[Federal Register: January 13, 2009 (Volume 74, Number 8)]
[Notices]
[Page 1690-1692]
[DOCID:fr13ja09-57]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Advisory Committees; Tentative Schedule of Meetings for 2009

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a
tentative schedule of forthcoming meetings of its public advisory
committees for 2009. During 1991, at the request of the Commissioner of
Food and Drugs (the Commissioner), the Institute of Medicine (the IOM)
conducted a study of the use of FDA's advisory committees. In its final
report, one of the IOM's recommendations was for the agency to publish
an annual tentative schedule of its meetings in the Federal Register.
This publication implements the IOM's recommendation.

FOR FURTHER INFORMATION CONTACT: Theresa L. Green, Advisory Committee
Oversight and Management Staff (HF-4), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The IOM, at the request of the Commissioner,
undertook a study of the use of the FDA's advisory committees. In its
final report in 1992, one of the IOM's recommendations was for FDA to
adopt a policy of publishing an advance yearly schedule of its upcoming
public advisory committee meetings in the Federal Register; FDA has
implemented this recommendation. The annual publication of tentatively
scheduled advisory committee meetings will provide both advisory
committee members and the public with the opportunity, in advance, to
schedule attendance at FDA's upcoming advisory committee meetings.
Because the schedule is tentative, amendments to this notice will not
be published in the Federal Register. However, changes to the schedule
will be posted on the FDA

advisory committees' Internet site located at http://www.fda.gov/oc/
advisory/default.htm. FDA will continue to publish a Federal Register
notice 15 days in advance of each upcoming advisory committee meeting,
to announce the meeting (21 CFR 14.20).
    The following list announces FDA's tentatively scheduled advisory
committee meetings for 2009. You may also obtain up-to-date information
by calling the Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC area).

------------------------------------------------------------------------
                                                     Advisory Committee
     Committee Name           Tentative Date of     10-Digit Information
                                 Meeting(s)               Line Code
------------------------------------------------------------------------
                       OFFICE OF THE COMMISSIONER
------------------------------------------------------------------------
Pediatric Advisory        March 23-24, June 22-23,<PHONE_NUMBER>
 Committee                 September 21-22,
                           December 7-8
------------------------------------------------------------------------
Risk Communication        February 26-27, April 30-<PHONE_NUMBER>
 Advisory Committee        May 1, August 13-14,
                           November 12-13
------------------------------------------------------------------------
Science Board to the      February 24, May 18,<PHONE_NUMBER>
 Food and Drug             August 17, November 16
 Administration
------------------------------------------------------------------------
              CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
------------------------------------------------------------------------
Allergenic Products       March 5, October 22<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Blood Products Advisory   January 9, April 1, July<PHONE_NUMBER>
 Committee                 20-21, November 16-17
------------------------------------------------------------------------
Cellular, Tissue and      May 14-15, November 5-6<PHONE_NUMBER>
 Gene Therapies Advisory
 Committee
------------------------------------------------------------------------
Transmissible Spongiform  To be announced<PHONE_NUMBER>
 Encephalopathies
 Advisory Committee
------------------------------------------------------------------------
Vaccines and Related      February 18-19, May 20-<PHONE_NUMBER>
 Biological Products       21, September 23-24,
 Advisory Committee        November 18-19
------------------------------------------------------------------------
                 CENTER FOR DRUG EVALUATION AND RESEARCH
------------------------------------------------------------------------
Anesthetic and Life       January 29-30, April<PHONE_NUMBER>
 Support Drugs Advisory    dates to be announced
 Committee
------------------------------------------------------------------------
Anti-Infective Drugs      To be announced<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Antiviral Drugs Advisory  To be announced<PHONE_NUMBER>
 Committee
------------------------------------------------------------------------
Arthritis Advisory        March 5, June 16-17,<PHONE_NUMBER>
 Committee                 October 27-28
------------------------------------------------------------------------
Cardiovascular and Renal  February 3, March 18-19,<PHONE_NUMBER>
 Drugs Advisory            July 28-29, December 7-
 Committee                 8
------------------------------------------------------------------------
Dermatologic and          To be announced<PHONE_NUMBER>
 Ophthalmic Drugs
 Advisory Committee
------------------------------------------------------------------------
Drug Safety and Risk      January 30, April dates<PHONE_NUMBER>
 Management Advisory       to be announced
 Committee
------------------------------------------------------------------------
Endocrinologic and        April 2-3<PHONE_NUMBER>
 Metabolic Drugs
 Advisory Committee
------------------------------------------------------------------------
Gastrointestinal Drugs    February 17<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Nonprescription Drugs     April dates to be<PHONE_NUMBER>
 Advisory Committee        announced
------------------------------------------------------------------------
Oncologic Drugs Advisory  February 25, March 24-<PHONE_NUMBER>
 Committee                 25, May dates to be
                           announced, July 14-15,
                           September 15-16,
                           December 16-17
------------------------------------------------------------------------
Peripheral and Central    January 7-8<PHONE_NUMBER>
 Nervous System Drugs
 Advisory Committee
------------------------------------------------------------------------
Pharmaceutical Science    March dates to be<PHONE_NUMBER>
 and Clinical              announced
 Pharmacology, Advisory
 Committee for
------------------------------------------------------------------------
Psychopharmacologic       March 26<PHONE_NUMBER>
 Drugs Advisory
 Committee
------------------------------------------------------------------------
Pulmonary-Allergy Drugs   February 4<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
Reproductive Health       May and August dates to<PHONE_NUMBER>
 Drugs, Advisory           be announced
 Committee for
------------------------------------------------------------------------
               CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
------------------------------------------------------------------------
Device Good               April 15, October 5-6<PHONE_NUMBER>
 Manufacturing Practice
 Advisory Committee
------------------------------------------------------------------------
Medical Devices Advisory Committee (Comprised of 18 Panels)
------------------------------------------------------------------------

Anesthesiology and        February 5, April 30,<PHONE_NUMBER>
 Respiratory Therapy       July 23, September 17,
 Devices Panel             November 12
------------------------------------------------------------------------
Circulatory System        February 25, May 27,<PHONE_NUMBER>
 Devices Panel             September 24
------------------------------------------------------------------------
Clinical Chemistry and    March 18-19, June 17-18,<PHONE_NUMBER>
 Clinical Toxicology       October 21-22
 Devices Panel
------------------------------------------------------------------------
Dental Products Panel     February 11, May 6, June<PHONE_NUMBER>
                           17, September 16,
                           December 9
------------------------------------------------------------------------
Ear, Nose, and Throat     February 24, May 19,<PHONE_NUMBER>
 Devices Panel             August 18, November 17
------------------------------------------------------------------------
Gastroenterology-Urology  March 20, October 15<PHONE_NUMBER>
 Devices Panel
------------------------------------------------------------------------
General and Plastic       February 26-27, June 9-<PHONE_NUMBER>
 Surgery Devices Panel     10, October 15-16
------------------------------------------------------------------------
General Hospital and      March 25-26, July 29-30,<PHONE_NUMBER>
 Personal Use Devices      October 21-22
 Panel
------------------------------------------------------------------------
Hematology and Pathology  April 24, July 17,<PHONE_NUMBER>
 Devices Panel             October 23
------------------------------------------------------------------------
Immunology Devices Panel  October 15-16<PHONE_NUMBER>
------------------------------------------------------------------------
Medical Devices Dispute   Meetings occur as needed<PHONE_NUMBER>
 Resolution Panel
------------------------------------------------------------------------
Microbiology Devices      February 24-25,<PHONE_NUMBER>
 Panel                     September 22-23,
                           October 27-28
------------------------------------------------------------------------
Molecular and Clinical    April 15, October 5-6<PHONE_NUMBER>
 Genetics Panel
------------------------------------------------------------------------
Neurological Devices      February 26-27, May 14-<PHONE_NUMBER>
 Panel                     15, September 17-18,
                           December 2-3
------------------------------------------------------------------------
Obstetrics and            February 5-6, May 14-15,<PHONE_NUMBER>
 Gynecology Devices        August 13-14, November
 Panel                     12-13
------------------------------------------------------------------------
Ophthalmic Devices Panel  February 12-13, May 14-<PHONE_NUMBER>
                           15, September 24-
                           25,November 19-20
------------------------------------------------------------------------
Orthopaedic and           February 3-4, April 14-<PHONE_NUMBER>
 Rehabilitation Devices    15, June 9-10, August
 Panel                     11-12, October 15-16,
                           December 1-2
------------------------------------------------------------------------
Radiological Devices      February 18, May 12,<PHONE_NUMBER>
 Panel                     August 4, November 17
------------------------------------------------------------------------
National Mammography      November 4-5<PHONE_NUMBER>
 Quality Assurance
 Advisory Committee
------------------------------------------------------------------------
Technical Electronic      No meeting tentatively<PHONE_NUMBER>
 Product Radiation         scheduled for 2009
 Safety Standards
 Committee
------------------------------------------------------------------------
              CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
------------------------------------------------------------------------
Food Advisory Committee   May 20-21<PHONE_NUMBER>
------------------------------------------------------------------------
                     CENTER FOR VETERINARY MEDICINE
------------------------------------------------------------------------
Veterinary Medicine       April 14<PHONE_NUMBER>
 Advisory Committee
------------------------------------------------------------------------
             NATIONAL CENTER FOR TOXILOGICAL RESEARCH (NCTR)
------------------------------------------------------------------------
Science Advisory Board    November 17-18<PHONE_NUMBER>
 to NCTR
------------------------------------------------------------------------

    Dated: December 24, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-451 Filed 1-12-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Rules and Regulations]
[Pages 65131-65132]
[FR Doc No: 2023-20460]

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

Coast Guard

33 CFR Part 100

[Docket No. USCG-2023-0666]

Special Local Regulations; Marine Events Within the Captain of
the Port of Charleston

AGENCY: Coast Guard, DHS.

