Selected tags: carcinogen

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.

 

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

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 »

Posted in Health Policy, Health Science | Also tagged , | 2 Responses, comments now closed

A mission corrupted: Your tax dollars pay for ACC to coach big industry on how to undercut EPA’s IRIS program

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

On February 22, the Advocacy Office of the Small Business Administration, an agency of the Federal Government, held a meeting without any public notice and from which the press was barred.  And while the office’s mission is supposed to be to provide “an independent voice for small business within the federal government,” many if not most of the attendees were from large companies and the trade associations and Washington lobbyists that represent their interests.

This meeting was the latest in a long and continuing series of so-called “environmental roundtables” that serve as a basis for the SBA’s Advocacy Office to weigh in against environmental or workplace regulations that big business opposes.   

There are no records from these meetings that are made publicly available.  Agendas and attendee lists are not disclosed, though I was able to obtain an agenda for this particular meeting at the last minute.  I noted with interest that the first half of the meeting focused on the US Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program, which provides health assessments of chemicals used by public health and environmental officials around the world. 

The key draw in this meeting:  a senior official from the American Chemistry Council (ACC), whose dominant members are huge global chemical companies like ExxonMobil, BASF, Dow and DuPont – in short, Big Chem.   The ACC official spent a full hour coaching representatives of Big Chem and other global mining companies and automobile corporations like GM in how to pick apart and challenge recent documents developed by the IRIS program.  IRIS has become a focal point of the chemical industry’s multi-front attack on independent government science.  Here is the deck of Powerpoint slides used by the ACC representative and the other industry speaker.  Read More »

Posted in EPA, Health Policy, Health Science, Industry Influence | Also tagged , , , | Comments closed

Hands off the Report on Carcinogens

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

Information, and importantly, access to reliable and objective information, is the cornerstone of a democratic society.  That is why recent efforts by the chemical industry and its allies to block Congressionally-mandated, scientific information on carcinogenic hazards by defunding the Report on Carcinogens (ROC) have many researchers and public health officials alarmed. 

Today, in a letter sent to House and Senate appropriations committee leaders, 75 occupational and environmental health scientists and professionals from around the country called on Congress to maintain funding for the ROC.  Their letter is in response to a legislative proposal that, if passed into law, would withhold funding for any work on the ROC until the National Academy of Sciences (NAS) completes its review of the listings of formaldehyde and styrene in the 12th ROC—a process the NAS has only just begun.  If such a proposal were successful, it would effectively delay public access to critical information on chemical carcinogens for years.     Read More »

Posted in Health Policy, Health Science, Industry Influence | Also tagged , , , | 3 Responses, comments now closed

Labor and public health advocates to the chemical industry: Stop bullying federal scientists!

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

After my long post this morning, I’ll keep this one brief:  The United Steelworkers, one of the nation’s top occupational physicians and EDF, represented by Earthjustice, have filed a motion to intervene in D.C. District Court, seeking to help defend the U.S. Department of Health and Human Services’ listing of styrene as "reasonably anticipated to be a human carcinogen."  The motion is in response to a chemical industry lawsuit attempting to force the agency's National Toxicology Program to withdraw the styrene warning, which was published in the 12th edition of the Congressionally mandated Report on Carcinogens.

Posted in Health Policy, Industry Influence, TSCA Reform | Also tagged , , | Comments closed

More “A”-level work under REACH: ECHA adds eight chemicals to the Authorization List

Allison Tracy is a Chemicals Policy Fellow.

The European Commission has formally added eight more chemicals to the list of chemicals subject to authorization under the European Union’s Regulation on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).  These eight chemicals, which were proposed for addition to the Authorization List (or Annex XIV) in December 2010, join the six inaugural chemicals that were formally listed last February (see EDF’s blog post on that occasion).  The full Authorization List is available on ECHA’s website; the list also specifies the corresponding sunset date by which time uses of a chemical must cease unless specifically authorized. Read More »

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

Twin dangers from TCE: Widespread exposure, and now a strong link to Parkinson disease

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

A study published online in the Annals of Neurology last week, “Solvent Exposures and Parkinson Disease Risk in Twins,” adds to scientific evidence linking exposure to the solvent trichloroethylene, or TCE, and other common solvents with onset of Parkinson disease.  Parkinson disease is a debilitating condition well known for symptoms of trembling but can also include slowed motion, impaired posture and balance, and loss of automatic movements (e.g. blinking, arm swaying when walking).  Most unfortunately, it has no cure. 

According to the authors, this new twin study is the first confirmation in a population-based study of a significant association between exposure to TCE and incidence of Parkinson disease.    Read More »

Posted in Emerging Science, Health Policy, Health Science, Regulation | Also tagged , , , , , , | 1 Response, comments now closed

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

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 EU REACH, Health Policy | Also tagged , , , | Comments closed

ACC resorts to smear tactics to defend its cash cows, formaldehyde and styrene

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

An increasingly common tactic in modern bare-knuckle politics is to divert attention away from your own weakness or vulnerability by loudly – and falsely – accusing your opponent of having that very defect you possess but won’t admit to.

