EPA Takes Next Step in Test Rule for BPA

Almost a year ago the EPA issued a Chemical Action Plan (CAP) for bisphenol-A, commonly called simply BPA, a chemical used in many plastics.  And just before the holiday break EPA took the next step in managing what it sees as potential risks of BPA by sending a proposed test rule to the Office of Management and Budget (OMB).  The proposed rule looks to require toxicity testing related to environmental effects, including the potential for endocrine disruption.

No human health-related testing is being proposed at this time since most human exposure seems to be through packaging and that comes under the jurisdiction of the Food and Drug Administration.  FDA and the Centers for Disease Control are undertaking new studies.  But EPA is looking at evaluating the potential for environmental exposures from BPA in surface, ground, and drinking waters, and also may request monitoring near landfills, soil and sediment, as well as other sources of BPA leakage.

It's unclear how long OMB will take in its review.

The CAP for BPA can be downloaded here.

Other action plans and information can be found on EPA's Existing Chemicals web site.

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)

ECHA says over 3.1 million chemical classification and labeling notifications received in Europe

By the January 3, 2011 deadline, the European Chemical Agency (ECHA) received 3,114,835 notifications of 24,529 substances under its Classification, Labelling and Packaging (CLP) regulation.  All of these notifications go on the C&L Inventory and are accessible on ECHA's website.  Any chemical substance that is hazardous or subject to registration under REACH were required to be notified.  In their press release, ECHA Executive Director Geert Dancet noted:

This is a perfect start for the International Year of Chemistry. The Classification and Labelling Inventory, which will be publicly available later this year, will significantly improve safety by providing up-to-date information on all the hazardous substances that are on the EU market today.

Many manufacturers and importers notified as part of their REACH registration that was due November 30, 2010.  But others who produced or imported less than 1000 metric tons per year, and thus have either a 2013 or 2018 REACH registration deadline, were also required to notify if their substances or mixtures were classified as hazardous according to the CLP.

As expected, the big three chemical manufacturing countries in the EU - Germany, the UK and France - were the source of the greatest number of notifications.  Between them they accounted for over half of all the notifications received.

What if you missed the deadline for notification? Do it NOW!  ECHA has provided some Q&A on the C&L Inventory and notification procedures if you haven't do so already.

More details on the notifications can be found in this PDF.

The New Congress is in Session with the GOP in Charge of the House - And Industry is Worried

Yes, you heard right.  With Republicans taking over control of the House of Representatives and gaining seats to increase their minority position in the Senate, it seems industry is more than a little worried about the outcome.  In short, industry likes regulatory certainty, even if it means more regulation.  Industry can plan and invest and make business decisions when they know what requirements they need to meet.  Uncertainty (ironically) is a big old wet blanket on innovation and investment.


So while industry isn't going to be out there begging for stronger regulations, they do see a quagmire of uncertainty as Republicans follow through on their promises to put their legislative efforts into oversight investigations rather than regulatory predictability. Areas of environmental regulation that could be in a state of unrest include climate change and TSCA reform.  With last year's attempt to pass cap-and-trade legislation effectively dead for at least the next two years, new House Energy and Commerce Chairman Fred Upton has said he will fight EPA rules regulating greenhouse gas emissions.  Fellow Republican John Shimkus, who lost his bid to chair the committee to Upton, has been assigned a key subcommittee chairmanship, from whence he has promised also to hold hearings on EPA's authority to regulate greenhouse gases.  On the TSCA reform side, what seemed like a clear path forward in the last Congress appears now to be in a state of confusion as to how, or if, legislation to reform the now 35 year old law can be accomplished.

All of this has industry very very worried.  There is a general feeling among industry leaders that attacking the EPA, which was started by a Republican President by executive order, could be going too far and would not only create a potential for backlash but effectively stymie industry attempts to rebuild their way out of the deep recession.  Many in industry actually very much want to see government incentives for innovative new technologies, including green technologies.  And that could be severely debilitating to the utility and other energy-intensive industries.

What industry most wants now is not some partisan gamesmanship from the GOP but rather some regulatory certainty, and for climate change and EPA's greenhouse gas emissions rules, industry acknowledges that some control of CO2 emissions is both an environmental necessity and offers a regulatory certainty that will allow them to innovate.  Without some sort of certainty, industry will continue to sit out the recovery while China and other countries continue to pass by us in development of new renewable technologies.

It's January 1st, where is California's Green Chemistry Law?

Not in California.  At least not yet.  The California Department of Toxic Substances Control (DTSC) has missed the January 1, 2011 deadline for issuing its final Safer Chemical Product Alternatives (SCPA) regulations - aka, the green chemistry regs.  The regulations remained unfinalized in part because of severe criticism that the draft regulations didn't go far enough.  Even the primary legislative sponsor of the green chemistry bill, Assemblyman Mike Fleuer, felt the rules were not strict enough.  Many critics felt the proposed rules had been watered down so much that they would actually reverse progress that had already been made to control chemicals.

The plan is to revisit SCPA this month (or so) and try to beef them up.  One major concern is that the proposed regulations would make it easier for manufacturers to replace chemicals that were identified as harmful with other chemicals in which no determination of safety had even been made at all.  Hardly the best option, as the world is full of examples of unintended consequences when eliminating one hazard without adequate assessment of the substitutes.

So it is back to the drawing board with an eraser and a thicker pencil.  The goal seems to be to "get it right" instead of just get it done by the deadline.  The delay also shifts the burden to the incoming Democratic Governorship of Jerry Brown, though outgoing Republican Governor Arnold Schwarzenegger had also supported the green chemistry initiative.

Whatever form the final SCPA regulations take could have far-reaching ramifications.  As has happened in the past, as California goes, so often go other states and/or federal level regulations.  While certainly not a universal truth, the state does tend to be a trendsetter in this regard, in large part because the size of its economy requires companies that want access to its market must comply or lose out.  And companies much prefer to have one set of rules to live by, not 50 individual sets of (often conflicting) rules.

Happy New Year!