Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 7

Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 7

Read the Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. II, Issue 7 newsletter.

Jones Day Announcements

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Top News

FDA to Hold Public Meeting on FSMA Implementation Strategy
FDA recently announced a public meeting on its implementation strategy for the Food Safety Modernization Act ("FSMA"), titled "FDA Food Safety Modernization Act: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards." During the meeting, FDA intends to discuss its current efforts and next steps for implementation of new standards that will affect food and feed facilities, farmers, importers and others who supply the nation's food. No formal public comment session is planned; instead, FDA anticipates stakeholders will provide comments and opinions at the meeting. The meeting will take place from April 23 to 24 in Washington, D.C. and can be attended both in person and online.

Senators Introduce Bill for BPA Food Warning Label
Senators Feinstein and Leahy recently introduced the "BPA in Food Packaging Right to Know Act," which would require food manufacturers to include in the packaging of food containers containing Bisphenol-A ("BPA") a warning label that says: "This food packaging contains BPA, an endocrine-disrupting chemical, according the National Institutes of Health." The bill would also require the U.S. Department of Health and Human Services ("HHS") to conduct a safety assessment determining whether exposure to BPA from food containers could harm consumers. Feinstein said she believes that "knowledge is empowering, and knowledge about BPA ingredients can also stimulate further reforms by the marketplace."

FDA recently reaffirmed its stance that current levels of BPA in food supplies do not pose a health risk in their currently approved uses. In 2012, FDA banned the use of BPA in baby bottles, sippy cups, and infant formula packaging on the basis that children are more sensitive than adults. In January 2015, the European Food Safety Authority ("EFSA") announced a re-evaluation of BPA exposure and toxicity and concluded BPA poses no health risk to consumers of any age group, including unborn children, infants, and adolescents (see previous Jones Day Update). 

FDA Concludes Some GMO Apples and Potatoes are Safe for Consumption
FDA recently deemed genetically modified ("GM") varieties of apples and potatoes safe for consumption. In contrast to existing GM crops, which are generally designed to withstand certain pesticides, the "Arctic apple" was designed to resist browning when cut open, and the "Innate potato" is designed to have fewer black spots from bruising and produce lower levels of acrylamide, a potential carcinogen. It could be quite some time before consumers can purchase the Arctic apple, but the Innate potato could be introduced in the next few months. 

Although FDA has never required labels for GM foods, the Agency for the first time suggested the products "may require disclosure to the consumer" about the "characteristics of these varieties of apples and potatoes that differ from their conventional counterparts." The statement touches on the labeling debate currently playing out in Congress. Democrats have proposed bills to require labels on GM foods, and Republicans recently introduced competing legislation asking for a new, voluntary certification for non-GM foods meant to counter mandatory food labeling proposals in various states. 

Beef Deal Between U.S. and China Falls Apart While "Huge Amounts" of American Beef Enter Hong Kong
An attempt to reopen the Chinese market to U.S. beef exports recently fell apart. China has banned imports of U.S. beef since 2003, following detection of bovine spongiform encephalopathy ("BSE") or "mad cow disease" in U.S. beef. However, Hong Kong fully reopened its beef market to the U.S. last July, which resulted in 154,500 tons of American meat entering Hong Kong. That amount is more than can be consumed in Hong Kong, leading U.S. trade officials to claim that "huge amounts" of American beef are entering China via Hong Kong despite China's ban. In February 2015, 33 Chinese customs officials were arrested for allegedly smuggling 6,000 tons of beef into China via Hong Kong.

Canada Finalizes Soy Health Claim
Health Canada's Food Directorate recently finalized a health claim on the ability of protein-rich soy foods to lower cholesterol. In response to a 2011 application for the claim, the Directorate determined that sufficient scientific evidence exists to support a health claim about soy protein's impact on lowering blood cholesterol. The Directorate provides options for soy health claims that can be made in the labeling and advertising of food products that meet certain conditions, such as a minimum amount of soy protein and maximum amounts of cholesterol, alcohol, and sodium. 

