Monthly Update for August 2015


TSCA/FIFRA/IRIS/NTP/TRI

EPA Issues Direct Final Rule On Significant New Use Notification Electronic Reporting: On July 20, 2015, the U.S. Environmental Protection Agency (EPA) issued a direct final rule amending the Toxic Substances Control Act (TSCA) Section 5 electronic reporting regulations. 80 Fed. Reg. 42739. The electronic reporting regulations establish standards and requirements for use of EPA's Central Data Exchange (CDX) to submit electronically premanufacture notices (PMN), other TSCA Section 5 notices, and support documents to EPA. The rule provides the user community with new methods for accessing the electronic-PMN (e-PMN) software, new procedures for completing the e-PMN form, changes to the CDX registration process, adds the requirement to submit "bona fide intents to manufacture" electronically, and changes to the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA. This action is intended to further streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA. The direct final rule is effective January 19, 2016, without further notice, unless EPA receives adverse comment on or before August 19, 2015. If EPA receives adverse comments on this action, EPA will withdraw the rule before its effective date. EPA will then issue a proposed rule, providing a 30-day period for public comment.

EPA Schedules Webinars On Updated PMN Submission System: In a related action, on August 12, 2015, EPA announced that it will hold three webinars to assist submitters with the new features of its electronic, web-based system for receiving TSCA Section 5 submission forms and support documents. The webinars are scheduled for 1:00-4:00 p.m. (EDT) on the following days: August 26, 2015 (focusing on the CDX registration process and user roles); September 16, 2015 (focusing on the PMN form and related submissions); and September 30, 2015 (focusing on Notices of Commencement (NOC), biotechnology, and other submissions). More information is available online.

EPA Proposes Partial Exemption Of Certain Chemical Substances From Reporting Additional Chemical Data: On July 22, 2015, EPA proposed to amend the list of chemical substances that are partially exempt from reporting additional information under the Chemical Data Reporting (CDR) rule. 80 Fed. Reg. 43383. EPA has determined that, based on the totality of information available on the chemical substances listed in the proposed rule, there is a low current interest in their CDR processing and use information. EPA is proposing to add the following chemical substances to the list of chemical substances that are exempt from reporting the information described in 40 C.F.R. § 711.15(b)(4):

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service Registry Number (CASRN) 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CASRN 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CASRN 129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CASRN 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CASRN 61788-61-2); and
     
  • Soybean oil, methyl esters (CASRN 67784-80-9).

EPA reached this conclusion after considering a number of factors, including the risk of adverse human health or environmental effects, information needs for CDR processing and use information, and the availability of other sources of comparable processing and use information. EPA originally issued a draft final rule on January 27, 2015, to add these chemical substances to the list of chemical substances that are partially exempt from reporting, however, an adverse comment to the rule was submitted. Comments must be received on or before September 21, 2015.

EPA Releases Preliminary Toxics Release Inventory Dataset: On July 21, 2015, EPA released preliminary 2014 Toxics Release Inventory (TRI) data. The posted information represents about 99 percent of the total data EPA has or expects to receive. TRI reports were due July 1, 2015. EPA will release later additional information, including: revised and corrected information for 2014; pollution prevention data; TRI online searching tools, such as TRI Explorer; the complete TRI dataset; and EPA's analysis of the complete dataset. The preliminary 2014 TRI data are available online.

EPA Proposes Trichloroethylene SNUR: On August 7, 2015, EPA proposed a Significant New Use Rule (SNUR) for trichloroethylene (TCE). 80 Fed. Reg. 47441. The proposed significant new use is manufacture or processing for use in a consumer product, with a proposed exception for use of TCE in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing of TCE for a significant new use. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs. Comments must be received on or before October 6, 2015.

EPA Extends Comment Period On Draft Series 810 Test Guidelines And The Proposed Antimicrobial Pesticide USI Guidance Document: On July 24, 2015, EPA extended until October 1, 2015, the comment period on the draft Series 810 Product Performance Test guidelines EPA first issued on June 17, 2015. 80 Fed. Reg. 44102. In the same Federal Register notice, EPA extended the comment period for the proposed guidance document called the Antimicrobial Pesticide Use Site Index (USI) to August 31, 2015. In 2014, EPA issued a final rule amending the regulations setting forth the data requirements that support an application to register a pesticide product. The final rule contains the data requirements specifically applicable to antimicrobial pesticides, which were codified in 40 C.F.R. Part 158, subpart W. The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201. The data requirements applicable to a pesticide product depend in part on the product's use pattern. The general use patterns are broad designations and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site. EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product. EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the 12 general use patterns. The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC's July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit.

