SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG)
(Revision)

1.  Identification of the Information Collection

1(a)  Title of the Information Collection

NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) .
This is a revised information collection request (ICR).  The EPA ICR
tracking number is 1781.05, and the OMB Control Number 2060-0358.

1(b)  Short Characterization/Abstract

This ICR is prepared for a U.S. Environmental Protection Agency (EPA)
rulemaking developed under authority of section 112 of the Clean Air Act
(CAA).  The rulemaking amends title 40, chapter I, part 63, subpart GGG,
National Emission Standards for Hazardous Air Pollutants from
Pharmaceuticals Production, of the Code of Federal Regulations (CFR).
The current Pharmaceuticals Production NESHAP were proposed on April 2,
1997, and promulgated on September 21, 1998.  These standards apply to
facilities in the pharmaceuticals manufacturing operations that are
major sources of hazardous air pollutants (HAP).  The affected
facilities encompass all pharmaceuticals manufacturing operations that
include process vents, storage tanks, equipment components, and
wastewater systems commencing construction or reconstruction after the
date of that proposal.  This information is being collected to assure
compliance with 40 CFR part 63, subpart GGG.  HAP emissions are the
pollutants regulated under this subpart.  The amendments to the rule
eliminate the startup, shutdown, and malfunction exemption, remove the
SSM plan requirement, add provisions to provide an affirmative defense
against civil penalties for exceedances of emission standards caused by
malfunctions, and a requirement for electronic submittal of performance
test data, and correct an editorial error.  The remaining portions of
the NESHAP remain unchanged.

In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports.  Owners or operators are also
required to maintain records of the occurrence and duration of any
malfunctions 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, in
general, are required of all sources subject to NESHAP.  This
information is used by the Agency to identify sources subject to the
standards to insure that the maximum achievable control technologies are
being applied.  Semiannual summary reports are also required.

Any owner or operator subject to the provisions of this part will
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).

We have determined that there are an estimated 27 respondents currently
subject to this rule.  It is estimated that no additional sources will
become subject to the standard over the next three years.

All of the pharmaceutical production facilities in the United States are
owned and operated by the pharmaceutical industry (the “Affected
Public”).  None of the facilities in the United States are owned by
state, local, tribal or the Federal government.  They are all privately,
owned for-profit businesses.  The burden to the “Affected Public” is
listed below in Table 1: Annual Respondent Burden and Cost - NESHAP for
Pharmaceutical Production (40 CFR Part 63, Subpart GGG) (Revision).  The
Federal government burden associated with the review of reports
submitted by the respondent is shown below in Table 2: Average Annual
EPA Burden - NESHAP for Pharmaceutical Production (40 CFR Part 63,
Subpart GGG) (Revision).

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 HAP.  These standards are
applicable to new or existing sources of HAP and shall require the
maximum degree of emission reduction.  In addition, section 114(a)
states that the Administrator may require any owner or 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 pollutant emissions from
pharmaceuticals production (predominately methanol, methylene chloride
and toluene) cause, or contribute to air pollution that may reasonably
be anticipated to endanger public health or welfare.  Therefore, the
NESHAP standards were promulgated for this source category at 40 CFR
part 63, subpart GGG.

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.  In addition, the collected
information is 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 tests, 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 ensure that 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.

	The information generated by the monitoring, recordkeeping and
reporting requirements described in this ICR is used by the Agency to
ensure that facilities affected by the NESHAP continues to operate the
control equipment in compliance with the regulation.

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

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

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 their 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

This is a rule-related ICR and comments were solicited on the proposal
package and the proposed ICR, which included no revisions.  This ICR
contains revisions from the proposed ICR to include burden associated
with the provisions for affirmative defense.

3(c)  Consultations

The Agency’s industry experts have been consulted, and the Agency’s
internal data sources and projections of industry growth over the next
three years have been considered.  The primary source of information as
reported by industry, in compliance with the recordkeeping and reporting
provisions in the standard, is the Online Tracking Information System
(OTIS) which is operated and maintained by the EPA Office of Compliance.
 OTIS is the EPA database for the collection, maintenance, and retrieval
of all compliance data.  The growth rate for the industry is based on
our consultations with the Agency’s internal industry experts.

Industry trade associations and other interested parties were provided
an opportunity to comment on the burden associated with the standard as
it was being developed.  During development of the original standards,
we contacted the Pharmaceutical Research and Manufacturers of America
(PhRMA), at<PHONE_NUMBER>, and Noramco Incorporated, at<PHONE_NUMBER>.

The number of sources was obtained by information gathered and public
comments for pharmaceutical facilities subject to 40 CFR part 63,
subpart GGG on the Residual Risk and Technology Review that was
completed in October of 2008, by EPA’s Office of Air Quality Planning
and Standards

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 emission limitations are met.  If the information required
by these standards was collected less frequently, the proper operation
and maintenance of control equipment and the possibility of detecting
violations would be less likely.

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.  The retention of records for five
years allows EPA to establish the compliance history of a source, any
pattern of non-compliance, and to determine the appropriate level of
enforcement action.  EPA has found that the most flagrant violators have
violations extending beyond the five years.  Without the five-year
record retention, EPA would be prevented from pursuing the violators due
to the destruction or nonexistence of essential 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
pharmaceutical production facilities.  The North American Industry
Classification System (NAICS) codes are listed below for each source
category description.

Standard (40 CFR, part 63, subpart GGG)	NAICS Codes

Pharmaceutical Preparation Manufacturing	325412

Medicinal and Botanical Manufacturing	325411

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

In this ICR, all the data recorded or reported is required by the NESHAP
for Pharmaceuticals Production (40 CFR Part 63, Subpart GGG).

