• As reported previously on this blog, the failure of a net pen structure near Cypress Island, Washington, in August 2017, resulting in the escape of more than 100,000 salmon into Puget Sound, led to calls by members of the Washington State legislature to ban Atlantic salmon net pen farming. Canadian-based Cooke Aquaculture owns the net pen structure that failed.
  • On December 17, Hilary Franz, Washington State Commissioner of Public Lands, announced the termination of Cooke Aquaculture Pacific’s Port Angeles net pen lease. An inspection of the net pen operation at Port Angeles earlier in the month by the Washington State Department of Natural Resources (DNR) determined that:
    • Cooke’s had net pens outside of the leasehold,
    • Two of the net pens’ anchor chains were not connected, and
    • Styrofoam from the net pen was leaching into the environment.
  • The termination of the Port Angeles lease came as a surprise to Cooke, according to the Seattle Times. The farm at Port Angeles currently holds nearly 700,000 Atlantic salmon.
  • DNR is still investigating the circumstances of the failure of Cooke’s net pen operation at Cypress Island, which is operated under a separate lease agreement. The investigation is expected to be completed in January 2018. Once it is complete, Commissioner Franz will assess DNR’s full range of options under its lease with Cooke for the Cypress Island net pens.
  • As previously covered on this blog, on January 19, 2017, USDA published 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, as well as adds new provisions for livestock handling and transport for slaughter. 82 FR 7042.  The effective date for this rule was initially March 20, 2017.  On February 9, 2017, USDA delayed the effective date to May 19, 2017.  On May 10, 2017, USDA published a Notice in the Federal Register (82 FR 21677) delaying the effective date of the final rule for an additional six months to November 14, 2017.  And on November 9, 2017, USDA announced a further delay of the effective date of the Final Rule to May 14, 2018.
  • Today, USDA published a notice in the federal register formally announcing its intention to withdraw the final rule (82 FR 59988).  USDA is basing its proposal to withdraw the final rule on its contention that the final rule exceeds USDA’s statutory authority and on USDA’s revised assessments of the rule’s benefits and burdens. If this withdrawal is finalized, the existing organic livestock and poultry regulations now published at 7 CFR part 205 would remain effective. Stakeholder reaction has been mixed.
  • The Organic Trade Association (OTA) stated that it is “dismayed” at USDA’s action. In a press release, OTA stated: “This groundless step by USDA is being taken against a backdrop of nearly universal support among the organic businesses and consumers for the fully vetted rules that USDA has now rejected. By the department’s own count, out of the more than 47,000 comments the department received in the last public comment period for the regulation, 99 percent were in favor of the rule becoming effective without further delay on Nov 14. USDA noted that of those 47,000 comments, only 28 supported withdrawing the rule.” The OTA is pursuing legal action in federal court to salvage the final rule.
  • On the other hand, the National Pork Producers Council issued a statement commending USDA’s move: “The Obama-era regulation … would have incorporated into the National Organic Program welfare standards that were not based on science and that were outside the scope of the Organic Food Production Act of 1990 . . . We’d like to thank Sec. Perdue and the Trump administration for listening to our concerns with the rule and recognizing the serious challenges it would have presented our producers.”
  • USDA will be accepting comments on the proposal to withdraw the final rule through January 17, 2018. Given the controversial nature of the Final Rule, its ultimate fate continues to remain unclear.
  • Created in 2011, the Interagency Food Safety Analytics Collaboration (IFSAC) is a partnership of three federal agencies—the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS). IFSAC aims to enhance the coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use.  In particular, IFSAC’s projects and studies seek to identify foods that are important sources of human illness and focuses its analytic efforts on four priority pathogens: Salmonella, Escherichia coli ( coli) O157:H7, Listeria monocytogenes (Lm), and Campylobacter.
  • Today, IFSAC released a report titled “Foodborne illness source attribution estimates for 2013 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States.” The authors used outbreak data to update previous analyses to estimate which foods are responsible for illness related to four foodborne pathogens. CDC estimates that, together, these four pathogens cause 1.9 million cases of foodborne illness in the U.S. each year. This latest analysis builds on a method developed by IFSAC in 2015 to estimate foodborne illness source attribution – the process of estimating the most common food sources responsible for specific foodborne illnesses. IFSAC described this method and the estimates for the year 2012 in a report and at a public meeting. The estimates for 2013 were derived using the same method as the 2012 estimates with a few modifications. Highlights of the findings noted in the report include:
    • Salmonella illnesses came from a wide variety of foods.
    • E. coli O157 illnesses were most often linked to Vegetable Row Crops (such as leafy greens) and Beef.
    • Listeria monocytogenes illnesses were most often linked to Fruits and Dairy products.
    • Non-Dairy Campylobacter illnesses were most often linked to Chicken.
  • The updated foodborne illness source attribution estimates combined with other data may potentially shape FDA priorities and influence the development of regulations and performance standards and measures.
