Tag Archives: EPA

Glass of water

EPA Announces PFAS Drinking Water Standard and Remediation Funding

By Food Safety Tech Staff
No Comments
Glass of water

The EPA has issued a final rule to reduce exposure to harmful per-and polyfluoroalkyl substances (PFAS) through drinking water. The final rule supports President Biden’s government-wide action plan to combat PFAS pollution.

EPA also announced nearly $1 billion in newly available funding through the Bipartisan Infrastructure Law to help states and territories implement PFAS testing and treatment at public water systems and to help owners of private wells address PFAS contamination. An additional $12 billion is available through the Bipartisan Infrastructure Law for general drinking water improvements, including addressing emerging contaminants like PFAS.

The rule sets limits for five individual PFAS: PFOA, PFOS, PFNA, PFHxS, and HFPO-DA (also known as “GenX Chemicals”). The rule also sets a limit for mixtures of any two or more of four PFAS: PFNA, PFHxS, PFBS, and “GenX chemicals.”

  • For PFOA and PFOS, EPA is setting a Maximum Contaminant Level Goal (MCLG), a non-enforceable health-based goal, at zero. This reflects the latest science showing that there is no level of exposure to these contaminants without risk of health impacts, including certain cancers.
  • EPA is setting enforceable Maximum Contaminant Levels (MCL) at 4.0 parts per trillion for PFOA and PFOS, individually.
  • For PFNA, PFHxS, and “GenX Chemicals,” EPA is setting the MCLGs and MCLs at 10 parts per trillion.
  • EPA is also setting a limit for any mixture of two or more of the following PFAS: PFNA, PFHxS, PFBS, and “GenX Chemicals.” These limits are based on a Hazard Index that is calculated by dividing the concentration of each of the four PFAS compounds by its Health-Based Water Concentration (HBWC; 10 ppt for PFNA, 10 ppt for HFPO-DA (GenX), 9 ppt for PFHxS, and 2000 ppt for PFBS) and then adding the results together, with an MCL of 1.0.

“Drinking water contaminated with PFAS has plagued communities across this country for too long,” said EPA Administrator Michael S. Regan. “That is why President Biden has made tackling PFAS a top priority, investing historic resources to address these harmful chemicals and protect communities nationwide. Our PFAS Strategic Roadmap marshals the full breadth of EPA’s authority and resources to protect people from these harmful forever chemicals. Today, I am proud to finalize this critical piece of our Roadmap, and in doing so, save thousands of lives and help ensure our children grow up healthier.”

“President Biden believes that everyone deserves access to clean, safe drinking water, and he is delivering on that promise,” said Brenda Mallory, Chair of the White House Council on Environmental Quality. “The first national drinking water standards for PFAS marks a significant step towards delivering on the Biden-Harris Administration’s commitment to advancing environmental justice, protecting communities, and securing clean water for people across the country.”

EPA estimates that between 6% and 10% of the 66,000 public drinking water systems subject to this rule may have to take action to reduce PFAS to meet these new standards. All public water systems have three years to complete their initial monitoring for these chemicals. They must inform the public of the level of PFAS measured in their drinking water. Where PFAS is found at levels that exceed these standards, systems must implement solutions to reduce PFAS in their drinking water within five years.

The EPA stated that the new limits in this rule are achievable using a range of available technologies and approaches including granular activated carbon, reverse osmosis, and ion exchange systems. Drinking water systems will have flexibility to determine the best solution for their community, and EPA will work with state co-regulators in supporting water systems and local officials to implement this rule.

In the coming weeks, EPA will host a series of webinars to provide information to the public, communities, and water utilities about the final PFAS drinking water regulation. To learn more about the webinars, visit EPA’s PFAS drinking water regulation webpage.

 

FDA Logo

FDA Withdraws Guidance on Enforcement of Human Food with Chlorpyrifos Residues

By Food Safety Tech Staff
No Comments
FDA Logo

The FDA is withdrawing a 2022 guidance document titled Questions and Answers Regarding Channels of Trade Policy for Human Food Commodities with Chlorpyrifos Residues: Guidance for Industry, following a decision by the U.S. Court of Appeals for the Eighth Circuit to vacate, or void, an Environmental Protection Agency (EPA) final rule that revoked all tolerances for the pesticide chemical chlorpyrifos.

