Food, Dietary Supplement & Cosmetics Regulatory Update | Vol. III, Issue 16
FDA Amends Regulation Regarding Health Claims on Fruits and Vegetables
FDA issued an interim final rule amending the regulation that governs when a food label may make a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease ("CHD"). Health claims, in general, are used on foods containing one or more of vitamin A, vitamin C, iron, calcium, protein, or fiber at or above 10 percent of the Reference Daily Intake or Daily Reference Value. Some fruits and vegetables, like grapes, plums, beets, and cucumbers, had been ineligible to bear the CHD health claims because they do not contain a minimum amount of certain nutrients and/or they do not meet the definition of a "low fat" food. The new rule allows low saturated fat and low cholesterol fruits and vegetables to bear the CHD health claims.
The FDA is not amending the health claim requirements for frozen or canned vegetables at this time but invites comment on the issue. This interim final rule is effective immediately and has a 75-day comment period.
FDA Issues Regulation Related to FSMA's Third-Party Certification Bodies
FDA published the final rule "Amendments to Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications to Provide for the User Fee Program" and the final guidance "Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards" under the FDA Food Safety Modernization Act ("FSMA").
In November 2015, the FDA announced the final rule "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications," which establishes a voluntary program to accredit third-party certification bodies, or auditors, to conduct food safety audits of foreign food entities and certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements. The new final rule provides for a reimbursement, or user-fee, program to assess fees and require reimbursement for the work the agency performs to establish and administer the third-party certification program. The final guidance contains FDA recommendations and describes the standards for accreditation of third-party certification bodies as required by FSMA under the voluntary third-party certification program. The FDA issued a draft version of this guidance in July 2015. In establishing the model standards, FDA refers specifically to International Organization for Standardization ("IOS")/International Electrotechnical Commission ("IEC") recommendations.
FDA Starts Publishing Adverse Event Report Data for Foods and Cosmetics
On December 6, 2016, FDA announced that the Center for Food Safety and Applied Nutrition ("CFSAN") will post on a quarterly basis data extracted from adverse event reports related to the use of conventional foods (including dietary supplements) and cosmetics, in order to "increase transparency and improve access to government data for consumers, health care providers, researchers and academics."
The FDA uses adverse event reports to help monitor the safety of foods and cosmetics. The CFSAN Adverse Event Reporting System, or CAERS, captures minor to major medical events, as well as complaints about off-taste or color of a product, defective packaging, and other non-medical issues. The information in the database has not been edited or (in many cases) evaluated by the FDA; the agency has not necessarily determined if the product or products in question were the actual cause of the events reported. In addition, only adverse events related to the use of dietary supplements are required to be reported to FDA. Adverse event reporting is voluntary for food and cosmetic companies. The FDA anticipates that "this increased transparency will help to spur the submission of more detailed and complete reports from consumers, health care providers and other members of the public."
USDA Proposes Revisions to Nutritional Fact Panel for Meat and Poultry Products
On December 1, 2016, USDA's Food Safety and Inspection Service ("FSIS") proposed to amend the nutrition labeling regulations for meat and poultry products to parallel FDA's final nutrition regulations, published on May 27, 2016. Specifically, FSIS proposed to: (i) update the list of nutrients that are required or permitted to be declared (for example, requiring the declaration of "added sugars"); (ii) provide updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports (for example, lowering the sodium value from 2,400 mg to 2,300 mg); (iii) amend the labeling requirements for foods represented or purported to be specifically for children under the age of four years and for pregnant and lactating women, and establish nutrient reference values specifically for these population subgroups; (iv) revise the format and appearance of the Nutrition Facts label to, among other things, increase the prominence of "Calories" and "Serving size"; (v) amend the definition of "single-serving container"; (vi) require dual-column labeling for certain containers; (vii) update and modify several reference amounts customarily consumed; and (viii) consolidate the nutrition labeling regulations for meat and poultry products into a new Code of Federal Regulations part. FSIS intends the proposed rule to "better reflect the most recent scientific research and dietary recommendations and to improve the presentation of nutrition information to assist consumers in maintaining healthy dietary practices." FSIS is seeking public comment for 60 days from the publication date.
