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ABOUT THE FIRM
The Acta Group, L.L.C. (Acta) and The Acta Group EU, Ltd (Acta EU) are
consulting firms established to control the spiraling costs and
inefficiencies encountered by clients seeking approvals to market
chemicals, biocides, products of biotechnology and nanotechnology, and
medical device products. Acta and Acta EU manage products from concept
to approval, utilizing the skills and experience of professionals who
have worked in the specific product areas in government and industry.
The Acta Group, L.L.C. provides a monthly newsletter summarizing recent
federal developments in the chemical regulation, pesticide,
environmental, occupational safety and health, and related areas.
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2010-M.4
Recent Federal Developments
January 15, 2010
TSCA/FIFRA/NTP/EPCRA
EPA Announces Peer Review Workshop On 1,1,2,2-Tetrachloroethane --
On December 17, 2009, the U.S. Environmental Protection Agency (EPA) announced
the scheduling of an external scientific peer review workshop to review the
external review draft document titled, "Toxicological Review of
1,1,2,2-Tetrachloroethane: In Support of Summary Information on the Integrated
Risk Information System (IRIS)" (EPA/635/R-09/001). 74 Fed. Reg. 66963. The
draft document was prepared by the National Center for Environmental Assessment
(NCEA) within EPA's Office of Research and Development (ORD). The workshop is
on January 27, 2010. Please consult the Federal Register for
details.
Debbie Edwards Retires From EPA -- On
December 17, 2009, Debbie Edwards, Ph.D., Director of EPA's Office of Pesticide
Programs (OPP), announced her retirement. "I have decided to retire from federal
service to pursue other interests and to spend more time in Latin America,"
Edwards said. "I have worked in the EPA's OPP since November of 1985 and have
enjoyed a very fulfilling career," Edwards said. "The work of OPP is challenging,
always interesting and, in my view, of great importance to our society." Her
retirement was effective January 14, 2010.
NTP Recommends Formaldehyde Be Classified As A Known Human Carcinogen --
On December 21, 2009, the National Toxicology Program (NTP) requested comment
on the recommendation from an expert panel on the listing status for formaldehyde
in the 12th Report on Carcinogens (RoC) and the scientific justification for the
recommendation. 74 Fed. Reg. 67883. The Formaldehyde Expert Panel identified
epidemiological studies of workers exposed to formaldehyde that in its view
suggested a causal relationship between exposure to formaldehyde and cancer in
humans, according to a summary of the Panel's recommendations. The Panel
considered evidence for head and neck, brain, respiratory, lymphatic, and
stemcell cancers. It concluded that the evidence was strongest and most
consistent for nose and throat cancer along with leukemia, a cancer of the
blood or bone marrow. "Overall, the evidence from epidemiologic studies for
each of these three sites is consistent with a causal relationship between
formaldehyde and cancer in humans, and the panel believed that the patterns
observed could not be explained by bias, confounding, or change," according
to the summary. The RoC Center convened a ten-member Expert Panel of scientists,
plus four technical scientific experts, on November 2-4, 2009, in Research
Triangle Park, NC. The Panel was asked to apply the RoC listing criteria to
the relevant scientific evidence and make a recommendation regarding listing
status (i.e., known to be a human carcinogen, reasonably anticipated to be a
human carcinogen, or not to list) for formaldehyde in the 12th RoC and to
provide the scientific justification for its recommendation. Comments on the
Expert Panel Report for formaldehyde will be accepted until February 8, 2010.
EPA Seeks To Disclose Pesticide Inert Ingredients --
On December 23, 2009, EPA requested comment on options for disclosing inert
ingredients in pesticides. 74 Fed. Reg. 68215. EPA is seeking ideas for
greater disclosure of inert ingredient identities. Inert ingredients are part
of the end-use product formulation and are not active ingredients. EPA is
considering two general types of approaches to increasing public availability
of inert ingredient identities. One would mandate disclosure only of
potentially hazardous ingredients, and the other would promote or mandate
public availability of most or all inert ingredient identities, regardless of
hazard. Each approach has variations and issues associated with it, which
the Federal Register notice outlines. On October 1, 2009, EPA responded to
two petitions (one by Northwest Coalition for Alternatives to Pesticides, and
a second by several state attorneys general), that designated more than 350
inert pesticide ingredients as hazardous. The petitioners asked EPA to require
that these ingredients be identified on the labels of products that include them
in their formulations. Comments are due by February 22, 2010.
