Monthly Update for January 2017
Bergeson & Campbell, P.C. wishes everyone a healthy, safe, and Happy New Year. If you have not already done so, please read our 2017 Forecast Memorandum, available at http://www.lawbc.com/regulatory-developments/entry/predictions-and-outlook-for-u.s.-federal-and-international-chemical-regulat.
Register for our complimentary WEBINAR - Chemical Substance Regulation in Central and South America: A Deeper Dive, Thursday, February 16, 2017, 2:00 p.m. Eastern Standard Time. More information below. Register online.
EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Toxic Substances Control Act (TSCA) Section 8(a) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processors, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale materials not previously reported to EPA, must also report certain information to EPA prior to manufacture or processing. The information to be reported includes, insofar as “known to or reasonably ascertainable” by the person reporting, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a new discrete form of a reportable existing chemical substance on or after the effective date of the rule. These persons are required to report to EPA at least 135 days before manufacture or processing of that discrete form with certain exceptions. The final rule will be effective on May 12, 2017. More information is available in our January 12, 2017, memorandum, “EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.”
EPA Proposes Prohibiting Certain Uses Of TCE For Aerosol Degreasing And Spot Cleaning: On December 16, 2016, EPA proposed to prohibit the manufacture, processing, and distribution in commerce of trichloroethylene (TCE) for certain uses under Section 6 of TSCA based on EPA’s determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities. 81 Fed. Reg. 91592. The proposed action is significant for several reasons, including that it represents the first use in a very long time of TSCA Section 6 and the first Section 6 control action taken under new TSCA. EPA specifically is proposing to prohibit the use of TCE in “aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.” EPA states that its 2014 risk assessment found TCE to be “carcinogenic to people through all routes of exposure, which include inhalation, dermal (skin), and ingestion.” Comments are due by February 14, 2017.
EPA Proposes Ban Of TCE For Use In Vapor Degreasing: On January 11, 2017, EPA announced it would be issuing a rule proposing to prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing; to prohibit commercial use of TCE in vapor degreasing; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping. EPA is proposing under Section 6 of TSCA to prohibit these uses due to its determination that there are “significant health risks associated with TCE use in vapor degreasing,” and they present “an unreasonable risk to human health.” The pre-publication of the proposed rule is available on EPA’s website. Once it has been published in the Federal Register, comments must be submitted within 60 days of publication.
EPA Publishes Initial List Of TSCA Section 6 Chemicals For Risk Evaluation: On December 19, 2016, EPA published the initial ten chemical substances on which risk evaluations will be conducted under TSCA Section 6(b)(2)(A). 81 Fed. Reg. 91927. The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments are: 1,4-dioxane, 1-bromopropane, TCE, carbon tetrachloride, hexabromocyclododecane (HBCD), methylene chloride, pigment violet 29, perchloroethylene (PERC), N-methyl-2-pyrrolidone (NMP), and asbestos. EPA is required under TSCA Section 6(b)(2)(A) to announce the chemicals within 180 days of enactment, or by December 19, 2016. Interestingly, several of the chemicals are the subject of Section 6 rules that are currently undergoing review by the Office of Management and Budget (OMB). These include TCE, methylene chloride, and NMP. Assuming that EPA continues with these rules (relying on the savings provision at TSCA Section 26(p)(3) to use the completed risk evaluations on these chemicals in taking the Section 6 actions), the inclusion of the chemicals on the list may suggest that EPA will broaden the risk evaluations to include other conditions of use beyond those in the completed risk assessments. For more on the chemicals listed and additional information, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/evaluating-risk-existing-chemicals-under-tsca.
EPA Amends Procedures For TSCA Section 6 Rulemaking: On December 21, 2016, EPA published a final rule amending procedures for rulemaking under TSCA Section 6. 81 Fed. Reg. 93633. Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow. As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates certain procedural requirements, and this rulemaking removes the regulations specifying those procedures. The final rule was immediately effective.
EPA Announces Pilot To Evaluate Alternative Animal Testing Tool: On December 20, 2016, EPA announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.” For this pilot program, EPA is requesting submission of acute oral and acute inhalation toxicity study data paired with mathematical calculations (GHS Mixtures Equation data) to support the evaluation of pesticide product formulations; instructions for doing so are available on the GHS Equation Pilot Program webpage, and Guidance on the GHS Mixtures Equation is available in the Guidance on the Application of the CLP (Classification, Labeling and Packaging) Criteria. The program is an interesting approach considering the conceptual differences of risk assessment and hazard determination that exist at the core of EPA risk approaches and GHS fundamentals. Also, the definition of the EPA Categories compared to GHS has been problematic for hazard communication applications. Mixture calculation tools rely on the availability of data for all components and would only be applicable if the data for each were generated using the same species under similar exposure conditions. This pilot program is being developed under EPA’s initiative to develop non-animal alternatives for acute toxicity testing, as well as EPA’s Office of Pesticide Programs’ (OPP) Strategic Vision for Adopting 21st Century Science Methodologies. More information on these initiatives can be found on our Pesticide Law and Policy Blog® under key phrase “toxicity testing.”
EPA Issues Changes To OCSPP Final Test Guidelines For Series 850 Group A -- Ecological Effects: On December 29, 2016, EPA issued a Federal Register notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and TSCA. 81 Fed. Reg. 95989. The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.” The changes to the test guidelines are varied. Some of the changes include: simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements; housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet; the addition of a limit test option to several acute invertebrate toxicity tests; changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.
