FDA Announces Proposed EU Shellfish Equivalence Determination

  • The United States and the European Union (EU) have not traded live shellfish for nearly eight years. Since 2010, U.S. shellfish imports have not been allowed to enter the EU, and the U.S. Food and Drug Administration (FDA) has not permitted the import of live, fresh or fresh-frozen molluscan shellfish from the EU since the 1980s.
  • On March 8, 2018, the FDA published a proposed determination in the Federal Register, stating that the safety controls for shellfish in the EU are equivalent to those in the U.S.  If the determination becomes final, Massachusetts and Washington state will once more be able to send bivalve molluscan shellfish (shellfish) to the EU. Shellfish exporters from Spain and the Netherlands will also be able to sell shellfish in the U.S. market. FDA notes that the Agency will continue to work with the EU on procedures to add more states and European countries.
  • In a complementary action, the European Commission is completing administrative procedures for its own proposed determination that U.S. safety controls for shellfish are equivalent to those in the EU, a necessary step towards resuming trade.
  • The FDA will be accepting public comments on the Federal Register notice through May 23, 2018.

WHO Names South African Listeria Outbreak World’s Largest

  • According to the UN World Health Organization (WHO), South Africa is currently in the middle of the largest listeria outbreak ever seenAs of this week, the outbreak has sickened almost 1,000, with at least 180 fatalities, and has received extensive press coverage globally (see e.g., here and here).  The cause of the outbreak has been unknown for the past several months.
  • On March 4, 2018, the South African health minister stated that the source of the outbreak was linked to a nationally popular ready-to-eat (RTE) meat product called “polony” manufactured by two unrelated brands. The products are being recalled. Africa’s health ministry is now concerned about the risk of cross-contamination and so has advised members of the public to avoid all processed meat products that are sold as ready-to-eat.
  • This event will inevitably lead the implicated companies to revisit their respective food safety protocols, and could potentially lead regulators in South Africa to consider new approaches to achieving food safety goals with specific regard to RTE meat products.

GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

  • The Food Safety Modernization Act (FSMA), enacted in January 2011, shifted the FDA’s focus from responding to illnesses to preventing food contamination.  A new report by the U.S. Government Accountability Office, released on March 5, 2018, examines FDA’s actions on food safety since FSMA became effective.
  • The GAO report, titled “FDA Can Build on Existing Efforts to Measure Progress and Implement Key Activities,” notes that since the enactment of FSMA, the FDA has conducted numerous food safety- and nutrition-related activities, including publishing 33 proposed or key final regulations, and 111 draft or final key guidance documents with a focus on food safety.
  • In the report, the GAO calls upon the FDA to implement three recommendations:
    • Direct the Food and Veterinary Medicine (FVM) program staff to uniformly document the basis for their decisions on issuing either regulations or guidance related to food safety and nutrition, such as using concept papers or guidance initiation sheets.
    • Develop FVM program performance measures with associated targets and timeframes for all eight of FDA’s food safety and nutrition-related objectives.
    • Complete an implementation plan including specific actions, priorities and milestones for the FVM program’s strategic plan.
  • The Report notes that the Agency agrees with GAO’s recommendations and has identified actions to implement them.

