Frequent Questions and Answers: Draft Sewage Sludge Risk Assessment for PFOA and PFOS
Question Topics:
- Key Definitions
- Risk Assessment
- Monitoring
- Review Process
- Risk Management
- Recent EPA Actions that Address PFAS in Biosolids
- Exposure and Risk
- Regulations and Permitting
- PFAS Usage
Key Definitions
1. What is sewage sludge?
When domestic sewage is transported and conveyed to a wastewater treatment plant (WWTP), it is treated to separate the liquids from the solids, which produces a semi-solid, nutrient-rich product known as sewage sludge. In some instances, industrial wastewater is also conveyed to a WWTP and combined with domestic sewage. The terms “biosolids” and “sewage sludge” are often used interchangeably by the public; however, the EPA typically uses the term “biosolids” to mean sewage sludge that has been treated to meet the requirements in the EPA’s regulation entitled, “Standards for the Use or Disposal of Sewage Sludge,” promulgated at 40 CFR part 503, and intended to be applied to land as a soil amendment or fertilizer.
Sewage sludge is defined as the “solid, semi-solid, or liquid residue generated during the treatment of domestic sewage in a treatment works. Sewage sludge includes, but is not limited to, domestic septage; scum or solids removed in primary, secondary, or advanced wastewater treatment processes; and a material derived from sewage sludge. Sewage sludge does not include ash generated during the firing of sewage sludge in a sewage sludge incinerator or grit and screenings generated during preliminary treatment of domestic sewage in a treatment works.” 40 CFR §503.9(w)
Clean Water Act regulations codified at 40 CFR Part 503 (“Standards for the Use or Disposal of Sewage Sludge”) govern minimum requirements for sewage sludge quality, management practices, and monitoring and reporting applicable to the generation of sewage sludge from a treatment works treating domestic sewage or use or disposal of that sewage sludge by any person. These regulations ensure that sewage sludge meets federal requirements when it is: 1) applied to land as a fertilizer or soil conditioner; 2) placed on a surface disposal site (e.g., sewage sludge-only landfills); or 3) fired in a sewage sludge incinerator.
2. What are PFOA and PFOS?
PFOA and PFOS are two chemicals in a large class of synthetic chemicals called per- and polyfluoroalkyl substances (PFAS). PFOA and PFOS persist in the environment for long periods of time and have been linked to a variety of adverse human health effects. In 2024, the EPA classified both PFOA and PFOS as likely to be carcinogenic to humans and concluded that these chemicals are likely to cause a range of non-cancer effects in humans, including hepatic, immunological, cardiovascular, and developmental effects, given sufficient exposure conditions (see the EPA’s Final Toxicity Assessment for PFOA and Final Toxicity Assessment for PFOS).
PFAS have been manufactured and used by a broad range of industries since the 1940s, and there are estimated to be thousands of PFAS present in the global marketplace that are used in many consumer, commercial, and industrial products. PFOA and PFOS have been widely studied and they were once high production volume chemicals within the PFAS chemical class. PFAS manufacturers voluntarily phased out domestic manufacturing of PFOA and PFOS and their uses have been restricted by Significant New Use Rules (SNURs) issued by the EPA under the Toxic Substances Control Act (TSCA) (see the EPA’s Risk Management for PFAS under TSCA). Though concentrations of PFOA and PFOS in people’s blood have lowered since the voluntary phase out, blood levels can be elevated in communities where there is significant contamination and exposure.
Learn more about PFAS, the EPA’s PFAS Strategic Roadmap, and PFAS exposure in impacted communities.
Risk Assessment
3. What does the EPA mean by risk? What is a risk assessment?
The EPA considers risk to be the chance of harmful effects to human health or to ecological systems resulting from exposure to an environmental stressor. A stressor is any physical (e.g., radiation), chemical (e.g., pesticides), or biological entity (e.g., microbes) that can induce an adverse response. A risk assessment is a scientific process that is used to characterize the nature and magnitude of health risks to humans (i.e., children and adults) and ecological receptors (e.g., aquatic and terrestrial plants and wildlife) from pollutants. An environmental risk assessment considers three primary factors: 1) presence (i.e., how much of a pollutant is present in the environment), 2) exposure (i.e., how much contact a human or wildlife has with the pollutant), and 3) the toxicity of the pollutant (i.e., the health effects the pollutant causes in humans or wildlife) (see the EPA’s Risk Assessment Basics).