In April 2021, the U.S. Court of Appeals for the Ninth Circuit ordered EPA to issue a final rule either revoking all chlorpyrifos tolerances or modifying the chlorpyrifos tolerances, provided EPA could make a determination that those modified tolerances met the safety standard mandated by the Federal Food, Drug, and Cosmetic Act (FFDCA). As a result of the short timeframe, EPA found that, based on the available data and anticipated exposure from registered uses of chlorpyrifos, it could not determine that there was a reasonable certainty of no harm from aggregate exposure, including food, drinking water and residential exposure. Consequently, on August 30, 2021 EPA issued a final rule amending 40 CFR 180.342 to revoke all tolerances for residues of chlorpyrifos.

Gharda Chemicals and several grower groups challenged EPA’s revocation of the tolerances in the U.S. Court of Appeals for the Eighth Circuit. On November 2, 2023, the Eighth Circuit issued its decision, vacating EPA’s final rule and remanding the matter to EPA for further proceedings. As a result of this ruling, EPA issued the final rule to reinstate previous tolerances for chlorpyrifos; 40 CFR 180.342 reflects the current legal status of the tolerances for chlorpyrifos. The FDA guidance was intended to explain the agency’s enforcement policy for foods containing chlorpyrifos residues after the tolerances expired, per the 2021 final rule, which is now void.

 

 

 

 

 

 

James Jones

Jim Jones to Serve as First FDA Deputy Commissioner for Human Foods

By Food Safety Tech Staff
No Comments
James Jones

James “Jim” Jones will serve as the FDA’s first Deputy Commissioner for Human Foods. Per the FDA’s announcement, Jones, in this new executive position will lead the charge in setting and advancing priorities for a proposed unified Human Foods Program (HFP). Program areas would include food safety, chemical safety and innovative food products, including those from new agricultural technologies, that will bolster the resilience of the U.S. food supply in the face of climate change and globalization, as well as nutrition to help reduce diet-related diseases and improve health equity. Jones is scheduled to begin at the FDA on September 24, 2023.

For more than 30 years, Jones has held various positions in the U.S. Environmental Protection Agency (EPA), stakeholder community and private industry where he has managed teams and provided strategic planning and thought leadership around issues related to chemical safety and sustainability in the environment. His work has focused on lessening the impact that chemicals and pollution have on the U.S. food supply. At the EPA, he was a principal architect of the 2016 overhaul of the Toxic Substances Control Act, the first update of that statute in more than 40 years. He was also responsible for decision-making related to the regulation of pesticides and commercial chemicals. He also led several national sustainability programs, including the EPA’s Environmental Preferable Purchasing Program and the Presidential Green Chemistry Awards Challenge. He is a seasoned leader whose experience managing change initiatives within the federal government will be invaluable as we continue to build a unified HFP.

“I’m delighted to welcome Jim to the FDA. His impressive career, extensive leadership experience, and passionate vision for the future of the Human Foods Program make him an ideal selection for this pivotal position,” said FDA Commissioner Robert M. Califf, M.D. “Our proposed reorganization is the largest undertaking of its kind in recent history for our agency. I’m confident that under Jim’s leadership, we will build a stronger organization that will be integrated with other components of the FDA and focused on keeping the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in food science and nutrition. I’m looking forward to working with him when he joins us next month.”

Jones was an integral member of the Reagan-Udall Foundation’s Independent Expert Panel for Foods, which submitted a report in December 2022 on the operational evaluation of the FDA’s Human Foods Program. He holds a master’s degree in economics from the University of California at Santa Barbara and a bachelor’s degree in economics from the University of Maryland.

“Jim is among the most public-spirited and able government leaders I know.  I cannot think of a better choice for this crucial role.  In his 20 years in leadership positions at EPA, Jim demonstrated know-how to lead complex, science-based regulatory programs in a visionary and inclusive way. Jim knows food safety and the food system from his leadership of EPA’s pesticide program, and he knows the food safety and nutrition challenges FDA faces through his service on the Reagan-Udall Foundation Expert Panel,” said Mike Taylor, board member emeritus of STOP Foodborne Illness and former FDA Deputy Commissioner for Foods and Veterinary Medicine.

In the role of Deputy Commissioner for Human Foods, Jones will report directly to the FDA Commissioner. He will exercise decision-making authority over all HFP entities when the reorganization is in effect, including related Office of Regulatory Affairs (ORA) activities. He will provide executive leadership over the entire program as well as over resource allocation, risk-prioritization strategy, policy, and major response activities involving human foods. The leadership for Center for Food Safety and Applied Nutrition and Office of Food Policy and Response will report to Jones until the proposed HFP reorganization is implemented.

