Category Archives: Health Policy

Only a 2-month wait, down from 28 years: New EPA risk assessments find paint stripper chemicals pose significant health risks

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

In June, I blogged about the first final risk assessment EPA had issued in 28 years using its authority under the Toxic Substances Control Act (TSCA), for the solvent trichloroethylene (TCE).  Happily, we only had to wait two months for EPA’s TSCA office to issue final risk assessments for three more chemicals.

One of the three is dichloromethane (DCM), also known as methylene chloride.  DCM is a common ingredient of paint strippers, the use on which EPA’s risk assessment focused.  As with TCE, EPA found DCM-laden paint strippers pose significant health risks to workers, consumers and the general public.  Here’s what EPA said in its press release:

The risk assessment for Dichloromethane (DCM), which is widely used in paint stripping products, indicates health risks to both workers and consumers who use these products, and to bystanders in workplaces and residences where DCM is used.  EPA estimates that more than 230,000 workers nationwide are directly exposed to DCM from DCM-containing paint strippers.

Read More »

Also posted in Health Science, TSCA Reform| Tagged | Comments closed

Nothing is forever – and chemical industry trade secret claims shouldn’t be an exception

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

A coalition of health, labor, environmental and environmental justice groups (including EDF), represented by Earthjustice, filed a petition today with the Environmental Protection Agency (EPA) that requests EPA establish a limit on how long information on chemicals submitted and claimed confidential by the chemical industry under the Toxic Substances Control Act (TSCA) can be protected from disclosure.

The petition asks EPA to close a loophole in its current regulations that by default grants indefinite protection for nearly all chemical information claimed confidential.  Because EPA’s only option under its current regulations is to challenge these claims on a case-by-case basis, industry bears no responsibility to ensure that its claims remain valid over time.  The lack of any expiration date for such claims has contributed to a large backlog of excessive and often unwarranted claims – the protection of which imposes large costs on EPA and the American taxpayer and denies public and market access to information that could lead to better-informed decisions about chemicals.

The petition filed today offers a simple solution, one called for in virtually every internal and external review of EPA trade secret policy conducted over the last several decades (see list at the end of this post):  EPA should alter its regulations to create a “sunset” for confidential business information (CBI) claims, which would expire after a set period of time (5 years is proposed) unless the claimant shows that continued protection is warranted.  This approach would allow true trade secrets to continue to be protected while providing public access to information that no longer warrants trade secret protection.  Read More »

Also posted in TSCA Reform| Tagged , , | 1 Response, comments now closed

Twice in 2 weeks: National Academy of Sciences again strongly affirms federal government’s science, agrees formaldehyde is a known human carcinogen

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

Just last week I blogged that a panel of the National Academy of Sciences (NAS) had fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

Today a separate NAS panel strongly endorsed NTP’s listing of formaldehyde as a “known human carcinogen” in its 12th Report on Carcinogens (RoC).  As with styrene, this second NAS panel both peer-reviewed the RoC listing and conducted its own independent review of the formaldehyde literature – and in both cases found strong evidence to support NTP’s listing.  See the NAS press release here, which links to the full report.  Read More »

Also posted in Health Science, Industry Influence| Tagged , , , | Comments closed

National Academy of Sciences strongly affirms science showing styrene is a human carcinogen

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

It’s been a ridiculously long road to get here, because of the delay tactics of the chemical industry.  But yesterday a panel of the National Academy of Sciences (NAS) fully backed the National Toxicology Program’s (NTP) listing of styrene as “reasonably anticipated to be a human carcinogen.”

We have blogged earlier about this saga.  In June 2011, after years of delay, the NTP released its Congressionally mandated 12th Report on Carcinogens (RoC), in which it upgraded formaldehyde to the status of “known to be a human carcinogen,” and for the first time listed styrene as “reasonably anticipated to be a human carcinogen.”  The chemical industry launched an all-out war to defend two of its biggest cash cows, filing a lawsuit to try to reverse the styrene listing (which it lost), and seeking to cut off funding for the RoC.  

In late 2011, the industry managed to get its allies in Congress to slip into the Consolidated Appropriations Act of 2012, without any debate, a rider that mandated NAS to review the styrene and formaldehyde listings in the 12th RoC.  Yesterday’s NAS report on styrene is the first installment, with the second one on formaldehyde expected shortly.

The NAS report could not be more supportive of the NTP’s listing of styrene, finding “that ‘compelling evidence’ exists in human, animal, and mechanistic studies to support listing styrene, at a minimum, as reasonably anticipated to be a human carcinogen.” (emphasis added)  Read More »

Also posted in Health Science, Industry Influence| Tagged , , , | 2 Responses, comments now closed

New bill puts BPA back in the spotlight

Sarah Vogel, Ph.D., is Director of EDF's Health Program.