Learn more about the EPA’s risk assessment process.
4. What are the indications of risk in the EPA’s Draft Sewage Sludge Risk Assessment for PFOA and PFOS?
The draft risk assessment focuses on those living on or near impacted sites (e.g., farm families and their neighbors) or those that rely primarily on their products (e.g., food crops, animal products, drinking water); the draft risk assessment does not model risks for the general public. Based on the modeling in the Draft Sewage Sludge Risk Assessment for PFOA and PFOS, the EPA finds that there may be human health risks exceeding the EPA’s acceptable thresholds for some modeled scenarios when land-applying sewage sludge that contains 1 part per billion (ppb) of PFOA or PFOS. The EPA also finds that there may be human health risks associated with drinking contaminated groundwater sourced near a surface disposal site when sewage sludge containing 1 ppb of PFOA or sewage sludge containing 4 to 5 ppb of PFOS is disposed in an unlined or clay-lined surface disposal unit. The EPA provides a qualitative description of the potential risks to communities living near a sewage sludge incinerator (SSI) in the draft risk assessment but does not provide quantitative risk estimates due to significant data gaps related to the extent to which incineration in an SSI destroys PFOA and PFOS and the health effects of exposure to products of incomplete combustion.
The draft risk calculations are not conservative estimates because (1) they model risk associated with sewage sludge containing 1 ppb PFOA or PFOS, which is on the low end of measured U.S. sewage sludge concentrations (2) reflect median exposure conditions (e.g., 50th percentile drinking water intake rates) rather than high end exposure conditions, (3) do not take into account non-sewage sludge exposures to PFOA and PFOS (e.g., consumer products, other dietary sources), (4) do not account for the combined risk of PFOA and PFOS, and (5) do not account for additional exposures from the transformation of PFOA and PFOS precursors. As such, risk estimates that account from multiple pathways, multiple sources of exposure, and multiple PFAS would be greater than presented in this draft assessment.
5. Does the risk assessment evaluate aggregate (e.g., multiple exposure pathways, like drinking water plus milk, eggs, fish, other foods) and cumulative (e.g., PFOA plus PFOS) risk?
No, the draft risk assessment shows human health risk estimates for each exposure pathway individually and for PFOA and PFOS individually. Based on the preliminary findings of the draft sewage sludge risk assessment for PFOA and PFOS, human health risk to those living on or near impacted sites or primarily relying on their products can exceed the EPA’s acceptable thresholds for certain individual exposure pathways and for each individual chemical. As human health risk can exceed the EPA’s acceptable thresholds for individual pathways and chemicals, calculations of aggregate risk from multiple exposure pathways and cumulative risk from both chemicals would be even higher than the risk calculations presented in the draft risk assessment. For example, if the hypothetical farm family drank both the modeled amount of contaminated milk from their dairy cows and the modeled amount of contaminated drinking water from their well, the risks would be higher.
6. What is the “relative risk” of biosolids compared to other sources of PFOA and PFOS (e.g., food, dust, cosmetics, etc.)?
For most people, diet, including drinking water, is the most significant source of PFOA and PFOS exposure (see Sultan et al., 2023). For families that primarily consume foods from farms where biosolids containing PFOA and PFOS have been applied, this may be especially true. Though concentrations of PFOA or PFOS might be higher in other types of environmental media (like dust or soil), people ingest far less dust and soil than they do food and water.