Other News
Republicans Propose New, Voluntary Certification for GMO-Free Foods

The U.S. and New Zealand Ask WTO to Settle Battle Over Indonesia's Meat Export Restrictions

New Research Suggests Environmental Benefits of Mediterranean Diet 

UK Will Become First EU Country to Introduce Plain Packaging for Cigarettes

Regulatory Updates

FDA Amends Listing of Color Additives Exempt from Certification
In the March 20, 2015, Federal Register, FDA issued a final rule amending the color additive regulations to provide for the expanded safe use of synthetic iron oxide as a color additive for use in soft and hard candy, mints, and chewing gum. The amendments were made in response to a September 17, 2013, petition, which requested that the proposed uses be permitted at levels consistent with current good manufacturing practice. The petition also proposed to lower the specification limit for lead in synthetic iron oxide for human food use from 10 milligrams per kilogram to five milligrams per kilogram. The rule is effective April 21, 2015; objections and requests for hearings are due April 20, 2015.

FSIS Announces New Dollar Limitations for Meat and Poultry Products Retail Stores Can Sell to Hotels, Restaurants, and Similar Institutions to Qualify for Inspection Exemptions
In the March 24, 2015, Federal Register, USDA's Food Safety and Inspection Service ("FSIS") announced the dollar limitations on the amount of meat and meat food products, poultry, and poultry products that a retail store can sell to hotels, restaurants, and similar institutions without disqualifying itself for exemption from federal inspection requirements. For 2015, the dollar limitation for meat and meat food products is being increased from $70,400 to $76,900 and for poultry products from $57,100 to $58,200 to reflect price changes in these products pursuant to the Consumer Price Index. The new limits are effective April 23, 2015.

AMS Interim Rule Changes Reporting Requirements for Commodities Exempt from Import Regulations
In the March 25, 2015, Federal Register, USDA's Agricultural Marketing Service ("AMS") issued an interim rule that, among other things, changes the reporting requirements for commodities exempt from import regulations under the Agricultural Marketing Agreement Act of 1937 by adding an option for electronic filing of the exemption form. The change brings the regulations into conformance with current practices of electronic filing. The interim rule also supports a White House economic initiative, the International Trade Data System, that will automate the filing of import and export information. The interim rule was effective March 30, 2015; comments are due May 26, 2015.

APHIS Reopens Comment Period for Proposed Rule Amending Regulations for Livestock Marketing Facilities
In the March 30, 2015, Federal Register, USDA's Animal and Plant Health Inspection Service ("APHIS") announced the reopening of the comment period for a proposed rule that would amend the regulations governing approval of facilities that receive livestock moved in interstate commerce, as well as the conditions under which livestock may move to such facilities without official identification or prior issuance of an interstate certificate of veterinary inspection or alternative documentation. The reopening of the comment period will allow the public additional time to submit comments. The proposed rule was issued in the January 2, 2015, Federal Register. Comments are due April 15, 2015.

APHIS Announces Receipt of Petition to Amend the Animal Welfare Act
In the March 30, 2015, Federal Register, USDA's APHIS announced the receipt of a petition by the Physicians Committee for Responsible Medicine to amend the Animal Welfare Act ("AWA") regulations. The proposed amendments include defining the term "alternatives," clarifying the existing definition of "painful procedure," and establishing standards governing the consideration of such alternatives at research facilities that are registered under the AWA regulations. APHIS is releasing the petition to the public and soliciting comments on the petition. Comments are due May 29, 2015.

APHIS Extends Comment Period for Issues Arising from Agriculture Stakeholder Workshop on Coexistence
In the March 30, 2015, Federal Register, USDA's APHIS announced the extension of the comment period for issues and proposals discussed during the March 12–13, 2015, workshop on agricultural coexistence. This action will allow interested persons additional time to prepare and submit comments. The objective of the two-day workshop was to advance an understanding of agricultural coexistence and discuss how to make coexistence achievable for all stakeholders. Comments are due April 10, 2015.

Other USDA Announcements

  • AMS Proposes Rule to Implement Spearmint Oil Administrative Committee's Recommendation on Regulating Handling of Spearmint Oil Produced in the Far West
  • AMS Adopts as Final Two Interim Rules on Spearmint Oil Produced in the Far West
  • APHIS Determines Saudi Arabia Free of African Horse Sickness
  • APHIS Authorizes Importation of Fresh Figs from Mexico
  • APHIS Authorizes Importation of Fresh Tejocote Fruit from Mexico
  • AMS Proposes Rule to Implement Recommendation from the California Olive Committee to Increase Assessment Rate for California Olives

