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* V7j77 | U.S. ENVIRONMENTAL PROTECTION AGENCY
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OFFICE OF INSPECTOR GENERAL
Limited Public Comment on
EPA's Regulatory Flexibility
Act Section 610 Reviews
Report No. 12-P-0579	July 19, 2012

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Report Contributors:	Daniel Carroll
Jerri Dorsey
Heather Drayton
Gabby Fekete
Abbreviations
EPA	U.S. Environmental Protection Agency
GAO	U.S. Government Accountability Office
OP	Office of Policy
RAPIDS	Rule and Policy Information and Development System
RFA	Regulatory Flexibility Act
SISNOSE	Significant Economic Impact on a Substantial Number of Small Entities
Hotline
To report fraud, waste, or abuse, contact us through one of the following methods:
e-mail:	OIG Hotiirie@epa.aov	write: EPA Inspector General Hotline
phone:	1-888-546-8740	1200 Pennsylvania Avenue NW
fax:	202-566-2599	Mailcode 2431T
online:	http://www.epa.aov/oia/hotline.htm	Washington, DC 20460

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.* *. U.S. Environmental Protection Agency	12-P-0579
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' At a Glance
Why We Did This Review
The purpose of this review was
to assess the reasons behind the
lack of comment on Regulatory
Flexibility Act (RFA) Section
610 reviews conducted by the
U.S. Environmental Protection
Agency (EPA).
Background
Under Section 610 of the RFA,
agencies are required to review
rules which have or will have a
significant economic impact on
a substantial number of small
entities anytime within 10 years
of promulgation. The purpose
of these reviews is for the
agency to determine whether
such regulations should be
continued as written or should
be amended or rescinded,
consistent with the stated
objectives of applicable
statutes, to minimize their
impact on small entities.
Limited Public Comment on EPA's Regulatory
Flexibility Act Section 610 Reviews
For further information, contact
our Office of Congressional and
Public Affairs at (202) 566-2391.
The full report is at:
www.epa.gov/oiq/reports/2012/
20120719-12-P-0579.pdf
What We Found
An essential aspect of Section 610 reviews is obtaining public comment on the
impact of regulations. We found that EPA receives little to no public comment
when Section 610 review notices are published in the Federal Register. This
limited public comment can hinder the ability of the Agency to implement an
effective Section 610 review process.
EPA's ability to conduct effective retrospective reviews is dependent on
feedback from the public and the regulated community. We found that the
shortage of comments may be the result of the following reasons:
•	If small business concerns are identified, the Agency is mandated by the
RFA to address these during the initial rulemaking process, which could
result in concerns being addressed at the outset.
•	EPA is required by a number of other statutes to conduct retrospective
reviews; the Agency may have already reviewed and modified
regulations before the 10-year mark for the Section 610 review. These
other reviews are generally not coordinated with Section 610 reviews.
•	Ten years after a rule is finalized may not be the optimal time to seek
feedback; some rules may benefit from a review closer to issuance.
•	Some of the stakeholders in the regulated community that we contacted
were unaware of the purpose or execution of the Section 610 reviews.
Recommendations/Planned Agency Corrective Actions
We recommend that EPA's Associate Administrator for Policy coordinate the
Section 610 review with other required retrospective reviews, and implement
additional public outreach efforts to increase awareness of the Section 610
purpose and process.
The Agency indicated that it is committed to coordinating Section 610 reviews
with other required reviews when appropriate. EPA agreed to implement
additional public outreach to increase awareness of the Section 610 review
purpose and process, including making changes to its Small Entities and
Rulemaking website within 3 months.

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
THE INSPECTOR GENERAL
July 19, 2012
MEMORANDUM
SUBJECT: Limited Public Comment on EPA's Regulatory Flexibility Act
Section 610 Reviews
Report No. 12-P-0579
FROM: Arthur A. Elkins, Jr.
TO:
Michael Goo
Associate Administrator, Office of Policy
This is a report on the subject evaluation conducted by the Office of Inspector General (OIG) of
the U.S. Environmental Protection Agency (EPA). This report contains findings that describe the
problems the OIG has identified and corrective actions the OIG recommends. This report
represents the opinion of the OIG and does not necessarily represent the final EPA position.
