Download PDF
Monthly Federal Developments Memorandum
August 1, 2011

Monthly Update for August 2011

Bergeson & Campbell, P.C.

TSCA/FIFRA/NTP/EPCRA

EPA Announces Chemical Data Reporting Rule: The U.S. Environmental Protection Agency (EPA) is expected to publish in the Federal Register this month a final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The CDR is intended to enable EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the TSCA Chemical Substance Inventory. This includes current information on chemical substance production volumes, manufacturing sites, and how the chemical substances are used. According to EPA, this information helps it determine whether humans or the environment potentially are exposed to reported chemical substances in ways that could prove harmful. EPA will publish submitted CDR data that are not confidential business information (CBI). The final CDR Rule amends the previous IUR Rule to require submission of information that EPA believes will better address its and the public’s information needs, improve the usability and reliability of the reported data, and ensure that data are available in a timely manner. EPA is requiring electronic reporting of CDR information and modifying reporting requirements, including certain circumstances that trigger reporting, the specific data to be reported, the reporting standard for processing and use information, and CBI reporting procedures. The CDR Rule establishes the upcoming submission period, which will be from February 1, 2012, to June 30, 2012, and which will include submission of production information from 2010 and production, processing, and use information from 2011. The CDR Rule will be effective 30 days after publication in the Federal Register. More information is available online. More detailed information is available online.

OPP Issues Guidelines For Antimicrobial Ingredient Disclosure: On July 15, 2011, EPA’s Office of Pesticide Programs (OPP) issued the Guidelines for Voluntary Disclosure of Antimicrobial Ingredient Information on Company Websites and/or Labels. The document provides guidance to antimicrobial pesticide registrants who voluntarily communicate ingredient information to consumers regarding registered antimicrobial pesticides on their company website and/or pesticide product labels. In December 2009, EPA published an Advance Notice of Proposed Rulemaking (ANPR) regarding disclosure of the identities of inert ingredients on pesticide labels. In addition, some companies formulating consumer products were beginning to communicate information to consumers on company websites and/or product labels. At the same time of the rulemaking, EPA was also having discussions with the Consumer Specialty Products Association (CSPA) regarding how companies might begin communicating information regarding consumer antimicrobial pesticide ingredients prior to the issuing of any rulemaking. The result of their discussions was a partnership between EPA and CSPA and a pilot program that establishes guidance for registrants seeking voluntarily to disclose ingredient information on their websites and/or labels. The guidance document includes two types of guidance. First, the document addresses guidance regarding useful ways of presenting ingredient information on company websites and on antimicrobial pesticide product labels. The guidance was developed jointly by CSPA and EPA, drawing upon CSPA’s experience with the industry’s voluntary ingredient communication initiative established in January 2010. Information on company websites is not normally subject to approval by EPA, but may become part of the labeling and therefore subject to EPA’s regulatory authority. Companies that wish to make changes to pesticide labels must apply for and receive EPA approval of the label changes, consistent with existing requirements at 40 C.F.R. parts 152 and 156. Second, the guidance addresses practical considerations companies face when voluntarily disclosing ingredient information on their websites and/or product labels. This guidance was developed solely by EPA.

Companies are encouraged to disclose information on all intentionally added ingredients. The voluntary disclosure of ingredients on a website is not a substitute for any Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) label requirements. If companies voluntarily disclose ingredient information on their websites under this pilot, they should include the website address (i.e., the website URL) on the product label. EPA interprets 40 C.F.R. Section 168.22 to mean that when a website address is referenced on the pesticide label, the website is considered labeling under FIFRA Section 2(p)(2) and is subject to the misbranding provisions of FIFRA Sections 2(q) and 12(a)(1)(E). If the website address changes and the label is not modified accordingly, the label would become inaccurate. Companies are urged to link products on the website to their EPA registration numbers. Companies are also encouraged to include bi-lingual language on the website and the entire label. Companies should use a widely recognized chemical naming scheme. While EPA does not endorse any specific nomenclature systems for purposes of the guidance, it notes that some companies use the International Nomenclature of Cosmetic Ingredients (INCI) online, the CSPA’s Consumer Product Ingredients Dictionary online, the International Union of Pure and Applied Chemistry (IUPAC) online, or the Chemical Abstracts Service (CAS) online; a product’s fragrance may be designated as “fragrance” with optional reference to the company’s palette of fragrance ingredients. For more information, companies should consult the guidance, which is available online.

Coalition Files TSCA Petition Seeking Regulation Of Chemicals Used In Oil And Natural Gas Wells: On August 4, 2011, a broad coalition of environmental and health groups petitioned EPA to use its authority under TSCA Section 21 to regulate chemicals used in oil and natural gas exploration and production (E&P). The petition focuses on hydraulic fracturing chemicals and specifically on public disclosure of the identity of the chemicals and their potential risks to human health and the environment. TSCA Section 21 authorizes citizens to petition EPA for relief under TSCA. Petitioners requested EPA to adopt a rule under TSCA Section 4 requiring manufacturers of E&P chemicals to conduct certain toxicity testing. Petitioners also requested that EPA issue a rule under Section 8 requiring the submission of various records to EPA. The petition is available online.

