Modernizing the U.S. Food Supply— A Progress Report on FDA Proposals

Food Safety Modernization Progress Report

Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States.  Major accomplishments include a final rule and four proposed rules.Here is a synopsis of the final and proposed rules.

Final Rule Administrative Detention of Food 

Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption which amended the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. The final rule issued February 2013 adopts the interim final rule, “Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption,” published in May 2011, without change.  

Guidance For Industry on Administrative Detention

On March 7, FDA released a revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”

Proposed Rules: Prevention, Produce Safety, Foreign Supplier Verification and Accreditation

  • Preventive Controls;
  • Produce Safety;
  • Foreign Supplier Verification, and
  • Third Party Accreditation

Proposed Rule on Preventive Controls for Human Food

Preventive Controls Major Provisions Summary: This proposed rule, issued January 2013, would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:

  • A written food safety plan;
  • Hazard analysis;
  • Preventive controls for hazards that are reasonably likely to occur;
  • Monitoring;
  • Corrective actions;
  • Verification; and
  • Associated records.

Proposed Rule for Produce Safety

Produce Safety Major Provisions Summary: This proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. The following are the proposed new standards in the following major areas:

  • Worker Training and Heath and Hygiene;
  • Agricultural Water;
  • Equipment, Tools, and Buildings; and
  • Sprouts

Foreign Supplier Verification Program 

Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Summary: On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. Under the Foreign Supplier Verification Program (FSVP) regulations, importers would be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food producers. The FSVP regulations would implement section 301 of the FDA Food Safety Modernization Act (FSMA).

FSVP Requirements: Under the proposed FSVP regulations, an importer would be required to develop, maintain, and follow an FSVP for each food it imports, which, in general, would need to include the following:

  • Compliance Status Review
  • Hazard Analysis
  • Verification Activities
  • Corrective Actions
  • Periodic Reassessment of the FSVP
  • Importer Identification and
  • Recordkeeping

Third Party Accreditation of Auditors or “Certification Bodies” 

Accreditation Rule Summary: On July 26, 2013, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. The proposed rule would implement Section 307 of the FDA Food Safety Modernization Act (FSMA). The proposed rule contains requirements relating to auditing and certification of foreign food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health.

Model Accreditation Standards Although not part of the proposed rule, the FDA plans to issue draft model accreditation standards that would specify what qualifications a certification body must have to qualify for accreditation, such as the minimum requirements for education and experience for third-party auditors and their audit agents. FDA will issue the Model Accreditation Standards in draft and open a docket to accept comments. After considering the comments received, the FDA will finalize the standards.

Assessment Issues

The major issue with these proposals involves the timeframe for these proposed rules. Many will opine that FDA is again “dragging its feet”. After all, the Food Safety Modernization Act was signed into law in early January 2011. Now, over two years later FDA finally announced four proposed rules and only one final rule was solidified. Why did it take so long or did it? The answer is far from clear cut. Perhaps the lengthy timeframe as some would argue is because these are complicated issues and FDA needs to ensure that administrative law due process procedures are adhered to with proper notice and comment. The question remains though as to when the four proposed rules will be finalized. If FDA receives comments that would essentially change the proposed rule in a substantial manner, then FDA would have to return to the “drawing board” and announce a new proposed rule(s).  Hopefully, that will not occur as the safety of the United States food supply remains at stake.