82 FR 6571 - Advice About Eating Fish, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 12 (January 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 12 (January 19, 2017)
| Page Range | 6571-6574 | |
| FR Document | 2017-01073 |
[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)] [Notices] [Pages 6571-6574] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-01073] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-0595] Advice About Eating Fish, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: In June 2014, the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA) (the Agencies) jointly released a draft update to a March 2004 document entitled ``What You Need to Know About Mercury in Fish and Shellfish.'' FDA and EPA are now announcing revised fish advice that contains advice and supplemental questions and answers for those who want to understand the advice in greater detail. FOR FURTHER INFORMATION CONTACT: FDA: William R. Jones, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1422, [email protected]; EPA: Lisa Larimer, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., MS 4305T, Washington, DC 20460, 202-566-1017, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of June 11, 2014 (79 FR 33559), FDA, in coordination with EPA, announced the availability of the draft updated fish advice, entitled ``Fish: What Pregnant Women and Parents Should Know'' (the notice), and made the draft updated advice available for public comment. The draft fish advice was intended to update advice previously published by EPA and FDA in March 2004 (Ref. 1), to make it consistent with the 2010 Dietary Guidelines for Americans and to modify the wording and organization of the 2004 advice to enhance the likelihood that it would be followed by the target audience. The 2004 advice on fish consumption itself was preceded by earlier recommendations published by FDA in September 1994 and revised in May 1995 (http://www.fda.gov/ohrms/dockets/ac/02/briefing/3872_advisory%207.pdf), followed by separate, but simultaneously issued, FDA and EPA fish consumption advice in 2001. FDA's 2001 advice addressed commercial fish; EPA's 2001 advice addressed locally caught fish. The 2014 notice announcing the availability of the draft updated fish advice stated that the comment period would be open until 30 days after the last transcript became available from either the FDA Risk [[Page 6572]] Communication Advisory Committee (RCAC) meeting to be held on the draft advice or any other public meeting that the Agencies chose to hold on the draft advice (79 FR 33559). The notice also stated that the date for closure of public comment would be published in a future notice in the Federal Register (id.). The RCAC meeting was held on November 3 and 4, 2014, and the transcript of the meeting became available on December 2, 2014. The meeting addressed the draft updated fish advice in great detail and included presentations by the Agencies on both the substance and the presentation of the draft updated fish advice, and included presentations by invited experts in risk communications. The meeting also provided members of the public with an opportunity to express their views to the RCAC and to officials of the Agencies who were in attendance. FDA and EPA concluded that the thoroughness of this public meeting, in addition to the public comments received and still to be received, removed the need for additional public meetings, and announced in the Federal Register that the comment period for the draft updated advice would be closed on March 26, 2015 (80 FR 9732). The transcript from the RCAC meeting is available electronically at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/RiskCommunicationAdvisoryCommittee/UCM425352.pdf and http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials. A summary table of joint responses from FDA and EPA to the comments we received on the draft updated fish advice is available in the docket (Ref. 2). The comments themselves are also available in the Docket. In August 2016, an external peer review of FDA-EPA's method for categorizing species of fish into consumption categories was conducted at the request of FDA and EPA. Information on the external peer review and FDA's and EPA's responses to the peer review are available at http://www.fda.gov/fishadvice (and also on FDA's Completed Peer Reviews page at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm) (Refs. 3 and 4). Fish and shellfish (referred to collectively in this notice as ``fish'') provide protein, are low in saturated fat, are rich in many micronutrients, and provide certain omega-3 fatty acids (Ref. 5). However, as a result of natural processes and human activity, fish also contain mercury in the form of methylmercury. Methylmercury can adversely affect the central nervous system, particularly the developing