A source must make the following reports:

Notifications

Change in area source status (as applicable)	63.1(c)(5)

Application and notification of construction/reconstruction 	63.5(b)(4),
63.5(d), 63.1260(c)

Notification of applicability	63.9(a), 63.1260(b)

Notification of initial startup	63.9(b), 63.9(d), 63.1260(b)

Notification of initial performance test, submittal of test plan,
request of waiver of performance test	63.7(b)(1-2), 63.7(c), 63.7(f),
63.7(h), 63.9(e), 63.1257(b)(8), 63.1260(1)

Notification of delay (reschedule) of initial performance test
63.7(b)(2)

Notification of CMS performance evaluation and results	63.8(e)(2),
63.9(e)(5), 63.9(g)(1), 63.10(e)(2), 63.1260(d)

Notification of continue use of alternative to relative accuracy testing
has been exceeded	63.9(g)(3), 63.1260(d)

Notification of compliance status report (NOCSR)	63.9(h), 63.1260(f)

Initial performance test results	63.10(d)(2), 63.7(g) 63.1260(f)

Request for compliance extension and progress reports for compliance
extension (as applicable)	63.10(d)(4), 63.1250(f)(6), 63.1260(m)

Reports of  malfunctions 	63.1260(i)

Pre-compliance report (as applicable)	63.1260(e)

Notification of process change	63.1260(h)

Periodic reports	63.1260(g)

Reports of leak detection and repair (LDAR)	63.1260(j), 63.1255(h)

Reports of emissions averaging	63.1260(k)

Reports of malfunctions that result in an exceedances of the standard
for the purpose of affirmative defense	63.1250(g)(4)

A source must keep the following records:

Recordkeeping

Recordkeeping requirements	63.10(a), 63.1259(a)

All reports and notifications	63.10(b)(1), 63.1259(a)(1)

Record of applicability	63.10(b)(3), 63.1259(a)(2)

	Records of sources with continuous monitoring systems (CMS)
63.10(c)(1-14),

63.1259(a)(4)

Application for approval of construction/reconstruction	63.1259(a)(5)

Records of equipment operation	63.1259(b)

Records of operating scenarios	63.1259(c)

Records of LDAR programs	63.1259(d), 63.1255(g)

Records of emissions averaging	63.1259(e)

Records of delay of repair	63.1259(f)

Records of wastewater stream or residual transfer	63.1259(g)

Records of extensions	63.1259(h)

Records of inspections	63.1259(i)

Records should be retained for 5 years	63.10(b)(1), 63.1259(a)(1)

Electronic Reporting

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

Also, regulatory agencies, in cooperation with the respondents, continue
to create reporting systems to transmit data electronically.  However,
electronic reporting systems are not widely used.  At this time, it is
estimated that approximately 20 percent of the respondents are reporting
electronically.

The amendments to the NESHAP require that any performance tests
performed after December 31, 2011 be submitted electronically to EPA’s
Central Data Exchange by using the Electronic Reporting Tool (ERT) for
test methods that are compatible with ERT.  This new requirement to
submit the data to the ERT is in addition to the other existing
submission requirements for this data.

(ii)  Respondent Activities

Respondent Activities

Read instructions.

Plan compliance strategy (includes preparing implementation plans)

Perform initial performance test and repeat performance tests if
necessary.

Perform initial performance test, Reference Methods 1, 2, 3, 4, 18, 25,
and 26 test, 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.

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.

Transmit, or otherwise disclose the information.

	Currently, sources are using monitoring equipment that provides
parameter data in an automated way (e.g., continuous parameter
monitoring system).  Although personnel at the source still need to
evaluate the data, this type of monitoring equipment has significantly
reduced the burden associated with monitoring and recordkeeping.

EPA is including in Table 3 (located at the end of this supporting
statement) an estimate of the burden associated with performing an
affirmative defense.   EPA is providing this as an illustrative example
of the potential additional administrative burden a source may incur to
assert in an Affirmative Defense in response to an action to enforce the
standards set forth in the applicable subpart.

This illustrative estimate is not considered a duplicate estimate of
cost under the General Duty to Minimize Emissions clause under
63.6(e)(1)(i), which states:  “At all times, the owner and operator
must operate and maintain any affected source, including associated air
pollution control equipment and monitoring equipment, in a manner
consistent with safety and good air pollution control practices for
minimizing emissions.  Determining whether such operation and
maintenance procedures are being used will be based on information
available to the Administrator which may include, but is not limited to,
monitoring results, review of operation and maintenance procedures,
review of operation and maintenance records, and inspection of the
source.”

To provide the public with an estimate of the relative magnitude of the
burden associated with an assertion of the affirmative defense position
adopted by a source, EPA provides an administrative adjustment to this
ICR that estimates the costs of the notification, recordkeeping and
reporting requirements associated with the assertion of the affirmative
defense.  EPA’s estimate for the required notification, reports and
records, including the root cause analysis, associated with a single
incident totals approximately $3,141 and is based on the time and effort
required of a source to review relevant data, interview plant employees,
and document the events surrounding a malfunction that has caused an
exceedance of an emission limit.  The estimate also includes time to
produce and retain the records and reports for submission to EPA.  EPA
provides this illustrative estimate of this burden because these costs
are only incurred if there has been a violation and a source chooses to
take advantage of the affirmative defense.

Of the number of excess emission events reported by source operators,
only a small number would be expected to result from a malfunction, and
only a subset of excess emissions caused by malfunctions would result in
the source choosing to assert the affirmative defense.  Thus we believe
the number of instances in which source operators might be expected to
avail themselves of the affirmative defense will be extremely small.
For this reason, we estimate no more than 2 or 3 such occurrences for
all sources within a given category over the 3-year period covered by
this ICR.  For the purpose of this estimate, we are adding two (2)
instances of affirmative defense.  We expect to gather information on
such events in the future and will revise this estimate as better
information becomes available.

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,
excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the OTIS.

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 operational.  Performance test reports are used
by the Agency to discern a source’s initial capability to comply with
the emission standard, and note the operating conditions under which
compliance was achieved.  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 OTIS which is
operated and maintained by the EPA Office of Compliance.  OTIS is the
EPA database for the collection, maintenance, and retrieval of
compliance data for approximately 125,000 industrial and
government-owned facilities.  EPA uses OTIS for tracking air pollution
compliance and enforcement by local and state regulatory agencies, EPA
regional offices, and EPA headquarters.  EPA edit, store, retrieve and
analyze the data.

