IFAC Regulatory Update May 2020

Following is the May 2020 IFAC Regulatory Update. Please note the following requests for feedback by Friday, June 12 and see additional background below.

 Please advise staff whether you support development of IFAC comments regarding FDA’s third draft guidance intended to support compliance with the FSMA Intentional Adulteration rule by Friday, June 12.

COVID-19 Updates

IFAC Co-Signs Coalition Letter on Liability Protections for Essential Businesses IFAC was one of hundreds of organizations to sign a coalition letter urging Congress to take quick action on liability protections for essential businesses during COVID-19. The letter, which was developed by the National Association of Manufacturers and sent to Congressional leadership on May 3, notes essential businesses that have had to stay open during the COVID crisis may become targets of lawsuits depending on the tentative nature of federal and state guidance amid efforts to prevent COVID transmission. So Congress is asked to create targeted and limited safe harbors to allow businesses to operate during this uncertain time.

Stakeholder call with FMCSA On May 8, IFAC staff participated in a Federal Motor Carrier Safety Administration (FMCSA) call where they discussed the emergency declaration that expired on May 15 and provided regulatory relief for commercial truck drivers providing direct assistance in support of emergency relief efforts due to COVID-19. The agency stated that it partnered with the Federal Emergency Management Agency (FEMA) and distributed masks to one million truck drivers, and would continue to issue masks along with COVID-19 tests to truck drivers to make sure the supply chain is protected. It was stated that no specific complaints or reports have been filed on truck driver price gauging. The agency reiterated that if there any supply chain or transportation issues to contact them immediately. Attached are detailed staff notes of the call.

FDA Issues Documents for Businesses Dealing with Impacts of COVID-19* On May 8, the U.S. Food and Drug Administration (FDA) issued a checklist and related infographic, designed to assist retail food establishments that might have been closed or partially closed during the COVID-19 pandemic and are preparing to reopen. The two documents are designed to help businesses that prepare food to serve or sell to the public directly, such as restaurants, bakeries, bars, and carry-outs, protect employee and public health as they reopen for business. FDA Guidance on Adverse Event Reporting Requirements During a Pandemic On May 11, FDA re-issued a guidance document from 2018 that provides recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high focus on the reporting of adverse events related to widespread use of medical products indicated to treat pathogen and help offset the pandemic.

FDA Issues COVID-19 Related Guidances* On May 12, FDA published a notice on the Federal Register announcing the availability of FDA guidance documents related to the COVID-19 public health emergency. This action followed the process that FDA announced in March, for making available to the public COVID-19-related guidance documents. The guidance documents listed in this notice address issues related to the COVID-19 and have been issued in accordance with the prior announced process. Those relevant to IFAC members include:

 Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency (March 2020)  Temporary Policy Regarding Nutrition Labeling of Standard Menu Items in Chain Restaurants and Similar Food Establishments During the COVID-19 Public Health Emergency (April 2020)  Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March 2020)  Temporary Policy for Manufacture of Alcohol for Incorporation into Alcohol- Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March and April 2020)  Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (March and April 2020)

The FDA published an additional notice that contained more guidance documents on May 26. The guidance documents have been implemented without prior comment, but they remain subject to comment like other agency guidance. IFAC does not plan to comment on these guidance documents unless otherwise advised by Friday, June 12.

USDA, FDA Strengthen U.S. Food Supply Chain Protections On May 19, Mindy Brashears, Ph.D., U.S. Department of Agriculture (USDA) Under Secretary for Food Safety, and Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response, issued a joint statement on their agencies’ COVID-19 response. They stated that the USDA and FDA have been working to support the food sector and make sure Americans continue to have access to food. To continue their effort, the agencies announced a Memorandum of Understanding (MOU) to help prevent interruptions at FDA-regulated food facilities, including fruit and vegetable processing. This is an important step in preparing for peak harvesting seasons and allows the agencies to make determinations about potential future circumstances. To read more from IFAC regulatory counsel Covington & Burling, please click here.