Washington Senate Passes Bill to Phase Out Salmon Farming

  • Current efforts to ban salmon farming in Washington State began shortly after the August 2017 failure of a net pen structure owned by Canadian-based Cooke Aquaculture that resulted in the escape of more than 240,000 invasive Atlantic salmon into Puget Sound. On March 2, 2018, the Washington State Senate passed HR 2957 by a vote of 31 to 16. The bill prohibits the state from issuing or renewing any leases or permits authorizing the use of state-owned aquatic lands for the purpose of Atlantic salmon aquaculture. The House passed the bill on Feb. 14 by a vote of 67-31.
  • While Washington State Governor Jay Inslee is expected to sign HR 2975, the Washington Fish Growers Association (WFGA) has asked him to veto the bill, which the group calls “ill-conceived” and not based on the best available science. WFGA executive director Dan Swecker expressed appreciation for the support received from “many of the world’s leading fisheries scientists, expressing alarm over a legislative measure that is founded on the baseless fear that Atlantic salmon, when and if they escape, could interbreed with Pacific stocks or colonize our rivers.”
  • In a statement issued in response the Senate passage of HR 2957, Cooke Aquaculture said that it was deeply disappointed concerning the impact that the legislation could have on Washington’s 30-year salmon farming industry. The company added, “As an immediate next step, Cooke Aquaculture Pacific will take the time we need to fully evaluate our operations and investments in Washington and explore all our available options.” Although, the previous month, Cooke’s Vice President of Public Relations, Joel Richardson, told the Washington House Agriculture & Natural Resources Committee that Cooke could make a claim for mandatory arbitration under NAFTA to compensate for its $70-plus million investment if the state banned salmon farming.
  • Current leases for Atlantic salmon farming in Washington State expire in 2022. Although, as previously reported on this blog, Washington’s Department of Natural Resources (DNR) has already terminated two of Cooke’s of leases and is currently reviewing the company’s remaining two leases. In other West Coast states, Oregon, California, and Alaska have effectively banned saltwater fish farms in their waters (see OPB article).

New Study: UV-bacteriophage Combination Found to Improve Salmonella Control in Ground Beef

  • In a comparison study of microbial interventions, researchers at the University of Nevada, Reno found that a combination of ultraviolet (UV) light and bacteriophages was most effective in reducing Salmonella populations in ground beef.
  • The researchers analyzed the comparative effectiveness of organic acids, bacteriophages and UV light, individually and combined. Highlights of the study’s findings include:
    • Certain organic acids do not reduce Salmonella in ground meat.
    • Bacteriophage and UV light individual applications reduced Salmonella in ground beef by 1 log.
    • Combined applications of bacteriophages and UV light reduced Salmonella by 2 log.
    • Combined applications of Bacteriophages and UV light improve Salmonella control in ground beef.
  • The study suggests that the combined application of UV and bacteriophages may be an effective measure to be used in industry settings to improve Salmonella control in ground beef.


FDA Details Efforts to Implement New Nutrition Facts Labels and Publishes New Practical Guidance

  • As our readers are aware, in May 2016, FDA issued final rules to implement changes to the nutrition labeling and serving size regulations. On  March 1, 2018, Commissioner Scott Gottlieb, M.D. released a statement about the new Nutrition Facts label and FDA issued practical guidance documents on fiber, added sugars, and serving size declarations, in order to provide industry with the information needed to effectively implement the new version of the Nutrition Facts label.
  • Commissioner Scott Gottlieb’ statement announced that FDA is launching an educational campaign for consumers surrounding the new label. The educational campaign will allow the FDA to reach consumers directly through educational videos, social media campaigns, and user-friendly websites to help them discern the relationship between their dietary choices and the impact those choices have on their health.
  • FDA published a final guidance on dietary fiber.  The May 2016 final rule established a definition for the term “dietary fiber,” which includes naturally occurring fibers, like those found in fruits, vegetables, and whole grains, and seven isolated or synthetic non-digestible carbohydrates (NDCs), each having a physiological health benefit.  A party may submit a citizen petition for FDA’s consideration to add a given isolated or synthetic NDC to the FDA’s regulatory definition of “dietary fiber.” The final guidance communicates FDA’s revised standard of review of the scientific evidence that shows the NDC has a beneficial physiological effect on human health. Evaluation of whether the evidence supports a conclusion of a physiological effect will be based on the number of studies and sample sizes of each study, the dose response data, the types of foods tested, the relevance of the body of scientific evidence to the U.S. population or target subgroup, and the overall consistency of the total body of evidence
  • FDA published a draft guidance to help industry declare added sugars on the label of honey, maple syrup, and certain cranberry products. The draft guidance addresses FDA’s intent to allow manufacturers to use a symbol immediately after the added sugars daily value, directing consumers to language that provides truthful and not misleading contextual information about “added sugars” and what it means for each of these specific products.
  • The final guidance on the requirements for serving sizes provides appropriate reference amounts customarily consumed (RACC) for a variety of products to aid manufacturers in determining the appropriate serving sizes to include on the labels of their products.
  • The FDA is now working to respond to citizen petitions requesting that the agency include additional NDCs in the regulatory definition of “dietary fiber,” to finalize the rule regarding the compliance dates for the Nutrition Facts label rules, and to issue several additional technical guidance documents related to nutrition labeling.