CSPI Files Petition with USDA to Add Cancer Warnings on Meat and Poultry Products
On December 1, 2016, the Center for Science and the Public Interest ("CSPI") requested that USDA's FSIS mandate a warning label on processed meat and poultry products preserved by smoking, curing, salting, and/or the addition of chemical preservatives that informs the public that their frequent consumption may increase the risk of colorectal cancer, and that the consumption of these products should be limited. FSIS is the agency responsible for safeguarding the public by ensuring that the labels on meat and poultry products provide consumers with information about nutrition, ingredients, and health risks.
The petition is based in part on the findings of the International Agency for Research on Cancer, which concluded in 2015 that processed meat is "carcinogenic to humans." The memo is also supported by a letter from a dozen nutrition and epidemiology experts, who state that "the level of risk posed by processed meats may have contributed to as many as 5,000 colorectal cancer deaths in 2015 alone." The letter, which endorses the idea of the warning label, also states that "people want clear and accurate information about potential health hazards in the foods they eat to help them make wise choices at the grocery store and restaurants," and it emphasizes that "food that is associated with cancer risks is certainly a matter of great public concern." In June 2016, the U.S. Preventive Services Task Force recommended that all adults aged 50 be screened with colonoscopy, fecal occult blood tests, or other measures.
FDA Issues Draft Guidance on Fiber and Requests Comments
On May 27, 2016, FDA published its final nutrition labeling rule requiring that only certain naturally occurring dietary fibers be declared on the label under "Dietary Fiber." Qualifying dietary fibers include those found in fruits, vegetables, and whole grains, and seven added isolated or synthetic fibers that FDA determined have a physiological effect that is beneficial to human health. The FDA is now requesting scientific data, information, and comments to evaluate the beneficial physiological effects to human health of isolated or synthetic nondigestible carbohydrates that are added to foods. This information is aimed at helping the Agency determine whether certain fibers should be added to the definition of "dietary fiber" for purposes of being declared as dietary fiber in a Nutrition Facts or Supplement Facts label. FDA also issued a report where a review of the scientific evidence identified for 26 additional specific types of fiber is provided.
The draft guidance explains how FDA reviews the scientific evidence to determine whether these other isolated or synthetic fibers (beyond the seven identified in the rule) should be added to the regulations. Comments can be submitted until January 9, 2017.
U.S. Senators Request President Obama to Further China's GMO Approvals
On November 15, 2016, 37 senators sent President Barack Obama a joint letter requesting that the President continue the dialogue with China to obtain its cooperation to approve agriculture biotechnology products from the United States at the Joint Commission Commerce and Trade ("JCCT") meeting held at the end of November. The letter, which acknowledges last year's efforts to revise Chinese regulatory policies, also states that China's commitments for these approvals have not yet been effectuated as "there are currently outstanding products pending final approval, some of which have been awaiting approval for over five years." Both the United States and China agreed during the JCCT to "further cooperation and discussions regarding import requirements related to food safety."
UK Bans Advertisement of Unhealthy Foods to Children
On December 8, 2016, the UK's Committee of Advertising Practices announced new rules banning the advertising of high fat, salt, or sugar ("HFSS") food or drink products in children's media. The rules will apply across all non-broadcast media including in print, cinema, and online and in social media. The purpose of the ban is to help protect the health and wellbeing of children in the context of wider concerns in society about childhood obesity and the public health challenges it poses. The new rules also respond to shifting media habits among young people and evolving advertising techniques that have fundamentally changed children's relationship with the media and advertising. The rules, which will apply in media targeted at under-16s, will come into effect on July 1, 2017.
