[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Rules and Regulations]
[Pages 26356-26359]
[FR Doc No: 2018-12218]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. FDA-2017-C-0935]

Listing of Color Additives Subject to Certification; D&C Black
No. 4

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of D&C Black No.
4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non-
absorbable sutures for use in general surgery. This action is in
response to a color additive petition (CAP) submitted by DSM
Biomedical.

DATES: This rule is effective July 10, 2018. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing on the
final rule by July 9, 2018.

ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before July
9, 2018. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of July 9, 2018.
Objections received by mail/hand delivery/courier (for written/paper
submissions) will be considered timely if they are postmarked or the
delivery service acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets
Management Staff, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-C-0935 for ``Listing of Color Additives Subject to
Certification; D&C Black No. 4.'' Received objections, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We
will review this copy, including the claimed confidential information,
in our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph M. Thomas, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register on March 6, 2017 (82 FR 12531), we
announced that we filed a color additive petition (CAP 7C0310)
submitted by DSM Biomedical (petitioner), 735 Pennsylvania Dr., Exton,
PA 19341. The petition proposed to amend the color additive regulations
in part 73 (21 CFR part 73), Listing of Color Additives Exempt from
Certification, to provide for the safe use of high-purity carbon black
for coloring UHMWPE non-absorbable sutures for use in general
surgery.\1\ After the petition was filed and during our review, we
determined that the color additive will require batch certification by
FDA. We intend to give each certified batch of the subject color
additive the name D&C Black No. 4. Therefore, this color additive will
be identified as D&C Black No. 4 and will be listed in part 74 (21 CFR
part 74), Listing of Color Additives Subject to Certification.
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    \1\ The original petition did not specify that the color
additive is to be used in sutures that are non-absorbable.
Therefore, our March 6, 2017, notice of filing did not specify that
the color additive is intended for use in non-absorbable sutures.
However, petitioner's subsequent submissions to FDA indicated that
the intended use of the additive is for sutures that are non-
absorbable.
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II. Identity and Specifications

    D&C Black No. 4 is a high-purity carbon black prepared by the oil
furnace process. It is manufactured by injecting

a heated aromatic petroleum feedstock into the combustion zone of a
natural gas-fired furnace to produce carbon black. The reaction is
quenched with water and the carbon particles are further cooled and
separated by a filter. The recovered high-purity carbon black is dried
and pelletized to produce the final D&C Black No. 4 commercial product,
consisting of aggregated particles with a surface area ranging from 50
to 260 meters squared per gram (m\2\/g). D&C Black No. 4 is
mechanically mixed at a maximum level of 1 percent by weight with the
UHMWPE suture raw materials to form a homogenous suspension, absent of
chemical reaction between components, and extruded to form black
colored sutures.
    As explained in section III, the color additive D&C Black No. 4 may
contain low levels of potentially carcinogenic polycyclic aromatic
hydrocarbon (PAH) contaminants. To limit the amounts of these
contaminants in the color additive, FDA is setting specifications for
total PAHs, as well as for the individual PAH species benzo[a]pyrene
(B[a]P) and dibenz[a,h]anthracene. These specifications are consistent
with specifications for other high-purity carbon blacks approved by
FDA, including the color additive D&C Black No. 2 (Sec.  74.2052 (21
CFR 74.2052)), which is approved for use in certain cosmetics,
including cosmetics for use in the area of the eye (i.e., eyeliner,
brush-on-brow, eye shadow, mascara), and high-purity furnace black,
which is approved for use in food-contact polymers (Sec.  178.3297 (21
CFR 178.3297)). These specifications are also supported by the safety
information reviewed as a part of this petition (see section III). In
addition, to ensure compliance with these specifications, FDA is
requiring that D&C Black No. 4 for use in UHMWPE non-absorbable sutures
be from a batch of the color additive certified by FDA.
    The identity for D&C Black No. 4 is the same as D&C Black No. 2,
except for the surface area. For D&C Black No. 2, we set specifications
for arsenic, lead, and mercury, total color (as carbon), total sulfur,
ash content, surface area, and weight loss on heating, in addition to
the specifications for total PAHs, benzo[a]pyrene (B[a]P), and
dibenz[a,h]anthracene. We are setting the same specifications that were
established for D&C Black No. 2 for D&C Black No. 4 for these
parameters with the exception of surface area specification, which is
broader for D&C Black No. 4.

III. Safety Evaluation

A. Determination of Safety

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed
for a particular use unless a fair evaluation of the data and
information available to FDA establish that the color additive is safe
under the intended conditions of use. Furthermore, under 21 CFR
70.5(c), a color additive intended for use in a surgical suture must
have a listing specifically providing for this use. FDA's color
additive regulations in 21 CFR 70.3(i) define ``safe'' to mean that
there is convincing evidence that establishes with reasonable certainty
that no harm will result from the intended use of the color additive.
    Section 721(b)(5)(B)(ii) of the FD&C Act provides that for any use
of a color additive that will not result in ingestion of any part of
such additive, the color additive shall be deemed to be unsafe and
shall not be listed if, after tests that are appropriate for the
evaluation of the safety of additives for such use, or after other
relevant exposure of man or animal to such additive, it is found to
induce cancer in man or animal. Importantly, however, section
721(b)(5)(B) of the FD&C Act applies to the additive itself and not to
impurities in the additive. That is, where an additive itself has not
been shown to cause cancer, but contains a carcinogenic impurity, the
additive is properly evaluated under the general safety standard using
risk assessment procedures to determine whether there is a reasonable
certainty that no harm will result from the intended use of the
additive (Scott v. FDA, 728 F.2d 322 (6th Cir. 1984)).

