Archives

May 1, 2023

OMB Seeks Input on Bioeconomy-Related Industries and Products

By Lynn L. Bergeson and Carla N. Hutton   The Office of Management and Budget (OMB) published a request for information (RFI) on April 27, 2023, seeking public input on existing or potential bioeconomy-related industries and products that are established, emerging, or currently embedded in existing industry/manufacturing processes. 88 Fed. Reg. 25711. As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a...
March 3, 2023

OIRA Calls for Feedback on Recommendations to Encourage More Engagement in the Regulatory Process; Will Hold Listening Session on March 7

In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invites feedback on the recommendations as it continues to...
March 3, 2023

OIRA Calls for Feedback on Recommendations to Encourage More Engagement in the Regulatory Process; W

By Lynn L. Bergeson and Carla N. Hutton   In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invites feedback on the recommendations...
February 16, 2022

EPA Submits Final Rule on PIP (3:1) Compliance Date Extension to OMB

On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles and the PIP (3:1) used to make those articles until October 31, 2024, along with the associated recordkeeping...
February 9, 2022

EPA Seeks Comment on Proposed Renewal of ICR for TSCA Section 8(e) and FYI Notices

On February 8, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): “Notification of Substantial Risk of Injury to Health and the Environment under the Toxic Substances Control Act (TSCA),” identified by EPA ICR No. 0794.17 and OMB Control No. 2070-0046. 87 Fed. Reg. 7173. The ICR represents the renewal...
January 31, 2022

OMB Reviewing Proposed Rule on Procedures for Submitting Information Subject to CBI Claims under TSCA

On January 20, 2022, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) concerning the procedures for submitting information subject to business confidentiality claims under the Toxic Substances Control Act (TSCA). According to an item in the fall 2021 Unified Agenda, EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential...
August 27, 2020

EPA Proposes to Extend ICR Regarding TSCA Section 8(a) Reporting and Recordkeeping Requirements for Certain Nanoscale Materials

The U.S. Environmental Protection Agency (EPA) announced on August 27, 2020, that it submitted an information collection request (ICR), “Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials” to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA).  85 Fed. Reg. 52995.  The ICR covers reporting and recordkeeping requirements for persons who manufacture or...
June 10, 2020

OMB Begins Review of Final SNUR on LCPFAC and PFAS Chemical Substances

On June 3, 2020, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances.  On March 3, 2020, EPA published a proposed supplemental SNUR for LCPFAC chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface...
February 19, 2020

OMB Finishes Review of Proposed SNUR on LCPFAC and PFAS Chemical Substances

As reported in our October 1, 2019, blog item, on September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  According to OMB’s website, OMB completed its review on February 14, 2020.  EPA has not yet publicly released the proposed rule. According...
October 1, 2019

EPA Submits Proposed SNUR on LCPFAC and PFAS Chemical Substances to OMB for Review

On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC...
September 12, 2019

CDC Seeks Additional Comment on Proposed NIOSH Project That Will Survey Engineered Nanomaterial Occupational Safety and Health Practices

The Centers for Disease Control and Prevention (CDC) published a Federal Register notice on September 11, 2019, to provide an additional 30-day comment period on its proposed information collection project entitled “Survey of Engineered Nanomaterial Occupational Safety and Health Practices.”  84 Fed. Reg. 47957.  As reported in our April 24, 2019, blog item, on April 23, 2019, CDC published a Federal Register notice inviting comment on the proposed...
August 23, 2019

FDA Announces Collection Of Information Submission To OMB

By Lynn L. Bergeson On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which...
November 16, 2018

EPA Submits ICR To OMB On RFS Recordkeeping And Reporting

By Lynn L. Bergeson On November 13, 2018, the U.S. Environmental Protection Agency (EPA) announced the submission for review of an information collection request (ICR) on the Renewable Fuel Standard (RFS) Program to the Office of Management and Budget (OMB).  83 Fed. Reg. 56319.  The Federal Register notice states that purpose of this submission is to obtain OMB approval of an ICR that consolidates some existing collections.  By consolidating the existing collections and...
November 9, 2018

FDA Submits A Collection Of Information Proposal To OMB

By Lynn L. Bergeson On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act...
September 7, 2018