7. If my farm has used biosolids, am I at risk? How can I reduce my risk?
The modeling in this risk assessment applies to hypothetical farms with various climates, soil types, crop types, biosolids application histories, and other set conditions. Each real farm in America will be unique from the modeled farms in the risk assessment. The true presence and magnitude of human health risks to those living on or near farms where PFOA or PFOS-containing biosolids have been land applied is dependent on many site-specific factors. Specifically, the modeling in the risk assessment includes certain assumptions that are not representative of all farms, such as application duration (a single application or 40 years of annual applications), application rate (10 or 50 dry metric tons per hectare), duration of individual exposure (1 or 10 years of living/working on an impacted farm), concentration of PFOA and PFOS in sewage sludge (1 ppb), and the median consumption rates of impacted products for households who farm. Every farm is unique, and the amount of PFOA or PFOS that moves from biosolids into food products will vary considerably based on a wide range of factors, including the type of food, geography and climate, soil types, and the uses of agricultural land (e.g., for livestock pasture, feed crops, or vegetables and fruits).
The draft risk assessment models a range of biosolids land application scenarios, some of which may not be common practice. For example, the EPA acknowledges that the majority of food crops grown in the United States do not use sewage sludge as a soil conditioner or fertilizer and some states have restricted the land application of sewage sludge to food crops. However, this practice is not consistent across all states. Furthermore, because of the extreme persistence of PFOA and PFOS in soils, a property with previous biosolids land application that has been repurposed as a food or feed crop farm may result in risk exceedances.
The draft risk assessment indicates that some farming practices may be especially vulnerable to PFOA and PFOS impacts. Farmers may consider adjusting farming practices to reduce risk. Consider avoiding land application in fields used to graze livestock or grow feed, especially for dairy cows, or those with sensitive groundwater, like those regions in karst geology. Fields used to grow fruits and grain may be better alternatives to those growing hay or leafy greens like spinach or kale. Human health risks are expected to be lower when sewage sludge is applied to areas with protected groundwater, sites that are distant from surface waters used for fishing or as a drinking water source, and when applied to certain crops, such as grain, fuel, or fiber crops.
The draft risk assessment relies on models where risks scale linearly with the amount of PFOA or PFOS added to the site, assuming all other factors are held constant. For example, a hypothetical farm that applied biosolids containing PFOA or PFOS for 1 year, but at an application rate of only 5 dry metric tons per hectare instead of the 50 dry metric tons per hectare modeled in the risk assessment, this farm would have estimated risks that are 10 times lower than the risks presented in this draft risk assessment. The same logic applies to the concentration of PFOA and PFOS in biosolids (meaning if the concentration of PFOA or PFOS were doubled compared to the value of 1 ppb in the risk assessment, all else held equal, the estimated risks at this farm would also double). Though these types of “back of the envelope” scaling of the risk assessment results may be helpful in providing some context for potential risks at different biosolids land application sites, the draft risk assessment is not meant to predict true risks at any specific site.
Monitoring
8. What is the recommended analytical method to measure PFOA and PFOS in sewage sludge?
The EPA recommends using EPA Method 1633 to measure 40 PFAS analytes, including PFOA and PFOS, in sewage sludge. EPA Method 1633 finished multi-laboratory validation and was finalized in January 2024. The EPA signed a new proposed Methods Update Rule (MUR), MUR 22, on December 6, 2024. This action proposed to promulgate EPA Method 1633, among other methods, into 40 CFR Part 136.
Learn more about EPA Method 1633 and Methods Update Rules.
9. What is the EPA currently recommending for monitoring?
In December 2022, the EPA released a NPDES memorandum, entitled, “Addressing PFAS Discharges in NPDES Permits and Through the Pretreatment Program and Monitoring Programs.” This memo recommends pretreatment best management practices to reduce PFAS sources, along with quarterly monitoring of influent, effluent, and sewage sludge using EPA Method 1633.
10. What state monitoring has been done so far?
Several states have begun monitoring for PFAS in sewage sludge and published reports and data that are publicly available (e.g., Michigan, Maine, California, New Hampshire, Vermont, and Connecticut). The sewage sludge risk assessment provides an overview of PFOA and PFOS occurrence data from peer-reviewed literature and state reports in Section 2.4 and Appendix A. Several states are in the process of collecting more sewage sludge PFAS monitoring data.
