Monthly Update for December 2015
Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.
EPA Issues Final Rule Adding 1-Bromopropane To EPCRA Section 313 List: On November 23, 2015, the U.S. Environmental Protection Agency (EPA) issued a final rule adding 1-bromopropane 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 (PPA) of 1990. 80 Fed. Reg. 72906. 1-Bromopropane has been classified by the National Toxicology Program (NTP) in its 13th Report on Carcinogens (RoC) as “reasonably anticipated to be a human carcinogen.” EPA has determined that 1-bromopropane meets the EPCRA Section 313(d)(2)(B) criteria because it can reasonably be anticipated to cause cancer in humans. The final rule is effective November 30, 2015, and applies for the reporting year beginning January 1, 2016, with reports due July 1, 2017.
EPA Issues Significant New Use Rules On Certain Chemical Substances: On December 4, 2015, EPA issued final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 29 chemical substances that were the subject of premanufacture notices (PMN). 80 Fed. Reg. 75812. The final rule requires persons who intend to manufacture (including import) or process any of the chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit the activity before it occurs. The final rule is effective February 2, 2016.
EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration: On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-7335, EPA filed a motion to vacate voluntarily and remand its registration of Dow AgroSciences LLC’s (DowAgro) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. The case commenced in October 2014 when the Natural Resources Defense Council (NRDC) and other environmental groups, including the Center for Food Safety (CFS, et al.) (Petitioners), filed petitions for review challenging EPA’s decision to register Enlist Duo, a new product designed for use with crops genetically modified to be resistant to glyphosate and 2,4,-D. Petitioners argued, in part, that EPA failed to consider the impacts of increased glyphosate use on monarch butterflies, and did not fully assess the potential human health effects from 2,4-D. EPA’s motion reverses its previous position that DowAgro’s application for Enlist Duo satisfied the requirements for issuance of an unconditional registration under FIFRA Section 3(c)(5). EPA states that it is seeking a voluntary remand to reconsider the Enlist Duo registration in light of new information regarding potential synergistic effects referred to as “synergistic herbicidal weed control” between the two active ingredients — 2,4-D and glyphosate — contained in Enlist Duo on non-target plants. EPA is in the process of evaluating information submitted to it by DowAgro on November 9, 2015, in response to EPA’s request for all available information related to synergistic effects. EPA asserts that none of this information was submitted to EPA prior to EPA’s issuance of the Enlist Duo registration.
On December 7, 2015, in the U.S. Court of Appeals for the Ninth Circuit Case Nos. 14-73353, et al. (consolidated), Intervenor DowAgro filed a response, and Petitioner CFS, et al. filed joinder in and response to EPA’s motion for voluntary vacatur and remand of EPA’s registration of DowAgro’s Enlist Duo herbicide under FIFRA, as well as a response to DowAgro’s Fact Sheet, a public statement made by DowAgro after EPA’s motion was filed.
For more information, see Bergeson & Campbell, P.C.’s (B&C®) Pesticide Law and Policy Blog®.
EPA Launches eDisclosure Portal: On December 9, 2015, EPA announced that it is modernizing implementation of its self-disclosure policies by creating a centralized web-based ”eDisclosure” portal to receive and automatically process self-disclosed civil violations of environmental law. 80 Fed. Reg. 76476. Under the automated eDisclosure system, “large and small businesses will quickly be able to get some of their more routine types of disclosures resolved.” The new eDisclosure portal will handle only disclosures under EPA’s Audit Policy and its Small Business Compliance Policy; the new owner self-disclosures and potential criminal violations disclosed to the Voluntary Disclosure Board will continue to be accepted and processed outside of the eDisclosure system. Potential violations through the new eDisclosure portal may qualify for one of two types of automated treatment:
- Category 1. Category 1 disclosures include: EPCRA violations that meet all Audit Policy conditions; and EPCRA violations that meet all Small Business Compliance Policy conditions.
- Category 2. Category 2 disclosures include: All non-EPCRA violations; EPCRA violations where the discloser can only certify compliance with Audit Policy Conditions 2-9 (i.e., discovery was not systematic); and EPCRA/Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) violations excluded from Category 1.