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

5(c)  Small Entity Flexibility

	The 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 to be the minimum
requirements 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 below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart
GGG) (Revision).

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.  Wherever 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 44,266
(Total Labor Hours from Table 1).  These hours are based on Agency
studies and background documents from the development of the regulation,
Agency knowledge and experience with the NESHAP program, the previously
approved ICR, and any comments received.

6(b)  Estimating Respondent Costs

This ICR uses the following labor rates:

Managerial	$114.49 ($54.52 + 110%)

Technical	$98.20 ($46.76 + 110%)

Clerical	$48.53 ($23.11 + 110%)

These rates are from the United States Department of Labor, Bureau of
Labor Statistics, September 2009, ”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) Cost

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)

Data-logger and Thermocouple	$4,400	0	$0	$4,158	27	$112,266

Total

	$0

	$112,266

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

The total operation and maintenance (O&M) costs for this ICR are
$112,266.  This is the total of column G.

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 $112,266.

(iv)  Affirmative Defense, Root Cause Analysis, and Malfunction Costs.

EPA’s estimate for a affirmative defense and root cause analysis is
based on general experience to calculate the time and effort required of
a source to review relevant data, interview plant employees, and
reconstruct the events prior to a malfunction in order to determine
primary and contributing causes.  The level of effort also includes time
to produce and retain the report in document form so that the source
will have it available should EPA or state enforcement agencies ever
request to review it.

6(c)  Estimating Agency Burden and Cost

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

The average annual Agency cost during the three years of the ICR is
estimated to be $71,518.

This cost is based on the average hourly labor rate as follows:

		Managerial	$62.27 (GS-13, Step 5, $38.92 + 60%)

		Technical	$46.21 (GS-12, Step 1, $28.88 + 60%)

		Clerical	$25.01 (GS-6, Step 3, $15.63 + 60%)

These rates are from the Office of Personnel Management (OPM), 2010
General Schedule, which excludes locality rate of pay.  The rates have
been increased by 60 percent to account for the benefit packages
available to government employees.  Details upon which this estimate is
based appear below in Table 2: Average Annual EPA Burden - NESHAP for
Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision).

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 27 respondents will be subject to the standard.  It
is estimated that no new respondents per year will become subject.  The
overall average number of respondents, as shown in the table below is 27
per year.

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

Number of Respondents

Year	(A)

Number of New Respondents 1	(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	0	27	0	0	27

2	0	27	0	0	27

3	0	27	0	0	27

Average	0	27	0	0	27

1 New respondent include sources with constructed, reconstructed and
modified affected facilities.

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 27.

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 construction/reconstruction	0	1	0	0

Notification of physical or operational changes	27	3	0	81

Notification of actual startup	0	1	0	0

Notification of initial performance test	0	1	0	0

Notification of applicability	0	1	0	0

Notification of demonstration of CMS	0	1	0	0

Notification of compliance status	0	1	0	0

Pre-compliance report (emission averaging)	0	1	0	0

Malfunction	27	2	               0	54

No deviations	24	2	0	48

Deviations	3	2	0	6

LDAR report	27	2	0	54

Emissions averaging report	3	2	0	6

Reports of malfunctions that result in an exceedances of the standard
for the purpose of affirmative defense	27	0.025	0	0.7

Total Number of Annual Responses

	Total	250

The number of Total Annual Responses is 250.

The total annual labor costs are $4,187,309.  Details regarding these
estimates may be found below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart
GGG) (Revision).

6(e)  Bottom Line Burden Hours Burden Hours 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 hours are 44,266.  Details regarding these
estimates may be found below in Table 1: Annual Respondent Burden and
Cost - NESHAP for Pharmaceuticals Production (40 CFR Part 63, Subpart
GGG) (Revision).

Furthermore, the annual public reporting and recordkeeping burden for
this collection of information is estimated to average 177 hours per
response.

The total annual capital/startup and Operation and Maintenance (O&M)
costs to the regulated entity are $112,266.

(ii)  The Agency Tally

The average annual Agency burden and cost over next three years is
estimated to be 1,587 labor hours at a cost of $71,518.  See below Table
2: Average Annual EPA Burden and Cost – NESHAP for Pharmaceuticals
Production (40 CFR Part 63, Subpart GGG) (Revision).

6(f)  Reasons for Change in Burden

There is an increase in the labor hour burden in this ICR compared to
the previous ICR due to the inclusion of the new requirements of the
amendments to the NESHAP.  EPA provides an adjustment to this ICR that
estimates the costs of the notification, recordkeeping, and reporting
requirements associated with the assertion of the affirmative defense.
EPA’s estimate for the required notification, reports and records,
including the root cause analysis, associated with a single incident
totals approximately $3,141 and is based on the time and effort required
of a source to review relevant data, interview plant employees, and
document the events surrounding a malfunction that has caused an
exceedance of an emission limit.  The estimate also includes time to
produce and retain the records and reports for submission to EPA.  For
the purpose of estimating the annual burden, EPA is attributing a total
of 2 instances of affirmative defense over a three year period across
all sources in the category.  EPA is using this frequency of 2 events in
three years because, of the number of excess emission events reported by
source operators, only a small number would be expected to result from a
malfunction, and only a subset of excess emissions caused by
malfunctions would result in the source choosing to assert the
affirmative defense.  Thus we believe the number of instances in which
source operators might be expected to avail themselves of the
affirmative defense will be extremely small.

