[Federal Register Volume 87, Number 232 (Monday, December 5, 2022)]
[Notices]
[Page 74446]
[FR Doc No: 2022-26371]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2022-0011]

Maritime Advisory Committee on Occupational Safety and Health
(MACOSH); Charter Renewal

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Renewal of the MACOSH charter.

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SUMMARY: The Secretary of Labor (Secretary) has renewed the charter for
MACOSH.

FOR FURTHER INFORMATION CONTACT:
    For press inquiries: Mr. Frank Meilinger, Director, OSHA Office of
Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    For general information: Ms. Amy Wangdahl, Director, Office of
Maritime and Agriculture, Directorate of Standards and Guidance, OSHA,
U.S. Department of Labor; telephone:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION: The Secretary has renewed the MACOSH
charter. The charter will expire two years from its filing date.
    MACOSH is established in section 7(d) of the Occupational Safety
and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) to advise, the
Secretary of Labor through the Assistant Secretary of Labor for
Occupational Safety and Health (Assistant Secretary) in order to inform
the administration of the OSH Act with respect to the maritime
industry. The Assistant Secretary may seek the advice of this Committee
on activities related to priorities set by the Agency, including:
Worker training, education, and assistance; setting and enforcing
standards; and assuring safe and healthful working conditions in the
maritime industry.
    MACOSH is a non-discretionary advisory committee of indefinite
duration, operating in accordance with the Federal Advisory Committee
Act (FACA) (5 U.S.C. App. 2), its implementing regulations (41 CFR
parts 101-6 and 102-3), chapter 1-900 of the Department of Labor Manual
Series 3 (Aug. 31, 2020) and OSHA's regulations on Advisory Committees
(29 CFR part 1912). Pursuant to FACA (5 U.S.C. App. 2, 14(b)(2)), the
MACOSH charter must be renewed every two years.
    The new MACOSH charter is available to read or download at http://www.regulations.gov (Docket No. OSHA-2022-0011), the federal rulemaking
portal. The charter also is available on the MACOSH page on OSHA's web
page at http://www.osha.gov and at the OSHA Docket Office, N-3653, U.S.
Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210;
telephone<PHONE_NUMBER>. In addition, the charter is available for
viewing or download at the Federal Advisory Committee Act Database at
http://www.facadatabase.gov.

Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice under the authority granted by 29 U.S.C. 656; 5 U.S.C. App. 2;
29 CFR part 1912a; 41 CFR part 102-3; and Secretary of Labor's Order
No. 8-2020 (85 FR 58393, Sept. 18, 2020).

    Signed at Washington, DC, on November 21, 2022.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-26371 Filed 12-2-22; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12473-12474]
[FR Doc No: 2021-04374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1413]

Michael Gurry: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act)
permanently debarring Michael Gurry from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Gurry was
convicted of a felony under Federal law for conduct that relates to the
regulation of a drug product under the FD&C Act. Mr. Gurry was given
notice of the proposed permanent debarment and an opportunity to
request a hearing to show why he should not be debarred. As of October
22, 2020 (30 days after receipt of the notice), Mr. Gurry had not
responded. Mr. Gurry's failure to respond and request a hearing
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is applicable March 8, 2021.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029) Division of
Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Drive, Rockville, MD 20857,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B))
requires debarment of an individual from providing services in any
capacity to a person that has an approved or pending drug product
application if FDA finds that the individual has been convicted of a
felony under Federal law for conduct relating to the regulation of any
drug product under the FD&C Act. On January 13, 2020, Mr. Gurry was
convicted as defined in section 306(l)(1) of the FD&C Act when judgment
was entered against him in the U.S. District Court for the District of
Massachusetts, after a jury verdict, on one count of racketeering
conspiracy in violation of 18 U.S.C. 1962(d). The pattern of
racketeering activity he was convicted of included engaging in multiple
acts of mail fraud (18 U.S.C. 1341) and wire fraud (18 U.S.C. 1343).
    The factual basis for this conviction is as follows: Mr. Gurry held
executive management positions, to include Vice President of Managed
Markets, of Insys Therapeutics Inc. (Insys), a Delaware Corporation,
with headquarters in Chandler, Arizona. Insys developed and owned a
drug called SUBSYS, a liquid formulation of fentanyl to be applied
under the tongue. FDA approved SUBSYS for the management of
breakthrough pain in adult cancer patients who are already receiving
and are already tolerant to opioid therapy for their underlying
persistent cancer pain. From early 2012 and continuing through 2015,
Mr. Gurry participated in a conspiracy whereby employees of Insys
bribed medical practitioners in various states to get those
practitioners to increase prescribing SUBSYS to their patients, many of
whom did not have cancer. Mr. Gurry, along with his coconspirators,
measured the effect of these bribes on each practitioner's prescribing
habits and on the revenue that each bribed practitioner generated for
Insys. Mr. Gurry, along with his coconspirators, reduced or eliminated
bribes paid to those practitioners who failed to meet the minimum
prescription requirements or failed to generate enough revenue to
justify additional bribes. To further this conspiracy, Mr. Gurry and
his coconspirators misled and defrauded health insurance providers to
ensure those providers approved payment for SUBSYS. Insys achieved this
goal by establishing the ``Insys Reimbursement Center'', which was
designed to shift the burden of seeking prior authorization for SUBSYS
from practitioners to Insys. This allowed Insys to determine what
medical information was presented to insurers. Mr. Gurry and his
coconspirators directed Insys employees to mislead insurers to obtain
payment authorization.
    As a result of this conviction, FDA sent Mr. Gurry, by United
Parcel Service, on September 21, 2020, a notice proposing to
permanently debar him from providing services in any capacity to a
person that has an approved or pending drug product application. The
proposal was based on a finding, under section 306(a)(2)(B) of the FD&C
Act, that Mr. Gurry was convicted of a felony under Federal law for
conduct relating to the regulation of a drug product under the FD&C
Act. The proposal also offered Mr. Gurry an opportunity to request a
hearing, providing him 30 days from the date of receipt of the letter
in which to file the request, and advised him that failure to request a
hearing constituted an election not to use the opportunity for a
hearing and a waiver of any contentions concerning this

