NOTE

DATE:  March 5, 2012

TO:  Docket EPA-HQ-OAR-2011-0660

FROM:  Mary Johnson

SUBJECT:  Summary of June 17, 2011 Meeting with Small Entities

Standards of Performance for GHG Emissions for New Stationary Sources:
EGUs:  Proposed Rule

The EPA’s outreach to small entities regarded planned actions for new
and existing sources, but only new sources would be affected by the
currently proposed action.  At that time, the EPA believed it likely
that proposed regulations for greenhouse gas (GHG) emissions from
electric utility generating units (EGUs) (new sources as well as
existing sources) would not result in a significant economic impact on a
substantial number of small entities (SISNOSE).  However, because the
EPA believes that outreach to small entities is an important element in
the development of these regulations, the EPA requested that a Small
Business Advocacy Review (SBAR) Panel be convened to allow that outreach
to occur.

It has since been determined that new source performance standards
(NSPS) for emissions of carbon dioxide (CO2) for new affected
fossil-fuel-fired EGUs will be proposed at this time.  At a future date,
the EPA intends to promulgate emission guidelines for states to develop
plans reducing CO2 emissions from existing fossil-fuel-fired EGUs.

Summary of June 17, 2011 Meeting with Small Entities

The EPA conducted outreach with representatives from 20 various small
entities that potentially would be affected by GHG regulations rule.
The representatives included small entity municipalities, cooperatives,
and private investors.  The EPA distributed outreach materials to the
small entity representatives; these materials included background, an
overview of affected sources and GHG emissions from the power sector, an
overview of CAA section 111, an assessment of CO2 emissions control
technologies, potential impacts on small entities, a summary of the
listening sessions held with various stakeholders, applicable small
entity definitions, and small entities potentially subject to
regulation.

The SBAR Panel (EPA, OMB, SBA) met with eight of the small entity
representatives, as well as three participants from organizations
representing power producers (participating as viewers/technical
backup), on June 17, 2011.  The goal of the meeting was to familiarize
the small entity representatives with the background on the rulemaking
itself, as well as the Panel process, and their role as a small entity
representative (SER) in the Panel process.  When conducted, this meeting
with small entity representatives was referred to as the first SBAR
Panel Outreach Meeting.  A list of meeting participants is attached to
this note.  Copies of four documents used during the meeting are
included as attachments to the docket entry Agenda and Materials for
first Outreach Meeting_06-17-2011_email and include:

Agenda for the 6-17-11 Meeting)

Presentation by the Small Business Advocacy Chair

Presentation on the Rulemaking

Document outlining the regulatory options that EPA heard at the GHG NSPS
listening sessions

The meeting began with the EPA’s Small Business Advocacy Review Chair
presenting an overview of the SBAR Panel process; this included a
presentation that explained what a SBAR Panel is, how the Panel fits
into the rulemaking process, how SERs participate in the Panel process,
and what the Panel does with SER recommendations.  The EPA’s Office of
Air Quality Planning and Standards (OAQPS) went through its presentation
on the rulemaking and then directed the SERs’ focus to the list of
questions the EPA prepared for SERs (actual questions shown below).  The
purpose of these questions was for the EPA to collect the SERs’ advice
and recommendations regarding the rulemaking to be proposed and its
potential impact on small entities.  Main topics for which the EPA
solicited input included appropriate CO2 control levels, mechanisms for
achieving CO2 emissions reductions, and State equivalency with the
emission guidelines.  The SERs were encouraged to provide comment on the
specific questions as well as on regulatory alternatives that could
minimize the impact on small entities while still meeting the statutory
objectives of the CAA.

In addition, OMB and SBA solicited the SERs’ views on the use of
alternative applicability thresholds, alternative ways to address
modified sources, how the EPA should choose between the various
regulatory alternatives, whether the EPA should establish a
cost-effectiveness benchmark for energy efficiency or other
technological improvements at each unit, whether the EPA should
establish a system of CO2-equivalent credits and trading among EGUs or
among a broader set of industries and/or sources, and whether the EPA
should adopt BACT guidance as BDT for new and existing sources and rely
on case-by-case evaluation of facilities for cost-effective improvements
(actual questions shown below).

EPA’s questions for SERs:

Applicability

Is EPA’s description of applicability of these standards on slides
29-31 appropriate?

Should applicability include stationary combustion turbines (combined
cycle gas turbines and simple cycle gas turbines)?

Current Practices

Do you employ measures to ensure that your EGU operates in an energy
efficient manner?

What are the energy efficient measures you employ?

Are these measures a result of regulatory requirements, initiated
voluntarily, or employed for other reasons?

What are the estimated emissions reductions associated with the energy
efficient measures?

What are the costs of implementing the energy efficient measures?

 Appropriate Control Levels for New Sources

Should new source standards be based on fuel and technology specific
efficiency standards based on the best performing coal units being
permitted/ built (e.g., IGCC and/or ultra-supercritical coal)?

Alternatively, should tighter standards that require new coal units to
go beyond technologies such as IGCC and ultra-supercritical coal and be
designed/built to perform at lower CO2/MWh levels be considered?

Given the existence of generation alternatives such as natural gas
combined cycle and renewables, tighter standards could be based on the
use of technologies such as co-firing of lower carbon fuels, integration
of renewables or the use of some level of CCS.

Should new source standards include emission rate averaging?

Should the new source standards be fuel neutral (i.e., standards would
not be fuel or technology specific but instead would be based on use of
lower GHG fuels such as natural gas)?

 Should EPA consider a phased approach where a fuel and technology
specific standard based on existing technologies would apply initially
and, after several years, a tighter standard would apply?

Are there other options that should be considered?

Appropriate Control Levels for Modified Sources

Will compliance with other regulations impacting the power sector cause
EGUs to become modified sources subject to the GHG standards?

How should modified sources be addressed in the GHG standards?

Should modified source standards be based on efficiency improvements?

Alternatively, given that the modifications are likely to involve more
significant changes to the boiler and/or turbine, is it appropriate to
consider other options such as fuel switching or co-firing with lower
carbon fuels?

Are there other options that should be considered (e.g. different
applicability thresholds)?

 Appropriate Control Levels for Existing Sources

Should existing source guidelines be based on efficiency improvements?

What is an appropriate heat rate reduction to require for existing EGUs?

Should replacement of older generation be part of the guidelines?

Should there be a linkage between remaining useful life and tightened
standards?

Should  guidelines be based on a system wide generation performance
standard that would decrease as there was fleet turnover?

Should EPA consider a phased approach where a fuel and technology
specific efficiency standard based on existing technologies would apply
initially and, after several years, a tighter standard would apply?

