Saturday, March 6, 2010

So What are the Stockholm/Rotterdam/LRTAP Conventions Mentioned in Thursday's TSCA Chemical Reform Hearing?

At Thursday's House Subcommittee hearing on TSCA Reform, one of the points made by both Jim Jones of EPA and John Thompson of the Department of State was that they thought the US should ratify three international agreements for which we had signed onto but never officially joined through passage of acts from Congress. So what are these agreements? Today I'll take a look at one of them - the Stockholm Convention on Persistent Organic Pollutants. I'll examine the others in ensuing days.

The Stockholm Convention on Persistent Organic Pollutants (POPs) is a "global treaty to protect human health and the environment from chemicals that remain intact in the environment for long periods, become widely distributed geographically and accumulate in the fatty tissue of humans and wildlife."

In other words, that are persistent (P), bioaccumulative (B), and can transport to remote locations. The assumption is that exposure to POPs can "lead to serious health effects including certain cancers, birth defects, dysfunctional immune and reproductive systems, greater susceptibility to disease and even diminished intelligence." Inherent in the agreement is the fact that since these chemicals can be transported in the air, water, or biota for long distances, "no one governing acting alone can protect is citizens or its environment from POPs," and thus an international effort was required. The result was the Stockholm Convention adopted in 2001 and entered into force 2004. It "requires Parties to take measures to eliminate or reduce the release of POPs into the environment. The Convention is administered by the United Nations Environment Programme and based in Geneva, Switzerland.

Initially, twelve POPs were recognized as "causing adverse effects on humans and the ecosystem," and these fit into 3 general categories:

Pesticides: aldrin, chlordane, DDT, dieldrin, endrin, heptachlor, hexachlorobenzene, mirex, toxaphene;

Industrial chemicals: hexachlorobenzene, polychlorinated biphenyls (PCBs); and

By-products: hexachlorobenzene; polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans (PCDD/PCDF), and PCBs.

These 12 chemicals are often referred to as "the dirty dozen." Depending on the Annex in which the chemicals are listed, the goal is for countries who have signed the agreement to take steps to eliminate (Annex A), restrict (Annex B), or protect from unintentional production (Annex C) these 12 chemicals.

However, in May 2009, the Conference of the Parties (COP) adopted amendments to these Annexes to list nine additional chemicals as persistent organic pollutants, again placed into one or more of the three general categories:

: chlordecone, alpha hexachlorocyclohexane, beta hexachlorocyclohexane, lindane, pentachlorobenzene;

Industrial chemicals
: hexabromobiphenyl, hexabromodiphenyl ether and heptabromodiphenyl ether, pentachlorobenzene, perfluorooctane sulfonic acid, its salts and perfluorooctane sulfonyl fluoride, tetrabromodiphenyl ether and pentabromodiphenyl ether; and

: alpha hexachlorocyclohexane, beta hexachlorocyclohexane and pentachlorobenzene.

So why is ratifying this Convention important? Well, even though we signed onto the agreement it has never been ratified by Congress, which means that all we can do is act as an observer. We can present our case at meetings, but we cannot vote. So this places the US in the position of having no real power to stand up for our own interests. Thus, we are susceptible to having outside interests dictate what happens here in the US.

Friday, March 5, 2010

First Summary of House TSCA Chemical Reform Hearing - And Another Senate Hearing on Tuesday!

Well, the House Subcommittee on Commerce, Trade and Consumer Protection held its TSCA reform hearing yesterday on the subject of "TSCA and Persistent, Bioaccumulative, and Toxic Chemicals: Examining Domestic and International Actions." Full statements for each of the witnesses can be found on the Hearing site here. Meanwhile, the Senate has scheduled yet another hearing for next Tuesday, March 9th (more on that below).

As is the norm, the opening statements by lawmakers followed pretty much the usual partisan talking points, with "sound science," "jobs," and "modernization" being heard from several folks. It was rather humorous to hear virtually all the lawmakers stumble each time they had to say the word "bioaccumulative." But a few interesting points came up in the statements of the witnesses and the Q&A period.

1) The US will likely make a push to ratify three international agreements for which we had signed onto but never officially joined through passage of acts from Congress. The three - the Stockholm Convention on Persistent Organic Pollutants (POPs), the Rotterdam Convention, and the Convention on Long Range Transboundary Air Pollution (LRTAP), all deal with identifying and restricting certain PBTs or POPs. Currently the US can be an observer but cannot vote, which means we are not fully able to stand up for US interests versus the interests of the voting members from Europe and worldwide. This will probably have to be done separate from a TSCA reform bill.