EPA Proposes Revisions To General Tolerance Regulations --
On January 6, 2010, EPA proposed revisions to its pesticide tolerance crop
grouping regulations, which allow establishment of tolerances for multiple
related crops, based on data from a representative set of crops. 75 Fed. Reg.
807. The revisions would create a new crop group for oilseeds, expand
existing crop groups by adding new commodities, establish new crop subgroups,
and revise the representative crops in some groups. EPA expects these
revisions to promote greater use of crop groupings for tolerance-setting
purposes and, in particular, will assist in making available lower risk
pesticides for minor crops both domestically and in countries that export
food to the United States. This is the second in a series of planned crop
group updates expected to be proposed over the next several years. EPA is
also proposing to delete 40 C.F.R. Section 180.1(h), which addresses when
tolerances apply to post-harvest uses. Comments must be received on or
before March 8, 2010.
EPA Issues Final Rule Revising TSCA Section 5 Notification Regulations --
On January 6, 2010, EPA issued a final rule amending Toxic
Substances Control Act (TSCA) Section 5 reporting regulations. 75 Fed. Reg.
773. The amendments establish electronic reporting requirements for TSCA
Section 5 submissions. The rule is intended to streamline and reduce the
administrative costs and burdens of TSCA Section 5 notifications for both
industry and EPA by establishing standards and requirements for the use of
EPA's Central Data Exchange (CDX) to electronically submit premanufacture
notices (PMN) and other TSCA Section 5 notices and support documents to EPA.
EPA is also amending TSCA Section 5 user fee regulations by adding a new
User Fee Payment Identity Number field to the PMN form, to enable the Agency
to match more easily a particular user fee with its notice submission.
Lastly, EPA is amending the PMN form by removing the Agent signature block
field, and thus the requirement for designated agents to sign the form.
The final rule is effective April 6, 2010.
EPA Announces External IRIS Peer Review Draft Of Methanol --
On January 12, 2010, EPA announced a public comment period and a public
listening session for the external review draft document titled "Toxicological
Review of Methanol: In Support of Summary Information on the Integrated
Risk Information System (IRIS)" (EPA/635/R-09/013). 75 Fed. Reg. 1617.
The draft document was prepared by NCEA. The public comment period and
the EPA Science Advisory Board (SAB) meeting, which will be scheduled at
a later date, are separate processes that provide opportunities for
interested parties to comment on the document. EPA is also announcing a
listening session to be held on February 23, 2010, during the public comment
period for this draft document. The public comment period ends March 15, 2010.
Technical comments must be in writing and received by EPA by March 15, 2010.
EPA Announces Approach To Using Toxicogenomic
Data In Human Health Risk Assessments -- On January 13, 2010,
EPA announced the availability of a final report titled, "An Approach to
Using Toxicogenomic Data in U.S. EPA Human Health Risk Assessments: A Dibutyl
Phthalate Case Study" (EPA/600/R-09/028F), prepared by NCEA. 75 Fed. Reg.
1770. Toxicogenomics is the application of genomic technologies to study
effects of environmental chemicals on human health and the environment.
EPA provides no guidance for evaluating and incorporating genomic data
into risk assessment. The report describes an approach to evaluate
toxicogenomic data for use in risk assessment and a case study for
dibutyl phthalate (DBP). In this approach, the genomic data and the
human outcome and/or toxicity data are considered to determine the
relationship between genomic changes and toxicity or health outcomes
and inform mechanisms and modes of toxicity. The DBP case study focuses
on male reproductive developmental effects and the use of genomic data in
qualitative aspects of the risk assessment because of the type of genomic
data available for DBP. The document is available electronically through
the NCEA website online
CAA/CWA
EPA Issues NESHAP For Chemical Preparations Industry --
On December 30, 2009, EPA issued National Emission Standards for Hazardous Air Pollutants
(NESHAP) for the chemical preparations area source category. 74 Fed. Reg. 69194.