FDA Amends Food Labeling Regulations Related to Saturated Fat and Cholesterol
As discussed above, in the December 19, 2016, Federal Register, FDA issued an interim final rule amending 21 C.F.R. § 101.75, which authorizes a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease, to permit raw fruits and vegetables that fail to comply with the "low fat" definition and/or the minimum nutrient content requirement to be eligible to bear the claim. FDA is making the amendment in response to a petition submitted by the American Heart Association. The rule was effective December 19, 2016, and comments are due March 6, 2017.
FDA Announces Draft Guidance for Industry: Fruit and Vegetable Juice as Color Additives
In the December 14, 2016, Federal Register, FDA announced the availability of a draft guidance for industry titled "Fruit Juice and Vegetable Juice as Color Additives in Food." Once finalized, the draft guidance will help manufacturers determine whether a color additive derived from a plant material meets the specifications under FDA color additive regulations at 21 C.F.R. § 73.250 (fruit juice) and § 73.260 (vegetable juice). Specifically, the guidance interprets terms used in the regulations, including "fruit," "vegetable," "mature," "fresh," "expressing the juice," "water infusion of the dried fruit or vegetable," and "edible." Comments are due February 13, 2017.
FDA Issues Final Rule Amending Regulations on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits
As noted above, in the December 14, 2016, Federal Register, FDA issued a final rule amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to administer the third-party certification program under the FSMA. The rule is effective January 13, 2017.
FDA Announces Draft Guidance for Industry: Food Contact Notifications for Infant Formula and Human Milk
In the December 9, 2016, Federal Register, FDA announced the availability of a draft guidance for industry titled "Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk." The draft guidance provides recommendations for preparing food contact notification submissions for FDA review and evaluation of the safety of food contact substances used in contact with infant formula and/or human milk. Food contact substances affected by the guidance include infant formula packaging for both liquid and powdered formula, baby bottles, bottle inserts, nipples, and any other materials in contact with infant formula and human milk. Comments are due February 7, 2017.
FDA Announces Guidance for Industry: Third-Party Certification Body Accreditation for Food Safety Audits
As noted above, in the December 7, 2016, Federal Register, FDA announced the availability of a guidance for industry and FDA staff titled "Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards." The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under the FSMA. The guidance describes the standards for accreditation of third-party certification bodies as required under the regulations. In addition, the guidance recommends that accreditation bodies consider using certain clauses of IOS/IEC conformity assessments as a model when making accreditation decisions.
FDA Approves Food Additive
In the November 30, 2016, Federal Register, FDA amended the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG. The rule was effective November 30, 2016, and objections and requests are due December 30, 2016.
FDA Issues Final Rule Related to the Submission of FDA Import Data in the Automated Commercial Environment
In the November 29, 2016, Federal Register, FDA issued a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment ("ACE") or any other electronic data interchange ("EDI") system authorized by the U.S. Customs and Border Protection Agency ("CBP"), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System, automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. FDA also updated certain sections of FDA regulations related to imports. This rule aims to facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk. The rule is effective December 29, 2016.
FDA Establishes Uniform Compliance Date for Food Labeling Regulations
In the November 25, 2016, Federal Register, FDA issued a final rule establishing January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. FDA periodically announces uniform compliance dates for new food labeling requirements intended to minimize the economic impact of label changes. The rule was effective November 25, 2016, and comments are due January 24, 2017.
FDA Amends Food Additive Regulations
In the November 22, 2016, Federal Register, FDA amended the food additive regulations to no longer provide for the use of two specific perfluoroalkyl-containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods. FDA found that these uses have been permanently and completely abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of 3M Corporation. The rule was effective November 22, 2016, and objections and requests are due December 22, 2016.
FDA Reopens Period to Comment on Draft Guidance: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling
In the November 21, 2016, Federal Register, FDA reopened the comment period for the notice, published in the Federal Register of September 9, 2016, announcing the availability of the draft guidance for industry titled "Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling." The draft guidance, when finalized, will describe the type and quality of evidence that FDA recommends that infant formula manufacturers and distributors have to substantiate structure/function claims in infant formula labels and labeling. FDA is reopening the comment period in response to a request for an extension to allow interested persons additional time to submit comments. Comments are due February 21, 2017.
