Federal Development Update for April 2017


TSCA/FIFRA

EPA Denies TSCA Section 21 TBBPA Petition: On March 17, 2017, the U.S. Environmental Protection Agency (EPA) denied a Toxic Substances Control Act (TSCA) Section 21 petition submitted by, among others, Earthjustice, seeking a TSCA Section 4 test rule for tetrabromobisphenol A (TBBPA). 82 Fed. Reg. 14171. EPA determined that the petition failed to set forth facts demonstrating that there is insufficient information available to EPA to determine or predict reasonably effects from exposure to TBBPA from a variety of exposure pathways, including via inhalation or ingestion, resulting from manufacturing, processing, recycling, degradation, or disposal. As a result, EPA was unable to conclude TBBPA may present an unreasonable risk of injury under TSCA Section 4(a)(1)(A)(i).

EPA Announces Availability Of Initial Mercury Inventory: On March 29, 2017, EPA announced the availability of the Initial Mercury Inventory. 82 Fed. Reg. 15522. EPA was directed by Congress under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) to carry out and publish in the Federal Register no later than April 1, 2017, an inventory of mercury supply, use, and trade in the United States. Lautenberg defines “mercury” as “elemental mercury” or “a mercury compound.” Consistent with this mandate, EPA announced the availability of this initial inventory report, which is a compilation of publicly available data on the supply, use, and trade of elemental mercury and mercury compounds.

EPA Denies Petition To Require More Testing On Flame Retardant: On April 12, 2017, EPA denied a petition submitted by Earthjustice and others seeking toxicity data on three flame retardants. 82 Fed. Reg. 17601. According to EPA, the petition did not provide sufficient evidence for EPA to conclude that the data it has are inadequate to evaluate the health or environmental effects of the flame retardants known as the chlorinated phosphate ester (CPE) cluster. The three retardants that make up the cluster are: tris(2-chloroethyl) phosphate, or TCEP, Chemical Abstracts Service (CAS) No. 115-96-8; 2-propanol, 1-chloro-, phosphate, or TCPP, CAS No. 13674-84-5; and 2-propanol, 1,3-dichloro-, phosphate, or TDCPP, CAS No. 13674-87-8.

EPA Requests Pesticide Program Dialogue Committee Nominations: On March 22, 2017, EPA’s Office of Pesticide Programs (OPP) invited nominations from a diverse range of qualified candidates to be considered for appointment to the Pesticide Program Dialogue Committee (PPDC). 82 Fed. Reg. 14724. The PPDC is chartered to provide advice and recommendations to the EPA Administrator on a broad range of issues concerning pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from pesticide use. To maintain the representation outlined by the charter, nominees will be selected to represent: environmental/public interest and animal rights groups; farm worker organizations; pesticide industry and trade associations; pesticide user, grower, and commodity groups; federal/state/local and tribal governments; academia; and public health organizations. Vacancies are expected to be filled by July 2017. Nominations should be submitted no later than April 21, 2017.

EPA Denies Petition To Ban Chlorpyrifos: On April 5, 2017, EPA issued an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDA) requesting that EPA revoke all tolerances and cancel all registration for the pesticide chlorpyrifos. 82 Fed. Reg. 16581. EPA’s decision denying the petition addresses each of the petition’s ten claims and the history of EPA’s review and responses to those claims. The order contains significant discussion on three key claims, which the order states all relate to the same issue: “Whether the potential exists for chlorpyrifos to cause neurodevelopmental effects in children at exposure levels below EPA’s existing regulatory standard (10% cholinesterase inhibition).” The order states that because “Congress has provided that EPA must complete registration review by October 1, 2022,” and because EPA has “concluded that it will not complete the human health portion of the registration review or any associated tolerance revocation of chlorpyrifos without first attempting to come to a clearer scientific resolution” on the issues concerning potential neurodevelopmental effects in children, EPA is denying the claims, given the Ninth Circuit Court of Appeals’ August 12, 2016, order that “made clear” that further extensions to the March 31, 2017, deadline for responding to the petition would not be granted. EPA states that the “science addressing neurodevelopmental effects remains unresolved,” and “further evaluation of the science during the remaining time for completion of registration review is warranted to achieve greater certainty as to whether the potential exists for adverse neurodevelopmental effects to occur from current human exposures to chlorpyrifos.” The order was effective immediately. Objections and requests for hearings must be received on or before June 5, 2017. More information on the prior proceedings concerning this matter is available on our blog under key phrase chlorpyrifos.

RCRA/CERCLA/CWA/CAA/HMT

Trump Executive Order Begins Rollback Of Obama Climate Change Initiatives: Standing among a group of coal miners at EPA headquarters, President Donald Trump on March 28, 2017, signed an executive order (EO) that begins unraveling many of President Obama’s climate change initiatives, including the centerpiece Clean Power Plan. Entitled “Promoting Energy Independence and Economic Growth,” the EO seeks to advance “safe development of our Nation’s vast energy resources, while at the same time avoiding regulatory burdens that unnecessarily encumber energy production, constrain economic growth, and prevent job creation.” The EO requires all federal agencies to begin an immediate review of all existing regulations, orders, guidance documents, policies, and any other similar agency actions that potentially burden the development or use of domestically produced energy resources, with particular attention to oil, natural gas, coal, and nuclear energy resources. Agencies have 45 days to submit to the Office of Management and Budget (OMB) a plan to carry out this review and four months to complete the review and submit a draft final report detailing the agency actions to comply with the mandate. The final report should be completed within six months of the date of the EO. President Trump’s EO also rescinds the following EOs and reports issued during the Obama Administration:

  • Executive Order 13653 of November 1, 2013 (Preparing the United States for the Impacts of Climate Change);
     
  • The Presidential Memorandum of June 25, 2013 (Power Sector Carbon Pollution Standards);
     
  • The Presidential Memorandum of November 3, 2015 (Mitigating Impacts on Natural Resources from Development and Encouraging Related Private Investment);
     
  • The Presidential Memorandum of September 21, 2016 (Climate Change and National Security);
     
  • The Report of the Executive Office of the President of June 2013 (The President's Climate Action Plan); and
     
  • The Report of the Executive Office of the President of March 2014 (Climate Action Plan Strategy to Reduce Methane Emissions).
     

The Council on Environmental Quality (CEQ) also must rescind its final guidance entitled “Final Guidance for Federal Departments and Agencies on Consideration of Greenhouse Gas Emissions and the Effects of Climate Change in National Environmental Policy Act Reviews,” which is referred to in the August 5, 2016, Notice of Availability. 81 Fed. Reg. 51866. Of course the main target of the EO is EPA’s Clean Power Plan. Under the EO, EPA must “immediately take all steps necessary to review the [Clean Power Plan] . . . for consistency with the policy set forth in section 1 of this order and, if appropriate, shall, as soon as practicable, suspend, revise, or rescind the guidance, or publish for notice and comment proposed rules suspending, revising, or rescinding those rules.” Also on the chopping block is the social cost of the carbon rule. The EO also lifts the Department of the Interior’s (DOI) ban on coal mining on federal land. It also orders EPA to review the June 2016 emission standards for oil and gas sites. In response to the order, EPA on April 4, 2017, announced in the Federal Register that it is reviewing the Clean Power Plan (82 Fed. Reg. 16329), the New Source Performance Standards (NSPS) for greenhouse gas (GHG) emissions from new, modified, and reconstructed power plants (82 Fed. Reg. 16330), and the Oil and Gas NSPS (82 Fed. Reg. 16331). For each of these rulemakings, EPA stated that after the review, it may “if appropriate . . . initiate[] proceedings to suspend, revise, or rescind” the rules.

