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IFAC Updates IFAC Signs on to Industry Comments on Proposed

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IFAC Updates IFAC Signs on to Industry Comments on Proposed IFAC Updates IFAC Signs on to Industry Comments on Proposed Rule on Gene Editing On August 6, IFAC and other food and agriculture associations submitted the attached comments on the U.S. Department of Agriculture’s (USDA) proposed rule titled “Movement of Certain Genetically Engineered Organisms”. The new rule would allow crops grown with genetic modification techniques with a long history of safe use to bypass USDA’s regulatory process. Furthermore, crops produced with gene-editing techniques such as CRISPR would also continue to be nonregulated if they don’t pose a plant pest risk. Note, the rule will not impact how the U.S. Food and Drug Administration (FDA) regulates GM food products. Given that this rule would permit genetically-engineered plants on the market that are not acknowledged by USDA, consumer transparency would be limited. Industry comments requested the proposed rule be modified to ensure transparency between industry and consumers. Other than avoiding risking consumer transparency and trust, the letter also highlighted the potential for the proposed rule to generate trade disruptions for U.S. exports. According to an article published August 6 by Feedstuffs, several comments submitted to the docket were in favor of the new science-based regulatory approach, while several strongly encouraged USDA to require developers to notify the agency of their intent to market new plants produced through biotechnology. Many organizations expressed concerns on the reduction of consumer awareness and potential for trade disruptions. IFAC Submits Resolution for 2020 USP Convention; Endorses USP & IPEC Resolutions On August 30, IFAC submitted the attached proposed resolution for next year’s U.S. Pharmacopeia (USP) Convention. As agreed at IFAC’s Mid-Year Meeting, staff also shared the resolution with FDA as well as dietary supplement organizations, including the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and the International Probiotics Association (IPA), for their potential endorsement at the 2020 USP Convention. Based on member support, IFAC also endorsed a resolution developed by the USP Council of Conventions titled “Quality Standards”. The resolution states, “USP will be a definitive source and a recognized leader in quality standards for medicines, dietary supplements, excipients, and food ingredients, to help protect patient and consumer safety and to meet the needs of regulators and policy makers, healthcare practitioners, and industry working in evolving global regulatory environments. In doing so, USP will work to identify emerging trends, align with technological advances, and develop innovative and agile approaches to address the future needs of industry, regulators, practitioner, and patient needs.” Finally, based on member feedback, IFAC agreed to endorse the International Pharmaceutical Excipients Council’s (IPEC) resolution titled “Quality Standards for Dietary Supplements and Their Ingredients” (IA USP Resolution 1; attached) and their second resolution titled “Develop a Framework for Non-Standard Excipient Monographs” (IA USP Resolution 2; attached) at the 2020 USP Convention. August 2019 IFAC China Monitoring Report Attached is the August 2019 IFAC China Regulatory Monitoring Report, which contains the following four public announcements published by the China National Center for Food Safety Risk Assessment (CFSA) and the National Health Commission of the People's Republic of China (NHC). Call for Comments on 21 New Food Related Products including Wollastonite: On August 21, CFSA announced an expanded scope of use and usage amount allowed for food additives used for food contact material and its products. The products include Wollastonite, Erucamide; cis-13- Docosenam. They also included new food additives, expansion of use scope of resins, new resins. The list can be found on the attached document. The deadline to submit comments on these products is September 19. As the additives covered do not appear relevant to members, IFAC does not plan to provide comments unless otherwise advised by Friday, September 20. Call for Comments on 8 New Food Additives including Polygalacturonase: On August 9, CFSA requested comments on food additives such as Polygalacturonase and maltotetraohyrolase. There were also increased of use scope of processing aid and food nutrition enhancer. As the deadline has passed and the additives covered do not appear relevant to members, IFAC does not plan to submit comments unless otherwise advised by Friday, September 20. Announcement of Maximum Limits for Pesticide Residue in Food: On August 28, NHC issued three national food safety