26 Advocacy Groups File Comments in Support of EPA Policy to Limit Confidential Business Information

Back in May 2010 the USEPA issued a "Notice of General Practice of Reviewing Confidentiality Claims for Chemical Identities in Health and Safety Studies Submitted Under the Toxic Substances Control Act (TSCA)."  Today twenty-six health, labor and environmental advocacy organizations filed a 19-page set of detailed comments "voicing resounding support for a long-overdue change" in EPA's policies.

In short, EPA will no longer accept routine claims of confidentiality for chemical names when companies submit what are called TSCA 8(e) notices, i.e., reports of significant adverse effects.  Companies are required to report immediately if they become aware of such significant effects, usually as a result of toxicity testing that indicates unexpected levels of toxicity.  These health and safety studies themselves cannot be held confidential, but the advocacy organizations argue that by withholding the name of the chemical tested the health and safety result is meaningless.  After all, the public would have no idea on what chemical the study was conducted. [EPA, of course, does know what chemical is being reported, but the portion made public may be significantly redacted to protect competitive advantage for the company, which is important for example if the chemical is being newly developed for the marketplace or a new use in the marketplace.

One of the primary advocacy organizations preparing the comments is the Environmental Defense Fund, which has played a leading role in the advocacy community when it comes to chemical safety issues.  More information on the EPA action and the 26 advocacy groups can be found on EDF's web site.

OSHA Wants You - To Help Identify Top Chemicals of Concern

The Occupational Safety and Health Act - OSHA - is looking for input from stakeholders as they seek to update and set new Permissible Exposure Limits (PELs).  Most of OSHA's PELs are old, and many wonder if the data on which they were based are sound.

PELs are "regulatory limits on the amount or concentration of a substance in the air."  They have been one of the primary mechanisms by which OSHA sets and enforces standards for "preventing occupational illnesses and injuries." 

By asking for input, OSHA is hoping to incorporate substantial advances in the science and our knowledge of chemical since PELs were first adopted decades ago. In particular there is concern that new methods of analyzing chemicals to very low levels and better understanding of more subtle effects has resulted in many of the PELs being set too high, i.e., they are no longer sufficiently protective of public health.

So, "as an initial step," OSHA wants to here from you, and me, and anyone with input so that they can identify the chemicals of most concern.  OSHA recommends that "when nominating a particular chemical, please include the criteria you used for selecting that chemical for nomination (e.g., the OSHA PEL is inadequate, there is widespread use of the chemical and potential worker exposure)."

OSHA has provided an online form for nominations and criteria of chemicals of concern.

EPA to Issue HPV Chemical Test Rule; Hold Public Meeting

EPA is preparing to issue a new HPV test rule.  This will be the third (or possibly fourth) such rule, though only one of them has ever gone final.  The test rules, issued under the authority of TSCA Section 4, are designed to require testing of chemicals that are "orphans" of the High Production Volume Chemical Challenge Program.  These lost orphan chemicals are one reason why TSCA reform is needed.

So what is an orphan?  When the HPV Challenge program started in 1998, with much fanfare as then Vice-President Al Gore made the Earth Day announcement, there were high hopes that industry would voluntarily provide data on about 2800 of the highest production volume chemicals in the US.  The program had some caveats to it, which I won't rehash here, but by the (extended) 2005 completion date only about half of the chemicals had full data packages submitted.  Five years later that number has barely moved.  And that doesn't even count all the chemicals that have become HPV since the initial program list was written in stone.  It also doesn't include several hundred chemicals for which no one even bothered to volunteer data.  These are the "orphan" chemicals.

EPA has been trying to require testing for these nearly 300 unsponsored "orphan" chemicals.  They have gone through the iterative process of identifying the need, establishing the regulatory authority, and publishing "Proposed Test Rules" in the Federal Register.  Following comment periods these rules should be finalized and the required testing begun by the manufacturers.  In reality the proposed rules have languished unfinalized for a very long time, the earlier ones measured in years.  Only one has become final.

Today the EPA is supposed to announce an open meeting to be held on September 9th to listen to comments from interested parties, including the general public, the manufacturers and downstream users, and various health and environmental advocacy groups.  Here is the link to the meeting announcement.  Still, one has to wonder whether this is just another baby step to nowhere.  The elections are still a little over 2 months away, and Congress is hunkered down in reelection mode with no energy or desire to do any legislating.  Meanwhile, stakeholders in industry and the advocacy communities appear to have gone into bunker mode in an attempt to protect their individual objectives.  So whether this action means much is anyone's guess.

