• On December 11, 2017, the Food and Drug Administration of Taiwan (TFDA) released an announcement intending to repeal the existing food allergen labeling regulations and replace it by a new regulation, which was published at the same time for comments.
  • Under the proposed new regulation, TFDA consolidates the existing six categories of foods that are of allergen concern (i.e., mango, shrimp, milk, egg, peanuts, crab) and subject to mandatory labeling, and expands them to eleven categories as follows:  (1) Crustacea and products thereof; (2) mango and products thereof; (3) peanuts and products thereof; (4) sesame, sunflower seeds and products thereof; (5) milk, goat milk and products thereof except lactitol derived from milk and goat milk; (6) egg and products thereof; (7) nuts and products thereof, including almond, hazelnut, walnut, cashew nut, pecan, brazil nut, pistachio nut, macadamia nut, pine nuts, chestnuts etc.; (8) cereals containing gluten and products thereof, including wheat, barley, rye, oats etc.; (9) soybean and products thereof, except highly refined or purified soybean oil (fat), tocopherols and their deviation, phytosterols and phytosterol esters; (10) the use of sulphites and sulphur dioxide etc., at concentrations of 10 mg/kg or more in term of total SO2 which are to be calculated for final products; and (11) Salmon, mackerel, codfish, Dissostichus eleginoides (Yuan xue ) , Reinhardtius hippoglossoides (Bian xue ) and products thereof.
  • TFDA also specifies the format to declare allergen information on the label, such as “the product contains XX” or other wordings expressing the similar meaning. The common allergen statement used by industry like “may contain” is not addressed in the proposal, which needs further clarification from the authority.
  • The new regulation, once adopted, is scheduled to take effect on July 1, 2019. TFDA is accepting comments on the proposal for 60 days following its publication on the website, which is by February 11, 2018. Please feel free to contact us at fooddrug@khlaw.com if you are interested in submitting comments or if you have  any questions.
  • Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA). 83 FR 598. In short, this guidance document outlines the Agency’s intent to not enforce certain FSMA requirements as they currently apply to certain entities and/or activities. This enforcement discretion specifically relates to certain provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to:
    • facilities that would be farms except for certain factors and activities
    • written assurances provisions in all four rules related to the customer’s control of identified hazards that are a potential risk to public health
    • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and
    • FSVP requirements for importers of food contact substances.
  • As our readership is well aware, FDA had previously extended the compliance dates for many of the provisions covered by this guidance (see August 2016 compliance date extension). The enforcement discretion policies enumerated in the guidance will remain in place until and unless FDA decides to take further action on any of these issues.
  • Our detailed summary of the enforcement discretion policies and their potential impact on industry will be posted to our Firm’s website shortly. In the meantime, please feel free to contact us with any questions at fooddrug@khlaw.com.
  • The U.S. Department of Agriculture (USDA) administers the National Organic Program (NOP), which includes standards for “organic” food in the United States.  Throughout 2017, The Washington Post has published several stories calling into question the authenticity of products from some of the largest “organic” producers of milk, eggs and imported grains.
  • Congress is currently considering legislation that would increase protections for consumers against food that is advertised as organic but does not meet the standards of USDA’s NOP. More specifically, the Organic Farmer and Consumer Protection Act, introduced by Representatives John Faso (R-N.Y.) and Michelle Lujan (D-N.M.), calls for a modernization of organic import documentation, new technology advancements and stricter enforcement of organic products entering the U.S.  The proposed legislation roughly doubles the budget for the USDA’s organic program over the next five years. The Washington Post recently reported that the bill has 33 House cosponsors so far, and its supporters are hopeful that bipartisan support will facilitate its passage this year.
  • Industry has also stepped in to seek to halt the increasing incidences of fraud in organic.  Earlier this year, for example, the Organic Trade Association formed its own anti-fraud task force.  Given the increased attention this issue has received over the past year, and industry’s concerns, it is not inconceivable that an organic food fraud bill could come to fruition in the near future.
  • As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.