Court Gives EPA Three Years To Conduct Risk And Technology Review Under The CAA For 20 Industrial Sectors: On March 13, 2017, the U.S. District Court for the D.C. Circuit issued a ruling giving EPA three years to complete risk and technology reviews (RTR) under the Clean Air Act (CAA) for 20 industrial sectors. In the case, California Communities Against Toxics had filed suit over EPA’s failure to conduct RTRs for these sectors. Under the CAA, EPA is required to conduct these reviews once it has promulgated a national emission standard for hazardous air pollutants (NESHAP). If the review finds any “residual risks” or a new cost-effective technology to control pollutants, or both, EPA has the authority to strengthen the NESHAP. The industrial sectors affected by the ruling are: Solvent Extraction for Vegetable Oil; Boat Manufacturing; Surface Coating of Metal Coil; Cellulose Products Manufacturing; Ethylene Production; Paper and Other Web Coating; Municipal Solid Waste Landfills; Hydrochloric Acid Production; Reinforced Plastic Composites Production; Asphalt Processing and Roofing Manufacturing; Integrated Iron and Steel Manufacturing; Engine Test Cells/Stands; Site Remediation; Miscellaneous Organic Chemical Manufacturing; Surface Coating of Metal Cans; Surface Coating of Miscellaneous Metal Parts and Products; Organic Liquids Distribution; Stationary Combustion Turbines; Surface Coating of Plastic Parts and Products; and Surface Coating of Automobiles and Light-Duty Trucks.

EPA Releases NOx/SOx/PM Ecological Assessment For Comment: EPA on March 30, 2017, released for public comment its draft “First External Review Draft Integrated Science Assessment for Oxides of Nitrogen, Oxides of Sulfur, and Particulate Matter -- Ecological Criteria.” 82 Fed. Reg. 15702. The draft document was prepared by the National Center for Environmental Assessment (NCEA) within EPA’s Office of Research and Development (ORD) as part of the review of the secondary National Ambient Air Quality Standards (NAAQS) for oxides of nitrogen (NOx), oxides of sulfur (SOx), and particulate matter (PM). The document, along with additional technical and policy assessments, provides the scientific basis for EPA’s decisions on the adequacy of the current NAAQS and the appropriateness of possible alternative standards. EPA will take comments on the draft document until May 24, 2017. The document is available online.

PHMSA Issues Final Rule Harmonizing HMRs With International Standards: On March 30, 2017, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a final rule to amend the Hazardous Materials Regulations (HMR) to maintain consistency with international regulations and standards. 82 Fed. Reg. 15796. The rule incorporates various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. PHMSA states that these revisions are necessary to harmonize the HMR with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization’s (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the United Nations (UN) Recommendations on the Transport of Dangerous Goods -- Model Regulations. Additionally, PHMSA is adopting several amendments to the HMR that result from coordination with Canada under the U.S.-Canada Regulatory Cooperation Council. The changes were effective March 30, 2017.

PHMSA Extends Comment Period On Adding Volatility Criteria To Classification Of Flammable Materials: On March 21, 2017, PHMSA extended for 60 days the comment period on its January 18, 2017, advance notice of proposed rulemaking (ANPRM) addressing the volatility of unrefined petroleum products and potentially all Class 3 flammable liquids. 82 Fed. Reg. 14499. The ANPRM discussed a possible change to the HMRs based on a petition for rulemaking submitted by the Attorney General of the State of New York regarding vapor pressure limits for crude oil. The ANPRM posed 39 questions on a wide variety of topics ranging from sampling and testing, proper classification, and numerous characteristics of crude oil relevant to its unique hazards. Specifically, PHMSA sought comments on whether there should be national vapor pressure standards for petroleum products and/or other Class 3 hazardous materials and, if so, recommendations for such thresholds. PHMSA received an initial request from the American Petroleum Institute to extend the comment period by 30 days. PHMSA subsequently received additional requests from several other parties to extend the comment period. Given the number and variety of requests, PHMSA is extending the comment period by 60 days to May 19, 2017.

FAA And PHMSA To Hold Virtual Public Meeting On Potential Revisions To Dangerous Goods Regulations: DOT’s Federal Aviation Administration (FAA) and PHMSA will hold a virtual public meeting via WebEx on April 20, 2017, from 9:00 a.m. to 12:00 p.m. (Eastern). 82 Fed. Reg. 18071. The purpose of the meeting is to take public comment to help FAA and PHMSA prepare for the upcoming ICAO Dangerous Goods Panel meeting. That meeting will take place April 24 - 28, 2017, in Montreal, Canada. Copies of working papers, informal papers, the meeting agenda, and report will be posted online when they are available. Participants are requested to register by using the following e-mail address: 9-AWA-ASH-ADG-HazMat@faa.gov.

EPA Proposes To Delay RMP Final Rule: On April 3, 2017, EPA proposed to delay the effective date of the final rule that amends the Risk Management Program (RMP) regulations under the CAA published in the Federal Register on January 13, 2017. 82 Fed. Reg. 16146. On March 16, 2017, EPA published in the Federal Register a stay and delay of the effective date pending reconsideration to June 19, 2017. EPA is proposing further to delay the effective date to February 19, 2019. This action would allow the Agency time to consider petitions for reconsideration of this final rule and take further regulatory action, which could include proposing and finalizing a rule to revise the RMP amendments. Written comments must be received by May 19, 2017. EPA will hold a public hearing on this proposed rule on April 19, 2017, in Washington, D.C.

Supreme Court Moves Forward With Resolving Venue Debate In Clean Water Rule Legal Challenge: On April 3, 2017, the U.S. Supreme Court issued an order denying EPA’s and the U.S. Army Corps of Engineers’ (Corps) motion to postpone proceedings in the Court’s review of the U.S. Court of Appeals for the Sixth Circuit’s ruling on a threshold venue issue in the litigation over the Clean Water Rule (CWR) , or “Waters of the U.S.” (WOTUS) rule. The Court previously granted a September 2, 2016, petition for review filed by a group of industry litigants led by the National Association of Manufacturers (NAM), and supported by several agriculture groups and states. NAM and others disagree with the Sixth Circuit’s application of Clean Water Act (CWA) Section 509(b), which outlines seven categories of agency actions for which original jurisdiction to review the action resides with the U.S. Circuit Courts of Appeal. The industry challengers assert that the CWR does not fit within any Section 509(b) categories, and petitions filed with the U.S. District Court should have been allowed to proceed. Following President Trump’s February 28, 2017, EO directing EPA and the Corps to review and rescind or replace the CWR, EPA and the Corps moved to postpone the Supreme Court’s review on the grounds that the rule is likely to be substantially revised in the near future. The Supreme Court disagreed and briefing will now resume with the petitioners’ briefs due April 27, 2017. The Court is expected to schedule oral arguments sometime during the October 2017 term. NAM and others support Supreme Court review in spite of the likely rescission of the CWR. Proponents assert that resolving the debate over which court should review a rule clarifying the definition of WOTUS will avoid revisiting this issue and delay a review of the merits in any future legal challenge of the revised rule. The litigation over the CWR began in summer 2015 and several months were consumed with disputes amongst the parties over the appropriate venue. The Administration has signaled its intention to move quickly with rescinding the CWR and proposing a revised rule as early as summer 2017. Additional information on the anticipated fate of WOTUS, as well as a summary and comparison of some of the key concepts and provisions within the CWR are available in our memorandum What’s Next for “Waters of the U.S.”?