For disclosures that qualify for Category 1 treatment, the eDisclosure system automatically will issue an electronic Notice of Determination (eNOD) confirming that the violations are resolved with no assessment of civil penalties, conditioned on the accuracy and completeness of the submitter’s disclosure. For disclosures that qualify for Category 2 treatment, the eDisclosure system automatically will issue an Acknowledgement Letter (AL) noting EPA’s receipt of the disclosure and promising that EPA will make a determination as to eligibility for penalty mitigation if and when it considers taking enforcement action for environmental violations. EPA will spot check Category 1 disclosures to ensure conformance with EPCRA, the Audit Policy, the Small Business Compliance Policy, and eDisclosure requirements. EPA will screen Category 2 disclosures for significant concerns, such as criminal conduct and potential imminent hazards. The eDisclosure system has an automated process for handling requests for extension of deadlines for correcting violations:
- For Category 1 disclosures, to obtain an eNOD, disclosers must correct their violations within 60 days of the date of discovery for disclosers under the Audit Policy; or within 90 days of the date of discovery for disclosers under the Small Business Compliance Policy. Extensions of the violation correction deadline and corresponding compliance certification deadline are not allowed for Category 1 disclosures. If an entity requests an extension of the violation correction deadline for an EPCRA disclosure that is potentially eligible for Category 1 treatment, the disclosure will be potentially eligible only for Category 2 treatment.
- Category 2 disclosers under both the Audit Policy and the Small Business Compliance Policy can make an online request for up to 30 additional days to correct their violations, with no explanation required. Such extensions will be considered granted at the time of the request, and the Compliance Certification due date will automatically be extended.
- Category 2 disclosers under the Audit Policy can make an online request for more than 30 additional days to correct their violations, provided the violation correction date does not extend beyond 180 days after the date of discovery, but disclosers must include a justification for such extension and the request is not considered automatically granted at the time of the request.
- Category 2 disclosers under the Small Business Compliance Policy can make an online request for more than 90 additional days to correct their violations, provided the violation correction date does not extend beyond 360 days after the date of discovery, but disclosers must include a justification for such extension and the request is not considered automatically granted at the time of the request.
Entities wishing to disclose potential violations through the eDisclosure system must follow a three-step process: (1) register with EPA’s Central Data Exchange (CDX) system; (2) submit disclosure of any violation, within 21 calendar days of the entity’s discovery that such potential violations may have occurred to be considered prompt; and (3) submit a Compliance Certification, within 60 days for an Audit Policy disclosure and within 90 days for a Small Business Compliance Policy disclosure, identifying the specific violations, and certifying that the violations have been corrected and that policy conditions have been met. These modifications to the implementation of EPA’s Audit Policy and Small Business Compliance Policy, and the launch of the eDisclosure portal, became effective on December 9, 2015. General information on EPA’s eDisclosure portal is available online.
EPA Makes Available Supporting Documents For Endangered Species Biological Evaluations: On December 11, 2015, EPA’s Office of Pesticide Programs (OPP) made publicly available several documents associated with the Biological Evaluations (BE) for the first three “pilot” chemicals that are being evaluated: chlorpyrifos, diazinon, and malathion. For each chemical, the following supporting documents are now available: problem formulation; fate and effects characterizations; and related appendices. The provisional models are available here.
EPA states on its website that these documents contain the analysis plan and underlying data that will be used to make effects determinations as part of the pesticide consultation process. The entire draft BEs for the three chemicals, including the effects determinations, will be released for public comment in the spring of 2016.
These BEs are a product of the collaboration among the National Marine Fisheries Service (NMFS), the U.S. Fish & Wildlife Service (FWS) (together, the Services), EPA, and the U.S. Department of Agriculture (USDA) in response to the National Academy of Sciences’ April 2013 report, Assessing Risks to Endangered and Threatened Species from Pesticides, which examined topics pertaining to tools and approaches for assessing the effects of proposed FIFRA actions on endangered and threatened species and their critical habitats, and provided recommendations.
USDA provided expertise on crop production and pesticide uses and assistance with the use of the National Agricultural Statistics Service Cropland Data Layer to help define the footprint of agricultural use patterns. The FWS and the NMFS will use the analyses and data from the biological evaluations and integrate it into their final Biological Opinions for the three chemicals due in December 2017. For more information, see B&C®‘s Pesticide Law and Policy Blog®.
EPA To Hold Four Public Webinars On EPA’s Enhanced Section Seven Tracking System: EPA recently updated the electronic reporting option for pesticide establishments using the FIFRA Section Seven Tracking System (SSTS), now referred to as the Enhanced Section Seven Tracking System (eSSTS). On December 17, 21, 22, and 28, 2015, EPA will hold four public webinars to explain the CDX registration process for the eSSTS and demonstrate report submission using eSSTS. EPA states that any establishments/authorized agents that used electronic reporting last year should automatically be registered to use the new eSSTS system. CDX registration for eSSTS will be open after December 18, 2015; submitters will need to register to use the new system. Pesticide establishments can use the CDX to submit EPA Form 3540-16 “Pesticide Report for Pesticide-Producing and Device-Producing Establishments,” the annual pesticide establishment report required under FIFRA Sections 7 and 17 to be submitted by all active domestic and foreign pesticide producing establishments, regardless of whether or not the establishment produced or distributed a pesticide, active ingredient, or device, by March 1 of each calendar year.
