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EPA Proposes Landmark Rule Setting General Requirements and Procedures for Guidance Documents

On May 22, 2020, the U.S. Environmental Protection Agency (EPA) published a proposed rule in the Federal Register establishing procedures for issuing and managing guidance documents.[1] The rule was required by the 2019 Executive Order (E.O.) 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents[2] and complements EPA’s consolidated Guidance Portal established earlier this year. Comments on the proposal are due June 22, 2020.

This is the first time EPA has proposed to codify formal procedures for developing, modifying, and rescinding guidance. However, unlike most other procedural rules, these procedures would not have the force and effect of law, and would not be binding on EPA or enforceable by the public. Nevertheless, they are expected to significantly alter the way EPA issues and uses guidance and to offer the regulated community and public a clearer pathway to seek changes to Agency interpretive decisions reflected in guidance.

  • Scope. Consistent with implementing guidance from the Office of Management and Budget (OMB), the “guidance” subject to the rule would include “any Agency statement of general applicability, intended to have future effect on the behavior of regulated parties, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.” It would not apply to adjudication decisions, advisory opinions intended for particular parties, legal briefs, or statements that communicate general news updates about the Agency (e.g., press releases).

  • Requirements for All Future Guidance. All guidance documents would be required to include certain, standardized elements (e.g., identifying number, the term “guidance,” date of issuance, disclaimer of legal effect) and to avoid including mandatory language (i.e., “shall,” “must,” etc.), unless used in the context of describing a statutory or regulatory requirement. New guidance would be added to the EPA Guidance Portal, which became available in February 2020.[3] Guidance not listed in the Portal is deemed to not be in effect and would, thus, require unlisted guidance – of which there are numerous examples – to meet the new procedural requirements. Importantly, any existing guidance that is not posted to the Portal prior to OMB’s June 27, 2020 deadline[4] is considered rescinded.[5]The Agency is seeking comment on how to provide public notice of new or amended guidance.

  • Requirements for Issuing “Significant” Guidance Documents. Perhaps most significantly, the rules would require EPA in most cases to follow public notice and comment procedures prior to adopting, modifying, or withdrawing a subset of guidance deemed to be “Significant Guidance Documents.” All guidance in this category also would need to be signed by a Presidentially-appointed (politically accountable) EPA official.  

“Significant” guidance documents are defined by E.O. 13891 to include, among other things, those that may reasonably be anticipated to (i) give rise to new legal or policy issues “arising out of legal mandates, the President’s priorities, or the principles of Executive Order 12866,” (ii) affect the economy by at least $100 million annually, (iii) have a material adverse effect on a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or the states; or (iv) interfere with actions by another federal agency. 

  • Procedures to Petition for Modification or Withdrawal of Guidance. The rules would establish a procedure for preparing, submitting and EPA action on petitions to modify or withdraw active guidance. EPA generally would be required to respond to complete petitions (i.e., those containing all required informational elements) within 90 days.

EPA is soliciting comments from the public regarding the processes and procedures established by the proposed rulemaking, which will be accepted for 30 days. 

[1] EPA Guidance; Administrative Procedures for Issuance and Public Petitions, 85 Fed. Reg. 31,104 (May 22, 2020)

[2] See generally 84 Fed. Reg. 55,235 (Oct. 15, 2019). 

[3] 85 Fed. Reg. 11,986 (Feb. 28, 2020). 

[4] Guidance Implementing Executive Order 13891, Title “Promoting the Rule of Law Through Improved Agency Guidance Documents,” Office of Information and Regulatory Affairs (Oct. 31, 2019), p. 2.  

[5] Companies interested in adding existing guidance to the Portal are advised to act well in advance of the June 27, 2020 deadline, as EPA staff still will need to review the guidance and consider whether to keep it in effect.

© 2023 Keller and Heckman LLPNational Law Review, Volume X, Number 147

About this Author

 Thomas C. Berger, Keller Heckman, Environmental Protection lawyer, Product Liability Management Attorney

Tom Berger joined Keller and Heckman in 1993. Mr. Berger is a partner in Keller and Heckman's Washington DC office and heads Keller and Heckman's Indianapolis satellite office.

Mr. Berger has extensive experience in representing foreign and domestic companies, large and small, in a broad range of areas, including counseling, advocacy, and rulemaking in environmental law, occupational safety and health law, contracts, EPA enforcement proceedings, and chemical and product liability management. Mr. Berger assists clients in bringing new products to...

Gregory A. Clark, Keller Heckman, EPA Contractor Lawyer, Environmental matters Attorney

Gregory Clark joined Keller and Heckman in 2010. He practices in the area of environmental law.

While in law school, Mr. Clark served as an articles editor for the Virginia Journal of Law and Technology. Prior to law school, Mr. Clark worked as an EPA contractor, primarily for the Water Security Division in the Office of Groundwater and Drinking Water. In this arena, Mr. Clark worked on validation of molecular biology and microbiology methods and on emergency preparedness. He led development of what is now EPA's Water Laboratory Alliance...

Herbert Estreicher Ph.D., Keller Heckman, International Regulation Lawyer, Environmental law Attorney

Herbert Estreicher, Ph.D. joined Keller and Heckman in 2003. He has a broad practice in international environmental regulatory law.

Dr. Estreicher has an interdisciplinary approach combining law and science. He represents leading manufacturers of chemicals, pesticides, insect repellents, food additives, and consumer products before Federal and State regulatory agencies.

Dr. Estreicher provides advice on product liability risk control and assists clients with crisis management for embattled products, including...

votaw, KH, portrait

James Votaw has an extensive practice focusing on environmental and health and safety regulation.Within that arena, he concentrates on the regulation of conventional and nanoscale chemicals, pesticides, consumer and industrial products, and industrial processes and wastes.

For his clients, Mr. Votaw obtains pre-market product approvals and exemptions, including the first U.S. approval of a nanoscale pesticide. He negotiates testing orders, defends enforcement actions, advises on restrictions and disclosures associated with the chemical content...

Alexis Pecht DC Attorney Keller Heckman Environmental Law

Alexa Pecht practices primarily in the area of environmental law, where she counsels clients on regulatory compliance and enforcement matters under the Resource Conservation and Recovery Act, the Clean Air Act and other U.S. Federal and state environ statutes.

Prior to joining the firm, Ms. Pecht served as a law clerk in EPA’s Office of Enforcement and Compliance Assurance, Waste and Chemical Enforcement Division where she worked on civil litigation and enforcement matters concerning the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

While in law school, Ms....