[Federal Register: January 15, 2009 (Volume 74, Number 10)]
[Rules and Regulations]
[Page 2373-2376]
[DOCID:fr15ja09-15]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-1236]
RIN 1625-AA87

Security Zone; Steam Generator Transit, Captain of the Port Zone
San Diego; San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving security
zone around steam generators as they transit through and when moored in
the Captain of the Port(COTP) zone San Diego. This security zone is
needed to prevent vessels from transiting in the vicinity of the
generators to help ensure the safety and security of the operation.
Entry into this zone will be prohibited unless specifically authorized
by the Captain of the Port, San Diego, or his designated
representative.

DATES: This rule is effective from 11:59 p.m. on January 2, 2009, to
11:59 p.m on January 22, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-1236 and are available online
at http://www.regulations.gov. They are also available for inspection
or copying two locations: the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590,

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays, and the U.S. Coast Guard Sector San Diego, 2710 N. Harbor
Drive, San Diego, CA 92101 between 8 a.m. and 3 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Petty Officer Shane Jackson, USCG, Waterways
Management, U.S. Coast Guard Sector San Diego at<PHONE_NUMBER>. If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it was impracticable since the
logistical details of the steam generators transit in the Captain of
the Port Zone San Diego was not finalized nor presented to the Coast
Guard in enough time to draft and publish an NPRM. As such, the event
would occur before the rulemaking process was complete.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. The issuance of the final approval
and permitting was so recent that the rule would be made effective less
than 30 days after publication.

Background and Purpose

    Steam Generators will be transiting to San Onofre Nuclear Power
Plant. Due to the operational significance of the cargo the Captain of
the Port is establishing a security zone to prevent vessels from
transiting the area and to protect the generators and personnel from
potential damage and injury.

Discussion of Rule

    The Coast Guard is establishing a temporary moving security zone
that will be enforced from 11:59 p.m. on January 2, 2009, to 11:59 p.m
on January 22, 2009. The limits of the security zone will include all
waters of the Pacific Ocean extending from the surface to the sea
floor, within 200 yards ahead, and 100 yards on each side and astern of
the steam generators while underway and 100 yards on all sides when
moored in the navigable waters of COTP zone San Diego.
    Persons and vessels are prohibited from entering into or transiting
through this security zone unless authorized by the Captain of the
Port, or his designated representative. By prohibiting all vessel
traffic from entering the waters surrounding these generators, the
security of the cargo will be enhanced. U.S. Coast Guard personnel will
enforce the security zone.
    The Captain of the Port may, in his discretion grant waivers or
exemptions to this rule, either on a case-by-case basis or
categorically to a particular class of vessel that otherwise is subject
to adequate control measures.
    The Coast Guard will issue a Broadcast Notice to Mariners to
further ensure the local boating traffic is aware of the security zone
and its geographical boundaries. Vessels or persons violating this
section will be subject to both criminal and civil penalties.
    The security zone will be effective from 11:59 p.m. on January 2,
2009, to 11:59 p.m on January 22, 2009. A Broadcast Notice to Mariners
will notify the public on the specific days of transit.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. This
determination is based on the size and location of the security zone.
The affected area will be relatively small in size and will only
briefly affect the transits of other vessels.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    We anticipate that the security zone would not have a significant
economic impact on a substantial number of small entities for the
following reasons. This rule would only affect those small portions of
the waterways immediately surrounding the military operations within
the COTP Zone. Before the effective period, the Coast Guard will issue
maritime advisories widely available to users of the waterways so
owners and operators can make necessary preparations. Traffic may also
be allowed to pass through the security zone with the permission of the
Coast Guard patrol commander or COTP.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process. Small
businesses may send comments on the actions of Federal employees who
enforce, or otherwise determine compliance with, Federal regulations to
the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard
will not retaliate against small entities that question or complain

about this rule or any policy or action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
under the Instruction that there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T11-132 to read as follows:

Sec.  165.T11-132  Security zone; Steam generator transit, Captain of
the port zone San Diego; San Diego, California.

    (a) Location. The security zone will include all waters of the
Pacific Ocean extending from the surface to the sea floor, within 200
yards ahead, and 100 yards on each side and astern of the steam
generators, while underway and 100 yards on all side when moored in the
navigable waters of COTP zone San Diego, as defined in 33 CFR 3.55-15.
    (b) Enforcement Period. This section will be enforced from 11:59
p.m. on January 2, 2009, to 11:59 p.m on January, 22, 2009. If the need
for the security zone ends before the scheduled termination time, the
Captain of the Port will cease enforcement of this security zone and
will announce that fact via Broadcast Notice to Mariners.
    (c) Definitions. The following definition applies to this section:
    Designated representative, means any Commissioned, Warrant, and
Petty Officers of the Coast Guard onboard Coast Guard, Coast Guard
Auxiliary, or local, state, and federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port to
assist in enforcement of this section.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated on-scene representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Sector San Diego
Command Center (COMCEN). The COMCEN may be contacted on VHF-FM Channel
16.
    (3) All persons and vessels shall comply with the instructions of
the

Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies in the enforcement of this section.

    Dated: January 2, 2009.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. E9-849 Filed 1-14-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Proposed Rules] [Pages 52787-52789] [FR Doc No: 2018-22659]

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Proposed Rules

                                                Federal Register

________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of

the proposed issuance of rules and regulations. The purpose of these

notices is to give interested persons an opportunity to participate in

the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 /

Proposed Rules

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0577; FRL-9984-21]

Receipt of Several Pesticide Petitions Filed for Residues of

Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of several

initial filings of pesticide petitions requesting the establishment or

modification of regulations for residues of pesticide chemicals in or

on various commodities.

DATES: Comments must be received on or before November 19, 2018.

ADDRESSES: Submit your comments, identified by the docket

identification (ID) number and the pesticide petition number (PP) 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 http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along

with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division

(7505P), main telephone number:<PHONE_NUMBER>, email address:

[email protected]; or Robert McNally, Biopesticides and Pollution

Prevention Division (7511P), main telephone number:<PHONE_NUMBER>,

email address: [email protected]. 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).

     Pesticide manufacturing (NAICS code 32532).

    If you have any questions regarding the applicability of this

action to a particular entity, consult the person listed under FOR

FURTHER INFORMATION CONTACT for the division listed at the end of the

pesticide petition summary of interest.