NTP Releases Report On Carcinogens Handbook: On July 24, 2015, the National Toxicology Program (NTP) issued a handbook describing the process it uses to prepare the descriptions of chemicals used in the Report on Carcinogens (RoC). The RoC lists chemicals, viruses, and other agents that are known or reasonably anticipated carcinogens. Inclusion in the RoC can trigger the need to update safety data sheets (SDS) and other hazard communications. The NTP announcement and a copy of the RoC handbook are available online.

EPA Issues Cumulative Risk Guidance: On July 29, 2015, EPA announced the availability of draft guidance on how it will conduct cumulative risk assessments. 80 Fed. Reg. 45218. The guidance, entitled "Pesticide Cumulative Risk Assessment: Framework for Screening Analysis Purpose," provides information on how EPA intends to conduct such assessments. EPA is specifically looking for comment on ways to streamline the process. The draft guidance is available online. Comments are due by August 28, 2015.

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 13, 2014, EPA released for public comment three Problem Formulations and Initial Assessments and a Data Needs Assessment document for one of four structurally similar flame retardant chemical clusters being reviewed under the TSCA Work Plan assessment effort. The goal of these assessments is to identify scenarios where further risk analysis may be necessary. The documents address the likely exposure and hazard scenarios to workers and consumers based on current production, use, and exposure information for the following flame retardant chemical clusters:

  • Tetrabromobisphenol A (TBBPA), also known as Brominated Bisphenol A, cluster -- used as flame retardants in plastics/printed circuit boards for electronics.
     
  • Chlorinated Phosphate Esters -- used as flame retardants in furniture foams and textiles.
     
  • Cyclic Aliphatic Bromides/Hexabromocyclododecane (HBCD) cluster -- used as a flame retardant in extruded and expanded polystyrene foams (EPS/XPS), polystyrene (PS) products.

The Data Needs Assessment document addresses the Brominated Phthalates (TBB and TBPH) cluster of flame retardants that are used in polyurethane foam products. EPA reviewed previous assessments and identified critical gaps in toxicity, exposure, and commercial mixtures data. The Data Needs Assessment document is intended to guide the collection of additional data and information. A pre-publication copy of the Federal Register Notice, a list of the flame retardant chemical clusters, a fact sheet with key questions and answers, and additional information on the TSCA Work Plan effort is available online.

FDA

FDA Issues Final Guidance On Use Of Nanomaterials In Food For Animals: On August 5, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled "Guidance for Industry: Use of Nanomaterials in Food for Animals." 80 Fed. Reg. 46587. The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology. FDA states that the Guidance is applicable to food ingredients intended for use in animal food that: (1) consist entirely of nanomaterials; (2) contain nanomaterials as a component; or (3) otherwise involve the application of nanotechnology. FDA states:

This final guidance addresses the legal framework for adding nanomaterial substances to food for animals and includes recommendations for submitting a Food Additive Petition (FAP) for a nanomaterial animal food ingredient. This guidance also recommends manufacturers consult with FDA early in the development of their nanomaterial animal food ingredient and before submitting an FAP. At this time, we are not aware of any animal food ingredient engineered on the nanometer scale for which there is generally available safety data sufficient to serve as the foundation for a determination that the use of such an animal food ingredient is generally recognized as safe (GRAS).

FDA Extends Food Labeling Compliance Deadline: On July 10, 2015, the FDA Center for Food Safety and Applied Nutrition (CFSAN) issued a one year extension to its compliance deadline for disclosure of nutrition information for stand-alone and retail food establishments. 80 Fed. Reg. 39675. FDA indicates the extension is being provided to allow impacted parties time to "implement the final rule's requirements." The rule is intended to "ensure that consumers are provided accurate, clear and consistent nutrition information." FDA also indicates draft guidance will be available in August to provide answers to some of the more frequent questions. The compliance deadline for the final rule is December 1, 2016.

