EPA Adds Five PFAS Chemicals to List of Regional Screening and Removal Management Levels to Protect Human Health and the Environment

May 23, 2022
EPA is taking an important step forward to protect people from per- and polyfluoroalkyl substances (PFAS) by adding five PFAS chemicals for a total of six PFAS chemicals to a list of risk-based values that help EPA determine if response or remediation activities are needed. EPA’s action provides the Agency with critical tools needed for Superfund and other Agency programs to investigate contamination and protect people from these PFAS chemicals using the latest peer-reviewed science.
 
“Aggressively addressing PFAS across America is an active and ongoing priority to the Biden-Harris Administration,” said Carlton Waterhouse, EPA Deputy Assistant Administrator for the Office of Land and Emergency Management. “One key way that EPA is leading this effort is by relying on sound science to investigate risk from PFAS at Superfund sites.”
 
Screening and removal management levels are not cleanup standards. They are risk-based values that help EPA determine if further investigation or actions are needed to protect public health, such as, sampling, assessing risks, and taking further action, which could include providing alternative drinking water. These mechanisms allow site teams to make better site decisions that will protect nearby communities. 
 
The five PFAS additions include: hexafluoropropylene oxide dimer acid and its ammonium salt (HFPO-DA – sometimes referred to as GenX chemicals), perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS). EPA added the first PFAS substance, PFBS or perfluorobutanesulfonic acid, to the Regional Screening Level and Regional Removal Management Level lists in 2014 and updated it in 2021 when EPA released its updated toxicity assessment for PFBS.
 
The science of PFAS is rapidly evolving. For PFOA, PFOS, PFNA, and PFHxS, EPA selected levels using the most updated final peer-reviewed information based on Minimal Risk Levels from the Agency for Toxic Substances and Disease Registry’s 2021 toxicological profile. For the fifth chemical, HFPO-DA, EPA used a final peer-reviewed EPA toxicity value. EPA regularly reviews and updates Regional Screening Levels and Regional Removal Management Levels twice a year. As the science on PFAS evolves, EPA may update these values and add other PFAS chemicals.
 
Regional Screening Levels are used to identify contaminated media (i.e., air, tap water, and soil) at a site that may need further investigation. In general, if a contaminant concentration is below the screening level, no further action or investigation is needed. If the concentration is above the screening level, further investigation is generally needed to determine if some action is required. Regional Removal Management Levels are used to support EPA’s decisions to undertake a removal action under CERCLA, such as providing alternative drinking water, or remediation of contaminated media, if necessary.
 
In addition to updating the Regional Screening Levels and Regional Removal Management Levels, EPA is moving as quickly as possible to update the interim health advisories for PFOA and PFOS to reflect new science and input from the Science Advisory Board. Concurrently, EPA will continue to develop a proposed PFAS National Drinking Water Regulation for publication in fall 2022. EPA anticipates finalizing the rule in fall of 2023.
 
For more information for risk assessors:
 
EPA Considers Classifying Discarded PVC Plastic as Hazardous Waste
 
In yet another “sue and settle” case, the U.S. Environmental Protection Agency has proposed entering into a consent decree agreeing to rule on the Center for Biological Diversity’s (CBD) petition to classify discarded polyvinyl chloride (PVC) as a hazardous waste under the Resource Conservation and Recovery Act (RCRA). Part of a broader initiative to decrease the volume of plastic waste, this may result in a rule classifying a wide range of PVC-containing industrial, commercial, and retail materials and products as hazardous wastes when discarded.

The consent decree would resolve CBD’s August 2021 complaint in Center for Biological Diversity v. U.S. Environmental Protection Agency, in which CBD alleged that EPA unreasonably delayed acting on a 2014 petition to list discarded PVC as hazardous waste. The proposed consent decree requires that EPA propose a decision on CBD’s petition by Jan. 20, 2023. Interested parties may file comments on this proposed decision, and EPA must issue a final decision by April 12, 2024. EPA published a notice in the Federal Register providing information on the proposed consent decree. Any written comments on the consent decree must be received by June 3, 2022.          

CBD asserts that many products ranging from building materials to food packaging to children’s toys contain PVC, which it states can have a harmful effect on human health, the environment, and wildlife. Specifically, CBD asserts that PVC contains vinyl chloride and states EPA has acknowledged that vinyl chloride is a human carcinogen. CBD also asserts that PVC contains chemical additives, such as phthalate plasticizers, which it states have toxic and carcinogenic effects on human and wildlife. Accordingly, CBD believes that PVC should be listed a hazardous waste under RCRA.

