[Congressional Record Volume 147, Number 35 (Thursday, March 15, 2001)]
[Senate]
[Pages S2409-S2411]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. LEAHY (for himself and Mr. Harkin):
  S. 555. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
require the Secretary of Health and Human Services to establish a 
tolerance for the presence of methylmercury in seafood, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Mr. LEAHY. Mr. President, last month the Food and Drug Administration 
issued new consumer guidance, warning pregnant women, women of 
childbearing age, nursing mothers, and young children not to eat shark, 
swordfish, king mackerel, and tilefish in order to avoid exposure to 
methylmercury. I commend the FDA

[[Page S2410]]

for issuing this guidance, which is important information for the most 
vulnerable members of our population. Unfortunately, despite 
acknowledging the problem of mercury contamination in large fish, the 
FDA still has not revised its so-called ``action level,'' which is 
important data for consumers and local governments, nor do they enforce 
this level. There is a lot more to be done to protect the public, and 
after so many years of delays, we should not wait any longer.
  That is why Senator Harkin and I are introducing important 
legislation today to promote food safety and protect thousands of 
Americans, especially pregnant women and young children, from the 
serious risks of methylmercury. The ``Mercury-Safe Seafood Act of 
2001'' requires the Food and Drug Administration to establish a formal 
tolerance for safe methylmercury levels in seafood. It mandates seafood 
testing to ensure compliance, along with public education and health 
advisories to inform the public.
  Mercury is a dangerous poison that is still not fully regulated in 
the United States. According to the Environmental Protection Agency, 
coal-fired power plants, waste incinerators, and other sources spew 150 
tons of mercury into the atmosphere each year. Although new and 
expected EPA rules address much of this pollution, full compliance and 
large emission reductions are still years away. Much of this mercury 
returns to earth with rain to pollute our waterways. It accumulates in 
fish as methylmercury, especially in large predatory species, and is 
passed on to the humans who eat these fish. Methylmercury is a powerful 
neurotoxin that affects the human central nervous system. It is 
especially harmful to pregnant women, infants, and young children, 
where even small doses can cause permanent damage to their developing 
brains and nervous systems.
  Last year's comprehensive report by the National Academy of Sciences, 
``Toxicological Effects of Methylmercury,'' estimates that 60,000 
newborns each year may be at risk from prenatal mercury exposure. Two 
weeks ago, the Centers for Disease Control released preliminary results 
from an ongoing study showing that 10 percent of American women may 
have potentially hazardous levels of mercury. This means that a lot 
more newborns may be at risk. This is a public health problem we cannot 
ignore.
  Certain commercial seafood species--large predators such as 
swordfish, shark, mackerel, and tuna--can have dangerously high levels 
of methylmercury contamination. Food and Drug Administration data 
throughout the 1990's showed numerous fish samples with high mercury 
levels, exceeding FDA's own action level and presenting a direct hazard 
to consumers. FDA stopped testing for mercury in 1998, which means they 
have no way to enforce their action level. Yet recent testing by 
independent organizations still shows high mercury levels in some fish 
species.

  FDA's action level of 1.0 part per million was established in 1979 
using information from the 1970's, without regard for the greater 
vulnerability of pregnant women, infants, and children. More recent 
studies have highlighted the damaging effects of mercury, especially 
for these populations. In 1997, EPA's ``Mercury Study Report to 
Congress'' recommended a level five times more strict than FDA's action 
level, and this was confirmed by last year's National Academy of 
Sciences report. FDA's current action level, even if there were 
sampling and enforcement, is not stringent enough to protect the most 
vulnerable American consumers from mercury.
  Last month the General Accounting Office released a report on seafood 
safety, at the request of Senator Harkin and Senator Lugar. That report 
confirms that FDA has not acted vigorously enough to address the issue 
of mercury in seafood.
  This bill seeks to remedy these problems. It amends the Federal Food, 
Drug, and Cosmetic Act to require a tolerance level for methylmercury 
in seafood, with special attention to pregnant women, infants, and 
children. This will replace FDA's outdated and unenforced action level 
with a formal tolerance that must be enforced. It mandates ongoing 
sampling of mercury levels to ensure compliance. This will restart the 
testing which FDA stopped three years ago. It mandates public education 
and health advisories to ensure the public is aware of the new 
standards and of the risks of mercury contamination in seafood. It 
requires consideration of last year's National Academy of Sciences 
report, which clearly shows the need for prompt, strong action. 
Finally, it authorizes modest appropriations to support not only FDA's 
sampling and public education but also the efforts of our States to 
protect our citizens from methylmercury in freshwater fish.
  I enjoy fishing and I love eating fish. This legislation is not meant 
to harm the fishing industry--it is meant to help bring the safest fish 
to market for the American consumer. Most importantly, this bill will 
protect pregnant women and young children who may now unknowingly be 
exposed to high levels of mercury. No one can dispute the science that 
tells us mercury is toxic and unsafe at certain levels in fish. We need 
to bring those levels down. But, until we do, we also need to keep the 
food supply safe for all Americans--especially those most at risk.
  We have a responsibility to protect the American public, especially 
our children. Until such time as mercury emissions are drastically 
reduced and seafood is no longer contaminated, we must take this action 
to protect Americans from this dangerous pollutant..
  The American Public Health Association has endorsed this bill.
  I ask unanimous consent that the text of bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows.

