FDA Releases Two New Proposed Food Safety Rules

On January 4, 2013, exactly two years after the Food Safety Modernization Act (FSMA) was signed into law by President Obama, the Food and Drug Administration (FDA) published two new proposed food safety rules that will be available for public comment for the next 120 days.

The first rule on “Preventive Controls for Human Food” sets safety requirements for facilities that process, package or store food to be sold in the United States, whether produced at a foreign or domestic-based facility, for human consumption. A separate rule will be issued for animal food in the near future. The rule will require that food facilities implement “preventive controls,” a science-based set of measures intended to prevent foodborne illness similar to Hazard Analysis and Critical Control Points (HACCP) systems that are already required by FDA for juice and seafood processors. Each covered facility would be tasked with preparing and implementing a written food safety plan, which would include the following:

  • Hazard analysis;
  • Risk based preventive controls;
  • Monitoring procedures;
  • Corrective actions; verification; and
  • Recordkeeping. 

The FDA is also seeking public comment on a second proposed rule, which proposes enforceable safety standards for the production and harvesting of produce on farms.

This proposed “Standards for Produce Safety” rule proposes science- and risk-based standards that would address the major areas of concern for the fruit and vegetable industry including:

  • Irrigation and other agricultural water;
  • Farm worker hygiene;
  • Manure and other additions to the soil;
  • Intrusion of animals in the growing fields;
  • Sanitation conditions affecting buildings, equipment and tools.

FDA indicated that the effective date of both proposed rules would be 60 days after the final rule is published. However, in order to allow all businesses, particularly small and very small facilities, adequate time to comply with the new requirements of the rule, FDA plans to adjust the compliance dates based on the facility’s size.

Although many in the food industry believe these rules are long overdue, FDA notes that it conducted extensive outreach to the produce industry, the consumer community, other government agencies and the international community. Since January 2011, FDA staff have toured farms and facilities of all sizes nationwide and participated in hundreds of meetings and presentations with global regulatory partners, industry stakeholders, consumer groups, farmers, state and local officials, and the research community. The goal was to develop proposed rules that could be applied to small and large food facilities alike.

FDA intends to release additional proposed rules addressing importer foreign supplier verification, preventive controls for animal food, and accreditation of third party auditors.

The attorneys at Stoel Rives will be providing more details about the proposed rules implementing FSMA here at the Food Liability Law Blog in the coming weeks. Stay tuned.

FDA Extends Food Facility Registration Deadline Until January 31

The Food and Drug Administration (FDA) has extended the deadline for food facilities to submit their registration until January 31, 2013.

Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to renew their facility registration by December 31, 2012, and every two years after that. FSMA directed that the food facility registration portal would be available starting on October 1, 2012.

However, FDA experienced a delay in implementing the biennial registration renewal for the 2012 cycle. As a result, the registration renewal portal did not become available until October 22, 2012. Food industry members requested that FDA extend the time to register in order to allow companies a full three-month window to complete the renewal requirement. In a new guidance document issued on December 12, 2012, FDA noted that it would exercise its enforcement discretion with respect to registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013. 

Failure to register a facility, renew the facility registration, or update required registration information can have serious consequences. For instance, the U.S. can bring a civil or criminal action in federal court against a company that handles food without a proper facility registration. In addition, if food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food could be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food until the foreign facility is registered with FDA.

Along with the month-long extension, the FDA released an updated question-and-answer on facility registrations, and a shorter, simplified compliance guidance document for small businesses.

American Cheese Society Conference

I attended the American Cheese Society conference in Montreal earlier in the month. The conference was attended by cheese producers and suppliers from around the world. At the conference I presented a PowerPoint on Food Safety Modernization Act  (FSMA) .  There were several talks on Food Safety and clearly, the industry is concerned about the new provisions where cheese in particular has been identified as one of the high-risk foods that will be subject to some of the more stringent new regulations.

Because of the conferences’ location, FSMA’s features related to import and export certifications and foreign inspections were of particular interest (see below). It is clear that imported food will garner additional attention under FSMA. This is particularly true given accounts of food safety issues in China involving vinegar, meat and bread

 

FSMA IMPORT REQUIREMENTS

 

1.   The FDA has a stepped up their foreign facility inspection program to be carried out in a manner to be negotiated with the relevant foreign authority. If inspections are not allowed within 24 hours of the request, a ban on the importation from that facility is authorized.

 

2.  FSMA contains a new section (sec. 808) that requires the FDA to create a system for the accreditation of third party auditors for certification of eligible foreign facilities. The certification in turn will be used for the Foreign Voluntary Qualified Importer Program (see below) to provide assurance for food imports and to target foreign inspection resources. There are express requirements for auditors and certifications set out in this statute.

 

3.  The Foreign Supplier Verification Program (sec. 805) requires every United States importer to perform risk-based reviews of foreign suppliers to verify that the food they import is produced in compliance with the Food and Drug Administration (FDA) standards (produce and hazard analysis and preventive controls) and is not altered or misbranded. In January 2012, the FDA is required to issue regulations specifying the contents of the specific verification programs. Each importer is required to perform foreign supply verification activities which may include monitoring records, inspections or annual on site inspections. It may also require reviewing the hazard prevention programs for foreign suppliers, periodic sampling and testing of shipments. 

 

4.  The law has clarified the definition of inspection to include: An “importer,” for this program, is defined as the United States owner or consignee of the article of food at the time of entry of such articles into the United States, or, if there is no United States owner or consignee, the importer is defined as the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry into the United States. (Note that FDA seafood and juice facilities subject to Hazard Analysis and Critical Control Points (HACCP) or low-acid canned food requirements are exempt.)

 

5.  In January 2012, the FDA is required to issue a guidance document to assist importers in developing their foreign verification program.

 

6.  Each importer is required to maintain records related to the Foreign Supplier Verification program for at least two years.

 

7.  The FDA is required to maintain on its website a current list of the names, locations and other information deemed necessary by the importers in compliance with Section 2805 exemptions. 

 

8.  There is also a Foreign Voluntary Qualified Importer Program (FVQIP) (sec. 806) which requires the FDA to establish in consultation with the Department of Homeland Security a “voluntary” program to expedite movement of materials through the process. Under this program, an “importer” is defined as the person that brings food, or causes the food to be brought from a foreign country into the United States.  This is an important distinction from the definition under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program.  The deciding factors will not be known until the final regulations are issued. FVQIP regulations are not required to be finalized by the U.S. FDA until July 2013. In July 2012, the FDA is required to issue a guidance document regarding participation, revocation, reinstatement compliance of the qualified importer program. To be eligible the importer must be importing food from its facility that has been certified by a third party auditor that year.

 

9.  The FDA is authorized to require as a condition to granting admission to an article of food imported or offered for export to certification or such other assurances FDA deems appropriate.

 

In short, the following is the relevant time table:

January 2011 Authority to require import certification.
July 2011 Require importers to notify the FDAof any country tot which food was denied access.
January 2012 FDA to publish guidance AND regulations for the Foreign Supplier Verification Program.
July 2012 Establish program for Voluntary Qualified Importer Program.
January 2013 Effective date for Foreign Supplier Verification Program.