B. Safety of the Petitioned Use of D&C Black No. 4

    In evaluating the safety of a color additive, FDA customarily
reviews the available data on each relevant chemical impurity to
determine whether the chemical induces tumors in animals or humans. If
FDA concludes that the chemical impurity causes cancer in animals or
humans, the Agency calculates the unit cancer risk for the chemical and
the upper bound limit of lifetime human cancer risk from the chemical's
presence in the additive. To establish with reasonable certainty that
D&C Black No. 4 intended to color UHMWPE non-absorbable sutures is not
harmful under the intended conditions of use, we have considered the
exposure to the color additive and its impurities, the additive's
toxicological data, and other relevant information (such as published
literature) available to us.
    The petitioner incorporated safety information that was previously
submitted to FDA on behalf of Cabot Corp. in Food Additive Petition
5B4464 by reference to support the safety of high-purity furnace black
as a colorant for polymers in food-contact applications. D&C Black No.
4 is manufactured in the same manner as the referenced high-purity
furnace black.
    The petitioner also submitted data from an extraction study testing
the migration of D&C Black No. 4 from UHMWPE sutures and provided data
from two studies demonstrating biocompatibility of UHMWPE sutures along
with other information. The petitioner's data from the extraction study
indicated that D&C Black No. 4, when added to UHMWPE non-absorbable
sutures at the maximum level of 1 percent, remains physically embedded
in the suture matrix resulting in the color additive not being detected
in the extracts at the limit of quantitation. This study evaluated the
amount of non-volatile residue (NVR) and any extractables that could
migrate from the suture. The study was performed with water, hexane,
and ethanol at 50 [deg]C for 24 hours and demonstrated that D&C Black
No. 4 does not migrate from the suture following exposure to solvents
with varying polarities and exposure to heat. The study also yielded
NVRs not able to be analyzed. To estimate potential exposure from D&C
Black No. 4, the petitioner used data from the extraction study and the
conservative assumption that all of the NVR that was extracted and not
able to be analyzed was D&C Black No. 4. The petitioner derived an
estimate for the mass amount of D&C Black No. 4 expected to migrate
over a lifetime, expressed as the mean daily exposure, based on its
proposed use level in surgical sutures, and using data for the maximum
NVR extracted and the surface area of the tested sutures.
    While FDA agrees with using the conservative assumption that all
NVR extracted was D&C Black No. 4, the petitioner's exposure estimate
represents the scenario where D&C Black No. 4 would migrate from the
sutures 1 day post-implantation. However, since non-absorbable sutures
are intended to be left in the body indefinitely post-implantation, it
is necessary to average the petitioner's exposure estimate over an
individual's lifetime post-implantation (assumed to be 70 years) to
estimate the lifetime average exposure to D&C Black No. 4. In this
manner, we estimated the lifetime average exposure to D&C Black No. 4
to

be 15.3 nanograms per person per day (ng/p/d). However, as carbon black
is known to be thermally stable, inert, and insoluble in water and
common solvents, we agree with the petitioner's conclusion that D&C
Black No. 4 is firmly embedded and does not migrate from the suture
matrix, resulting in no potential exposure to D&C Black No. 4 from
sutures that are in contact with the body (Ref. 1).
    As discussed in section II, D&C Black No. 4 has been shown to
contain low levels of PAH impurities, some of which are carcinogenic.
We have previously considered the safe use of high-purity carbon black
as a color additive in cosmetics (D&C Black No. 2; Sec.  74.2052) and
as a colorant in food-contact polymers (high-purity furnace black;
Sec.  178.3297) and set limits for PAHs in these high-purity carbon
blacks to minimize exposure. We are setting similar limits for PAHs in
D&C Black No. 4 as those established for D&C Black No. 2: Total PAHs
(not more than 0.5 milligrams per kilogram (mg/kg) (500 parts per
billion)); B[a]P (not more than 0.005 mg/kg (5 parts per billion)); and
dibenz[a,h]anthracene (not more than 0.005 mg/kg (5 parts per
billion)).
    There were no detectable PAHs at the limit of quantitation
resulting from the petitioner's extraction study. The petitioner stated
that the trace levels of PAHs in the color additive, as limited by
specifications, are strongly bound to the surface of D&C Black No. 4
carbon particles due to the powerful adsorption capabilities of the
color additive. FDA concurs that any PAH impurities are not expected to
migrate under the proposed specifications and conditions of use (Ref.
1). In calculating the lifetime average exposure to PAHs from the use
of D&C Black No. 4 in sutures, we used the conservative assumption that
total PAHs, B[a]P, and dibenz[a,h]anthracene are present in the color
additive at their specification limits. These assumptions, along with
the assumption that all NVR extracted from the sutures is D&C Black No.
4, calculated over a 70-year lifespan, results in a conservative
estimated lifetime average exposure of total PAHs of 7.7 x
10-\6\ ng/p/d, B[a]P of 7.7 x 10-\8\ ng/p/d, and
dibenz[a,h]anthracene of 7.7 x 10-\8\ ng/p/d (Ref. 1).
    Current data have shown B[a]P to be a high contributor to the total
carcinogenic potential for the PAH family (Ref. 2). To assess the risk
from exposure to PAHs, FDA has used a worst-case assumption that all
PAHs are present in D&C Black No. 4 as B[a]P. We used data from a
carcinogenesis bioassay on B[a]P, conducted by H. Brune, et al., to
estimate the upper-bound limit of lifetime human risk from exposure to
B[a]P equivalents resulting from the petitioned use of the color
additive (Ref. 3). The authors reported treatment-related benign
forestomach tumors or esophageal tumors in male rats exposed to B[a]P.
Using a linear-at-low-dose extrapolation method and tumor incidence
data from the H. Brune, et al. study, we estimated the unit cancer risk
(UCR) for B[a]P to be 1.75 (milligrams per kilogram bodyweight per day
(mg/kg bw/day))-\1\ (Ref. 4). The UCR represents the derived
cancer risk calculated per unit dose of the additive. This same UCR was
used to assess the risk from exposure to PAHs for D&C Black No. 2 (69
FR 44927, July 28, 2004) and high-purity furnace black (Ref. 5). The
lifetime cancer risk (LCR) was calculated by multiplying the UCR for
B[a]P by the estimated lifetime average exposures. This results in LCRs
of 2.24 x 10-\15\ and 2.24 x 10-\13\ for B[a]P
and total PAHs, respectively. Because of the conservative assumptions
we used to calculate the exposure estimate and the carcinogenic potency
of PAHs in the color additive, and the fact that PAHs bind tightly to
carbon black and are not expected to migrate, the lifetime-averaged
individual exposure to PAHs is likely to be substantially less than our
worst-case exposure estimate. Thus, the probable lifetime human risk
would be less than the estimated LCR. Therefore, we conclude that there
is reasonable certainty that no harm from exposure to PAHs will result
from the petitioned use of the additive (Refs. 1 and 3).

