F.D.A. revises four proposed food safety rules

by Jay Sjerven
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The Food and Drug Administration on Sept. 29 published in the Federal Register revisions to four proposed rules implementing the F.D.A. Food Safety and Modernization Act, including the rules on produce safety, preventive controls for human food, preventive controls for animal feed, and the foreign supplier verification program. The F.D.A. said the revisions to the proposed rules were made in response to stakeholder comments and aimed to make each rule more flexible and targeted. While all of the proposed rules and the announced revisions affect the food industry, most attention was directed to the rule on preventive controls for human food.

The Federal Register indicated comments on the rules’ revisions would be accepted until Dec. 15. The F.D.A. said that comments must relate to the proposed revisions. No further comments related to the four underlying proposed rules would be accepted as the comment periods for the proposed rules already expired. Comments on the proposed rules and the announced revisions will be considered together as the F.D.A. crafts final rules to be issued in 2015.

“Based on valuable input from farmers, consumers, the food industry and academic experts, the F.D.A. is proposing to update these four proposed rules to ensure a more flexible and targeted means to ensure food safety,” said Michael R. Taylor, F.D.A. deputy commissioner for foods and veterinary medicine.

There are five key revisions to the proposed rule on preventive controls for human food. The first related to the farm level. The F.D.A. proposed that a farm would no longer be required to register as a food facility merely because it packs or holds raw agricultural commodities grown on another farm under a different ownership. The F.D.A. proposed to define such packing and holding activities as traditional farming activities. In general, on-farm packing and holding of produce would be subject to the proposed produce safety rule, not the human food preventive controls rule. At the same time, farms that conduct additional processing or manufacturing may be subject to preventive controls rule for those activities.

Second, the F.D.A. proposed to define a “very small business” as a firm having less than $1 million in total annual sales of human food, adjusted for inflation.

The third proposed revision would establish procedures to guide the F.D.A. in withdrawing an exemption for a qualified facility for food safety reasons. The F.D.A. first may consider alternatives to protect public health and would provide advance notification to the facility and an opportunity for the facility to respond. The revisions also provided procedures for reinstating a withdrawn exemption.

The fourth revision addressed product testing, environmental monitoring and supplier controls. The F.D.A. noted the preamble to the proposed rule made reference to these potential provisions although they were not included in the regulatory text.

Specifically, the F.D.A. sought comment on whether the preventive controls for human food should require a facility, as appropriate to the facility, the food, and the nature of the preventive control, to conduct product testing to verify implementation and effectiveness of preventive controls. The agency also sought comment on whether the rule should require a facility to conduct environmental monitoring to verify implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard.

The F.D.A. further proposed supplier controls when the 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 F.D.A. said if these provisions were to be included in the final rule, the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing) unless there was reasonable probability that exposure to the hazard would result in serious adverse health consequences or death.

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.

The fifth revision to the proposed rule involved the agency asking for comment on whether a facility should be required to address hazards that may be intentionally introduced for purposes of economic gain as part of its hazard analysis.

David Acheson, founder and chief executive officer of The Acheson Group, commented, “Much of what is in the re-proposals was expected, but there are few surprises in these documents. At the same time, there is generally increased clarity around what a facility will need to do in order to comply, although in some instances, F.D.A.’s move toward providing increased flexibility might be viewed as providing increased ambiguity.”

Dr. Acheson pointed to the revisions’ testing requirements, which he said raised the questions, “When is ingredient testing appropriate, and when is finished product testing required? It appears that ingredient testing is an option to verify suppliers whom you are relying on to control hazards. But how do you know if that is the best option to manage the risk? F.D.A. leaves that determination up to each facility.”

He noted that similarly, the F.D.A. proposed that finished product testing may be used as a verification tool to demonstrate that the food safety plan is working.

“When should finished product testing be conducted? F.D.A. says ‘as appropriate to the facility, the food, and the nature of the preventive control.’ At this stage of thinking about this new part of preventive control rules, we are seeing the finished product testing provision as one that is not a mandate,” Dr. Acheson observed. “It is likely that the F.D.A. was between a ‘rock and a hard place’ on finished product testing. Many non-governmental organizations are strong advocates for it, but many food safety experts recognize that it is not a cost effective way to ensure safe food. Worse, resources devoted to finished product testing would be resources that could be used for preventive controls. We were interested to see that in the cost calculations, F.D.A. estimated that only 319 facilities would need to develop a finished product testing plan. We sincerely hope that F.D.A. does not expect the majority of the food industry to look for that ‘needle in a haystack’ since the successful implementation of preventive controls should make it increasingly difficult to find that needle.

“The agency has not proposed to specify the appropriate frequency of testing, sampling strategy, or test method. While we agree that it would be inappropriate for F.D.A. to be prescriptive, we have found that in some cases, the industry lacks the knowledge and understanding to properly implement testing.”

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