On December 1, 2017, the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS or the agency) issued its Fiscal Year 2018 Annual Plan.  The Annual Plan, which is directly aligned with the agency’s 2017 – 2021 Strategic Plan, outlines the ways FSIS plans to achieve its strategic goals over the next fiscal year. It serves as an operational guide for FSIS, where the agency explains the progression of activities from the key milestones the agency achieved in FY 2017, outlines what it plans to achieve in FY 2018 and why, and describes how it will assess progress by using Strategic and Annual Plan measures and targets.

Overall, the agency anticipates focusing on prevention of product contamination and foodborne illness, modernizing systems and approaches, and streamlining to enhance business. Continuing priorities for FY 2018 include further implementation of the New Poultry Inspection System (NPIS) and Siluriformes fish inspection, effectively using Public Health Risk Evaluations (PHREs) and pathogen reduction performance standards for Salmonella and Campylobacter in poultry, and modernizing swine and egg products inspection systems. The agency plans to continue increasing use of whole genome sequencing, further develop key informational tools and resources for inspection personnel, and work with public health partners to prevent Listeria monocytogenes in retail  delicatessens. The agency will also encourage industry continued adoption of food defense and humane handling practices, and consumer adoption of safe food-handling practices.

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On November 16, 2017, the Food and Drug Administration (FDA or the agency) issued a federal register notice soliciting comments on its Draft Guidance for Industry, “Best Practices for Convening a GRAS Panel.”

The Draft Guidance is intended for persons responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) when that person convenes a panel of experts (GRAS panel) to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human or animal food.

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The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food on its behalf and, as explained below, will affect contracts between brand owners and co-manufacturers, and brand owners and suppliers.

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The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

The FSA is developing an innovative “whole system strategy” to feed law control and enforcement. The proposed amendments to the Code and Guidance aim to improve consistency of enforcement and reduce the regulatory burden for feed businesses, while maintaining a high level of public and animal protection.

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FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) rules. Second, FDA finalized its Guidance on current Good Manufacturing Practice (cGMP) requirements for animal food. Third, FDA developed a training program for carriers who are subject to the Sanitary Food Transportation rule. Finally, FDA released a new web page that lists compliance dates for rules that form the foundation of FSMA.

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The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorized novel foods.

A ‘novel food’ is a food or ingredient that has not been consumed to a significant degree in the EU prior to 15 May 1997. These include products traditionally eaten outside the EU prior to this date, such as chia seeds, argan oil and noni fruit juice, as well as foods produced using innovative processes, such as UV-treated mushrooms.

Currently, food manufacturers looking to use a novel food or ingredient in their products have to obtain prior authorisation from the first country in the EU in which the food/ingredient will be marketed. That authorization applies across the EU but is personal to the applicant, so other companies wishing to use the same food/ingredient have to apply for a separate authorization.

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This post originally appeared on Hogan Lovells Focus on Regulation.

October 25 – 27
Hogan Lovells Office, Beijing, China

The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s.  FDA has started conducting inspections for compliance with the rule, both domestically and internationally.

The rule requires that key food safety management activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk-based preventive controls.”  This requirement typically applies even if a company is located outside of the U.S., so long as it manufactures food for U.S. consumption.

Hogan Lovells attorneys Maile Hermida (Partner) and Xin Tao (Associate), both Food Safety Preventive Controls Alliance (FSPCA) lead instructors for this regulation, will present the  training program developed by the FSPCA.  This is the “standardized curriculum” recognized by FDA.  Successfully completing this course is one way to meet the requirement to become “preventive controls qualified individual.”

For more information and to register, click here.

October 31, 2017
12:00pm-1:30pm ET

Listeria monocytogenes bacteria sickens an estimated 1,600 people each year and of those about 260 die. The dangers of Listeria foodborne illness impacting U.S. consumers are very real and the implications of an outbreak can be enormously costly to the food processing industry.

FDA is currently reviewing public comments to the “Draft Guidance to the Industry on Control of Listeria Monocytogenes” which was published in January 2017. The industry can expect final Guidance from FDA soon. The new Guidance coupled with the Preventive Controls for Human Food (PCHF) enforcement is already resulting in a much more targeted approach by FDA with focus on both industry and FDA environmental swabbing. Positive swabs for L. mono. or indicator organisms could trigger aggressive FDA enforcement action.

Join presenters representing FDA, attorneys from Hogan Lovells and an EAS Independent Consultant and internationally known research microbiologist for a webinar focusing on the challenges and new FDA regulatory requirements for the detection and elimination of L. mono. This will provide attendees with leading edge and cross-cutting information on regulatory expectations as well as control mechanisms for L. mono. With this information, the food processing industry can improve existing L. mono. control programs, ultimately benefiting the consuming public. This webinar shares the perspectives of the new FDA enforcement strategy (preventive) from FDA’s view, a microbiologist sharing the latest information about L. mono as well as food industry counsel’s view. It is a “must attend” event for anyone with responsibility for complying with FDA’s new enforcement approach.

What do we know today about the “new” dangers of Listeria? What key monitoring and corrective action measures should the industry pay attention to, adopt and implement and how can we turn today’s risk assessment results into a safer and proactive approach to Listeria control?

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The Department of Health and Human Services’ Office of Inspector General (OIG) issued a report last week detailing the results of its review the Food and Drug Administration’s (FDA’s) inspection of domestic food facilities, as well as its advisory and enforcement actions taken in response to significant inspection violations. The key takeaway from the report is that FDA should do more to ensure the food supply is safe by taking “swift and effective action” to ensure facilities promptly correct problems identified during inspections. We summarize the OIG’s key findings and recommendations and also discusses how the report may affect facility inspections and subsequent agency actions in the future.  Read more.

The Food and Drug Administration (FDA) has issued a proposed rule to extend the compliance date for the final rules revising the requirements for the Nutrition and Supplement Facts Labels and the declared serving sizes and reference amounts customarily consumed (RACCs). Under the proposed rule, the compliance date would be extended by about 18 months – from July 26, 2018 until January 1, 2020 for large manufacturers and from July 26, 2019 until January 1, 2021 for manufacturers with $10 million or less in annual food sales. If FDA finalizes the proposed extension, it will result in a total compliance period of about 3.5 years from the date the final rules were initially published (May 27, 2016). In comparison, a number of food industry trade associations requested a 5-year compliance period – i.e., a May 2021 compliance date – that would have allowed for harmonization with the mandatory disclosure standards for bioengineered foods that are being developed by the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS).

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