6(g)  Burden Statement

The annual public reporting and recordkeeping burden for this collection
of information is estimated to average 177 hours per response.  Burden
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, disclose or provide information to or for
a Federal agency.  This includes the time needed to review instructions;
to 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; to adjust the existing ways to comply with any previously
applicable instructions and requirements; to train personnel to be able
to respond to a collection of information; to search data sources; to
complete and review the collection of information; and to 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-2009-0381.  An electronic version of the public docket is
available at   HYPERLINK "http://www.regulations.gov/"
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 content of the docket, and to access those
documents in the public docket that are available electronically.  When
in the system, select “search” than 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 Avenue, N.W., 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, N.W.,
Washington, DC 20503, Attention: Desk Officer for EPA.  Please include
the EPA Docket ID Number EPA-HQ-OECA-2009-0381 and OMB Control Number
2060-0358 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
Pharmaceuticals Production (40 CFR Part 63, Subpart GGG) (Revision)

Assumptions:

a  We have assumed that the average number of respondents that will be
subject to this rule will be 27.  There will be no new additional
sources during the next three years of this ICR.

b  This ICR uses the following labor rates:  $114.49 per hour for
Executive, Administrative, and Managerial labor; $98.20 per hour for
Technical labor, and $48.53 per hour for Clerical labor.  These rates
are from the United States Department of Labor, Bureau of Labor
Statistics, September, 2009, 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.

c  We have assumed that there will be no new or reconstructed facilities
during the next three years of this ICR.

d  We have assumed that 20 percent of respondents would have to repeat
performance tests due to failure.

e  We have assumed that each source will require an average of three
processing changes each year to complete this task over the next three
years of this ICR.

f  We have assumed that each respondent will take 40 hours two times per
year to complete the startup, shutdown, malfunction reports.

g  We have assumed that 90 percent of respondents will each take eight
hour two times per year to complete the no deviation report.

h  We have assumed that 10 percent of respondents will each take 24
hours two times per year to complete the deviation report.

i  We have assumed that it will take each respondent 432 hour two times
per year to complete the LDAR report.

j  We have assumed that ten percent of respondents will each take 20
hours two times per year to complete the emissions averaging report.

k  We have assumed that it will take each respondent 1 hour 365 times
per year to record the operating parameters for control devices.

l  We have assumed that it will take each respondent 2 hours 26 times
per year to record the SSM plans.

m  We have assumed that it will take each respondent 16 hours one time
per year to record the calibration of CMS. n  Assumes 2 affirmative
defense reports for entire industry during the 3-yr ICR period.
Formulas are not followed for person-hours per year.  For affirmative
defense hours required assumes 18 hours technical, 12 hours management,
0 clerical for each instance of affirmative defense.

Table 2:  Average Annual EPA Burden - NESHAP for Pharmaceuticals
Production (40 CFR Part 63, Subpart GGG) (Revision)

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

1.  Required activities

         i.   Initial performance test c	2	1	2	0	0	0	0	$0

         ii.  Repeat performance test d	24	1	24	0	0	0	0	$0

2.  Report review – one time

         i.  Notification of construction/reconstruction	2	1	2	0	0	0	0
$0

         ii.  Notification of actual startup	2	1	2	0	0	0	0	$0

         iii. Notification of initial CMS demonstration	2	1	2	0	0	0	0	$0

         iv. Initial notification	2	1	2	0	0	0	0	$0

         v.  Notification of compliance status report	40	1	40	0	0	0	0	$0

         vi. Pre-compliance report e

              a.  With emissions averaging f	20	1	20	0	0	0	0	$0

              b.  Without emissions averaging 	4	1	4	0	0	0	0	$0

3.  Report review – on-going

         i.  Semiannual summary report

              a.   No deviations g	2	2	4	24	96	4.8	9.6	$4,975.16

              b.  Deviations h	8	2	16	3	48	2.4	4.8	$2,487.58

         ii. Notification of physical/operational change i	8	3	24	27	648
32.4	64.8	$33,582.28

         iii. SSM report j	2	2	4	27	108	5.4	10.8	$5,597.05

         iv. LDAR report k	8	2	16	27	432	21.6	43.2	$22,388.18

         v.  Emission averaging report l	8	2	16	3	48	2.4	4.8	$2,487.58

Subtotals Labor Burden and cost

	1,380	69	138	$71,517.83

TOTAL ANNUAL BURDEN AND COST (rounded)

	1,587	$71,518

Assumptions:

a  We have assumed that the average number of respondents that will be
subject to this rule will be 27.  There will be no new additional
sources during the next three years 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: $62.27 Managerial rate (GS-13, Step 5, $38.92 x 1.6), $46.21
Technical rate (GS-12, Step 1, $28.88 x 1.6), and $25.01 Clerical rate
(GS-6, Step 3, $15.63 x 1.6).  These rates are from the Office of
Personnel Management (OPM) 2010 General Schedule which excludes locality
rates of pay.

c  We have assumed that there will be no new or reconstructed facilities
during the next three years of this ICR.

d  We have assumed that 20 percent of respondents would have to repeat
performance tests due to failure.

e  We have assumed that 50 percent of new facilities will submit a
pre-compliance report.

f  We have assumed that 10 percent of existing facilities will have to
comply with emission averaging requirements; new facilities are not
allowed to use emissions averaging.

g  We have assumed that 90 percent of respondents will each take two
hours two times per year to complete this report.

h  We have assumed that 10 percent of respondents will have to report
deviation.

i  We have assumed that each respondent will be required to review the
physical/operational changes for each facility three times per year over
the next three-year period of this ICR.

j  We have assumed that each respondent will report actions taken during
startup, shutdown, or malfunction that are consistent.

k  We have assumed that each respondent will have to comply with the
LDAR report two times per year.

l  We have assumed that 10 percent of respondents will have to review
the emission averaging report.

Table 3:  Single Affirmative Defense Burden Estimate

Personnel 	Number of Personnel 	Time Requirement (hours)	Total Hours
Hourly Rate ($/hr)	Total

Technical Personnel	3	6	18	98.20	$ 1,768

Managerial Personnel	2	6	12	114.49	$ 1,374

Total	5

30

$3,141

 PAGE

 PAGE   2

 PAGE


[Federal Register: October 23, 2008 (Volume 73, Number 206)]
[Proposed Rules]
[Page 63112-63113]
[DOCID:fr23oc08-25]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 158 and 161

[EPA-HQ-OPP-2008-0110; FRL-8388-7]

Pesticides; Data Requirements for Antimicrobial Pesticides;
Notice of Public Workshop

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; supplemental information about public workshop;
availability of web conference.

