EDF Health

How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

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

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

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City of Washington, DC requires lead pipe disclosure and tackles past partial LSL replacements

Tom Neltner, J.D.Chemicals Policy Director

Washington, DC estimates there are 48,000 lead service lines (LSLs) on private property, 46 percent of the total number of service lines identified by the District. While the District has not yet set a goal of eliminating LSLs, it has taken positive steps to assist residents in replacing LSLs. It has prioritized avoiding partial LSL replacements, which are likely to increase residents’ exposure to lead, especially in the months following the disturbance.

On January 16, 2019, the District passed a new law that takes additional positive steps. First, it requires property owners to disclose the presence of an LSL to potential homebuyers and renters. The city joins Cincinnati, OH and Philadelphia, PA in requiring disclosure to renters and New York, Delaware, Connecticut, and Pennsylvania in requiring disclosure to homebuyers.

Second, it redresses past partial LSL replacements by providing financial support to homeowners who did not replace the portion on private property when they were expected to shoulder the entire burden. This is the first city we have seen take this approach. The fiscal impact statement for the law also provides insight into the cost of LSL replacement; the District of Columbia Water and Sewer Authority (DC Water), the city’s utility, estimates the average cost to replace the portion on private property is $2,000 per line. The total cost of the law over four years if fully funded is $21 million.

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ACC to retailers, consumers, and the rest of us: You just don’t get that TSCA implementation is coming along swimmingly

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

Regular readers of this blog know it is our view that, under the Trump EPA, implementation of the 2016 reforms to the Toxic Substances Control Act (TSCA) has pretty much gone off the rails, deviating from what the law requires, failing to reflect the best available science, and not protecting public health.  It’s a view shared by, among others, former top EPA officials, members of Congress, state and local governments, labor groups, firefighters, water utilities, public health groups, and a broad range of environmental groups.

But in this era of alternative facts, the chemical industry says that’s because we’re all simply misinformed.  And it’s taking steps to correct those alleged misperceptions.   Read More »

Posted in EPA, Health Policy, Industry Influence, Regulation, TSCA Reform / Tagged | Comments are closed

The Trump EPA’s first TSCA risk evaluation is an epic fail

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

Yesterday Environmental Defense Fund (EDF) filed more than 100 pages of comments on a 40-page draft risk evaluation the Trump Administration’s Environmental Protection Agency (EPA) has prepared for Pigment Violet 29 (PV29).  PV29 is the first of 10 chemicals undergoing risk evaluations under the Toxic Substances Control Act (TSCA).  Our comments were so much longer than the EPA document we were commenting on because there was far more to say about what information EPA failed to obtain, make available or consider than what EPA included in its draft.

The essence of our lengthy comments can be boiled down to a single sentence, however:  EPA has utterly failed to demonstrate that PV29 does not present unreasonable risk of injury to health or the environment.

For folks who want somewhat more detail than this, our comments start with a 4-page Executive Summary that capsulizes the many serious deficiencies we identified in EPA’s draft.  I’ll provide some highlights in this post.   Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence, Regulation, TSCA Reform / Tagged , | Comments are closed

FDA is dragging its feet while children continue to be exposed to perchlorate in food

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

It has been more than 18 months since EDF and other advocates challenged the Food and Drug Administration’s (FDA) May 2017 decision to continue allowing perchlorate in dry food plastic packaging and food handling equipment.

While Congress gives FDA 180 days to act on food additive petitions, FDA must act “as soon as possible” on a challenge such as ours. However, the agency has yet to complete a review of its May 2017 decision in light of our concerns and evaluate whether to either stand by it, or reverse it. We did not expect FDA would take three times longer to review a decision already made, especially since our objection is largely based on the agency’s own data.

In the meantime, perchlorate in food continues to threaten children’s brains. The chemical, a component of rocket fuel, disrupts the thyroid gland’s normal function and reduces production of the thyroid hormone needed for healthy fetal and child brain development. FDA’s own studies show increased levels of perchlorate in foods such as baby food dry cereal, indicating the chemical’s intentional use in dry food packaging is the likely source of increased exposure for young children.

How FDA got it wrong

In FDA’s May 2017 decision to continue allowing intentional use of perchlorate in contact with dry food, the agency largely relied on flawed science to assess dietary exposure. Its three central errors were:

  1. Ignoring its own data showing significantly increased exposure for children;
  2. Woefully underestimating exposure based on a flawed migration test; and
  3. Unrealistically assuming that perchlorate-laden plastic would only contact food once.

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Posted in FDA, Food, Health Policy, Health Science, perchlorate, Public Health / Tagged , , | Comments are closed

EDF considers potential health equity impacts of partial lead service line replacement

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

“LSL replacement initiatives should address barriers to participation so that consumers served by LSLs can benefit equitably, regardless of income, race or ethnicity.”

– A founding principle of the Lead Service Line Replacement Collaborative

States and communities across the country are taking important steps to accelerate replacement of lead service lines (LSLs) – lead pipes connecting the water main under the street to homes and other buildings. As part of this progress, many programs have strictly limited the standard practice of partial LSL replacement – replacing only the portion of the LSL on public property, which commonly arises when rehabilitating the main and reconnecting the existing line. Partial replacement is likely to increase, at least temporarily, lead levels in drinking water in homes and may not reduce lead exposure in the long run.

The default approach for most water utilities rehabilitating their main has been to simply alert property owners to the risk of partial replacement and advise them to hire a contractor to voluntarily replace the remaining portion of the LSL on their property.

Other utilities have rejected this approach and gone further to protect residents. For example, Washington, DC offers to coordinate private side and public side replacement to reduce costs and make participation easier but still expects the property owner to pay for the private side. Others, such as Cincinnati, OH, have required full LSL replacement, providing a significant subsidy to the homeowner and allowing the cost to be spread over ten years through a property tax assessment. Indiana American Water and Philadelphia, PA go even further and pay for the cost of full LSL replacement out of ratepayer or capital improvement funds. States are acting too, with Michigan requiring utilities to pay the cost of replacement on private property and Wisconsin requiring cost sharing. For more examples, see our webpages recognizing communities and states that are leading the way.

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