2020 Civil Penalties Inflation Adjustments for Oil, Gas, and Sulfur Operations in the Outer Continental Shelf

• Published date: 07 February 2020
• Citation: 85 FR 7218
• Record Number: 2020-02059
• Section: Rules and Regulations
• Court: Ocean Energy Management Bureau

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Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Rules and Regulations

1

The FCPIA Improvements Act amended the

Federal Civil Penalties Inflation Adjustment Act of

1990. Public Law 101–410 (codified at 28 U.S.C.

2461 note).

2

Under the FCPIA Improvements Act, Federal

agencies were required to adjust their civil

monetary penalties for inflation with an initial

‘‘catch-up’’ adjustment through an interim final

rulemaking in 2016 and are required to make

subsequent inflation adjustments not later than

January 15 annually, beginning in 2017. Public Law

114–74, sec. 701(b)(1).

(ix) A limitation statement that

detection of a genomic drug resistance

mutation may not correlate with

phenotypic gene expression.

(x) A limitation statement that the test

does not detect all genetic mutations

associated with antiviral drugs.

(xi) A limitation statement listing the

HIV types for which the test is not

intended, if any.

(3) Device verification and validation

must include:

(i) Design of primer sequences and

rationale for sequence selection.

(ii) Computational path from collected

raw data to reported result.

(iii) Detailed documentation of

analytical studies including, but not

limited to, characterization of the cutoff,

analytical sensitivity, inclusivity,

reproducibility, interference, cross

reactivity, instrument and method

carryover/cross contamination, sample

stability, and handling for all genomic

mutations claimed in the intended use.

(iv) Precision studies that include all

genomic mutations claimed in the

intended use.

(v) Detailed documentation of a

multisite clinical study evaluating the

sensitivity and specificity of the device.

Clinical study subjects must represent

the intended use population and device

results for all targets claimed in the

intended use must be compared to

Sanger sequencing or other methods

found acceptable by FDA. Drug

resistance-associated mutations at or

above the 20 percent frequency level

must detect the mutations in greater

than 90 percent of at least 10 replicates,

for each of drug class evaluated.

(vi) Documentation that variant

calling is performed at a level of

coverage that supports positive

detection of all genomic mutations

claimed in the intended use.

(vii) Detailed documentation of limit

of detection (LoD) studies in which

device performance is evaluated by

testing a minimum of 100 HIV-positive

clinical samples including samples with

analyte concentrations near the clinical

decision points and near the LoD.

(A) The LoD for the device must be

determined using a minimum of 10

HIV–1 group M genotypes if applicable.

A detection rate at 1 × LoD greater than

or equal to 95 percent must be

demonstrated for mutations with a

frequency greater than 20 percent.

(B) The LoD of genetic mutations at

frequency levels less than 20 percent

must be established.

(viii) A predefined HIV genotyping

bioinformatics analysis pipeline (BAP).

The BAP must adequately describe the

bioinformatic analysis of the sequencing

data, including but not limited to read

alignment, variant calling, assembly,

genotyping, quality control, and final

result reporting.

(ix) A clear description of the

selection and use of the standardized

database that is used for sequence

comparison and results derivation.

(4) Premarket notification

submissions must include the

information in paragraphs (b)(3)(i)

through (ix) of this section.

Dated: January 27, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

[FR Doc. 2020–01725 Filed 2–6–20; 8:45 am]

BILLING CODE 4164–01–P

DEPARTMENT OF THE INTERIOR

Bureau of Ocean Energy Management

30 CFR Parts 550 and 553

[Docket ID: BOEM–2019–0079]

RIN 1010–AE05

2020 Civil Penalties Inflation

Adjustments for Oil, Gas, and Sulfur

Operations in the Outer Continental

Shelf

AGENCY

: Bureau of Ocean Energy

Management, Interior.

ACTION

: Final rule.

SUMMARY

: This final rule implements

the 2020 inflation adjustments to the

maximum daily civil monetary penalties

contained in the Bureau of Ocean

Energy Management (BOEM) regulations

for violations of the Outer Continental

Shelf Lands Act (OCSLA) and the Oil

Pollution Act of 1990 (OPA), pursuant

to the Federal Civil Penalties Inflation

Adjustment Act Improvements Act of

2015 (FCPIA Improvements Act) and

relevant Office of Management and

Budget (OMB) guidance. The 2020

adjustment multiplier of 1.01764

accounts for one year of inflation from

October 2018 through October 2019.

