Is the Lautenberg Safe Chemicals Act A Jump Start on Serious Discussions About TSCA Reform?

As I noted last week, Senator Frank Lautenberg has introduced the 2011 version of his Safe Chemicals Act.  The question at that time was whether the bill would end up in the same place as the 2010 bill, that is, nowhere.  Some, but not all, industry organizations found positive changes made in the bill.  Now at least one NGO is hoping that the changes will jump start serious discussions and engage industry in finding a path forward for what all parties agree is a need to reform the 35 year old Toxic Substances Control Act.

Richard Denison of the Environmental Defense Fund (EDF) has expressed his hope that "this bill, with its enhancements, will push the reset button on the stalled discussion over TSCA reform, and bring all of the parties to the table for an honest dialogue on how we can finally bring this vital law into the modern era."  He further states:

It is in everyone’s interest – health advocates and industry alike – to restore market, consumer and public confidence in the safety of chemicals.

Denison offers the following highlights of the changes made in the new bill:

• It establishes an orderly process that categorizes chemicals into high-, some- and low-concern classes and directs those chemicals along specific paths of action.
• It requires expedited action be taken to reduce exposure to chemicals of high concern – those that are persistent, bioaccumulative and toxic (PBT) to which people are exposed.
• It calls for EPA to identify and prioritize chemicals requiring safety determinations, and tie the pace of that activity to EPA’s capacity to expeditiously make these needed determinations.
• It clarifies that EPA would tailor minimum data requirements to different types or classes of chemicals, while still ensuring that basic safety information is provided in a timely manner for all chemicals.
• It clarifies that States receiving confidential business information (CBI) must have an agreement in place to ensure the information is kept confidential.
• It ensures that State governments have a right to take actions that are different from or in addition to those under TSCA, unless compliance with both the TSCA and the State requirement or standard is impossible.

He has even put together a handy table providing a "side-by-side" comparison of the 2010 and 2011 versions of the bill.

So will this bill stimulate some honest discussion? While Denison and others hope so, it seems unlikely in this divided Congress with a critical presidential and congressional election already looming in the minds of incumbents and contenders alike.  Especially since there is a good chance the Senate will switch parties next year.  Still, since all parties agree that change is needed, it will be interesting to see if they put in a serious effort or just give it lip service.

ECHA REACH News - Companies Must Notify Substances of Very High Concern by June 1, 2011

For those who thought their REACH obligations were over after diligently registering their substances last fall and notifying their classifications by January...wrong.  ECHA has issued a press release reminding companies that they must notify the Agency "if any Substance of Very High Concern (SVHC) included on the candidate lists is present in their articles above the threshold of 0.1% weight by weight and if the quantity of such substance in those articles is over 1 tonne per producer/importer per year."

The Candidate List is a list of substances that have been officially identified as being of very high concern due to their hazardous properties in relation to the environment and/or human health. Companies will have to notify ECHA of the presence of such a substance in their articles not later than 6 months after the inclusion of such a substance in the Candidate List. For those substances included in the Candidate List by 1 December 2010, the relevant notifications have to be submitted not later than 1 June 2011. 

ECHA recently updated their online submission tool REACH-IT to allow the submission of notifications for substances in articles. They have also prepared a new Data Submission Manual for substances in articles, which can be downloaded as a PDF file here.


More information about the deadline and requirements can be found on the ECHA web site.

Senator Lautenberg Introduces the Safe Chemicals Act of 2011 - Similar Song, Same Ending?

Senator Frank Lautenberg has introduced the Safe Chemicals Act of 2011.  He had introduced a similar bill last year, and bills also versions in 2008 and 2005, all in the hopes of reforming/modernizing the Toxic Substances Control Act of 1976.  The new bill builds on the 2010 bill by incorporating feedback received in a series of hearings with "industry leaders, public officials, scientists, doctors, academics, and non-profit organizations."

Changes made to improve the bill include inclusion of risk-based prioritization categories, for which industry lobbied and the EPA likes because it allows them to "focus...resources on the highest-risk chemicals." As with the earlier bill it requires chemical companies to "submit basic hazard and exposure data to quickly determine the risk and assess the need for further testing or restrictions."

