Weekly Compliance Digest – FDA Food Safety Modernization Act

November 20, 2015 By
Last Friday, three rules implementing the U.S. FDA’s Food Safety Modernization Act (FSMA) were finalized:

  • Produce Safety rule
  • Foreign Supplier Verification Programs rule
  • Accredited Third-Party Certification rule

In this edition of the Weekly Compliance Digest, we cover the first two rules. The third establishes a voluntary program for the accreditation of third-party certification bodies (auditors) to conduct food safety audits and issue certifications of foreign facilities and the foods they produce.

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

What is it?

The Produce Safety rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

Who is affected?

Farms and businesses in the Food and Beverage industry in the U.S. involved with the growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.

The rule does not apply to the following:

  • Produce that is not a raw agricultural commodity, i.e. any food not in its raw or natural state.
  • Commodities that FDA has identified as rarely consumed raw (e.g. asparagus, some types of beans, chickpeas, cocoa beans, coffee beans, cranberries, dates, eggplants, figs, hazelnuts, peanuts, potatoes, pumpkins, etc.).
  • Food grains (e.g. barley, oats, rice, rye, wheat, etc.) and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed).

What are the requirements?

The standards in the final rule include key requirements related to the following:

  • Agricultural Water: Criteria for microbial water quality, and approach for testing untreated water used for certain purposes.
  • Biological Soil Amendments: Application of untreated biological soil amendments of animal origin; and microbial standards for processes used to treat biological soil amendments.
  • Sprouts: Requirements to help prevent the contamination of sprouts, which have been frequently associated with foodborne illness outbreaks.
  • Domesticated and Wild Animals: Requirements for farms that rely on grazing animals (such as livestock) or working animals for various purposes.
  • Worker Training and Health and Hygiene: Measures to prevent contamination of produce and food-contact surfaces by ill or infected persons, and use of hygienic practices.
  • Equipment, Tools and Buildings: Standards related to equipment, tools and buildings to prevent these sources, and inadequate sanitation, from contaminating produce.

What is next?

The final rule was finalized on November 13, 2015. It is expected to be published in the Federal Register on November 27, 2015, and to be effective 60 days afterwards.

Companies have two years to comply with covered activities, except for those involving sprouts, after the effective date of the final rule. Businesses with less than $500,000 in average annual produce sales during the previous three-year period have different compliance dates.

Companies have one year to comply with covered activities involving sprouts after the effective date of the final rule.
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Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

What is it?

The Foreign Supplier Verification Programs rule requires food importers to verify that foreign suppliers are producing food in a manner that meets U.S. safety standards, and that they are achieving the same level of food safety as domestic farms and food facilities.

Who is affected?

U.S. companies that import food. An importer is the U.S. owner or consignee of a food offered for import into the U.S. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.

Certain categories of imported food are not covered by FSVP, such as:

  • Juice, fish, and fishery products subject to and in compliance with HACCP regulations, and certain ingredients for use in juice, fish and fishery products subject to the HACCP regulations.
  • Food for research or evaluation.
  • Alcoholic beverages and certain ingredients for use in alcoholic beverages.
  • Food that is imported for processing and future export.
  • Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards).
  • Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation.

What are the requirements?

Importers are responsible for requirements that include:

  • Hazard Analysis. Determining known or reasonably foreseeable hazards with each food.
  • Evaluation of Food Risk. Evaluating the risk posed by a food, based on the hazard analysis and the foreign supplier’s performance.
  • Evaluation of Supplier Performance. Approving suppliers and determining appropriate supplier verification activities based on the evaluation of the risk posed by an imported food and the supplier’s performance.
  • Supplier Verification. Conducting supplier verification activities, such as annual on-site audits of the supplier’s facility, sampling and testing, review of the supplier’s relevant food safety records, etc.
  • Corrective Action. Conducting corrective actions, which could include temporarily discontinuing use of the foreign supplier.

Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance. Importers must develop, maintain and follow an FSVP for each food brought into the U.S. and the foreign supplier of that food.

The evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance.

What is next?

The final rule was finalized on November 13, 2015. It is expected to be published in the Federal Register on November 27, 2015. Importers must comply 18 months after publication of the final rule.

For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, importers must comply six months after the foreign supplier is required to meet the relevant regulations.

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Categories: EHS

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