Food, Dietary Supplement & Cosmetics Regulatory Update, Volume II, Issue 15
FDA Issues Draft Guidance and Proposed Rule under FSMA Proposed Rule on Accreditation of Third-Party Auditors
Under the Food Safety Modernization Act ("FSMA") proposed rule on Accreditation of Third-Party Auditors, FDA issued a draft guidance on model accreditation standards and a proposed rule on user fees for participation in the program created by the third-party auditors/certification bodies proposed rule. By these means, FDA would recognize the entities that would accredit third-party auditors to conduct food safety audits and to issue certifications. Audits and certifications for eligible foreign entities under this program will allow food importers to apply for expedited review through the Voluntary Qualified Importer Program. FDA may also require the same audits and certifications when certain food safety risks have been identified.
House Agriculture Committee Approves Voluntary Labeling of Non-GMO Foods
On July 14, 2015, the House Agriculture Committee submitted a report amending and approving H.R. 1599, the Safe and Accurate Food Labeling Act, introduced by Mike Pompeo (R-Kan.) in March 2015, to create a uniform national standard for voluntary labeling of genetically engineered foods (commonly referred to as "genetically modified organisms" or "GMOs"). In addition, the Act would preempt state and local jurisdictions from banning the production of GMO crops and from passing mandatory GMO labeling laws, thereby overturning the laws passed in Vermont, Connecticut, and Maine. Under the Act, USDA's Agricultural Marketing Service ("AMS") would create a voluntary genetically engineered food certification program for GMO-Free claims. However, this certification would not suggest whether the product is safer or of higher quality for being GMO or non-GMO. Notwithstanding the above, FDA would have the authority to require foods to be labeled as GMOs when "(A) there is a material difference in the functional, nutritional, or compositional characteristics, allergenicity, or other attributes between the food so produced and its comparable food; and (B) the disclosure of such material difference is necessary to protect public health and safety or to prevent the label or labeling of the food so produced from being false or misleading in any particular."
In the same week, the Senate Appropriations Committee ("Committee") introduced a GMO salmon labeling provision as part of the FY 2016 Agriculture Bill. Under the Act, FDA would assess the Committee's request and determine whether salmon labels need to indicate if the product is GMO.
FDA Issues Proposed Nutrition Facts Label Rule to Include %DV for Added Sugars
FDA proposed additional revisions to the Nutrition Facts label for packaged foods to, among other things, include a 10 percent Daily Valuerequire, among other things, a declaration when the product contains 10 percent or more of the Daily Value ("%DV") for added sugars. The agency relied on the scientific data report of the 2015 Dietary Guidelines Advisory Committee, which found that staying within calorie requirements is difficult if 10 percent of total calories from added sugar is exceeded. Susan Mayne, Ph.D., director of the FDA's Center for Food Safety and Applied Nutrition, said that "for the past decade, consumers have been advised to reduce their intake of added sugars, and the proposed percent daily value for added sugars on the Nutrition Facts label is intended to help consumers follow that advice." FDA is also proposing to shorten the current footnote on the Nutrition Facts label to read "*The percent daily value (%DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice."
FDA Extends Menu Labeling Compliance Date
Earlier this month, FDA announced a one-year extension of the Menu Labeling Final Rule, titled "Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments," originally effective on December 1, 2015. Restaurants and other food retailers that are part of a chain of 20 or more locations (including retailers such as movie theaters and amusement parks) will have to conspicuously display calorie information on their menus and menu boards by December 1, 2016. The final rule, published on December 1, 2014, has been extended several times due to the complexity of its implementation. A group of senators sent a letter in May 2015 to FDA requesting a one-year enforcement delay for lack of clarity and consistency of the current guidance. Subsequently, FDA announced it will issue a draft guidance in August 2015 to provide "answers to some of the more frequently asked and crosscutting questions that the agency has received." FDA will also increase its support of businesses and state, local, and tribal regulatory partners through educational and technical assistance. FDA encourages companies to comment on the guidance and to consider it for compliance with the final rule.
European Parliament Opposes Commission Proposal on GMO Food and Feed
On July 15, 2015, Members of the European Parliament ("MEPs") debated a European Commission proposal that would enable any Member State to restrict or prohibit EU-approved GMO food or feed on its territory. The Commission's proposal, published on April 22, 2015, attempts to extend to GMO food and feed the solution adopted recently in Directive (EU) 2015/412, in which Member States can restrict or prohibit the cultivation of approved GMOs in their territory. During the discussion, MEPs strongly opposed the draft law, claiming it is incompatible with single market and WTO rules. Further, MEPs raised concerns regarding implementation challenges, the lack of any impact assessment, the proposal's vagueness, and inevitable legal uncertainty. The Environment Committee will vote on the proposal in mid-October before the draft is put to a vote at the Parliament's October 2015 plenary session in Strasbourg.