FDA To Hold Public Meeting In Preparation Of ICCR: On July 15, 2015, FDA CFSAN announced it will hold a public meeting on September 10, 2015, to receive comments on various topics relating to the regulation of cosmetics. 80 Fed. Reg. 41506. FDA anticipates the input received will be utilized in preparation for the International Cooperation of Cosmetic Regulation (ICCR) meeting to be held in November 4-6, 2015, in Belgium. The ICCR is a voluntary international group of regulatory authority members, including Canada, Japan, the European Union (EU), and Brazil.

FDA Publishes Revised Guidance On Refuse To Accept Policy For 510(k): On August 4, 2015, the FDA Centers for Devices and Radiological Health (CDRH) issued a revised guidance entitled "Refuse to Accept Policy for 510(k)s." The guidance details the FDA procedures and criteria used to assess the completeness of a 510(k) submission to determine if the "minimum threshold of acceptability" for a substantive review has been met. The current 510(k) Refuse to Accept (RTA) policy includes an early review within the first 15 calendar days after submission to determine if the submission is administratively complete. The revised guidance offers industry and FDA staff updated checklists to assist in this early review process. For more details, see "Refuse to Accept Policy for 510(k)s."

RCRA/CERCLA

EPA Issues Interim Procedure For Submitting Notifications Under 2015 RCRA DSW Final Rule: On January 13, 2015, EPA issued revisions to the Definition of Solid Waste (DSW) rule under the Resource Conservation and Recovery Act (RCRA). 80 Fed. Reg. 1694. The rule requires certain facilities impacted by the changes to comply with certain notification requirements under the final rule using the existing Subtitle C Site Identification Form, more commonly known as EPA Form 8700-12. EPA has not, however, updated the form to reflect the new 2015 DSW final rule, and admits that it likely will be unable to do so by the time regulated facilities are required to notify under the rule. EPA thus issued in July a document entitled "Interim Procedure for Submitting Notifications under the 2015 Definition of Solid Waste Final Rule." The document, which is available online, explains how facilities should meet their notification requirement under the 2015 DSW final rule. These revisions became effective on July 13, 2015.

EPA Updates SW-846: EPA on August 13, 2015, announced the availability of Final Update V to the Third Edition of the Test Methods for Evaluating Solid Waste, Physical/Chemical Methods, more commonly known as the SW-846. 80 Fed. Reg. 48522. The SW-846 is a compendium of EPA-approved test methods that the regulated community may use to demonstrate compliance with the RCRA hazardous waste regulations.

CAA/CWA/SDWA

EPA Releases Final Clean Power Plan: On August 3, 2015, EPA released the final version of its highly anticipated Clean Power Plan rule. The rule has not yet been published in the Federal Register. The rule establishes emission limits on greenhouse gases (GHG) for new and existing fossil-fueled power plants. The final Clean Power Plan is more ambitious than the proposed rule; it would reduce power-sector carbon pollution 32 percent from 2005 levels in 2030, a 9 percent increase over the proposal, EPA states. The final rule will also drive a more aggressive transition to zero-carbon renewable energy sources than the proposed rule. The share of renewable energy generation capacity in 2030 is projected to be over 25 percent higher than in the proposed rule, at 28 percent, compared to 22 percent. The proposed rule relied on a large, early shift of coal generation to natural gas. For example, the share of natural gas in the generation mix was projected to be significantly higher in 2020 than in the baseline. In the final rule, that early rush to gas is eliminated and the share of natural gas is essentially flat. Instead, the rule drives early reductions from renewable energy and energy efficiency, which EPA believes will drive a more aggressive transformation in the domestic energy industry. A driver of these outcomes is likely to be the Clean Energy Incentive Program, which EPA believes will incentivize early deployment of renewable energy and energy efficiency. Under the program, credits for electricity generated from renewables in 2020 and 2021 will be awarded to projects that begin construction after participating state plans are submitted. The program also prioritizes early investment in energy efficiency projects in low-income communities; these projects will be awarded double the number of credits in 2020 and 2021 as compared to qualifying renewable energy projects. EPA did extend the compliance date for states, from 2020 to 2022. States also have a new "glide path" to compliance, with three periods of increasingly more stringent emission limits that end at final compliance by 2030. The final rule also differs from the proposed rule in that it promulgates a specific emission performance rate for both coal and natural gas facilities. States would have the option of adopting one of three methods to meet their obligations under the final rule: emissions standard approach, a rate-based emissions approach, or a mass-based emissions approach. Promulgation of the rule has sparked a firestorm of protest from opponents of the rule. In perhaps the most significant sign of displeasure over the rule, on August 13, 2015, Attorneys General from 15 states filed a petition in the U.S. Court of Appeals for the D.C. Circuit asking the court to stay implementation of the rule, even though it has not yet been published in the Federal Register.