FDA, USDA Recommendations to Food and Agriculture Sector on PPE* On May 22, FDA published a CFSAN Constituent Update announcing it and USDA created recommendations to help address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industry during the COVID-19 pandemic. It was noted the current shortages of these supplies are causing concerns about potential interruptions to the food supply chain. The recommendation states that PPE should go first to healthcare, public health, and emergency services sectors and then to food and agriculture sector workers. The recommendations provide information on potential sourcing of supplies and steps they should take when ordering supplies as the food and agriculture sector.

FDA Announces Temporary Policy on Labeling Requirements On May 22, FDA issued a guidance document to provide additional temporary flexibility to food manufacturers and vending machine operators regarding labeling requirements. The goal is to provide regulatory flexibility, where appropriate, to help reduce any disruptions to the supply chain associated with the current COVID-19. FDA is providing flexibility for manufacturers to make minor changes in certain circumstances without making required label changes.

The guidance was issued following an exchange between FDA and the Food & Beverage Issue Alliance (FBIA), during which several FBIA member associations requested that FDA allow flexibility regarding certain de minimis and intermediate changes. IFAC became aware of the FBIA request after it had been submitted, and shared IFAC member feedback opposing a number of the substitution requests with FBIA.

FDA accepts comments on guidance documents at any time. Based on previous member feedback objecting to some of FBIA’s requests, please advise me whether you support; IFAC does not plan to comment on this guidance unless otherwise advised by Friday, June 12.

FDA Guidance on Temporary Closures or Production Reductions In May, the FDA issued a guidance document entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.” The guidance provides a mechanism for FDA-regulated establishments of human food facilities and farms to voluntarily notify the agency of temporary closures and significant changes to operations. Facilities can request support from FDA on issues that might impact their operations during the pandemic. FDA accepts comments on guidance documents at any time; IFAC does not plan to comment on this guidance unless otherwise advised by Friday, June 12.

Grocery Store Prices Soar in April A May 8 Washington Post article notes grocery stores experienced the sharpest price increases in almost 50 years. The record prices for meats, vegetables, and cereals were seen amid a drop in the consumer price index and significant job loss. Geri Henchy, director of nutrition policy for the Food Research & Action Center, attributed the increases to shifts in where consumers purchase food and supply chain disruptions due to COVID-19. It is noted high grocery prices are expected for the next several months while production challenges are addressed.

IFAC Updates

IFAC 2020 Mid-Year Meeting to Be Held Virtually Due to the ongoing COVID-19 pandemic, IFAC will hold the 2020 Mid-Year Meeting as a virtual meeting from June 15-16. The meeting schedule and calendar invites have been sent. If you have not received the schedule and invites, please reach out to staff. We look forward to having productive meetings later this month!

IFAC Signs on to Stakeholder Letter Supporting AG CHAIN Act On May 12, the International Dairy Foods Association (IDFA) sent a stakeholder letter to Congress, that IFAC signed on to, supporting the “Assistance and Gratitude for Coronavirus Heroes in Agribusiness who are Invaluable to the Nation Act” or the AG CHAIN Act. The AG CHAIN Act was officially introduced in the House by Representatives G.T. Thompson (R-PA) and Dwight Evans (D-PA). You can access a copy of the Thompson/Evans press release and a link to the bill as introduced here. Attached is a copy of the final version of the stakeholder letter in support of the legislation. Thirty organizations signed on to this letter which signals growing support for proposals like this among the food and agriculture community.

Webinar on the National Bioengineered Food Disclosure Standard On May 26, IFAC staff attended a webinar on USDA's National Bioengineered Food Disclosure Standard (NBFDS). This webinar was organized by FBIA and the Institute of Food Technologists (IFT), in partnership with the Consumer Brands Association. It discussed the requirements of NBFDS to highlight concerns and offer recommendations for ingredient suppliers as food and beverage manufacturers to comply with the regulation. Attached are staff notes of the webinar and a recording of the webinar is available here.

Webinar on Dietary Ingredient Master Files On May 27, IFAC staff attended a webinar hosted by the Council for Responsible Nutrition (CRN) entitled “What New Dietary Ingredient Master Files Mean for Innovation & Compliance.” FDA first raised the concept of Master Files for dietary supplements in its 2016 revised guidance on New Dietary Ingredient Notifications (NDINs). The agency views master files as a tool to promote better compliance with NDIN requirements.