brain of the fetus. After a careful review and consideration of the RCAC transcript, the comments received on the draft updated fish advice (Ref. 2), and the peer review, EPA and FDA are issuing revised fish advice. The 2004 advice was issued to help individuals in the target population limit their exposure to mercury while still obtaining the health benefits of fish consumption. The 2004 advice recommended avoiding four types of commercially available fish that have the highest average mercury concentrations: Tilefish, shark, swordfish, and king mackerel. The advice further recommended that women in the target population eat up to--but not exceed--12 ounces per week of most other types of commercially available fish. It recommended limiting consumption of one species, white (albacore) tuna, to no more than 6 ounces per week. For local fish caught by family and friends, the advice recommended following locally posted fish advisories regarding safe catch. Where no such advice exists, it recommends limiting consumption of locally caught fish to 6 ounces per week and eating no other fish that week. While the 2004 advice encourages fish consumption as part of a healthy diet, it does not encourage consumption of a minimum amount of fish. In June 2014, FDA and EPA issued the draft updated advice to encourage women who are pregnant or breastfeeding to consume 8 to 12 ounces of a variety of fish per week to maximize the potential benefits that fish could provide. The Agencies also proposed to modify the wording and organization of the 2004 advice in order to enhance the likelihood that it will be followed by the target audience. II. What is in the revised fish advice? The revised fish advice is designed to encourage women who are pregnant and breastfeeding to consume 8 to12 ounces of a variety of fish per week, and it includes further modified wording and organization to further enhance the likelihood that it will be followed by the target audience. The revised fish advice includes a chart and supplemental questions and answers. The chart provides recommendations for how often the target audience (pregnant women, women who might become pregnant, breastfeeding women, and young children) should eat more than 60 different fish, based on mercury concentrations. FDA and EPA used sampling data from FDA and, to a limited extent, from the U.S. National Marine Fisheries Service as the source for mercury amounts in fish (Ref. 6), with support from other sources (Refs. 7 through 12). The revised fish advice makes the following recommendations for the target audience:Eat 2 to 3 servings a week of a variety of fish. The revised fish advice translates the consumption target of 8 to 12 ounces of a variety of fish per week into 2 to 3 servings a week of a variety of fish, with a typical adult serving as 4 ounces. The chart in the revised fish advice shows which fish the target audience can eat 2 to 3 servings a week. Eat 1 serving a week of some fish. Since 2004, the advice has recommended limiting albacore (``white'') tuna to 1 serving a week (or 6 ounces per week). The revised fish advice adds 18 fish with similar mercury concentrations to the list of fish to eat 1 serving a week. Avoid certain fish with the highest mercury concentrations. Since 1994, the advice has recommended limiting or avoiding shark and swordfish. In 2001, tilefish and king mackerel were added to this list of recommended fish to avoid. This revised fish advice adds marlin, orange roughy, and bigeye tuna, which have similar mercury concentrations. The revised fish advice recommends avoiding tilefish only from the Gulf of Mexico, consistent with the draft updated fish advice. Data on tilefish from the Atlantic Ocean indicate that these fish have much lower levels of mercury on average (Ref. 6). Check for advisories for fish caught by family and friends and where no advisory exists, limit eating those fish to one serving a week and do not eat other fish that week. The revised fish advice retains the recommendations included in the 2004 advice for fish caught by family and friends. There are waters where there may have been little or no monitoring and, therefore, the extent of potential mercury contamination is unknown. Fish caught for recreation or subsistence can contain higher levels of mercury than commercially available species. III. How does the revised fish advice differ from the draft updated fish advice? The revised fish advice presents the recommended consumption for more than 60 fish in a color-coded chart. The fish are presented in categories of ``Best Choices,'' those which the target audience can eat 2 to 3 servings a week; ``Good Choices,'' which the target audience can eat 1 serving a week; and ``Choices to Avoid.'' See Ref. 13 for a description of how FDA and EPA [[Page 6573]] decided which fish went in each category. The draft