The final test guidelines may be of unique interest to TSCA stakeholders. The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing. This change facilitates test plan design, including tiered approaches for initial testing for premanufacture notices (PMN). EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines. In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.
NAS Releases Report On New Strategies To Predict Chemical Hazards: On January 5, 2017, the National Academies of Sciences (NAS), Engineering, and Medicine issued a new report providing recommendations on integrating new scientific approaches into evaluating public health and environmental risks. The report, Using 21st Century Science to Improve Risk-Related Evaluations, onsiders the scientific advances that have occurred following the publication of the Academies’ reports Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy, and proposes best ways to integrate and use the emerging results in evaluating chemical risk and identify how traditional human-health risk assessment can incorporate the new science.
Final EPA Rule Requires Stronger Standards For Applying Riskiest Pesticides: On January 4, 2017, EPA published its final rule revising its regulation concerning the certification of applicators of restricted use pesticides (RUP). 82 Fed. Reg. 952. The final rule is intended to ensure federal certification program standards adequately protect applicators, the public, and the environment from risks associated with the use of RUPs. According to EPA, the final rule will improve the competency of certified applicators of RUPs, increase protection for noncertified applicators using RUPs under the direct supervision of a certified applicator through enhanced pesticide safety training and standards for supervision of noncertified applicators, and establish a minimum age requirement for certified and noncertified applicators using RUPs under the direct supervision of a certified applicator. EPA states that in recognition of its commitment to work more closely with tribal governments to strengthen environmental protection in Indian country, the final rule will provide more practical options for establishing certification programs in Indian country. For a detailed summary of the final rule, see our memorandum. The final rule will be effective on March 6, 2017. EPA has posted several supplemental materials on its pesticide worker safety website, including a fact sheet, comparison tables of the final rule’s revisions to the existing rule, and questions and answers concerning the final rule.
White House Announces Release Of Final Updated Coordinated Framework For The Regulation Of Biotechnology: On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update). The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:
- Graphics that illustrate agency-specific overviews of regulatory roles;
- Case studies that demonstrate how a product developer might navigate the regulatory framework; and
- A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.
In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.” EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities. In addition, the agencies commissioned an independent study by the NAS on future biotechnology products. When completed, the agencies will consider the study’s findings, as well as the comments. More information on the Update to the Coordinated Framework is available in our memorandum.
EPA Proposes Requirements For TSCA Inventory Notification (Active-Inactive): EPA published a proposed rule on January 13, 2017, that would require a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. 82 Fed. Reg. 4255. EPA would also accept such notices for chemical substances that were processed. The recent TSCA amendments require EPA to designate chemical substances on the TSCA Inventory as either “active” or “inactive” in U.S. commerce. EPA states that it would use these notifications to distinguish active substances from inactive substances. EPA would include the active and inactive designations on the TSCA Inventory and as part of its regular publications of the Inventory. EPA also proposes to establish procedures for forward-looking electronic notification of chemical substances on the TSCA Inventory that are designated as inactive, if and when the manufacturing or processing of such chemical substances for non-exempt commercial purposes is expected to resume. According to the proposed rule, upon receipt of a valid notice, EPA would change the designation of the pertinent chemical substance on the TSCA Inventory from inactive to active. The proposed rule includes the procedures to submit retrospective and forward-looking activity notifications, the details of the notification requirements, exemptions from such requirements, and procedures for handling claims of confidentiality. Comments are due March 14, 2017. More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.
EPA Proposes Procedures To Prioritize Chemicals For Risk Evaluation Under TSCA: EPA is scheduled to publish a proposed rule in the January 17, 2017, Federal Register that would establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The pre-publication version of the proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final designations of priority. EPA notes that prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to TSCA. Publication of the notice will begin a 60-day comment period. More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.
EPA Releases Final Policy To Address Acute Risks To Bees From Pesticides And Three Pollinator-Only Risk Assessments For Neonicotinoid Insecticides: On January 12, 2017, EPA released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) that describes methods for addressing acute risks to bees from pesticides. EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an acute risk, and with the goal of reducing potential impact of this effort on growers.” EPA states that it will use its Tier 1 acute risk assessment to, in part, determine the products that trigger concerns about pollinator risk that the label restrictions are intended to address. EPA will begin implementing this Policy in 2017 by sending letters to registrants describing steps that must be taken to incorporate the new labeling. More information on the Mitigation Policy, including its supporting documents, and EPA’s response to comments submitted on the proposed policy, is available on www.regulations.gov under Docket ID EPA-HQ-OPP-2014-0818.
Also on January 12, 2017, EPA published preliminary pollinator-only risk assessments for the neonicotinoid insecticides clothianidin, thiamethoxam, and dinotefuran, and an update to its preliminary risk assessment for imidacloprid, published in January 2016. EPA states that the preliminary assessments for clothianidin, thiamethoxam, and dinotefuran are similar to the preliminary pollinator assessment for imidacloprid, in that they showed that “most approved uses do not pose significant risks to bee colonies,” but “spray applications to a few crops, such as cucumbers, berries, and cotton, may pose risks to bees that come in direct contact with residue.” As for the updated imidacloprid assessment, EPA states that it looked at potential risks to aquatic species, and identified some risks for aquatic insects. Interested parties will have 60 days to comment on the preliminary risk assessments after notice is published in the Federal Register. In terms of comments, EPA states that it is especially interested in getting input from stakeholders “on the new method for assessing potential exposure and risk through pollen and nectar.” Links to risk assessment dockets for each individual insecticide are available on EPA’s website under Schedule for Review of Neonicotinoid Pesticides. EPA states it hopes to release the final neonicotinoid risk assessments by mid-2018. For more information, please see our blog at http://pesticideblog.lawbc.com/entry/epa-releases-final-policy-to-address-acute-risks-to-bees-from-pesticides-an.