Should other options such as fuel switching or co-firing with lower
carbon fuels be considered?

Should States incorporate considerations of fleet turnover when
considering potential GHG reductions?

Are there other options that should be considered?

Mechanisms to Get Emissions Reductions

Do output based standards (e.g. lbs/MWh) make sense? ?

Does a net output based standard make sense for new facilities?

Should emission averaging be allowed?

Traditionally new source standards have been set at the individual unit
level.

If EPA considers alternatives, should different approaches for new,
modified and existing sources be considered?

Should all generating sources (e.g., renewables, nuclear) be included?

Over what universe of sources should emissions averaging be considered?

Within a facility

Within a State

Within a company within a State

Within a company across State lines

Across state lines

Should other alternatives be considered?

Should EPA develop a model rule that States can follow or just develop
general guidelines?

 How should useful thermal output from CHP be credited?

State Equivalency With the Emission Guidelines

Should EPA set a more prescriptive set of requirements or a more general
set of principals?

Are there certain types of programs that should (or should not) be
allowed?

Programs that allow crediting of reductions from, or averaging with,
non-affected sources (e.g., generation performance standards or
California’s AB-32 program)

Programs that allow crediting of reductions from, or averaging with,
sources in other States (e.g., the RGGI program)

Are there other important factors for EPA to address as it sets forth
criteria for demonstrating equivalency?

 Compliance, Monitoring, Recordkeeping & Reporting

Should fewer requirements be placed on low mass emission units?

If so, what should those requirements be?

Are there compliance and monitoring alternatives that would simplify the
requirements?

Are there recordkeeping and reporting alternatives that would simplify
the requirements?

How should useful thermal output from CHP facilities be monitored?

Issues that may Impact Control Options

What types of subcategories based on class, type, or size do you think
EPA should consider and why?

What type of size cut-off, if any, do you think EPA should consider and
why?

Are there other regulatory options or small entity flexibilities that
EPA should consider?

Additional topics that OMB and SBA were interested in SERs’ views on:

The use of alternative applicability thresholds (e.g. 50 MWs instead of
25 MWs)

Alternative ways to address modified sources

How should EPA choose between the regulatory alternatives offered?

What factors should EPA consider?

What emissions benefits should be included in EPA’s consideration -
just GHGs or all pollutants that would be reduced by either reducing
fuel utilization or the decommissioning of facilities?

Should EPA establish an economy-wide emissions goal, an energy-intensity
goal, or a cost-effectiveness goal for GHG emissions reductions?

Should EPA establish a cost-effectiveness benchmark for energy
efficiency or other technological improvements at each unit?

For example, if the social cost of carbon is currently approximately
$20/ton (understanding that under current guidance this would grow over
time), should EPA only require improvements at any particular unit that
cost less than $20/ton CO2 equivalent (CO2e)?

Should the cost of improvements be based on case-by-case engineering
evaluations or economy-wide projections?

Should EPA establish a cost-effectiveness benchmark for energy
efficiency or other technological improvements for the economy as a
whole?

If not $20/ton or the social cost of carbon, what other monetary
benchmark could be used?

Should EPA establish a system of CO2e credits and trading among EGUs?
Among a broader set of industries and/or sources?

What should credits represent - allowances or emission reductions?

If allowances, how should the supply of allowances be set? Be allocated?

If emissions reductions, how should EPA establish emissions benchmarks?

Are there any reasons - legal, practical or competitive - that a trading
scheme should be restricted?

Should EPA adopt the Best Available Control Technology (BACT) guidance
as Best Demonstrated Technology (BDT) for new and existing sources and
rely on case-by-case evaluation of facilities for cost-effective
improvements?

Information for the docket was provided during the meeting (4 documents)
and is attached to this note.  The information included support for
SERs’ concerns that geologic sequestration is not proven and that
there are limitations caused by other regulations (statutory issues that
are non-air) and that fuel switching to natural gas is not available in
all instances due to the inadequate infrastructure.

Attachments


  SEQ CHAPTER \h \r 1

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

	OFFICE OF PREVENTION, PESTICIDES

                                                                                AND TOXIC SUBSTANCES

MEMORANDUM

Date:  6-May-08

SUBJECT:	Cyprosulfamide: Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Section 3 Registration Action (New Active Ingredient) for the proposed uses on field corn, pop corn, sweet corn and sorghum (seed treatment)

PC Code:877400  	DP Barcode: D351493

Decision No.: 378533	Registration No.: None

Petition No.: 7E7206	Regulatory Action: Section 3 Registration, Tolerance Petitions

Risk Assessment Type: Single chemical aggregate 	Case No.: None

TXR No.: None	CAS No.: 221667-31-8

MRID No.: None	40 CFR: None

FROM:	Seyed Tadayon, Chemist

Reregistration Action Branch 3

Health Effects Division (7509P)

THROUGH:	Thurston Morton, Chemist

David Hrdy, Sr. Scientist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

William Donovan, Chemist

Reregistration Branch III

Health Effects Division (7509P)

TO:		Karen Angulo, PM

Inert Branch

Registration Division (7505P)

Executive Summary

Acute and cancer dietary assessments were not conducted for cyprosulfamide.  An acute dietary assessment was not conducted because an endpoint attributable to a single dose was not identified from the available data.  A cancer dietary assessment was also not conducted because cyprosulfamide is not likely to be carcinogenic to humans (CARC February 29, 2008).

A chronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model DEEM-FCID™, Version 2.03, which uses food consumption data from the U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.  The analysis was performed to support Section 3 requests and permanent tolerances for cyprosulfamide residues in/on field corn, pop corn and sweet corn.

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization

The chronic dietary (food and drinking water) exposure assessment was a conservative assessment using the recommended tolerance levels and assuming that 100% of the crop was treated.  Default processing factors were used in cases where an adequate processing study was not available for particular matrices in DEEM.

The chronic dietary (food and drinking water) exposure to cyprosulfamide is below HED’s level of concern for the general U.S. population and all population subgroups.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose (i.e., the dose which HED has concluded will result in no unreasonable adverse health effects).  This dose is referred to as the population adjusted dose (PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors.

This memorandum presents the first dietary risk assessment for cyprosulafamide,t Therefore

no CFR is yet available.

II.	Residue Information

(See D341999, W.Donovan, 20-May 2008)

Cyrosulfamide applied on field corn, pop corn, sweet corn and sorghum.

