EPA Brings to 1000 the Number of Chemicals Being Tested with ToxCast

Perhaps lost in all the attention with the REACH deadline was an announcement last week by the USEPA that ToxCast screening program has "entered a new phase," in which it will add another 700 chemicals for testing "potential toxicity to people and the environment."  About 300 chemicals, mostly pesticides, were tested in the first phase, which puts chemicals through a series of fast, automated assays to screen for possible toxicity.  The hope is that ToxCast will be able to rapidly screen the roughly 85,000 chemicals on the TSCA Inventory, as well as screen new chemicals before they are put on the market.  Those chemicals for which ToxCast suggests some concern would be put into a more comprehensive evaluation process.

More information on ToxCast can be found here.

ToxCast employs a battery of rapid assays. Rather than rely on animal testing to discern toxicity, the battery includes tests that look at such things as gene expression, real-time electronic sensing, in vitro genomics, biochemical markers, and for those that want to see actual organisms, zebra fish development.

More information on the chemicals being tested can be found here and more information on EPA's computational toxicology program is here.

Lisa Jackson Marks the 40-Year Anniversary of EPA

Forty years ago, Americans across the nation took up a call for cleaner air, safer water and unpolluted land.  They saw that to keep our families healthy, to build clean communities, and to make America stronger for the future, we needed to protect and preserve our environment.  That grassroots movement led to the creation of the U.S. Environmental Protection Agency.  At its formation, the EPA was tasked with repairing the damage already done to the environment and establishing guidelines to help Americans make their environment cleaner and safer.

That is how EPA Administrator Lisa Jackson starts off her "40th Anniversary Message" marking forty years of EPA's existence, which officially started December 2, 1970.  She goes on to say:

As we look to the past, we are also focused on the future.  The EPA is strongly committed to protecting and preserving our country's environment through taking action on climate change; improving air quality; ensuring chemical safety; cleaning up our communities; protecting America's waters; working for environmental justice; and building strong state and tribal partnerships.

The EPA has set up a whole page called EPA@40: Healthier Families. Cleaner Communities. A Stonger America.  The page highlights "40 years of achievements" (and a proclamation from President Obama).

See it all here.

The Final REACH Registration Numbers Are In - ECHA Reports Nearly 25,000 Registrations

Yesterday (November 30, 2010) marked the first deadline for registration of chemicals under the European Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.  And the European Chemicals Agency (ECHA) has quickly issued a press release summarizing the results - "ECHA had received 24,675 registration dossiers, submitted for nearly 3,400 phase-in substances."

While companies have had almost 3 years to prepare dossiers on their chemicals, most of that time was spent working with other companies in consortia and navigating the new idea of SIEFs (Substance Information Exchange Forums).  According to ECHA:

T"the numbers of registrations increased steadily throughout the year, but from September 2010, the trend changed. Numbers soared dramatically - incoming registrations in a single month totalled four times the number of dossiers previously registered. The increase became more gradual again in October – an increase of 7% percent - with statistics increasing again over the last month."



About 12% of dossiers were submitted by "Lead Registrants," i.e., the company who volunteered to present the data developed by consortia and other groups of companies manufacturing or importing the same chemicals.  About 82% of the submissions were from "Member Registrants," those companies who contributed to consortium development of the dossier submitted by the Lead.  Only 6% of the submissions were from individual registrants, i.e., single companies that provided all the data for a chemical.


Nearly a quarter of submissions came from one country - Germany - which shouldn't be too surprising given the number of larger firms located there.  Most of the submissions (86%) came from large companies, with medium, small, and micro sized companies accounting for only 9%, 4%, and 1% of the submissions, respectively.


Only 580 of the nearly 25,000 dossiers contained testing proposals, for a total of 1,548 proposed tests.  ECHA will review all of these and any test proposed on animals will be subject to public consultation.



More details can be found in the ECHA press memo and registration statistics.