EPA Issues Final Rule To Reduce HFCs: On July 20, 2015, EPA issued a final rule prohibiting certain uses of chemicals that significantly contribute to climate change in favor of safer, more climate-friendly alternatives. 80 Fed. Reg. 42869. The rule responds to President Obama's Climate Action Plan by reducing emissions of hydrofluorocarbons (HFCs) used in air-conditioning, refrigeration, and other equipment. Under the Clean Air Act (CAA) and EPA's Significant New Alternatives Policy (SNAP) Program, EPA reviews alternatives to HFCs on an ongoing basis and issues updates to the lists of acceptable and unacceptable substitutes. This rule changes the status of certain high-global warming potential (GWP) HFCs that were previously listed as acceptable under the SNAP Program as unacceptable in specific end uses. These changes are based on information showing other alternatives are available for the same uses that pose lower risk overall to human health and the environment. The HFCs and HFC-containing blends affected by the rule are used in aerosols, foam blowing, motor vehicle air conditioning, retail food refrigeration, and vending machines. EPA estimates this final rule will reduce GHG emissions of 54 to 64 million metric tons of carbon dioxide equivalent in 2025, equal to the carbon dioxide emissions from the annual energy use of more than 5.8 million homes. The rule takes effect August 19, 2015.

EPA Releases 2014 Effluent Guidelines Program Plan: EPA on August 4, 2015, issued its Final 2014 Effluent Guidelines Program Plan and 2014 Annual Effluent Guidelines Review Report. 80 Fed. Reg. 46280. Section 304(m) of the Clean Water Act (CWA) requires EPA to publish biennially a plan for new and revised effluent guidelines. The Plan identifies new or existing industrial categories selected for effluent guidelines and provides a schedule for issuing those guidelines. The Plan is available online.

NANOTECHNOLOGY

Companies Appeal ECHA's Requests For Information Concerning Nanoforms: On July 16, 2015, the European Chemicals Agency (ECHA) announced the following appeals in which the keywords include nanoforms:

The cases all concern silicic acid, aluminum sodium salt. The contested decisions were adopted December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration. In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation. ECHA requested that each appellant submit the following information:

  • Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
     
  • Composition of the substance (Annex VI, 2.3); and
     
  • Description of the analytical methods used (Annex VI, 2.3.7).

In each case, the appellant contends that ECHA breached the principle of legal certainty by requesting information related to undefined terms, such as "forms," "grades," and "nanoforms." Each appellant asks the Board of Appeal to annul the contested decision in so far as it requests the appellant to submit information as identified in the appeal.

Canada Begins Mandatory Survey With Respect To Certain Nanomaterials In Canadian Commerce: The July 25, 2015, Canada Gazette includes a notice announcing that the Minister of the Environment requires, for the purpose of assessing whether the substances described in the notice are toxic or are capable of becoming toxic, or for the purpose of assessing whether to control, or the manner in which to control the listed substances, any person described in the notice who possesses or who may reasonably be expected to have access to the information required to provide that information. The notice applies to a substance that has a size of between 1 and 100 nanometers in at least one external dimension, or internal or surface structure; and is provided in the list in Schedule 1 of the notice. The list includes over 200 substances. The notice applies to any person who, during the 2014 calendar year, manufactured a total quantity greater than 100 kilograms (kg) of a substance set out in Schedule 1. The notice also applies to any person who, during the 2014 calendar year, imported a total quantity greater than 100 kg of a substance set out in Schedule 1, at any concentration, whether alone, in a mixture, or in a product. The notice does not apply to a substance in Schedule 1, whether alone, in a mixture, or in a product, that:

  1. Is in transit through Canada;
     
  2. Is naturally occurring;
     
  3. Is incidentally produced;
     
  4. Is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and that was imported in 2014 pursuant to a permit issued under those Regulations;
     
  5. Is, or is contained in, a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act where that pest control product is registered under the Pest Control Products Act;
     
  6. Is, or is contained in, a fertilizer or supplement within the meaning of section 2 of the Fertilizers Act where that fertilizer or supplement is registered under the Fertilizers Act;
     
  7. Is, or is contained in, a feed within the meaning of section 2 of the Feeds Act where that feed is registered under the Feeds Act; or
     
  8. Is mixed with, or attached to, a seed within the meaning of section 2 of the Seeds Act where that seed is registered under the Seeds Act.

