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8000 - Miscellaneous Statutes and Regulations
CHAPTER 6.—THE ANALYSIS OF REGULATORY
FUNCTIONS *
Sec.
601.
Definitions.
602.
Regulatory agenda.
603.
Initial regulatory flexibility analysis.
604.
Final regulatory flexibility analysis.
605.
Avoidance of duplicative or unnecessary analyses.
606.
Effect on other law.
607.
Preparation of analyses.
{{2-28-03 p.8050}}
608.
Procedure for waiver or delay of completion.
609.
Procedures for gathering comments.
610.
Periodic review of rules.
611.
Judicial review.
612.
Reports and intervention rights.
§ 601. Definitions.
For purposes of this chapter--
(1) the term "agency" means an agency as defined in section
551(1) of this title;
(2) the term "rule" means any rule for which the agency
publishes a general notice of proposed rulemaking pursuant to
section 553(b) of this title, or
any other law, including any rule of general applicability governing
Federal grants to State and local governments for which the agency
provides an opportunity for notice and public comment, except that the
term "rule" does not include a rule of particular applicability
relating to rates, wages, corporate or financial structures or
reorganizations thereof, prices, facilities, appliances, services, or
allowances therefor or to valuations, costs or accounting, or practices
relating to such rates, wages, structures, prices, appliances,
services, or allowances;
(3) the term "small business" has the same meaning as the
term "small business concern" under section 3 of the Small
Business Act, unless an agency, after consultation with the Office of
Advocacy of the Small Business Administration and after opportunity for
public comment, establishes one or more definitions of such term which
are appropriate to the activities of the agency and publishes such
definition(s) in the Federal Register;
(4) the term "small organization" means any not-for-profit
enterprise which is independently owned and operated and is not
dominant in its field, unless an agency establishes, after opportunity
for public comment, one or more definitions of such term which are
appropriate to the activities of the agency and publishes such
definition(s) in the Federal Register;
(5) the term "small governmental jurisdiction" means
governments of cities, counties, towns, townships, villages, school
districts, or special districts, with a population of less than fifty
thousand, unless an agency establishes, after opportunity for public
comment, one or more definitions of such term which are appropriate to
the activities of the agency and which are based on such factors as
location in rural or sparsely populated areas or limited revenues due
to the population of such jurisdiction, and publishes such
definition(s) in the Federal Register;
(6) the term "small entity" shall have the same meaning as
the terms "small business", "small organization" and
"small governmental jurisdiction" defined in paragraphs (3), (4)
and (5) of this section; and
(7) the term "collection of information"--
(A) means the obtaining, causing to be obtained, soliciting, or
requiring the disclosure to third parties or the public, of facts or
opinions by or for the agency, regardless of form or format, calling
for either--
(i) answers to identical questions posed to, or identical
reporting or recordkeeping requirements imposed on, 10 or more persons,
other than agencies, instrumentalities, or employees of the United
States; or
(ii) answers to questions posed to agencies, instrumentalities,
or employees of the United States which are to be used for general
statistical purposes; and
(B) shall not include a collection of information described under
section 3518(c)(1) of title 44, United States Code.
(8) RECORDKEEPING REQUIREMENT.--The term
"recordkeeping requirement" means a requirement imposed by an
agency on persons to maintain specified records.
[Codified to 5 U.S.C. 601]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96-354; 94 Stat. 1165), effective January 1, 1981; as amended by
section 241(a)(2) of title II of the Act of March 24, 1996 (Pub. L. No.
104-121; 110 Stat. 864), effective March 29, 1996]
{{10-31-97 p.8051}}
§ 602. Regulatory agenda.
(a) During the months of October and April of each year, each
agency shall publish in the Federal Register a regulatory flexibility
agenda which shall contain--
(1) a brief description of the subject area of any rule which the
agency expects to propose or promulgate which is likely to have a
significant economic impact on a substantial number of small entities;
(2) a summary of the nature of any such rule under consideration
for each subject area listed in the agenda pursuant to paragraph (1),
the objectives and legal basis for the issuance of the rule, and an
approximate schedule for completing action on any rule for which the
agency has issued a general notice of proposed rulemaking, and
(3) the name and telephone number of an agency official
knowledgeable concerning the items listed in paragraph (1).
(b) Each regulatory flexibility agenda shall be transmitted to the
Chief Counsel for Advocacy of the Small Business Administration for
comment, if any.
(c) Each agency shall endeavor to provide notice of each regulatory
flexibility agenda to small entities or their representatives through
direct notification or publication of the agenda in publications likely
to be obtained by such small entities and shall invite comments upon
each subject area on the agenda.
