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April 1, 2010

Monthly Update for April 2010

Bergeson & Campbell, P.C.


EPA To Increase Restrictions On Flea And Tick Products: On March 18, 2010, the U.S. Environmental Protection Agency (EPA) announced that it will begin reviewing labels to determine which pesticide products for flea and tick control need revised labeling statements. 75 Fed. Reg. 13125. EPA intends to develop more stringent testing and evaluation requirements for both existing and new products, and expects these steps will help prevent adverse reactions. Following the 2008 increase in adverse incident reports, EPA received additional information from the pet spot-on pesticide registrants and others and began an intensive evaluation of these products. Among immediate actions that EPA will pursue are: requiring manufacturers of spot-on pesticide products to improve labeling, making instructions clearer to prevent product misuse; requiring more precise label instructions to ensure proper dosage per pet weight; requiring clear markings to differentiate between dog and cat products, and disallowing similar brand names for dog and cat products — similar names may have led to misuse; requiring additional changes for specific products, as needed, based on product-specific evaluations; when new products are registered, granting only conditional, time-limited registrations to allow for post-marketing product surveillance — if there are incidents of concern associated with the product, EPA will take appropriate regulatory action; and restricting the use of certain inert ingredients that EPA finds may contribute to the incidents. EPA’s report on the evaluation of products and incidents is available online. EPA recommends that veterinarians use the National Pesticide Information Center’s Veterinary Pesticide Adverse Effects Portal to report incidents, which is available online. More information on pet products and safety tips is available online. Comments are due by May 17, 2010.

EPA Planning To Release More Chemical Action Plans: On March 17, 2010, EPA announced that it is preparing action plans for nonylphenol/nonylphenol ethoxylate (NP/NPE), hexabromocyclododecane (HBCD), siloxanes, and diisocyanates. EPA is also preparing final action plans for the chemicals remaining on EPA’s initial list — bisphenol A (BPA) and benzidine dyes. EPA chose the chemicals based on a range of criteria, including identification as persistent, bioaccumulative, and toxic; high production volume chemicals; chemicals in consumer products; chemicals of particular potential concern for children’s health because of reproductive or developmental toxicity; chemicals subject to review and potential action in international forums; chemicals found in human blood in biomonitoring programs; and chemicals in categories generally identified as being of potential concern in the new chemicals program. According to EPA, it intends to release a set of chemical action plans every four months, and anticipates releasing the next set of action plans in late Spring 2010. More information is available online.

It remains to be seen what EPA has in mind for the siloxanes and diisocyanates, two potentially large and complex categories. Regarding the siloxanes, EPA has been assessing D4 and D5 as well as octamethylcyclotetrasiloxane (OMCTS) and information on those efforts can be found on the Office of Pollution Prevention and Toxics’ (OPPT) website. OPPT’s Design for the Environment (DfE) Program has been implementing the Automotive Refinishing Partnership (available online), which focuses in part on diisocyanates and associated with that is an OPPT hazard profile on the diisocyanates (available online).

EPA Issues ANPRM On Reassessment Of PCB Use Authorizations: On April 7, 2010, EPA issued an Advanced Notice of Proposed Rulemaking (ANPRM) for the use and distribution in commerce of certain classes of polychlorinated biphenyls (PCB) and PCB items and certain other areas of the PCB regulations under the Toxic Substances Control Act (TSCA). 75 Fed. Reg. 17645. EPA is reassessing its TSCA PCB use and distribution in commerce regulations to address: the use, distribution in commerce, marking, and storage for reuse of liquid PCBs in electric and non-electric equipment; the use of the 50 parts per million (ppm) level for excluded PCB products; the use of non-liquid PCBs; the use and distribution in commerce of PCBs in porous surfaces; and the marking of PCB articles in use. EPA is also reassessing the definitions of “excluded manufacturing process,” “quantifiable level/level of detection,” and “recycled PCBs.” EPA is soliciting comments on these and other areas of the PCB use regulations. EPA is not soliciting comments on the PCB disposal regulations. Comments on this extensive ANPRM must be received on or before July 6, 2010.

