Update on FSMA – May 2015

1. U.S. Food Safety Modernization Act (FSMA)

Background:
The new legislation represents a major reform of the food safety provisions of the Federal Food, Drug and Cosmetic Act and empowers FDA to take appropriate preventive and control measures to safeguard the food supply chain in the US. The implementation of the provisions of the Act is a major milestone for the domestic food industry and also for the exporters of food products to the United States.

The FSMA is divided into four titles: prevention of food safety hazards, detection of and response to food safety problems, improving the safety of imported foods, and miscellaneous provisions.

Highlights of FSMA:

• Food facilities are required to register with FDA biennially. Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.
• Registered food facilities are required to conduct hazard analyses and develop and implement written preventative control plans.
• Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
• Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory and lab results must be sent directly to FDA.
• Food facilities will be inspected with greater frequency and not less often than once every 5 years.

2. Hazard Analysis and Preventative Controls:

The FSMA requires registered facilities to perform hazard analyses and implement a preventive control plan. The written plan must include- hazard analysis, preventive controls (including preventive controls; certain on-farm operation, and Critical Control Points, if any), monitoring, verification, corrective action and record keeping.

Exemptions:
Facilities in compliance with FDA seafood or juice HACCP regulations or FDA low-acid canned food regulation; facilities subjected to fresh produce standards; dietary supplement (21 CFR Part 111); certain specialized facilities (production of animal feed, storage of raw commodities, alcoholic beverages); certain on-farm operations; qualified facilities.

3. Import Requirements:

Sections 301-309 of FSMA deals with the requirements for importing food into the country. There are two important programs that are of business interests to us, namely, Foreign Supplier Verification Program (FSVP) and Voluntary Qualified Imported Program (VQIP).

The Foreign Supplier Verification Program (FSVP) requires every exported to have an imported in the U.S. and the imported is required to perform risk-based foreign supplier verification to verify that the food it imports is produced in compliance with the requirements of FSMA and is not adulterated. Each importer is required to perform foreign supplier verification which may include monitoring of records of shipments, lot-by-lot certification, annual on-site inspection of foreign suppliers, checking the food safety plans and periodic testing of shipments.

Implementation date- October 31, 2015.

Voluntary Qualified Imported Program (VQIP): This program is to expedite the import of food products through the import process. To be eligible to participate in the VQIP an importer must be importing food from a facility that has been certified by an accredited third party auditor under Section 808 of FSMA and such certification must accompany the imported food. The importer is required to submit an application to FDA to qualify the facility that exports products into the U.S. Section 808 OF FSMA establishes a system for FDA recognition of accreditation bodies that accredit third-party auditors to certify eligible foreign facilities.

Implementation date- October 31, 2015.

4. Laboratory Accreditation:

Accreditation of food laboratories. All independent and foreign labs must be accredited under 17025 under FSMA.