FSIS Issues Final Rule Establishing Uniform Compliance Date for Food Safety Regulations
In the December 19, 2016, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") issued a final rule establishing January 1, 2020, as the uniform compliance date for new meat and poultry product labeling regulations that are issued between January 1, 2017, and December 31, 2018. FSIS periodically announces uniform compliance dates for new meat and poultry product labeling regulations to minimize the economic impact of label changes. The rule was effective December 19, 2016, and comments are due January 18, 2017.
FNS Issues Final Rule Enhancing Retailer Standards in SNAP
In the December 15, 2016, Federal Register, USDA's Food and Nutrition Service ("FNS") issued a final rule updating Supplemental Nutrition Assistance Program ("SNAP") regulations that govern when retail food stores are eligible to participate in the program. The rule, which finalized a proposed rule published on February 17, 2016, codified mandatory requirements in the Agricultural Act of 2014 pertaining to retail food stores. Specifically, the Act increased the requirement that certain SNAP-authorized retail food stores have available on a continuous basis at least three varieties of items in each of four staple food categories to a mandatory minimum of seven varieties and increased the minimum number of staple food categories in which perishable foods are required from two to three. In addition, the final rule codifies several other discretionary changes to the existing eligibility criteria: (i) establishes a minimum of three stocking units per staple food variety; (ii) amends the definitions of "staple food," "retail food store," and "ineligible firms"; and (iii) allows FNS to consider the need for food access when making a SNAP authorization determination for applicant firms that fail to meet certain authorization requirements and reaffirms FNS's authority to disclose to the public certain information about retailers who have violated SNAP rules. The rule is effective January 13, 2017.
AMS Proposes Changes to PACA Regulations
In the December 14, 2016, Federal Register, USDA's Agricultural Marketing Service ("AMS") issued a proposed rule to amend the regulations under the Perishable Agricultural Commodities Act ("PACA") to enhance clarity and improve administration and enforcement. Specifically, the proposed revisions to the regulations would provide greater direction to industry on how growers and other principals that employ selling agents may preserve their PACA trust rights. The proposed revisions would further provide greater direction to industry on the definition of "written notification" and the jurisdiction of USDA to investigate alleged PACA violations. Comments are due February 13, 2017.
FNS Issues Final Rule Updating SNAP EBT Requirements
In the December 13, 2016, Federal Register, USDA's FNS issued a final rule updating SNAP regulations to set implementation parameters, prerequisites and operational standards required of state agencies that intend to implement the photo Electronic Benefit Transfer ("EBT") card option provided under the Food and Nutrition Act of 2008. Specifically, the updated regulations establish procedures to ensure state implementation is consistent with all federal requirements as they relate to photo EBT cards, including establishing procedures to ensure: (i) any other appropriate member of the household or authorized representative (including any individual permitted by the household to purchase food on its behalf) who is not pictured on the photo EBT card may use the card; and (ii) placing photos on EBT cards does not affect the eligibility process and does not impose additional conditions of eligibility or adversely impact the ability of appropriate household members to access the nutrition assistance they need. Failure by a state agency to adhere to the provisions of this rule may result in penalties, including loss of federal funding. The rule is effective January 12, 2017.
FAS Issues Technical Amendment to Dairy Tariff-Rate Quota Import Licensing Program
In the December 6, 2016, Federal Register, USDA's Foreign Agricultural Service ("FAS") issued a final rule amending the Dairy Tariff-Rate Quota Import Licensing Program to clarify that, for the purposes of the program, U.S. Customs and Border Protection import entries submitted electronically, as well as on paper, are acceptable. The rule was effective December 6, 2016.
