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House TSCA reform discussion draft: Major problem #1 – EPA regulatory hoops

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

Imagine the following scenario under a new TSCA based on the House discussion draft issued last week:  A major consumer products company decides to expand its line of air fresheners with a new peppermint flavor.  After introducing the new product, information surfaces indicating that one of the product’s ingredients that imparts that aroma causes mutations in a standard genetic toxicity test.

Based on the high hazard and exposure potential, EPA designates the chemical as high priority, requires additional data to be generated, and conducts its safety assessment, concluding the chemical is very likely to be a human carcinogen and poses significant risk when inhaled at levels associated with normal use of the air freshener.

EPA’s safety determination concludes the chemical “will result in an unreasonable risk of harm to human health,” and so EPA initiates the requisite rulemaking to restrict use of the chemical.  Under the House discussion draft (section 6(f)(4)), here’s what EPA would have to prove in order to take any regulatory action:

  • its restriction is “proportional” to the risk involved;
  • the restriction “will result in net benefits;”
  • the restriction is “cost-effective” compared to all alternative restrictions;

AND, here’s the real kicker:

  • there are “technically and economically feasible alternatives that materially reduce risk to human health or the environment compared to the use proposed to be prohibited.”

In other words, before it could act, EPA would have to find a safer, ready-off-the-shelf alternative peppermint flavor for the consumer products company to use instead of the human carcinogen.  And all of the burden of proof – of proportionality, net benefits, cost-effectiveness, technical feasibility, economic feasibility and comparative safety – would rest entirely on EPA and none of it on the company that markets the product or makes the chemical for that intended use.

Something just doesn’t smell right, wouldn’t you say?

These provisions of the House discussion draft would take what is arguably the most fatal flaw in current TSCA – EPA’s inability to regulate dangerous chemicals due to an onerous and paralyzing cost-benefit analysis requirement – and actually make it worse.  While the draft would strike TSCA’s requirement that EPA show any restriction it proposes is the “least burdensome,” it would replace it with evidentiary and analytic burdens that are even more onerous and paralyzing.

There’s a far better and fairer way to deal with the scenario I’ve outlined:  Give EPA the authority to grant exemptions for certain uses of an unsafe chemical – but only for uses that are critical or essential.  That would ensure EPA can effectively restrict non-critical or essential uses of dangerous chemicals.

The seeds of this exemption approach are planted in the Senate’s Chemical Safety Improvement Act (in section 6(c)(10)), although there are other major problems with those provisions of CSIA as introduced (happily, considerable progress toward resolving those problems has been made in the ongoing negotiations on CSIA).

Here’s how an exemption process should work:  EPA would have authority to grant exemptions for uses of an unsafe chemical it finds to be critical or essential.  And companies who believe their use of a chemical is critical or essential could seek such an exemption – but the burden would be on them to show there are no safer, viable alternatives.  The exemptions would be time-limited, and renewable if the need for the exemption is demonstrated to remain.  And EPA would have full authority to impose conditions on such uses needed to protect human health and the environment.

But to force EPA – as the House discussion draft would do – to have to find for a company viable, safer alternatives to a dangerous chemical for each and every use of that chemical it proposes to restrict is simply preposterous.

 

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This SNUR is not a SNORE!

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

Yesterday EPA finalized a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) that requires manufacturers and importers of certain perfluorinated chemicals to notify EPA at least 90 days before commencing any “significant new use” of these chemicals.  (See below for what EPA has designated to be a “significant new use.”)

These notifications afford EPA an opportunity to evaluate the designated new uses before they start and address any risks the new uses may pose.  Read on to learn more about some novel aspects of this final rule, including the scope of what EPA has designated as significant new uses of these chemicals.  Read More »

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My mother is not Angelina Jolie

Rachel Shaffer is a research assistant.

Last week, Angelina Jolie announced that she recently had a double mastectomy: surgery to remove both of her breasts. She chose to undergo such a difficult procedure because she, like her mother who had breast cancer (and died of ovarian cancer), carries the BRCA1 gene, a genetic mutation that significantly raises her risk of breast and ovarian cancer. While Jolie does not have cancer, this surgery lowers her chances of developing the disease in the future.

That otherwise healthy women are choosing to take such drastic steps to reduce their risks of cancer demonstrates a willingness to make profound sacrifices for health.  But it also raises the question of what options for prevention are available to the millions of other women who develop breast cancer, even though they have no known genetic risk factor. Approximately 90-95% of breast cancer cases cannot be attributed to BRCA1 or other genetic mutations; these cases are triggered by various factors in a woman’s environment.  

My mother’s cancer, diagnosed ten years ago this month, falls into this category. So once again, I’m reminded of the obvious: the life of superstar Angelina Jolie does not reflect the life of my mother or the lives of the vast majority of women.  Read More »

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Two safer chemicals initiatives garner national headlines: Mind the Store campaign and The Safe Chemicals Act of 2013

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

This morning, two major daily newspapers carried stories on initiatives to ensure the safety of products containing chemicals to which people are increasingly exposed in their daily lives.

A story in USA Today covers the launch of Mind the Store, a campaign that asks the top 10 retailers in the country to develop and make public their plans to address toxic chemicals in the consumer products they sell. 

Also today, the Philadelphia Inquirer ran a story on the introduction of the Safe Chemicals Act of 2013 in the U.S. Senate, which would amend the core provisions of the Toxic Substances Control Act (TSCA) for the first time since its passage 37 years ago. 

See more information on each of these initiatives below.  Read More »

Posted in Health Policy, Markets and Retail, TSCA Reform / Also tagged , , , | Comments are closed

Prevention as cure: Confronting the environmental contributions to breast cancer

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

Breast cancer is a personal issue for too many of us.  For six years I have watched the disease overtake a very dear friend’s life.  First diagnosed at 32, she underwent radical treatments— surgeries, radiation and chemo— and three years later faced metastatic breast cancer that is now ravaging her body. 

She is one of the three million women in the U.S. currently facing, or who have been treated for, for breast cancer.  She is also one of a growing number of women under 50 getting the disease with no family history of breast cancer. 

Many women today live longer with or after the disease due to remarkable advancements in medicine, but treatment is not a path anyone would choose.  It takes a heavy emotional and physical toll, and often comes with serious impacts on a women’s life, such as the loss of fertility and the risk of reoccurrence.  Medical costs for treatment of breast cancer totaled $17.35 billion in 2012. And even with advances in treatment, in 2012, more than 40,000 women died from the disease.  

The question every woman must ask is: “What can I do to prevent the disease for myself or my daughter?” Read More »

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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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