DATES

: This rule is effective on February

7, 2020.

FOR FURTHER INFORMATION CONTACT

:

Deanna Meyer-Pietruszka, Chief, Office

of Policy, Regulation, and Analysis,

Bureau of Ocean Energy Management, at

(202) 208–6352 or by email at

deanna.meyer-pietruszka@boem.gov.

SUPPLEMENTARY INFORMATION

:

I. Legal Authority

II. Background

III. Calculation of 2020 Adjustments

IV. Procedural Requirements

A. Statutes

1. National Environmental Policy Act

2. Regulatory Flexibility Act

3. Paperwork Reduction Act

4. Unfunded Mandates Reform Act

5. Small Business Regulatory Enforcement

Fairness Act

6. Congressional Review Act

B. Executive Orders (E.O.)

1. Governmental Actions and Interference

With Constitutionally Protected Property

Rights (E.O. 12630)

2. Regulatory Planning and Review (E.O.

12866); Improving Regulation and

Regulatory Review (E.O. 13563); and

Reducing Regulation and Controlling

Regulatory Costs (E.O. 13771)

3. Civil Justice Reform (E.O. 12988)

4. Federalism (E.O. 13132)

5. Consultation and Coordination With

Indian Tribal Governments (E.O. 13175)

6. Actions Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use (E.O. 13211)

I. Legal Authority

OCSLA authorizes the Secretary of the

Interior to impose a daily civil monetary

penalty for a violation of OCSLA or its

regulations, leases, permits, or orders

and directs the Secretary to adjust the

maximum penalty at least every three

years to reflect any inflation increase in

the Consumer Price Index. 43 U.S.C.

1350(b)(1). Similarly, OPA authorizes

civil monetary penalties for failure to

comply with OPA’s financial

responsibility provisions or its

implementing regulations. 33 U.S.C.

2716a(a). OPA does not include a

maximum daily civil penalty inflation

adjustment provision. Id.

The FCPIA Improvements Act

1

requires that Federal agencies publish

inflation adjustments to their civil

monetary penalties in the Federal

Register not later than January 15

annually.

2

Public Law 114–74, sec.

701(b)(1). The purposes behind these

inflation adjustments are to maintain

the deterrent effect of civil penalties and

to further the policy goals of the

underlying statutes. Federal Civil

Penalties Inflation Adjustment Act of

1990, Public Law 101–410, sec. 2

(codified at 28 U.S.C. 2461 note).

II. Background

BOEM implemented the 2019

inflation adjustment for its civil

monetary penalties through a final rule

published in the Federal Register on

March 26, 2019, which accounted for

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3

The delayed publication resulted from a lapse of

Federal government funding from December 22,

2018, until January 25, 2019. 84 FR 11,222, 11,222

(Mar. 26, 2019).

4

Specifically, Congress directed that agencies

adjust civil monetary penalties ‘‘notwithstanding

section 553 of title 5, United States Code

[Administrative Procedure Act (APA)],’’ which

generally requires prior notice of proposed

rulemaking, opportunity for public comment on

proposed rulemaking, and publication of a final

rule at least 30 days before its effective date. FCPIA

Improvements Act, sec. 4(b)(2); APA, 5 U.S.C. 553.

OMB confirmed this interpretation of the FCPIA

Improvements Act. OMB M–20–05 at 4 (‘‘This

means that the public procedure the APA generally

requires—notice, an opportunity for comment, and

a delay in effective date—is not required for

agencies to issue regulations implementing the

annual adjustment.’’).

5

The annual inflation adjustment is based on the

percent change between the Consumer Price Index

for All Urban Consumers (CPI–U) for the October

preceding the date of the adjustment and the prior

year’s October CPI–U. Consistent with OMB M–20–

05, the 2020 multiplier can be calculated by

dividing the October 2019 CPI–U by the October

2018 CPI–U. In this case, October 2019 CPI–U

(257.346)/October 2018 CPI–U (252.885) = 1.01764.

inflation through October 2018. Oil and

Gas and Sulfur Operations in the Outer

Continental Shelf-Civil Penalties

Inflation Adjustments, 84 FR 11,222

(Mar. 26, 2019).

3

For 2020, OMB issued guidance that

explains agency statutory

responsibilities for identifying

applicable civil monetary penalties and

performing the annual adjustment;

publishing revisions to regulations to

implement the adjustment in the

Federal Register; applying adjusted

penalty levels; and performing agency

oversight of inflation adjustments.

