SF-83 SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Secondary Aluminum Production

1.  Identification of the Information Collection

	1(a)  Title of the Information Collection

NESHAP for Secondary Aluminum Production (40 CFR part 63, subpart RRR)

( Renewal)

	1(b)  Short Characterization/Abstract

The National Emission Standards for Hazardous Air Pollutants (NESHAP),
for semiconductor manufacturing were proposed on February 11, 1999,
promulgated on March 23, 2002, and final rule amendments published on
December 30, 2002.  These regulations apply to component processes at
secondary aluminum production plants that are major sources and area
sources including aluminum scrap shredders, thermal chip dryers, scrap
dryers/delacquering kilns/decoating kilns, secondary aluminum processing
units (SAPUs) composed of in-line fluxers and process furnaces
(including both melting and holding furnaces of various configurations),
sweat furnaces dross-only furnaces, and rotary dross coolers, commencing
construction, or reconstruction after the date of proposal.  As a result
of a rule amendment in the year 2002, owners and operators of certain
aluminum die casting facilities, aluminum foundries, and aluminum
extrusion facilities were excluded from the rule coverage.  Respondents
do not include the owner or operator of any facility that is not a major
source of HAP emissions except for those that are area sources of
dioxins/furans emissions

	In general, all NESHAP standards require initial notifications,
performance tests and periodic reports.  Owners/operators 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 summary 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 our consultations with industry representatives, there is an
average of one affected facility at each plant site and that each plant
site has only one respondent (i.e., the owner/operator of the plant
site).

	There are approximately 1,484 sources (i.e. 81 major sources and 1,403
sweat furnaces) that are subject to the regulations.  It is estimated
that there will be an increase of 5 percent of new sources subject to
the dioxins/furans requirements of the rule based on the number of new
sweat furnaces meeting the requirements over the three years period of
this ICR (i.e. approximately 70 sweat furnaces per year) for an average
of 1,624 sources per year that will become subject to the regulations.
There will be no additional new major sources over the three-year period
of this ICR.

The Office of Management and Budget (OMB) approved the current
Information Collection Request (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 facilities in
semiconductor manufacturing 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 RRR.

	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.  Nonduplication, Consultations, and Other Collection Criteria

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

	3(a)  Nonduplication

	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 (70 FR 55368) on September 20,
2005.  No comments were received on the burden published in the Federal
Register.

	3(c)  Consultations

	We were unable to get in contact with the Trade Associations.  After
repeated calls to the associations they did not return any of our calls.

	We also referenced the most recent ICR, consulted with the preparer of
the active ICR, and used other resources to obtain the most recent data
available.  We 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 secondary aluminum production.  We also consulted with
EPA's Office of Air Quality Planning and Standards, Information Transfer
and Program Integration Division.

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/SIC Codes

The respondents to the recordkeeping and reporting requirements are
secondary aluminum production.  The United States Standard Industrial
Classification (SIC) code, for the respondents affected by the standard
which corresponds to the North American Industry Classification System
(NAICS) is listed below:

Standard for 40 CFR part 63, subpart RRR

SIC Codes

NAICS Codes

Secondary Smelting and Alloying of Aluminum	3341	331314

Primary Aluminum Production	3334	331312

Aluminum Sheet, Plate, and Foil Manufacturing	3353	331315

Aluminum Extruded Product Manufacturing	3354	331316

Other Aluminum Rolling and Drawing	3355	331319

Aluminum Die-Casting Foundries	3363	331521

Aluminum Foundries (except Die-Casting)	3365	331524

Secondary Smelting and Alloying of Aluminum	3399	331314

	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 Secondary Aluminum Production (40 CFR Part 63, Subpart RRR).

	A source must make the following reports:

Notifications for 40 CFR part 63, subpart RRR	Standard Citation by
Sections

Initial notification	63.9(b)(1)-(2)

Intention to construct/reconstruct	63.9(b)(4), 63.1515(4)

Initial performance test and visible emission observations	63.10(d)(2)

Anticipated and actual date of startup	63.1515(a)(3)

Reschedule initial performance test	63.7(b)(2)

Special compliance obligations for a new source	63.1515(5)

Demonstration of continuous monitoring systems	63.9(g)

Opacity or visible emissions for major sources	63.10(d)(3),
63.1515(a)(6)

Notification of compliance status	63.9(h), 63.1515(b)

Periodic startup, shutdown, malfunction reports	63.10(d)(5)(i)

Operation, maintenance, and monitoring plan for each emission unit to be
approved by the permitting authority	63.6(e)(1)-(2)

Semiannual report	63.10(e), 63.1516(b)

	A source must make the following reports:

Recordkeeping

Startup, shutdown, malfunction periods where the continuous monitoring
system is inoperative	63.10(b)(2)

Emission test results and other data needed to determine emissions
61.13(g)

All reports and notifications	63.10(b)

Record of applicability	63.10(b)(3)

Records for sources with continuous monitoring systems	63.10(3)

Records are required to be retained for five years	63.10(b)(1), 63.1517

Electronic Reporting

	At the present, 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 responses are done
electronically.