(d) Nothing in this section precludes an agency from considering or
acting on any matter not included in a regulatory flexibility agenda,
or requires an agency to consider or act on any matter listed in such
agenda.
[Codified to 5 U.S.C. 602]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96--354; 94 Stat. 1166), effective January 1,
1981]
§ 603. Initial regulatory flexibility analysis.
(a) Whenever an agency is required by
Section 553 of this title, or
any other law, to publish general notice of proposed rulemaking for any
proposed rule or publishes a notice of proposed rulemaking for an
interpretative rule involving the internal revenue laws of the United
States, the agency shall prepare and make available for public comment
an initial regulatory flexibility analysis. Such analysis shall
describe the impact of the proposed rule on small entities. The initial
regulatory flexibility analysis or a summary shall be published in the
Federal Register at the time of the publication of general notice of
proposed rulemaking for the rule. The agency shall transmit a copy of
the initial regulatory flexibility analysis to the Chief Counsel for
Advocacy of the Small Business Administration. In the case of an
interpretative rule involving the internal revenue laws of the United
States, this chapter applies to interpretative rules published in the
Federal Register for codification in the Code of Federal Regulations,
but only to the extent that such interpretative rules impose on small
entities a collection of information requirement.
(b) Each initial regulatory flexibility analysis required under
this section shall contain--
(1) a description of the reasons why action by the agency is
being considered;
(2) a succinct statement of the objectives of, and legal basis
for, the proposed rule;
(3) a description of and, where feasible, an estimate of the
number of small entities to which the proposed rule will apply;
(4) a description of the projected reporting, recordkeeping and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities which will be subject to the
requirement and the type of professional skills necessary for
preparation of the report or record;
(5) an identification, to the extent practicable, of all relevant
Federal rules which may duplicate, overlap or conflict with the
proposed rule.
(c) Each initial regulatory flexibility analysis shall also contain
a description of any significant alternatives to the proposed rule
which accomplish the stated objectives of applicable statutes and which
minimize any significant economic impact of the proposed
{{10-31-97 p.8052}}rule on small entities.
Consistent with the stated objectives of applicable statutes, the
analysis shall discuss significant alternatives such as--
(1) the establishment of differing compliance or reporting
requirements or timetables that take into account the resources
available to small entities;
(2) the clarification, consolidation, or simplification of
compliance and reporting requirements under the rule for such small
entities;
(3) the use of performance rather than design standards; and
(4) an exemption from coverage of the rule, or any part thereof,
for such small entities.
[Codified to 5 U.S.C. 603]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96--354; 94 Stat. 1166), effective January 1, 1981, except that
the requirements of this section shall apply only to rules for which a
notice of proposed rulemaking is issued on or after January 1, 1981; as
amended by section 241(a)(1) of title II of the Act of March 24, 1996
(Pub. L. No. 104--121; 110 Stat. 864), effective May 29,
1996]
§ 604. Final regulatory flexibility analysis.
(a) When an agency promulgates a final rule under
section 553 of this title, after
being required by that section or any other law to publish a general
notice of proposed rulemaking, or promulgates a final interpretative
rule involving the internal revenue laws of the United States as
described in section 603(a), the agency shall prepare a final
regulatory flexibility analysis. Each final regulatory flexibility
analysis shall contain--
(1) a succinct statement of the need for, and objectives of, the
rule;
(2) a summary of the significant issues raised by the public
comments in response to the initial regulatory flexibility analysis, a
summary of the assessment of the agency of such issues, and a statement
of any changes made in the proposed rule as a result of such comments;
(3) a description of and an estimate of the number of small
entities to which the rule will apply or an explanation of why no such
estimate is available;
(4) a description of the projected reporting, recordkeeping and
other compliance requirements of the rule, including an estimate of the
classes of small entities which will be subject to the requirement and
the type of professional skills necessary for preparation of the report
or record; and
(5) a description of the steps the agency has taken to minimize
the significant economic impact on small entities consistent with the
stated objectives of applicable statutes, including a statement of the
factual, policy, and legal reasons for selecting the alternative
adopted in the final rule and why each one of the other significant
alternatives to the rule considered by the agency which affect the
impact on small entities was rejected.
(b) The agency shall make copies of the final regulatory
flexibility analysis available to members of the public and shall
publish in the Federal Register such analysis or a summary thereof.