ACTION: Notification of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a special local regulation for
the Swim around Charleston on September 24, 2023, to provide for the
safety of life on navigable waterways during this event. Our regulation
for marine events within the Captain of the Port Charleston identifies
the regulated area for this event in Charleston, SC. During the
enforcement periods, the operator of any vessel in the regulated area
must comply with directions from the Captain of the Port Charleston or
a designated representative.

DATES: The regulations in 33 CFR 100.704 will be enforced for the
location identified in Item 9 of Table 1 to Sec.  100.704, from 9 a.m.
through 4 p.m. on September 24, 2023.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notification of enforcement, call or email Petty Officer Adam
Krukowski, Sector Charleston, Waterways Management Division, U.S. Coast
Guard;<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations in 33 CFR 100.704, Table 1 to Sec.  100.704, Item 9, for
the Swim Around Charleston regulated area from 9 a.m. to 4 p.m. on
September 24, 2023. This action is being taken to provide for the
safety of life on navigable waterways during this event. Our regulation
for marine events within the Captain of the Port Charleston Sec.
100.704, specifies the location of the Swim Around Charleston as a
moving safety zone including all waters 50 yards in front of the lead
safety vessel preceding the first race participants, 50 yards behind
the safety vessel trailing the last race participants,

and at all times extends 100 yards on either side of safety vessels.
The Swim Around Charleston swimming race consists of a 12 mile course
that starts at Remley's Point on the Wando River in approximate
position 32[deg]48'49'' N, 79[deg]54'27'' W, crosses the main shipping
channel under the main span of the Ravenel Bridge, and finishes at the
I-526 bridge and boat landing on the Ashley River in approximate
position 32[deg]50'14'' N, 80[deg]01'23'' W. During the enforcement
periods, as reflected in Sec.  100.704(c)(1), if you are the operator
of a vessel in the regulated area you must comply with directions from
the Captain of the Port Charleston or a designated representative.
    In addition to this notification of enforcement in the Federal
Register, the Coast Guard plans to provide notification of this
enforcement period via the Local Notice to Mariners and marine
information broadcasts.

    Dated: September 12, 2023.
Francis. J. DelRosso,
Captain, U.S. Coast Guard, Captain of the Port.
[FR Doc. 2023-20460 Filed 9-20-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Page 4406]
[FR Doc No: 2013-01136]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meeting related to the transmission planning activities of the South
Carolina Regional Transmission Planning (SCRTP) group:

SCRTP Stakeholder Group

January 15, 2013

    The above-referenced meeting is open to stakeholders and will be
held at: SCE&G--Lake Murray Training Center, Lexington, SC.
    For additional information, see www.scrtp.com.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket No. ER13-107-000, South Carolina Electric & Gas Company
    For more information, contact Michael Lee, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: January 14, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-01136 Filed 1-18-13; 8:45 am]
BILLING CODE 6717-01-P


Reassessment of Commodity Tolerances that are

Insignificant Contributors to the N-methyl Carbamate Cumulative Risk

June 29, 2006

I. 	Background and Introduction

The Food Quality Protection Act (FQPA) of 1996 requires EPA to consider
available information concerning the cumulative effects on human health
resulting from exposure to multiple chemicals that have a common
mechanism of toxicity.  In 2001, EPA concluded that the N-methyl
carbamate (NMC) pesticides share a common mechanism of toxicity and
therefore require a cumulative assessment under FQPA.  The ten
pesticides in the NMC common mechanism group are aldicarb, carbaryl,
carbofuran, formetanate hydrochloride, methiocarb, methomyl, oxamyl,
pirimicarb, propoxur, and thiodicarb.  The Agency’s tolerance
reassessment decisions for these ten NMC pesticides must be based on the
interim tolerance reassessment decisions for each individual compound,
as well as the NMC cumulative assessment.  EPA released the Preliminary
Assessment of Cumulative Risk from N-Methyl Carbamate Pesticides in
August 2005.

As part of its ongoing work to complete the NMC cumulative assessment,
EPA has determined that 144 of the NMC tolerances are insignificant
contributors to the overall dietary exposure to the NMCs.  These
commodity/chemical combinations, when considered together, make such a
minor or negligible contribution to the cumulative risk of the NMCs that
the addition or subtraction of those uses from the risk cup would have
no quantified significance and would therefore have no impact on whether
the NMCs as a group meet the FQPA safety standard in section 408(b)(2)
of the Federal Food, Drug and Cosmetic Act (FFDCA).  Because these uses,
by themselves, add no meaningful risk, and because, as a result, they
will have no effect on the retention or revocation of other NMC
tolerances, EPA intends to count these negligible uses as reassessed
before the final NMC cumulative assessment is issued.  As described in
detail below, the Agency has taken a conservative, health-protective
approach in determining the criteria for this analysis and is thus
confident that these tolerances can be considered to be reassessed as
required under section 408(q).

	For each of the 144 tolerances being reassessed at this time, the
Agency has issued an Interim Reregistration Eligibility Decision (IRED)
which found that, apart from consideration of the potential cumulative
risks from all of the NMCs, each tolerance would meet the section
408(b)(2) safety standard.  EPA has also considered the impact of these
tolerances on the NMC cumulative risks and has determined that they make
an insignificant contribution to the overall risks from the NMCs.
Therefore, these tolerances will be maintained regardless of the outcome
of the NMC cumulative assessment and any potential regulatory action
taken as a result of that assessment.  Accordingly, EPA believes it is
appropriate to consider these 144 tolerances reassessed for the purposes
of FQPA section 408(q) as of today’s date, June 29, 2006.

NMC Tolerances Requiring Reassessment under FQPA

FQPA required EPA to reassess all tolerances in existence when FQPA
became law on August 3, 1996.  For the ten pesticides in the NMC common
mechanism group, there were a total of 320 tolerances that required
reassessment because they were in existence on the day that FQPA was
enacted.

To date, ninety-two of the 320 NMC tolerances requiring reassessment
under FQPA have already been reassessed.  The ninety-two tolerances
include seven methiocarb tolerances, eighty methomyl tolerances, and
five thiodicarb tolerances.  The methiocarb tolerances are considered
reassessed because all methiocarb tolerances were revoked in 1998.  The
methomyl and thiodicarb tolerances are considered reassessed because EPA
issued REDs and associated tolerance reassessment decisions for methomyl
and thiodicarb in 1998, prior to the Agency’s determination that these
compounds would be part of the NMC common mechanism group.  Please see
Table A.6 in the Appendix for a listing of the reassessed tolerances for
methiocarb, methomyl, and thiodicarb.

Determination of Insignificant Contributors

This section describes the procedures EPA followed to determine the
number of NMC tolerances that could be reassessed based on an
insignificant contribution to the total NMC risk in food.  These NMC
tolerances, termed Insignificant Contributors, are the subset of NMC
crop/chemical combinations that, when expressed in terms of
index-chemical equivalents and considered together as part of a
cumulative risk assessment, contribute to only a small fraction of the
NMC cumulative risk from food.  Such a designation to specific
crop/chemical combinations permits the Agency to conclude that the
contribution to dietary risk of the NMC tolerances associated with these
crop/chemical combinations is relatively small and that these tolerances
can thus be reassessed prior to EPA’s issuance of the revised NMC
cumulative risk assessment.  Only tolerances for NMCs with completed
IREDs were eligible for designation as Insignificant Contributors.

The Agency notes that this is a screening-level assessment designed to
ensure that risk will not be underestimated.  EPA fully expects that
additional NMC tolerances will be eligible for reassessment in the near
future when the Agency issues the revised NMC cumulative assessment,
which will use more refined information.

Hazard/Relative Potency Factors

In the current analysis, EPA used the relative potency factors (RPFs)
and points of departure established in the preliminary cumulative risk
assessment (August 2005) for brain cholinesterase inhibition.  For
details about the data and methods used to derive these values, please
refer to Chapter I.B and associated appendices and data sets in the
preliminary cumulative risk assessment (August 2005) (available at
HYPERLINK "http://www.epa.gov/pesticides/cumulative"
http://www.epa.gov/pesticides/cumulative ).  The Agency used benchmark
dose (BMD) methods to estimate the dose expected to result in 10% brain
cholinesterase inhibition (BMD10) in adult rats following acute
exposures.  EPA calculated RPFs by dividing BMDs for specific pesticides
by the BMD for the index chemical, oxamyl.

The Agency anticipates that most of the RPFs and points of departure
used in this Insignificant Contributors analysis (and also in the August
2005 preliminary NMC cumulative assessment) will be substantially
similar to those that will be used in the forthcoming revised NMC
cumulative assessment.  If some values do differ, it will be because the
revised cumulative assessment uses values that have been further refined
based on recently-submitted data.

Dietary Exposure

EPA began the process of identifying Insignificant Contributors by
performing a baseline dietary exposure analysis.  The baseline
assessment for the Insignificant Contributors analysis used the same
residue and consumption data from the August 2005 preliminary NMC
cumulative risk assessment (except that 2004 PDP data were also
included), and it also included similar assumptions about processing
factors, zero residues, and crop translations.

EPA used pesticide residues reported in PDP from 1994-2004 (registered
or not) from all ten NMC pesticides for this Insignificant Contributors
analysis.  The PDP residue data were further extended (translated) to
other commodities identified as reasonable for translation of pesticide
residue data per Agency policy.  Residues from fish and eggs were not
included in this assessment and, based on examination of FDA monitoring
results, are not anticipated to contribute significantly to risk
associated with the NMC pesticides.  However, recent PDP data on beef,
pork, and poultry were included in the assessment.  Together, the food
commodities in the PDP program and those commodities to which the
residues are translated account for greater than 90%-95% of children’s
diets.  Exposure for children 1-2 years of age was earlier identified as
of specific interest since this was the subgroup with the highest
exposure in the preliminary NMC cumulative risk assessment.  Dietary
(food only) exposure was estimated using the Dietary Exposure Evaluation
Model (DEEMTM) software which incorporates the 1994-96/1998 USDA
continuing Surveys for Food Intake by Individuals (CSFII) data and
EPA’s Revised Food Commodity Intake Database (Revised FCID).  For more
information, please refer to Chapter I.C and the associated appendices
and datasets in the preliminary NMC cumulative risk assessment.