HBCD - A Flame Retardant by Any Other Name

As mentioned previously, EPA has issued three new "action plans" for chemicals that they believe need greater attention.  One of these is Hexabromocyclododecane, or thankfully, simply HBCD.  So what is the big deal with HBCD?  Well, according to EPA, HBCD is "used as a flame retardant in expanded polystyrene foam in the building and construction industry, as well as consumer products."  That means it gets into a lot of houses, or at least into the foam insulation used in a lot of houses and other buildings.

EPA also says that HBCD is "persistent, bioaccumulative and can undergo long-range atmospheric transport." These have become big qualifiers for chemical concern.  If something is persistent it means it can stay in the environment for a very long time.  And if it is bioaccumulative it means all that chemical in the environment could possibly build up in the bodies of plants and/or animals, then the animals that eat those plants or animals, then the animals that eat those animals, etc.  But the "long-range atmospheric transport" is an added concern.  That means that the chemical could persist and bioaccumulate not only near where it is released into the environment, but in remote locations like the Arctic. 

Add in EPA's contention that "studies show HBCD is highly toxic to aquatic organisms" and that "health concerns include potential reproductive, developmental and neurological effects in humans," and you have the reason why they feel they need a plan of action.

But as I've discussed in the past, these actions are planned for the future, or in some cases, just the consideration of taking action is planned for the future.  Given the old adage that a plan is obsolete as soon as it is printed, the actual actions taken by EPA and industry could be much different when they actually take place.  But for now, EPA's plan to deal with HBCD is to:

• Consider initiating TSCA §5(b)(4) Concern List rulemaking on HBCD. Proposed rule in late 2011.
• Initiate TSCA §5(a)(2) Significant New Use Rule to designate HBCD use in consumer textiles as a flame retardant as a significant new use.
• Consider initiating rulemaking under TSCA §6(a) to regulate HBCD.
• Initiate rulemaking to add HBCD to the Toxics Release Inventory. Action expected in late 2011.
• Conduct a Design for the Environment and Green Chemistry alternatives assessment of HBCD.

Nonylphenols and Nonylphenol Ethoxylates - Why the EPA Action Plan?

Yesterday I noted that three new action plans had been posted by EPA in their continuing efforts to deal with chemicals they believe are in need of immediate review.  One of them is Nonylphenol (NP) and its cousin Nonylphenol Ethoxylate (NPE).  So what does EPA want, and why?

Well to begin with, NP and NPEs are produced in extremely large amounts.  And unlike some basic chemicals that are used primarily to make other chemicals, uses of these can, as EPA puts it, "lead to widespread release to the aquatic environment" (e.g., from industrial laundry detergent use).  Add in the fact that NP is a PBT, i.e., it is persistent in the aquatic environment, has a low to moderate ability to bioaccumulate in animals, and is "extremely toxic" to aquatic organisms and you have legitimate cause for concern.  One particular concern is that NP has been found in umbilical cord blood and breast milk, and "toxic burden" or "toxic trespass" (depending on your vantage point) is a hot button issue with most people.  As is the possibility of estrogenic effects (i.e., endocrine disruption).

So EPA wants to get more information and take some steps to reduce the risks they have already identified.  To do that they have proposed to work with the Textile Rental Services Association of America (TRSA) to continue with a phaseout of NPE use in industrial laundry detergents.  The phase-out, already in progress, is being coordinated with EPA's Design for the Environment (DfE) "Safer Detergents Stewardship Initiative."

Besides voluntary industry efforts, EPA is also looking at rule-making, in particular a TSCA section 5 SNUR (significant new use rule) and a TSCA section 4 testing program.  Both of these are authorities already given to EPA under the 34-year old TSCA law whose modernization has been the subject of debate for quite some time.  EPA is also considering another option it has under section 5 of TSCA, which is to add NP and NPEs to the "Concern List," a list of chemicals for which they believe "present or may present an unreasonable risk of injury to health or the environment."  While the authority has always been there to create such a list, EPA has never used it.

Finally, EPA would initiate a rule-making to add NP and NPEs to the Toxic Release Inventory (TRI).  The TRI requires companies to report their emissions of a list of chemicals, though that list is pretty short when compared to the list of chemicals that were grandfathered onto another "inventory," the TSCA Inventory of existing substances that largely have received no testing or evaluation since being listed over 30 years ago.


The timing for these actions varies from later this year to next year to not for several years.  Phase-outs obviously take time, as does the rule-making process in which EPA must propose a rule, allow a reasonable time for comments, address all of the comments received, and then issue a final rule with the appropriate revisions.  Sometimes rules don't ever become final, but that's a subject for another post.

EPA Issues Three New Action Plans to Assess Flame Retardants, Dyes and NonylPhenols

The USEPA posted on their web site three new "action plans" in their continuing efforts to "strengthen and reform chemical management" and make the most of the authority under the current chemicals law, TSCA, while Congress debates ways to modernize it.  These plans summarize EPA's intent to regulate potential health risks of benzidine dyes, hexabromocyclododecane (HBCD) and nonylphenol (NP)/nonylphenol ethoxylates (NPEs). According to their release, "the chemicals are widely used in both consumer and industrial applications, including dyes, flame retardants, and industrial laundry detergents."