New EFSA Report Finds Antimicrobial Resistance Persists in Humans, Animals and Food

  • Antimicrobial use in food-producing animals remains a hot button issue. In the United States, 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 European Union (EU), the European Food Safety Authority (EFSA) has spearheaded similar efforts to reduce antimicrobial resistance. EFSA monitors and analyses the situation on antimicrobial resistance in food and animals across Europe, and is assisted by EFSA’s network on zoonoses data collection: a pan-European network of national representatives of EU Member States, other reporting countries, the World Health Organization (WHO) and World Organization for Animal Health (OIE).
  • A new report by EFSA and the European Centre for Disease Prevention and Control (ECDC), published on February 27, 2018 and based on data from 2016, has found that bacteria from humans and animals continue to show resistance to antimicrobials. Key findings include (but are not limited to):
    • Resistance to carbapenem antibiotics was detected at very low level in poultry and in chicken meat in two Member States (fifteen E. coli bacteria). Carbapenems are used to treat serious infections in humans and are not authorized for use in animals.
    • Combined clinical resistance to critically important antimicrobials was observed at low to very low levels in Salmonella (0.2%), Campylobacter (1%) and E. coli (1%) in poultry.
    • Resistance to colistin was observed at low levels (2%) in Salmonella and E. Coli in poultry.
    • Prevalence of ESBL-producing E. coli in poultry varies markedly between the EU Member States, from low (less than 10%) to extremely high levels (more than 70%). Bacteria that produce ESBL enzymes show multi-drug resistance to β-lactam antibiotics – a class of broad spectrum antibiotics which include penicillin derivatives, cephalosporins and carbapenems. This is the first time that the presence of extended-spectrum beta-lactamase (ESBL)-producing E. coli was monitored in poultry and poultry meat
    • One out of four infections in humans are caused by Salmonella bacteria that show resistance to three or more antimicrobials commonly used in human and animal medicine. The proportion is significantly higher in S. Kentucky and S. Infantis (76.3 and 39.4% respectively).
    • For the first time, ESBL-producing S. Kentucky with high resistance to ciprofloxacin was detected in four countries. These bacteria are not possible to treat with critically important antibiotics.
  • In announcing these findings, Vytenis Andriukaitis, European Commissioner for Health and Food Safety reaffirmed his commitment to tackle antimicrobial resistance stating: “Levels of antimicrobial resistance still differ significantly from one EU country to another. To win the fight, we need to join our efforts and implement stringent policies on the use of antibiotics across sectors. It is vital that we all renew our commitment to fight antimicrobial resistance by focusing on the key areas set out in the EU One Health Action Plan against antimicrobial resistance.”

USDA and HHS Accepting Public Comments on Topics and Scientific Questions for the 2020-2025 Dietary Guidelines for Americans (DGA)

  • As our readership is well aware, every five years, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) release the Dietary Guidelines for Americans (DGA) — a set of recommendations based on up-to-date nutrition science that is intended to help the U.S. population make healthy food and beverage choices.
  • On February 26, 2018, HHS and USDA announced a new step in the Dietary Guidelines for Americans (DGA) development process for the 2020-2025 DGA edition. Specifically, the departments will seek public comments on the proposed priority topics and supporting scientific questions that will guide the development of the upcoming 2020-2025 DGA. The public is invited to submit comments through the Federal Register starting today, February 28, 2018, through March 30, 2018. The topics, supporting scientific questions, and link to submit public comments are available at gov.
  • For the 2020-2025 edition of the DGA, HHS and USDA are proposing a life stage approach, focusing on priority scientific questions from birth through older adulthood. This approach is consistent with the 2014 farm bill which mandated that starting with the 2020-2025 edition, the DGA must specifically provide guidance for women who are pregnant, as well as infants and toddlers from birth to 24 months. Proposed topics and scientific questions are grouped by life stage. For each stage of life, current dietary patterns, including intakes of food groups and nutrients, will also be described.
  • In a joint USDA/HHS statement inviting comments to support the 2020-2025 DGA, the departments noted that “the topics and supporting questions for public comment reflect a continued focus on patterns of what we eat and drink as a whole, on average and over time, not on individual foods or food groups.”