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 http://www.epa.gov/dockets/comments.html.

    3. Environmental justice. EPA seeks to achieve environmental

justice, the fair treatment and meaningful involvement of any group,

including minority and/or low-income populations, in the development,

implementation, and enforcement of environmental laws, regulations, and

policies. To help address potential environmental justice issues, the

Agency seeks information on any groups or segments of the population

who, as a result of their location, cultural practices, or other

factors, may have atypical or disproportionately high and adverse human

health impacts or environmental effects from exposure to the pesticides

discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing its receipt of several pesticide petitions filed

under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),

21 U.S.C. 346a, requesting the establishment or modification of

regulations in 40 CFR part 180 for residues of pesticide chemicals in

or on various food commodities. The Agency is taking public comment on

the requests before responding to the petitioners. EPA is not proposing

any particular action at this time. EPA has determined that the

pesticide petitions described in this document contain the data or

information prescribed in FFDCA section 408(d)(2), 21 U.S.C.

346a(d)(2); however, EPA has not fully evaluated the sufficiency of the

submitted data at this time or whether the data support granting of the

pesticide petitions. After considering the public comments, EPA intends

to evaluate whether and what action may be warranted. Additional data

may be needed before EPA can make a final determination on these

pesticide petitions.

    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions

that are the subject of this document, prepared by the petitioner, is

included

in a docket EPA has created for each rulemaking. The docket for each of

the petitions is available at http://www.regulations.gov.

    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA

is publishing notice of the petitions so that the public has an

opportunity to comment on these requests for the establishment or

modification of regulations for residues of pesticides in or on food

commodities. Further information on the petitions may be obtained

through the petition summaries referenced in this unit.

A. Amended Tolerance For Inerts

    PP IN-11139. (EPA-HQ-OPP-2018-0243). Monsanto Company, 1300 I

Street, NW, Washington, DC 20005, requests to amend tolerances 40 CFR

180.471 for residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2,2-

dimethyloxazolidine; CAS Reg. No. 121776-33-8) when used as an inert

ingredient (herbicide safener) in or on the raw agricultural

commodities corn, sweet, forage at 0.01 ppm, corn, sweet, kernel plus

cob with husks removed at 0.01 parts per million (ppm), and, corn,

sweet, stover at 0.01 ppm. The gas liquid chromatography/mass

spectrometry with selected ion monitoring method is used to measure and

evaluate the chemical furilazole. Contact: RD.

B. Amended Tolerances for Non-Inerts

    1. PP 8E8684. (EPA-HQ-OPP-2018-0514). Interregional Research

Project Number 4 (IR-4), Rutgers, The State University of New Jersey,

500 College Road East, Suite 201W, Princeton, NJ 08540, proposes upon

establishment of the tolerances referenced in this document under ``New

Tolerances'' for PP 8E8684, to remove existing tolerances in 40 CFR

180.585 for residues of the herbicide pyraflufen-ethyl, ethyl 2-[2-

chloro-5-(4-chloro-5-difluoromethoxy)-1-methyl-1H-pyrazol-3-yl]-4-

fluorophenoxy] acetate, and its acid metabolite, E-1, 2-chloro-5-(4-

chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-

fluorophenoxyacetic acid, calculated as the stoichiometric equivalent

of pyraflufen-ethyl in or on cotton, undelinted seed at 0.04 ppm;

fruit, stone, group 12 at 0.01 ppm; grape at 0.01 ppm; nut, tree, group

14 at 0.01 ppm; olive at 0.01 ppm; and pistachio at 0.01 ppm. Contact:

RD.

    2. PP 8E8689. (EPA-HQ-OPP-2018-0560). IR-4, Rutgers, The State

University of New Jersey, 500 College Road East, Suite 201W, Princeton,

NJ 08540, proposes upon establishment of the tolerances referenced in

this document under ``New Tolerances'' for PP 8E8689, to remove

existing tolerances in 40 CFR 180.553 for residues of the fungicide

fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-1-methyl

cyclohexanecarboxamide in or on the raw agricultural commodities:

Bushberry subgroup 13B at 5.0 ppm; caneberry subgroup 13A at 20.0 ppm,

cilantro, leaves at 30.0 ppm, fruit, stone, group 12, except plum,

prune, fresh, postharvest at 10.0 ppm; grape at 4.0 ppm; juneberry at

5.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A,

except spinach at 30.0 ppm; lingonberry at 5.0 ppm; salal at 5.0 ppm;

strawberry at 3.0 ppm; and vegetable, fruiting, group 8, except nonbell

pepper at 2.0 ppm. The ``Method for the Determination of KBR 2738 (TM-

402) Residues in Plant Material by HPLC'' is used to measure and

evaluate the chemical fenhexamid. Contact: RD.

C. New Tolerance Exemptions for Inerts (Except PIPs)

    1. IN-11109. (EPA-HQ-OPP-2018-0201). Exponent, Inc. (1150

Connecticut Ave, Suite 1100, NW, Washington, DC 20036) on behalf of

Croda, Inc. (315 Cherry Lane, New Castle, DE 19720) requests to

establish an exemption from the requirement of a tolerance for residues

of C1-C4 linear and branched chain alkyl d-glucitol dianhydro alkyl

ethers (C1-C4 Linear and Branched Chain AD-GDAE) cluster (D-glucitol,

1,4:3,6-dianhydro-2,5-di-O-methyl-(CAS Reg. No. 5306-85-4), D-glucitol,

1,4:3,6-dianhydro-2,5-di-O-ethyl- (CAS Reg. No. 30915-81-2), D-

glucitol, 1,4:3,6-dianhydro-2,5-di-O-propyl) (CAS Reg. No.107644-13-3),

D-glucitol, 1,4:3,6-dianhydro-2,5-bis-O-(1-methylethyl) -,(iso-propyl

diether) (CAS Reg. No. 103594-41-8), D-glucitol, 1,4:3,6-dianhydro-2,5-

di-O-butyl-(CAS Reg. No. 103594-41-9), D-glucitol, 1,4:3,6-dianhydro-

2,5-di-O-(1-methylpropyl)-, (CAS Reg. No. not assigned) and D-glucitol,

1,4:3,6-dianhydro-2,5-di-O-(2-methylpropyl)-, (CAS Reg. No. not

assigned) when used as an inert ingredient (solvent, co-solvent,

viscosity modifier and adjuvant) in pesticide formulations applied to

growing crops and raw agricultural commodities after harvest under 40

CFR 180.910, applied in/on animals under 40 CFR 180.930, in

antimicrobial formulations used in food contact surfaces in public

eating places, dairy processing equipment, and food-processing

equipment and utensils under 40 CFR 180.940(a) and in antimicrobial

formulations used for dairy processing equipment, and food-processing

equipment and utensils under 40 CFR 180.940(b). The petitioner believes

no analytical method is needed because it is not required for an

exemption from the requirement of a tolerance. Contact: RD.

