EDF Health

Broken GRAS: Secret GRAS determinations may outnumber those reviewed by FDA

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 13, 2023

What Happened?

FDA estimates that, each year, food companies designate 82 new food chemicals as “GRAS” (Generally Recognized as Safe) for use in food. On average, FDA reviews only 64 of those new chemicals for safety. For the remaining 18 chemicals in FDA’s estimate, the companies making and marketing them for use in food or in the food-production process choose not to seek a voluntary review by FDA.

In comments to the agency, we said we think FDA’s estimate may be too low – and the number of new chemicals added to food that bypass FDA review may be as high as 130 new food chemicals a year (significantly higher than 18). This is based on searches of company marketing claims. In an 8-week period, we identified 10 chemicals claimed as GRAS without a submitted notice to FDA seeking voluntary review. (Please see our comments for a full explanation of our estimate.)

Why It Matters

I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.—Robert Califf, MD, FDA Commissioner

FDA’s review of GRAS safety determinations is critical to ensure food chemicals are safe. When agency scientists receive GRAS notices, they closely review them and ask notifiers tough questions about the safety of the chemical alone—and the potential consequences when that chemical is combined with other chemicals on the market.

But FDA allows companies to withdraw their notices – which they do in about 17% of cases. Sometimes companies fix the problems and resubmit the notice. FDA does not require companies to do this, however. Too many simply continue to market the chemical for food uses as GRAS without seeking further FDA review. That is in addition to the GRAS safety determinations companies choose never to file, which leads to chemicals entering our food system without any FDA notice or review at all.

Our Take

While the GRAS system is clearly broken (something we’ve blogged about at length and the Washington Post covered in-depth back in 2014), FDA does retain the ability and the duty to monitor the marketplace to ensure unsafe chemicals that food companies claim as GRAS are kept off the market. Unfortunately, the agency appears to lack any system to ensure that monitoring takes place. The only examples of agency action to pull industry-certified GRAS products off the market have been caffeinated alcoholic beverages and partially hydrogenated oils (aka artificial trans fat). Both were prompted, in part, by state and media calls for action.

Examples of inaction, however, are numerous and include: tara flour, COZ corn oil, Apocynun ventron, gamma aminobutyric acid (GABA), aquaequorin/Prevagen, and many more.

One of the key breakdowns that contributes to FDA’s failure to monitor is the lack of coordination between the regulatory programs in the Center for Food Safety and Applied Nutrition (CFSAN) and the inspection/enforcement programs in the Office of Regulatory Affairs (ORA).

Next Steps

In January 2023, FDA Commissioner Califf announced a proposal to reorganize the food safety program in response to stakeholder calls for action after the infant formula debacle and to a recent review of the agency by the Reagan-Udall Foundation. This review noted that one key step is to appoint a new Deputy Commissioner for Human Food. This person would have greater responsibility to coordinate efforts between CFSAN and ORA. The Commissioner’s proposal has been strongly criticized since there would be no clear line of authority between the new Deputy Commissioner and ORA.

But Commissioner Califf has stated that chemical safety is a priority, telling a reporter that “I want to throw in chemical safety as another really, really important area for the future – for humankind, really – and where science is evolving rapidly.”[1]

Fixing GRAS is an important step to rebuild consumer confidence and reduce the ongoing risk to public health. Until the broken GRAS system is fixed, FDA will continue to be hamstrung in preventing health risks posed by chemicals of unknown safety. Until the system is fully fixed—which includes ensuring that no chemicals enter our food system without notice to, and review by, the agency—FDA needs to be coordinating with ORA and CFSAN to proactively monitor and enforce GRAS evaluations on chemicals entering the market to ensure they are actually safe.

Go deeper: You can learn more from these resources:

 

NOTES

[1] FoodFix, January 31, 2023, edition.

Posted in Deep Dives / Authors: , / Comments are closed

Alternative Figures: FDA’s food chemical reports to Congress don’t add up

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: April 10, 2023

In its annual justification of budget estimates to Congress, FDA describes its activities and tracks its performance. One of those performance measures is the percentage of food- and color-additive petitions (FAPs/CAPs) the agency has reviewed and completed within 360 days of receipt.[1]

We analyzed FDA’s reports to Congress published from 2016 to 2023 and found that FDA told Congress it had completed 100% of its reviews within 360 days in every year but one. The exception was FY2020, when the rate dropped to 89%. During that 7-year period, the agency reported that it had filed a total of 51 petitions. (See Table 1.)