The rule applies to area source chemical preparations facilities, which have one year
to comply with the new standards. The rule requires facilities to control 95 percent
of particulate emissions or meet an alternate emission standard of 0.03 grams per
day standard cubic foot at the outlet of the emissions-control device. The rule
was effective immediately.
EPA Proposes Revisions To Lead Ambient Air Monitoring Requirements --
On December 30, 2009, EPA proposed revisions to the final National Ambient Air Quality
Standards (NAAQS) for lead and associated monitoring requirements issued in November 2008.
74 Fed. Reg. 69050. The proposal is in response to petitions from various environmental
and public health groups urging EPA to reconsider the lead emission rate at which
monitoring is required, currently 1.0 ton per year. EPA granted the request as to
the monitoring requirements portion of the November 2008 rule. EPA has proposed revisions
to the requirements for both source-oriented and non-source-oriented monitoring for lead.
Comments are due February 16, 2010.
EPA Proposes To Revise The NAAQS For Ozone --
EPA is proposing to strengthen the NAAQS for ground-level ozone, the main component
of smog. The proposed revisions are based on scientific evidence about ozone and
its effects on people and the environment. EPA is proposing to strengthen the 8-hour
"primary" ozone standard, designed to protect public health, to a level within the
range of 0.060-0.070 parts per million (ppm). EPA is also proposing to establish a
distinct cumulative, seasonal "secondary" standard, designed to protect sensitive
vegetation and ecosystems, including forests, parks, wildlife refuges and wilderness
areas. EPA is proposing to set the level of the secondary standard within the
range of 7-15 ppm-hours. The proposed revisions result from a reconsideration of
the identical primary and secondary ozone standards set at 0.075 ppm in 2008. EPA
is reconsidering the ozone standards to ensure that two of the nation's most
important air quality standards are clearly grounded in science, protect public
health with an adequate margin of safety, and protect the environment. The ozone
standards set in 2008 were not as protective as recommended by EPA's panel of
science advisors, the Clean Air Scientific Advisory Committee (CASAC). The
proposed standards are consistent with CASAC's recommendations. The proposal
to strengthen the primary standard places more weight on key scientific and
technical information, including epidemiological studies, human clinical studies
showing effects in healthy adults at 0.060 ppm, and results of EPA's exposure and
risk assessment. The proposal to set a distinct secondary standard places more
weight on the importance of a biologically relevant standard by recognizing that
cumulative, seasonal exposure to ozone harms sensitive vegetation. Comments will
be due 60 days after the notice is published in the Federal Register. The
pre-published Federal Register notice is available
online.
EPA also will hold public hearings on the proposal. Please
consult the Federal Register for details. In a related notice issued on
January 12, 2010, EPA announced concurrent public hearings on the proposed rule
in Arlington, Virginia, and Houston, Texas, on February 2, 2010, and in
Sacramento, California, on February 4, 2010. 75 Fed. Reg. 1566
EPA To Hold Public Listening Sessions On Potential
Stormwater Rule -- On January 5, 2010, EPA announced that it would
hold five listening sessions to provide information to the public about a
potential rule to strengthen stormwater regulations and to establish a program
to reduce stormwater from new development and redevelopment. EPA seeks input
on several regulatory considerations: expand the area subject to federal
stormwater regulations; establish specific requirements to control stormwater
discharges from new development and redevelopment; develop a single set of
consistent stormwater requirements for all municipal separate storm sewer
systems; require those sewer systems to address stormwater discharges in areas
of existing development through retrofitting the sewer system or drainage area
with improved stormwater control measures; and explore specific stormwater
provisions to protect sensitive areas. The public can register by going to
the website below. EPA will accept written comments on the preliminary
rulemaking considerations until February 26, 2010. More information on the
dates of listening sessions, the potential rule, and instructions for
submitting written comments is available
online.
CBD Petitions EPA Over Endocrine Disruptors --
On January 11, 2010, the Center for Biological Diversity (CBD) petitioned EPA to
develop water quality criteria under the Clean Water Act (CWA) for numerous
chemicals the Center said could damage the endocrine system. In addition to
atrazine, the Center urged EPA to establish criteria for desethyl atrazine,
benfluralin, DCPA (dacthal), diuron, metolachlor, phenanthrene, prometon,
simazine, and trifluralin. The petition called for the establishment of
water quality criteria for certian pharmaceuticals and personal care products.
