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HHS/FDA

RIN: 0910-AG64

Publication ID: Spring 2011

Title: ●Foreign Supplier Verification Program
Abstract: The proposed rule would establish regulations concerning the content of foreign supplier verification programs. The regulations will require that each importer have a foreign supplier verification program that is adequate to provide assurances that each foreign supplier produces food in compliance with: (1) Processes and procedures that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and risk-based preventative controls) or section 419 (concerning produce safety standards) of the FD&C Act; and (2) sections 402 (concerning adulteration) and 403(w) (concerning major food allergens) of the FD&C Act. In promulgating the foreign supplier verification regulations, we will, as appropriate, take into account differences among importers and types of imported foods, including differences related to the level of risk posed by an imported food. Methods of foreign supplier verification may include monitoring records for shipments, lot-by-lot certifications of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined	Unfunded Mandates: Undetermined
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Title III, sec 301 of FDA Food Safety Modernization Act, PL 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		01/04/2012

Timetable:

Action	Date	FR Cite
NPRM	07/00/2011

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No
Agency Contact: Brian L. Pendleton Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-3541 Email: brian.pendleton@fda.hhs.gov