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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.

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