11. What plans exist for PFAS monitoring in sewage sludge nationwide?
The EPA is currently planning the next National Sewage Sludge Survey (NSSS) in collaboration with the Publicly Owned Treatment Works (POTW) Influent PFAS Study. The NSSS will focus on obtaining current national occurrence and concentration data for 40 target PFAS analytes using EPA Method 1633. The data generated by the NSSS will help inform future risk assessments and risk management actions for sewage sludge. A Voluntary Data Submission Portal also will be available throughout the duration of the POTW Influent PFAS Study and NSSS to collect more PFAS data nationwide.
Learn more about the National Sewage Sludge Survey and the POTW Influent PFAS Study.
Review Process
12. What was the review process for the draft sewage sludge risk assessment for PFOA and PFOS?
The draft sewage sludge risk assessment underwent intra-agency review by scientists across multiple EPA offices. Livestock and crop uptake portions of the draft risk assessment were additionally reviewed by scientists at the FDA and USDA. Finally, the draft assessment underwent an independent, contractor-led external peer review by five experts. The EPA has published a response to the external peer review comments with the draft risk assessment, which provides the reviewers comments and EPA’s responses. The draft risk assessment is now being released for a 60-day public comment period, which will begin upon publication of the draft risk assessment in the Federal Register. After the public comment period has closed, the EPA will consider the comments received, revise the draft risk assessment as appropriate, and prepare a final risk assessment.
Risk Management
13. What are the EPA’s next steps after the final risk assessment is released?
After the public comment period has closed, the EPA will consider the comments received, revise the draft risk assessment as appropriate, and prepare a final risk assessment. The final risk assessment will help inform the EPA’s potential future regulatory actions under the Clean Water Act (CWA). If the final risk assessment indicates that there are risks above acceptable thresholds when using or disposing of sewage sludge, the EPA expects to propose a regulation under CWA section 405 to manage PFOA and/or PFOS in sewage sludge to protect public health and the environment. During the risk management deliberation process, the results of the final risk assessment may be integrated with other considerations, such as economic costs and treatment feasibility, to reach decisions regarding the need for and practicability of implementing various risk reduction activities.
14. When could a future regulation occur?
Any future regulation under CWA section 405 would occur after the completion of the final risk assessment. If the EPA proposes regulatory standards for PFOA and/or PFOS in sewage sludge, the public will have an opportunity to provide comment.
15. Given that there are only three common options for sewage sludge management (land application, landfilling/surface disposal, and incineration), how should WWTPs manage their sludge before there are any regulatory thresholds available? What is the least risky option?
The EPA’s draft risk assessment has preliminary results that indicate that each of the three available use or disposal options may result in elevated risk levels for sewage sludge with typical concentrations of PFOA or PFOS. With the understanding that eliminating these risks is likely not possible at this time, the EPA recommends, in addition to pretreatment to reduce PFAS at the source, that WWTPs consider management options or practices that can mitigate or lessen risks.
For land application: Consider land application in areas that may be less sensitive to PFOA and PFOS pollution, like areas far from fishable waters or with deep protected drinking water aquifers. Consider avoiding land application in fields used to graze livestock or grow feed, especially for dairy cows. Fields used to grow fruits and grain may be better alternatives to those growing hay or leafy greens like spinach or kale.
For surface disposal or landfilling: Consider using disposal sites with composite liners and leachate and gas collection and treatment systems. Understand how that leachate will be disposed of or treated.
For incineration: Consider performance testing incinerators to gain information about potential releases of PFOA, PFOS, and other PFAS that may be generated through incomplete combustion.
Please refer to the EPA’s 2024 Interim Guidance on the Destruction and Disposal of PFAS and Materials Containing PFAS for more information on incineration and landfilling.
Recent EPA Actions that Address PFAS in Biosolids
16. What is the EPA doing to reduce exposure to PFOA and PFOS in sewage sludge?
The EPA recommends that states monitor sewage sludge for PFAS contamination, identify likely industrial discharges and other sources of PFAS, and implement industrial pretreatment programs where appropriate. Doing so will help prevent downstream PFAS contamination and lower the concentration of PFAS in sewage sludge as described in Section C of the EPA’s December 2022 memorandum entitled, “Addressing PFAS Discharges in NPDES Permits and Through the Pretreatment Program and Monitoring Programs.”