Tolerances have recently been proposed for residues of cyprosulfamide, [N-[[4-[(cyclopropylamino) carbonyl]phenyl]sulfonyl]-2-methoxybenzamide], on corn at 0.01 ppm. HED is presently recommending for the following tolerances for cyprosulfamide:

Corn, field, grain……………………………….………….0.01PPM

Corn, pop, grain…………………………………………   0.01PPM

Corn, sweet, kernel plus cob with husks removed………0.01 PPM

Cattle, meat byproduct……………………………………0.02PPM

Goat, meat byproduct……………………………………..0.02PPM

Horse, meat byproduct……………………………………0.02PPM

Sheep, meat byproduct……………………………………0.02PPM

Residue Data used for the Chronic Assessment:

 (See D341999, W.Donovan, XX-May 2008)

The chronic dietary (food and drinking water) exposure assessment for cyprosulfamide was a conservative assessment using the recommended/established tolerance levels and assuming that 100% of the crop was treated.

   Drinking Water Data

The drinking water residues used in the dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED).  Water residues were incorporated in the DEEM-FCID into the food categories “water, direct, all sources” and “water, indirect, all sources.”

This drinking water exposure value addresses potential human exposure to cyprosulfamide residue through ingestion of drinking water from uses on corn.  No monitoring data of cyprosulfamide were available to the Environmental Fate and Effects Division (EFED).  Surface water concentrations were estimated using the Tier I model FIRST.  Ground water concentrations were estimated using the Tier I SCI-GROW (Screening Concentration in Ground Water) model.  Cyprosulfamide may be applied by aerial or ground as per the label for this product.

Based on modeling result, the estimated chronic surface water (drinking water) concentration for cyprosulfamide and metabolites M02 and M04 is:

2.4 ug/L for the 1-in-10 year annual mean concentration (non-cancer chronic)

The SCI-GROW estimated ground water (drinking water) concentrations for cyprosulfamide are not expected to exceed 0.14 μg/L, which was based on 1 application of 0.141 lb ai/acre per application.

This chronic dietary assessment used the value of 2.4 ug/L (ppb) for drinking water and will represent a conservative estimate for ground water.

The model and its description are available at the EPA internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ .

FCID™ Program and Consumption Information

A cyprosulfamide chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID™, Version 2.03, which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  The 1994-96, 98 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire U.S. population and within population subgroups, but for acute exposure assessment are retained as individual consumption events.  Based on analysis of the 1994-96, 98 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (e.g., orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

V.	Toxicological Information

The cyprosulfamide Risk Assessment Team selected endpoints for this new pesticide.  The cyprosulfamide CARC was held on 29-FEB-2008.  An HED ROCKS meeting was held on 06-MAR-2008 and the RARC was held on 24-APR-2008.

It is recommended that the 10X FQPA safety factor for the protection of infants and children be removed.  There were two developmental toxicity studies in rabbits and together these studies demonstrated a NOAEL of 125 mg/kg/day for maternal toxicity and 250 mg/kg/day for developmental toxicity.  Thus, neither study indicated an increased sensitivity of the fetuses relative to the doses.  The reproduction study did not demonstrate increased susceptibility of the offspring to cyprosulfamide.  Specific neurotoxicity was not identified in the rat, mouse and dog subchronic or chronic studies or in the rat acute and subchronic neurotoxicity screen studies.

Table 1.   Summary of Toxicological Doses and Endpoints for Cyprosulfamide for Use in Dietary Exposure Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD, Level of Concern 	Study and Toxicological Effects

Acute Dietary (All Populations)	None	None	None	An endpoint attributable to a single dose was not identified from the available data.

Chronic Dietary (All Populations)	NOAEL= 39 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD =

0.39

mg/kg/day

cPAD = 0.39 mg/kg/day	Chronic feeding/carcinogenicity - rat

LOAEL = 159 mg/kg/day based on nephropathy.

Cancer (oral, dermal, inhalation)	Classification:  “Not Likely to be Carcinogenic to Humans”

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and  used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures.  NOAEL = no observed adverse effect level.  LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.  UFA = extrapolation from animal to human (interspecies).  UFH = potential variation in sensitivity among members of the human population (intraspecies).  FQPA SF = FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c = chronic).  RfD = reference dose.

VI.	Results/Discussion

As stated above, for the chronic assessment, HED is concerned when dietary risk exceeds 100% of the PAD.  The DEEM-FCID™ analyses estimate the dietary exposure of the U.S. population and various population subgroups.  The results reported in Table 2 are for the general U.S. Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis

The chronic dietary (food and drinking water) exposure analysis was a conservative assessment using the recommended tolerance levels and assuming that 100% of the crop was treated.  Default processing factors were used in cases where an adequate processing study was not available for particular matrices in DEEM.  Based on a bovine feeding study with cyprosulfamide, livestock tolerances are required for cyprosulfamide.

The chronic dietary (food and drinking water) exposure to cyprosulfamide is below HED’s level of concern for the general U.S. population and all population subgroups.

Table 2.  Summary of Dietary (Food and Drinking Water) Exposure and Risk for Cyprosulfamide

Population Subgroup	Chronic Dietary

	Dietary Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.000072	<1

All Infants (< 1 year old)	0.000194	<1

Children 1-2 years old	0.000119	<1

Children 3-5 years old	0.000121	<1

Children 6-12 years old	0.000087	<1

Youth 13-19 years old	0.000065	<1

Adults 20-49 years old	0.000065	<1

Adults 50+ years old	0.000060	<1

Females 13-49 years old	0.000064	<1

VII.	Characterization of Inputs/Outputs

A conservative chronic dietary (food and drinking water) exposure assessment was

conducted.  Recommended tolerance level residues of cyprosulfamide (parent) were used.  The

assessment assumed 100% of the crop was treated.  Default DEEM 7.81 processing factors were

used for corn syrup.

VIII.	Conclusions

A chronic dietary (food and drinking water) exposure assessment was conducted for the proposed uses on corn.  A conservative assessment was conducted using tolerance level residues and assuming 100% of the crop was treated.

The chronic dietary (food and drinking water) exposure to cyprosulfamide is below HED’s level of concern for the general U.S. population and all population subgroups. The chronic dietary exposure estimates are <1% cPAD for the general U.S. population and for all other population subgroup.

