Two of the proposed rules—“Accreditation of Third Party Auditors” and “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals”—were published on July 29, 2013, with the public-comment period running through November 26, 2013. A public meeting to solicit stakeholder comments and views on these proposals and to inform the public about the rulemaking process has been slated for September 19 in Washington, D.C. Requests to present during the meeting must be submitted by August 29; advance registration is required by September 10; comments must be submitted by November 26. Additional public meetings in diverse U.S. regions will be announced at a later date.

For the other two proposals—“Current Good Manufacturing Practices and Hazard Analysis and Risk Based Preventive Controls for Human Food” and “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption”— FDA has extended the public-comment periods through November 15.

Please note as to the produce standards, that FDA has published a notice of intent to prepare an environmental impact statement (EIS) to evaluate its potential environmental effects. The public scoping process for the EIS also closes on November 15. According to the agency, public comments and additional analysis since the proposed rule was issued have made the need for an EIS manifest because “the proposed action may significantly affect the quality of the human environment.”

Also note that FDA is currently subject to court-imposed deadlines as to these and the three remaining FSMA implementing regulations; thus all rules must be finalized by June 30, 2015. The order could be appealed, but it is in effect, and the court has denied a stay or rehearing of its order.

Salient Rulemaking Features

(1) Foreign Supplier Verification Programs (FSVP)

All importers [unless otherwise exempted] would be required to verify that food imported into the United States meets the health standards required of domestic food producers. The FSVP would require importers to:

  • Review the compliance status of the food and the potential foreign supplier before importing the food and periodically thereafter.
  • Analyze the hazards and severity of those hazards that are reasonably likely to occur for each type of food imported.
  • Ensure that the hazards identified as reasonably likely to occur are adequately controlled through onsite audits, testing or other appropriate measures.
  • Review complaints received concerning the foods they import, investigate causes of adulteration or misbranding in some circumstances and take appropriate corrective actions.
  • Reassess FSVP every three years or if they become aware of new information about potential hazards associated with the food.
  • Obtain Dun and Bradstreet Data Universal Numbering System (DUNS) number for their company and to ensure that, for each food product offered for importation into the United States, their name and DUNS number are provided electronically when filing for entry with Customs and Border Protection.
  • Keep certain records, including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations and corrective actions, and FSVP reassessments.

(2) Accreditation of Third-Party Auditors/Certification Bodies

A regulatory regime for recognition of foreign government agencies or private companies as accredited auditors of foreign food production facilities would be established. These accredited auditors would conduct audits of foreign facilities and issue certifications that FDA could use in deciding whether to allow import of foreign foods into the United States. The accreditation certifications will not be mandatory, but importers would be encouraged to obtain them for two reasons:

  • Certification would render foreign food facilities eligible for the Voluntary Qualified Importer Program, which provides for expedited review and entry of food into the United States.
  • Certification would be required as a condition of entry for certain foods that FDA determines pose a food safety risk.

(3) Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food

To prevent food borne illness, food producers would be required to adopt food safety plans. The rule would require domestic and foreign companies that manufacture, process, pack, or hold human food products to create written food safety plans.

These plans must: 1) identify potential health hazards; 2) define steps to minimize those hazards; 3) create monitoring procedures, verify their effectiveness and maintain records documenting these actions; and 4) specify corrective actions if problems arise. FDA would review these plans and continue to conduct facility inspections to ensure that these plans have been properly implemented.

The proposed rule also modifies Current Good Manufacturing Practices (CGMP) regulations to clarify that protections against contaminated foods also require protection against cross-contamination of food by allergens. FDA also requests comments on whether it should mandate CGMP training for employees and supervisors of covered companies.

(4) Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption

Applicable to producers of most fruits and vegetables intended for market in their unprocessed state, this proposed rule sets standards associated with identified routes of microbial contamination. These standards include:

  • Provisions setting specific water quality criteria and requiring that system components be inspected for conditions that might introduce pathogens to produce.
  • Requirements to reduce health risks from Biological Soil Amendments of Animal Origin (e.g., composting manure).
  • Health and hygiene provisions requiring that farm personnel engage in hand washing and maintain adequate personal cleanliness.
  • Animal presence provisions requiring adequate waiting periods between animal grazing or use of work animals and harvesting produce as well as monitoring for wild animal intrusion events to avoid contamination.
  • Standards for equipment, tools and buildings used for produce operations.

The rule will not apply to agricultural commodities that are rarely consumed raw (such as potatoes) or those destined for commercial processing, or to farms marketing less than $500,000 in produce annually.