, 2011,
and 84 FR 22854, May 20, 2019) is
revised to reflect FDA, OC’s ODT.
The changes to ODT’s organizational
structure consolidate similar functions
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
91769
and resources across multiple areas and
align the organizational structure with
federal and industry standards. This
will create a more agile organization,
improve resource management, enhance
customer service, and better align the
name of organizational components
with current functions. The
reorganization will maintain a
reasonable span of control and clear and
appropriate lines of authority and
responsibilities between organizations.
This will also ensure optimal resource
utilization and leveraging of existing
staff talent and will allow ODT more
efficiency and effectiveness in the
advancement of continuous
improvement efforts.
DCAD. ORGANIZATION: ODT is
headed by the Chief Information Officer
and includes:
Office of Digital Transformation (DCAD)
Office of Information Management and
Technology (DCADA)
Enterprise Architecture Staff (DCADA2)
Office of Technology and Delivery
(DCADAA)
Division of Infrastructure Services
(DCADAAA)
Network Services Support Staff
(DCADAAA10)
Systems Operations Support Staff
(DCADAAA11)
Operations and Planning Staff
(DCADAAA12)
Data Center Facilities Branch
(DCADAAA13)
Quality Assurance Branch (DCADAAA14)
Network Communications Branch
(DCADAAA15)
Server Operations Services Branch
(DCADAAA16)
Enterprise Management Operations Branch
(DCADAAA17)
Cloud Operations Branch (DCADAAA18)
Division of Application Services
(DCADAAB)
Operations Support Staff (DCADAAB10)
Enterprise Business and Post-Market Staff
(DCADAAB11)
Scientific Support Staff (DCADAAB12)
Human Food Support Branch
(DCADAAB13)
Regulatory Science Support Branch
(DCADAAB14)
Compliance and Enforcement Branch
(DCADAAB15)
Application Services Support Branch
(DCADAAB16)
Platform Management Support Branch
(DCADAAB17)
Digital Solutions Partners Branch
(DCADAAB18)
Business Intelligence Data Branch
(DCADAAB19)
Products Review and Approval Branch
(DCADAAB20)
Digital Solution Delivery Branch
(DCADAAB21)
Registration Listing Services Branch
(DCADAAB22)
User Fee Support Branch (DCADAAB23)
Division of Engineering (DCADAAD)
E:\FR\FM\20NON1.SGM
20NON1
]]>Agencies
[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91765-91769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27070]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4604]
Per- and Polyfluoroalkyl Substances in Seafood; Request for
Information
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice; request for information.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is requesting
information to help fill data gaps that remain regarding per- and
polyfluoroalkyl substances (PFAS) in seafood. The purpose of this
request is to help increase our understanding of the potential for PFAS
exposure from seafood. We intend to use the information submitted in
response to this request to help inform future activities to reduce
dietary exposure to PFAS that may pose a health concern.
DATES: Either electronic or written comments on the notice must be
submitted by February 18, 2025.
ADDRESSES: You may submit comments and information as follows. Please
note that late, untimely filed comments will not be considered. The
https://www.regulations.gov electronic filing system will accept
comments until 11:59 p.m. Eastern Time at the end of February 18, 2025.
Comments received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are received on or
before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you
[[Page 91766]]
do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2024-N-4604 for ``Per- and Polyfluoroalkyl Substances in Seafood;
Request for Information.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Stacey Wiggins, Office of Dairy and
Seafood Safety, Human Foods Program, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-1470; or Alexandra Beliveau
or Jessica Ritsick, Office of Policy, Regulations, and Information,
Human Foods Program, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
A. PFAS in Food, Generally
PFAS are a diverse group of thousands of synthetic chemicals--
including perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid,
perfluorononanoic acid, perfluorohexane sulfonic acid, and
perfluorodecanoic acid--that are used in a wide range of consumer and
industrial products. PFAS do not easily break down, and some types have
been shown to accumulate in the environment and in our bodies. Exposure
to certain types of PFAS has been linked to serious health effects,
including hepatic, cardiovascular, immune, and developmental effects
(Refs. 1 through 4).
FDA has developed validated methods for testing for certain PFAS at
very low levels (i.e., in the parts per trillion) in increasingly
diverse types of foods (Ref. 5). We select specific PFAS for testing
based on, for example, information from the scientific literature, the
expected PFAS uptake in foods, and the availability of chemical
standards to accurately detect and identify the presence of PFAS.