IX.		List of Attachments

1.	Chronic Food plus Water Residue Input File

2.	Chronic Food plus Water Results File

Attachment 1:  Chronic Food plus Water Residue Input File

Documents and Settings\stadayon\Desktop\Cyprosulfamid.R98

Chemical: Cyprosulfamide

RfD(Chronic): .39 mg/kg bw/day  NOEL(Chronic): 0 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 04-17-2008/08:54:47/8          Program ver. 2.03

Comment: Cyprosulfamid Deem run

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

  EPA    Crop                                   Def Res     Adj.Factors   Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2

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

21000460 M    Beef, meat byproducts             0.020000   1.000  1.000

21000480 M    Beef, kidney                     	    0.020000   1.000  1.000

21000490 M    Beef, liver                                 0.020000   1.000  1.000

15001200 15   Corn, field, flour                      0.010000   1.000  1.000

15001201 15   Corn, field, flour-babyfood     0.010000   1.000  1.000

15001210 15   Corn, field, meal                      0.010000   1.000  1.000

15001211 15   Corn, field, meal-babyfood     0.010000   1.000  1.000

15001220 15   Corn, field, bran                      0.010000   1.000  1.000

15001230 15   Corn, field, starch                   0.010000   1.000  1.000

15001231 15   Corn, field, starch-babyfood  0.010000   1.000  1.000

15001240 15   Corn, field, syrup                    0.010000   1.500  1.000

15001241 15   Corn, field, syrup-babyfood   0.010000   1.500  1.000

15001250 15   Corn, field, oil                         0.010000   1.000  1.000

15001251 15   Corn, field, oil-babyfood        0.010000   1.000  1.000

15001260 15   Corn, pop                                0.010000   1.000  1.000

15001270 15   Corn, sweet                             0.010000   1.000  1.000

15001271 15   Corn, sweet-babyfood            0.010000   1.000  1.000

23001700 M    Goat, meat byproducts         0.020000   1.000  1.000

23001720 M    Goat, kidney                          0.020000   1.000  1.000

23001730 M    Goat, liver                              0.020000   1.000  1.000

26003391 M    Sheep, meat-babyfood           0.020000   1.000  1.000

26003400 M    Sheep, meat byproducts        0.020000   1.000  1.000

26003420 M    Sheep, kidney                         0.020000   1.000  1.000

26003430 M    Sheep, liver                             0.020000   1.000  1.000

86010000 O    Water, direct, all sources       0.002400   1.000  1.000

86020000 O    Water, indirect, all source     0.002400   1.000  1.000

Attachment 2:  Chronic Food plus Water Results File

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for CYPROSULFAMIDE                   (1994-98 data)

Residue file name: C:\Documents and Settings\stadayon\Desktop\Cyprosulfamid.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 04-17-2008/09:19:07     Residue file dated: 04-17-2008/08:54:47/8

Reference dose (RfD, Chronic) =0.39 mg/kg bw/day

COMMENT 1:

======================================================================== ====

                    Total exposure by population subgroup

                                                    		Total Exposure

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

          Population                         		mg/kg             		 Percent of

           Subgroup                      		 body wt/day            		 Rfd

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

U.S. Population (total)                    		 0.000072                		     0.0%

U.S. Population (spring season)            	 0.000072                	                    0.0%

U.S. Population (summer season)                   0.000077               	                    0.0%

U.S. Population (autumn season)                    0.000069               	                    0.0%

U.S. Population (winter season)                      0.000069              	                    0.0%

Northeast region                            	               0.000065                                               0.0%

Midwest region                              		 0.000075                                               0.0%

Southern region                            	               0.000070                                               0.0%

Western region                                                0.000079                                               0.0%

Hispanics                                 	               0.000082                                              0.0%

Non-hispanic whites                                        0.000070                                              0.0%

Non-hispanic blacks                                         0.000072                                             0.0%

Non-hisp/non-white/non-black                         0.000080                                             0.0%

All infants (< 1 year)                                         0.000194                                              0.0%

Nursing infants                                                  0.000070                                              0.0%

Non-nursing infants                                           0.000241                                              0.0%

Children 1-6  yrs                                                0.000118                                              0.0%

Children 7-12 yrs                                               0.000083                                              0.0%

Females 13-19 (not preg or nursing)                  0.000060                                             0.0%

Females 20+ (not preg or nursing)                     0.000064                                             0.0%

Females 13-50 yrs                                              0.000068                                             0.0%

Females 13+ (preg/not nursing)                          0.000066                                             0.0%

Females 13+ (nursing)                                         0.000085                                            0.0%

Males 13-19 yrs                                                   0.000070                                             0.0%

Males 20+ yrs                                                      0.000062                                             0.0%

Seniors 55+                                                          0.000059                                             0.0%

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12 yrs                                                  0.000087                                           0.0%

Youth 13-19 yrs                                                    0.000065                                           0.0%

Adults 20-49 yrs                                                    0.000065                                          0.0%

Adults 50+ yrs                              		       0.000060                                          0.0%

Females 13-49 yrs                          		       0.000064              0.0%

Cyprosulfamide	Dietary Exposure and Risk Assessment	DP Number: D351493

PC Code:  877400

________________________________________________________________________ ______________

 PAGE

                                                                                Page   PAGE  1  of   NUMPAGES  10


[Federal Register Volume 86, Number 52 (Friday, March 19, 2021)]
[Rules and Regulations]
[Pages 14832-14834]
[FR Doc No: 2021-05514]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R09-OAR-2019-0145; FRL-10019-97-Region 9]

Approval and Promulgation of Implementation Plans; Designation of
Areas for Air Quality Planning Purposes; California; South Coast
Moderate Area Plan and Reclassification as Serious Nonattainment for
the 2012 PM2.5 NAAQS; Correcting Amendment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Correcting amendment.

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

SUMMARY: On November 9, 2020, the Environmental Protection Agency (EPA)
issued a final rule titled ``Approval and Promulgation of
Implementation Plans; Designation of Areas for Air Quality Planning
Purposes; California; South Coast Moderate Area Plan and
Reclassification as Serious Nonattainment for the 2012 PM2.5
NAAQS.'' That publication inadvertently omitted from the description of
the Riverside County portion of the designated area, language
indicating that the lands of the Santa Rosa Band of Cahuilla Mission
Indians and Pechanga Band of Luiseno Mission Indians of the Pechanga
Reservation are excluded from that portion of the Los Angeles-South
Coast Air Basin nonattainment area for the 2012 national ambient air
quality standard (NAAQS) for fine particulate matter
(PM2.5). This document corrects the error in the regulatory
text.

DATES: This rule is effective on March 19, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R09-OAR-2019-0145. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available through https://www.regulations.gov, or please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section for additional availability information. If you need assistance
in a language other than English or if you are a person with
disabilities who needs a reasonable accommodation at no cost to you,
please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section.

