Service(s) related to this article:  Food Safety & Quality, FSMA Consulting Services

FDA issues new guidance documents for several items under Food Safety Modernization Act (FSMA)

If you are an importer of food or a foreign supplier of food to the US market, you should be aware of the requirements for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. Compliance dates for some businesses began as early as May 30, 2017, and with that date now being well in the past, we have seen a ramping up of FDA activity related to FSMA FDA in recent weeks.

The FDA Food Safety Modernization Act (FSMA) enables the FDA to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to establish and issue food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur.

In August alone, there have been five different Guidance for Industry documents, plus two other general announcements, released:

1. Compliance Guide, Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation, issued August 7
2. Compliance Guide, Seafood HACCP and FSMA, issued August 7
3. Compliance Guide, Juice HACCP and FSMA, issued August 7
4. What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule, issued August 10
5. Compliance Guide, Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule, issued August 14
6. FDA Launches Food Safety Plan Builder to Help Businesses Comply with FSMA Requirements, issued August 22
7. Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule, issued August 24

For Low-Acid Canned Foods, FSMA recognizes that FDA has previously established a regulation (21CFR part 113) that addresses biological hazards unique to low-acid canned foods (i.e., “low-acid canned foods,” or LACF). The new guidance addresses exemptions published under FSMA to the LACF requirements.

The Seafood HACCP Guidance Document recognizes that FDA has previously established a preventive control type regulation for fish and fishery products (21 CFR part 123, the seafood HACCP regulation), based on the Hazard Analysis and Critical Control Point (HACCP) concept.

In addition, the seafood HACCP regulation requires importers of certain seafood products to comply with requirements designed to help ensure that these imported products are processed in accordance with the seafood HACCP regulation.

The new Seafood HACCP Guidance Document addresses the exemptions to the seafood HACCP regulation that have been published in connection with the FSMA regulations, and also provides information about the seafood HACCP regulation in connection with the FSMA regulations.

Similar to the Seafood HACCP guidance, under the Juice HACCP Guidance Document, FDA has previously established a preventive control type regulation for juice (21 CFR part 120, the juice HACCP regulation).

The new Juice HACCP Guidance Document addresses the exemptions to the juice HACCP regulation that have been published in connection with the FSMA regulations, and also provides information about the juice HACCP regulation in connection with the FSMA regulations.

It is important for stakeholders to be aware that some seafood and some juice products are also subject to 21 CFR part 113 mentioned above.

On August 10^th, a Q&A was published titled What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule.

On August 14^th, further Guidance was published to clarify certain Food Establishment waivers from the requirements of the Sanitary Transportation of Human and Animal Food Rule. This guidance provides clarification for food establishments providing food directly to consumers in response to questions the FDA received since publication of the final rule.

August 22^nd saw the launch of the Food Safety Plan Builder to help businesses comply with FSMA Requirements. The Plan Builder is a new software tool to help owners and operators of food facilities create a food safety plan specific to their facilities.

One other very important Guidance for Industry document was published on August 24th: Mitigation Strategies to Protect Food Against Intentional Adulteration – What You Need to Know About the FDA Regulation: Small Entity Compliance Guide. The Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration was published on May 27 and became effective July 26. This guidance document is meant to assist small businesses in complying with the rule set forth in 21 CFR part 121. The rule is binding and has the full force and effect of law, so stakeholders are encouraged to become familiar with this Guidance Document.

In summary, activities under the Food Safety Modernization Act (FSMA) regulations continue at a fast pace, and industry and stakeholders need to keep fully abreast of all these developments. We encourage anyone having difficulties in this area or in the general area of Food Safety to reach out to dicentra for further discussions.

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can also assist you with your classification determinations for delivery systems or combination drug-device products. We can be reached at 1-866-647-3279 or info@dicentra.com.