Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from fluorinated polyethylene food containers. The purpose of the request is to ensure that FDA has current information to support its review of the use of fluorinated polyethylene containers used in food contact applications to help ensure that this use continues to be safe. According to the RFI, FDA may use submitted information to update dietary exposure estimates and safety assessments for the authorized food contact use of fluorinated polyethylene. Either electronic or written comments and scientific data and information are due October 18, 2022.
The RFI notes that tests performed by the U.S. Environmental Protection Agency (EPA) found that certain PFAS can form and migrate from some fluorinated high-density polyethylene (HDPE, which is a type of polyethylene) containers into the pesticide within the containers. EPA’s testing was conducted on containers that are not FDA-regulated, specifically containers intended to hold mosquito-controlling pesticides. The RFI states that EPA’s testing raises questions about the potential for PFAS to form and migrate from fluorinated polyethylene containers that are intended for food contact use. As such, FDA is interested in obtaining information on current food uses of fluorinated polyethylene containers, as well as information on current manufacturing processes for these containers and any analytical testing information about substances that may migrate from fluorinated polyethylene containers to food. More information on EPA’s testing is available in our October 4, 2021, blog item.


By Lynn L. Bergeson and Carla N. Hutton
On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration aims to establish a framework for the Next Generation of Risk Assessments based on NAMs. The collaboration will bring together more than $2 million in both monetary and in-kind contributions, including scientific expertise and equipment, to develop a comprehensive NAMs dataset for a minimum of 40 chemicals. According to EPA, the chemicals will be selected and grouped such that half will be benign and the other half will have known adverse implications for human health. These chemicals will be tested using a wide variety of NAMs, and the results will be compared between the two groups to determine how well particular NAMs can infer differences in risk. EPA states that these data will be used in case studies to evaluate the potential to use NAMs in regulatory decisions. All data generated through the collaboration will be in the public domain, allowing academic, corporate, government, and nonprofit scientists to use the project results in their own research.
EPA states that in addition to the data generated through the collaboration, EPA and Unilever will use chemical data from EPA’s high-throughput screening efforts and the federal government’s Tox21 consortium, which is a collaboration among EPA, the National Institutes of Health (NIH), and the U.S. Food and Drug Administration (FDA). According to EPA, “[t]hese automated chemical screening technologies rapidly test thousands of chemicals for their effects on human cells or cellular components that are critical to normal function.” EPA notes that data from these technologies are then incorporated into computational models to predict potential adverse health effects and estimate the amount of chemical that may cause these effects.


By Susan M. Kirsch and Margaret R. Graham

On May 1, 2018, the Hawaii Senate and House of Representatives passed a bill that will ban the sale, offer of sale, or distribution in Hawaii of any sunscreen that contains oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider to preserve marine ecosystems, beginning January 1, 2021S.B. No. 2571, Environment; Water Pollution; Sunscreen; Oxybenzone; Octinoxate; Sale; Distribution; Prohibition.  The bill received unanimous approval in the Senate and only four of 51 House members voted against it, but Governor David Y. Ige (D) has not signed the bill as yet.  The bill states that scientific studies have shown that both chemicals can induce “feminization in adult male fish and increase reproductive diseases in marine invertebrate species (e.g., sea urchins), vertebrate species (e.g., fish such as wrasses, eels, and parrotfish), and mammals (in species similar to the Hawaiian monk seal)” and induce “deformities in the embryonic development of fish, sea urchins, coral, and shrimp and induce neurological behavioral changes in fish that threaten the continuity of fish populations.” 

Oxybenzone and octinoxate are among a group of chemical filters of ultraviolet (UV) light used in sunscreens.  According to an Environmental Working Group 2017 survey, oxybenzone is found in 65 percent of commercially available chemically based sunscreens.  There is disagreement among the scientific community about the role that oxybenzone and other chemical sunscreens play in the degradation of coral reefs.  This February 2017 article in Nature discusses available science on reefs and sunscreens, including research findings that legislative champions of the Hawaii bill used as support for proposing its ban.  As a possible alternative, mineral-based sunscreens, such as those with titanium dioxide and zinc oxide, have not been shown to cause harm to corals, according to the National Oceanic and Atmospheric Administration (NOAA).

Hawaii’s Department of Land and Natural Resources (DLNR) has been requesting that people who enter the ocean and use beach showers avoid using sunscreens containing oxybenzone since September 2016, stating that “studies have shown that oxybenzone causes deformities in coral larvae (planulae), making them unable to swim, settle out, and form new coral colonies.  It also increases the rate at which coral bleaching occurs.”

Several sunscreen manufacturers and trade associations opposed the bill, citing the U.S. Food and Drug Association’s (FDA) approval of oxybenzone and octinoxate (a/k/a octyl methoxycinnamate) as active ingredients in sunscreen.  FDA’s website lists oxybenzone and octyl methoxycinnamate as “acceptable active ingredients in products that are labeled as sunscreen” that protect “skin from the sun’s harmful UV rays.”

If enacted, Hawaii’s ban will be the first of its kind in the U.S. and in the world.  Among U.S. states and territories, coral reefs can also be found off the coasts of Florida, Texas, Puerto Rico, and the Virgin Islands.  These states and territories, and other countries with direct interests in preserving reef ecosystems, may begin to explore similar bans.