Implementation of Penalty Inflation

Adjustments for 2020, Pursuant to the

Federal Civil Penalties Inflation

Adjustment Act Improvements Act of

2015, OMB Memorandum M–20–05,

December 16, 2019 (OMB M–20–05),

available at https://

www.whitehouse.gov/wp-content/

uploads/2019/12/M-20-05.pdf.

BOEM is implementing the 2020

inflation adjustments to the OCSLA and

OPA maximum daily civil monetary

penalties through this final rule

pursuant to the FCPIA Improvements

Act and OMB M–20–05. A proposed

rule is unnecessary. The FCPIA

Improvements Act expressly exempts

annual civil penalty inflation

adjustments from the Administrative

Procedure Act’s (APA) notice of

proposed rulemaking, public comment,

and standard effective date provisions.

FCPIA Improvements Act, Public Law

114–74, sec. 701(b)(1)(D); APA, 5 U.S.C.

553.

4

III. Calculation of 2020 Adjustments

OMB issued guidance to Federal

agencies on implementing the 2020

annual civil monetary penalties

inflation adjustments, including the

adjustment multiplier: 1.01764. OMB

M–20–05; FCPIA Improvements Act,

sec. 701(b)(4).

5

In accordance with the

FCPIA Improvements Act and OMB M–

20–05, BOEM determined that the

OCSLA and OPA maximum daily civil

monetary penalties require annual

inflation adjustments and is issuing this

final rule adjusting those penalty

amounts for inflation through October

2019.

For 2020, BOEM multiplied the

current OCSLA maximum daily civil

penalty of $44,675 by the multiplier

1.01764 to equal $45,463.07 rounded to

nearest cent ($44,675 × 1.01764 =

$45,463.07). The FCPIA Improvements

Act requires the resulting amount be

rounded to the nearest dollar.

Accordingly, the 2020 adjusted OCSLA

maximum daily civil penalty is $45,463.

For 2020, BOEM multiplied the

current OPA maximum daily civil

penalty amount of $47,357 by the

multiplier 1.01764 to equal $48,192.38

rounded to nearest cent ($47,357 ×

1.01764 = $48,192.38). The FCPIA

Improvements Act requires that the

resulting amount be rounded to the

nearest dollar. Accordingly, the 2020

adjusted OPA maximum daily civil

penalty is $48,192.

The adjusted penalty amounts take

effect immediately upon publication of

this rule. Under the FCPIA

Improvements Act, the adjusted

amounts apply to civil penalties

assessed after the date the increase takes

effect, even if the associated violation

predates the increase.

This table summarizes BOEM’s 2020

maximum daily civil monetary penalties

for each OCSLA and OPA violation:

CFR citation Description of

the penalty

Current

maximum

penalty Multiplier Adjusted

maximum

penalty

30 CFR 550.1403 (OCSLA) ............................ Failure to comply per day per violation ......... $44,675 1.01764 $45,463

30 CFR 553.51(a) (OPA) ................................ Failure to comply per day per violation ......... $47,357 1.01764 48,192

IV. Procedural Requirement

A. Statutes

1. National Environmental Policy Act

This rule does not constitute a major

Federal action significantly affecting the

quality of the human environment. A

detailed statement under the National

Environmental Policy Act (NEPA, 42

U.S.C. 4321 et seq.) is not required

because, as a regulation of an

administrative nature, this rule is

covered by a categorical exclusion. See

43 CFR 46.210(i). BOEM also has

determined that the rule does not

implicate any of the extraordinary

circumstances listed in 43 CFR 46.215

that would require further analysis

under NEPA. Therefore, a detailed

statement under NEPA is not required.

2. Regulatory Flexibility Act

The Regulatory Flexibility Act (RFA,

5 U.S.C. 601 et seq.) requires an agency

to prepare a regulatory flexibility

analysis for all rules unless the agency

certifies that the rule will not have a

significant economic impact on a

substantial number of small entities.

The RFA applies only to rules for which

an agency is required to first publish a

proposed rule. See 5 U.S.C. 603(a) and

604(a). The FCPIA Improvements Act

expressly exempts these annual

inflation adjustments from the

requirement to publish a proposed rule

for notice and comment. FCPIA

Improvements Act, Public Law 114–74,

sec. 701(b)(1)(D); OMB M–20–05 at 4.