  • For years, FDA, USDA, and various industry stakeholders have sought to tackle public health concerns associated with the use of medically important antibiotics to promote growth or feed efficiency in food-producing animals.  In the U.S., FDA is working with industry to gradually phase out the use of medically important antimicrobials in food animals for production purposes.
  • FDA released a report this month showing that domestic sales and distribution of all antimicrobials destined for food-producing animals were down 10% from 2015 to 2016.  For medically important antimicrobials, the decrease was 14%. This is the first time antibiotic sales have declined since such data were first collected in 2009.
  • Key findings of the report include:
    • Most of the domestic use of medically important antibiotics is in cattle (43 percent) and swine (37 percent), with lower sales in chicken (6 percent) and turkey (9 percent)
    • Domestic sales and distribution of medically important antimicrobials accounted for 60% of the domestic sales of all antimicrobials approved for use in food-producing animals. Tetracyclines accounted for 70% of these sales, penicillins for 10%, macrolides for 7%, sulfas for 4%, aminoglycosides for 4%, lincosamides for 2% and cephalosporins and fluoroquinolones each for less than 1%.
  • As industry and regulatory bodies around the world continue to tackle public health concerns associated with the use of medically important antibiotics, it is expected that we will continue to see a decline in the sale, distribution and use of medically important antimicrobials in food animals.
  • The Food Advisory Committee was established on March 6, 1992 (57 FR 8064).  Over the years, the Committee has provided advice to the Commissioner of Food and Drugs and other appropriate officials on emerging food and cosmetic safety, food science, nutrition, and other food-related health issues.
  • Today, the FDA announced in the Federal Register (82 FR 58553) that it will not renew the charter of the Food Advisory Committee.  In announcing the discontinuation of this Committee, FDA noted that the Food Advisory Committee has held only a handful of meetings over the past several years and has not met since 2015. On this basis, FDA has determined that the effort and expense of maintaining the advisory committee is no longer justified.
  • In lieu of the Food Advisory Committee, FDA indicates that it will instead address relevant issues using other standing committees and consulting with individual additional experts in appropriate subjects as needed. In addition, FDA will continue to solicit broad public and expert input on its policy documents and regulations.
  • The termination of the Food Advisory Committee is effective December 12, 2017.
  • The European Commission (EC) announced on December 8, 2017, that discussions on the EU-Japan Economic Partnership Agreement had concluded. Among other things, the agreement ensures the protection in Japan of more than 200 Geographical Indications (GIs) for European agricultural products. In a press release on the agreement, EU commissioner for Agriculture and Rural Development Phil Hogan stated, “This agreement represents the most significant and far reaching deal ever concluded by the EU in agri-food trade.”
  • As reported on this blog in October, several U.S. dairy trade association had written to Japan’s Minister of Agriculture, Forestry and Fisheries, to urge Japan to respect current trade relationships with regard to GIs by ensuring that “generic names and terms remain accessible to all.” The associations suggested that the term “Parmigiano Reggiano” is an acceptable GI but that “parmesan” should be a generic term.
  • The Consortium for Common Foods Names (CCFN), along with the dairy trade associations, continue to work towards safeguarding common food and beverages names. CCFN announced that it worked with the Pan American Dairy Federation to develop a resolution requesting, in part, that the countries of the Americas: “Deny or reject the recognition and/or protection of foreign geographical indications as part of the negotiations of free trade agreements, if these could affect rights previously acquired in good faith or prevent that the common names in common language (also known as generic or of common use) can continue to be used to market dairy products in our countries;…” The resolution was issued November 30, 2017.
  • Section 807(b) of the Federal Food, Drug, and Cosmetic Act, added by section 306 of the Food Safety Modernization Act (FSMA) authorizes the U.S. Food and Drug Administration (FDA) to refuse imported food from being admitted into the United States if the Agency is not permitted to inspect the foreign establishment that produced the food.
  • Today, the FDA issued draft guidance to explain what type of actions by a foreign food establishment or government would constitute a “refusal of inspection.” The draft guidance provides a non-exhaustive list of examples to illustrate some of the situations that the FDA may encounter when attempting to conduct inspections. Prohibiting entry of FDA investigators, withholding records, causing delays during an inspection and rejecting FDA’s attempts to schedule an inspection by not agreeing to an inspection start date (and not giving a reasonable explanation for its failure to do so) are all listed as examples of situations that the FDA would consider to constitute a “refusal of inspection.”
  • FDA will be accepting comments on the draft guidance for 75 days following its imminent publication in the Federal Register.
  • Created in 2011, the Interagency Food Safety Analytics Collaboration (IFSAC) is a partnership of three federal agencies—the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the Food Safety and Inspection Service of the United States Department of Agriculture (FSIS). IFSAC aims to enhance the coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use.  In particular, IFSAC’s projects and studies seek to identify foods that are important sources of human illness and focuses its analytic efforts on four priority pathogens: Salmonella, Escherichia coli ( coli) O157:H7, Listeria monocytogenes (Lm), and Campylobacter.