The potential risks posed by PFOA, PFOS, and other PFAS demand that the EPA address the problem on many fronts using all applicable statutory authorities. The EPA continues to fund research and take actions to reduce the concentration of PFOA and PFOS discharged to wastewater treatment plants, lower the concentration of these chemicals in sewage sludge, and reduce risk from use or disposal of sewage sludge. Specifically:
- The EPA has provided over twenty million dollars in research funding through the Evaluation of Pollutants in Biosolids and Research for Understanding PFAS Uptake and Bioaccumulation in Plants and Animals in Agricultural, Rural, and Tribal Communities grants.
- The EPA continues to work toward restricting industrial PFAS discharges to WWTPs using Effluent Limitations Guidelines. Current actions include:
- Revising the Organic Chemicals, Plastics, and Synthetic Fibers Effluent Limitation Guidelines (ELGs) to address wastewater PFAS discharge from PFAS manufacturing facilities;
- Revising the Metal Finishing and Electroplating ELGs to address wastewater discharge of PFAS from metal finishing and electroplating operations focusing on facilities using PFAS-based fume suppressants and wetting agents; and
- Revising the Landfills ELGs to address PFAS discharges from landfill leachate.
- The EPA’s upcoming Publicly Owned Treatment Works (POTW) Influent PFAS Study will also help the Agency prioritize industrial point source categories for future study and, as appropriate, ELGs.
- To better understand occurrence, the Agency has announced the next National Sewage Sludge Survey to obtain national concentration data on PFAS in sewage sludge.
- The EPA continues to track releases through Toxics Release Inventory Reporting. In May 2024, the EPA added 7 additional PFAS to the Toxics Release Inventory. A total of 196 PFAS are reportable for 2024 with forms due by July 1, 2025. In January 2025, the EPA announced the addition of 9 additional PFAS to the Toxics Release Inventory. A total of 205 PFAS are currently reportable for 2025 with forms due by July 1, 2026.
- In January 2024, the EPA finalized EPA Method 1633 after multi-laboratory validation, which measures 40 PFAS analytes in eight matrices, including sewage sludge. The EPA signed a new proposed Methods Update Rule (MUR), MUR 22, on December 6, 2024. This action proposed to promulgate EPA Method 1633, among other methods, into 40 CFR Part 136.
- In April 2024, the EPA updated the Interim Guidance on the Destruction and Disposal of PFAS and Materials Containing PFAS, which presents the state-of-the-science information on methods to remediate, dispose of, and destroy PFAS contamination.
- In April 2024, the EPA finalized the PFAS National Primary Drinking Water Regulation for six PFAS.
- In October 2024, the Agency published Final Ambient Water Quality Criteria for Aquatic Life for PFOA and PFOS, which can be used for WWTP effluent permitting.
- The EPA also released draft Human Health Criteria for PFOA, PFOS, and PFBS which, when finalized, can be used for WWTP effluent permitting.
Learn more about the EPA’s recent actions to address PFAS in sewage sludge.
Exposure and Risk
17. I live on a farm with past or ongoing biosolids land application:
Should I test my well water?
The EPA’s draft risk assessment indicates that some drinking water wells near biosolids land-application sites may be impacted by PFOA and PFOS, while other wells may not be impacted. The likelihood that your well is impacted will depend on the specifics of your site, including factors like the location and depth of your well, the climate and soil types on your farm, and the history of biosolids land application. There is more information about testing private drinking water wells for PFAS in the EPA’s PFAS National Primary Drinking Water Regulation factsheet for small and rural communities under the section “Information for Communities and Households Served by Privately-Owned Wells.”
Should I test my soil?