Thus, the RFA does not apply to this

rulemaking.

3. Paperwork Reduction Act

This rule does not contain

information collection requirements,

and, therefore, a submission to OMB

under the Paperwork Reduction Act (44

U.S.C. 3501 et seq.) is not required.

4. Unfunded Mandates Reform Act

This rule does not impose an

unfunded mandate on state, local, or

tribal governments, or the private sector,

of more than $164 million per year. The

rule does not have a significant or

unique effect on state, local, or tribal

governments or the private sector.

Therefore, a statement containing the

information required by the Unfunded

Mandates Reform Act (2 U.S.C. 1531 et

seq.) is not required.

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6

Office of Mgmt. & Budget, Exec. Office of the

President, OMB M–19–14, Guidance on Compliance

with the Congressional Review Act (2019).

7

5 U.S.C. 804(2).

5. Small Business Regulatory

Enforcement Fairness Act

This rule is not a major rule under 5

U.S.C. 804(2). This rule:

(a) Will not have an annual effect on

the economy of $100 million or more;

(b) Will not cause a major increase in

costs or prices for consumers,

individual industries, Federal, State, or

local government agencies, or

geographic regions; and

(c) Will not have significant adverse

effects on competition, employment,

investment, productivity, innovation, or

the ability of U.S.-based enterprises to

compete with foreign-based enterprises.

6. Congressional Review Act

Pursuant to the Congressional Review

Act (5 U.S.C. 801 et seq.) and OMB

guidance,

6

the Office of Information and

Regulatory Affairs (OIRA) designated

this rule as not a major rule as defined

by that act.

7

Office of Info. & Regulatory

Affairs, Office of Mgmt. & Budget, Fall

2019 Unified Agenda of Regulatory and

Deregulatory Actions, Dep’t of the

Interior, RIN 1010–AE03 (note the RIN

for this rule is listed in error, the correct

RIN is 1010–AE05), available at https://

www.reginfo.gov/public/do/eAgenda

ViewRule?pubId=201910&RIN=1010-

AE03.

B. Executive Orders (E.O.)

1. Governmental Actions and

Interference with Constitutionally

Protected Property Rights (E.O. 12630)

This rule does not effect a taking of

private property or otherwise have

takings implications under E.O. 12630.

Therefore, a takings implication

assessment is not required.

2. Regulatory Planning and Review (E.O.

12866); Improving Regulation and

Regulatory Review (E.O. 13563); and

Reducing Regulation and Controlling

Regulatory Costs (E.O. 13771)

E.O. 12866 provides that OIRA will

review all significant rules. OIRA has

determined that this rule is not

significant. See OMB M–20–05 at 3.

E.O. 13563 reaffirms the principles of

E.O. 12866 while calling for

improvements in the nation’s regulatory

system to reduce uncertainty and to

promote predictability and the use of

the best, most innovative, and least

burdensome tools for achieving

regulatory ends. E.O. 13563 directs

agencies to consider regulatory

approaches that reduce burdens and

maintain flexibility and freedom of

choice for the public where these

approaches are relevant, feasible, and

consistent with regulatory objectives.

E.O. 13563 further emphasizes that

regulations must be based on the best

available science and that the

rulemaking process must allow for

public participation and an open

exchange of ideas. However, there is no

science being used in this rulemaking,

as Congress directed agencies to adjust

the maximum daily civil penalty

amounts using a particular equation and

BOEM does not have discretion to use

any other factor in the adjustment.

BOEM has developed this rule in a

manner consistent with these

requirements, to the extent relevant and

feasible given the limited discretion

provided agencies under the FCPIA

Improvements Act.

E.O. 13771 directs Federal agencies to

reduce the regulatory burden on

regulated entities and control regulatory

costs. E.O. 13771, however, applies only

to significant regulatory actions, as

defined in section 3(f) of E.O. 12866.

OIRA has determined this rule is not

significant. This final rule exclusively

implements the annual inflation

adjustments consistent with OMB’s

guidance and its determination that this

rule is not a significant regulatory

action. OMB M–20–05 at 3. Thus, this

rule is not considered an E.O. 13771

regulatory action. Id.

3. Civil Justice Reform (E.O. 12988)

This rule complies with the

requirements of E.O. 12988.

Specifically, this rule:

(a) Meets the criteria of section 3(a)

requiring that all regulations be

reviewed to eliminate errors and

ambiguity and be written to minimize

litigation; and

(b) Meets the criteria of section 3(b)(2)

requiring that all regulations be written

in clear language and contain clear legal

standards.