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

SUMMARY: This notice provides supplemental information to the notice
published on October 10, 2008, that announced the scheduling of a
November 6, 2008, public workshop to explain the provisions of its
recently proposed rule to update and revise the data requirements for
registration of antimicrobial pesticides. EPA has arranged for a web
conference for those persons who cannot attend in-person the public
workshop. The workshop is intended to provide an opportunity for
members of the public to ask questions about the proposed rule and seek
any clarification they believe may assist them in submitting comments
to the docket for the proposed rule. Any person wishing to comment on
the proposed rule must submit any comments to the docket within the
timeframe set forth in the Notice of Proposed Rulemaking.

DATES: The meeting will be held on November 6, 2008, from 8:30 a.m. to
4 p.m.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at the Office of Pesticide Programs
(OPP), First Floor Conference Center, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA 22202.
    To facilitate the Agency's planning, your intention to participate
in the web conference for the Antimicrobials Workshop, may be submitted
to the person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Amaris Johnson, Field and External
Affairs Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are a producer of
pesticide products (NAICS 32532), antifoulants (NAICS 32551),
antimicrobial pesticides (NAICS 32561) or wood preservatives (NAICS
32519), importers of such products, or any person or company who seeks
to register an antimicrobial, antifoulant coating, ballast water
treatment, or wood preservative pesticide or to obtain a tolerance for
such a pesticide. This listing is not intended to be exhaustive, but
rather provides a guide for readers regarding entities likely to be
affected by this action. Other types of entities not listed above could
also be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, please contact Norm Cook, Chief of the Risk
Assessment and Science Support Branch in the Antimicrobials Division of
the Office of Pesticide Programs at<PHONE_NUMBER> or via email,
<EMAIL_ADDRESS>
B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket ID number EPA-HQ-OPP-2008-0110. Publicly available docket
materials are available either in the electronic docket athttp://
www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
The hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings athttp://www.epa.gov/fedrgstr.

II. Background

    EPA is convening a public workshop to explain the proposed
revisions to the data requirements for the registration of
antimicrobial pesticides. Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act
(FFDCA), anyone seeking to register a pesticide product is required to
provide information to EPA to demonstrate that their products can be
used without posing ``unreasonable adverse effects on the environment''
as defined by FIFRA section 2(bb).
    The public workshop will include presentations by staff from the
Antimicrobial, and the Field and External Affairs Divisions of the
Office of Pesticide Programs. The proposed revisions are directed at
antimicrobial pesticides, not conventional pesticides, biochemical and
microbial pesticides or product performance data requirements.
Nonetheless, all interested parties are welcome and may benefit from
the discussions since two areas not addressed in the conventional
pesticide (72 FR 60934, October 26, 2007) (FRL-8106-5), or biochemical
and microbial pesticide (72 FR 60988, October 26, 2007) (FRL-8109-8)
data requirements final rules are addressed in the antimicrobial data
requirements proposed rule. These two areas are: Down-the-drain data
requirements and the Program's use of structure-activity-relationship
(SAR).
    During the workshop, persons in attendance will be able to ask
questions regarding the proposed rule and/or material being presented
and seek any clarification they believe may assist them in submitting
comments to the docket for the proposed rule. Any person wishing to
comment on the proposed rule must submit any comments to the docket
within the timeframe set forth in the Notice of Proposed Rulemaking.
    The proposed revisions were issued in the Federal Register of
October 8, 2008 (73 FR 59382) (FRL-8358-2). A 90-day comment period
will end on January 6, 2008. The notice of the workshop was published
on October 10, 2008 (73 FR 60211) (FRL-8383-6). A limited number of
copies of the proposed rule will be available at the workshop.
Attendees are encouraged to access the electronic version of the
proposed rule from the regulations.gov website under Docket ID number
EPA-HQ-OPP-2008-0110.
    The Agency has arranged for a web conference to serve as an
alternate means of participating in the workshop. You can join the web
conference starting at 8 a.m. on November 6, 2008. To access the web
conference go to http://portal.epa.gov/webconference, and complete the
Join Conference box on the right of the screen using the following
information: Conference ID: 309742 and Conference Key: 12345. Type in
your full name and then select: Join Conference. For the audio portion
call<PHONE_NUMBER> and then use code<PHONE_NUMBER>. Additional
information on web conferencing can be accessed from the
regulations.gov website under Docket ID number EPA-HQ-OPP-2008-0110.

List of Subjects

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 17, 2008.
Martha Monell,
Acting Director, Office of Pesticide Programs.
[FR Doc. E8-25350 Filed 10-22-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Rules and Regulations]
[Pages 66626-66630]
[FR Doc No: 2019-26158]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0644; FRL-10000-97]

Etoxazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
etoxazole in or on beet, sugar, roots and beet, sugar, leaves. The
Interregional Research Project Number 4 (IR-4) requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2019. Objections and
requests for hearings must be received on or before February 3, 2020
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2018-0644, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The 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 Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2018-0644 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
February 3, 2020. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2018-0644, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 18, 2018 (84 FR 9737) (FRL-9989-
71), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
8E8701) by IR-4, Rutgers, The State University of New Jersey, 500
College Road East, Suite 201 W. Princeton, NJ 08540. The petition
requested that 40 CFR part 180.593 be amended by establishing
tolerances for residues of the insecticide etoxazole, (2-(2,6-
difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on the following sugar beet commodities: Roots
at 0.02 parts per million (ppm); dried pulp at 0.04 ppm; and leaves at
1 ppm. In addition, the petition requested tolerances for etoxazole
residues in or on the leaves of many other commodities at 1 ppm. That
document referenced a summary of the petition prepared by Valent U.S.A.
Corporation,

