Last month, the Food and Drug Administration (“FDA”) proposed changes to four rules enacted under the Food Safety Modernization Act (“FSMA”). These four rules include rules regarding the following topics: (1) produce safety; (2) preventive controls for human food; (3) preventive controls for animal food; and (4) the foreign supplier verification program for importers of food for humans and animals.
According to the FDA, the changes are intended to make the rules “more flexible, practical and targeted,” and were drafted in response to the “unprecedented level of outreach” it received during the comment period. The FDA is accepting comments on the proposed changes until December 15, 2014, but is not accepting additional comments on the original rules.
The FDA has proposed to revise the produce safety rule to include a tiered and more targeted approach for determining the safety of agricultural water. The new approach accounts for natural variations in water sources and sets the frequency of water testing based on the results of prior testing.
The revised rule also proposes to defer key decisions relating to the regulation of manure and compost used in crop production, pending further research on the issue.
Another significant proposed change is to the definition of “covered farms.” The revised rule proposes to define “covered farms” as farms with $25,000 or less in produce sales, compared to the previous definition, which set the threshold based on all food sales, not just produce sales. The effect of this change is to exclude more farms from application of the produce safety rule.
Preventive controls for human food
The FDA has proposed several changes to the rule for preventive controls for human food. The proposed changes include: (1) exempting farms that pack or hold food for other farms from certain requirements; (2) replacing the term “hazard reasonably likely to occur” with the term “significant hazard”; (3) creating an option for suppliers to determine the appropriate verification method after a significant hazard has been identified; and (4) defining a “very small business” as businesses having less than $1 million in total annual human food sales.
The FDA specifically seeks comments on whether the rule should require facilities to conduct product testing and environmental monitoring as part of verifying the implementation and effectiveness of preventive controls for human foods.
Preventive controls for animal food
The FDA has proposed similar changes to the rule for preventive controls for animal food. These changes include creating an option for suppliers to determine the appropriate verification method after a significant hazard, revising the Current Good Manufacturing Practices so that they are more applicable to the animal food industry, and defining a “very small business” as businesses having less than $2.5 million in total annual sales of animal food.
The proposed changes also exempt human food processors that already comply with the FDA’s safety standards for human food from implementing additional preventive controls when supplying byproducts used as animal food. The exemption, however, does not extend to human food processors that further process byproducts for animal food through heating, drying, and pelleting, for example.
Foreign supplier verification programs
Finally, the FDA has proposed to revise the rule for foreign supplier verification programs. The revised rule establishes a more comprehensive system for evaluating the safety of imported food, which includes an expanded list of factors that importers must consider when evaluating food coming into the US. These expanded factors include: (1) the nature of hazards in food; (2) which entity is applying the hazard controls; (3) the procedures, processes, and practices used by the foreign supplier; (4) the applicable US food safety regulations and foreign supplier’s history of complying with those regulations; and (5) the foreign supplier’s food safety performance history.
The revised rule also provides that annual on-site auditing of foreign suppliers would not be required in all circumstances. When exposure to food hazards is unlikely to result in serious adverse health consequences for humans or animals, importers would be allowed to use alternative standards for verification.