EPA Gives Advance Notice - Wants Input on Whether to Require Toxicity Testing on Bisphenol A

The USEPA is considering a rulemaking in which they would require additional toxicity testing on bisphenol-A, known commonly as BPA.  Yesterday EPA published an "Advanced Notice of Proposed Rulemaking" asking for public comment on whether and/or how they should require testing "to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations."  The notice is subject to a 60-day comment period.

According to the Federal Register notice, BPA is a high production volume (HPV) chemical and "is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic."  The concern is that while there have been quite a few studies conducted, many of these have what some believe are significant flaws, thus calling into question their validity and/or ability to be used for regulatory purposes.  BPA is a common ingredient in plastics and has come under intense scrutiny for its potential to be an endocrine disruptor.  Given the disagreement over the scientific evidence and the significant ramifications of a BPA ban (and the similarly significant ramifications of a lack of BPA should the potential adverse effects be demonstrated), EPA is seeking to conduct definitive testing to settle the science.

In addition to toxicity testing, EPA is also considering environmental monitoring to determine the levels of BPA in "surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases."  At present, the advanced notice is focused "only  toward the environmental presence and environmental effects of BPA."  While EPA continues to work with the Department of Health and Human Services on potential human health issues, it "is not considering any additional testing specifically in regard to human health issues at this time."

The full Federal Register notice can be viewed here.  The deadline for public comment is September 26, 2011.

EPA to Issue Test Rules for Remaining Unsponsored HPV Chemicals

Recently the USEPA published a final test rule requiring testing on 19 High Production Volume chemicals.  These were chemicals that were not sponsored by chemical manufacturers during the voluntary HPV Challenge program.  Since no one claimed them they came to be known as "orphan" chemicals.  And now EPA is planning to get the rest of them into the orphanage this year for testing.

At least that is the plan.

The reality is a bit less ambitious.  This second final test rule, which was published in the Federal Register only a week or so ago, was proposed way back in July of 2008...2-1/2 years ago.  The first final test rule was published in 2006 after having been proposed in the year 2000!  A third proposed rule was published almost a year ago and EPA hopes to get it final "sometime this year."  A fourth proposed rule is in the works.  The likelihood of the fourth rule going final this year is, well, not.

Even then this will cover only about 100 of the orphan chemicals from the 10-year long (plus 5-year overdue) HPV Challenge program.  There are several hundred other chemicals that are high production volume, that is, produced at over 1 million pounds per year, that are not even on EPA's radar to be proposed for testing.  And then there are the thousands of chemicals grandfathered onto the TSCA Inventory that have not been fully tested.  The orphan chemical question is one of the reasons put forth for why TSCA reform is so desperately needed.

All of this plays into the ongoing debate about what, or even if, will happen with TSCA reform this year.  The bills introduced last year are dead and new bills, should anyone in the House try to introduce one, will most likely have a different flavor than those from the last Congress.  A different flavor may or may not be a good thing, depending on your point of view, but the real question is whether there will be any flavor.  Industry says they want a federal law so they don't have to deal with a patchwork of state laws.  Environmental and health advocacy groups (NGOs) clearly want there to be TSCA reform.  Which would suggest that the path forward is clear.

But then.  This is Congress.

EPA Issues Final Test Rule for 19 Chemicals - With or Without TSCA Reform, EPA Moves Forward

In their continuing attempts to collect data on "orphan" chemicals, that is, those High Production Volume (HPV) chemicals for which no company volunteered to provide data under the HPV Challenge program, EPA has issued a final TSCA Section 4 Test Rule listing 19 specific chemicals and the tests they are requiring. The goal is to obtain the data EPA needs to assure "the safety of chemicals."  HPV chemicals are those produced in the US in quantities of 1 million pounds per year or more.

According to Assistant Administrator Steve Owens:

“This chemical data reporting will provide EPA with critical information to better evaluate any potential risks from these chemicals that are being produced in large quantities in this country. Having this information is essential to improve chemical safety and protect the health of the American people and the environment.”

Testing includes everything from physical/chemical properties to environmental fate to ecotoxicity to mammalian toxicity, which each chemical having a specific set of data being required within a specified period of time.

