Selected tags: test rule

Maybe not surprising, but still upsetting: New report highlights role of election-year politics in OIRA delays

Rachel Shaffer is a research assistant.

Earlier this month, the Administrative Conference of the United States (ACUS) completed an investigation into the Office of Information and Regulatory Affairs’ (OIRA) long delays in reviewing proposed and final rules and to offer recommendations for improving the efficiency and transparency of OIRA’s review process. The final report – which was featured in a front page story in the Washington Post – echoes and expands upon concerns we discussed in a previous blog post and a joint letter sent to Senator Blumenthal’s office earlier this year.

ACUS documents that the average time for OIRA reviews has significantly increased in recent years. From 1994-2011, the average review time was 50 days. However, in 2012, the average review time rose to 79 days. And in the first part of 2013, the average review time rose further to 140 days

The reason for these growing delays?  Read More »

Posted in Health Policy, Regulation | Also tagged , , | Comments closed

NGOs ask Senators to investigate chronic delays in OMB’s review of TSCA regulatory actions

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

Last Friday afternoon, we received the discouraging news that EPA has withdrawn two draft rules it had developed under its Toxic Substances Control Act (TSCA) authority.  As discussed in our earlier blog post, these proposed rules had been kept in limbo by the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), for 1,213 and 619 days, respectively – far longer than the 90-day limit for such reviews set by Executive Order 12866.

Unfortunately, these delays are anything but unique.  OIRA’s reviews of draft rules and other actions now routinely exceed by large margins their mandated deadlines.  Our examination of EPA’s TSCA regulatory agenda over the past several years reveals just how extensive OIRA’s “rulemaking purgatory” has become.  

Since 2009, a total of 33 TSCA-related notices or proposed or final regulatory actions have been submitted to OIRA:

  • Eighteen submissions were proposed or final rules subject to a 90-calendar-day deadline.  Reviews of only six of these rules were completed within this deadline; on average, they have been held at OIRA for over 300 days.
  • The other 15 were advance notices of proposed rulemakings or other notices subject to a 10-working-day deadline.  Of these notices, only one was completed within this deadline; on average, they were kept under review by OIRA for over 70 working days.

Today, EDF, Earthjustice, Union of Concerned Scientists, and League of Conservation Voters sent a letter documenting these delays and expressing our serious concerns to Senator Richard Blumenthal (D-CT) and Senator Orrin Hatch (R-UT), Chairman and Ranking Member, respectively, of the Senate Judiciary Committee’s Subcommittee on Oversight, Federal Rights, and Agency Action.  Our letter emphasized that such delays both prevent the public from providing input in the rulemaking process and limit EPA’s already constrained ability to obtain and share basic safety information on chemicals under TSCA.

Our letter was sent in response to an August 1, 2013, hearing held by that subcommittee, titled Justice Delayed: The Human Cost of Regulatory Paralysis, which began a much-needed discussion of the real-world impact of OIRA’s protracted review of proposed regulations.  We urged a further investigation into the causes and consequences of this too-hidden obstruction of the long-established rulemaking process. 

You can read our letter here, and stay tuned for updates in the coming months.

 

Posted in Health Policy, Regulation | Also tagged , | Comments closed

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

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 EPA, Health Policy, Regulation | Also tagged , , , , | Comments closed

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

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 Reform | Also tagged , , , , | 2 Responses, comments now closed

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

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, Industry Influence, Regulation | Also tagged , , , , , | Comments closed

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

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 EPA, Health Policy, Regulation | Also tagged , , , | Comments closed

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

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 EPA, Health Policy, Regulation | Also tagged , | Comments closed

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

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 EPA, Health Policy, Regulation | Also tagged , , , | 1 Response, comments now closed

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

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 EPA, Health Policy, Regulation | Also tagged , , , , , , , , , , , , , | Comments closed

Regulating nanomaterials to life, not death

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, Regulation | Also tagged , , , , | 3 Responses, comments now closed
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