EPA Issues External Review Draft Of Microbial Risk Assessment Guideline: On July 26, 2011, EPA announced a 60-day public comment period for the External Review Draft of Microbial Risk Assessment Guideline: Pathogenic Microorganisms with Focus on Food and in Water. 76 Fed. Reg. 44586. EPA developed the Guideline in collaboration with the U.S. Department of Agriculture, Food Safety Inspection Service (USDA/FSIS) and with scientists from other federal agencies. The document is being released to obtain public comment prior to peer review. The document will undergo independent peer review during an expert peer review meeting that will be convened, organized, and conducted by an EPA contractor later this year. According to EPA, both EPA and USDA/FSIS have an established history of conducting human health risk assessments on chemical agents but less experience on microbial agents. EPA conducts microbial risk assessments on agents under a number of different statutes for a variety of purposes. These include both naturally occurring and genetically modified microorganisms with the potential for environmental exposure. USDA/FSIS is charged with ensuring the safety of food from the farm to the consumer. Microbial risk assessment entails addressing issues that are not considered in chemical risk assessment (e.g., die off and regrowth of bacteria, effects of prior exposure, and immune status). EPA, USDA/FSIS, and other federal agencies often conduct risk assessments on similar pathogens albeit in different media and under different scenarios. EPA believes that a common approach to conducting these assessments will foster better interaction among participating agencies leading to a more efficient and consistent process. To harmonize the way that EPA conducts its assessments across programs, EPA initiated and was joined by USDA/FSIS and scientists from other agencies to develop guidelines to promote greater consistency within the government and provide more transparency to stakeholders and other interested parties. This cross-agency activity has generated the draft Guideline. Comments are due by September 26, 2011.

EPA Releases Initial 2010 TRI Dataset: On July 28, 2011, EPA released the initial 2010 Toxics Release Inventory (TRI) dataset. EPA noted that its ability to make TRI data available within the same month as the reporting deadline is part of its continuing commitment to open government and transparency. The initial dataset for 2010 is available on the TRI website online and in downloadable data files through Envirofacts online. The files will also be accessible through links from Data.gov. The dataset will be updated in August, September, and October as EPA continues to process facility reports for 2010. Additional information is available in the Question and Answer document on the TRI website.

ITC Adds Cadmium To TSCA Priority Testing List: On August 1, 2011, the TSCA Interagency Testing Committee (ITC) added cadmium and 103 cadmium compounds to the TSCA Priority Testing List. The Consumer Product Safety Commission (CPSC) is concerned about cadmium and cadmium compounds in children’s toys, jewelry, and other consumer products. 76 Fed. Reg. 46174. The ITC revises the Priority Testing List and recommends testing or information gathering every six months under TSCA Section 4(e). The listing will provide EPA and the CPSC with a streamlined means of obtaining studies, through requirements that manufacturers and importers submit certain production and exposure information. In other action, the ITC removed 29 chemicals from the list because EPA has included them in a proposed testing rule. Those chemicals are in a high production volume (HPV) category and are included in the HPV Challenge Program, established to obtain more data on chemicals from industry. The ITC also removed lead and 11 lead compounds from the list because EPA has done what the ITC had recommended earlier in terms of information gathering on those substances. Specifically, EPA has reviewed certain unpublished health and safety studies on those substances. Comments are due by August 31, 2011.

OPP Issues Guidance On CSF Completion: On July 25, 2011, EPA’s OPP issued guidelines on Confidential Statements of Formula (CSF) for Technical Grade Active Ingredients (TGAI). According to the guidelines, some TGAI registrants have proposed a different approach to completing EPA Form 8570-4, the CSF, for TGAIs. Instead of providing multiple, alternate CSFs reflecting each manufacturing site, and each country in which the product is produced, the registrants have proposed to provide an attachment to the CSF that lists the following information: additional sites at which the technical product may be manufactured; and additional countries in which the TGAI is produced. EPA has determined that it will accept this alternate format, provided certain conditions are met. The conditions that registrants must meet for EPA to accept an attachment to a basic or an alternate CSF listing alternate manufacturing sites and production countries are as follows:

  • The manufacturing process associated with the new site must result in the same impurity profile as the original manufacturing site listed on the original (basic or alternate) CSF.
     
  • The registrant must provide the following information:
    • The name(s) and address(es) of the alternate site or sites,
       
    • The establishment numbers for the alternate site or sites, and
       
    • The Master Record Identification (MRID) number for the supporting representative batch analysis and the date of approval for the manufacturing site.
       
  • The registrant must indicate “see attachment” in box 2 of the basic or alternate CSF to which the attachment applies (to clearly link the two documents).
     
  • The registrant must list the date of the CSF to which the attachment applies on the attachment itself (in most cases, the dates should match).
     
  • The registrant must sign and date the attachment.

A copy of the guideline is available online.

