EPA Proposes Changes to TSCA Reporting Requirements

The move to strengthen TSCA, or at least the move to more fully utilize the current authority given to EPA under TSCA, took another step this week as EPA proposed changes to the TSCA Inventory Update Rule (IUR) reporting requirements.  The changes would increase public disclosure by limiting what companies can protect as confidential, as well as increase the amount and frequency of data submitted.  The new changes would also require the submission of these data electronically.


According to EPA, "this information helps the agency determine whether chemicals may pose risks to people or the environment."

“Enhanced reporting on the production and use of chemicals will help give the American people greater access to information on the chemicals to which their children and families are exposed every day,” said Steve Owens, EPA’s assistant administrator for the Office of Chemical Safety and Pollution Prevention. “The proposal being announced today will allow the agency to more effectively and expeditiously identify and address potential chemical risks and improve the information available to the public on chemicals most commonly used in commerce.”

Commenting on the proposed rule is open until October 25, 2010, and if finalized in time would be effective for the next IUR reporting period schedule for June 1 - September 30, 2011.

California Environmental Health Office Publishes Green Chemistry Hazard Traits

Many people know that the state of California has been working on a "green chemistry" program, though it has struggled because of the severe economic downturn.  The 2008 statute requires the Office of Environmental Health Hazard Assessement (OEHHA) to specific "hazard traits," i.e., environmental and toxicological endpoints and other relevant data that are to be included in the state's "Toxics Information Clearinghouse."  The California Department of Toxic Substances Control (DTSC) will use the clearinghouse information to help identify chemicals of concern in consumer products.

To get things started, and to jump start the process, OEHHA has developed what they are calling a "pre-regulatory draft" for discussion.  Based on feedback, the final language may change substantially.  Which is highly likely given that it lists some pretty specific - and new - types of hazard traits that they will consider using in regulation.  Besides the usual acute and chronic toxicity studies, they also include:

• Carcinogenicity
• Cardiovascular toxicity
• Dermotoxicity
• Developmental toxicity
• Endocrine effects
• Epigenetic toxicity
• Specific organ toxicity (e.g., liver, kidney)
• Neurotoxicity
• Ocular (eyes) and Ototoxicity (ears)
• Respiratory toxicity
• and more!!

For environmental hazard traits, besides acute and chronic toxicity they suggest:

• Wildlife survival impairment
• Wildlife reproductive and developmental impairment
• Wildlife growth impairment
• Non-target phytotoxicity
• Loss of genetic and biodiversity
• Eutrophication
• Ambient ozone formation
• Global warming
• and more!!

Quite a list.  

Getting TSCA Chemical Reform Right - Are We Close?

What’s important is that we do it right. With 96 percent of all manufactured goods touched by chemistry, any new law must protect public safety without destroying jobs or America’s ability to continue leading the world in innovation.

Such are the words of Cal Dooley, President and CEO of the American Chemistry Council, one of the leading trade associations representing the chemical industry.  Dooley, who is a former Congressman so knows how the political process works, was responding to an editorial in the Las Vegas Sun. The editorial supported the idea that chemicals on the market should be tested to "ensure product safety."  The paper asserted that "manufacturers can simply refuse to test their chemicals, allowing them to claim that they do not have information on toxicity or cancer-causing potential."

Dooley took exception to some of what the editorial said, saying that the editorial "significantly exaggerates the state of the nation’s product safety regulations, serving to confuse rather than inform your readers."  He agrees that the current TSCA law "needs to be updated," and reminded the Sun that the American Chemistry Council "has been participating in the public discussion of this for the past two years."

Yesterday I mentioned that "jobs" had become a new catchword for TSCA reform.  In his letter to the editor, Dooley noted that "in Nevada alone, our industry contributes to over 2,000 direct jobs, and for every chemical industry job, an additional 1.7 jobs are created within the state’s economy. With an unemployment rate at an astounding 14.2 percent, Nevadans should look carefully at any new regulation that might affect their jobs, and not just accept proposals at face value."

The key to all of this is getting TSCA reform right.  Advocacy groups want all chemicals to be tested; industry wants to have a focused, prioritized testing regime that is more manageable for both them and EPA.  They rightly point to the massive ongoing REACH effort, including the creation of an entirely new chemicals agency to handle the receipt of tens of thousands of data dossiers. Given that EPA is unlikely to get that kind of new funding, a more workable solution that provides data on the most toxic and/or most widely used chemicals is probably closer to being "doable."

With TSCA Chemical Reform Likely to be Pushed Off Until Next Year - What Happens Now?

TSCA reform is dead.  Long live TSCA reform.

Okay, maybe too melodramatic.  But it would seem that the chances of passing a TSCA bill anytime in this session of Congress are pretty much done.  So with that in mind, what's next?  The answer of course is nobody really knows, and we aren't likely to know until after we see the outcome of the elections in November.

But we can make some guesses.  To begin with, we can assume that some sort of bill will be reintroduced in the next Congress, probably mid to late next year (2012 is a presidential election year).

