The Food and Drug Administration (“FDA”) and the Environmental Protection Agency (“EPA”) jointly seek comment on the substance and structure of their updated advice regarding the safety of eating fish. This draft update will include “both advice and supplemental questions and answers for those who want to understand the advice in greater detail.”
In 2004, the FDA and EPA released a document named, “What You Need to Know About Mercury in Fish and Shellfish,” to assist the public in reaping the health benefits of eating fish, while reducing mercury exposure. Fish (which includes both fish and shellfish) contain protein, omega-3 fatty acids, and many micronutrients, and are low in saturated fat, but they also contain methylmercury, a form of mercury that can harm the central nervous system and the developing brain of fetuses.
The FDA and EPA now propose to update this 2004 advice in order to align it with the Dietary Guidelines for Americans 2010.” The FDA drafted its assessment in 2009 and recently modified it after receiving comments and advice from peer reviewers, the public, and federal agencies, including the EPA. Although these recommendations are directed toward a target audience of women who are pregnant, may become pregnant, or are breastfeeding, this information is intended for the public at large as well.
The updated advice from FDA and EPA includes the following four recommendations for the target audience. First, these women should consume at least 8 and up to 12 ounces (2 or 3 servings) per week “of a variety of fish lower in mercury within their calorie needs.” Second, they should avoid tilefish from the Gulf of Mexico, shark, swordfish, and king mackerel because these four fish contain the highest mercury concentrations. Third, they should eat no more than 6 ounces of white (albacore) tuna per week.
Fourth, as the 2004 FDA guidelines advised, those who eat local fish caught by family and friends should follow “locally posted fish advisories regarding safe catch.” Although the amount of mercury in local waters is unknown, the levels tend to be higher in local fish than in commercially available fish. In the absence of such advisories, consumers of locally caught fish should eat no more than 6 ounces per week and refrain from consuming any other fish in the same week. In addition, given the continued development of their nervous systems, the FDA and EPA recommend that children eat less fish than adult women.
Furthermore, the FDA and EPA wish to solicit comments regarding ways to change the substance and structure of their updated advice in order to make the recommendations “both understandable and influential.” The agencies also invite comment regarding whether to add orange roughy and marlin to the list of fish that both young children and the target audience of women who are pregnant, may become pregnant, or are breastfeeding should avoid. These two fish contain less mercury than the aforementioned four fish that the target audience should avoid, but orange roughy and marlin contain more mercury than “nearly all other commercial fish” and “can be unusually low in omega-3 fatty acids.” Thus, their benefits do not outweigh the costs.
Finally, the FDA and EPA seek public comment on the following:
1. Whether the final updated advice should track the Dietary Guidelines for Americans 2010 more or less closely than the draft of that updated advice now does.
2. Any new science that has become available since the Dietary Guidelines for Americans 2010 were issued that would be relevant to the updated advice.
3. Information upon which to base advice on young children’s fish consumption. There have been a number of studies that have examined the effects of both postnatal exposure to mercury as well as postnatal fish consumption by young children, but this research has not been as extensive as the research on prenatal exposures and maternal fish consumption.
4. As stated previously, suggestions for improving the clarity and utility of the advice.
5. How to integrate advice from local advisories for those who consume fish from local streams, rivers, and lakes.
In addition to inviting comments, the FDA and EPA will hold a public meeting, in which the FDA Advisory Committee on Risk Communication will offer its thoughts on the updated advice. The agencies will also publish information in the Federal Register about other public meetings that they plan to host around the country.
The comment period will close 30 days after the transcripts of the aforementioned meetings are published. The closure date will be published in a Federal Register notice. Interested parties are invited to submit comments by any of the following methods:
- Federal eRulemaking Portal: http://www.regulations.gov
- Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852
The FDA will share with EPA all of the comments that it receives.
This post was originally published on the legacy ABA Section of Administrative Law and Regulatory Practice Notice and Comment blog, which merged with the Yale Journal on Regulation Notice and Comment blog in 2015.
