Federal Development Update for August 2018


PRE-ORDER NOW “Chemical Regulation In The Middle East” By Michael S. Wenk, M.S.: Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce the August 27, 2018, publication of “Chemical Regulation in the Middle East,” written by Michael S. Wenk, M.S., Senior Regulatory Consultant with B&C and Acta. This handbook offers an essential guide to the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage chemicals in the countries of the Middle East. It also explores the range of ministry, legislative, and other decrees that encompass pesticides, occupational safety and health, as well as safety data sheets (SDS) and product labels that address regulation to widely-varying degrees. In conjunction with the release of this handbook, Michael Wenk will present a complimentary webinar on Chemical Regulation in the Middle East on September 12, 2018, 12:00 p.m. - 1:00 p.m. (EDT).Registration for the webinar is now open.

WEBINAR -- TSCA Confidential Business Information And Generic Naming: Analyzing The New Rules, September 18, 2018, 1:00 p.m. - 2:00 p.m. (EDT): B&C and Bloomberg BNA are pleased to present “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules,” the fourth webinar in the 2018 Chemical Policy Summit Series. Protecting confidential business information (CBI), including chemical identity, has never been easy but remains an essential component of a successful commercial chemical strategy. New Toxic Substances Control Act (TSCA) Section 14 is much more prescriptive about what can and cannot be protected and what submitters must do to substantiate CBI to withstand scrutiny. This complimentary, hour-long webinar will focus on what is new, what is not, and how best strategically to create generic names to protect specific chemical substance identity. Tracy C. Williamson, Ph.D., Chief, Industrial Chemistry Branch, U.S. Environmental Protection Agency (EPA); Scott M. Sherlock, Attorney Advisor, EPA; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present.

Lynn L. Bergeson, Publishes “U.S. Consumer Product Ingredient Disclosure Measures Pick Up Momentum,” In The International Chemical Regulatory And Law Review: The “right-to-know” has been a foundational element of U.S. environmental law and policy for decades. As more information becomes known about the potential health and environmental impacts of chemical substances in industrial, commercial, and especially consumer products, the public’s interest in product ingredients has sharply increased. Recently, this interest has taken a new direction, one targeting consumer cleaning products. Two state initiatives, originating in opposite sides of the country, reflect different approaches to compelling product ingredient disclosure, and portend similar state measures elsewhere. Consumer product manufacturers are bracing for renewed challenges in preserving consistent product labeling and maintaining CBI. Information-saturated consumers likely do not know what to think as they sort through ever more detailed product information. How these state measures might impact European manufacturers and trade and commerce in general remains to be seen. This publication includes an overview of the new measures and their implications.

TSCA/FIFRA/TRI

EPA OIG Finds Opportunities Exist To Improve CDR Rule: On July 27, 2018, EPA’s Office of Inspector General (OIG) issued a report entitled EPA’s Chemical Data Reporting Rule Largely Implemented as Intended, but Opportunities for Improvement Exist. OIG conducted an audit to determine how EPA is ensuring that companies are compliant with the Chemical Data Reporting (CDR) Rule requirements under TSCA and whether EPA is using CDR data to prioritize chemicals for the purpose of identifying their potential risks to human health and the environment. OIG found that implementing policies for data quality checks will help tailor the information reported by manufacturers and importers to meet EPA’s needs and improve its usefulness. More information is available at http://www.lawbc.com/regulatory-developments/entry/epa-oig-finds-opportunities-exist-to-improve-cdr-rule.

EPA Issues Direct Final Rule Promulgating SNURs For 145 Chemicals: On August 1, 2018, EPA issued a direct final rule promulgating significant new use rules (SNUR) under TSCA for 145 chemical substances that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 37702. EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e). The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of these 145 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination. The rule will be effective on October 1, 2018. Written adverse comment must be received by August 31, 2018. If EPA receives timely written adverse comment on one or more of the SNURs, it will withdraw the relevant section(s) of the direct final rule. More information is available at http://www.lawbc.com/regulatory-developments/entry/epa-issues-direct-final-rule-promulgating-snurs-for-145-chemicals.

EPA Adds Clarity To Interpretation Of “Reasonably Foreseeable Conditions Of Use”: EPA’s release in late July of its TSCA Section 5(a)(3)(C) determination for P-16-0510 represents a significant step in EPA’s implementation of the New Chemicals Program under revised TSCA Section 5. The substance, a polymer (a copolymer of ethylene glycol and propylene glycol end-capped with acrylamide groups), is intended to be used as a deodorizer in a variety of products, including floor cleaners, cat litter, fabric freshener sprays, and other consumer products. EPA’s determination document specifies the conditions of use that are intended, known, and reasonably foreseen. EPA states that there are no known or reasonably foreseen conditions of use other than those intended by the submitter. Based on EPA’s interpretation of “conditions of use,” it would not pass legal muster to speculate that “anybody could manufacture or use it for anything” and, hence, impose use restrictions to prevent purely speculative applications with no basis in fact or reality. More information on this important development is available at our blog.

EPA Extends Comment Period On TSCA Problem Formulations: On August 7, 2018, EPA announced the extension of the comment period on the problem formulations for the risk evaluations for the first ten chemicals under TSCA Section 6. 83 Fed. Reg. 38691. Reportedly EPA received several requests to extend the deadline. The notice extends the comment period on the problem formulations and the document titled Application of Systematic Review in TSCA Risk Evaluations an additional 21 days, until August 16, 2018.

Oral Argument Held In Case Challenging EPA’s Denial Of Petition To Revoke Chlorpyrifos Tolerances: On July 9, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held oral argument in League of United Latin American Citizens (LULAC) v. Pruitt, a case brought to challenge the decision by EPA to deny a 2007 petition by Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC). The 2007 petition requested that EPA revoke all chlorpyrifos tolerances granted under the Federal Food, Drug, and Cosmetic Act (FFDCA) and all chlorpyrifos registrations granted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Ninth Circuit issued a writ of mandamus in In re PANNA v. EPA requiring that EPA take action to grant or to deny the petition no later than March 31, 2017. Although EPA proposed in November 2015 partially to grant the 2007 petition and to revoke all chlorpyrifos tolerances based on concerns about neurodevelopmental effects in children, EPA ultimately decided to deny the entire PANNA and NRDC tolerance revocation petition in a decision dated March 29, 2017. More information on EPA’s March 29, 2017, decision is available in our blog item “EPA Denies Petition to Ban Chlorpyrifos.” After the March 29, 2017 denial decision, the Ninth Circuit denied a motion for further mandamus relief in the PANNA case. The court stated that, once EPA denies a tolerance revocation petition under FFDCA, “[f]iling objections and awaiting their resolution by the EPA Administrator is a prerequisite to obtaining judicial review of EPA’s final response to the petition.” The petitioners in the current LULAC case filed administrative objections to EPA’s denial decision on June 5, 2017, but, on the same date, they also brought a new action seeking immediate judicial review. Five states and the District of Columbia subsequently intervened in the new case. EPA filed a motion to dismiss the LULAC case for lack of jurisdiction on August 21, 2017, but the court denied that motion, without prejudice to EPA renewing its jurisdictional arguments during briefing on the merits. More information is available in our blog item.