AMS Announces Guidance for Calculating the Percentage of Organic Ingredients in Multi-Ingredient Products
In the December 6, 2016, Federal Register, USDA's AMS announced the availability of a draft guidance document intended for use by accredited certifying agents and certified handling operations titled "Calculating the Percentage of Organic Ingredients in Multi-Ingredient Products." Specifically, the guidance provides procedures on how to: (i) calculate organic percentages of multi-ingredient ingredients used in organic processed products; (ii) determine the organic content of single-ingredient ingredients (raw or processed); (iii) exclude water from ingredients used in organic processed products; (iv) calculate the organic content of carbonated beverages; and (v) exclude salt from ingredients used in organic processed products. Comments are due February 6, 2017.
AMS Proposes Changes to Reporting and Notification Requirements and Other Clarifying Changes for Imported Fruits, Vegetables, and Specialty Crops
In the December 5, 2016, Federal Register, USDA's AMS issued an interim rule that updates reporting and notification requirements associated with, and makes clarifying changes to, the fruit, vegetable, and specialty crop import regulations for certain commodities regulated under section 608(e) of the Agricultural Marketing Agreement Act of 1937. The updates include shifting the exempt reporting requirement for imported tomatoes destined for noncommercial outlets for experimental purposes from the tomato import regulations to the safeguard procedures section of the vegetable import regulations. In addition, the pistachio import regulations will be updated by removing reference to a paper-based notification of entry process. The rule was effective December 8, 2016, and comments are due February 3, 2017.
AMS Proposes Changes to Export Reporting Requirements for Apples, Grapes, and Plums
In the December 5, 2016, Federal Register, USDA's AMS proposed to change the reporting of export certificate information under regulations issued pursuant to the Export Apple Act (7 CFR part 33) and the Export Grape and Plum Act (7 CFR part 35). This change would require shippers of apples and grapes exported from the United States to electronically enter an Export Form Certificate number or a USDA-defined exemption code into the Automated Export System. This rule would also define "shipper," shift the current file retention requirement from carriers to shippers, and require shippers to provide, upon request, copies of the certificates to AMS. These changes are intended to enable AMS to track exported apple and grape shipments to ensure that exports meet inspection and certification requirements. Comments are due January 4, 2017.
FNS Proposes Amendments to the Supplemental Nutrition Assistance Program
In the December 1, 2016, Federal Register, USDA's FNS proposed to implement four sections of the Agricultural Act of 2014, affecting eligibility, benefits, and program administration requirements for the Supplemental Nutrition Assistance Program ("SNAP"). Section 4007 clarifies that participants in a SNAP Employment & Training program are eligible for benefits if they are enrolled or participate in specific programs that will assist SNAP recipients in obtaining the skills needed for the current job market. Section 4008 prohibits anyone convicted of federal aggravated sexual abuse, murder, sexual exploitation and abuse of children, sexual assault, or similar state laws, and who are also not in compliance with the terms of their sentence or parole or are a fleeing felon, from receiving SNAP benefits. Section 4009 prohibits households containing a member with substantial lottery and gambling winnings from receiving SNAP benefits, until the household meets the allowable financial resources and income eligibility requirements of the program. Section 4009 also provides that state SNAP agencies are required, to the maximum extent practicable, to establish cooperative agreements with gaming entities in the state to identify SNAP recipients with substantial winnings. Section 4015 requires all state agencies to have a system in place to verify income, eligibility, and immigration status. Comments are due January 30, 2017.
AMS Proposes to Revise U.S. Standards for Grades of Shelled Walnuts and Walnuts in the Shell
In the November 25, 2016, Federal Register, USDA's AMS proposed to revise the U.S. Standards for Grades of Shelled Walnuts and the U.S. Standards for Grades of Walnuts in the Shell by including red colored walnuts. In addition, AMS proposed to remove the "Unclassified" section. The changes aim to modernize the standards and meet growing consumer demand by providing greater marketing flexibility. Comments are due January 24, 2017.