“I am very excited about the opportunity to serve as the first Deputy Commissioner for Human Foods at the FDA. I had the pleasure of serving on the expert panel that provided operational recommendations for the FDA’s foods-related activities, and I now look forward to helping the agency realize its vision for the proposed Human Foods Program, including carrying out important nutrition initiatives to improve the health of our country,” said Jones. “As a former pesticide regulator, I have a deep understanding of the unique needs of government programs involved in upholding safety of the U.S. food supply, as well as the important role that the agriculture community and state partners play in this paradigm. I am honored to serve the FDA and the country in this new capacity.”

 

 

 

Wiping down table

EPA Draft Guidance on Virus Claims for Antimicrobial Products

By Food Safety Tech Staff
No Comments
Wiping down table

In July, EPA released the draft guidance “Evaluation of Products for Claims against Viruses,” which proposes how registrants of antimicrobial products with sanitizing claims could add claims that these products are effective against viruses. The guidance, once finalized, would expand the availability of antimicrobial products that are effective against viruses such as SARS-CoV-2.

At the IAFP Conference in Toronto, Tajah Blackburn of EPA, Veronica Moore of FDA and Lee-Ann Jaykus of North Carolina State University, looked at the goals of EPA in proposing changes to registration and labeling of sanitizers that make viral claims, noting that the agency’s focus is on viruses transmitted by food. In particular, EPA is concerned with viruses known to be resistant to the most commonly used physical cleansers and disinfectants, and environmentally persistent viruses.

Under federal law, all antimicrobial products that claim to kill pathogens like viruses and bacteria on surfaces must be registered with EPA before they can be sold or distributed in the U.S. EPA primarily classifies antimicrobial products as sanitizers, disinfectants, and/or sterilants based on the product performance, test methods used to demonstrate efficacy, and microorganisms tested. Many products are registered with EPA as both sanitizers and disinfectants because they have undergone testing to support both claims.

The EPA noted in its announcement of the new draft guidance that products registered with only sanitizing claims may contain lower amounts of active ingredients and may have shorter contact times compared to products registered as disinfectants. Certain types of sanitizers can be used in food service and food processing facilities on surfaces such as dishes and utensils. Historically, EPA guidance has addressed the addition of claims against bacteria—but not against viruses—to products registered only with sanitizing claims.

Based on the proposed guidance, if laboratory data indicate that a product registered only with sanitizing claims meets EPA’s criteria for efficacy against viruses, the product could include claims against viruses on its label. New virucidal claims for sanitizers would rely on the same performance and testing standards currently used to assess products efficacy against viruses, such as disinfectants. If the draft guidance is finalized, it could lead to changes in the FDA Food Code to reflect new labeling regulations, said Blackburn.

EPA proposes to pilot this draft guidance over seven years to allow enough time to assess the outcome. Based on the outcomes, the agency will determine whether the guidance should be modified, terminated or made permanent.

The draft guidance is available for public comment (docket EPA-HQ-OPP-2023-0288) at regulations.gov.

 

 

Food in compost pile

Strategies to Reduce Food Loss and Waste

By Food Safety Tech Staff, Nicolle Portilla
No Comments
Food in compost pile

Food waste is a major problem that negatively impacts the environment. While the world wastes about 1.4 billion tons of food every year, the U.S. discards more food than any other country in the world: nearly 40 million tons every year. That’s estimated to be 30% to 40% of the entire U.S. food supply. And that excess food often ends up in landfills where it contributes significantly to CO2 emissions.

A 2021 report from the EPA on the environmental impacts of food waste estimated that each year, U.S. food loss and waste embodies 170 million metric tons of carbon dioxide equivalent (million MTCO2e) GHG emissions (excluding landfill emissions)—equal to the annual CO2 emissions of 42 coal-fired power plants. EPA data also show that food waste is the single most common material landfilled and incinerated in the U.S., comprising 24% and 22% of landfilled and combusted municipal solid waste, respectively.

Subscribe to the Food Safety Tech weekly newsletter to stay up-to-date on the latest news and information on food safety.

Restaurants and food manufacturing companies all over the country are making it a priority to reduce their food waste and loss. Below, we outline the most effective strategies—as well as resources available—to help food manufacturers and restaurant staff cut food loss and waste in their facilities.

Train Cooking Staff to Make Waste Reduction Priority

Make waste reduction part of your business culture. Start with the leadership and have them employ waste reduction throughout the entire organization.

Food prep is an area that can contribute to food waste; your suppliers may be able to help. “We work with a company that includes black beans in their burritos and burrito bowls,” says Kari Hensien, president of Rizepoint. “Because the supplier was providing those beans in a size that was greater than the recipes called for restaurant employees were just dumping the whole bag in because it was ‘close enough.’”

