•  FDA has made halting progress in establishing and implementing “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,” as mandated by the Food Safety Modernization Act (FSMA) of 2011.  It has been especially challenging to come up with key requirements for agricultural water used with covered produce (other than sprouts).  In this regard, we have reported  on FDA’s December 6, 2021 proposed rule that would replace the microbial criteria and testing requirements for pre-harvest agricultural water under the Produce Safety Rule (PSR), finalized in 2015, with new systems-based assessments.
  • On August 11, 2022, FDA announced the release of a paper-based version of its Agricultural Water Assessment Builder (also available in Spanish).  FDA’s intent is to make the content of its Agricultural Water Assessment Builder that was released on-line in March 2022 more accessible to a broader array of users.  All versions of the tool, available here, are designed to help farms understand the proposed, systems-based pre-harvest agricultural water requirements by guiding them through an assessment of the main elements as follows:
    • Agricultural Water System Components
    • Animal Impacts and Activities
    • Biological Soil Amendments of Animal Origin (BSAAOs)
    • Human Waste
    • Other Water Users
    • Other Potential Sources of Hazards
    • Crop Characteristics
    • Agricultural Water Use Practices
    • Environmental Conditions
    • Other Relevant Factors
    • Outcomes and Measures
  • FDA has not made any further announcements since the notice discussed here about proposed compliance dates for the pre-harvest agricultural water provisions for covered produce (other than sprouts) and its enforcement discretion policy applicable to the harvest and post-harvest agricultural water provisions of the PSR.  Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions regarding the PSR or other FDA rules implementing FSMA.

 

  • On August 10, 2022, FDA announced that it had issued a final guidance document for shell egg producers who provide laying hens with access to outside areas. The guidance intends to help shell egg producers to comply with certain provisions of the final rule on the “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation” (egg rule), which was finalized in 2009.
  • The final guidance, titled “Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation: Questions and Answers Regarding the Final Rule”, focuses on how producers who allow hens to access areas outside of the poultry house (including porches, outdoor runs, and pastures) can meet the egg rule requirements to prevent Salmonella Enteritidis (SE) from contaminating shell eggs. The guidance provides producers with steps they can take to ensure that there is no transfer of SE into, or among, the poultry houses, including monitoring for flies and rodents in areas outside the poultry house.
  • The egg rule is intended to prevent SE from contaminating shell eggs on the farm and prevent SE growth during transportation and storage. FDA notes that SE is the most common cause of foodborne illnesses that are associated with the consumption of shell eggs.

 

  • The Center for Science in the Public Interest (CSPI), the Association of SNAP Nutrition Education Administrators (ASNNA), and the Association of State Public Health Nutritionists (ASPHN) submitted a Citizen Petition to FDA that requested an amendment to the regulations to require front-of-pack nutrition labels. The citizen groups asked that 21 CFR 101 be amended to require on the principal display panel of a food an easy-to-understand, standardized system that is (1) mandatory, (2) nutrient-specific, (3) includes calories, and (4) is interpretative with respect to levels of added sugars, sodium, and saturated fat per serving.
  • The groups argue that current US food labeling requirements (i.e., the Nutrition Facts Panel (NFP)) and voluntary industry initiatives (i.e., Facts Up Front) have low utilization and are insufficient to promote healthy diets. They further cite to experimental studies and example countries that have already implemented interpretative front of pack nutrition labeling and which have seen improved health outcomes. For instance, the groups explain that after Chile adopted a mandatory nutrient warning label policy in 2016, there were statistically significant reductions in purchases of calories (-3.5%), sugars (-10.2%), saturated fat (-3.9%), and sodium (-4.7%) (all p<0.05). The groups encourage the FDA to learn from “experiences abroad and follow the science to select a system with the greatest potential to promote equitable access to information, improve diets, promote reformulation, and advance public health.”
  • The petition includes examples of labels that would meet the four-pronged criteria, including warning labels that would alert consumers to high levels of nutrients, and traffic light labels that rate the levels of nutrients as high, medium, or low. Other formats, like Nutri-Score (i.e., assigning the product an A, B, C, D, or E score) or Health Star Ratings (i.e., assigning a product a number of stars out of a total of 5 stars) would not meet the criteria because they are not nutrient-specific and interpret the overall healthfulness of the food as opposed to specific nutrient levels.
  • Last month, the Court of Justice of the European Union (CJEU) confirmed that Member States may restrict or prohibit by law the cultivation of authorized Genetically Modified Organism (GMO) crops, provided that the conditions set forth in Directive 2001/18/EC (on the deliberate release into the environment of GMOs) and Regulation (EC) No. 1829/2003 (on genetically modified food and feed) are met.
  • The case arose following the imposition of sanctions on a farmer for violation of a regional Italian law (No. 5/2011) prohibiting the cultivation of MON810, an authorized GMO maize. The farmer filed an opposition against the sanction with the national court, which halted the proceedings to request a preliminary ruling from the Court of Justice (a court within CJEU) on the correct interpretation of the EU regulatory framework on GMOs.