the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA is
establishing tolerances that vary from what the petitioner requested,
in accordance with section 408(d)(4)(A)(i). The reasons for these
changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for etoxazole including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with etoxazole follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity database and considered
its validity, completeness, and reliability as well as the relationship
of the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    The effects in the etoxazole database show liver toxicity in all
species tested (enzyme release, hepatocellular swelling and
histopathological indicators), and the severity does not appear to
increase with time. In rats only, there were effects on incisors
(elongation, whitening, and partial loss of upper and/or lower
incisors). There is no evidence of neurotoxicity or immunotoxicity. No
toxicity was seen at the limit dose in a 28-day dermal toxicity study
in rats.
    No increased quantitative or qualitative susceptibilities were
observed following in utero exposure to rats or rabbits in the
developmental studies; however, offspring toxicity was more severe
(increased pup mortality) than maternal toxicity (increased liver and
adrenal weights) at the same dose (158.7 milligram/kilogram/day (mg/kg/
day)) in the rat reproduction study indicating increased qualitative
susceptibility. Etoxazole is not mutagenic and not likely to be
carcinogenic based on the lack of carcinogenicity effects in the
database.
    Specific information on the studies received and the nature of the
adverse effects caused by etoxazole as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Etoxazole: Human Health Risk
Assessment for Registration Review and a Proposed Section 3 Use on
Sugar Beets'' at pages 33-37 in docket ID number EPA-HQ-OPP-2018-0644.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for etoxazole used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Etoxazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                         POD and uncertainty/    RfD, PAD, LOC for risk  Study and toxicological
          Exposure/scenario              FQPA safety factors           assessment                effects
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)....  NOAEL= 4.62 mg/kg/day..  cPAD = cRfD = 0.046 mg/  Chronic Oral Toxicity
                                       UFA = 10X..............   kg/day.                  Study--Dog.
                                       UFH = 10X..............                           LOAEL = 23.5 mg/kg/day
                                       FQPA SF = 1X...........                            based upon increased
                                                                                alkaline phosphatase
                                                                                activity, increased
                                                                                liver weights, liver
                                                                                enlargement (females),
                                                                                and incidences of
                                                                                centrilobular
                                                                                hepatocellular
                                                                                swelling in the liver.
                                      --------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)....  EPA has classified etoxazole as ``not likely to be carcinogenic to
                                        humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to etoxazole, EPA considered exposure under the petitioned-for
tolerances as well as all existing etoxazole tolerances in 40 CFR
180.593. EPA assessed dietary exposures from etoxazole in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
etoxazole; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the Dietary Exposure Evaluation Model software
with the Food Commodity Intake Database (DEEM-FCID), Version 3.16. This
software uses food consumption data from the USDA National Health and
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA;
2003-2008). As to residue levels in food, EPA assumed tolerance-level
residues and 100% crop treated (PCT) for all food commodities. EPA's
2018 default processing factors were used except in cases where
adequate processing data were available. In the cases where there was
no significant concentration, the default processing factors were set
to 1.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
classified etoxazole as ``not likely'' to be carcinogenic to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for etoxazole. Tolerance level residues and 100 PCT
were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for etoxazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of etoxazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Etoxazole residues of concern in drinking water, which were used in
the dietary exposure assessment for this new use, include the parent
and two major metabolites, R-8 and R-13. Based on the First Index
Reservoir Screening Tool (FIRST), and Pesticide Root Zone Model Ground
Water (PRZM GW) models, the estimated drinking water concentrations
(EDWCs) of etoxazole for chronic exposures are estimated to be 4.761
parts per billion (ppb) for surface water and <0.01 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the chronic dietary
exposure and risk assessment, the water concentration of value 4.761
ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Etoxazole is not registered for any specific use patterns that
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to etoxazole and any other
substances and etoxazole does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this action,
therefore, EPA has not assumed that etoxazole has a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's website at
http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. No increased quantitative or
qualitative susceptibilities were observed following in utero exposure
to rats or rabbits in the developmental studies. There is evidence of
increased qualitative offspring susceptibility in the rat reproduction
study, but the concern is low since: (1) The effects in pups are well-
characterized with a clear NOAEL; (2) the selected endpoints are
protective of the doses where the offspring toxicity is observed; and
(3) offspring effects occur in the presence of parental toxicity.
    3. Conclusion. Based on the available hazard and exposure database
for

etoxazole, EPA recommends that the FQPA SF be reduced to 1X for all
exposure scenarios relevant to the current safety assessment.
    EPA has determined that reliable data show the safety of infants
and children would be adequately protected if the FQPA SF were reduced
to 1X for current exposure scenarios. That decision is based on the
following findings:
    i. The toxicity database for etoxazole is complete including
acceptable developmental toxicity studies in rats and rabbits, a two-
generation reproduction study in rats, and acute and subchronic
neurotoxicity studies in rats.
    ii. There is no evidence of neurotoxicity in the etoxazole database
including guideline acute and subchronic neurotoxicity studies.
    iii. There are no residual uncertainties for pre- and/or post-natal
toxicity. The observed qualitative postnatal susceptibility is
protected for by the selected endpoints.
    iv. There are no residual uncertainties identified in the exposure
databases. Adequate data are available to determine the nature and
magnitude of the residue in all proposed/registered crops and in
livestock. The current dietary exposure analysis assumed 100 PCT,
tolerance-level residues, modeled drinking water estimates, and in the
absence of empirical data, default processing factors. Therefore, the
dietary exposure analysis is conservative and unlikely to underestimate
exposure. There are no registered residential uses for etoxazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
etoxazole is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
etoxazole from food and water will utilize 3.6% of the cPAD for the
U.S. population and 15% of the cPAD for children 1-2 years old, the
population group receiving the greatest exposure. There are no
residential uses for etoxazole.
    3. Short- and Intermediate term risks. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term risk is assessed based on short- or intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
short- or intermediate-term residential exposure and chronic dietary
exposure has already been assessed under the appropriately protective
cPAD (which is at least as protective as the POD used to assess short-
or intermediate-term risks), no further assessment of short- or
intermediate- term risk is necessary. EPA relies on the chronic dietary
risk assessment for evaluating short- and intermediate-term risk for
etoxazole.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, etoxazole is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to etoxazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, Valent Method RM-37, gas
chromatography/mass-selective detector (GC/MSD) or GC/nitrogen-
phosphorus detector (NPD), is available for enforcing the current plant
and livestock tolerances.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are no Codex MRLs for residues of etoxazole in/on sugar beet
commodities.