Not only did this affect the quality of the end product, it resulted in increased costs and food loss. In similar cases, employees may throw out the excess in a can or package if it contains more than a recipe requires. “Working with your supply chain to optimize packaging to correspond with the formulation of your recipes can drive significant cost savings and reduce food waste for the business,” says Hensien. “You can also raise awareness with your staff of the importance of following that recipe and what to do with the nonstandard size materials. For example, saving it for the next batch rather than throwing it away.”

Improve Food Storage Standards and Follow Regulations

Ensure that the cooking staff and waiters know how to properly store food and use items promptly to prevent produce from spoiling. “So often food waste at retail occurs because employees are not following simple quality control techniques,” says Hensien. “Whether it’s the holding temp for food you’ve prepared or maintaining the temps for food you are storing, you want to make sure that you are reinforcing the basics of having a solid quality control HACCP program in place for doing those temp checks.”

Use Every Part of Food Products

You can use your food more efficiently and cut costs by utilizing every part of meat products, fruits, vegetables, dairy and grains. Have the cooks use every food scrap. For example, bits of tomatoes left over after making burgers can get used up in sauces or salsas.

You can use bones and vegetable leftovers to make chicken broth for a tasty noodle soup. Do you have bread that’s no longer super fresh? Then make some breadcrumbs to sprinkle on top of a fish filet or croutons for a salad.

Restaurants and food manufacturers are also finding creative ways to partner with other businesses to repurpose and make use of their leftover food products. “Are there other facilities that would take food scraps off your hands for a cost to put it into something else?” asks Hensien. “For example, a company may be willing to take your lemon peels and make them into disinfectants. Through creative collaborations you can reduce your food waste and help another company produce their product or service.”

Compost to Cut Food Waste

Composting is a great sustainability strategy for your organization. Add old bread, vegetable and fruit peels, egg shells and coffee grounds to a compost pile or work with a local composting company to take your leftovers. You can also forge partnerships with local farms and gardeners who will take you compostable materials to develop and use your nutrient-rich compost.

Legislation is making it both necessary—and easier—for food businesses to take part in composting programs. California, Connecticut, Massachusetts, New York, Rhode Island and Vermont have passed laws that restrict the amount of food waste going to landfills. Vermont’s “Universal Recycling Law,” which went into effect in July 2020, bans food scrap waste entirely.

Pending legislation in California, Colorado and Massachusetts would establish programs to fund private-sector composting and organic collection programs. In addition, several states including Tennessee and Washington, and cities like Los Angeles and Madison, Wisconsin, have created food waste task forces to reduce waste by creating composting education and infrastructure.

“You can often partner with a set of local nonprofits and/or local state agencies that will help you with a solution where they will come and get your food scraps or you can drop them off at a certain location. This does require some logistics and coordination but oftentimes we’re finding that there are simple solutions with local nonprofits available that are already in place,” says Hensien.

Inspect Your Food Deliveries and Work with Local Suppliers

You will need to check every food delivery sent to your place of business. Only accept food deliveries with fresh ingredients and nothing that looks like it’s about to spoil. Work with high-quality delivery services and certified suppliers, who follow all appropriate food safety protocols.

Also, focus on seasonal produce and ingredients from the local area, when possible. “Businesses can optimize their supply chain geographically, especially for the fresher items such as tomatoes and lettuce,” says Hensien. “The closer that supplier is to its retail destination, the lower the transportation costs and the greater the likelihood that the product will arrive in a good quality state.”

Donate Food to the Hungry

Donate excess food that is still edible to local food banks, soup kitchens and homeless shelters to feed the hungry or partner with “food rescue” initiatives that bring excess food from retailers and restaurants to people in need. Oftentimes, these organization will pick up the unused food from your business.

“A lot of those nonprofits are actively searching for partners because food insecurity in the U.S. is at an all-time high and donations to those food pantries and soup kitchens are at an all-time low,” says Hensien.

Start by connecting with your local nonprofits. You can also find U.S.-based food rescue organizations in your region here.

Use Tech Tools to Predict Ordering Quantities

A key step in reducing food loss and waste is ensuring you are ordering only the ingredients you will need and can use. “The simplest thing an organization can do to reduce loss and waste is to marry their operational data—what they are using—with their transactional data—what they are selling” says Hensien.

There are technologies and tools that will help you track historical trends and predict your sales, but tracking this data can be done manually or in spreadsheets as well.

Identify Areas of Waste or Loss

One of the best ways to reduce food waste at food manufacturing plants is to utilize a tracking system. Pay attention to the data with the help of software, such as an Enterprise Resource Planning (ERP) tool.

You will have the information you need regarding packaging, shipping and production. The data found via a tracking system can help you define areas of waste and inefficiency. You can then target those areas to decrease food waste.