UK Association Publishes Gluten Labeling Guidance
The Food and Drink Federation has published best practices on "How to Label Pre-Packed Foods Which Include Cereals Containing Gluten." In response to the Food Information to Consumers Regulation (Regulation (EU) No. 1169/2011, as amended), which entered into force in December 2014 and introduced changes to the labeling of allergens, the guide provides recommendations to manufacturers on labeling food products containing gluten through review of the relevant EU legislation, guidance notes, and with reference to claims for gluten-free foods.
FDA Proposes Rule on Accreditation of Third-Party Auditors under FSMA
In the July 24, 2015, Federal Register, FDA issued a proposed rule to amend the proposed rule, "Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications." The proposed rule also seeks to establish a reimbursement (user fee) program to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under FSMA. Comments are due October 7, 2015.
FDA Revises Proposed Rule on Labeling Regulations
In the July 27, 2015, Federal Register, FDA announced certain revisions to the March 2014 proposed rule to amend FDA's labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the Nutrition Facts and Supplement Facts labels. FDA is proposing to require the additions of a Daily Reference Value of 10 percent of total energy intake from added sugars and the declaration of the Daily Value percentage of added sugars to the Nutrition Facts and Supplement Facts. Comments are due October 13, 2015.
FDA Extends Comment Period on Proposed Rule to Revise Nutrition Labels
In the July 27, 2015, Federal Register, FDA announced the reopening of the comment period regarding the proposed rule to revise the Nutrition Facts and Supplement Facts labels for the sole purpose of inviting public comments on two consumer studies being added to the administrative record. The consumer studies pertained to proposed changes to the Nutrition Facts label formats. Comments are due September 25, 2015.
FDA Extends Compliance Date for Finale Rule on Menu Disclosures
In the July 10, 2015, Federal Register, FDA announced a one-year extension of the compliance date for the final rule on Menu Labeling, which requires disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. Final rule is effective December 1, 2015.
FDA Amends Regulation Pertaining to Canned Pacific Salmon
In the July 15, 2015, Federal Register, FDA announced it is amending a regulation pertaining to canned Pacific salmon, thereby removing a paragraph that contains an obsolete cross-reference to a rule that was revoked in 1996. Regulation is effective July 15, 2015.
FDA Announced Filing of Food Additive Petition
In the July 16, 2015, Federal Register, FDA announced that Alzchem AG has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in diets for broiler chickens and turkeys.
APHIS Amends Virus-Serum-Toxin Act to Require Single Label Format for Veterinary Biological Products
In the July 10, 2015, Federal Register, USDA's Animal and Plant Health Inspection Service ("APHIS") amended the Virus-Serum-Toxin Act regulations to provide for the use of a simpler, uniform labeling format including safety and efficacy data. The regulations issued pursuant to the Act are intended to ensure veterinary biological products are pure, safe, potent, and efficacious when used according to label instructions. A simpler label format, along with publicly available safety and efficacy data, will help biologics producers to more clearly communicate product performance to customers. The rule is effective September 8, 2015.
FNS Proposes Rule to Revise Supplemental Nutrition Assistance Program
In the July 15, 2015, Federal Register, USDA's Food and Nutrition Service ("FNS") proposed a rule to revise the Supplemental Nutrition Assistance Program regulations in order to implement changes made by the Agricultural Act of 2014, amending the definition of "retail food store" in the Food and Nutrition Act of 2008. The definition now includes governmental or private nonprofit food purchasing and delivery services that purchase and deliver food to households in which the head of household is unable to shop for food and is 60 years of age or older or physically or mentally handicapped or otherwise disabled. Comments are due September 14, 2015.
FAS Issues Final Rule on Dairy TRQ Import Licensing Program
In the July 27, 2015, Federal Register, USDA's Foreign Agricultural Service ("FAS") issued a final rule amending the regulation providing for the issuance of licenses to import certain dairy articles under tariff-rate quotas ("TRQs") as set forth in the U.S. Harmonized Tariff Schedule. The three most significant changes to the rule are to: (i) suspend the historical license reduction provision that was set to expire with the beginning of quota year 2016 for an additional seven years; (ii) modify procedures for collecting licensing fees in order to better align the fee collection to the costs of administering the program; and (iii) exclusively use electronic communications in the application, reporting, and payment processes. Final rule is effective September 1, 2015.