Federal Court Invalidates Air Reporting Exemption For Large-Scale Livestock Operations: On April 11, 2017, the U.S. Court of Appeals for the District of Columbia issued a decision vacating EPA’s rule exempting livestock feeding operations from air reporting requirements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the Emergency Planning and Community Right-to-Know Act (EPCRA). Large-scale animal feeding operations that confine, for example, more than 1,000 cattle, 2,500 hogs, or 125,000 chickens are categorized as concentrated animal feeding operations (CAFO) for regulatory purposes. Animal waste from CAFOs is collected in lagoons that release ammonia and hydrogen sulfide into the air. Ammonia and hydrogen sulfide are classified as “hazardous” under CERCLA, and “extremely hazardous” under EPCRA. Under both statutes, the reportable quantity is 100 lbs/day. EPCRA’s parallel reporting requirement mandates notification of releases to state and local authorities. In 2008, EPA promulgated the CERCLA/EPCRA Administrative Reporting Exemption for Air Releases of Hazardous Substances from Animal Waste at Farms. 73 Fed. Reg. 76948. The final rule exempted all farms from CERCLA reporting requirements for air releases from animal wastes. In response to concerns raised in public comments, EPA scaled back a similar proposed EPCRA exemption, and required CAFOs to continue reporting air emissions under EPCRA.

Environmental groups led by Waterkeeper Alliance challenged the final 2008 rule and an industry coalition led by National Pork Producers Council (NPPC) intervened. Waterkeeper asserted that EPA does not have authority under either CERCLA or EPCRA to carve out exemptions, and that the exemption was arbitrary in treating CAFOs separately from other sources like waste at zoos or slaughterhouses. NPPC asserted that the exception requiring EPCRA reporting from CAFOs goes beyond the statutory purpose of facilitating emergency response as EPA based its decision on the public’s interest in information. NPPC and others also pointed to legal precedent for recognizing an agency’s de minimis authority to create certain categorical exceptions to a statute “when the burdens of regulation yield a gain of trivial or no value.” EPA noted that notifications of air releases from animal waste have never resulted in response action, and it could not foresee future enforcement “because in all instances the source (animal waste) and nature (to the air over a broad area) are such that on-going releases makes an emergency response unnecessary, impractical and unlikely.”

The D.C. Circuit Court disagreed with EPA’s assertion that the reporting requirements would yield no regulatory benefit. The court cited numerous scenarios raised in public comments which support that the reports will be helpful in meeting statutory goals, including cases where people have become seriously ill or even died from the rapid release of hydrogen sulfide and ammonia during manure pit agitation for pumping purposes. The court noted the role of information in enabling a response from local and state authorities. The court also highlighted EPA’s broad response authority, including remedial and removal actions under CERCLA. The court was also not persuaded by cost-benefit arguments (i.e., the final rule estimated a ten-year cost savings of $60 million for operators, and 160,000 hours and $8 million in federal resources). It is unclear at this time whether EPA or the industry litigants will appeal the decision.

Although the exemption at issue applies to livestock operations, the decision could be used as precedent for challenges to other federal agency exemptions from statutory requirements. With an Administration in favor of regulatory rollbacks, any rules that carve out regulatory exemptions are likely to be met with strong opposition by environmental groups. Even in cases where enforcement may be impractical, if the requirement creates a public benefit or ameliorates a potential harm, then an agency will need to rely on more than practicality to justify an exemption. With an estimated 15,500 feeding operations impacted nationwide, there is sufficient need for technological advancements that will control and mitigate hazardous emissions from manure pits. The U.S. Department of Agriculture Agricultural Research Service (USDA-ARS) published research in 2010 demonstrating ammonia removal and recovery from liquid manure using gas-permeable membranes. USDA-ARS subsequently filed a patent to develop the technology and is seeking a commercial partner to develop the technology.

EPA To Reconsider Utility ELG; Issues Administrative Stay Of The Rule: In a letter dated April 12, 2017, EPA Administrator Scott Pruitt stated that EPA is reviewing the 2015 final rule setting effluent limitations guidelines (ELG) for the steam electric power sector (80 Fed. Reg. 67893 (Nov. 3, 2015)). Mr. Pruitt also stated that EPA has administratively stayed the rule during the reconsideration process. The letter responds to petitions from the Utility Water Action Group dated March 24, 2017, and the U.S. Small Business Administration dated April 5, 2017, to EPA requesting reconsideration and an administrative stay of provisions of the final rule. Mr. Pruitt stated that “[a]fter considering your petitions, I have decided that it is appropriate and in the public interest to reconsider the rule. The EPA is acting promptly to issue an administrative stay of the compliance dates in the rule that have not yet passed pending judicial review.” The stay will be effective upon its publication in the Federal Register. Mr. Pruitt added that EPA intends to request that the U.S. Court of Appeals for the Fifth Circuit stay the pending litigation on the rule until September 12, 2017. By that time, EPA intends to inform the court of the portions of the rule, if any, that it seeks to have remanded to EPA for further rulemaking. Also, because an administrative stay lasts only during the pendency of judicial review, EPA intends to conduct notice and comment rulemaking during the reconsideration period to stay or amend the compliance deadlines for the rule.

FDA

FDA To Host Regional Public Meeting With Health Canada On ICH: On March 13, 2017, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register of a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH),” scheduled for April 24, 2017, from 11:00 a.m. to 2:00 p.m. (EDT) at 10903 New Hampshire Avenue, Bldg. 31, Rm. 1503 Section A, in Silver Spring, Maryland 20993. 82 Fed. Reg. 13458. The notice states that the goal of this meeting is to “provide information and receive comments on the current activities of ICH, as well as the upcoming ICH meetings in Montreal,” and the topics to be covered are the topics for discussion at the forthcoming ICH Assembly Meeting in Montreal, Canada, scheduled for May 28 through June 1, 2017. FDA will also solicit public input prior to the ICH Assembly meeting and the Expert Working Group meetings in Montreal, Canada, and is accepting comments on the public meeting until May 12, 2017.

FDA Issues Guidance For Industry Recognizing DUNS Number As Acceptable For Importer Identification: On March 31, 2017, FDA announced the issuance of its guidance for industry formally recognizing the Data Universal Numbering System (DUNS) as an acceptable unique facility identifier (UFI) for Foreign Supplier Verification Programs (FSVP), Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation. FDA states that it is a step towards ensuring the accuracy of its inventory of importers responsible for meeting the requirements of the FSVP rule, and that the identification of importers will help FDA effectively implement, monitor compliance with, and enforce the FSVP requirements, which are designed to help ensure that imported foods meet U.S. safety standards. The DUNS number, assigned and managed by Dun & Bradstreet (D&B), is available free of charge to importers and can be obtained by contacting D&B. The first compliance date for importers subject to the FSVP rule is May 30, 2017.