Furthermore, CBD’s petition is not aimed merely at PVC waste that might be generated at the initial chemical manufacturing stage: it seeks to have EPA declare that finished materials and products containing PVC are hazardous wastes when discarded. This could encompass, for example, discarded PVC pipe and even trimmings at a construction site, or PVC-containing products that might be discarded by retail stores (e.g., unusable or damaged customer returns
 
FDA Allows Hormone-Disrupting Phthalates in Food Packaging
 
The Food and Drug Administration (FDA) recently denied petitions submitted by health and environmental advocates in 2016 to ban phthalates from food packaging and food production equipment. Studies show that these toxic petrochemicals leach into food and drinks, causing serious harm to human health. The decision allows for phthalate contamination of food and drinks—ranging from infant formula to meat, milk, spices, and cooking oils—to continue, despite the fact that Congress determined more than a decade ago that several of these chemicals are too dangerous to use in children’s toys. At the same time, FDA acknowledged that its safety assessment for food-contact uses of phthalates is out of date and requested new information from the public.    
 
Phthalates interfere with hormone-regulated processes in the body and are linked to a range of health harms including birth defects, infertility, miscarriage, breast cancer, diabetes, and asthma. Phthalates also harm the developing brain, leading to reduced IQ and attention and behavior disorders in children.  Babies and young children are most vulnerable to harm from phthalates and suffer the greatest exposure. People of color in all age groups, as well as economically insecure people, also face higher risks of serious health problems from exposure to phthalates compared to the general population.  Safer substitutes for these chemicals are readily available. 
 
“FDA’s decision recklessly green-lights ongoing contamination of our food with phthalates, putting another generation of children at risk of life-altering harm to their brain development and exacerbating health inequities experienced by Black and Latina women,” said Earthjustice attorney Katherine O’Brien.  “FDA’s announcement that it will now start reviewing new data on phthalate safety—six years after advocates sounded the alarm—is outrageous and seeks to sidestep FDA’s legal duty to address the current science in proceedings on the existing petitions.”
 
Federal law prohibits the use of chemical additives in food or food-contact materials, unless the available scientific evidence establishes that the additives are safe, taking into account the cumulative effect of all related chemicals in the diet.  FDA is charged with implementing this mandate by evaluating new food additives and reviewing the safety of additives already on the market when new evidence shows that they are not safe. 
 
Given the well-established—and growing—body of studies linking phthalate exposure through food and drinks to serious health harms, a coalition of advocacy groups submitted two related petitions asking FDA to ban phthalates as food additives in March 2016.  Despite a legal mandate to make a final decision on the principal petition within 180 days, FDA sat on the petition for years.  Advocates sued FDA in federal court in December 2021, forcing the agency to finally make a decision.
 
FDA also granted a plastics industry petition to revoke federal approval for multiple phthalates added to food packaging and processing equipment based on industry assertions that those uses have been abandoned.  But FDA’s decisions leave multiple phthalates—including substances with the most well-developed body of scientific evidence demonstrating their toxic effects—on the market.  In addition to food and drinks, phthalates can be found in personal care products, cosmetics, pharmaceuticals, cleaning products, building materials, and other consumer products.  The cumulative exposure that people experience to multiple phthalates from numerous sources increases their risk of health harms. 
 
The 2016 petitions were submitted by Earthjustice, Environmental Defense Fund, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Clean Water Action, Consumer Federation of America, Improving Kids’ Environment, Learning Disabilities Association of America, Breast Cancer Prevention Partners, and Natural Resources Defense Council.  Defend Our Health and Alaska Community Action on Toxics joined the litigation to force FDA action on the petitions after years of delay.   
 
Washington State Takes Steps Toward Banning Persistent PFAS Chemicals in Food Packaging
 
Washington state took an important step toward eliminating the use of persistent chemicals known as per- and polyfluoroalkyl substances, or PFAS, in common types of food packaging. A new report to the Washington State Legislature from the Department of Ecology identifies additional alternatives to food packaging that contains toxic chemicals and starts a two-year clock for manufacturers and retailers to remove PFAS from their food packaging.
 
The report adds flat serviceware, open-top containers, closed containers, bags and sleeves, and bowls to the list of products for which safer alternatives are available. Paper wraps and liners, food boats, pizza boxes, and plates were included in Ecology’s first report, published February 2021, which found that there are replacements for these products that don’t contain PFAS.
 
“This report starts a two-year countdown to when PFAS will be banned in these five types of products,” said Katrina Lassiter, manager of Ecology’s Hazardous Waste and Toxics Reduction Program. “The work that’s been done by Ecology, at the Legislature, and by community organizations will go a long way toward making Washington safer for human health and the environment.”
 
