EPA holds hearing on HPV chemical test rule

As noted a few weeks ago, EPA is working on a new proposed test rule for High Production Volume "orphan" chemicals.  The rules are authorized under Section 4 of TSCA and are designed to obtain test data that the Agency needs to better assess risk.  That was the third such rule proposed.  Well, last week EPA held a public hearing to get input on the proposed rule.  And not everyone thought testing was needed.

The sometimes odd pairing of industry and animal welfare groups again were on the same side, with industry objecting to the need to conduct some of the testing and animal welfare groups like PETA objecting because much of the testing uses animal models like rats.  Others were supportive of testing, noting that without actual data it is difficult for EPA to make sound scientific assessments of risk.

Since this is a proposed rule it will need to be finalized and published again in the Federal Register before manufacturers will be required to provide data.  EPA Chemical Control Division chief Jim Willis suggested that the final rule for this third group of HPV chemicals could be issued within 6 to 9 nine months, though he admitted that timeline was optimistic.  It seems even more optimistic when one considers that the 2nd proposed HPV orphans rule was issued in July of 2008 and to date that one still has not been finalized over two years later (though Willis did suggest it may be made final within the next month or so).

Meanwhile, EPA is working on a 4th proposed rule, though it seems it is still in the very early stages of development.  Look for that one sometime in 2011.

So while Congress sits on the proposed TSCA reform bills, EPA is trying to work within the current TSCA system.  Given that all of these test rules are for chemicals that are HPV "orphans," that is, chemicals produced in high volumes yet for which none of the manufacturers stepped forward voluntarily to provide data under the HPV Challenge program, it seems that TSCA has only limited ability to address chemical concerns in a timely fashion. 

New Polling Data Indicates Overwhelming Public Support for Chemicals Regulation

My title is cribbed from the Safer Chemicals Healthy Families (SCHF) announcement of a new poll conducted by the Mellman Group.  According to SCHF, the public opinion poll "finds overwhelming public support for reforming our out-of-date system for managing chemicals."  Furthermore, this support apparently was "regardless of political affiliation," in that "voters are much more likely to support a candidate for public office who promotes better health and safety standards for chemicals."

I haven't read the entire poll yet, but the results SCHF reports are actually somewhat surprising.  Despite the current political environment that seems to favor less government intervention, and at least according to SCHF, there is widespread concern about our exposure to chemicals:

The majority of respondents said they think the threat posed by everyday exposure to toxic chemicals is serious (73%, with 33% saying it is "very serious"). 78% said that the threat posed to children by exposure to everyday toxic chemicals is “serious.” (45% called the threat “very serious.”)

Not surprising, however, is that the poll also seems to suggest that the public looks unfavorably on the chemical industry, with 45% of the public viewing the industry in a bad light.  That pretty much is status quo for the chemical industry, who despite their stewardship efforts are often seen as the bad guys (usually when some chemical is in the news or we find out it is in the blood stream of babies).

All of this plays out in a time when it is likely nothing will happen with TSCA reform this year.  With only a handful of actual legislative days left on the calendar, and a lot of incumbents facing their most challenging reelection bids ever, Congress is in no hurry to pass a bill.  So that 74% of the public that supports stronger controls on "toxic chemicals" will have to wait until at least next year.  And with Congress likely to look a lot different when it gets sworn in next January, the fate of TSCA reform could range from a bill that is workable to no bill at all.

A PDF of the poll can be seen here or on the Safer Chemicals Healthy Families web site.

Small Chemicals Business Group Says No to New Regulations

The Society of Chemical Manufacturers and Affiliates (SOCMA) issued a call last week for Congress "to avoid imposing large, new financial burden that would threaten their businesses."  SOCMA is concerned that several pending bills, in particular "those to reform the Toxic Substances Control Act (TSCA) and another designed to tighten chemical security laws by mandating product substitution, could significantly add to the financial burden of complying with regulation."


Organizations like SOCMA serve the batch, custom and speciality chemical industry, which are mostly smaller and mid-size companies.  Unlike the bigger multinational companies, these smaller producers have fewer resources to deal with new requirements. 

Which is why the TSCA reform proposals on the table now have provisions to help small and medium sized businesses.  Whether they are enough or sufficiently balance the needs of specialty businesses with the needs of the public to know that chemicals have been demonstrated to be safe is still open to debate.  As SOCMA notes, there is a "high likelihood that the next Congress to convene early next year will look very different from this one."  And that could mean significant differences in what the final TSCA reform bills look like.

Does the BPA debate epitomize the need for reform of the TSCA chemical law?

