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Tom Neltner, Senior Director, Safer Chemicals Initiative and Roya Alkafaji, Manager, Healthy Communities
Last year, the White House set a goal of eliminating lead service lines (LSLs) by 2032 and worked with Congress to enact the Infrastructure Investment and Jobs Act (IIJA)—also known as the Bipartisan Infrastructure Law—which included critical resources to help meet this goal.
Through IIJA, communities across the United States have access to federal funds to replace an estimated 9 million LSLs, which are the pipes that connect homes to water mains under the street. EDF fully supports the President’s goal and related efforts to protect public health and advance environmental justice.
EPA is off to a good start. The agency:
However, as states begin to administer SRF funds from the $11.7 billion in general infrastructure funding, EPA’s lack of clarity on what the funds can and cannot be used for reveals problems. Specifically, some states may allow this funding to pay for partial – as opposed to full – LSL replacements when a utility works on aging water mains that have LSLs attached to them.
By Lauren Ellis, MPH, Research Analyst, Safer Chemicals
What’s New: A peer-reviewed study by Danish researchers found that a male fetus who is exposed to PFAS (per- and polyfluoroalkyl substances—also known as “forever chemicals”) during early pregnancy is more likely to have lower sperm quality in early adulthood.
It’s the first study to explore the impact of exposure to more than two PFAS compounds (as measured in maternal blood samples during early pregnancy) on adult male reproductive hormones and sperm quality.
Why It Matters: Poor sperm quality is directly related to male infertility. In addition, it has been linked to other health problems such as testicular cancer, heart disease, and all-cause mortality.
This study adds to decades of literature linking environmental chemical exposures to negative impacts on reproductive health.
Key Lessons from the Study:
Our Takeaway: The new study presents a startling finding—developmental exposures to chemicals are associated with long lasting harm, including impacts that can affect future generations. It also adds to the growing evidence of PFAS health risks and demonstrates the urgent need for more health-protective PFAS policies and regulations.
Next Steps: EDF and our partners are pushing EPA to revoke existing PFAS exemptions and require those PFAS (and new PFAS coming to market) to undergo a full safety review under the Toxic Substances Control Act, our nation’s primary chemical safety law.
It is critical that these evaluations also consider the cumulative risk of exposure to PFAS mixtures in the environment.
Note: In June 2021, EDF, with a group of health, environmental, and consumer organizations, sent a formal petition to FDA asking the agency to ban all PFAS that accumulate in the body. That petition is still under review.
Tom Neltner, Senior Director, Safer Chemicals
This is the sixth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and the implications for the agency’s Closer To Zero program.
A core tenet of FDA’s Closer to Zero program is the “Cycle of Continuous Improvement” represented by the image below on the program’s webpage. The four-stage, outer ring represents FDA’s process for revising its action levels for food contaminants. The inner, grey ring describes the agency’s on-going monitoring, research, and compliance program.
This approach makes sense, and we fully support it. However, the success of this approach relies on FDA addressing several significant structural weaknesses.
Tom Neltner, Senior Director, Safer Chemicals
This is the fifth in our Unleaded Juice blog series exploring how the Food and Drug Administration (FDA) sets limits for toxic elements like lead, arsenic, and cadmium in food and its implications for the agency’s Closer To Zero program.
FDA’s approach to setting draft action levels for lead in juice is based on two ill-conceived presumptions:
To its credit, the agency has shown it is willing to go beyond the 5% impact for three types of juices (grape at 12%, pomegranate at 6%, and prune at 6%),[2] and it has proposed the most protective lead-in-juice standards in the world. However, for a heavy metal like lead where relatively short-term exposures can result in long-term harm to young children’s developing brains, the current approach has serious weaknesses.
We think the agency should evaluate alternatives that impact more than 5% of the market and protect more than 90% of children. And when FDA evaluates impacts, it should assess the socioeconomic benefits of the alternatives. For substances like lead (and arsenic), these societal benefits can be quantified using established methods. In a previous blog, we showed that reducing young children’s overall dietary intake of lead by just 6% would yield $1 billion a year in benefits. The agency should compare these benefits to the investments that industry would need to make to achieve these action levels using best practices.
Roya Alkafaji, Manager, Healthy Communities and Lindsay McCormick, Senior Manager, Safer Chemicals
Denver Water has one of the most successful lead service line (LSL) replacement programs in the country. Since it began the program in 2020, the utility has replaced nearly 14,000 LSLs—prioritizing lines to buildings serving vulnerable populations, such as child-care facilities. Denver Water has also distributed over 102,000 filters to local residents. EPA should continue to support their innovative approach.
In 2019, we blogged about a novel program that Denver Water designed to address the estimated 64,000 to 84,000 LSLs in its system. These lead pipes connect buildings to water mains under the street. At the time, the water utility proposed to fully replace all LSLs in their entirety within 15 years under its Lead Reduction Program.
The utility decided to fund the work through water rates and bonds, hydropower production, and other sources. In addition, they proposed to provide filters to residents until six months after replacement of the LSL.
Critically, the program includes a comprehensive effort to engage local partners to reach all members of the community. For example, Denver Water partnered with CREA Results, a local community-based organization that is helping to engage and educate Spanish-speaking and immigrant communities on the risks of lead in drinking water and to ensure that residents understand the steps involved with LSL replacement in their neighborhoods. Denver Water’s program has emerged as a national model and its success is recognized by the Lead Service Line Replacement Collaborative and EPA (including its recent service line inventory guidance).
Maricel Maffini, consultant and Tom Neltner, Chemicals Policy Director
In May, FDA decided to allow continued use of nine ortho-phthalates in food packaging and processing equipment but punted on deciding whether or not using those phthalates is safe. We’ve written about the petitions that resulted in the decision, along with the agency’s decision to “abandon” the use of 19 other phthalates (here, here, here, and here). We’ve also written about how phthalates that industry and FDA say are no longer on the market are showing up in our food (here and here). Today, however, we focus on whether those nine phthalates are a class of related substances—and the implications for public health if they are.
FDA’s obligation to evaluate related chemicals as a class
FDA’s regulations state that additives “that cause similar or related pharmacological effects will be regarded as a class, and in the absence of evidence to the contrary, as having additive toxic effects.” In denying our petition, FDA acknowledged that some phthalates could be in a class of related substances. For example, FDA described studies showing that seven phthalates reduced testosterone production – an effect called antiandrogenicity – during fetal development. This caused malformation of the male reproductive system (primarily malformed genitals in male infants). The agency balked at declaring all phthalates anti-androgenic because four of them did not show that effect.[1]
But rather than move forward with a safety assessment of the use of the antiandrogenic phthalates as a class of chemicals with similar toxicity, FDA dropped the issue, implicitly sending the message the chemicals are safe. This is contrary to the agency’s obligation. When making a final decision on a food additive petition that allows the use of a substance, FDA must explicitly decide the use is safe after considering the cumulative effect of it and related substances in the diet.[2]
In contrast to FDA’s failure to act, the Consumer Product Safety Commission, responding to safety concerns, took action five years earlier and banned use of antiandrogenic phthalates in children’s products.
A phthalate scorecard: Where we stand on which phthalates can be used and their health effects
The table below provides a scorecard for the nine phthalates that remain in use. Of those substances, studies showed that seven were associated with developmental effects, including four which have antiandrogenic effects. Two phthalates were never studied for developmental effects.
