Monthly Update for December 2013
Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, and peaceful New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.
EPA Statement Of Regulatory Priorities Includes Taking Action On Toxics And Chemical Safety: On November 26, 2013, the Office of Information and Regulatory Affairs (OIRA) posted the Fall 2013 Unified Agenda and agency statements of regulatory priorities. According to the statement of regulatory priorities for the U.S. Environmental Protection Agency (EPA), EPA has six guiding priorities: making a visible difference in communities across the country; addressing climate change and improving air quality; taking action on toxics and chemical safety; protecting water; launching a new era of state, tribal, and local partnerships; and working toward a sustainable future. EPA’s statement of regulatory priorities is available online. The Fall 2013 Unified Agenda is available online.
EPA Denies Petition To Delist Chlorsulfuron: On December 9, 2013, EPA announced its decision to deny a petition to remove chlorsulfuron from the list of chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) of 1986 and Section 6607 of the Pollution Prevention Act (PPA) of 1990. 78 Fed. Reg. 73787. EPA reviewed the available data and determined that chlorsulfuron does not meet the deletion criterion of EPCRA Section 313(d)(3). EPA confirmed its view that chlorsulfuron meets the listing criterion of EPCRA Section 313(d)(2)(C) due to its toxicity to some species of aquatic plants. EPA also confirmed that chlorsulfuron “is not reasonably anticipated to cause acute or chronic toxicity to humans.” EPA denied this petition on November 18, 2013.
EPA Issues Final Rule: On December 4, 2013, EPA issued a final rule amending certain reporting requirements promulgated under the Toxic Substances Control Act (TSCA) to require the use of electronic reporting. 78 Fed. Reg. 72818. EPA is requiring the use of electronic reporting to minimize the paperwork burden associated with the underlying regulatory requirements and to minimize the cost to the federal government of the creation, collection, maintenance, use, dissemination, and disposition of information. EPA believes the action will also improve the quality and use of information to strengthen decision-making, accountability, and openness in government and society, as well as provide for the timely dissemination of public information and in a manner that promotes the utility of the information to the public and makes effective use of information technology. The final rule is effective March 4, 2014.
EPA Develops New Web-based e-PMN Submission System: On December 5, 2013, EPA held a webinar to demonstrate its new web-based system for the creation and submission of TSCA Section 5 notifications, including premanufacture notifications (PMN), Low Volume Exemptions (LVE), Low Release and Low Exposure Exemptions (LoREX), and Test Marketing Exemptions (TME), and related support documents. EPA expects to promulgate in early 2014 a rule requiring the use of the web-based system for Section 5 submissions, eliminating the use of the current e-PMN software. One of the enhancements in the new e-PMN software is the addition of links to EPA’s Substance Registry Services and Facility Registry System, allowing for easy integration of any chemicals that are listed in these databases, and with the sites of the submitter and users of the substance. Also, because attachments are uploaded directly to the web-based system, there will no longer be a limit to the size or number of attachments, as there is with the current software. Submitters still will be able to use the current e-PMN software to create a draft submission and then transfer the information by an XML upload to the web-based system. Attachments, however, cannot be uploaded from the current software to the web-based system. The current e-PMN software will not be maintained, however, and validation problems may eventually occur. Companies with their own data collection systems will also be able to upload data directly to the web-based system. Anyone accessing and editing an e-PMN on the new web-based system must have a CDX registration. On December 17, 2013, EPA will hold a webinar on the new CDX registration process and changes to the e-PMN roles of Primary Authorized Official (Primary AO), Primary Support, Secondary Authorized Official (Secondary AO), and Secondary Support and additional categories for consultants. EPA states that the CDX registration will become faster, taking just one to two days for registrants based in the United States. Foreign suppliers who are part of a joint submission or are submitting support documents must also have a CDX registration. Additional information on the webinar is available online.