action. Mr. Gurry received the proposal on September 22, 2020. He did
not request a hearing within the timeframe prescribed by regulation and
has, therefore, waived his opportunity for a hearing and any
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr. Gurry
has been convicted of a felony under Federal law for conduct otherwise
relating to the regulation of a drug product under the FD&C Act.
    As a result of the foregoing finding, Mr. Gurry is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application, effective (see DATES)
(see sections 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Gurry in any capacity during his
debarment, will be subject to civil money penalties (section 307(a)(6)
of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Gurry provides services
in any capacity to a person with an approved or pending drug product
application during his period of debarment, he will be subject to civil
money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA
will not accept or review any abbreviated new drug application from Mr.
Gurry during his period of debarment, other than in connection with an
audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the
FD&C Act). Note that, for purposes of section 306 of the FD&C Act, a
``drug product'' is defined as a drug subject to regulation under
section 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382)
or under section 351 of the Public Health Service Act (42 U.S.C. 262)
(section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).
    Any application by Mr. Gurry for special termination of debarment
under section 306(d)(4) of the FD&C Act should be identified with
Docket No. FDA-2020-N-1413 and sent to the Dockets Management Staff
(see ADDRESSES). The public availability of information in these
submissions is governed by 21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.

    Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04374 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Rules and Regulations]
[Pages 42523-42524]
[FR Doc No: 2016-15502]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2016-0479]

Safety Zones; Superior Man Triathlon, Duluth, MN

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the Safety Zone for the Superior
Man Triathlon in Duluth, MN August 28, 2016. This action is necessary
to protect the participants during the event. During the enforcement
period, entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Duluth or his
designated on-scene representative.

DATES: The regulations in 33 CFR 165.943(b) will be enforced from 5:30
a.m. through 9:30 a.m. on August 28, 2016.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Lieutenant Junior Grade John Mack,
Waterways

Management Division, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a safety zone
for the annual Superior Man Triathlon in Duluth, MN in 33 CFR
165.943(a)(8) from 5:30 a.m. until 9:30 a.m. August 28, 2016. This
safety zone will include all U.S. navigable waters of the Duluth Harbor
Basin, Northern Section within an imaginary line beginning at point
46[deg]46'36.12'' N. 092[deg]06'06.99'' W., running southeast to
46[deg]46'32.75'' N. 092[deg]06'01.74'' W., running northeast to
46[deg]46'45.92'' N. 092[deg]05'45.18'' W., running northwest to
46[deg]46'49.47'' N. 092[deg]05'49.35'' W. and finally running
southwest back to the starting point. Entry into, transiting, or
anchoring within the safety zone is prohibited unless authorized by the
Captain of the Port Duluth or his designated on-scene representative.
The Captain of the Port's designated on-scene representative may be
contacted via VHF Channel 16.
    This notice of enforcement is issued under authority of 33 CFR
165.943 and 5 U.S.C. 552 (a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of the enforcement of this safety
zone via Broadcast Notice to Mariners.

    Dated: June 24, 2016.
A.H. Moore, Jr.,
Commander, U.S. Coast Guard, Captain of the Port, Duluth.
[FR Doc. 2016-15502 Filed 6-29-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Notices]
[Pages 31402-31403]
[FR Doc No: 2014-12620]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2003-15340]

Petition for Waiver of Compliance

    In accordance with Part 211 of Title 49 Code of Federal Regulations
(CFR), this document provides the public notice that by a letter dated
November 28, 2013, the American Association of Private Railroad Car
Owners (AAPRCO) petitioned the Federal Railroad Administration (FRA)
for a renewal of its waiver of compliance from certain provisions of
the Federal railroad safety regulations contained at 49 CFR Part 238,
Passenger Equipment Safety Standards. FRA assigned the petition Docket
Number FRA-2003-15340.

    AAPRCO seeks renewal of its relief from 49 CFR 238.321(m)(2), Brake
system. This section specifies that ``up to two cars may be operated in
direct release mode when the rest of the cars in the train are operated
in graduated release mode, provided that the cars operated in direct
release mode are hauled at the rear of the train consist.'' The present
relief provides that ``up to two cars may be operated in direct release
mode when the rest of the cars in the train are operated in graduated
release mode,'' thereby eliminating the placement restrictions of the
direct release cars to the rear of the train. AAPRCO was granted its
original relief in 2003; this relief was renewed for 5 years in 2008.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by July 17, 2014 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on May 27, 2014.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2014-12620 Filed 5-30-14; 8:45 am]
BILLING CODE 4910-06-P


SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Hydrochloric Acid Production (40 CFR Part 63, Subpart NNNNN)
(Renewal)

1.  Identification of the Information Collection

	1(a)  Title of the Information Collection

NESHAP for Hydrochloric Acid Production (40 CFR Part 63, Subpart NNNNN)
(Renewal),    EPA ICR Number 2032.06, OMB Control Number 2060-0529

	1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP)
for Hydrochloric Acid Production were proposed on September 18, 2001 (66
FR 48174), final rule on April 17, 2003 (68 FR 19076), amended on August
24, 2005 (70 FR 49530), and promulgated on April 7, 2006 (71 FR 17738).
This subpart applies to each new, reconstructed, or existing affected
major source at a hydrochloric acid (HCI) production facility.  A major
source of hazardous air pollutants (HAP) is one that emits or has the
potential to emit any single HAP at a rate of 9.07 megagrams (10 tons)
or more per year, or any combination of HAP at a rate of 22.68 megagrams
(25 tons) or more per year.  The HAP identified as being emitted from
HCI production sources are hydrochloric acid (HCI) and chlorine (C12).
All existing major sources must be in compliance with the requirements
of the HCI production by April 17, 2006.  All new or reconstructed
affected sources must be in compliance with the requirements of the HCI
production on the date of startup or the effected date of April 17,
2003, whichever is later.