Final determinations on matters in this report will be made by EPA managers in accordance with
established audit resolution procedures.
Action Required
In accordance with EPA Manual 2750, you are required to provide a written response to this
report within 90 calendar days. You should include a corrective actions plan for agreed-upon
actions, including milestone dates. Your response will be posted on the OIG's public website,
along with our memorandum commenting on your response. Your response should be provided
as an Adobe PDF file that complies with the accessibility requirements of Section 508 of the
Rehabilitation Act of 1973, as amended. The final response should not contain data that you do
not want to be released to the public; if your response contains such data, you should identify the
data for redaction or removal. We have no objections to the further release of this report to the
public. We will post this report to our website at http ://www.epa. gov/oig.
If you or your staff have any questions regarding this report, please contact Carolyn Copper at
(202) 566-0829 or copper.carolvn@,epa. gov, or Jerri Dorsey at (919) 541-3601 or
dorsev.ierri@,epa.gov.

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Limited Public Comment on EPA's	12-P-0579
Regulatory Flexibility Act Section 610 Reviews
	Table of Contents	
Purpose		1
Background		1
Scope and Methodology		2
Prior Audit Coverage		3
Section 610 Reviews Receive Limited Public Comments		3
Conclusion		5
Recommendations		6
Agency Comments and OIG Evaluation		6
Status of Recommendations and Potential Monetary Benefits		7
Appendices
A EPA's 2008-2010 Section 610 Reviews		8
B Agency Response and OIG Comments		9
C Distribution		11

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Purpose
The purpose of this review was to identify the reasons for the lack of public
comments and responses to the U.S. Environmental Protection Agency's (EPA's)
Regulatory Flexibility Act (RFA) Section 610 retrospective reviews.1
Background
The RFA requires agencies to examine the impact of their proposed and final
regulations on small entities. The purpose of the RFA is:
to establish as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of
applicable statutes, to fit regulatory and informational requirements
to the scale of the businesses, organizations, and governmental
jurisdictions subject to regulation. To achieve this principle,
agencies are required to solicit and consider flexible regulatory
proposals and to explain the rationale for their actions to assure
that such proposals are given serious consideration.
In addition, under the 1996 amendments to the RFA, EPA is required to convene
panels to address small business concerns when these are identified in the
rulemaking process.2
Under Section 610 of the RFA, agencies are required to review rules that have or
will have a significant economic impact on a substantial number of small entities
(SISNOSE) within 10 years of promulgation. The purpose of these reviews is to
determine whether such regulations should be continued without change or should
be amended or rescinded, consistent with the stated objectives of applicable
statutes, to minimize their impact on small entities.
A Section 610 review involves:
•	Identifying a promulgated rule that was not certified (i.e., did not contain a
finding that there was no SISNOSE)3
•	Determining whether the rule should be amended, rescinded, or left
unchanged based on five statutorily prescribed factors:
1	The initial purpose of this review was to assess the efficiency and effectiveness of the EPA's policies and
procedures in place for conducting Section 610 retrospective reviews and outcomes from past reviews. Our purpose
was amended based on the lack of public comment received.
2	The Small Business Regulatory Enforcement Fairness Act, enacted in 1996, added a judicial review provision to
the RFA, which means the Agency can be challenged in court as to its compliance with the provisions of this section
on a rule-by-rule basis.
3	This review did not include an assessment of the SISNOSE determination; our evaluation focused on those rules
that met the criteria of the Agency, not on critiquing those criteria.
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1.	The continued need for the rule
2.	The nature of complaints or comments received concerning the
rule from the public
3.	The complexity of the rule
4.	The extent to which the rule overlaps, duplicates, or conflicts with
other federal rules, and, to the extent feasible, with state and local
governmental rules
5.	The length of time since the rule has been evaluated or the degree
to which technology, economic conditions, or other factors have
changed in the area affected by the rule.