There are also self-assessment tools available to help both you and your suppliers identify areas of food loss and waste. “Our industry is notorious for saying you should do an LCA assessment and then implement an FLW protocol into your auditing program, and everyone just sees: ‘Oh gosh, I’ve got to send another auditor into all these locations and do an bunch of work to get this up and going,’” says Hensien. “But you can start with simple self-assessments that you can easily assign as a task with very little overhead.”

You can download self-assessment resources through the FLW as well as the EPA, which offers a Food Assessment Guidebook and Toolkit for Reducing Wasted Food & Packaging.

By involving your entire team in the goal of reducing food waste and loss, the industry can have a significant impact in reducing food insecurity, improving profitability and protecting the environment.

 

Water fountain

EPA Proposes Designating Certain PFAS as Hazardous Substances

By Food Safety Tech Staff
No Comments
Water fountain

The EPA is proposing to designate two of the most widely used per- and polyfluoroalkyl substances (PFAS) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), also known as “Superfund.” In its August 26 announcement, the agency noted that this would increase transparency around releases of these harmful chemicals and help to hold polluters accountable for cleaning up their contamination.

The proposal applies to perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their salts and structural isomers, and is based on significant evidence that PFOA and PFOS may present a substantial danger to human health or welfare or the environment. PFOA and PFOS can accumulate and persist in the human body for long periods of time. Evidence from laboratory animal and human epidemiology studies indicates that exposure to PFOA and/or PFOS may lead to cancer, reproductive, developmental, cardiovascular, liver and immunological effects.

“Communities have suffered far too long from exposure to these forever chemicals. The action announced today will improve transparency and advance EPA’s aggressive efforts to confront this pollution, as outlined in the Agency’s PFAS Strategic Roadmap,” said EPA Administrator Michael S. Regan.Under this proposed rule, EPA will both help protect communities from PFAS pollution and seek to hold polluters accountable for their actions.”

If finalized, the rulemaking would trigger reporting of PFOA and PFOS releases, providing the EPA with better data and the option to require cleanups and recover cleanup costs to encourage better waste management.  It would also improve EPA, state, Tribal nation and local community understanding of the extent and locations of PFOA and PFOS contamination throughout the country and help communities avoid or reduce contact with these potentially dangerous chemicals.

The EPA said that it is focused on holding responsible those who have manufactured and released significant amounts of PFOA and PFOS into the environment. It will use enforcement discretion and other approaches to ensure fairness for minor parties who may have been inadvertently impacted by the contamination.

If this designation is finalized, releases of PFOA and PFOS that meet or exceed the reportable quantity would have to be reported to the National Response Center, state or Tribal emergency response commissions, and the local or Tribal emergency planning committees.

Additionally, the proposed rule would, in certain circumstances, facilitate making the polluter pay by allowing EPA to seek to recover cleanup costs from a potentially responsible party or to require such a party to conduct the cleanup. In addition, federal entities that transfer or sell their property will be required to provide a notice about the storage, release or disposal of PFOA or PFOS on the property and a covenant warranting that it has cleaned up any resulting contamination or will do so in the future, if necessary.

EPA will be publishing the Notice of Proposed Rulemaking in the Federal Register in the next several weeks. Upon publication, EPA there will be a 60-day comment period.

 

 

EPA logo

EPA Stops Use of Pesticide Deemed Harmful to Children

By Food Safety Tech Staff
No Comments
EPA logo

The Environmental Protection Agency (EPA) will no longer permit the use of the pesticide chlorpyrifos on food. The organophosphate insecticide, which is used on fruit and nut trees, broccoli, cauliflower, row crops and other agriculture, has been linked with neurotoxicity in children.

“Today EPA is taking an overdue step to protect public health. Ending the use of chlorpyrifos on food will help to ensure children, farmworkers, and all people are protected from the potentially dangerous consequences of this pesticide,” said Administrator Michael S. Regan in an agency news release. “After the delays and denials of the prior administration, EPA will follow the science and put health and safety first.”

The EPA also issued a Notice of Intent to Cancel under the Federal Insecticide, Fungicide, and Rodenticide Act to cancel registered food uses of the pesticide.

magnifying glass

Surveying the Phthalate Litigation Risk to Food Companies

By Kara McCall, Stephanie Stern
1 Comment
magnifying glass

Boxed macaroni and cheese—comforting, easy, and, according to a 2017 article by The New York Times, containing “high concentrations” of “[p]otentially harmful chemicals.” Roni Caryn Rabin, The Chemicals in Your Mac and Cheese, N.Y. TIMES, June 12, 2017. Those “chemicals” referenced by the Times are phthalates—versatile organic compounds that have been the focus of increased media, advocacy, and regulatory scrutiny. But what are phthalates and what is the litigation risk to food companies who make products that contain trace amounts of this material?