The first webinar on December 17, 2015, from 1:00 p.m. to 2:00 p.m. (EST) will explain the CDX registration process for the eSSTS. Webinars 2, 3, and 4 will cover eSSTS training, but will all have the same information — participants only need to attend one of these sessions. Additional announcements and reporting instructions are posted on EPA’s Pesticide Establishment web page. More information on the specific trainings is listed below. The links will not be active until the time of the webinar:
- CDX Registration Training for EPA’s eSSTS, Thursday, December 17, 2015, 1:00 p.m. – 2:00 p.m. (EST) (Recorded): An Overview of how to set up an EPA CDX account and set up a user role under EPA’s eSSTS, will be available online.
- EPA’s eSSTS Industry User Training 1, Monday, December 21, 2015, 11:00 a.m. – 12:00 p.m. (EST) (Recorded): Industry overview of EPA’s eSSTS, will be available online.
- EPA’s eSSTS Industry User Training 2, Tuesday, December 22, 2015, 2:30 p.m. – 3:30 p.m. (EST): Industry overview of EPA’s (eSSTS), will be available online.
- EPA’s eSSTS Industry User Training 3, Monday, December 28, 2015, 11:00 a.m. – 12:00 p.m. (EST): Industry overview of EPA’s eSSTS, will be available online.
EPA Updates IRIS Agenda: On December 15, 2015, EPA posted a list of chemicals and metals that it will begin to assess under its Integrated Risk Information System (IRIS) over the next few years, referred to as the IRIS Program Multi-Year Agenda or the IRIS Agenda. EPA has not updated the IRIS Agenda since 2012. The IRIS Agenda provides information on the following three topics:
- IRIS assessments currently underway and their status;
- Prioritization of assessments that will be initiated over the next few years; and
- Evaluation of assessment needs and development of an update process for existing IRIS values.
The prioritized list of chemicals and metals includes the availability of new information that would alter existing toxicity and the importance of a chemical or metal to regions and programs within EPA. The chemicals that the IRIS program will newly begin to assess, listed in priority, are:
- Group 1: manganese, mercury, methylmercury, nitrate and nitrite, perfluoroalkyl compounds, and vanadium and compounds;
- Group 2: acetaldehyde, ammonia (oral), cadmium and compounds, and uranium (effects not associated with radioactivity); and
- Group 3: di-(2-ethylhexyl) phthalate, dichlorobenzene isomers, methyl t-butyl ether (MTBE), nickel and compounds, and styrene.
EPA Requests Scientific View On Draft Aquatic Life Ambient Water Quality Criteria For Cadmium: On December 1, 2015, EPA announced its draft recommended aquatic life water quality criteria for cadmium and requested public comment on the criteria. 80 Fed. Reg. 75097. EPA is updating its national recommended ambient water quality criteria for cadmium to reflect the latest scientific information, and current EPA policies and methods. EPA will consider scientific views from the public on this draft document as well as any new data or information received. The draft 2015 updated criteria include new data for 70 species and 49 genera not previously represented. The draft freshwater acute criterion was derived, according to EPA, to be protective of endangered species and further lowered to protect the commercially and recreationally important rainbow trout, consistent with procedures described in EPA’s current aquatic life criteria guidelines; the freshwater acute value is approximately the same as the 2001 acute criterion for dissolved cadmium. The draft freshwater chronic criterion is slightly higher (i.e., less stringent) compared to the 2001 criterion for dissolved cadmium; this increase is primarily due to the inclusion of new data. The draft estuarine/marine acute criterion for dissolved cadmium is slightly more stringent than the 2001 recommended criterion, which is primarily due to the addition of data. Draft changes in suggested values between 2001 are:
Summary of 2001 and 2015 Draft Aquatic Life AWQC for Cadmium
|2015 AWQC Update||2001 AWQC|
|Acute (1-hour, dissolved Cd)c||Chronic (4-day, dissolved Cd)||Acute (1-day, dissolved Cd)||Chronic (4-day, dissolved Cd)|
|Freshwater (Total Hardness = 100 mg/L as CaCO3)a Estuarine/marine||2.1 µg/Lb|
- Freshwater acute and chronic criteria are hardness-dependent and were normalized to a hardness of 100 mg/L as CaCO3 to allow the presentation of representative criteria values.