4. Federalism (E.O. 13132)

Under the criteria in section 1 of E.O.

13132, this rule does not have sufficient

federalism implications to warrant the

preparation of a federalism summary

impact statement. To the extent State

and local governments have a role in

outer continental shelf activities, this

rule will not affect that role. Therefore,

a federalism summary impact statement

is not required.

5. Consultation and Coordination With

Indian Tribal Governments (E.O. 13175)

The Department of the Interior and

BOEM strive to strengthen their

government-to-government

relationships with Indian tribes through

a commitment to consultation with

Indian tribes and recognition of their

right to self-governance and tribal

sovereignty. BOEM has evaluated this

rule under the Department of the

Interior’s consultation policy, under

Departmental Manual part 512, chapters

4 and 5, and under the criteria in E.O.

13175. BOEM has determined that this

rule has no substantial direct effects on

Federally-recognized Indian tribes or

Alaska Native Claims Settlement Act

(ANCSA) Corporations, and that

consultation under the Department of

the Interior’s and BOEM’s tribal and

ANCSA consultation policies is not

required.

6. Actions Concerning Regulations That

Significantly Affect Energy Supply,

Distribution, or Use (E.O. 13211)

This rule is not a significant energy

action under the definition in E.O.

13211. Therefore, a Statement of Energy

Effects is not required.

List of Subjects

30 CFR Part 550

Administrative practice and

procedure, Continental shelf,

Environmental impact statements,

Environmental protection, Federal

lands, Government contracts,

Investigations, Mineral resources, Oil

and gas exploration, Outer continental

shelf, Penalties, Pipelines, Reporting

and recordkeeping requirements, Rights-

of-way, Sulfur.

30 CFR Part 553

Administrative practice and

procedure, Continental shelf, Financial

responsibility, Liability, Limit of

liability, Oil and gas exploration, Oil

pollution, Outer continental shelf,

Penalties, Pipelines, Reporting and

recordkeeping requirements, Rights-of-

way, Surety bonds, Treasury securities.

Dated: January 28, 2020.

Casey Hammond,

Acting Assistant Secretary, Land and

Minerals Management.

For the reasons stated in the

preamble, BOEM amends title 30,

chapter V, subchapter B, parts 550 and

553 of the Code of Federal Regulations

as follows:

PART 550—OIL AND GAS AND

SULPHUR OPERATIONS IN THE

OUTER CONTINENTAL SHELF

■1. The authority citation for part 550

continues to read as follows:

Authority: 30 U.S.C. 1751; 31 U.S.C. 9701;

43 U.S.C. 1334.

■2. Revise § 550.1403 to read as

follows:

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§ 550.1403 What is the maximum civil

penalty?

The maximum civil penalty is

$45,463 per day per violation.

PART 553—OIL SPILL FINANCIAL

RESPONSIBILITY FOR OFFSHORE

FACILITIES

■3. The authority citation for part 553

continues to read as follows:

Authority: 33 U.S.C. 2704, 2716; E.O.

12777, as amended.

■4. Revise § 553.51(a) to read as

follows:

§ 553.51 What are the penalties for not

complying with this part?

(a) If you fail to comply with the

financial responsibility requirements of

OPA at 33 U.S.C. 2716 or with the

requirements of this part, then you may

be liable for a civil penalty of up to

$48,192 per COF per day of violation

(that is, each day a COF is operated

without acceptable evidence of OSFR).

* * * * *

[FR Doc. 2020–02059 Filed 2–6–20; 8:45 am]

BILLING CODE 4310–MR–P

DEPARTMENT OF THE INTERIOR

Office of Natural Resources Revenue

30 CFR Part 1241

[Docket No. ONRR–2017–0003; DS63644000

DRT000000.CH7000 201D1113RT]

RIN 1012–AA25

Inflation Adjustments to Civil Monetary

Penalty Rates for Calendar Year 2020

AGENCY

: Office of the Secretary, Office

of Natural Resources Revenue, Interior.

ACTION

: Final rule.

SUMMARY

: The Office of Natural

Resources Revenue (ONRR) publishes

this final rule to increase our maximum

civil monetary penalty (CMP) rates for

inflation occurring between October

2018 and October 2019.

DATES

: This rule is effective on February

7, 2020.