FDA Submits Petition Proposing The Repeal Of The Color Additive Regulation For Lead Acetate: On April 4, 2017, FDA issued a notice in the Federal Register announcing that it filed a color additive petition submitted by a group of petitioners including the Environmental Defense Fund, Earthjustice, and the Environmental Working Group, among others, proposing that FDA repeal the color additive regulation for lead acetate that permits the use of lead acetate in cosmetics intended for coloring hair on the scalp only. 82 Fed. Reg. 16321. Petitioners claim that “there is no longer a reasonable certainty of no harm from the use of lead acetate for coloring hair on the scalp,” as new data demonstrate. The petitioners cite conclusions by the National Toxicology Program, the Centers for Disease Control and Prevention, EPA, and decisions related to lead and lead compounds by other national regulatory agencies, including Health Canada. Comments are due by June 5, 2017.

FDA Announces Three Waivers To Sanitary Transportation Rule: On April 6, 2017, FDA published three waivers to the now final Sanitary Transportation rule mandated by the FDA Food Safety Modernization Act (FSMA) for businesses whose transportation operations are subject to separate state-federal controls in the Federal Register. 82 Fed. Reg. 16733. The waivers include:

  • Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products;
     
  • Food establishments authorized by the regulatory authority to operate when engaged as receivers, or as shippers and carriers in operations in which food is delivered directly to consumers, or to other locations the establishments or affiliates operate that serve or sell food directly to consumers (e.g., restaurants, supermarkets, and home grocery delivery services); and
     
  • Businesses transporting molluscan shellfish (such as oysters, clams, mussels, or scallops) that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority.
     

FDA reviewed comments on the waivers after they were included in the proposed rule and found that the waivers would not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest. The waivers became effective on April 6, 2017.

FDA Calls On Experts For Answers Regarding Evolution Of Federal-State Partnership To Implement The FSMA: On April 6, 2017, FDA posted on its website the transcript of a conversation among Erik Mettler, Acting Deputy Commissioner for Foods and Veterinary Medicine, Richard Ball, New York’s Commissioner of Agriculture and Markets, and Joseph Corby, Executive Director of the Association of Food and Drug Officials, about the evolution of the federal-state partnership to implement the FDA FSMA. FDA posted answers to the following questions that were posed to Mettler, Ball, and Corby:

  • Why are the cooperative agreements with the states so important in implementing the produce safety rule?
     
  • When FDA was establishing the produce safety cooperative-agreement framework, what was it hearing from the states? What drove this decision to award this funding?
     
  • Could the states protect the health of their citizens without this kind of FDA involvement?
     
  • What challenges and critical issues do you see ahead, especially as it relates to the produce rule?
     
  • Is there anything that has surprised you about this FDA-state partnership?
     
  • How do you see the federal-state partnership evolving?
     

FDA To Hold Public Meeting In Preparation For International Cooperation On Cosmetics Regulation (ICCR-11) Meeting: On April 7, 2017, FDA issued a notice in the Federal Register announcing that it will hold a public meeting to receive input on topics pertaining to the regulation of cosmetics on May 25, 2017, from 2:00 p.m. to 4:00 p.m. (EDT) at the Harvey W. Wiley Federal Building, 5001 Campus Drive, Auditorium (first floor) in College Park, Maryland 20740, in preparation for the International Cooperation on Cosmetics Regulation-11 (ICCR-11) meeting to be held July 12-14, 2017, in Brasilia, Brazil. 82 Fed. Reg. 17012. At the ICCR meeting, the ICCR regulatory authority members will enter into constructive dialogue with their relevant cosmetics industry trade associations and public advocacy groups. The notice states that the purpose of the multilateral framework on the ICCR is to “pave the way for the removal of regulatory obstacles to international trade while maintaining global consumer protection.” Registration is requested by May 11, 2017, via e-mail to Jonathan Hicks at the Office of Cosmetics and Colors (jonathan.hicks@fda.hhs.gov) (include your name, title, affiliation, address, e-mail, and telephone number).

Comment Periods Extended For Documents Related To Certain Biotechnology And Mosquito-related Products: On April 13, 2017, FDA issued two Federal Register notices extending the comment period for (1) the draft guidance for industry, Regulation of Intentionally Altered Genomic DNA in Animals (82 Fed. Reg. 17844), and (2) comments on the use of genome editing techniques to produce new plant varieties that are used for human or animal food (82 Fed. Reg. 17840), in response to several requests for an extension. For the draft guidance, comments were specifically requested on expanding the scope of the guidance to address animals intentionally altered through use of genome editing techniques, nomenclature, and on whether certain types of genome editing may pose minimal risk. For the use of genome editing techniques, comments were specifically requested on specific questions related to foods derived from such genome edited plant varieties. Comments for both the draft guidance and the use of genome editing techniques are now due by June 19, 2017.

NANOTECHNOLOGY

SCCS Issues Final Opinion On Additional Coatings For Titanium Dioxide (Nano Form) As UV-Filter In Dermally Applied Cosmetic Products: On March 7, 2017, the Scientific Committee on Consumer Safety (SCCS) issued a final opinion on additional coatings for titanium dioxide (nano form) coated with cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane as an ultraviolet (UV)-filter in dermally applied cosmetics. The conclusion states that given a general lack of dermal absorption and low general toxicity of nano-forms of titanium dioxide, SCCS considers that the use of the three titanium dioxide nanomaterials, coated with either cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane, can be considered safe for use in cosmetic products intended for application on healthy, intact, or sunburned skin. The opinion does not apply to applications that might lead to exposure of the consumer’s lungs to the titanium dioxide nanoparticles through the inhalation route (such as powders or sprayable products). The public consultation will end May 14, 2017.

IRSST Publishes Report For Project On Development And Validation Of Methods For Sampling And Characterizing Engineered Nanomaterials In Air And On Workplace Surfaces: On March 7, 2017, the Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST) published the final report for Project 2013-0059, “The Development and Validation of Methods for Sampling and Characterizing Engineered Nanomaterials in Air and on Workplace Surfaces.” The report is available in French, but the abstract is available in English. The main goal was to develop innovative methodological approaches for detailed qualitative and quantitative characterization of workplace exposure to engineered nanomaterials. IRSST states the project helped to advance its knowledge of workplace assessments of engineered nanomaterials by documenting specific tasks and industrial processes, as well as certain “little investigated” engineered nanomaterials, such as nanocellulose. IRSST proposes a strategy for more accurate assessment of engineered nanomaterials exposure using methods that require a minimum of preanalytical handling: (1) testing with different direct-reading instruments, as well as sample collection and subsequent microscopic analysis, to identify clearly the work tasks that generate engineered nanomaterials; and (2) once work exposure is confirmed, specific quantification of the engineered nanomaterials detected.