IFAC’s Microbial Food Cultures & Probiotics Task Force has been discussing the Master File concept for demonstrating the safety of live microbial dietary ingredients (LMDI) and probiotics with FDA’s Office of Dietary Supplement Programs for several years. Staff has reached out to CRN to discuss their approach and explore opportunities to align and collaborate.

FDA Updates

FDA Files Color Additive Petition on Spirulina On May 8, FDA published a notice in the Federal Register announcing that the agency filed a petition, submitted by GNT USA, Inc., proposing to amend the color additive regulations to expand the use of spirulina extract (Arthrospira platensis). This expanded use includes alcoholic beverages, non-alcoholic beverages, condiments and sauces, dips, plant-based products, salad dressings, and seasoning mixes at levels consistent with good manufacturing practice.

The notice indicates FDA filed the petition on February 21, 2020. It also states the agency has determined this type of action does not have a significant effect on humans, so does not require an environmental assessment or environmental impact statement. Therefore, it appears the proposed expanded uses have been approved.

FDA Files Food Additive Petition for Animal Feed On May 11, FDA published a notice in the Federal Register announcing that the agency filed a petition, submitted by Adisseo France S.A.S., proposing that the food additive regulations be amended to include selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle. The notice indicates FDA filed the petition on March 27, 2020, and states the petitioner claims this action is categorically excluded because it does not have a significant effect on humans. FDA is reviewing the petition to determine whether it agrees, in which case neither an environmental assessment nor an environmental impact statement will be needed.

FDA’s Botanical Safety Consortium Holds First Meeting On May 4, FDA published a CFSAN Constituent Update announcing the Botanical Safety Consortium (BSC) would host its first annual meeting on May 29. The BSC was established by the FDA, the National Institute of Environmental Health’s Sciences (NIEHS), and the Health and Environmental Sciences Institute (HESI), and follows FDA’s activities to address responsible innovation in dietary supplements. The purpose of the meeting was to recruit new members and have discussions on current scientific challenges and opportunities related to botanical ingredient safety. A recording of the webcast can found here.

IFAC’s Microbial Food Cultures & Probiotics Task Force has asked that FDA consider creating a similar public-private partnership related to the LMDI and probiotics industry. These discussions are ongoing.

FDA Update on Food Additives Permitted in Animal Feed and Drinking Water On May 14, FDA published a notice in the Federal Register announcing that it is amending a notice relating to a Canadian Oilseed Processors Association (COPA) petition requesting to amend the food additive regulations to provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. The petition also proposes that the regulations be amended to provide for the safe use of silicon dioxide and diatomaceous earth as components of spent bleaching clay. FDA asked that COPA submit a revised environmental assessment (EA), so this notice is to announce that the EA has been placed in the docket for public review and comment.

Comments may be submitted on the revised EA by June 15. IFAC does not plan to submit comments unless otherwise advised by Friday, June 12.

FDA Opens Comment Period for Third Party Disclosure and Recordkeeping On May 14, FDA published a notice in the Federal Register announcing the opportunity for public comment on a proposed collection of certain information regarding third party disclosure and recordkeeping. This notice requests comments on the requirements for certain FDA applications or submissions to be accompanied by a certification to ensure all appropriate regulatory requirements have been met. FDA estimates the annual reporting burden for firms in charge of a domestic or foreign facility engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. who have information on a reportable food.

The comment period ends on July 13. IFAC does not plan to submit comments unless otherwise advised by Friday, June 12.

FDA Sends Proposed Collection of Data on Nutrition Labeling to OMB On May 20, FDA published a notice on the Federal Register announcing that a proposed collection of information related to nutrition labeling for food and dietary supplements has been submitted to the Office of Management and Budget (OMB) for review. The information collection will be on food regulations (including labeling) and requires respondents be manufacturers and distributors of food products such as supermarkets and restaurants. The comment period ends on June 19. IFAC does not plan to submit comments.

