FDA Releases Small Entity Compliance Guide for FSMA Sanitary Transportation Rule

  • 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 November 21, 2017, FDA announced the availability of a Small Entity Compliance Guide (SECG) to help small businesses understand the requirements of the Final Rule on the Sanitary Transportation of Human and Animal Food (Sanitary Transportation Rule). Small businesses have until April 6, 2018, to comply with the rule.
  • The SECG provides descriptions of the rule requirements in a question and answer format that includes information on topics such as training and record keeping. Comments may be submitted to FDA at any time. Instructions on how to submit comments are available in the Federal Register Notice available here (82 FR 55503).

The Daily Intake will return on Monday, November 27.  We extend our best wishes to those of you celebrating the Thanksgiving holiday.

Washington State Senator Considering Ban on Atlantic Salmon Farming

  • Washington State Senator Kevin Ranker (D-Orcas Island) plans on proposing legislation in the upcoming session to ban Atlantic salmon net-pen farming, reports the Seattle Times. The legislation is in response to an August 2017 incident where 100,000 fish escaped into Puget Sound from a net-pen farm. The Washington Department of Ecology defines Net-Pen finfish aquaculture as the practice of raising fish in an underwater net that serves as a pen.
  • The salmon escaped due to a failed net-pen structure owned by Cooke Aquaculture, a multi-billion dollar, privately held corporation based in Canada. The Washington Department of Natural Resources manages the land on which the net-pen farm is located and has a tenant contract with Cooke Aquaculture. Sen. Ranker’s bill would allow the leases for eight existing Atlantic net-pen farms in Washington to expire in 2025 but would not allow any new permits to be issued or existing ones to be renewed.
  • Also in response to the August incident, the Wild Fish Conservancy (WFC) filed a citizen suit against Cooke under the Clean Water Act. WFC explained in a press release, “These discharges represent blatantly negligent violations of the National Pollutant Discharge Elimination System (NPDES) permits under which Cooke Aquaculture’s Atlantic salmon net pens currently operate.”

GMO Labeling Update: Some Senators Calling for On-Package Text to disclose the presence of GM Ingredients

  • As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law, entitled the National Bioengineered Food Disclosure Standard, directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018.  Under the new law, food companies would have three options to disclose GMO ingredients: the use of on-package text, a USDA-created symbol, or an internet link — i.e., a QR code printed on the package that directs customers to GMO information.
  • Earlier this month, eleven senators, led by Senator Jeff Merkley (D-Oregon), wrote a letter to USDA Secretary Sonny Perdue recommending that “bioengineered ingredient disclosures should consist of clearly worded, on-package text labels indicating the presence of [ ] ingredients.” The senators further stated that “QR codes or other electronic disclosure methods should not be used until broadband internet access and smartphone adoption are near universal, and no longer present obstacles to consumer access to bioengineered ingredient information.”
  • As the law specifically authorizes the use of on-package text, a USDA-created symbol, or an internet link to covey the presence of GM ingredients to consumers, it remains to be seen what impact, if any, the senators’ letter will have on the forthcoming mandatory disclosure requirements. We will continue to monitor developments on the National Bioengineered Food Disclosure Standard and report them to you here.