At least one person thinks so.  Writing in the online OnEarth Magazine, Wendy Gordon believes that the seemingly endless debate over BPA - the chemical used in myriad plastic bottles and other products - is a strong signal of the need for TSCA reform.  She laments that "[a]fter more than 10 years of research involving hundreds of studies, government health officials according to The New York Times (September 6, 2010) "still cannot decide" whether the science is adequate to regulate BPA more strictly, an action the Food and Drug Administration has the authority to take but just won't, or can't...or would rather put off until after the next round of studies."

And herein lies a recurring problem with chemical regulation.  How much data are enough?  Rarely are the data so overwhelmingly clear that a particular chemical will definitely create adverse effects that the path forward is obvious to regulators, industry, and NGOs alike.  Rather, the norm is that there are some data that suggest, maybe even strongly suggest, that there are concerns.  But then the realities of decision-making come into play. What is the threshold of concern for taking action?  Should BPA, as an example, be banned outright based on the data we have?  Or should more studies be conducted to dig deeper into the specific concerns suggested by earlier studies?  These are often more value judgments than clear scientific direction.

The answer is that we don't have an answer. Each case will be different as the circumstances of hazard and exposure will be different from one chemical to another and one use pattern to another.  Which is why the debate seems to go on and on with no resolution.  Given the significant business and personal consequences of making the wrong decision - banning something that doesn't need to be or not banning something that should be - clearly a better process is required.

Will the proposed TSCA reform bills now sitting idle in the House and Senate be that better process?  It seems like it could be a moot point given the current predictions for the fall elections in the US.  No matter what happens in November the bills will have to be reintroduced in the next congress and the debate will start anew.  But the direction the bills take could be significantly affected by the make up of the two bodies of governance.

Or perhaps, as Wendy Gordon suggests, we will just see the continuation of "endless debate."

Global Warming Requires Global Action According to UN

UN Secretary-General Ban Ki-moon has called for "global leadership" and a "new way of thinking" in dealing with climate change.   Speaking at Liechtenstein's Vaduz-Saal, the UN chief emphasized the world has become a smaller place, where the activity of 7 billion humans and growing can have global impacts.  He cautioned that "We must think green, too – an ambitious climate change agreement -- and environmental governance that protects the resource basis."  His full speech can be read here.

While all parties work to protect their own interests - the wealthy countries their status of living and the poor countries their options for the future in a world for which they largely aren't responsible.  But in another sense, we are all in this together.  This planet is the only one we have, and our actions are having dramatic and long-term effects on the climate in which future generations will have to live.  We have a responsibility to be good stewards for our children and grandchildren.  How we proceed will tell them more about us than how big the wide screen TV is that we bring home.

According to Ban Ki-moon:

What I mean, quite simply, is sovereign states coming together -- pragmatically, as partners.

I mean people transcending borders and narrow national identities to defend against common threats – and to seize common opportunities.  

European Chemicals Agency Proposes More Substances of Very High Concern

The European Chemicals Agency (ECHA) in Helsinki, Finland, last week announced the addition of 11 more substances of very high concern (SVHCs) they intend to put on the REACH candidate list.  Chemicals on the candidate list could eventually end up on Annex IX of REACH, after which they could be banned or severely restricted from the market unless "authorized" for specific uses and only for limited periods of time while alternatives are developed.

Stakeholders have until October 14, 2010 to comment on the addition of the substances to the candidate list.  So far all of those proposed have been added, totally nearly 40 to date.  Commenters are asked to focus on hazards of the chemicals since that is the focus at this point.  If companies apply for Authorization then use patterns, exposure and risk will be considered in final decision-making.

The candidate list as it currently stands can be found on ECHA's web site.

States push for TSCA chemical control law reform

ECOS, the Environmental Council of the States, held its annual meeting last week and among other activities passed a resolution calling for reform of the 34-year old Toxic Substances Control Act.  ECOS is an organization of state environmental agency leaders.

According to the resolution, which can be downloaded here, ECOS supports congressional action that would place the onus on the chemical industry to prove their chemicals are safe, to give EPA sufficient authority to ensure that chemicals are safe, including the ability to do so in a timely fashion, to provide EPA with a mechanism by which they can share confidential business information they receive with the states, to require safer alternatives (substitutes), and authorize EPA to take expedited action when a chemical presents "imminent or substantial endangerment or is persistent, bioaccumulative and toxic (or very persistent and very bioaccumulative whether or not it is toxic), etc.

The states have been very active in pushing for federal legislation because otherwise they would have to undertake state-level legislation, which not only is a burden to the states but a burden to industry who could be faced with complying with 50+ different state regulations.

Given the current lack of federal action likely before the mid-term elections, the states will have to wait until next year for TSCA reform on a national level.

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.