EPA Finalizes Third TSCA Test Rule for HPV Chemicals

The USEPA is finally promulgating a final rule under Section 4 of TSCA "to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule."  The 15 chemicals represent only half of the 29 HPV chemicals that were listed in the the draft rule, which was originally proposed nearly two years ago on February 25, 2010.  According to EPA, based on comments received on the proposed rule, the remaining chemicals were dropped because they did not" meet the criteria for testing at this time."

For the 15 chemicals listed in this final rule, manufacturers will need to conduct the specified tests and provide the data to EPA prior to the deadline, which is set for the end of 2012.  EPA notes that "this test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety."  Required tests vary by chemical but can include physical-chemical properties, environmental fate and degradation, aquatic toxicity, mammalian acute and reproductive/developmental toxicity, and genotoxicity.

Companies that are effected by the rule must submit test plans for each chemical within 90 days of the effective date (i.e., 90 days from November 21, 2011).

The list of chemicals can be accessed here.

A full hyperlinked version of the Federal Register notice can be accessed here.

ECHA Goes to Commission on REACH Testing Proposal

How many Member State Competent Authorities does it take to make a decision on REACH testing proposals?  Apparently more than they have.  The Member State Committee (MSC) at the European Chemicals Agency (ECHA) "could not find unanimous agreement based on scientific and technical arguments on a draft decision for a testing proposal."

Let's go to the Commission!  For the first time ECHA will employ Article 51(7) of the REACH Regulation and refer a case to the European Commission for decision making.

This non-decision by the MSC took place last week.  Not that they were stymied on all decisions.  They did agree on the draft decisions "for all five compliance checks" they were charged with reviewing.  And they did come to unanimous agreement on two of the four draft decisions on "testing proposal examinations." But two testing proposals were particularly tricky.  For one, the MSC refined the proposal during the meeting and expect to agree in writing shortly. 

The final testing proposal reached stalemate, hence the referral to the Commission.  The proposal:

"concerns a testing proposal examination where the registrant has proposed to perform a two-generation reproductive toxicity test in accordance with the EU test method B.35. This information would be necessary to fill the data gap regarding reproductive toxicity for the substance that is produced in quantities of over 1000 tonnes per annum.  Some MSC members preferred to ask the registrant to use the recently adopted OECD test guideline 443, the extended one-generation reproductive toxicity study (EOGRTS). Others wanted to maintain the present requirement of performing a two-generation study."

No information on when (or if) the Commission will make its decision.

More on what the Member States Committee does can be found on their web page here.

Korea Joins Effort to Reduce Animal Testing of Chemicals - Find Alternative Methods

Europe has one (ECVAM), the United States has one (ICCVAM), and now Korea has one (KoCVAM).  Last week the Republic of Korea (i.e., South Korea)'s Center for the Validation of Alternative Methods (KoCVAM) officially joined a collaborative effort to find alternative chemical test methods.  The international agreement, the International Cooperation on Alternative Test Methods (ICATM), "was officially created in April 2009, when an agreement was signed between validation bodies from Europe, USA, Canada and Japan." 

The goal of collaboration is to develop and validate chemical testing methods that reduce, or preferably eliminate, the need for live animals (i.e., in vivo methods).  The non-animal methods (in vitro) can include any number of tests ranging from excised tissues, artificially grown tissues or cells, and genetic methods, as well as computer generated structure activity relationship (SAR) modeling.  The formal addition of KoCVAM to the agreement, it's fifth member, occurred during the 50th annual meeting of the Society of Toxicology in Washington DC.

With REACH entering its next stage, which includes review of proposed testing plans from the first registration deadline, and new chemical control efforts in Korea, Turkey, Switzerland and (maybe) the United States, a great deal of effort is being made to find alternatives to traditional animal testing.  REACH specifically encourages the use of non-animal methods such as QSARs, in vitro, ex vivo, and read-across from data available for related chemicals. 

For more information.

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.

Chemical Companies Register Thousands of Chemicals Under REACH - Now What?

The first 25,000 registration dossiers under REACH - for nearly 3,400 chemicals - were submitted to the European Chemicals Agency (ECHA) by the November 30, 2010 deadline.  Over 3.1 million classification and labeling notifications were received by the January 3, 2011 deadline.  The next tier registration deadline is not until June of 2013.  So now what?  A lot, so while many companies are feeling a sense of relief from meeting the deadlines they should not get too comfortable.

ECHA has a statutory requirement to review a minimum of 5% of the REACH registration dossiers submitted.  Sure, that's only about 1,250 dossiers, right?  Not so fast.  The 5% figure is a minimum.  ECHA could conceivably review 100% of the dossiers if they wanted to, assuming they could come up with the time and manpower resources (which is highly unlikely).  But many of the dossiers submitted contain "Annex IX and X testing proposals."  For those less familiar with REACH there are a series of Annexes that list the various test endpoints for which data must be provided.  The endpoints listed in Annexes VII and VIII were required to be provided, including testing if necessary, along with the registration.  But for Annexes IX and X, which include most of the longer-term, animal-intensive, test methods, registrants were required only to provide results they already had in-house but were banned from conducting any additional animal testing prior to submission.  Instead they provided "testing proposals" indicating what additional Annex IX and X tests they planned to conduct.

What all this means is that ECHA must review all of the dossiers that include testing proposals in order to determine whether or not the proposed studies will actually inform their decision-making process.  They will not allow animal testing if they think it will not change their decision.  They also will insist that any testing be conducted in collaboration with other registrants in order to minimize animal testing.  To do this they will publish a list of substances proposing testing and ask for anyone with available data to come forward.  These third parties then have 45 days to provide valid data to address the endpoint, and assuming it fulfills the data requirement the registrants will have to pay the data holder for use of the existing data.

ECHA has until December of 2012 to respond to testing proposals received by the first registration deadline. Companies then will have a set period of time in which they must conduct the studies and update their registration dossier.  The time frames will vary depending on the type and amount of testing since some studies could take 2 to 3 years to conduct.

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)

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.