Five Chemical Manufacturers Agree To ECA For Siloxane: On December 12, 2013, five chemical manufacturers agreed to the terms of an enforceable consent agreement (ECA) requiring the generation of data on octamethylcyclotetrasiloxane (CAS Number 556-67-2) (D4). Under the ECA, Momentive Performance Materials USA Inc., Dow Corning Corporation, Evonik Goldschmidt Corporation, Shin-Etsu Silicones of America Inc., and Wacker Chemical Corporation will conduct environmental monitoring to characterize specified sources and pathways of release of D4 to the environment and resulting exposure of aquatic and sediment dwelling organisms to D4. The chemical manufacturers will develop environmental testing data for D4 in the vicinity of manufacturing and processing (including product formulating) sites and wastewater treatment plants in the U.S. To implement the ECA, EPA will issue an order under TSCA Section 4 that incorporates the terms of the ECA. The terms of the ECA will take effect on the date of publication of the notice in the Federal Register, which is expected in 2014. A November 22, 2013, draft ECA is available online.
California To Issue Product Safety Draft Guidance In January: On November 15, 2013, California’s Department of Toxic Substances Control (DTSC) reported that it will release by January 2014 draft guidance to help chemical and product manufacturers, retailers, and importers evaluate different ways to make a product safer. The guidance is expected to describe DTSC’s proposed approach to conducting the first of two parts of an alternative assessment that may be required under California’s Safer Consumer Products Regulations. The Safer Consumer Products Regulations went into effect October 1, 2013.
EPA Proposes Purchasing Guidelines: On November 27, 2013, EPA released proposed guidelines intended to help the federal government buy greener and safer products. 78 Fed. Reg. 70938. The draft guidelines were designed to assist federal purchasing decision makers in more consistently using existing non-governmental product environmental performance standards and ecolabels. The draft guidelines are organized into the following four sections: guidelines for the process of developing standards, which address the procedures used to develop and maintain a private standard; guidelines for the environmental effectiveness of standards, which address the criteria that support claims of environmental preferability; guidelines for conformity assessment, which address the assessment of products for conformity to the criteria specified by standards and ecolabel programs; and guidelines for management of ecolabeling programs, which address the organization and management practices of ecolabeling programs. EPA is seeking public input on these draft guidelines and a potential approach to assessing non-governmental environmental standards and ecolabels already in the marketplace which can help federal purchasers identify and select products that are greener and safer for the environment. The draft guidelines were developed by EPA, the General Services Administration, and others following several listening sessions with stakeholders on how the federal government can be more sustainable in its purchasing and how it can best meet the numerous federal requirements for the procurement of sustainable and environmentally preferable products and services. The draft guidelines are available online. A more detailed memorandum is available online. Comments are due by February 25, 2014.
EPA Honors Winners Of The 2013 Presidential Green Chemistry Challenge Awards: On December 11, 2013, EPA announced this year’s Presidential Green Chemistry Challenge program winners. The Presidential Green Chemistry Challenge Awards are presented in five categories: academic, small business, greener synthetic pathways, greener reaction conditions, and designing greener chemicals. In the academic category, Professor Richard Wool, University of Delaware, Newark, Delaware, was recognized for creating materials from less toxic and renewable biobased feedstocks such as vegetable oils, chicken feathers, and flax that can be used as adhesives, composites, foams, and circuit boards and as a leather substitute. In the small business category, Faraday Technology Inc., Clayton, Ohio, was recognized for developing a plating process that allows chrome coatings to be made from trivalent chrome. Winners in the “greener reaction conditions, designing greener chemicals, and greener synthetic pathways” categories are:
- Life Technologies, Austin, Texas — for developing a more efficient, much less wasteful way to manufacture the key chemicals used to perform genetic testing. The new process prevents about 1.5 million pounds of hazardous waste a year.
- The Dow Chemical Company, Midland, Michigan — for improving titanium dioxide (TiO2)-based paints. Dow’s EVOQUE™ technology uses a polymer coating that, when applied to TiO2, improves dispersion of the pigment, decreasing the amount of the chemical needed and allowing it to work better. This technology will significantly reduce energy usage, water consumption, NOx and SOx emissions, and algae bloom.
- Cargill, Inc., Brookfield, Wisconsin — for developing a vegetable oil-based transformer fluid that is much less flammable, less toxic, provides superior performance compared to mineral oil-based fluids, and has a lower carbon footprint.
More information is available online.