	In general, all NESHAP standards require one-time only initial
notifications, compliance status reports, and performance tests by the
owners/operators of the affected facilities.  They are also required to
maintain records of the occurrence and duration of any startup,
shutdown, or malfunction (SSM) in the operation of an affected facility,
or any period during which the monitoring system is inoperative.  These
notifications, reports, and records are essential in determining
compliance, and are required of all affected facilities subject to
NESHAP.  Semiannual compliance reports are also required.

	Any owner/operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintenance reports,
and records.  All reports are sent to the delegated state or local
authority.     In the event that there is no such delegated authority,
the reports are sent directly to the United States Environmental
Protection Agency (EPA) regional office.

	Based on previous consultations with industry representatives, there is
an average of one affected facility at each plant site, and each plant
site has only one respondent (i.e., the owner/operator of the plant
site).

	There are approximately 75 respondents that will be subject to the
regulation over the period covered by this Information Collection
Request (ICR), and it is estimated that two

additional respondents per year will become subject to the regulation in
the next three years.

The Office of Management and Budget (OMB) approved the current ICR
without any “Terms of Clearance.”

2.  Need for and Use of the Collection

	2(a)  Need/Authority for the Collection

The EPA is charged under section 112 of the Clean Air Act, as amended,
to establish standards of performance for each category or subcategory
of major sources and area sources of hazardous air pollutants.  These
standards are applicable to new or existing sources of hazardous air
pollutants and shall require the maximum degree of emission reduction.
In addition, section 114(a) states that the Administrator may require
any owner/operator subject to any requirement of this Act to:

(A) Establish and maintain such records; (B) make such reports;   (C)
install, use, and maintain such monitoring equipment, and use such audit
procedures, or methods; (D) sample such emissions (in accordance with
such procedures or methods, at such locations, at such intervals, during
such periods, and in such manner as the Administrator shall prescribe);
(E) keep records on control equipment parameters, production variables
or other indirect data when direct monitoring of emissions is
impractical; (F) submit compliance certifications in accordance with
Section 114(a)(3); and (G) provide such other information as the
Administrator may reasonably require.

In the Administrator's judgment, HAP emissions from hydrochloric acid
production facilities cause or contribute to air pollution that may
reasonably be anticipated to endanger public health or welfare.
Therefore, the NESHAP were promulgated for the source category at 40 CFR
part 63, subpart NNNNN.

	2(b)  Practical Utility/Users of the Data

	The recordkeeping and reporting requirements in the standard ensure
compliance with the applicable regulations which were promulgated in
accordance with the Clean Air Act.  The collected information is also
used for targeting inspections and as evidence in legal proceedings.

Performance tests are required in order to determine an affected
facility’s initial capability to comply with the emission standard.
Continuous emission monitors are used to ensure compliance with the
standard at all times.  During the performance test, a record of the
operating parameters under which compliance was achieved may be recorded
and used to determine compliance in place of a continuous emission
monitor.

	The notifications required in the standard are used to inform the
Agency or delegated authority when a source becomes subject to the
requirements of the regulations.  The reviewing authority may then
inspect the source to check if the pollution control devices are
properly installed and operated, that leaks are being detected and
repaired, and that the standards are being met.  The performance test
may also be observed.

	The required semiannual reports are used to determine periods of excess
emissions, identify problems at the facility, verify
operation/maintenance procedures and for compliance determinations.

3.  Non-duplication, Consultations, and Other Collection Criteria

	The requested recordkeeping and reporting are required under 40 CFR
part 63, subpart NNNNN.

	3(a)  Non-duplication

	If the subject standards have not been delegated, the information is
sent directly to the appropriate EPA regional office.  Otherwise, the
information is sent directly to the delegated state or local agency.  If
a state or local agency has adopted its own similar standards to
implement the Federal standards, a copy of the report submitted to the
state or local agency can be sent to the Administrator in lieu of the
report required by the Federal standards.  Therefore, no duplication
exists.

	3(b)  Public Notice Required Prior to ICR Submission to OMB

	An announcement of a public comment period for the renewal of this ICR
was published in the Federal Register (73 FR 31088) on May 30, 2008.  No
comments were received on the burden published in the Federal Register.

	3(c)  Consultations

	During the previous ICR renewal, EPA consulted with an industry
representative from the Chlorine Chemistry Council to find ways to
reduce the recordkeeping and reporting burden or to improve the language
in the standard, in order to facilitate compliance.

	EPA reviewed information available from the United States Census
Bureau, the AIRS Facility Subsystem (AFS), which is the primary source
of information regarding the number of existing sources, and websites
covering hydrochloric acid production.

3(d)  Effects of Less Frequent Collection

	Less frequent information collection would decrease the margin of
assurance that facilities are continuing to meet the standards.
Requirements for information gathering and recordkeeping are useful
techniques to ensure that good operation and maintenance practices are
applied and that emission limitations are met.  If the information
required by these standards was collected less frequently, the
likelihood of detecting poor operation and maintenance of control
equipment and noncompliance would decrease.