Several Departments Issue Final Rules on Resource Agency Hearings and Alternatives Development Procedures in Hydropower Licenses
In the November 23, 2016, Federal Register, Departments of Agriculture, the Interior, and Commerce jointly issued final rules for procedures for expedited trial-type hearings and the consideration of alternative conditions and fishway prescriptions required by the Energy Policy Act of 2005. The hearings are conducted to expeditiously resolve disputed issues of material fact with respect to conditions or prescriptions developed for inclusion in a hydropower license issued by the Federal Energy Regulatory Commission under the Federal Power Act. The final rules make no changes to existing regulations that have been in place since the revised interim rules were published on March 31, 2015, and took effect on April 30, 2015. At the time of publication of the revised interim rules, the Departments also requested public comments on additional ways the rules could be improved. The Departments now respond to the public comments received on the revised interim rules by providing analysis and clarifications in the preamble. The Departments have determined that no revisions to existing regulations are warranted at this time. The rule was effective November 23, 2016.
FCIC Amends Common Crop Insurance Regulations
In the November 23, 2016, Federal Register, USDA's Federal Crop Insurance Corporation ("FCIC") amended the (a) Small Grains Crop Insurance Provisions, (b) Cotton Crop Insurance Provisions, (c) Extra Long Staple Cotton Crop Insurance Provisions, (d) Sunflower Seed Crop Insurance Provisions, (e) Sugar Beet Crop Insurance Provisions, (f) Hybrid Sorghum Seed Crop Insurance Provisions, (g) Coarse Grains Crop Insurance Provisions, (h) Safflower Crop Insurance Provisions, (i) Popcorn Crop Insurance Provisions, (j) Peanut Crop Insurance Provisions, (k) Onion Crop Insurance Provisions, (l) Tobacco Crop Insurance Provisions, (m) Green Pea Crop Insurance Provisions, (n) Dry Pea Crop Insurance Provisions, (o) Rice Crop Insurance Provisions, (p) Northern Potato Crop Insurance Provisions, (q) Central and Southern Potato Crop Insurance Provisions, (r) Dry Bean Crop Insurance Provisions, (s) Hybrid Seed Corn Crop Insurance Provisions, (t) Processing Sweet Corn Crop Insurance Provisions, (u) Processing Bean Crop Insurance Provisions, (v) Canola and Rapeseed Crop Insurance Provisions, (w) Millet Crop Insurance Provisions, and (y) Mustard Crop Insurance Provisions. The purpose of the final rule with comment is to update prevented planting coverage levels through the actuarial documents to improve actuarial considerations and coverage offered, program integrity, and to reduce vulnerability to program fraud, waste, and abuse. The changes to the Crop Provisions made in this rule are applicable for the 2017 and succeeding crop years for all crops with a 2017 contract change date on or after the effective date of the rule, and for the 2018 and succeeding crop years for all crops with a 2017 contract change date prior to the effective date of the rule. The rule was effective November 23, 2016, and comments are due January 23, 2017.
AMS Proposes United States Standards for Grades of Frozen Onions
In the November 23, 2016, Federal Register, USDA's AMS solicited comments on its proposal to create new United States Standards for Grades of Frozen Onions. The American Frozen Food Institute petitioned AMS to develop new grade standards for frozen onions. AMS has received additional industry comments on several discussion drafts of the proposed standards. The grade standards would provide a common language for trade, a means of measuring value in the marketing of frozen onions, and guidance on the effective use of frozen onions. Comments are due January 23, 2017.
AMS Proposes Provisions for Removing Commodity Research and Promotion Board Members and Staff
In the November 23, 2016, Federal Register, USDA's AMS proposed to amend the research and promotion orders—or the regulations under the orders—overseen by AMS to provide uniform authority for the removal of board members and staff who fail to perform their duties or who engage in dishonest actions or willful misconduct. The removal provisions in 13 of the orders would be modified to allow USDA to take action necessary to ensure the boards can continue to fulfill their intended purposes with minimal disruption. Removal provisions would be added to the six orders that do not currently provide for such action. Comments were due December 8, 2016.
