Tag Archives: test rule

Doing its best under a flawed law: 35 groups file comments supporting EPA efforts to reduce exposure to toxic flame retardants

By Jennifer McPartland | Bio | Published: July 31, 2012

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

Today Environmental Defense Fund and Earthjustice, joined by 33 other health and environmental groups, filed comments that urge the U.S. Environmental Protection Agency (EPA) to swiftly move forward with two proposed actions to regulate a group of toxic flame retardants called PBDEs (polybrominated diphenyl ethers).

The first proposed rule would require anyone intending to begin production, processing or import of any PBDE, or a product containing one, to notify EPA before doing so. This would give the agency an opportunity to evaluate the risks of the proposed activity and if necessary take action to restrict or prohibit it. The second proposed rule would require anyone who continues after 2013 to produce, process or import any PBDE, or a product containing one, to conduct extensive tests needed to allow EPA to determine the risks posed by those ongoing activities. Read More »

Posted in Health Policy, TSCA | Also tagged endocrine disruption, flame retardants, PBDEs, Persistent Bioaccumulative and Toxic (PBT), Significant New Use Rule (SNUR) | Comments closed

More evidence that protecting Americans from toxic chemicals is not a partisan issue

By Richard Denison | Bio | Published: July 9, 2012

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

Another encouraging sign emerged today that efforts to ensure the chemicals we all encounter every day are safe need not fall into the partisan food fight that seems to consume so much of Washington, DC these days: A bipartisan group of 26 Senators — more than a quarter of the U.S. Senate — has sent a letter to U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson in support of actions EPA is taking to limit Americans' exposure to a class of very toxic chemicals widely used for decades as flame retardants in furniture, electronics and even childrens' products.

The chemicals in question have gained even greater notoriety in recent months after an in-depth investigation published in the Chicago Tribune exposed a coordinated campaign of deception by the chemical and tobacco industries to hide the truth about these toxic chemicals.

The Senators' letter urges EPA to pursue a variety of actions on these chemicals, including to finalize proposed notification and testing rules — now undergoing public comment — as quickly as possible. But the Senators also call attention to the severe limits on EPA's authority under the Toxic Substances Control Act (TSCA), and they urge prompt action to reform TSCA:

"While we commend the EPA for taking steps to address PBDEs, it is concerning that the agency must undertake lengthy rulemaking processes merely to secure additional health and safety data on a chemical of concern and to receive notifications regarding expansions of its uses. Further, EPA is not evaluating steps to actually restrict existing unsafe production and uses of these toxic flame retardants. This reinforces why there is broad agreement that TSCA must be reformed to protect American families from dangerous chemicals in a cost-effective way and we urge you to continue to work with Congress to enact consensus reforms."

The letter's signatories are as follows:

Frank Lautenberg (D-NJ), Olympia Snowe (R-ME), Dick Durbin (D-IL), Lisa Murkowski (R-AK), Chuck Schumer (D-NY), Susan Collins (R-ME), Ron Wyden (D-OR), Bernie Sanders (I-VT), Richard Blumenthal (D-CT), Al Franken (D-MN), Joe Lieberman (I-CT), Patrick Leahy (D-VT), Tom Harkin (D-IA), Dianne Feinstein (D-CA), Sheldon Whitehouse (D-RI), Kirsten Gillibrand (D-NY), Jeff Merkley (D-OR), Jon Tester (D-MT), Jack Reed (D-RI), Tom Udall (D-NM), John Kerry (D-MA), Amy Klobuchar (D-MN), Maria Cantwell (D-WA), Sherrod Brown (D-OH), Daniel Akaka (D-HI), and Michael Bennet (D-CO).

Posted in Health Policy, TSCA | Also tagged bipartisan, Chicago Tribune, consumer products, flame retardants, PBDEs | Comments closed

No shame: ACC plunges to new low in fighting your right to know

By Richard Denison | Bio | Published: May 21, 2012

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

This post is longer than usual and starts with a rather esoteric topic, but I urge you to read it through, as it vividly shows there is no limit to the lengths to which the American Chemistry Council (ACC) will go to squirm out of a regulatory requirement, even if it means violating rules by which ACC had agreed to abide.

But that’s far from the worst of it. Going farther than even I could imagine when I blogged earlier about its tactics, ACC is sparing no effort to deny your right to know about the health impacts of chemicals, by mustering every argument it can invent – however far-fetched – to keep health and safety studies from being shared with the public.

ACC insists that the U.S. Environmental Protection Agency (EPA) should hassle the European Union (EU) instead of its members for the health and safety data ACC promised to provide – despite the fact that the chemical industry itself has thrown up major roadblocks to such sharing. And reaching a new low in tortured logic, ACC argues that, should EPA succeed in getting its hands on the health and safety data submitted to the EU, EPA can and should deny the public access to those data – despite the fact that the Toxic Substances Control Act (TSCA) clearly prohibits EPA from withholding such information. Read More »

Posted in Health Policy, TSCA and REACH | Also tagged American Chemistry Council (ACC), chemical identity, Confidential Business Information (CBI), data requirements, High Production Volume (HPV), industry tactics | Comments closed

No orphan left behind: Health and environmental NGOs support EPA’s proposed paired rules to address high production volume "orphan" chemicals

By Richard Denison | Bio | Published: January 18, 2012

Richard Denison, Ph.D., is a Senior Scientist. Allison Tracy is a Chemicals Policy Fellow.