NIOSH Extends Comment Period On Proposed Survey Of Engineered Nanomaterial OSH Practices: On March 14, 2017, the National Institute for Occupational Safety and Health (NIOSH) extended the comment period on the proposed information collection entitled “Survey of Engineered Nanomaterial Occupational Safety and Health (OSH) Practices.” 82 Fed. Reg. 13607. According to NIOSH, because of an improper docket opening, the comment period is extended from April 11, 2017, to May 11, 2017. More information about the survey is available in our February 14, 2017, blog item, “NIOSH Seeks Comment on Proposed Survey of Engineered Nanomaterial OSH Practices.”

CRS Report On Science And Technology Issues In The 115th Congress Includes Nanotechnology And The NNI: The Congressional Research Service (CRS) prepared a March 14, 2017, report entitled Science and Technology Issues in the 115th Congress. The report outlines science and technology policy issues that may come before the 115th Congress. The category Physical and Material Sciences includes the subcategory “Nanotechnology and the National Nanotechnology Initiative (NNI).” In 2003, Congress enacted the 21st Century Nanotechnology Research and Development Act (P.L. 108-153), providing a legislative foundation for some of the activities of the NNI, establishing programs, assigning agency responsibilities, and setting authorization levels through fiscal year (FY) 2008. The report notes that although legislation has been introduced in successive Congresses to amend and reauthorize the Act, none has been enacted into law. According to the report, Congress “has directed its attention primarily to three topics that may affect the realization of nanotechnology’s hoped-for potential: [research and development (R&D)] funding; U.S. competitiveness; and environmental, health, and safety (EHS) concerns.”

NIOSH Will Hold Public Meeting And Seeks Comments On Draft CIB On The Occupational Exposure Banding Process: Guidance For The Evaluation Of Chemical Hazards: On March 15, 2017, NIOSH published a Federal Register notice announcing the availability of a draft Current Intelligence Bulletin (CIB) entitled The NIOSH Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards for public comment. 82 Fed. Reg. 13809. NIOSH states that it recently developed a process to apply the occupational exposure banding process to a broad spectrum of occupational settings. The NIOSH process uses available, but often limited, toxicological data to determine a potential range of chemical exposure levels that can be used as targets for exposure controls to reduce risk among workers. Subchapter 3.15 of the draft CIB, “Consideration of Special Categories of Aerosols,” notes that some particles have unique physical characteristics that support modifications to the general occupational exposure banding process. According to the draft CIB, modification is necessary to address the observation that the total mass dose delivered does not always describe well the dose-response behavior for a single chemical across all particulate sizes and forms. Examples of particle categories include nanoscale solid-phase particles. NIOSH will hold a public meeting May 23, 2017, in Cincinnati, Ohio. Registration to attend the meeting in person or via remote participation is due April 21, 2017, and April 7, 2017, for non-U.S. citizens who wish to attend in person. Comments are due June 13, 2017. More information is available in our March 17, 2017, blog item, “NIOSH Will Hold Public Meeting and Seeks Comments on Draft CIB on the Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards.”

AIHA Publishes Nanomaterial Stewardship Guidance: On March 29, 2017, the American Industrial Hygiene Association (AIHA) announced the availability of nanomaterial stewardship guidance sponsored by the AIHA Nanotechnology Working Group. The guidance addresses stewardship considerations for nanomaterials and nanoproducts based on the evolving state of the science for human health hazard, exposure, and risk assessment. The guidance promotes a life cycle approach and safer design principles for particles, production, and products; reviews the regulatory landscape; and provides practical suggestions to help determine the presence of nanoscale ingredients in raw materials from suppliers. The guidance includes literature references and links related to nanomaterial stewardship compiled by the authors. More information is available in our April 3, 2017, blog item, “AIHA Publishes Nanomaterial Stewardship Guidance.”

Nanodatabase Adds 3,000th Product: The Nanodatabase, developed by the Technical University of Denmark Department of Environmental Engineering (DTU Environment), the Danish Ecological Council, and the Danish Consumer Council, announced on April 4, 2017, that it added product number 3,000. According to The Nanodatabase, most products fall into the health and fitness category (1,845) while only about one-sixth of the products fall into the home and garden category (555). Of the 1,845 products in the health and fitness category, a little more than 700 products are personal care products, about 400 are clothing, and approximately another 400 are sporting goods. The Nanodatabase states that silver is the nanomaterial reported to be used in most products, but for 60 percent of the products, the identity of the nanomaterials was not reported. The Nanodatabase includes instructions for reporting products. More information is available in our April 4, 2017, blog item, “Nanodatabase Adds 3,000th Product.”

EU Addresses The Use Of Nanomaterials In Medical Devices: On April 5, 2017, the European Parliament (EP) approved a regulation on medical devices, as well as a regulation on in vitro diagnostic medical devices. The EP’s April 5, 2017, press release states that the medical devices regulation is intended to ensure that medical devices are traceable and comply with European Union (EU) safety requirements. The medical devices regulation addresses the use of nanomaterials in medical devices. The European Commission’s April 5, 2017, fact sheet states that the critical factor in classifying devices incorporating or consisting of nanomaterials is the potential for nanomaterials to be in contact with membranes inside the body. Those devices presenting a high or medium potential for such contact will be in the highest risk class and thus be subject to the most stringent conformity assessment procedures. To allow manufacturers and authorities time to implement the regulations, the regulation on medical devices includes a three-year transition period, and the regulation on in vitro diagnostic medical devices includes a five-year transition period.

Swiss National Research Program Will Hold Closure Event In June: On June 2, 2017, the National Research Program “Opportunities and Risks of Nanomaterials” (NRP 64) will hold a closure event, parallel to the Swiss Nano Convention, which will be held June 1-2, 2017. NRP 64 began its research work in December 2010 and has studied the development, use, behavior, and degradation of synthetic nanomaterials, as well as their impact on humans and the environment. During the closure event, NRP 64 will present the most important findings and current state of the art in nanotechnology research. NRP 64’s final brochure on the results, outcome, and perspectives provides an overview of the most important highlights, insights, and recommendations to industry and regulatory entities with regard to a “suitable handling of nanomaterials from the point of fabrication, to use in practice, right down to their disposal.” More information is available in our April 12, 2017, blog item, “Swiss National Research Program Will Hold Closure Event in June.”

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (B&C®) consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.