As with other chemical contaminants for which there are no
established action levels or tolerances, FDA evaluates PFAS in food on
a case-by-case basis. When we detect PFAS in food, we may conduct a
human health assessment to evaluate whether the levels detected present
a possible human health concern. We consider the level of the
contaminant in the specific food, consumption patterns for that
specific food in various sectors of the population (by age), and
current toxicological data for the PFAS chemical(s) detected to
determine whether the concentration of PFAS found in the food poses a
health concern (see Ref. 5 for additional information on our approach
to human health assessments, generally).
Addressing potential effects of Americans' PFAS exposure is a
national priority and is coordinated across several Federal Agencies.
Through these interagency collaborations, we are working to identify
routes of PFAS exposure, understand associated health risks, and reduce
the public's dietary exposure to PFAS that may pose health concern. FDA
is a part of the Council on Environmental Quality-led Interagency
Policy Committee on PFAS, which is tasked with coordinating the Federal
response to PFAS contamination in the environment and in products.
Additionally, FDA also participates in an interagency Strategy Team on
PFAS, focused on research and development.
B. PFAS in Seafood
For purposes of this document, we use the term ``seafood'' to refer
to fresh or saltwater finfish, crustaceans, other forms of aquatic
animal life (e.g., alligator) other than birds or mammals, and all
mollusks, where such animal life is intended for human consumption,
which is consistent with our definition of ``fish'' under 21 CFR
123.3(d). Since 2019, we have been utilizing samples collected from the
Total Diet Study (TDS) to evaluate the presence of PFAS in foods,
including seafood. The analysis of TDS samples was a preliminary step
in determining whether more targeted or larger surveys of PFAS in foods
may be needed. To date, we have analyzed 810 TDS food samples,
including samples from 7 regional collections and 1 national
collection. PFAS were detected at relatively low levels in 23 out of
810 TDS food samples. Of those 23 food samples with PFAS detected, 19
were seafood samples (Ref. 6). Using human health assessments, we
determined that none of the TDS seafood samples had levels of PFAS that
would be considered a human health concern. However, FDA's testing
indicates that seafood may be at higher risk for environmental PFAS
contamination compared to other types of food. This request for
information is one way we are working to better understand PFAS
contamination in commercial seafood to reduce dietary exposure to PFAS
that may pose a health concern.
To expand on the results from the TDS samples and evaluate
potential exposure to PFAS from other seafood
[[Page 91767]]
types, we collected additional seafood samples for PFAS analysis in
2021 and 2022. The survey targeted the most commonly consumed seafood
in the United States and consisted of 81 samples comprised of clams,
cod, crab, pollock, salmon, shrimp, tilapia, and canned tuna--most of
which were imported to the United States. This work advances our
efforts to understand PFAS levels in commercial seafood and is also a
part of our comprehensive approach to help ensure the safety of
imported seafood, as outlined in the ``Activities for the Safety of
Imported Seafood'' report released in March 2023 (Ref. 7). Based on the
PFOA concentrations found in canned clams, we concluded that
consumption of the canned clams sampled from China were likely a human
health concern. Two voluntary recalls of processed clams from China
have occurred due to these findings (Refs. 8 and 9).
Because many potential hazards can be introduced at the source--in
growing areas, in aquaculture farms, and on fishing vessels--seafood
presents a unique challenge and opportunity to prevent contamination.
This request for information is an opportunity for interested entities
(including the seafood industry, academia, and state and other Federal
Agencies) (you) to provide information to address the data gaps that
exist. This request is consistent with FDA's efforts to increase our
understanding of the potential for PFAS exposure from seafood and to
reduce dietary exposure to PFAS that may pose a health concern. The
information submitted in response to this request for information will
help enhance FDA's knowledge about the types of seafood prone to
accumulate PFAS and harvest locations with PFAS contamination, improve
our comprehensive understanding of the sources of PFAS in seafood,
prioritize our sampling strategies and seafood targets for testing, and
inform potential mitigation strategies. Additional information about
existing data and information on PFAS in seafood will help us advance
our public health mission and further support the current
Administration's comprehensive approach to addressing PFAS and
advancing clean air, water, and food (Refs. 10 through 12).
II. Request for Information
This request focuses on PFAS in seafood. We request data and
information in response to specific questions presented below that fall
under the following categories: (1) PFAS concentrations in seafood; (2)
PFAS concentrations in the environment; (3) PFAS concentrations in
processing water; and (4) mitigation strategies for PFAS in seafood.