EPA Proposes To Revise Emergency And Hazardous Chemical Inventory Forms: On August 8, 2011, EPA proposed to revise the Emergency and Hazardous Chemical Inventory Forms (Tier I and Tier II) under Section 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA) to add new data elements and revise some existing data elements. 76 Fed. Reg. 48093. Under the proposal, EPA is seeking the following changes: add new data elements for facility phone number, latitude and longitude, and number of full-time employees; add data elements for facility identification numbers that are assigned under the Risk Management Program under Section 112(r) of the Clean Air Act (CAA) or the TRI Program under EPCRA Section 313; require facilities to provide information on the facility’s parent company and the owner or operator of the facility, such as name, address, and phone number, as well as the Dun and Bradstreet number of the facility’s parent company; provide the local emergency planning committee (LEPC) with the name and contact information of a facility representative who will participate in the emergency planning process as a facility emergency coordinator; require facilities to notify LEPCs of any changes relevant to the emergency planning within 30 days after the changes have occurred (EPA believes this information should also be provided on the facility’s annual inventory form since LEPCs and other emergency response coordinators may need this information during an emergency); require the name, title, phone number, and e-mail address of the person knowledgeable or responsible for completing the information on the Tier I and Tier II forms; add a new data element to indicate if facilities are subject to the emergency planning notification under EPCRA Section 302; add a new data element to both the Tier I and Tier II forms to indicate whether the facility is subject to chemical accident prevention under CAA Section 112; and expand the ranges for the reporting codes for the maximum amount and average daily amounts of hazardous chemicals present at the site in the preceding calendar year. Comments are due by October 7, 2011.

EPA Publishes ANPR Concerning Testing Of BPA: On July 26, 2011, EPA published an ANPR concerning testing of bisphenol A (BPA). 76 Fed. Reg. 44535. EPA is requesting comments on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA is also seeking comments on requiring environmental testing consisting of sampling and monitoring for BPA in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA that are at or above levels of concern for adverse effects, including endocrine-related effects. EPA states that the ANPR is directed only toward the environmental presence and environmental effects of BPA. According to the notice, EPA is working with the U.S. Department of Health and Human Services (HHS) on potential human health issues, but is not considering any additional testing regarding human health issues at this time. Comments are due on or before September 26, 2011.

The ANPR includes the following questions for commenters:

  1. Whether EPA should propose requiring specific toxicity testing to characterize more fully the effects of BPA on environmental organisms at low concentrations;
     
  2. Whether EPA should propose requiring environmental testing consisting of sampling and monitoring, particularly in the vicinity of reported releases of BPA into the environment, and what design and protocol it should use for such sampling and monitoring, to identify potential sources and pathways of exposure and determine the extent to which environmental organisms may be exposed to BPA concentrations of concern as determined by existing data and by additional studies that are either already underway or would be conducted under a test rule; and
     
  3. EPA additionally requests comment and supporting information regarding which TSCA Section 4(a)(1) finding authority would be most appropriate for the purpose of a BPA test rule proposal. Any proposal would ultimately be based on EPA’s assessment of the relevant information available at the time of proposal.

EPA reaffirms that, as stated in the EPA BPA Action Plan, it does not intend to initiate regulatory action under TSCA at this time on the basis of human health. EPA notes that most human exposure, including exposure to children, comes through food packaging materials, which are under the jurisdiction of the Food and Drug Administration (FDA). According to EPA, FDA, together with the Centers for Disease Control and Prevention (CDC) and the National Institute of Environmental Health Sciences (NIEHS), “is investing in important new health studies in both animals and humans to better determine and evaluate the potential health consequences of BPA exposures.” EPA will continue to coordinate closely with FDA, CDC, and NIEHS on this activity. EPA states that, to the extent that FDA may identify health concerns from BPA in food contact materials, EPA will work with FDA to identify and assess potential substitutes. Levels of exposure that may be identified by the ongoing review as being of concern to human health, including children’s health, will affect the extent to which EPA would take additional action to address potential risks to human health resulting from uses within TSCA jurisdiction.

OECD Releases Guidance And Surveys Regarding Minor Use Pesticide Registration Incentives: The Organization for Economic Cooperation and Development (OECD) recently released three documents on pesticide minor uses: (1) Guidance Document on Regulatory Incentives for the Registration of Pesticide Minor Uses (Minor Use Guidance); (2) OECD Survey on Regulatory Incentives for the Registration of Pesticide Minor Uses: Survey Results; and (3) OECD Survey on Efficacy & Crop Safety Data Requirements & Guidelines for the Registration of Pesticide Minor Uses: Survey Results. The documents are available online. More detailed information is available online.

CRS Releases Reports Concerning TSCA And TSCA Reform Legislation: The Congressional Research Service (CRS) has released two reports concerning TSCA — a February 23, 2011, report entitled The Toxic Substances Control Act (TSCA): A Summary of the Act and Its Major Requirements, and a July 25, 2011, report entitled Proposed Reform of the Toxic Substances Control Act (TSCA) in the 112th Congress: S. 847 Compared with Current Law. Senator Frank R. Lautenberg (D-NJ) introduced the Safe Chemicals Act of 2011 (S. 847), which is intended to modernize TSCA to require chemical companies to demonstrate the safety of industrial chemicals and EPA to evaluate safety based on the best available science. The CRS report summarizing TSCA is available online, and the report comparing the TSCA reform legislation with TSCA is available online.