CCC Amends Rules for the Agriculture Pima Trust and the Agriculture Wool Trust Programs
In the November 18, 2016, Federal Register, USDA's Commodity Credit Corporation ("CCC") issued a final rule making amendments to the final rule, with request for comments, published in the Federal Register on March 9, 2015, that established regulations for the Pima Agriculture Cotton Trust Fund and the Agriculture Wool Apparel Manufacturers Trust Fund programs. This final rule is amended based on comments received and to add details for the Refund of Duties Paid on Imports of Certain Wool Products payment. The administration of the Wool Duty Refund payment was transferred to USDA beginning in 2016 and assigned to the Foreign Agricultural Service. It was previously administered by the Customs and Border Protection Agency of the Department of Homeland Security. The rule was effective November 18, 2016.
FSN Proposes to Update Civil Rights Language Contained in SNAP
In the November 17, 2016, Federal Register, USDA's FNS proposed to update civil rights assurance language contained in SNAP regulations on the Federal-State Agreement ("FSA"). The FSA is the legal agreement between the Department of Agriculture and the state agency through which the state elects to operate SNAP and to administer the program in accordance with the Act, SNAP regulations, and the state plan. The rule does not contain any new requirements and would codify protections already required by federal law and existing policy. Comments are due January 17, 2017.
EU Regulatory Updates
EU Agencies Develop Scientific Guidance to Enable Identification of Endocrine Disruptors
The European Food Safety Authority and the European Chemicals Agency have jointly started working on a Draft Guidance regarding to the identification of endocrine disruptors (see minutes of the kick-off meeting of November 30, 2016). This Draft Guidance follows the European Commission's proposal of earlier this year for science-based criteria for identifying endocrine disruptors in the context of EU legislation on pesticides and biocides. Discussions with Member States and experts are ongoing, and the final criteria are expected to enter into force in 2017.
A draft guidance document will be prepared during the first half of 2017 and made available for public consultation. The guidance is expected to be finalized next year.
EFSA Publishes Advice on Thiamin (Vitamin B1)
On December 19, 2016, the European Food Safety Authority ("EFSA") published dietary reference values for thiamin (vitamin B1) as part of its review of scientific advice on nutrient intakes. Thiamin is a water-soluble vitamin that plays an important role in maintaining healthy nervous and cardiovascular systems. The Panel on Dietetic Products, Nutrition and Allergies ("NDA") confirms a Population Reference Intake ("PRI") of 0.1 mg per megajoule of energy requirements for all population groups older than seven months.
Call for Applications for Membership in the Advisory Group on the Food Chain and Animal and Plant Health
The European Commission ("Commission") is calling for applications to update the membership of the food chain and animal and plant health advisory group. The advisory group advises the Commission on food safety policy, specifically on issues related to food and feed safety, food and feed labeling and presentation, human nutrition in relation to food legislation, animal health and welfare, and matters related to plant health. In addition, the Commission consults the group on any measures the Commission has to take or propose in these fields. Interested organizations operating at the European level are invited to apply by January 31, 2017.
Meetings, Workshops, and Conferences
Public Meeting Sponsored by USDA and AMS, January 17, 2017, in Washington, D.C., to provide information and receive public comments on agenda items and draft U.S. positions to be discussed at the 3rd Session of the Codex Committee on Spices and Culinary Herbs, taking place in Chennai, India on February 6–10, 2017.
Public Meeting of FDA's Sixth National Consumer Food Safety Education Conference, January 25–27, 2017, in Washington, D.C.
Public Meeting of the National Organic Standards Board to assist the USDA in the development of standards for substances to be used in organic production and to advise the Secretary of Agriculture on any other aspects of the implementation of Organic Foods Production Act, April 13, 2017, via webinar, and April 19–21, 2017, in Denver, CO.
Laura E. Koman and Marina E. Moreno of the Washington Office assisted in the preparation of this Update.
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