Environmental Defense Fund today submitted comments along with 15 other health, environmental justice and state and national environmental organizations, in support of EPA’s proposed rule to address the final batch of 45 “orphan” chemicals that were never sponsored under the agency’s earlier High Production Volume (HPV) Challenge Program.

An earlier post to this blog highlighted and applauded the novel, innovative and efficient approach EPA has proposed, which actually entails the coupling of two rules:

(1) a test rule for 23 of these HPV chemicals for which EPA can make the requisite exposure findings to require testing, combined with:

(2) a Significant New Use Rule (SNUR) for the other 22 HPV chemicals for which EPA cannot presently make such findings, which requires companies to notify EPA if their production or use of those chemicals changes so as to increase the potential for exposure and then warrant testing.

The comments we filed today reiterate our strong support for this approach – and propose that the same approach be extended to several additional batches of HPV chemicals that still lack a basic set of hazard data.

Read More »

Posted in Health Policy, TSCA | Also tagged data requirements, High Production Volume (HPV), IUR/CDR, Significant New Use Rule (SNUR) | Comments closed

Making do under TSCA: EPA to require reporting of health data by makers of chemicals used in hydraulic fracturing

By Richard Denison | Bio | Published: December 9, 2011

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

Last August, Earthjustice, Environmental Defense Fund (EDF) and over one hundred other groups recently filed a petition under the Toxic Substances Control Act (TSCA) calling on the Environmental Protection Agency (EPA) to require manufacturers and processors of chemicals used in oil and gas exploration and production (E&P chemicals) – including those used in hydraulic fracturing fluids – both to conduct testing and submit to EPA health and environmental data they already have on hand.. The aim of the petition was to ensure EPA obtains better information on the identity, production, use and health/environmental effects of these chemicals in order to evaluate their health and environmental risks. Late last month, EPA announced its decision. Read More »

Posted in Health Policy, TSCA | Also tagged aggregate exposure, chemical identity | Comments closed

EPA proposes yet another TSCA workaround: Creative, yes, but why not just give it the authority it needs?

By Richard Denison | Bio | Published: November 2, 2011

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

One thing I’ve learned in observing EPA try to operate under the Toxic Substances Control Act (TSCA) over the years is that – faced with limited authority and significant evidentiary and resource burdens – the Agency often has to resort to a workaround to get something it needs to do done.

Can’t ban a nasty chemical? Wait until it’s voluntarily withdrawn and then pounce on it with a Significant New Use Rule (SNUR) to try to wedge the door closed. Witness PFOS and penta and octaBDE. (Under TSCA, without a SNUR in place on a chemical, a new producer or importer could start up without even letting EPA know; where EPA has issued a SNUR for a chemical, advance notification is required and EPA least has a chance to weigh in before production or import proceeds.)

Can’t require an up-front minimum data set for new chemicals? Recommend to companies that for certain chemicals they submit such a data set along with the pre-manufacturing notice (PMN) they’re required to file, or risk having EPA extend the review of their new chemical or negotiate with them to do the testing. EPA has made such “recommendations” for those relatively few new chemicals where the company “anticipates” at the outset producing it in large amounts in the first three years or where significant release or exposure is projected.

The latest such workaround? EPA’s simultaneous issuance of a proposed test rule and a proposed SNUR for a batch of high production volume (HPV) “orphan” chemicals that no company agreed to sponsor under the Agency’s voluntary HPV Challenge Program.

Necessity is the mother of invention, they say, and these creative new proposals are a case in point. But, my oh my, there’s gotta be a better way…. Read More »

Posted in Health Policy, TSCA | Also tagged American Chemistry Council (ACC), High Production Volume (HPV), risk assessment, Significant New Use Rule (SNUR) | Comments closed

Avoiding paralysis by analysis: EPA proposes a sensible approach to identifying chemicals of concern

By Richard Denison | Bio | Published: September 13, 2011

Richard Denison, Ph.D., is a Senior Scientist. Thanks to my colleagues Jennifer McPartland and Allison Tracy for their analysis of the EPA proposal discussed in this post.

Last week, the Environmental Protection Agency (EPA) held stakeholder meetings to get public input into the criteria it will use to identify additional chemicals of concern beyond the 11 chemicals or chemical classes it has already identified. EPA used these meetings (as well as an online forum open until September 14) as an opportunity for the public to respond to a “discussion guide” it issued in August that sets forth draft criteria and identifies data sources it intends to use to look for chemicals that meet the criteria.

The day before the EPA meetings, the American Chemistry Council (ACC) issued its own “prioritization tool” which lays out its own criteria and ranking system for identifying chemicals of concern. This post will make a few observations about EPA’s proposal. My next post will provide a critique of ACC’s proposed tool.