  • Today, FDA announced that new research from IFSAC scientists on how to categorize foods linked to foodborne disease outbreaks was recently published in a paper entitled, “An Updated Scheme for Categorizing Foods Implicated in Foodborne Disease Outbreaks: A Tri-Agency Collaboration.” The paper updates previous food categories used by the CDC and has five levels with subcategories at each level, for a total of 234 food categories. Highlights of the IFSAC food categorization scheme include:
    • Close alignment with the food product definitions used by the FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) for regulatory purposes;
    • Separation of Aquatic Animals, Land Animals, and Plant foods into increasingly specific animal (for example, Fish, Dairy, Beef) or botanical (for example, Fruits, Fungi, Root/Underground) food categories;
    • Separation of foods based on food processing, preparation, and consumption type (for example, ready-to-eat meats, canned/containerized produce); and
    • New categories for “Other” foods and foods not assigned to a category under the previous scheme (for example, “Multiple-Ingredient Food,” “Multiple Foods Reported”).
  • The increased specificity of food categories noted in the paper could potentially improve source attribution analyses, ultimately leading to improved foodborne illness source attribution estimates and enhanced food safety and regulatory efforts.
  • FDA’s Produce Safety Rule, implemented under the Food Safety Modernization Act (FSMA), establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption.  Our detailed summary of the rule is available here.
  • When the Produce Safety Rule became final in November 2015, FDA began building the Produce Safety Network (PSN) to support the efforts of farmers, state regulators and other key stakeholders to implement the rule.  The network is comprised of FDA produce safety experts, located in various locations throughout the country, and is staffed by seven produce safety experts and one team leader from the Center for Food Safety and Applied Nutrition (CFSAN), and 11 investigators and two branch chiefs from the Office of Regulatory Affairs (ORA). They work closely with key produce stakeholders, such as state produce safety programs, to provide regulatory support and technical assistance.  In particular, the PSN:
    • establishes regionally based policy and regulatory experts throughout the country, making them uniquely suited to address the issues specific to the states they’re supporting; and
    • places these experts, from two very different FDA offices, within one team. The network combines the regulatory expertise from the FDA’s Office of Regulatory Affairs (ORA) with the policy and science expertise from the Center for Food Safety and Applied Nutrition (CFSAN).
  • This week, FDA released an interview with Stephen Hughes, the PSN’s Team Lead from CFSAN and Brittany Laymon, one of two Branch Chiefs leading the investigators from ORA, discussing how the PSN works with industry to achieve FDA’s food safety and public health goals.  The complete interview is available here.  Of note, Hughes indicated that PSN investigators will be involved with domestic and foreign inspections.  Domestically, in states that do not have a produce safety program under the State Produce Implementation Cooperative Agreement Program (CAP), PSN intends to conduct routine and for-cause inspections. In states that do develop a produce safety program, FDA may accompany state inspectors during for-cause and routine inspections upon request.
  • USDA quality grades are used by companies to provide information to consumers about meat’s tenderness, juiciness, and flavor and are a key factor in determining the value of beef and live cattle.  Last summer, USDA requested stakeholder feedback on a petition asking to amend standards for beef carcass grades.  That petition requested that the standards be revised to include dentition and documentation of actual age as an additional determination of maturity grouping for official quality grading.
  • USDA’s Agricultural Marketing Service (AMS) announced yesterday that it is updating the voluntary S. Standards for Grades of Carcass Beef.  With this update, companies using the USDA grading program can now rely on dentition or age documentation to establish the maturity of animals.  Under the revised standards, producers and processors can ensure that cattle 30 months old or younger are included in the youngest maturity group recognized as “beef”.  Skeletal and muscular evidence will still be used to determine maturity for those animals over 30 months of age.
  • The revised standards will be implemented on Monday, December 18, 2017.  Prior to that date, companies using the USDA voluntary grading program must:
    • Provide documentation to the AMS Supervisor and Graders describing how carcasses over 30 months of age are identified and segregated within the plant. AMS will review these procedures either during routine QSA audits or during supervisory visits. Plants with a Quality Systems Assessment (QSA) program (e.g., for Export Verification) will provide the applicable section from their quality manual which details this process. Plants without a QSA program will document their process through a Standard Operating Procedure or similar document; and
    • Ensure the AMS Supervisor and Graders are aware of how carcasses over 30 months of age are identified and marked. The carcasses must be identified in a manner that allows the AMS Grader to easily see the identification when presented for grading.
  • On December 18, companies may only offer carcasses for initial quality and/or yield grading.  No carcasses shall be presented for grading that were held as regrades from the previous week.