EPA Issues Final RMP Rule: On January 13, 2017, EPA published in the Federal Register its final rule amending the Accidental Release Prevention Requirements for Risk Management Programs (RMP) under Clean Air Act (CAA) Section 112(r)(7). 82 Fed. Reg. 4594. The amendments are intended to modernize EPA’s RMP regulations as required under Executive Order (EO) 13650, which directs the federal government to carry out certain tasks intended to prevent chemical incidents, such as the explosion in West, Texas, on April 17, 2013. Specifically, the amendments are intended to address and improve accident prevention program elements; enhance the emergency preparedness requirements; and ensure Local Emergency Planning Committees, local emergency response officials, and the public can access information in a user-friendly format to help them understand the risks at RMP facilities and better prepare for emergencies. The rule is effective March 14, 2017.
EPA Proposes To Regulate N-Propyl Bromide As A Hazardous Air Pollutant Under The CAA: EPA on January 9, 2017, issued a proposed rule to add n-propyl bromide (nPB), also known as 1-bromopropane (1-BP) (Chemical Abstract Service No. 106-94-5), to the list of hazardous air pollutants (HAP) regulated under the CAA. 82 Fed. Reg. 2354. The Halogenated Solvents Industry Alliance (HSIA) and New York State Department of Environmental Conservation (NYSDEC) submitted petitions requesting that EPA add nPB to the list of HAPs. Based on EPA’s evaluation of HSIA’s and NYSDEC’s data and information concerning potential hazards, emissions, and atmospheric dispersion modeling that provided estimates of ambient concentrations of nPB, EPA has determined adequate evidence exists supporting a determination that emissions and ambient concentrations of nPB may reasonably be anticipated to cause adverse health effects. The comment period on the proposed addition of nPB to the HAPs list closes on March 10, 2017.
EPA Denies Petition To Reconsider Endangerment Finding For Aircraft Emissions: EPA on December 30, 2016, denied a petition to reconsider its finding that greenhouse gas (GHG) emissions from certain aircraft engines endanger public health and welfare. 81 Fed. Reg. 96413. EPA on July 25, 2016, issued its “Finding that Greenhouse Gas Emissions from Aircraft Cause or Contribute to Air Pollution that May Reasonably Be Anticipated to Endanger Public Health and Welfare.” That action included two findings under CAA Section 231(a)(2)(A): (1) concentrations of six well-mixed GHGs in the atmosphere endanger the public health and welfare of current and future generations (the endangerment finding); and (2) GHGs emitted from certain classes of engines used in certain aircraft are contributing to the air pollution that endangers public health and welfare (the cause or contribute finding, or contribution finding). The Biogenic CO2 Coalition submitted a petition on October 14, 2016, asking EPA to reconsider the finding with respect to EPA’s treatment of biogenic carbon dioxide emissions from short-cycle annual herbaceous crops. EPA states that it “carefully reviewed the petition for reconsideration and evaluated all the information presented on the issues raised, along with information contained in the docket for the 2016 Findings, in reaching a decision on the petition.” EPA concluded, however, that the petition does not meet the criteria for reconsideration in CAA Section 307(d)(7)(B). EPA consequently denied the petition for reconsideration.
EPA Issues Long Awaited Guidance On Post-Closure Care For RCRA Hazardous Waste TSDFs: EPA on January 4, 2017, issued long-awaited guidance to help state and federal regulators determine whether to lengthen or shorten the 30-year closure period for hazardous waste treatment, storage and disposal facilities (TSDF) under the Resource Conservation and Recovery Act (RCRA). The purpose of the guidance is to assist regulators in determining whether 30-year closure period for those TSDFs coming to the end of the period should be ended or extended. RCRA regulations establish a post-closure care period for specific TSDFs that leave hazardous wastes in place after closure. Typically, post-closure care extends for 30 years after a TSDF completes closure. To determine whether states or EPA regions should extend the post-closure care period, the guidance states that the “overarching consideration . . . is the inherent uncertainty associated with the long-term presence of hazardous waste in the unit.” EPA cites a number of factors that may warrant the extension of post-closure care periods, including whether engineering controls will continue to function as planned, changes in groundwater flow, degradations in landfill caps and lines, and other factors. The guidance thus states that “continued monitoring and maintenance activities may be appropriate unless or until it can be demonstrated that site-specific conditions adequately minimize the risk that contaminants will migrate from the unit . . . or that, in the event the engineering controls fail, a release would not pose an unacceptable risk to human health and the environment.”
EPA Agrees To Revisit RCRA Subtitle D Oil And Gas Waste Provisions: In a consent decree filed with the U.S. District Court for the D.C. Circuit on December 28, 2016, EPA agreed to make a determination as to whether the regulation of oil and gas wastes warrants revision under RCRA. In the consent decree between EPA and the Environmental Integrity Project, EPA agreed to make a determination by March 15, 2019, to either amend the Subtitle D regulations pertaining to oil and gas wastes or to issue a determination that a revision is unnecessary. If EPA determines that revision of the regulations is required, the decree mandates that EPA promulgate a final rule amending the Subtitle D standards by July 15, 2021.
