• As previously reported on this blog, Cooke Aquaculture (Cooke) sued the Washington State Department of Natural Resources (DNR) last month for terminating its Port Angeles net pen lease for salmon farming. On February 4, Washington State DNR announced that it was also terminating the lease for the company’s Cypress Island Atlantic salmon net pens. In August 2017, one of Cooke’s Cypress Island net pens failed, releasing more than 240,000 Atlantic salmon into the Puget Sound.
  • The termination of the Port Angeles net pen lease followed the January 30 release of a report on the net pen failure. The investigative report—prepared jointly Washington State’s Department of Ecology, Department of Fish and Wildlife, and DNR—determined that the probable cause of the incident was due to failure of Cooke to adequately clean the nets containing the fish. The report also faulted Cooke for underreporting the number of fish that escaped during the net pen collapse and for over-reporting the number of salmon it recovered. Furthermore, on January 30, the Washington State Department of Ecology fined Cooke $332,000 for violating it water quality permit leading up to and during the net pen collapse.
  • The future of Cooke’s remaining two leases for Atlantic salmon net pen facilities in Washington State (Rich Passage and Hope Island) is also uncertain. DNR is currently reviewing those leases. In addition, several bills have been introduced in the Washington legislature that would restrict aquaculture in Washington State. They range from HB 2956 that would restrict future salmon farming leases to production of single-sex salmon to SB 6086 that would ban any new leases for aquaculture of Atlantic salmon.
  • On March 29, 2017, the United Kingdom (UK) officially notified its intention to leave the European Union (EU).  As of March 30, 2019, EU food law will no longer be applicable to the UK unless a possible withdrawal agreement specifies otherwise.
  • On February 1, 2018, the European Commission published a Notice to Stakeholders on Withdrawal of the United Kingdom and EU food law. Highlights of the Notice include:
    • The importation of products of animal origin from the UK into EU-27, will only be possible if the following conditions are met:
      • the United Kingdom is “listed” by the Commission for public and animal health purposes;
      • the establishment in the United Kingdom from which the food is dispatched, and obtained or prepared in, is “listed” by the Commission for public health purposes;
      • the United Kingdom is “listed” by the Commission as having a residue control plan approved in accordance with Directive 96/23/EC39 for the animals and animal products specified therein;
      • The imported food satisfies all food hygiene requirements set out in the applicable EU legislation.
    • For foods of non-animal origin imported from the UK, the EU authorities will be carrying out regular official controls in accordance with the EU legislation. In addition, compliance with certain EU phytosanitary requirements for imports will be required.
    • Organic production certificates issued by UK authorities to operators who sell their organic products in the EU will no longer be valid as of the withdrawal date. In addition, import of organic products from the UK will be subject to special rules.
  • In light of the uncertainties surrounding the content of a possible withdrawal agreement, affected stakeholders are advised to follow closely future developments related to the EU-UK negotiations.  Our colleagues in Brussels are well-positioned to answer any questions you may have regarding these developments.
  • As previously covered on this blog, in November 2015, the U.S. Food and Drug Administration (FDA) finalized The Food Safety Modernization Act (FSMA) rule on Accredited Third-Party Certification that established a program for the accreditation of third-party certification bodies to conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.
  • On January 31, 2018, the FDA announced that ANSI-ASQ National Accreditation Board (ANAB) – an organization jointly owned by the American National Standards Institute (ANSI) and the American Society for Quality (ASQ) – became the first accreditation body to receive FDA recognition under the voluntary Accredited Third-Party Certification Program, created by the Food Safety Modernization Act (FSMA). FDA explained that it recognized ANAB for a five-year term because it met the applicable FDA requirements, which were validated through application review and on-site assessment.  Additional information on this development is available in our client alert available here.
  • Keller and Heckman will continue to monitor and provide updates regarding FDA’s implementation of the Accredited Third-Party Certification Program and other FSMA-related issues.
  • California residents may see more Proposition 65 warnings at coffee shops in the near future.  A state court is expected to issue a decision in the coming months regarding a 2010 60-day notice and 2012 court filing in which the Council for Education and Research on Toxics alleged 90 companies had failed to warn consumers regarding the presence of acrylamide, which is listed as a carcinogen and reproductive toxicant under Proposition 65.
  • While many coffee retailers (including 7-Eleven) have settled and agreed to both pay $2 million in penalties and other fees and provide a warning, Starbucks and other companies have resisted and are hopeful that a Los Angeles court will find that their coffees contain an adequately low level of acrylamide so as to not require a warning.  (In the meantime, at least some stores of companies that have yet to settle have placed warnings in their stores, pending the outcome of the litigation.) Products causing exposure of more than 0.2 micrograms per day require a warning under Proposition 65.
  • A private mediation with the nine remaining defendants is scheduled for February 8.
