FSMA rules: Where from here?

FSMA rules: Where from here?

FDA continues to sort through comments on new food safety rule and plans to re-propose several important components later this year.

THE Food & Drug Administration is in the middle of finalizing a massive overhaul of the food system that's required under the Food Safety Modernization Act (FSMA).

Where animal agriculture is concerned, FDA is expected to reopen many components of the rule to allow further comments on certain provisions.

Leah Wilkinson, director of ingredients, pet food and state affairs for the American Feed Industry Assn. (AFIA), said FDA has been very open with the industry to date as far as answering questions and creating opportunities to get the regulations right.

She noted that FDA is looking to the industry to be the first line of compliance and, with that in mind, has been very open to making sure the industry understands the regulations in order to create a workable final rule.

"If it has the right language implemented, it ultimately will produce an even safer product than we do today," Wilkinson said.

As such, FDA has indicated that it will reopen the produce, human food and animal feed portions of FSMA for comment.

Dave Fairfield, National Grain & Feed Assn. (NGFA) vice president of feed services, said he anticipates that FDA will seek comments on certain aspects of the human food rule later this summer, potentially in August.

The agency likely would provide a 60-day comment period for this second round (Table).

One of the major industry concerns with the human food rule is the proposed definition of "holding." Groups have asked FDA to revise the definition to give facilities that store grains and oilseeds a clear exemption from the proposed requirements, and Fairfield said FDA has heard that message and likely will provide an exemption for facilities such as grain elevators.

Another area FDA will likely reopen for comment is on hazards reasonably likely to occur under the animal feed rule. There has been some concern that the current proposal calls for a full hazard analysis and critical control point (HACCP) plan, which is not what Congress intended. A HACCP framework would require certain activities and recordkeeping.

Fairfield said FDA may re-propose some of the rule's language to better describe the scope of requirements that will apply to food safety hazards.

Trade groups had called on FDA to significantly modify its proposed requirements for current good manufacturing practices (CGMPs) so they are clearly and appropriately delineated from those established for human food.

Wilkinson said AFIA at first didn't believe the agency would re-propose this section, but now that appears more likely, and it would be good for the industry to have another look at what FDA would require of it.

The human food industry has had decades to adjust to and make language workable in GMP regulations. While CGMPs have been in place for medicated feed, this will be the first time a regulation has mandated CGMPs for non-medicated animal feed and pet food companies.

Both AFIA and NGFA also expect a proposal for the domestic supplier verification program when the rules are reopened for comments.


Preparing now

NGFA and AFIA are already working to encourage their members to lay a foundation for when the final FSMA rules are implemented.

Courts have ruled that FDA must release the final animal feed rule no later than Aug. 30, 2015. Larger firms would have one year to comply, and tiered phase-ins would give medium to small companies two to three years to comply.

AFIA is hosting three FSMA regional seminars this summer, titled "Phase 1: Building a Foundation for Compliance," in Des Moines, Iowa; Atlanta, Ga., and Sacramento, Cal.

Wilkinson and Fairfield said an important step to prepare for FSMA now is to make sure to have the right documentation and paperwork.

"If you can better formalize your practices and document what you're doing, you'll be in a better place," Fairfield said. "It is clear that regulations are going to require more records. Inspections will rely more on reviewing documentation. Companies can formalize procedures and verify procedures in place now."


Deadlines for Food Safety Modernization Act rules




Publication of

Close of



proposed rule

comment period

final rule

Produce Rule

Jan. 16, 2013

Nov. 22, 2013

Oct. 31, 2015

CGMPs & Preventive Controls-Human Food

Jan. 16, 2013

Nov. 22, 2013

Aug. 30, 2015

Foreign Supplier Verification Programs

July 29, 2013

Jan. 27, 2014

Oct. 31, 2015

Accreditation of Third-Party Auditors




CGMPs & Preventive Controls-Animal Feed & Pet Food

Oct. 29, 2013

March 31, 2014

Aug. 30, 2015

Food Defense/Intentional Adulteration

Dec. 24, 2013

June 30, 2014

May 31, 2016

Sanitary Transportation of Food/Feed

Feb. 5, 2014

July 30, 2014

March 31, 2016

Source: National Grain & Feed Assn.


Volume:86 Issue:26

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