Food Safety Bills’ “Belt And Suspenders” Approach Is Costly – Trade Groups

Dietary supplement industry representatives are keeping an eye on burdensome requirements in two food safety bills working their way through Congress, including standards that potentially overlap or supersede GMPs.

The House Energy and Commerce Committee issued a draft of the Food Safety Enhancement Act of 2009 May 26. Sen. Dick Durbin, D-Ill., introduced the FDA Food Safety Modernization Act, S. 510, in March (¹ (Also see "Durbin Food Safety Bill Emphasizes Targeted Fees, Industry Responsibility" - Pink Sheet, 9 Mar, 2009.), p. 6).

Alongside issues such as mandatory recall authority for FDA, country of origin labeling and creating a fair fee system, one core concern for stakeholders in both bills is maintaining the primacy of FDA's good manufacturing practices for supplements.

In particular, they want to ensure any final law does not allow Hazard Analysis and Critical Control Point standards to supersede GMPs or create a redundant layer of requirements.

HACCP currently applies to high-risk conventional foods regulated by the Department of Agriculture like meat and poultry, and to juice and seafood under FDA. It requires producers to identify hazards and develop plans to prevent them.

Neither piece of legislation specifies that GMPs "remain the overarching principles" for supplement manufacturers, said Natural Products Association VP of Scientific and Regulatory Affairs Daniel Fabricant.

While neither the Senate bill nor the House draft refers specifically to supplements, former FDA Chief Counsel Peter Barton Hutt, an attorney at Washington-based Covington & Burling, notes supplements are "subject to all food provisions unless specifically exempt."

Fabricant said, "Even though we are not spelled out [in the bill], in a lot of ways it affects us." For example, the draft discusses "fishery products and it's understood that fish oil is a fishery product."

But leaving supplements largely undefined could confuse firms as to which standards to follow, he said.

Fabricant said the "biggest point" NPA will make to lawmakers will be to clarify in the legislation that the HACCP approach, currently included in both the House draft and S. 510 should not replace the supplement GMPs. NPA would like the bill to state that supplement firms have GMPs and their own adverse event reporting system, he said.

Council for Responsible Nutrition President Steve Mister agrees. "We'd like to have something that says that where the GMPs are already in place, that that will trump the HACCP requirements and you don't have to comply with both."

Mister noted HACCP is a safety standard, whereas GMPs ensure both safety and quality and are more rigorous than HACCP alone.

He said having both HACCP and GMPs would create "conflicting standards" and would be costly and unnecessary. "Belts and suspenders do the same thing," he said. "But to have both would cost more money."

CRN VP of Scientific and Regulatory Affairs Andrew Shao said he hopes that FDA will to prevent redundant standards even without explicit mention.

"The good news could be the extent that the legislation mentions or gives the secretary of HHS discretion to undertake rulemaking," Shao said. FDA "hopefully would step in and separate out dietary supplements that have the new ... GMPs, which FDA itself has said repeatedly are actually better and more stringent than HACCP."

Marc Ullman, a partner at New York-based Ullman, Shapiro & Ullman, said supplement GMPs are "much more rigorous than anything in place for food."

Since supplement firms are in the second year of the three-year GMP compliance phase-in, Ullman said, "It would not seem to make very much sense to scrap that system" before it is even completely underway.

Ben England, a food and drug attorney and former regulatory counsel in FDA's Office of Regulatory Affairs, said he expects supplements will ultimately be exempt from HACCP.

However, "FDA might build a Hazard Analysis requirement in for all dietary supplement products, and if the dietary supplement GMP program in any given facility controls the potential hazards identified in the analysis, then the new GMP program will be sufficient to meet the HACCP and GMP standards," he said.

He noted ingredient manufacturers, who are not required to comply with supplement GMPs, would be required to follow HACCP under both bills.

What Fee Structure Works?

User fee requirements differ significantly between the House draft and Durbin's Senate bill, but both draw some objections.

The Senate bill generates funding for FDA's food safety enforcement through targeted re-inspection fees, but the House draft requires $1,000 annual registration fees, recall and re-inspection fees and fees for domestic firms requesting export certificates for exports.

Durbin says bipartisan support in the Senate depends on not including general user fees.

Calling the re-inspection fees proposed in S. 510 a "cause and effect system," Fabricant said it is "more reasonable in comparison" to the House draft, "especially now with the budget crunch."

"Paying on inspections is a bit more pay-for-play and I think folks will have an easier time swallowing something like that," Fabricant said.

Mister said CRN understands the industry would have to "kick in" some funding. The association has a board meeting next week to discuss the fees and what CRN will and will not support.

He said depending on how much the registration fees are, CRN would "likely accept" the provision.

Mister said CRN would like to see fees proportional to firm size, as well as assurance that funds generated from supplement firms will be used for that industry.

In contrast to NPA's view, Mister said re-inspection fees are of concern, but CRN will not necessarily oppose them. He said there is no assurance that FDA will not be encouraged to re-inspect facilities to generate additional funds.

COOL Provisions Uncool For Industry

The House draft includes country of origin labeling provisions, while Durbin's bill does not.

Fabricant noted implementing COOL would be difficult and confusing for supplement firms. Products often contain many ingredients, and manufacturers may source from one country one week and another the next. "I don't know how reasonable or responsible it is" to have COOL, he said, noting the benefit to a consumer is questionable.

"I think it is important to have it with produce because that's where we've seen the issues, but with manufactured goods I think you'll see more label than product," he added. "And that cost will get passed on to the consumer and right now, I don't think that would be in everyone's best interest."

Mister said the draft notes that for processed food, COOL can be displayed on the Web site, calling it "an improvement" from requiring it on the labels.

However, he said, "it still creates a logistical issue" for firms that source from numerous companies and countries. COOL feeds "consumers who are very xenophobic," rather than give them information on "the quality of the ingredients."

Further Concerns

Mister said one concern in the House draft is that third-party certification applies only to plants outside the U.S. While CRN would not "throw ourselves on our sword" over this issue, he said the group wants certification also to apply to domestic firms.

Mandatory recall authority for FDA is included in the Senate and House proposals. Ullman said that section should be expanded to provide firms recourse, should the FDA recall a product improperly, for example, on the basis of a false-positive test.

"If we are going to look at formalizing this authority, the question of, 'What if the agency is wrong?' deserves some discussion."

NPA is concerned about the draft's language on small businesses, which make up most of the industry. While the draft would give small firms additional time for compliance, Fabricant said defining a small business is left to the secretary of HHS. That is not necessary because the Office of Management and Budget already defines business sizes, he said.

An Energy and Commerce subcommittee is scheduled to discuss the draft June 3. A markup of the legislation is expected the following week.

The House draft is "largely based" on the food provisions from the FDA Globalization Act of 2009, a more comprehensive bill covering the regulation of drugs and food, a committee release says. Energy and Commerce Democrats introduced FDAGA in January (² (Also see "Salmonella Problem Stirs Food Safety Bills, Hearing From Energy & Commerce" - Pink Sheet, 2 Feb, 2009.), p. 6).

- Katie Stevenson ([email protected])