		(ii)  Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate continuous parameter monitors
(e.g. temperature monitors), continuous opacity monitors, flow monitors
and bag leak detectors, if applicable.

Perform initial performance test using required referenced methods, as
specified in Section 63.1511(c), and repeat performance test 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.

	5(d)  Collection Schedule

The specific frequency for each information collection activity within
this request is shown in Table 1: Annual Industry Burden for NESHAP for
Secondary Aluminum Production (40 CFR part 63, subpart RRR).

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 93,725
(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 type 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)

Bag leak detectors	$29,786	0	$0	$5,250 1	27	$141,750

Flow meters 2	$3,000	0	$0	$0	0	$0

Temperature monitors 3	$1,200	70	$84,000	$0	0	$0

Continuous opacity monitors 4	$36,000	0	$0	$7,500	0	$0

Assume that 34 percent (or 27 respondents) will use bag leak detectors
on fabric filters with an average cost to industry at $29,786.  The
actual cost of the bag leak detectors depends on the number of probes on
the unit, and O&M costs for bag leak detectors is approximately $5,250.

All chlorine injection systems already have chlorine flow meters and the
operation and maintenance costs are negligible.

Temperature monitors will be installed at new sweat furnaces (70 per
year) at a cost of $1,200.  The O&M costs for temperatures monitors are
negligible.

Sources with fabric filters will be complying with the monitoring
requirements through the use of a bag leak detector or visible emissions
observations and not continuous opacity monitors.

The total capital/startup costs for this ICR are $84,000.  This is the
total of column D in the above table.  These costs are shown on the OMB
83-I form in block 14(a), Total annualized capital/startup costs.

The total operation and maintenance (O&M) costs for this ICR are
$141,750.  This is the total of column G.  These costs are shown on the
OMB 83-I form in block 14(b), Total annual costs (O&M).

The total respondent costs in block 14 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 $226,000 (rounded).  This cost will not be
shown on the OMB 83-I form in block 14(c), Total annualized cost
requested.  It is too minuscule a total to be used, since block 14 of
the OMB 83-I form are rounded to show the cost in thousands of dollars.

	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 $13,872.  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 Secondary Aluminum Production (40 CFR part 63,
subpart RRR).

	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 1,624 existing respondents will be subject to the
standard.  It is estimated that an additional 70 respondent per year
will become subject.  The chart below only accounts for sweat furnaces
with an average of 1,543, but there are also 81 major sources for a
total of 1,624 respondents 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	70	1,403	0	0	1,473

2	70	1,473	0	0	1,543

3	70	1,543	0	0	1,613

Average	70	1,473	0	0	1,543

	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 one.  This number appears on the OMB 83-I form in block
13(a), Number of respondents.

	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

Notification of applicability	70	1	0	70

Notification of construction/reconstruction	0	0	0	0

Notification of actual startup	0	0	0	0

Notification of special compliance requirements	0	0	0	0

Notification of performance test	0	1	0	0

Notification of compliance status	81	1	0	81

Waiver application	0	1	0	0

Semiannual reports	1,554	2	0	3,108

Startup, shutdown, malfunction report	2	1	0	2

	Total	3,261

	The number of Total Annual Responses is 3,261.  This number is shown on
the OMB 83-I form in block 13(b), Total annual responses.

	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 Hours Requested is shown on the OMB 83-I form in block 13(c).
The total annual labor costs are $7,938,143.  The annual labor costs are
not shown on the OMB 83-I form.  Details regarding these estimates may
be found in Table 1. Annual Respondent Burden and Cost, NESHAP for,
NESHAP for Secondary Aluminum Production (40 CFR part 63, subpart RRR).
Furthermore, the annual public reporting and recordkeeping burden for
this collection of information is estimated to average 29 hours per
response.