EPA Proposes Federal Plan For Emissions From Incineration Units: EPA on January 11, 2017, issued a rule proposing the federal plan for existing commercial and industrial incineration (CISWI) units. 82 Fed. Reg. 3554. The proposed rule implements the emission guidelines (EG) that EPA promulgated on February 7, 2013 (and revised on June 23, 2016). The plan is effective in states that do not have an approved state plan implementing the EG in place by the effective date of this federal plan. The proposed federal plan requires owners or operators of CISWI units in states without approved state plans to come into compliance by February 7, 2018. If a CISWI unit does not achieve final compliance by February 7, 2018, the proposed federal plan requires the CISWI unit to shut down by February 7, 2018, complete the retrofit while not operating, and be in compliance upon restarting. The comment period on the proposed rule closes on February 27, 2017.
EPA Proposes CERCLA Financial Assurance Requirements For Hardrock Mining: EPA on January 11, 2017, proposed requirements under Section 108(b) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) for demonstrating financial responsibility within the hardrock mining industry. 82 Fed. Reg. 3388. The proposed rule could be costly: EPA estimates the costs imposed by the rule to the hardrock mining industry will exceed $7 billion. The proposed rule would require financial responsibility under CERCLA Section 108(b), define requirements for demonstration of financial responsibility, define requirements for maintenance of financial responsibility instruments, and establish criteria for owners and operators to be released from financial responsibility requirements. EPA also proposes specific financial responsibility requirements applicable to certain classes of mines and associated mineral processing facilities within the hardrock mining industry. The proposed rule would require owners and operators subject to demonstrate and maintain financial responsibility consistent with the degree and duration of risk associated with the treatment, production, transportation, storage and disposal of hazardous substances at their facilities. EPA proposes that current owners and operators of facilities be required to demonstrate financial responsibility to cover the three types of costs associated with releases and potential releases of hazardous substances from their facilities: response costs, health assessment costs, and natural resource damages. These are the same types of costs that CERCLA makes specified parties, including current owners or operators, liable for under CERCLA Section 107. By requiring current owners or operators of facilities that manage hazardous substances to set aside funds for cleanup (or otherwise demonstrate their ability to pay for it), EPA believes the rule would increase the likelihood that owners or operators subject to the rule will be able to pay the costs associated with releases or potential releases of hazardous substances from their facilities for which they are responsible, in the event a CERCLA cleanup becomes necessary. The proposal would establish a process for owners and operators subject to the proposed rule to identify a financial responsibility amount for their sites, to demonstrate evidence of financial responsibility, and to maintain the required amount of financial responsibility until the requirement for financial responsibility for the site is released by EPA. The proposal includes a formula by which EPA expects facilities to calculate an amount of financial responsibility. The formula is also structured to allow facilities, upon certain showings, to reduce that calculated amount to account for the current conditions of their sites. EPA expects that many, if not most, facilities will be able to adjust the amount required based on the calculation. The proposal also includes a provision that would release an owner and operator from financial responsibility requirements when EPA makes a determination that the risks from the facility are minimal. The comment period on the rule closes on March 13, 2017.
EPA Intends To Establish CERCLA Financial Assurance Rule For Three Additional Industrial Sectors: Fresh on the heels of its CERCLA rule proposing financial assurance requirements for the hardrock mining industry, EPA on January 11, 2017, published its intent to promulgate similar regulations for three additional industry sectors. 82 Fed. Reg. 3512. The additional sectors identified by EPA are chemical manufacturing; petroleum and coal products manufacturing; and the electric power, distribution, and transmission industries.
EPA Proposes To Require EPCRA Section 313 Reporting From Natural Gas Processing Facilities: EPA on January 6, 2017, proposed to add natural gas processing (NGP) facilities to the scope of the industrial sectors covered by the reporting requirements of Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), commonly known as the Toxics Release Inventory (TRI), and Section 6607 of the Pollution Prevention Act (PPA). 82 Fed. Reg. 1651. EPA states that adding these facilities “would meaningfully increase the information available to the public on releases and other waste management of listed chemicals from the natural gas processing sector and further the purposes of EPCRA section 313.” EPA estimates that at least 282 NGP facilities would be subject to the new TRI reporting obligations. The proposed rule states that NGP facilities manufacture, process, or otherwise use more than 20 TRI-listed chemicals, including n-hexane, hydrogen sulfide, toluene, benzene, xylene, and methanol. The comment period on the proposed rule closes on March 7, 2017.
Emissions Of TRI Chemicals Slashed By Half In Ten Years, EPA Annual TRI Report Shows: EPA on January 12, 2017, released its annual TRI National Analysis under EPCRA. The report states that air emissions of TRI chemicals fell 56 percent from 2005-2015 at TRI- regulated facilities. The report also includes a section highlighting the new Frank R. Lautenberg Chemical Safety for the 21st Century Act. This section focuses on the overlap between TRI chemicals and chemicals designated as Work Plan chemicals by EPA’s OCSPP under TSCA. The report is available online.
FDA Releases Revised Guidance On Food Facility Registration: On December 27, 2016, FDA announced the availability of a revised draft guidance for industry entitled Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry, which contains 17 sections of a multi-section guidance intended to provide updated information and answer frequently asked questions regarding FDA registration requirements. 81 Fed. Reg. 95068. The notice states that this revised draft guidance supersedes the version of the food facility registration draft guidance announced on November 8, 2016, and that, when finalized, this guidance is intended to provide updated information relating to the food facility registration requirements in the FFDCA. FDA is requesting comments to be submitted by March 27, 2017.