FOR FURTHER INFORMATION CONTACT: Ashley Graham, Air Planning Office
(AIR-2), EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105,
(415) 972-3877 or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On November 9, 2020, the EPA issued a final
rule titled ``Approval and Promulgation of Implementation Plans;
Designation of Areas for Air Quality Planning Purposes; California;
South Coast Moderate Area Plan and Reclassification as Serious
Nonattainment for the 2012 PM2.5 NAAQS.'' \1\ That
publication inadvertently omitted from the description of the Riverside
County portion of the designated area, language indicating that the
lands of the Santa Rosa Band of Cahuilla Mission Indians and Pechanga
Band of Luiseno Mission Indians of the Pechanga Reservation are
excluded from that portion of the Los Angeles-South Coast Air Basin
nonattainment area for the 2012 PM2.5 NAAQS. This action
corrects the omission and revises the entry as intended in the November
9, 2020 final rule.
    The EPA has determined that this action falls under the ``good
cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedure Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation where public notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest. Public notice and comment for this action are
unnecessary because the underlying rule for which this correcting
amendment has been prepared was already subject to a 30-day comment
period, and this action merely corrects an error in the rule text.
Further, this action is consistent with the purpose and rationale of
the final rule, which is corrected herein. Because this action does not
change the EPA's analyses or overall actions, no purpose would be
served by additional public notice and comment. Consequently,
additional public notice and comment are unnecessary.
---------------------------------------------------------------------------

    \1\ 85 FR 71264.
---------------------------------------------------------------------------

    The EPA also finds that there is good cause under APA section
553(d)(3) for this correction to become effective on the date of
publication of this action. Section 553(d)(3) of the APA allows an
effective date of less than 30 days after publication ``as otherwise
provided by the agency for good cause found and published with the
rule.'' 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period
prescribed in APA section 553(d)(3) is to give affected parties a
reasonable time to adjust their behavior and prepare before the final
rule takes effect. This rule does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. This action merely corrects an error in a
previous rulemaking. For these reasons, the EPA finds good cause under
APA section 553(d)(3) for this correction to become effective on the
date of publication of this action.

Statutory and Executive Order Reviews

    This action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is not subject to the regulatory flexibility provisions of
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);
     Is not subject to sections 202 and 205 of the Unfunded
Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4);
     Does not impose a significant intergovernmental mandate or
significantly or uniquely affect small governments, as described in
sections 203 and 204 of the UMRA;
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this error correction action does not involve technical
standards; and
     Does not involve special consideration of environmental
justice related issues as required by Executive Order 12898 (59 FR
7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land

or in any other area where the EPA or an Indian tribe has demonstrated
that a tribe has jurisdiction. In those areas of Indian country, the
rule does not have tribal implications and will not impose substantial
direct costs on tribal governments or preempt tribal law as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000).
    In issuing this rule, the EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). The
EPA has complied with Executive Order 12630 (53 FR 8859, March 15,
1998) by examining the takings implications of the rule in accordance
with the ``Attorney General's Supplemental Guidelines for the
Evaluation of Risk and Avoidance of Unanticipated Takings'' issued
under the executive order.
    The Congressional Review Act (CRA) (5 U.S.C. 801 et seq.), as added
by the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. Section 808 allows the issuing agency to
make a rule effective sooner than otherwise provided by the CRA if the
Agency makes a good cause finding that notice and public procedure is
impracticable, unnecessary or contrary to the public interest. This
determination must be supported by a brief statement. 5 U.S.C. 808(2).
As stated previously, the EPA has made such a good cause finding,
including the reasons therefore, and established an effective date of
March 19, 2021. The EPA will submit a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This correction to
40 CFR part 81 for California is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, Particulate
matter.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: March 11, 2021.
Deborah Jordan,
Acting Regional Administrator, Region IX.
    For the reasons stated in the preamble, the EPA corrects Part 81,
Chapter I, Title 40 of the Code of Federal Regulations by making the
following correcting amendments:

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for Part 81 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart C--Section 107 Attainment Status Designations

0
2. In section 81.305 amend the table titled ``California--2012 Annual
PM2.5 NAAQS [Primary],'' by revising the entries under
``Riverside County (part)'' under ``Los Angeles-South Coast Air Basin,
CA'' to read as follows:

Sec.  81.305  California.

* * * * *

                                       California--2012 Annual PM2.5 NAAQS
                                                    [Primary]
----------------------------------------------------------------------------------------------------------------
                                                Designation                             Classification
     Designated area \1\     -----------------------------------------------------------------------------------
                                     Date \2\                  Type                  Date \2\            Type
----------------------------------------------------------------------------------------------------------------
Los Angeles-South Coast Air
 Basin, CA:

                                                  * * * * * * *
    Riverside County (part):  ......................  Nonattainment.........  December 9, 2020......  Serious.
     That portion of
     Riverside County which
     lies to the west of a
     line described as
     follows: Beginning at
     the Riverside-San Diego
     County boundary and
     running north along the
     range line common to
     Range 4 East and Range
     3 East, San Bernardino
     Base and Meridian; then
     east along the Township
     line common to Township
     8 South and Township 7
     South; then north along
     the range line common
     to Range 5 East and
     Range 4 East; then west
     along the Township line
     common to Township 6
     South and Township 7
     South to the southwest
     corner of Section 34,
     Township 6 South, Range
     4 East; then north
     along the west
     boundaries of Sections
     34, 27, 22, 15, 10, and
     3, Township 6 South,
     Range 4 East; then west
     along the Township line
     common to Township 5
     South and Township 6
     South; then north along
     the range line common
     to Range 4 East and
     Range 3 East; then west
     along the south
     boundaries of Sections
     13, 14, 15, 16, 17, and
     18, Township 5 South,
     Range 3 East; then
     north along the range
     line common to Range 2
     East and Range 3 East;
     to the Riverside-San
     Bernardino County line
     (excluding the lands of
     the Santa Rosa Band of
     Cahuilla Mission
     Indians, and excluding
     the lands of the
     Pechanga Band of
     Luiseno Mission Indians
     of the Pechanga
     Reservation).

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Includes areas of Indian country located in each county or area, except as otherwise specified.
\2\ This date is April 15, 2015, unless otherwise noted.