updated fish advice recommended eating 8 to 12 ounces of a variety of fish per week and choosing fish lower in mercury, but it only mentioned 7 of those fish (salmon, shrimp, pollock, tuna (light canned), tilapia, catfish, and cod). The revised fish advice also retains the recommendation to eat a variety of fish. The revised fish advice adds 18 fish that the target audience can eat 1 serving a week (see ``Good Choices'' category in the revised fish advice). The draft updated fish advice included only white (albacore tuna) as a fish to limit to 6 ounces per week. Another change between the draft updated advice and the revised fish advice is that the revised fish advice adds marlin, orange roughy, and bigeye tuna to the list of fish that the target audience should avoid eating (see ``Choices to Avoid'' category in the revised fish advice). These fish were added because they have comparable mercury levels to fish included in the draft updated advice as fish that should be avoided (i.e., shark, swordfish, tilefish from the Gulf of Mexico, and king mackerel). The Agencies reorganized the questions and answers (Qs and As) into topic areas, simplified the responses, and added new questions as a result of comments received during the comment period. The chart includes a link to two fish advice Web sites (http://www.fda.gov/fishadvice) and http://www.epa.gov/fishadvice), images to show serving size, and is designed to make it clear and easy to read for display at point of sale, doctors' offices and elsewhere. The Web site contains the advice and the Qs and As. Educational and outreach materials will be added to the Web site as they are developed. IV. What comments were received and how does the revised fish advice reflect them? FDA and EPA received over 200 comments from States, industry, academia, various organizations, and concerned individuals. The comments covered a range of topics from the scientific basis of the advice to communication. There was a wide range of opinions expressed in the comments, not all of which were relevant to the advice. The majority of the comments pertained to the clarity and effectiveness of how the advice was presented. In response to comments, the Agencies revised the presentation of the advice, as discussed in part III of this document. Other comments suggested a more restrictive set of consumption recommendations or disagreed with setting consumption th resholds for specific species of fish or for any but the species highest in mercury. After reviewing the comments, FDA and EPA adopted an approach in which fish species are separated into three categories based on average measured mercury content (``Best Choices,'' ``Good Choices,'' and ``Choices to Avoid''). An evaluation of available information led the Agencies to recommend eating 2 to 3 servings a week for some fish and 1 serving a week for others. The advice to eat 2 to 3 servings of a variety of fish a week is consistent with the recommendation in the 2015-2020 Dietary Guidelines for Americans that women who are pregnant or breastfeeding consume at least 8 and up to 12 ounces of a variety of fish lower in mercury per week. Consuming 8 to12 ounces of fish per week while pregnant or breastfeeding would be a significant dietary change for most women. In a survey of over 1,200 pregnant women conducted by FDA in 2005, median fish consumption was 1.8 ounces per week (Ref. 14). The approach in the revised fish advice differs from that taken in the draft updated fish advice not only in that it categorizes more than 60 fish types, but also in its analytical basis. In categorizing the fish species for recommended consumption, the revised fish advice compares the reference dose (RfD) developed by EPA (Ref. 15) to the predicted exposure from the consumption of different fish species. Because the RfD is a rate of exposure that a person can experience over a lifetime without appreciable risk of harm and includes a 10-fold uncertainty factor to allow for variability among individuals and groups, this was a highly protective approach for determining which fish belong in each category. Specifically, the RfD for mercury is protective of neurodevelopmental effects from a critical window of development for a fetus during pregnancy. We believe the new approach is more protective of public health. This new approach is also consistent with a number of the comments received, and the external peer review conducted. V. What did the peer reviewers say and how did FDA and EPA respond? Overall, the reviewers agreed upon the necessity of mercury fish advice for pregnant women, those trying to get pregnant, and children, to encourage fish consumption while helping to avoid mercury. The reviewers were generally supportive of the technical information and methodology used to support the scientific basis for the fish consumption recommendations. The