Well Done


On Friday, the US Food and Drug Administration (FDA) announced the public availability of three new rules that will help prevent the contamination of foods: the Standards for Growing , Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule), the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule), and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule). The rules, which will be published on November 27, implement several important sections of the FDA Food Safety Modernization Act (FSMA).

The Produce Safety rule establishes standards for growing, harvesting, packing, and holding produce grown for human consumption. Specifically, the rule sets criteria to prevent contamination of produce through the water supply, soil, domesticated and wild animals, ill or infected farm workers, and insanitary equipment, tools, and buildings. Special standards are included to prevent the contamination of sprouts, which are frequently associated with food-borne illnesses.

Notably, the Produce Safety rule does not apply to produce that is not a raw agricultural commodity (food in its raw or natural state); certain produce commodities that FDA has identified as rarely consumed raw (such as coffee beans, potatoes, and pumpkins); food grains; produce that is used for personal or on-farm consumption; produce from farms that had average sales of $25,000 or less in the past three years; or produce that receives commercial processing that adequately reduces the presence of microorganisms under certain conditions.

The Produce Safety rule also includes qualified exemptions for farms that had average sales of $500,000 or less in the last three years and, additionally, those whose sales to qualified end-users exceed sales to all others combined during the previous three years. States, tribes, and foreign countries may submit a petition requesting a variance from one or more of the requirements. Compliance with the rule is required within two to four years, depending on the average annual produce sales during the previous three-year period (and within one to three years for activities involving sprouts).

Compliance for the FSVP rule must be achieved, for some businesses, within 18 months. Under the rule, importers must perform certain risk-based activities to verify that food imported into the United States has been produced according to the applicable US safety standards. These standards ensure that “foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations” and to further ensure that food is not adulterated and has proper allergen labeling. Modified FSVP requirements are in place for small importers (sales of no more than $1 million for human food and $2.5 million for animal food) and for certain small suppliers.

The Accredited Third-Party Certification rule establishes a voluntary program for the accreditation of auditors to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals produced therein. Foreign entities can use the certifications to establish eligibility for participation in the Voluntary Qualified Importer Program, which expedites review and entry of food into the United States. The rule does not apply to alcoholic beverages manufactured by foreign facilities or to meat, poultry, and egg products subject to US Department of Agriculture oversight at the time of importation. Although no specific compliance deadline is mentioned, FDA stated that it “intends to implement this program as soon as possible after publication of the final Model Accreditation Standards guidance, and the final user fee rule, both of which will be published separately.”

Collectively and when read in conjunction with the rules for preventive controls for the production and handling of human and animal foods, these regulations complete the major portion of FDA’s efforts to establish the regulatory architecture of FSMA (final rules regarding transportation and intentional product adulteration remain to be published). FDA contemplates oversight of a regulatory system with global reach that will affirmatively establish and document the safety of the vast majority of food available to US consumers.

Now that the rules have been established, it is incumbent upon the members of all segments of the food industry, well in advance of any official compliance deadlines, to either initiate or accelerate their own efforts to ensure appropriate compliance. Toward that end, FDA has announced two upcoming webinars (a webinar on the Produce Safety rule on Tuesday, November 17, 2015, 2:00–3:00 p.m. eastern time, and a webinar on the FSVP rule and the Accredited Third-Party Certification rule on Monday, November 23, 2015, 10:00–11:30 a.m. eastern time) that may be of interest. In addition, we anticipate the generation of other guidance materials and other forms of outreach from the agency in the coming weeks and months.