Information to be provided includes:

  • The basis on which the substance identified was determined to be in nanoscale form by indicating "research & development sources," "technical data," "information available from patents," "marketing claim," "assumption," or "other (specify)";
     
  • The total quantity of the substance manufactured or imported;
     
  • The consumer and commercial codes that apply to the known or anticipated final substance, mixture, or product containing the substance;
     
  • For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in commercial activities;
     
  • For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in consumer activities;
     
  • For each applicable consumer and commercial code, whether any known or anticipated final substance, mixture, or product containing the substance is intended for use by or for children 14 years of age or younger; and
     
  • The study title(s) of any unpublished or published data or studies on the substance with regard to physical-chemical properties, bioaccumulation, persistence, toxicity, metabolism, degradation, release, or disposal of the substance from the final mixture or product.

Any person who provides information in response to this notice may submit a written request that the information or part of it be treated as confidential. Responses are due February 23, 2016.

Non-governmental Organizations (NGO) Challenge Nanosilva's Conditional Registration: On July 27, 2015, two petitions for review of EPA's second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit. The Natural Resources Defense Council (NRDC) filed a petition (Case Number 15-72308), as well as the Center for Food Safety (CFS) and International Center for Technology Assessment (ICTA) (Case Number 15-72312). Both suits ask the court to set aside EPA's final order granting a conditional registration for a nanosilver-containing antimicrobial pesticide product named "NSPW-L30SS," or "Nanosilva." NRDC challenged EPA's first conditional registration of a nanosilver product, which it granted to HeiQ in 2011. On November 7, 2013, the U.S. Court of Appeals for the Ninth Circuit granted in part and denied in part NRDC's petition for review of HeiQ AGS-20 and AGS-20 U (collectively, AGS-20). The court held that "substantial evidence" supported EPA's decision to use the characteristics of toddlers rather than infants in determining whether AGS-20 placed consumers at risk. The court vacated EPA's decision "insofar as it concluded that there was no risk concern requiring mitigation for short- and intermediate-term aggregate oral and dermal exposure to textiles that are surface-coated with AGS-20."

EPA Will Continue Review Of Engineered Nanomaterials In Wastewater: On August 4, 2015, EPA announced the availability of its Final 2014 Effluent Guidelines Program Plan. 80 Fed. Reg. 46280. The Final Program Plan includes the following findings from EPA's review of engineered nanomaterials in industrial wastewater:

  • Some manufacturing and processing methods likely generate wastewater, but the quantity generated and waste management practices are not documented;
     
  • Toxicity hazards from engineered nanomaterials have been demonstrated in the laboratory, but the environmental and human health risks are largely unknown;
     
  • Fate of and exposure to industrial wastewater releases of engineered nanomaterials to the environment have not been studied;
     
  • The small size, unique properties, and complexity of engineered nanomaterials present a challenge for environmental monitoring, risk assessment, and regulation;
     
  • Methods for detecting and characterizing nanomaterials in complex media, like industrial wastewater, are under development;
     
  • EPA has not approved any standardized methods for sampling, detecting, or quantifying of nanomaterials in aqueous media; and
     
  • Research has shown that common treatment technologies employed at municipal wastewater treatment plants can remove nanomaterials from the wastewater, but that these may then accumulate in the sludge.

EPA states that its review also identified four main areas of further research appropriate to assess better the potential presence and impact of engineered nanomaterials in industrial wastewater:

  • Development of standard methods and sampling techniques to detect and characterize nanomaterials in industrial wastewater;
     
  • Evaluation of engineered nanomaterial toxicity impacts and potential occurrence in industrial wastewater, taking into consideration relevant forms and concentrations of engineered nanomaterials;
     
  • Identification of the universe of engineered nanomaterial facilities, their production values, and the waste generated and disposed of during the manufacturing and processing of engineered nanomaterials; and
     
  • Evaluation and characterization of the fate, transformation, and treatment of engineered nanomaterials in industrial wastewaters.