EPA Acknowledges Receipt Of Petition From CLA Regarding Endocrine Testing: On August 10, 2011, EPA requested public comment on a June 21, 2011, petition from CropLife America (CLA), Consumer Specialty Products Association (CSPA), and the Responsible Industry for a Sound Environment (RISE) requesting EPA to develop and publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the Endocrine Disruptor Screening Program (EDSP). 76 Fed. Reg. 49473. In October 2009, EPA initiated the EDSP Tier 1 screening for the first list of 67 chemicals by issuing orders between October 29, 2009, and February 26, 2010, pursuant to the authority provided to EPA under Section 408(p)(5) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The orders require the testing of chemicals through 11 Tier 1 screening assays. The purpose of the 11 Tier 1 screening assays is to determine the potential for a chemical to interact with estrogen, androgen, and thyroid hormone systems. Based on the data from the Tier 1 assays, should the determination be made that the chemical is shown to interact, additional Tier 2 testing may be required.

EPA is seeking public comment on the June 21, 2011, petition requesting that EPA publish guidance explaining the criteria by which EPA will make its decisions on data received in response to the test orders issued under the EDSP; provide sufficient time for list 1 chemical test order recipients to prepare and submit their Tier 1 screening results in compliance with the guidance once developed; and fully analyze the Tier 1 screening data received in response to the list 1 test orders and revise the guidance to be developed to reflect what is learned by the analysis to ensure scientifically sound determinations and to protect the public health and the environment. Comments are due by October 11, 2011.

EPA Posts New EDSP Materials, Including SEPs: On August 11, 2011, EPA posted new materials to the EDSP website. The materials include:

  • Resources for Test Order Recipients — The web page includes a compilation of information available to assist individuals who have received test orders in complying with test order requirements. The information includes assay information; test order response and status tracking; how to submit information in response to an EDSP test order/data call-in; published information; and chemicals for screening. The page is available online;
     
  • Standard Evaluation Procedures (SEP) — EPA states that SEPs provide guidance for the review and evaluation of environmental and human health effects data submitted in response to test orders for the 890 Guideline Series for the EDSP Tier 1 battery. The objective of the SEPs is to assist EPA reviewers and support comprehensive and consistent evaluations of major scientific topics; the SEPs also provide interpretive scientific and policy guidance where appropriate. EPA posted SEPs for the aromatase and steroidogenesis assays online;
     
  • Study Profile Templates — The study profile templates describe the layout and scope of information that should be contained within a study profile and can serve as a guide for the preparation of study documents. Applicants may include additional information beyond that prescribed in a particular study profile, however, it should be done in such a way that the format and content of the template is not affected or changed. EPA posted templates for the aromatase and steroidogenesis assays online; and
     
  • Technical Questions/Answers about the Assays — EPA has issued clarifications about technical aspects of the conduct of Tier 1 assays for the EDSP in response to questions raised by test order recipients and others. According to EPA, in some cases, these questions pointed out “simple but significant errors in test guidelines (e.g., incorrect references to tables and misplaced decimal points),” while in other cases, “questions pointed out ambiguous language that required clarification; and in yet other cases, questions were raised about whether alternative techniques had been considered by the Agency and rejected, or whether they might be acceptable to use.” The web page is available online.

RCRA/CERCLA

EPA Seeks Comment On MSW Characterization Report: EPA published on August 2, 2011, a notice soliciting stakeholder input regarding the efficacy and scope of the Municipal Solid Waste (MSW) Characterization Report entitled Municipal Solid Waste in the United States as part of a broader discussion about sustainable materials management. 76 Fed. Reg. 46290. According to EPA, this information will be used to develop new measurement definitions and protocols for measurement of these materials, and the possible addition of construction and demolition (C&D) materials and non-hazardous industrial materials to the list of materials addressed in future efforts. This effort could lead to the creation of a new measurement report that EPA will make publicly available. Comments are due August 31, 2011.

GREEN CHEMISTRY DEVELOPMENTS

Green Ribbon Science Panel Meets To Discuss Safer Consumer Product Alternatives Regulations: The Green Ribbon Science Panel (Panel) met on July 14-15, 2011, to discuss potential revisions to the California Department of Toxic Substances Control’s (DTSC) Safer Consumer Product Alternatives (SCPA) regulations, as required by AB 1879. Under AB 1879 and Health and Safety Code (HSC) 25253, DTSC is required to adopt regulations “that establish a process for evaluating chemicals of concern in consumer products, and their potential alternatives, to determine how best to limit exposure or to reduce the level of hazard posed by a chemical of concern.” The Panel had previously convened three Subcommittees that met between May 31 and June 16, to discuss issues related to the alternatives assessments (AA) process. For more information on these three Subcommittees, please see our memorandum available online.

The Panel meeting opened with an introduction from Debbie Raphael, recently appointed as DTSC Director. Raphael also concluded the meeting by providing a timeline for the release and review of revised SCPA regulations. Specifically, DTSC plans by mid-October 2011 to release “informal” regulations for public review. Raphael stated that based on DTSC’s experience with the last release of SCPA regulations, DTSC understands that the public comment period must be more than 15 days. In addition, DTSC will convene the Panel on November 14-15, 2011, to meet to discuss and comment upon the informal regulations. Before the release of the informal regulations, Raphael stated that DTSC also plans to reach out to stakeholders on specific issues that have not been covered by the Panel. More detailed information is available online.