Of course, the real question is less what is in the bill as whether it will ever be taken up by the Senate.  Previous bills never made it out of committee, and given the unlikelihood of the Republican-held House introducing a similar bill, we may just see the Senate bill languish in committee once again.  Then again, the Senate is still controlled by the Democrats (at least until the next election) and Lautenberg has shown amazing persistence and passion for protecting human health and the environment, so we may see the Environment and Public Works Committee hold hearings in an attempt to set the stage for action in future Congresses.

A summary of Lautenberg's bill as presented in his press release is below. Click on the links for The Text or A Summary of the bill.

Highlights of the “Safe Chemicals Act of 2011”

 Provides EPA with sufficient information to judge a chemical’s safety.  Requires manufacturers to develop and submit a minimum data set for each chemical they produce, while also preventing duplicative or unnecessary testing and encouraging the use of rapid, low-cost, non-animal tests that provide high quality data.  EPA will have full authority to request additional information needed to determine the safety of a chemical.

Prioritizes chemicals based on risk.  Calls on the EPA to categorize chemicals based on risk, and focus resources on evaluating those most likely to cause harm.

Takes fast action to address highest risk chemicals.  Requires EPA to take fast action to reduce risk from chemicals that have already been proven dangerous.  In addition, the EPA Administrator is given authority to act quickly if any chemical poses an imminent hazard.

Ensures safety threshold is met for all chemicals on the market.  Places the burden of proof on chemical manufacturers to prove the safety of their chemicals.  All uses must be identified and determined safe for the chemical to enter the market or continue to be used.

Creates open access to reliable chemical information.  Establishes a public database to catalog the chemical information submitted to the EPA by manufacturers, as well as the safety determinations made by the EPA.  The EPA will impose requirements to ensure the information collected is reliable.

Promotes innovation and development of green chemistry.  Establishes grant programs and research centers to foster the development of safe chemical alternatives, and brings some new chemicals onto the market using an expedited review process.

EPA Announces Two More Chemical Action Plans

The USEPA has finally released two more chemical action plans.  These new plans "address the potential health risks of methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI), and related compounds."  According to EPA, diisocyanates are used to make polyurethane polymers, but they were clear to point out that "most polyurethane products, such as foam mattresses or bowling balls, are fully reacted or "cured," and are not of concern."  They are concerned, however, about other products "such as adhesives, coatings, and spray foam," that would be expected to "continue to react while in use, and may contain "uncured" diisocyanates to which people may be exposed."


According to EPA, diisocyanates "are known to cause severe skin and breathing responses in workers who have been repeatedly exposed to them. The chemicals have been documented as a leading cause of work-related asthma, and in severe cases, fatal reactions have occurred."

“There has been an increase in recent years in promoting the use of foams and sealants by do-it-yourself energy-conscious homeowners, and many people may now be unknowingly exposed to risks from these chemicals,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “EPA is working to protect the health of the American people and the environment.”

Proposed actions include data call-in rules, exposure monitoring studies for consumer products, and possibly bans or restrictions on consumer products containing uncured MDI or TDI.


More information about spray polyurethane foam can be found on EPA's Design for the Environment (DfE) web site.  The action plans are found on the specific pages for MDI and TDI as linked on their initials above.

The action plans are how EPA is dealing with the lack of TSCA reform legislation; essentially better utilizing the authority it believes it has under the current TSCA law.

Republicans Schedule Three Hearings This Week to Limit EPA Authority on Clean Air Act

The Republican majority in the US House of Representatives, in particularly those chairing subcommittees of the House Energy and Commerce Committee, has scheduled three hearings this week in their continuing attempts to limit EPA authority.  The ranking Democrat on the Committee, Henry Waxman, yesterday sent a letter to Republican Representatives Fred Upton, Ed Whitfield, and John Shimkus complaining that the Committee is not giving adequate notice to EPA officials of the hearings.