The Food and Drug Administration (“FDA”) and the Environmental Protection Agency (“EPA”) jointly seek comment on the substance and structure of their updated advice regarding the safety of eating fish. This draft update will include “both advice and supplemental questions and answers for those who want to understand the advice in greater detail.”
In 2004, the FDA and EPA released a document named, “What You Need to Know About Mercury in Fish and Shellfish,” to assist the public in reaping the health benefits of eating fish, while reducing mercury exposure. Fish (which includes both fish and shellfish) contain protein, omega-3 fatty acids, and many micronutrients, and are low in saturated fat, but they also contain methylmercury, a form of mercury that can harm the central nervous system and the developing brain of fetuses.
The FDA and EPA now propose to update this 2004 advice in order to align it with the Dietary Guidelines for Americans 2010.” The FDA drafted its assessment in 2009 and recently modified it after receiving comments and advice from peer reviewers, the public, and federal agencies, including the EPA. Although these recommendations are directed toward a target audience of women who are pregnant, may become pregnant, or are breastfeeding, this information is intended for the public at large as well.
The updated advice from FDA and EPA includes the following four recommendations for the target audience. First, these women should consume at least 8 and up to 12 ounces (2 or 3 servings) per week “of a variety of fish lower in mercury within their calorie needs.” Second, they should avoid tilefish from the Gulf of Mexico, shark, swordfish, and king mackerel because these four fish contain the highest mercury concentrations. Third, they should eat no more than 6 ounces of white (albacore) tuna per week.
Fourth, as the 2004 FDA guidelines advised, those who eat local fish caught by family and friends should follow “locally posted fish advisories regarding safe catch.” Although the amount of mercury in local waters is unknown, the levels tend to be higher in local fish than in commercially available fish. In the absence of such advisories, consumers of locally caught fish should eat no more than 6 ounces per week and refrain from consuming any other fish in the same week. In addition, given the continued development of their nervous systems, the FDA and EPA recommend that children eat less fish than adult women.
Furthermore, the FDA and EPA wish to solicit comments regarding ways to change the substance and structure of their updated advice in order to make the recommendations “both understandable and influential.” The agencies also invite comment regarding whether to add orange roughy and marlin to the list of fish that both young children and the target audience of women who are pregnant, may become pregnant, or are breastfeeding should avoid. These two fish contain less mercury than the aforementioned four fish that the target audience should avoid, but orange roughy and marlin contain more mercury than “nearly all other commercial fish” and “can be unusually low in omega-3 fatty acids.” Thus, their benefits do not outweigh the costs.
Finally, the FDA and EPA seek public comment on the following:
1. Whether the final updated advice should track the Dietary Guidelines for Americans 2010 more or less closely than the draft of that updated advice now does.
2. Any new science that has become available since the Dietary Guidelines for Americans 2010 were issued that would be relevant to the updated advice.
3. Information upon which to base advice on young children’s fish consumption. There have been a number of studies that have examined the effects of both postnatal exposure to mercury as well as postnatal fish consumption by young children, but this research has not been as extensive as the research on prenatal exposures and maternal fish consumption.
4. As stated previously, suggestions for improving the clarity and utility of the advice.
5. How to integrate advice from local advisories for those who consume fish from local streams, rivers, and lakes.
In addition to inviting comments, the FDA and EPA will hold a public meeting, in which the FDA Advisory Committee on Risk Communication will offer its thoughts on the updated advice. The agencies will also publish information in the Federal Register about other public meetings that they plan to host around the country.
The comment period will close 30 days after the transcripts of the aforementioned meetings are published. The closure date will be published in a Federal Register notice. Interested parties are invited to submit comments by any of the following methods:
The FDA will share with EPA all of the comments that it receives.
This post was originally published on the legacy ABA Section of Administrative Law and Regulatory Practice Notice and Comment blog, which merged with the Yale Journal on Regulation Notice and Comment blog in 2015.