2) Risk versus solely hazard was the preferred assessment mechanism from most witnesses, with the possible exception of Linda Greer who felt that we already know enough about the hazard of some substances so should act now rather than "do more study" (which delays action).

3) Should specific PBT chemicals be listed by name in the statute? The answer to this was somewhat unclear although most agreed that there are some obvious chemicals that could be listed (for example, perhaps the "dirty dozen" from the Stockholm Convention). On the other hand, there was also general agreement that there should be a process to identify chemicals that would be consistent with EPA's "risk-based principles" announced by Administrator Jackson last year. The question of the availability of alternatives before listing was rasied, as was the question of whether there were essential uses that could not be replaced. In the end I think the new law will not list specific chemicals but will require EPA to create a list of PBT and other chemicals to either be banned outright (e.g., the dirty dozen) or be (relatively) rapidly assessed further for safety.

4) The PBT criteria won't work for metals. Bill Adams noted that the new chemical law in Europe, REACH, has agreed that the usual criteria for assessing P, B and even T just isn't appropriate for metals since metals all will meet the criteria because, well, because they are metals and not the organic chemicals for which the criteria were designed to assess.

And now, for another hearing: Following on the heels of the House hearing is another Senate hearing scheduled for next Tuesday, March 9th. Senator Lautenberg, who held a TSCA reform hearing only a month ago and since then has been battling stomach cancer, will chair a subcommittee hearing on "Business Perspectives on Reforming U.S. Chemical Safety Laws" in which "leaders of businesses that manufacture or use chemicals to examine their business perspectives on reforming U.S. chemical safety laws." Witnesses are to include:

Kathy Gerwig - Vice President, Workplace Safety and Environmental Stewardship Officer, Kaiser Foundation Health Plan, Inc.

Charlie Drevna - President, National Petrochemical and Refiners Association

Dr. Neil C. Hawkins Sc.D. - Vice President, EH&S and Sustainability for The Dow Chemical Company

Beth Bosley - Managing Director, Boron Specialties, On behalf of Society of Chemical Manufacturers & Affiliates

Howard Williams - Vice President, Construction Specialties, Inc.

Linda Fisher - Vice President, Safety Health and the Environment, DuPont

This is almost certainly going to be the last hearing before Senator Lautenberg introduces the bill, with Representative Rush introducing the companion bill in the House. Expect it this month. That said, there is no guarantee the bill will ever be passed. The previous two versions introduced in 2005 and 2008 died unnoticed in committee. And with some tough elections coming up in 8 months and several other contentious legislation bogging down the calendar, it's possible this Congress may end without a new law in place. However, given that all parties involved agree that TSCA should be "modernized" and the industry in particular does not want to have to deal with a patchwork of state-level regulations, my bet is that the federal-level TSCA reform will actually get done before election day. But as I said, there are no guarantees.

Thursday, March 4, 2010

Witnesses Announced for Today's House Hearing on TSCA Chemical Reform

The House of Representatives Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection has announced it will hold a hearing on “TSCA And Persistent, Bioaccumulative, And Toxic Chemicals: Examining Domestic And International Actions.”

The hearing is scheduled for today, Thursday March 4th.

Invited Witnesses:

James Jones, Deputy Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, Environmental Protection Agency

John Thompson, Division Director, Office of Environmental Policy, Bureau of Oceans, Environment, and Science, Department of State

Ted Sturdevant, Director, Department of Ecology, State of Washington

Linda Greer, Director, Health and Environment Program, Natural Resources Defense Council

Christina Cowan-Ellsberry, CE2 Consulting, Former Principal Scientist, Environmental Sciences Department, Procter & Gamble

William J. Adams, Chairman, North American Metals Council

A briefing memo introduces the goals of the hearing.

I'll have a report after the hearing. Expect the bill in the next few weeks.

Wednesday, March 3, 2010

As TSCA Chemical Reform Nears, EPA Toxics Office Changes its Name and Lisa Jackson Pushes Senate

The reintroduction of the Kid Safe Chemical Act, the updated/reformed/modernized version of the Toxic Substances Control Act (TSCA) is expected "in the next few weeks to a month" according to Steve Owens speaking at a trade association meeting on Monday. Meanwhile, Administrator Lisa Jackson meets with Democratic Senator Sheldon Whitehouse of Rhode Island to push for swift introduction of the bill. And if that isn't enough, EPA is changing the name of the key office dealing with toxic chemicals.