EPA Announces BPA Action Plan: On March 29, 2010, EPA announced its action plan on BPA. In its press release, EPA states that the BPA action plan “focuses on the environmental impacts of BPA and will look to add BPA to EPA’s list of chemicals of concern and require testing related to environmental effects.” EPA notes that, in January 2010, the Food and Drug Administration (FDA) announced that it had some concerns about the potential human health impacts of BPA, and would study the potential effects and ways to reduce exposure to BPA in food packaging. According to EPA, it “share[s] FDA’s concern about the potential health impacts from BPA,” and “EPA and FDA, and many other agencies are moving forward to fully assess the environmental and health impacts to ensure that the full range of BPA’s possible impacts are examined.” EPA states in its press release that “[f]ood packaging represents the most obvious source of BPA exposure to people and is regulated by FDA” and that EPA’s efforts would focus on the “potential environmental impacts of BPA,” noting that releases of BPA to the environment exceed 1 million pounds per year. According to EPA, BPA has caused reproductive and developmental effects in animal studies and may also affect the endocrine system. More information is available online. The BPA action plan is available online.

EPA Proposes To Add 16 Chemicals To Section 313 List: On April 6, 2010, EPA proposed to add 16 chemicals to the list of toxic 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 of 1990 (PPA). 75 Fed. Reg. 17333. These 16 chemicals have been classified by the National Toxicology Program (NTP) in its Report on Carcinogens (RoC) as “reasonably anticipated to be a human carcinogen.” EPA believes that these 16 chemicals meet the EPCRA Section 313(d)(2)(B) criteria because they can reasonably be anticipated to cause cancer in humans. EPA adopted a production volume screen for the development of this proposed rule to screen out those chemicals for which no reports are expected to be submitted. Based on a review of the available production and use information, these 16 chemicals are expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA Section 313 reporting thresholds. Comments must be received on or before June 7, 2010.

EPA Posts Fact Sheet On Determining If A Cleaning Product Is A Pesticide: In a March 2010 fact sheet, EPA described how to determine whether a cleaning product is a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under FIFRA, pesticide products must be registered if they are considered to be intended for a pesticidal purpose. EPA states that products are considered to be for a pesticidal purpose “if the person who distributes or sells them claims, states or implies that they can or should be used to prevent, destroy, repel or mitigate a pest.” Claims that a product affects a pest’s habitat or food source are claims that the product mitigates the pest, according to EPA. EPA states: “A product need not act directly on a pest in order for it to mitigate the pest and therefore be considered a pesticide.” Direct or indirect claims that a product mitigates a pest by removing food or habitat are pesticidal claims and require the product to be registered under FIFRA. The list of products, including cleaning agents, that are not pesticides because they are not used for a pesticidal effect is limited to those products for which no pesticidal claim is made on the product’s labeling or in connection with its sale and distribution. The fact sheet is available online.

EPA provides the following examples of pesticidal claims that require EPA registration:

  • Removal of pest breeding sites;
  • Removal of pest habitats, including removing nutrients from areas where insect larvae may mature;
  • Cleaning claims that the product can be used where “contamination” is habitat or food for pests;
  • Cleaning claims for direct removal of the pest;
  • Removal of scum where pests breed;
  • Claims the product works through out-competing the pest for nutrition or habitat;
  • Removal of the pest through physical means such as by suffocating or drowning the pest (not a habitat claim) (products intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants do not require registration);
  • Removal or digestion of biofilm;
  • Claims that a product sanitizes or disinfects;
  • Mention of a specific microorganism or “germs” or the removal of habitat where microorganisms can hide, thrive, or grow;
  • Removal of bacterial odors; and
  • Removal of unspecified “allergens” or the habitat where “allergens” can hide, thrive, or grow.

According to EPA, unregistered cleaning products sold in association with Integrated Pest Management (IPM) product lines “frequently appear to be making unlawful claims related to pest control.” EPA notes that, if a company’s logo mentions pest control, “the label as a whole may be seen to imply it is a pest control product. Attaching such logos to a cleaning product can require registration of the cleaning product.” If unregistered cleaning products are sold or marketed in association with pesticides, they should be clearly distinguishable from the claims made for the pesticides. If not, according to EPA, the associated pesticidal claims may be considered to be claims attached to the cleaning products, making them pesticides that need to be registered.

EPA states that, similarly, images of pests, or characteristic pest habitats, on the labels of products aimed at pest habitat or food removal “imply the product is a pesticide and may require EPA registration.” FIFRA prohibits pesticidal claims in brochures, pamphlets, and Internet sites connected with the sale or distribution of unregistered pesticides. This prohibition also extends to testimonial claims, as well as claims made by sales staff, either the manufacturer’s or service provider’s.

EPA notes that, when appropriate, it takes enforcement action against any person who sells or distributes a pesticide that does not meet the requirements of FIFRA. Once EPA decides that a FIFRA violation has occurred, EPA determines the appropriate level of enforcement response for the violation. Enforcement options include, but are not limited to:

  • Notices of Warning;
  • Stop Sale, Use, or Removal Orders; and
  • Civil Penalties.


