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[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]

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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.

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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

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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) 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.

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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-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
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