According to data provided by EPA's Office of Policy (OP), since 1996 EPA has
completed 35 Section 610 reviews.4 In conducting a Section 610 review, EPA's
guidance provides that the Agency must specifically address and ask the public
for comment on the five factors outlined above. In addition to the Section 610
reviews, EPA conducts other mandatory reviews to comply with statutes that
apply specifically to areas that program offices regulate.5
Scope and Methodology
We conducted this evaluation in accordance with generally accepted government
auditing standards. Those standards require that we plan and perform the evaluation
to obtain sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our objectives. We believe that the evidence
obtained provides a reasonable basis for the results reported based upon our
objectives. We performed this evaluation from September 2011 through May 2012.
We reviewed EPA planning and implementation documents, federal documents and
information related to the RFA, Section 610 reviews, and retrospective reviews in
general. We reviewed EPA's internal Rule and Policy Information and
Development System (RAPIDS) database. We conducted interviews with staff at
EPA's OP, as well as with EPA's Office of Air and Radiation and Office of Water.
We also reviewed the Agency's Regulatory Agendas for 2007-2010, which include
the list of regulations to be reviewed under Section 610 each year. We conducted a
detailed analysis of the universe of Section 610 reviews completed by EPA during
the calendar year 2010 (see appendix A for the list of reviews and details6). In
assessing the four reviews completed in 2010, we interviewed external stakeholder
groups active in the Agency's rulemaking process but not specifically involved in
4	We found one Section 610 review that was scheduled to be conducted in 2009 that was not conducted within the
10-year timeframe: Heavy-Duty Engine Emission Standards & Diesel Fuel Sulfur Control Requirements
(RIN: 2060-AI69; SAN: 4355). The Agency is currently executing this review.
5	According to the U.S. Government Accountability Office, some statutes that require EPA to conduct mandatory
retrospective reviews include: Clean Air Act; Clean Water Act; Federal Food, Drug, and Cosmetic Act; Federal
Insecticide, Fungicide, and Rodenticide Act; Comprehensive Environmental Response, Compensation and Liability
Act; and Safe Drinking Water Act.
6	Appendix A lists the four reviews completed during calendar year 2010, as well as those done in 2008 and 2009.
We completed a detailed review of those done in 2010 and a limited assessment of those from 2008 and 2009.
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the Section 610 review process.7 We also did a cursory assessment to determine the
number of comments received on and any changes made to Section 610 reviews
conducted in calendar years 2008 and 2009.
Prior Audit Coverage
The U.S. Government Accountability Office (GAO) reviewed the RFA and
o
EPA's work under Section 610 in at least five reports since the late 1990s.
In general, GAO found that EPA used Section 610 as a notice and comment
requirement. GAO noted the importance of EPA utilizing a systematic approach
to conducting Section 610 retrospective reviews. GAO found that it was unclear if
the Section 610 provision in the RFA had been consistently and effectively
implemented. In a series of reports on agencies' compliance with Section 610,
specifically in GAO-07-791, GAO identified important practices that can have an
impact on the effectiveness and transparency of each phase of the review process
and assessed the extent to which these three practices were a part of agencies'
processes and standards. Important practices identified by GAO include:
(1) use of a standards-based approach, (2) incorporation of public involvement,
and (3) documentation of review processes and results. GAO found that, for the
mandatory reviews completed within the timeframe for their evaluation, the most
common result for a Section 610 review was that no changes were needed to the
regulation. There were no previous OIG reviews of this subject matter.
Section 610 Reviews Receive Limited Public Comments
EPA receives little to no public comment on Section 610 reviews. During 2008
through 2010, EPA conducted eight Section 610 reviews. Specifically:
• In 2010, EPA conducted four Section 610 reviews. EPA received relevant
comments on two of the four reviews.9 After reviewing these comments
and posting them in the federal docket, the Agency concluded that
revisions or amendments to minimize economic impacts on small entities
were not warranted for these rules at that time.
7	These stakeholders were selected because they commented on draft EPA rulemakings but not on the Section 610
reviews related to these rules. During field work, we contacted seven stakeholders to determine their reasons for not
participating in the Section 610 process and to obtain their perspectives; however, we were ultimately only able to
discuss these reviews with four of the seven.