The result of this "insufficient notice" has been that EPA is unable to provide a witness for two of the three hearings.

The three hearings as noted in Waxman's letter and in the online Congressional newspaper The Hill are:

·        On Wednesday, April 13, the Energy and Power Subcommittee will hold a legislative hearing on draft legislation to amend the Clean Air Act as it relates to drilling on the Outer Continental Shelf.

·        On Thursday, April 14, the Environment and Economy Subcommittee will hold a legislative hearing on H.R. 1391, legislation to amend the Resources Conservation and Recovery Act to block an EPA proposal designed to ensure the safe disposal of coal ash.

·        On Friday, April 15, the Energy and Power Subcommittee will hold a hearing on five rulemakings under the Clean Air Act and one under the Resource Conservation and Recovery Act.  The Clean Air Act rulemakings address toxic air pollutants, including mercury, from a variety of different types and sizes of sources.  The Resource Conservation and Recovery Act rule addresses the definition of solid waste.  Draft legislation relating to these rulemakings is expected to be circulated during the week.

According to Waxman, EPA was not contacted about the hearing until after it was publicly announced, a trend that goes against historical practice in which the chair (including Waxman when the Democrats were in the majority) would reach out to relevant organizations weeks in advance of a hearing in order to allow time for them to prepare a response to any concerns.

Waxman also called for "a second legislative hearing on the Clean Air Amendment that will be examined by the Committee" in order to give EPA a chance to provide a witness to testify. 

The Hill article, including the full letter by Waxman to the Republican Chairs, can be read here.

EPA Announces Plan of Action to Address Four IRIS Assessments

The USEPA  will be taking a closer look at "four draft Integrated Risk Information System (IRIS) assessments that were placed on hold in June 2010, pending a review of some of the underlying studies relied on in the assessments." The four assessments are methanol, methyl tertiary-butyl ether (MTBE), ethyl tertiary-butyl ether (ETBE), and acrylonitrile. 



These assessments have been on hold now for nearly a year because a National Toxicology Program (NTP) report questioned research completed by "the Ramazzini Institute, a lab in Italy that conducts animal testing to evaluate the potential cancer-causing effects of chemicals."   According to a previous press release:

NTP researchers reportedly raised questions about findings at the Ramazzini Institute, a controversial Italian animal testing lab that studies chemical carcinogenicity. The Institute has long been criticized by the chemical industry, particularly over its findings that aspartame sweetener can cause cancer.

EPA and the National Institute of Environmental Health Sciences (NIEHS) "decided to jointly sponsor an independent Pathology Working Group (PWG) review, in cooperation with the Ramazzini Institute, of selected studies, including the methanol cancer assessment study. The review has begun and will continue over the next several months. The results will be made public and the cancer assessment for methanol will remain on hold until its completion."
The USEPA announcement can be read here.

ECHA Publishes New Guidance on Labelling and Packaging of Chemicals

The European Chemicals Agency (ECHA) last Friday issued yet another new guidance document related to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and Classification, Labeling and Packaging (CLP) regulations.  The newest guidance document "gives more details on labelling and packaging than the earlier Guidance on the Application of the CLP Criteria."

In particular, the guidance clarifies:

• what aspects to consider when estimating the label size needed;
• what types of supplemental information are possible, and where to place this information on the label;
• the conditions for small packaging exemptions;
• the interaction between CLP and the transport labelling rules;
• how to select the most appropriate set of precautionary statements for the label;
• the transitional provisions for substances and mixtures already on the market.

According to ECHA, "the new stand-alone guidance document replaces the sections dealing with labelling and selection of precautionary statements of the existing Guidance on the Application of the CLP Criteria."

The Guidance on Labelling and Packaging can be downloaded as a PDF document here.

