On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), proposed to adopt a new regulation that would significantly change the warning requirements for listed chemicals formed by the cooking or heat processing of foods. The proposed regulation would provide that intake of such chemicals does not represent an exposure for the purposes of Prop 65 if the concentrations are reduced to the lowest level currently feasible using appropriate quality control measures. The proposal would establish maximum concentration levels for acrylamide in specific foods that are deemed by OEHHA to be the lowest levels currently feasible. Concentrations of the chemical at or below the level identified for the specified products would not require a warning.

It is noteworthy the proposed regulation is published at a time when a new wave of Prop 65 challenges are targeting acrylamide in food. In the past three months alone, private litigants have filed close to one hundred 60-day notices indicating their intent to sue food companies for acrylamide. This translates to about one Prop 65 notice filed every day in California for acrylamide in food. In its Initial Statement of Reasons, OEHHA stated the proposal is intended to (1) reduce exposures to listed chemicals present in food due to the human activities of cooking or heat processing, (2) provide warnings for avoidable exposures to acrylamide, and (3) safeguard the effectiveness of those warnings.

The public can request a hearing on the proposed changes and the request must be received no later than September 21, 2020. Written comments to the proposed regulation are due on October 6, 2020.

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Hogan Lovells is changing how we deliver our food law and policy content. On August 17 we will be moving the A Seat at the Table blog to a new technology platform: Hogan Lovells Engage.

You’ll soon receive an email with details on how to join us on Engage to continue to stay up-to-date on the latest developments in food law and policy. We look forward to seeing you there.

On July 31st 2020, the Interinstitutional Accord between the Ministry of Economy and the Ministry of Health, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Consumer Protection Federal Bureau (PROFECO) regarding the surveillance activities of the Amendment to the Modification of the Mexican Official Standard NOM-051-SCFI/SSA1-2010, was published on the Federal Official Gazette.

The Interinstitutional Accord mainly provides the following:

  • Non-sanction- From August 1st until November 30th, 2020, manufacturers, importers or marketers will not be sanctioned during the verifications/inspections visits carried out by PROFECO and COFEPRIS regarding those prepackaged foods and non-alcoholic beverages subject to the amendment of the NOM-051 and the Amendment.
  • Previous compliance- A period from August 1st, 2020, to September 30th, 2020, is granted in order for  products that comply in advance with the Amendment of the NOM-051 can be marketed to the final consumers before its entry into force (October 1st, 2020). It should be noted that this exemption is not applicable to importer of record of the products.
  • Extension – A period from October 1st, 2020 to November 30th, 2020, is exclusively granted, so that prepackaged foods and non-alcoholic beverages that complies with the NOM-051 but do not comply with the Front Warning Labeling System (labels and legends) referred in the Amendment can be marketed to the final consumers.

Please be informed, that it is expressly established that neither COFERPIS nor PROFECO will administratively sanction with warnings, fines, closure, arrest, suspension, revocation, cancellation, prohibit immobilization, insurance, withdrawal of the market and/or issuance of alerts, in the terms of the provisions referred above. The Interinstitutional Accord came into effect on August 1st, 2020.

 

The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) is seeking comments on recommendations to update the List of Bioengineered Foods (List) under the National Bioengineered Food Disclosure Standard (NBFDS). AMS seeks comment on four issues: (1) whether it should add insect-resistant sugarcane to the List; (2) whether it should add the modifier “virus-resistant” to summer squash, which already is on the List; (3) whether additional information is available to support adding cowpea or golden rice to the List; and (4) whether AMS should consider adding any other foods to the List. Comments are due to AMS by August 24, 2020.

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The CDC recently released updated its guidance on the criteria for determining when a worker diagnosed with COVID-19 may return to work. The interim guidance, Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (July 20, 2020), is focused on when individuals diagnosed with COVID-19 may end home isolation. It is also incorporated into CDC’s guidance for food companies managing return-to-work requirements for employees and contractors.

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On July 15, 2020, the Virginia Safety and Health Codes Board passed first-in-the-nation codified emergency temporary standards (the Standards) establishing requirements for employers to control, prevent, and mitigate the spread of SARS-CoV-2 (COVID-19) in the workplace. The Standards were issued at the direction of the Governor to create enforceable regulations. With these Standards, the Virginia Occupational Safety and Health (VOSH) Program will enforce requirements similar in many ways to guidance issued by the U.S. Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA).

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The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will begin in March 2021. The IA rule requires food facilities covered by the rule to develop and implement a food defense plan that identifies significant vulnerabilities at actionable process steps and implements mitigation strategies to address those vulnerabilities.

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The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s work implementing the FDA Food Safety Modernization Act (FSMA) by establishing a new approach to food safety that leverages technology and other tools to create a safer and more traceable food system. The Blueprint “envision[s] a framework that will enable food to be traced to its source in seconds and will utilize new data analytical techniques to strengthen prevention of foodborne illnesses, alerting consumers in real time before contaminated or misbranded foods are consumed.” In many respects, the Blueprint is a strategic plan that will guide FDA’s food safety priorities in the coming years. As such, there are no specific timelines or action steps set out in the document.

FDA was poised to release the Blueprint in March 2020, but was delayed when the agency pivoted to focus its efforts on its response to the COVID-19 pandemic. In his comments announcing the release of the Blueprint, Dr. Stephen M. Hahn, the Commissioner of Food and Drugs, explained how events and trends that arose following the outbreak of COVID-19, such as supply-chain imbalances and increased reliance on food delivery services, have underscored the importance of the initiative.

The Blueprint outlines goals for FDA over the next decade to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of a food safety culture. It is organized around the four core elements, explained below, which the agency initially identified in the “Food for Thought” outline of ideas the agency released in October 2019. FDA also has identified the senior leaders who will lead FDA’s efforts in achieving the goals in each of the four core elements.

This post highlights some of the goals within in each of the four core elements. More details are provided in the Blueprint itself. Click here to read more. 

The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), Animal Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS).

After highlighting the most significant priorities, we provide charts that enumerate other relevant rules included on each agency’s agenda. More information can be found by clicking on the blue “RIN” link, which will direct you to a page on OMB’s website dedicated to each agenda item.

We want to caution that the dates included in the Unified Agenda are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations. Note, for example, that dates for some planned actions have already passed. Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.

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A recent action by the National Advertising Division (NAD), a self-regulatory arm of the Better Business Bureau, addresses the level of proof necessary to support “natural” and “satiety” claims involving competing experts and a variety of scientific data in dispute. The Proctor & Gamble Company (P&G) successfully challenged three claims made by GlaxoSmithKline Consumer Healthcare, LLC (GSK) for its Benefiber Original and Benefiber Healthy Shape products. GSK disagreed with the case outcome, appealing NAD’s findings and recommendations to the National Advertising Review Board (NARB). Beyond the NAD’s specific findings, the decision also provides useful insight into how NAD evaluates health benefit and related claims and analyzes the corresponding scientific evidence and other substantiation. The outcome of the NARB appeal will likely shed further light on how the claims substantiation issues involved should be addressed by advertisers in the future.

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