As described in more detail in the preliminary NMC cumulative
assessment, EPA adjusted the amount of residue of each chemical by
multiplying by an RPF to obtain the equivalent residue of an index
chemical and summed these within each sample.  The new calculated
residue is termed the Index Equivalent Residue (ResidueIE) and the
exposure value resulting from combining ResidueIE and consumption is
termed the Index Equivalent Exposure (ExposureIE).  EPA calculated
Margins of Exposure (MOEs) by comparing the potency adjusted exposure to
the point of departure for the index chemical (ie, oxamyl).

Figure 1 below provides a graphical description of the major
contributors to the baseline cumulative dietary risk when all 10 NMCs
are included.

Figure 1.  Plot of major contributors to the NMC cumulative risk from
food

Criteria for Designation as an Insignificant Contributor

EPA established several criteria for designating crop/chemical
combinations as Insignificant Contributors.

Crop/chemical combinations that produce an MOE greater than 1000 when
considered together are Insignificant Contributor tolerances.

The Agency selected 1000 as a highly-conservative point of comparison,
incorporating a 10x for interspecies extrapolation, a 10x for
intraspecies extrapolation, and a 10x FQPA safety factor for protection
of infants and children.  The assignment of a value of 10x for the
interspecies extrapolation factor is conservative given that human
studies are available to inform the chemical-specific interspecies
factor for some NMCs.   The assignment of a value of 10x for the FQPA
safety factor is also conservative given that there are studies
available for some NMCs which compare the relative sensitivity in
juvenile and adult rats, and which will be used to inform the
chemical-specific FQPA factors.

Only tolerances for chemicals with completed IREDs are eligible for
designation as Insignificant Contributors.

Any pesticide/crop combination with NO detects in all years of PDP
monitoring was considered an Insignificant Contributor.

Meat, Milk, Poultry and Egg tolerances for which exposure is deemed
negligible were considered Insignificant Contributors.

Livestock feedstuffs associated with the meat, milk, poultry, and egg
samples with few, small, or no detectable residues were considered
Insignificant Contributors.

Procedure for Identifying the Insignificant Contributors

As described in section II of this document, there were a total of 320
NMC tolerances that required reassessment because they were in existence
on the day that FQPA become law.  Ninety-two of the NMC tolerances have
already been reassessed (7 methiocarb tolerances, 80 methomyl
tolerances, and 5 thiodicarb tolerances).  So, EPA used 228 tolerances
as the starting point for the ‘Insignificant Contributors’ analysis.

EPA notes, however, that some methomyl uses appear to be contributors to
the cumulative food exposure assessment.  Thus, the
previously-reassessed methomyl tolerances were reintroduced into the
analysis and methomyl is included in the cumulative dietary risk
analysis described below.  Methomyl does in fact contribute to the MOEs
provided in Table 1, and the tolerance count is given in two different
ways in Table 1, to reflect the status of the methomyl tolerances.

EPA has developed the list of Insignificant Contributor tolerances using
the stepwise approach described below.

EPA performed a baseline cumulative dietary analysis using all 10 NMCs.

EPA removed all tolerances for aldicarb and carbofuran.  The IREDs for
these two NMCs have not yet been completed as of June 29, 2006, and
therefore these tolerances are ineligible for Insignificant Contributor
designation.

EPA performed a cumulative dietary analysis of the remaining potential
Insignificant Contributor crop/chemical combinations.  The results are
displayed in Figure 2.  The plot provides a rank order of the
chemical-commodity combinations that contribute to the NMC cumulative
food exposure assessment.

EPA removed from the analysis, in groups of several tolerances, the
crop/chemical combinations which made the highest contribution to the
cumulative risk.  The DEEM-estimated MOEs that resulted from the
sequential removal of each group of tolerances are provided in Table 1.
The “removed” crop/chemical combinations in column 1 of Table 1 are
not deemed Insignificant Contributors at this time because they
potentially contribute to NMC cumulative risk (i.e., they are
responsible, jointly, for MOEs less than 1000).

EPA repeated the removal process described in step 4 until the MOEs at
the 99.9th percentile of exposure exceeded 1000 for children age 1-2,
the population subgroup determined to have the lowest MOEs.  EPA’s
analysis of risk to this population subgroup is therefore protective of
all other population subgroups groups.

All remaining crop/chemical combinations are considered Insignificant
Contributors since, when considered together, they contribute only minor
amounts to risk, with MOEs of greater than 1000.

Figure 2.  Plot of major contributors to the NMC cumulative risk from
food, excluding aldicarb and carbofuran

Results of the Insignificant Contributors Analysis

Table 1 presents a summary of the results of the Insignificant
Contributors analysis.  The table shows, sequentially, the crop/chemical
combinations that were removed at each step in the process.  The table
also provides the number of tolerances removed that were associated with
the these crop/chemical combinations, the number of tolerances that
remain, the associated MOE, as well as a reference run identification
number for the DEEM computer files used to produce these exposure
estimates (the DEEM files are provided on the NMC cumulative web page at
www.epa.gov/pesticides/cumulative).   Table 1.  Summary of
Insignificant Contributors analysis conducted with DEEM

Scenario*	Number of Crop/Chemical Combinations Removed	Number of
Tolerances	MOE	Ref.

Run ID

NMC tolerances (excluding those previously assessed)	All NMC

tolerances

Baseline (all NMCs)

	0	228	320	31	1

Remove all aldicarb and carbofuran crop/chemical combinations 	62	166
258	49	2

Remove 12 crop/chemical combinations – methomyl on strawberry,
cucurbits, and grape; carbaryl on strawberry, pome fruit, plum, and
peach; formetanate hydrochloride on nectarine, plum (no tolerance), and
peach; and oxamyl on summer squash and cucumber.	12	158	247	154	3

Remove 7 crop/chemical combinations – carbaryl on grape; formetanate
hydrochloride on apple; methomyl on spinach, lettuce, cabbage, and
peach; oxamyl on apple	7	155	240	348	4

Remove 6 crop/chemical combinations – formetanate hydrochloride on
pear; carbaryl on apricot and beans; and oxamyl on celery and
watermelon; methomyl on plum (no tolerance)	6	150	235

519	5

Remove 6 crop/chemical combinations – formetanate hydrochloride on
apricot (no tolerance); carbaryl on citrus fruit and peppers;  oxamyl on
bell pepper; methomyl on apple and succulent beans	6	147	230	783	6

Remove 5 crop/chemical combinations – carbaryl on nectarine and
cherry;  oxamyl on pear; methomyl on orange and tomato	5	144	225	1224	7

* Italicized crop/chemical combinations are ones for which there are no
tolerances, or for which tolerances were previously reassessed (i.e.,
methomyl).

A total of 144 of the 228 NMC tolerances that remain to be reassessed
meet EPA’s criteria for designation as Insignificant Contributors due
to no exposure or low exposure.  A total of 84 tolerances do not meet
the Agency’s criteria for designation as Insignificant Contributors,
either because they are aldicarb or carbofuran tolerances, or because
their inclusion in the analysis results in MOEs of less than 1000.
Please see Table 2, below, for a summary of the tolerance breakdown.  (A
listing of the 144 tolerances being reassessed at this time appears in
Table A.1.  A listing of the 84 tolerances not meeting the Insignificant
Contributors criteria appears in Tables A.4 and A.5.)  EPA may require
mitigation for some of the uses associated with the 84 tolerances not
meeting the Insignificant Contributors criteria, in connection with its
completion of the outstanding IREDS and release of the revised NMC
cumulative risk assessment.

Sixty-nine of the 80 previously-reassessed methomyl tolerances meet
EPA’s criteria for designation as ‘Insignificant Contributors’ due
to no exposure or low exposure.  (A listing of these 69 tolerances
appears in Table A.2.)  However, eleven methomyl tolerances do not meet
the ‘Insignificant Contributors’ criteria because the Agency needed
to remove them from the analysis in order to reach MOEs of greater than
1000.  (A listing of these 11 tolerances appears in Table A.3.)
Notwithstanding the fact that the methomyl tolerances were reassessed in
connection with the 1998 methomyl RED, the Agency may require additional
mitigation for some of the methomyl uses associated with the eleven
methomyl tolerances that do not meet the ‘Insignificant
Contributors’ criteria.  The Agency will make its decision about the
necessity of mitigation in conjunction with its completion of the final
NMC cumulative risk assessment.

The Agency notes that this is a screening-level assessment designed to
ensure that risk is not underestimated.  By selecting a
point-of-comparison value of 1000, the Agency has produced a
conservative assessment that assumes that the interspecies,
intraspecies, and FQPA factors will be assigned values of 10.  These
values are conservative because the Agency anticipates that the
interspecies and/or FQPA safety factors for some of the NMCs will be
assigned lower values in the revised NMC cumulative assessment, based on
recently-submitted data.

Following the completion of the revised NMC cumulative risk assessment,
more tolerances are expected to be eligible for reassessment.  However,
for purposes of this screening-level analysis, the Agency has elected to
assign maximum safety factor values to ensure that risk is not
underestimated.

Table 2.  Summary of tolerances designated as ‘Insignificant
Contributors’ compared with tolerances excluded from the assessment

Insignificant Contributors 	Tolerances Excluded from the Assessment

        144 tolerances

11 tolerances:  Crop/chemical combinations with NO detects in all years
of PDP monitoring [listed in Table A.1 as “ND”]

27 tolerances:  Meat, milk, poultry and egg  tolerances for which
exposure is deemed negligible [listed in Table A.1 as “M”]

32 tolerances:  Livestock feed stuffs associated with the meat, milk,
poultry, and egg samples for which few, small, or no detectable residues
were found [listed in Table A.1 as “FS”]

74 tolerances: Low contributorsa to cumulative risk (i.e., MOEs of
greater than 1000 when considered together ) [listed in Table A.1 as
“LC”]

84 Tolerances

62 tolerances not eligible (aldicarb and carbofuran)

52 low contributorsa

10 high contributors

62 TOTAL

23 aldicarb

39 carbofuran

62 TOTAL

[Listed  in Table A.5]

22 tolerances not eligible (high contributors)

11 carbaryl

4 formetanate HCl

7 oxamyl

22 TOTAL

[Listed in  Table A.4]

a Low contributors are those tolerances that produce MOEs of >1000 when
the high contributors are not included in the analysis.

