EPA’s PFAS Reporting Rule Requires Data Going Back to 2011

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) released its final Toxic Substances Control Act (TSCA) Section 8(a) reporting rule. It expands reporting and recordkeeping requirements for companies that have manufactured or imported per- and polyfluoroalkyl substances (PFAS) for a commercial purpose—whether as a chemical substance or in a mixture or article—since January 1, 2011. Entities subject to this rule will need to submit reporting forms for retrospective data either 18 or 24 months following the rule’s effective date, which is 30 days after its publication in the Federal Register.

Read the full Alert on the Duane Morris LLP website.

PFAS Listed in EPA’s National Enforcement and Compliance Initiatives

On August 17, 2023, the United States Environmental Protection Agency’s Office of Enforcement and Compliance Assurance (“EPA”) listed “Addressing Exposure to Per- and Polyfluoroalkyl Substances” (“PFAS”) as one of six new National Enforcement and Compliance Initiatives (“NECIs”) for FY 2024-2027. The NECIs are the issues that EPA has recognized as particularly urgent and challenging, which require additional resources and consideration on a national level.

While the EPA and State agencies have been taking actions and developing a regulatory framework to address PFAS contamination and exposure, listing PFAS as an NECI marks EPA’s intention to increase these efforts and prioritize the use of time, money and resources. Continue reading “PFAS Listed in EPA’s National Enforcement and Compliance Initiatives”

EPA Looking to Expand PFAS Substances Regulated under Superfund

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On September 6, 2022, the United States Environmental Protection Agency (“USEPA”) had previously issued a notice of proposed rulemaking to designate two (2) specific PFAS substances, known as perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as CERCLA hazardous substances. We have previously blogged about this Notice and it can be found on our website if of interest. The comment period to that proposed rulemaking has now closed and USEPA is presently evaluating comments received.

In the meantime, however, USEPA is considering a new initiative to expand the list of Comprehensive Environmental Response, Compensation and Liability Act (“CERCLA”) regulated PFAS beyond PFOA and PFOS to include seven (7) additional PFAS, their salts and precursors and, possibly, certain categories of PFAS.

In a pre-publication notice issued by the USEPA on April 13, 2023 (to be published in the Federal Register on that same date), USEPA announced its intention to consider expansion of its CERCLA hazardous substances list developed under potentially to include seven (7) additional per- and polyfluoroalkyl substances (PFAS) on that list.

As set forth in the pre-publication notice, additional PFAS under consideration for regulation includes:

Perfluorobutanesulfonic acid (PFBS), CASRN 375-73-5;
Perfluorohexanesulfonic acid (PFHxS), CASRN 355-46-4;
Perfluorononanoic acid (PFNA), CASRN 375-95-1;
Hexafluoropropylene oxide dimer acid (HFPO-DA), CASRN 13252-13-6 (sometimes called GenX);
Perfluorobutanoic acid (PFBA) CASRN 375-22-4;
Perfluorohexanoic acid (PFHxA) CASRN 307-24-4; and
• Perfluorodecanoic acid (PFDA) CASRN 335-76-2.

Take Aways:

USEPA will also be giving consideration to the precursors to PFOA, PFOS, and other PFAS listed above as well as whether USEPA should take action to designate whole categories of PFAS based on shared characteristics among the PFAS listed in those categories.

To these ends, USEPA is seeking a variety of data sources and information to assist them is deciding whether to expand the CERCLA list. The Comment period will run until approximately July 6, 2023 (i.e., sixty (60) days from publication in the Federal Register which is anticipated on April 13, 2023).

Duane Morris has an active PFAS Team to help organizations and individuals plan, respond to, and execute on your PFAS issues and initiatives. We would be happy to discuss your concerns and objectives and how new rules, regulations and rulings might apply to you. For more information or if you have any questions about this post, please contact Lori Mills, the author, or Lindsay Brown, Sharon Caffrey, Brad A. Molotsky, Alice Shanahan,  Seth Cooley, Alyson Walker Lotman, Kelly Bonner, Sharon Caffrey or the attorney in the firm with whom you in regular contact or the attorney in the firm with whom you are regularly in contact.

