EPA: Standards of Performance for New Stationary Sources and Emission Guidelines for Existing Sources--Hospital/Medical/Infectious Waste Incinerators

Published by the Government Accountability Office on 1997-10-01.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

      United States
GAO   General Accounting Office
      Washington, D.C. 20548

      Office of the General Counsel


      October 1, 1997

      The Honorable John H. Chafee
      The Honorable Max Baucus
      Ranking Minority Member
      Committee on Environment and Public Works
      United States Senate

      The Honorable Thomas J. Bliley, Jr.
      The Honorable John D. Dingell
      Ranking Minority Member
      Committee on Commerce
      House of Representatives

      Subject:   Environmental Protection Agency: Standards of Performance for New
                 Stationary Sources and Emission Guidelines for Existing Sources:
                 Hospital/Medical/Infectious Waste Incinerators

      Pursuant to section 801(a)(2)(A) of title 5, United States Code, this is our report on
      a major rule promulgated by the Environmental Protection Agency (EPA), entitled
      "Standards of Performance for New Stationary Sources and Emission Guidelines for
      Existing Sources: Hospital/Medical/Infectious Waste Incinerators" (RIN: 2060-AC62).
      We received the rule on September 16, 1997. It was published in the Federal
      Register as a final rule on September 15, 1997. 62 Fed. Reg. 48348.

      The final rule promulgates new source performance standards for hospital/medical/
      infectious waste incinerators (HMIWI) and emission standards for existing HMIWI's
      to reduce air emissions.

      Enclosed is our assessment of the EPA's compliance with the procedural steps
      required by section 801(a)(1)(B)(i) through (iv) of title 5 with respect to the rule.
      Our review indicates that the EPA complied with the applicable requirements.

      If you have any questions about this report, please contact James Vickers, Assistant
      General Counsel, at (202) 512-8210. The official responsible for GAO evaluation

work relating to the Environmental Protection Agency is Peter Guerrero, Director,
Environmental Protection Issues. Mr. Guerrero can be reached at (202) 512-6111.

Robert P. Murphy
General Counsel


cc: Mr. Thomas E. Kelly
    Director, Office of Regulatory
     Management and Information
    Environmental Protection Agency

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      ANALYSIS UNDER 5 U.S.C. § 801(a)(1)(B)(i)-(iv) OF A MAJOR RULE
                               ISSUED BY
                            (RIN: 2060-AC62)

(i) Cost-benefit analysis

EPA performed a Regulatory Impact Analysis which included a cost-benefit analysis.
The analysis discusses the costs and benefits of six regulatory options which were
considered by EPA. The costs of the selected options in the final rule are estimated
to be between $71 million and $146 million per year. The costs depend on the
degree to which entities switch their current methods of disposal and the degree to
which additional waste segregations (infectious and non-infectious waste) are

EPA states that it cannot quantify or monetize many of the benefits, such as the
reduction in the emission of hazardous air pollutants which include cadmium,
hydrogen chloride, lead, mercury, and dioxin/furan. In addition, reductions in
emissions of particulate matter, sulfur dioxide, carbon monoxide, and nitrogen
oxides are expected. EPA did quantify the benefits from the reduction in
particulate matter to be $6075/ton reduced, resulting in benefits valued at
$5.5 million to $5.8 million per year

(ii) Agency actions relevant to the Regulatory Flexibility Act, 5 U.S.C. §§ 603-605,
607, and 609

Following an analysis of the impacts of the emission guidelines and new stationary
source performance standards on small entities, the Administrator of the EPA has
determined that the final rule will not have a significant economic impact on a
substantial number of small entities. Therefore, EPA determined that it was not
necessary to prepare a Regulatory Flexibility Analysis under the act.

(iii) Agency actions relevant to sections 202-205 of the Unfunded Mandates Reform
Act of 1995, 2 U.S.C. §§ 1532-1535

Based on the cost-benefit analysis performed by EPA, it is estimated that the final
rule will impose costs on the private sector and governmental entities in excess of

$100 million per year. Therefore, EPA has prepared the statement required by the
Unfunded Mandates Reform Act of 1995.

EPA's statement, contained in the preamble to the final rule, gives the statutory
authority for the action; a summary of the costs and benefits contained in the
Regulatory Impact Analysis, in both qualitative and quantitative terms; and a
description of EPA's consultation efforts with state, local, and tribal officials. Also,
EPA describes the regulatory alternatives it considered and why it finds the rule to
be the most cost-effective alternative for regulation of these sources which meets
the statutory requirements of the Clean Air Act.

(iv) Other relevant information or requirements under acts and executive orders

Administrative Procedure Act, 5 U.S.C. §§ 551 et seq.

Instead of the notice and comment procedures in the Administrative Procedure Act,
EPA promulgated this rule using the procedures, which have similar notice and
comment requirements, contained in section 307(d) of the Clean Air Act, as
amended. 42 U.S.C. § 7607(d). The use of these procedures regarding rules
pertaining to standards of performance is mandated by section 307(d)(1)(C) of the
Clean Air Act. 42 U.S.C. § 7607(d)(1)(C).

On February 27, 1995 (60 Fed. Reg. 10654), EPA issued proposed new source
performance standards and emission guidelines for HMIWI's. After receiving over
700 comments, EPA reevaluated every aspect of the proposed standards and

This resulted in an announcement on June 20, 1996 (61 Fed. Reg. 31736), in the
Federal Register advising the public of the availability of the new information and
how EPA may change the standards and guidelines in response. Based on
comments received, EPA considered the June 20 announcement as a re-proposal
and held a public meeting to review the contents of the re-proposal. In addition,
EPA received another 70 comments. EPA discusses the comments it received and
its response to them in the preamble to the final rule.

Paperwork Reduction Act, 44 U.S.C. §§ 3501-3520

The final rule contains an information collection requirement that is subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act. EPA has submitted the collection requirement to OMB for approval
and it will not have to be complied with until OMB issues its approval.

The preamble summarizes the information forwarded to OMB. The requirement,
based on EPA's prediction of 14 new HMIWI's constructed in a year, has an

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estimated total burden hours for completing the required report of 14,106 person
hours per year. EPA also explains the need for the report and the steps it took to
reduce the burden, including test emissions once every 3 years instead of annually if
they demonstrate that they consistently meet the emissions requirement.

Statutory authorization for the rule

The final rule was promulgated pursuant to sections 111 and 129 of the Clean Air
Act, as amended, 42 U.S.C.§§ 7411 and 7429.

Executive Order No. 12866

The final rule has been determined to be an "economically significant regulatory
action" by the Office of Management and Budget and was approved by OMB on
August 14, 1997, as complying with the requirements of the executive order.

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