	The total annual capital/startup and O&M costs to the regulated entity
are $141,750.  This number is shown on the OMB 83-I form in block 14(c),
Total annualized cost requested.  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 13,872 labor hours at a cost of $574,271.  See Table 2.
Annual Agency Burden and Cost, NESHAP for Secondary Aluminum Production
(40 CFR part 63, subpart RRR).

	6(f)  Reasons for Change in Burden

	The increase in burden cost from the most recently approved ICR is due
to a change in labor rates.  There was a decrease in burden hours which
was due to a decrease in the number of sources.  This decrease in
sources was due to a number of sweat furnaces going out of business
because of grieve economic outlook the industry is experiencing.  There
is also four less additional sources per-year as compared to the
previous ICR.

	There was a decrease in the capital/startup and operations and
maintenance (O&M) costs from the previous ICR.  This was due to the fact
that there are four less sources as compared to the previous ICR.

	6(g)  Burden Statement

	The annual public reporting and recordkeeping burden for this
collection of information is estimated to average 29 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-2005-0072, which is available for online viewing at
www.regulations.gov,  or in person viewing at the Enforcement and
Compliance  Docket and  Information Center in the EPA Docket Center
(EPA/DC),  EPA West, Room B102, 1301 Constitution Avenue, 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<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket and
Information Center is<PHONE_NUMBER>.  An electronic version of the
public docket is available through EPA Dockets www.regulations.gov.
This site can be used to submit or view public comments, access the
index listing of the contents of the public 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 above.  You can also send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention Desk Officer for EPA.
Please include the EPA Docket Number:  EPA-HQ OECA-2005-0072, and OMB
Control Number 2005-0072 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 Secondary
Aluminum Production (40 CFR part 63, subpart RRR)

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.  Acquisition, installation, and utilization        of technology and
systems c	54	1	54	70	3,780	189	378	$368,173.89

4.  Reporting Requirements

   A. Read instructions d	0.13	1	0.13	70	9.1	0.455	0.91	$886.35

   B. Required activities

        Initial performance test e, f	24	1	24	0	0	0	0	$0

        Repeat performance test e, f	24	0.20	4.8	0	0	0	0	$0

        Operating, maintenance and                          monitoring
plan e, f	32	1	32	70	2,240	112	224	$218,177.12

        Startup, shutdown, malfunction

        (SSM) plan g	32	1	32	70	2,240	112	224	$218,177.12

   C.  Create information 	See 4B

	   D. Gather existing information	See 4B

	   E. Write reports

         Notification of applicability e, f	2	1	2	70	140	7	14	$13,535.07

         Notification of construction/
reconstruction	N/A

	         Notification of actual startup	N/A

	         Notification of special compliance                requirements
N/A

	         Notification of performance test e	2	1	2	0	0	0	0	$0

         Notification of compliance status e	4	1	4	81	324	16.2	32.4
$31,557.76

         Waiver application h	2	1	2	0	0	0	0	$0

         Report of performance test	See 4B

	         Semiannual reports i	8	2	16	1,554	24,864	1,243.2	2,486.4
$2,421,766.03

         SSM report j	8	1	8	2	16	0.8	1.6	$1,557.40

5.  Recordkeeping requirements

   A. Read instructions 	4	1	4	81	324	16.2	32.4	$31,557.76

   B. Plan activities	See4E

	   C. Implement activities 	See 4B

	   D. Develop record system	N/A

	   E. Time to enter/ transmit information

         Records of all information required              by the
standards

             Major sources k	1.5	52	78	81	6,318	315.9	631.8	$615,370.04

             Sweat furnaces l	0.5	52	26	1,543	40,118	2,005.9	4,011.8
$3,907,513.26

   F. Time to train personnel m	4	1	4	70	280	14	28	$27,272.14

  G. Time to adjust existing ways to comply        with previously
applicable                            requirements	N/A

	  H. Time to disclose information

             New sources n	0.25	2	0.5	70	35	1.75	3.5	$3,409.02

             All sources o	0.25	2	0.5	1,624	812	40.6	81.2	$79,089.200

  I.  Time for audits	N/A

	Subtotals Labor Burden and cost

	81,500.1	4,075.005	8,150.01	$7,938,143.16

TOTAL LABOR BURDEN AND COST (rounded)