    2. PP IN-11126. (EPA-HQ-OPP-2018-0191). Spring Trading Company on

behalf of Clariant, 4000 Monroe Rd., Charlotte, NC 28205, requests to

establish an exemption from the requirement of a tolerance for residues

of N,N-Dimethylnonanamide (CAS Reg. No. 6225-08-7) when used as a

pesticide inert ingredient in pesticide formulations applied to growing

crops and raw agricultural commodities after harvest under 40 CFR

180.910 and in pesticide formulations applied to animals under 40 CFR

1280.930. The petitioner believes no analytical method is needed

because it is not required for an exemption from the requirement of a

tolerance. Contact: RD.

    3. PP IN-11175. (EPA-HQ-OPP-2018-0545). SciReg, Inc., 12733

Director's Loop, Woodbridge, VA 22192, on behalf of Eden Research plc,

6 Priory Court, Priory Court Business Park, Poulton, Cirencester GL7

5JB, United Kingdom, requests to establish an exemption from the

requirement of a tolerance for residues of cell walls of Saccharomyces

cerevisiae when used as a pesticide inert ingredient in pesticide

formulations applied to growing crops only under 40 CFR 180.920. The

petitioner believes no analytical method is needed because it is not

required for an exemption from the requirement of a tolerance. Contact:

RD.

    4. PP IN-11189. (EPA-HQ-OPP-2018-0546). Keller and Heckman LLP,

1001 G Street, NW, Suite 500 West, Washington, DC 20001, on behalf of

Synthomer USA LLC, requests to establish an exemption from the

requirement of a tolerance for residues of Polyvinyl acetate--polyvinyl

alcohol copolymer (CAS Reg. No. 25213-24-5) when used as a pesticide

inert ingredient in pesticide formulations under 40 CFR 180.960. The

petitioner believes no analytical method is needed because it is not

required for an exemption from the requirement of a tolerance. Contact:

RD.

D. New Tolerances for Non-Inerts

    1. PP 8E8684. (EPA-HQ-OPP-2018-0514). IR-4, Rutgers, The State

University of New Jersey, 500 College Road East, Suite 201W, Princeton,

NJ 08540, requests to establish tolerances in 40 CFR part 180.585 for

residues of the herbicide pyraflufen-ethyl, including its metabolites

and degradates in or on the raw agricultural commodities (RACs).

Compliance with the plant commodity tolerance levels specified below is

to be determined by measuring only the sum of the parent

pyraflufen-ethyl, ethyl 2-[2-chloro-5-(4-chloro-5-difluoromethoxy)-1-

methyl-1H-pyrazol-3-yl]-4-fluorophenoxy] acetate, and its acid

metabolite, E-1, 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-

pyrazol-3-yl)-4-fluorophenoxyacetic acid, calculated as the

stoichiometric equivalent of pyraflufen-ethyl in or on the following

RACs: Cottonseed subgroup 20C at 0.04 ppm; fruit, small, vine climbing,

except fuzzy kiwifruit, subgroup 13-07F at 0.01 ppm; fruit, stone,

group 12-12 at 0.01 ppm; hop, dried cones at 0.02 ppm; nut, tree, group

14-12 at 0.01 ppm; tropical and subtropical, small fruit, edible peel,

subgroup 23A at 0.01 ppm; and vegetable, tuberous and corm, subgroup 1C

at 0.02 ppm. Available analytical methodology involves multiple-step

extractions of the chemical residues from plants and using Gas

Chromatograph-Mass Spectrometry (GC-MS) to measure and evaluate

pyraflufen-ethyl residues. Contact: RD.

    2. PP 8E8689. (EPA-HQ-OPP-2018-0560). IR-4, Rutgers, The State

University of New Jersey, 500 College Road East, Suite 201W, Princeton,

NJ 08540, requests to establish tolerances in 40 CFR part 180.553 for

residues of the fungicide fenhexamid (N-2,3-dichloro-4-hydroxyphenyl)-

1-methyl cyclohexanecarboxamide in or on the raw agricultural

commodities: Arugula at 30.0 ppm; berry, low growing, subgroup 13-07G

at 3.0 ppm; bushberry subgroup 13-07B at 5.0 ppm; caneberry subgroup

13-07A at 20.0 ppm; fruit, small, vine climbing, except fuzzy

kiwifruit, subgroup 13-07F at 4.0 ppm; fruit, stone, group 12-12,

except plum, prune, fresh, postharvest at 10.0 ppm; garden cress at

30.0 ppm; kiwifruit, fuzzy at 30.0 ppm; leafy greens subgroup 4-16A,

except spinach at 30.0 ppm; onion, bulb, subgroup 3-07A at 2.0 ppm;

onion, green, subgroup 3-07B at 30.0 ppm; upland cress at 30.0 ppm; and

vegetable, fruiting, group 8-10, except nonbell pepper at 2.0 ppm. The

``Method for the Determination of KBR 2738 (TM-402) Residues in Plant

Material by HPLC'' is used to measure and evaluate the chemical

fenhexamid. Contact: RD.

    Authority:  21 U.S.C. 346a.

    Dated: October 1, 2018.

Delores Barber,

Director, Information Technology and Resources Management Division,

Office of Pesticide Programs.