IV. Conclusion

    Based on the data and information in the petition and other
available relevant material, FDA concludes that the petitioned use of
D&C Black No. 4 for coloring UHMWPE non-absorbable sutures for use in
general surgery is safe. We further conclude that the additive will
achieve its intended technical effect and is suitable for the
petitioned uses. Based on the available information, we are amending
the color additive regulations in part 74 as set forth in this
document. In addition, in accordance with 21 CFR 71.20(b), we conclude
that batch certification of D&C Black No. 4 is necessary for the
protection of public health because of the need to limit the levels of
PAHs, some of which have been shown to be carcinogenic. Therefore, part
74 should be amended as set forth in this document.

V. Public Disclosure

    In accordance with Sec.  [thinsp]71.15 (21 CFR 71.15), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition will be made available for public
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.
[thinsp]71.15, we will delete from the documents any materials that are
not available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the notice of petition published in the Federal Register of
March 6, 2017. We stated that we had determined, under 21 CFR 25.32(l),
that this action ``is of a type that does not individually or
cumulatively have a significant effect on the human environment'' such
that neither an environmental assessment nor an environmental impact
statement is required. We have not received any new information or
comments that would affect our previous determination.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VIII. Objections

    This rule is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we

have received or lack thereof in the Federal Register.

IX. References

    The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they also are
available electronically at https://www.regulations.gov. References
that are published articles and books are not on display.

1. Memorandum from H. Lee, Division of Petition Review, Office of
Food Additive Safety (OFAS), CFSAN, FDA to J. Thomas, Division of
Petition Review, OFAS, CFSAN, FDA, dated April 27, 2018.
2. Choi H, R. Harrison, H. Komulainen, et al., ``Polycyclic Aromatic
Hydrocarbons.'' WHO Guidelines for Indoor Air Quality: Selected
Pollutants. Geneva: World Health Organization; 2010.
3. Brune H., R. P. Deutsch-Wenzel, M. Habs, et al., ``Investigation
of the Tumorigenic Response to Benzo(a)pyrene in Aqueous Caffeine
Solution Applied Orally to Sprague-Dawley Rats,'' Journal of Cancer
Research and Clinical Oncology, 102(2):153-157, 1981.
4. Memorandum from N. Anyangwe, Division of Petition Review, OFAS,
CFSAN, FDA to J. Thomas, Division of Petition Review, OFAS, CFSAN,
FDA, dated April 27, 2018.
5. Memorandum from the Indirect Additives Branch, FDA, to the
Executive Secretary, Quantitative Risk Assessment Committee, FDA,
concerning ``Estimation of the Upper-bound Lifetime Risk from
Polynuclear Aromatic Hydrocarbons (PAH's) in High-Purity Furnace
Black (HPFB): subject of Food Additive Petition No. 5B4464 (Cabot
Corp.),'' dated May 9, 1996.

List of Subjects in 21 CFR Part 74

    Color additives, Cosmetics, Drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
74 is amended as follows:

PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

0
1. The authority citation for part 74 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Section 74.3054 is added to subpart D to read as follows:

Sec.  74.3054  D&C Black No. 4.

