• As previously covered on this blog, mandatory country of origin labeling (COOL) rules for beef products have long been the subject of controversy and challenge, culminating in a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico, and Congress repealing COOL as of December 21, 2015.
  • On February 3, 2017, a majority of House Agriculture Committee members in Wyoming voted in favor of sending a bill to the full House of Representatives that would require retail beef products sold in the state to bear a country-of-origin label. This comes on the heels of a similar bill that was introduced in South Dakota.
  • In the past, the meat processing industry has opposed mandatory federal country-of-origin labeling.  It remains to be seen whether either state bill will advance, and whether other states will follow suit.
  • Three months before new FDA regulations take effect that require restaurants and similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) to provide calorie and other nutrition information for standard menu items, Congress is again considering legislation to modify the requirements. (For background information on the new menu labeling requirements that are scheduled to take effect on May 5, 2017, see previous blog entries, Final Menu Labeling Guidance Issued and Menu Labeling Update.)
  • The Common Sense Nutrition Disclosure Act (R.772/S.261) was introduced in the House by Reps. Cathy McMorris Rodgers (R-WA) and Tony Cárdenas (D-CA) on January 31, 2017, and by Sens. Roy Blunt (R-MO) and Angus King (I-ME) on February 1, 2017. A Common Sense Nutrition Disclosure Act was also introduced in both the House and the Senate in late 2015 and passed in the House on February 12, 2016 (see our blog entry, Menu Labeling in the House, for details). While the Act does not reduce the amount of nutritional information that must be provided by restaurants and retailers, it provides flexibility in determining how to disclose nutrition information.
  • “The FDA’s one-size-fits-all approach places additional burdens on the backs of our nation’s small business owners without giving them the flexibility they need to actually comply with the regulations. How businesses provide that information should be consistent with how their customers actually place orders – including by phone, online or through mobile apps,” Rep. McMorris Rodgers explained in a release about the Act.
  • The bill would also reduce penalties and liability under certain circumstances, and allow the opportunity for establishments to correct mistakes after receiving a notice of the violation from FDA. Sponsors of the bill estimate that new menu labeling requirements will cost nearly $1 billion for just grocers, in addition to requiring 14.5 million hours of paperwork. Several industry groups have called for enactment of this legislation as soon as possible (for examples, see releases from FMI and NACS).
  • As our readership is well aware, FDA regularly issues guidance documents that provide the Agency’s current thinking on how best to comply with laws and regulations governing food, feed and other FDA-regulated products.  In addition, associations or organizations associated with a specific industry also draft guidance documents to help industry understand best practices when producing food, feed and other regulated products.
  • On Tuesday, January 31, 2017, FDA released tips for industry on crafting industry guidance called “5 Steps Toward Working with FDA on Human and Animal Food Guidance Documents”.  In general, FDA encourages industry to consult with the Agency when drafting guidance documents.  In this way, FDA can potentially: (1) provide technical advice as needed in the development of the guidance document, (2) link to the final document for informational purposes, and (3) incorporate industry guidelines into its own guidance.
  • Keller and Heckman attorneys are well-versed in the laws governing FDA regulated products and stand ready to assist interested parties in developing industry guidance.

FDA has denied a petition seeking to require methylmercury labeling on seafood. (subscription to Food Chemical News is required)