EPA Issues Hazardous Waste Technical Corrections And Clarifications Rule: On March 18, 2010, EPA issued a direct final rule making a number of technical changes that correct or clarify several parts of the Resource Conservation and Recovery Act (RCRA) hazardous waste regulations that relate to hazardous waste identification, manifesting, the hazardous waste generator requirements, standards for owners and operators of hazardous waste treatment, storage and disposal facilities, standards for the management of specific types of hazardous waste and specific types of hazardous waste management facilities, the land disposal restrictions program, and the hazardous waste permit program. 75 Fed. Reg. 12989. The changes correct existing errors in the hazardous waste regulations that have occurred over time in numerous final rules published in the Federal Register, such as typographical errors, incorrect or outdated citations, and omissions. Some of the corrections are necessary to make conforming changes to all appropriate parts of the RCRA hazardous waste regulations for new rules that have since been promulgated. In addition, these changes clarify existing parts of the hazardous waste regulatory program and update references to Department of Transportation (DOT) regulations that have changed since the publication of various RCRA hazardous waste final rules. The direct final rule is effective on June 16, 2010, without further notice unless EPA receives adverse comments by May 3, 2010. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the Federal Register informing the public that the rule will not take effect. In a related notice issued on the same day, EPA proposed the same amendments. 75 Fed. Reg. 13066. Comments are due May 3, 2010.


EPA Issues Direct Final Rule Amending Greenhouse Gas Reporting Rule: On March 16, 2010, EPA issued a direct final rule amending the general provisions for the Mandatory Greenhouse Gas (GHG) Reporting Rule. 75 Fed. Reg. 12451. The amendments do not change the requirements of the regulation for facilities and suppliers covered by the 2009 final rule. Rather, the amendments make “minor changes” to the format of several sections of the general provisions to accommodate the addition of new subparts in the future. These changes include updating the language for the schedule for submitting reports and calibrating equipment to recognize that subparts that may be added in the future would have later deadlines. These revisions do not change the requirements for subparts included in the 2009 final rule. This direct final rule is effective May 17, 2010, without further notice, unless EPA receives adverse comments by April 15, 2010, or by April 30, 2010, if a public hearing is held. In a relevant measure, EPA issued a proposed rule making the same changes. 75 Fed. Reg. 12489. Comments are due on April 15, 2010.

EPA Proposes To Require GHG Emission Reporting From Additional Sources Of Fluorinated GHGs: On April 12, 2010, EPA proposed actions to require reporting of fluorinated greenhouse gas (fluorinated GHG) emissions from certain source categories. 75 Fed. Reg. 18652. Specifically, EPA revised its initial proposal to require reporting of fluorinated GHG emissions from electronics manufacturing, production of fluorinated gases, and use of electrical transmission and distribution equipment. EPA also proposed to require such reporting from manufacture or refurbishment of electrical equipment and import and export of pre-charged equipment and closed cell foams. The proposed rule would not require control of GHGs; rather it would require only that sources above certain threshold levels monitor and report emissions. There will be a public hearing from 9 a.m. to 12 noon on April 20, 2010, at 1310 L St., NW., Room 152, Washington, DC 20005. Comments must be received on or before June 11, 2010.

EPA Schedules Public Hearings For The Mandatory Reporting Rule For GHGs: On April 6, 2010, EPA announced the scheduling of two public hearings on proposed rules related to mandatory reporting of GHGs. 75 Fed. Reg. 17331. The proposed rules would amend the Mandatory Reporting of Greenhouse Gases rule, published on October 30, 2009, by requiring reporting of GHGs from additional industry source categories. One hearing will be held in Arlington, Virginia (which is in the Washington, DC, area) on April 19, 2010. It will cover the proposed rule “Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems” and the proposed rule “Mandatory Reporting of Greenhouse Gases: Injection and Geologic Sequestration of Carbon Dioxide.” The other hearing will be held in Washington, DC, on April 20, 2010. It will cover the proposed rule “Mandatory Reporting of Greenhouse Gases: Additional Sources of Fluorinated GHGs,” which will be published in a separate notice of proposed rulemaking. Please consult the Federal Register for details.

EPA Proposes To Amend Mandatory Reporting Of GHGs: On April 12, 2010, EPA proposed to amend the Mandatory Greenhouse Gas (GHG) Reporting Rule to require reporters subject to the rule to provide: the name, address, and ownership status of their U.S. parent company; their primary and all other applicable North American Industry Classification System (NAICS) code(s); and an indication of whether or not any of their reported emissions are from a cogeneration unit. 75 Fed. Reg. 18455. The Mandatory GHG Reporting Rule requires GHGs emitting facilities and suppliers of fuels and industrial gases from all sectors of the economy to report their GHG emissions and to provide certain additional supporting data in annual reports submitted to EPA. Comments must be received on or before June 11, 2010.

