EPA Heralds 2500 "Safer Products" Under Design for the Environment Program

Last week, "as part of the Earth Day 2011 tribute," the USEPA announced that "more than 2,500 products are now authorized by the agency under its Design for the Environment (DfE) Safer Product Labeling Program."  These products now can display the DfE label, which signifies that they "do not contain known chemicals of potential concern, like carcinogens, reproductive or developmental toxicants."  And coming shortly, says EPA, will be a requirement for "manufacturers with products that bear the DfE logo to disclose their ingredients to consumers."

According to Assistant Administrator Steve Owens in the press release:

“EPA’s DfE Program helps empower people to choose products that are safer for their families and our planet. The DfE program provides important information about the safety of certain products that contain chemicals and gives consumers confidence that DfE products meet rigorous requirements.”

As part of the DfE program, EPA "conducts a scientific evaluation to ensure that candidate products are formulated from the safest possible ingredients," then works with manufacturers to find safer alternatives. The DfE label "means that EPA has screened each ingredient for potential human health and environmental effects and that the product contains only ingredients that, in EPA’s scientific opinion, pose the least concern among chemicals in their class."

More information on the DfE Safer Product Labeling Program and Standard for Safer Products can be found at: http://epa.gov/dfe.

National Research Council Recommends Climate Change and Other Research Plans for the Oceans

The National Research Council (NRC), part of the National Academies of Sciences, has issued a report recommending several actions related to ocean research.  According to the report, "the United States has jurisdiction over 3.4 million square miles of ocean in its exclusive economic zone," which "represents a prime national domain for activities such as maritime transportation, national security, energy and mineral extraction, fisheries and aquaculture, and tourism and recreation." But the NRC notes that "the 2010 Gulf of Mexico Deepwater Horizon oil spill and the 2011 Japanese earthquake and tsunami are vivid reminders that ocean activities and processes have direct human implications both nationally and worldwide, understanding of the ocean system is still incomplete, and ocean research infrastructure is needed to support both fundamental research and societal priorities."

The report, Critical Infrastructure for Ocean Research and Societal Needs in 2030, "identifies major research questions anticipated to be at the forefront of ocean science in 2030 based on national and international assessments, input from the worldwide scientific community, and ongoing research planning activities." It "defines categories of infrastructure that should be included in planning for the nation's ocean research infrastructure of 2030 and that will be required to answer the major research questions of the future."

Ocean research infrastructure supports both fundamental and applied scientific research that addresses urgent societal concerns such as climate change, human health, domestic offshore energy production, national security, marine shipping, tsunami detection and severe storm tracking, sustainable fisheries and aquaculture growth, and changes in marine ecosystem services. However, significant components of national infrastructure are aged, obsolete, or insufficient to meet growing societal demand for scientific information to enable safe, efficient, and environmentally sustainable use of the ocean. A comprehensive range of ocean research infrastructure will be needed to overcome these challenges, and more interdisciplinary and multidisciplinary research will require a growing suite of infrastructure.

The report can be ordered from the National Academy Press.  A summary and a "report in brief" can also be read online or downloaded as a PDF file.

Pediatricians Call for Overhaul of TSCA Chemical Law

Industry, NGOs and States have all offered their reaction to Senator Lautenberg's introduction of the Safe Chemicals Act of 2011.  And now the American Academy of Pediatrics (AAP) is calling for "an overhaul of the nation’s chemical management policy."  According to the AAP, "the current system fails to protect children and pregnant women, who are most vulnerable to hazardous chemical exposures."

The AAP notes that the current chemical control law – the Toxic Substances Control Act (TSCA) – has "not undergone any meaningful revision since it was first passed in 1976, and since then, the TSCA has been used to regulate only five chemicals or chemical classes."  The organization, which includes 60,000 pediatricians as members, published a policy statement in the May 2011 issue of Pediatrics that calls for chemical control policy in the US to be “substantially revised” to "consider the consequences on children and their families." Among the AAP's recommendations:

• The regulation of chemicals must be based on evidence, but decisions to ban chemicals should be based on reasonable levels of concern rather than demonstrated harm. 
• Any testing of chemicals should include the impact on women and children, including potential effects on reproduction and development.
• Chemicals should meet safety standards similar to those met by pharmaceuticals or pesticide residues on food.
• There should be post-marketing surveillance of chemicals, and the EPA must have the authority to remove a chemical if needed.
• Federal funding should be provided for research to prevent, identify and evaluate the effects of chemicals on children’s health.

The policy statement can be found here.