Benzidine dyes are primarily "used in the production of textiles, paints, printing inks, paper, and pharmaceuticals."  EPA's main concern is the potential for these dyes "to be leached from textiles, such as clothing, that are in prolonged contact with human skin." According to the action plan, EPA believes that the following actions would be warranted:

1. Initiate rulemaking to add four benzidine-based dyes to an existing TSCA section 5(a)(2) significant new use rule (SNUR) for benzidine-based substances at 40 CFR 721.1660. A SNUR requires manufacturers who intend to use a chemical for the identified significant new use to submit an application to the Agency for review prior to beginning that activity.
2. Initiate rulemaking to establish a new TSCA section 5(a)(2) SNUR for benzidine congener-based dyes, including 44 specific such dyes.
3. Consider proposing to eliminate the article exemption applied to SNURs to address potential concerns for exposure to these dyes on imported finished textiles.
4. Consider initiating action under TSCA section 6, if EPA learns that these dyes are present in imported finished textiles.
5. Consider additional regulatory action, if EPA determines that there are other ongoing uses for these dyes and needs to obtain information necessary to determine whether those uses present concerns which need to be addressed.

Similar actions are planned for nonylphenol and nonylphenol ethoxylates.  NP and NPE are "nonionic surfactants that are used in a wide variety of industrial applications and consumer products. Many of these, such as laundry detergents, are “down-the-drain” applications."  EPA is especially concerned because NP and NPEs are manufactured in very large volumes, and due to their common usage in detergents lead to "to widespread release to the aquatic environment."  NP is persistent, bioaccumulative and extremely toxic in the environment, and according to EPA "has also been shown to exhibit estrogenic properties in in vitro and in vivo assays.



The third action plan is for the brominated flame retardant, hexabromocyclododecane.  HBCD is "used in expanded polystyrene foam (EPS) in the building and construction industry, as well as in consumer products. People may be exposed to HBCD from products and dust in the home and workplace, as well as its presence in the environment."  EPA's concern with HBCD is that it is persistent, bioaccumulates, can be transported long distances, and there are "animal test results indicating potential reproductive, developmental and neurological effects."


I'll take a look at these further in future posts, but for now you can access the full documents at:

Benzidine Dyes

NP and NPE

HBCD

California OEHHA to Hold Public Workshop on Green Chemistry

As I noted last week, California EPA's Office of Environmental Health Hazard Assessment (OEHHA) issued a "pre-regulatory draft" of a hazards traits document. Now they have announced that next week, Monday, August 23, 2010, OEHHA will hold a workshop to discuss the draft, which is called "Green Chemistry Hazard Traits, Endpoints, and Other Relevant Data."

According to OEHHA, the draft document:

"identifies and defines the hazard traits; lists general categories of endpoints and other relevant data for each toxicological and environmental hazard trait; provides general methods for determining whether or not a chemical has a toxicological hazard trait; and provides specific methods for determining whether or not a chemical has carcinogenicity, developmental toxicity or reproductive toxicity hazard traits." 

The workshop will take place at the California EPA headquarters in Sacramento.  For more information on the workshop, timing and directions go to the OEHHA page.

Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray

According to a Federal Register notice published on Friday, August 13th, EPA is announcing the release of a draft document entitled “Nanomaterial Case Study:  Nanoscale Silver in Disinfectant Spray" and opening it up for a 45-day public comment period (which ends September 27, 2010). The draft was issued by the National Center for Environmental Assessment within EPA's Office of Research and Develpment, and is "intended to serve as part of a process to help identify and prioritize scientific and technical information that could be used in conducting comprehensive environmental assessments of selected nanomaterials."  At this point the document doesn't draw any safety conclusions regarding nanoscale silver, just what is known and unknown so that they can make decisions on what to require for future assessments. 

The document can be found on the NCEA web site. 

From the site, "engineered nanoscale materials...have been described as having at least one dimension between 1 and 100 nanometers (nm). They often have novel or unique properties that can arise from their small size.  Like all technological developments, nanomaterials offer the potential for both benefits and risks.  The assessment of such risks and benefits requires information, but given the nascent state of nanotechnology, much remains to be learned about the characteristics and effects of nanomaterials."

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.

New design for The Dake Page

Okay, I'm working on a new design template for The Dake Page. 

See, for example, the link tools below. You can email the article to someone you think would find it interesting.  You can also tweet it to your Twitter account or share it on your Facebook...or link to your blog or even Google buzz it.

Let me know if the new design is better...or worse...or the same.