EDF Health

Selected tag(s): Chemical identity

EDF tells EPA it must modify its proposed CBI Claim Review Rule to comply with recent D.C. Circuit decision

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

Yesterday Environmental Defense Fund (EDF) sent a letter to the Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention in follow-up to last month’s decision by the D.C. Circuit Court of Appeals in EDF’s challenge to EPA’s Inventory Notification Rule (EDF v. EPA, 17-1201).

The letter identifies “immediate, time-sensitive implications [of the decision] for EPA’s ongoing rulemaking for” EPA’s proposed Confidential Business Information (CBI) Claim Review Rule, which is currently undergoing public comment.  EDF noted that, in addition to addressing problems the Court identified in EPA’s regulations promulgated pursuant to its Inventory Notification Rule, EPA will need to modify the current proposed rule to ensure it is consistent with the Court’s Opinion, and accept comments on the modified proposal.

This is because the proposed rule explicitly references and applies regulatory provisions that the Court found were unlawful.  Specifically, the Court found that EPA’s CBI claim substantiation questions were flawed because they failed to inquire into “a chemical identity’s susceptibility to reverse engineering” and “effectively excised a statutorily required criterion from the substantiation process.”  Hence, to align the proposed rule with the Court’s ruling and the representations that EPA made to the Court in its briefing and at argument, EPA will need to revise the substantiation questions and the substantive standard that EPA plans to use when reviewing claims under the CBI Claim Review Rule.

EDFs letter also notes that the proposed rule allows persons to rely on the voluntary substantiations they submitted as part of the Inventory notification process.  But the Court’s Opinion establishes that these substantiations are inadequate because they fail to address a chemical’s susceptibility to reverse engineering, and EPA will need to modify the proposed rule to require companies to provide substantiations that address this statutory factor for confidentiality claims.

See EDF’s letter for more details.

Posted in Health policy, TSCA reform / Also tagged , | Comments are closed

Compromise that strengthens, not weakens, TSCA is the key to getting a new law

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

My recent blog post about the public’s right to know the names of chemicals in health and safety studies brought a response from the Vice President for Government and Public Relations at the Society of Chemical Manufacturers and Affiliates (SOCMA), a trade association of specialty chemical firms.

The response devotes considerable space to arguing for something we don’t oppose:  why it’s important for a company to be able to protect information relating to the process by which a chemical is made.  We have no quarrel with that:  EDF has never sought to change the provision of TSCA that precludes EPA from disclosing such information, even in the context of a health and safety study.  That provision is preserved in both the Senate and House bills, and that has been and remains acceptable to us.

Let me be crystal clear:  EDF has not sought to alter TSCA’s requirement that EPA withhold the identity of a chemical even in a health and safety study if revealing that identity would reveal process information.

What we do strongly oppose, however, is the effort to expand TSCA’s exclusion so as to allow a company always to hide from the public the identity of the chemical in a health and safety study – even where knowing that chemical’s name would not reveal the process used to make it.  That is exactly what the provision in the House TSCA reform bill that SOCMA is pressing for would do.

This would be a major weakening of current TSCA that would severely limit the public’s right to know about health and environmental impacts of chemicals in use today.

SOCMA’s response argues this would be okay for two reasons:  First, EPA will know the chemical’s identity, so no one else needs to know.  And second, the public should be content with a “generic” name.  Let me briefly address each of these arguments.   Read More »

Posted in Health policy, TSCA reform / Also tagged | Comments are closed

Will private interests trump public ones when it comes to our right to know under TSCA?

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

Why this matters …

… to an exposed worker

Today: You are a worker handling a new product. You look at the label, which lists it as containing the chemical dimethyl doorknob. You want to know what health information is available on the chemical, so you go to EPA’s TSCA chemical information databases and search for dimethyl doorknob. You find several studies EPA has received from a company indicating it found dimethyl doorknob to be a potent carcinogen in animal studies it conducted. This is because, under EPA’s TSCA CBI policy, EPA has declassified those studies, making them public and linking them to dimethyl doorknob. You are now able to alert your coworkers and management, and press for actions to reduce or eliminate your exposure to dimethyl doorknob.
If SOCMA gets its way: You are a worker handling a product containing the same chemical. You do your search and find none of the studies EPA has received. This is because under SOCMA’s TSCA, the company was able to claim the identity of dimethyl doorknob to be CBI when it submitted the studies, and EPA could not challenge the claim; it made the studies public – but did not link them to dimethyl doorknob.

… to an environmental health researcher

Today: You are a university-based researcher studying the water quality in a local town. You identify a chemical – unobtanium trichloride – in water samples you’ve collected that has quadrupled in concentration since a local business significantly expanded its production. You want to know what health information is available on unobtanium trichloride, so you go to EPA’s TSCA chemical information databases and search for unobtanium trichloride. You find several studies EPA has received from a company indicating it found unobtanium trichloride to cause birth defects in animal studies it conducted at levels at or below those you’re seeing in the water the submitted studies. This is because, under EPA’s TSCA CBI policy, EPA has declassified those studies, making them public and linking them to unobtanium trichloride. You are now able to alert state authorities of your findings, which leads it to tighten restrictions on discharges of wastewater from the company’s production site containing unobtanium trichloride. The cost of these additional regulations leads the company to reformulate its product, eliminating altogether the use of unobtanium trichloride.
If SOCMA gets its way: You are the same university-based researcher. You do your search and find nothing. This is because under SOCMA’s TSCA, the company was able to claim the identity of unobtanium trichloride to be CBI when it submitted the studies, and EPA could not challenge the claim; it made the studies public – but did not link them to unobtanium trichloride.

One of the few bright spots of the original Toxic Substances Control Act (TSCA) was Congress’ clear intention that the public have access to health and safety information on chemicals and mixtures.