EPA Releases Public Database On Risk Assessments: On March 24, 2010, EPA released the Health and Environmental Research Online (HERO) database. HERO provides access to the scientific studies used in making key regulatory decisions, including EPA’s periodic review of the National Ambient Air Quality Standards (NAAQS) for six major pollutants. The initiative is part of the open government directive to conduct business with transparency, participation, and collaboration. The HERO database includes more than 300,000 scientific articles, including the authors, titles, dates, and abstracts. In addition, through a simple keyword search, anyone can see information from the articles that were used to develop specific risk assessments. HERO includes peer-reviewed literature used by EPA to develop its Integrated Science Assessments (ISA) that support the NAAQS review, and includes references and data from the Integrated Risk Information System (IRIS). More information on the HERO database is available online.

EPA Opens Comment Period On Possibility Of Changes To Four Drinking Water Rules: On March 29, 2010, EPA requested public comment on its consideration of revisions to four drinking water standards. 75 Fed. Reg. 15500. EPA seeks comment on the standards for trichloroethylene, tetrachloroethylene, acrylamide, and epichlorohydrin, the four candidates selected for possible revision of regulations after the six-year review of primariy drinking water standards. EPA has identified the chlorinated solvents trichloroethylene and tetrachloroethylene for possible rule changes because improvements in analytical feasiblity allow for accurate assessments of the contaminants at lower levels. Acrylamide and epichlorohydrin are residual chemicals found in the coagulant chemicals that water utilities use to help sanitize drinking water. Coagulation causes particulate matter to clump together so that filtration can more easily remove the particles. Comments are due by May 28, 2010.

EPA Proposes Air Toxics Control Guidance For States: On March 30, 2010, EPA proposed to amend the rule on how to make case-by-case determinations on maximum achievable control technology (MACT) standards for emissions of toxic air pollutants from industrial facilities. 75 Fed. Reg. 15655. The proposal would apply when EPA has not issued national emission standards for hazardous air pollutants (NESHAP) for substances listed under Clean Air Act (CAA) Section 112(d), or when those standards have been overturned as a result of lawsuits. The proposed rule seeks to streamline the permit application process, establish new deadlines for submitting the applications for affected industries, and remove industries’ ability to request a determination by state regulators that the air toxics rules are applicable. Section 112(j) of the statute requires covered sources to submit permit applications to state or federal regulators for a case-by-case determination of applicable air toxics emissions limits, a provision known as the “MACT hammer.” Comments must be received on or before April 29, 2010, unless a public hearing is requested by April 14, 2010. If a hearing is requested on the proposed amendments, written comments must be received by May 14, 2010. Under the Paperwork Reduction Act, comments on the information collection provisions are best assured of having full effect if the Office of Management and Budget (OMB) receives comments on or before April 29, 2010.

EPA Issues Final Rule Regulating Fuels And Fuel Additives: On March 26, 2010, EPA issued a final rule under CAA Section 211(o), as amended by the Energy Independence and Security Act of 2007 (EISA), implementing changes to the Renewable Fuel Standard program. 75 Fed. Reg. 14670. The rule implements the requirements of the EISA, including the cellulosic, biomass-based diesel, advanced biofuel, and total renewable fuel that must be used in transportation fuel. The final rule also imposes a GHG emission threshold for renewable fuels and new limits on renewable biomass feedstocks. This is the first rulemaking in which a GHG emission performance limit is being applied in a nationwide program Two trade associations filed suit against EPA over the rule on March 29, 2010. National Petrochemical and Refiners Association v. EPA, D.C. Cir. No. 10-1070; American Petroleum Institute v. EPA, D.C. Cir., No. 1071. The rule is effective on July 1, 2010.

EPA Stays Inclusion Of Fugitive Emissions In PSD Program: On March 31, 2010, EPA issued a final rule staying for 18 months the inclusion of fugitive emissions requirements in the federal Prevention of Significant Deterioration (PSD) program published on December 19, 2008, in the final rule entitled “Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Reconsideration of Fugitive Emissions” (Fugitive Emissions Rule). 75 Fed. Reg. 16012. The Fugitive Emissions Rule under the federal PSD program requires that fugitive emissions be included in determining whether a physical or operational change results in a major modification only for sources in industries that have been designated through rulemaking under CAA Section 302(j). The existing stay is in effect until March 31, 2010. The final rule puts in place an additional stay for 18 months or until October 3, 2011, which EPA believes will allow for sufficient time for it to propose, take public comment on, and issue a final action concerning the inclusion of fugitive emissions in the federal PSD program.