  • Citing to Article 26-bis(1) of Directive 2001/18/EC, which states that “Member States may take appropriate measures to avoid the unintended presence of GMOs in other products,” the Court held that Member States may only adopt preventive measures to avoid the unintended presence of GMOs in other products. Consistent with the Commission Recommendation of 13 July 2010, this allows Members States to ensure that farmers and consumers have a choice between organic, conventional, and GMO production. However, these restrictive measures cannot be justified by the need to protect human health or the environment, since all authorized GMOs are already assessed for such risks according to the procedures laid out in Directive 2001/18/EC and Regulation No. 1829/2003. Furthermore, all such measures must be proportionate, insofar as they must minimize their restrictive effects to what is necessary to achieve their purpose.
  • Therefore, consistent with this ruling, the national court must determine whether the regional law is necessary and proportionate to avoid cross-contamination between GMOs and conventional crops. The national court must base its decision on the degree of contamination and the likelihood of further contamination, taking into account specific geographic factors and the economic consequences for producers if a higher degree of contamination occurs.
  • The ruling is based on Directive 2001/18/EC, which, although still in force, has subsequently been amended by Directive (EU) 2015/412 to provide a procedure (in new Article 26b) through which Member States may request that the geographic scope of a GMO notification be submitted or that an already granted authorization be adjusted to exclude all or part of the territory from cultivation.
  •  We have reported on developments regarding toxic elements of concern that may be present in the food supply and, in particular, FDA’s “Closer to Zero” plan to reduce the levels of arsenic, lead, cadmium, and mercury in food for babies and young children.  These toxic elements cannot be completely avoided in the fruits, vegetables, or grains that are used in baby foods, juices, and infant cereals because they are present in the environment and may enter the food supply through soil, water, or air.
  • On July 15, 2022, FDA released the Fiscal Years 2018 – 2020 Total Diet Study (TDS) Elements Report on the analytical results for nutrients and toxic elements from 307 foods (including beverages and water), as well as 384 baby food (BF) products, that FDA sampled and analyzed over the 3-year period of the latest TDS and a Supplement (table) that summarizes the data.  Highlights from FDA’s report include:
    • Total arsenic, lead, and mercury were detected in less than half of the FY2018-FY2020 vegetable samples (35%, 10%, and 6% detects respectively); whereas cadmium was detected in 93% of vegetable samples (mean concentrations in vegetables range from: total arsenic, not detect (ND) – 15 ppb; cadmium, ND–222 ppb; lead, ND–12 ppb; mercury, ND – 1.8 ppb)
    • Among the foods with the highest mean concentrations of each analyte:
      • Arsenic (total) was ND in most of the foods tested (i.e., 57%), but was detected in all 27 samples of Baked cod, all 3 samples of Canned Tuna, all 3 samples of Fish sticks, all 27 samples of Baked salmon, and all 27 samples of Pre-cooked shrimp, with the highest reported level of 10,900 parts per billion (ppb) found in Baked cod;
        • Other than seafoods, Crisped rice cereal, BF Rice cereal, and Brown and White rice also had high mean total arsenic concentrations;
        • The results of the subset of samples that were further analyzed for inorganic arsenic ranged from 6.1 to 103 ppb and the highest mean concentration (i.e., 93 ppb) was found at in Crisped rice cereal;
      • Cadmium was ND in only 39% of the foods tested, and was detected in all 3 samples of Sunflower seeds, all 27 samples of Raw spinach, all 3 samples of Potato chips, all 27 samples of Leaf lettuce, and all 27 samples of French fries, with the highest reported level of 400 ppb found in both Raw Spinach and Sunflower seeds;
      • Lead was ND in most foods (86%) but was detected in all 8 samples of BF Sweet potatoes, all 8 samples of BF Teething biscuits, all 3 samples of Sandwich cookies, all 3 samples of White wine, and all 3 samples of Ranch salad dressing (low-calorie), with the highest reported level of 38 ppb found in BF Sweet potatoes; and
      • Mercury was ND in most foods (93%) but was detected in all 3 samples of Canned tuna, all 27 samples of Baked cod, all 27 samples of Baked salmon, all 27 samples of Pan-cooked catfish, and 27 samples of Pre-cooked shrimp, with the highest reported level of 250 ppb found in Canned tuna.
    • For TDS foods with FDA Action Levels, i.e., Apple juice (10 ppb lead, 10 ppb inorganic arsenic), Chocolate and Hard candy (100 ppb lead), and Infant rice cereal (100 ppb inorganic arsenic), or Standards, i.e., Bottled water standards (5 ppb lead, 10 ppb arsenic, 5 ppb cadmium, 2 ppb mercury), all results were below the levels/standards established by FDA.
  • While these new results add significantly to the analytical database for toxic elements of concern, especially for cadmium, which had been the most lacking, FDA has not posted any revisions to its Closer to Zero plan or otherwise provided any updates on establishing interim reference levels (IRLs) since the update in June that is discussed here.  Keller and Heckman will continue to monitor and report on developments impacting the Closer to Zero plan.