	3(e)  General Guidelines

	None of these reporting or recordkeeping requirements violate any of
the regulations established by OMB at 5 CFR part 1320, section 1320.5.

	These standards require the respondents to maintain all records,
including reports and notifications for at least five years.  This is
consistent with the General Provisions as applied to the standards.  EPA
believes that the five-year records retention requirement is consistent
with the Part 70 permit program and the five-year statute of limitations
on which the permit program is based.  Also, the retention of records
for five years would allow EPA to establish the compliance history of a
source and any pattern of compliance for purposes of determining the
appropriate level of enforcement action.  Historically, EPA has found
that the most flagrant violators frequently have violations extending
beyond the five years.  If records were retained for less than five
years, EPA would be prevented from pursuing the worst violators due to
the destruction or nonexistence of records.

	3(f)  Confidentiality

	Any information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in Title 40, Chapter 1, Part 2, Subpart B -
Confidentiality of Business Information (CBI) (see 40 CFR 2; 41 FR
36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43
FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

	3(g)  Sensitive Questions

	None of the reporting or recordkeeping requirements contain sensitive
questions.

4.  The Respondents and the Information Requested

	4(a)  Respondents, SICS and NAICS Codes

The respondents to the recordkeeping and reporting requirements are
hydrochloric acid production.  The United States Standard Industrial
Classification (SIC) codes for the respondents affected by the
standards, which corresponds to the North American Industry
Classification System (NAICS) codes, are listed below for source
category descriptions.

Standard (40 CFR part 63, subpart NNNNN)	SIC Codes	NAICS Codes

Industrial Inorganic Chemicals, Nonvulcanizable Elastomer Compounds
(NEC) (except activated carbon and charcoal, alumina, recovering sulfur
from natural gas, and inorganic dyes).	2819	325188

Plastics Materials, Synthetic and Resins, and Nonvulcanizable Elastomers
	2821	325211

Industrial Organic Chemicals, NEC (except aliphatics, carbon bisulfide,
ethyl alcohol, cyclopropane, diethylcyclohexane, naphthalene sulfoni).
2869	325199

	4(b)  Information Requested

	None of these reporting or recordkeeping requirements violate any of
the regulations established by OMB at 5 CFR part 1320, section 1320.5.

		(i)  Data Items

All data in this ICR that are recorded and/or reported are required by
NESHAP for Hydrochloric Acid Production (40 CFR part 63, subpart NNNNN).

	A source must make the following reports:

Notifications	Standard Citation by Sections

Initial notification	63.9(b)(2) & (4), and 63.9045(b)-(c)

Notification of intent to conduct performance test	63.7(b)-(c),
63.8(f)(4) & (6), 63.9(b)-(h), and 63.9045(a)

Notification of compliance status	63.9(h)(2), and 63.9045(e)-(f)

First compliance report	63.10(a), and 63.9050(b)(2)

Semiannual compliance report	63.9050(b)

Annual performance test report	63.10(d)(2), 63.9050

Startup, shutdown, malfunction report	63.10(d)(5), and 63.9050(d)

	A source must make the following reports:

Recordkeeping

Initial notification or notification of compliance status
63.10(b)(2)(xiv), and 63.9055(a)

Record of startup, shutdown, and malfunctions	63.6(e)(3), and
63.9055(b)(1)

Conduct performance tests 	63.10(b)(2)(viii), and 63.9055(a)(2)

Record of continuous parameter monitoring systems (CPMS) measurements
63.10(b), and 63.9055(b)(3)

CMPS calibration and maintenance	63.9055(b)

Check for and repair leaks	63.9055(b)(5)

Records are required to be retained for five years	63.10(b)(1)

Electronic Reporting

	Currently, respondents are using monitoring equipment that
automatically records parameter data.  Although personnel at the
affected facility must evaluate the data, this internal automation has
significantly reduced the burden associated with monitoring and
recordkeeping at the plant site.

	Also, regulatory agencies in cooperation with the respondents continue
to create reporting systems to transmit data electronically.  However,
electronic reporting systems are still not widely used.  At this time,
it is estimated that approximately 10 percent of the respondents use
electronic reporting.

		(ii)  Respondent Activities

Respondent Activities

Read instructions.

Perform initial performance test, and repeat performance tests if
necessary.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and
utilizing technology and systems for the purpose of collecting,
validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the
purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the
purpose of disclosing and providing information.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

	Currently, sources are using automated monitoring equipment that
provides parameter data.  Although personnel at the sources still need
to evaluate the data, this type of monitoring equipment has
significantly reduced the burden associated with monitoring and
recordkeeping.

5.  The Information Collected: Agency Activities, Collection
Methodology, and Information Management

	5(a)  Agency Activities

	EPA conducts the following activities in connection with the
acquisition, analysis, storage, and distribution of the required
information.

Agency Activities

Observe initial performance tests and repeat performance tests if
necessary.

Review notifications and reports, including performance test reports,
and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the AIRS Facility Subsystem (AFS).

	5(b)  Collection Methodology and Management

	Following notification of startup, the reviewing authority might
inspect the source to determine whether the pollution control devices
are properly installed and operated.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard.  Data and records maintained by the respondents
are tabulated and published for use in compliance and enforcement
programs.

	Information contained in the reports is entered into the AFS which is
operated and maintained by EPA's Office of Compliance.  AFS is EPA’s
database for the collection, maintenance, and retrieval of compliance
data for approximately 125,000 industrial and government-owned
facilities.  EPA uses the AFS for tracking air pollution compliance and
enforcement by local and state regulatory agencies, EPA regional offices
and EPA headquarters.  EPA and its delegated Authorities can edit,
store, retrieve and analyze the data.