EPA Now Taking Comments on Its PFAS Enforcement Discretion Policy

On September 6, 2022, the U.S. Environmental Protection Agency (EPA) issued its proposed rulemaking to designate certain per- and polyfluoroalkyl substances (PFAS) as Hazardous Substances under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), which would have a significant legal impact across the country and create potential liability for PFAS release and/or contamination for a broad set of entities in numerous industries. Accordingly, the EPA has been developing an enforcement discretion policy and recently concluded two public listening sessions to seek stakeholder input on concerns about CERCLA enforcement for PFAS contamination. The EPA will review and consider the input received as it finalizes the CERCLA PFAS enforcement discretion policy.

Read the full text of this Alert on the Duane Morris LLP website.

PFAS Limits in Public Drinking Water Set Forth in Proposed EPA Rule

On March 14, 2023, the Environmental Protection Agency (EPA) announced a proposed new National Primary Drinking Water Regulation (NPDWR), which standardizes and sets the legally enforceable maximum contaminant levels (MCLs) of six per- and polyfluoralkyl substances (PFAS) in drinking water. The proposed regulation also sets nonenforceable maximum contaminant level goals (MCLGs).

Read the full text of this Alert on the Duane Morris LLP website.

EPA to Host CERCLA PFAS Enforcement Listening Sessions

The EPA has announced that it will host two public listening sessions “to seek individual input on concerns about enforcement under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) for per- and polyfluoroalkyl substances (PFAS) contamination.”

According to the EPA’s announcement, the sessions will focus on “enforcement policy related to responsible parties’ financial obligations under PFAS contamination response actions.”  The input will be considered by the Agency in drafting a CERCLA PFAS enforcement discretion policy.  That policy is intended to clarify when EPA intends to use its CERCLA enforcement authorities or its CERCLA enforcement discretion, to the extent PFAS cleanup enforcement efforts occur under CERCLA.  According to the EPA:

The policy will take into account various factors, such as EPA’s intention to focus enforcement efforts on PFAS manufacturers and other industries whose actions result in the release of significant amounts of PFAS into the environment, and EPA’s intention to not focus on pursuing entities where factors do not support taking an enforcement action.

The announcement does not provide any insight into what the EPA considers to be “significant amounts of PFAS” or what other “various factors” will be considered when deciding whether to take an enforcement action.  Presumably, these factors will be discussed at the listening sessions.

These listening sessions are not intended to seek comment on EPA’s perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) hazardous substance designation rulemaking process. That rulemaking comment period has closed.  The EPA has yet to issue a final rule on the matter, although the fact that EPA is working on a CERCLA PFAS enforcement discretion policy hints that the rule may be coming soon.

The sessions are scheduled for Tuesday, March 14, 2023 from 1:00 p.m. to 3:00 p.m. (EST) and Thursday, March 23, 2023, from 10 a.m. to noon (EST).  The sessions will also be recorded and made available on the EPA’s enforcement webpage.

You can register for the sessions using the links on this WEBSITE.   You can also submit written remarks on or before March 31, 2023 using the links on that same page.

Check back after the session dates for a summary of the discussion!

New Jersey and PFAS Regulation — What’s Come Before and What Does 2023 Have in Store?

From 2018 through 2020, the New Jersey Department of Environmental Protection (the Department or NJDEP) adopted a suite of new rules to address certain per- and polyfluoroalkyl substances (PFAS), specifically, PFOA, PFOS and PFNA, under multiple Department programs. Since that time, the Department continued to advance additional measures targeting these compounds under the auspices of its regulatory and enforcement authorities. More recently, the New Jersey Legislature has taken aim at these and other PFAS, expanding the scope of certain existing laws and introducing a collection of new bills regulating the use, detection and research of PFAS throughout the State. Here’s an overview of the current regulation of PFAS in New Jersey and what to expect in 2023.