* * * * *
[FR Doc. 2021-05514 Filed 3-18-21; 8:45 am]
BILLING CODE 6560-50-P


reasonable framework for addressing this issue and I look forward to
reviewing the comments we receive.
---------------------------------------------------------------------------

    \22\ 18 CFR 292.204(a) (2019).
    \23\ See Statement of Paul Kjellander, Docket No. AD16-16-000,
at 4-5 (June 29, 2016); Portland General Electric Company Comments,
Docket No. AD16-16-000, at 6 (June 29, 2016).
---------------------------------------------------------------------------

    24. In addition, I support the proposal to require that QFs
demonstrate commercial viability before securing a legally
enforceable obligation with the relevant utility. It seems only fair
to require that a proposed QF demonstrate that it is not speculative
and will likely enter service before a utility incurs an obligation
to purchase that QF's output at any particular price. The proposal
in today's NOPR appears to strike a reasonable balance between
allowing QFs to secure a commitment for purchase early enough in
their development cycle so that they can use it to facilitate
financing while preventing QFs from locking-in avoided-cost rates
too far ahead of their actual delivery of any energy or capacity.
Nevertheless, in contrast to the one-mile rule, the record on this
question is relatively underdeveloped and I hope that parties will
address the specifics of this proposal in detail.
    25. Finally, I support the proposal to allow stakeholders to
protest self-certification of QFs. If an entity believes a resource
does not qualify as a QF, it should have the opportunity to protest
the QF's filing in the same way that stakeholders have the
opportunity to protest most other Commission filings. At the very
least, it seems unfair to require them to file a declaratory order,
and pay tens of thousands of dollars, in order to inform the
Commission of their views.
    * * *
    26. The Commission seems to believe that PURPA's time has
passed. But that is Congress's decision to make, not the
Commission's. So long as PURPA is on the books, we must faithfully
implement the requirements of the law. Although I support certain
elements of today's NOPR, I am concerned that many of the
Commission's proposals will fall short of our statutory obligations.
In addition, I am also disappointed that the Commission is not doing
more to explore using PURPA to expand opportunities for genuine
competition, including through section 210(m)--the avenue for reform
that Congress enacted in 2005. I believe that focusing on expanding
opportunities for genuine competition would far better serve the
public interest than simply rebalancing the scales against QFs,
which seems to be the principal goal of today's NOPR.

    For these reasons, I respectfully dissent in part.
-----------------------------------------------------------------------

Richard Glick,
Commissioner.

[FR Doc. 2019-20803 Filed 10-3-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 15, 2008 (Volume 73, Number 200)]
[Notices]
[Page 61188-61190]
[DOCID:fr15oc08-162]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2008-0175]

Qualification of Drivers; Exemption Applications; Diabetes

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt forty-seven individuals
from its rule prohibiting persons with insulin-treated diabetes
mellitus (ITDM) from operating commercial motor vehicles (CMVs) in
interstate commerce. The exemptions will enable these individuals to
operate CMVs in interstate commerce.

DATES: The exemptions are effective October 15, 2008. The exemptions
expire on October 15, 2010.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room W64-224,
Department of Transportation, 1200 New Jersey Avenue, SE., Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document

Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's complete Privacy Act Statement in the
Federal Register (65 FR 19476, Apr. 11, 2000). This statement is also
available at http://Docketsinfo.dot.gov.

Background

    On August 5, 2008, FMCSA published a notice announcing receipt of
applications for exemption from the Federal diabetes standard from
forty-seven individuals, and requested comments from the public (73 FR
45519). The public comment period closed on September 4, 2008, and
three comments were received.
    FMCSA has evaluated the eligibility of the forty-seven applicants
and determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current standard for diabetes in 1970
because several risk studies indicated that diabetic drivers had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The 2003 Notice (68 FR 52442) in conjunction
with the November 8, 2005 (70 FR 67777) Federal Register Notice
provides the current protocol for allowing such drivers to operate CMVs
in interstate commerce.
    These forty-seven applicants have had ITDM over a range of 1 to 46
years. These applicants report no hypoglycemic reaction that resulted
in loss of consciousness or seizure, that required the assistance of
another person, or that resulted in impaired cognitive function without
warning symptoms in the past 5 years (with one year of stability
following any such episode). In each case, an endocrinologist has
verified that the driver has demonstrated willingness to properly
monitor and manage his or her diabetes, received education related to
diabetes management, and is on a stable insulin regimen. Each driver
reports no other disqualifying conditions, including diabetes-related
complications. Each meets the vision standard at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the August 5, 2008, Federal Register
Notice (73 FR 45519). Therefore, they will not be repeated in this
notice.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision and
reviewed the treating endocrinologist's medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that exempting these applicants from the
diabetes standard in 49 CFR 391.41(b)(3) is likely to achieve a level
of safety equal to that existing without the exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submits to FMCSA a quarterly monitoring
checklist completed by the treating endocrinologist as well as an
annual checklist with a comprehensive medical evaluation; (2) that each
individual reports to FMCSA within 2 business days of occurrence, all
episodes of severe hypoglycemia, significant complications, or
inability to manage diabetes; also, any involvement in an accident or
any other adverse event in a CMV or personal vehicle, whether or not
they are related to an episode of hypoglycemia; (3) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (4) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the certification when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

Discussion of Comments

    FMCSA received three comments in this proceeding. Two of the
comments were recommendations in favor of granting the Federal diabetes
exemption to Mr. Tyree L. Murdock II. and Mr. Brian Wallisch. The third
comment was also a recommendation in favor of granting Federal diabetes
exemptions to individuals with ITDM.

Conclusion

    After considering the comments to the docket, and based upon its
evaluation of the forty-seven exemption applications, FMCSA exempts,
Robert V. Balmes, David R. Bauerdorf, Stephen R. Bortz, John A.
Broeker, Daniel A. Brown, Floyd G. Burbach, Kenneth M. Brinker, Richard
A. Bruyere, Randie L. Burrows, Scott R. Butler, Jay P. Cave, Jeffrey A.
Clark, Terry C. Conwell, Steven M. French, Glennon E. Goetting, Philip
P. Gray, John L. Hansen, Darin D. Harries, William E. Hollowell, Cindy
L. Hushin-Brink, Steven L. Jensen, Mark A. Kabriel, Kevin K. Kimbro,
Richard D. Knoche, Jonathan D. Koehn, Robert J. Lanczkowski, Terry G.
Lindahl, Paula S. Lewis, Edward M. Mason, John M. McAuliffe, John A.
McMurray, Kurt V. Miller, William W. Moffat, Tyree L. Murdock, II.,
Edward A. Ortega, David W. Payne, Richard Rodriguez, Scott D. Schultz,
Daniel S. Sherman, Marvin R. Shipman, Mark W. Seem, Ricky Sirico, Daryl
L. Vaughn, Brian K. Wallisch, Steven S. Whitt, Jr., Andrew A. Zizza,
Mick B. Zoske, from the ITDM standard in 49 CFR 391.41(b)(3), subject
to the conditions listed under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid

for two years unless revoked earlier by FMCSA. The exemption will be
revoked if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315. If the exemption is
still effective at the end of the 2-year period, the person may apply
to FMCSA for a renewal under procedures in effect at that time.