Health Canada Publishes Proposed Front-of-Package Labeling Regulations and Launches Stakeholder Consultation

  • As previously reported on this blog, Health Canada recently announced revisions to food labeling requirements as a part of the Healthy Eating Strategy for Canada. One of the key initiatives under the Strategy is Front-of-Package (FOP) labeling for foods that are high in nutrients designated by the agency as being of public health concern: saturated fat, sugars, and sodium. Health Canada intends the FOP labeling to provide quick and easy guidance to consumers in order to make informed choices about their food.
  • On February 10, 2018, Health Canada published proposed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D). The regulations detail the FOP nutrition symbol requirement. The label of prepackaged products that meet or exceed prescribed thresholds for sodium, sugars, and/or saturated fat would be required to carry a nutrition symbol on the principal display panel (PDP) to indicate that the food is high in one or more of the nutrients. Health Canada has drafted four FOP nutrition symbol options.
  • The triggering threshold for the general population would be 15% of the Daily Value (DV) for each nutrient of concern, based on the reference amount for the food or the serving of stated size that appears in the Nutrition Facts Table (NFT), whichever is greater; for foods with a reference amount less than 50g, the threshold would be based on 50g of the food when it provides at least 5% of the DV of the nutrient of concern per reference amount or serving of stated size, whichever is greater.
  • The proposed regulations also provide information regarding applicable exemptions from the required labeling, formatting and location of the symbol, as well as use of other voluntary nutrition and health-related statements, claims, or symbols.
  • The proposed regulation would end the requirement for front-of-pack disclosure of the use of certain sweeteners.
  • Health Canada launched a FOP labeling consultation, which runs from February 10 to April 26, 2018, and asks for stakeholder feedback on the proposed FOP labeling.
  • Health Canada will host a one-hour webinar on March 1, 2018 to provide a technical overview on the proposed regulations.

NTP Releases Draft Report on Bisphenol A for Public Comment

  • Bisphenol A (BPA) has been the subject of global controversy in recent years, with some jurisdictions restricting its use in children’s products and baby bottles due to concerns about potential exposure risks. FDA’s longstanding position on BPA is that BPA is safe at the current levels occurring in foods.
  • On February 23, 2018, the National Toxicology Program (NTP) released for public comment a pre-peer review draft report on the findings of a comprehensive two-year rodent study examining the potential effects of BPA on health. The study – conducted by senior scientists at the FDA’s National Center for Toxicological Research (NCTR) – is part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA).  CLARITY-BPA had two components: the core study conducted at NCTR according to FDA Good Laboratory Practice regulations and CLARITY-BPA academic studies of various health endpoints, conducted by grantees at academic institutions and using offspring of rodents derived from the core study.
  • The draft report includes data from the NCTR core study.  The core study analyzed the effects of several different doses of BPA evaluating chronic and early life exposure in two different groups of rodents. The doses ranged from low doses that would be comparable to typical human exposures, to doses that greatly exceed human exposures. The study found “minimal effects” for the BPA-dosed groups of rodents. The report did identify some areas that could merit further research, such as the increase in occurrence of mammary gland tumors at one of the five doses, in one of the groups. But the significance of these findings will be assessed through the peer review process.
  • Dr. Stephen Ostroff, Deputy Commissioner for Foods and Veterinary Medicine at FDA, issued a statement highlighting the fact that the draft report points towards “minimal effects” and supports FDA’s longstanding position that BPA, at current levels occurring in food is safe. A peer-review meeting is scheduled for April 26, 2018 and will be open to the public