The agenda, meeting notice, and other meeting materials for the July 14-15, 2011, Panel meeting are available online.

OEHHA Revises Proposed Regulation For Hazard Traits And Environmental And Toxicological Endpoints: The Office of Environmental Health Hazard Assessment (OEHHA) announced on July 29, 2011, that it revised its proposed regulation concerning the specification of hazard traits, environmental and toxicological end-points, and other relevant data that are to be included in California’s Toxics Information Clearinghouse. The California DTSC will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of its Green Chemistry Program. Comments are due September 12, 2011.

OEHHA’s August 2010 pre-regulatory draft regulation included a “nanomaterial hazard trait,” as well as other references to nanoparticles, which OEHHA removed from its December 17, 2010, draft regulation. The current draft regulation does not refer to nanomaterials or nanoparticles. It includes the following definition regarding particle size or fiber dimension:

  1. The particle size or fiber dimension hazard trait is defined as the existence of a chemical substance in the form of small particles or fibers or the propensity to form into such small-sized particles or fibers with use or environmental release.
     
  2. Evidence for the particle size or fiber dimension hazard trait includes, but is not limited to: measures of particle size less than or equal to 10 micrometers in mass median aerodynamic diameter for inhalation exposure, or less than 10 micrometers in any dimension for dermal or ingestion exposure, or fibers with a 3:1 aspect ratio and a width less than or equal to 3 micrometers.

More information is available online.

NANOTECHNOLOGY

IATP Criticizes Development Of Nanotechnology Products Without Regulatory Oversight: The Institute for Agriculture and Trade Policy (IATP) issued a June 29, 2011, report entitled Racing Ahead: U.S. Agri-Nanotechnology in the Absence of Regulation, which claims that at least 1,300 products with engineered nanotechnology materials (ENM) have been commercialized, “despite myriad uncertainties about the public health and environmental effects of ENMs.” According to the report, several steps are needed for an operative and mandatory regulatory structure for nanotechnology products and processes, including an agreed legal definition of what constitutes an ENM and nanotech product data. The report describes the June 9, 2011, announcement by EPA and FDA of their intent to issue voluntary guidance to industry on nanotechnology products as “a small, but encouraging first step toward regulation.” The report is available online.

EPA Regulatory Agenda Includes Notices Concerning Nanoscale Materials: EPA’s July 7, 2011, Regulatory Agenda includes several notices concerning nanoscale materials:

  • Test Rule for Certain Nanoscale Materials — EPA states that it is developing a test rule under TSCA Section 4(a) to require manufacturers (defined by statute to include importers) and processors of the multiwall carbon nanotube described in Premanufacture Notice (PMN) P-08-199, certain clays (e.g., kaolin (including halloysite) and bentonite (including montmorillonite)), alumina, and spray-applied nanomaterials to conduct testing for health effects, ecological effects, and environmental fate, as well as provide material characterization data. EPA intends to issue a notice of proposed rulemaking (NPRM) in August 2011.
     
  • Significant New Use Rule (SNUR) — EPA is developing a SNUR for nanoscale materials under TSCA Section 5(a)(2). The SNUR would require persons who intend to manufacture, import, or process this/these chemical substance(s) for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. In addition, according to the notice, EPA is developing a proposal to require reporting and recordkeeping under TSCA Section 8(a), which would require that persons who manufacture these nanoscale materials notify EPA of certain information, including production volume, methods of manufacture and processing, exposure and release information, and available health and safety data. The notice regarding a TSCA Section 8(a) rulemaking was previously separate, but EPA states “those two efforts were combined into a single rulemaking.” EPA submitted a proposed rule regarding TSCA Section 8(a) reporting to the Office of Management and Budget (OMB) for review on November 22, 2010, where it remains. According to the notice, EPA intended to publish an NPRM in June 2011. Nothing has been published to date, however.

NNI Releases Reports From EHS Workshops: On July 19, 2011, the National Nanotechnology Initiative (NNI) announced the release of four reports from a series of workshops focusing on issues in the nanotechnology environmental, health, and safety (EHS) arena. According to NNI, the workshops were a part of an ongoing strategy to coordinate nanotechnology-related EHS research by convening experts from industry, academia, and the federal government to share the latest information and newest developments, to discuss the current state-of-the-science, and to identify research gaps in the nanotechnology-related EHS field. NNI states that “knowledge gleaned from the nanoEHS workshop series was critical to the development of the soon-to-be-released, updated NNI EHS Research Strategy.” Through four separate workshops, experts examined the following areas:

  • Nanomaterials and Human Health and Instrumentation, Metrology, and Analytics;
     
  • Nanomaterials and the Environment and Instrumentation, Metrology, and Analytics;
     
  • Human and Environmental Exposure Assessment; and
     
  • Risk Management Methods and Ethical, Legal, and Societal Implications of Nanotechnology.

The reports are available online.