California DPR Releases Final Toxic Air Contaminant Evaluation For Chlorpyrifos: In July 2018, the California Environmental Protection Agency’s Department of Pesticide Regulation (DPR), Human Health Assessment (HHA) Branch, issued its final toxic air contaminant (TAC) evaluation of chlorpyrifos. This final TAC evaluation updates the December 2017 draft evaluation of chlorpyrifos as a TAC for the Scientific Review Panel (SRP)0, which updated the August 2017 draft and was reviewed by the SRP on TACs, and incorporates certain changes based on SRP recommendations. As part of its review of the December 2017 draft, the SRP recommended “additional and detailed review of developmental neurotoxicity studies, in particular recent in vivo animal studies as well as a more in depth analysis of human effects of chlorpyrifos” and “that DPR reevaluate the critical endpoints, the associated [(uncertainty factors (UF)], and the resulting [reference concentrations (RfC)] and [reference doses (RfD)] for each endpoint.” DPR determines that a pesticide is a TAC for a non-cancer adverse effect if the projected air concentrations associated with use of the pesticide are more than one-tenth of the inhalation RfC established based on animal toxicity and epidemiology data. In the draft TAC evaluation for chlorpyrifos, DPR utilized the threshold for red blood cell (RBC) acetylcholinesterase (AChE) inhibition in humans and a target margin of exposure (MOE) of 100, including a factor of 10 intended to account for potential neurodevelopmental effects below the threshold for RBC AChE inhibition. In the final TAC evaluation for chlorpyrifos, DPR increased the MOE for AChE inhibition to 300, based on deficiencies in the human inhalation parameters used to model the threshold for AChE inhibition. More information is available at our blog. Please see our blog item “Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos” for more information on the Ninth Circuit’s August 9, 2018, decision.

EPA Announces Registration Review Proposed Interim Decisions For Several Pesticides: On August 8, 2018, EPA announced the availability of its proposed interim registration review decisions and opens a 60-day public comment period on the proposed interim decisions. 83 Fed. Reg. 39085. The pesticides are:

  • Ammonia & Ammonium Sulfate, Case Numbers 7440 & 5073;
     
  • Bacillus popilliae, Case 4102;
     
  • Benfluralin, Case 2030;
     
  • Chlorpropham, Case 0271;
     
  • Citronellol (3, 7-Dimethyl-6-Octen-1-ol), Case 6086;
     
  • Clomazone, Case 7203;
     
  • Cytokinins, Case 4107;
     
  • Dichlobenil, Case 0236;
     
  • Diflufenzopyr & Diflufenzopyr-Sodium, Case 7246;
     
  • Emamectin Benzoate, Case 7607;
     
  • Fluopicolide, Case 7055;
     
  • Fluridone, Case 7200;
     
  • German cockroach pheromone, Case 6023;
     
  • Gibberellins, Case 4110;
     
  • Indole-3-Butyric Acid, Case 2330;
     
  • Indoxacarb, Case 7613 ;
     
  • Methyl Eugenol, Case 6203;
     
  • Methyl Isopropenyl, Case 6090;
     
  • Naphthenate salts, Case 3099;
     
  • Nuranone, Case 4113;
     
  • Oxamyl, Case 0253;
     
  • Prometryn, Case 0467;
     
  • Pyriproxyfen, Case 7424;
     
  • Quillaja extract (Quillaja Saponins), Case 6512;
     
  • Quinoa Saponins (Extract of Chenopodium Quinoa Saponins), Case 6200;
     
  • Rhamnolipid biosurfactant, Case 6085;
     
  • Salicylic Acid and Methyl Salicylate, Case 4080;
     
  • Trifloxystrobin, Case 7028; and
     
  • (Z)-9-tricosene (Muscalure), Case 4112.
     

Comments must be received on or before October 9, 2018.

EPA Announces Availability Of Draft Human Health And/Or Ecological Risk Assessments For Several Pesticides: On August 9, 2018, EPAannounced the availability of EPA’s draft human health and ecological risk assessments for the registration reviews of dithiopyr, fluthiacet-methyl, hydramethylnon (pyrimidinone), and trifluralin. 83 Fed. Reg. 39437. Comments must be received on or before October 9, 2018.

EPA Schedules A FIFRA Scientific Advisory Panel Public Meeting And Requests Nominations Of Ad Hoc Expert Members: On August 8, 2018, EPA announced the schedule of a four-day, in-person meeting of the FIFRA Scientific Advisory Panel (SAP) to consider and review the Evaluation of a Proposed Approach to Refine the Inhalation Risk Assessment for Point of Contact Toxicity: A Case Study Using a New Approach Methodology (NAM). 83 Fed. Reg. 39087. Preceding the in-person meeting, there will be a half-day virtual preparatory meeting to consider and review the clarity and scope of the meeting’s draft charge questions. EPA is also requesting nominations of prospective candidates for service as ad hoc members of FIFRA SAP for this meeting. Interested persons or organizations may nominate qualified individuals to be considered as prospective candidates for this meeting by following the instructions provided in the Federal Register. The four-day, in-person meeting will be held December 4-7, 2018, from approximately 9:00 a.m. to 5:00 p.m. Nominations of candidates to serve as ad hoc members of the FIFRA SAP for this review should be provided on or before September 7, 2018.