[Codified to 5 U.S.C. 604]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96--354; 94 Stat. 1167), effective January 1, 1981, except that
the requirements of this section shall apply only to rules for which a
notice of proposed rulemaking is issued on or after January 1, 1981; as
amended by sections 241(b)(1) and (b)(2) of title II of the Act of
March 24, 1996 (Pub. L. No. 104--121; 110 Stat. 864 and 865), effective
March 29, 1996]
§ 605. Avoidance of duplicative or unnecessary analyses.
(a) Any Federal agency may perform the analyses required by
Sections 602, 603, and 604 of this title in conjunction with or as a
part of any other agenda or analysis required by any other law if such
other analysis satisfies the provisions of such sections.
(b) Sections 603 and 604 of this title shall not apply to any
proposed or final rule if the head of the agency certifies that the
rule will not, if promulgated, have a significant
{{6-28-96 p.8053}}economic impact on a
substantial number of small entities. If the head of the agency makes a
certification under the preceding sentence, the agency shall publish
such certification in the Federal Register at the time of publication
of general notice of proposed rulemaking for the rule or at the time of
publication of the final rule, along with a statement providing the
factual basis for such certification. The agency shall provide such
certification and statement to the Chief Counsel for Advocacy of the
Small Business Administration.
(c) In order to avoid duplicative action, an agency may consider a
series of closely related rules as one rule for the purposes of
Sections 602, 603, 604 and 610 of this title.
[Codified to 5 U.S.C. 605]
[Source: Section 3 of the Act of September 19, 1980 (Pub. L. No.
96-354; 94 Stat. 1167), effective January 1, 1981; as amended by
section 243(a) of title II of the Act of March 24, 1996 (Pub. L. No.
104--121; 110 Stat. 866), effective March 29,
1996]
§ 606. Effect on other law.
The requirements of Sections 603 and 604 of this title do not alter
in any manner standards otherwise applicable by law to agency action.
[Codified to 5 U.S.C. 606]
[Source: Section 3 of the Act of September 19, 1980 (Pub. L. No.
96-354; 94 Stat. 1168), effective January 1,
1981]
§ 607. Preparation of analyses.
In complying with the provisions of Sections 603 and 604 of this
title, an agency may provide either a quantifiable or numerical
description of the effects of a proposed rule or alternatives to the
proposed rule, or more general descriptive statements if quantification
is not practicable or reliable.
[Codified to 5 U.S.C. 607]
[Source: Section 3 of the Act of September 19, 1980 (Pub. L. No.
96-354; 94 Stat. 1168), effective January 1,
1981]
§ 608. Procedure for waiver or delay of completion.
(a) An agency head may waive or delay the completion of some or all
of the requirements of Section 603 of this title by publishing in the
Federal Register, not later than the date of publication of the final
rule, a written finding, with reasons therefor, that the final rule is
being promulgated in response to an emergency that makes compliance or
timely compliance with the provisions of Section 603 of this title
impracticable.
(b) Except as provided in Section 605(b), an agency head may not
waive the requirements of Section 604 of this title. An agency head may
delay the completion of the requirements of Section 604 of this title
for a period of not more than one hundred and eighty days after the
date of publication in the Federal Register of a final rule by
publishing in the Federal Register, not later than such date of
publication, a written finding, with reasons therefor, that the final
rule is being promulgated in response to an emergency that makes timely
compliance with the provisions of Section 604 of this title
impracticable. If the agency has not prepared a final regulatory
analysis pursuant to Section 604 of this title within one hundred and
eighty days from the date of publication of the final rule, such rule
shall lapse and have no effect. Such rule shall not be repromulgated
until a final regulatory flexibility analysis has been completed by the
agency.
[Codified to 5 U.S.C. 608]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96-354; 94 Stat. 1168), effective January 1, 1981]
{{6-28-96 p.8054}}
§ 609. Procedures for gathering comments.
(a) When any rule is promulgated which will have a significant
economic impact on a substantial number of small entities, the head of
the agency promulgating the rule or the official of the agency with
statutory responsibility for the promulgation of the rule shall assure
that small entities have been given an opportunity to participate in
the rulemaking for the rule through the reasonable use of techniques
such as--
(1) the inclusion in an advanced notice of proposed rulemaking,
if issued, of a statement that the proposed rule may have a significant
economic effect on a substantial number of small entities;
(2) the publication of general notice of proposed rulemaking in
publications likely to be obtained by small entities;
(3) the direct notification of interested small entities;
(4) the conduct of open conferences or public hearings concerning
the rule for small entities including soliciting and receiving comments
over computer networks; and
(5) the adoption or modification of agency procedural rules to
reduce the cost or complexity of participation in the rulemaking by
small entities.