The very first section of the 1976 law expressly states:  “It is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment.”  The law goes on to expressly exclude “data from health and safety studies” submitted to the Environmental Protection Agency (EPA) from the reach of TSCA’s confidential business information (CBI) provisions, by stating that those provisions do not prohibit disclosure of health and safety information.  Congress provided only two narrow exceptions:  where disclosure of such information would disclose the process by which a chemical is made or processed, or the portion of a mixture that a particular chemical comprises.

Now some in the chemical industry are brazenly pressing to thwart that original intent, by codifying into the law the ability of companies to black out the names of chemicals when health and safety studies they submit on a chemical are released to the public.

The Society of Chemical Manufacturers and Affiliates (SOCMA), a trade association of specialty chemical manufacturers, is publicly taking credit for adding a provision to the House’s TSCA reform legislation that would do just that.  In its annual report, SOCMA touted “successfully inserting provisions strengthening Confidential Business Information protections.”  (SOCMA also took credit for the fact that the House bill maintains TSCA’s current New Chemicals provisions, another of its severe weakness about which I blogged last week.)

Should SOCMA get its way and its pet provision ends up in the final TSCA legislation, then you – whether you are a worker, consumer, business, researcher, or concerned member of the public – would get to learn that a new study shows a chemical in a product you may make, use, study or are otherwise exposed to is, say, a potent human carcinogen.  What you would not be allowed to know, however, is what chemical it is!  How useless is that?

See the sidebar for why this matters.

More background for TSCA geeks

I’ll spend the remainder of this post diving a little deeper into the law and history on this issue that SOCMA seeks to wipe out with just a few words inserted into a bill.   Read More »

Posted in Health policy, TSCA reform / Also tagged | Comments are closed

6 years in the making: A new and improved snapshot of U.S. chemical manufacture

Richard Denison, Ph.D., is a Senior Scientist.   Alissa Sasso is a Chemicals Policy Fellow.

Well, it’s finally hit the street:  Today, the Environmental Protection Agency (EPA) released information on the manufacture and use of nearly 7,700 industrial chemicals in 2011.  The data were collected last year under a revamped Chemical Data Reporting (CDR) program, and is the first update of such information since way back in 2005, the year of Hurricane Katrina and Star Wars Episode III.

In releasing the data, EPA Administrator Lisa Jackson noted:  “The CDR data also highlight the clear need for TSCA reform. Updating this critical law will ensure that EPA has access to the tools and resources it needs to quickly and effectively assess potentially harmful chemicals, and safeguard the health of families across the country.”

Getting even to this point has been a long and bumpy road.  Just getting from the proposed to a final CDR rule took over 16 months, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget and the chemical industry’s efforts to delay and dilute the rule.  It then took another year for EPA to collect the data, in no small part thanks to repeated efforts by the chemical industry and its allies in Congress to further delay the program.

Finally, it’s taken EPA six more months to compile and process the data in preparation for today’s release – though that’s a decided improvement over the 21 months it took EPA to release the data collected in the last cycle (the faster pace due in part to a requirement this time around for electronic reporting, a feature the chemical industry and its Congressional allies opposed).

So what do the new data reveal?  EPA has provided some nice summary materials, which we won’t duplicate here.  See especially the table on this page.  We’ll have more to say on this as we further analyze the data, but here are a few important things to note:

  • While 7,674 chemicals were publicly reported, these are limited to those being produced in or imported into the US in 2011 at volumes above the reporting threshold of 25,000 pounds per year per site.
    • The count excludes the likely much larger number of chemicals produced or imported at volumes below the reporting threshold, as well as the many chemicals exempt from reporting, such as most polymers.
  • Nearly 33,000 “records” have been made available by EPA.  Each record represents a single chemical reported by a single site of a company producing or importing that chemical.
    • In contrast to EPA’s reporting in the last cycle, a record for every single chemical-single site combination has been provided even if the information provided in the record is confidential business information (CBI).  In this way, the extent and nature of CBI claims is far clearer than was the case in the last cycle.
  • Extent of CBI claims:  Of all of the reported elements in these records that could potentially have been claimed CBI, about 16% were so claimed.  But that percentage varied a lot among the elements.
    • For 624 records (about 2%), the chemical identity was not provided and instead replaced with a unique identifier called an accession number.  These are new chemicals that are listed on the confidential portion of the TSCA Inventory, which are the only chemicals for which EPA allows chemical identity to be claimed CBI.
    • For 3,420 records (10.4%), the company claimed its identity to be CBI.
    • For 9,686 records (29.4%), the company claimed its domestically manufactured production volume to be CBI.
    • For 10,351 records (31.5%), the company claimed its exported volume to be CBI.

More to come, so stay tuned!

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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 »

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A ray of sunlight up ahead: ECHA to release more information through REACH dossiers

Allison Tracy is a Chemicals Policy Fellow.

After many months of increasing the quantity but not the quality of dossiers available to the public for chemicals registered under REACH, the European Chemicals Agency (ECHA) has recently announced two improvements.  (REACH is the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.)  According to the agency, the public will soon have access to more data from the dossiers that were submitted by companies as part of the first wave of REACH’s Registration process.

In a press release issued a couple of weeks ago, ECHA announced that it will publish information from registered chemicals’ Safety Data Sheets – including the identity of the registrant and whether the chemical was found to be Persistent, Bioaccumulative and Toxic (PBT).  And last week, ECHA said it will also publish (by June) the aggregate production volume ranges (called “tonnage bands”) for chemicals registered under REACH.  These decisions will improve ECHA’s record on disclosure and transparency by increasing the amount of both hazard and exposure data available to the public on chemicals in use.  Read More »

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