  • On August 21, 2014, FSIS published a final rule called the “Modernization of Poultry Slaughter Inspection” (79 FR 49566, Aug. 21, 2014) which amended the Agency’s poultry regulations to establish an inspection system called the New Poultry Inspection System (NPIS) for young chicken and turkey slaughter establishments. Under the final rule, the maximum line speed for young chicken slaughter establishments that operate under NPIS is 140 birds per minute.  See 9 C.F.R. 381.69(a). As previously covered on this blog, on September 1, 2017, the National Chicken Council (NCC) petitioned USDA-FSIS to implement a waiver system to permit young chicken slaughter establishments participating in the NPIS and the Salmonella Initiative Program (SIP) to operate without the line speed limitations imposed under the NPIS.  FSIS accepted comments on the petition through December 13, 2017, receiving over 100,00 comments in total.
  • On January 29, 2017, rejected NCC’s petition. Acting Deputy Undersecretary for Food Safety Carmen Rottenberg explained in a letter that FSIS has already implemented procedures for establishments to request regulatory waivers, and on this basis, the Agency has determined that “it is not necessary to establish a separate system to provide line speed waivers to young chicken establishments operating under the NPIS.”
  • FSIS also specifically denied NCC’s request to allow for waivers that would permit young chicken establishments to operate under NPIS without maximum line speeds. In its response letter, FSIS explained that based on its experience under the HACCP-Based Inspection Models Project (HIMP) pilot study, FSIS inspectors are able to conduct an effective online inspection of each carcass at line speeds of up to 175 bpm (79 FR 49592), and noted that NCC’s petition did not include data to demonstrate that inspectors can conduct an effective carcass-by-carcass inspection at line speeds faster than those authorized under HIMP.
  • FSIS did state in its January 29th letter that FSIS now has more than a year of documented process control history for many young chicken establishments operating under NPIS and “therefore, in the near future, FSIS intends to make available criteria that it will use to consider waiver requests from young chicken establishments, in addition to the current 20, to operate at line speeds up to 175 bpm.”
  • As previously reported on this blog (see here, here and here), the U.S. Food and Drug Administration (FDA) has issued guidance documents, fact sheets, and a Q&A document on how to comply with the foreign supplier verification program (FSVP) final rule, under the Food Safety Modernization Act (FSMA). The FSVP regulation establishes requirements relating to: the use of qualified individuals to conduct FSVP activities, hazard analysis, food and supplier evaluation, foreign supplier verification, corrective actions, recordkeeping, and importer identification. On January 25, 2018, FDA released three additional guidance documents related to the FSVP.
  • The guidance document, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide, explains who is eligible to use FDA’s modified procedures for very small importers or importers of food from certain small foreign suppliers. It also discusses the actions that a small entity must take to comply with the rule.
  • The guidance document, Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities, explains FDA’s intent to exercise enforcement discretion for importers of grain raw agricultural commodities (RACs) that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import.
  • The draft guidance, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, includes information on how importers can meet the modified FSVP requirements for importers of dietary supplements, very small importers, importers of food from certain small foreign suppliers, and importers of food from countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the United States. This draft guidance also provides a different interpretation on two issues addressed in the preamble to the FSVP final rule.
    • First, the preamble to the FSVP final rule states that waxing and cooling raw agricultural commodities, when done by a packing operation for purposes of storage or transport, may be considered a packing activity; while the draft guidance states that such activities may be packing activities and/or holding activities, depending on the circumstances.
    • Second, FDA states in the preamble to the FSVP final rule importers may need to address hazards that may be intentionally introduced by acts of terrorism. The draft guidance clarifies that importers are not required under the FSVP regulation to consider in their hazard analysis hazards that are intentionally introduced to cause wide scale public health harm but should consider warning letters or other enforcement action taken by FDA against foreign suppliers for violation of FDA’s regulation on intentional adulteration as part of their evaluation of potential suppliers.
  • FDA will be accepting comments on the draft FSVP guidance until May 25, 2018 (instructions on how to submit comments can be found in the Federal Register notice announcing the availability of the draft guidance (83 FR 3445). We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities.
  • USDA Secretary Sonny Perdue has released a set of legislative principles for Congress to consider as the new 2018 Farm Bill is developed. Issues covered include: farm production, trade, nutrition, food safety and development.
  • Key principles with specific regard to food safety efforts include:
    • Protect public health and prevent foodborne illness by committing the necessary resources to ensure the highest standards of inspection, with the most modern tools and scientific methods available.
    • Support and enhance FSIS programs to ensure efficient regulation and the safety of meat, poultry and processed egg products, including improved coordination and clarity on execution of food safety responsibilities.
    • Continue to focus USDA resources on products and processes that pose the greatest public health risk.
  • Secretary Perdue’s legislative priorities also addressed the Supplemental Nutrition Assistance Program (SNAP). In particular, Secretary Perdue indicates that USDA would “support work as the pathway to self-sufficiency, well-being, and economic mobility for individuals and families receiving supplemental nutrition assistance.” According to The Wall Street Journal, Secretary Perdue wants some recipients of food stamp benefits to be required to work for them, stating that such a provision regarding SNAP would be key to renegotiating the $900-billion farm bill.