Ninth Circuit Directs EPA To Revoke All Tolerances And Cancel All Registrations For Chlorpyrifos: On August 9, 2018, the majority of a three-judge panel of the Ninth Circuit issued an opinion in the latest chlorpyrifos case (League of United Latin American Citizens (LULAC) v. Wheeler, No. 17-71636) granting the petition for review of a 2017 order by EPA that denied an administrative petition to revoke the tolerances for chlorpyrifos; vacating the 2017 order; and remanding the matter back to EPA with explicit directions to EPA to “revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days.” A separate dissent stated that the court should have dismissed the case for lack of jurisdiction. See our blog item “EPA Denies Petition to Ban Chlorpyrifos” for more information on EPA’s denial of the petition in 2017. EPA argued in its brief that the court lacks jurisdiction to review the 2017 order denying the petition to revoke the tolerances for chlorpyrifos because FFDCA Section 408(g)(2)(C) requires EPA to rule on administrative objections to its denial of the petition to revoke the tolerances for chlorpyrifos before judicial review is available under FFDCA Section 408(h)(1). The majority opinion rejected this argument, stating that FFDCA Section 408(h)(1) “does not ‘clearly state’ that obtaining a section (g)(2)(C) order in response to administrative objections is a jurisdictional requirement.” Rather than a jurisdictional limitation, the majority construed the objections process in FFDCA as a non-jurisdictional “claims-processing rule.” In contrast, the dissenting judge agreed with EPA’s argument that the court lacks jurisdiction to review this matter until after EPA responds to the objections to the 2017 order. More information is available in our blog.

RCRA/CERCLA/CWA/CAA

EPA Extends Comment Period On Accidental Release Prevention Requirements: On July 24, 2018, EPA provided notice that it is supplementing the record for the proposed Risk Management Program (RMP) Reconsideration rule published on May 30, 2018. 83 Fed. Reg. 34967. To afford the public an opportunity to comment on the updated RMP database and its impacts on the proposed Reconsideration rule, EPA also extended the comment period for the proposed rule. The comment period for the proposed rule published on May 30, 2018, at 83 Fed. Reg. 24850, is extended. Comments and additional material must be received on or before August 23, 2018.

Superfund Task Force Announces One-Year Anniversary Accomplishments And Plan For Year Two: On July 23, 2018, EPA marked the one-year anniversary of its Superfund Task Force Report. EPA issued an update to the Task Force recommendations (available online) and noted “significant progress in carrying out the report’s recommendations.” EPA pledged to complete all 42 of the Task Force’s recommendations by the end of 2019. The Superfund Task Force was commissioned on May 22, 2017, to provide recommendations on how EPA could streamline and improve the Superfund program. On July 25, 2017, EPA issued the Superfund Task Force Report, which included 42 recommendations in five goal areas: expediting cleanup and remediation; re-invigorating responsible party cleanup and reuse; encouraging private investment; promoting redevelopment and community revitalization; and engaging partners and stakeholders. The 2018 update highlights EPA’s progress in carrying out the Task Force recommendations. These include:

  • Achieving Key Milestones at Sites on the Administrator’s Emphasis List.EPA released the initial Administrator’s Emphasis List (AEL) on December 8, 2017, which included 21 National Priorities List (NPL) sites targeted for immediate and intense attention. Substantial progress has been made at AEL sites, EPA states.
     
  • Moving More Sites Towards Deletion/Partial Deletion. The program achieved seven full site deletions and two partial deletions since EPA released the Task Force report. An additional ten sites are proposed for partial or full deletion.
     
  • Improving Information on Human Exposure Status. EPA launched a Human Exposure Dashboard providing real-time human exposure status for all NPL sites on a web page. In Fiscal Year 2017, EPA designated an additional 24 sites as having human exposure to contamination under control for a total of 1,493 sites under control.
     
  • Promoting Redevelopment and Community Revitalization at Targeted Sites. After releasing a Redevelopment Focus List of 31 NPL sites with the greatest reuse potential, EPA has responded to over 120 redevelopment-related prospective purchaser inquiries and created a new informational mapping tool that provides site-specific details on each of the 31 sites.
     
  • Developing Tools and a Process to Encourage Third-Party Investment. EPA created a national team of redevelopment experts led by EPA and the U.S. Department of Justice (DOJ) to help address liability concerns of third-party entities and developers. EPA and DOJ issued a new policy that encourages more frequent consideration of Bona Fide Prospective Purchaser Agreements and Prospective Purchaser Agreements to foster cleanup and reuse of NPL sites.
     
  • Engaging with Partners and Stakeholders. EPA held or participated in more than 1,370 public meetings and 3,190 in-person meetings or interviews with community members living near Superfund sites. EPA leaders also met with environmental justice groups and other federal agencies and a variety of state and tribal organizations to obtain their ongoing input on Task Force work.
     

EPA states in the 2018 update that it will complete implementation of all of the Superfund Task Force recommendations by September 2019 and will have fully integrated that work into EPA’s Superfund program.

EPA Issues Final RCRA Rule On Disposal Of Coal Combustion Residues: On July 30, 2018, EPA issued a final rule under the Resource Conservation and Recovery Act (RCRA) establishing management standards for the disposal of coal combustion residues (CCR). 83 Fed. Reg. 36435. The rule would amend the national minimum criteria EPA established on April 17, 2015, for existing and new CCR landfills and existing and new CCR surface impoundments. 80 Fed. Reg. 21302. These standards are codified at 40 C.F.R. Parts 257 and 258. The July 30, 2018, final rule makes several revisions to the 2015 standards. First, EPA is adopting two alternative performance standards that either Participating State Directors in states with approved CCR permit programs (participating states) or EPA where EPA is the permitting authority may apply to owners and operators of CCR units. Second, EPA is revising groundwater protection standards (GWPS) for four constituents that do not have an established Maximum Contaminant Level (MCL). Finally, EPA is extending the deadline by which facilities must cease the placement of waste in CCR units closing for cause in two situations: Where the facility has detected a statistically significant increase above a GWPS from an unlined surface impoundment; and where the unit is unable to comply with the aquifer location restriction. The revisions become effective on August 29, 2018.

EPA Issues Final Rule Exempting Certain Releases Of Hazardous Substances From Animal Waste From CERCLA Reporting Requirements: Seeking to implement the Fair Agricultural Reporting Method (FARM) Act, EPA on August 1, 2018, issued a final rule exempting certain air releases of hazardous substances from animal waste from release reporting obligations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund). 83 Fed. Reg. 37444. On December 18, 2008, EPA issued an administrative reporting exemption for air releases from animal waste at farms. 73 Fed. Reg. 76948. The rule exempted farms from CERCLA’s reporting requirements for air releases of any hazardous substance from animal waste. The reporting exemption was ultimately vacated, however, by the U.S. Court of Appeals for the District of Columbia Circuit in Waterkeeper Alliance v. EPA, 853 F.3d 527 (D.C. Cir. 2017). In vacating the rule, the court found that EPA could not rely on general rulemaking authority or a de minimis exception to issue an administrative reporting exemption for this category of releases, particularly where EPA had failed to identify any statutory ambiguity as the basis for its interpretation of the reporting requirements. Alarmed by the requirement for farms to report these releases, lawmakers introduced legislation that would exempt the releases from CERCLA reporting requirements. On March 23, 2018, President Trump signed that legislation into law as part of the Consolidated Appropriations Act (Omnibus Bill). Title XI of Division S of the Omnibus Bill -- the FARM Act -- exempts the reporting of air emissions from animal waste at a farm under CERCLA Section 103(e). In the final rule, EPA is adding this exemption to the CERCLA release reporting regulation in 40 C.F.R. Section 302.6 as well as the definitions of “animal waste” and “farm” to 40 C.F.R. Section 302.3. Due to the FARM Act, farms remain exempt from CERCLA release reporting requirements despite the D.C. Circuit’s vacatur of the 2008 final rule. This final rule became effective on August 1, 2018.