EPA states that it plans to continue to monitor ongoing research on engineered nanomaterials in future annual reviews and will collect any new information as it becomes available, particularly related to the following data gaps:

  • Development of standard methods and sampling techniques to detect and characterize nanomaterials in industrial wastewater;
     
  • Evaluation of engineered nanomaterial toxicity impacts and potential occurrence in industrial wastewater, taking into consideration relevant forms and concentrations of engineered nanomaterials;
     
  • Identification of the universe of facilities, their production values, and the nature of the waste generated and disposed by manufacturing and processing of engineered nanomaterials; and
     
  • Evaluation and characterization of the fate, transformation, and treatment of engineered nanomaterials in industrial wastewaters.
BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.'s (B&C®) 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 Posts Information On Biotechnology Algae Project: EPA has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology. EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches. EPA's recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states that it is focusing its project around these biotechnology algae applications. As part of its efforts to implement TSCA, EPA provides technical support for reporting on new chemical substances and microorganisms that are not yet in commerce. EPA's 1997 document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) assists those who intend to submit pre-manufacture microbial commercial activity notices (MCAN) or TSCA experimental release applications (TERA) for various commercial products. According to EPA, the Points to Consider document helps submitters identify and organize the information and data they provide to inform EPA's required risk assessments. An important component of EPA's recent announcement is a somewhat muted statement that it is "currently updating the Points to Consider to accommodate the development of new information relevant to risk assessment of biotechnology products regulated under TSCA." According to EPA, the Points to Consider document does not currently provide specific support for those using the emerging technologies of algae production and biotechnology. EPA states that to keep its risk assessment process for biotechnology algae open and transparent, it intends "to develop a separate document on the scientific and technological issues it currently understands to be key and unique for evaluating risks from the production and use of biotechnology algae." EPA will develop its "Considerations for Biotechnology Algae" document in parallel with updating the Points to Consider. More information is available in our memorandum.

OSHA DEVELOPMENTS

OSHA Proposes To Amend Recordkeeping Requirements For Work-Related Injuries And Illnesses: The Occupational Safety and Health Administration (OSHA) on July 29, 2015, issued a proposed rule amending its recordkeeping regulations to clarify that the duty to make and maintain accurate records of work-related injuries and illnesses is an ongoing obligation. 80 Fed. Reg. 45116. OSHA specifically is proposing to amend its regulations at 29 C.F.R. Part 1904 to clarify that the duty to record an injury or illness continues for as long as the employer must keep records of the recordable injury or illness and that the duty does not expire just because the employer fails to create the necessary records when first required to do so. The proposed amendments consist of revisions to the titles of some existing sections and subparts, and changes to the text of some existing provisions. The proposed amendments add no new compliance obligations; the proposal would not require employers to make records of any injuries or illnesses for which records are not currently required to be made. The comment period on the proposed rule ends on September 28, 2015.

OSHA Proposes Revisions To Beryllium PEL: OSHA on August 7, 2015, proposed revisions to its existing permissible exposure limits (PEL) for occupational exposure to beryllium and beryllium compounds. 80 Fed. Reg. 47565. OSHA currently enforces PELs for beryllium in general industry, construction, and shipyards. These PELs were adopted in 1971 and OSHA has not updated them since. The current time-weighted average (TWA) PEL for beryllium is 2 micrograms per cubic meter of air (µg/m3) as an 8-hour TWA. OSHA is proposing a new TWA PEL of 0.2 µg/m3 in general industry. OSHA is also proposing other elements of a comprehensive health standard, including requirements for exposure assessment, preferred methods for controlling exposure, respiratory protection, personal protective clothing and equipment (PPE), medical surveillance, medical removal, hazard communication, and recordkeeping. The comment period on the proposed rule closes on November 5, 2015.

OSHA Issues Updated Training Guidance For Several Industry Categories: OSHA has released an updated version of its guide to regulatory-required training. The guide organizes the training requirements into five categories: General Industry, Maritime, Construction, Agriculture, and Federal Employee Programs. The guidance is available online.