PFAS are a large group of manufactured chemicals that are extremely difficult to remove from the environment, a trait that has earned them the nickname “forever chemicals.” Studies show that many consumer products and product packaging contain PFAS that can leach into food, ultimately exposing people to these toxic chemicals. Many of them can bioaccumulate, or build up in people and the environment. They can easily contaminate groundwater and can be hard to filter out. Since these substances don’t break down naturally, human and animal exposure to PFAS could continue for hundreds or thousands of years.  
 
The Next Phase
Ecology’s first and second reports looked at food packaging meant to contain food for only a short while. The agency’s upcoming third report will focus on food packaging used for periods of longer-term storage. Work on that project is ongoing throughout 2022. Stakeholders and the public can hear an overview of the second report results and learn how to get involved in the third report at a webinar Monday, June 6, 2022 from 2:30 p.m. to 4:30 p.m. PST.
 
These reports use an alternatives assessment process, which looks for replacement chemicals or changes in design that can eliminate the need for a toxic chemical. To be deemed an acceptable replacement, an alternative must be shown to be safer than PFAS, work in the product as well or better than PFAS, and be available for purchase to consumers and businesses, among other criteria (see more in Chapter 70A.222 Revised Code of Washington).
 
To learn more about the alternatives assessment process or to get involved with the next assessment, visit the PFAS in Food Packaging AA website.
 
State Laws Incentivize Chemical Recycling, but Environmental Advocates Are Critical
 
As the public grows more concerned about plastic pollution, some elected officials are getting onboard with “advanced recycling,” which is being promoted by industry groups. Although this process might sound like a good way to deal with the plastics problem, environmental advocates warn that it’s not all it’s cracked up to be, according to a cover story in Chemical & Engineering News, an independent news outlet of the American Chemical Society.
 
Unlike mechanical recycling, which grinds plastic into small pieces to be reused, advanced recycling chemically breaks down the plastic into molecular building blocks, writes Senior Correspondent Cheryl Hogue. These raw materials go into the production of new plastic items or are converted into fuels such as gasoline or home heating oil. Plastic-to-plastic recycling does not stop the production of single-use plastic items, which environmental advocates maintain would have the biggest impact on the plastic pollution crisis. And because the plastic-to-fuel strategy involves energy-intensive processes and air pollution, it is not circular, which advocates say defeats the purpose of recycling. Thus, they say that plastic-to-fuel recycling should not be considered advanced recycling under the new laws.
 
Policymakers in 18 states have already enacted legislation that encourages advanced recycling, and even more are considering taking similar action. Most of these laws reclassify advanced recycling facilities as manufacturing plants, rather than solid waste facilities. Environmental groups are crying foul because that means chemical recyclers can receive government financial incentives and qualify for looser regulations. And currently, industry groups are asking the EPA to exempt pyrolysis and gasification units—two processes used for chemically recycling plastic—from stringent Clean Air Act regulations. As more states line up bills promoting advanced recycling, industry groups are hoping this momentum will also push for regulatory changes at the federal level. The Biden administration is currently seeking comment from both industry groups and environmental activists, and a decision on this matter is expected soon.
 
Oregon DEQ Issues 11 Penalties in April for Environmental Violations
 
The Oregon Department of Environmental Quality issued 11 penalties totaling $115,648 in April for various environmental violations. A detailed list of violations and resulting penalties is at https://ordeq.org/enforcement.
 
Fines ranged from $2,025 to $36,000. Alleged violations included a city discharging untreated sewage to Rock Creek, a truck spilling 25 gallons of diesel into Hedges Creek, and a developer illegally open burning construction materials, plastic and other garbage.
 
DEQ issued civil penalties to the following organizations:
  • Aladdin Heating & Air Conditioning Corp., $2,200, Portland, asbestos
  • Alpha 3 LLC, 1800 Cordon Rd LLC, and Sides, Charles; $5,309, Salem, open burning
  • Arnold J. Thomas & Son, Inc. dba Thomas & Son Distributors, $36,000, Tualatin, emergency response
  • Banyan Tree Investments, LLC, $7,200, Portland, asbestos
  • City of Vernonia, $7,800, Vernonia, water quality
  • Farm Power Tillamook LLC, $20,369, Tillamook, air quality
  • Multnomah County, $3,211, Portland, asbestos
  • Oregon Department of Transportation, $3,900, Dodson, water quality
  • Traeger Pellet Grills LLC, $8,434, Redmond, air quality
  • Westport Service District Sewage Treatment Plant, $2,025, Westport, water quality
  • Zien Phan, $19,200, Portland, asbestos
 
Organizations or individuals must either pay the fines or file an appeal within 20 days of receiving notice of the penalty. They may be able to offset a portion of a penalty by funding a supplemental environmental project that improves Oregon’s environment. Learn more about these projects at https://ordeq.org/sep.
 