Japan Announces Voluntary Guidance On Measuring Airborne Carbon Nanotubes In Workplaces: Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces. The Technology Research Association for Single Wall CNTs (TASC), a consortium of nine companies and AIST, prepared the guidance, which is intended to provide a means of CNT safety management. The guidance summarizes the available practical methods for measuring airborne CNTs: (1) on-line aerosol measurement; (2) off-line quantitative analysis (e.g., thermal carbon analysis); and (3) sample collection for electron microscope observation. The guidance also presents measurement cases performed by TASC. TASC developed the guidance under the project “Innovative carbon nanotubes composite materials project toward achieving a low-carbon society,” which is sponsored by the New Energy and Industrial Technology Development Organization (NEDO). The guidance notes that a specific method has not yet been definitively determined, and many challenges still remain. More information is available online.
Finnish Institute Of Occupational Health Releases Report On MWCNTs: The Finnish Institute of Occupational Health released a report in October 2013 entitled Evaluation of the health effects of carbon nanotubes. According to the Institute, recent studies have suggested that some types of multiwalled carbon nanotubes (MWCNT) have similar effects as asbestos. The Institute states that the report “shows that rigid, long and needle-like MWCNTs induce inflammation and DNA damage in the lungs and in cultured cells, while flexible, long and tangled MWCNTs do not. It appears that the rigidity of MWCNTs is a key feature in triggering a specific inflammatory reaction and in causing cellular alterations involved in cancer formation.” The Institute states that this new information on the adverse effects of MWCNTs will be useful in assessing which forms of MWCNTs require regulatory attention and special safety measures in occupational settings. More information is available online.
Switzerland Updates Precautionary Matrix For Synthetic Nanomaterials: In November 2013, Switzerland’s Federal Office of Public Health (FOPH) updated its precautionary matrix for synthetic nanomaterials, which industry can use to assess nano-specific health and environmental risks of nanoproducts. FOPH states that the precautionary matrix “enables the structured assessment of the ‘nano-specific need for precautions’ when handling synthetic nanomaterials.” FOPH intends the matrix to assist industry with due diligence requirements, and their “duty to exercise self-control opposite employees, consumers and the environment.” According to FOPH, the precautionary matrix can identify “potentially risky applications,” allowing the initiation of precautionary measures to protect people’s health and the environment. FOPH notes that the precautionary matrix “is upgraded in close cooperation with industry, science and trade as well as consumer and environmental organisations.” More information is available online.
Draft NNI Strategic Plan Released For Public Comment: On November 19, 2013, the National Science and Technology Council, Committee on Technology, and Subcommittee on Nanoscale Science, Engineering, and Technology requested public comments on the draft 2014 National Nanotechnology Initiative Strategic Plan. 78 Fed. Reg. 69463. The Strategic Plan provides the framework within which each National Nanotechnology Initiative (NNI) agency will carry out its nanotechnology programs and is intended to sustain coordination of interagency activities. The Strategic Plan includes the following goals: (1) advance a world-class nanotechnology research and development program; (2) foster the transfer of new technologies into products for commercial and public benefit; (3) develop and sustain educational resources, a skilled workforce, and a dynamic infrastructure and toolset to advance nanotechnology; and (4) support responsible development of nanotechnology. According to the draft Strategic Plan, “success will be measured by continual and substantive progress toward the four goals.” The program component areas were revised to represent better the current state of nanotechnology, improving their alignment with the goals and objectives of the Strategic Plan. Objectives in the draft Strategic Plan were revised to reflect advances in nanotechnology and evolving stakeholder needs. Sub-objectives were assigned to each objective to improve consistency among the goals. NNI requests comments of approximately one page or less in length (4,000 characters). According to the November 19, 2013, Federal Register notice, comments are due December 17, 2013. The NNI website states that comments are due December 18, 2013, however. More information is available online.
