USDA’s Modernized Pork Slaughter Rule Clears OMB

  • Last year, we reported that USDA’s Food Safety & Inspection Service intends to move forward with plans to modernize swine slaughter inspections by way of a “Modernization of Pork Slaughter” rule. The new rule – which has garnered significant industry support – aims to increase the efficiency and effectiveness of the federal inspection process for pork and to allow for the rapid adoption of new food safety technologies in pork slaughter.  The rule could potentially lead to an increase in U.S. hog slaughter capacity.  The rule also calls for certain food safety responsibilities to be shifted from federal inspectors to packing plant workers and could thus lead to faster pork production lines.
  • This week, the White House Office of Management of Budget (OMB) cleared the rule.  OMB’s approval is the last step in the rule-making process before the Modernization of Swine Slaughter Inspection Rule is finalized for publication in the Federal Register.
  • Although some pushback is expected from food and worker safety advocates, the “Modernization of Pork Slaughter” rule – which bears many similarities to the “Modernization of Poultry Slaughter Inspection” rule – is anticipated to ultimately become law.  (As our readership will recall, food and worker safety advocates met with OMB officials in 2012 seeking to upend USDA’s efforts to implement the poultry rule which has since become law).  We will, of course, continue to keep an eye on any developments related to the “Modernization of Pork Slaughter”  rule as they unfold and report them to you here.

FDA Denies Qualified Health Claim Linking Vitamin D Intake and Reduced Risk of MS

  • Since 1990, the U.S. Food and Drug Administration (FDA) has evaluated health claims on packaged foods to ensure that they are adequately substantiated. A health claim characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition (see 21 CFR 101.14).  A health claim must contain the elements of a substance and a disease or health-related condition.  In addition, health claims are limited to claims about disease risk reduction, and cannot be claims about the diagnosis, cure, mitigation, or treatment of disease.  Health claims are required to be reviewed and evaluated by FDA prior to use via a petition process. There are two types of health claims: (1) health claims that meet the standard of significant scientific agreement (SSA) and (2) qualified health claims. A “qualified health claim” must be accompanied by qualifying language or a disclaimer communicating the level of scientific evidence supporting the claim.
  • FDA denied a request for the use of a qualified health claim suggesting that the consumption of vitamin D may reduce the risk of developing multiple sclerosis (MS) in healthy individuals. The petition, submitted on June 3, 2016, requested that FDA authorize the claim for use on the labels of conventional food and dietary supplements containing vitamin D. In a letter to the petition submitter, FDA stated that after reviewing 85 publications submitted with the petition and all of the publications cited in the petition’s appendix, and conducting an independent literature review, it concluded that “there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of MS.”
  • FDA also stated that it considered the use of a disclaimer or qualifying language to accompany the proposed claim for Vitamin D intake and a reduction in the risk of multiple sclerosis, but concluded that neither would suffice to prevent consumer deception. FDA concluded the letter by stating that it would evaluate any new scientific information that becomes available that supports the use of a qualified health claim or significant scientific agreement if it is submitted to the Agency.

 

CDC expands use of Whole Genome Sequencing in Foodborne Illness

  • Whole genome sequencing (WGS) provides insight into the genetic fingerprint of a pathogen by sequencing the chemical building blocks that make up its DNA and is increasingly being employed in food safety efforts. Since 2012, the U.S. Food and Drug Administration (FDA) has regularly turned to WGS to better understand foodborne pathogens, including identifying the nature and source of microbes that contaminate food and cause outbreaks of foodborne illness.
  • This week, the Centers for Disease Control and Prevention (CDC) announced that the use of whole genome sequencing to monitor for outbreaks of Listeria, Salmonella, Campylobacter and coli that are commonly transmitted through food and animal contact has expanded to 38 states and two cities. This data is reported in the CDC’s Antibiotic Resistance (AR) Investment Map, which shows early progress by states to combat antibiotic resistance. This year’s Antibiotic Resistance Investment Map features more than 170 state-reported successes, including rapidly identifying and containing rare and concerning resistant germs to protect communities. Each state reported multiple successes.
  • You can learn more about CDC’s AR Solutions Initiative and ongoing work to combat antibiotic resistance at cdc.gov/DrugResistance.

Colorado Legislators Propose Stronger Version of COOL

  • As previously covered on this blog, mandatory country of origin labeling (COOL) rules for beef products have long been the subject of controversy and challenge, culminating in: (1) a World Trade Organization (WTO) ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL as of December 21, 2015.
  • Since then, some states have sought to require COOL labeling for beef within their states.  For example, as previously reported on this blog, in 2017, Wyoming, South Dakota and Colorado considered state-level COOL legislation, but in each case, the measures were defeated.
  • Against this backdrop, on January 5, 2018, Colorado state legislators introduced a bill titled “Beef Country of Origin Recognition System” also referred to as the “Beef COORS bill.”  If passed, the bill would require Colorado retailers to post signage informing consumers whether beef was derived exclusively from animals that were born, raised, and slaughtered in the United States, or whether the beef was imported or derived from imported animals.
  • As states like Colorado continue their attempts to implement stronger versions of COOL at the behest of livestock producers, efforts to reinstate COOL at the federal level continues.  For example, in November 2017, Public Justice, The Ranchers-Cattlemen Action Fund (R-CALF), Food & Water Watch, and Farm Aid delivered the signatures of 37,299 Americans demanding that the Trump Administration follow through on its campaign promise to create a level playing field for independent domestic meat producers through increasing transparency for consumers, i.e., that COOL comprise a key element of the Administration’s North American Free Trade Agreement (NAFTA) renegotiations.
  • Given the controversial nature of COOL requirements, it remains to seen whether we will see COOL implemented at the state or federal level.