EPA Releases Annual Air Quality Report: On July 31, 2018, EPA released its annual report on air quality, which tracks national progress in improving air quality. The report, “Our Nation’s Air: Status and Trends Through 2017,” documents considerable improvements in air quality across America over more than 45 years. The report highlights that, between 1970 and 2017, the combined emissions of criteria pollutants dropped by 73 percent, while the U.S. economy grew more than three times. Between 1990 and 2017, the average concentrations of the criteria air pollutants decreased significantly:

  • Sulfur dioxide -- 88 percent reduction;
     
  • Lead -- 80 percent reduction;
     
  • Carbon monoxide -- 77 percent reduction;
     
  • Nitrogen dioxide -- 56 percent reduction;
     
  • Fine Particulate Matter (PM2.5) -- 40 percent reduction;
     
  • Coarse Particulate Matter (PM10) -- 34 percent reduction; and
     
  • Ground-level ozone -- 22 percent reduction.
     

The report is available online.

EPA Announced It Will Not Revisit 2015 Ozone NAAQS: EPA on August 1, 2018, announced that it will not revisit the National Ambient Air Quality Standard (NAAQS) for ozone promulgated by EPA on October 26, 2015. 80 Fed. Reg. 65292. Instead, EPA will re-evaluate the NAAQS by 2020 as part of its five-year review required under the Clean Air Act (CAA). EPA’s announcement came in a final status report it filed with the U.S. Court of Appeals for the D.C. Circuit on a case challenging the 2015 ozone rule. Murray Energy Corporation v. EPA, Case No. 15-1385. The 2015 rule lowered the ozone NAAQS from 75 parts per billion (ppb) to 70 ppb. In the status report, DOJ, speaking for EPA, states that the administration “has been intensively considering and developing a new approach for the EPA’s program for the National Ambient Air Quality Standards, as reflected by two recent, high-level directives.” On April 12, 2018, President Trump issued a memorandum directing EPA to evaluate whether it was fully complying with applicable procedural, scientific, and technical requirements pertaining to its periodic five-year NAAQS reviews. See Memorandum for the Administrator of the Environmental Protection Agency § 7 (dated April 12, 2018). 83 Fed. Reg. 16761, April 16, 2018 (Presidential Memo). The Presidential Memo specifically directed EPA to evaluate compliance with provisions relating to the scope and characterization of advice received by EPA from the Clean Air Scientific Advisory Committee (CASAC), “including requirements that the Committee advise the Administrator regarding background concentrations and adverse public health or other effects that may result from implementation of revised air quality standards.” Following up on the Presidential Memo, on May 9, 2018, former EPA Administrator Scott Pruitt issued a memorandum setting out principles to govern NAAQS reviews. See Memorandum: Back-to-Basics Process for Reviewing National Ambient Air Quality Standards (Back-to-Basics Memo). Among other things, the Back-to-Basics Memo stressed EPA’s commitment to completing the periodic five-year NAAQS reviews in a timely fashion, and outlined specific steps that EPA will take to improve the efficiency of the next ozone NAAQS review. One of the specific issues that the Back-to-Basics Memo identifies as needing additional attention by EPA and CASAC during review of the NAAQS is “the relative contribution of natural and anthropogenic activity,” including additional information on background concentrations of ozone and other pollutants. The Back-to-Basics Memo goes on to specify that EPA, consistent with the provisions of CAA Section 109(d)(2(C), intends to solicit advice from CASAC during each NAAQS review on that question, and to ask that CASAC discuss relative proximity to background ozone concentrations in its advice on any recommended NAAQS levels. On June 26, 2018, EPA, to fulfill the Back-to-Basics Memo’s direction, initiated the next five-year review of the NAAQS for ozone. 83 Fed. Reg. 29785. Also on June 26, 2018, EPA issued a second call for information related to adverse effects from various strategies for attainment and maintenance of NAAQS. 83 Fed. Reg. 29785. EPA stated that it intends to implement the new approach to review of the NAAQS in the current review of the ozone NAAQS, and to complete that review by 2020. As part of this review of the ozone NAAQS, EPA intends to consider and solicit comment from the CASAC and the public, on topics related to background ozone, including assessments of the relative contribution of natural and anthropogenic ozone to design values, which are used to determine whether areas are attaining the NAAQS.

EPA And DOT Propose To Roll Back Obama Era Fuel Economy Standards And Repeal Of California Waiver: On August 1, 2018, EPA and the Department of Transportation (DOT) signed a proposed rule that seeks to roll back Obama era fuel economy standards for model year (MY) 2021-2026 vehicles. The proposal seeks to “correct the national automobile fuel economy and greenhouse gas emissions standards to give the American people greater access to safer, more affordable vehicles that are cleaner for the environment.” The proposal would gut a 2012 EPA rule that sought to reduce greenhouse gas (GHG) emissions from cars and trucks and set corporate average fuel economy (CAFÉ) standards for MY 2017 to 2025 light-duty vehicles. In the proposal, EPA and DOT state their preferred alternative is to freeze the GHG standards for vehicles at 2020 levels, abandoning the Obama Administration’s approach of escalating stringency from 2021 through 2025. The proposal states that cars and trucks manufactured from 2021 to 2025, which would have been required to meet higher standards than those manufactured from 2017 to 2021, might no longer have to do so. EPA also has proposed to rescind a CAA waiver issued to California, which allows the state to create its own vehicle emissions standards, as long as they are at least as strict as the federal ones. If EPA does that, California is certain to bring suit to defend its right to create its own emissions standards. A dozen other states use California’s standards. A copy of the pre-publication of the rule is available online. Comments will be due 60 days after the publication of the rule in the Federal Register.