    (a) Identity. The color additive D&C Black No. 4 is a high-purity
carbon black prepared by the oil furnace process. It is manufactured by
the combustion of aromatic petroleum oil feedstock and consists
essentially of pure carbon, formed as aggregated fine particles with a
surface area range of 50 to 260 meters (m)\2\/gram.
    (b) Specifications. D&C Black No. 4 must conform to the following
specifications and must be free from impurities other than those named
to the extent that such other impurities may be avoided by good
manufacturing practice:
    (1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method,
50 to 260 m\2\/gram.
    (2) Weight loss on heating at 950 [deg]C for 7 minutes (predried
for 1 hour at 125 [deg]C), not more than 2 percent.
    (3) Ash content, not more than 0.15 percent.
    (4) Arsenic (total), not more than 3 milligrams per kilogram (mg/
kg) (3 parts per million).
    (5) Lead (total), not more than 10 mg/kg (10 parts per million).
    (6) Mercury (total), not more than 1 mg/kg (1 part per million).
    (7) Total sulfur, not more than 0.65 percent.
    (8) Total polycyclic aromatic hydrocarbons (PAHs), not more than
0.5 mg/kg (500 parts per billion).
    (9) Benzo[a]pyrene, not more than 0.005 mg/kg (5 parts per
billion).
    (10) Dibenz[a,h]anthracene, not more than 0.005 mg/kg (5 parts per
billion).
    (11) Total color (as carbon), not less than 95 percent.
    (c) Uses and restrictions. (1) D&C Black No. 4 may be safely used
at a level not to exceed 1.0 percent by weight of the suture material
for coloring ultra-high molecular weight polyethylene non-absorbable
sutures for general surgical use.
    (2) Authorization and compliance with this use must not be
construed as waiving any of the requirements of sections 510(k), 515,
and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to
the ultra-high molecular weight polyethylene surgical sutures in which
D&C Black No. 4 is used.
    (d) Labeling. The label of the color additive must conform to the
requirements of Sec.  70.25 of this chapter.
    (e) Certification. All batches of D&C Black No. 4 must be certified
in accordance with regulations in part 80 of this chapter.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12218 Filed 6-6-18; 8:45 am]
BILLING CODE 4164-01-P


Technical Support Document (TSD)

for the final Transport Rule

Docket ID No. EPA-HQ-OAR-2009-0491

Assurance Penalty Level Analysis Final Rule TSD

U.S. Environmental Protection Agency

Office of Air and Radiation

June 2011Assurance Penalty Level Analysis Final Rule TSD

	This Technical Support Document (TSD) supports EPA’s determination
that the final Transport Rule’s assurance provision penalty
requirement provides sufficient deterrence against a state exceeding its
assurance level. Section VII.E in the final Transport Rule preamble
discusses the assurance provisions, including the allowance surrender
penalty analyzed in this TSD. This TSD is organized as follows:

1. Background

2. Approach

3. Results

1. Background

The final Transport Rule’s limited interstate trading programs include
assurance provisions to ensure that the necessary reductions will occur
within each covered state.  The assurance provisions limit emissions
from covered units in a state to the state’s emissions budget plus
variability limit, i.e., the state’s assurance level.

As described in preamble section VI.D, EPA used a multi-factor analysis
to determine each state’s emissions budget.  Subsequently, as
described in VI.F, EPA determined variability limits for each state that
reflect a percentage of the state’s budget (e.g., 10%).  This
variability limit is then added to the state budget to yield the
state’s assurance level. If emissions from covered sources in a state
in a compliance period exceed the state’s assurance level, then EPA
applies additional criteria to determine which owners and operators of
units in the state will be subject to an allowance surrender penalty of
two allowances per ton for their share of the emissions over the
assurance level.  This penalty is in addition to the standard program
requirement that owners and operators of covered units hold one
allowance for each ton emitted; therefore, for any emissions identified
by EPA as being over the state’s assurance level, the relevant owners
and operators must submit a total of three allowances per ton – one of
which is for standard compliance for emitting under the program, and two
of which are for the assurance provision penalty.

As discussed in preamble section VI.F, EPA does not find reason to
expect that emissions from covered sources in any state will exceed that
state’s assurance level.  The description and tables below describe a
sensitivity analysis EPA conducted to determine whether the two-for-one
allowance surrender penalty provides a sufficient deterrent to keep
emissions from covered sources in each state from exceeding the
assurance levels.

2. Approach

To determine if a penalty of two allowances for every ton of excess
emissions would be sufficient, EPA used the Integrated Planning Model
(IPM) to assess a “TR_Penalty_Scenario” whose results, along with
the results of other IPM model runs for the Transport Rule, can be found
in the docket. More information on IPM can be found in the Documentation
Supplement for EPA Base Case v.4.10_FTransport – Updates for Final
Transport Rule, which is also in the docket. This penalty scenario
offered covered sources in each state the choice to emit beyond the
state’s assurance level and incur a fine for each excess ton worth
twice the value of an allowance (in addition to having to submit one
allowance for emitting each ton, per standard compliance procedures).
In this analysis, the “state assurance level” is the state’s
emissions budget plus the state’s variability limit and corresponds to
the “state emissions assurance level” in tables VI.F-1 and VI.F-2 of
the preamble. The size of the penalty was calculated as twice the
allowance price for the relevant pollutant taken from the IPM analysis
of the final rule’s remedy (TR_Limited_Trading_Final), as shown in
Table 1.

