The House Energy and Commerce Committee added a requirement that FDA reassess bisphenol A risks before approving a food safety reform bill.

Chairman Henry Waxman, D-Calif., included the BPA requirement in a substitute he introduced for the Food Safety Enhancement Act, H.R. 2749, which the committee approved by voice vote in a June 17 markup.

FDA Commissioner Margaret Hamburg said during an Energy and Commerce Health Subcommittee hearing June 3 that the agency would take another look at BPA in containers (¹ 'The Tan Sheet' June 15, 2009).

However, Waxman agreed with Rep. Ed Markey, D-Mass., to make the assessment a requirement in the bill. FDA must report its findings to the committee, "and if they find a risk, to take appropriate actions to address it," Waxman said.

Members of Congress questioned FDA's conclusion under the Bush administration that BPA, which is used in packaging for some infant formula and food products, is safe, pointing out the agency relied on industry studies.

FDA's Science Board in October 2008 asked the agency to reconsider its finding that current levels of BPA that transfer to foods and are absorbed by children are safe.

The board's request followed a Journal of the American Medical Association study that concluded higher concentrations of BPA in human urine are associated with cardiovascular disease, diabetes and liver-enzyme abnormalities (² 'The Tan Sheet' Nov. 10, 2008).

While the bill still does not clarify whether supplement firms will be subjected to multiple manufacturing standards, it requires food firms to implement hazard analysis and critical control point systems, such as those currently required for some high-risk foods.

Supplement firms already are subject to specific good manufacturing practices, but their products are regulated as food and could be covered by FSEA unless explicitly exempted.

This issue is still "a gray area," Natural Products Association executive Daniel Fabricant said.

However, food science researcher Kathryn Boor said she expects supplement manufacturers could efficiently add HACCP requirements with their current GMPs.

Boor, a professor at Cornell University, spoke during a June 15 food industry briefing on Capitol Hill and later responded in an e-mail to questions about her outlook for food safety reform.

"Having GMPs solidly in place is a requirement for development of a HACCP plan, so it isn't a wasted effort to put them in place, even if HACCP becomes required, at some later point. If you take that point of view, it actually makes some sense," Boor said.

Fee Requirements Changed

Waxman noted the version of the bill sent to the House floor also adds importers to the entities required to pay $500 annual registration fees. Previous versions imposed those fees on food manufacturers and distributors, but not importers (³ Also see "Food Safety Legislation Moves Forward In House With Lower Fees" - Pink Sheet, 15 June, 2009.).

The Energy and Commerce-approved bill also clarifies that FDA would have additional authority to prevent contaminated products from leaving food facilities. The agency "has the authority to require finished product testing at high-risk facilities if FDA finds that such testing or reporting would provide useful information," according to the bill.

The version of H.R. 2749 the Health Subcommittee approved in a June 10 markup was a substitute Chairman Frank Pallone, D-N.J., introduced. Pallone's version lowered the annual registration fees to $500 from $1,000 in Rep. John Dingell's D-Mich., original version.

The approved version also lowered the amount of civil monetary penalties FDA can impose, a key issue for Republican members.

The penalty for an individual in violation of food safety regulations dropped to $20,000 from $100,000 in previous iterations of the bill, and the penalty for other entities linked to a violation dropped to $250,000 from $500,000.

During a June 18 teleconference roundtable with reporters, Hamburg reiterated her support for the bill along with her concern that the funding included would not be enough (⁴ Also see "House Food Safety Price Tag Exceeds Budget Request – Hamburg" - Pink Sheet, 8 June, 2009.).

"I am concerned about having adequate resources to take on the important set of tasks outlined in the legislation," she said, but added that the bill "would give us very important new tools and authorities and a framework for action that will go an enormous way to strengthen our ability to do food safety right," she said.

COOL Toned Down

Country-of-origin labeling requirements remain in the bill, but in less burdensome form than previously proposed. H.R. 2749 requires firms to include only where a product was finished on the label, instead of listing the origin of each ingredient.

Sen. Dick Durbin's Food Safety Modernization Act, S. 510, the chamber's likely vehicle for food safety reform, does not include a COOL provision (⁵ Also see "Durbin Food Safety Bill Emphasizes Targeted Fees, Industry Responsibility" - Pink Sheet, 9 March, 2009.).

The Illinois Democrat's bill, which remains in committee, includes requirements similar to those in H.R. 2479, but would impose only targeted user fees rather than registration fees.

Fabricant said FSEA may "move rapidly in the House," but added it appears the Senate will prioritize health care reform over food safety.

Energy and Commerce members called on the Senate to act on complementary legislation, but no companion bill has been introduced in the Senate.

Separately, Sens. Amy Klobuchar, D-Minn., and Saxby Chambliss, R-Ga., June 17 introduced the Food Safety Rapid Response Act, S. 1269, to direct the Centers for Disease Control and Prevention to improve analysis, collection, reporting and the use of data among regulators and stakeholders. They say the bill is a complement to S. 510.

- Katie Stevenson (k.stevenson@elsevier.com)

BPA Study Added To Food Safety Bill, But Supplements Remain “Gray Area”

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