8	GAO/T-GGD-98-64, Regulatory Reform: Agencies' Section 610 Review Notices Often Did Not Meet Statutory
Requirements. February 1998; GAO/RCED-99-250, Environmental Protection: Assessing the Impacts of EPA's
Regulations through Retrospective Studies. September 1999; GAO/GGD-00-193. Regulatory Flexibility Act:
Implementation in EPA Program Offices and Proposed Lead Rule. September 2000; GAO-Q6-998T. Regulatory
Flexibility Act: Congress Should Revisit and Clarify Elements of the Act to Improve Its Effectiveness. July 2006; and
GAO-07-791. Reexamining Regulations: Opportunities Exist to Improve Effectiveness and Transparency of
Retrospective Reviews. July 2007.
9	EPA received five comments on the Radionuclides Section 610 review and eight on the Arsenic review. See
appendix A for specific details.
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•	In 2009, EPA conducted one review and received one comment
supporting the continued need for the rule.10
•	In 2008, EPA completed three reviews for which one received comment
from a stakeholder. This comment suggested additional coverage for one
of the rules; EPA considered this comment and provided a response in the
Section 610 review decision document the Agency published and
suggested an EPA contact person for the commenter.
None of the eight reviews conducted from 2008 to 2010 resulted in a change to a
rule or regulation. According to Agency staff, it is typical that Section 610
reviews do not result in a revision.
External stakeholders and program office staff offered a number of reasons why
EPA garners little to no response to these reviews. First, a Small Business
Advocacy Review Panel would have been convened in the initial rule writing
process if there were small business concerns. If the concerns are vetted by the
public and addressed by the Agency during the rulemaking process, the frequency
and amount of comments received during the Section 610 review process could be
reduced.
Second, program office staff reiterated that EPA is required by other statutes to
conduct mandatory retrospective reviews, including requirements in the Clean Air
Act and the Clean Water Act. The frequency of these reviews ranges from every
2 years to every 10 years. For instance, the frequency of reviews conducted by the
Office of Water ranges from every 2 years to every 6 years, depending on the
review requirement. The Office of Air and Radiation is required to conduct
reviews under the Clean Air Act ranging from every 5 years to every 8 years.
These reviews are in addition to the Section 610 review requirement. Therefore,
when reviews that have predetermined schedules and review factors (such as the
Section 610 reviews) arise, the Agency might have already reviewed and
potentially modified the regulation one or more times. We found this to be the
case for two of the eight Section 610 reviews we assessed in our evaluation. The
Agency, recognizing the potential for overlap, is assessing the potential for
coordinating these reviews as part of its work under Executive Order 13563,
"Improving Regulation and Regulatory Review."
Third, Section 610 requires that EPA review the rule within 10 years of the date
the rule became final.11 According to the Agency's guidance, conducting the
review close to the 10-year anniversary allows for a more focused perspective on
any changed impacts on small entities. However, external stakeholders and
10	According to EPA's internal tracking system, there were two Section 610 reviews conducted in 2009. However,
there is no record in the Federal Register or in www.regulations.gov indicating that the rule cited actually underwent
a Section 610 review. EPA's OP staff found that this rule never received the scheduled Section 610 review, and OP
is currently executing it. This was the only error we found of this type in conducting our review.
11	EPA adopted the practice of conducting the Section 610 reviews at the 10-year mark.
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program staff expressed concerns surrounding the 10-year time frame. For
example, one external stakeholder representative expressed that prior to the
10-year mark, entities were already in compliance and therefore lacked the
incentive to provide comments. Additionally, regulated entities may be more
concerned with what comes next rather than the 4tten year old rule."
Finally, there are external stakeholders in the regulated community who are
unaware of the purpose or execution of the Section 610 reviews. Section 610
requires EPA to publish a plan semiannually in the Federal Register that lists the
existing rules EPA plans to review, which it does as part of its semiannual
Regulatory Agenda. We found that EPA issues notification of Section 610
reviews through the Agency's normal notice and comment procedures in the
Federal Register. In not conducting additional outreach, EPA may be missing
affected external stakeholders who would otherwise participate in the process.
Two of the four external stakeholder groups with whom we spoke stated that they
had no knowledge of the Section 610 review process prior to our conversations.
One of these two stakeholders was particularly concerned and indicated that it
was a significant lost opportunity. External stakeholders expressed the concern
that solely publishing a notice in the Federal Register of a regulation undergoing a
review is not sufficient.