[FR Doc. 2018-22659 Filed 10-17-18; 8:45 am]

 BILLING CODE 6560-50-P


Adding to the unknowns and complex movements of labor within the regulated sector and across the larger U.S. economy, effects on employment are also likely to change over time. Employment in some sectors will be affected at the time of promulgation or when a regulation becomes effective, while others may be affected farther into the future. In addition, environmental regulation may affect labor supply and productivity. In particular, pollution and other environmental risks may impact labor productivity or employees' ability to work. The empirical findings regarding labor supply are reviewed below.
Empirical Findings
The labor economics literature contains an extensive body of peer-reviewed empirical work analyzing various aspects of labor demand, relying on the theoretical framework discussed in the preceding section. This work focuses primarily on effects of employment policies such as labor taxes and minimum wages. In contrast, the peer-reviewed empirical literature specifically estimating employment effects of environmental regulations is growing, but is more limited. This section presents an overview of the latter.
Empirical studies, such as Berman and Bui (2001) and Ferris, Shadbegian et al. (2014), suggest that regulation-induced net employment impacts may be zero or slightly positive, but small in the regulated sector. Gray, Shadbegian et al. (2014) find that pulp mills that had to comply with both the air and water regulations in EPA's 1998 "Cluster Rule" experienced relatively small, and not always statistically significant, decreases in employment. Other research on regulated sectors suggests that employment growth may be lower in more regulated areas (Greenstone (2002);Walker (2011; 2013); Kahn and Mansur (2013)). However since these latter studies compare more regulated to less regulated counties this methodological approach likely overstates employment impacts to the extent that regulation causes plants to locate in one area of the country rather than another, which would lead to "double counting" of the employment impacts. List, Millimet et al. (2003) find some evidence that this type of geographic relocation may be occurring.
The empirical literature on environmental regulatory employment impacts focuses primarily on labor demand. However, there is a nascent literature focusing on regulation-induced effects on labor productivity and supply. Although this literature faces empirical challenges, researchers have found that air quality improvements lead to reductions in lost work days (e.g., Ostro (1987)). Limited evidence suggests worker productivity may also improve when pollution is reduced. Graff Zivin and Neidell (2012) used detailed worker-level productivity data from 2009 and 2010, paired with local ozone air quality monitoring data for one large California farm growing multiple crops, with a piece-rate payment structure. Their quasi-experimental structure identifies an effect of daily variation in monitored ozone levels on productivity. They find "ozone levels well below federal air quality standards have a significant impact on productivity: a 10 parts per billion (ppb) decreases in ozone concentrations increases worker productivity by 5.5 percent." (Graff Zivin and Neidell, 2012, p. 3654).
As noted above, it is very difficult to estimate the net national employment impacts of environmental regulation. Given the difficulty with estimating national impacts of regulations, EPA has not generally estimated economy-wide employment impacts of its regulations in its benefit-cost analyses. However, in its continuing effort to advance the evaluation of costs, benefits, and economic impacts associated with environmental regulation, EPA has formed a panel of experts as part of EPA's Science Advisory Board (SAB) to advise EPA on the technical merits and challenges of using economy-wide economic models to evaluate the impacts of its air pollution regulations, including the impact on net national employment. Once EPA receives guidance from this panel it will carefully consider this input and then decide if and how to proceed on economy-wide modeling of employment impacts of its regulations.
Conclusions Regarding the Literature. This section has outlined the challenges associated with estimating regulatory effects on both labor demand and supply for specific sectors. These challenges make it difficult to estimate net national employment estimates that would appropriately capture the way in which costs, compliance spending, and environmental benefits propagate through the macro-economy. Overall, the peer-reviewed literature does not contain evidence that environmental regulation has a large impact on net employment (either negative or positive) in the long run across the whole economy.
Section 9.1.3 presents a qualitative assessment of immediate and short term employment impacts of the current rulemaking. Section 9.1.4 describes longer term impacts.
Qualitative Assessment: Immediate and Short-term Employment Impacts
Firms impacted by this rule are manufacturers and processors of certain nanoscale materials. The initial activities that firms may need to perform to comply with this rule are rule familiarization, form completion, electronic reporting, and recordkeeping. The average initial year cost per firm is shown in Table 9-1, and costs per firm in the subsequent nine years of the economic analysis period are shown in Table 9-2. See Chapter 3 for a discussion of how per-firm costs were estimated. The net effect on short-term labor demand in the regulated sector is ambiguous but expected to be small.
Table 9-1: Summary of Costs per Firm in First Year (2015$)
                                   Firm Type
                                Number of Firms
                               First Year Costs
Manufacturer
                                      165
                                   $50,285
Processor
                                     1,788
                                   $10,904

Table 9-2: Summary of Costs per Firm in Subsequent Years (2015$)
                                   Firm Type
                                Number of Firms
                             Subsequent Year Costs
                                Annualized Cost

                                      3%
                                      7%
Manufacturer
                                      165
                                    $5,593
                                    $9,846
                                   $10,809
Processor
                                      199
                                   $10,904
                                   $10,053
                                   $10,214

Qualitative Assessment: Longer-term Employment Impacts
EPA is not anticipating any significant longer term cost impacts on regulated entities and therefore the rule is not expected to have any significant longer term employment effects.
Summary of Qualitatively Assessed Employment Impacts
The direction of change in employment in the regulated and environmental sectors from this rulemaking is ambiguous. This is true for both the short term or first year employment impacts and the long term or subsequent year employment impacts. However, the increase in total costs, labor costs, and labor hours per firm as a consequence of this rule is reasonably small, thus EPA expects employment impacts to be small as well.
Paperwork Reduction Act (PRA)
According to the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that requires Office of Management and Budget (OMB) approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The information collection requirements related to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0067 (EPA ICR No. 1198). The rule will impose a burden requiring additional OMB approval. The ICR addendum is available for comment in the public docket for the rule.
 This section estimates the burden and costs for both the respondents and the Agency associated with the recordkeeping and reporting requirements of the rule.  In this context, the term "burden" is interpreted as the total time, effort, or financial resources expended by people to generate, maintain, retain, disclose, or provide information to or for a federal agency. This includes the time needed by regulated entities to review instructions and to develop, acquire, install, and use technology and systems to collect, validate, verify, and disclose information. Time taken to adjust existing ways to comply with any previously applicable instructions and requirements and to train personnel to respond to the information collection task is also included. In this section, burden hours for both the industry respondents and the government are estimated.
Table 9-3 presents a summary of the total burden and costs to industry associated with the rule over the first three years of its promulgation. The data used to populate this table are explained in greater detail in Chapter 3.
Table 9-3: Industry Burden Estimates for the Final Rule
                                     Year
                             Reporting Population
                      Rule Familiarization Burden (Hours)
    Form Completion, CBI Substantiation, and Record Keeping Burden (Hours)
                      Electronic Reporting Burden (Hours)
                               Number of Reports
                             Total Burden (Hours)
Manufacturers
                                       1
                                      165
                                     0.82
                                      139
                                     1.42
                                      771
                                    107,616
                                       2
                                      165
                                       0
                                      139
                                     0.174
                                      86
                                    11,991
                                       3
                                      165
                                       0
                                      139
                                     0.174
                                      86
                                    11,991
                                    Average
                                      165
                                     0.27
                                      139
                                     0.59
                                      314
                                     43866
Processors
                                       1
                                     1,788
                                     0.82
                                      139
                                     1.42
                                     1,788
                                    252,715
                                       2
                                      199
                                     0.82
                                      139
                                     1.42
                                      199
                                    28,127
                                       3
                                      199
                                     0.82
                                      139
                                     1.42
                                      199
                                    28,127
                                    Average
                                      729
                                     0.82
                                      139
                                     1.42
                                      729
                                    102,990
Notes: Values may not calculate due to rounding.
See Chapter 3 for more details.