FOR FURTHER INFORMATION CONTACT

: For

questions on procedural issues, contact

Luis Aguilar, Regulatory Specialist, by

telephone at (303) 231–3418 or email to

Luis.Aguilar@onrr.gov. For questions on

technical issues, contact Michael

Marchetti, Chief of Enforcement, by

telephone at (303) 231–3125 or email to

Michael.Marchetti@onrr.gov. You may

obtain a paper copy of this rule by

contacting Mr. Aguilar by phone or

email.

SUPPLEMENTARY INFORMATION

:

I. Background

II. Inflation-Adjusted Maximum Rates

III. Procedural Requirements

A. Regulatory Planning and Review (E.O.

12866)

B. Regulatory Flexibility Act

C. Small Business Regulatory Enforcement

Fairness Act

D. Unfunded Mandates Reform Act

E. Takings (E.O. 12630)

F. Federalism (E.O. 13132)

G. Civil Justice Reform (E.O. 12988)

H. Consultation With Indian Tribes (E.O.

13175)

I. Paperwork Reduction Act

J. National Environmental Policy Act

K. Effects on the Energy Supply (E.O.

13211)

L. Clarity of This Regulation

M. Administrative Procedure Act

I. Background

The Federal Civil Penalties Inflation

Adjustment Act of 1990, as amended by

the Federal Civil Penalties Inflation

Adjustment Act Improvements Act of

2015 (collectively, ‘‘the Act’’), codified

at 28 U.S.C. 2461 (specifically, see the

notes for more information), requires

Federal agencies to adjust their civil

monetary penalty (CMP) rates for

inflation every year.

In accordance with sections 4 and 5

of the Act, the annual CMP inflation

adjustment for 2020 is based on the

percent change in the Consumer Price

Index for all Urban Consumers (CPI–U)

between October 2018 and October

2019. The CPI–U for October 2018 was

252.885, and for October 2019 was

257.346, for an increase of 1.764%. In

accordance with section 5(a) of the Act,

the new maximum CMP rates must be

rounded to the nearest whole dollar. In

accordance with section 6 of the Act,

the new maximum penalty rates will

apply only to CMPs, including those

which are associated with violations

predating the increase, that are assessed

after the date the increase takes effect.

ONRR assesses CMPs under the

Federal Oil and Gas Royalty

Management Act, 30 U.S.C. 1719, and

our regulations at 30 CFR part 1241. We

calculate and assess CMPs per violation,

at the applicable rate, for each day such

violation continues.

II. Inflation-Adjusted Maximum Rates

This final rule increases the

maximum CMP rates for each of the four

categories of violations identified in 30

U.S.C. 1719(a)–(d) and 30 CFR part

1241. The following list identifies the

existing ONRR regulations containing

CMP rates and shows those rates before

and after this increase.

30 CFR citation Current penalty

rate

2020 inflation

adjustment

multiplier

2020 adjusted

penalty rate

1241.52(a)(2) ............................................................................................................. $1,251 1.01764 $1,273

1241.52(b) .................................................................................................................. 12,519 1.01764 12,740

1241.60(b)(1) ............................................................................................................. 25,037 1.01764 25,479

1241.60(b)(2) ............................................................................................................. 62,595 1.01764 63,699

III. Procedural Requirements

A. Regulatory Planning and Review

(Executive Orders 12866 and 13563)

Executive Order (E.O.) 12866 provides

that the Office of Information and

Regulatory Affairs (OIRA) in OMB will

review all significant rules. OIRA has

determined that this rule is not

significant.

E.O. 13563 reaffirms the principles of

E.O. 12866, while calling for

improvements in the Nation’s regulatory

system to promote predictability, to

reduce uncertainty, and to use the best,

most innovative, and least burdensome

tools for achieving regulatory ends. E.O.

13563 directs agencies to consider

regulatory approaches that reduce

burdens and maintain flexibility and

freedom of choice for the public where

these approaches are relevant, feasible,

and consistent with regulatory

objectives. E.O. 13563 emphasizes

further that regulations must be based

on the best available science and that

the rulemaking process must allow for

public participation and an open

exchange of ideas. We developed this

rule in a manner consistent with these

requirements.

B. Regulatory Flexibility Act

This rule will not have a significant

economic effect on a substantial number

of small entities under the Regulatory

Flexibility Act (RFA), 5 U.S.C. 601, et

seq., because the rule only makes

adjustments for inflation. The Federal

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