The hotly debated chemical BPA is back in the policy spotlight. This week Senator Edward Markey (D-Mass) joined Representatives Lois Capps (D-CA) and Grace Meng (D-NY) to announce the Ban Poisonous Additives (BPA) Act.  The bill would ban the use of BPA or bisphenol A from food packaging and mandates extensive consideration of the hazardous properties of any BPA alternative, so as to avoid substituting chemicals that may pose just as many health risks (as increasingly it appears to be with the case of the common BPA replacement, BPS).

Low dose exposure to BPA has been associated with a wide range of health effects including behavioral problems, prostate, breast and liver cancer as well as obesity.  A study released just last week demonstrated how low dose exposure to BPA during fetal development can alter gene expression in the mammary gland of female rats, resulting in abnormal development of the breast and increased susceptibility to breast cancer later in life.   Read More »

Also posted in Health Science, Regulation| Tagged | 1 Response, comments now closed

EPA releases final risk assessment for TCE: One down, 84,999 to go*

Richard Denison, Ph.D., is a Lead Senior Scientist.  Jennifer McPartland, Ph.D., is a Health Scientist.

EPA achieved a rather significant milestone today in releasing a final risk assessment for the solvent trichloroethylene (TCE).  This document is for the first of a group of 83 “work plan chemicals” EPA identified in 2012 as needing risk assessments and, where warranted, risk management.

Why do we call it a milestone?  It is the first final risk assessment issued by EPA using its authority under the Toxic Substances Control Act (TSCA) in – wait for it – 28 years.

The last time EPA issued a final risk assessment for a chemical under TSCA was in 1986, for asbestos.  (EPA has developed a few draft assessments under TSCA over the years, but today marks the first time since 1986 that one of them has been finalized.)

So, kudos to EPA for finally getting this risk assessment to the finish line.  Now what’s next?  Read More »

Also posted in TSCA Reform| Tagged | Comments closed

Imbalanced act: An EPA IRIS agenda that speaks 1000 words

Richard Denison, Ph.D., is a Lead Senior Scientist.  Rachel Shaffer is a research assistant.

[UPDATE 6/24/14:  Perhaps in response to this post of last week, an updated agenda for this week's IRIS meeting was posted by EPA today that reflects a somewhat more balanced set of speakers.  Industry interests appear to have consolidated their number of slots, down from a high of 8 to a high of 6 per issue, and down from a high of 6 to a high of 4 individuals per issue from the same consulting firm.  In addition, several additional slots are assigned to non-industry speakers.  If you wish to see the changes, here is the agenda we linked to that was current as of last week, and here's the updated agenda posted today.]

In comments EDF made at a November 2012 stakeholder meeting held by EPA’s Integrated Risk Information System (IRIS) program, we warned that the tendency of the IRIS program to respond to criticism by expanding opportunities for “public” input would serve to increase rather than decrease the imbalance in stakeholder input.

We noted that providing more opportunities for participation not only lengthens the timeline for completing assessments; it also virtually ensures the input received by EPA is imbalanced and badly skewed toward the regulated community. That’s because companies that produce and use each chemical to be assessed – and the trade associations and myriad hired consultants that represent them – have a clear vested financial interest in the outcome of the assessment.  They can and will take advantage of each and every opportunity for input, and they will be better represented than other stakeholders each and every time.

IRIS recently began holding bimonthly meetings focused on “key science issues” relating to upcoming assessments.  And guess what?  An army of industry representatives, including staff for trade associations and paid consultants, are overwhelming the agendas.

Exhibit A:  Have a quick look at the list of speakers in the agenda for this month’s bimonthly meeting.  A striking imbalance, no?  As many as 8 industry representatives are set to speak on a given issue, including 6 from the same consulting firm!  [UPDATE 6/24/14:  See the top of this post for a description of the updated, slightly more balanced agenda; here is the agenda we had linked to that was current as of last week, and here's the updated agenda posted today.] Read More »

Also posted in Health Science, Industry Influence| Tagged , , , | 2 Responses, comments now closed

ECHA keeps the ball rolling on Authorisation under REACH

Alissa Sasso is a Chemicals Policy Fellow.

In our last update on the European Union’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the “A” of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: as of May 19th, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA’s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round.  Read More »

Also posted in EU REACH| Comments closed

Chemical Safety Reform: Will the Center Hold?