Why It Matters

FDA’s impressive claims about the percentage of FAP/CAP reviews it completed run contrary to our experience and the available evidence:

  • FDA’s own webpage describes seven petitions that have been under review for over 360 days. (See Table 2.) Five of those overdue petitions were filed in FY2021, when the agency claimed it had reviewed and completed 89% of them. The agency reports filing and reviewing only two petitions in that year.
  • Four of five petitions submitted by food safety advocates for which the agency has made a decision were in FDA’s review pipeline for over 360 days.[2] For three of those overdue petitions, FDA acted only after petitioners sued in court for unreasonable delay. (See Table 3.)
  • FDA’s guidance for industry on these petitions says, “the average time between submission until a final rule is published for a direct food additive petition is 24 months and for color additive petitions, the approval process varies significantly.”

Our Take

Accurate and transparent reporting empowers Congress to:

  • See that the agency is having difficulty meeting its deadline for reviewing FAPs/CAPs; and
  • Set priorities and evaluate FDA’s funding requests more effectively.

Our Research Findings

Table 1 summarizes those findings. We excluded years where we did not have data for both petitions filed/reviewed in the fiscal year and the percent of petitions reviewed within 360 days.[3]

Table 1: FDA’s Reporting of Office of Food Additive Safety Activity

(Year of Budget Justification Reports)
Fiscal Year FAPs/CAPs

Filed/ Reviewed*

 FAPs/CAPs Percent Reviewed within 360 days
FY2015

10 / 11
(2016 report, p. 61)

100%

(2017 report p. 57 &

2016 report p. 59)
FY2016 7 / 7

(2017 report, p. 60)

100%

(2018 report p. 54 &

2017 report p. 57)
FY2017 10 / 10

(2018 report p. 57)

100%

(2019 report p. 67 &

2018 report p. 54)
FY2018 10 / 10

(2018 report p. 57)

100%

(2021 report p. 80 &

2020 report p. 68 &

2019 report p. 67)
FY2019 5 / 5

(2021 report p. 82 &

2020 report p. 70)

100%

(2022 report p. 96 &

2021 report p. 80 &

2020 report p. 67)

FY2020

 7 / 7

(2021 report p. 82)

89%

(2023 report p. 66)
FY2021

 

 2 / 2

(2022 report p. 98)

100%

(2023 report p. 64 &

2022 report p. 96)

* Reviewed includes approved, withdrawn, or placed in abeyance due to deficiencies during the fiscal year.

 

Table 2 identifies all food and color additive petitions that FDA’s website reported as under review (and not in abeyance or decided) as of April 7, 2023. “Days Under Review” is calculated as of that date.

Table 2: Status of Food and Color Additive Petitions
Under Review as of April 7, 2023
Substance and Requested Action Petition No. Filing Date Days Under Review
Revoke BHA FAP 0A4216 6/22/90 11,977
Allow jagua (genipin-glycine) blue CAP 0C0317 7/31/20 980
Allow Vitamin D3 FAP 1A4827 2/3/21 793
Allow Gardenia Blue Powder CAP 1C0319 4/20/21 717
Allow vitamin D2 mushroom powder FAP 1A4828 6/8/21 668
Allow blue Galdieria (Galdieria sulphuraria) extract CAP 1C0320 7/27/21 619
Allow vitamin D2 heat-killed (“inactive”) baker’s yeast FAP 1A4829 9/28/21 556
Allow myoglobin CAP 2C0322 12/13/21 480
Revoke bisphenol A (BPA) FAP 2B4831 5/2/22 340
Revoke Red Dye No. 3 CAP 3C0323 11/15/22 143

 

Table 3 reviews the timing of FAPs/CAPs submitted by food safety advocates since 2014. Where available, FDA’s decision on the petition is noted, as well as whether petitioners went to court asking a judge to issue a writ of mandamus to order the agency to act. For each of those lawsuits, FDA agreed relatively quickly to a schedule to make a final decision on the petition.

Table 3: Timing of Review for Advocates’ Petitions
Seeking Revocation of Food and Color Additive Approvals (as of April 7, 2023)
Substance and Requested Action Filing Date Decision Date Days Under Review Decision Lawsuit Filing Date
Perchlorate as FCS 12/31/14 4/28/17 849 Denied 3/31/16
Long-chain PFAS (non-sulfonated) as a food contact substance (FCS) 1/7/15 12/29/15 356 Accepted None
Carcinogenic flavors as food ingredient 8/17/15* 10/2/18 963 Accepted for 6 of 7 5/17/18
Ortho-phthalates as FCS 4/12/16** 5/20/22 1516 Denied 2/7/21
Lead acetate as cosmetic color additive 2/24/17 10/25/18 618 Accepted None
Bisphenol A as FCS 5/2/22 Pending
Red Dye No. 3 11/15/22 Pending
* Revised to 2/12/16 due to substantive amendments provided by petitioner.