FDA Announces Updated Training Strategy For FSMA Food Industry Training: On December 21, 2016, FDA published an updated training strategy for food industry training for implementation of the Food Safety Modernization Act (FSMA), to reflect the progress that has been made in the past year. FDA states that “the most important goal … of any training program is the outcome -- that it advances knowledge among the food industry to meet FSMA requirements.” To that end, FDA lists a variety of training options and delivery formats, including:
- Training through public-private alliances funded primarily by FDA as a resource for industry and to facilitate widespread understanding of the new standards to support compliance is now available;
- FDA is funding cooperative agreements that will develop training options for local food production systems and tribal operations; and
- FDA has partnered with USDA’s National Institute of Food and Agriculture (NIFA) to provide grants to fund a National Coordination Center (NCC) and four Regional Centers (RC) to provide training opportunities for owners and operators of farms, small food processors, and small fruit and vegetable merchant wholesalers.
FDA Issues Draft Guidance On Recommended Maximum Levels Of Lead: On December 22, 2016, FDA announced the availability of a draft guidance for industry entitled Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level. 81 Fed. Reg. 93940. FDA states that this draft guidance provides “a recommended maximum level of 10 parts per million (ppm) for lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United States.” FDA considers the recommended maximum lead level to be achievable with the use of good manufacturing practices and consistent with the 10 ppm maximum lead level for similar products recommended by other countries, and has concluded that the recommended maximum lead level would not pose a health risk. FDA is requesting comments to be submitted by February 21, 2017.
FDA Bans Powdered Gloves Due To Risk Of Illness Or Injury: On December 19, 2016, FDA issued a final rule banning Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove, stating that these devices present an unreasonable and substantial risk of illness or injury to health care providers, patients, and other individuals, and that the risk cannot be corrected or eliminated by labeling or a change in labeling. 81 Fed. Reg. 91722. FDA states that these devices are associated with an extensive list of potentially serious adverse events, including “severe airway inflammation, hypersensitivity reactions, allergic reactions (including asthma), lung inflammation and damage or post-surgical bands of fibrous scar tissue that form between internal organs and tissues (adhesions),” and that “these adverse events have been attributed to the use of glove powder with all types of gloves.” This rule becomes effective on January 18, 2017.
Presentations Available From 2016 Nanosafe Conference: The fifth Nanosafe conference was held November 7-10, 2016, in Grenoble, France. The conference included panel discussions on responsible development with non-governmental organizations; urban particles mitigation: what is reasonably possible; and nanomedicine: benefit-risk. Topics addressed during the conference included:
- Measurement and characterization of nano objects;
- Manufactured nano objects;
- Urban particles;
- Nano objects and health; and
Presentations from the conference are now available.
France Releases 2016 Report On Nanomaterial Reporting Scheme: In November 2016, the Ministry of the Environment, Energy, and the Sea released its 2016 report, in French, Éléments issus des déclarations des substances à l'état nanoparticulaire. The report analyzes nanomaterial declarations received in 2016 for reporting year 2015. Under Decree No. 2012-232, companies that manufacture, import, and/or distribute a “substance with nanoparticle status” in an amount of at least 100 grams per year must submit an annual report with substance identity, quantity, and use information. According to the report, while the number of declarations received in 2016 decreased from 2015, the quantity of materials produced increased (350,487 tonnes vs. 300,822 tonnes in 2015), as well as the quantity imported (125,279 tonnes vs. 114,951 tonnes in 2015).
OSHA Sustainability Paper Notes Opportunity To Integrate Sustainability And Nanotechnology Research: The Occupational Safety and Health Administration (OSHA) released on December 20, 2016, a white paper entitled Sustainability in the Workplace: A New Approach for Advancing Worker Safety and Health. The paper highlights the importance of including worker safety and health in the growing movement toward sustainability and corporate responsibility. According to the paper, research on sustainability does not include occupational safety and health. The paper notes that sustainability research opportunities include nanotechnology:
Horizon Scanning: Emerging issues impacting workers (e.g., aging workforce, worker well-being, nanotechnology, green chemistry) are a potential path for integrated sustainability research. For example, climate change is one of the most talked about areas of sustainability and workers have been and will continue to be disproportionately impacted. It will be critical to recognize exposures, anticipate hazards and responses, and possible adaptation mechanisms for these responses (chemicals, pathogens, conflict, heat, etc.).
President Obama Signs Bill Lengthening Time Between NNI Strategic Plans, Reviews, And Evaluations: On January 6, 2017, President Obama signed the American Innovation and Competitiveness Act (Pub. L. No. 114-329), amending the 21st Century Nanotechnology Research and Development Act (15 U.S.C. § 7501 et seq.) to change the frequency of National Nanotechnology Initiative (NNI) reports. The strategic plan will be released every five instead of every three years, and the triennial review will be renamed the quadrennial review and be prepared every four years instead of every three. The evaluation of the NNI, which is submitted to Congress, will be due every four instead of every three years. Under the amendments, the strategic plan will address how the NNI will “move results out of the laboratory and into application for the benefit of society”; its support for long-term funding for interdisciplinary research and development in nanotechnology; and the allocation of funding for interagency nanotechnology projects. The Senate passed the bill on December 10, 2016, and the House passed it on December 16, 2016.
Germany Begins Consultation On Announcement Concerning Manufactured Nanomaterials: The Committee on Hazardous Substances (AGS) of the Federal Institute for Occupational Safety and Health (BAuA) began a public consultation on its update to several technical rules. AGS seeks comment on Bekanntmachung zu Gefahrstoffen (BekGS) 527, “Hergestellte Nanomaterialien.” Although BAuA has published an English translation of Announcement 527, “Manufactured Nanomaterials,” BAuA notes that it is not up-to-date and is unofficial. The German documents are more recent and include a chart listing edits to the 2015 version. Comments are due March 31, 2017.