The petition by the CBD is available online.
EPA Seeks Comment On Incorporating Climate Change In Land Protection Planning --
On December 31, 2009, EPA requested comment on a document entitled "An
Assessment of Decision-Making Processes: The Feasibility of Incorporating
Climate Change Information into Land Protection Planning." 74 Fed. Reg.
69335. The document was prepared by NCEA and reviews the decision-making
processes of selected land-protection programs to assess the feasibility of
incorporating climate change impacts information into the evaluation of these
programs. The assessment identifies several strategies that "might be useful
for incorporating climate change information into decision making." Comments
are due by February 1, 2010.
RCRA/CERCLA
EPA Has Identified Additional Classes Of Facilities For Development Of Financial Responsibility Requirements Under CERCLA Section 108(B) --
On January 6, 2010, EPA issued an Advance Notice of Proposed Rulemaking (ANPR)
that would identify additional classes of facilities for development of
financial responsibility requirements under Section 108(b) of the
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)
of 1980, as amended. 75 Fed. Reg. 816. The statutory language addresses the
promulgation of regulations that require classes of facilities to establish
and maintain evidence of financial responsibility consistent with the degree
and duration of risk associated with the production, transportation, treatment,
storage, or disposal of hazardous substances. In a July 28, 2009, notice, EPA
identified classes of facilities within the Hardrock Mining industry as those for
which EPA will first develop financial responsibility requirements under CERCLA
Section 108(b). In that notice, EPA also stated its belief that additional classes
of facilities -- that is, other than those in the Hardrock Mining industry --
also may warrant the development of financial responsibility requirements under
CERCLA Section 108(b), and stated that EPA would identify additional classes of
facilities it plans to evaluate regarding the development of financial responsibility
requirements. EPA has identified the classes of facilities within three industries --
the Chemical Manufacturing industry (NAICS 325), the Petroleum and Coal Products
Manufacturing industry (NAICS 324), and the Electric Power Generation, Transmission,
and Distribution industry (NAICS 2211) -- as those for which EPA plans to develop,
as necessary, a proposed regulation identifying appropriate financial responsibility
requirements under CERCLA Section 108(b). EPA will carefully examine specific
activities, practices, and processes involving hazardous substances at these
facilities, as well as federal and state authorities, policies, and practices
to determine the risks posed by these classes of facilities and whether
requirements under CERCLA Section 108(b) will effectively reduce these risks.
Comments are due on or before February 5, 2010.
EPA Announces Availability And Public Comment Period On Preliminary Remediation Goals For Dioxin --
On January 7, 2010, EPA announced a 50-day public comment period for draft
recommended interim preliminary remediation goals (PRG) developed in the Draft
Recommended Interim Preliminary Remediation Goals for Dioxin in Soil at
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)
and Resource Conservation and Recovery Act (RCRA) Sites. 75 Fed. Reg. 984. EPA's
Office of Solid Waste and Emergency Response (OSWER) has developed the draft
recommended interim PRGs for dioxin in soil. These draft recommended interim PRGs
were calculated using existing, peer-reviewed toxicity values and current EPA
equations and default exposure assumptions. Comments may be submitted in writing
by February 26, 2010.
EPA Issues Final Revisions To Requirements For Export Of
Spent Lead-Acid Batteries -- On January 8, 2010, EPA issued final
amendments to certain existing regulations promulgated under the hazardous waste
provisions of the Resource Conservation and Recovery Act (RCRA) regarding hazardous
waste exports from and imports into the United States. 75 Fed. Reg. 1236. The
amendments implement recent changes to the agreements concerning the transboundary
movement of hazardous waste among countries belonging to the Organization for
Economic Cooperation and Development (OECD), establish notice and consent
requirements for spent lead-acid batteries intended for reclamation in a foreign
country, specify that all exception reports concerning hazardous waste exports be
sent to the International Compliance and Assurance Division in the Office of
Enforcement and Compliance Assurance's Office of Federal Activities in Washington,
D.C., and require U.S. receiving facilities to match EPA-provided import consent
documentation to incoming hazardous waste import shipments and to submit to EPA a
copy of the matched import consent documentation and RCRA hazardous waste manifest
for each import shipment. The final rule is effective July 7, 2010.