LEGISLATIVE DEVELOPMENTS

Trump Budget Proposal Would Slash EPA’s Coffers And Staff: On March 13, 2017, President Trump released his “budget blueprint.” President Trump states in the introduction that his goal is “to reprioritize Federal spending so that it advances the safety and security of the American people.” The President’s 2018 Budget requests $5.7 billion for EPA, a cut of $2.6 billion, or 31 percent, from the 2017 level. This would result in approximately 3,200 fewer positions at EPA, whose mission would be transformed to “primarily support States and Tribes in their important role protecting air, land, and water in the 21st Century.” The budget request includes $2.3 billion for the State Revolving Funds, a $4 million increase over the 2017 level. It also provides $20 million for the Water Infrastructure Finance and Innovation Act program, equal to the funding provided in 2017. The budget request, however, discontinues funding for the Clean Power Plan, international climate change programs, climate change research and partnership programs, and related efforts. Consistent with the President’s America First Energy Plan, the budget reorients EPA’s air program “to protect the air we breathe without unduly burdening the American economy.” The budget also “reins in Superfund administrative costs and emphasizes efficiency efforts” by funding the Hazardous Substance Superfund Account at $762 million, $330 million below the 2017 level. Instead of relying on Superfund to finance remediation, EPA instead “would prioritize the use of existing settlement funds to clean up hazardous waste sites and look for ways to remove some of the barriers that have delayed the program’s ability to return sites to the community.” EPA’s enforcement offices would also be cut. The budget request “avoids duplication by concentrating EPA’s enforcement . . . on programs that are not delegated to States, while providing oversight to maintain consistency and assistance across State, local, and tribal programs.” This reduces EPA’s Office of Enforcement and Compliance Assurance budget to $419 million, $129 million below the 2017 level. President Trump would also cut almost in half the budget for EPA’s Office of Research and Development (ORD), providing funding of approximately $250 million, $233 million less than the current level. ORD would instead prioritize activities that support decision-making related to core environmental statutory requirements, as opposed to extramural activities. Another controversial aspect of the budget is that it would eliminate funding for specific regional efforts such as the Great Lakes Restoration Initiative, the Chesapeake Bay, and other geographic programs. In total, President Trump seeks to eliminate more than 50 EPA programs.

House Subcommittee Holds Hearing On Ozone Standards Implementation Act: On March 22, 2017, the House Energy and Commerce Subcommittee on the Environment held a hearing on H.R. 806, the Ozone Standards Implementation Act. The bill was introduced on February 1, 2017, by Representatives Pete Olson (R-TX), Bill Flores (R-TX), Bob Latta (R-OH), Henry Cuellar (D-TX), Sanford Bishop (D-GA), Jim Costa (D-CA), Majority Whip Steve Scalise (R-LA), Majority Leader Kevin McCarthy (R-CA), and others. The bill’s primary purpose is to delay until October 26, 2025, the date by which EPA must revise the national ambient air quality standards (NAAQS) for ground-level ozone. In October 2015, EPA promulgated a new ozone NAAQS of 70 parts per billion (ppb), a move that has been harshly criticized by many. Testifying at the hearing were Seyed Sadredin, Executive Director/Air Pollution Control Officer, San Joaquin Valley Air Pollution Control District; Nancy Vehr, Air Quality Administrator, Wyoming Department of Environmental Quality; Marc A. R. Cone, P.E., Director, Bureau of Air Quality, Maine Department of Environmental Protection; Sean Alteri, Director, Division of Air Quality, Kentucky Department of Environmental Protection; Kurt Karperos, Deputy Executive Officer, California Air Resources Board; and Homer Boushey, M.D., Division of Pulmonary/Critical Care Medicine, University of California, San Francisco. A webcast of the hearing, witness testimony, and Subcommittee member statements are available online.

House Unanimously Passes Pesticide Registration Enhancement Act: On March 20, 2017, the House unanimously passed the Pesticide Registration Enhancement Act of 2017 (H.R. 1029). Introduced by Representative Rodney Davis (R-IL), the bill reauthorizes the Pesticide Registration Improvement Act of 2003 (PRIA) and makes minor improvements. Mr. Davis is Chair of the House Agriculture Committee’s Subcommittee on Biotechnology, Horticulture, and Research. The bill would, among other things, require pesticide registratnts to pay fees to offset governmental oversight expenses and sets timelines for EPA regulatory decisions. The law “provides predictable timelines for over 200 product categories allowing industry to grow and innovate, adding jobs to the U.S. economy and providing additional options for producers,” Mr. Davis stated. H.R. 1029 is supported by a broad coalition of industry and environmental advocates, including CropLife America, NRDC, Responsible Industry for a Sound Environment, and others. The bill increases and clarifies categories covered, uses maintenance fees for registration review, protects funds for grants programs, and increases funding. The current PRIA legislation expires on September 30, 2017. H.R. 1029 extends the Act for seven years instead of the current five-year authorization. It also provides two increases of five percent each on registration fees over the seven years. The bill provides $500,000 set aside, from fees paid-for by the industry, for EPA to meet deadlines for efficacy guidelines for pesticides to combat bed bugs, and crawling and flying insects, which will inform industry what efficacy tests are required. It also increases maintenance fees to $31 million annually from 2017-2023 and provides increased funding for grant programs, promoting Good Laboratory Practices, and farm worker protection education.

Bill Would Repeal CAFE Standards For Automobiles: On March 17, 2017, Representative Roger Williams (R-TX) introduced legislation (H.R. 1593) that would repeal the corporate average fuel economy (CAFE) standards imposed on car manufacturers. The CAFE standards were created by the 1975 Energy Policy Conservation Act. They require automobile manufacturers to achieve certain targets for fuel economy. The current CAFE standards require an average fuel economy of 54.5 miles per gallon by 2025.

Latta Reintroduces Legislation To Improve Water Infrastructure: On March 21, 2017, Representative Robert Latta (R-OH) reintroducedthe Drinking Water Affordability Act (H.R. 1653) to help public water systems improve infrastructure and ensure safer drinking water. The legislation provides increased flexibility to state and local governments to meet their specific needs, develops cost-efficient ways to protect drinking water, and ensures funds are utilized efficiently and effectively. The bill would increase flexibility for the repayment of federal loans for states and local communities that use the funds to finance clean drinking water infrastructure projects. It also would remove duplicative reporting and paperwork requirements when state standards are equally stringent than federal standards. The bill also seeks to encourage the development of a long-term strategy to addressing drinking water issues and the economic barriers that make it difficult for communities to rehabilitate and replace their drinking water infrastructure.

Bipartisan Bill Would Create Foundation To Aid In Mine Cleanup: On March 22, 2017, Representatives Jody Hice (R-GA) and Alan Lowenthal (D-CA) introduced H.R. 1668, the Bureau of Land Management Foundation Act. The bill would establish a new nonprofit foundation -- the Bureau of Land Management Foundation -- that will leverage private funding to assist federal land management agencies with abandoned mine lands cleanup as well as other mission areas. Representative Hice stated that by replacing “substandard federal regulations with private sector policies and procedures, the Bureau of Land Management Foundation will increase the pace and scale of cleaning up contaminated water at abandoned mine sites across the nation.” Last Congress, Representative Hice sponsored a similar bill, H.R. 3884, the Bureau of Land Management Foundation Act, and it passed the House by a bipartisan voice vote on July 5, 2016.