If biosolids containing PFOA and PFOS have been applied on a farm field, the soil may contain elevated levels of PFOA and PFOS because of their extreme persistence in soils. Testing the PFOA and PFOS concentrations in your soil could provide you with some information about the potential risks associated with growing fruits or vegetables, growing feed for livestock, or allowing livestock to graze on this land. However, there are currently no “safe thresholds” available from the FDA, USDA, or EPA for PFOA and PFOS in soils used for agricultural purposes so it may be difficult to understand how soil concentrations translate to risk. Further, as presented in the draft risk assessment, many factors affect the presence and magnitude of risks to humans stemming from elevated PFOA or PFOS concentrations in soils, so knowing the PFOA and PFOS concentration in soil alone would not fully determine the potential for human health risks. If your farm or farming practices might be vulnerable to PFAS impacts (e.g., dairy farms where the pastures or fields used to grow feed have biosolids application, farms with pasture-raised hens or cattle in fields with biosolids application, farms growing leafy greens like lettuce or spinach, farms with a home drinking water well and sensitive groundwater, like those in regions with karst geology) you may consider reaching out to your local extension coordinator, USDA service center, or other state and local experts to understand how testing your soil would help you better understand potential risks at your specific property.
Should I continue to eat fish from my farm pond or other waterbodies near fields where biosolids have been applied?
It is possible that waterbodies receiving runoff from fields where biosolids were applied may have elevated levels of PFOA or PFOS in the water, such that eating the fish in those waterbodies could be a significant source of PFOA or PFOS exposure. If you are concerned about the potential for PFOA or PFOS presence in fish that you eat from your farm pond or other nearby waterbody, then consult your state, Tribe, or territory for information on local fish advisories to determine the safe frequency for eating fish caught from specific waterbodies.
Can I continue to sell my foods?
The FDA and USDA work closely with state departments of agriculture and health to share information to work to reduce the public’s dietary exposure to PFAS. As part of FDA’s technical assistance to states, the FDA tests foods grown, raised, or produced in areas with known environmental contamination, to detect and evaluate potential contamination of human and animal food. If it is determined that the level of PFAS creates a health concern in a particular food, the appropriate agencies take action, which may include working with growers to resolve the issue and taking steps to prevent the product from entering, or remaining in, the U.S. market. For more information on PFAS on my farm, and where to go for more information about what to do if you are concerned about potential PFAS issues, please see EPA’s fact sheet for farmers.
Could there be other non-biosolids sources of PFOA and PFOS to my farm?
Yes. Biosolids are just one potential source of PFOA or PFOS on land used for farming. Other residuals used as a soil amendment, like sludges from paper manufacturing, textiles, or processing leather, may also contain PFOA or PFOS. If PFOA or PFOS were released from a military facility, landfill, or other industrial source, they could travel through air, groundwater, or surface water to your property.
I am concerned about my health. How can I get more information on health risks and protect my health?
Current science indicates that lower levels of PFAS exposure present less risk, so all efforts to reduce PFAS exposure help protect public health. The EPA has a webpage with information on meaningful and achievable steps you can take to reduce your risk. The National Academies of Sciences, Engineering, and Medicine also have guidance for patients and their doctors on dealing with PFAS exposures.
I am pregnant or planning to become pregnant. How can I get more information about actions I can take to protect myself and my children?
The National Academies of Sciences, Engineering, and Medicine also have guidance for patients and their doctors on dealing with PFAS exposures. This guidance includes advice for women who are pregnant and parents of infants.
Should I continue to use biosolids as a source of fertilizer?
Biosolids, when free from harmful levels of contaminants, can be beneficial to soil health and an inexpensive source of fertilizer. The top priority of EPA’s Biosolids Program is to assess the potential human health and environmental risk posed by pollutants found in biosolids such that they can continue to be safely used as a beneficial soil amendment. This draft risk assessment indicates that some biosolids have levels of PFOA and PFOS that may adversely affect human health or the environment when they are land applied or disposed of in an unlined or clay-lined surface disposal unit. If you are concerned about the potential for PFOA or PFOS contamination in your biosolids, the EPA recommends working with your biosolids supplier, as well as other experts (such as your state environmental or agricultural agency, or a regional cooperative extension program), to take steps to understand the levels of PFOA and PFOS in your biosolids product to better understand the potential risks to your property. The specific levels of risk posed by PFOA or PFOS in biosolids on your farm will depend on a variety of site-specific factors, including how often you apply biosolids and at what rate, the land-use at the site, the type of soil, and ground and surface water characteristics.
Are there potential risks to my pets?