Conclusions

	EPA has concluded that the 144 tolerances identified in this document
as Insignificant Contributors to the NMC cumulative risk meet the safety
standard of section 408(b)(2) of the FFDCA, and may therefore be
considered reassessed, pursuant to section 408(q) as of today’s date,
June 29, 2006.

	As a result of this decision, there are 84 NMC tolerances that remain
to be reassessed.  These remaining 84 tolerances will be reassessed when
EPA completes the IREDs for aldicarb and carbofuran and issues the final
NMC cumulative risk assessment.

APPENDIX

Table A.1 Insignificant Contributor Tolerances due to no exposure or low
exposure

Pesticide Name	Commodity Name	Reason For Insignificant Contributor
Status1

Carbaryl	Alfalfa	FS

Carbaryl	Alfalfa, Hay	FS

Carbaryl	Almonds	LC

Carbaryl	Almonds, Hulls	FS

Carbaryl	Asparagus	LC

Carbaryl	Bananas	ND

Carbaryl	Beets, Garden, Roots	LC

Carbaryl	Beets, Garden, Tops	FS

Carbaryl	Beets, Sugar	LC

Carbaryl	Blackberries	LC

Carbaryl	Blueberries	LC

Carbaryl	Boysenberries	LC

Carbaryl	Broccoli	LC

Carbaryl	Brussels Sprouts	LC

Carbaryl	Cabbage	LC

Carbaryl	Cabbage, Chinese	LC

Carbaryl	Carrots	LC

Carbaryl	Cattle, Fat	M

Carbaryl	Cattle, Kidney	M

Carbaryl	Cattle, Liver	M

Carbaryl	Cattle, Meat By Products (excluding kidney & liver)	M

Carbaryl	Cattle, Meat	M

Carbaryl	Cauliflower	ND

Carbaryl	Celery	LC

Carbaryl	Chestnuts	LC

Carbaryl	Clover	FS

Carbaryl	Clover, Hay	FS

Carbaryl	Collards	LC

Carbaryl	Corn (including sweet) (kernel + cobs w/ husks removed)	ND

Carbaryl	Corn, Fodder	FS

Carbaryl	Corn, Forage	FS

Carbaryl	Cotton, Seed	FS

Carbaryl	Cranberries	LC

Carbaryl	Cucumbers	LC

Carbaryl	Dandelions	LC

Carbaryl	Dewberries	LC

Carbaryl	Dill	LC

Carbaryl	Eggplant	LC

Carbaryl	Endive (Escarole)	LC

Carbaryl	Filberts (Hazelnuts)	LC

Carbaryl	Flax, Seed	LC

Carbaryl	Goats, Fat	M

Carbaryl	Goats, Kidney	M

Carbaryl	Goats, Liver	M

Carbaryl	Goats, Meat By Products (excluding kidney & liver)	M

Carbaryl	Goats, Meat	M

Carbaryl	Grasses	FS

Carbaryl	Grasses, Hay	FS

Carbaryl	Hogs, Fat	M

Carbaryl	Hogs, Kidney	M

Carbaryl	Hogs, Liver	M

Carbaryl	Hogs, Meat By Products	M

Carbaryl	Hogs, Meat	M

Carbaryl	Horseradish	LC

Carbaryl	Horses, Fat	M

Carbaryl	Horses, Kidney	M

Carbaryl	Horses, Liver	M

Carbaryl	Horses, Meat By Products (excluding kidney & liver)	M

Carbaryl	Horses, Meat	M

Carbaryl	Kale	LC

Carbaryl	Kohlrabi	LC

Carbaryl	Lentils	ND

Carbaryl	Lettuce	LC

Carbaryl	Loganberries	LC

Carbary	Melons	LC

Carbaryl	Milk	M

Carbaryl	Millet, Proso, Grain	FS

Carbaryl	Millet, Proso, Straw	FS

Carbaryl	Mustard, Greens	LC

Carbaryl	Okra	LC

Carbaryl	Olives	LC

Carbaryl	Oysters	M

Carbaryl	Parsley	LC

Carbaryl	Parsnips	LC

Carbaryl	Peanuts	LC

Carbaryl	Peanuts, Hay	FS

Carbaryl	Peas, Cowpeas	LC

Carbaryl	Peas, Cowpeas, Forage	FS

Carbaryl	Peas, Cowpeas, Hay	FS

Carbaryl	Peas, Vines	FS

Carbaryl	Peas, with Pods	LC

Carbaryl	Pecans	LC

Carbaryl	Pineapples	LC

Carbaryl	Pistachios	LC

Carbaryl	Potatoes	ND

Carbaryl	Prickly Pear Cactus, Fruit	LC

Carbaryl	Prickly Pear Cactus, Pads	LC

Carbaryl	Pumpkins	LC

Carbaryl	Radishes	LC

Carbaryl	Raspberries	LC

Carbaryl	Rice	LC

Carbaryl	Rice, Straw	FS

Carbaryl	Rutabagas	LC

Carbaryl	Salsify, Roots	LC

Carbaryl	Salsify, Tops	LC

Carbaryl	Sheep, Fat	M

Carbaryl	Sheep, Kidney	M

Carbaryl	Sheep, Liver	M

Carbaryl	Sheep, Meat By Products (kidney & liver)	M

Carbaryl	Sheep, Meat	M

Carbaryl	Sorghum, Forage	FS

Carbaryl	Sorghum, Grain	FS

Carbaryl	Soybeans	ND

Carbaryl	Soybeans, Forage	FS

Carbaryl	Soybeans, Hay	FS

Carbaryl	Spinach	LC

Carbaryl	Squash, Summer	LC

Carbaryl	Squash, Winter	LC

Carbaryl	Sunflower, Seeds	LC

Carbaryl	Sweet Potatoes	LC

Carbaryl	Swiss Chard	LC

Carbaryl	Tomatoes	LC

Carbaryl	Trefoil, Birdsfoot, Forage	FS

Carbaryl	Trefoil, Birdsfoot, Hay	FS

Carbaryl	Turnips, Roots	LC

Carbaryl	Turnips, Tops	FS

Carbaryl	Walnuts	LC

Carbaryl	Wheat, Fodder, Green	FS

Carbaryl	Wheat, Grain	FS

Carbaryl	Wheat, Straw	FS

Formetanate HCl	Grapefruit	LC

Formetanate HCl	Lemons	LC

Formetanate HCl	Limes	LC

Formetanate HCl	Oranges	LC

Formetanate HCl	Tangerines	LC

Oxamyl	Bananas	ND

Oxamyl	Cantaloupes	LC

Oxamyl	Citrus Fruits	LC

Oxamyl	Cotton, Seed	LC

Oxamyl	Eggplant	LC

Oxamyl	Honeydew	LC

Oxamyl	Peanuts	LC

Oxamyl	Peanuts, Hay	FS

Oxamyl	Peppermint, Hay	FS

Oxamyl	Peppers, Non-Bell	LC

Oxamyl	Pineapples	ND

Oxamyl	Pineapples, Bran	FS

Oxamyl	Potatoes	ND

Oxamyl	Pumpkins	LC

Oxamyl	Soybeans	ND

Oxamyl	Spearmint, Hay	FS

Oxamyl	Squash, Winter	LC

Oxamyl	Tomatoes	LC

Oxamyl	Vegetables, Root Crop	ND

1 FS = Feed Stuff; LC = Low Contribution; M = Meat, Milk, Poultry, Eggs;
ND = No detects in PDP.

Table A.2  Previously reassessed methomyl tolerances which are
‘Insignificant Contributors’ due to no exposure or low exposure

Pesticide Name	Commodity Name

Methomyl	Alfalfa

Methomyl	Asparagus

Methomyl	Avocados

Methomyl	Barley, grain

Methomyl	Barley, hay

Methomyl	Barley, straw

Methomyl	Beans, dry

Methomyl	Beets, Tops

Methomyl	Blueberries

Methomyl	Broccoli

Methomyl	Brussels Sprouts

Methomyl	Cabbage, Chinese

Methomyl	Cauliflower

Methomyl	Celery

Methomyl	Collards

Methomyl	Corn, Fodder

Methomyl	Corn, Forage

Methomyl	Corn, fresh (inc sweet, kernel plus cob with husks removed)

Methomyl	Corn, grain (inc pop)

Methomyl	Cotton, seed

Methomyl	Dandelions

Methomyl	Endive (Escarole)

Methomyl	Grapefruit

Methomyl	Grasses, Bermuda

Methomyl	Grasses, Bermuda, hay (dry, dehydrated)

Methomyl	Kale

Methomyl	Leeks

Methomyl	Lemons

Methomyl	Lentils

Methomyl	Mint, hay

Methomyl	Mustard, greens

Methomyl	Nectarines

Methomyl	Oats, forage

Methomyl	Oats, grain

Methomyl	Oats, hay

Methomyl	Oats, straw

Methomyl	Onions, green

Methomyl	Parsley

Methomyl	Peanuts

Methomyl	Pears

Methomyl	Peas

Methomyl	Peas, vines

Methomyl	Pecans

Methomyl	Peppers

Methomyl	Pomegranates

Methomyl	Rye, forage

Methomyl	Rye, grain

Methomyl	Rye, straw

Methomyl	Sorghum, forage

Methomyl	Sorghum, grain

Methomyl	Soybeans

Methomyl	Soybeans, forage

Methomyl	Swiss chard

Methomyl	Tangerines

Methomyl	Turnips, greens, tops

Methomyl	Vegetables, brassica, leafy, group 5

Methomyl	Vegetables, fruiting

Methomyl	Vegetables, leafy

Methomyl	Wheat, forage

Methomyl	Wheat, grain

Methomyl	Wheat, hay

Methomyl	Wheat, straw

Table A.3  Previously reassessed methomyl tolerances which are not
‘Insignificant Contributors’ due to high contribution to exposure