(b) Prior to publication of an initial regulatory flexibility
analysis which a covered agency is required to conduct by this
chapter--
(1) a covered agency shall notify the Chief Counsel for Advocacy
of the Small Business Administration and provide the Chief Counsel with
information on the potential impacts of the proposed rule on small
entities and the type of small entities that might be affected;
(2) not later than 15 days after the date of receipt of the
materials described in paragraph (1), the Chief Counsel shall identify
individuals representative of affected small entities for the purpose
of obtaining advice and recommendations from those individuals about
the potential impacts of the proposed rule;
(3) the agency shall convene a review panel for such rule
consisting wholly of full time Federal employees of the office within
the agency responsible for carrying out the proposed rule, the Office
of Information and Regulatory Affairs within the Office of Management
and Budget, and the Chief Counsel;
(4) the panel shall review any material the agency has prepared
in connection with this chapter, including any draft proposed rule,
collect advice and recommendations of each individual small entity
representative identified by the agency after consultation with the
Chief Counsel, on issues related to
subsections 603(b), paragraphs
(3), (4) and (5) and 603(c);
(5) not later than 60 days after the date a covered agency
convenes a review panel pursuant to paragraph (3), the review panel
shall report on the comments of the small entity representatives and
its findings as to issues related to subsections 603(b), paragraphs
(3), (4) and (5) and 603(c), provided that such report shall be made
public as part of the rulemaking record; and
(6) where appropriate, the agency shall modify the proposed rule,
the initial regulatory flexibility analysis or the decision on whether
an initial regulatory flexibility analysis is required.
(c) An agency may in its discretion apply subsection (b) to rules
that the agency intends to certify under subsection 605(b), but the
agency believes may have a greater than de minimis impact on a
substantial number of small entities.
(d) For purposes of this section, the term "covered agency"
means the Environmental Protection Agency and the Occupational Safety
and Health Administration of the Department of Labor.
(e) The Chief Counsel of Advocacy, in consultation with the
individuals identified in subsection (b)(2), and with the Administrator
of the Office of Information and Regulatory Affairs within the Office
of Management and Budget, may waive the requirements of subsections
(b)(3), (b)(4), and (b)(5) by including in the rulemaking record a
written finding, with reasons therefor, that those requirements would
not advance the effective
{{6-28-96 p.8054.01}}participation of small
entities in the rulemaking process. For purposes of this subsection,
the factors to be considered in making such a finding are as follows:
(1) In developing a proposed rule, the extent to which the
covered agency consulted with individuals representative of affected
small entities with respect to the potential impacts of the rule and
took such concerns into consideration.
(2) Special circumstances requiring prompt issuance of the rule.
(3) Whether the requirements of subsection (b) would provide the
individuals identified in subsection (b)(2) with a competitive
advantage relative to other small entities.
[Codified to 5 U.S.C. 609]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96-354; 94 Stat. 1168), effective January 1, 1981; as amended by
section 244(a) of title II of the Act of March 24, 1996 (Pub. L. No.
104--121; 110 Stat. 867), effective March 29,
1996]
§ 610. Periodic review of rules.
(a) Within one hundred and eighty days after the effective date of
this chapter, each agency shall publish in the Federal Register a plan
for the periodic review of the rules issued by the agency which have or
will have a significant economic impact upon a substantial number of
small entities. Such plan may be amended by the agency at any time by
publishing the revision in the Federal Register. The purpose of the
review shall be to determine whether such rules should be continued
without change, or should be amended or rescinded, consistent with the
stated objectives of applicable statutes, to minimize any significant
economic impact of the rules upon a substantial number of such small
entities. The plan shall provide for the review of all such agency
rules existing on the effective date of this chapter within ten years
of that date and for the review of such rules adopted after the
effective date of this chapter within ten years of the publication of
such rules as the final rule. If the head of the agency determines that
completion of the review of existing rules is not feasible by the
established date, he shall so certify in a statement published in the
Federal Register and may extend the completion date by one year at a
time for a total of not more than five years.
(b) In reviewing rules to minimize any significant economic impact
of the rule on a substantial number of small entities in a manner
consistent with the stated objectives of applicable statutes, the
agency shall consider the following factors--
(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; and
(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.
(c) Each year, each agency shall publish in the Federal Register a
list of the rules which have a significant economic impact on a
substantial number of small entities, which are to be reviewed pursuant
to this section during the succeeding twelve months. The list shall
include a brief description of each rule and the need for and legal
basis of such rule and shall invite public comment upon the rule.