As Europe Bans BPA in Baby Bottles, USEPA Works with BPA Manufacturers in Design for the Enviroment

Bisphenol-A, more commonly known as BPA, has gotten a lot of attention lately.  As noted last week, the EU has voted to ban BPA from baby bottles beginning in March 2011, and not long ago Canada declared BPA to be CEPA-toxic.  Meanwhile in the USA the Environmental Protection Agency is following through on at least some of the provisions of its Chemical Action Plan for BPA.  One of those provisions was for EPA to engage industry in its Design for the Environment program, or DfE.

Initially the DfE program is focusing on "finding safer alternatives to BPA used as a developer for dyes in thermal paper, which is often used in cash register or sales receipts."  This narrowing down into a specific use of the chemical is typical of DfE, where the goal is to examine all the ways to solve one particular identified risk area.  In the case of BPA, the DfE program officially kicked off in July 2010 and is just now compiling a list of viable BPA alternatives and alternative technologies.  The goal is to complete a draft evaluation of ecological and human health hazards and environmental fate by May of 2011, with a final report in October 2011.

According to the DfE site, "some receipts made of thermal paper may now contain as much as 10 mg of BPA, which could pose a risk for human exposure, as well as account for substantial environmental releases of BPA. The goal of this assessment is to facilitate movement towards safer alternatives used in thermal paper."

More information on the program, and a list of participating companies and their representatives, see here.  Participants include thermal paper manufacturers and converters, chemical manufacturers, retailers, trade associations, trade unions, NGOs, government representatives, green chemistry consultants, and others.  All working to find solutions for a particular identified chemical use pattern.

ECHA offers help for REACH registrants still blocked by data sharing disputes

Tomorrow (November 30) is the final day to register chemicals manufactured or imported at over 1000 tonnes per annum under the REACH regulation in Europe.  Most companies have registered their chemicals (and many are rushing to complete the process now).  But some companies are still having some problems negotiating letters of access (LOAs) with data owners for endpoints they are hoping to fulfill with read-across or other data owned by other companies.

ECHA stipulates that companies should have worked out these details long ago, but understands that there are cases where cost disputes are still raging.  So they have offered some assistance.

Until 30 November at noon (Helsinki time), companies can request ECHA's help when they cannot agree with a previous registrant on sharing the costs of data already registered. 

The goal is to allow companies "to submit a registration dossier, even if the final decision has not been taken on their data sharing complaint. This is a temporary solution to enable these potential registrants to submit dossiers while their data sharing dispute is still awaiting resolution."  But ECHA goes on to say that "in any case, these potential registrants must be able to demonstrate that they have made every effort to share the cost of submitted data in a fair, transparent and non discriminatory way and that the other party did not make such efforts."

If your company is facing this problem, you are still responsible for registering your substance.  Contact ECHA immediately.

More more information, see the ECHA web site.

ECHA Will Charge a Fee if You Said You Were an SME (REACH Rhymes)

The European Chemical Agency (ECHA) has issued a notice that it will charge an administrative fee to those companies who wrongly claimed to be a small or medium sized enterprise (SME). Apparently quite a few companies have claimed that they were smaller than they actually are, either through misunderstanding of how to calculate their size or through an attempt to benefit from reduced registration fees for smaller entities.  According to ECHA:

"As from 1 December 2010, ECHA will collect an administrative charge from registrants who wrongly claimed to be entitled to a fee reduction or a fee waiver. If ECHA concludes that the size of a company is larger than registered under REACH, the company will not only have to pay the difference in registration fee but also an administrative charge as follows (all values in Euros):"

Size of company	Administrative charges
Large (non-SME)	20 700
Medium	14 500
Small	8 300
Micro (*)	2 070

(*) Refers to fee waivers only

Also according to ECHA, with only a few days left to the November 30th registration deadline, over 16,000 registration dossiers have been received.  This is less than ECHA anticipated, which means either there will be a large proportion registering at the last minute or a lot of chemicals will not meet the statutory deadline.  The latter means that companies would not be able to continue production until they submit and pass all the completeness checks for their dossiers.