    Issued on: September 25, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E8-24380 Filed 10-14-08; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 186 (Friday, September 25, 2015)]
[Proposed Rules]
[Page 57755]
[FR Doc No: 2015-24159]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No.FAA-2015-3084; Airspace Docket No. 15-AGL-13]

Proposed Establishment of Class E Airspace; International Falls,
MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM), correction.

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

SUMMARY: This action makes a correction to the NPRM published in the
Federal Register of August 27, 2015, proposing to establish Class E en
route domestic airspace in the International Falls, MN area.
Exclusionary reference to Canadian airspace was omitted from the
regulatory text.

DATES: Comments due date remains October 13, 2015.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You
must identify the docket number FAA-2015-3084/Airspace Docket No. 15-
AGL-13, at the beginning of your comments. You may also submit comments
through the Internet at http://www.regulations.gov. You may review the
public docket containing the proposal, any comments received, and any
final disposition in person in the Dockets Office between 9:00 a.m. and
5:00 p.m., Monday through Friday, except Federal holidays. The Docket
Office (telephone 1-800-647-5527), is on the ground floor of the
building at the above address.
    FAA Order 7400.9Y, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy and Regulations Group, Federal Aviation Administration,
800 Independence Avenue SW., Washington, DC, 20591; telephone: 202-267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go to
http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Raul Garza, Jr., Central Service
Center, Operations Support Group, Federal Aviation Administration,
Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone:
817-868-2927.

SUPPLEMENTARY INFORMATION:
    History. A notice of proposed rulemaking was published in the
Federal Register of August 27, 2015 (80 FR 51972). In the regulatory
text of the proposed rule, exclusionary language was inadvertently
omitted from the legal description of the airspace. This action makes
the correction. The legal description is rewritten for clarity.

Proposed Amendment Correction

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of August 27, 2015 (80 FR 51972), FR Docket 2015-
21087, the legal description on page 51973, column 2, beginning at line
31, is corrected to read as follows:

Sec.  71.1  [Amended]

AGL MN E6 International Falls, MN [Corrected]

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 49[deg]00'00'' N., long. 095[deg]00'00''
W.; to lat. 49[deg]00'00'' N., long. 093[deg]30'00'' W.; to lat.
48[deg]06'30'' N., long. 090[deg]06'00'' W.; to lat. 47[deg]53'00'' N.,
long. 090[deg]55'00'' W.; to lat. 48[deg]34'00'' N., long.
094[deg]00'00'' W.; to lat. 48[deg]40'00'' N., long. 095[deg]00'00''
W., thence to the point of beginning, excluding that airspace within
Federal airways and within Canadian airspace.

    Issued in Fort Worth, TX, on September 9, 2015.
Robert W. Beck,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-24159 Filed 9-24-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Proposed Rules]
[Pages 29016-29019]
[FR Doc No: 2017-13365]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0625; Directorate Identifier 2016-NM-089-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2014-22-
08, for all Airbus Model A318 and A319 series airplanes; Model A320-
211, -212, -214, -231, -232, and -233 airplanes: and Model A321-111, -
112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2014-22-08
requires revising the maintenance or inspection program to incorporate
new or revised airworthiness limitation requirements. Since we issued
AD 2014-22-08, we have determined that more restrictive maintenance
instructions and airworthiness limitations are necessary. This proposed
AD would require revising the maintenance or inspection program to
incorporate new or revised airworthiness limitation requirements. The
proposed AD also removes airplanes from the applicability. We are
proposing this AD to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by August 11, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0625; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2017-0625;
Directorate Identifier 2016-NM-089-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On October 28, 2014, we issued AD 2014-22-08, Amendment 39-18013
(79 FR 67042, November 12, 2014) (``AD 2014-22-08''), for all Airbus
Model A318 and A319 series airplanes; Model A320-211, -212, -214, -231,
-232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -
213, -231, and -232 airplanes. AD 2014-22-08 was prompted by a
determination that more restrictive airworthiness limitations were
necessary. AD 2014-22-08 requires revising the maintenance or
inspection program as applicable. We issued AD 2014-22-08 to prevent a
safety-significant latent failure (which is not annunciated), which, in
combination with one or more other specific failures or events, would
result in a hazardous or catastrophic failure condition. Since we
issued AD 2014-22-08, we have determined that more restrictive
maintenance instructions and airworthiness limitations are necessary.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2016-0092, dated May 13, 2016 (referred to
after this as the

Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for all Airbus Model A318 and A319 series
airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes;
and Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes. The MCAI states:

    The airworthiness limitations for Airbus A320 family aeroplanes
are currently defined and published in Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) documents. The airworthiness
limitations applicable to the Certification Maintenance Requirements
(CMR), which are approved by EASA, are published in ALS Part 3.
    The instructions contained in the ALS Part 3 have been
identified as mandatory actions for continued airworthiness. Failure
to comply with these instructions could result in an unsafe
condition.
    Previously, EASA issued AD 2013-0148 [which corresponds to FAA
AD 2014-22-08] to require accomplishment of all maintenance tasks as
described in ALS Part 3 at Revision 01. The new ALS Part 3 Revision
03 (hereafter referred to as `the ALS' in this [EASA] AD) includes
new and/or more restrictive requirements.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2013-0148, which is superseded, and requires
accomplishment of all maintenance tasks as described in the ALS.

    The unsafe condition is a safety-significant latent failure (that
is not annunciated), which, in combination with one or more other
specific failures or events, could result in a hazardous or
catastrophic failure condition. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating Docket No. FAA-2017-0625.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus A318/A319/A320/A321 ALS Part 3 CMR,
Revision 03, dated December 21, 2015. The service information describes
maintenance instructions and airworthiness limitations, including
updated inspections and intervals to be incorporated into the
maintenance or inspection program. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.
    This proposed AD would require revising the maintenance or
inspection program to include new actions (e.g., inspections).
Compliance with these actions is required by 14 CFR 91.403(c). For
airplanes that have been previously modified, altered, or repaired in
the areas addressed by this proposed AD, the operator may not be able
to accomplish the actions described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must request
approval for an alternative method of compliance (AMOC) according to
paragraph (k)(1) of this proposed AD. The request should include a
description of changes to the required inspections that will ensure the
continued operational safety of the airplane.