EPA Seeks Comment On Proposed Aggregation Amendments: On April 15, 2010, pursuant to a proceeding for reconsideration, EPA requested comments on the New Source Review (NSR) Aggregation Amendments, which were promulgated on January 15, 2009. 75 Fed. Reg. 19567. The NSR Aggregation Amendments established a new interpretation of the existing NSR rules governing the modification of major sources by requiring sources and permitting authorities to combine emissions from nominally-separate activities at a major stationary source only when the activities are “substantially related.” The proposed reconsideration is in response to a petition filed by the Natural Resources Defense Council (NRDC) received on January 30, 2009. EPA requests public comment on all issues included in NRDC’s petition. Comments must be received on or before May 17, 2010.


New REACH-IT Version Released: As of March 25, 2010, the new version of REACH-IT is now online. It includes new features such as group Classification and Labelling notifications, Legal Entity change, and cease manufacture declarations. Registration dossiers should be submitted using the new version of IUCLID 5.2. The new version of REACH-IT has significant changes in terms of dossier submission. These changes are outlined in the revised manuals. The European Chemicals Agency (ECHA) urges all companies submitting dossiers to read the relevant manual to minimize the chances of a business rule failure. REACH-IT 2.0 will only accept dossiers created in IUCLID 5.2. The new version of IUCLID, rendering the tool coherent with the Classification, Labeling, and Packaging (CLP) Regulation, is available on the IUCLID website. The new version of the Technical Completeness Check (TCC) plug-in is fully compatible with IUCLID 5.2 and allows companies to verify the technical completeness of their dossier before submitting it. Recent analysis of the dossier submissions have revealed that the use of the TCC IUCLID plug-in substantially increases your chance of passing the completeness check. ECHA encourages companies to check their dossiers with the TCC tool before submission via REACH-IT. Invoices will be sent from March 25, 2010, onwards electronically only via REACH-IT. Paper invoices will not be sent out anymore. Companies will be informed by an automatic message to their REACH-IT account that the invoice is available for download. Similar automatic messages will notify companies of credit notes and invoice reminders. More detailed instructions on how to sort and view invoices in REACH-IT can be found in the “Industry User Manual 8: invoicing.”

Turkey Begins Consultation On Chemicals Inventory Deadline Extension: Companies located in European Union (EU) countries have expressed relief at news that they may have won more time to comply with a significant new chemicals control law adopted by the Turkish government. A delegation of EU chemicals manufacturers and exporters organized by the European Chemical Industry Council (CEFIC) visited the Turkish Ministry of Environment and Forestry (MOEF) in February to ask for more time to comply with its By-Law on Inventory and Control of Chemicals, which was first published at the end of 2008. This was amended in November 2009 to extend the deadline for compliance to June 30, 2010, but even this was considered too onerous for EU companies who are struggling to comply with a major Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) deadline for this year.

Speaking at ChemCon Europe in Prague in March, Eylem Öslem Nalbantoglu, MOEF, noted that the government was considering two amendments to the law to make it easier for EU-based companies with operations in Turkey to comply. One is an extension of the compliance deadline to March 30, 2011, and the other is the ability to establish a “legal trusty” in Turkey to file registrations on behalf of importers.

Ms. Nalbantoglu has since confirmed that MOEF has prepared a draft revised version of the By-law to include these two amendments, which has been sent to stakeholders, including public authorities, non-governmental organizations, and industry, for comment. If this process goes smoothly, an official amendment is likely to be published within two months.

The By-law seeks to establish a first inventory of the chemicals manufactured in and imported into Turkey. It applies to manufacturers and importers of substances on their own or in preparations who introduced the substances in Turkey in the three years up to December 26, 2008. Registration of such chemicals is required according to tonnage bands of 1-1,000 tpa and over 1,000 tpa. Chemicals newly produced or imported since that date must be registered within 14 months according to the amendment published in November 2009.

The By-law is part of a suite of changes planned by the Turkish government as it proceeds with accession talks to join the EU. Discussions on the environmental chapter of the accession deal were started on December 21, 2009.

Turkey already takes part in meetings of the EU’s Competent Authorities for REACH and Classification and Labeling (CARACAL) and is part of the REACH Helpdesk Correspondents’ Network (REHCORN) EU helpdesks for the REACH and CLP regulations. Turkey has established an industry REACH helpdesk and plans to establish a national helpdesk within MOEF. A REACH portal has also been established, which is available online.