                                 S. 555

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Mercury-Safe Seafood Act of 
     2001''.

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) mercury pollution from coal-fired power plants, waste 
     incinerators, and other anthropogenic sources continues to 
     contaminate inland waterways and territorial waters of the 
     United States;
       (2) mercury accumulates in fish as methylmercury and is 
     passed on to humans that eat those fish;
       (3) methylmercury is a potent neurotoxin that, even in 
     small quantities--
       (A) can cause serious damage to the human central nervous 
     system and adverse effects on many other systems in the human 
     body;
       (B) is especially harmful to pregnant women and young 
     children; and
       (C) puts an estimated 60,000 newborns at risk for adverse 
     neurodevelopmental effects each year in the United States 
     from in utero exposure;
       (4) certain commercial seafood species can have dangerously 
     high levels of methylmercury, as evidenced by Food and Drug 
     Administration data acquired in the 1990's, up to the time 
     that the agency discontinued domestic sampling in 1998;
       (5) the Food and Drug Administration's long-standing action 
     level of 1.0 parts per million for methylmercury in fish--
       (A) is out of date; and
       (B) according to scientific evidence, does not adequately 
     protect pregnant women and young children;
       (6) the comprehensive Mercury Study Report to Congress 
     issued by the Environmental Protection Agency in December 
     1997 recommended a methylmercury consumption limit of 0.1 
     micrograms per kilogram of body weight per day, which is 5 
     times lower than the Food and Drug Administration's current 
     action level;
       (7) the report entitled ``Toxicological Effects of 
     Methylmercury'', issued by the National Academy of Sciences 
     in July 2000, confirmed that the Environmental Protection 
     Agency's limit is ``scientifically justifiable for the 
     protection of public health'';
       (8) the report entitled ``Food Safety: Federal Oversight of 
     Seafood Does Not Sufficiently Protect Consumers'', issued by 
     the General Accounting Office in February 2001, highlights 
     the inadequacies of Food and Drug Administration guidance 
     regarding methylmercury in commercial seafood;
       (9) many States have been forced to issue mercury 
     advisories for inland waterways and health warnings regarding 
     the fish that may be caught in those waterways; and
       (10) some States have also issued mercury advisories for 
     commercial seafood.

     SEC. 3. TOLERANCE FOR METHYLMERCURY IN SEAFOOD.

       Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 341 et seq.) is amended--
       (1) in section 402(a)(2), by inserting after ``section 512; 
     or'' the following: ``(D) if it is seafood that bears or 
     contains methylmercury that is unsafe within the meaning of 
     section 406A(a); or''; and
       (2) by inserting after section 406 the following:

[[Page S2411]]

     ``SEC. 406A. TOLERANCE FOR METHYLMERCURY IN SEAFOOD.