House And Senate Introduce Bipartisan Bills Addressing Brownfields Program: On March 28, 2017, Representatives Elizabeth Esty (D-CT) and John Katko (R-NY) introduced bipartisan legislation to help communities revitalize neighborhoods and spur economic development through brownfields assessment and remediation. Both Esty and Katko serve on the Committee on Transportation and Infrastructure. The Brownfields Reauthorization Act of 2017 (H.R. 1758) would reauthorize and amend EPA’s Brownfields program under CERCLA (or Superfund). Originally authorized in 2002, EPA’s Brownfields program empowers states, communities, and stakeholders to assess, clean up, and redevelop sites. The program was allowed to expire in 2006, though it has continued to receive nominal funding. The Brownfields Reauthorization Act would reauthorize the Brownfields program through FY 2022, at a rate of $250 million per year. It would also increase the cleanup grant amount from $200,000 to $600,000, as well as expand eligibility requirements to certain nonprofits, limited liability corporations, limited partnerships, and community development entities. The Brownfields Reauthorization Act of 2017 would also benefit Area-Wide Revitalization Planning Grants, which are commonly used by communities when creating long-term remediation plans for brownfield sites. These grants assist communities to assess a site and the state of its infrastructure, determine the level of investment needed, and identify private and public resources available at the local and federal level while keeping current and future markets in mind. Planning Grants oftentimes expedite the time frame between the assessment and cleanup of a brownfield site. In the Senate, on April 5, 2017, Senators Jim Inhofe (R-OK), Edward Markey (D-MA), Tom Carper (D-DE), Mike Rounds (R-SD), Cory Booker (D-NJ), and Mike Crapo (R-ID) introduced S. 822, the Brownfields Utilization, Investment, and Local Development (BUILD) Act. Among other things, the BUILD Act would provide funding for technical assistance grants to small communities and rural areas, expand the scope of eligible grant recipients to include nonprofit community groups, and authorize funding for multi-purpose grants to tackle more complex sites. The bill authorizes up to $7,500 in technical assistance grants to eligible entities in small communities, Indian tribes, rural areas, and disadvantaged areas. It also expands the eligibility for brownfields grants for nonprofit organizations to include certain nonprofit organizations, limited liability corporations, limited partnerships, and community development entities. S. 822 also increases the funding limit for remediation grants to $500,000 for each site, with some exceptions for higher funding, and authorizes multi-purpose grants up to $950,000, which provide greater certainty for long-term project financing The bill reauthorizes the Brownfields program at the same authorized funding level ($250 million per year) through FY 2018.

Velázquez Seeks To Thaw EPA Hiring Freeze: Representative Nydia M. Velázquez (D-NY) on March 27, 2017, introduced legislation aimed at ensuring adequate staffing levels at EPA. The bill, H.R.1716, would exempt EPA from a Presidential Memorandum that froze staffing levels at all federal agencies. The bill was referred to the House Committee on Oversight and Government Reform and has garnered nine co-sponsors.

House Passes HONEST Act: The House of Representatives on March 29, 2017, passed the Honest and Open New EPA Science Treatment Act of 2017 (HONEST Act). Introduced by House Science, Space and Technology Committee Chair Lamar Smith (R-TX), the bill (H.R. 1430) wouldamend the Environmental Research, Development, and Demonstration Authorization Act of 1978 to prohibit EPA from proposing, finalizing, or disseminating a covered action unless all scientific and technical information relied on to support such action is the best available science, specifically identified, and publicly available in a manner sufficient for independent analysis and substantial reproduction of research results. The bill defines a “covered action” broadly to include a risk, exposure, hazard assessment, criteria document, standard, limitation, regulation, regulatory impact analysis, or guidance. The bill passed by a vote of 228 to 194.

House Passes Bill To Reform EPA Science Advisory Board: The House on March 30, 2017, by a vote of 229-193 passed the EPA Science Advisory Board Reform Act of 2017 (H.R. 1431), sponsored by Representative Frank Lucas (R-OK). The bill amends the Environmental Research, Development, and Demonstration Authorization Act of 1978 to revise the process of selecting members of the Science Advisory Board (SAB). It also sets forth guidelines for participation in SAB advisory activities and terms of office. Under the bill, at least ten percent of SAB members would be required to come from state, local, or tribal governments. The bill requires that the SAB provide its advice “independently.” It prohibits registered lobbyists from being appointed to the SAB. Under the bill, SAB members also may not have current grants or contracts from EPA and may not apply for them for three years following the end of their SAB term. EPA also would be required to provide to the SAB for review any draft risk or hazard assessments it uses in its regulatory proposals. SAB’s advice and comments must be included in the record regarding those proposals and published in the Federal Register. SAB committees and investigative panels would be required to operate in accordance with the membership, participation, and policy requirements contained in the bill, including new requirements for public participation in advisory activities of the board. The legislation also requires that the SAB strive to avoid making policy determinations or recommendations, communicate uncertainties, encourage dissenting members to make their views known, conduct periodic reviews to ensure that its activities address the most important scientific issues affecting EPA, and respond to Congress fully and in a timely manner.

Lawmakers Introduce Legislative Package To Protect Public Health, Environment From Oil And Gas Development Risk: On April 6, 2017, Representatives Matt Cartwright (D-PA), Diana DeGette (D-CO), Jared Polis (D-CO) and Jan Schakowsky (D-IL) introduced the Safe Energy Future Plan, a package of five bills intended to protect public health and the environment from the risks of oil and gas production. The main target of the package is hydraulic fracturing activities (fracking). The Focused Reduction of Effluence and Stormwater Runoff Through Hydrofracking Environmental Regulation (FRESHER Act), introduced by Cartwright, would amend the CWAto require National Pollutant Discharge Elimination System (NPDES) permits for discharges of stormwater runoff from mining and oil and gas operations or transmission facilities for collecting and conveying precipitation runoff that are not contaminated by contact with any overburden, raw material, intermediate products, finished product, byproduct, or waste products located on the site of the operations. Under the bill (H.R. 2001), DOI also must study stormwater runoff associated with oil or gas operations. Also introduced by Cartwright, H.R. 2000, the Closing Loopholes and Ending Arbitrary and Needless Evasion of Regulations (CLEANER) Act, would eliminate the Bentsen Amendment under the Resource Conservation and Recovery Act (RCRA). That provision, RCRA Section 3001(b)(2)(A), exempts from RCRA regulationdrilling fluids, produced waters, and other wastes associated with the exploration, development, and production of crude oil or natural gas or geothermal energy. H.R. 2012, introduced by DeGette, would close the so-called Halliburton Loophole under the Safe Drinking Water Act (SDWA). The bill would subject fracking operations to CWA regulation. H.R. 2059, sponsored by Polis, would eliminate exemptions in the CAA that exempt the oil and gas industry from certain regulation. Specifically, the bill would require that emissions from multiple related small sources be aggregated to determine their total emissions. Schakowsky’s bill, H.R. 1969, would amend the SDWA to require testing of underground sources of drinking water in connection with fracking operations.

House Bill Would Strengthen CWA Lead And Copper Rule: Representative Dan Kildee (D-MI) on April 6, 2017, reintroduced legislation that would require EPA to update the CWA Lead and Copper Rule within nine months. The rule has not been updated by EPA since 1991. The bill, the National Opportunity for Lead Exposure Accountability and Deterrence (NO LEAD Act; H.R. 1974), would update the rule. It would lower the action level for lead in drinking water from its current level of 15 ppb to 10 ppb by 2020, and 5 ppb by 2026.

MISCELLANEOUS

OMB Issues Memorandum Reorganizing And Reforming Federal Government: On April 12, 2017, OMB Director Mick Mulvaney issued a memorandum to the heads of all executive departments and agencies laying forth a plan to reorganize and reform the federal government. Entitled “Comprehensive Plan for Reforming the Federal Government and Reducing the Federal Civilian Workforce,” the memorandum seeks to “make government lean, accountable, and more efficient.” It also promises “to chart the course for a restrained, effective, and accountable Government to better serve the American people.” Mr. Mulvaney issued the memorandum to comply with a March 13, 2017, Presidential Executive Order on a Comprehensive Plan for Reorganizing the Executive Branch. Federal agencies must immediately act to streamline their operations. They also must develop plans to take immediate action to save taxpayer money and reduce their workforces, develop a plan to maximize the performance of government workers by the end of June 2017, and submit an Agency Reform Plan in 180 days to modernize and streamline their operations.