  • The farm bill is slated to be reauthorized this year for five years.
  • The term “egg” is not specifically defined by FDA.  In fact, 21. C.F.R. 160.100 provides that “no regulation shall be promulgated” to define “the food commonly known as eggs.” The rule has been on the books for decades. That being said, FDA does expressly define dried eggs, frozen eggs, liquid eggs, egg whites, dried egg whites, frozen egg whites, egg yolks, dried egg yolks and frozen egg yolks.
  • On January 19, 2018, Panera Bread (Panera) announced that it had petitioned the FDA to establish a clear definition for the term “egg.” Panera, which recently launched a new breakfast sandwich featuring “100% real eggs, is asking FDA to restrict the term “egg” to products free of additives and most processing. Sara Burnett, director of wellness and food policy at Panera, contends that “when a consumer orders an ‘egg,’ they expect to get an egg . . . I don’t think consumers understand these other products that have five or more ingredients.”  Panera’s competitors, some of whom use egg products containing additives, dispute that stance, as well as the petition itself, contending that even processed egg products are made from “real eggs”.
  • It is unclear whether FDA will take action on Panera’s petition given competing regulatory interests, i.e., the Agency has been under pressure to regulate the term “natural” and “healthy” following years of petitions and lawsuits.  As recently covered on this blog, however, in its strategic policy plan for 2018, FDA announced that it will focus on modernizing food definitions this year — a feat the Agency has not attempted in earnest since the Clinton administration.
  • 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: (1) a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL for beef and pork as of December 18, 2015.
  • Against this backdrop, on June 19, 2017, the Ranchers-Cattlemen Legal Action Fund, United Stockgrowers of America (R-CALF USA) and Cattle Producers of Washington (CPoW) filed a complaint in the U.S. District Court for the Eastern District of Washington against the U.S. Department of Agriculture (USDA). The complaint alleges that USDA regulations that allow beef and pork to be classified as “domestic products,” even when those meat products are imported from other countries, confuse consumers and harm American farmers.
  • In court documents filed on January 12, 2018, R-CALF USA and the Cattle Producers of Washington clarified their stance, in response to USDA’s motion for summary judgment which contended that the groups were attempting to invalidate Congress’s repeal of COOL for beef and pork. The cattlemen groups contend that they are not seeking to reinstate COOL, which required country-of-origin labeling on all meat products, including imports and domestic. Instead, the groups state that they would like USDA to interpret the Federal Meat Inspection Act to require country-of-origin labels specifically on imported meat until it undergoes a substantial transformation in the U.S. Under current USDA regulations and policy, the cattlemen groups are concerned that meatpackers can label imported beef as “Products of the USA” even if that product receives only minor processing in the U.S.
  • USDA contends that the repeal of COOL for beef and pork in December 2015 resolves the issue presented in the groups’ complaint. USDA also disputes the plaintiffs’ claim that the Agency’s actions have caused them financial injury.
  • Given the controversial nature of COOL, coupled with its potential role in NAFTA renegotiations and recent state level efforts to reinstate COOL for beef and pork, it remains to be seen whether we will see a COOL comeback of sorts in the near future for beef and pork products.
  • As previously reported on this blog, FDA published final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. The Federal Register publication of the final animal HARPC rule (80 Fed. Reg. 56170) can be found here. Businesses that are not small or very small businesses under the rule were required to comply with the animal food preventive control provisions as of September 18, 2017. Small businesses need to comply by no later than September 17, 2018, and very small businesses need to comply with limited provisions by September 17, 2019. In August 2017, FDA announced that it intends to delay routine preventive controls inspections for large businesses until fall 2018 to allow the animal food industry more time to focus on development of their food safety plans and to consider information in the draft guidance.
  • To assist industry with complying with the Final Animal HARPC rule, this week, FDA published Draft Guidance for Industry #245 titled, “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.” The draft guidance currently contains the following chapters:
    • Introduction
    • Chapter One—The Food Safety Plan
    • Chapter Two—Conducting a Hazard Analysis
    • Chapter Three—Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Animal Food
    • Chapter Four—Preventive Controls
    • Chapter Five—Overview of Preventive Control Management Components
  • Based on comments made by the American Feed Industry Association (AFIA) at yesterday’s AAFCO Feed and Feed Ingredient Manufacturing Committee meeting, industry was surprised to see that the guidance documents contained a list of hazards and 145 references – some of which date back to 1989.
  • FDA is developing additional guidance on the animal food preventive controls provisions and will continue to announce additional guidance as it becomes available. Comments on Draft Guidance for Industry #245 are due by July 23, 2018. Details on how to submit comments can be found in the Federal Register notice on the Draft Guidance (83 Fed. Reg. 3160). If you have any questions concerning the Draft Guidance or any other FDA-related questions, please contact us at fooddrug@khlaw.com.