Released U.S. FDA documents and information

In the last weeks, the U.S. Food and Drug Administration released information and documents that may be of interest to Canadian stakeholders.

1.       Preventive Controls for Animal Food

In line with the U.S. Food Safety Modernization Act (FSMA), by September 17, 2018, both large and small animal food facilities in the U.S. must comply with preventive controls requirements for animal food mandated by FSMA. The definition of animal food in the U.S. includes any article used for food or drink for animals and articles used for components of any such article.

In a Q&A webpage released on August 14, 2018, the FDA indicated that it will begin conducting routine regulatory inspections of facilities that are large animal food business this year to ensure compliance with the preventive controls requirements for animal food. Foreign Supplier Verification Programs (FSVP) inspections of U.S. importers whose foreign suppliers are large facilities will also begin this fall to ensure compliance with these requirements.

The FDA also indicated that it intends to delay FSVP inspections of U.S. animal food importers whose foreign suppliers are small and very small facilities until 2019 and 2020, respectively, to align with the planned delay in routine preventive controls inspections under the PC animal food rule. Large businesses are those with 500 or more full-time equivalent employees, and small businesses are those with fewer than 500 such employees. Very small businesses are those averaging less than $2.5 million per year in sales plus the market value of animal food they make or hold.

More information on PC animal food rule can be found at the following address: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm

2.       Nutrition Innovation Strategy

On August 16, 2018, the FDA extended the public comment period for the agency's Nutrition Innovation Strategy by 45 days. The docket will now remain open until October 11, 2018. The FDA is extending the comment period in response to numerous stakeholder requests for additional time and an opportunity to review the public meeting materials. More information can be found on the Public Meeting Page.

3.       Food Facility Registration Guidance

On August 17, 2018, the FDA issued the seventh edition of a guidance document to help the owners and operators of facilities (including foreign facilities) that manufacture/process, pack, or hold food for human or animal consumption in the U.S. understand the registration requirements.  The FDA also released a supplemental draft guidance to the seventh edition which includes questions and answers that clarify their thinking about the registration requirements in situations in which multiple entities are involved in the use of shared physical space.

As a reminder, the 2018 biennial registration renewal period begins October 1st and concludes December 31st.To register or find more information about registration, owners and operators of facilities should visit the Registration of Food Facilities page at FDA.gov.

4.       Accredited Third-Party Certification

On August 23, 2018,  the FDA announced that it has recognized International Accreditation Services, Inc. (IAS) of Brea, California, as an accreditation body under the Accredited Third-Party Certification Program for a period of five years.

IAS is being recognized as having the authority to accredit certification bodies with the ability to conduct food safety audits as they pertain to the following regulations (Preventive Controls for Human Food rule, Preventive Controls for Animal Food rule, Produce Safety Rule, Juice HACCP, Seafood HACCP, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, Acidified Foods)

A Public Registry of Accreditation Bodies is available at the following address: https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm594398.htm

This has been provided by Agriculture and Agri-Food Canada.