- Lowered to protect the commercially and recreationally important species (rainbow trout), as per the 1985 Guidelines, Stephen et al. (1985).
- The duration of the 2015 acute criteria was changed to 1-hour to reflect the 1985 Guidelines-based recommended acute duration.
Comments are due on or before February 1, 2016.
FDA Issues Final Rules: On November 27, 2015, the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) issued three final rules. The three new rules, the Produce Safety rule, the Foreign Supplier Verification Programs (FSVP), and the Accredited Third-Party Certification rule, are part of the implementation of the preventative measures of the Food Safety Modernization Act (FSMA). The Produce Safety rule is intended to minimize risk by establishing standards for the safe growing, harvesting, packing, and holding of fruits and vegetables. 80 Fed. Reg. 74353. The FSVP establishes flexible hazard analysis and risk-based preventive control standards by food types and is intended to help ensure the safety of imported foods. 80 Fed. Reg. 74225. The Accredited Third-Party Certification rule establishes the framework, procedures, and requirements to provide for accreditation of third-party certification bodies to conduct food safety audits for foreign food facilities. 80 Fed. Reg. 74569. The effective date for all three rules is January 26, 2016.
FDA Releases EIS For Produce Safety Rule: On November 27, 2015, FDA’s CFSAN released the final Environmental Impact Statement (EIS) for the Produce Safety rule. 80 Fed. Reg. 74669. The EIS “places the produce safety rule in the context of its likely impact on the environment, including human health and socioeconomic effects.” The EIS discusses the beneficial impact to improved human health from the produce safety preventive measures and outlines flexible water quality standards to address potential groundwater shortages.
FDA Issues Proposed Rule: On November 18, 2015, FDA’s CFSAN issued a proposed food labeling rule “Gluten-Free Labeling of Fermented or Hydrolyzed Foods.” 80 Fed. Reg. 71990. The proposed rule would amend the current gluten-free labeling rule to provide “alternative means for [FDA] to verify compliance based on records that are maintained by the manufacturer of the food bearing the ‘gluten-free’ claim and made available to [FDA] for inspection and copying.” The proposed rule would cover foods (i.e., yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers) where there is uncertainty with the current gluten methods. The comment period is open until February 16, 2016.
FDA Issues Draft Guidance For Sunscreen Innovation Act: On November 23, 2015, FDA’s Center for Drug Evaluation and Research (CDER) released four draft guidance documents to industry regarding various aspects of the Sunscreen Innovation Act (SIA). The SIA amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a review and alternative approval process for over-the-counter (OTC) sunscreen actives. The four draft guidance documents include details for Industry on addressing certain elements of the SIA, including generating safety and effectiveness data (Over-the Counter Sunscreens: Safety and Effectiveness Data (80 Fed. Reg. 72975)), advisory committee processes (Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process (80 Fed. Reg. 72972)), submission formats and content requirements (Nonprescription Sunscreen Drug Products — Content and Format of Data Submissions to Support GRASE Determination Under the Sunscreen Innovations Act (80 Fed. Reg. 72973)), and procedures for withdrawal of a 586A request or pending requests (Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request (80 Fed. Reg. 72970)). Comments for the four draft guidance documents are due by January 22, 2016.
PHMSA Denies Petitions On Flammable Train Rule: On November 18, 2015, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) denied petitions from five parties to amend its final rule establishing enhanced tank car standards and operational controls for high-hazard flammable trains. 80 Fed. Reg. 71952. PHMSA, in the Federal Railroad Administration (FRA), published the final rule on May 8, 2015. 80 Fed. Reg. 26642. The rule is intended to reduce the consequences and the probability of accidents involving trains transporting large quantities of Class 3 flammable liquids. The Hazardous Materials Regulations provide persons with an opportunity to appeal a PHMSA action, including a final rule. PHMSA received six appeals regarding the final rule, one of which was subsequently withdrawn. The other petitions were submitted by the Dangerous Goods Advisory Council, the American Chemistry Council, the Association of American Railroads, the American Fuel & Petrochemical Manufacturers, and jointly the Umatilla, Yakama, Warm Springs, and Nez Perce tribes (Columbia River Treaty Tribes) and the Quinault Indian Nation (Northwest Treaty Tribes). PHMSA’s November 18 notice denies all five of the petitions.
EP And Council Of The EU Reach Agreement On Proposed Novel Food Regulation:. On November 11, 2015, the Council of the European Union (EU) announced that its Permanent Representatives Committee approved the proposed novel food regulation. On November 16, 2015, the European Parliament (EP) and the Council of the EU reached an agreement on the proposal. The European Commission (EC) issued a November 16, 2015, press release and a November 16, 2015, Questions and Answers (Q&A) document concerning the final regulation. The Q&A includes the following concerning nanomaterials:
What are nanomaterials and what are the conditions for their use in food?