	93,725	$7,938,143

Assumptions:

a  We have assumed that the average number of respondent that will be
subject to the rule will be 1,624.  There are approximately 1,403 sweat
furnaces and 81 major sources that are currently subject to the rule.
It is estimated that there will be an additional 5 percent new source
subject to the dioxins/furans requirements of the rule based on the
number of new sweat furnaces meeting the requirements over the three
year period of the ICR (i.e. approximately 70 sweat furnaces per year).
There will be no additional new major sources 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  We have assumed that it will take each new respondent 54 hours to
complete the task.

d We have assumed that each respondent will take 0.13 hours to read
instructions.

e  We have assumed that all existing sources are in compliance with the
initial rule requirements.  It is further assumed that new sweat
furnaces will comply by meeting the equipment specifications rather than
by conducting performance tests.  Respondents that are major sources are
required to demonstrate initial compliance with the applicable emission
limit, equipment, work practice, or operational standard for affected
source or emission unit and report results in the notification of
compliance status report.

f  Since we have assumed that there will be no new major sources over
the next three-year period of this ICR, there will be no new sources
conducting initial performance tests.  We have determined that
respondents of new sweat furnaces will not be required to conduct
emissions testing to show compliance with the emission limit, since it
was determines that sweat furnaces sold in the United States now have an
afterburner installed and meet the design residence time of 0.8 seconds
or greater and an operating temperature of 1600 oF or greater.  All new
respondents are required to submit for approval an operation,
maintenance and monitoring plan for affected sources.

We have assumed that each respondent will take four hours two times per
year to write semiannual summary reports.

g  We have assumed that respondent of sweat furnaces may submit with the
notification of compliance report information on the manufacturers
specifications and the SSM plan.

h  It is assume that there will be no new sources requesting a waiver
from performance test requirements.

i  It is assumed that each respondent will take 8 hours to semiannual
report of excess emissions or no excess emissions.

j  It is assumed that two major sources will have a startup, shutdown,
malfunction occurrence per year that is not managed according to plan.

k  It is assumed that it will take1.5 hours for major sources to enter
and transmit records.

l  It is assumed that it will take 0.5 hours for existing sweat furnaces
respondents to enter and transmit records.

m  We have assumed that it will take 4 hours to train new sweat furnaces
employees.

n  We have assumed that it will take 0.25 hours for each new sweat
furnaces sources to disclose information.

o  We have assumed that it will take 0.25 hours for each source to
disclose information.

Table 2:  Average Annual EPA Burden - NESHAP for Secondary Aluminum
Production (40 CFR part 63, subpart RRR)

	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

Initial performance tests	40	1.4	56	0	0	0	0	$0

Repeat performance test including retesting c	48	1	48	0	0	0	0	$0

Notification of applicability	0.5	1	0.5	70	35	1.75	3.5	$1,666.21

Notification of construction/reconstruction	N/A

	Notification of actual startup	N/A

	Notification of special compliance requirements	N/A

	Notification of performance test	2	1	2	0	0	0	0	$0

Notification of compliance status  d	2	1	2	70	140	7	14	$6,664.84

Waiver application	N/A

	Report of performance test c	40	1	40	0	0	0	0	$0

Repeat of performance test report c	40	1	40	0	0	0	0	$0

Semiannual reports e	4	2	8	1,484	11,872	593.6	1,187.2	$565,178.43

Startup, shutdown, malfunction report f	8	1	8	2	16	0.8	1.6	$761.71

Subtotals Labor Burden and cost

	12,063	603.15	1,206.3	$574,271.19

 TOTAL ANNUAL BURDEN AND     COST (rounded)

	13,872	$574,271

Assumptions:

     a  We have assumed that the average number of respondent that will
be subject to the rule will be 1,624.  There are approximately 1,403
sweat furnaces and 81 major              sources that are currently
subject to the rule.  It is estimated that there will be an additional 5
percent new source subject to the dioxins/furans requirements of the
rule            based on the number of new sweat furnaces meeting the
requirements over the three year period of the ICR (i.e. approximately
70 sweat furnaces per year).  There will be      no additional new major
sources 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) “2005 General Schedule” which
excludes locality rates of pay.

    c  We have assumed that all existing respondent are in compliance
with the initial rule requirements.  It is further assumed that new
sweat furnaces will comply by meeting      the equipment specifications
than by conducting performance tests.

    d  We have assumed that it will take 2 hours for each respondent to
complete notification of compliance status.

    e  We have assumed that each existing respondents will take 4 hours
twice a year to complete semiannual reports.

    f  It is assumed that two major sources will have a startup,
shutdown, malfunction occurrence per year that is not managed according
to plan.