	The records required by this regulation must be retained by the
owner/operator for five years.

	5(c)  Small Entity Flexibility

	A majority of the respondents are large entities (i.e., large
businesses).  However, the impact on small entities (i.e., small
businesses) was taken into consideration during the development of the
regulation.  Due to technical considerations involving the process
operations and the types of control equipment employed, the
recordkeeping and reporting requirements are the same for both small and
large entities.  The Agency considers these requirements the minimum
needed to ensure compliance and, therefore, cannot reduce them further
for small entities.  To the extent that larger businesses can use
economies of scale to reduce their burden, the overall burden will be
reduced.  According to the Economic Impact Analysis of the Hydrochloric
Acid Production NESHAP, 13 percent of the parent companies affected by
proposed action were estimated to be small entities as defined by the
Small Business Administration. The Agency assumes that 13 percent of the
75 facilities affected by this ICR, or 10 facilities, are small
entities.

	5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Hydrochloric Acid Production (40 CFR Part 63, Subpart
NNNNN) (Renewal).

6.  Estimating the Burden and Cost of the Collection

	Table 1 documents the computation of individual burdens for the
recordkeeping and reporting requirements applicable to the industry for
the subpart included in this ICR.  The individual burdens are expressed
under standardized headings believed to be consistent with the concept
of burden under the Paperwork Reduction Act.  Where appropriate,
specific tasks and major assumptions have been identified.  Responses to
this information collection are mandatory.  The Agency may not conduct
or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB Control Number.

	6(a)  Estimating Respondent Burden

	The average annual burden to industry over the next three years from
these recordkeeping and reporting requirements is estimated to be 94,104
(Total Labor Hours from Table 1).  These hours are based on Agency
studies and background documents from the development of this
regulation, Agency knowledge and experience with the NESHAP program, the
previously approved ICR, and any comments received.

	6(b)  Estimating Respondent Costs

		(i)  Estimating Labor Costs

	This ICR uses the following labor rates:

		Managerial	$100.99 ($48.09 + 110%)

		Technical	$87.97   ($41.89 + 110%)

		Clerical	$43.81   ($20.86 + 110%)

	These rates are from the United States Department of Labor, Bureau of
Labor Statistics, December, 2005, “Table 2. Civilian Workers, by
Occupational and Industry group.”  The rates are from column 1,
“Total Compensation.”  The rates have been increased by 110 percent
to account for the benefit packages available to those employed by
private industry.

		(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

	The types of industry costs associated with the information collection
activities in the subject standard are labor costs which are addressed
elsewhere in this ICR and the costs associated with continuous
monitoring.  The capital/startup costs are one-time costs when a
facility becomes subject to the regulation.  The annual operation and
maintenance costs are the ongoing costs to maintain the monitor and
other costs such as photocopying and postage.

(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Continuous Monitoring Device	(B)

Capital/Startup Cost for One Respondent	(C)

Number of New Respondents 	(D)

Total Capital/Startup Cost,

(B X C)	(E)

Annual O&M Costs for One Respondent	(F)

Number of Respondents with O&M	(G)

Total O&M,

(E X F)

Continuous monitoring systems (CMS)	$712	75	$53,500	$8,473	71 (existing)
$601,583

CMS

$16,385	2 (new)	$32,770

The total capital/startup costs for this ICR are $53,500.  This is the
total of column D in the above table.

The total operation and maintenance (O&M) costs for this ICR are
$634,353.

The total respondent costs have been calculated as the addition of the
capital/startup costs, and the annual operation and maintenance costs.
The average annual cost for capital/startup and operation and
maintenance costs to industry over the next three years of the ICR is
estimated to be $687,853.

	6(c)  Estimating Agency Burden and Cost

	The only costs to the Agency are those costs associated with analysis
of the reported information.  EPA's overall compliance and enforcement
program includes activities such as the examination of records
maintained by the respondents, periodic inspection of sources of
emission, and the publication and distribution of collected information.

	The average annual Agency cost during the three years of the ICR is
estimated to be $15,996.  This cost is based on the average hourly labor
rate as follows:

		Managerial	$57.20   (GS-13, Step 5, $35.75 x 1.6)

		Technical	$42.45   (GS-12, Step 1, $26.53 x 1.6)

		Clerical	$22.96   (GS-6, Step 3, $14.35 1.6)

These rates are from the Office of Personnel Management (OPM) “2006
General Schedule” which excludes locality rates of pay.  Details upon
which this estimate is based appear in Table 2: Average Annual EPA
Burden - NESHAP for Hydrochloric Acid Production (40 CFR Part 63,
Subpart NNNNN) (Renewal).

	6(d)  Estimating the Respondent Universe and Total Burden and Costs

	Based on our research for this ICR, on average over the next three
years, approximately 75 existing respondents will be subject to the
standard.  It is estimated that two additional respondent per year will
become subject.  The overall average number of respondents, as shown in
the table below is 75 per year.

	The number of respondents is calculated using the following table which
addresses the three years covered by this ICR.

Number of Respondents

	Respondents That Submit Reports	Respondents That Do Not Submit Any
Reports

	Year	(A)

Number of New Respondents	(B)

Number of Existing Respondents	(C)

Number of Existing Respondents That Keep Records but Do Not Submit
Reports	(D)

Number of Existing Respondents That Are Also New Respondents	(E)

Number of Respondents(E=A+B+C-D)

1	2	71	0	0	73

2	2	73	0	0	75

3	2	75	0	0	77

Average	2	73	0	0	75

	To avoid double-counting respondents, column D is subtracted.  As shown
above, the average Number of Respondents over the three-year period of
this ICR is 75.

