FDA Publishes Final Rule Announcing the Effective Date for Components of FSMA Supplier Verification Regulations

FDA Publishes Final Rule Announcing the Effective Date for Components of FSMA Supplier Verification Regulations

October 31, 2022, Covington Alert

Today, the Food and Drug Administration (FDA) published a final rule in the Federal Register announcing the effective date of certain provisions of the FDA Food Safety Modernization Act (FSMA) regulations. The regulatory sections relating to the following topics and collectively addressing both human and animal food were first published in the September 17, 2015 Federal Register, but did not take effect until today’s Federal Register publication:

• Circumstances in which a receiving facility that is an importer need not conduct certain supplier verification activities
• Documentation related to the supply-chain program that a receiving facility which is an importer is required to maintain
• Conditions under which an onsite audit is not subject to certain audit regulations

Implications for Human Food

Today’s Federal Register Notice provides that 21 C.F.R. §§ 117.405(a)(2), 117.475(c)(2), and 117.435(d) take effect as of today, October 31, 2022:

• Section 117.405(a)(2) states that supplier verification activities for raw materials or other ingredients are not needed for a receiving facility that: (i) is an importer, (ii) is in compliance with the foreign supplier verification program requirements, and (iii) has documentation of verification activities conducted to provide assurances that any hazards requiring a supply-chain-applied control have been minimized or prevented.
• Section 117.475(c)(2) requires a receiving facility that is an importer to maintain documentation of its compliance with foreign supplier verification program requirements.
• Section 117.435(d) specifies that an onsite audit conducted solely to meet the supply-chain program requirements of 21 C.F.R. § 117 by a certification body accredited in accordance with 21 C.F.R. part 1 subpart M, is not subject to the requirements in that subpart.

Implications for Animal Food

The Federal Register Notice also stated that parallel provisions for animal foods, codified at 21 C.F.R. §§ 507.105(a)(2), 507.175(c)(2), and 507.135(d), also become effective today:

• Section 507.105(a)(2) provides that supplier verification activities for raw materials or other ingredients are not needed for a receiving facility that: (i) is an importer, (ii) is in compliance with the foreign supplier verification program requirements, and (iii) has documentation of verification activities conducted to provide assurances that any hazards requiring a supply-chain-applied control have been minimized or prevented.
• Section 507.175(c)(2) requires a receiving facility that is an importer to maintain documentation of its compliance with foreign supplier verification program requirements.
• Section 507.135(d) specifies that an onsite audit conducted solely to meet the supply-chain program requirements of 21 C.F.R. § 507 by a certification body accredited in accordance with 21 C.F.R. part 1 subpart M, is not subject to the requirements in that subpart.

 If you have any questions concerning the material discussed in this client alert, please contact the members of our Animal Food and Drug practice.