 PAGE   12

 PAGE   13


[Federal Register: December 18, 2009 (Volume 74, Number 242)]
[Proposed Rules]
[Page 67143-67144]
[DOCID:fr18de09-23]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-1057; Airspace Docket No. 09-AWP-9]

Proposed Establishment of Class E Airspace; Battle Mountain, NV

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: This action proposes to establish Class E airspace at Battle
Mountain Airport, Battle Mountain, NV, to accommodate aircraft using
the VHF Omni-Directional Radio Range (VOR)/Distant Measuring Equipment
(DME) Standard Instrument Approach Procedures (SIAPs) at the airport.
The FAA is proposing this action to enhance the safety and management
of aircraft operations at Battle Mountain Airport, Battle Mountain, NV.

DATES: Comments must be received on or before February 1, 2010.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2009-
1057; Airspace Docket No. 09-AWP-9, at the beginning of your comments.
You may also submit comments through the Internet at http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2009-1057 and Airspace Docket No. 09-AWP-9) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2009-1057 and Airspace Docket No. 09-AWP-9''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The

proposal contained in this action may be changed in light of comments
received. All comments submitted will be available for examination in
the public docket both before and after the closing date for comments.
A report summarizing each substantive public contact with FAA personnel
concerned with this rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to establish Class E surface airspace at
Battle Mountain Airport, Battle Mountain, NV. Controlled airspace is
necessary to accommodate aircraft using the VOR/DME SIAPs at Battle
Mountain Airport. This action would enhance the safety and management
of aircraft operations at the airport.
    Class E airspace designations are published in paragraph 6002 of
FAA Order 7400.9T, signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified that this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Battle Mountain Airport,
Battle Mountain, NV.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

    1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009, is amended as follows:

Paragraph 6002 Class E Airspace Designated as Surface Areas.

* * * * *

AWP NV E2 Battle Mountain, NV [New]

Battle Mountain Airport, NV
    (Lat. 40[deg]35'57'' N., long. 116[deg]52'28'' W.)

    Within a 4.2-mile radius of Battle Mountain Airport, and within
1.4 miles each side of the 218[deg] bearing extending from the 4.2-
mile radius to 7.4 miles southwest of the Battle Mountain Airport.
This Class E airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.
* * * * *

    Issued in Seattle, Washington, on December 9, 2009.
H. Steve Karnes,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. E9-30182 Filed 12-17-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Notices]
[Page 53193]
[FR Doc No: 2014-21293]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9916-34-OCFO]

Meeting of the Environmental Financial Advisory Board--Public
Notice

AGENCY: Environmental Protection Agency.

ACTION: Notice of open meeting of the Environmental Financial Advisory
Board.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency's (EPA) Environmental
Financial Advisory Board (EFAB) will hold a public meeting on October
28-29, 2014. EFAB is an EPA advisory committee chartered under the
Federal Advisory Committee Act (FACA) to provide advice and
recommendations to EPA on creative approaches to funding environmental
programs, projects, and activities.
    The purpose of this meeting is to hear from informed speakers on
environmental finance issues, proposed legislation, and EPA priorities;
to discuss activities, progress, and preliminary recommendations with
regard to current EFAB work projects; and to consider requests for
assistance from EPA offices.
    Environmental finance discussions and presentations are expected on
the following topics:
    Small Water Systems in Puerto Rico; Financing Small Community/Rural
Brownfields Site Remediation; Certified Green Bonds; Leveraging
Technology and Finance; and Financial Capability Assessment Framework.
    The meeting is open to the public; however, seating is limited. All
members of the public who wish to attend the meeting must register in
advance no later than Friday, October 17, 2014.

DATES: The full board meeting will be held on Tuesday, October 28, 2014
from 1:00 p.m. to 5 p.m., EST and Wednesday, October 29, 2014 from 9:00
a.m. to 5 p.m., EST.

ADDRESSES: Corporation for Enterprise Development (CFED), 1200 G Street
NW., Suite 400, Washington, DC 20005.

FOR FURTHER INFORMATION CONTACT: For information on access or services
for individuals with disabilities, or to request accommodations for a
person with a disability, please contact Sandra Williams, EPA, at (202)
564-4999 or<EMAIL_ADDRESS>at least 10 days prior to the
meeting, to allow as much time as possible to process your request.