reviewers made suggestions to improve clarity, transparency, and presentation, and to enhance the scientific underpinnings of the fish advice. The reviewers suggested supplementing FDA's data on mercury levels in seafood with other published sources to support the fish categorization for species with small sample sizes and/or large variability in mercury levels. The reviewers also provided various suggestions of where additional details could be added to aid the reader and support the conclusions. FDA and EPA implemented many of the reviewers' recommendations. A report of the FDA-EPA response to the peer review is available at http://www.fda.gov/fishadvice (and also on FDA's Completed Peer Reviews page at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm) (Ref. 4). VI. How can I access the documents? The revised fish advice and supplemental questions and answers are available electronically at http://www.fda.gov/fishadvice and http://www.epa.gov/fishadvice. VII. References The following references are on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 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 http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. ``What You Need to Know About Mercury in Fish and Shellfish; 2004 EPA and FDA Advice for: Women Who Might Become Pregnant, Women Who are Pregnant, Nursing Mothers, Young Children,'' available at http://www.fda.gov/food/foodborneillnesscontaminants/buystoreservesafefood/ucm110591.htm. 2. Summary Table of Responses to Public Comments on EPA's and FDA's Draft Updated Advice About Eating Fish (Docket No. FDA-2014-N-0595). 3. External Peer Review of FDA/EPA's ``Technical Information on the Development of Fish Consumption Advice,'' available at http://www.fda.gov/fishadvice and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. 4. FDA and EPA's Response to External Peer [[Page 6574]] Review on the FDA-EPA's Technical Information on the Development of Fish Consumption Advice, available at http://www.fda.gov/fishadvice and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. 5. Institute of Medicine, Committee on Nutrient Relationships in Seafood: ``Selections to Balance Benefits and Risks,'' (2007). Seafood Choices, Balancing Benefits and Risks. The National Academies Press, Washington, DC. 6. ``Mercury Levels in Commercial Fish and Shellfish 1990-2010,'' available at http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm115644.htm. 7. Karimi, R., Fitzgerald, T.P., and Fisher, N.S. (2012). ``A Quantitative Synthesis of Mercury in Commercial Seafood and Implications for Exposure in the United States.'' Environ Health Perspect 120, 1512-1519, available at http://ehp.niehs.nih.gov/1205122/. 8. U.S. Environmental Protection Agency (U.S. EPA) 2003. Mercury in Marine Life Database. Office of Wetlands, Oceans and Watersheds, available at https://cfpub.epa.gov/si/si_public_record_Report.cfm?dirEntryId=58213. 9. U.S. Environmental Protection Agency. (U.S. EPA) (2016). National Coastal Assessment (NCA): Northeast 2000-2006 Summary Data, available at https://archive.epa.gov/emap/archive-emap/web/html/index-124.html. 10. U.S. Environmental Protection Agency (U.S. EPA). (2016). National Coastal Condition Assessment (NCCA) Office of Water & Office of Research Development, EPA 841-R-15-006, Washington, DC. 2010 Results, available at https://www.epa.gov/national-aquatic-resource-surveys/national-coastal-condition-assessment-2010-results. 11. Health Canada, (2007) Human Health Risk Assessment of Mercury in Fish and Health Benefits of Fish Consumption, Bureau of Chemical Safety Food Directorate Health Products and Food Branch, Ottawa, Ontario, Canada. 12. Cladis, D.P., Kleiner, A.C., and Santerre, C.R. (2014). ``Mercury Content in Commercially Available Finfish in the United States.'' J Food Prot 77, 1361-1366, available at http://www.ncbi.nlm.nih.gov/pubmed/25198598. 13. FDA-EPA Fish Advice: Technical Information, available at http://www.fda.gov/fishadvice. 14. Lando, A.M., S.B. Fein, and C.J. Choini[egrave]re, ``Awareness of Methylmercury in Fish and Fish Consumption Among Pregnant and Postpartum and Women of Childbearing Age in the United States,'' Environmental Research, vol. 116, pp. 85-92, 2012. 15. U.S. Environmental Protection Agency's Integrated Risk Information System (IRIS), available at http://www.epa.gov/iris/subst/0073.htm. Dated: January 11, 2017. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-01073 Filed 1-18-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6571
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
Number of Total annual Average burden
Type of information responses per Total hours
respondents responses per response
respondent
Follow up information to payors regarding previously 260 2 520 2 ............................ 1,040
communicated information about investigational
drugs and devices.