REACH
ECHA Publishes Information On Safe Use Of Chemicals --
On December 18, 2009, the European Chemicals Agency (ECHA) published on its
website hazard and safe-use information on chemical substances that have been
registered. The database is intended to permit the public to make well informed
decisions about the use of chemicals or articles containing chemicals they purchase.
The information was provided by companies who manufacture or import these substances.
It will be updated each time additional information is received by ECHA. According
to ECHA, public access to information on chemicals is a central element of the
Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
regulation and shall allow European Union (EU) citizens to make informed decisions
about the use of chemicals to which they may be exposed. Also, workers will
benefit from this by safer use of chemicals at the work place. In a dedicated
section of the ECHA webpage, information is available on substances that companies
manufacture or import in the EU, including their hazardous properties,
classification and labeling information, and instruction on how to use them safely.
EU Chemical Makers Issue Guidance On Data Use --
On December, 21, 2009, the European Chemical Industry Council (Cefic) published
guidance on the use of published data. The document is intended to assist
chemical consortia prepare REACH dossiers or other documents for regulatory
purposes. Cefic's "Legal Guidance on REACH & Intellectual Property: Use of
Published Information" is available online.
ECHA Adds 14 Substances To REACH Candidate List Of
Substances Of Very High Concern For Authorization -- On January 13,
2010, ECHA added 14 chemical substances to the Candidate List of Substances of
Very High Concern (SVHC) for authorization. Companies manufacturing or
importing these substances need to check their potential obligations that result
from the listing. The substances which ECHA added on the Candidate List are:
| Substance Name |
EC Number |
CAS Number |
| Anthrance oil |
292-602.7 |
90640-80-5 |
| Anthrance oil, anthrance paste, distn. Lights |
295-278-5 |
91995-17-4 |
| Anthrance oil, anthrance paste, anthrance fraction |
295-275-9 |
91995-15-2 |
| Anthrance oil, anthrance-low |
292-604-8 |
90640-82-7 |
| Anthrance oil, anthrance paste |
292-603-2 |
90640-81-6 |
| Pitch, coal tar, high temp. |
266-028-2 |
65996-93-2 |
Aluminosilicate Refractory Ceramic Fibres
Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number
650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No 1272/2008,
and fulfil the two following conditions:
- Al2O3 and SiO2 are present within the following concentration:
- Al2O3: 43.5 – 47% w/w, and SiO2: 49.5 – 53.5% w/w,
or
- Al2O3: 45.5 – 50.5% w/w, and SiO2: 48.5 – 54% w/w.
- fibres have a length weighted geometric mean diameter less two standard geometric
errors of 6 or less micrometers (μm).
|
- |
- |
Zirconia Aluminosilicate, Refractory Ceramic Fibres
Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index
number 650-017-00-8 in Annex VI, part 3, table 3.2 of Regulation (EC) No
1272/2008, and fulfil the two following conditions:
- Al2O3, SiO2 and ZrO2 are present within the following concentration ranges:
- Al2O3: 35 – 36% w/w, And
- SiO2: 47.5 – 50 % w/w, and
- ZrO2: 15 - 17 % w/w,
- fibres have a length weighted geometric mean diameter less two standard
geometric errors of 6 or less micrometers (μm)
|
- |
- |
| 2,4-Dinitrotoluene |
204-450-0 |
121-14-2 |
| Diisobutyl phthalate |
201-553-2 |
84-69-5 |
| Lead chromate |
231-846-0 |
7758-97-6 |
| Lead chromate molybdate sulphate red (C.I. Pigment Red 104) |
235-759-9 |
12656-85-8 |
| Lead sulfochromate yellow (C.I. Pigment Yellow 34) |
215-693-7 |
1344-37-2 |
| tris(2-chloroethyl)phosphate |
204-118-5 |
115-96-8 |
Decisions on whether the substances need to be subject to
authorization will be made later. A summary of the obligations linked to the Candidate
List is available online
NANOTECHNOLOGY
EPA Reopens Comment Period On Carbon Nanotube SNUR --
On January 8, 2010, EPA reopened the comment period on the proposed significance
new use rule (SNUR) for specific carbon nanotubes. 75 Fed. Reg. 1024. The request
was submitted by the U.S. World Trade Organization (WTO) Technical Barriers to Trade
(TBT) Inquiry Point at the National Institute of Standards and Technology (NIST) on
behalf of the European Economic Community (EEC) WTO TBT Enquiry Point. Comments
are now due February 8, 2010.