Table 1. Allowance prices (2007$) in the final remedy
(TR_Limited_Trading Final) and Penalty Costs in the “assurance penalty
sensitivity” run (TR_Penalty_Scenario)

 	Emission Allowance Prices ($/Ton) from final remedy run	Emission
Penalty Costs ($/Ton) in the assurance penalty sensitivity run

 	2012	2014	2012	2014

SO2 Region 1 (TR)	971	1,127	1,942	2,254

SO2 Region 2 (TR)	576	663	1,152	1,327

NOx Annual (TR)	497	577	994	1,153

NOx Ozone Season (TR)	1,321	1,532	2,642	3,064

It is important to consider that while the effective fine in this
scenario (twice the value of the relevant pollutant’s allowance price)
is a technically valid representation of the final rule’s penalty
structure, it is an analytic understatement of the actual deterrence
value of this penalty in practice.  The penalty in practice will have
more of a deterrent effect than what this scenario models it to have for
two reasons.  First, the penalty cost as modeled is fixed at twice the
allowance price in the final remedy scenario (TR_Limited_Trading_Final)
for every ton of emissions in excess of a state’s assurance level.  In
reality, excess emissions would increase the allowance price (and
therefore the cost of the penalty itself) since allowances would have to
be bought and surrendered for the penalty, raising allowance demand and
thus making them more valuable.  The modeling imposed a fine and did not
adjust the allowance pool to account for penalty surrenders, and so it
understates the cost of the penalty incurred.  Second, the model has
perfect foresight of all future emitting behavior and thus does not take
any “risk” into account when determining whether excess emissions
are “worth it” at the penalty cost modeled.  In reality, owners and
operators of covered units will assign a risk premium to the nominal
penalty consequence because they do not have perfect foresight and
cannot be sure of their precise emissions until the compliance period is
complete.  Therefore, program participants can be expected to act more
“conservatively” than the modeling would suggest when determining
whether excess emissions are “worth it” at the penalty cost modeled,
which suggests again that this analysis understates the deterrence value
of the penalty in practice.

3. Results

EPA compared the state-level emissions in 2012 and 2014 in this analysis
to the state assurance levels to determine whether the penalty level
deterred excess emissions.  Tables 2 through 5 show the state assurance
levels and modeled emissions from covered sources in each state.  The
modeled allowance prices in 2012 and 2014 for each pollutant are shown
at the bottom of each table. The penalty for exceeding the assurance
level would be equal to twice the allowance price.

In no case do the covered emissions in a state exceed that state’s
assurance level in 2012 or 2014. This result indicates that the penalty
offers a sufficient deterrent to ensure emissions do not exceed
assurance levels in 2012 and 2014.  Even though the modeling of this
scenario understated the actual value of the deterrent in practice, in
no state did the covered sources find it economic to exceed the
states’ assurance levels in 2012 and 2014.

	In some states, the covered sources in a state are modeled to have
collective emissions that are exactly equal to the state’s assurance
level.  These projections occur because the model operates under perfect
foresight and perfect information, and it therefore allows sources in
the modeling to emit up to the state’s assurance level with full
certainty that emissions will respect that constraint to the last ton
emitted, successfully avoiding additional emissions which are shown to
be uneconomic under the assurance penalty.  In reality, the deterrence
value of the penalty would likely lead a state’s covered sources to
act conservatively by emitting below a state’s assurance level (rather
than exactly up to it) to ensure that unexpected fluctuations in
emissions do not result in a penalty.

	In some cases, notably SO2 Group 1 states, the covered emissions are
projected to be significantly lower than the states’ assurance levels
in 2012.  This would occur if covered sources decide to reduce their
emissions beyond what is required so they can bank the excess
allowances. These banked allowances could then used to cover emissions
in future years. Specifically, the SO2 Group 1 state budgets were
determined by the feasible emission reductions at $500/ton SO2 in 2012
and $2300/ton SO2 in 2014 (see Significant Contribution and State
Emissions Budgets Final Rule TSD). Covered sources in these states may
decide to reduce their emissions further than required in 2012 and 2013
and bank the unused allowances for use in 2014 and later years. This
pattern effectively smooths their emission reductions over time to
minimize total compliance costs in those states.  The modeled allowance
prices in those states also reflect this smoothing of emission reduction
patterns. For example, as seen in Table 2, the 2012 and 2014 projected
allowance prices for Group 1 SO2 states are closer to each other than
the marginal cost thresholds used to formulate their budgets in those
years ($500 per ton in 2012 and $2,300 per ton in 2014).  This banking
behavior to smooth emission reductions over time is shown in this
analysis to be entirely consistent with each state’s assurance levels
in both 2012 and 2014.

	As noted above, EPA’s modeling of this scenario projects no instance
in which covered sources would find it economic to exceed a state’s
assurance level in any of the programs in 2012 or 2014.  This analysis
also projects that the penalty provides sufficient deterrence for
virtually all states in these programs over the 2020-2030 timeframe as
well.  However, the projections appear to suggest small exceedances in
two states in 2020 and in three states in 2030.  In most of these cases,
the projected exceedances are marginal – on the order of two hundred
tons of pollutant.  EPA does not believe that these longer-run results
actually indicate a likelihood of these exceedances occurring.  It is
important to note that this modeling assumes perfect foresight and
perfect information, even into the 2020-2030 timeframe, and that under
those assumptions, unit owners and operators would be willing to expend
banked allowances in those years even to the point of paying assurance
penalties on them.  In reality, operators of covered units do not have
perfect foresight or perfect information and will therefore act more
conservatively than “optimal” banking patterns from IPM modeling
would indicate.