Total ........................................................................ ...................... ............................ ...................... ............................... 81,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This draft guidance also refers to which the principles provided in update to a March 2004 document
previously approved collections of section III.A could be applicable to entitled ‘‘What You Need to Know
information found in FDA regulations. communications of HCEI about animal About Mercury in Fish and Shellfish.’’
The collections of information in 21 drugs with appropriate audiences for FDA and EPA are now announcing
CFR 314.81(b)(3)(i) (Form FDA 2253) such information. To the extent that revised fish advice that contains advice
have been approved under OMB control commenters believe that different and supplemental questions and
number 0910–0001. considerations should apply to animal answers for those who want to
drugs or that guidance is needed on understand the advice in greater detail.
III. Other Issues for Consideration additional issues with respect to animal FOR FURTHER INFORMATION CONTACT:
Although section 502(a) is specific to drug firms’ communications of HCEI FDA: William R. Jones, Center for Food
approved drugs and section III.A of this about approved new animal drugs to Safety and Applied Nutrition, Food and
draft guidance addresses firms’ appropriate audiences, FDA is Drug Administration, 5001 Campus Dr.,
communications of HCEI to payors only interested in input on those topics as College Park, MD 20740–3835, 240–
about approved drugs, FDA is interested well. 402–1422, William.Jones@fda.hhs.gov;
in whether similar principles to those IV. Electronic Access EPA: Lisa Larimer, U.S. Environmental
outlined in that section should apply to Protection Agency, 1200 Pennsylvania
firms’ communications of HCEI to Persons with access to the Internet Ave. NW., MS 4305T, Washington, DC
payors about approved/cleared devices may obtain the draft guidance at http:// 20460, 202–566–1017, Larimer.Lisa@
or whether different principles should www.fda.gov/Drugs/Guidance epa.gov.
be considered. FDA is specifically ComplianceRegulatoryInformation/
Guidances/default.htm, http:// SUPPLEMENTARY INFORMATION:
interested in identifying principles that,
if applied to communications of HCEI www.fda.gov/BiologicsBloodVaccines/ I. Background
about approved/cleared devices, could GuidanceCompliance
In the Federal Register of June 11,
help ensure that such information is RegulatoryInformation/Guidances/
2014 (79 FR 33559), FDA, in
truthful and non-misleading and aids default.htm, http://www.fda.gov/
coordination with EPA, announced the
payors in making informed selection MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/ availability of the draft updated fish
and/or coverage and reimbursement advice, entitled ‘‘Fish: What Pregnant
default.htm, or https://
decisions about these products. FDA is Women and Parents Should Know’’ (the
www.regulations.gov.
interested in comments from interested notice), and made the draft updated
parties on any of the topics addressed in Dated: January 6, 2017. advice available for public comment.
this draft guidance and specifically Jeremy Sharp, The draft fish advice was intended to
requests comments from interested Deputy Commissioner for Policy, Planning, update advice previously published by
parties on the extent to which the Legislation, and Analysis. EPA and FDA in March 2004 (Ref. 1), to
principles provided in section III.A [FR Doc. 2017–01011 Filed 1–18–17; 8:45 am] make it consistent with the 2010 Dietary
could be applicable to communications BILLING CODE 4164–01–P Guidelines for Americans and to modify
of HCEI about approved/cleared the wording and organization of the
devices. To the extent that interested 2004 advice to enhance the likelihood
parties believe that different DEPARTMENT OF HEALTH AND that it would be followed by the target
considerations should apply to medical HUMAN SERVICES audience. The 2004 advice on fish
devices or that guidance is needed on consumption itself was preceded by
additional issues with respect to Food and Drug Administration
earlier recommendations published by
medical device firms’ communications [Docket No. FDA–2014–N–0595] FDA in September 1994 and revised in
of HCEI about approved/cleared medical May 1995 (http://www.fda.gov/ohrms/
devices to payors, FDA is interested in Advice About Eating Fish, From the dockets/ac/02/briefing/3872_
input on those topics as well. Environmental Protection Agency and advisory%207.pdf), followed by