That Rovian tactic was on display last week, with the American Chemistry Council (ACC) as the accuser, and the National Toxicology Program (NTP) as its “opponent.”  Mind you, NTP is the nation’s leading authoritative body on cancer-causing chemicals.

The precipitating event?  NTP’s long-overdue release of its 12th Report on Carcinogens (RoC).  Among other additions NTP made since its last report was published way back in 2005, it had the audacity – according to ACC – to:

  • upgrade its classification of formaldehyde to “Known to be a human carcinogen,” from its earlier classification (dating back to 1981) as “Reasonably anticipated to be a human carcinogen,” and
  • for the first time include styrene on its list of chemicals linked to cancer, classifying it as “reasonably anticipated to be a human carcinogen.”

The accusation hurled at NTP was this gem from ACC President and CEO, Cal Dooley:

“We are extremely concerned that politics may have hijacked the scientific process and believe this report by HHS is an egregious contradiction to what the President said early in his administration, ‘…That science and the scientific process must inform and guide decisions of my administration…’.”

Talk about the pot calling the kettle black (per the “second, subtler interpretation” of that phrase).

Read More »

Posted in Health Policy, Industry Influence, Regulation | Also tagged , , , , | 1 Response, comments now closed

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

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 EU REACH, Health Policy | Also tagged , , , , , | Comments closed
  • About this blog

    Science, health, and business experts at Environmental Defense Fund comment on chemical and nanotechnology issues of the day.

    Our work: Chemicals

  • Categories

  • Get blog posts by email

    Subscribe via RSS

  • Filter posts by tags

    • aggregate exposure (9)
    • Alternatives assessment (3)
    • American Chemistry Council (ACC) (55)
    • arsenic (3)
    • asthma (3)
    • Australia (1)
    • biomonitoring (9)
    • bipartisan (6)
    • bisphenol A (18)
    • BP Oil Disaster (18)
    • California (1)
    • Canada (7)
    • carbon nanotubes (24)
    • carcinogen (21)
    • Carcinogenic Mutagenic or Toxic for Reproduction (CMR) (12)
    • CDC (6)
    • Chemical Assessment and Management Program (ChAMP) (13)
    • chemical identity (30)
    • chemical testing (1)
    • Chemicals in Commerce Act (3)
    • Chicago Tribune (6)
    • children's safety (22)
    • China (10)
    • computational toxicology (10)
    • Confidential Business Information (CBI) (52)
    • conflict of interest (4)
    • consumer products (48)
    • Consumer Specialty Products Association (CSPA) (4)
    • contamination (4)
    • cumulative exposure (4)
    • data requirements (45)
    • diabetes (4)
    • DNA methylation (4)
    • DuPont (11)
    • endocrine disruption (28)
    • epigenetics (4)
    • exposure and hazard (49)
    • FDA (8)
    • flame retardants (20)
    • formaldehyde (15)
    • front group (13)
    • general interest (21)
    • Globally Harmonized System (GHS) (5)
    • Government Accountability Office (5)
    • hazard (6)
    • High Production Volume (HPV) (22)
    • in vitro (14)
    • in vivo (11)
    • industry tactics (41)
    • informed substitution (1)
    • inhalation (18)
    • IUR/CDR (27)
    • Japan (3)
    • lead (6)
    • markets (1)
    • mercury (4)
    • methylmercury (2)
    • microbiome (3)
    • nanosilver (6)
    • National Academy of Sciences (NAS) (20)
    • National Institute for Occupational Safety and Health (NIOSH) (7)
    • National Institute of Environmental Health Sciences (NIEHS) (5)
    • National Nanotechnology Initiative (NNI) (6)
    • obesity (6)
    • Occupational Safety and Health Administration (OSHA) (3)
    • Office of Information and Regulatory Affairs (OIRA) (4)
    • Office of Management and Budget (OMB) (15)
    • Office of Pollution Prevention and Toxics (OPPT) (3)
    • oil dispersant (18)
    • PBDEs (16)
    • Persistent Bioaccumulative and Toxic (PBT) (22)
    • pesticides (7)
    • phthalates (16)
    • polycyclic aromatic hydrocarbons (PAH) (5)
    • prenatal (6)
    • prioritization (35)
    • risk assessment (69)
    • Safe Chemicals Act (24)
    • Safer Chemicals Healthy Families (33)
    • Significant New Use Rule (SNUR) (19)
    • Small business (1)
    • South Korea (4)
    • styrene (6)
    • Substances of Very High Concern (SVHC) (15)
    • systematic review (1)
    • test rule (16)
    • tributyltin (3)
    • trichloroethylene (TCE) (3)
    • Turkey (3)
    • U.S. states (14)
    • vulnerable populations (1)
    • Walmart (2)
    • worker safety (23)
    • WV chemical spill (11)
  • Archives