In EPA's guidance on the RFA as a whole, public involvement is given
substantial consideration, noting that "simply providing notice of EPA's intent is
not enough. Adequate outreach also requires that we seek opportunities for
genuine engagement that places the Agency in a position to hear from and
respond to small entities." Furthermore, the Small Business Administration's
Office of Advocacy recommended that agencies additionally communicate
information on Section 610 reviews via an agency website or other electronic
media. Some external stakeholders said that EPA should attempt to disseminate
information about the Section 610 review process and any upcoming reviews,
particularly when already speaking to the regulated community.
Conclusion
Given that the 10-year review period for Section 610 reviews is a window and not
a deadline, the possibility exists for consolidating the program offices' review
workload. Both EPA and the Small Business Administration's Office of
Advocacy recognize the potential to coordinate reviews wherever there is
functional equivalency. As previously noted by GAO, Section 610 of the RFA is
essentially a notification requirement that is designed to provide opportunities for
the public to comment. EPA's ability to conduct retrospective reviews is critically
dependent on feedback from the public and the regulated community. EPA is
receiving little to no comment when Section 610 review notices are published in
the Federal Register. Limited public comment may hinder the ability of the
Agency to implement an effective Section 610 review process. By making the
public and stakeholder groups more aware of the Section 610 review process,
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EPA may identify beneficial regulatory improvements for a broad representation
of the public.
Recommendations
We recommend that the Associate Administrator for EPA's Office of Policy:
1.	Coordinate the Section 610 reviews with other required retrospective
reviews across regulated communities to the extent practicable.
2.	Implement additional public outreach efforts to increase awareness of the
Section 610 review purpose and process.
Agency Comments and OIG Evaluation
The Agency concurred with both recommendations as currently worded, and was
in general agreement with the report's description of the Section 610 review
process. EPA agreed that opportunities exist to enhance the Section 610 review
process. The Agency acknowledged that the reviews studied did not result in
changes to regulations, but disagreed with the OIG's characterization of the
process as minimally effective. We revised the sentences of concern to better
reflect the link between limited public comment and the Agency's ability to
conduct effective Section 610 reviews. The Agency's detailed response with the
OIG's evaluation is provided in appendix B.
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Status of Recommendations and
Potential Monetary Benefits
RECOMMENDATIONS
Rec. Page
No. No.
Subject
Status1
Action Official
Coordinate the Section 610 reviews with other
required retrospective reviews across regulated
communities to the extent practicable.
Implement additional public outreach efforts to
increase awareness of the Section 610 review
purpose and process.
Associate Administrator,
Office of Policy
Associate Administrator,
Office of Policy
POTENTIAL MONETARY
BENEFITS (in $000s)
Planned
Completion
Date
Claimed
Amount
Agreed-To
Amount
1 0 = recommendation is open with agreed-to corrective actions pending
C = recommendation is closed with all agreed-to actions completed
U = recommendation is unresolved with resolution efforts in progress
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Appendix A
EPA's 2008-2010 Section 610 Reviews
Year
Rule Title and Docket Locator Information
Number of Relevant
Comments Received
Rule Changed:
Yes/No
2010
National Primary Drinking Water Regulations:
Radionuclides (Section 610 Review) (RIN:2040-
AF19; 2040-AC98; SAN:3992 SAN:5445)
5
No
2010
Effluent Guidelines and Standards for the
Centralized Waste Treatment Industry (Section
610 Review) (RIN:2040-AF18; SAN:5444;
RIN:2040-AB78; SAN:2805)
0
No
2010
Tier II Light-Duty Vehicle and Light-Duty Truck
Emission Standards and Gasoline Sulfur
Standards (Section 610 Review) (RIN:2060-
AQ12; SAN:5432; (RIN:2060-AI23; SAN:4211)
0
No
2010
National Primary Drinking Water Regulations:
Arsenic and Clarifications to Compliance and
New Source Contaminants Monitoring
(RIN: 2040-AF24; SAN:5487)
8
No
200912
Revisions to the Underground Injection Control
(UIC) Requirements for Class V Wells (RIN:2040-
AF04; SAN:5332; RIN:2040-AB83; SAN:2778)
1
No
2008
Control of Emissions of Air Pollution From
Nonroad Diesel Engines (Section 610 Review)
(RIN:2060-A082; SAN:5254;2060-AF76;
SAN:3645)
0
No
2008
National Primary Drinking Water Regulations:
Stage I Disinfectant/Disinfection By-Products Rule
(Section 610 Review) (RIN:2040-AE97;
SAN:5258; RIN:2040-AB82; SAN:2772)
0
No
2008
VOC Regulation for Architectural Coatings
(Section 610 Review) (RIN:2060-AP09;
SAN:5255; RIN:2060-AE55; SAN:3351)
1
No
Source: OIG analysis.
