Revised FSMA Proposed Rules Address Stakeholder Concerns


The Food and Drug Administration’s supplemental texts for four proposed rules that would implement provisions of the Food Safety Modernization Act (FSMA), published September 29 in the Federal Register, address numerous concerns raised by stakeholders. The agency, for example, changed its thinking on significant issues in response to comments on the proposed rule for Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food.

Under the new proposal, for example, a farm would not be required to register as a food facility just because it packs or holds raw agricultural commodities grown on another farm under a different ownership. In addition, on-farm packing and holding of produce would be subject to the proposed produce safety rule, not the human food preventive controls rule. However, farms that conduct additional processing or manufacturing may be subject to preventive controls rules for those activities, the agency says.

In another policy shift, FDA proposes to exempt distribution centers from the requirement to conduct hazard analyses and supplier verifications.

FDA now proposes to define a “very small business” as one having less than $1 million in total annual sales of human food. Previously, the agency had proposed three options: annual sales of $250,000, $500,000, and $1 million. The new proposed definition would exempt less than 1 percent of the dollar value of food produced in the United States, the agency says.

Under the new proposal, very small businesses would have three years after publication of the final rule to comply. Very small business would be categorized as “qualified facilities,” and would be subject to modified preventive control requirements. Small businesses, defined as those with fewer than 500 persons would have two years after publication of the final rule to comply, unless they qualify for an exemption. All other businesses would have to comply with the final rule one year after its publication.

FDA is seeking comment on whether the preventive controls for human food rule should require a facility, in certain circumstances, to conduct product testing and environmental monitoring to verify preventive controls – if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard, for example.

Supplier controls are proposed when a receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier, the agency says. In such situations, the facility would have the flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing) unless there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans, FDA says.

In that instance, an annual onsite audit of the supplier would be required unless the facility can show that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazards are controlled.

In addition, the agency is inviting comment on whether a facility should be required to address, as part of its hazard analysis, hazards that may be intentionally introduced for purposes of economic gain as part of its hazard analysis.

The agency is inviting comment through Dec. 15, 2014 on just the newly proposed changes in the supplemental text and is planning to hold a public meeting on the revised proposals on Thursday, November, 13, 2014 in College Park, Md.

Expediting FDA Approval of Sunscreen Ingredients

By EAS Senior Consultant, Norma Skolnik

Eight new sunscreen active ingredients have been awaiting approval—or any sort of decision—from the FDA for at least 12 years, with the last over-the-counter sunscreen ingredient approved by the agency in the 1990s. Meanwhile, some of these sunscreen ingredients have been available in Europe, Asia, or Latin America for more than 15 years.

However, the 12-year backlog may soon be ending. On July 28, the House of Representatives passed a bill, HR 4250, known as the Sunscreen Innovation Act, to expedite the FDA’s approval process for sunscreen ingredients. The Sunscreen Innovation Act passed by a voice vote just before Congress left for their August recess. The bill is expected to be taken up by the Senate in the near future.

The legislation aims to improve on FDA’s latest attempt to make new OTC active ingredients more available—a 2002 procedural change from the FDA that the agency hoped would speed up its approval process. In 2002 the agency created a new process, called the Time and Extent Application (TEA), to give an alternate pathway for over the counter drug ingredients to be approved. Since then, eight sunscreen ingredients have been submitted for review under that process; none has yet been approved.

Without a single ingredient being approved since then, Rep. Ed Whitfield (R-KY) and John Dingell (D-MI) introduced HR 4250, the Sunscreen Innovation Act. HR 4250 sets up a system under which sunscreen active ingredients that have been marketed continuously for at least 5 years in another country and that meet certain other conditions, would be eligible for review by an FDA advisory committee. After the advisory committee issues a recommendation, FDA would have 45 days to affirm or deny the recommendation. If FDA didn’t deny an approval recommendation within 45 days, the sunscreen would automatically be approved as generally recognized as safe and effective. The bill also provides an appeals process for situations in which the sponsoring company disagrees with the FDA determination.

The Sunscreen Innovation Act not only would institute a timeline for review, it would no longer require the FDA to issue a regulation every time it wants to approve an active ingredient. The bill requires final decisions on pending applications within 300 days for new requests and a shorter timeframe for requests that were pending before enactment of the law. Under current law, if an ingredient is on the market in another country for five years, it may go through a process to be determined eligible by the FDA. FDA’s advisory committee of experts weighs in on the safety and effectiveness of the product, and the agency then makes the final determination as to whether the ingredient is approved. However, there’s currently no timeline for review or decision making.

The Sunscreen Innovation Act also directs the Comptroller General of the Governmental Accountability Office (GAO) to report on the progress of the Secretary of HHS in establishing this new process and the role of the FDA Commissioner in issuing determinations on pending sunscreen active ingredient requests. It requires the HHS Secretary to report on decisions made about the safety and efficacy of sunscreen active ingredients, the amount of time between submission and decision for each request, the cost of the review process, and recommended improvements to the review process.

Prior to passage of the bill, an FDA spokesperson said that the agency has “prioritized reviewing the safety and effectiveness of additional sunscreen ingredients as quickly as possible given the agency’s resources.”

FDA recently issued feedback letters about two sunscreen ingredients. Both asked for more data to prove the ingredients are generally recognized as safe and effective. Andrea Fischer, a spokeswoman for the FDA, said that “the FDA will issue responses to the safety and efficacy data submitted for each ingredient in the near future. We are committed to completing the TEA process for the sunscreen active ingredients currently under review as quickly as possible, consistent with available agency resources and competing public health priorities.”

It remains to be seen if the Senate will pass this act and if passage of the act could set a precedent for expediting the approval process for other categories of OTC active ingredients.