Background

Phthalates are a class of organic compounds that are commonly used to soften and add flexibility to plastic.1 Ninety percent of phthalate production is used to plasticize polyvinyl chloride (PVC).2 Di-(2-ethylhexl) phthalate (DEHP) is the most commonly used phthalate plasticizer for PVC.3 Due to the prevalence of plastics in the modern world, phthalates are everywhere—from food packaging to shower curtains to gel capsules. Consequently, almost everyone is exposed to phthalates almost all of the time and most people have some level of phthalates in their system.4

Recently, various epidemiological studies have purported to associate phthalates with a range of different injuries, from postpartum depression to obesity to cancer. However, as the Agency for Toxic Substances and Disease Registry (ATSDR) stated in its 2019 toxicology profile for DEHP, these epidemiology studies are flawed because, inter alia, they often rely on spot urine samples to assess exposure, which does not provide long-term exposure estimates or consider routes of exposure.5 To date, claims regarding the effects of low-level phthalate exposure on humans are not supported by human toxicology studies. Instead, phthalate toxicology has only been studied in animals, and some phthalates tested in these animal studies have demonstrated no appreciable toxicity. Two types of phthalates—DBP and DEHP—are purported to be endocrine disrupting (i.e., affecting developmental and reproductive outcomes) in laboratory animals, but only when the phthalates are administered at doses much higher than those experienced by humans.6 Indeed, there is no causal evidence linking any injuries to the low-level phthalate exposure that humans generally experience. Nonetheless, advocacy and government groups have extrapolated from these animal studies to conclude that DEHP may possibly adversely affect human reproduction or development if exposures are sufficiently high.7 Indeed, in the past two decades, a number of regulatory authorities began taking steps to regulate certain phthalates. Most notably:

  • In 2005, the European Commission identified DBP, DEHP, and BBP as reproductive toxicants (Directive 2005/84/EC), and the European Union banned the use of these phthalates as ingredients in cosmetics (Directive 2005/90/EC).
  • In 2008, Congress banned the use of DBP, DEHP, and BBP in children’s toys at concentrations higher than 0.1%. See 15 U.S.C. § 2057c.
  • The EU added four phthalates (BBP, DEHP, DBP, and DIBP) to the EU’s list of Substances of Very High Concern (SVHCs) and, subsequently, to its Authorization List, which lists substances that cannot be placed on the market or used after a given date, unless authorization is granted for specific uses. BBP, DEHP, DBP, and DIBP were banned as of February 21, 2015, except for the use of these phthalates in the packaging of medicinal products.
  • In 2012, the FDA issued a statement discouraging the use of DBP and DEHP in drugs and biologic products. At the time, the agency said that these phthalates could have negative effects on human endocrine systems and potentially cause reproductive and developmental problems.8

More recently, phthalate exposure through food has become a trending topic among consumer advocates. Phthalates are not used in food, but can migrate into food through phthalates-containing materials during food processing, storing, transportation, and preparation. Certain studies report that ingestion of food accounts for the predominant source of phthalate exposure in adults and children. However, in assessing DEHP, the ATSDR noted that the current literature on “contamination of foodstuffs comes from outside the United States or does not reflect typical exposures of U.S. consumers; therefore, it is uncertain whether and for which products this information can be used in U.S.-centered exposure and risk calculations.”9 Further, the concentration of phthalates found in food are very low-level—multiples lower than the doses used in animal toxicology studies.10

In 2017, a study published on the advocacy site “kleanupkraft.org” stated that phthalates were detected in 29 of 30 macaroni and cheese boxes tested.11 The study notes that “DEHP was found most often in the highest amounts.” Notably, however, the “amounts” are provided without any context, likely because there is no universally accepted threshold of unsafe phthalate consumption. Thus, although the boxed macaroni and cheese study found “that DEHP, DEP, DIBP, and DBP were frequently detected in the cheese items tested,” and “[t]he average DEHP concentration was 25 times higher than DBP, and five times higher than DEP,” none of this explains whether these numbers are uniquely high and/or dangerous to humans. Meanwhile, on December 10, 2019, the European Food Safety Authority announced an updated risk assessment of DBP, BBP, DEHP, DINP, and DIDP, and found that current exposure to these phthalates from food is not of concern for public health.12

Phthalate Litigation

For years, phthalates in food have been targeted by environmental groups seeking to eliminate use of phthalates in food packaging and handling equipment. Most recently, several lawsuits were filed against boxed macaroni and cheese manufacturers alleging misrepresentation and false advertising due to their undisclosed alleged phthalate contamination. See, e.g., McCarthy, et al. v. Annie’s Homegrown, Inc., Case No. 21-cv-02415 (N.D. Cal. Apr. 2, 2021). Perhaps acknowledging that the amounts contained in the food packages have not been shown to present any danger, these claims are being pursued as consumer fraud claims based on failure to identify phthalates as an ingredient, rather than as personal injury claims.