A REACH Advisory Group is planning several projects this year to assess the impact of REACH implementation in Turkey while at the same time raising awareness and preparing companies for implementation of both REACH and CLP.


PCAST Issues Assessment On NNI: On March 25, 2010, the President’s Council of Advisors on Science and Technology (PCAST) issued its Report to the President and Congress on the Third Assessment of the National Nanotechnology Initiative. The report is part of a periodic update required under the 21st Century Nanotechnology Research and Development Act. In general, the report concluded that the National Nanotechnology Initiative (NNI) has had a “catalytic and substantial impact” on the growth if the U.S. Nanotechnology industry and should be continued. The report noted, however, that China, South Korea, and the EU are “aggressively investing” in nanotechnology and threatening U.S. leadership. The report recommends changes in the Federal programs and policies. In the environmental, health, and safety area, the report recommends greater coordination among agencies and urged the Nanotechnology Environmental and Health Implications (NEHI) to development of “clear principles” to support the identification of plausible risks associated with the products of nanotechnology. The report is available online.


FDA Reopens Bottled Water Comment Period: On April 1, 2010, the Food and Drug Administration (FDA) reopened the comment period for the proposed rule, published in the Federal Register of August 4, 1993, amending the quality standard for bottled water. 75 Fed. Reg. 16363. In the 1993 proposed rule, FDA proposed to revise the bottled water quality standard to establish or modify the allowable levels for five inorganic chemicals and 18 synthetic organic chemicals, and to maintain the existing allowable level for the inorganic chemical sulfate. In a final rule published March 26, 1996, FDA maintained the existing allowable level for sulfate and adopted the proposed allowable levels for the five inorganic chemicals and 17 of the synthetic organic chemicals, but deferred final action on the proposed allowable level for the chemical di(2-ethylhexyl)phthalate (DEHP). FDA is reopening the comment period on the 1993 proposed rule to seek further comment on finalizing the allowable level for DEHP in the bottled water quality standard. Comments are due by June 1, 2010.


Lautenberg Announces Safe Chemicals Act of 2010: On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, which is intended to address the “core failings” of TSCA. The Safe Chemicals Act would:

  • Ensure EPA will have information on chemical hazards, uses, and exposures sufficient to judge a chemical’s safety. The bill would require manufacturers to develop and submit a minimum data set for each chemical they produce. Under the bill, EPA would have the authority to require more data it believes is necessary to determine the safety of a chemical;
  • Require EPA to use this information to categorize and prioritize chemicals, based on their hazard and exposure characteristics. EPA would identify and prioritize chemicals by their likely risk, based on the anticipated use, production volume, toxicity, persistence, bioaccumulation, and other properties that indicate risk;
  • Ensure that expedited action is taken to reduce the use of or exposures to chemicals of highest concern. According to Lautenberg’s summary, the bill calls for EPA “to act quickly on chemicals that clearly demonstrate high risk”;
  • Require all chemicals to be shown to be safe to remain in or enter commerce. The bill summary states:The burden of proving safety rests on chemical manufacturers and users, not on government to show harm before it can act. All uses of a chemical must be identified, and the resulting aggregate exposure measured against a health-based safety standard set to protect both the general population and vulnerable subpopulations that may be more susceptible or more exposed to the chemical, such as children. If the safety standard is not met, the chemical cannot be marketed.
  • Ensure broad public, market, and worker access to reliable chemical information. The bill would establish a public database that would include chemical information submitted to EPA, and EPA’s decisions regarding chemicals. The bill would also narrow the conditions under which data could be claimed as confidential business information (CBI), and would provide access to CBI by workers and local, state, tribal, and (in some cases) foreign governments, provided they protect its confidentiality; and
  • Promote innovation and the development and use of green chemistry and safer alternatives to chemicals of concern. EPA would establish a program to develop market and other incentives for safer alternatives, and a research grant program “targeted at priority hazardous chemicals for which alternatives do not presently exist.” The bill would allow some new chemicals to enter the market, using an expedited process for reviewing safety.

The bill summary is available online, and the text of the 169-page bill is available online.

A variety of interested parties will now be able to read what is actually proposed and go beyond the general rhetoric of “principles” and goals. At this early point, the fact that the text on both sides of the Hill has been released as a draft bill is one sign the door is open for some serious discussion among the various groups. Also ongoing is a series of weekly meetings among groups hosted by Congressional staff to discuss various elements of the proposals. This also is a sign that some attempt at achieving consensus will initially be sought. At the same time, given the wide variety of groups claiming an interest in the legislation, consensus, by definition, will be difficult to attain.