USDA Audit Shows Deficiencies in Brazil’s Meat Inspection System

  • As previously covered on this blog, Brazilian federal police raided several meat producers earlier this year for allegedly doling out bribes to inspectors to certify meat that was either rotten or tainted with Salmonella.  Following the bribery scandal, USDA’s Food Safety and Inspection Service (FSIS) instituted 100% point-of-entry re-inspection of all Brazilian meat products imported into the United States and – since then – has refused entry to approximately 1.9 million pounds of Brazilian beef products due to public health concerns, sanitary conditions and animal health issues.  In June of this year, USDA Secretary Sonny Perdue announced the suspension of all imports of fresh beef from Brazil because of recurring concerns about the safety of the products intended for the American market.  The suspension of shipments will continue to remain in place until the Brazilian Ministry of Agriculture takes corrective action which the USDA finds satisfactory.
  • A newly released USDA report identified a number of deficiencies in Brazil’s meat inspection system that the Agency discovered during its onsite equivalence verification audits of Brazilian establishments conducted from May 15 to June 2, 2017.  The audits were conducted to determine whether the country’s meat inspection system remains equivalent to that of the United States, with the ability to export products that are safe, wholesome, unadulterated, and correctly labeled and packaged. Key findings of the USDA audit include:
    • Brazilian authorities failed to establish procedures to prevent conflict of interest between inspectors and meat plants,
    • Sanitation requirements in plants were not enforced adequately to prevent product contamination
    • Post-mortem inspection procedures were “inadequate” to ensure that only “wholesome carcasses, free of contamination and defects receive the mark of inspection.”
    • Brazilian authorities have failed to develop procedures to standardize the assessment of competence and performance of in-plant inspection personnel assigned to United States-certified establishments; and
    • Official methods of chemical analysis used by the government laboratories is inconsistent with FSIS requirements.
  • According to Carmen Rottenberg, the Acting Deputy Under Secretary at FSIS, the audit findings confirm the problems the U.S. had previously flagged and played a role in USDA’s decision earlier this year to suspend fresh beef imports from Brazil. Brazil’s authorities have pledged to take corrective actions.  It remains to be seen whether USDA will view those actions to be adequate. If not, Brazil could potentially lose its U.S. equivalency status and all Brazil meat imports would then be suspended.

FDA Issues Long Awaited Guidance on GRAS Panels and the GRAS Regulatory Framework

Date: November 15, 2017

  • The U.S. Food and Drug Administration (FDA) has released two guidance documents regarding “generally recognized as safe” (GRAS) substances:  (1) Guidance for Industry: Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act, and (2) Draft Guidance, Best Practices for Convening a GRAS Panel: Guidance for Industry.  GRAS substances are excluded from the definition of a “food additive” under Section 201(s) of the Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) and, therefore, are not subject to mandatory premarket review by FDA under section 409 of the FD&C Act (21 U.S.C. 348).  FDA’s GRAS Final Rule (81 Fed. Reg. 54960, August 17, 2016), formally established a long-standing procedure that began April 17, 1997 (Proposed Rule, 62 Fed. Reg. 18938) for voluntarily submitting a GRAS notice for review by FDA.
  • In addition to expounding upon the required criteria for reaching a GRAS conclusion in the new guidance on the GRAS regulatory framework, FDA also “strongly encourages” the submission of a GRAS notice.  Additionally, if a GRAS notice is not submitted, FDA recommends documenting the GRAS conclusion using the regulatory framework for a GRAS notice in 21 CFR part 170, subpart E (for a substance that would be used in human food) or 21 CFR part 570, subpart E (for a substance that would be used in animal food).
  • Although not required – and, thus, not addressed in FDA’s GRAS Final Rule – FDA recognizes that convening a GRAS panel has historically been a way to provide evidence that generally available data and information are generally accepted by the expert scientific community.  In this regard, FDA’s draft guidance on convening a GRAS panel stresses that a GRAS panel is only one mechanism for demonstrating the safety of a substance under the conditions of its intended use is generally recognized by qualified experts, and also that a favorable report from a GRAS panel does not necessarily mean that the GRAS criteria have been met.  FDA’s draft guidance focuses on best practices applicable to a GRAS panel that is convened when the statutory basis for the proponent’s conclusion of GRAS status is through scientific procedures (as opposed to common use in food prior to January 1, 1958).  It provides FDA’s recommendations on (1) identifying GRAS panel members who have appropriate and balanced expertise; (2) taking steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the “GRAS panel report,” including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and (3) providing only public information to the GRAS panel and not information that is trade secret.
  • We are working on a Client Alert which will contain more detail on FDA’s newly issued guidance on the regulatory framework for GRAS substances and draft guidance on best practices for convening a GRAS panel.