       ``(a) In General.--Not later than 1 year after the date of 
     enactment of this section, the Secretary shall by regulation 
     establish a tolerance for the presence of methylmercury in 
     seafood.
       ``(b) Requirements.--The tolerance established under 
     subsection (a) shall--
       ``(1) be based on a scientific analysis of the health risks 
     attributable to methylmercury; and
       ``(2) be set at a level for which the Secretary determines 
     that there is a reasonable certainty that no harm will result 
     from aggregate exposure to methylmercury in seafood, 
     including all anticipated dietary exposures for which there 
     is reliable information.
       ``(c) Seafood Deemed Unsafe.--Any seafood bearing or 
     containing methylmercury shall be deemed to be unsafe for 
     purposes of section 402(a)(2)(D) unless the quantity of 
     methylmercury is within the limits of the tolerance.
       ``(d) Pregnant Women, Infants, and Children.--In 
     establishing or modifying the tolerance under subsection (a), 
     the Secretary shall ensure that there is a reasonable 
     certainty that no harm will result to pregnant women, 
     infants, and children from aggregate exposure to 
     methylmercury.
       ``(e) Sampling System.--
       ``(1) In general.--Not later than 18 months after the date 
     of enactment of this section, the Secretary, after 
     consultation with the Secretary of Agriculture, shall 
     establish a system for the collection and analysis of samples 
     of seafood to determine the extent of compliance with the 
     tolerance under subsection (a).
       ``(2) Monitoring.--The sampling system shall provide 
     statistically valid monitoring (including market-basket 
     studies) with respect to compliance with the tolerance.
       ``(3) Avoidance of duplication of effort.--To the extent 
     practicable, the sampling system shall be consistent with, 
     and shall be coordinated with, other seafood sampling systems 
     that are in use, so as to avoid duplication of effort.
       ``(f) Public Education and Advisory System.--
       ``(1) Public education.--The Secretary, in cooperation with 
     private and public organizations (including cooperative 
     extension services and appropriate State entities) shall 
     design and implement a national public education program 
     regarding the presence of methylmercury in seafood.
       ``(2) Features.--The program shall provide--
       ``(A) information to the public regarding--
       ``(i) Federal standards and good practice requirements; and
       ``(ii) promotion of public awareness, understanding, and 
     acceptance of the standards and requirements;
       ``(B) information to health professionals so that health 
     professionals may improve diagnosis and treatment of mercury-
     related illness and advise individuals whose health 
     conditions place those individuals at particular risk; and
       ``(C) such other information or advice to consumers and 
     other persons as the Secretary determines will promote the 
     purposes of this section.
       ``(3) Health advisories.--The Secretary, in consultation 
     with the Secretary of Agriculture and the Administrator of 
     the Environmental Protection Agency, shall work with the 
     States and other appropriate entities to--
       ``(A) develop and distribute regional and national 
     advisories concerning the presence of methylmercury in 
     seafood;
       ``(B) develop standardized formats for written and 
     broadcast advisories regarding methylmercury in seafood; and
       ``(C) incorporate State and local advisories into the 
     national public education program under paragraph (1).''.

     SEC. 4. CONSIDERATION OF REPORT OF NATIONAL ACADEMY OF 
                   SCIENCES.

       In carrying out section 406A(a) of the Federal Food, Drug, 
     and Cosmetic Act (as added by section 3), the Secretary of 
     Health and Human Services, acting through the Commissioner of 
     Food and Drugs, shall consider the findings of the National 
     Academy of Sciences regarding the Environmental Protection 
     Agency's recommended level for methylmercury exposure and the 
     presence of methylmercury in seafood, as such findings are 
     described in the report issued by the National Academy of 
     Sciences in July 2000.

     SEC. 5. AUTHORIZATION OF APPROPRIATIONS.

       (a) Sampling.--There is authorized to be appropriated to 
     carry out sampling under section 406A(e) of the Federal Food, 
     Drug, and Cosmetic Act (as added by section 3) $500,000 for 
     each of fiscal years 2002 through 2011.
       (b) Public Education and Advisory System.--There is 
     authorized to be appropriated to develop and implement the 
     public education and advisory system under section 406A(f) of 
     the Federal Food, Drug, and Cosmetic Act (as added by section 
     3) $500,000 for each of fiscal years 2002 through 2011.
       (c) State Support.--
       (1) In general.--There is authorized to be appropriated to 
     support efforts of the States to sample noncommercial fish 
     and inland waterways for mercury and to produce State-
     specific health advisories related to mercury $2,000,000 for 
     each of fiscal years 2002 through 2011.
       (2) Equitable distribution.--The Administrator of the 
     Environmental Protection Agency shall distribute amounts made 
     available under paragraph (1) equitably among the States 
     through programs in existence on the date of enactment of 
     this Act.

     SEC. 6. REPORT.

       (a) In General.--Not later than 180 days after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs, 
     shall submit to Congress a report on the progress of the 
     Secretary in establishing the tolerance required by section 
     406A of the Federal Food, Drug, and Cosmetic Act (as added by 
     section 3).
       (b) Contents.--The report shall include a description of 
     the research that has been conducted or reviewed with respect 
     to the tolerance.
                                 ______