• The Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food was published on September 17, 2015 (80 FR 55907), and compliance dates for some businesses began in September 2016.  The final rule implements hazard analysis and risk-based preventive controls (HARPC) for human food production. The new HARPC requirements implemented by the final rule are codified at 21 CFR Part 117, Subpart C. A corresponding Draft Guidance document is available here. The Draft Guidance explains FDA’s current thinking on how to comply with certain HARPC requirements and specifically addresses how food producers should go about developing an appropriate food safety plan.
  • On August 22, 2017, FDA launched the Food Safety Plan Builder (FSPB), a free software application developed by FDA to further assist businesses meet the requirements of the FSMA Final Rule for Preventive Controls for Human Food.  The software is downloadable from FDA’s website and is designed to guide businesses, step-by-step, through the creation of a food safety plan, as required by FSMA. FDA has released videos that provide tutorials on how to use the FSPB software.
  • Use of the software is strictly optional. FDA is not requiring use of this tool to develop a facility’s food safety plan, but use of the software could potentially help companies organize their food safety information and minimize the burden of creating their food safety plan. Manufacturers with questions about how to use the FSPB software may contact FDA at: FoodSafetyPlanBuilder@fda.hhs.gov.
  • The labeling of meat and poultry products primarily falls under the jurisdiction of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). FSIS administers the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). Both the FMIA and the PPIA require food manufacturers to obtain prior approval for labels of meat and poultry products before such products may be marketed in commerce. Prior approval is granted in one of two ways:
    • “Sketch approval” which entails Agency review of food labels; and
    • “Generic approval” which is label approval obtained by virtue of the label being in compliance with applicable regulations.
  • On Friday, August 18, 2017, FSIS issued an updated FSIS Compliance Guideline for Label Approval to clarify when meat and poultry companies must submit labels to FSIS for approval. In particular, FSIS updated the guidelines to provide clarification on:
    • Special statements or claims in labels which require submission to FSIS for approval.
    • Changes to labels approved with special statements and claims that require FSIS approval.
    • Changes that can be made to labels approved with special statements and claims without additional FSIS review.
    • How companies can ask FSIS for “blanket approval” so that they can use a special claim for an entire line of products or multiple products without having to submit every single label to FSIS for approval.
  • FSIS has opened up a 60-day comment period on the guidelines.  Comments may be submitted via regulations.gov or by mail to USDA-FSIS, Patriots Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, 8-163A, Washington, D.C. 20250-3700. Our detailed summary of the updated compliance guideline is forthcoming.  In the meantime, please feel free to contact us with any questions at: fooddrug@khlaw.com
  • Antimicrobial use in food producing animals remains a hot button issue. 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.  In an address to the UN General Assembly late last year, Dr. Margaret Chan, Director-General of the World Health Organization (WHO) called on consumers to choose “antibiotic free” meat, noting that doing so would help stem the “slow motion tsunami” of antimicrobial resistance. And, recently, states have also jumped into the fray, with California, for example, adopting strict limits in 2015 on the use of antibiotics in healthy livestock, effectively barring their routine use to prevent illness or promote growth.
  • Earlier this month, the World Organization for Animal Health (OIE) published for the first time a report outlining how livestock producers use antimicrobials in animals around the world. The report, titled “OIE Annual report on the use of antimicrobial agents in animals — Better understanding of the global situation,” provides a global and regional analysis based on data ranging from 2010 to 2015, with 130 of OIE’s 180 member countries participating in data collection.  Key findings include but are not limited to:
    • A total of 96 of 130 (74%) OIE member countries indicated that they do not authorize antimicrobial agents for growth promotion in animals.
    • Twenty-five member countries provided a list of antimicrobial agents authorized for growth promotion; Tylosin and Bacitracin were most frequently quoted. Colistin was mentioned by 10 of 25 member countries.
    • Tetracyclines and macrolides were the most commonly used antimicrobial agents.
    • The main route of administration in animals was oral.
  • OIE notes that the information provided in this new report represents an important first step to better understanding the global use of antimicrobial agents in animals.
  • Argentina has blocked imports of American pork since 1992, citing animal health concerns.
  • On August 17, 2017, the White House announced that the United States and Argentina have agreed to terms that will allow U.S. pork to enter the Argentine market for the first time since 1992.  The agreement follows an August 15, 2017 meeting between Vice President Mike Pence and President Mauricio Macri of Argentina during the Vice President’s visit to Buenos Aires. President Trump first raised the issue with President Macri during their bilateral meeting at the White House on April 27, 2017.
  • All fresh, chilled, and frozen pork and pork products from U.S. animals will be eligible for export to Argentina. Argentine food safety officials will visit the U.S. to conduct on-site verification of the U.S. meat inspection system, after which U.S. pork exports will resume pending resolution of any outstanding technical issues.
  • The White House statement notes that the U.S. is the world’s top pork exporter, and the agreement opens up a potential $10-million-per-year market for U.S. pork producers.