Drinking Water Maximum Contaminant Levels

New Jersey was at the forefront of regulating PFAS in drinking water, being one of the first states to propose and adopt regulations setting a maximum contaminant level (MCL) for PFNA (13 parts per trillion (ppt)) in 2019, followed closely by the adoption of MCLs for PFOA (14 ppt) and PFOS (13 ppt) in 2020. These regulations require public water systems to routinely monitor for these contaminants, notify their customers of any violation within 30 days of determining that a violation has occurred, and report MCL violations to the public in their annual Consumer Confidence Reports.

Because the current New Jersey MCL regulations apply to public water systems only, New Jersey also expanded the testing of private wells under the Private Well Testing Act (PWTA), to address PFOA, PFOS and PFNA. The PWTA requires the testing of private potable wells prior to closing the sale of the property and also requires landlords to test private potable wells every five years and provide those test results to their tenants. As of December 2021, PFOA, PFOS and PFNA were added to the PWTA list of water quality parameters required to be tested.

New Jersey’s MCLs for PFOA and PFOS could change in 2023. The United States Environmental Protection Agency (US EPA) anticipates issuing a proposed National Primary Drinking Water Regulation for PFOA and PFOS in 2023. The proposal, which is expected in March, will include a maximum contaminant level goal (which is unenforceable) and an enforceable standard, which may be an MCL or a required treatment technique. In the event the US EPA adopts an MCL for PFOA or PFOS that is lower than the standard adopted by New Jersey, the US EPA MCL will apply (as would any treatment technique that it may require). US EPA anticipates finalizing the drinking water regulation by year-end. Continue reading “New Jersey and PFAS Regulation — What’s Come Before and What Does 2023 Have in Store?”

PFAS – Pennsylvania DEP Adopts new limits on 2 PFAS Chemicals – Required Testing, Reporting and Treatment

Earlier this past week, the Pennsylvania Department of Environmental Protection (“DEP”) adopted new limits on two classes of PFAS chemicals.

Pennsylvania joins a growing list of states that have implemented limits and, in some cases, bans, on certain types of PFAS and PFOS chemicals. According to the new rule, Pennsylvania will now mandate that all public and private drinking water treatment facilities in the Commonwealth, together with schools and healthcare facilities, and  commercial bottled water plants, will all be required to test their water for PFAS and PFOS, report the findings and treat affected water for the chemicals present above the new maximum contaminant levels (MCLs).

Pennsylvania’s new regulations will restrict the PFAS compounds PFOS (perfluoro-octane sulfonic acid) at 14 parts per trillion, and PFOA (perfluorooctanoic acid) at 18 parts per trillion.

Studies have indicated that over 97% of all humans have PFAS compounds in their blood stream that bio accumulates over time.

For decades, PFAS chemicals have been widely used in consumer products such as cosmetics, personal care products, furniture stain resistant applications, carpet stain guard, flame retardant fire fighting  foam (including foam used at all airports in the US), non-stick cookware, flame-retardant clothing, weather resistant outdoor clothing, some food packaging, as well as in firefighting foam used at current and decommissioned military bases.

While the new DEP regulations set the MCLs for these chemicals for the first time in Pennsylvania, critics have pressed for a lower MCL, for more PFAS compounds to be regulated and for private wells to be protected. 

New Jersey recently proposed a 4-bill set of additional PFAS restrictions and already restricts PFAS at 13 parts per trillion for PFOS and PFNA, and 14 parts per trillion for PFOA. Delaware is also considering regulations akin to Pennsylvania’s and has proposed implementing its own MCLs.

At the federal level, the Environmental Protection Agency is continuing to study PFAS and had set a federal health advisory level for PFAS, but unlike the PA MCLs, the federal advisory is just that, advisory, and, as such, is not per se actionable. As part of its ongoing effort to study and limit the effects of PFAS, in June, 2022, the EPA revised its prior advisory guidance set in 2016 at 70 parts per trillion down to .004 parts per trillion, after announcing the compounds were more concerning than EPA had previously thought.

Key Take Away – Pennsylvania joins a growing list of states that are actively reviewing and setting standards on what is acceptable and not in drinking water, soil, products, food packaging, and other consumer products. The new PA rule will require testing, reporting and treatment for affected water which exceeds the noted standard.