standards relating to limits of pesticide residue, identification of pesticides, and determination of oxine-copper residue in plant-based foods. The regulations will go into effect 6 months after the announcement, or approximately February 15, 2020. Announcement of 2019 National Food Safety Standards Development Plan: On August 12, NHC announced the final working plan for the 2019 work on food standards. This final working plan has some changes from the previous draft of working plan that called for public comments in May. The order of projects has been modified due to the removal or modification of certain previously proposed projects. The attached IFAC China update has a list of the final version. U.S. FDA Updates FDA Issues Fact Sheet on Menu Labeling Implementation On August 13, the U.S. Food and Drug Administration (FDA) released a fact sheet to notify parties about the agency’s efforts to institute menu labeling in chain restaurants and similar food establishments. FDA stated that they will continue to work with industry as well as engage with regulatory partners to ensure common implementation of the menu labeling requirements. Chain restaurants and similar retail food establishments were required to implement the menu labeling requirements on May 7, 2018. The requirements are meant to provide consumers with consistent nutrition information to enable informed and healthy dietary choices. For the first year, FDA worked with food establishments to understand the requirements; going forward the agency will continue to provide assistance and flexibly to successfully implement the requirements. FDA also plans to analyze industry implementation efforts of the menu labeling requirements to improve agency education and outreach. FDA Announces Public Meeting on Connection between Color Additives and Children's Behavior On September 12, the Science Board to the FDA announced in the Federal Registrar that it will host a public meeting on October 7 in Silver Spring, Maryland, to discuss the effects of color additives in children’s behavior. The Science Board is an FDA Advisory Committee that provides advice to the FDA Commissioner and other officials on specific, complex scientific and technical issues important to FDA and its mission. The meeting will be available via webcast for those unable to attend in person. There is also an opportunity to provide written comments by September 30, 2019. IFAC staff is not planning to attend. However, please let me know if you are planning to attend or would like IFAC to develop written comments by Tuesday, September 24. FDA Issues Warning Letter to Importer of Tahini On August 13, FDA announced its first warning letter using the specific authority granted by the Food Safety Modernization Act (FSMA) Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals. Until now, FDA had been conducting FSVP inspections to help educate firms on FSVP expectations. Now, the agency is taking more steps to ensure industry compliance with FSVP. The warning letter was issued to the Brodt Zenatti Holdings LLC, which imported tahini from an Israel-based manufacturer. This tahini was recalled due to a Salmonella outbreak in May. FDA found the company in significant violation of the FSVP rule. FDA Issues Guidance on Conversion of Certain Nutrients for Labeling On August 15, FDA issued a final guidance for industry on how to convert past units of measure for folate, niacin, vitamin A, vitamin D, and vitamin E to new units required on the updated Nutrition Facts and Supplement Facts labels. The guidance serves to address the 2016 amendment to FDA’s regulation for labels to include updated Daily Values (DV) as Reference Daily Intakes (RDIs), which reflect new units of measure associated with updated Recommended Dietary Allowances (RDAs) established by the National Academies of Medicine. The conversions are as follows: Folate: Micrograms Micrograms dietary folate equivalents (mcg DFE) Niacin: Milligrams (mg) Milligrams Niacin Equivalents (mg NE) Vitamins A: International units (IU) Micrograms (mcg) Vitamins D: International units (IU) Micrograms (mcg) Vitamin E: International units (IU) mg alpha (α) tocopherol The compliance date for these changes is January 1, 2020 for manufacturers generating $10 million or more in annual food sales. Manufacturers generating less than $10 million annually have an additional year to comply. Other U.S. Updates White House Announces new Tariffs that will Impact Dietary Supplements On August 2, NutraIngredients reported on President Trump’s announcement of new 10% tariffs on an additional $300 billion worth of Chinese goods. The proposed levies were later postponed until December on August 13. These tariffs were supposed to be applied to most dietary supplements, which contain ingredients from China. Industry leaders
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