NANO Act Promotes Development And Responsible Stewardship Of Nanotechnology: Representative Mike Honda (D-CA) re-introduced on August 1, 2011, the Nanotechnology Advancement and New Opportunities Act (NANO Act), which seeks to promote the development and responsible stewardship of nanotechnology in the U.S. According to Rep. Honda, the legislation is designed to maintain the U.S.’s leadership role in nanotechnology research by promoting the development and commercialization of the results. At the same time, the NANO Act addresses concerns raised about the potential health and safety risks associated with nanotechnology. It would require the National Nanotechnology Coordination Office (NNCO) to develop a report for Congress outlining a national nanotechnology development strategy after consulting with relevant federal agencies, including EPA, NIEHS, and National Institute of Occupational Safety and Health (NIOSH) on nanotechnology’s potential risks. Through creation of research priorities for the federal government and industry that will help ensure development and responsible stewardship, the NANO Act looks to remove uncertainty about risk and future federal regulation — resolving uncertainty as one of the major obstacles to commercialization. The NANO Act also includes provisions to create partnerships, raise awareness, and implement policies promoting nanotechnology, including public-private investment partnerships; grant programs supporting research and education; tax credits for investments, education, and training in nanotechnology; and directing the National Science Foundation (NSF) to partner with industry to encourage development of training to support nanotechnology manufacturing. The NANO Act is available online.

Presentations Available From US-EU Workshop: Bridging NanoEHS Research Efforts: NNI has posted the presentations from the March 10-11, 2011, workshop entitled “US-EU: Bridging NanoEHS Research Efforts,” which was intended to continue the robust dialogue between the U.S. and European Union (EU) on issues of shared concern pertinent to nanotechnology research initiatives. The workshop covered the following areas:

  • Significant discussion about EHS questions for nanotechnology-enabled products;
     
  • Hands-on participation in joint programs of work that will better leverage resources; and
     
  • Development of communities of practice areas, including identification of key points of contact, interest groups, themes between key U.S. and EU researchers, and key U.S. and EU funding sources for near-term and future collaborations.

The presentations are available online.

Comment Deadline Approaches For EPA’s Policy On Nanoscale Materials In Pesticide Products: Comments on EPA’s proposed policy on nanoscale materials in pesticide products are due August 17, 2011. EPA offers two approaches for obtaining the information EPA believes it needs concerning nanoscale materials in pesticide products. Under the first approach, EPA would use FIFRA Section 6(a)(2) to obtain information regarding what nanoscale material is present in a registered pesticide product and its potential effects on humans or the environment. EPA states that it would “prefer” to use this approach, despite industry’s concern over the use of the “adverse effects” reporting provision to obtain information. Under the second approach, EPA would use a data call-in under FIFRA Section 3(c)(2)(B). EPA also proposes to apply an initial presumption that active and inert ingredients that are the nanoscale versions of non-nanoscale active and inert ingredients already present in registered pesticide products are potentially different from those conventionally sized counterparts. Registrants could rebut this initial presumption on a case-by-case basis.

At least one non-governmental organization, Friends of the Earth, has created an online petition that urges EPA to consider nanoscale active and inert ingredients in pesticides as new, and to use the FIFRA Section 6(a)(2) method to obtain information. With the comment deadline fast approaching, and the potential complexity, legal vulnerability, and burdens presented by the different options, it is critically important for potentially affected entities to consider carefully the issues and approaches discussed and offer strong and compelling comment of a caliber comparable to the quality and thoughtfulness of EPA’s notice.

CAA/CWA

EPA Propose Secondary National Ambient Air Quality Standards For Oxides Of Nitrogen And Sulfur: On August 1, 2011, EPA proposed a rule required by a consent decree governing the schedule for completion of the review of the air quality criteria and the secondary national ambient air quality standards (NAAQS) for oxides of nitrogen and oxides of sulfur. 76 Fed. Reg. 46084. Based on its review, EPA proposed to retain the current nitrogen dioxide (NO2) and sulfur dioxide (SO2) secondary standards to provide requisite protection for the direct effects on vegetation resulting from exposure to gaseous oxides of nitrogen and sulfur in the ambient air. Additionally, with regard to protection from the deposition of oxides of nitrogen and sulfur to sensitive aquatic and terrestrial ecosystems, including acidification and nutrient enrichment effects, EPA proposed to add secondary standards identical to the NO2 and SO2 primary 1-hour standards and not set a new multi-pollutant secondary standard in this review. The proposed 1-hour secondary NO2 standard would be set at a level of 100 parts per billion (ppb) and the proposed 1-hour secondary SO2 standard would be set at 75 ppb. In addition, EPA has decided to undertake a field pilot program to gather and analyze additional relevant data so as to enhance EPA’s understanding of the degree of protectiveness that a new multi-pollutant approach, defined in terms of an aquatic acidification index (AAI), would afford and to support development of an appropriate monitoring network for such a standard. EPA is seeking comment on the framework of such a standard and on the design of the field pilot program. EPA will sign a notice of final rulemaking for this review no later than March 20, 2012. Written comments on this proposed rule must be received by September 30, 2011.