Duane Morris has an active PFAS Team to help organizations and individuals plan, respond to, and execute on your PFAS issues and initiatives. We would be happy to discussion your concerns and objectives and how new rules, regulations and rulings might apply to you. For more information or if you have any questions about this post, please contact Lindsay Brown, Brad A. Molotsky, Alyson Walker Lotman, Alice Shanahan,  Seth Cooley, Sharon Caffrey or the attorney in the firm with whom you in regular contact or the attorney in the firm with whom you are regularly in contact.

PFAS – Request for Public Comment on Data Collection regarding “Human Health Effects of Drinking Water Exposures to Per-and Polyfluoroalkyl Substances: A Multi-Site Cross Sectional Study”

Earlier this week, the Agency for Toxic Substances and Disease Registry (“ATSDR”) issued a notice – “Proposed Data Collection Submitted for Public Comment and Recommendations”.

The notice was published in the Federal Register on January 11, 2023 by Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention (the “Notice”).

ATSDR is asking the general public and other federal agencies to comment on a continuing information collection as required by the Paperwork Reduction Act . This notice requests comment on a proposed information collection project entitled “Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS): A Multi-Site Cross-Sectional Study (the Multi-Site Study)”. The goal of the research is to develop and deploy sound study methods to better determine if and how drinking water exposure to PFAS is related to health outcomes.

ATSDR is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs

Per the Notice, ATSDR seeks to cumulatively enroll approximately 9,100 participants (7,000 adults and 2,100 children and their parents) from communities exposed to PFAS-contaminated drinking water. In total, each recipient will attempt to meet a target recruitment of 1,000 adults and 300 children. Annualized estimates are 3,033 participants (2,333 adults and 700 children). Over the first three years of the five-year cooperative agreement program, the recipients have enrolled over 3,000 adults and over 300 children (as of 11/17/2022). The enrollment of children has been especially challenging during and following major closures and access to schools and other educational facilities due to the COVID-19 pandemic.

Further, according to the Notice, the main goal of the cross-sectional study is to evaluate associations between measured and reconstructed historic serum levels of PFAS including PFOA, PFOS, and PFHxS, and selected health outcomes. The health outcomes of interest to the ADSDR include lipids, renal function and kidney disease, thyroid hormones and disease, liver function and disease, glycemic parameters and diabetes, as well as immune response and function in both children and adults. In addition, the study has been designed to investigate PFAS differences in sex hormones and sexual maturation, vaccine response, and neurobehavioral outcomes in children. In adults, additional outcomes of interest by the ATSDR include cardiovascular disease, osteoarthritis and osteoporosis, endometriosis, and autoimmune disease.

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118; Email: omb@cdc.gov

If interested in the full text of the Notice, please see attached: http://www.gpo.gov/fdsys/pkg/FR-2023-01-11/html/2023-00333.htm

Duane Morris has an active PFAS Team to help organizations and individuals plan, respond to, and execute on your PFAS issues and initiatives. We would be happy to discussion your concerns and objectives and how new rules, regulations and rulings might apply to you. For more information or if you have any questions about this post, please contact Lindsay Brown, Brad A. Molotsky, Alyson Walker Lotman, Alice Shanahan,  Seth Cooley, Sharon Caffrey or the attorney in the firm with whom you in regular contact or the attorney in the firm with whom you are regularly in contact.

Modernization of Cosmetics Regulation Act Requires FDA to Assess Use of PFAS

On December 23, 2022, Congress significantly expanded the FDA’s regulatory authority over cosmetics as part of its year-end Consolidated Appropriations Act of 2023, the first major statutory change to the Food, Drug and Cosmetics Act (FDCA) regarding the regulation of cosmetics since the FDCA’s enactment in 1938.

Passed with bipartisan support and garnering industry approval, the Modernization of Cosmetics Regulation Act (MCRA) amends Chapter VI of the FDCA and contains a number of key provisions, requirements and dates for compliance. The MCRA further requires the FDA to publish a report no later than 2025 assessing the use of per- and polyfluoroalkyl substances (PFAS) in cosmetics and safety risks associated with such use.

Read the full story on the Duane Morris LLP website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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