USDA Announces Proposed Rule to Amend Egg Products Inspection Regulations

  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is proposing to amend the egg products inspection regulations by requiring official plants that process egg products to develop Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the meat and poultry regulations. Under the HACCP system, plants that process egg products will be afforded the flexibility to tailor a food safety system that best fits their particular facility and equipment.
  • Highlights of the proposed rule include:
    • Those regulatory provisions not consistent with that of USDA’s meat and poultry regulations would be eliminated
    • Generic approval would be permitted as part of the prior label approval system for egg products
    • Labeling requirements for shell eggs would be updated to be consistent with those in the U.S. Food and Drug Administration’s (FDA’s) regulations
    • Special handling instructions would be required on egg products
    • Requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment would be eliminated
    • Egg products plants would be incorporated into the coverage of the “Rules of Practice” that the Agency follows when initiating administrative enforcement actions and
    • The Agency’s interpretation of the requirement for “continuous inspection” set out at 21 U.S.C. 1034(a) would be changed to be consistent with current inspection requirements applicable to meat and poultry processing operations such that inspection in egg products plants would be required at least once per shift, instead of during all processing operations.
  • USDA will be accepting comments on the proposed rule for 120 days following its imminent publication in the Federal Register. Keller and Heckman attorneys stand ready to assist interested parties with preparing comments for submission to the Agency and may be reached at fooddrug@khlaw.com.

Washington State Sued over Termination of Salmon Farming Lease

  • As previously reported on this blog last month, Washington State Department of Natural Resources (DNR) announced the termination of Cooke Aquaculture Pacific’s Port Angeles net pen lease for salmon farming. Canadian-based Cooke Aquaculture (Cooke) filed a lawsuit in Clallam County Superior Court on January 4, 2018, claiming that the decision to terminate the lease was based on erroneous and outdated information about the condition of the facility, and that closing the net pen operations will result in the loss of jobs.
  • As background, DNR approved the transfer of the lease to Cooke in 2016 when it purchased Icicle Seafoods. Since the Commissioner of Public Lands at that time “raised no concerns or objections to the manner in which Cooke’s predecessor company was managing the leased aquatic area,” the announcement to terminate the lease came as a surprise, stated Cooke in a press release.
  • Cooke representatives would like to meet with the current Commissioner of Public Lands, Hilary Franz, to discuss the basis for DNR’s decision to terminate the Port Angeles net pen operations. However, Cooke Vice President for Public Relations Joel Richardson explained, “While we regret the need to file suit before meeting with the Commissioner, we were required to do so in order to protect the company’s legal rights.” Hilary Franz issued a statement on January 5 that stated, in part, “The basis for terminating Cooke Aquaculture’s lease at its Port Angeles facility was made clear to the company and the public. My team will vigorously defend the termination against this meritless lawsuit.”
  • The day after Cooke filed the lawsuit, a bill to address the escape of nonnative fish populations—such as farmed salmon—was introduced in the Washington legislation. HB 2418 would implement a moratorium on new or extensions of leases for net pens for at least two years until a new review and certification process is developed. The review would determine how to protect: the health and safety of Washington waters and marine ecosystems, Pacific salmon health and habitat, and tribal treaty fishing rights. After the moratorium ended, new permits would not be issued unless it could be determined that there would not be any negative impact to those areas.
  • In a press release about the bill, Rep, Mike Chapman (D-Port Angeles) stated, “None of us want to have Atlantic salmon farmed in our waters, but immediately pulling the rug out from under businesses who have contracts is going to result in immediate litigation and at a huge cost to taxpayers. Instead of picking winners and losers, this bill lets businesses determine their best course of action while the state keeps our waters protected.”

