FDA Clarifies Sanitary Transportation Rule Waiver for Retail Food Establishments

  • 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.

FDA Approves New Source of Omega-6 Fatty Acids for Dog Food

  • 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.

FDA Delays Preventive Controls Inspections for Large Animal Food Facilities

  • 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.

FDA Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

  • 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.

New Final Rule Strengthens USDA Enforcement of COOL Requirements

  • 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.

USDA Proposes to Recognize Mexico as CSF-Free, Easing Restrictions on Mexican Pork Exports

  • The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has regulatory authority over both the import and export of livestock products.  In the import context, APHIS works to ensure that products entering the U.S. meet the Agency’s entry requirements to exclude pests and diseases.
  • In July 2014, USDA published a proposed rule (79 FR 43974) that would have recognized Mexico as a low-risk classical swine fever (CSF) region. Since the rule was published, the World Organization for Animal Health recognized Mexico as CSF-free.  As a result, Mexico’s government requested that APHIS suspend its rulemaking and instead continue evaluating Mexico’s CSF status.  APHIS reopened its evaluation and conducted a site visit in 2015. Based on the 2015 site visit report, along with updated surveillance data and additional information submitted by Mexico’s government, APHIS determined that current conditions support CSF-free recognition for all of Mexico.
  • On August 8, 2017, APHIS published a Notice (82 FR 37043) which proposes to recognize Mexico as free of classical swine fever (CSF).  In announcing the publication of this Notice, APHIS also noted that it will withdraw the 2014 proposed rule that would have recognized Mexico as a low-risk CSF region. Recognizing Mexico as CSF-free could potentially create new opportunities for Mexican pork products in the U.S. market.
  • APHIS will be accepting comments on the Notice for 60 days (or until October 10, 2017) prior to making a final determination on Mexico’s CSF status which will ultimately be published in the Federal Register.

FDA Issues Guidances on Exemptions from FSMA Rules

Canadian Study Identifies Off-Label Meat in 1 in 5 Sausages

  • Funded by the Canadian Food Inspection Agency (CFIA), University of Guelph researchers have conducted the first-ever Canadian study examining sausage mislabeling. The study examined 100 sausages that were labeled as containing just one ingredient — beef, pork, chicken or turkey.
  • Published on July 31, 2017 in Food Control, the study found cross-species contamination of meat ingredients in 20 percent of sausage samples from grocery stores across the country. Highlights of the study include:
    • The predominant meat species were determined in sausage samples using DNA barcoding.
    • Five turkey sausage samples contained chicken as the predominant species.
    • Contaminant meat species were detected using digital droplet PCR.
    • Undeclared species were detected in beef (6%), chicken (25%), and pork (5%) sausages.
    • Real-time PCR assay revealed that one pork sample contained horse meat.
  • CFIA states that the goal of the study was to explore whether CFIA might be able to employ scientific methods employed by the researchers – such as DNA barcoding and real-time Polymerase Chain Reaction (PCR) assays – in its regulatory practices as it concerns product mislabeling. CFIA says that the scientific tools show promising results. It remains to be seen whether these findings will prompt CFIA to launch a broader study of this issue and, ultimately, whether the CFIA will consider regulatory measures that incorporate such testing to assure that food product labels are truthful and not misleading.

New Poll Shows Consumer Confusion Abounds Over Date labels

  • As previously covered on this blog, the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) launched an initiative this past February to streamline and standardize the wording accompanying the date labels on packages to offer greater clarity regarding the quality and safety of products.  The new voluntary initiative calls for the use of just two standard phrases:
    • “BEST If Used By” – to describe product quality where the product may not taste or perform as expected but is safe to use or consume; and
    • “USE By” – which would apply to the few products that are highly perishable and/or have a food safety concern over time; these products should be consumed by the date listed on the package – and disposed of after that date.
  • A recent poll by GMA and the Food Policy Action Network found that the current range of variations of date labels such as “best by, use by, sell by, use or freeze by” on food products around the country is problematic for consumers.  Key poll findings include:
    • Nearly 60 percent of Americans have discussed the meaning of date labels on their food
    • 40 percent of adults say they have had disagreements within their household over whether a food product should be kept or thrown away
    • Older Americans are slightly more likely to keep food longer, while younger Americans are more likely to throw food away earlier based on the date label.
    • More men say they are the ones in the household arguing to keep food longer; 64 percent of men make this claim, versus 56 percent of women.
  • Following on these poll findings, GMA’s Director of Sustainability stated that “clarity on product date labeling will reduce confusion . . .  [and] cut food waste.” Broad industry adoption of the voluntary date labeling standard launched by GMA and FMI is expected to occur over time to allow companies flexibility to make the changes in a way that ensures consistency across their product categories.  It remains to be seen if FDA and/or USDA will ultimately choose to issue regulations tracking the date labeling terminology proffered by GMA and FMI.

House Committee Advances Changes to Menu Labeling Law

  • Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar menu items) must provide calorie and other nutrition information for standard menu items. The menu labeling requirements originally were scheduled to take effect on December 1, 2015. The compliance date has since been delayed until May 8, 2018.
  • In the meantime, Congress has been considering legislation to modify the menu labeling requirements to provide flexibility in determining how to disclose nutrition information. The Common Sense Nutrition Disclosure Act (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 in the Senate by Sens. Roy Blunt (R-MO) and Angus King (I-ME) on February 1, 2017. See previous blog coverage here.
  • On Thursday, July 27, 2017, The Common Sense Nutrition Disclosure Act advanced out of the House Energy and Commerce Committee. The bill would allow restaurants and grocery retailers the choice of listing calories for the whole menu item, by serving, or per “common unit” of a food item. The bill also provides additional flexibility on where establishments can post calorie information. More specifically, under the proposed bill, nutritional information may be provided solely by a remote-access menu (e.g., an Internet menu) for food establishments where the majority of orders are placed by customers who are off-premises.
  • Given the bipartisan support for this bill, to date, combined with the flexibilities afforded to industry under its provisions, this bill stands a good chance of ultimately becoming law. We will continue to monitor developments on this bill as they unfold and report them to you here.