Unfunded Mandates Reform Act (UMRA)
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Public Law 104-4), 2 U.S.C. 1531-1538 for State, local, or tribal governments or the private sector. Based on EPA's experience with similar information collection rules, State, local, and tribal governments have not been affected by this reporting requirement, and EPA does not have any reason to believe that any State, local, or tribal government will be affected by this rulemaking.
Executive Order 13132  -  Federalism
Under Executive Order 13132, "Federalism" (64 FR 43255, August 10, 1999), EPA has determined that the rule does not have "federalism implications" because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in the executive order. The rule establishes reporting and recordkeeping requirements that apply to manufacturers and processors of certain chemicals. Because EPA has no information to indicate that any state or local government manufactures or processes the chemical substances covered by this action, the rule does not apply directly to states and localities and will not affect state and local governments. Thus, EO 13132 does not apply to the rule.
Executive Order 13175  -  Consultation and Coordination with Indian Tribal Governments
As required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), EPA has determined that this rule does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. Thus, EO 13175 does not apply to the rule.
Executive Order 13045  -  Children's Health
Executive Order 13045, "Protection of Children from Environmental Health Risks and Safety Risks" (62 FR 19885, April 23, 1997), requires that federal agencies examine the impacts of each regulatory action on children for any economically significant regulation (as defined by Executive Order 12866) that the Agency has reason to believe may disproportionately affect children.
EPA interprets EO 13045 as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. The rule does not establish an environmental standard intended to mitigate health or safety risks and will not have an annual effect on the economy of $100 million or more, nor does it otherwise have a disproportionate effect on children. Nevertheless, the information obtained from the reporting required by this rule will be used to inform the Agency's decision-making process regarding chemicals to which children may be disproportionately exposed. This information will also assist the Agency and others in determining whether the chemicals in this rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.
Executive Order 12898  -  Environmental Justice
Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations" (59 FR 7629, February 16, 1994), establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
The Agency believes that the information collected under this rule, if finalized, will assist EPA and others in determining the potential hazards and risks associated with various chemicals manufactured and used at the nanoscale. Although not directly impacting environmental justice-related concerns, this information will enable the Agency to better protect human health and the environment, including in low-income and minority communities.
The rule is directed at all nanoscale substances for which basic production, use, and toxicity information is currently unavailable. All consumers of these chemicals and the products made from them and all workers who come into contact with these chemicals could benefit if data regarding the chemicals' health and environmental effects were developed. Therefore, it does not appear that the costs and the benefits of the rule will be disproportionately distributed across different geographic regions or among different categories of individuals.
Executive Order 13211  -  Energy Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, "Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.
National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
The rule does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

 -  Wage Rate Calculations
This appendix describes the derivation of the fully loaded wage rates and inflation factors used in calculating costs of labor, materials, and other inputs. All cost estimates are presented in 2015 dollars.
The fully loaded unit labor cost for managerial, professional/technical, and clerical labor in the regulated industry and for EPA staff is estimated by adding fringe benefits and overhead costs to the hourly wage or annual salary for each category following the method described in Wage Rates for Economic Analysis of the Toxics Release Inventory Program (EPA, 2002b). This appendix describes the method employed to estimate the fully loaded unit labor costs for each labor category and presents the results of the analysis.
Labor categories used in the analysis correspond to the U.S. Bureau of Labor Statistics (BLS) Standard Occupational Classification (SOC) system. In March 2004, BLS began using the North American Industry Classification System (NAICS) instead of the Standard Industrial Classification (SIC) System, and the Standard Occupational Classification (SOC) system instead of the Occupational Classification System (OCS). Exhibit A-1 summarizes the crosswalk between old and new occupational titles, and lists the SOC titles that correspond to the managerial, professional/technical, and clerical labor categories used in this analysis (Weinstein and Loewenstein, 2004).
Exhibit A-1: Detail of Labor Categories Used in the Analysis
Labor Category Used in the Analysis
BLS Old Title (OCS)
BLS New Title (SOC)
Managerial
Executive, administrative, and managerial
Management, business, and financial
Professional/Technical
Professional specialty and technical
Professional and related
Clerical
Administrative support, including clerical
Office and administrative support
Source: BLS (2016a); Weinstein and Loewenstein (2004).