When responding, please identify the question by its number (e.g.,
``1.1'') so that we can associate your response with a specific
question. Please be as detailed as possible in your response.
It is important to know whether samples were found to contain
detectable PFAS. Information about samples where no PFAS was detected
is just as important as samples where PFAS was detected. This
information helps identify where PFAS was observed and lets us know
that it was undetected, as opposed to simply not sampled.
When reporting PFAS concentrations detected (Questions 1-3), please
include information about sample preparations (e.g., individual samples
versus composites of subsamples) and analytical methods (e.g., the
analytical method(s) used and associated limits of detection, limit of
quantitation, and method detection limit (MDL)). Such information
provides context and helps enable better interpretation of data (e.g.,
determining which datasets can be compared to other datasets and what
conclusions may be drawn). For example, if analytical methods with high
MDLs were used and reported non-detectable concentrations, it is
possible that the concentrations may have been detectable if a more
sensitive method had been used.
While the questions presented below are aimed at gathering data and
information on PFAS in seafood that is most pertinent, we welcome any
additional data and information regarding PFAS in seafood that may
improve our understanding and advance our public health mission.
1. PFAS Concentrations in Seafood
FDA is interested in identifying which specific seafood types are
more prone to PFAS accumulation, as this could help inform future
seafood sampling plans. We have been analyzing the most commonly
consumed seafood in the United States for PFAS; however, there are many
other seafood types for which data are limited. Additionally, we are
interested in the harvest locations where the seafood samples were
collected. Information about geographical PFAS contamination and
harvest areas where seafood may be contaminated with PFAS will help
inform potential mitigation strategies.
For each item below, please provide the PFAS concentrations for
each type of PFAS detected (including samples where no PFAS was
detected), as well as any relevant data (e.g., sample collection date),
evidence, or other information to support your response.
1.1 Which types of seafood (e.g., scientific name, acceptable
market name, common name) have you tested for PFAS? Please describe the
sample (e.g., individual or composite) and provide the number of
subsamples used for composite samples. Please answer the following
questions for each type of seafood tested, providing any data and
evidence to support your response.
1.1.1 Was the seafood sample a commercial seafood product (i.e.,
was the seafood in or intended for interstate commerce whether
collected from harvest areas, processing stages, or at retail)? Or was
the seafood sample collected a non-commercial seafood product?
1.1.2 Was the seafood sample harvested from fresh water or salt
water? What else is known about the harvest location of the seafood
sample? Please provide latitude and longitude of harvest location, if
known.
1.1.3 Was the seafood sample raw or processed? If raw, was the
sample fresh or frozen? If processed, was the sample frozen, canned,
pouched, or other? Was the processed sample cooked, eviscerated,
smoked, dried, or other?
1.1.4 Was the seafood sample wild-caught or raised via aquaculture?
1.1.5 If the sample was a commercial seafood product, what was the
country of origin on the seafood label? The country of origin label
indicates the country where the last substantial transformation to the
seafood product was made, which may not be the country where the
seafood was harvested (19 U.S.C. 1304(a) and 19 CFR part 134; see also
Ref. 13).
1.2 Knowing whether the seafood sample (for commercial or non-
commercial seafood) has been tested whole or separated into parts is
valuable, particularly for informing potential mitigation strategies
(e.g., anatomical parts demonstrated to have higher PFAS concentrations
may be removed as a mitigation strategy for the remaining parts to be
sold for consumption). For each question below, please provide any
relevant data, evidence, or other information to support your response.
1.2.1 How would you characterize the seafood sample that was tested
(e.g., whole, muscle, roe, viscera)?
1.2.2 If the seafood was separated into different tissues, which
specific tissues were used to measure PFAS concentrations? Why were
those specific tissues chosen for testing?
[[Page 91768]]
2. PFAS Concentrations in the Environment (e.g., Water and Sediment in
Seafood Harvest Areas)
PFAS can enter seafood through environmental contamination. FDA is
interested in understanding PFAS sources and concentrations in the
environment that impact seafood. Such information can aid in the
identification of harvest areas to avoid. Examples of PFAS sources in
the environment include water and sediment.
For each item below, please provide the PFAS concentrations for
each type of PFAS detected (including samples where no PFAS was
detected), as well as any relevant data (e.g., sample collection date),
evidence, or other information to support your response.