** Revised to 3/26/18 due to substantive amendments provided by petitioner.

 

Next Steps

The agency should explain to Congress and stakeholders how it came up with its numbers and ensure accurate and transparent reporting.

NOTES

[1] The statutory deadline for a final decision on a food or color additive petition is 90 days, with an option to extend for an additional 90 days for a total of 180 days. See 21 U.S.C. §§ 348(c)(2) and 379e(d)(1). We do not know why FDA’s performance measure gives the agency twice as much time to complete a review than is allowed by the law.

[2] Long-chain PFAS food additive petition was processed in 356 days. See Table 3.

[3] FDA reported 100% for FY2014 in the 2016 report(p. 59) but did not include the number of FAPs/CAPs reviewed. In its 2023 report, the agency reported reviewing five FAPs/CAPs (p. 61) but did not provide the percentage of reviews that had been approved, withdrawn, or placed in abeyance in 360 days.

Posted in Deep Dives, FDA / Authors: / Comments are closed

National Teflon Day—Seriously?!

By Lauren Ellis / Published: April 7, 2023

What’s National Teflon Day?

According to National Day Calendar, yesterday (April 6th) was “National Teflon Day”—a day to “celebrate” the accidental discovery in 1938 of a chemical called polytetrafluoroethylene (PTFE for short)—better known by the product it became associated with, Teflon™.

Two 3D emoji rolling their eyes.

Teflon™ is PFAS Wrapped in a Bow

PTFE, the main component of Teflon™, is a fluorinated polymer that belongs to the PFAS chemical class—aka “forever chemicals.” PTFE is extremely heat- and stick-resistant—properties that lend themselves to a variety of uses, ranging from nonstick pans to semiconductors.

While some argue that PTFE itself does not present a health risk when used properly, the harms of PTFE become clear when you look across the chemical’s lifecycle—particularly the ways it’s produced and how it’s disposed of.

The Harms of PTFE Production

Harmful PFAS are used to produce PTFE and are also byproducts of the production process—exposing workers and surrounding communities.

PFOA—a notoriously toxic PFAS linked to cancer and heart disease—was used to manufacture PTFE for decades. In response to public pressure to phase out PFOA due to its harms, companies created other PFAS to replace PFOA—such as GenX, which has similar health effects as its predecessor. In addition to these harmful inputs, toxic PFAS byproducts are also created and released during the manufacturing of PTFE.

Decades of manufacturing PTFE have led to widespread PFAS contamination of our environment and our bodies.

The Harms of PTFE Disposal

At the end of the chemical lifecycle, fluoropolymers like PTFE may end up in a landfill—say, when you throw away your old Teflon™ pan. Over time, particles begin to disintegrate, leading to contamination of landfill liquids with PFAS that can then make their way into soil and drinking water.

Waste containing PTFE may also be incinerated. Burning of any type of PFAS is known to generate many other harmful PFAS—including potent greenhouse gases, such as tetrafluoromethane (which has a warming potential 6,500 times that of carbon dioxide).

Next Steps

Given the public health and climate effects of PTFE throughout its lifecycle, the next steps are clear: 1) Stop producing PTFE and other fluoropolymers for uses where there are clear alternatives; and 2) Stop celebrating the discovery of Teflon™ and the explosion of PFAS products (and pollution) that followed.

Posted in Environment, Public health / Authors: / Comments are closed

Health data needs to inform targeted environmental justice initiatives

By Ananya Roy and Veronica Southerland / Published: April 4, 2023

Key Findings and Recommendations 

  • Air pollution results in a large burden of childhood asthma across the country, and this burden is disproportionately borne by people of color.
  • More than $100 million in grants from the Environmental Protection Agency is available for environmental justice initiatives, but targeting programs to alleviate the health impacts of air pollution to overburdened communities requires local-level health information that is often not readily available.  
  • We recommend health advocates and researchers work with local and state public health departments and impacted communities to access existing fine-scale data where available.