Derivation of Industry Unit Wage Rates
Wages and fringe benefit data for managerial, professional/technical, and clerical labor are from the BLS Employer Costs for Employee Compensation (ECEC) historical data for December 2015 (BLS, 2016a). For attorney, the wage rate was taken from the BLS Occupational Employment Statistics (OES) May 2015 National Industry-Specific Occupational Employment and Wage Estimates for Sectors 31, 32, and 33  -  Manufacturing and SOC Code 23-1011  -  Lawyers (BLS, 2016b).
The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS report (BLS, 2016a). Fringe benefits as a percentage of wages are calculated separately for each labor category. For example, the wage rate for professional/ technical labor in 2015 was $44.06, and the average fringe benefit was $24.34. Therefore, fringe benefits as a percentage of wages were $24.34/$44.06 or approximately 55 percent (see Exhibit A-2). Since the fringe benefits for attorney were not available from the BLS report, EPA applied the managerial fringe benefit to wage ratio to this wage as well.
An additional loading factor of 17 percent is applied to wages to account for overhead. This approach is used for consistency with Office of Pollution Prevention and Toxics (OPPT) economic analyses for two major rulemakings: Wage Rates for Economic Analyses of the Toxics Release Inventory Program, June 2002 (EPA, 2002b), and the Revised Economic Analysis for the Amended Inventory Update Rule: Final Report, August 2002 (EPA, 2002a). This overhead loading factor is added to the benefits loading factor, and the total is then applied to the base wage to derive the fully loaded wage. For example, fully loaded wage for professional/technical labor in 2015 is $44.06 x (1+ 0.55 + 0.17) = $75.89.
Exhibit A-2: Derivation of Loaded Industry Wage Rates (2015$)
Fully loaded costs for attorney, managerial, and clerical labor are calculated in a similar manner, as shown in Exhibit A-2.
                                Labor Category
                       Data Source for Wage Information
                                     Wage
                                Fringe Benefit
                               Fringes as % wage
                              Overhead as % wage1
                           Fringe + overhead factor
                                 Loaded Wages

                                      (a)
                                      (b)
                                  (c)=(b)/(a)
                                      (d)
                                 (e)=(c)+(d)+1
                                  (f)=(a)x(e)
Attorney
BLS OES, Occupational Employment and Wages, 23-1011 Lawyers
                                    $65.51
                                    $32.65
                                    49.84%
                                      17%
                                     1.67
                                   $109.29
Managerial
BLS ECEC, Private Manufacturing industries, "Management, business, and financial occupations"2
                                    $48.66
                                    $24.25
                                    49.84%
                                      17%
                                     1.67
                                    $81.18
Professional/Technical
BLS ECEC, Private Manufacturing industries, "Professional and related occupations"2
                                    $44.06
                                    $24.34
                                    55.24%
                                      17%
                                     1.72
                                    $75.89
Clerical
BLS ECEC, Private Manufacturing industries, "Office and administrative support occupations"2
                                    $19.91
                                    $10.37
                                    52.08%
                                      17%
                                     1.69
                                    $33.66
Notes:
1  An overhead rate of 17% was used based on assumptions in Rice (2002) and U.S. EPA (2002).

Derivation of Agency Unit Wage Rates
Unit wage rates for EPA staff are calculated based on annual federal salaries for the Washington-Baltimore area published by the Office of Personnel Management (OPM) and effective January 2015 (OPM, 2015). The average salary for one full-time equivalent (FTE) technical/professional staff member is estimated as the salary for a GS-13 Step 5 employee, which is $102,932 annually without fringe benefits and overhead costs. In order to derive the fully loaded salary, EPA multiplied the annual salary by an assumed loading factor of 1.6 to reflect federal fringe benefits and overhead, which results in a fully loaded annual salary of $164,691(see Exhibit A-3).
The Agency loading factor of 1.6 is from an EPA guide entitled Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9). The 60 percent assumption was labeled "the benefits multiplication factor" in the EPA guide, but has been used in many EPA OPPT ICRs to reflect both fringe benefits and overhead for federal staff. For example, it was used in a document supporting EPA ICR No. 1139.06 (EPA, 2000), with the following explanation:
      The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 (the benefits multiplication factor). The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection Requests (ICRs) (June 1, 1992). An EPA internal phone call between Carol Rawie (OPPT/EETD/RIB) and Carl Koch (OPPE/RMD/IMB) on May 3, 1994, indicated that the 1.6 factor included not only benefits but also overhead.
Fully loaded costs for Agency labor are shown in Exhibit A-3.
Exhibit A-3: Derivation of Loaded Agency Wage Rates
Labor Category
Data Source for Wage Information
Date
Wage
Fringe Benefit
Fringes as % wage
Overhead as % wage
Fringe + overhead factor
Loaded Wages

(a)
(b)
(c)=(b)/(a)
(d)
(e)=(c)+(d)+1
(f)=(a)x(e)
EPA technical staff FTE
OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-13 Step 5 pay rates [a]
                                    Jan-15
                               $102,932 (annual)
                                      --
                          [Included in 60% overhead]
                                    60% [b]
                                      1.6
                               $164,691 (annual)

                                    $49,32
                                   (hourly)

                                $78.91 (hourly)
EPA attorney staff FTE
OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV, area, GS-14 Step 5 pay rates
                                    Jan-15
                               $121,635 (annual)

                          [Included in 60% overhead]
                                    60% [b]
                                      1.6
                               $194,616 (annual)

                                    $58.28
                                   (hourly)

                                $93.25 (hourly)
Notes:
[a]. Hourly rates are based on annual salary divided by 2,087 hours.
[b] The 60% fringe-and-overhead rate is from an EPA guide, Instructions for Preparing Information Collection Requests (ICRs) (EPA, 1992, page 30, footnote 9).
Source: OPM, 2015

  -  Small Business Sensitivity Analysis
The following presents an alternative small business analysis to demonstrate the sensitivity of the small business analysis to changes in the assumed number of nanomaterials produced by each small firm. The current small business analysis in Chapter 8 assumes that both small and large firms produce on average 4.67 "commercial" nanomaterials per firm. In this alternative analysis, we calculate the number of nanomaterials manufactured separately for large and small firms and how this change affects the number of small businesses significantly affected by the rule.
Estimation of the number of nanomaterials per small Firm
In Section 2.2.3 of this report, EPA calculates the number of nanomaterials produced by each firm, based on a subset of 19 large businesses, using the TSCA-based definition of annual revenue greater than $11 million. Within this group of 19 companies, EPA then calculated the median number of nanomaterials and makes the assumption that both small and large businesses produce the same number of nanomaterials. However, this assumption may overestimate the impact of the requirements on small businesses. In this appendix, we present the costs to small businesses using the subset of 19 businesses that are currently used in Chapter 2 to estimate the average number of nanomaterials produced by small and large companies as opposed to all companies.
Of the 19 nanomaterial-producing firms identified in Chapter 2, 14 had product information available on a company website. All of these firms manufactured nanomaterials for TSCA-related uses. Of these 14 firms, 3 are small and 11 are large using SBA's NAICS-specific sales or employee-based definitions. EPA calculated the median number of nanomaterials for these 3 small companies to be 1 nanomaterial.