Besides this recent litigation, however, there has been a notable dearth of phthalate litigation. This is likely due to several factors: First, in general, courts have rejected false claim lawsuits involving trace amounts of a contaminant chemical. See, e.g., Tran v. Sioux Honey Ass’n, Coop., 471 F. Supp. 3d 1019, 1025 (C.D. Cal. 2020) (collecting cases). For example, in Axon v. Citrus World, Inc., 354 F. Supp. 3d 170 (E.D.N.Y. 2018), the Court dismissed plaintiff’s claim that the use of the word “natural” constituted false advertising because the product contained trace amounts of weed killer. Id. at 182–84. The Court based this dismissal, in part, on the fact that the trace amounts of the commonly used pesticide was “not an ‘ingredient’ added to defendant’s products; rather, it is a substance introduced through the growing process.” Id. at 183. Similarly, phthalate is not an intentionally added ingredient—instead, it is a substance introduced, if at all, in trace amounts at various points throughout the manufacturing, handling, and packaging process. Second, proving that phthalate exposure from a particular food item caused an alleged injury would be extremely difficult. As mentioned above, there is no direct scientific evidence linking low-level phthalate exposure in humans to reproductive problems, cancer, or any other injury. Instead, plaintiffs must rely on animal studies where the subject, most commonly a rat, was exposed to enormous amounts of phthalates, many multiples of the amount that would be found in food. Moreover, the pervasive nature of phthalates makes it difficult to pinpoint any particular product as the source of the injury. If every food item a plaintiff ever consumed has been touched by a phthalate-containing material, it seems near impossible to prove that one particular food caused the alleged injury.

Although phthalate litigation has thus far proven unpopular, this landscape could change in the near future due to increased regulatory scrutiny. On December 20, 2019, the EPA stated that DEHP, DIBP, DBP, BBP, and dicyclohexyl phthalate were five of 20 high-priority chemicals undergoing risk evaluation pursuant to the Toxic Substances Control Act.13 The categorization of these phthalates as high-priority initiates a three- to three-and-a-half-year risk evaluation process, which concludes in a finding of whether the chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use.14 Although the same causation and product identification issues will remain, a revised risk analysis by the EPA may lead to increased phthalate litigation.

The views expressed in this article are exclusively those of the authors and do not necessarily reflect those of Sidley Austin LLP and its partners. This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.