Germany Publishes Results Of Research Project On The Perception Of Nanotechnology: The Federal Institute for Risk Assessment (BfR) announced on November 27, 2013, that it completed NanoView, a research project on the perception of nanotechnology by the German population and media. Under the project, BfR examined whether the population’s perceptions and attitudes towards nanotechnology have changed over the last five years, as well as whether the presentation of nanotechnology in the media has changed. According to BfR, the results show that the majority of respondents are still largely unfamiliar with the term nanotechnology, and that fewer reports on the subject appear in the media than five years ago. BfR notes that, despite the existing knowledge gaps, a “clear majority” see the benefits of nanotechnology as outweighing any potential risks. BfR describes a “noteworthy” finding regarding the differences between the sexes, in that “men’s attitudes towards nanotechnology are clearly more positive than those of women; men are more likely to advocate nanotechnology.” BfR states: “By implementing a targeted communications strategy, the BfR strives to make a contribution to closing the knowledge gaps. In particular, the different information needs of men and women must be taken into account: men tend to prefer fact-based information about nanotechnology, whereas women would like recommendations relevant to everyday life that they can easily convert into concrete behaviour.” More information is available online.
IARC Will Review “Some Nanomaterials And Some Fibres” In 2014: On November 28, 2013, the International Agency for Research on Cancer (IARC) announced that the Working Group for IARC Monographs Volume 111, “Some Nanomaterials and Some Fibres,” will meet September 30 to October 7, 2014. IARC states that “[d]etails will follow shortly.” This will include information concerning the call for data, call for experts, and request for observer status. During the meeting, the Working Group will review the latest available scientific literature and determine which classification is appropriate: Group 1, carcinogenic to humans; Group 2A, probably carcinogenic to humans; Group 2B, possibly carcinogenic to humans; Group 3, not classifiable as to its carcinogenicity to humans; and Group 4, probably not carcinogenic to humans.
France Assesses Mandatory Reporting Of Nanomaterials: On November 29, 2013, the Ministry of Ecology, Sustainable Development and Energy published an initial assessment, available only in French, of the mandatory reporting of nanomaterials, which took effect January 1, 2013. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the Ministry, as of June 30, 2013, more than 930 reporters submitted over 3,400 statements concerning substances placed on the market in France in 2012. More information is available online.
NIA Report Examines Impact Of Nanotechnologies On The Global Divide: The Nanotechnology Industries Association (NIA) recently published a report entitled Closing the Gap: The Impact of Nanotechnologies on the Global Divide, which looks at how nanotechnology-based inventions and their potential applications could be implemented in developing countries, and whether they could benefit the most underprivileged populations. The report examines obstacles and problematic issues that could arise, and addresses the following concerns:
- Will nanotechnologies reach the populations they wish to assist?
- What impact could they have on world trade and already weak economies?
- What of the unprecedented nature and uncertainties surrounding the risks of nanotechnology?
- Will inventors from the developing world have to circumvent challenging intellectual property rules in order to make full use of the technology?
The report discusses possible ways forward for the fair development of nanotechnologies, as well as the possibilities for scientists and entrepreneurs from low- and middle-income countries to scale-up the benefits for their countries with the help of international cooperation and global dialogue. The report is available online.
ISO Publishes Guidance On Voluntary Labeling For Consumer Products Containing Manufactured Nano-Objects: The International Organization for Standardization (ISO) has published Technical Specification (TS) 13830:2013, “Nanotechnologies — Guidance on voluntary labelling for consumer products containing manufactured nano-objects.” The purpose of the guidance “is to provide a framework to facilitate a harmonized approach for the voluntary provision of labelling for [consumer products containing manufactured nano-objects (PCMNO)] that may or may not exhibit or impart nanoscale phenomena.” ISO notes that the TS is a “voluntary guidance on conveying specific product information that a manufacturer may choose to disclose on product labels and is not intended to provide mandatory labelling requirements, which are established by relevant regulatory authorities.” The TS is not applicable to consumer products containing naturally occurring nano-objects that were not subjected to manufacturing processes, nor does it apply to consumer products containing nano-objects that are incidentally present. A preview of the standard is available on the ISO website, and the complete standard may be purchased online.