FDA

FDA Updates “Everything Added To Food” Inventory: On June 26, 2018, the U.S. Food and Drug Administration (FDA) launched its new Substances Added to Food inventory, an upgraded version of the original “Everything Added to Food in the U.S.” inventory. FDA states that the new searchable inventory contains approximately 4,000 substances, including the following types of ingredients regulated by FDA:

  • Food additives, color additives, and flavoring substances;
     
  • Generally Recognized as Safe (GRAS) substances;
     
  • Substances approved for specific uses in foods prior to September 6, 1958, known as prior-sanctioned substances; and
     
  • Substances formerly used, including:
     
    • Prohibited substances;
       
    • Delisted color additives; and
       
    • Some substances no longer GRAS by the Flavor and Extract Manufacturers Association (FEMA).
       

Additional features include:

  • A new search function that allows users to search multiple related food ingredient and packaging inventories;
     
  • Direct links to any applicable regulations for a substance; and
     
  • Additional information such as other known names, common uses, and information by other entities when available.
     

FDA Announces Proposal To Revise Type Size Labeling Requirements For FOP Calorie Declarations: On July 12, 2018, FDA announced it is proposing, in response to requests from the vending and packaged foods industries to reduce the regulatory burden and increase flexibility, while continuing to provide calorie declarations for certain articles of food sold from vending machines, to revise the type size labeling requirements for front of package (FOP) calorie declarations for packaged food sold from glass front vending machines. 83 Fed. Reg. 32221. Specifically, the notice states that FDA is proposing that “the type size be anchored to the net quantity of contents statement, such that the minimum type size is 150 percent (one and one-halftimes) the size of the net quantity of contents, instead of being based on the largest printed matter on the label,” and “would only apply when calories are displayed on the front of the package of foods sold in glass front vending machines.” Comments are due by September 25, 2018.

FDA Announces FY 2019 Fee Rates For Facility Reinspections, Failures To Comply With A Recall Order, And Importer Reinspections: On July 27, 2018, FDA announced the fiscal year (FY) 2019 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the FFDCA, as amended by the Food Safety Modernization Act (FSMA). 83 Fed. Reg. 35659. These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019.

FDA Commissioner Reaches Out To State Leaders On Implementation Of Produce Safety Rule: On July 31, 2018, FDA Commissioner Scott Gottlieb, MD, issued a letter to state agricultural commissioners, secretaries, and directors to update them on progress made on issues of joint interest related to implementation of the Produce Safety Rule mandated by FSMA. The Commissioner’s letter covers updates in the area of rulemaking: (1) the definition of a “farm”; (2) agricultural water; (3) biological soil amendments of animal origin; (4) produce guidance; and (5) domestic-foreign parity; in the area of implementation preparedness: (1) training; (2) on-farm readiness review visits; and (3) inspectional documentation and dispute mitigation and resolution procedures; and in the area of building on partnerships: (1) partnership with states; and (2) FDA/United States Department of Agriculture (USDA) formal agreement. Dr. Gottlieb states that FDA’s goal, “through better communication, smart regulation, and enhanced use of technology, is to shift our food system from one that reacts to problems to one that prevents them from happening in the first place.”

NANOTECHNOLOGY

Helsinki Chemicals Forum Includes Debate On Nanomaterials: The tenth Helsinki Chemicals Forum was held on June 14-15, 2018, in Helsinki, Finland. According to the Conference Report, prepared by Chemical Watch, 168 delegates from 37 countries attended. The final debate at the Forum used nanomaterials as a case study to argue whether product stewardship can replace regulation. Roger Drew, ToxConsult, moderated the debate between David Azoulay, Center for International Environmental Law and David Warheit, Ph.D., The Chemours Company. More information is available in our July 20, 2018, blog item.

EUON Publishes Study Identifying Key Parameters For Conducting Reliable Market Studies On Nanomaterials: On July 17, 2018, the European Union (EU) Observatory for Nanomaterials (EUON) announced the availability of a study that it commissioned, Critical review of the relevance and reliability of data sources, methods, parameters and determining factors to produce market studies on manufactured nanomaterials on the EU market. The study presents the results of a critical review of the relevance and reliability of data sources, methods, parameters, and determining factors to produce market studies on manufactured nanomaterials on the EU market. According to EUON, based on a review of a number of existing market studies and further data sources, the study identified a set of basic parameters for producing reliable market studies on nanomaterials. The study also determined additional parameters for comprehensive studies that take into account more variables and interactions.

Health-EU Newsletter Includes Editorial On Safety Of Nanomaterials In Sunscreens: The July 19, 2018, issue of the European Commission’s (EC) Health-EU Newsletter includes an editorial entitled “The only concern to have about sunscreen is … did you remember to put it on?” written by Qasim Chaudhry, Chair of the Scientific Committee on Consumer Safety (SCCS) and Ulrike Bernauer, Chair of the SCCS Working Group on Nanomaterials in Cosmetic Products. The editorial concludes that consumers can “rest assured” that any nanomaterials in cosmetics in Europe have already gone through “the most stringent safety assessment in the world.”

NIOSH Draft CIB On Occupational Risk Assessment Discusses Emerging Practices, Including Nanomaterials Risk Assessment: On July 26, 2018, the National Institute for Occupational Safety and Health (NIOSH) announced the availability of a draft Current Intelligence Bulletin: NIOSH Practices in Occupational Risk Assessment. 83 Fed. Reg. 35485. Appendix C of the draft Current Intelligence Bulletin (CIB) addresses emerging practices and includes a section on nanomaterials risk assessment. The draft CIB states: “Given the large and growing number of engineered nanomaterials (ENMs) with limited data, as for other emerging and existing substances produced or used in the workplace, alternative test strategies (i.e., a toxicological approach other than primary animal testing), such as high throughput screening and in vitro exposures, may help to fill the gaps by providing data that could be used in validated hazard and risk assessment models.” NIOSH will hold an online meeting on September 13, 2018, from 1 p.m. - 4 p.m. (EDT). Written comments must be submitted to the docket by October 15, 2018.

ACGIH® Will Not Proceed With TLV® For Carbon Nanotubes In 2019: As reported in our January 31, 2018, blog item, the American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee included carbon nanotubes on its 2018 list of chemical substances and other issues under study. Being placed on the under study list indicated that the TLV®-CS Committee had selected carbon nanotubes for development of a threshold limit value (TLV®). On July 26, 2018, ACGIH® announced the release of its two-tier under study list. Tier 1 lists the chemical substances and physical agents that may move forward as a notice of intended change or notice of intent to establish in the upcoming year, based on their status in the development process. Tier 2 consists of those chemical substances and physical agents that will not move forward, but will either remain on or be removed from the under study list for the next year. Carbon nanotubes are included in Tier 2. If carbon nanotubes are included on the 2019 under study list, stakeholders will have an opportunity to submit substantive data and comments.