	The total number of annual responses per year is calculated using the
following table:

Total Annual Responses

(A)

Information Collection Activity	(B)

Number of Respondents	(C)

Number of Responses	(D)

Number of Existing Respondents That Keep Records But Do Not Submit
Reports	(E)

Total Annual Responses

E=(BxC)+D

Initial notification	0	1	0	0

Application for construction	2	1	0	2

Notification of intent to conduct performance test	2	1	0	2

Notification of compliance status	2	1	0	2

First compliance report	2	1	0	2

Semiannual compliance report	73	2	0	146

Subsequent performance test report	0	1	0	0

Startup, shutdown, malfunction report	2	10	0	20

	Total	174

	The number of Total Annual Responses is 174.

	6(e)  Bottom Line Burden Hours Burden and Cost Tables

	The detailed bottom line burden hours and cost calculations for the
respondents and the Agency are shown in Tables 1 and 2, respectively,
and summarized below.

		(i)  Respondent Tally

The total annual labor costs are $7,959,759.  Details regarding this
cost and the Total Hours Requested may be found below in Table 1: Annual
Respondent Burden and Cost - NESHAP for Hydrochloric Acid Production (40
CFR Part 63, Subpart NNNNN) (Renewal).  Furthermore, the annual public
reporting and recordkeeping burden for this collection of information is
estimated to average 541 hours per response.

	The total annual capital/startup and O&M costs to the regulated entity
are $687,853.      The cost calculations are detailed in Section
6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs.

		(ii)  The Agency Tally

The average annual Agency burden and cost over the next three years is
estimated to be 386 labor hours at a cost of $15,996.  See below Table
2: Annual EPA Burden and Cost - NESHAP for Hydrochloric Acid Production
(40 CFR Part 63, Subpart NNNNN) (Renewal).

	6(f)  Reasons for Change in Burden

	There is no increase in burden hours from the most recently approved
ICR.

	6(g)  Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 541 hours per
response.  Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency.  This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid OMB
Control Number.  The OMB Control Numbers for EPA’s regulations are
listed at 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-OECA-2008-0434. An electronic version of the public docket is
available at http://www.regulations.gov/ which may be used to obtain a
copy of the draft collection of information, submit or view public
comments, access the index listing of the contents of the docket, and to
access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the docket ID number identified in this document.  The documents are
also available for public viewing at the Enforcement and Compliance
Docket and Information Center in the EPA Docket Center (EPA/DC), EPA
West, Room 3334, 1301

Constitution Ave., NW, Washington, DC.  The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.  The telephone number for the Reading Room is
(202) 566-1744, and the telephone number for the Enforcement and
Compliance Docket and Information Center Docket is<PHONE_NUMBER>.
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA. Please include the
EPA Docket ID Number EPA-HQ-OECA-2008-0434 and OMB Control Number
2060-0529 in any correspondence.

Part B of the Supporting Statement

	This part is not applicable because no statistical methods were used in
collecting this information.

Table 1:  Annual Respondent Burden and Cost – NESHAP for Hydrochloric
Acid Production (40 CFR Part 63, Subpart NNNNN) (Renewal)

Burden item

(A)

Person-

hours per

occurrence

(B)

No.  of

occurrences

per respondent

per year

(C)

Person-

hours per

respondent

per year

(C=AxB)

(D)

Respondents

per year  a

(E)

Technical

person-

hours per

year

(E=CxD)

(F)

Management

person-hours

per year

(Ex0.05)

(G)

Clerical

person-

hours per year

(Ex0.1)

(H)

Cost, $  b

1.  Applications	N/A

	2.  Survey and Studies	N/A

	3.  Reporting Requirements

   A.  Read instructions c	4	1	4	2	8	0.4	0.8	$779.13

   B.  Gather information c	4	1	4	2	8	0.4	0.8	$779.13

   C.  Write reports

      Initial notification c	2	1	2	0	0	0	0	$0

      Application for construction c	2	1	2	2	4	0.2	0.4	$389.68

      Notification of intent to conduct               performance test
2	1	2	2	4	0.2	0.4	$389.68

      Notification of compliance status c	19.5	1	19.5	2	39	1.95	3.9
$3,798.62

      First compliance report c, d	8.5	1	8.5	2	17	0.85	1.7	$1,655.81

      Semiannual compliance report e	4.5	2	9	73	657	32.85	65.7
$63,992.12

      Subsequent performance test reports f	4	1	4	0	0	0	0	$0

      Startup, shutdown, malfunction                report g	2	10	20	2
40	2	4	$3,896.02

4.  Recordkeeping Requirements

    A.  Plan activities c, h	10	1	10	2	20	1	2	$1,948.01

    B.  Implement activities

      Record startups, shutdown,                       malfunctions i	1
100	100	75	7,500	375	750	$720,763.70

      Conduct performance test	48.5	1	48.5	75	1,794.5	89.72	179.45
$174,766.74

      Record CPMS measurements j	1	365	365	75	27,010	1,350.5	2,701
$2,630,517.40

      CMPS calibration and maintenance k	3.9	50	195	75	14,430	721.5
1,443	$1,405,344.80