Penalties may also include orders requiring specific tasks to prevent ongoing violations or additional environmental harm.
 
Continental Tire Plant Cited for Multiple Safety Violations After 3 Workers Suffer Severe Injuries
 
In two separate incidents on consecutive days in November 2021, three workers at a southern Illinois tire plant suffered severe injuries in incidents associated with a mixer containing a combustible dust and a flammable gas, guarding moving equipment and the failure to implement and enforce procedures to control the unintentional energization of equipment during servicing.
 
On Nov. 13, 2021, OSHA received an employer-reported referral from Continental Tire the Americas, LLC after an employee unjamming a machine suffered the amputation of three fingers. The next day, one employee suffered severe burns requiring hospitalization and another employee suffered a concussion injury after an industrial rubber-compound mixer exploded.  
 
Following its investigations, OSHA issued the company citations for two repeated, 16 serious and five other than serious violations. Inspectors allege Continental Tire the Americas, LLC had deficient safety procedures for energy control, combustible dust preventative engineering, housekeeping, personal protective equipment, emergency egress routes and hazard communication. The company faces $341,866 in proposed penalties.
 
“OSHA standards are put in place to prevent workers from suffering life-altering injuries,” said OSHA’s Area Director Aaron Priddy in Fairview Heights. “Continental Tire the Americas must learn from these tragic injuries, review company safety procedures and employee training and make sure workers are safe on the job.”
 
Based in Fort Mill, South Carolina, Continental Tire the Americas, LLC manufactures passenger, light truck and commercial tires at facilities in Barnesville, Georgia; Mt. Vernon and Sumter, South Carolina. Continental is the North American subsidiary of the German-based tire and automotive component manufacturer Continental AG. 
 
OSHA’s machine guarding, control of hazardous energy and combustible dust webpages provide information on what employers must do to limit worker exposure to machine and combustible dust hazards.
 
EPA Takes Action Against Five Construction Companies in Massachusetts and New Hampshire to Address Clean Water Violations
 
The EPA has reached settlements with five Massachusetts and New Hampshire construction companies for violations of stormwater regulations that serve to reduce pollution from construction runoff. Under the settlements, the five companies agreed to pay penalties and follow the terms of their permits for discharging stormwater.
 
"In order to protect communities' clean water, developers must get stormwater permit coverage and implement erosion controls," said EPA New England Regional Administrator David W. Cash. "As we enter the busy construction season in New England, EPA is committed to ensuring developers comply with our rules so that they can perform their work, while being good stewards of the environment."
 
All construction sites one acre or larger, with the potential to discharge stormwater to surface waters, are required to obtain coverage under EPA's General Permit for Discharges from Construction Activities, comply with the terms of the permit, and thereby minimize sediment discharges.
 
The recent enforcement actions include:
  • GAIR, LLC agreed to pay a $6,600 penalty for allegedly failing to renew permit coverage at the Jennings Road development in Charlton, Mass. The site also lacked complete erosion controls.
  • Harbor Classic Homes, LLC agreed to pay a $6,750 penalty for allegedly discharging sediment to a stream at the Laurel Hill Estates site in Lancaster, Mass. The company had also paid a $4,200 penalty to EPA in 2021 for failing to have permit coverage at a construction site in Lunenburg, Mass.
  • Highfield Homes, LLC agreed to pay a $4,800 penalty for allegedly failing to implement adequate erosion controls at the Highfield Commons site in Rochester, NH.
  • Martelli Construction, Inc. agreed to pay a $10,500 penalty for allegedly failing to adequately control erosion at the Greenwood II development site in Holden, Mass. The company had also paid an $8,400 penalty to EPA in 2019 for erosion control failures at the same site.
  • U-Haul Co. of Western Massachusetts, has agreed to pay an $18,000 penalty for allegedly failing to obtain permit coverage at a construction site in Lancaster, Mass. Due to a lack of erosion controls at the site, sediment runoff from this site impacted nearby wetlands.
 
Dirt, sediment and other pollutants carried off construction sites can damage aquatic habitat, contribute to algal blooms, and physically clog streams and pipes. Operators of new construction sites must apply for permit coverage prior to initiating land-disturbing activity.
 
These settlements are the latest in a series of enforcement actions taken by EPA New England to address stormwater violations from industrial facilities and construction sites around New England.
 
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