USDA Announced the Following Requests for Information

  • Identifying and Reducing Regulatory Burdens

USDA Announced the Following Proposed Information Collections

  • Grazing Permit Administration Forms
  • Study on Nutrition and Wellness Quality in Childcare Settings
  • Animal Welfare Act Workshop Registration 

USDA Announced the Request for Revisions and/or Extensions of the Following Information Collections

  • Importation of Peppers from Certain Central American Countries
  • Hawaiian and Territorial Fruits and Vegetables Regulations
  • Importation of Fruits and Vegetables
  • Organizational Information
  • Importation of Small Lots of Seed

USDA Announced the Following Information Collections Have Been Submitted to OMB

  • Importation of Gypsy Moth Host Materials from Canada
  • Regulations Governing the Inspection and Grading of Manufactured or Processed Dairy Products—Recordkeeping
  • Importation of Longan from Taiwan
  • Milk and Milk Products
  • Sugar Imported for Exports as Refined Sugar, as a Sugar-Containing Product, or Used in Production of Certain Polyhydric Alcohols
  • Endangered Species Regulations and Forfeiture Provisions
  • Supplementation Nutrition Assistance Program Employment and Training Study
  • Rural Development Loan Servicing
  • Animal Welfare
  • The Integrity Program (TIP) Data Collection
  • Interstate Movement of Sheep and Goats; Recordkeeping for Approved Livestock Marketing Facilities and Slaughtering and Rendering Establishments

USDA Announced Its Intent to Reinstate the Following Previously Approved Information Collections

  • Census of Agriculture Content Test

FDA Announced the Opportunity to Comment on the Following Proposed Information Collections

  • Recommended Recordkeeping for Exempt Infant Formula Production
  • Regulations Under the Federal Import Milk Act

FDA Issued the Following Draft and Final Guidance Documents
Draft Guidance for Industry: Ensuring Safety of Animal Feed Maintained and Fed On-Farm, March 20, 2015, Federal Register. Comments are due June 3, 2015.

European Regulatory Updates

EFSA Find Over 97% of Foods in EU Contain Pesticide Residues Within Legal Limits
The European Food Safety Agency ("EFSA") found that more than 97 percent of the 81,000 food samples evaluated contain pesticide residues that fall within the legal limit and that 55 percent of samples contain no traces. The findings are part of EFSA's 2013 annual report on pesticide residues in food, which concluded that, for short-term exposure, European citizens have a low risk of exposure to harmful levels of residues via their diet.

European Commission Rejects Certain Health Claims on Foods
On March 11, 2015, the European Commission issued Commission Regulation (EU) 2015/402 of 11 March 2015, refusing to authorize certain health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health.

European Commission Amends Food Supplements Directive
On March 12, 2015, the European Commission issued Commission Regulation (EU) 2015/414 of 12 March 2015, amending Directive 2002/46/EC of the European Parliament and of the Council as regards (6S)-5-methyltetrahydrofolic acid, glucosamine salt used in the manufacture of food supplements.

European Commission Amends Food Additives Regulation
On March 19, 2015, the European Commission issued Commission Regulation (EU) 2015/463 of 19 March 2015, amending Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for polyvinyl alcohol (E 1203).

Upcoming Meetings, Workshops, and Conferences

Expert Panel on Federal Statistics on Women and Beginning Farmers in U.S. Agriculture, April 2–3, 2015, in Washington, D.C.

Grain Inspection, Packers, and Stockyards Administration Advisory Committee Meeting, April 7–8, 2015, in Kansas City, MO.

The National Agricultural Research, Extension, Education, and Economics Advisory Board Meeting, April 14, 2015, via teleconference. 

FDA-JIFSAN Dietetics and Nutrition Spring Webinar Series, April 20, 2015, via webcast.

USDA Agricultural Air Quality Task Force Meeting, April 22–23, 2015, in Knoxville, TN.

FDA FSMA Implementation Strategy Meeting, April 23–24, 2015, in Washington, D.C.

FDA Public Workshop: The 2015 Office of Regulatory Science and Innovation Science Symposium, April 27, 2015, in Silver Spring, MD.

National Organic Standards Board Meeting, April 27–30, 2015, in La Jolla, CA.

FDA and AFDO Conference titled In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation, June 20–24, 2015, in Indianapolis, IN.

EFSA's 2nd Scientific Conference, October 14, 2015, in Milan, Italy.

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