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

Copyright © 2014, Environmental Law Institute®, Washington, D.C. www.eli.org
Reprinted by permission from The Environmental Forum®, May/June 2014

Compromise is tough. It can be thankless and unsatisfying, and, by definition, you don’t get everything you want. But it’s the only way reform of the Toxic Substances Control Act will happen. Nearly everyone, from environmentalists to industry honchos, agrees TSCA is badly broken. But start talking about how to fix the problems and you’ll find there are legitimate core principles held by different stakeholders that are difficult to reconcile. Here are just three examples:

New chemicals. The common-sense notion that new chemicals should be shown safe before entering the market, versus the desire not to hinder innovation or U.S. companies’ ability to compete globally by getting chemicals to market quickly;

Preemption. The appeal of a single federal oversight system that does not impede interstate commerce, versus the view that states have the right to act to protect their residents; and

Confidential business information. The right of citizens, consumers, and the market to information on potential risks of chemicals they may use or be exposed to, versus assurance that legitimate trade secrets submitted to regulators will not generally be disclosed.

As an active participant in the past decade’s debate, I’ve seen firsthand how such conflicting principles complicate — politically and substantively — prospects for achieving reform. I’ve also learned that progress comes only when both sides accept they have to give something to get something. Conversely, progress stalls when stakeholders get greedy. The past year has seen both tendencies.

The late Senator Frank Lautenberg (D-NJ) assessed the landscape last year and saw the need for compromise. He took the political risk of working on legislation with Senator David Vitter (R-LA), who had been about to introduce his own legislation. The result was the first-ever bipartisan legislation to reform TSCA, the Chemical Safety Improvement Act.

Sadly, Senator Lautenberg died shortly after CSIA was introduced. But the legislation remains very much alive, and although it was (and is) far from perfect, there has been major progress thanks to the continuing work of Senator Vitter and Senator Tom Udall (D-NM) to address major concerns raised about the bill and strengthen its health protections.

Additional progress is endangered, however, as some players have fallen back to their core principles and hardened their positions. And after holding a promising series of constructive, balanced hearings on TSCA, the House majority floated reform legislation — albeit a discussion draft rather than a bill — that tilts heavily in industry’s favor.

These challenges have led some stakeholders to consider forgoing the present opportunity and either opt to retreat to the status quo or try to forestall action and wait for more political advantage in the future. In my view, this notion of an easier path any time in the foreseeable future is illusory. The conflicting needs of stakeholders are so fundamental, and the political climate so polarized, that counting on them to change appreciably is wishful at best.

The only recourse is to do the hard work of negotiating to forge a legitimate and fair compromise that delivers an efficient and effective chemicals management system. Let me use my earlier three examples to illustrate what common ground looks like:

New chemicals. EPA should make an affirmative determination of safety before market entry, but using a standard that allows prompt review based on the limited information available for a new chemical. Where that information is insufficient, EPA should be able to require more — or impose conditions sufficient to address potential risks even in its absence;

Preemption. States should be able to act to address a chemical’s risks wherever EPA has not, or when they can make the case for going further. Preemption should apply prospectively, and when, but only when, the agency has all the information it needs to make a definitive safety decision and takes final action on a chemical. Requirements that do not directly restrict a chemical’s manufacture or use — such as for reporting, warnings, monitoring or assessment, which do not unduly impede interstate commerce — should remain available to states; and

Confidential business information. Legitimate trade secrets should be protected, but not information on health and environmental effects or general information on a chemical’s use. Identities of chemicals should generally be available once they enter commerce. Up-front substantiation and EPA approval of claims should be required. Claims should generally be time-limited but renewable upon resubstantiation. State and local governments, medical personnel, first responders, and health and environmental officials should have access to confidential business information.

The opportunity before us is apparent: Our best chance to fix an outdated law that serves nobody’s interests. The alternative — sticking with a piecemeal system that undermines consumer confidence and puts our health at risk — is no alternative at all. All it takes to seize this opportunity is to agree that compromise doesn’t have to be a dirty word.

Also posted in TSCA Reform| Tagged , | 2 Responses, comments now closed

Flame retardants impair normal brain development: Even more evidence, still no action

Jennifer McPartland, Ph.D., is a Health Scientist.

Today a new study was published linking fetal exposure to certain flame retardants called polybrominated diphenyl ethers (PBDEs) with cognitive and behavioral effects that develop later in childhood.  While the specific findings in this study are new, the link between these types of neurodevelopmental effects and exposure to PBDEs is not. 

Numerous scientific studies and governmental bodies across the globe have flagged the health effects of PBDEs.  At the same time, current proposals by the Environmental Protection Agency (EPA) to better understand the hazards and sources of certain PBDEs remain in limbo.  Read on to learn more about today’s new study on PBDEs and the stalling of EPA initiatives to help protect us from exposure to them.  Read More »

Also posted in Health Science, Regulation| Tagged , , , , | Comments closed
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