FDA Proposes Two Rules Under FSMA


After a long wait, the Food Safety Modernization Act (FSMA) is finally coming to life with the first two of five proposed rules published for comment — Preventive Controls for Human Food and Produce Safety.

While it will take some time to thoroughly review the lengthy documents for implications for the California Almond industry, here are some highlights from the two rules:

Produce Safety

This rule would require farms that grow, harvest, pack or hold fruits and vegetables, including tree nuts, to follow standards aimed at preventing contamination with a focus on micro hazards, such as pathogens, and not pests. It allows for alternative methods to be implemented if they can be demonstrated to provide an equivalent level of safety. These alternative measures are subject to FDA review, but do not have to have prior approval by FDA.

The requirements address routes of contamination, such as animals, equipment/tools, worker health, worker sanitation, water and biosolid amendments/manure. A numeric standard for water quality will be applied only for water that comes in direct contact with produce.

Controls for Human Food

There are two major sections to this rule: hazard analysis and updated GMP provisions.

In addition to process controls, this rule would require more preventive controls in a food safety plan, including allergen controls.

Verification is the most significant issue in this rule and where comments would be desirable.

ABC is working closely with other produce organizations, including United Fresh, to review the rules and begin to develop comments. Comments are due to FDA on May 16.

Information on the proposed rules is available at the Federal Register website. The Federal Register notices will appear mid-January.

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The Handle