Difference Between This Proposed AD and the MCAI

    The MCAI specifies that if there are findings from the ALS
inspection tasks, then corrective action must be accomplished in
accordance with Airbus maintenance documentation. However, this
proposed AD does not include that requirement. Operators of U.S.-
registered airplanes are required by general airworthiness and
operational regulations to perform maintenance using methods that are
acceptable to the FAA. We consider those methods to be adequate to
address any corrective actions necessitated by the findings of ALS
inspections required by this proposed AD.

Airworthiness Limitations Based on Type Design

    The FAA recently became aware of an issue related to the
applicability of ADs that require incorporation of an ALS revision into
an operator's maintenance or inspection program.
    Typically, when these types of ADs are issued by civil aviation
authorities of other countries, they apply to all airplanes covered
under an identified type certificate (TC). The corresponding FAA AD
typically retains applicability to all of those airplanes.
    In addition, U.S. operators must operate their airplanes in an
airworthy condition, in accordance with 14 CFR 91.7(a). Included in
this obligation is the requirement to perform any maintenance or
inspections specified in the ALS, and in accordance with the ALS as
specified in 14 CFR 43.16 and 91.403(c), unless an alternative has been
approved by the FAA.
    When a TC is issued for a type design, the specific ALS, including
revisions, is a part of that type design, as specified in 14 CFR
21.31(c).
    The sum effect of these operational and maintenance requirements is
an obligation to comply with the ALS defined in the type design
referenced in the manufacturer's conformity statement. This obligation
may introduce a conflict with an AD that requires a specific ALS
revision if new airplanes are delivered with a later revision as part
of their type design.
    To address this conflict, the FAA has approved AMOCs that allow
operators to incorporate the most recent ALS revision into their
maintenance/inspection programs, in lieu of the ALS revision required
by the AD. This eliminates the conflict and enables the operator to
comply with both the AD and the type design.
    However, compliance with AMOCs is normally optional, and we
recently became aware that some operators choose to retain the AD-
mandated ALS revision in their fleet-wide maintenance/inspection
programs, including those for new airplanes delivered with later ALS
revisions, to help standardize the maintenance of the fleet. To ensure
that operators comply with the applicable ALS revision for newly
delivered airplanes containing a later revision than that specified in
an AD, we plan to limit the applicability of ADs that mandate ALS
revisions to those airplanes that are subject to an earlier revision of
the ALS, either as part of the type design or as mandated by an earlier
AD.
    This proposed AD, therefore, would apply to the airplanes
identified in paragraph (c) of this AD with an original certificate of
airworthiness or original export certificate of airworthiness that was
issued on or before the date of approval of the ALS revision identified
in this proposed AD. Operators of airplanes with an original
certificate of airworthiness or original export certificate of
airworthiness issued after that date must comply with the airworthiness
limitations specified as part of the approved type design and
referenced on the type certificate data sheet.

Costs of Compliance

    We estimate that this proposed AD affects 1,032 airplanes of U.S.
registry.
    The actions required by AD 2014-22-08, and retained in this
proposed AD

take about 1 work-hour per product, at an average labor rate of $85 per
work-hour. Based on these figures, the estimated cost of the actions
that are required by AD 2014-22-08 is $85 per product.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Based on these figures, we estimate
the cost of this proposed AD on U.S. operators to be $87,720, or $85
per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2014-22-08, Amendment 39-18013 (79 FR 67042, November 12, 2014), and
adding the following new AD:

Airbus: Docket No. FAA-2017-0625; Directorate Identifier 2016-NM-
089-AD.

(a) Comments Due Date

    We must receive comments by August 11, 2017.

(b) Affected ADs

    This AD replaces AD 2014-22-08, Amendment 39-18013 (79 FR 67042,
November 12, 2014) (``AD 2014-22-08'').

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1), (c)(2), (c)(3), and (c)(4) of this AD, certificated in any
category, with an original certificate of airworthiness or original
export certificate of airworthiness issued on or before December 21,
2015.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133
airplanes.
    (3) Model A320-211, -212, -214, -231, -232, and -233 airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that more restrictive
maintenance instructions and airworthiness limitations are
necessary. We are issuing this AD to prevent a safety-significant
latent failure (that is not annunciated), which, in combination with
one or more other specific failures or events, could result in a
hazardous or catastrophic failure condition.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Maintenance or Inspection Program Revision, With New
Terminating Action

    This paragraph restates the requirements of paragraph (g) of AD
2014-22-08, with new terminating action. Within 30 days after
December 17, 2014 (the effective date of AD 2014-22-08), revise the
maintenance or inspection program, as applicable, by incorporating
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS)
Part 3, Certification Maintenance Requirements (CMR), Revision 1,
dated June 15, 2012. The initial compliance time for accomplishing
the tasks specified in Airbus A318/A319/A320/A321 ALS Part 3, CMR,
Revision 1, dated June 15, 2012, is at the applicable time specified
in the Record of Revisions of Airbus A318/A319/A320/A321 ALS Part 3,
CMR, Revision 1, dated June 15, 2012; or within 30 days after
December 17, 2014, whichever occurs later. Accomplishing the actions
specified in paragraph (i) of this AD terminates the requirements of
this paragraph.

(h) Retained Provision Regarding Alternative Actions and Intervals,
With a New Exception

    This paragraph restates the requirements of paragraph (h) of AD
2014-22-08, with a new exception. Except as required by paragraph
(i) of this AD, after accomplishing the revisions required by
paragraph (g) of this AD, no alternative actions (e.g., inspections)
or intervals may be used unless the actions or intervals are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (k)(1) of this AD.

(i) New Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD: Revise the
maintenance or inspection program, as applicable, to incorporate
Airbus A318/A319/A320/A321 ALS Part 3 CMR, Revision 03, dated
December 21, 2015 (``ALS Part 3 CMR, R3''). The initial compliance
time for accomplishing the tasks specified in ALS Part 3 CMR, R3, is
at the applicable time specified in ALS Part 3 CMR, R3, or within 30
days after the effective date of this AD, whichever occurs later.
Accomplishing the actions specified in this paragraph terminates the
requirements of paragraph (g) of this AD.

(j) New Provision Regarding No Alternative Actions or Intervals

    After the action required by paragraph (i) of this AD has been
done, no alternative actions (e.g., inspections) or intervals may be
used unless the actions or intervals are approved as an AMOC in
accordance with the procedures specified in paragraph (k)(1) of this
AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested

using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the International Branch,
send it to the attention of the person identified in paragraph
(l)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously for AD 2014-22-08 are approved as
AMOCs for the corresponding provisions of paragraph (g) of this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or Airbus's EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2016-0092, dated May 13, 2016,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0625.
    (2) For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 20, 2017.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-13365 Filed 6-26-17; 8:45 am]
 BILLING CODE 4910-13-P