C. Revisions to Petitioned-for Tolerances

    EPA concluded that a separate tolerance for etoxazole residues in
or on Beet, sugar, dried pulp is not needed because available
processing data indicate that quantifiable residues of etoxazole are
unlikely to occur in sugar beet processed commodities following an
application at the maximum use rate. In addition, EPA is not
establishing any tolerances for residues on plant leaves (other than
the tolerance on beet, sugar, leaves) because the petitioner withdrew
its request for those tolerances. At this time, those tolerances are
not necessary.

V. Conclusion

    Therefore, a tolerance is established for residues of etoxazole,
(2-(2,6-difluorophenyl)-4-[4-(1,1-dimethylethyl)-2-ethoxyphenyl]-4,5-
dihydrooxazole), in or on Beet, sugar, leaves at 1 ppm and Beet, sugar,
roots at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order

13771, entitled ``Reducing Regulations and Controlling Regulatory
Costs'' (82 FR 9339, February 3, 2017). This action does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: November 21, 2019.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In the table in paragraph (a) of Sec.  180.593, add alphabetically
the commodities ``Beet, sugar, leaves'' and ``Beet, sugar, roots'' to
read as follows:

Sec.  180.593  Etoxazole; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Beet, sugar, leaves.........................................           1
Beet, sugar, roots..........................................        0.02

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-26158 Filed 12-4-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Notices]
[Pages 70855-70856]
[FR Doc No: 2021-26867]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2021-2039]

National Offshore Safety Advisory Committee; Vacancy

AGENCY: Coast Guard, Department of Homeland Security.

ACTION: Request for applications; re-solicitation for a member
representing individuals employed in offshore operations.

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

SUMMARY: The Coast Guard is re-soliciting applications from persons
interested in membership on the National Offshore Safety Advisory
Committee (Committee) to fill a vacant position representing
individuals employed in offshore operations. This recently established
Committee will advise the Secretary of the Department of Homeland
Security on matters relating to activities directly involved with, or
in support of, the exploration of offshore mineral and energy
resources, to the extent that such matters are within the jurisdiction
of the Coast Guard.

DATES: Your completed application should reach the Coast Guard on or
before February 11, 2022.

ADDRESSES: Applications should include a cover letter expressing
interest in an appointment to the Committee and a resume detailing
their experience along with a brief biography. Applications should be
submitted: Via email with subject line ``Application for NOSAC'' to Mr.
Patrick Clark at [email protected].

FOR FURTHER INFORMATION CONTACT: Mr. Patrick W. Clark, Designated
Federal Officer of the National Offshore Safety Advisory Committee;
Telephone<PHONE_NUMBER>; or Email at [email protected].

SUPPLEMENTARY INFORMATION: On March 17, 2020, the Coast Guard published
a request in the Federal Register (85 FR 15211) for applications for
membership in the National Offshore Safety Advisory Committee. The
Coast Guard is re-soliciting applications from persons interested in
membership on the National Offshore Safety Advisory Committee to
represent the viewpoint of individuals employed in offshore operations.
Applicants who responded to the previous notices do not need to
reapply.
    The National Offshore Safety Advisory Committee is a Federal
advisory committee. It will operate under the provisions of the Federal
Advisory Committee Act (5 U.S.C. Appendix), and the administrative
provisions in Sec.  601 of the Frank LoBiondo Coast Guard Authorization
Act of 2018 (specifically, 46 U.S.C. 15109).
    The Committee was established on December 4, 2018, by Sec.  601 of
the Frank LoBiondo Coast Guard Authorization Act of 2018, Public Law
115-282, 132 Stat. 4192 and amended by Sec.  8331 of the Elijah E.
Cummings Coast Guard Authorization Act of 2020, Public Law 116-283.
That authority is codified in 46 U.S.C. 15106. The Committee will
advise the Secretary of Homeland Security on matters relating to
activities directly involved with, or in support of, the exploration of
offshore mineral and energy resources, to the extent that such matters
are within the jurisdiction of the Coast Guard.
    The Committee is required to meet at least once a year in
accordance with 46 U.S.C. 15109(a). We expect the Committee to meet at
least twice a year, but it may meet more frequently. The meetings are
generally held in cities that have high concentrations of maritime
personnel and related marine industry businesses.
    All members serve at their own expense and receive no salary or
other compensation from the Federal Government.
    Under the provisions in 46 U.S.C. 15109(f)(6), if you are appointed
as a

member of the Committee, your membership term will expire on December
31st of the third full year after the effective date of your
appointment. The Secretary may require an individual to have passed an
appropriate security background examination before appointment to the
Committee, 46 U.S.C. 15109(f)(4).
    While there are two positions on the advisory committee
representing the viewpoints of individuals employed in offshore
operations, there is currently only one vacancy.
    The Department of Homeland Security does not discriminate in
selection of Committee members based on race, color, religion, sex,
national origin, political affiliation, sexual orientation, gender
identity, marital status, disabilities and genetic information, age,
membership in an employee organization, or any other non-merit factor.
The Department of Homeland Security strives to achieve a widely diverse
candidate pool for all of its recruitment selections.
    If you are interested in applying to become a member of the
Committee, email your cover letter and resume along with the brief
biography to Patrick W. Clark, Designated Federal Officer of the
National Offshore Safety Advisory Committee, via the transmittal method
provided in the ADDRESSES section by the deadline in the DATES section
of this notice.