  • The Canadian Food Inspection Agency (CFIA) oversees food safety, animal health and plant health regulatory programs in Canada. The CFIA works with federal, provincial and territorial science organizations, industry, universities and other partners across Canada to support and develop science that contributes to evidence-based decisions that aim to protect Canada’s food, animal and plant resources. With specific regard to plant health, the import and export of fruit plants must go through the CFIA to test for potentially devastating plant viruses. The CFIA reports that, currently, this testing and quarantine process takes an average of three years to complete, significantly hampering the speed of trade.
  • On August 15, 2017, the CFIA announced that it will lead two projects worth $500,000 that use new DNA-based technologies to reduce the quarantine testing time, thereby helping to boost trade and economic competitiveness in the $240 million Canadian fruit tree industry.
    • The first project aims to dramatically shorten the testing period of seeds, cuttings and bulbs imported into Canada to grow new varieties of plants. More specifically, scientists will use DNA technology to test for all viruses associated with imported plants to get an early indication of any plant diseases present. CFIA notes that this approach could reduce the quarantine testing time by up to two and a half years.
    • The second project aims to streamline the testing of strawberry plants. CFIA notes that, traditionally, multiple tests for viruses are required before exporting strawberry plants to foreign markets. This project will test for multiple viruses in a single test, thus reducing the time and cost to get plants to market.
  • To learn more about the CFIA’s work in DNA-based technologies, known as genomics, click here.
  • As previously covered on this blog, on April 6, 2016, FDA published a final rule to implement sanitary food transportation requirements under the FDA Food Safety Modernization Act (FSMA).  Click here for a complete copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule, and click here for our summary of the rule and its implications for entities in the food industry.  In short, the final rule establishes sanitary transportation practices for covered entities addressing: (1) vehicles and transportation equipment; (2) transportation operations; (3) training; (4) records; and (5) waivers. The compliance date for most companies was April 2017.  Small businesses have until April 2018 to comply.
  • On April 5, 2017, FDA announced the publication of three waivers to the final Sanitary Transportation rule. The waivers are for businesses whose transportation operations are subject to existing regulatory controls at the federal, state or local levels, including one that waives certain requirements for restaurants, retail food establishments, and nonprofit food establishments. See previous blog coverage here.
  • On August 14, 2017, FDA issued guidance to clarify that a waiver to the Sanitary Transportation of Human and Animal Food final rule (Sanitary Transportation rule) covers retail food establishments that sell food for humans, including those that sell both human and animal food, but does not apply to establishments that only sell food for animals.
  • We will continue to monitor and report on FDA’s activities in connection with the final Sanitary Transportation rule and other FSMA related activities.  Please feel free to contact us at fooddrug@khlaw.com with any questions.
  • The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announced the approval of a variety of bioengineered safflower as a source of omega-6 fatty acids in dry adult dog food. The final rule amends Title 21 Code of Federal Regulations (C.F.R.) Part 573 (“Food Additives Permitted in Food and Drinking Water of Animals”) by adding 21 C.F.R. 573.492 to permit the use of the food additive gamma-linolenic acid (GLA) safflower oil containing an omega-6 fatty acid in animal food.
  • FDA took this action in response to a food additive petition submitted by Arcadia Biosciences, Inc. (Arcadia); the Agency announced the filing of Arcadia’s food additive petition on September 12, 2012 (77 FR 56175). In the petition, Arcadia requested that the food additive regulations be amended to permit the use of GLA safflower oil—which was bioengineered to contain a gene from the water mold Saprolegnia diclina responsible for production of GLA in the seed oil—for use in dry food for adult dogs.
  • FDA stated in the August 15, 2017 Federal Register (82 Fed. Reg. 38595) that it had concluded that the data submitted by Arcadia established “the safety and utility of GLA safflower oil as a source of omega-6 fatty acids in complete dry adult maintenance dog food…”
  • Keller and Heckman regularly counsels clients on the regulatory status of animal feed ingredients and has submitted feed additive petitions and GRAS Notices to FDA CVM for a variety of animal feed additives.
  • The second major compliance dates are coming up for the Preventive Controls for Animal Food Rule under FDA’s Food Safety Modernization Act (FSMA). On September 18, 2017, larger animal food facilities must comply with preventive controls requirements mandated by FSMA. These facilities had to meet Current Good Manufacturing Practice (CGMP) requirements by September 2016.
  • As background, the Final Rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, 80 Fed. Reg. 56170 (Sept. 17, 2015) under FSMA became effective on November 16, 2015.  The final rule accomplishes the following:
    • It establishes for the first time CGMPs for food for animals, which are akin to the CGMPs that have long applied to human food;
    • It requires animal food facilities to develop a written food safety plan that includes hazard analysis and imposes risk-based preventive controls (HARPC);
    • It requires the establishment of a supply chain program; and
    • It clarifies the facilities that are subject to CGMPs and HARPC requirements, and the exemptions from these requirements, including exemptions for “farms.”