Nanomaterials are materials engineered at the scale of atoms and molecules. The new Regulation specifies that engineered nanomaterials defined in the new legislation, require a Novel Food authorisation before being used in foodstuffs. Their safety will be assessed by the European Food Safety Authority. The applicants must also demonstrate that most up-to-date test methods have been used for testing the engineered nanomaterials for which an authorisation is sought for.
The EP and the Council must still formally adopt the regulation before it will be published in the Official Journal of the European Union. The regulation will enter into force 20 days after its publication and will apply two years later (around the end of 2017, according to the EC).
EC Scientific Committee Releases Opinion On Hydroxyapatite (Nano) For Comment: The EC Scientific Committee on Consumer Safety (SCCS) has posted for comment its opinion on hydroxyapatite (nano). According to the opinion, the EC received 35 notifications of cosmetic products containing hydroxyapatite in nano form. The opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes, tooth whiteners, and mouth washes with a maximum reported concentration limit of ten percent and specifications. The opinion states that the EC has concerns because of the potential for nanoparticles of hydroxyapatite to be absorbed and enter into the cells. It requested from the SCCS a safety assessment of the nano form of hydroxyapatite covered in the notifications, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions. The SCCS states that applicants provided only a limited amount of data that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics and that the provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials. To facilitate the assessment, the SCCS also considered additional information gathered through a search of the published scientific literature. The SCCS concluded, however, that the evidence “is insufficient to allow drawing a conclusion on the safety of nano-hydroxyapatite when used in oral cosmetic products.” The SCCS states that it will need “toxicological data specific for the materials included in the submission for safety assessment, unless a close similarity with the materials used in the available studies can be demonstrated to allow data read-across.” The SCCS also concluded that the available data indicate that “nano-hydroxyapatite in needle form is of concern in relation to potential toxicity.” The opinion states that “needle-shaped nano-hydroxyapatite should not be used in cosmetic products.” Comments are due January 8, 2016.
OECD Working Party On Resource Productivity And Waste Posts Documents Concerning Nanomaterials: The Organization for Economic Cooperation and Development (OECD) recently posted four reflection papers that discuss the possible release of nanomaterials from waste treatment operations and a literature review on four specific waste treatment processes of recycling, incineration, landfilling, and wastewater treatment. The papers aim to point out the knowledge gaps and areas where further research is needed.
- Incineration of Waste Containing Nanomaterials: The paper was developed to attempt to improve the knowledge base and achieve progress on the discussion concerning the environmentally sound management of waste containing nanomaterials;
- Landfilling of Waste Containing Nanomaterials and Nanowaste: The purpose of the paper is to provide an initial scoping review of readily available scientific information about the source of engineered nanomaterials in landfills, their fate and behavior in landfills, and the effectiveness of treatment technologies;
- Recycling of Waste Containing Nanomaterials: The main objective of the paper is to review the current state of knowledge on the fate of nanomaterials in the course of recycling operations and identify the areas where further work on the environmentally sound management of waste containing nanomaterials would be needed;
- The Fate of Engineered Nanomaterials in Sewage Treatment Plants and Agricultural Applications: The paper investigates the current state of knowledge on engineered nanomaterials and their behavior in wastewater treatment processes to identify the current state of knowledge and areas for future research; and
- Nanomaterials in Waste Streams — Chapter 1: This report surveys the available evidence from the literature for four specific waste treatment processes of recycling, incineration, landfilling, and wastewater treatment to establish the current state of knowledge on the fate and possible impacts of engineered nanomaterials in these processes.
EPA Intends To Promulgate Final TSCA 8(A) Rule In October 2016: According to an item in EPA’s Fall 2015 Regulatory Agenda, EPA intends to promulgate a final TSCA Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale. EPA’s April 6, 2015, proposed rule includes one-time reporting for existing nanoscale materials and one-time reporting for new discrete nanoscale materials before they are manufactured or processed. EPA states that consistent with the President’s memorandum for Executive Agencies regarding Principles for Regulation and Oversight of Emerging Technologies, the proposed rule would facilitate assessment of risks and risk management, examination of the benefits and costs of further measures, and making future decisions based on available scientific evidence.