Cefic and Egypt Sign Cooperative Agreement on Chemical Safety

This past week the European Chemical Industry Council (Cefic) signed a cooperative agreement with the Chamber of Chemical Industries (CCI) of Egypt such that the two trade associations could collaborate "on areas that impact the chemicals industry in Egypt and the European Union."  According to the Cefic press release:

The signed six-point agreement includes cooperation on topics such as legislation, application of regulations, as well as trade and investment flows between the two regions. The memorandum delegates the Egyptian group to coordinate the Responsible Care initiative through its FEI Environmental Compliance office. It also details how both groups will consider how consultations and information exchange can take place on regulatory matters such as customs and REACH legislation.  

Responsible Care® is "a global initiative of the chemical industry to drive continuous improvement in its health, safety and environmental performance and to make a strong contribution to sustainable development. Responsible Care was first launched in 1985 in Canada and is now run by the national/regional chemical associations in more than 50 countries around the world."


More information is available on the Cefic web site.

Industry Association and Environmental NGO Reactions to Senate Greenhouse Gas Vote - Did They See the Same Vote?

As noted yesterday there were four votes in the Senate on amendments related to climate science.  Senate Democrats narrowly "defeated a Republican effort to ban the Environmental Protection Agency from controlling the gases blamed for global warming." Despite the unlikelihood of it ever becoming law, according to the Washington Post, "the Republican-led House moved Thursday to take away the Environmental Protection Agency’s authority to regulate greenhouse gases in a vote largely negated by Senate action a day earlier to reject such a repeal." 


Industry and the environmental NGOs had predictably different reactions to the votes.

The American Chemistry Council (ACC), a trade association representing most of the large chemical manufacturers, many of who are impacted by the Clean Air Act mandate for EPA to regulate pollutants, "welcomed signs of growing support in Congress for stopping the U.S. Environmental Protection Agency (EPA) greenhouse gas (GHG) regulations for stationary sources."  According to their press release:

“We are encouraged by these votes, which signal growing momentum toward stopping EPA’s GHG regulations,” said Cal Dooley, President and CEO of the American Chemistry Council. “Lawmakers from both parties agree this is a critical issue for the country, economic recovery and protecting American jobs. Congress must stop EPA so that business growth and hiring can continue.”

The NGO Environmental Defense Fund (EDF) had a different take on the votes. In EDF's press release, Tony Kreindler accused Congressional Republicans of attempting "to unravel public health protections under the Clean Air Act," and noted that "the amendments are a prelude to further attempts to weaken public health protections as the budget debate continues."  Further:

"Today's votes were an unprecedented assault on public health protections under the Clean Air Act. In 40 years we've never faced such a brazen attempt to rollback air quality standards," said Fred Krupp, president of Environmental Defense Fund. "It remains to be seen which Senators will continue to side with clean air and who will vote to go backward."

Clearly industry and NGOs see this differently.

Senate Narrowly Misses Their Chance to Deny Climate Science

Yesterday there were four votes in the Senate related to climate science.  The amendments were designed to either further limit EPA's ability to do what the Clean Air Act and a Supreme Court decision compelled them to do...complete an endangerment finding and then regulate accordingly greenhouse gases.  In March the Republican-led House voted to deny amendments acknowledging the state of the science.  And yesterday the Senate did essentially the same thing.

Brad Johnson, writing on a left-leaning blog called The Wonk Room describes it this way:

McConnell Amendment: Four pollution-fueled Democrats embraced the “Energy Tax Prevention Act” — the extremist legislation introduced by Sen. Jim Inhofe (R-OK) to literally deny the science of global warming. The Democrats who voted for the McConnell amendment, which failed by a 50-50 vote, were Sen. Mary Landrieu (LA), Joe Manchin (WV), Ben Nelson (NE), and Mark Pryor (AR). In the 2010 cycle, Koch Industries contributed $39,500 to Landrieu, $36,500 to Nelson, and $30,000 to Pryor. Manchin’s 2010 election was fueled by over $500,000 from coal and oil interests.

Rockefeller Amendment: Nine Democrats voted for Sen. Jay Rockefeller’s (D-WV) amendment for a two-year moratorium on climate rules, which failed by a 12-88 vote: Sen. Kent Conrad (ND), Tim Johnson (SD), Landrieu, Manchin, Claire McCaskill (D-MO), Nelson, Pryor, Rockefeller, and Jim Webb (VA).

