FDA Releases Updates to FSMA Proposals

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By April Collier, Oct 02, 2014

The Food and Drug Administration (FDA) proposed a number of new rules during 2013 which have been in various stages of “public comment” for some time. The FDA has recently announced updated proposals to four of the seven rules, based on feedback received from the public.

Four Food Safety Modernization Act Rule Revisions

These four updated proposed rules include:

1. Produce Safety – More flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing. A commitment to conduct extensive research on the safe use of raw manure in growing areas and complete a risk assessment.
2. Preventive Controls for Human Food – Requirements that human food facilities, when appropriate, test products and the food facility’s environment, as well as implement certain supplier controls.
3. Preventive Controls for Animal Food – Requirements that animal food facilities, when appropriate, test products and the food facility’s environment, as well as implement certain supplier controls.
4. Foreign Supplier Verification Program – A more comprehensive analysis of potential risks associated with foods and foreign suppliers, and more flexibility for importers in determining appropriate supplier verification measures based on their evaluation of those risk
    

Modifications to Originally Proposed Rules

Some of the modifications to the originally proposed rules include:

• Revisions to the water quality testing provisions to account for natural variations in water sources and to adjust its approach to manure and compost used in crop production pending further research.
• Revised definition of which farms would be subject to the produce safety rule, eliminating farms with $25,000 or less in produce sales from being subject to this rule.
• Spent grains, which are byproducts of alcohol brewing or distilling, commonly used as animal feed,would not be subject to both the animal food rule if the facility already complies with the human food rule.
• Extended flexibility to determine appropriate supplier verification measures based on risk and previous experience with suppliers.

Commenting on Proposed Regulations

The FDA states that they will accept comments on the proposed revisions for 75 days, and will continue to review previously submitted comments on parts of the rules that will remain the same in their final iterations.  Final rules are now scheduled to be issued in 2014, and will become final within 90 days of issuance.

We should bear in mind that there are still other proposed rules within the FMSA that are in different stages of completion. These are just four of those issues that we believe are of primary importance to importers and exporters who need to ensure all parties within your supply chain are complying with these rules that are now expected to be in place during 2015.

ABC Customs Brokers'  affiliate U.S. customs brokers company, Pacific Customs Brokers Inc., can assist you with food facility registration or renewal and U.S. Agent services. Our 24 hour, 7 days a week operation is available to provide immediate answers to your regulatory questions. Please address your comments and questions to the team at Pacific Customs Brokers Inc. at tcg@pcbusa.com or call us at 877.332.8534.

Additional Resources:

• Produce Safety
• Preventive Controls for Human Food
• Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
• Foreign Supplier Verificaiton Programs (FSVP) for Importers of Food For Human and Animals
• FDA releases updated proposals to improve food safety and help prevent foodborne illness in response to public comments
• FDA Seeks to Make FSMA Proposals More Flexible, Targeted