USDA Announces Public-Private Partnership To Advance Commercial Potential Of Cellulosic Nanomaterial From Wood: On December 11, 2013, the U.S. Department of Agriculture (USDA) announced a three-year public-private partnership intended to advance rapidly “the development of the first U.S. commercial facility producing cellulosic nanomaterial, a wood fiber broken down to the nanoscale.” The partnership is between the U.S. Endowment for Forestry and Communities (Endowment) and the U.S. Forest Service. According to USDA, potential applications include ballistic glass replacements, body armor, auto and aerospace structural materials, flexible electronic circuits, and solar panels. The partnership seeks to overcome technical barriers to large-scale wood-based nanotechnology processing, while filling gaps in the science and technology that are needed for commercialization. The new venture will:
- Emphasize the potential of wood- based nanotechnology for the economy and the environment;
- Overcome technical barriers to commercialization of wood- based nanotechnology;
- Demonstrate commitment to creating high paying jobs in rural America through value- added manufacturing and high value products; and
- Showcase the commitment of USDA and the Forest Service to innovation.
The partnership is currently seeking additional public and private sector funding.
BRAG™ Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s consulting affiliate, B&C® Consortia Management, L.L.C., manages the Biobased and Renewable Products Advocacy Group (BRAG™). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.
EPA Proposes Renewable Fuel Standard: On November 15, 2013, EPA issued a proposed rule establishing the levels of renewable fuels to be blended into gasoline and diesel as required under the Energy Independence and Security Act of 2007. The rule was published in the Federal Register on November 29, 2013. 78 Fed. Reg. 71732. Comments are due January 28, 2014. The proposal seeks public input on annual volume requirements for renewable fuels in all motor vehicle gasoline and diesel produced or imported by the U.S. in 2014. According to EPA, the proposal seeks to put the Renewable Fuel Standard (RFS) program on a steady path forward (i.e., ensuring the continued long-term growth of the renewable fuel industry) while seeking input on different approaches to address the “E10 blend wall.” The proposed rule rolls back a controversial 2007 biofuels mandate. It would require that the U.S. oil industry add 15.2 billion gallons of renewable fuel to the nation’s fuel supply in 2014, which is a reduction from 2013’s level of 16.55 billion gallons. The proposal discusses a variety of approaches for setting the 2014 standards, and includes a number of production and consumption ranges for key categories of biofuel covered by the RFS program. The proposal seeks comment on a range of total renewable fuel volumes for 2014 and proposes a level within that range of 15.21 billion gallons. Nearly all gasoline sold in the U.S. is now “E10,” which is fuel with up to 10 percent ethanol. Production of renewable fuels has been growing rapidly in recent years. At the same time, advances in vehicle fuel economy and other economic factors have pushed gasoline consumption far lower than what was expected when Congress passed the Renewable Fuel Standard in 2007. As a result, EPA claims that the U.S. is now at the “E10 blend wall,” the point at which the E10 fuel pool is saturated with ethanol. If gasoline demand continues to decline, as currently forecast, continuing growth in the use of ethanol will require greater use of higher ethanol blends such as E15 and E85.
House Passes Bill To Expedite Permitting Of Oil And Gas Operations On Federal Land; White House Threatens Veto: The House of Representatives on November 20, 2013, passed legislation that would require the Department of Interior (DOI) to decide whether to approve or reject permit applications for onshore oil and gas drilling on federal land within 60 days. Under the Federal Lands Jobs and Energy Security Act (H.R. 1965), if DOI fails to make a decision, the permit would be automatically approved. The bill also contains an amalgam of other bills that had been separately introduced that would promote research on oil shale formations, create a quadrennial energy strategy for federal lands, allow additional lease sales in the National Petroleum Reserve, and promote energy development on tribal lands. The bill would also require an interagency review board to examine ways to streamline review of federal permits. The White House on November 19, 2013, issued a Statement of Administration Policy promising to veto the legislation if it reaches President Obama’s desk. The White House opposes the bill because it believes it would, among other things, “undermine the Nation’s energy security; roll back policies that support the continued growth of safe and responsible energy production in the United States; [and] discourage environmental analysis and civic engagement in Federal decision-making.” It is unlikely, however, that the bill will end up on the President’s desk, as its prospects in the Senate are very dim.
Federal Authority To Regulate Fracking Would Be Limited Under Bill Passed By House In Face Of Veto Promise: The House on November 29, 2013, passed the Protecting States’ Rights to Promote American Energy Security Act (H.R. 2728), which would limit DOI from enforcing regulations for fracking operations on federal lands in any state that already has regulations in place governing the activity. DOI would similarly be prohibited from taking enforcement actions against fracking operations on tribal lands. President Obama has threatened to veto the legislation.