In the past, the lack of neighborhood-scale data on baseline disease rates, pollutant concentrations and children’s asthma has made it difficult to determine which U.S. communities bear the highest health burden from air pollution. Disparities in pollution exposures have been routinely underestimated. Generating more fine-scale data, together with advances in hyperlocal air monitoring, will make visible the disparities in exposure to air pollution across and within neighborhoods, allowing us to target mitigation and prevention efforts for maximum benefit. 

We now have an opportunity to make significant progress towards identifying, prioritizing and addressing the harms faced by the most burdened communities. EPA has made available over $100 million dollars for grants to advance environmental justice, including health impact assessments. Grant recipients can use the funds to obtain health information at the neighborhood level, data essential for identifying communities with the highest burden of air pollution health impacts. The application deadline is April 14, 2023. 

Pollution and racism 

Using new air monitoring techniques, advances in modeling, and community-based participatory research, studies confirm that neighborhoods which have experienced historical racism also experience higher levels of air pollution.

Decades of discriminatory and racist policies, practices and disenfranchisement have resulted in the disproportionate exposure to pollution sources in communities of color, along with disinvestment in housing and economic opportunities in these communities. Communities of color and areas of low wealth therefore face exposure to higher levels of air pollution and are more vulnerable to that air pollution, resulting in heavier health burdens borne by families.  

Air pollution data is only half of the story 

While air pollutant exposure is important in determining the effect of that pollutant on the health of a community, social factors and existing disease burden and risk play a large role in the impact that pollutant will have on the total health burden attributable to a pollutant in a community.  

Existing disease burdens and risks in populations are reflected in “baseline disease rates,” a key public health metric documented by public health agencies. Baseline disease rates vary within cities, but those rates are rarely made publicly available for use in risk assessment. 

Gaps in baseline disease data availability limit the ability of health impact assessments to determine which communities have existing vulnerabilities to the harmful effects of air pollution. For example, while studies of pediatric asthma attributable to nitrogen dioxide, a traffic-related air pollutant, have estimated there are 200,000 affected children living in American cities, these studies have relied on national-level estimates of asthma incidence. These national-level estimates hinder the ability of researchers to determine which areas within cities are experiencing the highest burden of asthma attributable to asthma. 

Local-level health data is needed to identify risks to overburdened communities  

The public health information available from city to city and within cities is a mix of fine-scale data (ZIP code level) and coarse-scale data (ZIP3 – aggregated data based on ZIP code information, roughly the size of counties.) The assessment of health risks, factors and outcomes can vary greatly depending on which level of data is used. 

Studies have repeatedly shown that using fine-scale baseline disease rates can make a profound difference when mapping the spatial distribution of health burdens attributable to air pollutants and on the ability to quantify disproportionate impacts in disadvantaged populations. For example, in an analysis of within-city air pollution risks in the San Francisco Bay Area of California, we found the highest census block group baseline mortality rate was 12 times higher than the rates in the census block group with the lowest rates, while the highest county rate was only four times greater than the lowest county mortality rate.

Lack of fine scale data leads to unreliable analysis 

Our work in New Jersey highlights the pitfalls of using only coarsely-resolved spatial data in identifying those communities that are at highest risk of the health burdens of air pollution. An analysis of the impact of pollution in that state found that 18,000 asthma emergency room visits by children could be attributed to fine particle pollution and 70% of those impacts were among communities of color (Asian, Black and Native American) and Hispanic populations.

Comparing the results using coarse-scale and fine-scale data, we found that:

  • Analysis using coarse-resolution emergency room visit information overestimated the burden to white populations. It underestimated the burden to people of color by as much as 90%. 
  • Using fine-scale data, we found emergency room visits for the ZIP code with the highest burden to be 1.5 times higher than the highest burden estimated using coarse-resolution data. 
  • We also found that using fine-scale data revealed double the variation between the ZIP code with the highest risk of PM-attributable visits and ZIP codes with the least risk of PM-attributable visits. Variation allows us to observe the relative disparities in risk within a community that are not otherwise observable with coarse-scale baseline disease data. 

The use of coarse-resolution (ZIP3) asthma emergency department visit data may underestimate PM-attributable asthma burdens (number of cases per 10,000) among non-white populations when compared to fine-scale (ZIP) data. Red shows communities where coarse-resolution health data underestimates risks.

Local-level health information can help EPA and other funders to identify and direct resources to the communities that need it most, which are too often communities of color facing legacy injustices. 

Our work in the Bay Area of California highlights the need for fine-resolution data on baseline disease rates, as pollutant concentrations alone were unable to capture the variation of air pollution health risks within Oakland.  

