The Food and Drug Administration in September released revisions to four proposed rules for implementing portions of the Food Safety Modernization Act (FSMA). The updates, which cover preventive controls for human food, preventive controls for animal food, foreign supplier verification programs and produce safety, reflect significant changes requested by IDFA and others in the food industry.
On Monday, IDFA submitted comments for each proposed rule, except produce safety, supporting many of FDA’s changes and requesting additional revisions that would make the final requirements consistently systems-based and risk-based.
For preventive controls for human food, perhaps the most important change for IDFA members is FDA’s flexibility with regard to environmental and finished-product testing for pathogens. The proposed rule would allow each facility to determine how best to conduct product testing and environmental monitoring to verify the implementation and effectiveness of the facility’s preventive controls.
“We endorse that approach and encourage FDA to provide equal clarity of that position in the codified section of the regulations,” the comments said.
IDFA also reiterated the value of the current cooperative federal and state food safety regulatory system covering Grade “A” milk and milk products and the need to avoid adding duplicative requirements.
“The Pasteurized Milk Ordinance (PMO), as administered by the National Conference on Interstate Milk Shipments (NCIMS) and inspected by state regulatory agencies, is the appropriate regulatory umbrella for these products,” the comments said. “Although we recognize that FDA did not address this issue in the supplemental proposed rule, we encourage FDA to work collaboratively with the NCIMS to achieve this result and address it in the final rule.”
IDFA suggested several ways to promote additional clarity and flexibility in the rule, including:
- Ensure preventative control components are risk-based and allow for flexibility when applied to a specific preventative control;
- Permit facilities to use risk-based and tailored testing requirements to validate a specific preventative control;
- Provide flexibility in supplier verification requirements; and
- Postpone proposing requirements for economically motivated adulterations to allow for implementation of the major provisions of FSMA.
Read IDFA’s “Preventive Controls for Human Food” comments here.
Food for Animals
Regarding preventive controls for animal foods, IDFA noted with appreciation that FDA made changes that recognize the low food-safety risk posed by human food by-products in animal foods. In the comments, IDFA requested minor modifications, including:
- Clarify that the holding and distribution practices prescribed should be tailored to the intended use of the product, which is as animal food, not human food;
- Clarify that “further processing” excludes activities that are incidental to holding and distributing human food by-products; and
- Update the compliance policy guides addressing the diversion of adulterated or contaminated human food to animal food.
Read the “Preventive Controls for Foods for Animals” comments here.
Foreign Supplier Verification Programs
In the comments about the proposed rule for foreign supplier verification programs, IDFA noted that significant revisions made in response to industry comments helped to make the proposed rule more risk-based and flexible. Still, IDFA said additional changes are necessary for the rule to better align with existing company practices and to accommodate the many ways to implement supplier verification activities.
Saying greater flexibility is needed to account for the diversity and complexity of the food supply chain, IDFA suggested several ways to make the rules more workable, including:
- Remove the annual documentation requirement for hazards controlled by an importer’s customers;
- Exempt intra-company shipments from supplier verification requirements;
- Focus on verifying shippers’ overall food safety system, not just verifying discrete hazard controls; and
- Allow for corporate-level supplier verification programs.
Read the “Foreign Supplier Verification Programs” comments here.
The deadline for submitting public comments to FDA was December 15. FDA will consider all comments before issuing final rules in 2015.
Read the proposed revisions to the FSMA proposed rules:
For more information, contact John Allan, IDFA vice president of regulatory affairs and international standards, at email@example.com.