The current Office of Prevention, Pesticides and Toxic Substances will officially become the Office of Chemical Safety and Pollution Prevention on April 22, 2010 (not coincidentally, Earth Day). Supposedly the name change is to reflect the Administrator's priority of ensuring the safety of chemicals, but in practice the name change is just a name change.

But the meeting with Senator Whitehouse is more significant as it either signifies that the bill is imminent, or that the bill is stuck in the mud. The conventional wisdom is the former, and I think this time the conventional wisdom is correct. Whitehouse gave the closing arguments at the Senate hearing held in early February, but Senator Lautenberg will clearly be the primary sponsor of the bill. After all, "Kid Safe" is his baby (or perhaps his "grandbaby" since he is always talking about his grandchildren). Expect the bill this month with a companion bill in the House to be introduced by Congressman Bobby Rush, who chairs the subcommittee that will be holding hearings tomorrow.

That House subcommittee hearing, entitled "TSCA and Persistent, Bioaccumulative, and Toxic Chemicals: Examining Domestic and International Actions," will be held Thursday, March 4th in the Rayburn House Office Building. The people to testify have not as this writing been listed on the committee web site, but are expected to include Jim Jones from EPA, Linda Greer of the Natural Resources Defense Council and Bill Adams representing the North American Metals Council. [UPDATE: In addition to the above, also testifying will be John Thompson from the Department of State, Ted Sturdevant from the Department of Ecology in the State of Washington, Christina Cowen-Ellsberry who is now a consultant but was with Procter & Gamble for many years.]

I'll have a full update on the hearing tomorrow and the next days.

Tuesday, March 2, 2010

EPA Proposes a Test Rule for Chemical "Orphans"

EPA is proposing to issue another TSCA Section 4 test rule that would require manufacturers of 29 "orphan" High Production Volume (HPV) chemicals to conduct testing for environmental fate (including five tests for physical/chemical properties and biodegradation), ecotoxicity (in fish, Daphnia, and algae), acute toxicity, genetic toxicity (gene mutations and chromosomal aberrations), repeated dose toxicity, and developmental and reproductive toxicity.

As I've reported before, EPA has been slowly issuing these test rules for chemicals that no manufacturer sponsored during the decade long voluntary HPV Challenge. This is now the fourth such test rule proposed, but the effectiveness of this process has been called into question as only the first one has been finalized to date. Which means all the manufacturers of chemicals in the second through the fourth proposed rules still have not been required to start testing. This is a real problem. Proposing is one thing, but unless the rules are finalized they are essentially moot.

Remember that these are only the "orphan" chemicals, that is, the HPV chemicals for which no one volunteered to provide data. There are also a few hundred HPV chemicals for which companies did promise to provide data but so far have not, even 5 years after the official end of the voluntary program. Add to that the chemicals that became HPV after the initial Challenge list was created and you can see that the process just isn't enough to evaluate even the highest volume chemicals, never mind the thousands of medium volume and specialty chemicals. Clearly the time is ripe for reform of TSCA.

The chemicals listed in this fourth TSCA Section 4 test rule are:

CAS # Chemical Name

83–41–0 Benzene, 1,2-dimethyl-3-nitro-

96–22–0 3-Pentanone

98–09–9 Benzenesulfonyl chloride

98–56–6 Benzene, 1-chloro-4-(trifluoromethyl)-

111–44–4 Ethane, 1,1'-oxybis[2-chloro-

127–68–4 Benzenesulfonic acid, 3-nitro-, sodium salt

506–51–4 1-Tetracosanol

506–52–5 1-Hexacosanol

515–40–2 Benzene, (2-chloro-1,1-dimethylethyl)

2494–89–5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, hydrogen sulfate (ester)

5026–74–4 Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)

22527–63–5 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester

24615–84–7 2-Propenoic acid, 2-carboxyethyl ester

25321–41–9 Benzenesulfonic acid, dimethyl-

25646–71–3 Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)

52556–42–0 1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt

61788–76–9 Alkanes, chloro

65996–79–4 Solvent naphtha, coal

65996–82–9 Tar oils, coal

65996–89–6 Tar, coal, high-temp.