NNCO Announces Upcoming Webinars: The National Nanotechnology Coordination Office (NNCO) periodically holds webinars to share information with the general public and the nanotechnology research and development community. Upcoming webinars include the following:
- On January 18, 2017, NNI will hold a webinar on “Water Sustainability through Nanotechnology: Enabling Next-Generation Water Monitoring Systems.” In this webinar, panelists will discuss the current state of and future opportunities related to water monitoring. Justin Mattingly, Water Environment & Reuse Foundation, will describe water monitoring needs related to reuse, and this broad overview will be followed by two specific use cases: Nick Dokoozlian, E&J Gallo Winery, will describe his work with distributed sensors for improved grape yield and water use efficiency, and Daniel Barta, National Aeronautics and Space Administration, will speak in technical detail about the water monitoring needs aboard spacecraft. Webinar viewers will be able to submit questions for the panelists to answer during the question and answer period. Submitted questions will be considered in the order received and may be posted on the NNI website;
- On January 25, 2017, NNCO will hold a webinar on “The Utility of Alternative Testing Strategies in Nanotechnology Health and Safety Evaluations.” Dr. Andre Nel, Distinguished Professor of Medicine and Director of the National Science Foundation- and EPA-funded Center for Environmental Implications of Nanotechnology, will review recent scientific advancements in developing alternative testing strategies. Dr. Nel’s presentation will describe how the connection between a molecular initiating event, tied to engineered nanomaterials’ physicochemical properties, and key intermediary responses can be linked to apical health outcomes. Dr. Nel will also address how data can be used for dose- and exposure-relevant tiered risk assessment, as well as data acquisition and submission for regulatory consideration; and
- On a date to be announced, NNCO will hold a webinar on “Water Sustainability through Nanotechnology: Improving the Efficiency of Water Delivery and Use.”
2017 Conference Will Focus On New Tools And Approaches For Nanomaterial Safety Assessment: On February 7-9, 2017, a conference focused on new tools and approaches for nanomaterial safety assessment will be held in Malaga, Spain. The conference is jointly organized by five major Seventh Research Framework Program (FP7) projects: NANOSOLUTIONS, GUIDEnano, Sustainable Nanotechnologies (SUN), NanoMILE, and eNanoMapper. It will present the main results achieved in the course of the projects, fostering a discussion about their impact in the nanosafety field and possibilities for future research programs. The conference will conclude with a stakeholder workshop that will provide a platform for an open discussion with interested stakeholders that could guide the research needs addressed in future projects. The conference welcomes consortium partners from the organizing projects, as well as representatives from other European Union projects, industry and government, civil society, and media.
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 http://www.braginfo.org.
House Passes Midnight Rules Relief Act: House Republicans wasted little time in trying to undo much of President Obama’s regulatory agenda in the waning days of Mr. Obama’s Administration. Only two days into the 115th Congress, on January 4, 2017, the House passed the Midnight Rules Relief Act (H.R. 21), by a 238-184 vote that largely fell along party lines. Introduced on January 3, 2017, by Representative Darrell Issa (R-CA), the bill would vest Congress with the ability to block regulations promulgated by an outgoing President, so called “midnight rules.” The bill offers a simple remedy: it would allow Congress to disapprove of any and all “midnight regulations” in one fell swoop by one en bloc disapproval resolution under the Congressional Review Act (CRA). Under the bill, no set number of regulations would have to be covered by a resolution. Nor would any category of regulation have to be included in or excluded from a resolution. The bill would allow any midnight rule disapproval resolution to be sweeping or narrow, depending on how many rules merited inclusion. On January 5, 2017, Senator Ron Johnson (R-WI) introduced a companion bill in the Senate.
House Passes Controversial REINS Act: Continuing its assault on the federal regulatory program, the Republican majority in the House on January 5, 2017, passed the controversial Regulations From the Executive in Need of Scrutiny Act (REINS Act). Passed by a largely party line vote of 237-187, the bill (H.R. 26) would require an up or down vote by Congress on federal regulations that impose an estimated annual economic impact of $100 million or more, so-called “major rules.” Congress would be authorized under the bill to approve or disapprove of major rules through joint resolutions. The bill does not stop there, however. It also would vest Congress with the authority to disapprove of non-major rules through joint resolutions.
House Passes Regulatory Reform Bill That Would Repeal Chevron Doctrine: By a vote of 238-183, the House on January 11, 2017, passed a bill that would overturn the so-called Chevron doctrine. Representative Rob Goodlatte (R-VA) introduced the bill on January 3, 2017. It is a regulatory reform package that would, among other things, overturn the U.S. Supreme Court’s longstanding Chevron Doctrine. The Supreme Court in 1984 established the Chevron Doctrine in its decision in Chevron U.S.A. Inc. v. Natural Resources Defense Council Inc. The doctrine requires courts to give deference to a federal agency’s reasonable interpretations of statutes it administers if the law is ambiguous or silent. Representative Goodlatte’s bill, the Regulatory Accountability Act of 2017 (H.R. 5), is a combination of regulatory reform initiatives reported out of the House Judiciary Committee and passed by the House of Representatives during the 114th Congress. The bill would require agencies to choose the lowest-cost rulemaking alternative that meets statutory objectives and require greater opportunity for public input and vetting of critical information -- especially for major and billion-dollar rules. It also would repeal the Cheveron and Auer doctrines to end judicial deference to agencies’ statutory and regulatory interpretations. The bill also would require agencies to account for the direct, indirect, and cumulative impacts of new regulations on small businesses and find flexible ways to reduce them. The legislation also would prohibit new “billion-dollar rules” from taking effect until courts can resolve timely-filed litigation challenging their promulgation. In addition, it would require agencies to publish online, timely information about regulations in development and their expected nature, costs, and timing.