EDF and the Safer Chemicals Healthy Families coalition strongly support EPA in this endeavor – both for what it is, and for what it is not. Read More »

Posted in Health Policy, TSCA | Also tagged American Chemistry Council (ACC), biomonitoring, Canada, Chemical Assessment and Management Program (ChAMP), chemical identity, exposure and hazard, Globally Harmonized System (GHS), in vivo, IUR/CDR, Persistent Bioaccumulative and Toxic (PBT), prenatal, prioritization, Safer Chemicals Healthy Families, worker safety | Comments closed

Regulating nanomaterials to life, not death

By Richard Denison | Bio | Published: January 28, 2011

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

As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but de rigueur. I will argue in this post that a little regulation would have done – and still could do – the world of nanotechnology a world of good.

Come again?

Back when the debate over nanomaterial safety really got started, which I would place ‘round about 2004 (or was that just my first involvement in it?), there seemed to be broad agreement on first-order needs to ensure that nanotechnology would survive and thrive. The aim was to “get it right the first time,” by identifying and addressing potential risks up front and in the open. That meant we needed to adequately fund and direct risk research. We also needed to make sure adequate regulatory authority existed to address potential risks, ideally before they arose.

Most fundamentally, there was virtual consensus on the need for prompt action to ensure regulatory agencies had at hand the basic information they needed to understand the lay of the nano-land: what nanomaterials are already being produced and are in the pipeline; in what applications and products are they being used; and where along the nanomaterial lifecycle are the most likely points for potential releases and exposures.

With respect to this most fundamental of needs, I’m sorry to say that, in 2011, we are essentially no closer to achieving it than we were in 2004. Read More »

Posted in Health Policy, Nanotechnology, TSCA | Also tagged Confidential Business Information (CBI), data requirements, National Nanotechnology Initiative (NNI), Office of Management and Budget (OMB), Significant New Use Rule (SNUR) | Comments closed

A near-sisyphusian task: EPA soldiers on to require more testing under TSCA

By Richard Denison | Bio | Published: January 5, 2011

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

The Environmental Protection Agency (EPA) announced yesterday that it has finalized a rule requiring testing [UPDATE 1/7/11: The published rule is available here] to determine basic health and environmental effects for 19 high production volume (HPV) chemicals. While I welcome this as well as any other effort to close the huge safety data gaps that exist even for the most widely used chemicals, the back story behind this rule reveals why it is actually a perfect poster child for what’s wrong with the Toxic Substances Control Act (TSCA).

For starters, consider that it took EPA two and a half years to move the rule from the proposed stage to finalization. And that doesn’t count the several preceding years EPA had to spend developing information sufficient to make the findings it has to make to justify proposing a test rule.

Then consider that the rule addresses only 19 of the many hundreds of HPV chemicals on the market today for which even the most basic, “screening level” hazard data are not publicly available.

And it gets worse. Read More »

Posted in Health Policy, TSCA | Also tagged data requirements, exposure and hazard, High Production Volume (HPV), Office of Management and Budget (OMB) | Comments closed

Why is OMB blocking EPA from using even its limited authority under TSCA?

By Richard Denison | Bio | Published: December 20, 2010

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

On May 12 of this year, the Environmental Protection Agency (EPA) sent a proposed rule to the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA) for its review, which is supposed to be completed within 90 days. The proposed rule is not considered a major rule, is classified as “not economically significant,” imposes no unfunded mandates and is unequivocally allowed under EPA’s statutory authority under the Toxic Substances Control Act (TSCA).

The proposed rule would establish a so-called “chemicals of concern” list and populate it with one chemical and two chemical categories. All of these chemicals are well-studied, already widely identified to be chemicals of significant concern and subject to numerous regulations by governmental bodies both in the U.S. and abroad.

Yet, as of today – more than seven months after receiving the draft of the proposed rule from EPA – OMB has not allowed EPA to release it for public notice and comment.

In 1976, when passing TSCA, Congress gave EPA the express authority to establish and populate a “chemicals of concern” list. There’s simply no excuse for OMB’s delay. Read More »

Posted in Health Policy, TSCA | Also tagged bisphenol A, Canada, CDC, FDA, Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB), PBDEs, phthalates, prioritization | Comments closed

Chemicals & Nanomaterials

Tag Archives: test rule

Doing its best under a flawed law: 35 groups file comments supporting EPA efforts to reduce exposure to toxic flame retardants

More evidence that protecting Americans from toxic chemicals is not a partisan issue

No shame: ACC plunges to new low in fighting your right to know

No orphan left behind: Health and environmental NGOs support EPA’s proposed paired rules to address high production volume "orphan" chemicals

Making do under TSCA: EPA to require reporting of health data by makers of chemicals used in hydraulic fracturing

EPA proposes yet another TSCA workaround: Creative, yes, but why not just give it the authority it needs?

Avoiding paralysis by analysis: EPA proposes a sensible approach to identifying chemicals of concern

Regulating nanomaterials to life, not death

A near-sisyphusian task: EPA soldiers on to require more testing under TSCA

Why is OMB blocking EPA from using even its limited authority under TSCA?

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