OMB Reviewing Final Rule Regarding TSCA User Fees

On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA).  As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical...
June 13, 2018

EPA’s Spring 2018 Unified Agenda and Regulatory Plan Includes Pesticide Rulemakings

On May 9, 2018, the Office of Information and Regulatory Affairs (OIRA) posted the Spring 2018 Unified Agenda and Regulatory Plan.  OIRA states that the semi-annual Unified Agenda and Regulatory Plan “provide uniform reporting of data on regulatory and deregulatory actions under development throughout the Federal government, covering over 60 departments, agencies, and commissions.”  Below are highlights of rulemakings from the U.S. Environmental Protection Agency’s (EPA)...
May 18, 2018

EPA Sends Proposed Rule For 2019 RFS Volumes To OMB

By Lynn L. Bergeson On May 11, 2018, the U.S. Environmental Protection Agency (EPA) sent a proposed renewable fuel standard (RFS) biofuel volumes rule for 2019 to the White House Office of Management and Budget (OMB) for pre-publication review.  The proposed rule addresses 2019 renewable blending obligations for cellulosic biofuel, advanced biofuel, and total biofuel, with a proposed 2020 percentage standard for biomass-based diesel. The 2019 blending requirement for biomass-based...
May 11, 2018

OMB Receives Final Rule on Mercury Reporting Requirements

On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory.  The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements...
April 27, 2018

EPA Releases Strengthening Transparency in Regulatory Science Proposed Rule

On April 30, 2018, the U.S. Environmental Protection Agency (EPA) will publish in the Federal Register a proposed rule entitled “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.”  EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of...
March 23, 2018

USDA Seeks Public Comment On Collection Of Biobased Procurement Data

By Lynn L. Bergeson On March 12, 2018, the U.S. Department of Agriculture (USDA) issued in the Federal Register a notice announcing the submission of an information collection request (ICR) on the guidelines for designating biobased products for federal procurement to the Office of Management and Budget (OMB). Pursuant to Section 9002 of the Farm Security and Rural Investment Act (FSRIA) of 2002, as amended by the Food, Conservation, and Energy Act (FCEA) of 2008, and...
September 1, 2017

OMB Reviewing Proposed Rule Regarding Reporting Requirements for a Mercury Inventory

On August 17, 2017, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule regarding reporting requirements for a mercury inventory to the Office of Management and Budget (OMB).  The proposed rule would establish reporting deadline(s) and information requirements for the purpose of assisting EPA’s periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  As required under the Frank R. Lautenberg Chemical Safety for the...
June 15, 2017

EPA Submits Guidance on Draft Risk Evaluations under TSCA to OMB

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested...
May 25, 2017

EPA Submits Final Rulemaking on Procedures to Prioritize Chemicals for Risk Evaluation under TSCA to OMB for Review and Approval

On May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the...
May 5, 2017

USDA Seeks Comment On Revision To Information Collection For The Advanced Biofuel Payment Program

By Kathleen M. Roberts On April 25, 2017, the U.S. Department of Agriculture’s (USDA) Rural Business-Cooperative Service published in the Federal Register a notice that it is requesting approval from the Office of Management and Budget (OMB) of a revision to a currently approved information collection for the Advanced Biofuel Payment Program, which provides funding to eligible advanced biofuel producers to support the production of biofuel products.  The Rural Business-Cooperative...
March 7, 2017

OMB Issues Data Call for Unified Agendas by March 31, 2017

On March 6, 2017, the White House’s Office of Management and Budget (OMB), via the Office of Information and Regulatory Affairs (OIRA), issued Memorandum:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions, a memorandum for regulatory policy officers at executive departments and agencies and managing and executive directors of certain agencies and commissions, with the subject:  Spring 2017 Data Call for the Unified Agenda of Federal...
March 3, 2017

President Trump Issues Executive Order Enforcing Regulatory Reform Agenda

On March 1, 2017, President Trump’s Executive Order (EO) 13777, Enforcing the Regulatory Reform Agenda, issued on February 24, 2017, was published in the Federal Register. 82 Fed. Reg. 12285.  This EO follows closely on the heels of his previous EO concerning government regulations (EO 13771), but is different in that it is intended to further and enforce President Trump’s EO as well as EO’s issued in prior administrations, instead of creating an entirely new set...
February 7, 2017