OECD Issues Report On Information Gathering Efforts For Nanomaterials --
On December 9, 2009, OECD published a report analyzing similarities and differences
in current and proposed information-gathering initiatives for manufactured nanomaterials,
and offered recommendations for what these programs should address. The report,
Analysis of Information Gathering Initiatives on Manufactured Nanomaterials,
provides "a number of considerations and recommendations" for countries considering
voluntary or mandatory information-gathering schemes for manufactured nanomaterials.
Among other things, the report urges that the following information elements be
considered: use pattern, physical and chemical properties, life cycle information,
fate, human health toxicity, ecotoxicity, and risk management measures.
The report is available online.
Bayer Sets Occupational Limit For Nanotubes --
On November 26, 2009, Bayer MaterialScience announced that it has established a product
stewardship program and set a limit of 0.05 milligram per cubic meter of air as
an occupational exposure limit for its Baytubes, on multi-wall carbon nanotubes.
Bayer's announcement of the occupational limit is available at online.
EU Commission Requests Comment On Research Needs --
On December 17, 2009, the European Commission's Research Directorate requested comment
on research needed to ensure that nanotechnologies are developed with emphasis
on sustainable development, competitiveness, and health, safety, and environmental
concerns. The consultation has questionnaires for different audiences, including the
general public, research, and other organizations, and for public agencies. Additional
information and links to related documents are available online.
The comment period closes on February 19, 2010.
LEGISLATIVE DEVELOPMENTS
President Obama Signs Military Site Cleanup Measure --
On December 21, 2009, President Obama signed into law the Department of Defense
Appropriations Act for 2010. Of the more than $635 billion appropriated, $1.5 billion
is designated for environmental cleanup and restoration at military sites. The monies
are variously designated for cleanup by the Army, Navy, Air Force, defense sites,
and defense-wide cleanup.
Mining Of Copper Lode Moves Forward --
A Senate Committee cleared by voice vote late in December a bill that would permit
work on a copper mine to tap a very large lode in Arizona beneath federal land
under the jurisdiction of the United States Forest Service. The bill would sanction
a land swap, with the joint venture of two large copper companies reimbursing the
federal government if the land they provide in the exchange is not as valuable as
the federal land involved. The companies also would have to protect certain scenic
lands and fund recreational opportunities. The project is anticipated to spread
over more than one-half century, with the first 16 years devoted to planning and
development and 50 years devoted to actual mining. The mining companies project
that they will be able to produce one-half million tons of copper each year.
That amount represents roughly one-third of the country's present annual production.
House Of Representatives Takes Action To Restore Funds For Clean Energy --
On December 16, 2009, the House acted to restore $2 billion to a clean energy loan
guarantee program that had been a part of the Stimulus package but gave way to create
funds for the "cash for clunkers" automobile program. The additional funds are also
to be used to guarantee loans for energy efficiency projects. Senators Feinstein (D-CA)
and Merkley (D-OR) introduced in the Senate on December 17, 2009, legislation that
would extend until 2012 the right of renewable energy developers to get 30% up
front payments for capital intensive projects instead of having to rely on filing
for 30% tax credits. The present legislation will expire at the end of 2010, and
the Senators stressed that the two-year extension is critical to fund solar and wind
projects stalled by present economic circumstances.
Bill To Allow Small Tree Cutting In Oregon Introduced --
Senator Ron Wyden (D-OR) introduced legislation on December 16, 2009, reflecting
a compromise he brokered between the logging industry and environmental groups to
permit the cutting of small trees in the forests of Central and Eastern Oregon.
If enacted, the measure would help preserve the few remaining sawmills in those
portions of the state, and it would clear land that would permit the growth of
desired species in the forests.