Pesticide Name	Commodity Name

Methomyl	Apple

Methomyl	Beans, succulent

Methomyl	Cabbage

Methomyl	Cucurbits

Methomyl	Grapes

Methomyl	Lettuce

Methomyl	Oranges

Methomyl	Peaches

Methomyl	Spinach

Methomyl	Strawberries

Methomyl	Tomatoes

Table A.4   Tolerances which require reassessment that are not
‘Insignificant Contributors’ due to high contribution to exposure

Pesticide Name	Commodity Name

Carbaryl	Apricots

Carbaryl	Beans

Carbaryl	Cherries

Carbaryl	Citrus Fruits

Carbaryl	Fruits, Pome

Carbaryl	Grapes

Carbaryl	Nectarines

Carbaryl	Peaches

Carbaryl	Peppers

Carbaryl	Plums (fresh prunes)

Carbaryl	Strawberries

Formetanate HCl	Apples

Formetanate HCl	Nectarines

Formetanate HCl	Peaches

Formetanate HCl	Pears

Oxamyl	Apples

Oxamyl	Celery

Oxamyl	Cucumbers

Oxamyl	Pears

Oxamyl	Peppers, Bell

Oxamyl	Squash, Summer

Oxamyl	Watermelons

Table A.5   Tolerances which require reassessment that are not
‘Insignificant Contributors’ because the associated IREDs have not
been completed

Pesticide Name	High Contributor versus

Low Contributor	Commodity Name

Aldicarb	High	Grapefruit

Aldicarb	High	Oranges

Aldicarb	High	Potatoes

Aldicarb	High	Sweet Potatoes

Aldicarb	Low	Beans, Dry

Aldicarb	Low	Beets, Sugar

Aldicarb	Low	Beets, Sugar, Tops

Aldicarb	Low	Citrus, Dried Pulp

Aldicarb	Low	Coffee Beans

Aldicarb	Low	Cotton, Seed

Aldicarb	Low	Cotton, Seed, Hulls

Aldicarb	Low	Lemons

Aldicarb	Low	Limes

Aldicarb	Low	Peanuts

Aldicarb	Low	Pecans

Aldicarb	Low	Sorghum, Grain

Aldicarb	Low	Sorghum, Bran

Aldicarb	Low	Sorghum, Bran

Aldicarb	Low	Sorghum, Grain, Fodder

Aldicarb	Low	Soybeans

Aldicarb	Low	Sugarcane

Aldicarb	Low	Sugarcane, Fodder

Aldicarb	Low	Sugarcane, Forage

Carbofuran	High	Cucumbers

Carbofuran	High	Grapes

Carbofuran	High	Melons

Carbofuran	High	Potatoes

Carbofuran	High	Raisins

Carbofuran	High	Squash

Carbofuran	Low	Alfalfa, Fresh

Carbofuran	Low	Alfalfa, Hay

Carbofuran	Low	Artichokes

Carbofuran	Low	Bananas

Carbofuran	Low	Barley, Grain

Carbofuran	Low	Barley, Straw

Carbofuran	Low	Beets, Sugar

Carbofuran	Low	Beets, Sugar, Tops

Carbofuran	Low	Coffee Beans

Carbofuran	Low	Corn, Fodder

Carbofuran	Low	Corn, Forage

Carbofuran	Low	Corn, Fresh (inc. sweet) (kernel + cob w/ husks removed)

Carbofuran	Low	Corn, Grain (including popcorn)

Carbofuran	Low	Cotton, Seed

Carbofuran	Low	Cranberries

Carbofuran	Low	Milk

Carbofuran	Low	Oats, Grain

Carbofuran	Low	Oats, Straw

Carbofuran	Low	Peppers

Carbofuran	Low	Pumpkins

Carbofuran	Low	Rice

Carbofuran	Low	Rice, Straw

Carbofuran	Low	Sorghum, Fodder

Carbofuran	Low	Sorghum, Forage

Carbofuran	Low	Sorghum, Grain

Carbofuran	Low	Soybeans

Carbofuran	Low	Soybeans, Forage

Carbofuran	Low	Soybeans, Hay

Carbofuran	Low	Strawberries

Carbofuran	Low	Sugarcane

Carbofuran	Low	Sunflower, Seeds

Carbofuran	Low	Wheat, Grain

Carbofuran	Low	Wheat, Straw

Table A.6 Tolerances that have already been reassessed

Pesticide Name	Commodity Name

Methiocarb	Citrus Fruits

Methiocarb	Corn, field, grains

Methiocarb	Corn, fodder

Methiocarb	Corn, forage

Methiocarb	Corn (including sweet) (kernel + cobs w/ husks removed)

Methiocarb	Corn, grain (including popcorn)

Methiocarb	Peaches

Methomyl	Alfalfa

Methomyl	Apples

Methomyl	Asparagus

Methomyl	Avocados

Methomyl	Barley, grain

Methomyl	Barley, hay

Methomyl	Barley, straw

Methomyl	Beans, dry

Methomyl	Beans, succulent

Methomyl	Beets, tops

Methomyl	Blueberries

Methomyl	Brassica (Cole) Leafy Vegetables

Methomyl	Broccoli

Methomyl	Brussels sprouts

Methomyl	Cabbage

Methomyl	Cabbage, Chinese

Methomyl	Cauliflower

Methomyl	Celery

Methomyl	Collards

Methomyl	Corn, fodder

Methomyl	Corn, forage

Methomyl	Corn (including sweet) (kernel + cobs w/ husks removed)

Methomyl	Corn, Grain (including popcorn)

Methomyl	Cotton, seed

Methomyl	Cucurbits

Methomyl	Dandelions

Methomyl	Endive (escarole)

Methomyl	Grapefruit

Methomyl	Grapes

Methomyl	Grasses, bermuda

Methomyl	Grasses, bermuda, hay (dry, dehydrated)

Methomyl	Kale

Methomyl	Leeks

Methomyl	Lemons

Methomyl	Lentils

Methomyl	Lettuce

Methomyl	Mint, hay

Methomyl	Mustard, greens

Methomyl	Nectarines

Methomyl	Oats, forage

Methomyl	Oats, grain

Methomyl	Oats, hay

Methomyl	Oats, straw

Methomyl	Onions, green

Methomyl	Oranges

Methomyl	Parsley

Methomyl	Peaches

Methomyl	Peanuts

Methomyl	Pears

Methomyl	Peas

Methomyl	Peas, vines

Methomyl	Pecans

Methomyl	Peppers

Methomyl	Pomegranates

Methomyl	Rye, forage

Methomyl	Rye, grain

Methomyl	Rye, straw

Methomyl	Sorghum, forage

Methomyl	Sorghum, grain

Methomyl	Soybeans

Methomyl	Soybeans, forage

Methomyl	Spinach

Methomyl	Strawberries

Methomyl	Swiss Chard

Methomyl	Tangerines

Methomyl	Tomatoes

Methomyl	Turnips, greens, tops

Methomyl	Vegetables, fruiting

Methomyl	Vegetables, leafy

Methomyl	Wheat, forage

Methomyl	Wheat, grain

Methomyl	Wheat, hay

Methomyl	Wheat,straw

Methomyl	Barley, Forage

Methomyl	Beans, Forage

Methomyl	Hops, Dried

Methomyl	Peanuts, Hulls

Methomyl	Rye, Hay

Methomyl	Vegetables, Root Crop

Methomyl	Watercress

Thiodicarb	Corn (including sweet) (kernel + cobs w/ husks removed)

Thiodicarb	Cotton, seed

Thiodicarb	Soybeans

Thiodicarb	Soybeans, hulls

Thiodicarb	Cotton, seed, hulls

 63 Federal Register 57067, October 26, 1998.

  In some cases, a crop/pesticide combination is really a crop
group/pesticide combination if the tolerance is applicable to a crop
group.  For example, if a tolerance were established for a given
pesticide on citrus fruits, this would be considered a single crop
(group)/pesticide combination despite the fact that the tolerance
applies to all crops in that crop group (e.g., oranges, grapefruits,
lemons, limes, etc.)

 The key differences between the food files used in the August 2005
preliminary NMC cumulative risk assessment and those used in the
Insignificant Contributors analysis are: (1) PDP residues were updated
to include the most recent PDP data (through 2004) including additional
data on methomyl on strawberries; (2) processing factors were updated to
account for new food forms that appeared in the new PDP data; and (3)
aldicarb data on potatoes was modified by deleting the pre-1996 aldicarb
data on potatoes.  The deletion of pre-1996 aldicarb data is appropriate
because the use of aldicarb on potatoes was voluntarily suspended in
1990.  The use was reinstated in 1995.  Accordingly, PDP data beginning
in 1996 is most appropriate to reflect current aldicarb use on potatoes.

 OPP/HED SOP 99.3.  Memorandum from Margaret Stasikowski, Health Effects
Division to Staff.  “Translation of Monitoring Data.” HED Standard
Operating Procedure 99.3 (3/26/99), USEPA.

 Three NMCs are not included in the legend – propoxur, thiodicarb, and
pirimicarb.  These pesticides were either not detected in the PDP data
or were detected at such low concentrations and frequencies that they
are not sufficient contributors to appear on the graph.

  Human studies for aldicarb, methomyl, and oxamyl were reviewed by the
Human Studies Review Board (HSRB) in April, 2006 and determined to be
appropriate for use in the NMC Cumulative Risk Assessment.  At the May,
2006 meeting of the HSRB, the board did not support the use of the
carbofuran oral human study for informing the inter-species factor.

