Russia Set to Ban Brazilian Pork Starting December 1

  • Last week, Russia’s Rosselkhoznador, the Federal Service for Veterinary and Phytosanitary Surveillance, announced that it would temporarily ban pork imports from Brazil beginning on December 1, 2017.  This announcement comes after the feed additive ractopamine was identified in some shipments.
  • Brazilian authorities have promised to conduct an internal investigation into the matter, and Brazilian and Russian authorities are expected to reach a swift agreement to lift the ban because Russia “still depends on Brazilian meats.”
  • The Russian ban comes after a year in which Brazilian exports of meat products came under severe scrutiny following a bribery scandal.  As previously covered on this blog, earlier this year Brazilian federal police raided several meat producers for allegedly doling out bribes to inspectors to certify meat that was either rotten or tainted with Salmonella.  The U.S. is currently banning imports of fresh beef from Brazil due to recurring concerns about the safety of those products, but currently permits the importation of Brazilian pork subject to certain restrictions. It remains to be seen whether or to what extent the recently announced Russian ban will influence the U.S. or other jurisdictions’ decision to continue importing Brazilian pork products.

FSMA For Cotton Ginners?

  • Are cotton farmers and ginners subject to FDA’s Food Safety Modernization Act (FSMA)?  If you are a cotton ginner that is not a farm the answer is currently yes. FDA is currently exploring the extent to which cotton ginners should be covered by FSMA. Cotton farmers and ginners, of course, produce the fabrics that we use every day, but they also produce food. After being separated from fibers in a process called ginning, cotton seeds and cotton plant parts are frequently used to feed livestock. Cotton seeds may also be further processed into cottonseed oil and cottonseed meal for animal food.  Because products derived from ginning enter the American food supply, the cotton industry has raised concerns about the impact of the new FSMA requirements on cotton ginners.
  • As background, cotton ginning has traditionally fallen under the general food adulteration provisions of the Federal Food, Drug, and Cosmetic Act.  With the implementation of FSMA, certain operations are now also subject to the FSMA-mandated preventive controls requirements, which applies to manufacturing facilities rather than farms. Most cotton ginning is done by farms, whose ginning operations do not fall under the new requirements.  But cotton gins that are not part of a farm are considered manufacturers subject to the preventive controls requirements, which include a hazard analysis and the implementation of controls to minimize hazards.
  • In August 2016, FDA extended the compliance date for cotton ginners subject to the Preventive Controls for Animal Food rule to allow for additional time to consider how best FSMA should be tailored to cotton ginners (81 FR 57784). Under the extension, regular businesses have until January 28, 2019 to comply, small business until January 27, 2020 and very small business until January 26, 2021.  In the meantime, to better understand industry’s concerns, FDA officials recently traveled to northern Alabama to visit a cotton farm, ginning operation and a cotton warehouse.  In a recent FDA blog post, Dr. Stephen Ostroff, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, indicated that the Agency wishes to further engage stakeholders “in pursuit of a solution that works for industry while protecting public health.”

China to Lower Tariff on Certain Food and Other Items

  • China announced tariff cuts on 187 products—including baby powdered milk, avocados and mineral water—effective December 1, 2017. (See Financial Times (subscription required) and S. News.) The import tariffs will average 7.7%, down from the current 17.3%. In addition to foods, the reduced tariffs will impact selected health supplements, pharmaceuticals, clothing items, shoes and other consumer goods.
  • The reductions in tariffs are being made in response to increased demand for quality goods that cannot currently be met domestically, explained China’s Finance Ministry in making the announcement. Additional benefits from the lower tariffs, suggested by Lu Zhengwei, an Economist with Industrial Bank in Shanghai, include consumers will be more likely to buy foreign goods from Chinese retailers instead of purchasing them while traveling abroad, which also could help generate jobs in China.
  • China faces pressure from the United States and other trading partners to allow better access to its growing markets. As reported on this blog in June, the Certification and Accreditation Administration of the People’s Republic of China (CNCA) and the U.S. Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) that formally established a registration process for U.S. food manufacturers that export milk and milk products, seafood, infant formula, and/or formula for young children to China. The U.S. Dairy Export Council reported that the MOU will increase access to China for more than 200 U.S. dairy exporters in the short-term and sets the stage for additional American companies to tap into the lucrative Chinese market going forward.
  • China reported a $510 billion global trade surplus last year. The tariff reductions to occur December 1, are relatively small and it is unclear how they will affect China’s trade balance.

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.
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