2.1 In conjunction with testing PFAS concentrations in seafood,
please describe any environmental samples (e.g., volume or amount of
matrix, individual or composite) you have tested from locations where
seafood was grown or harvested, including the number of subsamples used
for composite samples. Please provide latitude and longitude of sample
location, if known.
2.1.1 What type of environmental sample was collected and analyzed
for PFAS (i.e., water, sediment, or another type of sample (e.g., soil,
biosolids))? Please provide the date of sample collection, if known.
2.1.2 If water, was the sample fresh water or salt water? What was
the depth at which the water sample was collected? What was the
salinity of the salt water?
2.1.3 If sediment, was the sample mud, sand, or clay? What was the
depth at which the sediment was collected?
2.1.4 If another type of sample, please provide additional
information about the sample matrix (e.g., whether the samples were
biosolids or soils near the coast).
2.2 If known, please provide any historical data you have about
PFAS sources in the sampling locale and any information showing a
relationship between PFAS in the environmental samples and PFAS in the
seafood samples. Such historical information can help identify whether
there are patterns or trends in PFAS contamination that may be useful
in predicting potential PFAS contamination in seafood, which could
inform mitigation efforts.
2.2.1 Are there any factors specific to this geographic location
that play a role in PFAS accumulation? If yes, please elaborate.
2.2.2 Is the PFAS contamination in the geographic location
persistent? Please provide the rationale for this conclusion.
2.2.3 What, if anything, has the data shown about the source of the
PFAS contamination?
3. PFAS Concentration in Processing Water
PFAS can enter processed seafood through the use of contaminated
processing water. FDA would like to know about the occurrence of PFAS
contamination in processing water intended for use with seafood.
Identification of the source of contaminated water that was intended
for use as processing water will help FDA better understand potential
and likely routes of PFAS contamination, and may help inform mitigation
strategies, such as the need to find alternative source water for food
processing. It is also helpful to know if water that was intended for
use as processing water was tested but not found to contain detectable
concentrations of PFAS.
For each item below, please provide the PFAS concentrations for
each type of PFAS detected (including samples where no PFAS was
detected), as well as any relevant data (e.g., sample collection date),
evidence, or other information to support your response.
3.1 What processing water samples have been tested for PFAS? At
what stage of processing was the process water used or intended to be
used? Please describe the sample (e.g., individual or composite,
volume) and provide the number of subsamples used for composite
samples.
3.2 What is the source of the processing water (e.g., municipal,
private, well)? If known, please provide any historical data you have
about PFAS sources in the sampling locale of the processing water, and
any information showing a relationship between PFAS in the processing
water samples and seafood samples. Such information can help identify
whether patterns or trends are available to aid in mitigation efforts.
4. Mitigation Strategies for PFAS in Seafood
As PFAS are known to accumulate and persist in the environment, it
is important to develop mitigation strategies for reducing PFAS
contamination in seafood. Examples of mitigation strategies include
changing or closing seafood harvest locations if an area is
contaminated with PFAS or processing certain tissues of seafood that
have been determined to not accumulate PFAS. Understanding the rates of
PFAS accumulation and elimination from seafood can help to determine
whether natural or controlled reduction strategies may be effective at
removing PFAS. FDA is interested to learn about additional mitigation
strategies that may be used to reduce or prevent PFAS contamination of
seafood. For each item below, please provide any relevant data,
evidence, or other information to support your response.
4.1 Please describe the PFAS mitigation strategies that you have
used or of which you are aware to reduce PFAS in seafood, including any
industry-wide practices. Please provide details regarding, as
applicable, testing seafood products and/or processing water for PFAS,
changing seafood harvest areas and/or processing water sources based on
PFAS concentrations, eviscerating seafood and/or processing different
tissues for consumption, or depurating (i.e., storing in controlled
conditions to allow for elimination of impurities) PFAS from seafood.
4.1.1 Which mitigation strategies have you determined to be
successful at reducing PFAS in seafood? Please provide details about
the strategy, including your criteria for determining success and the
level to which PFAS was reduced.
4.1.2 What challenges have you encountered regarding mitigation
strategies for reducing PFAS contamination in seafood?
4.2 If any seafood growing areas or harvest areas have been found
to be contaminated with PFAS, please describe whether the area has been
placed in a closed or prohibited status, you have been impacted by
growing or harvest areas being placed in a closed status, or you have
avoided harvesting in the area. Please describe the contamination event
in as much detail as possible (e.g., PFAS concentration, location with
latitude and longitude if known, length of closure or avoidance).