65996–92–1 Distillates, coal tar

68082–78–0 Lard, oil, Me esters

68187–57–5 Pitch, coal tar-petroleum

68442–60–4 Acetaldehyde, reaction products with formaldehyde, by-products from

68610–90–2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters

68988–22–7 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from

70693–50–4 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[(2-nitrophenyl)azo]-

72162–15–3 1-Decene, sulfurized

73665–18–6 Extract residues, coal, tar oil alk., naphthalene distn. residues

Monday, March 1, 2010

UK Promotes Ways to Minimize Animal Testing Under REACH

The UK's Health and Safety Executive (HSE) has released guidance in the form of a leaflet to help REACH registrants minimize the use of animal testing as they prepare their final documents for submission this fall. Between 5,000 and 10,000 registrations expected by the November 30th, 2010 deadline. Each of those, without any attempt to minimize the number of animal tests, could require over 5000 animals according to HSE. The animal rights group, British Union of Anti-Vivisectionists (BUAV) predicts even more animals will be used, all told they say that over 75,000 chemicals may need new testing, which could mean 16-54 million animals over the next ten years. I think this number is highly unlikely, but nevertheless there will be significant animal testing proposed under REACH.

The guide recommends that wherever possible registrants should employ the basic principles of the "3Rs," that is, reduction, refinement and replacement, in order to reduce the number of animals used.

Besides some specific suggestions for particular endpoints, the guidance strongly suggests that registrants use the techniques listed in Annex XI of the REACH regulation, including:

- Use of all existing data: Search for previous studies done on the chemical

- Weight of evidence: Use information from multiple sources to avoid having to do new tests

- QSARs: Use computer modeling wherever validated and supportable for a particular chemical

- Grouping and Read Across: Maximize the value of data for similar chemicals that can be used to estimate the values for your chemical

- In Vitro: Use in vitro methods rather than methods that require animals; also use new Ex Vivo methods

- Waive Data Requirements if Not Technically Possible to Test: Some endpoints cannot be measured or are not appropriate to measure for certain substances

- Exposure-Based Waiving: Don't do animal testing in cases where there will be no exposure to humans or the environment

More specifics can be found in the UK guidance.

These considerations and the strong actions of the animal welfare organizations will most certainly need to be part of the "new TSCA" that is expected to be introduced shortly in the United States.

Sunday, February 28, 2010

European Chemicals Agency Gives Strategies for Improving Acceptance of REACH Dossiers

With the first major deadline for high volume and "substances of very high concern" registration dossiers rapidly approaching, the European Chemicals Agency (ECHA) has offered some help in a new report. The "Evaluation Under REACH: Progress Report 2009" (PDF) was published on Thursday and includes detailed recommendations for REACH registrants based on problems identified in the dossiers ECHA has reviewed so far.

The most common reasons for registration dossiers failing to pass the completeness and compliance checks, ECHA says, include:

* The identity of the registered substance and the substance used for testing were not clearly described (precise composition and impurities)

* Testing was omitted based on inappropriate or poorly justified scientific arguments

* The summaries of test reports did not include enough detailed information

* Shortcomings related to the risk assessment and the recommended risk management measures

* Omission of the classification and labelling information specified by the CLP Regulation

Registrants still working on their dossiers but that plan to submit them by the November 30, 2010 deadline will find some useful advice on how to avoid these problems.

According to ECHA, in 2009 the Agency:

* received 409 complete registration dossiers and initiated evaluation of 35 of these, 27 of which were compliance checks and 8 examinations of testing proposals

* took a decision for one testing proposal

* concluded 14 compliance checks resulting in seven 'quality observation letters' and three draft decisions being sent to companies

According to ECHA estimates, somewhere on the order of 9000 dossiers are expected to be submitted by November 30th of this year. So whereas they have been doing compliance checks on most of the dossiers received to date, they clearly will not be able to do that for all the new dossiers. The REACH regulation stipulates that ECHA should review 5% of the dossiers from each tonnage band, so in theory only about 450 of the new ones will receive a prompt and thorough review, though ECHA could choose to review more if it is capable of doing so.

All of this has ramifications for TSCA reform in the United States. It is likely that the new TSCA will have enough flexibility to utilize the data and dossiers submitted under the REACH program for chemicals that are manufactured or imported in Europe. The new TSCA should also be flexible enough to be informed by the recent Canadian assessment program.

As I noted Friday, the House will hold a hearing next week on TSCA reform and, pending Senator Lautenberg's chemotherapy schedule, I would expect the new bill to be introduced sometime in March. I'm guessing that Senator Klobuchar will co-sponsor with Lautenberg, or at the very least take over the responsibility for shepherding it through the committee process.