EDF Health

“Illegal, unscientific, and un-health protective”: Summing up EPA’s final methylene chloride risk evaluation

Richard Denison, Ph.D., is a Lead Senior Scientist.

Today, the Trump EPA released its first final risk evaluation and determination under the reformed Toxic Substances Control Act (TSCA), for the carcinogenic and acutely lethal chemical methylene chloride.

Sadly, despite EPA’s rush to issue this document as the 4th anniversary of TSCA reform on June 22 approaches, EPA doubled down on the illegal, unscientific, and un-health protective approach it has taken in all of its draft risk evaluations for the first 10 chemicals reviewed under TSCA.

EDF will be closely examining this final document, but it is already apparent that EPA has grossly and systematically underestimated the exposures to and risks of methylene chloride.  Read More »

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Revised national standard tightens lead leaching limits for new drinking water fixtures

Tom Neltner, J.D. is the Chemicals Policy Director

In September 2020, the joint committee posted an announcement on its revised NSF/ANSI/CAN 61 standard.

Effective today, the national consensus standard for plumbing devices, known as NSF/ANSI/CAN 61, was revised to require, by January 1, 2024, that manufacturers of faucets and fountains that dispense drinking water meet limits five times more protective for lead leaching than the current standard. Manufacturers have the option to have their products tested and certified to the revised standard beginning in the fall, after it is published. All states require plumbing devices comply NSF/ANSI/CAN 61.

Plumbing Manufacturers International (PMI), the trade association for the industry, tells us that its members are already gearing up to get their products certified, but that it will take time to complete the third-party review process and meet the expected demand. Consumers, retailers, and institutional buyers should begin requesting products that meet the new standard – which can be identified by the new “NSF/ANSI/CAN 61: Q ≤ 1”[1] text on the consumer-facing product label – in 2021 as the certification process ramps up.

A driving force for this change was legislation introduced by California Assembly Member Chris Holden, cosponsored by EDF and Environmental Working Group, with productive and collaborative engagement from PMI and NSF International.[2] On June 8, the Assembly unanimously passed AB 2060. It now moves to the Senate for consideration. The current version of the bill would require that all devices made or sold in California that are intended to convey or dispense drinking water meet the new NSF/ANSI/CAN 61 standard on a faster timeline – by January 1, 2021. PMI has requested an effective date of January 1, 2024 for the California requirement to provide manufacturers, third party certifiers, distributors, and retailers with adequate time to get products certified and in stock in the state. Stakeholders are considering the request but are concerned that child care facilities and schools will need the devices sooner. Because of the legislation, we expect that manufacturers, wholesalers, and retailers will prioritize the California market.

Read More »

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Reveal News exposes Trump Administration’s disregard for protecting the public from a highly dangerous chemical: 5 key takeaways

Richard Denison, Ph.D., is a Lead Senior Scientist.

This weekend, Elizabeth Shogren at Reveal News published an in-depth investigative report and hour-long radio segment delving into the Trump EPA’s latest abandonment of science and its serious consequences for public health.  The story focuses on the ubiquitous solvent trichloroethylene (TCE), a known human carcinogen and neurotoxicant that is also linked to birth defects at very low levels of exposure.

In reforming the Toxic Substances Control Act (TSCA) in 2016, Congress directed EPA to conduct comprehensive reviews of the risks posed by TCE and other widely used chemicals.  EPA was charged with identifying risks both to the general public and to “vulnerable subpopulations,” including pregnant women, infants, workers, and others.

EPA’s draft risk evaluation of TCE was released on February 21.  It suffers from many of the same gaping flaws as do EPA’s draft risk evaluations for other chemicals.  Once again, EPA has utterly failed to carry out the clear intent of the law, putting our health at greater risk.

  • EPA has ignored all exposures of the general population to TCE that arise from releases of the chemical to air, water and land – amounting to millions of pounds annually.
  • EPA has once again assumed, without any supporting data, that workers will wear personal protective equipment and that it will be effective in eliminating or reducing exposures.
  • EPA has inflated the acceptable level of risk of cancer that will allow workers to be exposed to as much as 100 times more of the chemical.

[pullquote]“This decision is grave. It not only underestimates the lifelong risks of the chemical, especially to the developing fetus, it also presents yet another example of this administration bowing to polluters’ interests over public health.”

Dr. Jennifer McPartland[/pullquote]But in this new draft EPA has gone even further in abandoning both science and the law.  Reveal’s exposé identifies key changes made at the 11th hour to the draft that were forced on career staff at the agency by the White House.

Here are five key takeaways from the Reveal story:  Read More »

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Top takeaways from The Intercept’s investigation into Trump’s toxic rollbacks

Regulatory decisions by federal agencies in Washington often feel distant – bureaucrats moving paper in ways that don’t matter to regular people. But a devastating new story by reporter Sharon Lerner of The Intercept makes clear just how awful the Trump administration’s actions on chemical safety have been for average Americans.