Stabenow-Brown Amendment: Seven Democrats voted for Sen. Debbie Stabenow (D-MI) and Sen. Sherrod Brown’s (D-OH) amendment to suspend, for 2 years, any Environmental Protection Agency enforcement of greenhouse gas regulations, to exempt American agriculture from greenhouse gas regulations, and to increase the number of companies eligible to participate in the Advanced Energy Manufacturing Tax Credit Program, which failed 7-93: Brown, Robert Casey (PA), Conrad, Amy Klobuchar (MN), Johnson, Pryor, and Stabenow.

Baucus Amendment: Seven Democrats voted for Sen. Max Baucus’s (D-MT) amendment to prohibit the regulation of greenhouse gases from certain sources, which also failed 7-93: Baucus, Mark Begich (AK), Kay Hagan (NC), Carl Levin (MI), Klobuchar, Conrad, and Johnson.

As I've noted here before, it's perfectly acceptable to debate the policy options for dealing with climate change.  But the votes on these amendments, and those earlier in the House, are not on policy options but rather politicians exerting their political veto of science itself.   Regarding climate change, the US National Academies of Sciences last year noted that:

A strong, credible body of scientific evidence shows that climate change is occurring, is caused largely by human activities, and poses significant risks for a broad range of human and natural systems….

This state of climate science is concurred by very nearly all active climate researchers, the most recent IPCC report, the National Academies of all of the major countries of the world, and pretty much all of the major scientific organizations on the planet.  Every single one of whom concur that the climate is changing and that human activity is the major cause.  The US National Academies even recently called it "settled fact."

And yet, here are both houses of Congress voting to deny the science because they don't want to have to do the hard work of honestly debating policy options to deal with the science.  The political debate should be focused on finding solutions, not denying the science and hog-tying the agency compelled by the science.

ECHA Provides Tools to Help Chemical Companies Prepare Authorization Applications for REACH

Now that the first deadline for REACH registration has passed, and responsible parties at registering companies have had a chance to take a vacation and catch up on other work, it's time for some companies to turn their attention to the "A" in REACH - Authorization.  And the European Chemicals Agency (ECHA) has now provided some tools to help companies do just that.

Authorization, of course, is the part of REACH where ECHA has determined that a particular "substance of very high concern" presents too great a risk and therefore intends to remove it from commerce.  Manufacturers of those chemicals put onto Annex XIV of REACH, the authorization list, must apply to receive authorization to continue using the chemical.  If no authorization is granted the chemical will be banned from commerce in the EU at the end of the specified sunset perios, which for the handful of chemicals added so far is 2014 or 2015.  If authorized, the chemical would be limited to uses that are critical and can be controlled, and where there are no available substitutes, and for only a limited period of time allotted to find or develop a substitute.

The new tools include "templates to document an analysis of alternatives, a socio-economic analysis and a substitution plan."   There is also a "Fee Calculator" to estimate how much it will cost to submit their application (but not how much to prepare the application). There are also a new Data Submission Manual that "explains in detail how to prepare an Application for Authorisation using IUCLID 5.3, and how to use the web forms for dossier submission."

More information is available on the ECHA web site.

Guidance on how to prepare the authorization application can be downloaded as a PDF here.

Guidance on how to prepare the socio-economic analysis can be downloaded as a PDF here.

Chemical Review Committee Recommends Six Additions to Rotterdam Convention PIC List of Hazardous Substances

Six new chemicals were recommended to be added to the Rotterdam Convention list of hazardous substances subject to prior informed consent (PIC) proceedings before shipment.  These recommendations were made by the Chemical Review Committee during meetings held in Rome on March 28-April 1.  The PIC procedure provides all Parties with an opportunity to make informed decisions as to whether they will consent to future imports of the chemicals listed in Annex III of the Convention.