The draft risk assessment did not evaluate potential risk to pets on a farm or property where biosolids have been land applied and the risk to pets is unknown at this time. If you are concerned about risks to the pets on your property, consider reducing your pet’s exposures to potentially impacted environmental media like water in a farm pond near a biosolids land application site.
Are there health concerns for children/adults if they play/work on fields where biosolids have been applied?
If biosolids containing PFOA and PFOS have been applied on a farm field, the soil will likely contain elevated levels of PFOA and PFOS because of their extreme persistence in soils. Testing the PFOA and PFOS concentrations in your soil could provide you with information about the potential risks associated with direct exposure to soil, including incidental soil ingestion by children and adults. On May 14, 2024, the EPA’s Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) program published Regional Screening Levels for PFOA and PFOS in residential soil based on direct exposures to children.
Learn more about Regional Screening Levels for PFOA and PFOS.
18. Can farmland be remediated after PFAS contamination?
It may be possible to alter farming practices to allow for continued use after the property has been contaminated with PFOA or PFOS. For example, it may be possible to use an alternative, non-contaminated source for livestock drinking water or feed to reduce concentrations of PFOA and PFOS in the milk of dairy cows previously pasture grazed on contaminated fields. The University of Maine Cooperative Extension program has published a guide for investigating PFAS risk on your farm, which includes information on mitigating risks through farming practices.
19. This draft risk assessment finds that risks can occur in some media (milk, water, beef, eggs) below levels of detection. How can I be sure my food and water are safe?
There may be amounts of PFOA and PFOS in foods and other environmental media that could pose risks and are below currently available detection limits. Current science indicates that lower levels of PFAS exposure present less risk, so all efforts to reduce PFAS exposure help protect public health.
Regulations and Permitting
20. How is the land application of biosolids regulated?
The federal biosolids regulation (40 CFR Part 503 or “Part 503”) sets limits and practices for the land application of biosolids to reduce risks from chemicals and pathogens and to reduce nutrient loading to surface waters. This rule is self-implementing, which means that the requirements of Part 503 must be met even if a permit has not been issued. An enforcement action can be taken against a person, entity, or wastewater treatment plant (WWTP) who does not meet the requirements of Part 503 even when that person, entity, or WWTP does not have a permit for the use or disposal of sewage sludge. States or other jurisdictions may require permits to land apply biosolids.
Certain treatment works specified by Part 503 are required to submit an annual report on biosolids treatment and management practices to their permitting authority by February 19th of each year. Additional information is available including annual reporting requirements, frequently asked questions, and training webinars on the EPA’s Compliance and Annual Biosolids Reporting Guidance website.
21. What are the next steps after release of the draft risk assessment?
The EPA has released a draft sewage sludge risk assessment for PFOA and PFOS that indicates these chemicals may be present in sewage sludge at concentrations that may adversely affect human health and the environment. The next steps in the EPA’s process are to seek public input on this draft risk assessment, incorporate relevant comments, and finalize the assessment. If the final risk assessment indicates that there are risks above acceptable thresholds when using or disposing of sewage sludge, the EPA expects to propose a regulation under Clean Water Act section 405 to manage PFOA and/or PFOS in sewage sludge to protect public health and the environment. The EPA may also consider developing regulations under other statutory authorities to further reduce PFAS discharged to WWTPs. Any future regulations would go through the EPA’s rulemaking process, which includes opportunity for public comment.
PFAS Usage
22. What is EPA doing to address ongoing use of PFOA and PFOS?
PFOA
To limit the use of PFOA, in 2006, the EPA invited eight major companies to commit to working toward the elimination of their domestic production and use of PFOA (and chemicals that degrade to PFOA) from emissions and products by the end of 2015. All eight companies have phased out domestic manufacture of PFOA. The EPA amended the 2013 Long Chain Perfluoroalkyl Carboxylate (LCPFAC) Significant New Use Rule in July 2020, in which the EPA determined that manufacturing (including importing) or processing of PFOA or its salts for any use not ongoing as of Jan. 21, 2015, is a significant new use. The EPA also made inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. The subset of LCPFAC chemical substances for which the exemption was lifted includes PFOA and its salts. This rule will ensure that the EPA receives notice and has an opportunity to review any efforts to reintroduce PFOA into the marketplace and take action, as appropriate, to address potential concerns.