    Dated: August 28, 2014.
David Bloom,
Acting Deputy Chief Financial Officer.
[FR Doc. 2014-21293 Filed 9-5-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Proposed Rules]
[Pages 66116-66120]
[FR Doc No: 2022-23844]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 80

[Docket No. FDA-2022-N-1635]
RIN 0910-AI69

Color Additive Certification; Increase in Fees for Certification
Services

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend the color additive regulation to increase the fee for
certification services. The change in fees will allow FDA to continue
to maintain an adequate color certification program as required by the
Federal Food, Drug, and Cosmetic Act (FD&C Act). The fees are intended
to recover the full costs of operation of FDA's color certification
program.

DATES: Either electronic or written comments on the proposed rule must
be submitted by January 3, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 3, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-N-1635 for ``Color Additive Certification; Increase in Fees
for Certification Services.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Bryan Bowes, Office of Cosmetics and
Colors (HFS-105), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-1122; or Carrol Bascus, Center for Food Safety and Applied
Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Need for the Regulation
III. Description of the Proposed Rule
IV. Proposed Effective Date
V. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
    C. Summary of Regulatory Flexibility Analysis
VI. Analysis of Environmental Impact
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    The proposed rule, if finalized, would amend the color additive
regulation to increase the fee for certification services. The change
in fees would allow FDA to continue to maintain an adequate color
certification program as required by the FD&C Act. The fees are
intended to recover the full costs of operation of FDA's color
certification program.

B. Summary of the Major Provisions of the Proposed Rule

    This proposed rule, if finalized, would amend the color additive
regulation to increase the fees for certification services. The fees
for straight colors including lakes would be $0.45 per pound ($0.10 per
pound increase) with a minimum fee of $288. There would be similar
increases in fees for repacks of certified color additives and color
additive mixtures.

C. Legal Authority

    We are issuing this proposed rule consistent with our statutory
which requires that fees necessary to provide, maintain, and equip an
adequate color additive certification program be specified in our
regulations. FDA also derives authority to issue this proposed rule
from the FD&C Act, which authorizes FDA to issue regulations for the
efficient enforcement of the FD&C Act.

D. Costs and Benefits

    The proposed rule, if finalized, would amend existing color
additive regulations by increasing fees for certification services. The
costs of this proposed rule include the cost to read and understand the
rule. As the increase in fees is not associated with any change in our
certification program, no economic benefits are expected to result from
the proposed rule. Similarly, the impact of the increase in
certification fees on color additive manufacturers is considered a
transfer, rather than an economic cost. Accordingly, we do not estimate
economic benefits associated with this proposed rule, and the impact of
the increase in color certification fees is estimated as an ongoing
transfer from manufacturers of color additives to the Federal
Government. The economic burdens of this proposed rule, if finalized,
would accrue to color additive manufacturers. We estimate a one-time
cost to read and understand the rule for all color additive
manufacturers. The present value of this cost is approximately $1,407
at a 3 percent rate of discount, and $1,354 at a 7 percent rate of
discount. The annualized value of these costs estimates is
approximately $165 at a 3 percent discount rate and $193 at a 7 percent
discount rate.

II. Background

A. Introduction

    Certification of color additives by a self-supporting process has
been required since the enactment of the FD&C Act. In accordance with
section 721(a)(1)(B) of the FD&C Act, certain color additives must be
certified for use by FDA in food, drugs, cosmetics, and medical
devices. FDA analyzes samples from each batch of color additive
received from a manufacturer and verifies that it meets composition and
purity specifications. Certification is performed before the additives
are permitted to be used in products. Manufacturers pay fees, based on
the weight of each batch for certification. These fees support FDA's
color certification program.
    In the Federal Register of March 29, 2005 (70 FR 15755), we issued
an interim final rule (IFR) amending the color additive regulations by
increasing the fees for certification services due to a general
increase in the cost associated with operating the certification
program. The IFR increased the fees per pound. The fee for straight
colors including lakes increased from $0.30 to $0.35 per pound (a $0.05
per pound increase) with a minimum fee increase from $192 to $224. The
fee for repacks of certified color additives and color additive
mixtures increased from $30 to $35 for 100 pounds or less, from $30 to
$35 plus $0.06 \1\ for each pound over 100 pounds up to 1,000 pounds,
and from $84 to $89 plus $0.02 per pound over 1,000 pounds.
---------------------------------------------------------------------------