[Codified to 5 U.S.C. 610]
[Source: Section 3 of the Act of September 19, 1980 (Pub.
L. No. 96-354; 94 Stat. 1169), effective January 1, 1981; as amended by
sections 244(a)(1)--(a)(4) of title II of the Act of March 24, 1996
(Pub. L. No. 104--121; 110 Stat. 867), effective March 29,
1996]
§ 611. Judicial review.
(a)(1) For any rule subject to this chapter, a small entity
that is adversely affected or aggrieved by final agency action is
entitled to judicial review of agency compliance with
the
{{6-28-96 p.8054.02}}requirements of
sections 601,
604,
605(b),
608(b), and
610 in accordance with chapter
7. Agency compliance with sections 607 and 609(a) shall be judicially
reviewable in connection with judicial review of section 604.
(2) Each court having jurisdiction to review such rule for
compliance with section 553, or under any other provision of law shall
have jurisdiction to review any claims of noncompliance with sections
601, 604, 605(b), 608(b), and 610 in accordance with chapter 7. Agency
compliance with sections 607 and
609(a) shall be judicially
reviewable in connection with judicial review of section 604.
(3)(A) A small entity may seek such review during the period
beginning on the date of final agency action and ending one year later,
except that where a provision of law requires that an action
challenging a final agency action be commenced before the expiration of
one year, such lesser period shall apply to an action for judicial
review under this section.
(B) In the case where an agency delays the issuance of a final
regulatory flexibility analysis pursuant to section 608(b) of this
chapter, an action for judicial review under this section shall be
filed not later than--
(i) one year after the date the analysis is made available to the
public, or
(ii) where a provision of law requires that an action challenging
a final agency regulation be commenced before the expiration of the
1-year period, the number of days specified in such provision of law
that is after the date the analysis is made available to the public.
(4) In granting any relief in an action under this section, the
court shall order the agency to take corrective action consistent with
this chapter and chapter 7, including, but not limited to--
(A) remanding the rule to the agency, and
(B) deferring the enforcement of the rule against small entities
unless the court finds that continued enforcement of the rule is in the
public interest.
(5) Nothing in this subsection shall be construed to limit the
authority of any court to stay the effective date of any rule or
provision thereof under any other provision of law or to grant any
other relief in addition to the requirements of this section.
(b) In an action for the judicial review of a rule, the regulatory
flexibility analysis for such rule, including an analysis prepared or
corrected pursuant to paragraph (a)(4), shall constitute part of the
entire record of agency action in connection with such review.
(c) Compliance or noncompliance by an agency with the provisions of
this chapter shall be subject to judicial review only in accordance
with this section.
(d) Nothing in this section bars judicial review of any other
impact statement or similar analysis required by any other law if
judicial review of such statement or analysis is otherwise permitted by
law.
[Codified to 5 U.S.C. 611]
[Source: Section 3 of the Act of September 19, 1980 (Pub. L. No.
96--354; 94 Stat. 1169), effective January 1, 1981; as amended by
section 242 of title II of the Act of March 24, 1996 (Pub. L. No.
104--121; 110 Stat. 165), effective March 29,
1996]
§ 612. Reports and intervention rights.
(a) The Chief Counsel for Advocacy of the Small Business
Administration shall monitor agency compliance with this chapter and
shall report at least annually thereon to the President and to the
Committees on the Judiciary and Small Business of the Senate and House
of Representatives.
(b) The Chief Counsel for Advocacy of the Small Business
Administration is authorized to appear as amicus curiae in any
action brought in a court of the United States to review a rule. In any
such action, the Chief Counsel is authorized to present his or her
views with respect to compliance with this chapter, the adequacy of the
rulemaking record with respect to small entities and the effect of the
rule on small entities.
{{6-28-96 p.8054.03}}
(c) A court of the United States shall grant the application of the
Chief Counsel for Advocacy of the Small Business Administration to
appear in any such action for the purposes described in subsection (b).
[Codified to 5 U.S.C. 612]
[Source: Section 3 of the Act of September 19, 1980 (Pub. L. No.
96--354; 94 Stat. 1170), effective January 1, 1981; as amended by
sections 243(b)(1) and (b)(2) of title II of the Act of March 24, 1996
(Pub. L. No. 104--121; 110 Stat. 866), effective March 29,
1996]
* Editor's Note: Chapter 6 of title 5, United States
Code, is known as the "Regulatory Flexibility Act". Go Back to Text
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