12 There was one additional Section 610 review that should have been completed in 2009: Heavy-Duty Engine
Emission Standards & Diesel Fuel Sulfur Control Requirements (RIN: 2060-AI69; SAN: 4355). The rule did not
undergo its Section 610 review within the 10-year window. The Agency is currently executing this review.
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Appendix B
Agency Response and OIG Comments
July 18, 2012
MEMORANDUM
SUBJECT: Response to Draft Report:
Limited Public Comment on EPA's Regulatory Flexibility Act Section 610
Project No: OPE-FY11-0024
FROM: Michael L. Goo, Associate Administrator
TO:	Jeffrey Harris, Director for Program Evaluation, Cross Media Issues
Office of Inspector General
EPA appreciates the opportunity to comment on the Office of Inspector General's (OIG) draft
evaluation report "Limited Public Comment on EPA's Regulatory Flexibility Act Section 610
Reviews."
We are in general agreement with the report's description of the Section 610 review process.
However, we believe that there is insufficient information included in the report to conclude that
the effectiveness of EPA's Section 610 reviews is "minimal." While we acknowledge that the
reviews studied did not result in changes to regulations, we believe that our process is effective.
As currently drafted the report implies that to be effective Section 610 reviews should result in
changes to regulations, notwithstanding the merits of such changes. Additionally, as noted in the
report there are a variety of reasons why the public may not respond to these reviews. As a result,
we suggest that OIG delete the two sentences in the report that contain this characterization.
OIG Response: The OIG appreciates EPA's general concurrence with our description of the
process. We revised the sentences of concern to better reflect the link between limited public
comment and the Agency's ability to conduct effective Section 610 reviews.
We agree that opportunities exist to enhance our Section 610 review process and concur with the
two recommendations offered in the report.
With respect to the first recommendation, as noted in the report, EPA is already committed to
harmonizing Section 610 Reviews with other required reviews when appropriate. EPA
committed to this in our Executive Order 13563 retrospective review plan and OP is working
with the program offices on implementation of this.
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With respect to the second recommendation, EPA agrees to implement additional public
outreach to increase awareness of the Section 610 review purpose and process. We plan to make
changes to our Small Entities and Rulemaking website (http ://www,epa. gov/rfa/) within three
months. Specifically we will be providing a list rules for which upcoming Section 610 reviews
are required, the due date for the review, and any other retrospective reviews required for the
rule. We will also be using our website to highlight any Section 610 reviews open for public
comment. Finally, we intend to suggest to the Small Business Administration's Office of
Advocacy that they include information about these reviews on their website and in their
newsletters.
OIG Response: The OIG appreciates EPA's response and commitment to making these
changes. In regard to the first recommendation, we acknowledge that the Agency has
agreed to the first option afforded in the recommendation and was silent on the second
option. We revised the recommendation to reflect the agreed-to recommendation as it
meets the overall intent. In its 90-day response to the final report, EPA should provide
estimated completion dates for all agreed-to actions and specific corrective action plans.
Again, thank you for the opportunity to comment on this report. If you or your staff has
questions regarding this response, please contact Nathaniel Jutras at 202-564-0301.
cc: Nicole Owens
Alex Cristofaro
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Distribution
Office of the Administrator
Associate Administrator, Office of Policy
Agency Follow-Up Official (the CFO)
Agency Follow-Up Coordinator
General Counsel
Associate Administrator for Congressional and Intergovernmental Relations
Associate Administrator for External Affairs and Environmental Education
Audit Follow-Up Coordinator, Office of the Administrator
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