  • For the CGMP requirements, food facilities generally had one year from publication of the final rule (September 19, 2016) to comply.  “Small Businesses” (a business employing fewer than 500 full-time equivalent employees, regardless of sales) and “Qualified Facilities” (which includes “Very Small Businesses,” i.e., businesses averaging less than $2.5 million per year (adjusted for inflation) in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale) have until September 18, 2017 and September 17, 2018, respectively, to comply with the CGMPs.
  • For the HARPC requirements, the general compliance date (i.e., for large facilities) is two years from publication of the final rule (September 18, 2017), while small businesses and qualified facilities (including very small businesses) must comply by September 17, 2018 and September 17, 2019, respectively.
  • FDA recently announced in a post by Jenny Murphy of FDA’s Center for Veterinary Medicine (CVM) that the Agency would be delaying preventive controls inspections until the fall of 2018. At the same time, FDA announced that there will be an increased level of oversight of CGMPs with more routine inspections because, as of September 18, 2017, both large and small facilities will be required to meet those requirements.  The Agency’s thinking here is that CGMPs are the foundation that must be in place before you establish preventive controls – “CGMPs establish a base to make sure you don’t contaminate the animal food and the preventive controls take it a step further by making you really concentrate on things that, if they’re found in animal food, could be a public health concern. Once you have CGMPs in place, you can see where you need extra layers of protection.”
  • For additional details concerning FDA’s plan to delay preventive controls inspections see FDA’s post on “What to Expect With the Next Compliance Dates for the FSMA Preventive Controls for Animal Foods Rule” here.
  • Mechanical filtration technologies available for milk processing include ultrafiltration.  Ultrafiltered milk (UF Milk) is milk that is mechanically filtered via semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the “casein to whey protein” ratio of the milk and resulting in a liquid product.
  • FDA’s regulations specify the standards of identity for cheeses and related cheese products in part 133 (21 CFR part 133). The relevant provisions within part 133 define “milk” and “nonfat milk” that may be used in the manufacture of cheeses and related cheese products. The definitions for “milk” and “nonfat milk” in § 133.3(a) and (b), respectively, list different forms of milk and nonfat milk, including concentrated, reconstituted, and dried forms, that may be used in the making of cheeses and related cheese products. Of note, fluid or dried filtered forms of milk obtained through mechanical filtration of milk or nonfat milk are not included within these definitions.
  • In the Federal Register of October 19, 2005 (70 FR 60751), FDA issued a proposed rule that would have amended the Agency’s regulations to provide for the use of fluid UF milk in the manufacture of standardized cheeses and related cheese products.  But due to competing priorities, as of August 2017, FDA has not completed the rulemaking.
  • Today, the U.S. Food and Drug Administration (FDA) issued guidance to industry indicating that FDA will exercise enforcement discretion regarding the use and labeling of fluid ultrafiltered milk and fluid ultrafiltered nonfat milk to make certain cheeses and related cheese products.
  • The FDA states that it is taking this action in light of recent changes in some export markets that have caused the U.S. dairy industry to experience an oversupply and pricing challenges with domestically produced UF milk. The FDA further states that the exercise of enforcement discretion seeks to mitigate the impact on U.S. companies producing UF milk, while the Agency considers rulemaking concerning the issues about the use and labeling of UF milk and UF nonfat milk in certain cheeses and cheese products.
  • The FDA is encouraging manufacturers of standardized cheeses and related cheese products to identify fluid UF milk and fluid UF nonfat milk, when used as ingredients, as “ultrafiltered milk” and “ultrafiltered nonfat milk” when feasible and appropriate. That being said, the Agency notes that it does not intend to take action against companies that manufacture standardized cheeses and related cheese products that contain fluid ultrafiltered milk or fluid ultrafiltered nonfat milk without declaring them in the ingredient statement provided their labels declare milk or nonfat milk in the ingredient statement.
  • FDA states that it intends to exercise enforcement discretion until: (1) FDA has completed rulemaking to amend its regulations with respect to the issues covered by this guidance or (2) FDA announces in the Federal Register its determination not to proceed with such a rulemaking.
  • Country of Origin Labeling (COOL) requirements at 7 CFR Part 60 and 7 CFR Part 65 require retailers to notify their customers of the country of origin of covered commodities, which include muscle cut and ground lamb, goat, and chicken; wild and farm-raised fish and shellfish; fresh and frozen fruits and vegetables; peanuts, pecans, and macadamia nuts; and ginseng. COOL regulations give retailers a number of options for marking commodities, including via placards, signs, labels, stickers, bands, twist ties, and pin tags. USDA’s Agricultural Marketing Service is responsible for the administration and enforcement of COOL.
  • On August 9, 2017, USDA published a final rule (82 FR 37171) which extends the current rules of practice under the Agricultural Marketing Act of 1946, as amended, to include COOL violations.  In particular, the final rule authorizes fines for a retailer or person engaged in the business of supplying a covered commodity that willfully violates COOL regulations.
  • It remains to be seen whether this final rule will lead to heightened surveillance and regulatory activity with respect to COOL compliance.  For questions on COOL, you may contact us at: fooddrug@khlaw.com.