Global Study Shows Confusion Concerning Whole Grains

  • A global study of over 16,000 people revealed that consumers are confused about the amount of whole grains they should consume daily and which foods contain whole grains. Of those surveyed, 83% did not know how many grams they should eat daily and less than half (47%) think that they eat enough whole grains. In addition, over one-third (38%) of the participants said that they do not know what foods contain whole grains; one in 10 said it is found in bananas and 18% said white bread contains whole grains. The study—which was released on November 13, 2017—was conducted by Cereal Partners Worldwide (CPW), a joint venture between Nestle and General Mills.
  • The Whole Grains Council defines whole grains as: “Whole grains or foods made from them contain all the essential parts and naturally-occurring nutrients of the entire grain seed in their original proportions. If the grain has been processed (e.g., cracked, crushed, rolled, extruded, and/or cooked), the food product should deliver the same rich balance of nutrients that are found in the original grain seed.”
  • The United States is one of only three countries to have a quantitative recommendation for whole grains (The Netherlands and Denmark are the other two). The U.S. recommendation is at least 48 grams per day. CPW would like to see global guidelines established for recommended daily whole grain intake. CPW President and CEO David Homer stated, We see an opportunity for governments, academics and industry to back a global commitment to help inform people about whole grain and to increase the availability of whole grain foods. The first step on this journey is to agree to a set of global guidelines for recommended daily whole grain intake.”

WHO Urges End to Routine Antibiotic Use in Food-Producing Animals

  • 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.  Antibiotic resistance has also emerged as a hot button issue on the global stage. In an address to the UN General Assembly in late 2016, 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, on February 27, 2017, WHO published its first ever list of antibiotic-resistant “priority pathogens” – a catalogue of 12 families of bacteria that WHO claims pose the greatest threat to human health.
  • On November 7, 2017, WHO issued a statement recommending that farmers and the food industry stop using antibiotics routinely to promote growth and prevent disease in healthy animals. In its statement WHO says that healthy animals should only receive antibiotics to prevent disease if it has been diagnosed in other animals in the same flock, herd or fish population. WHO also recommends that sick animals should be tested to determine the most effective and prudent antibiotic to treat a specific infection and the antibiotics used should be selected from those listed by WHO as “least important” to human health. The Agency cited research published in The Lancet Planetary Health that found interventions that restrict antibiotic use in food-producing animals reduced antibiotic-resistant bacteria in those animals by up to 39 percent.
  • The National Pork Producers Council immediately issued a statement calling a ban on disease prevention uses of antibiotics in food-animal production as “ill-advised and wrong.”  In addition, USDA’s Acting Chief Scientist pushed back against the WHO recommendations contending that “The WHO guidelines are not in alignment with U.S. policy and are not supported by sound science”, and stating that the “recommendations erroneously conflate disease prevention with growth promotion in animals.”
  • The International Poultry Council also questioned WHO’s stance on antibiotics, noting that “the IPC is very concerned that the WHO guidelines inappropriately tie the hands of producers and limit their options for using antimicrobials for prevention, control and treatment of diseases based on specific need.”  The IPC noted that it remains committed to an approach that balances the knowledge and scientific expertise of all stakeholders to ensure the responsible use of antimicrobials for human and animal needs and encouraged WHO “to be more inclusive of the veterinary community in its work so its deep expertise can guide proper antimicrobial use and animal care.”
  • It remains to be seen whether and to what extent WHO’s recommendations will impact U.S. policy in this arena going forward.