  • Mercury exposure via seafood consumption has been a health concern for years, so much so that FDA has an entire section of its website dedicated to the topic. By way of background, airborne mercury, produced from various industrial activities, is deposited into the ocean, where it converts into methylmercury.  The methylmercury, in turn, accumulates in fish and shellfish. Consumer advocacy groups, like Earthjustice, have argued that methylmercury exposure has been linked to learning disabilities, lowered IQ, and impaired cognitive and nervous system functioning.  In July 2011, Earthjustice filed a Citizen Petition asking the FDA to post signs near market seafood counters and on seafood labels to warn consumers about mercury in fish.
  • On January 18, 2017, FDA denied the Citizen Petition and instead issued new advice to consumers concerning fish consumption and health. In denying the petitioner’s request, FDA noted that its consumer outreach efforts should achieve the Agency’s food safety goals as it relates to potential methylmercury exposure.
  • Consumer advocacy groups continue to express concern on this issue, but given FDA’s recent action, any future efforts to require methylmercury labeling of seafood will likely face an uphill battle.
  • The Defending Against Imitations and Replacements of Yogurt, milk, and cheese to Promote Regular Intake of Dairy Everyday Act (DAIRY PRIDE Act), introduced by Sen. Tammy Baldwin (D-WI), would require non-dairy products made from nuts, seeds, plants, and algae to no longer be mislabeled with dairy terms such as milk, yogurt, or cheese. (A January 12, 2017 press release issued by Sen. Baldwin’s office on the Act can be found here.)  While the dairy industry and others applaud the bill (see our blog entry on opposition by members of Congress to labeling plant-based products as “milk”), others are strongly opposed.
  • Baldwin’s office issued a follow-up press release on January 27 announcing additional support for the Dairy Pride Act from the Wisconsin Farm Bureau and the American Farm Bureau. The release quotes American Farm Bureau Federation President Zippy Duvall view that the reputation that milk has earned “should not be falsely appropriated by marketers of non-dairy products.”
  • On the other side of the debate, the Good Food Institute is encouraging people to voice their opposition to the legislation by signing a petition, titled, “Tell Congress to Dump the “DAIRY PRIDE Act.” As of today, more than 27,000 people had signed the petition. The petition argues, “No one is purchasing plant-based milk, cheese, or yogurt because they’ve been tricked into thinking it’s a cow’s ‘lacteal secretions.’”
  • This debate is taking place as sale of milk is declining. The U.S. Department of Agriculture reports that per capita consumption of fluid milk in the U.S. has gone from 201 pounds per person in 1997 to 155 in 2015. The Good Food Institute argues that the Dairy Pride Act is an effort by the dairy industry to gain government help to target the competition.

The Union of Concerned Scientists has petitioned FDA to establish “disqualifying levels” of added sugars that would prohibit use of “healthy” labeling. (subscription to Law 360 required)

  • “Healthy” claims on foods continue to trend as a perennial hot topic in the food industry.  By way of background, FDA regulations prescribe qualifying criteria for foods to bear the claim that they are “healthy” (including related terms) (21 CFR 101.65(d)).  Among other factors, a “healthy” food generally must contain 3 grams or less of total fat per serving and 1 gram or less of saturated fat per serving.  (Fish and meat are required to contain 5 grams or less of total fat per serving and 2 grams or less of saturated fat per serving).  As previously covered on this blog, FDA received a Citizen Petition last December requesting that the Agency revisit the definition of “healthy” — which has not changed since 1994 — to take into account present-day scientific understanding about the health benefits of many nutrient-dense foods.  More recently, this past fall, FDA requested comments to help inform its decision-making as to whether the term “healthy” should be redefined. The Agency is accepting comments on this issue through April 26, 2017.
  • In the midst of all this “healthy” activity, on January 27, 2017, FDA received a Citizen Petition from the Union of Concerned Scientists urging the FDA to establish “disqualifying levels” of added sugars that would render a product ineligible to use labeling or advertising with “healthy” claims.  At the same time, however, the petition does not set forth a recommended “disqualifying level” for added sugars.
  • It is unclear whether FDA will ultimately set a “disqualifying level” for added sugars as part of its possible redefinition of the term “healthy”. Presumably, this issue will be discussed at FDA’s upcoming March 9, 2017 public meeting on the use of the term “healthy” in food labeling which we understand will be formally announced in a forthcoming Federal Register notice.

Funding issues could delay the implementation of new federal GMO food disclosure rules (subscription to Food Chemical News required)