States Offer Their Reaction to Lautenberg's Safe Chemical Act

Last week Senator Frank Lautenberg introduced the 2011 version of his Safe Chemicals Act.  I have already given an introduction of the bill, the NGO reaction and Industry reaction.  Today we take a look at the reaction from the states.  On Wednesday the heads of the environmental protection agencies of several states issued a group press release commending Lautenberg "for introducing comprehensive legislation that reforms the 35-year-old Toxic Substances Control Act (TSCA)."  They represent the states of California, Illinois, Oregon, Maryland, Minnesota, and Washington.

Overall, the states were very supportive...and in fact, very demanding...of a federal level modernization of TSCA.  According to Ted Sturdevant, Director of the Washington State Department of Ecology:

"We need a fix at the federal level so that we don’t have to do this in the states. States have limited resources and lack the tools of federal agencies to drive a national program. However, until we have a national solution, we will continue to act on chemical safety concerns in our states."

Like Washington State, California has been trying to deal with toxic chemical issues in the absence of an adequate federal law.  According to Linda Adams, Secretary of California EPA:

“In the absence of a unifying approach, interest groups and policy makers have been attempting to take these issues on one-by-one. We need a coordinated, comprehensive national strategy.  As we work toward these national reforms, California will continue to move ahead with its comprehensive green chemistry policy.”

Regulators in other states chimed in with similar stories.  All of them support a modernized TSCA that would, among other things:

• Give EPA the authority to establish chemical safety standards and to take risk management actions when chemicals fail to meet those standards. 
• Shift the burden to industry to demonstrate that chemicals meet safety standards.
• Make available to the public more data and information now claimed as confidential.
• Permit the sharing of confidential information with state regulators.
• Provide for an enhanced state role in implementing the federal law and improved state/federal coordination.

More information on states' reaction to the Lautenberg bill can be found in the combined press release (e.g., this one from the State of Maryland).

Industry Reaction to Lautenberg's Latest Iteration of Safe Chemicals Act

Last week I noted that Senator Frank Lautenberg introduced his Safe Chemicals Act of 2011, which is an updated version of the bill he introduced in the last Congress.  It incorporates much of the feedback received from a wide variety of stakeholders last year.  On Tuesday I provided some of the initial reactions from NGOs, most notably from Richard Denison of EDF.  Denison hoped that this bill would be a starting point for serious discussions that would lead to modernization of the 35-year old TSCA law.  Today I note some of the industry reactions to Lautenberg's bill.

The American Chemistry Council (ACC), which represents most of the largest chemical manufacturers in the country, offered a mixed early reaction.  According to ACC President Cal Dooley:

ACC supported many of the goals and objectives of the senator's legislation in the last Congress, but his earlier proposal was inconsistent with the principles that we have set out for a successful TSCA modernization in several important respects. Further, the bill contained provisions that would not have produced the benefits intended by its authors. Unfortunately, it appears many of our concerns have not been addressed in this new version, and the bill introduced today could put American innovation and jobs at risk.

The Consumer Specialty Products Association (CSPA) also felt that the bill was an improvement but that it still left many concerns unanswered.  According to CSPA President Chris Cathcart:

The new bill introduced today moves in the right direction as it seeks to adopt important concepts of prioritization and tiered minimum data set requirements.  These two elements, along with the preservation of a risk based system, are essential components of any workable regulatory framework under TSCA.  However, we remain concerned about other sections of the bill, including its approach on Reporting and Declarations, the protection of confidential business information (CBI) and the safety standard. A bi-partisan dialogue can resolve these issues.

The industry/free market advocacy group American Council on Science and Health (ACSH) made no pretense of liking parts of the bill, with its President Elizabeth Whelan asserting:

This law is based on the premise that trace level exposure to chemicals is hazardous to health. Sen. Lautenberg is trying to ‘protect’ us from these chemicals, but there’s absolutely no evidence they have harmed humans or the environment.

The National Petrochemical & Refiners Association (NPRA) seemed more concerned over the bills impact on the economy than health and safety.  According to NPRA President Charles Drevna:

NPRA acknowledges Senator Lautenberg's efforts to exclude chemical mixtures from certain requirements and to incorporate some risk-based parameters into the proposed regulatory process. The draft bill, however, would give EPA unprecedented authority over the American economy, allowing the agency to make decisions on what materials can and cannot be used in manufacturing without requiring scientific justification for those decisions. The bill would also give EPA greater authority to force companies to spend enormous sums of money on animal testing, regardless of the likelihood or extent of potential human exposure to particular materials. 

So what next? It seems that both NGOs and industry see improvement over last year's version of Lautenberg's bill, but will there be a willingness to move forward on the common ground established in an effort to actually put a TSCA reform bill into law?

The ball is in the middle of the court.  Now we have to wait to see if any team wants to show up and play.

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.