    \1\ We had originally specified ``$0.05'' for each pound over
100 pounds up to 1,000 pounds. Subsequently, in the Federal Register
of December 7, 2006 (71 FR 70873), we amended the IFR to correct
this typographical error.
---------------------------------------------------------------------------

B. Need for the Regulation

    The current fee schedule specified in part 80 (21 CFR part 80)
became effective in 2005 and was amended in 2006. Since 2005, the costs
of the certification program have significantly increased because of
general operating expenses, including the purchase and maintenance of
critical equipment, rent and facility charges, and escalating staff
payroll. Therefore, we propose to increase the fees for certifying
color additives to reflect increasing operating costs for the
certification program. The fee schedule for color additive
certification, as provided for in our regulations, is designed to cover
all the costs involved in certifying batches of color additives. This
includes the cost of specific tests required by the regulations and the
general costs associated with the certification program, such as costs
of accounting, reviewing data, issuing certificates, conducting
research, inspecting establishments, and purchasing and maintaining
equipment. The current fee schedule is insufficient to provide, equip,
and maintain an adequate certification program. Consistent with section
721(e) of the FD&C Act, the proposed increase is necessary to cover
increasing operating costs and maintain an adequate color certification
program.

III. Description of the Proposed Rule

    The proposed rule, if finalized, would revise Sec.  80.10 (21 CFR
80.10), ``Fees for certification services,'' to:
     increase the fee for certification services from $0.35 to
$0.45 per pound for straight colors including lakes, and change the
minimum fee from $224 to $288 (proposed Sec.  80.10(a));
     increase the fees for repacks of certified color additives
and color additive mixtures from $35 for 100 pounds or less to $45
(proposed Sec.  80.10(b)(1));
     increase the fees for repacks of certified color additives
and color additive mixtures over 100 pounds, but not over 1,000 pounds,
from $35 plus $0.06 for each pound over 100 pounds to $45 plus $0.08
for each pound over 100 pounds (proposed Sec.  80.10(b)(2)); and
     increase the fees for repacks of certified color additives
and color additive mixtures over 1,000 pounds from $89 plus $0.02 for
each pound over 1,000 pounds to $114 plus $0.03 for each pound over
1,000 pounds (proposed Sec.  80.10(b)(3)).
    Increasing the fees will ensure the viability of the certification
program and offset the increased costs of maintaining this program.

IV. Proposed Effective Date

    We propose that any final rule resulting from this rulemaking be
effective 30 days after the final rule's date of publication in the
Federal Register. We believe that this effective date is appropriate
because it will provide industry sufficient time to prepare for and
adjust to the change in fees.

V. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order

12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C.
601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563 direct us to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). We believe
that this proposed rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the increase in fees for color certification services
would not significantly increase costs to manufacturers, we propose to
certify that the proposed rule will not have a significant economic
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $165 million, using the most current (2021) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Summary of Costs and Benefits