  • On August 3, 2022, FDA announced the establishment of the Laboratory Accreditation for Analyses of Foods (LAAF) program Dashboard. The LAAF Dashboard will serve as a public registry listing for information on LAAF participants. The LAAF Dashboard allows users to search, view, and export lists of recognized accreditation bodies and LAAF-accredited laboratories.
  • As previously reported, and as demonstrated in the LAAF Dashboard, FDA has recognized six accreditation bodies under the LAAF program. Accredited bodies under LAAF may, in turn, accredit laboratories to the standards established under the Food Safety Modernization Act of 2011 (FSMA).
  • Interested accreditation bodies can apply for recognition under the LAAF program through FDA’s electronic portal, and interested laboratories may apply to one of the recognized accreditation bodies to seek LAAF accreditation. The LAAF Dashboard will be updated as participants are added or changed.
  • On August 1, the USDA’s FSIS announced that it will declare Salmonella an adulterant in breaded and stuffed raw chicken products. Breaded and stuffed raw chicken products will be considered adulterated when they exceed 1 colony forming unit (CFU) of Salmonella per gram. Products that exceed the limit would be subject to regulatory action. FSIS believes the limit of 1 CFU/gram will significantly reduce the risk of illness from consuming such products.
  • Breaded and stuffed raw chicken products have been associated with up to 14 food safety outbreaks and approximately 200 illnesses since 1998. The products at issue are those found in the freezer section and that appear to be cooked, but are only heat-treated to set the batter or breading; the products contain raw poultry. FSIS has found that continual efforts to improve product labeling have not reduced consumer illnesses.
  • FSIS is expected to publish a notice in the Federal Register in the fall and will be seeking public comments on whether a different standard for adulteration (i.e., zero tolerance or one based on specific serotypes) would be more appropriate, an implementation plan, and a verification testing program.
  • This announcement is part of FSIS’ effort to reduce Salmonella illnesses associated with poultry. In October 2021, USDA announced that it was reevaluating its Salmonella control strategy. USDA plans to present a proposed framework for a new comprehensive strategy to reduce Salmonella illnesses attributable to poultry in October and convene a public meeting to discuss in November.
  • FDA issued final guidance regarding its decision to exercise enforcement discretion with respect to the sale and distribution of dietary supplements containing N-acetyl-L-cysteine (NAC). The final guidance is substantively identical to the draft guidance issued in April 2022.
  • As we have previously reported, FDA concluded that NAC was excluded from the definition of a dietary supplement because it was approved as a drug before being marketed as a dietary supplement and because no regulation authorizing its use in dietary supplements has been promulgated.
  • Nevertheless, the Agency determined that enforcement discretion is appropriate because (1) it has not identified any safety issues thus far in its (ongoing) review of the safety of NAC in dietary supplements, (2) NAC has been used in dietary supplements for over 30 years, and (3) a strong demand for such use continues. FDA intends to continue exercising enforcement discretion until it either completes notice-and-comment rulemaking authorizing the use of NAC in dietary supplements, determines that rulemaking is not appropriate, or identifies safety issues in its ongoing review. We will continue to monitor and report on any developments related to the regulatory status of NAC in dietary supplements.
  •  We reported on the June 29, 2022 decree (in French) that prohibits the use of “sector-specific terminology traditionally associated with meat and fish” to describe plant-based products made in France.  The law banning “meaty” language, such as “steak,” “sausage,” or “chicken,” for plant-based foods was passed two years ago.  Per the decree that made the law official, the ban was set to take effect on October 1, 2022.
  • On July 27, 2022, however, according to FoodNavigator.com, France’s highest administrative court granted a request from the plant-based and alternative protein-focused association Protéines France for a temporary reprieve based on arguments that the industry would not have enough time to change branding and marketing before the October 1 deadline and the “impossibility for vegetable foodstuffs to leave the lexical field which comes close or far from meat.”  Protéines France also disputes whether some of the terms in question even have origins in meat, as targeted by the ban.  For example,  while “Carpaccio” would be banned, this name comes from the Renaissance painter, Vittore Carpaccio, who is known for his use of red and white tones.
  • The French decree will remain suspended until the court reaches a final decision that could possibly overturn the ban.  Keller and Heckman will continue to monitor changes in plant-based labeling requirements in France and other jurisdictions.
  • On July 15, 2022, the World Health Organization (WHO) issued a draft guideline titled “Use of Non-sugar Sweeteners.”  WHO is seeking public comments on the draft guideline. Those interested in submitting must do so by the August 14, 2022 deadline.
  • Based on what WHO describes as a “systematic review that assessed the health effects of higher compared to lower intake of non-sugar sweeteners,” the guideline document provides a “conditional” recommendation against using non-sugar sweeteners to achieve weight control or to reduce the risk of noncommunicable diseases. Notably, WHO prominently acknowledged  that the recommendation “is based on evidence of low certainty overall….”
  • The guideline’s target audience includes policymakers, health professionals, scientists, and food industry representatives.  However, any interested party may submit a comment at WHO’s website.  WHO notes that it particularly seeks comments on issues like potentially missing information, contextual issues, and implications for implementing the guideline.