FSA Proposes Rule to Amend the Conservation Reserve Program
In the July 16, 2015, Federal Register, USDA's Farm Service Agency ("FSA") proposed a rule amending the Conservation Reserve Program ("CRP") regulations to implement provisions of the Agricultural Act of 2014. The rule specifies eligibility requirements for enrollment of grassland in CRP and adds references to veteran farmers and ranchers to the provisions for Transition Incentives Program contracts, among other changes. The provisions in this rule for eligible land primarily apply to new CRP offers and contracts. For existing contracts, this rule provides additional voluntary options for permissive uses, early terminations, conservation and land improvements, and incentive payments for tree thinning. The rule also makes conforming changes to provisions applicable to multiple FSA and Commodity Credit Corporation programs, which include CRP, including acreage report requirements, compliance monitoring, and equitable relief provisions. The rule is effective July 16, 2015, and comments are due September 14, 2015.
APHIS Releases Supplemental Environmental Assessment for Oral Rabies Vaccine Trial
In the July 17, 2015, Federal Register, USDA's APHIS released the supplemental environmental assessment ("EA") relative to an oral rabies vaccination field trial in New Hampshire, New York, Ohio, Vermont, and West Virginia, necessary to evaluate whether the wildlife rabies vaccine will produce sufficient levels of population immunity against raccoon rabies. The EA analyzes expanding the trial to Ohio and increasing bait distribution density in West Virginia. Comments are due August 17, 2015.
FNS Announces National Average Payment and Maximum Reimbursement Rates for National School Lunch, Special Milk, and School Breakfast Programs
In the July 17, 2015, Federal Register, USDA's FNS announced the annual adjustments to (i) the "national average payments," which comprise the amount of money the federal government provides states for lunches, afterschool snacks, and breakfasts served to children participating in the National School Lunch and School Breakfast Programs; (ii) the "maximum reimbursement rates" from federal funds that a state can provide a school food authority for lunches served; and (iii) the rate of reimbursement for a half-pint of milk served to non-needy children in a school or institution participating in the Special Milk Program for Children. Rates are effective July 1, 2015.
AMS Renews the Fruit and Vegetable Industry Advisory Committee
In the July 27, 2015, Federal Register, USDA's AMS announced its intention to renew the Fruit and Vegetable Industry Advisory Committee for a two-year term from 2015–2017 to examine issues faced by the industry and provide ideas to the Secretary of Agriculture on how USDA can tailor its programs to better meet the fruit and vegetable industry's needs.
USDA Seeks Nominations to Peanut Standards Board
In the July 10, 2015, Federal Register, USDA announced it is seeking nominations for individuals to be considered for Board membership to the Peanut Standards Board ("Board"), pursuant to the Farm Security and Rural Investment Act of 2002. The Board consists of a total of 18 members, who will advise the Secretary on quality and handling standards for domestically produced and imported peanuts. Nominations are due August 24, 2015.
APHIS Affirms Necessity for New and Revised Treatments for Various Plant Commodities
In the July 21, 2015, Federal Register, USDA's APHIS affirmed its earlier determination to immediately add to the Plant Protection and Quarantine ("PPQ") Treatment Manual treatment schedules for various plant commodities to effectively mitigate and neutralize the risk from various plant pests. For example, a treatment schedule for methyl bromide fumigation of figs for certain pests, including Chilean false red mite, has been added to the PPQ treatment manual.
NRCS Proposes Changes in the National Handbook of Conservation Practices
In the July 21, 2015, Federal Register, USDA's National Resources Conservation Service ("NRCS") proposed changes to revise conservation practice standards in the National Handbook of Conservation Practices, including the open channel (Code 582) and the Pond (Code 378) standards, among others. NRCS, which helps America's farmers, ranchers, and forest landowners conserve the nation's soil, water, air, and other natural resources, states that NRCS state conservationists who choose to adopt these practices for use within their states will incorporate them into section IV of their respective electronic Field Office Technical Guide. Comments are due August 20, 2015.
APHIS Reopens Comment Period to Amend Animal Welfare Act Regulations
In the July 24, 2015, Federal Register, USDA's APHIS reopened the comment period of a proposal to amend the Animal Welfare Act regulations to specify ethologically appropriate standards researchers must adhere to in order to promote the psychological well-being of nonhuman primates used in research. Comments are due August 31, 2015.
NIFA Requests Commodity Boards Submission of Topics and Contribution Funding under the AFRI
In the July 24, 2015, Federal Register, USDA's National Institute of Food and Agriculture ("NIFA") solicited federal and state commodity boards topics related to the established priority areas of the Agriculture and Food Research Initiative Competitive Grants Program ("AFRI") to be considered for inclusion in future AFRI Requests for Applications. Comments are due September 22, 2014.