References

  1. The most commonly used phthalates are di-(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), benzyl butyl phthalate (BBP), di-n-butyl phthalate (DBP), and diethyl phthalate (DEP). See Angela Giuliani, et al., Critical Review of the Presence of Phthalates in Food and Evidence of Their Biological Impact, 17 INT. J. ENVIRON. RES. PUBLIC HEALTH 5655 (2020).
  2. COWI A/S, Data on Manufacture, Import, Export, Uses and Releases of Dibutyl Phthalate (DBP), As Well As Information on Potential Alternatives To Its Use 10-11 (Jan. 29, 2009). http://echa.europa.eu/documents/10162/
    13640/tech_rep_dbp_en.pdf (observing European Council for Plasticizers and Intermediates (ECPI)); Agency for Toxic Substances & Disease Registry, DI-n-BUTYL PHTHALATE, Production, Import/Export, Use, and Disposal (Jan. 3, 2013). http://www.atsdr.cdc.gov/ToxProfiles/tp135-c5.pdf; Peter M. Lorz, et al., Phthalic Acid and Derivatives. ULLMANN’S ENCYCLOPEDIA OF INDUSTRIAL CHEMISTRY (Wiley-VCH: Weinheim, 2000); Lowell Center for Sustainable Production, Phthalates and Their Alternatives: Health and Environmental Concerns 4 (Jan. 2011). https://www.sustainableproduction.org/downloads/PhthalateAlternatives-January2011.pdf.
  3.  Michael D. Shelby, NTP-CERHER Monograph on the Potential Human Reproductive and Developmental Effects of Di (2-Ethylhexyl) Phthalate (DEHP). National Toxicology Program, HHS. NIH Publication No. 06-4476 at 2–3 (Nov. 2006).
  4.  See Chris E. Talsness, et al., Components of Plastic: Experimental Studies in Animals and Relevance for Human Health, 364 PHIL. TRANS. R. SOC. B 2079, 2080 (2009). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873015/pdf/rstb20080281.pdf.
  5. Agency for Toxic Substances & Disease Registry, Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP), Draft for Public Comment 3 (Dec. 2019). https://www.atsdr.cdc.gov/toxprofiles/tp9.pdf.
  6. FDA Guidance for Industry, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
  7. NIH Publication No. 06-4476 at 2–3, supra n.3.
  8. FDA Guidance for Industry. Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products. HHS, FDA. (Dec. 2012).
  9. Toxicology Profile for Di(2-Ethylhexyl) Phthalate (DEHP) at 362, supra n.5.
  10. Compare id. at 5 (measuring effects of phthalate oral exposure in mg/kg/day) with Samantha E. Serrano, et al., Phthalates and diet: a review of the food monitoring and epidemiology data, 13 ENVIRON. HEALTH 43 (2014) (measuring phthalate concentration in food in μg/kg).
  11. Testing Finds Industrial Chemical Phthalates in Cheese, Coalition for Safer Food Processing and Packaging. http://kleanupkraft.org/data-summary.pdf.
  12. FAQ: phthalates in plastic food contact materials. European Food Safety Authority. (Dec. 10, 2019).
  13. EPA Finalizes List of Next 20 Chemicals to Undergo Risk Evaluation under TSCA. U.S. Environmental Protection Agency. (Dec. 20, 2019).
  14.  Risk Evaluations for Existing Chemicals under TSCA. U.S. Environmental Protection Agency.
FDA

FDA on How to Return Refrigerated Transport Vehicles and Storage Units to Food Use After Holding Human Remains

By Food Safety Tech Staff
2 Comments
FDA

The increase in deaths during the COVID-19 pandemic has pushed funeral homes and morgues beyond capacity, and other measures have been taken to store the bodies of victims. As a result, refrigerated food transport vehicles and food storage units have been temporarily used for this purpose. Now, FDA has released the guidance document, “Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using Them to Preserve Human Remains During the COVID-19 Pandemic” because when those additional storage units are no longer needed to store bodies, “industry may wish to return the trailers and storage units to use for food transport and storage”.

Returning these vehicles and storage units to use for food is possible—but only with thorough cleaning and disinfection. The agency recommends the use of EPA-registered disinfectants that are suitable for the material being disinfected. It also recommends these disinfectants be effective against SARS-CoV-2 and foodborne pathogens. When disinfecting, it is important to adhere to the instructions for use for guidance on how many times application is required, the contact time needed, and effectiveness at refrigeration temperatures. For instances in which the interior surfaces have been in direct contact with blood or bodily fluids, the FDA guidance provides the scenarios in which the vehicles and storage units should not be returned to use for transporting or storing food for humans or animals.

OSHA has also stated that compressed air or water sprays should not be used to clean contaminated surfaces due to the risk of aerosolizing infectious material.

Due to the public health emergency, the guidance has been issued without the agency’s usual 60-day comment period.

FDA

FDA’s Pesticide Analysis Finds Most Foods Tested Below EPA Tolerance Levels

By Food Safety Tech Staff
No Comments
FDA

Today FDA released the results of its yearly report on pesticide residues, and the good news is that of the 6504 samples taken, most of them were below EPA tolerance levels. As part of the Pesticide Residue Monitoring Program for FY 2017, FDA tested for 761 pesticides and industrial chemicals in domestic and imported foods for animals and humans. The following are some highlights of the FDA’s findings:

  • Percentage of foods compliant with federal standards
    • 96.2% of domestic human foods
    • 89.6% of imported human foods
    • 98.8% domestic animal foods
    • 94.4% imported animal foods
  • Percentage of food samples without pesticide residues
    • Milk and game meat: 100%
    • Shell egg: 87.5%
    • Honey: 77.3%
  • Percentage of food samples without glyphosate or glufosinate residues
  • Milk and eggs: 100%
  • Corn: 82.1%
  • Soybeans: 60%

“Ensuring the safety of the American food supply is a critical part of the work of the U.S. Food and Drug Administration. Our annual efforts to test both human and animal foods for pesticide residues in foods is important as we work to limit exposure to any pesticide residues that may be unsafe,” said Susan Mayne, Ph.D., director of FDA’s CFSAN, in an agency release. “We will continue to do this important monitoring work, taking action when appropriate, to help ensure our food supply remains among the safest in the world.”