NNCO Announces Reappointment Of Director And Appointment Of New Deputy Director: On July 30, 2018, the National Nanotechnology Coordination Office (NNCO) announced the reappointment of Dr. Lisa Friedersdorf as its Director and the appointment of Dr. Stacey Standridge as its Deputy Director. NNCO states that Dr. Friedersdorf joined NNCO in December 2011 and served as Senior Scientist and Program Manager for the Nanotechnology Signature Initiatives (NSI). Dr. Standridge became NNCO’s Deputy Director in May 2014 and NNCO’s Director in October 2016. Dr. Standridge joined NNCO in June 2011 and has been NNCO’s Acting Chief of Staff since October 2017. In that role, Dr. Standridge actively engaged with stakeholders in support of focused, high-priority interagency nanotechnology activities (NSIs). Dr. Standridge also has played a critical role in creating and sustaining a long-term collaboration with the European Commission and European scientists on the development of shared knowledge and best practices related to research on the safety of nanomaterials. She will also serve as the NNI Coordinator for Global Issues.

EFSA Panel Concludes New Titanium Dioxide Studies Do Not Merit Reopening Opinion: The July 2018 issue of the EFSA Journal includes an article entitled “Evaluation of four new studies on the potential toxicity of titanium dioxide used as a food additive (E 171).” The EC asked the European Food Safety Authority (EFSA) to carry out a scientific evaluation on four studies on the potential toxicity of titanium dioxide used as a food additive (E 171) and to indicate whether they would merit re-opening EFSA’s 2016 opinion on the safety of titanium dioxide (E 171) as a food additive. The article states that more research exploring the possible effects observed in three of the four studies could address their applicability to the risk assessment of the food additive E 171 under realistic conditions of use. Altogether, the Panel concluded that the outcome of the four studies did not merit re-opening the existing opinion of EFSA related to the safety of titanium dioxide (E 171) as a food additive.

German Environment Agency Publishes Fact Sheet On Use Of Nanomaterials In Plastic Packaging: The German Environment Agency (UBA) has published an August 2018 fact sheet, in German, regarding the use of nanomaterials in plastic packaging. The fact sheet addresses nanomaterials that promise new, technical, or improved packaging properties. According to UBA, the nanomaterials used for labeling and surface coating of packaging are partly the same as those used in (printing) paints and varnishes. Because most of the potential use of nanomaterials in packaging lies in the field of plastics and plastic packaging, the fact sheet focuses on the use of nanomaterials in these materials.

Registration Opens For NNI Webinar On NanoEHS And Nanomedicine: Registration has opened for an August 20, 2018, webinar on “NanoEHS and Nanomedicine: Similarities and Synergisms.” The National Nanotechnology Initiative (NNI) notes that there are many synergies between nanomedicine research, which addresses (among other topics) issues of efficacy and safety, and studies on the environmental, health, and safety effects of nanomaterials (nanoEHS), which include the exploration of potential toxicity and exposures. Panelists will provide a comparative overview of these two disciplines and discuss how each field’s tools and approaches have developed and how they can inform each other. Dr. Mark Hoover, Senior Research Scientist, NIOSH, and Dr. Christina Liu, Program Director, Nanodelivery Systems and Devices Branch, Cancer Imaging Program, National Cancer Institute, National Institutes of Health, will moderate the panel, which will include:

  • Dr. Hamid Ghandehari, Professor of Bioengineering, University of Utah;
     
  • Dr. Christine Payne, Associate Professor, Duke University; and
     
  • Dr. Monika Mortimer, Project Scientist, Bren School of Environmental Science and Management, University of California, Santa Barbara.
     
BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: 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.

LEGISLATIVE

House Passes EPA Funding Bill: The House of Representatives on July 19, 2018, passed EPA’s FY 2019 appropriations bill. EPA would receive $7.96 billion, $100 million below the FY 2018 level but more than $2.2 billion higher than what President Trump had proposed. Lawmakers approved several amendments: one would repeal the Waters of the United States (WOTUS) rule, another would block the use of the social cost of carbon in drafting any regulations or regulatory guidance, and one would block enforcement of the rule limiting methane emissions from oil and gas operations.

Brace Of Bills Seeks To Eliminate IRIS And Change How EPA Conducts Chemical Assessments: Representative Andy Biggs (R-AZ) introduced a pair of bills seeking to alter the manner in which EPA conducts chemical assessments. The Chemical Assessment Improvement Act (H.R. 6399), introduced on July 17, 2018, would eliminate the Integrated Risk Information System (IRIS) and require chemical assessments to be conducted by EPA program offices. It could alter fundamentally how EPA conducts assessments. EPA is to conduct the assessments according to procedures detailed in the bill. Specifically, the legislation would require that EPA conduct chemical assessments “using scientific information, technical procedures, measures, methods, protocols, methodologies, or models in a manner consistent with the best available science.” EPA would be required to “integrate all lines of scientific evidence” and must consider:

  • The extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the scientific information are reasonable for and consistent with the intended use of the scientific information;
     
  • The extent to which the scientific information is relevant for the relevant program office’s use in making a decision about a chemical substance;
     
  • The degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the scientific information are documented and publicly available in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification;
     
  • The extent to which the variability and uncertainty in the scientific information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized;
     
  • The extent of independent verification or peer review of the scientific information or of the procedures, measures, methods, protocols, methodologies, or models;
     
  • The ability of the scientific findings and research to be replicated or reproduced; and
     
  • The extent to which the available scientific information supports dose-response modeling, using non-linear approaches.
     

The legislation also specifies how EPA is to assign toxicity values. When supported by the available data, the toxicity value must include a range of point estimates of risk as well as sources and magnitudes of uncertainty associated with the estimates. When multiple point estimates can be developed, EPA must consider all datasets and make a determination about how best to represent the human health risk posed by the chemical substance involved. EPA also would be required to compile a chemical assessment database. EPA also is to establish a chemical hazard identification and dose response steering committee to oversee chemical assessments.

The Improving Science in Chemical Assessments Act (H.R. 6468) is similar to H.R. 6399. It would amend the Environmental Research, Development, and Demonstration Authorization to ensure that research priorities are aligned to “reflect the research needs and priorities of the relevant program offices, as well as the overall research needs and priorities” of EPA. It also would eliminate IRIS and require chemical assessments be completed in relevant program offices.

