FDA Extends Some FSMA Compliance Dates

The United States (US) Food and Drug Administration (FDA) continues to move forward implementing the Food Safety Modernization Act (FSMA). The first major compliance date was September 19, 2016, for large food facilities (more than 500 employees).

However, the agency issued a final rule on August 23, 2016, that extends the compliance dates by two years for providing customer assurances when controls are applied downstream in the distribution chain in four regulatory rules, including for animal food. These changes are part of the FDA’s continuing efforts to make the rules as practical as possible while still protecting public health. This final rule addresses technical issues and better aligns compliance dates across the four rules.

The changes to the final rule impact the compliance dates for certain provisions in these four rules: the two current good manufacturing practice (CGMP) and preventive control rules for human and animal food, foreign supplier verification program, and produce safety.

The changes provide more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions that align compliance dates for various other food operations or provide time for FDA to resolve specified issues.

Compliance dates for animal food producers for these provisions are now changed as follows:

• Small business (a business, including any subsidiaries and affiliates, employing fewer than 500 full-time equivalent employees): original date – September 17, 2018; extended date – September 17, 2020.

• A business that is neither small nor very small (having less than $2.5 million in total annual sales of animal food, adjusted for inflation): original date – September 18, 2017; extended date – September 18, 2019.

The extra two years will allow FDA to develop guidance on how to conduct these assurances efficiently to avoid the expense of excessive letters being sent back and forth to conduct routine business.

According to the National Renderers Association, the original compliance dates were making it challenging to meet paperwork requirements, including:

• documentation provided by the manufacturer/processor to its direct customer that the food is “not processed to control identified hazard”;

• written assurance provided by the customer to the manufacturer/processor that the customer is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements (written assurance provisions); and

• provisions relating to accountability for written assurances (accountability provision).

The main provisions in the final FSMA rules remain unchanged. Compliance dates for large food facilities that produce animal foods are as follows:

• Animal food companies other than small and very small businesses must be in compliance with CGMPs under the “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” rule by September 19, 2016, and with preventive controls by September 18, 2017.  

• Small businesses (businesses, including any subsidiaries and affiliates, employing fewer than 500 full-time equivalent employees) must comply with CGMPs by September 19, 2017, and with preventive controls by September 18, 2018.

Draft Guidance
In late August, FDA also issued new draft guidance to help industry comply with certain requirements in the preventive controls for human food rule. The draft guidance available for public comment by November 23, 2016, involves five chapters of what will be multi-chapter guidance designed to help businesses comply with the CGMP and preventive controls for human food rule. The draft guidance explains FDA’s stance on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan.

The draft guidance affecting renderers, Draft Guidance for Industry #235 – Current Good Manufacturing Practice Requirements for Food for Animals, is intended to help facilities that manufacture, process, pack, or hold animal food for consumption in the United States comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the preventive controls for animal food rule are flexible to address the diversity of facilities and animal foods, the wide range of animal food activities, and the potential safety risks posed by some animal foods. 

The draft guidance notice is available at www.federalregister.gov/articles/2016/08/25/2016-20300/guidance-current-good-manufacturing-practice-requirements-for-food-for-animals and the CGMP guidance document is posted at www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM499200.pdf.

October 2016 RENDER | back