FDA allows additional time on complex FSMA compliance issues

By Aerin Einstein-Curtis contact

- Last updated on GMT

© iStock/Thisisdavid88
© iStock/Thisisdavid88

Related tags: Food

The US Food and Drug Administration (FDA) has ushered in an enforcement discretion period for some feed producing entities in relation to FSMA provisions.

The US Grain and Feed Association (NGFA) says it appreciates the ruling regarding some aspects the Food Safety Modernization Act (FSMA).

“FDA’s announced policy allows additional time to work through a variety of complex compliance nuances.”

The US watchdog's decision was announced​ last Thursday (January 4). The goal is to address challenges the legislation brings to certain sectors while more permanent fixes are found.

The FDA said it is planning to not enforce some provisions of FSMA - Current Good Manufacturing Practice (CGMP), Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Rule - as they would apply to certain entities:

  • Facilities that would be farms except for certain factors and activities,
  • Written assurances provisions in all four rules related to the control of identified hazards or microorganisms that are a potential risk to public health
  • The animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and
  • FSVP requirements for importers of food contact substances.

The NGFA, in a statement sent to us, said it was looking forward to working with FDA, in this respect, on areas such as the characterization of certain raw agricultural commodities like dry beans and peas, the packing of grain, and written hazard disclosure and assurance requirements under the preventive control provisions.

In December, we spoke to David Fairfield, senior vice president of feed services, NGFA, regarding particular sections of the FSMA the trade group found worrisome. 

“As an association that represents grain handlers, we would like the FDA to take another look at those [areas] that should apply to grain elevators,”​ he said then.

Some of the Current Good Manufacturing Practices (CGMPs) and preventive controls outlined in FSMA are being applied in an inconsistent manner when it comes to grain operations, and are creating economic burdens for that sector, he added. 

Scott Gottlieb, FDA commissioner, said that the agency remains committed to ensuring that the food supply remains safe.

“While we’ve been setting in place the public health gains envisioned as part of FSMA by issuing new standards for food safety, we recognize that such a fundamental change in our food safety approach may require adjustments along the way to address issues that had not been previously anticipated,”​ he said. “We value the feedback we’ve received on the new rules and understand manufacturers, farmers and other stakeholders have faced certain challenges as they work to implement the new rules.”

Details  

Farms have been exempt from requirements for preventive controls and CGMPs rules, as per the FDA's guidance document​ on the enforcement discretion rule. Some entities not considered farms, though they use similar practices, have been subject to the preventive control and CGMP requirements.

The FDA said it intends to exercise enforcement discretion for the requirements in the PC rules for these specific entities and activities until the completion of a future rulemaking related to farm activities.

“The agency intends to initiate a rulemaking that could change the way the requirements in the PC rules apply to facilities that conduct activities similar to those that occur on farms, as farms are currently defined​. 

Such facilities would include:

  • Those that would qualify as secondary activity farms if facility ownership were different;
  • Facilities that would be considered farms if they did not color raw agricultural commodities (RAC);
  • Mixed-type facilities that make silage for animal feed; and
  • Facilities that would be considered secondary activity farms but “they pack, package, label, and/or hold processed food that consists only of RACs that have been dried/dehydrated to create a distinct commodity.

Under review is the use of written assurances or “customer provisions”​ in the PC animal food rule for those businesses, the agency said.  

“The agency intends to exercise enforcement discretion for the written assurance requirements, while it considers rulemaking that takes into consideration the complexity of supply chain relationships and the resources required to meet the current requirements of these provisions,”​ the FDA said.

Additionally, the resolution covers processors of food by-products for feed.

“Human food facilities that are subject to and in compliance with the human food CGMPs and FDA’s other food safety requirements, and that do not further manufacture/process their human food by-products once the by-products have been separated for use as animal food are only subject to a limited holding and distribution CGMP for their by-products,” ​the agency said. 

“Human food facilities that are subject to the PC Human Food rule that do further manufacture/process their human food by-products after they separate them for use as animal food are subject to all of the requirements in the PC Animal Food rule, unless an exemption applies. However, these facilities have the choice of complying with the PC and CGMP requirements in either the PC Human Food or Animal Food rules.”

The FDA said, since issuing its 2016 guidance on human food by-products for use as animal food, it has become aware of certain concerns over whether preventive controls requirements applied to certain activities performed on human food by-products for use as animal food before they are stored or transported and which do not affect their safety profile.

The agency, thus, said it intends to exercise enforcement discretion for the following activities:

  • Drying/dehydrating, evaporating, pressing, chopping and similar activities to reduce weight, bulk, or volume and/or
  • Mixing, centrifuging, and similar activities to combine ingredients or separate components.

 

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