    Date: December 2, 2021.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2021-26867 Filed 12-10-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]
[Page 41090]
[DOCID:fr17jy08-86]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0361]

Small Entity Compliance Guide: Standard of Identity for White
Chocolate; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a small entity compliance guide (SECG) for a final rule
published in the Federal Register of October 4, 2002 (67 FR 62171).
This SECG entitled ``Standard of Identity for White Chocolate'' is
intended to set forth, in plain language, the requirements of the
regulation and to help small businesses understand the regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
on the SECG to http://www.regulations.gov. Submit written requests for
single copies of the SECG to the Office of Nutrition, Labeling, and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740. Send one self-addressed adhesive label to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the SECG.

FOR FURTHER INFORMATION CONTACT: Geraldine June, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 4, 2002, FDA issued a final rule
establishing a standard of identity for white chocolate. That final
rule became effective January 1, 2004.
    FDA examined the economic implementation of the final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-602) and
determined that the final rule would have a significant economic impact
on a substantial number of small entities. In compliance with section
212 of the Small Business Regulatory Enforcement Fairness Act (Public
Law 104-121), FDA is making this SECG available by stating, in plain
language, the requirements of the regulation.
    FDA is issuing this SECG as level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG
represents the agency's current thinking on this subject. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
    (see ADDRESSES) written or electronic comments regarding this SECG.
Submit a single copy of electronic comments to or two paper copies of
any mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The SECG and received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov/guidance.html.

    Dated: July 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16394 Filed 7-16-08; 8:45 am]

BILLING CODE 4160-01-S


(http://www.fsis.usda.gov/Science/Microbiological_Lab_Guidebook/); these test procedures may
be useful in the experimental design of technical effect studies.  However, a petition or
notification will not be treated differently simply because an alternative study design was chosen.
K.
What is FDA’s performance standard for a new antimicrobial food additive?
A performance standard defines the minimal level of reduction of microorganisms from the use
of the antimicrobial food additive (e.g., a 5-log reduction in the number of microbe(s) targeted).
Given the variability in the intended technical effect of antimicrobial food additives and types of
food treated, FDA does not have a single performance standard for antimicrobial food additives.
However, to prove that an additive achieves its intended technical effect as an antimicrobial
agent, data from an efficacy study should demonstrate that, at a minimum, there is a measurable
difference between the treated samples and a negative control (e.g., the treatment absent the
active agent).  Such a demonstration may be achieved through statistical analysis, graphical
comparison, or another equivalent method.  In those particular cases where the intended
technical effect specifies the use of the additive as part of a process where a performance
standard has been established by regulation (e.g., Juice HAACP (21 CFR 120.24)) or regulatory
guidance (e.g., FSIS guidance on control of Listeria monocytogenes), FDA may consider that
performance standard when regulating the additive.
L.
What information may be helpful to provide to FDA to demonstrate the intended
technical effect of a source of radiation as an antimicrobial treatment for food?
A source of radiation used to treat food is included in the food additive definition (section 201(s)
of the Act).  Furthermore, section 402(a)(7) of the Act states that a food is adulterated if it has
been subjected to radiation, unless the use of the regulation was in conformity with a regulation
or exemption under section 409 of the Act.  Because a source of radiation used to treat food does
not meet the definition of a food contact substance in that it has a technical effect in the food, it
is regulated through the FAP process under section 409 rather than the FCN process or the TOR
exemption process.  In addition to information typically submitted in an FAP, a petition for the
use of a source of radiation as an antimicrobial treatment for food should include information
related to technical effect, such as:
1.
Information describing the microbiological profile of targeted foods (occurrence and
levels of pathogenic and non-pathogenic microorganisms); and
2.
Information describing the effects of the proposed irradiation on microorganisms in or on
the targeted food, including growth patterns of surviving microorganisms compared with food
that has not been irradiated.  For example, Clostridium botulinum is of particular concern as a
potential microorganism surviving irradiation.  Therefore, it may be necessary to consider

Contains Nonbinding Recommendations
10
whether C. botulinum is able to proliferate to a greater extent in food treated by irradiation than
in untreated food because of a reduced number of competing spoilage organisms.
M.
What additional safety information may be helpful to provide to FDA if my
antimicrobial food additive is derived from a microorganism?
If an antimicrobial food additive is derived from a microorganism, FDA recommends that the
following additional information be provided, at a minimum:
1.
The biological identity of the specific isolate of microorganism to be used for production.
If the strain has been genetically manipulated, a description of how the strain was derived,
including information about any strain contributing genetic material to the production strain
should be included with the submission;
2.
A description of the procedures used to maintain the cultural purity and genetic stability
of the production microorganism. Details of procedures employed to assure strain purity and
integrity should be included with the submission;
3.
A description of the quality control procedures used during production, the procedures
for assurance of cultural purity, and the procedures to be followed if contamination is observed
in the starter (pure) cultures or during production;
4.
A description of the methods used to verify the absence of clinically relevant antibiotics.
The production microorganism should not produce clinically relevant antibiotics in preparations
of the antimicrobial food additive;
5.
Information that demonstrates that the production strain is not infectious or toxicogenic,
and that no toxin is present at toxicologically significant levels in the preparation for use in food,
if it is necessary to employ a toxicogenic strain; and
6.
A description of the methods employed and relevant quality control procedures followed
to ensure that no viable cells of the production strain are found in the product when those cells
represent a safety concern.
FDA understands that there may be newly developed antimicrobial products for which some of
these recommendations may not be valid.  A petition or notification will not be treated
differently simply because safety information other than that recommended here was provided.
We will consider the sufficiency of the safety information provided with antimicrobial product
petitions on a case-by-case basis.


[Federal Register Volume 84, Number 50 (Thursday, March 14, 2019)]
[Notices]
[Page 9317]
[FR Doc No: 2019-04676]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1200-000]

Clearway Power Marketing LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Clearway Power Marketing LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is March 27, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: March 7, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-04676 Filed 3-13-19; 8:45 am]
BILLING CODE 6717-01-P