Other USDA Announcements
- Grain Inspection, Packers, and Stockyards Administration ("GIPSA") Designates Grain Inspection Services in AL, IL, and MN
- GIPSA Designates Opportunity for Official Agencies Servicing TX
- GIPSA Proposes Posting of 25 Stockyards and Deposting of One under the P&S Act
- FNS Announces the National Average Value of Donated Foods for the National School Lunch Program and Child and Adult Care Food Programs
- FNS Announces National Average Payment Rates, Day Care Home Food Service Payment Rates, and Administrative Reimbursement Rates for Sponsoring Organizations
- USDA Issues EA Finding No Significant Impact for Transfer of Land and Facilities inside of Florida for Agricultural Research
- AMS Proposes Rule and Referendum Order to Amend Marketing Order No. 905 Regulating Handling of Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida
- APHIS Adopts as Final Rule an Amended Interim Rule Adding Regulated Articles and Countries to Khapra Beetle Regulations
- APHIS Issues Final Rules and Requests Comments to Add Quarantined Areas to Prevent Spread of Emerald Ash Borer
- APHIS Issues Preliminary Plant Pest Risk Assessment and Draft EA for Maize Genetically Engineered for Increased Ear Biomass
- Commodity Credit Corporation Replaces Term "P&CP" with Term "Planted" in 7 C.F.R. §1412.45(b)(3)
- APHIS Issues Correction of 7 C.F.R. §319.56-57 for Sand Pears from China
- USDA Advises the Public of Availability of FY2014 Service Contract Inventory
USDA Announced the Opportunity to Comment on the Following Proposed Information Collections:
- Measurement Service Records
- WIC Federal and State Agreements
USDA Announced Its Intent to Revise, Extend, and/or Renew the Following Previously Approved Information Collections:
- Petitions for Rulemaking
- Current Population Survey Food Security Supplement
- Children, Youth, and Families at Risk Year End Report
- Veterinary Medicine Loan Repayment Program Veterinarian Shortage Situation Nomination
- Web Forms for Research Data, Models, Materials, and Publications as well as Study and Event Registration
- Reporting Requirements for State Plans of Work for Agricultural Research and Extension Capacity Grants
USDA Announced the Following Information Collections Have Been Submitted to OMB:
- Meeting the Information Requirements of the Animal Welfare Act Workshop Registration Form
- Debt Settlement Policies and Procedures
- Animal Disease Reporting System
- Request for Administrative Review
- Consumer Complaint Monitoring System—Food Safety Mobile Questionnaire.
FDA Announced the Following Information Collections Have Been Submitted to OMB:
- Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant Facility Types
FDA Announced the Following Information Collections Have Been Approved By OMB:
- Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: cGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
FDA Issued the Following Draft and Final Guidance Documents
Draft Guidance for Industry and Food and Drug Administration Staff: Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards, July 24, 2015, Federal Register. Comments are due October 7, 2015.
European Regulatory Updates
EFSA Publishes Scientific Opinion on Safety of UV-Treated Bread as Novel Food
On July 1, 2015, EFSA's Panel on Dietetic Products, Nutrition and Allergies published a Scientific Opinion on UV-treated bread as novel food that refers to baked bread treated with UV radiation in order to convert ergosterol, a compound present in bread as a result of yeast fermentation, to vitamin D2 (ergocalciferol). The Panel considers that bread enriched with vitamin D2 through UV treatment is safe under the conditions of use as specified by the applicant.
EFSA Delivers Scientific Opinion on Vitamin D Health Claims
On July 17, 2015, EFSA's Panel on Dietetic Products, Nutrition and Allergies delivered an opinion on the scientific substantiation of a health claim related to vitamin D and its contribution to the normal function of the immune system. The Panel concluded that a cause-and-effect relationship has been established between the dietary intake of vitamin D and contribution to the normal function of the immune system, and therefore the following wording reflects the scientific evidence: "Vitamin D contributes to the normal function of the immune system."
Other European Regulatory Updates
Meetings, Workshops, and Conferences
Public Meeting of the Beginning Farmers and Ranchers Advisory Committee, August 3–4, 2015, in Kansas City, MO.
Public Meeting of the Codex Alimentarius Commission Committee on Fresh Fruits and Vegetables, August 6, 2015, in Washington, D.C.
Public Meeting of the Plant Variety Protection Board, August 6, 2015, in Washington, D.C. or via teleconference
Public Meeting of the National Agricultural Research, Extension, Education, and Economics Advisory Board, August 11, 2015, via teleconference.
Public Meeting of the Codex Alimentarius Commission Committee on Spices and Culinary Herbs, August 19, 2015, in Washington, D.C.
Public Meeting in Preparation for International Cooperation on Cosmetics Regulation, September 10, 2015, in College Park, MD.
EFSA's 2nd Scientific Conference, October 14, 2015, in Milan, Italy.
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