The maps shown in Figure 2 are of the neighborhoods of West Oakland. Looking only at the spatial distribution of the highest pollutant concentrations (A), the area of highest risk appears to be the truck traffic corridor of I-880. However, when we incorporated census block group baseline disease rates (B), provided by the Alameda County Public Health Department, we found that the area of highest risk, and therefore where the largest emission reductions could result in the largest reduction in health burden, was another area of West Oakland where both baseline mortality rates and pollution levels were elevated.  

Pollutant concentrations and county baseline disease rates alone would not have revealed this vulnerable neighborhood. A better understanding of pollution hotspots can help direct federal funds intended to address long legacies of pollution burdens to communities where they’re most needed. 

West and Downtown Oakland. The map on the left (A) shows the spatial distribution of pollutant concentrations, with high concentrations highlighted in the blue circle near major roadways. The map on the right (B) shows the spatial distribution of air pollutant attributable health burdens when the spatial distribution of underlying disease patterns are taken into consideration. The area of highest air pollutant attributable health burdens in map (B) is highlighted in the blue circle.

Ways to expand and improve local-level health data 

Past investment in satellite-derived estimates and local air pollution monitoring has resulted in making exposure disparities visible. Similar investment is required now for developing fine-scale data on baseline disease rates, which will enable identification of communities with the highest air pollution-attributable health burdens.  

Mechanisms currently exist for developing more fine-resolution data on baseline asthma emergency department visits. As part of the analysis in New Jersey described above, we purchased discharge-level emergency department visit data for New Jersey from 2016 to 2019 from the Healthcare Cost and Utilization Project’s State Emergency Department Database (HCUP SEDD). We urge the Agency for Healthcare Research and Quality, which manages the HCUP SEDD, to develop baseline asthma emergency department visit datasets and that the Agency update these datasets annually and make them publicly available. 

We recommend that health advocates and researchers work with local and state public health departments to access existing fine-scale data where available. We have found that local health departments often have the data needed but lack the resources to dedicate staff and expertise to process and analyze the information. As an example, EDF has had success working with the Alameda County Public Health Department to develop mortality rates at the census block group level. Other impediments to developing baseline disease rates include lack of funding and concerns about privacy. 

Deadlines approaching for funding opportunities to develop local-level health data 

EPA is accepting environmental justice grant applications through April 14, 2023 through two avenues: the EJ Collaborative Problem-Solving Cooperative Agreement Program (EJCPS) and the Environmental Justice Government-to-Government (EJG2G) program. 

While both grant programs are relevant to the use of local-level health data, the Government-to-Government grants allow community-based organizations to partner with their local health department on use of local-level data in health impact assessments. This can help alleviate the problem discussed above regarding inadequate staffing and expertise at local health departments.  

Of the five broad categories listed in the funding announcement, use of local-level health data fits under the category “community-led air and other pollution monitoring, prevention, and remediation, and investments in low- and zero-emission and resilient technologies and related infrastructure and workforce development that help reduce greenhouse gas emissions and other air pollutants.” 

Posted in Air pollution, Deep Dives, Health science, Risk evaluation / Authors: , / Comments are closed

Carts Before Horses: Vinyl Institute Calls For EPA To Evaluate Risk Without Data

By Samantha Liskow / Published: March 28, 2023

Horse attached to the wrong end of the cart. Caption says "Whose bright idea was this again?"

What’s New?

Yesterday, (March 27), EDF—together with the National Wildlife Federation—filed a “friend of the court” brief in the case of Vinyl Institute v. EPA. We expressed our support for EPA’s authority to order companies to 1) Conduct health and safety studies for their chemicals and 2) Turn over those test data to EPA when the agency is evaluating risks the chemicals may pose to humans, wildlife, or the environment.

The Vinyl Institute, which lobbies for companies making vinyl chloride and other chemicals used to make PVC plastic, disagrees. It brought a case against EPA on behalf of its members, asking the U.S. Court of Appeals in Washington, DC, to overturn EPA’s order to test 1,1,2-trichloroethane—a chemical known to harm living beings.

Why It Matters

This case could affect EPA’s ability to order companies to conduct health and safety studies for their chemicals, and, by extension, the agency’s ability to regulate those chemicals. Our brief to the court examines the history that led Congress to grant EPA authority to issue test orders and explains why it is critical for EPA to retain this authority.