Bill Would Ban Organophosphate Pesticides: On July 26, 2018, Representative Nydia Velazquez (D-NY) introduced legislation that would ban organophosphate pesticides. The bill, H.R. 6631, would cancel the registrations of all organophosphate pesticides under FIFRA. The bill was referred jointly to the Energy and Commerce Committee and the Agriculture Committee.

Senators Collins, Coons Introduce Promoting Innovation In Sustainable Chemistry: On July 30, 2018, SenatorsSusan Collins (R-ME) and Chris Coons (D-DE) reintroduced the Sustainable Chemistry Research and Development Act of2018 (S. 3296). This bill encourages the development of new and innovative chemicals, products, and processes with an improved environmental footprint through efficient use of resources, reducing or eliminating exposure to hazardous substances, or otherwise minimizing harm to human health and the environment.The legislation is intended to support new innovations in chemistry that benefit the economy, the environment, and human health. The billsupports coordinated efforts in sustainable chemistry across all research agencies through research and development, technology transfer, commercialization, education, and training programs; including partnerships with the private sector. The bill does not include any regulatory components, nor does it authorize new spending. Its goal, rather, is to coordinate better federal activities in sustainable chemistry and encourage industry, academia, nonprofits, and the general public to innovate, develop, and bring to market new sustainable chemicals, materials, products, and processes. In addition, Senator Ed Markey (D-MA) joined Coons and Collins in requesting a Government Accountability Office (GAO) report on the status of sustainable chemistry practices in the United States. In the 114th Congress, Coons and Collins sponsored a broad sustainable chemistry bill, S. 1447, that sought to create a similar program encouraging development of alternatives to products that can be environmentally harmful. That bill did not advance, nor was it attached to the TSCA reform legislation (Frank R. Lautenberg Chemical Safety for the 21st Century Act, S. 697). Portions of S. 1447 were, however, incorporated into the Senate version of S. 697. But Coons’ sustainable chemistry legislation was stripped from the TSCA bill over concerns that it would expand the number of House Committees that would need to approve the bill language to include the science Committee, which had not previously reviewed the underlying bill. The legislation has been endorsed by the GC3 Sustainable Chemistry Alliance; the American Chemical Society; the American Chemistry Council; the American Sustainable Business Council; Ashland; BASF; Beautycounter; Chemours; The Dow Chemical Company; DuPont; Procter & Gamble; and the University of Delaware. It was referred to the Committee on Commerce, Science and Transportation.

Senators Introduce Legislation To Reform Water Quality Certification Implementation: On July 31, 2018,Senators James Inhofe (R-OK), John Barrasso (R-WY), Chair of the Senate Committee on Environment and Public Works (EPW), Shelley Moore Capito (R-WV), and Steve Daines (R-MT) introduced the Water Quality Certification Improvement Act of 2018 (S. 3303). The bill would amend Section 401 of the Clean Water Act (CWA) to clarify the scope of review for water quality certification and “place procedural guardrails to prevent future abuses.” The legislation makes several key clarifications to existing law about the appropriate scope of review for a water quality certification. In a statement accompanying the bill, Senator Inhofe stated: “States hostile to fossil fuels have been taking advantage of loopholes in the Clean Water Act 401 certification process to block projects they simply don’t like, circumventing the needs and interests of other states and communities . . . By clarifying the scope of the 401 reviews, we can ensure that these projects are assessed solely on their impacts to clean water as the statute originally intended.” The Water Quality Certification Improvement Act of 2018 would:

  • Clarify that the scope of a Section 401 review is limited to water quality impacts only;
     
  • Clarify that states, when evaluating water quality, can only consider discharges that would result from the federally permitted or licensed activity itself -- not from other sources;
     
  • Require states to publish clear requirements for water quality certification requests;
     
  • Require states to make final decisions on whether to grant or deny a request in writing based only on water quality reasons; and
     
  • Require states to inform a project applicant within 90 days whether the states have all of the materials needed to process a certification request.
     

Senate And House Bills Would Suspend Certain EPA Rules Until IG Reports On Scott Pruitt Are Complete: On July 31, 2018, Representative Gerald E. Connolly (D-VA), Vice Ranking Member of the House Oversight and Government Reform Committee, and Senator Jeff Merkley (D-OR), a senior member of the Senate Committee on EPW, introduced the Ensuring Pruitt is Accountable (EPA) Act of 2018 (H.R. 6644, S. 3312). The legislation seeks to ensure EPA’s Inspector General (IG) continues its investigations into former EPA Administrator Scott Pruitt’s conduct. The bill would suspend any proposed rulemaking signed by Pruitt until those investigations are completed and made public. The legislation specifically cites nine ongoing IG investigations. “Scott Pruitt may be gone but the stain of his venality still taints the Trump administration,” stated Connolly. “The [legislation] will protect the integrity of the Inspector General investigations and give the American public a full account of Pruitt’s rampant abuses while in office,” he added.

Senate Passes EPA Funding Bill: On August 1, 2018, by a vote of 92-6, the Senate passed EPA’s FY 2019 appropriations legislation. EPA would receive $8.058 billion under the bill (H.R. 6147), which largely leaves EPA funding intact and equal to its FY 2018 levels. But the Senate bill provides EPA with between $100 million and $500 million more than the House-passed version of its appropriations legislation, depending upon which programs are counted as base EPA funding. The funding differences mean that the two chambers must convene a Conference Committee to align the two measures. In addition, the House version of the bill contains amendments lacking in the Senate bill; those amendments will also have to be addressed in the Conference Committee.

Senate Committee Approves EPA And CEQ Nominations: On August 1, 2018, the Senate EPW Committee, approved the nomination of Peter Wright, formerly of Dow Chemical, to serve as the Assistant Administrator for EPA’s Office of Land and Environmental Management. The Committee also approved the nomination of Charles (Chad) McIntosh, the former Ford Motor Company vice president for environmental issues, to serve as the Assistant Administrator for the Office of International and Tribal Affairs. The panel also approved the nomination of Mary Bridget Neumayr to lead the White House Council on Environmental Quality (CEQ). All three of the votes were along party lines, 11-10.