LEGISLATIVE DEVELOPMENTS

Legislation Barring Regulation Of Coal Ash As Hazardous Waste Introduced In Senate: On July 16, 2015, Senators John Hoeven (R-ND) and Joe Manchin (D-WV) introduced legislation (S. 1803) that would ban EPA from regulating coal combustion residues (CCR) as hazardous waste under RCRA. The bill also would grant states a greater role in regulating CCRs. The Senators stated that the legislation will create a "states-first approach" to regulating CCR "that provides both certainty for the safe and efficient recycling of coal ash and an enforceable state permit program for the disposal of coal ash." The legislation is a companion to legislation introduced in the house by Representatives John Shimkus (R-IL) and David McKinley (R-WV). EPA's final CCR rule, announced last December, regulates CCR as a non-hazardous waste. But critics of the regulation argue that it does not provide non-hazardous designation certainty to CCR recyclers or create an effective enforcement mechanism for the disposal of CCR. The bill seeks to address these concerns by providing the certainty sought by CCR recyclers by permanently designating CCR as non-hazardous waste. It also incorporates standards in EPA's CCR rule for disposal in enforceable, mandatory state permit programs. The bill also provides state regulators the same flexibility for implementing the groundwater monitoring and corrective action standards that are currently provided under existing municipal solid waste regulations.

House Passes Coal Ash Bill; White House Threatens Veto: By a vote of 258-166, the House on July 22, 2015, passed legislation that would ban EPA from regulating CCRs as hazardous waste under RCRA. The Improving Coal Combustion Residuals Regulation Act (H.R. 1734), sponsored by Representative David McKinley (R-WV), would also vest states with the authority to tailor their permitting programs for regulating CCR, provided they incorporate minimum federal requirements promulgated by EPA in its 2014 CCR regulation. Stating that the bill "would undermine the protection of public health and the environment," the White House on July 21, 2015, issued a Statement of Administration Policy vowing to veto the legislation. The Obama Administration "strongly opposes" H.R. 1734 because it would "undercut important national protections provided by EPA's 2014 CCR management and disposal rule." The White House stated that the rule articulates clear and consistent national standards to protect public health and the environment, prevent contamination of drinking water, and minimize the risk of catastrophic failure at coal ash surface impoundments. H.R. 1734 would, however, substantially weaken these protections, stated the Administration.

House Committee Holds Hearing On Social Cost Of Carbon: On July 22, 2015, the House Committee on Natural Resources held a hearing on the process and development of the Obama Administration's Social Cost of Carbon (SCC), a controversial statistical model that is being incorporated into environmental reviews subject to approval under the National Environmental Policy Act (NEPA). The hearing was the second in a series of oversight hearings on NEPA and the Obama Administration's "unilateral expansion of regulations across the American economy," according to the Committee's website. Testifying before the Committee were Patrick J Michaels, Ph.D., Director, Center for the Study of Science, The Cato Institute; Kevin Dayaratna, Ph.D., Senior Statistician and Research Programmer, Center for Data Analysis, The Heritage Foundation; Scott H. Segal, Policy Resolution Group; and Dr. Michael K. Dorsey, Interim Director, Energy & Environment Program & Co-Founder (US Climate Plan), Joint Center for Political & Economic Studies & US Climate Plan. Republicans voiced their distaste for the rule. At the hearing, Committee Chair Rob Bishop (R-UT) stated that "[t]he Obama Administration has given itself -- and future administrations -- a mammoth blank check to stop any project based on a radical fantasy. The Social Cost of Carbon is exactly that -- a social restructuring of the way Americans live their lives." He referred to it as "unprecedented authority, disguised as an innocuous guideline for regulatory analysis," adding that it "is a dangerous ideological weapon for the Administration." A webcast of the hearing, witness testimonies, and member statements are available online.

House Passes REINS Act; White House Threatens Veto: The House on July 28, 2015, passed a bill that would subject major rules from EPA and other agencies to Congress for approval before they could take effect. The Regulations from the Executive in Need of Scrutiny (REINS) Act (H.R. 427) would require majority votes in both chambers of Congress to approve agencies' "major" rules. The bill is unlikely to move beyond the House. It faces an uncertain fate in the Senate and the White House on July 27, 2015, issued a Statement of Administration Policy vowing to veto the bill.