The 19 chemicals in this particular test rule are:

1. Acetaldehyde (CAS 75–07–0)
2. 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) (78–11–5)
3. 9,10-Anthracenedione (84–65–1)
4. 1H,3H-Benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone (89–32–7)
5. 2,4-Hexadienoic acid, (E,E)- (110–44–1)
6. Phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)- (118–82–1)
7. Methanone, diphenyl- (119–61–9)
8. Ethanedioic acid (144–62–7)
9. Methanesulfinic acid, hydroxy-, monosodium salt (149–44–0)
10. Phosphorochloridothioic acid, O,O-diethyl ester (2524–04–1)
11. 1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol (4719–04–4)
12. D-erythro-hex-2-enonic acid, gamma.-lactone, monosodium salt (6381–77–7)
13. D-gluco-heptonic acid, monosodium salt, (2.xi.)-   (31138–65–5)
14. C.I. Leuco Sulphur Black 1 (66241–11–0)
15. Castor oil, sulfated, sodium salt (68187–76–8)
16. Castor oil, oxidized (68187–84–8)
17. Benzenediamine, ar,ar-diethyl-ar-methyl- (68479–98–1)
18. Alkenes, C12-24 , chloro (68527–02–6)
19. Hydrocarbons, C>4 (68647–60–9)

Inspector General Inquires into EPA's Voluntary Children's Chemical Evaluation Program

The Voluntary Children’s Chemical Evaluation Program (VCCEP), which advocacy groups had criticized for years as ineffective and a "stall" by industry, was halted by the Obama administration.  Now it seems EPA’s Inspector General (IG) has launched an inquiry into the program because EPA has indicated it intends to model other programs on VCCEP.  The IG says it will determine “whether there are alternative mechanisms for achieving children’s health protection goals from chemical exposure.”

VCCEP was a product of the 1998 Chemical Right to Know Initiative, "the goal of which was to give citizens information on the effects of chemicals to enable them to make wise choices in the home and marketplace."  VCCEP itself was launched in December of 2000, and for many years was a focal point for EPA to work with industry to assess the potential effects of 23 chemicals on children's health.  Of the 23, only 20 were actually sponsored, with the chemicals selected being some for which children had a high likelihood of exposure. The intent was to have companies that manufactured or imported these chemicals to volunteer to provide information on health effects, exposure, risk, and data needs. Thirty-five companies in 10 consortia responded.

Unfortunately, 10 years after it was initiated the program seems to have not gotten past its initial pilot program.  Like the voluntary High Production Volume Chemical Challenge, the voluntary nature of the program resulted in actual participation dropping off as soon as the program fell out of the public's field of view.

The goal of the IG review is to learn from this experience before EPA initiates a new effort to assess the effects of chemicals on children's health.  Given the slow movement of TSCA reform in Congress, and the change in power structure for the next two years leading into a presidential election, EPA and others are looking for ways to carry on their mandate to protect public health, especially that of children.

More information can be found on the VCCEP program web site.

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.

Why TSCA Chemical Reform is Needed - The Lost Orphan Chemicals

As a Senate hearing on reform of the Toxic Substances Control Act (TSCA) gets underway today, word comes that EPA is working on a new rule that will mandate that companies who plan to manufacture or use dozens of High Production Volume (HPV) chemicals will have to provide the data EPA lacks before the agency will approves the new uses. The significant new use rule (SNUR) has been used before by EPA, but never to this extent. The SNUR is expected to be issued along with a new Section 4 test rule requiring data on "orphan chemicals."

And orphans are what I really want to talk about. Way back in 1998 a voluntary program called the HPV Chemical Challenge was initiated. Industry agreed to provide health and safety data on a list of about 2800 HPV chemicals, that is, chemicals that are produced at volumes of more than 1 million pounds per year. The program was supposed to be completed by 2003, later extended to 2005, and as of this writing in 2010 still has not been completed (though EPA long ago moved most of their resources to other programs). While there are many problems in compliance with the voluntary program, there were also several hundred chemicals for which no company stepped forward to sponsor. These "orphan chemicals" were the subject of three Section 4 test rules, plus the 4th that is now in preparation.

But the first one, originally proposed in 2000 but only finalized in 2006, is the only one that has actually been implemented...and then for only 17 of the original 37 chemicals proposed. The second and third test rules, covering only 19 and 29 chemicals respectively, have languished in the proposed stage as industry challenges the EPA request. Keep in mind that all EPA is doing is requiring there to be health and safety testing on chemicals that are produced in very high quantities and for which Agency experts suspect potential for hazard. Meanwhile, there are hundreds more "orphans" to be addressed, along with about 1800 other HPV chemicals for which industry did provide data and several hundred others for which industry promised to provide data but have failed to follow through.

This is just one of many examples of how the hurdles are so high for EPA under the current version of TSCA that they can't even require companies to provide health and safety testing on very high production volume chemicals. The process of even proposing such testing takes years and only a few chemicals can be addressed at a time.

Clearly the current TSCA law is broken in this respect. Perhaps today's hearing will help speed up the process of introducing the new bill. The time for action has arrived.

[Update on yesterday's post in which I suggested that perhaps Senator Boxer would be the one to sponsor the Senate version of the Kid Safe Chemical Act. However, I received a comment noting "on good authority that it is Senator Lautenberg who is writing the bill. Senator Boxer is still neck deep in Cap and Trade." Senator Lautenberg, of course, introduced the previous versions.]