Utah To Challenge Federal Ownership Of Land: On March 27, 2010, Utah Governor Gary Herbert (R-UT) signed two measures designed to utilize the exercise of eminent domain authority to contest federal ownership of certain lands in Utah ceded to the federal government when Utah entered the Union. Those lands surround and cut off state owned lands that could be sold or leased for commercial development. The state says that the situation impacts the ability of the State of Utah to generate funds to support education. One million dollars was appropriated for use in pursing the litigation over a three year period.

Foreign Manufacturers Legal Accountability Act Of 2010 Introduced: Representative Betty Sutton (D-OH) introduced legislation to ensure that a foreign manufacturer that produces goods in excess of a minimum value or quantity can be held accountable in litigation by requiring that the company appoint a registered agent in this country authorized to accept service of process in all civil and regulatory actions in both state and federal courts. The law would apply to all foreign manufacturers and producers of products or components used to produce them. The registered agent would have to be located in a state with substantial connection to the importation, distribution, or sale of the products, and companies with such agents would be deemed to consent to the personal jurisdiction of the state or federal courts in the state where the agent is located. The Accountability Act directs three agencies to act to implement the requirements. FDA would be responsible for measures dealing with drugs, cosmetics, devices, and biological products. The Consumer Products Safety Commission (CPSC) would be responsible for consumer products, and EPA would be responsible for chemical substances, new chemical substances, and pesticides. The FDA and the Department of Agriculture would be required to study the feasibility of requiring manufacturers of imported food to establish such an agent. The Commerce Department would be directed to establish and make available to the public a registry of the agents so appointed. It would be illegal to import a product or component manufactured outside the United States unless the product was produced by a company with a registered agent.

Green Manufacturing Equipment Exempt From California Taxes: Governor Arnold Schwarzenegger (R-CA) has signed a bill introduced by Senator Alex Padilla (D-CA) granting an exemption from the payment of state sales and use taxes for equipment that is utilized to generate energy from alternate sources, such as wind and the sun. The measure is intended to generate work in the state.

Polluters Would Pay: Senator Frank Lautenberg (D-NJ) introduced March 25, 2010, the Polluters Pay Restoration Act. The Act, if passed, would reinstate fees charged industries for the cleanup of Superfund sites. According to the Senator, President Bush allowed the trust fund to go bankrupt in 2003, and that shifted payment for cleanup to the general public. Senator Lautenberg said in a statement at the time of introduction that President Obama had proposed reinstating the polluter pays fee in his budget for 2011, which would generate over $1.3 billion in annual revenue.

Governor Vetoes Emission Reduction Grants: For the second year in a row, Democratic Governor David Paterson of New York has vetoed legislation that would have awarded grants to research projects relating to technologies that are aimed at the reduction of GHGs. In his Veto No. 2, Governor Paterson said the bill did not provide a means of funding and it duplicated other state programs.

Energy Efficiency Measure Starts Through Congress: The House of Representatives Energy and Commerce Subcommittee on Energy and the Environment agreed by a voice vote to a $6 billion homeowner energy efficiency rebate program that will go to the full committee for review later this month.

Support For Nanotechnology Education: Senators Olympia Snowe (R-ME) and Ron Wyden (D-OR) introduced on March 15, 2010, the “Promote Nanotechnology in Schools Act” to help schools purchase the advanced equipment needed to educate students and train workers in the emerging field of nanotechnology. The legislation tasks the Director of the National Science Foundation (NSF) to set up a matching grants program for eligible institutions to purchase nanotechnology equipment and software, and provide education to students regarding nanotechnology. Educational institutions at all levels are listed as eligible grantees, from four year and community colleges to public, private, parochial and charter secondary schools offering advanced or international baccalaureate science courses.

A Nutritional Boost For Children: The “Healthy, Hunger-Free Kids Act of 2010” was approved by the Senate Agriculture, Nutrition and Forestry Committee on March 24, 2010. The measure, written by Senator Blanche Lincoln (D-AR), provides a total of $4.5 billion in funding for the Child Nutrition Program. Some of the funding comes from a reduction in spending for the U.S. Agriculture Department Environmental Quality Incentives Program.