Senate EPW Committee Holds Hearing On EPA’s Agenda For Environmental Protection And Economic Growth: On August 1, 2018, the EPW Committee held a hearing entitled “Examining EPA’s Agenda: Protecting the Environment and Allowing America’s Economy to Grow.” Testifying at the hearing was Andrew Wheeler, EPA’s Acting Administrator. Witness testimony and an archive of the hearing are available online. The hearing was intended to provide Wheeler with the opportunity to present himself for the first time in front of the EPW Committee as the Acting Administrator, and to update the EPW Committee on EPA’s agenda since the resignation of Scott Pruitt, EPA’s former Administrator. Wheeler’s testimony highlighted three main priorities for EPA moving forward: (1) regulatory certainty between EPA and state/local governments; (2) improvement of programs within EPA; and (3) increased transparency in risk communication. Please see our full memorandum for more information and insights on this hearing.

MISCELLANEOUS

APHIS/USDA Prepare To Revise Regulations Pertinent To Genetically Engineered Organisms: USDA’s Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE organisms. APHIS requested comment on issues to be considered in preparing the EIS, as well as how to define the scope of the alternatives and environmental impacts. Comments were due by July 30, 2018. More information is available at http://www.lawbc.com/regulatory-developments/entry/aphis-usda-prepare-to-revise-regulations-pertinent-to-genetically-engineere.

Agency For Toxic Substances And Disease Registry Seeks Comment On PFAS ICR: On July 19, 2018, the Agency for Toxic Substances and Disease Registry (ATSDR) invited the public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995, on a proposed information collection project titled “Per- or Polyfluoroalkyl Substances (PFAS) Exposure Assessments.” 83 Fed. Reg. 34135. ATSDR and the Centers for Disease Control and Prevention (CDC) National Center for Environmental Health (NCEH) will conduct a minimum of eight exposure assessments (EA) at current or former military installations with known PFAS contamination in drinking water, groundwater, or another water source. ATSDR must receive written comments on or before September 17, 2018.

EPA OIG Audits EPA’s Implementation Of Its Recommendations For Presidential Green Chemistry Challenge Awards Program: On July 20, 2018, EPA’s OIG released a report on its audit of EPA’s implementation of the OIG recommendations for the Presidential Green Chemistry Challenge Awards (PGCCA) Program. The PGCCA Program is sponsored by EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) to promote the environmental and economic benefits of developing and using green chemistry by recognizing industry innovations. In 2015, OIG reported that award results submitted to the EPA’s Pollution Prevention (P2) Program from PGCCA recipients were not adequately supported or transparent. In its audit, OIG found that EPA discontinued the use of unverified PGCCA results in EPA performance metrics, but “a lack of documented controls presents risk that these data may be used in the future.” More information is available at http://www.lawbc.com/regulatory-developments/entry/epa-oig-audits-epas-implementation-of-its-recommendations-for-presidential.

OSHA Proposes To Rescind Requirement For Employers To Submit Case-Specific Forms Electronically:The Occupational Safety and Health Administration (OSHA) on July 30, 2018, proposed to rescind the requirement for employers to submit case-specific information electronically. 83 Fed. Reg. 36494.The proposed rule specifically eliminates the requirement in 29 C.F.R. Section 1904.41 to submit electronically information from OSHA Form 300 (Log of Work-Related Injuries and Illnesses), and OSHA Form 301 (Injury and Illness Incident Report) for establishments with 250 or more employees that are currently required to maintain injury and illness records. These establishments would instead be required to submit electronically information only from OSHA Form 300A (Summary of Work-Related Injuries and Illnesses). OSHA stated that it proposed the rule to protect personally identifiable information or data that could be breached under a Freedom of Information Act (FOIA) request. OSHA has determined that the electronic forms add uncertain enforcement value and pose a potential privacy risk, while the summary forms yield significant enforcement value with little privacy risk. The deadline for electronic submission of 2017 information from OSHA Forms 300 and 301 was July 1, 2018. In subsequent years, the deadline is March 2. OSHA is not currently accepting the Form 300 or 301 data and will not enforce the deadlines for these two forms without further notice while this rulemaking is underway. The electronic portal collecting Form 300A data is accepting 2017 data, although submissions after July 1, 2018, will be marked late. The comment period on the proposal ends on September 28, 2018.

ATSDR Announces Availability Of 29 Draft Tox Profiles: On August 2, 2018, ATSDR announced the availability of Set 29 Draft Toxicological Profiles for review and comment. 83 Fed. Reg. 37812. All toxicological profiles issued as “`Drafts for Public Comment” represent ATSDR’s best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of tribufos, bromodichloromethane, bromomethane, and 2-hexanone for review and potential inclusion in the profiles. Although ATSDR considers key studies for these substances during the profile development process, this document solicits any relevant, additional information. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.

ATSDR also seeks comments on the organization and format of the Toxicological Profile for Bromodichloromethane. In an effort to improve the usability of the profiles, ATSDR recently made content and organizational changes based on user feedback, as well as data identifying the most used profile content. Changes include: removing redundant content; adding summary figures and tables to Chapters 1, 2, 5, and 6 that did not exist in previous Toxicological Profiles; and reformatting the Levels of Significant Exposure (LSE) tables in Chapter 2. ATSDR has only applied the changes to the Draft Toxicological Profile for Bromodichloromethane, but intends to use the new format for future profiles. Specifically, ATSDR seeks answers to these questions:

  1. Does the chapter organization make it easier for you to find the information you need? For example, are you satisfied with the organization of the health effects chapter by organ system rather than exposure route?
     
  2. Are the new tables and figures clear and useful? Do they make the Toxicological Profile easier to read?
     
  3. If you have previously used any Toxicological Profile(s) for your work, which parts or content are the most useful to you, and what do you use it for?
     
  4. Does the profile contain all of the information you need? If no, please elaborate on what additional information would be helpful.
     
  5. Is there information you would like to see in the profile that is not currently included? If yes, please elaborate on the additional information you would like to see in the profile.
     

Comments must be submitted by October 31, 2018.

OSHA Extends Compliance Dates For General Industry Beryllium Standard: OSHA on August 9, 2018, extended to December 12, 2018, the compliance date for specific ancillary requirements of the general industry beryllium standard. 83 Fed. Reg. 39351. The extension affects provisions for methods of compliance, beryllium work areas, regulated areas, personal protective clothing and equipment, hygiene facilities and practices, housekeeping, hazard communication, and recordkeeping. OSHA also stated that it is developing a proposed rule to clarify certain provisions of the beryllium standard. OSHA began enforcing the new permissible exposure limits (PEL) for general industry, construction, and shipyards, and the general industry provisions for exposure assessment, respiratory protection, medical surveillance, and medical removal on May 11, 2018. Those requirements are unaffected by this rule. Provisions for which the standard already establishes compliance dates in 2019 (change rooms and showers) or 2020 (engineering controls) are also unaffected by this rule.

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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