  Comparative cholinesterase studies in adult and juvenile rats are
available for carbofuran, formetanate HCl, methomyl, and oxamyl which
evaluate peak and time course brain ChE inhibition.  A dose-response
study with adult and juvenile rats exposed at peak time of effect is
available for aldicarb.

 PAGE

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[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Proposed Rules]
[Pages 8367-8368]
[FR Doc No: 2014-03045]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0932; Airspace Docket No. 13-ASO-24]

Proposed Establishment of Class E Airspace; Nashville, TN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E Airspace at
Nashville, TN, to accommodate a new Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedure (SIAP)
serving Nashville International Airport. This action would enhance the
safety and airspace management of Instrument Flight Rules (IFR)
operations within the National Airspace System.

DATES: Comments must be received on or before March 31, 2014.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey SE., Washington, DC 20590-0001; Telephone: 1-
800-647-5527; Fax:<PHONE_NUMBER>. You must identify the Docket Number
FAA-2013-0932; Airspace Docket No. 13-ASO-24, at the beginning of your
comments. You may also submit and review received comments through the
Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2013-0932; Airspace Docket No. 13-ASO-24) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2013-0932; Airspace Docket No. 13-ASO-24.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
Holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except Federal Holidays, at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350, 1701 Columbia Avenue, College Park, Georgia 30337.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
to request a copy of Advisory circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace as an
extension to a Class C surface area at Nashville, TN, providing the
controlled airspace required to support the new RNAV (GPS) standard
instrument approach procedures for Nashville International Airport.
Accordingly, a segment of controlled airspace would extend from the 5-
mile radius of the airport to 11.7-miles south of the airport, and a
segment would extend from the 5-mile radius of the airport to 8.9 miles
southwest of the airport.
    Class E airspace designations are published in Paragraph 6003 of
FAA order 7400.9X, dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the

authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the agency's authority. This
proposed rulemaking is promulgated under the authority described in
Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This proposed regulation is within the scope of that
authority as it would establish Class E airspace at Nashville
International Airport, Nashville, TN.
    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1E, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71:

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment:

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

0
1. The authority citation for part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, effective September 15, 2013, is amended
as follows:

Paragraph 6003 Designated as an Extension to a Class C Surface Area

* * * * *

ASO TN E3 Nashville, TN [New]

Nashville International Airport, TN
    (Lat. 36[deg]07'31'' N., long. 86[deg]40'35'' W.)
Nashville VORTAC
    (Lat. 36[deg]07'62'' N., long. 86[deg]40'95'' W.)

    That airspace extending upward from the surface extending from
the 5-mile radius of the Nashville International Airport to an 11.7-
mile radius southeast of the airport, from the Nashville VORTAC
161[deg] radial clockwise to the 195[deg] radial, and to an 8.9-mile
radius southwest of the airport from the 195[deg] radial of the
VORTAC clockwise to the 231[deg] radial of the VORTAC.

    Issued in College Park, Georgia, on February 4, 2014.
Eric Fox,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2014-03045 Filed 2-11-14; 8:45 am]
BILLING CODE 4910-13-P


  SEQ CHAPTER \h \r 1 SUPPORTING STATEMENT

NATIONAL EMISSION STANDARDS FOR WOOL FIBERGLASS MANUFACTURING

PART A

1.0  	Identification of the Information Collection

(a) 	Title and Number of the Information Collection.

	“National Emission Standards Wool Fiberglass Manufacturing.”  This
is a new information collection request (ICR), and the EPA tracking
number is 1160.10.

 (b) 	Short Characterization.

	This ICR covers information collection requirements in the proposed
amendments to the Wool Fiberglass Manufacturing NESHAP (40 CFR part 63,
subpart NNN).

	The potential respondents are owners or operators of any existing, new,
or reconstructed Wool Fiberglass Manufacturing facilities. Per the
applicability section of subpart NNN, the following sources at a Wool
Fiberglass Manufacturing facility are covered: each glass-melting
furnace, each rotary spin (RS) manufacturing line, and each flame
attenuation (FA) manufacturing line producing a bonded product using a
phenol-formaldehyde based binder, and that is located at a plant site
that is a major source as defined in 40 CFR part 63.2. There are an
estimated 29 facilities currently producing Wool Fiberglass, but because
the industry is moving away from phenol-formaldehyde binders, we
estimate that only 2 facilities will be major sources of HAP emissions
on the compliance date for these amendments.

The proposed amendments would require HAP-specific emission limits for
HF, HCl, and chromium compounds from glass-melting furnaces; revised
emission limits for formaldehyde and new emission limits for phenol, and
methanol from RS manufacturing lines and FA manufacturing lines; and new
requirements for periods of startup and shutdown These amendments are
explained further in the following paragraphs.

The information collection requirements associated with the proposed
amendments to the NESHAP are listed in Attachment 1.

2.  	Need For and Use of the Collection

(a)	Need/Authority for the Collection.

	Section 112 of the Clean Air Act (CAA) requires EPA to establish NESHAP
for both major and area sources of HAP that are listed for regulation
under CAA section 112(c).  A major source is a stationary source that
emits or has the potential to emit more than 10 tons per year (tpy) of
any single HAP or more than 25 tpy of any combination of HAP.  An area
source is a stationary source that is not a major source (i.e., an area
source does not emit and does not have the potential to emit more than
10 tpy of any single HAP and more than 25 tpy of any combination of
HAP).  For major sources, these technology-based standards must reflect
the maximum degree of emission reductions of HAP achievable (after
considering cost, energy requirements, and non-air quality health and
environmental impacts) and are commonly referred to as maximum
achievable control technology (MACT) standards.  Section 112(d)(6)
requires EPA to review these technology-based standards and to revise
them “as necessary (taking into account developments in practices,
processes, and control technologies)” no less frequently than every 8
years.  In addition, section 112(f) of the CAA requires EPA to determine
for source categories subject to certain CAA section 112(d) standards
whether the emissions limitations provide an ample margin of safety to
protect public health.  For MACT standards for HAP “classified as a
known, probable, or possible human carcinogen" that "do not reduce
lifetime excess cancer risks to the individual most exposed to emissions
from a source in the category or subcategory to less than 1-in-1
million,” EPA must promulgate residual risk standards for the source
category (or subcategory) as necessary to provide an ample margin of
safety to protect public health.  In doing so, EPA may adopt standards
equal to existing MACT standards, if EPA determines that the existing
standards are sufficiently protective.  EPA must also adopt more
stringent standards, if necessary, to prevent an adverse environmental
effect, but must consider cost, energy, safety, and other relevant
factors in doing so.

	Certain records and reports are necessary for the Administrator to
confirm the compliance status of sources subject to NESHAP, identify any
new or reconstructed sources subject to the standards, and confirm that
the standards are being achieved on a continuous basis.  These
recordkeeping and reporting requirements are specifically authorized by
section 114 of the Clean Air Act (42 U.S.C. 7414) and set out in the
part 63 NESHAP General Provisions.  The recordkeeping and reporting
requirements for title V permits are contained in 40 CFR 70.6 and 40 CFR
71.6.  Under parts 63 and 70 or 71, the owner or operator must keep each
record for 5 years following the date of each occurrence, measurement,
maintenance, corrective action, report, or record.

 (b)	Use/Users of the Data.

	The information will be used by the delegated authority (State agency,
or Regional Administrator if there is no delegated State agency) to
ensure that the standards and other requirements are being achieved.
Based on review of the recorded information at the site and the reported
information, the delegated permitting authority can identify facilities
that may not be in compliance and decide which facilities, records, or
processes may need inspection.

3.	Nonduplication, Consultations, and Other Collection Criteria

(a)	Nonduplication.

A computer search of EPA’s ongoing ICRs revealed no duplication of
information-gathering efforts.

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

	This section is not applicable because this is a rule-related ICR.

(c)	Consultations.

The proposed amendments were developed in consultation with individual
companies, State agencies, and trade associations.  The non-EPA persons
consulted on the information collection activities are identified in
Table 1.

TABLE 1.  PERSONS CONSULTED ON THE INFORMATION COLLECTION ACTIVITIES

Contact	Organization	Telephone No.

Angus Crane	North American Insulation Manufacturers Association
703-684-0084

Mike Pettis	Owens Corning<PHONE_NUMBER>

Carlos Davis	CertainTeed Corporation<PHONE_NUMBER>

Steve Aldridge	Knauf Insulation<PHONE_NUMBER>

Jeffrey Tarde	Johns Manville<PHONE_NUMBER>

Tom Osborn	FiberTek Insulation<PHONE_NUMBER>

(d)	Effects of Less Frequent Collection.

	If the relevant information was collected less frequently, the
delegated permitting authority (State or EPA) will not be reasonably
assured that a facility is in compliance with the standards.

(e)	General Guidelines.

	None of the guidelines in 5 CFR 1320.6 are being exceeded.

(f)	Confidentiality.

	All 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 (see 40 CFR 2; 41 FR 36902,
September 1, 1976; amended by 43 FR 39999, September 28, 1978; 43 FR
42251, September 28, 1978; 44 FR 17674, March 23, 1979).

(g)  	Sensitive Questions.

	This section is not applicable because this ICR does not involve
matters of a sensitive nature.

4.	The Respondents and the Information Requested

(a)	Respondents/NAICS Codes.

Potential respondents under subpart NNN are owners or operators of any
existing or new facility engaged in Wool Fiberglass Manufacturing
operations.  Wool Fiberglass Manufacturing facilities are primarily
classified under NAICS code 327993, Mineral Wool Manufacturing.

There are an estimated 2 facilities that would be subject to the
proposed amendments to the NESHAP.   These facilities manufacture a
bonded product using a phenol-formaldehyde based binder on a FA or RS.
We are aware of one new Wool Fiberglass Manufacturing facility being
constructed, but it is not expected to be a major source of HAP
emissions; therefore, no new sources are expected during the 3year
period of this ICR.

 (b) Information Requested.