PFOA is still being used in a limited number of industries, including use in antireflective coating, light sensitive materials used in photo lithography and similar processes, surfactant for use in photomicrolithography, and other processes to produce semiconductors or similar components of electronic or other miniaturized devices.
PFOS
3M, the primary manufacturer of PFOS in the U.S., phased out its production of PFOS between 2000 and 2002. Subsequently, the EPA published a Significant New Use Rule (SNUR) in December 2002 for Certain Perfluoroalkyl Substances. The SNUR limits future manufacturing, including importation, of 75 PFAS chemicals specifically included in the voluntary phase out of PFOS by 3M without first submitting a notice to the EPA and having the EPA review the new use. A limited set of existing uses for PFOS, such as use in fire-resistant aviation hydraulic fluids, photography and film products, photomicrolithography processes to produce semiconductors, metal finishing and plating baths, and as a component of an etchant were excluded from the reporting requirement because these uses were ongoing and are therefore outside the scope of the SNUR authority (see 40 CFR § 721.9582).
PFOS was often used as an ingredient in aqueous film-forming foam for firefighting, and legacy stocks of this firefighting-foam concentrate may still exist. Federal agencies such as the Department of Defense and the Federal Aviation Administration are working to replace these legacy foams with PFOS- and PFAS-free alternatives.
23. Does EPA allow for any uses of PFOA/PFOS today?
PFOA
The EPA launched the PFOA Stewardship Program in January 2006 to work toward eliminating PFOA from emissions and product content no later than 2015. Though PFOA is no longer used in the U.S. to manufacture fluoropolymers, some fluoropolymers containing PFOA were outside the scope of the Long Chain Perfluoroalkyl Carboxylate (LCPFAC) SNUR because there were ongoing uses and may still be imported as part of articles. Fluoropolymers are used in many industry segments, including the aerospace, automotive, building/construction, chemical processing, electronics, semiconductors, and textile industries (see 40 CFR § 721.10536).
PFOS
With regard to perfluorooctanyl sulfonate (PFOS), on May 16, 2000, the EPA and 3M, the principal worldwide manufacturer of PFOS, announced the voluntary phase out of PFOS chemistry. Following the voluntary phaseout of PFOS by 3M, the EPA took prompt regulatory actions in 2002 and 2007 under the Toxic Substances Control Act to limit any future manufacture or importation of 271 perfluoroalkane sulfonate (PFSA) chemicals, essentially encompassing all PFAS chemicals on the U.S. market. Chemical Data Reporting (CDR) requires manufacturers (including importers) to report PFOS if they meet 2,500 lbs production volume threshold at a single site. The last time PFOS manufacture was reported to the EPA as part of this data collection effort was in 2002. There are some limited ongoing uses of PFOS (e.g., use as a component of a photoresist substance, use as a component of an anti-reflective coating, and use in a photomicrolithography process to produce semiconductors (see 40 CFR §721.9582)). So, any PFOS potentially still in use is in very small quantities.
24. What is the prevalence of imported goods containing PFOA or PFOS and how does EPA track that?
The EPA does not have a specific mechanism for tracking the import of articles containing PFOA or PFOS. However, in 2020, the EPA issued the Long Chain Perfluoroalkyl Carboxylate (LCPFAC) Significant New Use Rule (LCPFAC SNUR). The rule requires notice and the EPA’s review before the long-chain PFAS that have been phased out in the United States could be used again. Additionally, articles containing certain long-chain PFAS as a surface coating, and carpet containing perfluoroalkyl sulfonate chemical substances, can no longer be imported into the United States without the EPA’s review.
The EPA has proposed a rule in accordance with TSCA section 8(a)(7) to require reporting and recordkeeping on PFAS. This proposed rule would require certain persons who have manufactured (including imported) a PFAS at any time since 2011 to submit certain information to the EPA related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure and disposal.
Learn more about the EPA’s Risk Management for PFAS under TSCA.