      Check for and repair leaks l	1	365	365	75	27,010	1,350.5	2,701
$2,630,517.40

    C.  Develop record system

      Startup, shutdown, malfunction plan c 	40	1	40	2	80	4	8	$7,791.24

      Site-specific monitoring plan c	20	1	20	2	40	2	4	$3,896.02

      Site-specific test plan c	20	1	20	2	40	2	4	$3,896.02

      Leak detection and repair plan c     	40	1	40	2	80	4	8	$7,791.24

    D.  Time to train personnel

      CPMS acquisition and installation c	20	1	20	2	40	2	4	$3,896.02

      CPMS inspection and monitoring c	4	1	4	2	8	0.4	0.8	$779.13

    E. Store, file, and maintain records m	20	1	20	75	1,500	75	150
$146,085.75

    F. Retrieve records/reports n	20	1	20	75	1,500	75	150	$146,085.75

Subtotals Labor Burden and cost

	81,829.5	4,091.47	8.182.95	$7,959,759.41

TOTAL LABOR BURDEN AND COST (rounded)

	94,104	$7,959,759

Assumptions:

a  We have assumed that the average number of respondents that will be
subject to the rule will be 75.  There will be two additional new
sources per year that will become subject to the rule over the
three-year period of this ICR.

b  This ICR uses the following labor rates: $100.99 per hour for
Executive, Administrative, and Managerial labor; $87.97 per hour for
Technical labor, and $43.81 per hour for Clerical labor.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, March 19, 2005, “Table 2. Civilian Workers, by
Occupational

and Industry group.”  The rates are from column 1, “Total
Compensation.”  The rates have been increased by 110% to account for
the benefit packages available to those employed by private industry.

c  This is a one-time only activity for each facility.

d  We have assumed that two new respondents will prepare the first
compliance report.

e  We have assumed that it will take each respondent 4.5 hours two times
per-year to prepare the semiannual compliance report.

f  We have assumed that some facilities will take 4 hours to perform
tests after the initial compliance determination , by either brining a
new product on line or by significantly increasing its production.

g  We have assumed that it will take each new respondents two hours ten
times a year to prepare a SSM report.

h  We have assumed that it will take each respondent 10 hours to record
plan activities.

i  We have assumed that each respondent will have to implement SSM
activities 100 times per-year.

j  We have assumed that respondents will  have to record CPMS
measurements 365 time per year.

k  We have assumed that respondents will have to implement CMPS
calibration and maintenance activities 50 times per year.

l  We have assumed that respondent are required to check for and repair
leaks 365 times per-year.

m  We have assumed that each respondent will take 20 hours once per-year
to store, file and maintain records.

n  We have assumed that it will take respondent 20 hours to retrieve
records/reports once per-year.

Table 2:  Average Annual EPA Burden - NESHAP for Hydrochloric Acid
Production (40 CFR Part 63, Subpart NNNNN) (Renewal)

	Activity

(A)

EPA person-

hours per

occurrence

(B)

No. of

occurrences

per plant

 per year

(C)

EPA person

hours per

plant  per year

(C=AxB)

(D)

Plants per

year  a

(E)

Technical

person-hours

per year

(E=CxD)

(F)

Management

person-hours

per year

(Ex0.05)

(G)

Clerical

person-

hours per year

(Ex0.1)

(H)

Cost, $ b

   Review initial notification c	4	1	4	0	0	0	0	  $0

   Review application for construction c	4	1	4	2	8	0.4	0.8	$380.85

   Review notification of intent to conduct    test d	4	1	4	2	8	0.4	0.8
$380.85

   Review notification of compliance           status c	20	1	20	2	40	2	4
$1,904.24

   Review compliance report e	20	2	40	2	80	4	8	$3,808.48

   Review subsequent performance test        report f	10	1	10	0	0	0	0	$0

   Review startup, shutdown, malfunction    report	8	10	80	2	160	8	16
$7,616.96

   Attend performance test	20	1	20	2	40	2	4	$1,904.24

Subtotals Labor Burden and cost

	336	16.8	33.6	$15,995.62

TOTAL ANNUAL BURDEN AND COST (rounded)

	386

	$15,996

Assumptions:

    a  We have assumed that the average number of respondents that will
be subject to the rule will be 75.  There will be two additional new
sources per year that will become      subject to the rule over the
three-year period of this ICR.

b  This cost is based on the following labor rates which incorporates a
1.6 benefits multiplication factor to account for government overhead
expenses:  Managerial rate of $57.20 (GS-13, Step 5, $35.75 x 1.6),
Technical rate of $42.45 (GS-12, Step 1, $26.53 x 1.6), and Clerical
rate of $22.96 (GS-6, Step 3, $14.35 x 1.6).  These rates are from the
Office of Personnel Management (OPM) “2006 General Schedule” which
excludes locality rates of pay.

    c  This is a one-time only activity for each facility.

    d  We have assumed that each respondent will take 4 hours to review
notification of intent to conduct test.

    e  We have assumed that each respondent will take twenty hours to
review compliance report twice per year.

    f  We have assumed that some facilities will take ten hours to
perform tests after the initial compliance determination , by either
brining a new product on line or by                 significantly
increasing its production.

     g  We have assumed that it will take each new respondents eight
hours to review the SSM report.  This report will be done.