OMB Issues Guidance For Implementing “Two For One” EO: OMB on April 5, 2017, released guidance on the implementation of EO 13771, titled “Reducing Regulation and Controlling Regulatory Costs.” EO 13771 states that whenever a federal department or agency “publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed.” The guidance is in the form of Questions and Answers (Q&A) and addresses the requirements of EO 13771. It applies to FYs 2017 and beyond. This guidance supplements OMB’s interim guidance issued on February 2, 2017.

Trump Names Neomi Rao To Lead OIRA: President Trump announced his intent to nominate Neomi Rao as the Administrator of OMB’s Office of Information and Regulatory Affairs (OIRA), the agency charged with reviewing significant federal regulations. Rao is now associate professor of law and founder and director of the Center for the Study of the Administrative State, which is part of the Antonin Scalia Law School at George Mason University. Rao served as associate counsel to former President George W. Bush; counsel for nominations and constitutional law to the Senate Judiciary Committee; and law clerk to Supreme Court Justice Clarence Thomas.

OSHA Further Delays Effective Date For Beryllium Rule: The Occupational Safety and Health Administration (OSHA) on March 21, 2017, again delayed the effective date on its final rule setting occupational exposure levels for beryllium. 82 Fed. Reg. 14439. OSHA promulgated the standards on January 9, 2017, with an effective date of March 10, 2017. OSHA on February 1, 2017, then extended the effective date to March 21, 2017. OSHA’s action now extends the effective date to May 20, 2017.

OSHA Delays Effective Date Of Silica Rule For Construction Industry: OSHA on April 6, 2017, announced a delay in enforcement of the crystalline silica standard that applies to the construction industry to conduct additional outreach and provide educational materials and guidance for employers. OSHA has determined that additional guidance is necessary due to the unique nature of the requirements in the construction standard. Originally scheduled to begin June 23, 2017, enforcement will now begin September 23, 2017. OSHA expects employers in the construction industry to continue to take steps either to come into compliance with the new permissible exposure limit, or to implement specific dust controls for certain operations. OSHA also stated that construction employers should also continue to prepare to implement the standard’s other requirements, including exposure assessment, medical surveillance, and employee training.

EPA Seeks Comment On Existing Regulations: On April 13, 2017, in accordance with EO 13777, “Enforcing the Regulatory Reform Agenda,” EPA requested input on regulations that may be appropriate for repeal, replacement, or modification. 82 Fed. Reg. 17793. On February 24, 2017, President Trump signed EO 13777, which established a federal policy “to alleviate unnecessary regulatory burdens” on the American people. Section 3(a) of the EO directs federal agencies to establish a Regulatory Reform Task Force (Task Force). One of the duties of the Task Force is to evaluate existing regulations and “make recommendations to the agency head regarding their repeal, replacement, or modification.” The EO further asks that each Task Force attempt to identify regulations that: eliminate jobs, or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies; are inconsistent with the requirements of Section 515 of the Treasury and General Government Appropriates Act, 2001 or the guidance issued pursuant to that provision; or derive from or implement EOs or other Presidential directives that have been subsequently rescinded or substantially modified.

Section 3(e) of the EO calls on the Task Force to “seek input and other assistance, as permitted by law, from entities significantly affected by Federal regulations, including State, local, and tribal governments, small businesses, consumers, non-governmental organizations, and trade associations” on regulations that meet some or all of the criteria above. EPA seeks input from the public to inform its Task Force’s evaluation of existing regulations. EPA requests that commenters be as specific as possible, include any supporting data or other information such as cost information, provide a Federal Register or Code of Federal Regulations citation when referencing a specific regulation, and provide specific suggestions regarding repeal, replacement, or modification. Comments are due by May 15, 2017.

EPA Further Delays Effective Dates For Five Final Regulations: On March 20, 2017, and in accordance with the Presidential directive as expressed in the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” EPA issued a final rule further delaying the effective dates for the five regulations listed in the table below. 82 Fed. Reg. 14324. The effective date of each regulation listed in the table below is delayed to a new effective date of May 22, 2017. The regulations are:

Federal Register Citation

Title

Publication Date

Original Effective Date

New Effective Date

82 Fed. Reg. 2760

Addition of a Subsurface Intrusion Component to the Hazard Ranking System.

1/9/2017

2/8/2017

5/22/2017

81 Fed. Reg. 89674

Formaldehyde Emission Standards for Composite Work Products.

12/12/2016

2/10/2017

5/22/2017

82 Fed. Reg. 5182

Revisions to the Guideline on Air Quality Models: Enhancements to the AERMOD Dispersion Modeling System and Incorporation of Approaches to Address Ozone and Fine Particulate Matter.

1/17/2017

2/16/2017

5/22/2017

82 Fed. Reg. 952

Pesticides; Certification of Pesticide Applicators.

1/4/2017

3/6/2017

5/22/2017

82 Fed Reg. 2230

Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties, Issuance of Compliance or Corrective Action Orders, and the Revocation/Termination or Suspension of Permits; Procedures for Decisionmaking.

1/9/2017

3/10/2017

5/22/2017

The rule was effective March 21, 2017.

EPA Launches Back-To-Basics Agenda: Speaking at a Pennsylvania coal mine, EPA Administrator Scott Pruitt on April 13, 2017, announced EPA’s Back-to-Basics Agenda. The agenda “reinforces Administrator Pruitt’s commitment to refocusing EPA on its intended mission, returning power to the states, and creating an environment where jobs can grow.” Under the agenda, Mr. Pruitt is refocusing EPA to its core mission. This entails “protecting the environment; engaging with state, local and tribal partners; and creating sensible regulations that enhance economic growth.” Mr. Pruitt listed several specific actions EPA has taken or will take to implement this agenda. He noted that following the President’s Energy Independence EO, he signed four notices to review and, if appropriate, to revise or rescind major “economically significant, burdensome rules the last Administration issued. This includes the so-called Clean Power Plan that threatens over 125,000 U.S. jobs.” He noted that EPA is restoring states’ important role in the regulation of local waters by reviewing the WOTUS rule. As to TSCA issues, “EPA is clearing the backlog of new chemicals that were waiting approval from EPA, so they can go to market, and companies can innovate and create jobs,” he stated. “EPA is helping states achieve high air quality targets, clean up toxic waste sites and improve America’s water infrastructure.” And he lauded the fact that EPA rescinded “an unjustified, premature evaluation of greenhouse gas and fuel economy standards for model year 2022-2025 vehicles.” Also included is EPA’s review of the Oil and Gas Methane NSPS for new and modified sources to determine whether it is duplicative and the associated Information Collection Request (ICR). Finally, he stated that EPA has launched its Regulatory Reform Task Force to undergo extensive reviews of the “misaligned regulatory actions.”

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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