Prosafe Project Invites Experts To Online Forum On Whether Risk Management Is On Pace With Nanotechnology Innovation: ProSafe has launched an online Delphi Forum on whether risk management is on pace with innovation for nanomaterial uses. ProSafe will use expert discussion between those working with manufacture and health and safety of specific nanomaterial uses to develop a white paper proposing a path forward for risk management policies for nanomaterial uses. To join the Forum, follow the instructions below:
- Go to scipinion.com;
- In the access code box for “ProSafe Delphi Poll,” enter “Prosafe2015” as the Access Code and click “take survey”;
- Enter an e-mail address to enter the poll. A confirmation e-mail will be sent to confirm and create a user account.
The material classes considered in the Delphi Forum are titanium dioxide, silicon dioxide, cerium oxide, barium sulphate, silver, and carbon nanotubes.
NIOSH Posts AIHA Fact Sheet On PPE For Engineered Nanoparticles: In November 2015, the National Institute for Occupational Safety and Health (NIOSH) posted a fact sheet sponsored by the American Industrial Hygiene Association (AIHA) Nanotechnology Working Group entitled Personal Protective Equipment for Engineered Nanoparticles. The fact sheet defines engineered nanoparticles as intentionally produced solid particles with at least one dimension in the size range of approximately 1 to 100 nanometers. According to the fact sheet, “[r]ecent studies and experience support the fact that traditional exposure control approaches can also work for intentionally produced nanoparticles when selected and implemented as part of a comprehensive occupational safety and health plan.” The fact sheet recommends managing exposure risks by following the industrial hygiene hierarchy of controls approach. For best results, exposure prevention and control measures should be considered early in the planning of experiments, development of products, and design of manufacturing processes, so that appropriate controls can be planned and selected. The fact sheet describes personal protective equipment (PPE) as “the last line of defense” and states that it should be used when other controls are not feasible or not effective in reducing exposures to acceptable levels, or while controls are in the process of being implemented. According to the fact sheet, “PPE may also be used to supplement other control measures for added precaution, and should be used as part of a comprehensive workplace PPE program.”
Sweden Proposes Reporting Requirements For Nanomaterials: On December 1, 2015, the Swedish Chemicals Agency (KEMI) announced that it proposed to the government that those who report chemical products to the products register would, in addition to the information that is currently reported, also provide additional information regarding any nanomaterials contained in the product. According to the English summary in KEMI’s report, the proposal covers nanomaterials that have been intentionally added to the product, regardless of concentration. Under the proposal, nanomaterials would be defined in accordance with the recommended definition of the European Commission. KEMI notes that the proposal does not cover nanomaterials that are naturally occurring or unintentionally produced. The proposal includes exemptions from the reporting requirements for companies with a turnover of less than SEK 5 million per year during a period of evaluation. During the period of evaluation, the same exemption should also apply to nanomaterials in the form of pigment. According to KEMI, product groups that are already exempt from reporting requirements would remain exempt for any purposes of this proposal. Those product groups are waste, food and animal feed, pharmaceuticals, cosmetics, and tattoo ink. KEMI states that its proposal does not include any reporting requirements for nanomaterials in articles as a part of the report. KEMI suggests that such reporting requirements be studied in a separate investigation.
RAND Corporation Assesses NIOSH Nanotechnology Research Center: NIOSH posted a RAND Corporation (RAND) report entitled Nanomaterial Safety in the Workplace: Pilot Project for Assessing the Impact of the NIOSH Nanotechnology Research Center. In August 2014, NIOSH asked RAND to help develop and apply a method for assessing its Nanotechnology Research Center’s (NTRC) contribution to improving the safety and health of workers who could be affected by the production, use, reuse, or disposal of the products of nanotechnology that are of greatest concern to workers, such as engineered nanomaterials. The report describes the method used to construct the NTRC logic model and includes “insights and guidance” for gathering and organizing information about NTRC’s operations and their impact on or contributions to worker safety and health. The report states that RAND, in coordination with NTRC leadership, identified a portion of the NTRC to pilot the method and search for evidence of NTRC’s activities and outputs that contribute to worker safety and health. For purposes of the pilot study, RAND limited its data collection concerning NIOSH outputs and stakeholder engagement to information and organizations associated with nano-titanium dioxide and nano-silver. RAND identified a set of common categories of NTRC activities and outputs, as well as classes of stakeholders, including workers and industrial, advocacy, governmental, research, educational, and training organizations, each of which uses NTRC’s outputs in ways that could contribute to NIOSH’s mission. RAND also identified, with input from NTRC leadership, a small number of external customers and intermediate parties with whom to discuss NTRC’s outputs and services and how they are used to affect worker safety and health. RAND states that the discussions identified potential factors that might be inhibiting NIOSH’s ability to achieve its desired outcomes. For example, according to the report, “there is often not an explicit connection between the exposure to a particular nanomaterial, the health effect of that exposure, and the specific steps that should be taken in response to that exposure.” The report states that “the pace at which new nanomaterials are being developed and used by industry appears to exceed the pace of safety and health research and regulations, which can lead to outdated and insufficient rules,” and that the “lack of formal regulations may be limiting the use of on-site exposure monitoring.” The report notes that “premature regulation based on inadequate research and data may not be well received by NTRC customers and intermediate parties,” however. RAND concludes that “[a] more comprehensive review of NTRC across industry sectors, NIOSH-defined critical topic areas, and engineered nanomaterials or nanotechnologies is necessary to more fully characterize the breadth and scope of NTRC’s success and barriers to achieving impact.”