OMB Issues Guidance on Implementation of “One In, Two Out” Executive Order

On February 2, 2017, Dominic J. Mancini, Acting Administrator of the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued interim guidance in a questions and answers format (Q&A) to implement President Trumps’s recent Executive Order (EO) regarding the costs of agency rulemaking, Memorandum:  Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, Titled “Reducing Regulation and Controlling Regulatory...
February 7, 2017

OMB Issues Guidance on Implementation of “One In, Two Out” Executive Order

On February 2, 2017, Dominic J. Mancini, Acting Administrator of the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) issued interim guidance in a questions and answers format (Q&A) to implement President Trumps’s recent Executive Order (EO) regarding the costs of agency rulemaking, Memorandum:  Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017, Titled “Reducing Regulation and Controlling Regulatory...
November 9, 2016

OMB Receives Prioritization Process Rule From EPA Under New TSCA

On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency.  Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA’s process and criteria for identifying high priority...
May 19, 2016

EPA Intends to Promulgate Final Nanoscale Materials Rule in October 2016

According to an item in the Spring 2016 Regulatory Agenda, the U.S. Environmental Protection Agency (EPA) is “developing a final rule related to” its April 6, 2015, proposal to require reporting and recordkeeping requirements under Section 8(a) of the Toxic Substances Control Act (TSCA) for certain chemical substances when they are manufactured or processed at the nanoscale.  EPA proposed to require persons that manufacture, import, or process, or intend to manufacture, import, or process...
August 29, 2014

EPA Sends Final Targets For 2014 Biofuel To OMB

On August 22, 2014, the U.S. Environmental Protection Agency (EPA) sent the final 2014 Renewable Fuel Standard (RFS) rule to the Office of Management and Budget (OMB) for its review and formal publication in the Federal Register. This much anticipated review is the last step before public release. Nearly nine months behind schedule currently, it is unclear whether OMB will move quickly to release and publish the rule. Typically, OMB can take anywhere between 30...
June 14, 2011

White House ETIPC Releases Policy Principles Concerning Regulation and Oversight of Nanotechnology and Nanomaterials

On June 9, 2011, the Office of Science and Technology Policy (OSTP) announced that the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) has developed a set of principles specific to the regulation and oversight of applications of nanotechnology. The principles are intended to guide the development and implementation of policies, as described in the title “U.S. Decision-making Concerning Regulation and Oversight of Nanotechnology and Nanomaterials” that...
March 17, 2011

Obama Administration Sets Forth Principles for Regulation and Oversight of Emerging Technologies

A March 11, 2011, memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) sets forth the Obama Administration’s principles for regulation and oversight of emerging technologies, including nanotechnology. The ETIPC Co-Chairs include John P. Holdren, Assistant to the President for Science and Technology, Director, Office of Science and Technology Policy (OSTP); Cass R. Sunstein, Administrator, Office of Information and Regulatory...
November 23, 2010

EPA Submits Proposed TSCA Section 8(a) Reporting Rule for Nanoscale Materials to OMB for Review

On November 22, 2010, the U.S. Environmental Protection Agency (EPA) submitted a proposed Toxic Substances Control Act (TSCA) Section 8(a) reporting rule to the Office of Management and Budget (OMB) for review. According to EPA’s April 26, 2010, Regulatory Agenda, the proposed rule would require persons who manufacture nanoscale materials notify EPA of certain information including available use, production volume, methods of manufacture and processing, exposure and release information, and...
August 4, 2010

OMB Receives EPA Notice Concerning Pesticide Products Containing Nanoscale Materials

According to the Office of Management and Budget (OMB) website, on July 30, 2010, OMB received from the U.S. Environmental Protection Agency (EPA) a notice concerning “Pesticide Products Containing Nanoscale Materials.” No additional information regarding the notice is available on OMB’s website. During the April 29, 2010, meeting of EPA’s Pesticide Program Dialogue Committee (PPDC), William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), stated that EPA was in the...