FDA is also seeking comments from Food and Drug Administration; separate, but simultaneously issued,
interested parties regarding Revised Fish Advice; Availability FDA and EPA fish consumption advice
communications of HCEI about animal in 2001. FDA’s 2001 advice addressed
mstockstill on DSK3G9T082PROD with NOTICES
AGENCY: Food and Drug Administration,
drugs. Although FDA recognizes that HHS. commercial fish; EPA’s 2001 advice
the audience for HCEI about animal ACTION: Notice of availability. addressed locally caught fish. The 2014
drugs may be different from that notice announcing the availability of the
identified in section III.A as a result of SUMMARY: In June 2014, the Food and draft updated fish advice stated that the
differences in how payment decisions Drug Administration (FDA) and the U.S. comment period would be open until 30
are made for animal drugs, FDA is Environmental Protection Agency (EPA) days after the last transcript became
interested in learning the extent to (the Agencies) jointly released a draft available from either the FDA Risk
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![6574 Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices
Review on the FDA–EPA’s Technical Dated: January 11, 2017. confidential information that you or a
Information on the Development of Fish Jeremy Sharp, third party may not wish to be posted,
Consumption Advice, available at http:// Deputy Commissioner for Policy, Planning, such as medical information, your or
www.fda.gov/fishadvice and http:// Legislation, and Analysis. anyone else’s Social Security number, or
www.fda.gov/ScienceResearch/Special
[FR Doc. 2017–01073 Filed 1–18–17; 8:45 am] confidential business information, such
Topics/PeerReviewofScientific
InformationandAssessments/ BILLING CODE 4164–01–P as a manufacturing process. Please note
ucm079120.htm. that if you include your name, contact
5. Institute of Medicine, Committee on information, or other information that
Nutrient Relationships in Seafood: DEPARTMENT OF HEALTH AND identifies you in the body of your
‘‘Selections to Balance Benefits and HUMAN SERVICES comments, that information will be
Risks,’’ (2007). Seafood Choices, posted on https://www.regulations.gov.
Balancing Benefits and Risks. The Food and Drug Administration • If you want to submit a comment
National Academies Press, Washington, with confidential information that you
DC. [Docket No. FDA–2016–D–4482]
do not wish to be made available to the
6. ‘‘Mercury Levels in Commercial Fish and public, submit the comment as a
Shellfish 1990–2010,’’ available at http:// Regulation of Mosquito-Related
Products; Draft Guidance for Industry; written/paper submission and in the
www.fda.gov/Food/FoodborneIllness
Availability manner detailed (see ‘‘Written/Paper
Contaminants/Metals/ucm115644.htm.
7. Karimi, R., Fitzgerald, T.P., and Fisher,
Submissions’’ and ‘‘Instructions’’).
N.S. (2012). ‘‘A Quantitative Synthesis of
AGENCY: Food and Drug Administration,
HHS. Written/Paper Submissions
Mercury in Commercial Seafood and
Implications for Exposure in the United ACTION: Notice of availability. Submit written/paper submissions as
States.’’ Environ Health Perspect 120, follows:
1512–1519, available at http:// SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
ehp.niehs.nih.gov/1205122/. Administration (FDA or Agency) is written/paper submissions): Division of
8. U.S. Environmental Protection Agency announcing the availability of a draft Dockets Management (HFA–305), Food
(U.S. EPA) 2003. Mercury in Marine Life guidance for industry (GFI) #236 and Drug Administration, 5630 Fishers
Database. Office of Wetlands, Oceans entitled ‘‘Regulation of Mosquito- Lane, Rm. 1061, Rockville, MD 20852.
and Watersheds, available at https:// Related Products.’’ This draft guidance • For written/paper comments
cfpub.epa.gov/si/si_public_record_ provides information regarding submitted to the Division of Dockets
Report.cfm?dirEntryId=58213. Management, FDA will post your
regulatory oversight of mosquito-related
9. U.S. Environmental Protection Agency. comment, as well as any attachments,
(U.S. EPA) (2016). National Coastal products, defined as those articles for
use in or on mosquitoes. We are except for information submitted,
Assessment (NCA): Northeast 2000–2006
Summary Data, available at https:// clarifying circumstances under which marked and identified, as confidential,
archive.epa.gov/emap/archive-emap/ such products are regulated by FDA as if submitted as detailed in
web/html/index-124.html. new animal drugs under the Federal ‘‘Instructions.’’