  • A recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concludes that FDA’s current recall process can be too slow and puts consumers at risk.  This report follows on an “early alert” released by the OIG on June 8, 2016 finding that FDA did not have a process in place to ensure that regulated companies initiated food recalls promptly.
  • In preparing the December 2017 report, the OIG reviewed documentation from a sample of 30 voluntary food recalls initiated from October 1, 2012 to May 4, 2015 to analyze FDA’s oversight of companies’ initiation of recalls, as well as the Agency’s monitoring of firm-initiated recalls, and the Agency’s maintenance of data in an electronic recall data system.
  • In response to the OIG report, FDA Commissioner Scott Gottlieb issued a statement contending that FDA’s recall protocol is generally quite effective, noting, for example, that on average voluntary recalls are initiated within four calendar days of when a problem is discovered. At the same time, Commissioner Gottlieb acknowledged that there is room for improvement and stated that the Agency intends “to say more in early 2018 on additional policy steps [the Agency will] take as part of a broader action plan to improve [its] oversight of food safety and how [it] implements the recall process.” According to Commissioner Gottlieb, FDA is currently looking at ways to improve the timeliness and scope of information the Agency provides to the public about recalls of FDA regulated foods.
  • It remains to be seen whether this latest OIG report will prompt FDA to consider utilizing its mandatory recall authority on a greater scale.
  • As our readers are aware, sweetened beverage taxes have been in the spotlight for several years now. In November 2016, voters in three California cities and in Boulder, Colorado passed measures to tax sweetened beverages, and the Cook County Board of Commissioners voted to impose a controversial soda tax (see our November 15, 2016 blog). However, only two months after the Cook County, Illinois soda tax became effective in August 2017, it was repealed. Also in 2017, Santa Fe, New Mexico voters rejected a proposed tax of two cents per fluid ounce on sugar-sweetened beverages, and a proposal in Massachusetts to implement a tiered tax on sugar-sweetened beverages didn’t make it out of committee.
  • The soda tax debate is continuing into 2018. Seattle’s proposed tax of 1.75 cents per once of sweetened beverages became effective yesterday, January 1, 2018. The tax is 1.75 cents per ounce of sports, energy and other sweetened drinks to be paid by distributors of the beverages. This tax excludes drinks with non-caloric sweeteners.
  • Controversy also surrounds Philadelphia‘s sweetened beverage tax—in effect since January 2017 (see our June 17, 2017 blog). The American Beverage Association filled a petition last July with the Pennsylvania Supreme Court requesting that Philadelphia’s soda tax be overturned. And just last month, PillyPenn (a mobile news platform) reported that Pennsylvania state representative Mark Mustio (R-44) circulated a memo seeking co-sponsors for a bill to abolish the soda tax. Another concern with Philadelphia beverage tax is, it is not bringing the projected revenue. The Philadelphia Business Journal reports that the total revenue collected from January through November 2017 from the tax is $72.3 million. The estimated revenue for 2017 was $93 million.
  • Stay tuned for further developments concerning the success and/or failure of beverage taxes imposed by jurisdictions throughout the U.S.
  • Today, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced key 2017 data concerning its food safety efforts.
  • 2017 highlights include:
    • FSIS inspected more than 155 million head of livestock and 9.45 billion poultry carcasses.  FSIS Inspectors also conducted 6.9 million food safety and food defense procedures across 6,500 regulated establishments to ensure that meat, poultry and processed egg products was safe and wholesome.
    • FSIS continued its initiatives to modernize operations and inspection systems. In particular, FSIS continued to modernize poultry inspection under the New Poultry Inspection System (NPIS) through its science-based, preventive approach poultry inspection.
    • FSIS implemented inspection of Siluriformes fish by transitioning regulatory oversight from the FDA to FSIS, and prevented the entrance of, or removed over, 715,000 pounds of adulterated or ineligible imported Siluriformes product from U.S. commerce.
  • Looking ahead, FSIS expects to continue to increase its use of whole genome sequencing and to develop key informational tools and resources for inspection personnel.

The Daily Intake is taking a holiday hiatus and will return on January 2, 2018.  We wish you a joyous holiday season and a happy new year. 

  • 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.