First off, it is highly likely that the final reintroduced bills will shift toward a less data intensive system.  By that I mean that there will not likely be a requirement for all existing chemicals to have a complete data set produced and submitted to EPA in the fashion of REACH in Europe.  Even with the tiered approach (i.e., chemicals of highest tonnages are required to register first, smaller tonnages later), the REACH system has been a huge burden on industry.  Massive numbers of man-hours, costs, and coordination among sometimes hundreds of competitors to produce data dossiers have been needed, plus several years of activity, to get to a point where companies are struggling just to pass the initial completeness checks.  And then only 5% of those dossiers are required to be reviewed by the chemicals agency.  That's a lot of work to fill a lot of file cabinets.  But does it make us safer?  Not in the short run at least because it will take years of review even for those 5% to see if there are any risks.

Secondly, look for lots of action in the states. There are two reasons why industry has been publicly in favor of TSCA reform.  The first is simply public relations.  But the second is because they understand that TSCA reform is needed to avoid the patchwork of 50 sets of state regulations.  In the past industry had to worry about only a few states "going proactive," (e.g., California), but now there are many states who have been actively trying to ban specific chemicals, put restrictions on the use of chemicals like phthalates in baby bottles, and banning plastic bags.  And that is no accident.  Advocacy groups have actively worked with states to develop state-level regulations in an effort to push the federal-level process along.

Thirdly, look for Democrats (assuming they maintain control of both houses of Congress) to figure out how TSCA reform will help create jobs.  With the country still in the throes of a recession, and with predictions that it might be a while before we get the unemployment rate down, jobs are on everyone's mind.  The code word "jobs" was dropped by representatives of both parties in the House hearing held at the end of last month.  And industry representatives have been quoted saying that the new law cannot inhibit innovation or cost the industry jobs.  So if lawmakers want industry input they have to include the "jobs" code words in their language as they move forward.

Finally, this is an opportunity.  While no one could credibly argue that the process of TSCA reform is moving too fast (it took years of promises before the bills were introduced), the time between now and the reintroduction can be used wisely by all stakeholders to ensure the best combination of protection of human health and the environment with a workable plan that encourages job creation, green chemistry, and innovation.  Now is the time for everyone to put in a good faith effort.  I'm just not sure everyone is ready to do that.

Summary highlights changes between discussion draft and the formally introduced House TSCA chemical control reform bill

The recently released TSCA reform bill in the house has garnered a lackadaisical response from most stakeholders.  Sure, there have been statements from major stakeholders, but mostly these have been generic and in accordance with pre-scripted talking points.  In large part this is because all parties feel that the bills won't go anywhere in this session of Congress and will have to be reintroduced in some version in the next Congress, which may look quite different than it does now.


Still, this is the time to be working out the differences.  That said, will stakeholders and Congress start the process now, or just take a wait and see attitude until next year.  Until that time, these are the main changes between the "discussion draft" floated by the House in April and the current formal House bill.  Needless to say there are still differences between the House and Senate versions to deal with as well.

Mixtures. The legislation addresses concerns about the burden and workload associated with regulating all mixtures distributed in commerce by clarifying the definition of “mixture,” by allowing the Administrator to group multiple mixtures for treatment under TSCA, and by making the Administrator’s authority to regulate mixtures discretionary in all cases.

Safety standard. The legislation incorporates suggestions for making the safety standard more workable by modifying the standard to be based on the intended uses of the substance only, while still providing the Administrator authority to consider exposures associated with known or foreseeable uses that are not identified as intended uses.

New Uses and New Chemicals. To increase workability and support innovation, the scope of the pre-manufacture notice requirement for new mixtures and new uses has been changed significantly. Under the legislation, no new use of a chemical substance or mixture will require pre-manufacture notification unless the chemical substance or mixture has already received a safety standard determination. New mixtures will also be able to enter the market without satisfying the requirements of Section 5 of TSCA, as will chemical substances exempted because of their intrinsic properties and chemical substances approved as safer alternatives.

Minimum Data Set (MDS). The legislation provides more detail about the components of the MDS and improves the workability of the submission requirements by staggering submissions based on production volume. The bill also provides greater flexibility to the Administrator in determining the penalties for a failure to meet the requirements of a test rule or order.

Confidential Business Information (CBI). The legislation reduces the burden of reviewing requests for confidential treatment of information by requiring the Administrator to review only a representative sample of confidentiality designations and imposing penalties for wrongful designation. The legislation also responds to concerns by allowing for renewal of designations.

Penalties. The legislation provides greater flexibility to the Administrator in determining the penalties for violations committed by an individual manufacturer or processor to avoid unnecessary commercial disruptions.


Exemptions Based on Intrinsic Properties. The legislation responds to concerns about the burden on the Environmental Protection Agency to evaluate chemical substances known to be safe by creating a new exemption from core requirements of the Act for chemical substances or mixtures that have been determined by the Administrator to be safe based on their intrinsic properties.

Safer Alternatives and Green Chemistry and Engineering. This legislation improves and clarifies the process and requirements for approval of safer alternatives to existing chemical substances and mixtures. The legislation also requires the Administrator to promote and support green chemistry and engineering research and to establish a green chemistry workforce education and training program.

International Cooperation and Agreements. This legislation clarifies the obligation of the Administrator to cooperate in international efforts on chemical safety. The bill clarifies and improves the procedures to be implemented if and when the United States becomes a party to designated international agreements on the regulation of chemical substances and mixtures, to ensure that U.S. efforts are consistent with applicable obligations under those agreements.