Movement To Strip EPA Of Authority Over Greenhouse Gases --
All of the Democratic members of the Senate Environment and Public Works Committee
have announced that they intend to oppose a move by Senator Lisa Murkowski (R-AK) to
strip EPA of its authority to regulate greenhouse gas emissions under the Clean
Air Act (CAA). Senator Murkowski is likely to pursue one of two options to attempt
to secure passage, an amendment to other legislation or a resolution of disapproval.
According to her staff, the Senator has not decided yet when or how to proceed,
although she may go forward on January 20, 2010, with an amendment. The resolution
would not need to be filed until March. A large collection of environmental groups,
including the National Resources Defense Council, has written a joint letter to all members
of the Senate opposing the Murkowski move. In the House of Representatives, Congressman
Earl Pomeroy (D-ND) has introduced similar legislation.
Senate Confirms Two Key EPA Positions --
On December 24, 2009, the Senate Environment and Public Works Committee voted to
confirm Robert Perciasepe to become EPA Deputy Administrator and Dr. Paul Anastas
to become Assistant Administrator, ORD. Perciasepe was EPA's Assistant Administrator
for Water and then its Assistant Administrator for Air in the Clinton Administration.
Since leaving the Clinton Administration, Perciasepe has worked for the Audubon Society,
where he became chief operating officer. His nomination was held up by Senator
George V. Voinovich (R-OH), who sought to pressure EPA for more thorough answers
on questions about EPA’s economic analysis of climate change legislation. The
nomination of Dr. Anastas was held up by Senator David Vitter (R-LA), who was using
his hold on the nomination to urge EPA to allow an independent review of EPA's
Integrated Risk Information System (IRIS) assessment of health risks from formaldehyde.
EPA agreed.
MISCELLANEOUS
ATSDR Notice Of Availability Of Tox Profiles -- On December 17,
2009, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the
23rd set of toxicological profiles, which consists of three new and two updated
drafts prepared by ATSDR for review and comment. The profiles are:
| Toxicological Profile |
CAS Number |
| 1. Acrylamide |
79-06-1 |
| 2. Carbon Monoxide |
630-08-0 |
| 3. 1,3-Butadiene |
106-99-0 |
| 4. Phosphate Ester Flame Retardants |
78-51-3 |
| 126-73-8 |
| 126-71-6 |
| 115-86-6 |
| 13674-84-5 |
| 13674-87-8 |
| 115-96-8 |
| 5. Vanadium |
7440-62-2 |
To be considered, comments on these draft toxicological profiles
must be received on or before February 26, 2010.
OEHHA Adds Substances To Prop 65 List --
On December 18, 2009, California's Office of Environmental Health Hazard Assessment
(OEHHA) announced the addition of four substances to the list of carcinogens and
reproductive toxicants it maintains under Proposition 65, the Safe Drinking Water
and Toxic Enforcement Act of 1986. Wood dust and zidovudine, an antiviral drug also
called AZT, are the two new carcinogens on the list. The new reproductive toxicants
are tert-amyl methyl ether (TAME) and ethyl-ter-butyl ether (ETBE), chemicals used
to oxygenate fuels to reduce air pollution. The International Agency for Research
on Cancer (IARC) and NTP have linked wood dust to cancer in humans, according to state
documents. Zidovudine is an antiviral drug that IARC linked to cancer in 2000.
Zidovudine was the first drug approved to treat the acquired immune deficiency syndrome.
Studies in mice and rats linked TAME to developmental problems and ETBE to male
reproductive problems, OEHHA said. The agency based the two listings on information
from the American Conference of Governmental Industrial Hygienists. Information
on the California listing decision is available online.
EPA Releases Annual Enforcement Results And Mapping Tool --
On December 23, 2009, EPA released enforcement results for fiscal year 2009, and
announced that it has developed a new web-based tool and interactive map that allows
the public to obtain detailed information by location about the enforcement actions
taken at approximately 4,600 facilities. In FY2009, EPA concluded enforcement actions
requiring polluters to invest more than $5 billion on pollution controls, cleanup,
and environmental projects. Civil and criminal defendants committed to install
controls and take other measures to reduce pollution by approximately 580 million
pounds annually once all required controls are fully implemented. The new mapping
tool allows the public to view the locations of facilities that were the subject of
those enforcement actions on interactive maps of the U.S. and territories. The maps
show facilities where civil enforcement actions were taken for environmental laws
for air, water, and land pollution, and a separate map shows criminal enforcement
actions. More information is available online.
