Source: https://www.ngfa.org/newsletter/fda-issues-draft-guidance-on-establishing-a-supply-chain-program-under-fsma/
Timestamp: 2018-07-21 07:31:43
Document Index: 747132116

Matched Legal Cases: ['art 507', 'art 507', 'art 507', 'art 507', 'art 507', 'art 507', 'art 507', 'art 507']

FDA issues draft guidance on establishing a supply-chain program under FSMA
06.22.18 Feed, Newsletter
The U.S. Food and Drug Administration (FDA) on June 14 issued draft guidance to assist animal food facilities needing a supply chain program to meet the requirements established under its current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals rule (PC animal food rule).
The animal food preventive control requirements mandated by the Food Safety Modernization Act (FSMA) require animal food manufacturers receiving raw materials and ingredients to develop and implement a risk-based supply chain program when the facility determines that a supply-chain-applied control is the appropriate preventive control to address a hazard in an incoming ingredient. Not all receiving facilities will need a supply chain program, such as when the facility itself controls hazards as part of its own operation.
When finalized, FDA’s draft guidance, entitled “Guidance for Industry #246: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program,” will assist receiving facilities:
Identify and implement the appropriate supply chain program activities required to approve their suppliers and verify their supplier is controlling the hazard in raw materials or other ingredients;
In addition, the draft guidance provides clarification for receiving facilities that also are animal food importers that are subject to the supply chain program requirements of the foreign supplier verification programs (FSVP) rule. A draft guidance to help importers meet the requirements of the FSVP rule also is available.
If a supply chain program is needed by a facility, compliance dates for the requirements are determined based upon the size of the facility and the regulations that apply to its suppliers. Specifically:
Situation Compliance Date
You are a small business and your supplier will be subject to the CGMPs, but not the preventive control requirements, of part 507. Six months after your supplier of that raw material or other ingredient is required to comply with the CGMP requirements of part 507.
You are a small business and your supplier is subject to the CGMP and PCAF requirements of part 507. The later of: Sept. 17, 2018 or six months after your supplier of that raw material or other ingredient is required to comply with part 507.
You are not a small business or a very small business and your supplier will be subject to CGMPs, but not the preventive control requirements, of part 507. Six months after your supplier of that raw material or other ingredient is required to comply with the CGMP requirements of part 507.
You are not a small business or a very small business and your supplier will be subject to the CGMP and preventive control requirements of part 507. The later of: Sept. 18, 2017 or six months after your supplier of that raw material or other ingredient is required to comply with part 507.
FDA is seeking public comment on the supply chain program draft guidance until Dec. 12, 2018. NGFA’s feed-related committees will be reviewing the draft guidance and providing feedback to the agency.