As a result, EPA expects sources will collectively continue to respect
their states’ assurance levels in those instances by sustaining the
Transport Rule emission reductions into the 2020-2030 timeframe and
banking allowances further into the future to guard against
unanticipated developments that the model does not capture.
Consequently, EPA does not believe that these limited small instances of
projected exceedances in 2020 or 2030 are likely to occur in the actual
operation of these programs.  However, EPA will monitor the pattern of
compliance with these programs over the long-run and will be prepared to
adjust the penalty accordingly if evidence suggests that increased
deterrence would be necessary at those later stages to encourage states
to respect their assurance levels. At this point, EPA believes that it
is best to be sure in the initial years that the assurance penalty is
effective in keeping emissions within variability limits, while
encouraging trading to lower costs and increase flexibility and avoiding
actions that have a chilling effect on activities.  While doing this,
EPA believe it is important to remain mindful that we do want assurance
of meeting emission reductions over time.

EPA believes these findings support a determination that the penalty
requirement of surrendering two additional allowances for each ton of
excess emissions provides a sufficient deterrent in the final Transport
Rule such that EPA does not expect the covered sources in any state to
exceed the state’s assurance levels under these programs.

Table 2. Annual SO2 Group 1 State Assurance Levels and Emissions in 2012
and 2014 (TR_Penalty_Scenario)

 	2012	2014

	State Assurance Level 	Penalty Case Emissions	State Assurance Level
Penalty Case Emissions

 	(thousand tons)	(thousand tons)	(thousand tons)	(thousand tons)

Illinois	258	210	137	128

Indiana	314	241	177	177

Iowa	118	75	83	78

Kentucky	208	146	117	117

Maryland	33	27	31	30

Michigan	214	190	158	158

Missouri	228	182	183	177

New Jersey	7	6	7	7

New York	23	20	13	13

North Carolina	151	117	63	63

Ohio	341	229	151	151

Pennsylvania	307	250	123	123

Tennessee	163	97	65	65

Virginia	78	67	39	39

West Virginia	161	119	83	83

Wisconsin	87	77	44	44

Table 3. Annual SO2 Group 2 State Assurance Levels and Emissions in 2012
and 2014 (TR_Penalty_Scenario)

 	2012	2014

	State Assurance Level 	Penalty Case Emissions	State Assurance Level
Penalty Case Emissions

 	(thousand tons)	(thousand tons)	(thousand tons)	(thousand tons)

Alabama	238	219	235	173

Georgia	174	159	105	93

Kansas	46	41	46	46

Minnesota	46	43	46	45

Nebraska	72	65	72	70

South Carolina	97	85	97	97

Texas	268	244	268	266

Table 4. Annual NOX State Assurance Levels and Emissions in 2012 and
2014  (TR_Penalty_Scenario)

 	2012	2014

	State Assurance Level 	Penalty Case Emissions	State Assurance Level
Penalty Case Emissions

 	(thousand tons)	(thousand tons)	(thousand tons)	(thousand tons)

Alabama	80	74	79	68

Georgia	68	61	45	40

Illinois	53	48	53	49

Indiana	121	110	119	110

Iowa	42	37	41	38

Kansas	34	31	28	24

Kentucky	94	84	85	76

Maryland	18	16	18	17

Michigan	66	59	64	57

Minnesota	33	31	33	31

Missouri	58	52	54	49

Nebraska	29	26	29	27

New Jersey	8	7	8	8

New York	20	18	20	17

North Carolina	56	48	46	42

Ohio	102	85	96	84

Pennsylvania	132	118	131	117

South Carolina	36	33	36	36

Tennessee	39	33	21	20

Texas	147	133	147	137

Virginia	37	33	37	35

West Virginia	65	56	60	53

Wisconsin	35	31	33	30

Table 5. Ozone Season NOX State Assurance Levels and Emissions in 2012
and 2014  (TR_Penalty_Scenario)*

 	2012	2014

	State Assurance Level 	Penalty Case Emissions	State Assurance Level
Penalty Case Emissions

 	(thousand tons)	(thousand tons)	(thousand tons)	(thousand tons)

Alabama	35	32	35	30

Arkansas	18	15	18	17

Florida	31	28	31	29

Georgia	32	27	21	18

Illinois	23	21	23	21

Indiana	52	47	51	47

Iowa	18	16	18	16

Kansas	15	13	12	10

Kentucky	40	35	36	32

Louisiana	16	14	16	14

Maryland	8	7	8	7

Michigan	28	25	27	24

Mississippi	12	11	12	11

Missouri	25	22	23	21

New Jersey	4	3	4	4

New York	10	8	10	8

North Carolina	24	21	20	18

Ohio	44	35	42	36

Oklahoma	24	21	24	21

Pennsylvania	57	50	57	50

South Carolina	15	14	15	15

Tennessee	17	14	9	8

Texas	69	63	69	64

Virginia	17	14	17	15

West Virginia	28	23	26	22

Wisconsin	16	13	15	13

*As discussed in section III of the Transport Rule preamble, the final
rule does not include the states of Iowa, Kansas, Michigan, Missouri,
Oklahoma, or Wisconsin in the ozone season program.  EPA issued a
supplemental proposal to include these six states in the Transport Rule
ozone season program.

  The assurance provision allowance surrender penalty addressed in this
TSD is distinct from the penalties, discussed in preamble section VII.F,
that apply to the trading program requirement to hold allowances
sufficient to cover emissions for each compliance period.