Conclusions
EPA completed an analysis of impacts on small entities in Chapter 8 and found that no small businesses were impacted at greater than 1% of their sales. Costs to these entities were based upon the reporting costs per nanomaterial. In this section, EPA's calculations suggest that the number of nanomaterials that a small entity will necessarily report on could be overestimated. In this case, it follows that costs would also be overestimated if there are fewer reports required. Therefore, it is reasonable to conclude that no small entities would be impacted at greater than one percent of sales under the alternative estimate of the number of nanomaterials presented above.

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U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2002a. Economic Analysis for the Amended Inventory Update Rule: Final Report. EPA-HQ-OPPT-2002-0054-0260.
U.S. Environmental Protection Agency (EPA). Office of Pollution, Prevention and Toxics. 2002b. Wage Rates for Economic Analyses of the Toxics Release Inventory Program.
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2003a. Economic Analysis for the Addition of 47 Chemical Abstract Service (CAS)-numbered Chemicals Requested to be added to EPA's Preliminary Assessment Information Reporting (PAIR) Rule in the 48th, 50th, and 51st Reports of the TSCA Interagency Testing Committee. EPA-HQ-OPPT-2002-0061-0005.
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2003b. Economic Analysis of Expedited Significant New Use Rules for 65 Chemical Substances. EPA-HQ-OPPTS-2002-0078.
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2015. Supporting Statement for EPA ICR No. 1198.10: Information Collection Request for Toxic Substance Control Act Section 8(a) Chemical-Specific Information Gathering Rules
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2007. Supporting Statement for EPA ICR No. 2250.01: Information Collection in Support of EPA's Stewardship Program for Nanoscale Materials.
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2009a. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule (EPA-HQ-OPPT-2008-0296).
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2009b. Nanoscale Materials Stewardship Program Interim Report.
U.S. Environmental Protection Agency (EPA), Office of Research and Development. 2009c. Nanomaterial Research Strategy.
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2009d. "Nanoscale Materials Stewardship Program." Available at: http://www.epa.gov/oppt/nano/stewardship.htm. Accessed October 08, 2009.
U.S. Environmental Protection Agency (EPA). 2011. Supporting Statement for EPA Information Collection Request Number 2002.05, "Cross-Media Electronic Reporting Rule" Office of Environmental Information, U.S. Environmental Protection Agency. June 22, 2011.
U.S. Environmental Protection Agency (EPA). 2013. Supporting Statement for EPA Information Collection Request Number 1665.12, OMB Control No 2020-0003, "Renewal of Existing Information Collection Request for Confidentiality Rules"
U.S. Environmental Protection Agency (EPA). 2016. General Qs and As Relating to CBI under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Available at: https://www.epa.gov/tsca-cbi/general-qs-and-relating-cbi-under-tsca-amended-frank-r-lautenberg-chemical-safety-21st. Accessed September 7, 2016.
U.S. Office of Personnel Management (OPM). 2015. "Salary Table 2015-DCB: for the Locality Pay Area of Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA." Effective January 2015.  Available at: https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2015/DCB.pdf. Accessed August 2016.
U.S. Small Business Administration (SBA). 2014. "U. S. Small Business Administration Table of Small Business Size Standards Matched to North American Industry Classification System Codes effective July 14, 2014". Available at: https://www.sba.gov/content/small-business-size-standards. Accessed February 2015.
Walker, W. R. (2011). "Environmental Regulation and Labor Reallocation." American Economic Review 101(2): 442-447.
Walker, W. R. (2013). "The Transitional Costs of Sectoral Reallocation: Evidence From the Clean Air Act and the Workforce." The Quarterly Journal of Economics 128(4): 1787-1835.
Weinstein, Harriet G and Mark A. Loewenstein. U.S. Bureau of Labor Statistics (BLS). 2004. "Comparing Current and Former Industry and Occupation ECEC Series." Available at: http://www.bls.gov/opub/cwc/cm20040823ar01p1.htm. Accessed October 08, 2009.
White House Office of Management and Budget (OMB). 2003. Circular A-4. Available at: http://www.whitehouse.gov/omb/circulars/a004/A-4.html. Accessed October 08, 2009.


The in vitro test in human lymphocytes was positive for the induction
of chromosomal aberrations in both the presence and absence of S9 at
doses (5-50 µg/mL -S9; 100-200 µg/mL +S9) that were moderately to
severely cytotoxic (i.e., >16-70% reductions in mitotic cells,
respectively)

870.5385

Cytogenetics bone marrow	43678148 (1992)

Acceptable/guideline

5000 mg/kg

	The in vivo mouse bone marrow micronucleus assay was negative at 5000
mg/kg when administered once by oral gavage.  Overt toxicity and
depression of erythropoiesis seen in addition to cytotoxic effects on
the target cell in the males.

870.5550

Other: Unscheduled DNA synthesis	43678149 (1992)

Acceptable/guideline

1250 and 2000 mg/kg

	The in vivo/in vitro unscheduled DNA synthesis test in rat hepatocytes
was negative.  No toxicity to the treated animals or cytotoxic effects
on recovered hepatocytes up to the limit dose for acute testing (2000
mg/kg) when administered once by oral gavage.

870.6200a

Acute neurotoxicity screening battery in rats	43678134 (1994)

Acceptable/guideline

0, 200, 600, 2000 mg/kg	NOAEL < 200 mg/kg/day

LOAEL = 200 mg/kg/day based on transient diarrhea in both sexes.

870.6200b

Subchronic neurotoxicity screening battery in rats	43678138 (1994)

Acceptable/guideline

0, 100, 500, 2000 ppm

M: 0, 8.0, 38.5, 161 mg/kg/day

F: 0, 9.1, 47.9, 201.5 mg/kg/d	NOAEL = 39 mg/kg/day.

LOAEL = 161 mg/kg/day based on decreased body weight/weight gain and
food utilization in both sexes.

870.7485

Metabolism and pharmacokinetics	43678150<PHONE_NUMBER>678152
4367815343678154

issues at seven days postdosing. The primary route of excretion was via
the feces (≈73-89%) followed by urine (≈9-18%).  There were no
apparent sex- or dose-related differences in distribution or in the
pattern of excretion. In a bile duct cannulated single high-dose group,
assessment of biliary excretion suggested approximately 70% absorption
with ≈32% of the administered dose remaining as parent compound in the
gastrointestinal tract.  Absorbed azoxystrobin appeared to be
extensively metabolized with minor sex-related qualitative and
quantitative differences in biliary metabolites.  A metabolic pathway
was proposed showing hydrolysis and subsequent glucuronide conjugation
as the major biotransformation process.