OSHA/NIOSH

NIOSH Evaluating Its Cancer And REL Policies: On July 27, 2011, NIOSH announced that it is currently reviewing its cancer and Recommended Exposure Limits (REL) policies to ensure that they reflect current scientific and risk management practices. NIOSH will publish a Federal Register notice describing the review process and requesting comments and information from the public and interested stakeholders. NIOSH intends to hold a public meeting in November 2011 where stakeholders and other interested parties can ask questions and provide comments to NIOSH. According to NIOSH, it is re-evaluating its cancer policy to address concerns such as the use of the term “potential occupational carcinogen,” which allows for only one cancer category. NIOSH also is re-evaluating its REL policy to clarify issues such as the target working lifetime risk level and the application of “to the extent feasible” in the REL process. NIOSH stated that it will post additional information about the re-evaluation of its cancer and REL policies, including the Federal Register notice and the revised draft policies, online when it is available.

MISCELLANEOUS

Federal Government Issues Strategy On E-Waste: On July 20, 2011, an interagency workgroup of officials from the White House Council on Environmental Quality, EPA, General Services Administration (GSA), State Department, Department of Commerce, Office of the U.S. Trade Representative, and other federal agencies issued a new electronic waste (e-waste) stewardship strategy. Under the strategy, electronics purchased under information technology contracts to meet energy efficiency standards require agencies to use certified recyclers and to include more manufacturer collection program agreements in contracts. The government also will track the movement of used electronics in the United States and abroad to increase safe handling and reduce the harm of U.S. exports of e-waste. Under the strategy, GSA will remove products that do not comply with Energy Star or Electronic Product Environmental Assessment Tool (EPEAT) standards from government-wide IT acquisition contracts. GSA is also required to expand its use of manufacturer takeback agreements in procurement contracts, which will serve as a pilot program for the rest of government. By May 2012, GSA intends to issue guidance to federal agencies for incorporating certified recycler requirements into procurement contracts. Under the strategy, the government will track movement of used electronics both domestically and abroad and make the information available online. Under the strategy, EPA will launch voluntary partnerships with the electronics industry to encourage the use of certified recyclers and promote tracking of used electronics. The government will invite electronic product designers, recyclers, and environmental organizations to discuss ways to promote development of green electronics design standards. EPA and other government agencies also will launch prize competitions to drive innovation in green product design and recycling. The National Strategy for Electronics Stewardship is available online.

CERHR Transitions To Office Of Health Assessment And Translation: The National Toxicology Program (NTP) and NIEHS established the NTP Office of Health Assessment and Translation (OHAT) to serve as an environmental health resource to the public and to regulatory and health agencies. The office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels. Assessments of potential adverse effects of environmental substances on reproduction or development carried out by the Center for the Evaluation of Risks to Human Reproduction (CERHR) from 1998-2010, will now be carried out by OHAT. OHAT also organizes workshops or state-of-the-science evaluations to address issues of importance in environmental health sciences. OHAT assessments are published as NTP Monographs. More information is available online.

OIG Issues Report On VCCEP: On July 21, 2011, EPA’s Office of Inspector General (OIG) issued a report entitled EPA’s Voluntary Chemical Evaluation Program Did Not Achieve Children’s Health Protection Goals, Report No. 11-P-0379. According to the OIG, the VCCEP pilot did not achieve its goals to design a process to assess and report on the safety of chemicals to children. Specifically, the pilot’s design did “not allow for desired outcomes to be produced” as “the pilot had a flawed chemical selection process and lacked an effective communication strategy.” The program’s effectiveness was, according to OIG, “hampered by industry partners who chose not to voluntarily collect and submit information, and EPA’s decision not to exercise its regulatory authorities under the Toxic Substances Control Act to compel data collection.” OIG recommend that EPA design and implement a new process to assess the safety of chemicals to children that (1) identifies the chemicals with highest potential risk to children; (2) applies the TSCA regulatory authorities as appropriate for data collection; (3) interprets results and disseminates information to the public; and (4) includes outcome measures that assure valid and timely results. According to OIG, EPA concurred with its findings, indicating that work ongoing by the existing chemicals program addresses many of OIG’s concerns and agreed with OIG’s recommendations related to improving its chemical selection process and developing performance measures for children’s health protection. The report is available online.

Canadian Agencies Propose Ban On Four Types Of Chemicals: On July 23, 2011, Environment Canada and Health Canada published draft regulations that would, if implemented, ban four classes of chemicals. The proposed Prohibition of Certain Toxic Substances Regulations, 2012, issued under the Canadian Environmental Protection Act (CEPA), would ban the manufacture, use, sale, offer for sale, or import of benzenamine reaction products with styrene and 2,4,4-trimethylpentene (BNST), short-chain chlorinated alkanes, polychlorinated naphthalenes (PCN), and non-pesticidal tributyltins (TBT), or any products containing them. The regulations would provide interim measures to give industry time to adapt to the proposed ban. A two-year temporary permission would be provided for specified uses of BNST to permit industry to conduct additional research to find alternatives and obtain international product level performance certification for redesigned products containing BNST substitutes. The ban would not apply to products containing TBTs below a specified concentration. The draft regulations are available online.