Senate EPW Committee Passes Bill Eliminating CWA Permits For Certain Pesticide Uses: The Senate Environment and Public Works (EPW) Committee on August 5, 2015, passed legislation that would eliminate the requirement to obtain a National Pollution Discharge Elimination System (NPDES) permit under the CWA for parties that spray pesticides close to or on rivers and streams. The Committee approved the Sensible Environmental Protection Act of 2015 (S. 1500) by voice vote. No Democrats were in attendance. The bill would amend the CWA requirement for permits for pesticides or the residue of pesticides that get into navigable waters, provided the pesticides are not used in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Senator Mike Crapo (R-ID) sponsored the bill.

Senate Committee Passes Bill Blocking EPA Regulation Of GHGs From Power Plants: The Senate EPW Committee on August 5, 2015, passed a bill that would prohibit EPA from regulating emissions of carbon dioxide and other GHGs from power plants. The Affordable Reliable Electricity Now Act (ARENA, S. 1324) specifically would prohibit EPA from issuing, implementing, or enforcing any final or proposed rule under Section 111 of the CAA that establishes a standard of performance of any GHG from any new, existing, modified, or reconstructed fossil-fuel fired electric generating unit, unless such rule meets specific requirements. One of those conditions is that any such regulation must treat coal-fired and natural gas-fired utilities as separate sources. EPA also cannot establish a standard unless it has been demonstrated at six units for at least a year. EPA also would be required to submit 50 model plans demonstrating how each jurisdiction could meet any future regulatory requirements. Debate on the bill was partisan and heated. The Democratic members of the Committee walked out, leaving the passage of the bill solely to the Republican members. The bill now heads to the Senate floor.

Senate Bill Would Allow States To Restrict Waste Imports: Senator Robert Casey (D-PA) on August 5, 2015, introduced a bill that would allow states to restrict imports of wastes from other states. The bill -- the Trash Reduction and Sensible Handling Act of 2015 (TRASH Act, S. 1953) -- would amend Section 4003 of RCRA and vest states with the authority to limit the wastes imported from other states. Under the bill, states would have the ability to restrict waste imports by requiring that the waste imported from another state be only from states with equivalent or higher standards of waste handling and reduction. States would further be authorized to impose fees on waste imports.

Senate REVIEW Act Would Stay High Impact Rules During Legal Challenges: Senator Dan Coats (R-IN) on August 4, 2015, introduced a bill that would postpone the effective date of any "high-impact rule" pending judicial review. The Require Evaluation before Implementing Executive Wishlists Act of 2015 (REVIEW Act) (S. 1927) would automatically stay EPA and other agencies implementing such "high-impact rules" if legal challenges to the regulations are pending. The legislation is obviously targeted at EPA and its recently issued Clean Power Plan and Waters of the United States rules. The legislation defines a "high-impact rule" as any rule that the White House Office of Information and Regulatory Affairs (OIRA) determines may impose an annual cost on the economy of not less than one billion dollars.

MISCELLANEOUS

GAO Report Notes Gaps In Chemical Security Program: On July 24, 2015, the Government Accountability Office (GAO) issued a report noting the Department of Homeland Security (DHS) needs to verify submitted information to ensure the nation's highest-risk chemical facilities are identified and should develop standardized procedures to address noncompliance with a site's plan to prevent terrorist threats. The report noted DHS' Chemical Facility Anti-Terrorism Standards program has made significant progress in identifying the highest-risk sites nationally and could complete approving all plans to reduce the risks of terrorist attacks within nine to 12 months for the remaining 929 sites awaiting approval. A key issue identified by the report is that DHS reportedly lacks consistent procedures for handling facilities that are not in compliance with portions of their approved site security plans. Problems are now addressed on a "case-by-case basis." Another issue for GAO is that facilities self-report information on the distance from which exposure to a toxic chemical cloud could cause serious injury or fatalities. DHS does not verify the accuracy of that data, however. About 44 percent of the total facilities to complete the initial regulatory screening failed correctly to identify this distance of concern. Approximately 43 percent of those facilities with incorrect estimates underestimated the distance of concern. DHS reported that it is developing a new screening process to eliminate the distance of concern metric, but stated it would verify newly submitted data until that tool has been fully implemented. The report, DHS Action Needed to Verify Some Chemical Facility Information and Manage Compliance Process (GAO-15-614), is available online.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.

 
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