The Backstory

The Toxic Substances Control Act (TSCA), the nation’s primary chemical law, was first enacted in 1976. For decades afterwards, EPA managed to collect test data for only a few chemicals; in some years, EPA collected no test data from companies at all.

The original TSCA law required EPA to go through lengthy procedures and make risk determinations about a chemical before it could seek any data from companies. Members of Congress recognized this was a no-win position for EPA and tried for many years to change the law. In 2016, Congress enacted major bipartisan reforms to TSCA, giving EPA power to order companies to test their chemicals when the agency needs data to complete risk evaluations of those substances. This change was lauded by members of Congress and many others as one of the most important improvements to TSCA.

The Current Case

EPA has designated 1,1,2-trichloroethane as a “high priority” for risk evaluation and possible regulation under TSCA. The agency issued the test order because it has some data indicating that the chemical is toxic to birds—but EPA needs more information on just how toxic it is to understand the risks. The Vinyl Institute essentially argued that EPA should have shown the risk to birds before it issued a test order—a classic case of putting the cart before the horse.

On behalf of several multibillion-dollar companies, which produce vinyl chloride and are part of the case, the Vinyl Institute also complained about the cost of the test.

What’s Next?

The court will review the briefs and issue a decision. In the meantime, chemical companies are challenging other EPA testing orders in court, and we are keeping a close eye on those cases. We will continue supporting EPA’s ability to exercise the authority Congress gave it–along with the ability to gather the information it needs to understand how chemicals pose risks to us and the environment and it can take the actions necessary to protect us.

Go Deeper

Read the briefs for the case Vinyl Institute v. EPA:

Posted in Industry influence, Public health, TSCA / Authors: / Comments are closed

Rhode Island expects LSL replacements to be ‘simultaneous and complete’ when funded by SRF

By Roya Alkafaji / Published: March 17, 2023

Tom Neltner, Senior Director, Safer Chemicals Initiative
and Roya Alkafaji, Manager, Healthy Communities

What Happened: The Rhode Island Department of Health (RIDOH) published notices on January 18 and January 30 indicating that Providence Water would need to stop partial replacement of lead service lines (LSLs) when the work is funded by the State Revolving Fund (SRF) program.

RIDOH specified that “only [LSL] replacement that results in simultaneous and complete replacement of both the public (water main to curb stop) and private (curb stop to water meter inside buildings) portions of the lead service lines will occur.”

Why It Matters: EPA made it clear in its FAQs that federal SRF funds should not be used to support harmful partial LSL replacements, which increases the risk of lead exposure in drinking water.[1] To our knowledge, Rhode Island is the first state that has applied its National Environmental Policy Act (NEPA)-like environmental review process to protect residents from partial LSL replacements by requiring the simultaneous and complete replacement of an LSL. All states have a similar review process pursuant to EPA requirements and should be taking similar action.

Our Take: RIDOH’s determination is an important application of the state’s environmental review requirements for its SRF program. We strongly supported RIDOH’s action in comments. We also asked that it be applied to six other SRF-funded projects that are likely to disturb LSLs, like water main replacement and asked for a public hearing if RIDOH allows partials for those other projects.

The Backstory: EDF objected to RIDOH’s March 2022 proposal to grant Providence Water a categorical exclusion that would have allowed partial LSL replacements. We reasoned that the practice would “disproportionately and adversely affect the health of low-income, Black, Latinx, and Native American residents by increasing their risk of exposure to lead in drinking water.” Accordingly, the utility was not eligible for a categorical exclusion and must either stop partial LSL replacements or conduct a full environmental review. This review would likely demonstrate the project was not eligible for funding.

Later, RIDOH withdrew the proposal based on follow-up discussions with EDF and separate discussions with Childhood Lead Action Project.

Go Deeper: Read RIDOH’s April 2022 and January 2023 public notices, a related civil rights administrative complaint filed with EPA, and EDF’s objections to RIDOH’s April 2022 proposal.

 

[1] EPA Frequent Questions about Bipartisan Infrastructure Law State Revolving Funds and LSLR:

“Question 4. If some customers (e.g., homeowners) refuse to allow the water utility access to replace the privately-owned portion of the lead service line, does this affect the project’s DWSRF funding?

State DWSRF programs may still fund the overall project but are strongly encouraged to use technical assistance and other outreach methods to achieve the fullest possible participation. If the customer continues to refuse access, then the water system should leave the publicly-owned portion of the lead service line in place (so as to not create a partial replacement) and document this action. To be clear, partial service line replacements are not eligible for DWSRF funding (from any DWSRF funding source).”

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