Tag Archives: High Production Volume (HPV)

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

By | 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 , , , , , | Comments closed

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

By | 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 , , , | Comments closed

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

By | 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 , , , | Comments closed

Funny name, serious concern: EPA proposes Significant New Use Rule for 14 glymes

By | Bio | Published: July 11, 2011

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

EPA today proposed a Significant New Use Rule (SNUR) that, once finalized, would mandate that companies notify EPA prior to engaging in any “significant new use” of any of the 14 chemicals EPA has identified collectively as glymes.  Among other concerns, EPA has identified their use in various consumer products and their potential to cause reproductive and developmental toxicity.  For most of the glymes, the significant new use would be any use in a consumer product beyond those that are already ongoing.  For two of these chemicals, the significant new use would be any use.

This proposed SNUR, which was mired at the Office of Management and Budget (OMB) for more than six months, is now out for a 60-day public comment period.  A SNUR is essentially the only means available to EPA under the Toxic Substances Control Act (TSCA) by which it can try to limit the use of an existing chemical of concern.  It is far from a perfect means of doing so.

Nonetheless, within its limited authority under TSCA, today’s step by EPA brings at least some degree of scrutiny over a quite nasty group of chemicals.  Read More »

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

More progress under REACH: 13 more chemicals en route to the Authorization list

By | Published: June 20, 2011

Allison Tracy is a Chemicals Policy Fellow.

The European Chemicals Agency (ECHA), the agency responsible for implementation of the EU’s REACH Regulation, posted a press release last week listing 13 chemicals it proposes to advance from its list of "Substances of Very High Concern" (SVHCs), also known as the Candidate List for Authorization, to its list of chemicals subject to Authorization, also known as Annex XIV.

Authorization is one of the main pillars of REACH, via which use of designated SVHCs is limited to those uses specifically authorized by EU authorities. Following the public consultation period that is now underway, some or all of the 13 chemicals will move to the Authorization list.   Read More »

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

ECHA adds seven more Substances of Very High Concern to REACH Candidate List

By | Published: June 2, 2011

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

The European Chemicals Agency (ECHA) issued a press release on Tuesday announcing the addition of seven chemicals to the Candidate List of Substances of Very High Concern (SVHC) under the European Union’s REACH Regulation.  [Update 6/20/11:  The formal addition of these substances to the candidate list, the initial announcement of which this post addressed, happened today.  See ECHA's press release, which also contains some additional information about the uses of these chemicals.  The full candidate list including these seven substances is available here.]

All of the chemicals are officially classified as Carcinogenic, Mutagenic or Reproductive toxicants (CMRs).  Their addition brings the total number of chemicals on the Candidate List to 53.  Adding a chemical to REACH’s Candidate List is the first step toward subjecting it to REACH’s Authorization process, whereby the chemical can be used only if specifically authorized by EU authorities.

In this brief post we present a bit more information on these latest seven SVHCs, including the extent of their presence in U.S. commerce and their main uses.  Read More »

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

A sea of red herrings is behind opposition to EPA’s proposal to enhance chemical reporting

By | Bio | Published: April 7, 2011

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

With the chemical industry and now Congressional Republicans mounting a last-minute effort to derail the EPA’s long-time-in-coming enhancements to its Inventory Update Reporting (IUR) rule (see our last post), it’s worth examining their main objections.  That examination reveals a sea of red herrings.  Here are a few of the smelliest ones, discussed in detail in this post:

Red herring #1:  EPA has failed to indicate how it will use the information it collects.

Red herring #2:  Small businesses would be excessively burdened.

Red herring #3:  More frequent reporting is a “needless” burden on the industry.

Red herring #4:  EPA is expanding the IUR from data reporting to data-gathering.

Red herring #5:  EPA’s requirement for retroactive reporting is unfair.

Red herring #6:  Requiring electronic reporting is too inflexible.

Read More »

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

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

By | 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 , , , | Comments closed

Data and safety requirements for new chemicals: China blows past the US

By | Bio | Published: November 16, 2010

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

In yesterday’s post, I pointed to a number of ways in which China is taking a proactive stance on chemical safety.  I cited China because the U.S. chemical industry, when saber-rattling about what it regards as overly onerous proposals for TSCA reform, loves to chide all of us that those proposals will drive chemical production overseas to China and that innovation of new chemicals will still happen, only it will happen in China instead of the U.S.

I mentioned yesterday that China is in the process of enhancing its regulatory requirements, including making them more like the European Union’s REACH Regulation.  Well, a great article detailing China’s new requirements for new chemicals was published yesterday by Geraint Roberts in Chemical Watch’s Monthly Briefing for November (subscription required).

Those requirements – which actually took effect October 15 – include the very same elements the U.S. industry has been warning would send chemical production and innovation running to China if they were to be adopted in the U.S., including:

  • registration as well as notification requirements for all new chemicals, whatever their production volume;
  • a minimum data set, which increases with production volume;
  • a requirement for re-notification whenever production volume increases significantly or the uses of a chemical change or expand; and
  • risk assessments for all new chemicals produced or imported above one metric ton per year.

Next up for the Chinese?  Similar requirements for existing chemicals, according to the article.

So much for the chemical industry’s hand-wringing about us losing out to China. When it comes to raising the bar for chemical safety, it appears the U.S. is increasingly the odd one out.

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

EPA seeks to improve TSCA data reporting; a real litmus test looms for the chemical industry

By | Bio | Published: August 20, 2010

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

While I was on vacation last week, EPA's proposed rule to improve chemical information reporting under its so-called Inventory Update Rule (IUR) was finally published in the Federal Register.  (I say "finally" because the proposal languished for almost 6 months over at OMB, nearly double the 90 days such mandatory reviews are supposed to take.  That unfortunate delay is curious given the relatively modest changes that appear to have been made by OMB – mostly limited to compelling EPA to shift a few elements from proposals to options open to comment, and requiring EPA to expand the range of issues on which it now seeks comment.)

I won't summarize the EPA proposals here; EPA's factsheet does a good job of that, and Daniel Rosenberg at NRDC has also nicely recapped the proposal on his blog.  Suffice it to say that the proposed changes would go far to address the many failings of the current IUR, which amply manifested themselves in the last reporting cycle and severely hampered EPA's ability to assess high production volume (HPV) chemicals under its ill-fated ChAMP Initiative.

So how will the chemical industry react?  Here's why I'll be watching intently.  Read More »

Posted in Health Policy, TSCA and REACH | Also tagged , , , , , , , , | Comments closed

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