    This proposed rule, if finalized, would amend existing color
additive regulations by increasing fees for certification services. The
fee schedule for color additive certification, as provided for in this
proposed regulation, is designed to cover all the costs of operation of
FDA's color certification program. This includes both the cost of
specific tests required by the regulations and the general costs
associated with the certification program, such as the costs of
accounting, reviewing data, issuing certificates, conducting research,
inspecting establishments, and purchasing and maintaining equipment.
The fee for certification services of straight colors including lakes
would increase from $0.35 per pound to $0.45 per pound, with the
minimum fee increasing from $224 to $288. The fees for repacks of
certified color additives and color additive mixtures would increase
from $35 for 100 pounds or less to $45. The fee for repacks of
certified color additives and color additive mixtures over 100 pounds,
but not over 1,000 pounds would increase from $35 plus $0.06 for each
pound over 100 pounds to $45 plus $0.08 for each pound over 100 pounds.
The fee for repacks of certified color additives and color additive
mixtures over 1,000 pounds would increase from $89 plus $0.02 for each
pound over 1,000 pounds to $114 plus $0.03 for each pound over 1,000
pounds.
    The economic burdens of this proposed rule, if finalized, would
accrue to color additive manufacturers. We estimate a one-time cost to
read and understand the rule for all color additive manufacturers. The
present value of this cost is approximately $1,407 at a 3 percent rate
of discount, and $1,354 at a 7 percent rate of discount. The annualized
value of these costs estimates is approximately $165 at a 3 percent
discount rate and $193 at a 7 percent discount rate. Because the value
of these impacts is small relative to manufacturer revenues, we assume
that the supply of color additives would not be affected by this
proposed rule. Consequently, we estimate no other impacts associated
with this proposed rule.
    As noted in the preamble, the fees are intended to recover the full
costs of operation of FDA's color certification program. Since 2005,
the costs of the certification program significantly increased as a
result of escalating staff payroll, rent and facility charges, as well
as general operational expenses, including purchasing and maintaining
equipment. As the increase in fees is not associated with any change in
our certification program, no economic benefits are expected to result
from the proposed rule, if finalized. Similarly, the impact of the
increase in certification fees on color additive manufacturers is
considered a transfer, rather than an economic cost. Accordingly, we do
not estimate economic benefits associated with this proposed rule, and
the impact of the increase in color certification fees is estimated as
an ongoing transfer from manufacturers of color additives to the
Federal Government. Our estimates are summarized in table 1.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
                                                  [Millions of 2020 dollars over 10-year time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                               ------------------------------------
                 Category                     Primary       Low        High                               Period                    Notes
                                             estimate    estimate    estimate      Year      Discount     covered
                                                                                dollars    rate  (%)   (yearrs)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $/year...........  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                3
    Annualized Quantified.................  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                3
    Qualitative:..........................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
Costs:
    Annualized Monetized $/year...........    $0.00019  ..........  ..........        2020           7          10  ....................................
                                               0.00016                                2020           3          10
    Annualized Quantified.................  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                3
    Qualitative...........................  ..........  ..........  ..........  ..........  ..........  ..........  ....................................
Transfers:
    Federal Annualized Monetized $/year...       $2.46  ..........  ..........        2020           7          10  ....................................
                                                  2.46                                2020           3          10
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...............................  From: Manufacturers of color
                                            additives
                                            To: Federal Government              ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Other Annualized Monetized $/year.....  ..........  ..........  ..........  ..........           7  ..........  ....................................
                                                                                3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To...............................  From:
                                            To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: No
     effect..
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Small Business: The proposed rule, if finalized, would generate costs to small businesses, as well as transfers from small businesses to FDA that we
     treat as costs from the perspective of the small business. On average, these costs amount to approximately 0.2732% of annual average revenues of
     the small firms in the affected industry..
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Wages: No effect....................................................................................................................................
    Growth: No effect...................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

C. Summary of Regulatory Flexibility Analysis

    We have examined the economic implications of this proposed rule
for small entities as required by the Regulatory Flexibility Act. If a
proposed rule would have a significant economic impact on a substantial
number of small entities, the Regulatory Flexibility Act requires
Agencies to analyze regulatory options that would lessen the economic
effect of the proposed rule on small entities. Consequently, this
analysis, together with other relevant sections of this document and
the preamble of the proposed rule, serves as the Initial Regulatory
Flexibility Analysis, as required under the Regulatory Flexibility Act.
    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 1) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of
this action. We have concluded, under 21 CFR 25.30(h), that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive Order and,
consequently, a federalism summary impact statement is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would have a
substantial direct effect on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. FDA invites comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

X. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA, ``Color Additive Certification; Increase in Fees for
Certification Services'' Preliminary Regulatory Impact Analysis,
Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform
Act Analysis. Available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 80

    Color additives, Cosmetics, Drugs, Reporting and recordkeeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
that 21 CFR part 80 be amended as follows:

PART 80--COLOR ADDITIVE CERTIFICATION

0
1. The authority citation for part 80 continues to read as follows:

    Authority: 21 U.S.C. 371, 379e.

0
2. In Sec.  80.10, revise paragraphs (a) and (b) to read as follows:

Sec.  80.10  Fees for certification services.

    (a) Fees for straight colors including lakes. The fee for the
services provided by the regulations in this part in the case of each
request for certification submitted in accordance with Sec.
80.21(j)(1) and (2) shall be $0.45 per pound of the batch covered by
such requests, but no such fee shall be less than $288.
    (b) Fees for repacks of certified color additives and color
additive mixtures. The fees for the services provided under the
regulations in this part in the case of each request for certification
submitted in accordance with Sec.  80.21(j)(3) and (4) shall be:

    (1) 100 pounds or less--$45.
    (2) Over 100 pounds but not over 1,000 pounds--$45 plus $0.08 for
each pound over 100 pounds.
    (3) Over 1,000 pounds--$114 plus $0.03 for each pound over 1,000
pounds.
* * * * *

    Dated: October 21, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-23844 Filed 11-1-22; 8:45 am]
BILLING CODE 4164-01-P