	(i)  Data Items, Including Recordkeeping Requirements.  Attachment 1,
Information Requirements, summarizes the data items, including
recordkeeping and reporting requirements, for the Wool Fiberglass
Manufacturing source category.

	(ii)  Respondent Activities.  The respondent activities that will be
required by the proposed amendments to the Wool Fiberglass Manufacturing
NESHAP are identified in Table 3 and are introduced in section 6(a).

(iii) Summary of Requirements. EPA is including in Table 2 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.

 In this source category, it is unlikely that a control device
malfunction would cause an exceedence of any emission limit.  For
reasons explained in the FRN, we have asserted that although a cost for
affirmative defense is possible, we believe that malfunctions are
unlikely. Thus for these source categories, EPA is not assigning any
burden associated with affirmative defense.

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

(a)	Agency Activities.

	The Agency activities associated with the proposed amendments to the
Wool Fiberglass Manufacturing NESHAP are provided in Table 4 and are
introduced in section 6(c).

(b)	Collection Methodology and Management.

	Data and records maintained by the respondents are tabulated and
published for use in compliance and enforcement programs of the
delegated permitting authority.  EPA is the permitting authority until
the State agency is delegated authority to implement the final
amendments to the rule.  Therefore, information contained in any report
submitted to the Regional Administrator will be entered into the Air
Facility System (AFS), which is operated and maintained by EPA’s
Office of Compliance.  AFS is EPA’s database for the collection,
maintenance, and retrieval of compliance data for approximately 125,000
industrial and government-owned facilities.  EPA uses the AFS for
tracking air pollution compliance and enforcement by local and state
regulatory agencies, EPA regional offices and EPA headquarters.  EPA and
its delegated authorities can edit, store, retrieve and analyze the
data.

(c)  	Small Entity Flexibility.

	The Small Business Administration defines a small entity engaging in
Wool Fiberglass Manufacturing operations as a firm having no more than
500 employees.  There are two companies operating the two Wool
Fiberglass Manufacturing facilities that are expected to be affected by
this rule and neither of the companies are small businesses.  The
proposed amendments would not result in significant adverse impacts on
any of the small entities. The proposed amendments would create new
requirements for compliance testing for existing sources and associated
notification requirements, recordkeeping, and reporting requirements.

(d)  	Collection Schedule.

	The specific frequency for each information collection activity within
this request is shown in Table 3 for the Wool Fiberglass Manufacturing
Source Category.

6.   	Estimating the Burden and Cost of the Collection

(a)  	Estimating Respondent Burden.

	The annual burden estimates for the proposed amendments to the Wool
Fiberglass Manufacturing NESHAP are shown in Table 3.  These numbers
were derived from estimates based on EPA’s experience with other
standards.  No burden estimates are provided for new sources because no
new facilities are expected to become affected sources during the 3year
period of this ICR.

(b)  	Estimating Respondent Costs.

	The information collection activities for the proposed amendments to
the Wool Fiberglass Manufacturing NESHAP are presented in Table 3.
Because the data are already collected by respondents as part of normal
operations, no respondent development costs are associated with the
information collection activities.

(i)  Estimating Labor Costs.  Labor rates and associated costs are based
on Bureau of Labor Statistics (BLS) data.  Technical, management, and
clerical average hourly rates for private industry workers were taken
from the United States Department of Labor, Bureau of Labor Statistics,
Occupational Employment and Wages, May 2010 available at   HYPERLINK
"http://www.bls.gov/oes/current/naics4_327200.htm"
http://www.bls.gov/oes/current/naics4_327200.htm .   Wages for technical
labor are based on "Glass and Glass Product Manufacturing –
architectural and engineering," with a total compensation of
$36.97/hour.  Wages for management labor are taken from "Glass and Glass
Product Manufacturing – management, business, and financial," with a
total compensation of $47.38/hour.   Wages for clerical labor are based
on "Glass and Glass Product Manufacturing – production, planning, and
expediting clerks," with a total compensation of $20.36/hour.  These
rates represent salaries plus fringe benefits and do not include the
cost of overhead.  An overhead rate of 110 percent is used to account
for these costs.  The fully-burdened hourly wage rates used to represent
respondent labor costs are:  technical at $77.64 /hour, management at
$99.50 /hour, and clerical at $42.76 /hour.

	(ii)  Estimating Capital and Operations and Maintenance (O&M) Costs.
No capital costs or O & M costs are associated with the information
collection requirements of the proposed amendments to the Wool
Fiberglass Manufacturing NESHAP.  The proposed amendments would require
affected facilities to purchase new monitoring systems and conduct new
performance testing.

	(iii)  Annualizing Capital Costs.  No capital costs associated with the
information collection requirements of the proposed amendments to the
Wool Fiberglass Manufacturing NESHAP.

(iv) Affirmative Defense/Root Cause Analysis/Malfunction Costs. EPA’s
estimate for a 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.

TABLE 2.  COST ESTIMATE FOR ROOT CAUSE ANALYSIS

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

(c)  	Estimating Agency Burden and Cost.

	Because the information collection requirements were developed as an
incidental part of standards development, no costs can be attributed to
the development of the information collection requirements.  Because
reporting and recordkeeping requirements on the part of the respondents
are required under the operating permits rules in 40 CFR part 70 or part
71 and the part 63 NESHAP General Provisions, no operational costs will
be incurred by the Federal Government.  Publication and distribution of
the information are part of the Compliance Data System, with the result
that no Federal costs can be directly attributed to the ICR.
Examination of records to be maintained by the respondents will occur
incidentally as part of the periodic inspection of sources that is part
of EPA’s overall compliance and enforcement program, and, therefore,
is not attributable to the ICR.  The only costs that the Federal
government will incur are user costs associated with the analysis of the
reported information, as presented in Table 4.

	The Agency labor rates are from the Office of Personnel Management
(OPM) 2010 General Schedule, which excludes locality rates of pay.
These rates can be obtained from Salary Table 2010-GS available on the
OPM website,   HYPERLINK "http://www.opm.gov/oca/10tables/pdf/gs_h.pdf"
http://www.opm.gov/oca/10tables/pdf/gs_h.pdf . The government employee
labor rates are $15.63/hour for clerical (GS-6, Step 3), $28.88 for
technical (GS-12, Step 1), and $38.92/hr for management (GS-13, Step 5).
 These rates were increased by 60 percent to include fringe benefits and
overhead.  The fully-burdened wage rates used to represent Agency labor
costs are:  clerical at $25.01/hour; technical at $46.21/hour, and
management at $62.27/hour.

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

There are an estimated 29 existing facilities that are currently subject
to the Wool Fiberglass Manufacturing NESHAP. However, industry is
eliminating phenol-formaldehyde binders from their bonded products and
we estimate that there will be two facilities subject to the proposed
amendments.  No new major sources are expected during the next 3 years.
Consequently, the average number of wool fiberglass respondents during
the 3-year period of this ICR is 2 facilities / 3 = 0.67.

For the proposed amendments to the Wool Fiberglass Manufacturing NESHAP,
the components of the total annual burden attributable to this ICR
include reading the amendments to the NESHAP; conducting the performance
testing to demonstrate compliance with the proposed emission limits; and
reporting the results of those emissions tests; all other recordkeeping
and reporting activities are already accounted for in the ICR for the
NESHAP.

(e)	Bottom Line Burden Hours and Cost Tables.

(i)  Respondent tally.  The bottom line respondent burden hours and
costs, presented in Table3 are calculated by adding person-hours per
year down each column for technical, managerial, and clerical staff, and
by adding down the cost column.  The average annual burden for the
recordkeeping and reporting requirements in the proposed amendments to
subpart NNN for the five existing facilities that are subject to the
Wool Fiberglass Manufacturing NESHAP is 31.5 person-hours, with an
annual average cost of $14,033.  No capital costs would be expected for
the proposed amendments.

	(ii)  The Agency tally.  The average annual Federal Government cost is
$283 for 6.3 hours for the proposed amendments to subpart NNN.  The
bottom line Agency burden hours and costs presented in Table 4 are
calculated by adding person-hours per year down each column for
technical, managerial, and clerical staff, and by adding down the cost
column.

	(iii)  Variations in the annual bottom line.  This section does not
apply since no significant variation is anticipated.

(f)	Reasons for Change in Burden.

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 in this category, EPA is
attributing no instances of affirmative defense.  The costs below are
illustrative of affirmative defense, which we see sources having no need
for, given the technical reasons explained in the FRN.

 (g)  	Burden Statement

	The average annual respondent burden for the proposed amendments to the
Wool Fiberglass Manufacturing NESHAP is estimated at 31.5 hours per
facility.

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

	An agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.  The OMB control numbers for EPA’s
regulations in 40 CFR part 63 are listed in 40 CFR part 9.

	To comment on the Agency’s need for this information the accuracy of
the provided burden estimates, and any suggestions for minimizing
respondent burden, including through the use of automated collection
techniques, EPA has established a public docket for this ICR under
Docket ID No. EPA-HQ-OAR-2010-1042 which is available for online viewing
at   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
, or in person viewing at the Air and Radiation Docket and Information
Center in the EPA Docket Center (EPA/DC), EPA West, Room B-102, 1301
Constitution Ave., NW, Washington, DC.  The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays.  The telephone number for the Reading Room is
(202) 566-1744, and the telephone number for the Air Docket is (202)
566-1927.  An electronic version of the public docket is available at
HYPERLINK "http://www.regulations.gov."  http://www.regulations.gov.
This site can be used to submit or view public comments, access the
index listing of the contents of the public docket, and to access those
documents in the public docket that are available electronically.  When
in the system, select “search,” then key in the Docket ID Number
identified above.  Also, you can send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention Desk Officer for EPA.
Please include the relevant Docket ID Number (EPA-HQ-OAR-2010-1042) in
any correspondence.

