FDA-approved PFAS and drinking water – Q&A on textile mills and environmental permits

Tom Neltner, J.D., Chemicals Policy Director, and Maricel Maffini, Ph.D., Independent Consultant

In May 2018, we released a blog highlighting paper mills as a potentially significant source of drinking water contamination from 14 Food and Drug Administration (FDA)-approved poly- and per-fluorinated alkyl substances (PFAS) used to greaseproof paper. We showed that wastewater discharge could result in PFAS concentrations in rivers in excess of the Environmental Protection Agency (EPA)’s 70 parts per trillion (ppt) health advisory level for drinking water contamination for PFOA and PFOS, the most studied of the PFASs. We identified 269 paper mills with discharge permits that warrant investigation. Readers of the blog have asked some important questions highlighted below. As with most issues involving PFAS, there are many gaps in what we know. Based on the information provided in response to EDF’s Freedom of Information Act (FOIA) request to FDA, we hope to fill in some of the gaps and highlight key information needed to better understand the risks of PFASs.  

Question 1: Could textile mills also be a source of PFASs in drinking water?

The answer is “probably.” The FDA-approved PFASs can be used in coating paper that contacts food to repel oil, grease, and water. The same or similar FDA-approved PFASs may be used for non-food uses such as coating textiles to resist stains and repel water.

The processes used to coat paper and textiles differ in some aspects that could affect a mill’s environmental releases. For paper, the PFASs are typically added to the wet wood fibers to be made into paper. In contrast, we understand that PFASs are applied to textiles after the water is removed. Therefore, we would suspect that the amount of PFASs, whether as polymers or impurities, released with the wastewater of a textile mill would be lower compared to that of a typical paper mill. However, there is very little data available to assess the potential environmental release of PFASs from textile mills. Unlike with FDA approvals, there is no environmental review of a chemical’s use in non-food consumer products.[1] So, it would be worthwhile to investigate textile mills for use of PFASs in addition to looking at paper mills.

Using an EPA database[2], we identified 66 textile mills (PDF and EXCEL) in the US, two thirds of which are located in North and South Carolina. Based on wastewater flow, the two largest mills are both operated by Milliken. Its largest facility is in Greenville, South Carolina with a water discharge of 72 million gallons per day (MGD). The second largest is in Bacon, Georgia with a water discharge of 15 MGD. DuPont’s Old Hickory facility, near Nashville, Tennessee, had the third greatest flow at 10 MGD. We do not know whether any of the facilities use and discharge FDA-approved PFASs.

Question 2: Would an environmental permit writer be alerted to the presence of FDA-approved PFAS in wastewater discharge?

The answer is “no.” EPA has not added any PFAS to either the CWA’s Section 311 Hazardous Substance List or Section 307 Toxic Pollutant List, which would trigger required reporting or chemical testing. Since PFASs are not on either of these lists, a facility discharging wastewater to surface water does not need to notify the permit writer of the presence of PFASs when applying for or renewing its Clean Water Act (CWA) National Pollutant Discharge Elimination System (NPDES) permit. These permits must be renewed every five years.

To renew an NPDES permit, the facility must submit a Form 2C. A new facility must submit Form 2D. These forms provide the basis of the regulators review and approval of a permit. Absent any reporting or testing alerts, a permit reviewer would be unlikely to evaluate the potential environmental and public health impacts of the discharge and set appropriate limits.

In addition, chemicals on the CWA’s hazardous substance list are subject to significant release reporting and liability for cleanup costs. If a company notifies the state in its permit application that the chemical on the hazardous substance list may be present in the discharge, they can get an exemption from these release reporting and liability risks (also known as a permit shield).

This gap is not unique to NPDES permits. A manufacturer discharging wastewater to a municipal sewage treatment plant (STP) would not be obligated to notify the STP operator (as they would with some other chemicals) because no PFAS is on the CWA lists. Similarly, air pollution permits would not cover PFASs, because the chemicals are not on lists of criteria pollutants and hazardous air pollutants.

Question 3: Are there other benefits to adding PFAS to the CWA Hazardous Substance list?

The answer is “yes.” If PFASs were added to either of the CWA lists, they would be automatically added to the CERLA/Superfund Section 102 Hazardous Substance list[3] and, therefore, covered by the more expansive cleanup and reporting requirements under that law. Therefore, adding the chemicals to the CWA Hazardous Substance List would deliver all the benefits of CERCLA as well as the Clean Water Act.

At EPA’s PFAS National Leadership Summit in May 2018, the agency indicated it “is beginning the necessary steps to propose designating PFOA and PFOS as ‘hazardous substances’ through one of the available statutory mechanisms, including potentially CERCLA Section 102.”

We encourage EPA to add the chemicals to the CWA Section 311 Hazardous Substance List instead of the CERCLA Section 102 list because it would:

  • Result in the chemicals being added to both lists; and
  • Facilities would be required to notify the state as part of their NPDES permit new or renewal applications.

In addition, EPA should list PFAS as a class and not just list PFOA and PFOS to ensure that states are notified of chemicals with similar structures and potentially similar hazards. While most chemicals on the lists are individual substances, the class approach has been used before for polychlorinated biphenyls (PCBs) in CWA Section 311 hazardous substance list.

Question 4: Is there another way to find out if a facility near my home uses PFASs?

The answer is “probably, but it is complicated.” Under the Emergency Planning and Community Right-to-Know Act (EPCRA), a facility is required to report any hazardous chemical to a state emergency response commission and a local emergency planning committee if there is more than 10,000 pounds of a chemical on site at any time, and it is required to have a safety data sheet for the chemical under the OSHA Hazard Communication Standard. PFASs meet the definition of a hazardous chemical under the OSHA standard.

However, EPCRA exempts food additives regulated by FDA from reporting. Therefore, a facility is under no obligation to report FDA-approved PFASs if they are used pursuant to the notice to FDA. Only the portion used for non-food uses would be covered by EPCRA. A facility may voluntarily report this information.

However, because the reporting requirements are complicated, we suggest concerned residents contact the state. EPA provides a useful webpage listing the contacts in each state.

Summary and recommendations

As with most issues involving PFASs, there are many knowledge gaps. We only know about the potential magnitude of the releases because the information obtained through our FOIA provides important but narrow insights into the estimated environmental releases of PFASs that were developed in compliance with the National Environmental Policy Act. A wastewater discharge permit for a paper or textile mill is unlikely to have limits for PFASs, because the regulator would not be notified that the chemicals are present in the discharge. The state’s community right-to-know coordinator may have information on use of PFASs at a facility—like a paper or textile mill—but there are no requirements for reporting if the PFASs being used are dedicated solely to FDA-approved uses.

EPA needs to enable states to assess the environmental and public health impacts of PFASs and determine whether wastewater discharge permit limits are needed. We recommend that, at a minimum, EPA add PFASs as a class of chemicals to the Clean Water Act Section 311 Hazardous Substance List.


[1] An environmental review is triggered by a federal approval. Outside of a one-time Pre-Manufacturing Notice (PMN) required under the Toxic Substances Control Act, no approval is needed.

[2] Based on our analysis of a search on EPA’s Enforcement and Compliance History Online (ECHO) database.

[3] EPA provides a consolidated list of lists that is useful to keep track of the chemicals.

This entry was posted in Drinking water, FDA, Food, Health policy, Health science, PFAS, Public health, Regulation and tagged , , , , , , , . Authors: . Bookmark the permalink. Both comments and trackbacks are currently closed.