FDA releases additional guidance on Intentional Adulteration (IA) Rule

Today, the FDA published the second installment of a draft guidance document designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA).

The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date for large facilities arrives in July 2019.

This installment adds to and incorporates elements of the previously published guidance with chapters covering topics such as: Continue reading

FDA Strategic Plan to Ensure Safety of Imported Food

FDA releases 18-page food safety initiative to improve imported food safety.

Read more to learn how this may impact your business.

According to a recent press release by the US FDA, the U.S. imports about 15 percent of its overall food supply from more than 200 countries or territories, with 13.8 million food shipments in 2018. Mexico, Canada, Asia, and Europe account for the greatest number of imports, respectively. In 2019, between 14 and 15 million shipments of imported food are expected to enter the United States. Countries outside of the U.S. supply approximately 55 percent of fresh fruit, 32 percent of vegetables and 94 percent of seafood consumed in this country and will likely see the biggest impact of the FDA’s increased oversight.

For imported food, the volume and variety of imports and the complexity of global supply chains make food safety a challenging issue to address in the US. Further complicating the issue, some exporting countries may have food safety systems. The FDA has been provided with a range of tools and authorities to address the situation both domestically and in the foreign arena. The strategy document released today describes how FDA is integrating new import oversight tools with existing tools to help ensure that imported food is safe for consumers in the United States.

FSMA has granted FDA new and supplementary oversight and enforcement authorities to ensure industry is meeting these standards. While inspectional oversight remains the primary tool for domestic food producers and is an important tool for foreign producers, Congress determined that more was needed to control the food safety risks associated with imported foods. Through FSMA the FDA was provided with new tools and authorities to meet this need and the agency was charged with creating an oversight system designed primarily to prevent food safety problems from occurring, preferably before the food arrives at our border or reaches the plates of U.S. consumers.

The FDA’s recently published strategy document describes how FDA is integrating the new import oversight tools with existing tools as part of a comprehensive approach to imported food safety and is driven by the following four goals supported by the related objectives:

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What do food facilities need to know about this year’s biennial registration renewal period?

Food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration this year between October 1 and December 31. This fact sheet provides information about this biennial food facility registration renewal period.

Why are food facilities required to register with the FDA?

Food facility registration helps FDA determine the location and source of potential bioterrorism or foodborne illness outbreak incidents, and also helps the agency quickly notify facilities that may be affected. Food facility registration requirements were initially brought about by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.

The FDA Food Safety Modernization Act (FSMA) then amended the FD&C Act to require domestic and foreign facilities to submit certain additional new information to FDA and to renew registrations every other year. In 2016, FDA issued a final rule updating FDA’s registration regulation, including to reflect the FSMA amendments.

What food facilities must register with the FDA?

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FDA’s Issues Guidance on Mandatory Recall Authority

Mandatory Recall Authority for Foods

FSMA gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

The FDA issued final guidance answers the most common questions regarding FDA’s mandatory recall process, explains what FDA considers when moving forward with a mandatory recall, and more. See below for a few of the most common questions.

What foods are subject to the FDA’s mandatory food recall authority?

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citrus fruits

FDA Releases Information for Qualified Facilities under Preventive Controls Rules

September 14, 2018

Today, the U.S. Food and Drug Administration issued documents designed to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a “qualified facility” under those rules, and if so, what modified requirements are applicable to such facilities.

A qualified facility is generally a business that, because of its very small size, is to only modified requirements under the FDA Food Safety Modernization Act. (All facilities remain subject to current good manufacturing practice requirements.)

The first document is a guidance to help food facilities determine whether they meet the definition of a qualified facility under one of two FSMA rules: the Preventive Controls for Human Food (PC Human Food) or Preventive Controls for Animal Food (PC Animal Food) Rules.

Under each rule, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. These requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations.

The required attestation forms, Form FDA 3942a for facilities subject to the PC Human Food rule, and Form FDA 3942b for facilities subject to the PC Animal Food Rule, are also being released today along with instructions on how to fill them out and how they should be submitted. In addition, starting October 1, facilities will be able to submit these attestation forms electronically at https://www.access.fda.gov via the Qualified Facility Attestation Module. Please note that facilities must first create or have an existing FURLS account to access the module. Also, facilities must have a valid food facility registration to submit their attestation.

Facilities subject to the PC Human Food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018. Facilities subject to the PC Animal Food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019. Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.