House Passes Natural Gas Pipeline Permitting Reform Act; President Threatens Veto: On November 21, 2013, the House passed the Natural Gas Pipeline Permitting Reform Act (H.R. 1900). The bill would amend the Natural Gas Act to direct the Federal Energy Regulatory Commission (FERC) to approve or deny a certificate of public convenience and necessity for a prefiled project within 12 months after receiving a complete application that is ready to be processed. The bill would also require the agency responsible for issuing any federal license, permit, or approval regarding the siting, construction, expansion, or operation of a project for which a certificate is sought to approve or deny issuance of the certificate within 90 days after FERC issues its final environmental document regarding the project. It would also require FERC to grant an agency request for a 30-day extension of the 90-day time period if the agency demonstrates that it cannot otherwise complete the process required to approve or deny the license, permit, or approval, and therefore will be compelled to deny it. Rounding out the trifecta of veto threats levied against Republican-backed energy bills, the White House said that H.R. 1900 could create conflicts with existing statutory and regulatory requirements and practices, or could force federal agencies to render decisions on permit applications based on incomplete information. President Obama thus threatened to veto the legislation if it is presented to him for signature.
Bill Would Require EPA To Cut Workforce By 15 Percent: On December 3, 2013, Representative Morgan Griffith (R-VA) introduced the EPA Maximum Achievable Contraction of Technocrats Act of 2013 (H.R. 3641). The EPA MACT Act would require EPA to cut its workforce by 15 percent within three years. Griffith justified the bill’s introduction with a statement that more than nine out of every ten EPA employees were considered “non-essential” and were furloughed during the recent partial government shutdown. He also said that “[c]learly, EPA regulators are waging a war on common sense, American manufacturers, jobs, and more. There are real businesses that have closed and real people who have lost their jobs as a result of unreasonable EPA actions. The American people need some relief without delay. This bill would give a small measure of hope to those who face the prospects of the business they work for being shuttered and the loss of their jobs because of an overzealous EPA producing massive new unreasonable regulations.”
Senate Bill Would Clarify Scope Of Clean Air Act’s General Duty Clause: Legislation introduced on December 9, 2013, by Senator David Vitter (R-LA) would amend the Clean Air Act (CAA) to require EPA to promulgate regulations and guidance clarifying the scope of the CAA’s “general duty clause.” The general duty clause — CAA Section 112(r) (1) — states that owners and operators of facilities producing, processing, and storing extremely hazardous substances have a “general duty to identify hazards associated with an accidental release, design and maintain a safe facility, and minimize consequences of accidental releases.” EPA has never promulgated regulations defining the terms of the clause or providing direction on its scope. The General Duty Clarification Act of 2013 (S. 1781) would give EPA one year to define key terms in the general duty clause and to issue guidance ensuring that the clause would be applied in a “uniform and appropriate manner.” Vitter’s legislation would prohibit EPA from requiring the use of inherently safer technologies (IST) at chemical storage facilities.
EPA Appoints New Scientific Integrity Official: On November 25, 2013, EPA announced that Dr. Francesca Grifo has been appointed as EPA’s new scientific integrity official. Dr. Grifo’s responsibilities include coordinating and carrying out EPA’s scientific integrity policy and chairing a standing EPA scientific integrity committee. Dr. Grifo was with the Union of Concerned Scientists and, according to EPA’s press statement, has devoted her career to strengthening scientific integrity in the government. For more information on EPA’s Scientific Integrity Policy, see online.
California Announces Plans To Add Trichloroethylene To Proposition 65 Reproductive Toxicity List: On November 27, 2013, California’s Office Environmental Health Hazard Assessment (OEHHA) announced plans to add trichloroethylene (TCE) to the list of reproductive toxicants maintained under Proposition 65. In the notice of intent, OEHHA proposed listing TCE based on EPA’s 2011 Integrated Risk Information System (IRIS) document findings that TCE caused male reproductive toxicity and developmental toxicity in laboratory animals. The OEHHA notice of intent is available online.
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