870.7600

Dermal penetration (rat)	43678155 (1994)

Acceptable/guideline

0.01, 0.1, 0.9, 13.3 mg/kg	2 - 4 % Dermal Absorption

Appendix B:	International Residue Limit Status Sheet

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䀀&摧㠎¥܀) pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate	Common Name:

Azoxystrobin	( Proposed tolerance

X Reevaluated tolerance

( Other	Date: 07/16/09

Codex Status (Maximum Residue Limits)	U. S. Tolerances

(    No Codex proposal step 6 or above

(    No Codex proposal step 6 or above for the crops requested	Petition
Number:  PP#8E7474

DP#s:  362963 & 363046

Other Identifier:

Residue definition (step 8/CXL):  Azoxystrobin	Reviewer/Branch:  Meheret
Negussie, RAB3

	Residue definition in PP#8E7474

for plant commodities:  Combined residues of azoxystrobin and its
Z-isomer

 No Limits

√No Limits for the crops requested.	 No Limits

 No Limits for the crops requested

Residue definition  (αE)-methyl
2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]-α
-methoxymethylene)benzeneacetate,

including the isomer (Z)-methyl 2-[[6-(2-

cyanophenoxy)-4-pyrimidinyl]oxy]--(methoxymethylene)benzeneacetate
Residue definition:  Azoxistrobin

Crop(s)	MRL (mg/kg)	Crop(s)	MRL (mg/kg)

Barley	0.3

Notes/Special Instructions:  Codex barley value based on European trials
only:  Combined azoxystrobin residues in barley grain from the trials in
Europe (n = 38), in ranked order median underlined, were: 0.01 (4), 0.02
(6), 0.03 (4), 0.04 (3), 0.05, 0.08 (3), 0.09, 0.10 (2),0.11 (4), 0.12,
0.13 (4), 0.14, 0.19, 0.20, 0.23, and 0.28 mg/kg. Typical label in
Europe is 2 X 0.25 kg ai/ha, 35 day PHI.

No information is available of the derivation of the Mexican MRL for
barley, 0.3 ppm.  This is from 2004 and may have changed.  Mexico
typically adopts Codex or US standards for its export purposes.

S.Funk, 07/17/2009.

Page   PAGE  44  of   NUMPAGES  53

Should I delete it since it was not proposed.


[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Page 16072]
[FR Doc No: 2014-06467]

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

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 cybersecurity roundtable on March
26, 2014 from 9:30 a.m. to 3:00 p.m.
    Roundtable panelists will discuss the cybersecurity landscape and
cybersecurity issues faced by exchanges and other key market systems,
broker-dealers, investment advisers, transfer agents, and public
companies. Panelists also will be invited to discuss industry and
public-private sector coordination efforts relating to assessing and
responding to cybersecurity issues.
    The roundtable discussion will be held at SEC headquarters at 100 F
Street NE., in Washington, DC. The roundtable will be webcast on the
Commission's Web site at www.sec.gov and will be archived for later
viewing. Seating for the public will be available.
    For further information, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: March 19, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-06467 Filed 3-20-14; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81330-81332]
[FR Doc No: 2015-32591]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1318]

Electroconvulsive Therapy Devices for Class II Intended Uses:
Draft Guidance for Industry, Clinicians, and FDA Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Electroconvulsive Therapy
(ECT) Devices for Class II Intended Uses: Draft Guidance for Industry,
Clinicians, and FDA Staff.'' The purpose of this guidance is to make
recommendations for 510(k) submissions and complying with special
controls being proposed to support reclassification of ECT Devices into
Class II (special controls) for severe major depressive episode (MDE)
associated with Major Depressive Disorder (MDD) or Bipolar Disorder
(BPD) in patients 18 years of age and older who are treatment-resistant
or who require a rapid response due to the severity of their
psychiatric or medical condition. This draft guidance is not final nor
is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 28, 2016.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Electroconvulsive Therapy (ECT) Devices for Class II Intended Uses:
Draft Guidance for Industry, Clinicians, and FDA Staff'' to the Office
of the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request. You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1318 for ``Electroconvulsive Therapy (ECT) Devices for Class
II Intended Uses: Draft Guidance for Industry, Clinicians and FDA
Staff.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Peter G. Como, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G242, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document provides draft recommendations for
510(k) submissions and complying with special controls being proposed
to support reclassification of ECT Devices into Class II (special
controls) for severe MDE associated with MDD or BPD in patients 18
years of age and older who are treatment-resistant or who require a
rapid response due to the severity of their psychiatric or medical
condition. An ECT device is an electrical device used for treating
severe psychiatric disturbances by inducing in the patient a major
motor seizure by applying a brief intense electrical current to the
patient's head. This draft guidance is being issued in conjunction with
a Federal Register notice announcing the proposal to reclassify this
device type for this intended use. This guidance is issued for comment
purposes only.
    FDA is issuing a proposed administrative order to reclassify ECT
devices for the treatment of severe MDE associated with MDD or BPD in
patients 18 years of age or older who are treatment-resistant or who
require a rapid response due to the severity of their psychiatric or
medical condition, which are currently Class III devices, into Class II
(special controls) subject to premarket notification. FDA is proposing
this reclassification under the Federal Food, Drug and Cosmetic Act
(FD&C Act) based on new information pertaining to the device. This
guidance is intended to provide recommendations on how to comply with
the special controls proposed in 21 CFR 876.5540(b)(1) and indicate
what information is suggested for submission to FDA in a 510(k) to
demonstrate that the special controls have been met.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ECT devices
for Class II intended uses. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An

alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Electroconvulsive Therapy
(ECT) Devices for Class II Intended Uses: Draft Guidance for Industry,
Clinicians, and FDA Staff'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1823 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 807 subpart E have been
approved under OMB control number 0910-0120; the collection of
information in 21 CFR 801 has been approved under OMB control number
0910-0485; and the collection of information in 21 CFR part 820 have
been approved under OMB control number 0910-0073.

    Dated: December 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32591 Filed 12-28-15; 8:45 am]
 BILLING CODE 4164-01-P