BRAG Biobased Products News And Policy Report: B&C’s consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to www.braginfo.org.
EPA Releases Final Renewable Fuel Standard Rule: On December 14, 2015, EPA released the final Renewable Fuel Standard (RFS) rule. 80 Fed. Reg. 77420. The RFS sets the volume requirements and percentage standards for cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel for 2014, 2015, and 2016, and for biomass-based diesel for 2017. This rule decreases the amount of required ethanol from the original RFS volume requirements set in 2007. The 2016 volume requirements will decrease from 15 billion gallons to 14.5 billion gallons of corn-based ethanol, and from 22.3 billion gallons to 18.11 billion gallons of biofuels. USDA Secretary Tom Vilsack stated:
[It] is a positive step forward providing for continued growth in all parts of the Renewable Fuel Standard — advanced, biodiesel, cellulosic, and conventional — building on the Obama Administration’s and USDA’s commitment to biofuels and American-grown renewable energy.
This decrease in RFS requirements is disappointing, however, it was imperative that a final RFS rule was released to assuage the uncertainty that has impacted investment in the biofuel industry.
Advisory Committee On Biotechnology And 21st Century Agriculture To Meet: On November 19, 2015, USDA published a notice of the Advisory Committee on Biotechnology and 21st Century Agriculture (AC21) Meeting. 80 Fed. Reg. 72410. The meeting, which was held on December 14 and 15, 2015, reviewed the purpose, history, operational process, and member responsibilities of AC21; updated Committee members on relevant regulatory developments, initiatives, and USDA activities; and outlined new tasks for the Committee to address. General information about the Committee can be found online.
Congress Passes Resolutions Blocking Clean Power Plan Rules: On November 17, 2015, the Senate passed two resolutions that would block EPA’s Clean Power Plan rules, the regulatory pillars of President Obama’s Climate Action Plan. By votes of 52-46, lawmakers passed S. J. Res. 23 and S. J. Res. 24. Senate Majority Leader Mitch McConnell (R-KY) introduced S. J. Res. 23, which would use the Congressional Review Act to block implementation of EPA’s final rule issued on October 23, 2015, establishing emission limits for greenhouse gas emissions from new, modified, and reconstructed power plants. 80 Fed. Reg. 64510. Senator Shelley Capito (R-WV) introduced S. J. Res. 24, which similarly would block EPA’s final rule establishing emission limits for greenhouse gas emissions from existing power plants. (Oct. 23, 2015; 80 Fed. Reg. 64662). The House passed the resolutions on December 1, 2015, as Obama and other world leaders met in Paris for talks on a global agreement to combat global warming. The resolutions now move to the President for consideration. The votes are largely symbolic, however, as Obama has vowed to veto the measures. In two Statements of Administration Policy, Obama stated that the resolutions threaten “the health and economic welfare of future generations by blocking important standards to reduce carbon pollution from the power sector” and that if presented with the resolutions he would veto them both.
House Bill Would Eliminate RCRA Exemption For Oil And Gas Wastes: Joined by 100 co-sponsors and supported by over 200 organizations, Representative Matt Cartwright (D-PA) on December 10, 2015, introduced a bill that would amend the Resource Conservation and Recovery Act (RCRA) by eliminating the current exemption ? the so-called Bentsen amendment — for certain wastes associated with oil and gas exploration, development, and production. The Closing Loopholes and Ending Arbitrary and Needless Evasion of Regulations Act of 2015 (CLEANER Act, H.R. 4215) is intended to “hold oil and natural gas producers to the same standards that other industries have complied with for over 30 years.” Cartwright stated RCRA Section 3001(b)(2)(A) generally exempts from hazardous waste regulation “drilling fluids, produced waters and other wastes associated with the exploration, development, or production of crude oil or natural gas or geothermal energy.” The provision was added to RCRA in 1980 via an amendment sponsored by Senator Lloyd Bentsen (D-TX). Cartwright’s bill would subject oil and gas wastes, including fracking wastes, to potential regulation as hazardous waste.