	  PAGE   \* MERGEFORMAT  1

Deliberative – Do not cite or quote


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Notices]
[Page 72473]
[DOCID:fr28no08-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER05-644-009]

PSEG Energy Resources & Trade LLC; Notice of Filing

November 21, 2008.
    Take notice that on October 20, 2008, PSEG Energy Resources & Trade
LLC filed an informational filing of a memorandum of accounts of annual
increases to FERC Account No. 108, Accumulated Provision for
Depreciation of Electric Utility Plant using imputed depreciation rates
as set forth in Appendix B of the September 23, 2005, Stipulation and
Agreement, Article II, and accepted by the Commission's Order issued
November 28, 2005, PSEG Energy Resources & Trade LLC et al., 113 FERC
61,213 (2005).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on December 5, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28287 Filed 11-26-08; 8:45 am]

BILLING CODE 6717-01-P


John Silvasi/ RTP/ USEPA/ US 08/ 02/ 2005 03: 47 PM To Amy_ E._ Flynn@ omb. eop. gov, Arthur_ G._ Fraas@ omb. eop. gov, Denise Gerth, Dou Grano, Jim Ketcham Colwill, Lydia Wegman/ RTP/ USEPA/ US@ EPA, Robert Meyers/ DC/ USEPA/ US@ EPA, Sara Schneeberg, To Helms cc Subject CORRECTION: Re: Revised RACT language from t morning's call Amy pointed out that I had duplicated one of the sentences that was supposed to be moved, and I hadn't placed anothe sentence in the correct order. I believe this version will correct that; sorry for the errors.

John J. Silvasi Environmental Engineer Ozone Policy and Strategies Group ( C539 02) Office of Air Quality Planning and Standards U. S. Environmental Protection Agency Research Triangle Park, NC 27711 919 541 5666 ( v); 919 541 0824 ( fax) silvasi. john@ epa. gov John Silvasi/ RTP/ USEPA/ US 08/ 02/ 2005 01: 44 PM To Art Fraas, Amy Flynn cc Doug Grano, Tom Helms, Sara Schneeberg, Jim Ketcham Colwill, Robert Meyers/ DC/ USEPA/ US@ E Denise Gerth, Lydia Wegman/ RTP/ USEPA/ US@ EP Subject Revised RACT language from this morning's call Dealing with discussion from pp. 278 & 279 of 7/ 8/ 05 RLSO version:

John J. Silvasi Environmental Engineer Ozone Policy and Strategies Group ( C539 02) Office of Air Quality Planning and Standards U. S. Environmental Protection Agency Research Triangle Park, NC 27711 919 541 5666 ( v); 919 541 0824 ( fax) silvasi. john@ epa. gov


[Federal Register: October 6, 2008 (Volume 73, Number 194)]
[Notices]
[Page 58276]
[DOCID:fr06oc08-121]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Wednesday,
October 1, 2008, at 2 p.m.
    Commissioners, Counsels to the Commissioners, the Secretary to the
Commission, and certain staff members who have an interest in the
matter will attend the Closed Meeting.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions as set
forth in 5 U.S.C. 552b(c)(8) and (9) and 17 CFR 200.402(a)(8) and (9),
permit consideration of the scheduled matter at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the item
listed for the closed meeting in closed session, and determined that no
earlier notice thereof was possible.
    The subject matter of the Closed Meeting scheduled for Wednesday,
October 1, 2008, will be: Matters Related to the Financial Markets.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact: The Office of the Secretary at<PHONE_NUMBER>.

    Dated: October 1, 2008.
Jill M. Peterson,
Assistant Secretary.
 [FR Doc. E8-23498 Filed 10-3-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: May 19, 2010 (Volume 75, Number 96)]
[Proposed Rules]
[Page 27959-27961]
[DOCID:fr19my10-13]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0477; Directorate Identifier 2009-NM-226-AD]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited Model
BAe 146 and Avro 146-RJ Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as: Three events have been reported where insulation material
was found to be fouling pulleys in the aileron interconnect circuit in
the cabin roof area. Interference between the cable and the insulation
bag causes the material to be drawn into the gap between the pulley and
the pulley guard. This condition, if not detected and corrected, could
lead to restricted

aileron movement and consequently, reduced control of the aeroplane.
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by July 6, 2010.

ADDRESSES: You may send comments 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 W12-40, 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 proposed AD, contact BAE
Systems Regional Aircraft, 13850 McLearen Road, Herndon, Virginia
20171; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet http://www.baesystems.com/Businesses/RegionalAircraft/
index.htm. You may review copies of the referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW.,
Renton, Washington. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
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: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1175; 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-2010-0477;
Directorate Identifier 2009-NM-226-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 have lengthened the 30-day comment period for proposed ADs that
address MCAI originated by aviation authorities of other countries to
provide adequate time for interested parties to submit comments. The
comment period for these proposed ADs is now typically 45 days, which
is consistent with the comment period for domestic transport ADs.
    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

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2009-0205, Revision 1, dated January 12, 2010
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    Three events have been reported where insulation material was
found to be fouling pulleys in the aileron interconnect circuit in
the cabin roof area. The insulation material is contained in a bag,
the material of which tends to become brittle with age. During the
production life of the aeroplane type, several methods of bag
retention were applied, all of which involved puncturing the bag.
This puncture tends to result in a tear, which, if detected in time,
can be repaired with tape; however, the affected cabin roof area is
not frequently accessed for inspection. Over time, the weight of the
bag also tends to cause tears in the material, making the insulation
material sag, thereby causing interference with the cable and
pulley.
    Interference between the cable and the insulation bag causes the
material to be drawn into the gap between the pulley and the pulley
guard. This condition, if not detected and corrected, could lead to
restricted aileron movement and consequently, reduced control of the
aeroplane.
    For the reasons described above, this AD requires the
installation of additional guards, bolts and nuts on the aileron
interconnect cable pulleys at frame 29 (left and right).
    This AD has been revised to exclude aeroplanes from the
Applicability that have been modified to freighter configuration in
accordance with BAE Systems modification No. HCM50200B. As this
modification includes the removal of the insulation bags, the unsafe
condition that is addressed by this AD cannot exist or develop on
those aeroplanes.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    BAE Systems (Operations) Limited has issued Modification Service
Bulletin SB.27-183-36246A, dated December 9, 2008. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