Canada Proposes Toxic Designations For Chemicals: On March 6, 2010, Environment and Health Canada proposed designating three chemicals as toxic and imposing reporting requirements for nine other chemicals. The three chemicals are: Michler’s ketone, n-butyl glycidyl ether (n-BGE), and butanone oxime. Each chemical meets one or more of the toxicity criteria in Section 64 of the Canadian Environmental Protection Act (CEPA). They are among the 14 in the seventh batch of substances assessed under the Challenge to Industry program. The government is proposing to add the three chemicals to Schedule I of CEPA and to prepare risk management approaches for them, the departments said. The departments proposed for the application of Significant New Activity reporting requirements to nine other chemicals: Solvent Blue 5; Pigment Yellow 60; Solvent Yellow 18; Solvent Blue 4; two forms of propanenitrile, NBAPT and DAPEP; Pigment Brown 22; a form of methanesulfonamide known as DADM; and a form of benzoic acid known as MATCB. Significant New Activity designation under Section 81(3) of CEPA would require notification to the government of any new import, manufacture, or use of the substances, as well as completion of human health and ecological risk assessments before any new use is permitted. The remaining two chemicals — isophorone and 1,4-dioxane –were identified as neither posing a threat to the environment nor human health, and no further action was proposed for them. Comments are due by May 5, 2010. The assessments for the Batch 7 chemicals are available online.

Environment Canada Proposes Five Chemicals For Toxic Designations In Latest Assessment: On March 20, 2010, Environment Canada proposed designating five other chemicals as CEPA toxic and to require use notifications for five additional substances. The five substances — antimony oxide, vanadium oxide, potassium bromate, 1-vinyl-2-pyrrolidone, and a form of benzene known as methyl eugenol — are from among 17 chemicals in the ninth batch of substances assessed through Canada’s Challenge to Industry program. The department said new information was received from industry sources or interested stakeholders on all 17 of the substances in Batch 9 of the Challenge to Industry. The proposed assessments are open to a 60-day public comment period, through May 19, 2010. Final assessments are published in the Canada Gazette, Part II. More information on Canada’s Challenge to Industry program is available online.

NAC/AEGL Committee Announces Acute Exposure Guideline Levels Meeting: On March 24, 2010, the National Advisory Committee for Acute Exposure Guideline Levels for Hazardous Substances (NAC/AEGL Committee) announced that it will convene a meeting on April 13-15, 2010, in San Francisco. 75 Fed. Reg. 14153. At this meeting, the NAC/AEGL Committee will address aspects of the acute toxicity and the development of AEGLs for: 1,3-butadiene; acetaldehyde; acrylonitrile; arsenic trioxide; benzene; bromine pentafluoride; butane; carbon dioxide; chlorine pentafluoride; chloroacetone; dichlorvos; hexane; hydrogen bromide; hydrogen iodide; ketene; methyl isothiocyanate; methylene chloride; monoethanolamine; nerve agent VX; nitric oxide; oleum; propargyl alcohol; propionaldehyde; red phosphorus; ricin; selenium hexafluoride; sulfur trioxide; sulfuric acid; trichloroethylene; and vinyl chloride.

ATSDR Proposes Substances To Be Evaluated For Set 24 Toxicological Profiles: On March 31, 2010, the Agency for Toxic Substances and Disease Registry (ATSDR) requested comment on the proposed substances to be evaluated for Set 24 toxicological profiles. 75 Fed. Reg. 16153. ATSDR’s Division of Toxicology and Environmental Medicine is soliciting public comments on the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the nomination of any additional, substances, not on this list, that may have public health implications. Nominations must be submitted by April 30, 2010.

Canada Bans BPA In Polycarbonate Baby Bottles: On March 31, 2010, Health Canada published a finalized order prohibiting any BPA content in polycarbonate baby bottles advertised, sold, or imported into the country. A screening assessment concluded the chemical poses a threat to health and human life. “Recent research has identified uncertainty surrounding the potential for bisphenol A to cause neurological and behavioural effects at early stages of development in rodents,” the department stated. The prohibition followed significant consultation with industry and the general public, particularly since the October 18, 2008, publication of the final screening assessment report on BPA and a proposed risk management approach, Health Canada stated. The final order prohibiting BPA content in polycarbonate baby bottles advertised, sold, or imported into Canada is available online.

DOT Considering Changes To Regulations Governing Transportation Of Combustible Materials: The DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) on April 5, 2010, issued an ANPRM stating that it is considering revising the hazardous materials regulations (HMRs) governing the transportation of combustible materials. 75 Fed. Reg. 17111. Specifically, PHMSA is seeking to harmonize the domestic regulations applicable to the transportation of combustible liquids with international transportation standards. For a detailed summary of the ANPRM see online. Comments on the ANPRM are due by July 6, 2010.