  • As previously discussed on this blog, a new federal law requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018.  Under the new law, food companies would have three options to disclose GMO ingredients: the use of on-package text, a USDA-created symbol, or an internet link — i.e., a QR code printed on the package that directs customers to GMO information.  To support the development of the regulations and standards required by the new law, USDA is slated to conduct a study to identify potential technological challenges that might impact whether consumers would be able to rely on electronic or digital links on food packages.
  • A recent news report, however, indicates that USDA is struggling to secure the funds to move forward with the study which, under the law, should be completed by this July.  Despite the current delays, a USDA official indicates that the Agency “fully expects to meet all deadlines set forth in the law.”
  • Industry will continue to keep a close eye on developments as they unfold, particularly with a new administration at the helm.
  • As our readership is well aware, foods from genetically engineered (GE) plants must meet the same food safety requirements as foods derived from traditionally bred plants under the Federal Food, Drug, and Cosmetic Act.  As a routine premarket step, developers of new plant varieties, including those produced using genome editing, typically consult with FDA regarding the safety and regulatory status of foods derived from such plants.  These consultations serve to help ensure that applicable safety and legal questions are resolved prior to marketing.
  • To complement the existing framework in place for assuring the safety of products of biotechnology, including new plant varieties produced using genome editing, on September 16, 2016, the Obama administration’s Emerging Technologies Interagency Policy Coordination Committee released a National Strategy for Modernizing the Regulatory System for Biotechnology Products.  This strategy document sets forth a vision for ensuring that the federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology.
  • On January 18, 2017, FDA issued a request for comments related to the regulation of human and animals foods derived from plants produced using genome editing technologies to help inform its regulatory approach.  The Agency’s questions, include, but are not limited to:
    • In what ways are the food safety risks associated with human and animal foods from genome edited plants the same as or different from those associated with other plant development methods (g., hybridization, chemical or radiation-induced mutagenesis and non-targeted genetic modifications using in vitro recombinant DNA technologies)?
    • Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from such categories are unlikely to present food safety risks different from or greater than those for traditional plant breeding?
    • Are there categories of genome edited plant varieties for which there are scientific bases to conclude that foods from these categories are more likely than traditionally-bred plants to present food safety risks?; and
    • What steps can FDA take to help small firms, including those who may be considering using genome editing to produce new plant varieties for use in human or animal food, to engage with FDA about any questions related to food safety or the regulatory status of foods from their new plant varieties?
  • FDA will be accepting comments until April 19, 2017.  It remains to be seen how the information received will impact the new administration’s approach to regulating foods derived from genome edited plants.
  • As consumers increasingly demand ethically-minded foods such as “Cage Free” and “Pasture Raised”, animal welfare has become a hot-button issue in the food industry.  Coupled with a heightened focus from animal welfare advocacy groups on animal raising conditions, several states have been considering imposing minimum size requirements for farm animal containment.  And this past November, Massachusetts became the first state to regulate containment conditions for food animals.
  • On January 19, 2017, USDA jumped into the fray, publishing a controversial final rule on organic livestock and poultry which establishes minimum indoor and outdoor space requirements for chickens as a function of type of production and stage of life. 82 FR 7042.  The final rule also:
    • Clarifies how producers and handlers participating in USDA’s National Organic Program (NOP) must treat organic livestock and poultry to ensure their well-being;
    • Clarifies when and how certain physical alterations may be performed on organic livestock and poultry in order to minimize stress;
    • Defines outdoor space and requires that outdoor spaces for organic poultry include soil and vegetation;
    • Adds new requirements for transporting organic livestock and poultry to sale or slaughter; and
    • Clarifies the application of USDA Food Safety and Inspection Service (FSIS) requirements regarding the handling of livestock and poultry in connection with slaughter to certified organic livestock and poultry establishments, and provides for the enforcement of USDA organic regulations based on FSIS inspection findings.
  • As set forth in the final rule, these new requirements are slated to be fully implemented by March 20, 2018.  That said, with a new administration at the helm, the ultimate fate of this rule remains unclear.

Canada has proposed regulations to implement the Safe Foods for Canadians Act (SFCA), which was adopted on June 7, 2012. A pre-publication copy of the proposed rules is available in the Canada Gazette – Part I, Vol. 151, No. 3 (January 21, 2017).

  • The three key elements to the proposed Safe Foods for Canadians Regulations are discussed below.
    • Licenses would be required for anyone (1) importing food; (2) preparing food for export or interprovincial trade (with some exceptions); or (3) slaughtering food animals from which meat products for export or interprovincial trade may be derived. The license would be valid for a period of two years for a fee of approximately $250, and could be suspended or cancelled in cases of non-compliance.
    • International standards established by the Codex Alimentarius Commission for traceability would apply to anyone (1) importing, exporting or interprovincially trading food; (2) holding a license issued under the SFCA; or (3) growing or harvesting fruits or vegetables that are to be exported or traded interprovincially. Electronic or paper records would be required in order to track food forward to the immediate customer and backwards to the immediate supplier.
    • Companies that manufacture food or conduct activities that are subject to the Regulations would be required to have a preventive control plan (PCP) that is consistent with internationally-recognized agricultural and manufacturing practices (i.e., GAPs, GMPs and HACCP).
  • The proposed regulations are intended to be in line with approaches being taken by key trading partners – including the United States, the European Union, Australia and New Zealand. A 90 day consultation period is open through April 21, 2017. Information on how to submit comments can be found here.