Lerner shows that the Trump EPA has repeatedly bowed to industry lobbyists to allow dangerous chemicals to stay on or enter the market with little or no restrictions.

EPA’s actions are not abstract bureaucratic events to Angela Ramirez, who was diagnosed with breast cancer after years of living and working “near two facilities that were emitting a cancer-causing chemical called ethylene oxide.” EPA scientists knew “that exposure to ethylene oxide caused elevated rates of tumors in the brain, lungs, uterus, and lymph systems” – but under the Trump administration, following pressure from an industry trade group, EPA decided not to follow its own science deciding whether to limit the chemical.

Lerner reports that the Trump administration, stacked with political appointees who have worked, lobbied or advocated for the chemical, tobacco, and coal industries, has been systematically undermining EPA’s ability to use the best science and get the best expert advice to protect families. They’ve been attacking programs like the Integrated Risk Information System, or IRIS, which provides evidenced-based analysis to the government to make public health decisions.

From Texas to Delaware and across the country, Lerner shows the impact of an administration that seems entirely focused on doing the bidding of industry, rather than pursing its legal mission to protect public health. They are doing so both broadly – weakening a new chemical safety law –and in a series of individual chemical assessment decisions. “Each time we see one of these assessments, there are ways in which the science has been played with,” EDF’s Lead Senior Scientist Richard Denison told Lerner.

To read more about what Lerner calls “Trump’s cancer gang” and their attacks on science and public health, check out her full article.

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Which faucets and fixtures have the lowest lead levels? California asks plumbing manufacturers.

Tom Neltner, J.D. is the Chemicals Policy Director and Lindsay McCormick is a Program Manager.

[pullquote]

Until California Water Board publishes its lists of fixtures that leach minimal lead, we recommend that schools and child care facilities routinely flush newly installed drinking water fixtures for several weeks and retest before allowing children to consume the water.

[/pullquote]

In November, the California Water Board took an important step that should benefit anyone seeking to buy a new faucet, drinking water fountain or other fixture – especially schools and child care facilities. The Board sent letters to more than 300 plumbing manufacturers and certifiers asking them to voluntarily provide information on fixtures that leach minimal lead. Specifically, it seeks to identify fixtures that meet lead leaching limits that are five times more protective than the current limits in the NSF/ANSI 61 standard.

The Board plans to make the compiled responses publicly available and encourage the 14,000 licensed child care centers in the state to buy new fixtures from those on the list when water testing indicates the fixture should be replaced. We anticipate that the Board will utilize the list to identify fixtures to purchase through a $5 million grant program the California State General Legislature established when it enacted AB-2370 last year. The funds are designed to help licensed child care facilities meet the state’s new mandated water testing and remediation program.

Read More »

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Time for a safer food supply: The legal challenge to FDA’s GRAS Rule

Tom Neltner, J.D.Chemicals Policy Director, Environmental Defense Fund

This blog initially was published as a guest column in Chemical Watch on September 9, 2019. After publication, FDA filed its reply brief to the plaintiff’s August 23, 2019 brief. The briefings are complete and the case awaits a decision by the judge.

Litigation is a time-consuming and often inefficient means to fix a broken regulatory system. However, when there is a fundamental disagreement about a regulatory agency’s responsibilities under the law, it is an essential option. Such is the case with the “Generally Recognized as Safe” (GRAS) exemption from the requirement for pre-market approval of food additives in the Federal Food, Drug, and Cosmetic Act (FFDCA). The Food and Drug Administration (FDA) interprets this exemption as allowing companies to determine whether a substance’s use is GRAS in secret without any notice to the agency.

Next year, I anticipate a federal district court will make a final decision on a lawsuit[1] challenging the FDA’s 2016 GRAS Rule that formalized the agency’s broad interpretation of the exemption and its narrow interpretation of its responsibilities under the FFDCA to “protect the public health by ensuring that . . . foods are safe, wholesome, sanitary, and properly labeled . . . .” (21 U.S.C. §393(b)). It would come a decade after the U.S. Government Accountability Office (GAO), the independent, nonpartisan agency that works for Congress, concluded that “FDA’s oversight process does not ensure the safety of all new GRAS determinations.” The GRAS Rule does little to address the shortcomings described by GAO.

Environmental Defense Fund (EDF), represented by Earthjustice, and the Center for Food Safety (CFS) are the plaintiffs in the lawsuit asking the court to declare the GRAS Rule unlawful and vacate the rule. On August 23, we filed with the court our response to the agency’s brief on both parties’ motions for summary judgment. FDA is expected to file a reply in September. Based on these briefs, the court may order oral arguments before making a decision.

Read More »

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