10. U.S. Environmental Protection Agency Food, Drug, and Cosmetic Act (the Instructions: All submissions received
(U.S. EPA). (2016). National Coastal FD&C Act) and other circumstances must include the Docket No. FDA–
Condition Assessment (NCCA) Office of under which such products are 2016–D–4482 for ‘‘Regulation of
Water & Office of Research Development, regulated by the Environmental Mosquito-Related Products.’’ Received
EPA 841–R–15–006, Washington, DC. comments will be placed in the docket
Protection Agency (EPA) as pesticides
2010 Results, available at https:// and, except for those submitted as
www.epa.gov/national-aquatic-resource- under the Federal Insecticide,
Fungicide, and Rodenticide Act ‘‘Confidential Submissions,’’ publicly
surveys/national-coastal-condition-
(FIFRA). viewable at https://www.regulations.gov
assessment-2010-results.
11. Health Canada, (2007) Human Health or at the Division of Dockets
DATES: Although you can comment on Management between 9 a.m. and 4 p.m.,
Risk Assessment of Mercury in Fish and any guidance at any time (see 21 CFR
Health Benefits of Fish Consumption, Monday through Friday.
10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To
Bureau of Chemical Safety Food
Directorate Health Products and Food considers your comment on this draft submit a comment with confidential
Branch, Ottawa, Ontario, Canada. guidance before it begins work on the information that you do not wish to be
12. Cladis, D.P., Kleiner, A.C., and Santerre, final version of the guidance, submit made publicly available, submit your
C.R. (2014). ‘‘Mercury Content in either electronic or written comments comments only as a written/paper
Commercially Available Finfish in the on the draft guidance by February 21, submission. You should submit two
United States.’’ J Food Prot 77, 1361– 2017. copies total. One copy will include the
1366, available at http://
ADDRESSES: You may submit comments information you claim to be confidential
www.ncbi.nlm.nih.gov/pubmed/
25198598. as follows: with a heading or cover note that states
13. FDA–EPA Fish Advice: Technical ‘‘THIS DOCUMENT CONTAINS
Electronic Submissions CONFIDENTIAL INFORMATION.’’ The
Information, available at http://
www.fda.gov/fishadvice. Submit electronic comments in the Agency will review this copy, including
14. Lando, A.M., S.B. Fein, and C.J. following way: the claimed confidential information, in
Choinière, ‘‘Awareness of • Federal eRulemaking Portal: its consideration of comments. The
Methylmercury in Fish and Fish https://www.regulations.gov. Follow the second copy, which will have the
Consumption Among Pregnant and instructions for submitting comments. claimed confidential information
mstockstill on DSK3G9T082PROD with NOTICES
Postpartum and Women of Childbearing Comments submitted electronically, redacted/blacked out, will be available
Age in the United States,’’
including attachments, to https:// for public viewing and posted on
Environmental Research, vol. 116, pp.
85–92, 2012. www.regulations.gov will be posted to https://www.regulations.gov. Submit
15. U.S. Environmental Protection Agency’s the docket unchanged. Because your both copies to the Division of Dockets
Integrated Risk Information System comment will be made public, you are Management. If you do not wish your
(IRIS), available at http://www.epa.gov/ solely responsible for ensuring that your name and contact information to be
iris/subst/0073.htm. comment does not include any made publicly available, you can
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Document Created: 2018-02-01 15:15:58
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| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Contact | FDA: William R. Jones, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1422, [email protected]; EPA: Lisa Larimer, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., MS 4305T, Washington, DC 20460, 202-566-1017, [email protected] | |
| FR Citation | 82 FR 6571 |
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