The six chemicals recommended for listing include three pesticides (endosulfan, azinphos methyl, and Gramoxone Super) and three industrial chemicals (perfluorooctane sulfonate (PFOS), its salts, and precursors; pentabromodiphenyl ether (penta-BDE) commercial mixtures; and octabromodiphenyl ether (octa-BDE) commercial mixtures).  If approved by the conference of parties, the chemicals would be added to the Annex III list of controlled substances.  The next conference of the parties to the Rotterdam Convention will be held in Geneva, Switzerland on June 20-24, 2011.

More information about the Rotterdam Convention can be found here. 

As with other international agreements, the United States signed on to the agreement but has never ratified it.  Thus the US is relegated to offering opinions as an observer but has no voting rights.  Ironically, Jim Willis, the Chemical Control Division Director at EPA, is about to move to Geneva to take over as Executive Secretary for the Rotterdam, Stockholm and Basel Conventions.  

The article here talks about how the Rotterdam Convention and Prior Informed Consent fits into recent discussions on TSCA chemical reform in the US.

Democratic Congressman Waxman Requests PBT Data from Chemical Companies

Democratic Representative Henry A. Waxman (CA), who is Ranking Member of the Energy and Commerce Committee, is asking chemical manufacturers to provide information on "the production of chemicals that are persistent, bioaccumulative, and toxic (PBT’s)."  Waxman, along with Illionios Congressman Bobby Rush, introduced the House's version of the TSCA reform legislation in 2010.  Since those bills died at the end of the last Congress with no action, and little prospect of the Republican-led House introducing bill this year, Waxman seems intent on keeping the pressure on the chemical industry to reveal data.  According to the press release on the minority site for the House Committee on Energy & Commerce, Waxman states:

“These chemicals are of particular concern.  We need better information from manufacturers to understand what is already being done to protect the American people, and what more may need to be done through modernization of the Toxic Substances Control Act.”

PBTs are "highly resistant to degradation in the environment," "build up in the food chain and in the human body," and "cause adverse health effects in exposed individuals."  These persistent, bioaccumulative, and toxic properties have been used by the EPA and other jurisdictions (including Canada and the EU) to prioritize chemicals of greatest concern for closer evaluation.

Waxman sent letters to the CEOs of 15 major chemical manufacturers, including 3M, DuPont, BASF, Huntsman, Chevron, PPG, and others requesting information on what they are doing to determine if a chemical they plan to start producing is a PBT, and if so, whether they would continue to develop the chemical for production.  He also asked what companies are doing to determine if existing chemicals they already produce are PBT, and if so, whether they plan to continue production.  In both cases, if the decision is to continue to place the PBT chemical on the market, what steps are they taking to adequately address "the risks posed by the chemical."

Rep. Waxman indicated that he "would appreciate a response to these questions no later than April 22, 2011."

UK Intends to Stop Animal Testing on Household Products - Animal Rights Groups Rejoice

Recently the UK government signaled that it would end animal testing for household products.  And at least one animal welfare group has expressed its pleasure.  The British Union for the Abolition of Vivisection, more popularly known as BUAV, said that they welcomed "a statement made by Home Office Minister, Lynne Featherstone that the Government intends to ban the animal testing of both finished household products and their ingredients." 

BUAV notes that the "statement comes in response to a Parliamentary Question tabled by Adrian Sanders MP on March 28th 2011" and that the ban will include “all products that are primarily intended for use in the home, including detergents and other laundry products, household cleaners, air-fresheners, toilet blocks, polishes, paper products such as infant nappies [i.e., diapers], paints, glues (and removers), other furnishing and DIY products and household pesticides.”

Governments and animal welfare groups around the globe are working on ways to reduce or eliminate animal testing of chemicals.  I have discussed before how organizations are working to develop alternative testing methods.   Current protocols for testing chemicals and products involve doing in vivo, that is, in life, tests using various animals - mostly mice, rats and rabbits - as surrogates to assess toxicity.  So while some NGOs argue that more testing is necessary to characterize the hazards of chemicals, animal welfare groups argue that such animal testing is both cruel and unnecessary.

For more about BUAV you can check out their web sites: BUAV and Go Cruelty Free.