Canada Proposes To Amend The ECL: In a July 30, 2011, Canada Gazette notice, Canada published a proposed order to amend the Export Control List (ECL) in Schedule 3 to CEPA. The ECL is a list of substances whose exports are controlled because their use in Canada is prohibited or restricted, or because Canada has accepted to control the export under the terms of an international agreement, such as the Rotterdam Convention. The proposed order would add five substances to Part 1 of the ECL, which includes substances that are prohibited in Canada and can only be exported under very limited circumstances, such as for destruction. The substances are chlordecone, endrin, toxaphene, alpha-HCH, and beta-HCH. The current listings for endrin, toxaphene, and the HCH isomers would be removed upon their addition to Part 1 of the ECL. All of these substances are listed in Annex A of the Stockholm Convention. The proposed order would add three groups of substances to Part 2 of the ECL, which includes substances for which notification or consent for export is required under the Rotterdam Convention. The substances covered by this part of the draft order are dinitro-ortho-cresol (DNOC) and its salts; dustable powder formulations containing a combination of benomyl at or above 7 percent, carbofuran at or above 10 percent, and thiram at or above 15 percent; all tributyltin compounds, including oxide, fluoride, methacrylate, benzoate, chloride, linoleate, and naphthenate; tetraethyl lead; and tetramethyl lead. Tetraethyl lead and tetramethyl lead were previously included in Part 3 of the ECL, but are proposed to be moved to Part 2 because of a recent amendment to Annex III to the Rotterdam Convention. The proposed order also would add nine substances or groups of substances to Part 3 of the ECL, which includes substances whose use is restricted in Canada and for which notification is required before export can occur. The substances and groups covered are benzidine and benzidine dihydrochloride; 2-methoxyethanol; pentachlorobenzene; tetrachlorobenzenes; perfluorooctane sulfonate (PFOS) and its salts; compounds that contain one of the following groups: C8F17SO2, C8F17SO3, or C8F17SO2N; azinphos-methyl; phorate; and terbufos. Pentachlorobenzene is listed in Annex A of the Stockholm Convention. PFOS, its salts, and perfluorooctane sulfonyl fluoride (contains the group C8F17SO2) are listed in Annex B of the Stockholm Convention. The draft order would also modify the ECL to ensure that all CAS registry numbers appear in the descriptions of substances on the list to provide exporters with an additional means of identifying substances. It would amend the descriptions of certain substances currently listed in Part 2 to harmonize descriptions with those in Annex III of the Rotterdam Convention. Comments are due October 13, 2011. The proposed order is available online.

EPA Releases Draft Policy For Ensuring Scientific Integrity: On August 5, 2011, EPA released its draft Scientific Integrity Policy for public comment. The draft policy reflects the Obama Administration’s stated commitment to the ethical standards and transparency necessary for ensuring the highest quality science. The draft Scientific Integrity Policy was developed in response to a December 2010 memorandum from the White House Office of Science and Technology Policy (OSTP). The memorandum charged federal agencies to develop policies in four areas: foundations of scientific integrity in government, public communications, use of federal advisory committees, and professional development of government scientists and engineers. EPA’s draft Scientific Integrity Policy was developed by an ad hoc workgroup consisting of senior staff and scientists from EPA’s programs and regions. Public comments are due by September 6, 2011. EPA’s draft Scientific Integrity Policy is available online.

HHS And OSTP Publish ANPR To Improve Rules Protecting Human Health Research Subjects: On July 26, 2011, the Office of the Secretary of HHS, in coordination with OSTP, issued an ANPR to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. 76 Fed. Reg. 44512. The ANPR seeks comment on how to protect better human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. Comments are due no later than 5:00 p.m. on September 26, 2011. More information about the ANPR is available online. More detailed information is available online.

EPA Releases DfE’s Final Alternatives Assessment Criteria For Hazard Evaluation: On August 10, 2011, EPA announced the availability of the Design for the Environment’s (DfE) final criteria for evaluating human and environmental effects under the Alternatives Assessment Program. EPA states that publication of the final criteria “increases transparency of EPA’s evaluation of chemical alternatives. The criteria are applied in DfE Alternatives Assessments to designate a concern level for human health and environmental hazard.” DfE has applied the alternatives assessment methodology for flame retardants in furniture and in Printed Circuit Boards, and is now applying this approach for BPA alternatives in thermal paper, the flame retardant decabromodiphenylether (DecaBDE), and hexabromocyclododecane (HBCD) used in expandable polystyrene foam for insulation. DfE states that it will apply the approach to additional Action Plan Chemicals, including phthalates used as plasticizers and in other applications. More information is available online.

EPA Announces DfE Partnership On Alternatives To Certain Phthalates: On August 24, 2011, EPA will hold a kick-off meeting for its DfE Partnership on Alternatives to Certain Phthalates. EPA states that the goal is to help stakeholders identify safer chemicals and to provide a basis for informed decision-making by developing an in-depth comparison of potential human health and environmental impacts of chemical alternatives. The alternatives assessment will build upon existing knowledge with an emphasis on determining the potential for disproportionate impacts on children and other sensitive sub-populations. According to the project description, EPA intends to share a draft report for review and comment in October 2012, and prepare the final report and publicize the results in February 2013. More information 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.

TSCAblog® FIFRAblog® B&C® Biobased and Sustainable Chemicals Blog Nano and Other Emerging Chemical Technologies Blog Webinars On Demand Past Seminars and Webinars
Subscribe

2024 ©  Bergeson & Campbell, P.C.. All Rights Reserved.