OSHA Schedules Public Hearing On HCS --
On December 29, 2009, the Occupational Safety and Health Administration (OSHA)
scheduled informal public hearings on its proposal to revise the Hazard Communication
Standard (HCS). OSHA anticipates receiving several hearing requests, and the
Federal Register notice describes the procedures the public must use to participate
in the hearings. The hearings will begin at 9:30 a.m., local time, on the following
dates: March 2, 2010, in Washington, D.C.; March 31, 2010, in Pittsburgh, PA;
and April 13, 2010, in Los Angeles, CA. Please consult the Federal Register for details.
Canada Issues 12th Batch Of High-Priority Substances --
On December 26, 2009, Health Canada and Environment Canada issued the 12th batch
of substances, consisting of 16 substances, being reviewed for toxicity under the
Challenge to Industry process. Most of the substances are suspected of being
persistent, bioaccumulative, and inherently toxic to nonhuman organisms. The
substances are: Batch 12 substances identified as persistent, bioaccumulative, and
inherently toxic and believed to be in commercial use in Canada are mitotane;
chlorhexidine diacetate; a form of trisiloxane commonly known as MDM; musk moskene;
sclareol; a form of trisiloxane commonly known as M4Q; a form of benzenamine commonly
known as BMBPB; Disperse Yellow Brown; a form of ethanamine commonly known as HMSSA;
a form of silanamine commonly known as OMSSA; and a form of pyridine commonly known
as CPPP. The notice on the 12th batch of substances being reviewed for toxicity
under Canada's Challenge to Industry process is available online.
EPA Seeks Comment On Enforcement/Compliance National Priorities --
On January 4, 2010, EPA announced that it is soliciting comment and recommendations
on enforcement and compliance national priorities to be addressed for fiscal years
2011-2013. EPA selects these priority areas every three years in order to focus
federal resources on the most important environmental problems where noncompliance
is a significant contributing factor. EPA Office of Enforcement and Compliance
Assurance is collecting external comment on the preliminary set of national priority
candidates for FY 2011-2013 listed on its website online.
Comments must be received on or before January 19, 2010.
CRS Issues Report On Noncompliance With Congressional Review Act --
On December 29, 2009, the Congressional Research Service (CRS) issued an analysis
concluding that federal agencies have failed to meet statutory requirements to
provide notice to Congress and the Government Accountability Office (GAO) for more
than 1,000 final regulations issued since 1999, casting some doubt on whether the
regulations are legally in effect. In a report , CRS examined the failure by federal
agencies over a 10-year period to comply with a provision of the Congressional Review
Act that requires agencies to submit final rules to both houses of Congress and
GAO before the rules can take effect. The report cited 22 major rules reviewed by
the White House Office of Management and Budget from October 2008 to June 2009 that
had not been sent to GAO. A copy of the report is available online.
EPA Administrator Lisa P. Jackson Releases Memorandum To EPA Employees --
On January 12, 2010, Administrator Jackson issued a memorandum reiterating EPA's
priorities. These include: climate change, improving air quality, chemical safety,
cleaning up superfund sites, water protection, environmental justice, and enhancing
tribal partnership.
EPA Issues QSAR Application Toolbox --
On January 7, 2010, OECD released an updated set of computer tools to assist
governments, the chemical industry, and others save money and spare animals by
extrapolating toxicity and eco-toxicity data for chemicals rather than conducting
new toxicity tests. The new version 1.1 of the OECD QSAR application toolbox --
employing Quantitative Structure-activity Relationship (QSAR) computer modeling
techniques -- systematically groups chemicals into categories to evaluate them for
common mechanisms or action modes, toxicological behavior, or consistent trends among
results related to regulatory endpoints. The OECD toolbox is available online.
This Update is provided as a complimentary service to our clients and is
for informational purposes. This Update may be copied or quoted, provided proper
attribution is given. The contents are not intended and cannot be considered as
legal advice.
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