Lawmaker Introduces Duo Of Regulatory Reform Measures: Representative John Ratcliffe (R-TX) on January 5, 2017, introduced two bills intended to reform the federal regulatory process. The Separation of Powers Restoration Act of 2017 (H.R. 76) would seek to negate the Chevron doctrine. The bill would modify the scope of judicial review of federal agency actions. It would authorize courts reviewing agency actions to decide de novo (without giving deference to the agency’s interpretation) all relevant questions of law, including the interpretation of: (1) constitutional and statutory provisions, and (2) rules made by agencies. The All Economic Regulations are Transparent Act of 2017 (ALERT Act) (H.R. 75) requires each federal agency to submit a monthly report to the OMB Office of Information and Regulatory Affairs (OIRA) for each rule an agency expects to promulgate during the following year. The reports must include: (1) a summary of the rule; (2) the objectives of and legal basis for the rule; (3) the stage of the rulemaking as of the date of submission; and (4) whether the rule is subject to periodic review as a rule with a significant economic impact. Each agency must submit a monthly report for any rule expected to be issued in final during the following year. The reports must include an approximate schedule for completing the rule and an estimate of its cost and economic effects. OIRA must make such monthly reports publicly available on the Internet. The bill would also require that OIRA publish, no later than October 1 of each year, in the Federal Register: (1) information that OIRA receives from each agency under this bill; (2) the number of rules and a list of each such rule that was proposed by each agency and each rule that was issued in final by each agency; (3) the number of agency actions that repealed a rule, reduced the scope or cost of a rule, or accelerated the expiration date of a rule; (4) the total cost of all rules proposed or final; and (5) the number of rules for which an estimate of the cost of the rule was not available. OIRA must make publicly available on the Internet, not later than October 1 of each year: (1) the analysis of the costs or benefits of each proposed or final rule issued by an agency for the preceding year; (2) the docket number for each rule; (3) the number of rules reviewed by OMB for the preceding year;(4) the number of rules for which a review by the head of an agency was completed; (5) the number of rules submitted to the Government Accountability Office; and (6) the number of rules for which a resolution of disapproval was introduced in Congress. The bill prohibits a rule from taking effect until this information is posted on the Internet for not less than six months.
House Resolution Would Disapprove EPA Rule On Methane Emissions: Invoking the CRA, Representative Scott Perry (R-PA) on January 6, 2017, introduced a joint resolution of disapproval on EPA’s June 3, 2016, final CAA rule establishing methane emission limits from the oil and natural gas industry. 81 Fed. Reg. 35824. If passed by Congress and signed by the President, the EPA rule would be removed from the books and EPA would be prohibited from issuing a similar rule at a future date.
Bill Would Devolve NEPA Responsibilities To States: Representative Ken Calvert (R-CA) on January 12, 2017, introduced the Reducing Environmental Barriers to Unified Infrastructure and Land Development (REBUILD) Act (H.R. 481). The legislation would amend the National Environmental Policy Act (NEPA) to authorize assignment to states of certain federal agency environmental review responsibilities. The bill is intended to cut red tape and reduce costs for infrastructure projects. The REBUILD Act allows any state to enter into a Memorandum of Understanding with a designated federal agency that has environmental review responsibilities under NEPA and assume the review responsibilities of that agency. Under the bill, states would still be required to uphold the same NEPA standards or greater. The streamlined process is modeled after a pilot program that allowed states to take on the task of ensuring NEPA compliance for highway projects under the Federal Highway Administration (FHWA). In those states that chose to assume this responsibility, the length of time to complete a project review was reduced by an average of 17 months while also ensuring the goals of the NEPA process were not compromised.
We are pleased to offer our clients, associated businesses, and corporate product stewards and regulatory personnel a follow-up to our November 2016 webinar “Current Opportunities and Challenges with Chemical Substance Regulation in Mexico and Central and South America.” This second webinar, “Chemical Substance Regulation in Central and South America: A Deeper Dive,” will examine the chemical substance regulations of several additional countries in the region, whose regulatory environments are generally not well-known or understood. Exploring the requirements of Chile, Colombia, Costa Rica, Ecuador, Honduras, Uruguay, and Venezuela, the webinar will present a comprehensive overview of the key requirements firms should be aware of when manufacturing or importing chemical substances. Among the topics will be the status of GHS implementation, the development of chemical substance inventories, product stewardship efforts, key worker and workplace safety regulations, and related issues such as pesticide, packaging, and food contact legislation.
The 1-hour webinar will conclude with a discussion of key emerging issues in the region for both 2017 and beyond. The webinar, moderated by Lynn L. Bergeson, President, The Acta Group (Acta®), and presented by Michael S. Wenk, M.S., Senior Regulatory Consultant with Acta, will consist of 45 minutes of presentation with a 15-minute question and answer period at the end.