OSHA Releases Safety And Health Program Management Guidelines: The Occupational Safety and Health Administration (OSHA) recently released to the public an updated version of its voluntary Safety and Health Program Management Guidelines. The document represents “OSHA’s best thinking and experiences from employers” that have successfully adopted safety and health management systems (SHMS) focused on identifying, assessing, preventing, and controlling workplace hazards. The guidelines are intended to assist small- and medium-sized employers find and fix hazards before workers are injured. The guidelines, first published in 1989, have been updated to reflect modern technology and practices. The updated guidelines:
- Introduce more effective approaches to workplace safety and health;
- Help employers find and fix hazards before they cause injury, illness, or death;
- Encourage employee participation so all workers have a voice in workplace safety and health; and
- Show how multiple employers on the same worksite can coordinate efforts to make sure all workers are given equal protection against hazards.
The public is intended to review the draft guidelines and provide comment. Comments are due February 15, 2016. For more information on the draft guidelines and the public comment process, visit OSHA’s Safety and Health Program Management website.
OSHA Issues New Field Operations Manual: On October 1, 2015, the U.S. Occupational Safety and Health Administration (OSHA) released a revised Field Operations Manual (Manual), Directive Number CPL 02-00-159, available online. The Manual is intended to “provide OSHA offices, State Plan programs and federal agencies with policy and procedures concerning the enforcement of occupational safety and health standards.” Because OSHA is able to impose higher penalties as a result of the Bipartisan Budget Act of 2015, the document is a must read for companies subject to OSHA enforcement. The Manual was most recently updated in 2011. Two changes are particularly important. First, the Manual increases maximum civil penalty amounts. Under the Manual, OSHA increases penalty amounts by 10 percent for citations that have become part of a final order. In addition, and as a consequence of the enactment of the Bipartisan Budget Act of 2015, referenced above, civil monetary penalties will be increased to reflect inflation, a monetary factor that had not been taken into account since 1990 in monetary penalty assessments. The new Act eliminates the exemption available to OSHA under prior law requiring that civil monetary penalties be increased from time to time to account for inflation. Under the Bipartisan Budget Act, inflation increases will occur annually. Also under the Act, OSHA will seek to make up for the lost inflation increases to penalty amounts and calculate an initial increase that will be significantly larger than a typical inflation increase to account for inflation increases since 1990. The combined effect of the changes could make monetary penalty amounts considerably higher. Second, the Manual makes substantial changes to penalty adjustments to increase the potential dollar amount of penalties and restrict available reductions. Among other changes, these changes include increasing the maximum penalty amounts for high, moderate, and low gravity violations based on previous statutory authorization and basing penalty adjustments on a new calculus that can result in diminished reductions than would have been available under the earlier Manual. The Manual also increases from three to five years the length of time that prior citations remain relevant for use in determining “repeat” violations, and diminishes the good faith discount employers enjoyed to 25 percent, from 35 percent. Other changes include diminished penalty reductions for smaller employers and greater emphasis on an OSHA inspector’s discretion. For example, the Manual notes inspectors’ ability to deny an employer the right to participate in an inspection if the inspector believes that the employer or its representative’s conduct “interferes” with an inspection. OSHA’s authority to do so is not new, but the emphasis in the Manual is.
New Strategy To Limit Neonicotinoids And Other “High Risk” Pesticides In Québec: In a press release issued on November 22, 2015, the Canadian province of Québec (Quebec) announced its release of Québec Pesticide Strategy 2015-2018. Although the Strategy itself is available only in French, Québec has provided a summary of the Strategy in English, which is available here.
Québec’s press release states that the Strategy “sets out the major directions and goals that will guide government action to protect public health, pollinators, and the environment in the coming years.” For more information, see B&C®‘s Pesticide Law and Policy Blog®.
California Issues Notice Requiring Registration For Products Made From Pesticide Impregnated Materials And Bearing Pesticide Claim: On December 11, 2015, the California Department of Pesticide Regulation (DPR) issued California Notice 2015-13 that will require each person/company with products made from pesticide impregnated material that are sold into or within California under their own company name to register their product(s) as a pesticide. Examples of pesticide impregnated materials affected by this Notice include apparel (e.g., jackets, shirts, hats, socks, pants, shorts) and non-apparel (e.g., bedding, tents, seat covers, chopping blocks, shower curtains, mouse pads) that make pesticidal claims. The requirements will be effective November 1, 2016. For more information, see B&C®‘s Pesticide Law and Policy Blog®.
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.