Taiwan to Strengthen Allergen Labeling for Prepackaged Foods

  • On December 11, 2017, the Food and Drug Administration of Taiwan (TFDA) released an announcement intending to repeal the existing food allergen labeling regulations and replace it by a new regulation, which was published at the same time for comments.
  • Under the proposed new regulation, TFDA consolidates the existing six categories of foods that are of allergen concern (i.e., mango, shrimp, milk, egg, peanuts, crab) and subject to mandatory labeling, and expands them to eleven categories as follows:  (1) Crustacea and products thereof; (2) mango and products thereof; (3) peanuts and products thereof; (4) sesame, sunflower seeds and products thereof; (5) milk, goat milk and products thereof except lactitol derived from milk and goat milk; (6) egg and products thereof; (7) nuts and products thereof, including almond, hazelnut, walnut, cashew nut, pecan, brazil nut, pistachio nut, macadamia nut, pine nuts, chestnuts etc.; (8) cereals containing gluten and products thereof, including wheat, barley, rye, oats etc.; (9) soybean and products thereof, except highly refined or purified soybean oil (fat), tocopherols and their deviation, phytosterols and phytosterol esters; (10) the use of sulphites and sulphur dioxide etc., at concentrations of 10 mg/kg or more in term of total SO2 which are to be calculated for final products; and (11) Salmon, mackerel, codfish, Dissostichus eleginoides (Yuan xue ) , Reinhardtius hippoglossoides (Bian xue ) and products thereof.
  • TFDA also specifies the format to declare allergen information on the label, such as “the product contains XX” or other wordings expressing the similar meaning. The common allergen statement used by industry like “may contain” is not addressed in the proposal, which needs further clarification from the authority.
  • The new regulation, once adopted, is scheduled to take effect on July 1, 2019. TFDA is accepting comments on the proposal for 60 days following its publication on the website, which is by February 11, 2018. Please feel free to contact us at fooddrug@khlaw.com if you are interested in submitting comments or if you have  any questions.

FSMA Update: FDA Issues Guidance on Enforcement Discretion Related to FSMA Provisions

  • Today, the FDA published guidance outlining key areas where it intends to exercise enforcement discretion in four of the rules that implement aspects of the Food Safety Modernization Act (FSMA). 83 FR 598. In short, this guidance document outlines the Agency’s intent to not enforce certain FSMA requirements as they currently apply to certain entities and/or activities. This enforcement discretion specifically relates to certain provisions in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety) and how they apply to:
    • facilities that would be farms except for certain factors and activities
    • written assurances provisions in all four rules related to the customer’s control of identified hazards that are a potential risk to public health
    • the animal food preventive controls requirements for certain manufacturing/processing activities performed on human food by-products used as animal food, and
    • FSVP requirements for importers of food contact substances.
  • As our readership is well aware, FDA had previously extended the compliance dates for many of the provisions covered by this guidance (see August 2016 compliance date extension). The enforcement discretion policies enumerated in the guidance will remain in place until and unless FDA decides to take further action on any of these issues.
  • Our detailed summary of the enforcement discretion policies and their potential impact on industry will be posted to our Firm’s website shortly. In the meantime, please feel free to contact us with any questions at fooddrug@khlaw.com.

Congress Weighs Bill to Combat Food Fraud

  • The U.S. Department of Agriculture (USDA) administers the National Organic Program (NOP), which includes standards for “organic” food in the United States.  Throughout 2017, The Washington Post has published several stories calling into question the authenticity of products from some of the largest “organic” producers of milkeggs and imported grains.
  • Congress is currently considering legislation that would increase protections for consumers against food that is advertised as organic but does not meet the standards of USDA’s NOP. More specifically, the Organic Farmer and Consumer Protection Act, introduced by Representatives John Faso (R-N.Y.) and Michelle Lujan (D-N.M.), calls for a modernization of organic import documentation, new technology advancements and stricter enforcement of organic products entering the U.S.  The proposed legislation roughly doubles the budget for the USDA’s organic program over the next five years. The Washington Post recently reported that the bill has 33 House cosponsors so far, and its supporters are hopeful that bipartisan support will facilitate its passage this year.
  • Industry has also stepped in to seek to halt the increasing incidences of fraud in organic.  Earlier this year, for example, the Organic Trade Association formed its own anti-fraud task force.  Given the increased attention this issue has received over the past year, and industry’s concerns, it is not inconceivable that an organic food fraud bill could come to fruition in the near future.

OIG Report Finds FDA Recall Process is Slow

  • As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with companies to bring about voluntary recalls, with the goal of getting the product out of the marketplace as quickly and efficiently as possible.
  • A recent report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concludes that FDA’s current recall process can be too slow and puts consumers at risk.  This report follows on an “early alert” released by the OIG on June 8, 2016 finding that FDA did not have a process in place to ensure that regulated companies initiated food recalls promptly.
  • In preparing the December 2017 report, the OIG reviewed documentation from a sample of 30 voluntary food recalls initiated from October 1, 2012 to May 4, 2015 to analyze FDA’s oversight of companies’ initiation of recalls, as well as the Agency’s monitoring of firm-initiated recalls, and the Agency’s maintenance of data in an electronic recall data system.
  • In response to the OIG report, FDA Commissioner Scott Gottlieb issued a statement contending that FDA’s recall protocol is generally quite effective, noting, for example, that on average voluntary recalls are initiated within four calendar days of when a problem is discovered. At the same time, Commissioner Gottlieb acknowledged that there is room for improvement and stated that the Agency intends “to say more in early 2018 on additional policy steps [the Agency will] take as part of a broader action plan to improve [its] oversight of food safety and how [it] implements the recall process.” According to Commissioner Gottlieb, FDA is currently looking at ways to improve the timeliness and scope of information the Agency provides to the public about recalls of FDA regulated foods.
  • It remains to be seen whether this latest OIG report will prompt FDA to consider utilizing its mandatory recall authority on a greater scale.
LexBlog