PART B

	This section is not applicable because statistical methods are not used
in data collection associated with the proposed rule.TABLE 3.  ANNUAL
RESPONDENT BURDEN AND COST -- AMENDMENTS TO WOOL FIBERGLASS
MANUFACTURING NESHAP

Burden item	(A)

Person-hours per occurrence	(B)

No. of occurrences per respondent	(C)

Person-hours per respondent (C=A*B)	(D) Respondents per year	(E)

Technical person-hours per year (E=C*D)	(F)

Management person-hours per year

 (E*0.05)	(G)

Clerical person-hours per year (E*0.1)	(H)

Costa, $

1.  Applications	N/A

	2.  Surveys and Studies	N/A

	3.  Acquisition, Installation, and Utilization of Technology and
Systems	N/A

	4.  Reporting Requirements

A.  Read instructionsb	4	1	8	0.67	5.4	0.3	0.6	$475

B.  Required activitiesc  (compliance testing)	$17,400	1

0.67

$11,658

C.  Create informationc	8	2	16	0.67	10.8	0.55	1.1	$950

D.  Gather existing information	N/A

	E.  Write report	8	1	8	0.67	5.4	0.3	0.6	$475

5.  Recordkeeping Requirements

A.  Read instructions	See 4A

	B.  Plan activities	N/A

	C.  Implement activities	N/A

	D.  Develop record system	N/A

	E.  Time to enter information	See 4C

	F.  Time to train personnel	N/A

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

	H.  Time to transmit or disclose information	8	1	8	0.67	5.4	0.3	0.6
$475

I.  Time for audits	N/A

	TOTAL LABOR BURDEN AND COST (SALARY)

	27	1.5	3	$14,033

TOTAL NUMBER OF ANNUAL RESPONSES	7

ANNUAL CAPITAL COSTSd

	TOTAL ANNUALIZED COSTS

$14,033

N/A = not applicable.

a  This ICR uses the following labor rates: $99.50 for managerial labor,
$77.64 for technical labor, and $42.76 for clerical labor.  These rates
are based on the U.S. Department of Labor, Bureau of Labor Statistics,
Occupational Employment and Wages, May 2010.

b  There are an estimated 2 existing facilities; no new facilities are
expected; the average number expected to read the rule during the 3-yr
compliance period is 2 / 3 = 0.67.

cThe average facility cost for HF, HCl, Cr compound, phenol, and
methanol testing was calculated to be $34,800 / 2 facilities = $17,400.

d  There would be no capital costs associated with the reporting and
recordkeeping requirements of the proposed amendments.

 TABLE 4.  ANNUAL BURDEN AND COST TO THE AGENCY ---- AMENDMENTS TO WOOL
FIBERGLASS MANUFACTURING NESHAP

Burden item	(A)

Person-hours per occurrence	(B) Occurrences per respondent	(C)

EPA person-hours/year (C=A*B)	(D)

Facilities per year	(E)

Technical person-hours/year (E=C*D)	(F)

Management   person-hours/year (F=0.05*E)	(G)

Clerical person-hours/year (G=0.1*E)	(H)

Costa, $

Report Review:

   Review compliance test reports for HF, HCl, and Cr compounds for
cupolas and formaldehyde, phenol, and methanol for RS and FA
manufacturing linesb	8	1	8	0.67	5.4	0.3	0.6	$283

TOTAL BURDEN AND COST

$283

a   This ICR uses the following average hourly labor rates: $62.27 for
managerial (GS-13, Step 5), $46.21 (GS-12, Step 1) for technical, and
$25.01 (GS-6, Step 3) for clerical.  These rates are from the Office of
Personnel Management (OPM) 2010 General Schedule, which excludes
locality rates of pay.

b Assumes Agency will review all of the annual reports  - including the
HF, HCl, Cr, formaldehyde, phenol, and methanol emissions
testing.ATTACHMENT 1.  INFORMATION REQUIREMENTS ---- AMENDMENTS TO WOOL
FIBERGLASS MANUFACTURING NESHAP

Requirement	Citation for existing sources	Citation for new sources
General Provisions citation

 HF and HCl limit for glass furnaces	§ 63.1382(a)(1)	§ 63.1382(a)(1)

	Cr compound limit for glass furnaces with high Cr refractories
§ 63.1382(a)(1)(iii)	§ 63.1382(a)(1)(iii)

	Formaldehyde  limit for RS mfg lines  	§ 63.1382(a)(2)(i)
§ 63.1382(a)(2)(ii)

	Phenol  limit for RS mfg lines  	§ 63.1382(a)(2)(i)
§ 63.1382(a)(2)(ii)

	Methanol limit for RS mfg lines  	§ 63.1382(a)(2)(i)
§ 63.1382(a)(2)(ii)

	Formaldehyde  limit for FA mfg lines  	§ 63.1382(a)(3)(i)
§ 63.1382(a)(3))ii)

	Phenol  limit for FA mfg lines  	§ 63.1382(a)(3)(i)
§ 63.1382(a)(3)(ii)

	Methanol limit for FA mfg lines  	§ 63.1382(a)(3)(i)
§ 63.1382(a)(3)(ii)

	Notifications	§ 63.1386(a)	§ 63.1386(a)	N/A

Plans

	    Operation and Maintenance Plan	N/A	N/A	N/A

Records

	    Monitoring/inspection information	§ 63.1383	§ 63.1383	N/A

Reports	§ 63.1386(b) and (c)	§ 63.1386(b) and (c)	40 CFR 63.10(e)

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[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92821-92822]
[FR Doc No: 2016-30623]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4320]

Sun Pharmaceutical Industries, Inc.; Withdrawal of Approval of 28
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 28 abbreviated new drug applications held by Sun Pharmaceutical
Industries, Inc. (Sun Pharmaceutical), U.S. Agent for Sun
Pharmaceutical Industries Limited, 270 Prospect Plains Rd., Cranbury,
NJ 08512. The drug products are no longer marketed, and Sun
Pharmaceutical has requested that the approval of the applications be
withdrawn.

DATES: January 19, 2017.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The applications listed in the table in this
document are no longer marketed, and Sun Pharmaceutical has requested
that FDA withdraw approval of the applications. The company has also,
by its request, waived its opportunity for a hearing.

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         Application No.                            Drug
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065007...........................  Cephalexin Capsules USP, Equivalent
                                    to (EQ) 250 milligrams (mg) base and
                                    EQ 500 mg base.
065016...........................  Amoxicillin Capsules USP, 250 mg and
                                    500 mg.
065021...........................  Amoxicillin Tablets USP (Chewable),
                                    125 mg and 250 mg.
065059...........................  Amoxicillin Tablets USP, 500 mg and
                                    875 mg.
065060...........................  Amoxicillin Tablets USP (Chewable),
                                    200 mg and 400 mg.
065081...........................  Cephalexin for Oral Suspension USP,
                                    EQ 125 mg base/5 milliliters (mL)
                                    and EQ 250 mg base/5 mL.
065082...........................  Cefpodoxime Proxetil for Oral
                                    Suspension USP, EQ 50 mg base/5 mL
                                    and EQ 100 mg base/5 mL.
065083...........................  Cefpodoxime Proxetil Tablets USP, EQ
                                    100 mg base and EQ 200 mg base.

065102...........................  Amoxicillin and Clavulanate Potassium
                                    Tablets USP, 875 mg/EQ 125 mg base.
065109...........................  Amoxicillin and Clavulanate Potassium
                                    Tablets USP, 500 mg/EQ 125 mg base.
065113...........................  Amoxicillin for Oral Suspension USP,
                                    200 mg/5 mL and 400 mg/5 mL.
065115...........................  Cefadroxil for Oral Suspension USP,
                                    EQ 125 mg base/5 mL, EQ 250 mg base/
                                    5 mL, and EQ 500 mg base/5 mL.
065118...........................  Cefuroxime Axetil Tablets USP, EQ 125
                                    mg base, EQ 250 mg base, and EQ 500
                                    mg base.
065132...........................  Amoxicillin and Clavulanate Potassium
                                    for Oral Suspension USP, 200 mg/EQ
                                    28.5 mg base per 5 mL and 400 mg/EQ
                                    57 mg base per 5 mL.
065161...........................  Amoxicillin and Clavulanate Potassium
                                    Tablets USP (Chewable), 200 mg/EQ
                                    28.5 mg base and 400 mg/EQ 57 mg
                                    base.
065207...........................  Amoxicillin and Clavulanate Potassium
                                    for Oral Suspension USP, 600 mg/EQ
                                    42.9 mg base per 5 mL.
065323...........................  Cefuroxime Axetil for Oral Suspension
                                    USP, EQ 125 mg base/5 mL and EQ 250
                                    mg base/5 mL.
074975...........................  Acyclovir Capsules USP, 200 mg.
074980...........................  Acyclovir Tablets USP, 400 mg and 800
                                    mg.
075132...........................  Ranitidine Tablets USP, EQ 75 mg
                                    base.
075439...........................  Ranitidine Tablets USP, EQ 150 mg
                                    base and EQ 300 mg base.
076041...........................  Sotret (isotretinoin) Capsules USP,
                                    10 mg, 20 mg, and 40 mg.
076285...........................  Simvastatin Tablets USP, 5 mg, 10 mg,
                                    20 mg, 40 mg, and 80 mg.
076332...........................  Fluconazole for Oral Suspension, 10
                                    mg/mL and 40 mg/mL.
076409...........................  Nefazodone Hydrochloride Tablets USP,
                                    50 mg, 100 mg, 150 mg, 200 mg, and
                                    250 mg.
076503...........................  Sotret (isotretinoin) Capsules USP,
                                    30 mg.
076606...........................  Gabapentin Capsules USP, 100 mg, 300
                                    mg, and 400 mg.
076739...........................  Fosinopril Sodium and
                                    Hydrochlorothiazide Tablets USP, 10
                                    mg/12.5 mg and 20 mg/12.5 mg.
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    Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner,
approval of the applications listed in the table, and all amendments
and supplements thereto, is hereby withdrawn, effective January 19,
2017.

    Dated: December 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30623 Filed 12-19-16; 8:45 am]
 BILLING CODE 4164-01-P