 Economic Impact Analysis of the Proposed Hydrochloric Acid (HCl)
Production NESHAP, September 2001, EPA-452/R01-014

 PAGE   2

 PAGE

 PAGE   15

 PAGE   16

  PAGE  17


C. Section 179B Requirements A new section 179B, International Border Areas, was added to the statute. This section applies to nonattainment areas that are affected by emissions emanating from outside the United States. This section requires EPA to approve a SIP if: The SIP or SIP revision meets all of the requirements applicable to it under the Act, other than a requirement that it demonstrate attainment and maintenance of the relevant NAAQS by the applicable attainment date; and the affected State establishes to EPA's satisfaction, that the SIP or revision would be adequate to attain and maintain the relevant NAAQS by the applicable attainment date but for emissions emanating from outside the United States. Further, any State that establishes to the satisfaction of EPA with respect to an ozone, CO, or PM 10 nonattainment area in such a State that the State would have attained the relevant NAAQS but for emissions emanating from outside the United States, shall not be subject to the following provisions: extension of the ozone attainment dates pursuant to section 181( a)( 5), the fee provisions of section 185, and the bump up provisions for failure to attain for ozone ( section 181( b)( 2),/ 41/ CO ( section 186( b)( 2), and/ or PM 10 ( section 188( b)( 2) NAAQS./ 42/

NOTE / 41/ Note that the statute contained an erroneous reference to section 181( a)( 2) instead of 181( b)( 2).

NOTE / 42/ As noted, section 179B( d) states that PM 10 areas demonstrating attainment of the standards but for emissions emanating from outside the United States shall not be subject to section 188( b)( 2) ( reclassification for failure to attain). By analogy to this provision and applying canons of statutory construction, EPA will not reclassify before the applicable attainment date areas which can demonstrate attainment of the PM 10 standards but for emissions emanating from outside the United States. See section 188( b)( 1). First, EPA believes section 179( B)( d) evinces a general congressional intent not to penalize areas where emissions emanating from outside the country are the but for cause of the PM 10 attainment problems. Further, if EPA were to reclassify such areas before the applicable attainment date, EPA, in effect, would be reading section 179( B)( d) out of the statute. Specifically, if EPA proceeded to reclassify before the applicable attainment date those areas qualifying for treatment under section 179( B), an area would never be subject to the provision in section 179( B)( d) which prohibits EPA from reclassifying such areas after the applicable attainment date. Canons of statutory construction counsel against interpreting the law such that language is rendered mere surplusage. Finally, note that section 179( B)( d) contains a clearly erroneous reference to carbon monoxide instead of PM 10 and that this section contains other errors. See, e. g., section 179( B)( c) reference to section 186( b)( 9), which does not exist.

In demonstrating that an area could attain the relevant NAAQS but for emissions emanating from outside the United States, approved EPA modeling techniques should be used whenever possible. An emission inventory incorporating vehicle emissions occurring in the United States generated from vehicles registered in the adjacent foreign country must be completed by the State before modeling in the United States' side only and attempting to demonstrate attainment. The EPA recognizes that adequate data may not be available in areas outside the United States. Therefore, modeling ( consistent with EPA's " Guidance on Air Quality Models, Revised") may not be possible in all cases. Because very few areas are likely to be affected by this provision, EPA will determine on a case by case basis whether the State has satisfactorily made the required demonstration. The State is encouraged to consult with the EPA Regional Office in developing any alternate demonstration methods. Methods that the State may want to consider include: using ozone episodes that do not involve international transport of emissions for modeling ( see guidance document entitled " Criteria for Assessing Role of Transported Ozone/ Precursors in Ozone Nonattainment Areas"), running the model with boundary conditions that reflect general background concentrations on the U. S. side, analyzing monitoring data if a dense network has been established, and using receptor modeling for PM 10. States should confer with the appropriate EPA Regional Office to establish appropriate technical requirements for these analyses.

VI. Other Requirements A. Executive Order 12291 Under Executive Order 12291, EPA is required to judge whether an action is " major" and, therefore, subject to the requirement of a regulatory impact analysis. The Agency has determined that this action is exempt from classification as " major" because it is a compilation of interpretive rule and general statements of policy as defined in the Adminstrative Procedures Act ( APA). Nevertheless, this notice was submitted to the Office of Management and Budget ( OMB) for review.

A copy of the draft notice as submitted to OMB, any documents accompanying the draft, any written comments received from other agencies ( including OMB), and any written responses to these comments have been included in the Docket.

B. Regulatory Flexibility Act Whenever the Agency is required by section 553 of the APA or any other law to publish general notice and proposed rulemaking for any proposed rule, the Agency shall propose and make available for public comment an intial regulatory flexibility analysis.

The regulatory flexibility requirements do not apply for the General Preamble because it is not a regulatory action in the context of the APA or the Regulatory Flexibility Act.

Note: Appendices A through E will be published in a subsequent Federal Register. Dated: March 27, 1992.

William K. Reilly, Administrator.

( FR Doc. 92 7954 Filed 4 15 92; 8: 45 am)

BILLING CODE 6560 50 M Legal Publications: Pub. Law 95 95 SEC. 129 119  Clean Air Act Amendments of 1977 Pub. Law 90 148 SEC. 2  Air Quality Act of 1967; National Emissions Standards Act ( Act of 11/ 21/ 67) Pub. Law 84 159 SEC. 182 185 107 181 185 202 110 301 184 183 171 211 112 108 407 246 249 185 113 187 188 193 189 191 192 111 302 415 137 190 121  Air Pollution Control Act ( Act of 7/ 14/ 55) Pub. Law 88 206 SEC. 1  Clean Air Act of 1963 Pub. Law 89 272 SEC. 101  Solid Waste Disposal Act ( Act of 10/ 20/ 65); Motor Vehicle Air Pollution Control Act ( Act of 10/ 20/ 65) Pub. Law 101 549 SEC. 819 801 103 104 229 401 106  Clean Air Act, Amendments ( 11/ 15/ 90) Pub. Law 91 604 SEC. 4  Noise Pollution and Abatement Act of 1970; Clean Air Act Amendments of 1970 Pub. Law 95 621 SEC. 108  Natural Gas Policy Act of 1978 Pub. Law 85 767  Highways, Title 23 U. S. C., Enactment ( Act of 8/ 27/ 58) Federal Register

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