EPA Announces 2016 Annual Environmental Enforcement Results: EPA on December 19, 2016, released its Fiscal Year (FY) 2016 enforcement and compliance results. EPA states that it continues to make progress on its six National Enforcement Initiatives: Reducing Air Pollution from the Largest Sources; Cutting Hazardous Air Pollutants; Ensuring Energy Extraction Activities Comply with Environmental Laws; Reducing Pollution from Mineral Processing Operations; Keeping Raw Sewage and Contaminated Stormwater out of the Nation’s Waters; and Preventing Animal Waste from Contaminating Surface and Ground Water. In FY 2016 EPA enforcement actions secured $13.7 billion in investments by companies for projects to control pollution. EPA also secured enforceable commitments that ensure the proper treatment, storage and disposal of an estimated 62 billion pounds of hazardous waste, the majority coming through a settlement with Mosaic Fertilizer for their eight facilities across Florida and Louisiana. EPA’s enforcement results are highlighted by a series of high-impact cases. Two recent landmark settlements -- one with BP and one with Volkswagen -- “are among the most comprehensive and impactful environmental cases in U.S. history,” EPA states. On April 4, 2016, the court entered an agreement with BP for a $20.8 billion settlement to resolve Clean Water Act violations stemming from the Deepwater Horizon blowout and resulting oil spill, with more than $20 billion going to restore impacted communities and the environment. In a case that was lodged in FY 2015 but not entered by the court until October 25, 2016, Volkswagen agreed to spend up to $14.7 billion on projects to reduce air pollution, remedy environmental damage, and buy back 2.0 liter diesel vehicles to settle allegations of using illegal software to cheat emissions tests and deceive customers. EPA’s FY 2016 enforcement actions also secured:
- More than $1 billion in commitments from responsible parties to clean up Superfund sites, and return $55 million to the Superfund trust;
- $6 billion in combined federal administrative, civil judicial penalties, and criminal fines;
- $31.6 million for supplemental environmental projects (SEP);
- Commitments from companies to reduce, treat, or eliminate releases of pollution by an estimated 324 million pounds per year;
- Clean up of an estimated 174 million cubic yards of contaminated water or aquifers and 17 million cubic yards of contaminated soil; and
- $207 million in criminal fines and restitution, and a combined 93 years of incarceration for criminal violations of federal environmental laws.
NIOSH Issues Updated Workplace Carcinogen Policy: On December 27, 2016, the National Institute for Occupational Safety and Health (NIOSH) issued Current Intelligence Bulletin (CIB) 68, NIOSH Chemical Carcinogen Policy. Importantly, under the new policy, NIOSH notes:
Underlying this policy is the recognition that there is no known safe level of exposure to a carcinogen, and therefore that reduction of worker exposure to chemical carcinogens as much as possible through elimination or substitution and engineering controls is the primary way to prevent occupational cancer. Accordingly, this policy no longer uses the term recommended exposure limit (REL) for chemical carcinogens; rather NIOSH will only recommend an initial starting point for control, called the Risk Management Limit for Carcinogens (RML-CA). For each chemical identified as a carcinogen, this level corresponds to the 95% lower confidence limit of the risk estimate of one excess cancer case in 10,000 workers in a 45-year working lifetime. Keeping exposures within the risk level of 1 in 10,000 is the minimum level of protection and striving for lower levels of exposure is recommended. When measurement of the occupational carcinogen at the RML-CA is not analytically feasible at the 1 in 10,000 risk estimate, NIOSH will set the RML-CA at the limit of quantification (LOQ) of the analytical method. In addition, NIOSH will continue to evaluate available information on existing engineering controls and also make that information available when publishing the RML-CA.
The 1 in 10,000 workers exposed benchmark is a change from the 1 in 1,000 value included in the 2014 proposed CIB. To avoid “government duplication and to utilize transparent and systematic assessments,” NIOSH will also evaluate existing cancer hazard assessments completed by other federal agencies, including the U.S. Department of Health and Human Services (HHS) National Toxicology Program (NTP), EPA’s Integrated Risk Information System (IRIS), and the World Health Organization International Agency for Research on Cancer (IARC). The policy is available at https://www.cdc.gov/niosh/docs/2017-100/pdf/2017-100.pdf .
OSHA Amends Workplace Standards For Beryllium Exposure: OSHA on January 9, 2017, revised its existing standards for occupational exposure to beryllium and beryllium compounds. 82 Fed. Reg. 2470. OSHA has determined that employees exposed to beryllium at the previous permissible exposure limits (PEL) “face a significant risk of material impairment to their health.” The evidence indicates that workers exposed to beryllium are at increased risk of developing chronic beryllium disease and lung cancer, OSHA explained in lowering the PEL. The final rule lowers the PEL to 0.2 micrograms of beryllium per cubic meter of air (0.2 μg/m3) as an 8-hour time-weighted average and 2.0 μg/m3 as a short-term exposure limit determined over a sampling period of 15 minutes. The rule also requires employers to: use engineering and work practice controls (such as ventilation or enclosure) to limit worker exposure to beryllium; provide respirators when controls cannot adequately limit exposure; limit worker access to high-exposure areas; develop a written exposure control plan; and train workers on beryllium hazards. The rule requires employers to make available medical exams to monitor exposed workers and provide medical removal protection benefits to workers identified with a beryllium-related disease. The final rule covers three industry sectors: general industry, construction, and shipyards. The rule becomes effective on March 10, 2017.
EPA Final Rule Raises The Limits For Civil Penalties: In a final rule issued on January 12, 2017, EPA adjusted the level of statutory civil monetary penalty amounts under the statutes EPA administers. 82 Fed. Reg. 3633. The adjustments are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The latter law prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect of statutory civil penalties, and promote compliance. The rule does not necessarily revise the penalty amounts that EPA chooses to seek pursuant to its civil penalty policies in a particular case. EPA’s civil penalty policies, which guide enforcement personnel in how to exercise EPA’s statutory penalty authorities, take into account a number of case-specific considerations, e.g., the seriousness of the violation, the violator’s good faith efforts to comply, any economic benefit gained by the violator as a result of its noncompliance, and a violator’s ability to pay. The increases are relatively small. The rule will become effective on January 15, 2017.