FDA Extends Application Period for VQIP On May 22, FDA published a CFSAN Constituent Update announcing that it would be extending the application period for importers to submit their notice of intent and completed application to participate in the Voluntary Qualified Importer Program (VQIP) for the Fiscal Year 2021 benefits period. The application portal will continue to be open until July 31, 2020, after which it will close to allow time for the agency to review applications before the start of the annual benefits period that will begin on October 1, 2020.

FDA Extends Comment Period for IA Draft Guidance On May 27, FDA published a CFSAN Constituent Update announcing that it is extending the comment period for the third installment of the draft guidance intended to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule under the FDA Food Safety Modernization Act (FSMA). The Agency released the third installment of the draft guidance in February 2020. Since the last draft guidance, FDA has received a request to allow stakeholders adequate time to provide comprehensive feedback. The deadline for comments will be extended until August 14, 2020.

IFAC commented on the first IA draft guidance and agreed to wait until the third guidance is published before considering comments. Staff is also following the actions of FBIA, which will likely submit comments. Staff will circulate separate requests for input on possible IFAC comments on the second and third draft IA guidance documents, but if you have any initial suggested feedback please share with staff by Friday, June 12.

Other U.S. Updates

U.S. Food Safety Failing to Reduce Food Illnesses On May 1, Food Safety News reported that incidences of continue to increase across the U.S. According to the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), data from 2016-2018 show that the federal government’s Healthy People 2020 targets for reducing food illnesses were not met. The research team stated that the data could have been better if businesses would adopt proven food safety measures. Also, green produce and chicken were highlighted as the sources of many foodborne illness cases.

CRN 8th Legal, Regulatory and Compliance Forum on Dietary Supplements Between June 23-25, the CRN will be virtually hosting its 8th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. Throughout the three days, 35 leading speakers will discuss their industry insights on the Dietary Supplement Definition NDI notification vs. GRAS determination, the current legal status for CBD in dietary supplements, increased state consumer protection activity, and many more topics. If members are interested in learning and registering for the event, please click here (note, registration before June 5 is $2,095 and then increases to $2,295 until June 22). IFAC does not plan to participate.

International Updates

Health Canada Approves Use of and its Salts in Oyster Flavored Sauce On May 5, Health Canada issued a Notice of Modification enabling the use of benzoic acid and its potassium and sodium salts as a used at a maximum level of 1,000 parts per million in oyster-flavored sauce. According to the Notice, oyster-flavored sauce is an unstandardized fish product so is not permitted to contain either benzoic acid or salts of benzoic acid due to an exception per the List of Permitted . The agency reviewed its files and determined there was no scientific reason to uphold the exception, and also found benzoic acid and its salts have been shown to demonstrate effective antimicrobial activities with regard to the preservation of meat and fish. Based on this determination, Health Canada approved its use and updated the List of Permitted Preservatives.

EFSA Stakeholder News #49 On May 8, the European Food Safety Authority (EFSA) published its monthly Stakeholder News bulletin. Topics include residues in food, the Xylella fastidiosa pathogen, and Campylobacter in broiler meat.

EU Survey on Farm to Fork Strategy The European Union (EU) lunched a survey on “Testing and demonstrating systemic innovations for sustainable food from farm to fork.” The survey is part of the EU’s Farm to Fork Strategy, which outlines the ambition to transform European food systems into the global standard for sustainability. It tackles challenges such as climate change, biodiversity loss, and the degradation of land and sea. The deadline for comments is June 3. IFAC does not plan to comment.

Codex Decisions on Upcoming Meetings in 2020 On May 15, the Codex Alimentarius Commission (CAC) Secretariat, Tom Heilandt, circulated a letter (include link to pdf) to all Codex Contact Points indicating the status of upcoming Codex meetings. In short, a number of Codex Committees scheduled to meet in 2020 have been postponed or cancelled.  The Codex Committee on Food Additives (CCFA) has been postponed until March 8-12, 2021. Terms of reference for electronic Working Group efforts in advance of 2021 are expected to be distributed in June.  The Codex Committee on General Principles is being rescheduled for the first quarter of 2021.  The Codex Executive Committee (CCEXEC) and CAC meetings scheduled for June and July, respectively, have been postponed but not yet rescheduled.  The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), as well as other meetings scheduled to take place the second half of the year, are likely to be postponed but an official decision will be announced at a later date.