4.3 To what degree is PFAS in seafood testing being incorporated
into Seafood Hazard Analysis Critical Control Point (HACCP) plans? If
PFAS was detected in seafood or processing water, was PFAS added to
HACCP plans? Please provide details, such as what critical limit is
being considered.
III. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
[[Page 91769]]
1. Agency for Toxic Substances and Disease Registry, ``Toxicological
Profile for Perfluoroalkyls.'' Accessed June 14, 2024. Available at:
https://www.atsdr.cdc.gov/toxprofiles/tp200.pdf.
2. U.S. Environmental Protection Agency, ``Human Health Toxicity
Assessment for PFBS.'' Accessed June 14, 2024. Available at: https://www.epa.gov/chemical-research/learn-about-human-health-toxicity-assessment-pfbs.
3. U.S. Environmental Protection Agency, ``Human Health Toxicity
Assessments for GenX Chemicals.'' Accessed June 14, 2024. Available
at: https://www.epa.gov/chemical-research/human-health-toxicity-assessments-genx-chemicals.
4. U.S. Environmental Protection Agency, ``Final IRIS Assessment of
Perfluorobutanoic Acid (PFBA) and Related Salts.'' Accessed June 14,
2024. Available at: https://www.epa.gov/newsreleases/epa-publishes-iris-handbook-and-final-iris-assessment-perfluorobutanoic-acid-pfba-and.
5. U.S. Food and Drug Administration, ``Testing Food for PFAS and
Assessing Dietary Exposure.'' Accessed June 14, 2024. Available at:
https://www.fda.gov/food/process-contaminants-food/testing-food-pfas-and-assessing-dietary-exposure.
6. U.S. Food and Drug Administration, ``Analytical Results of
Testing Food for PFAS from Environmental Contamination.'' Accessed
June 14, 2024. Available at: https://www.fda.gov/food/process-contaminants-food/analytical-results-testing-food-pfas-environmental-contamination.
7. U.S. Food and Drug Administration, ``Activities for the Safety of
Imported Seafood, February 2023.'' Accessed June 14, 2024. Available
at: https://www.fda.gov/media/165447/download.
8. U.S. Food and Drug Administration, ``FDA Shares Results on PFAS
Testing in Seafood, July 15, 2022.'' Accessed June 14, 2024.
Available at: https://www.fda.gov/food/cfsan-constituent-updates/fda-shares-results-pfas-testing-seafood.
9. U.S. Food and Drug Administration, ``Crown Prince, Inc. Issues
Voluntary Recall of Smoked Baby Clams in Olive Oil Due to the
Presence of Detectable Levels of PFAS Chemicals.'' Accessed June 14,
2024. Available at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/crown-prince-inc-issues-voluntary-recall-smoked-baby-clams-olive-oil-due-presence-detectable-levels.
10. The White House, ``Fact Sheet: Biden-Harris Administration
Launches Plan to Combat PFAS Pollution, October 2021.'' Accessed
June 14, 2024. Available at: https://www.whitehouse.gov/briefing-room/statements-releases/2021/10/18/fact-sheet-biden-harris-administration-launches-plan-to-combat-pfas-pollution/.
11. The White House, ``Fact Sheet: Biden-Harris Administration
Combatting PFAS Pollution to Safeguard Clean Drinking Water for All
Americans, June 2022.'' Accessed June 14, 2024. Available at:
https://www.whitehouse.gov/briefing-room/statements-releases/2022/06/15/fact-sheet-biden-harris-administration-combatting-pfas-pollution-to-safeguard-clean-drinking-water-for-all-americans/.
12. The White House, ``Fact Sheet: Biden-Harris Administration Takes
New Action to Protect Communities from PFAS Pollution, March 2023.''
Accessed June 14, 2024. Available at: https://www.whitehouse.gov/briefing-room/statements-releases/2023/03/14/fact-sheet-biden-harris-administration-takes-new-action-to-protect-communities-from-pfas-pollution/.
13. U.S. Food and Drug Administration, ``CPG Sec. 560.200 Country of
Origin Labeling.'' Accessed June 14, 2024. Available at: https://www.fda.gov/media/71994/download.
Dated: November 12, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-27070 Filed 11-19-24; 8:45 am]
BILLING CODE 4164-01-P