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 the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 1 product of U.S. registry. We also estimate that it
would take about 5 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $340 per product. Where the
service information lists required parts costs that are covered under
warranty, we have assumed that there will be no charge for these costs.
As we do not control

warranty coverage for affected parties, some parties may incur costs
higher than estimated here. Based on these figures, we estimate the
cost of the proposed AD on U.S. operators to be $765.

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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

BAE Systems (Operations) Limited: Docket No. FAA-2010-0477;
Directorate Identifier 2009-NM-226-AD.

Comments Due Date

    (a) We must receive comments by July 6, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to BAE SYSTEMS (Operations) Limited Model
BAe 146-100A, -200A, and -300A series airplanes and Model Avro 146-
RJ70A, 146-RJ85A, and 146-RJ100A airplanes, certificated in any
category, all serial numbers, except those airplanes modified to
freighter configuration in accordance with BAE Systems modification
No. HCM50200B.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
Controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Three events have been reported where insulation material was
found to be fouling pulleys in the aileron interconnect circuit in
the cabin roof area.
    Interference between the cable and the insulation bag causes the
material to be drawn into the gap between the pulley and the pulley
guard. This condition, if not detected and corrected, could lead to
restricted aileron movement and consequently, reduced control of the
aeroplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 6 months after the effective date of this AD, install
new aileron interconnect cable pulley guards, in accordance with
paragraph 2.C. ``Modification'' of the Accomplishment Instructions
of BAE SYSTEMS (Operations) Limited Modification Service Bulletin
SB.27-183-36246A, dated December 9, 2008.

FAA AD Differences

    Note 1: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (h) 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. Send information to ATTN: Todd
Thompson, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0205, Revision 1, dated January 12, 2010; and BAE
SYSTEMS (Operations) Limited Modification Service Bulletin SB.27-
183-36246A, dated December 9, 2008; for related information.

    Issued in Renton, Washington, on May 4, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-11903 Filed 5-18-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60156-60157]
[FR Doc No: 2020-21109]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0049; FRL-10014-75]

Pesticide Product Registration; Receipt of Applications for New
Active Ingredients (August 2020)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and
opportunity to comment on these applications.

DATES: Comments must be received on or before October 26, 2020.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the File Symbol of interest as shown in the body of
this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Anne Overstreet, Biopesticides and
Pollution Prevention Division (7511P), main telephone number: (703)
305-7090, email address<EMAIL_ADDRESS>or Marietta Echeverria,
Registration Division (7505P), main telephone number:<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any currently registered
pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4)
(7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and
opportunity to comment on these applications. Notice of receipt of
these applications does not imply a decision by the Agency on these
applications. For actions being evaluated under EPA's public
participation process for registration actions, there will be an
additional opportunity for public comment on the proposed decisions.
Please see EPA's public participation website for additional
information on this process (http://www2.epa.gov/pesticide-registration/public-participation-process-registration-actions).

A. New Active Ingredient

    1. File Symbols: 93778-R, 93778-E, 93778-G, and 93778-U. Docket ID
number: EPA-HQ-OPP-2020-0250. Applicant: AgriMetis, LLC, c/o Wagner
Regulatory Associates Inc, P.O. Box 640, Hockessin, DE 19707. Product
names: L-Glufosinate Ammonium Technical, AgriMetis Glu-L280, AgriMetis
Glu-L 280 SL, and AgriMetis Glu-L 280 SLX. Active ingredient:
Herbicide--L-Glufosinate Ammonium at 77.62% (L-Glufosinate Ammonium
Technical) and 24.5% (AgriMetis Glu-L280, AgriMetis Glu-L 280 SL, and
AgriMetis Glu-L 280 SLX) Proposed uses: Banana; beet, sugar; bushberry,
subgroup 13-07B; canola; corn, field; corn, sweet; cotton; fruit,
citrus, group 10-10; fruit, pome, group 11-10; fruit, stone, group 12-
12; grape; juneberry; lingonberry; nut, tree, group 14-12; non-crop,
industrial areas and residential outdoor uses; olive; potato; salal and
soybean. Contact: RD.
    2. File Symbol: 94339-R. Docket ID number: EPA-HQ-OPP-2020-0457.
Applicant: Better Air International Limited, 1 Ha-Tsmikha St., High
Tech Park, Yokneam Illit 2069205, Israel (c/o Environmental Consulting,
15616 Plain Dealing Place, Manassas, VA 20112). Product name: EB-8.
Active ingredients: Fungicide and Bactericide--Bacillus subtilis strain
3 at 0.02%, Bacillus amyloliquefaciens strain 298 at 0.02%, and
Bacillus subtilis strain 281 at 0.02%. Proposed use: For the control or
suppression of odor-causing and discoloration-causing bacterial and
fungal growth in commercial and residential areas. Contact: BPPD.

    Authority: 7 U.S.C. 136 et seq.

    Dated: September 10, 2020.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2020-21109 Filed 9-23-20; 8:45 am]
BILLING CODE 6560-50-P