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Section 13: Attacking the FDA

It has come to our attention that both the Food and Drug Administration (FDA) and the National Marine Fisheries Service (NMFS) have submitted comments to the EPA critical of the scientific methodology in the EPA’s [draft] report. The FDA, which has federal statutory authority to ensure seafood safety, stated in a letter to the EPA dated February 16th that “the serious public misunderstanding about the safety of seafood which could result from the issuance of this report in its current form would be a disservice to the public and could lead to a further loss of confidence in government.
- U.S. Senate letter to EPA, March 14, 1996

Chicago Tribune:

During these years, the FDA did virtually nothing to warn people of the mercury threat. Nor did the agency test any fish for mercury throughout the 1980s, according to FDA data. The agency also conducted little basic research, such as studies to determine which fish have the most mercury or whether there were high-mercury "hot spots" in the oceans that fishing boats should avoid. It took a sharply critical 1991 report from the National Academy of Sciences, the nation's leading scientific advisory body, to coax the FDA to resume significant testing of fish for mercury. The agency promised several times during the 1990s to re-evaluate its mercury limit in fish. But the FDA never changed it, even though other government scientists were concluding the metal was far more harmful than previously thought. Once again, an important calculation--this one aimed at determining how much mercury can be safely consumed--was at the center of a debate. In 1997 the EPA, the agency responsible for monitoring recreationally caught fish, recommended a mercury-exposure limit in people based on the most recent scientific studies about the health risks. The EPA took a far stricter approach than the FDA did in setting its safety standard for mercury, concluding that a person could safely ingest only 0.1 grams of mercury per kilogram of body weight each day. The FDA's equivalent was 0.4. (December 12, 2005)

Response:

More Confusion

Again, CT appears confused.

The level should be 0.1 micro-grams, an amount one million times smaller than CT reported. Such a numerical error is equivalent to suggesting that a woman of childbearing age with an average body weight of 161 lbs could “safely” consume up to 375,000 lbs of canned albacore tuna (mean mercury level of 0.3 ppm) per week. The numerically correct consumption rate would be no more than 6 oz. for an exposure level below EPA’s highly restrictive guidelines.

More seriously, CT fails to emphasize that EPA’s “safety” standard is drawn from a Faroe Islands study concerned with consumption of whale meat and fat, not fish (see Sec. 1 and 7).

Pilot whale meat in the Faroes catches has highly elevated concentrations of MeHg. Pilot whale fat, or blubber, also consumed by Faroese mothers, contains a mixture of toxic chemicals including PCBs and DDT. It has been estimated that Faroese infants may have been exposed to PCB levels exceeding EPA standard by 600 times. This is why, contrary to popular belief, the basis for EPA's mercury standard is viewed as highly flawed and certainly neither directly applicable nor appropriate for fish-consumption standards in Chicago or anywhere else in the U.S.

From the beginning, it has not been universally accepted that EPA used the “best” or most recent science in forging its “safety” standard (see Sec. 1, 2 and 7).

A letter from the Senate

As another example, in the year prior to issuing the recommendations referred to by CT, EPA received a stern letter from the U.S. Senate expressing not only concerns over EPA’s “scientific methodology,” but also its by-passing normal procedures for guarding against “crucial errors.” The letter intimates deep concerns among other federal agencies that the Browner/Clinton EPA might itself be posing a public health risk; concerns which have proved prophetic. Here are excerpts from the March 14, 1996 Senate letter:

It has come to our attention that both the Food and Drug Administration (FDA) and the National Marine Fisheries Service (NMFS) have submitted comments to the EPA critical of the scientific methodology in the EPA’s [draft] report. The FDA, which has federal statutory authority to ensure seafood safety, stated in a letter to the EPA dated February 16th that “the serious public misunderstanding about the safety of seafood which could result from the issuance of this report in its current form would be a disservice to the public and could lead to a further loss of confidence in government.” [Specifically, EPA]

Similarly, NMFS also wrote to the OMB in a letter dated November 28, 1995, that “the public may become unduly alarmed and perceive the report as recommending against the consumption of fish.” We believe it is inappropriate to issue a report which could do great harm to the domestic seafood industry without resolving the concerns of these agencies and incorporating the Seychelles and Faroe Islands studies.

We share a final concern that the agency has not submitted this congressionally mandated report to its Scientific Advisory Board (SAB) for review prior to release. In the past, the SAB has been crucial identifying errors before publication. We believe it is critical that the mercury study be fully reviewed by the SAB, from a scientific standpoint, and to ensure that the report is based on the best available peer-reviewed science.

We urge you to delay sections of this report which address seafood safety until the report incorporates the Seychelles and Faroe Island studies, fully addresses the concerns of other agencies, and is reviewed by the SAB. The accuracy and careful analysis of this scientific information greatly outweighs a premature release of these sections of the report. [Emphasis added]

Sincerely,

[Signed]

Murkowski (R-AK), Stevens (R-AK), Hollings (D-SC), Kerry (D-MA), Breaux (D-LA), Inouye (D-HI), Snowe (R-ME), Cohen (D-ME), Johnston (D-LA), McConnell (R-KY), Lott (R-MS), Mack (R-FL)

To our knowledge, EPA never did submit its draft to the SAB for review. Its “incorporation” of the far more appropriate Seychelles findings, contradictive of the Faroe data, consisted solely in discounting them.
 
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