USDA Further Delays Organic Livestock and Poultry Practices Rule

  • 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.  The Agency also concurrently published a Second Proposed Rule (82 FR 21742) requesting comments on the final rule through June 9, 2017.
  • On November 9, 2017, USDA announced a further delay of the effective date of the Final Rule to May 14, 2018.
  • As industry is well aware, the rule has come under scrutiny from some trade groups who contend that the new standards would force farmers to make expensive modifications to existing animal enclosures and drive up costs for consumers. On the other hand, certain industry and advocacy groups believe that the new requirements will serve to bolster the integrity of the organic label and want the new requirements in place sooner rather than later.  For example, on September 13, 2017, the Organic Trade Association (OTA) filed a complaint against the USDA seeking judicial review of the Agency’s delay of the final rule.  The lawsuit cites violations of standard public process established by Congress in the Administrative Procedure Act as well as the Organic Foods Production Act. It further contends that the President’s regulatory freeze should not apply to standards in the voluntary organic program.  The lawsuit is pending and the USDA is expected to respond to it by mid-November.
  • Given the controversial nature of the Final Rule, its ultimate fate continues to remain unclear.

USDA Withdraws Biotech Regulation Proposal

  • As previously covered on this blog, on January 19, 2017, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS)published a proposed rule to update its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms in response to advances in genetic engineering and the Agency’s understanding of the plant pest and noxious weed risk posed by genetically engineered organisms.  These requirements have not been comprehensively revised since they were established in 1987.
  • On November 7, 2017, APHIS published a notice in the Federal Register (82 Fed. Reg. 51582) announcing its withdrawal of the January 19th proposed rule.  In withdrawing the proposed rule, APHIS cited stakeholder feedback critical of the proposed revisions.  As previously covered on our blog this summer, in comments submitted to APHIS, industry stakeholders applauded the Agency’s proposed rule as underscoring the need to promote innovation in biotechnology and for proposing to ease regulation of gene-edited products.  But at the same time, industry called out a number of proposed revisions as improperly expanding USDA’s review process in certain respects which could effectively hamstring developers before they can even begin testing products.
  • In its November 7th withdrawal of the proposed rule, APHIS stated that it is committed to exploring “a full range of policy alternatives” and that the Agency will “re-engage with stakeholders to determine the most effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.” Now that APHIS has decided to go back to the drawing board, industry has an opportunity to work with APHIS to develop revised requirements to facilitate a regulatory framework that promotes innovation in biotechnology.

Menu Labeling Update: FDA Releases Supplemental Draft Guidance

  • 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 7, 2018. And on August 25, 2017, FDA Commissioner Scott Gottlieb issued a statement in support of the menu labeling rule and announced that additional guidance would be issued by the end of 2017 to provide further clarity on regulatory compliance obligations under the new requirements.
  • On November 7, 2017, FDA released “draft” guidance, entitled “Menu Labeling: Supplemental Guidance for Industry.” The draft guidance addresses: calorie disclosure for self-service foods, such as buffets and grab-and-go foods; accounting for the natural variation of foods; compliance and enforcement of the rule; criteria for covered establishments; determining standard menu items; criteria for distinguishing between menus and other information presented to the consumer, like marketing materials; various methods for providing calorie disclosure information on foods such as pizza.
  • The draft guidance document specifically hones in on marketing materials, explaining that marketing materials — like pizza coupons, posters in store windows, signs on gas pumps, or paper inserts – are not menu or menu board items within the meaning of the final rule and, as such, would not require calorie declarations. Of note, the Agency is withdrawing two questions from the previous Menu Labeling Guidance that pertained to marketing materials. The Agency intends for this latest guidance to provide clarity on the FDA’s “flexible approach” to distinguishing between a menu/menu board and marketing material.
  • In a statement announcing the roll out of this new guidance, FDA Commissioner Scott Gottlieb noted that “over the next several months, [FDA] will continue to partner with restaurants and similar retail food establishments through each step in the implementation process and look forward to May, when consumers will have access to clear, consistent calorie information on the menus in their favorite chain restaurants and food establishments.”
  • Early reaction to the draft guidance was decidedly mixed – Lyle Beckwith, spokesman for the National Association of Convenience Stores, commented that the guidance “didn’t give flexibility or clear guidance on what you could do in any number of situations” and that “retailers remain concerned about potential consumer lawsuits.”
  • FDA will be accepting comments on the draft guidance for 60 days following its imminent publication in the Federal Register. Parties interested in submitting comments are invited to contact us at fooddrug@khlaw.com.
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