Regulatory Alerts: FDA Issues Two Draft Rules on Safety of Imported Food

One in six Americans suffers from a food borne illness every year, according to the Food and Drug Administration (FDA). In July, the FDA announced two proposed rules to ensure the safety of imported foods.

The rules are required by the FDA Food Safety Modernization Act (FSMA), the most sweeping reform of U.S. food safety laws in more than 70 years. Signed in 2011, FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, 78 Fed. Reg. 45729, published July 29, 2013.  The rule would require importers to conduct risk-based foreign supplier verification activities to verify that imported food is not, among other things, adulterated and that it was produced in compliance with FDA’s preventive controls or produce safety requirements, where applicable.  It would require importers to maintain a list of foreign suppliers, create and follow written procedures for supplier verification activities, review the results of verification activities and, if hazards are not adequately controlled, take appropriate corrective action.

Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and Issue Certifications, 78 Fed. Reg. 45781, published July 29, 2013. This rule would establish a program for accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities and their foods.  The proposal contains requirements relating to monitoring and oversight of participating accreditation bodies and auditors at every level.  These include procedures that FDA will follow when removing an auditor or an accreditation body from the program, for good cause.

In accordance with the Regulatory Flexibility Act, the FDA has compiled a detailed preliminary regulatory impact analysis of both rules. It spells out the projected small business impact of the rules. FDA’s analysis reflects small business input received at an Office of Advocacy roundtable in January.

Which Businesses Will These Rules Affect?  These rules will affect food importers, suppliers and other food importation subsectors.

Why Are These Rules Important to Small Businesses?   The Food Safety Modernization Act (FSMA) requires FDA to adopt regulations on the content of foreign supplier verification programs (FSVPs) of importers of food.  Table A1 in the regulatory impact analysis suggests that 51 percent of affected importers are small dietary supplement importers, very small, or only import from very small suppliers.  For their supplier verification programs to be deemed adequate they must provide assurances that their foreign suppliers are following processes and procedures that provide the same level of public health protection as those required under sections of the Food, Drug and Cosmetic Act. They must also provide assurances that the food they import is not adulterated or misbranded with respect to allergen labeling.

Key Issues and Potential Areas for Comment:

  • Do affected small entities agree with FDA’s definitions of small business?  FDA created two small categories:
    • very small importer defined as an importer whose average annual monetary value of sales of food during the previous 3-year period (on a rolling basis) is no more than $500,000, adjusted for inflation; and
    • very small foreign supplier defined as a foreign supplier whose average annual monetary value of sales of food during the previous 3-year period (on a rolling basis) is no more than $500,000, adjusted for inflation.
  • According to the cost assumptions in the FDA’s initial regulatory flexibility analysis, these new rules will cost very small importers (less than 20 employees) $5,824 in the first year and $5,702 in subsequent years. They will cost small importers (less than 100 employees) $4,202 in the first year and $4,062 thereafter. Do the affected small entities agree with these estimates?
  • Are the FDA’s assumptions regarding the costs of compliance reasonable? Compliance costs would include recordkeeping, inspection, acquiring written assurances from foreign suppliers, etc.
  • The rules cover almost every major industry subsector of the food importation industry. How will the rules affect other industries involved in food importation, e.g., U.S. food import agents and brokers?

Deadline for Comments for Both Rules: These rules are wide-ranging in their impact; the FDA is seeking comment on whether its analysis adequately captures the small business impact and whether reasonable alternatives have been considered. Comments are due November 26, 2013.

Advocacy Contact: Assistant Chief Counsel Linwood Rayford, (202) 205-6533.

To Learn More: FDA has a website dedicated to FSMA. It contains the text of the proposed rules and fact sheets highlighting their key provisions, plus the preliminary regulatory impact analyses.

—Assistant Chief Counsel Linwood Rayford