[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Proposed Rules]
[Pages 59945-59947]
[FR Doc No: 2016-20868]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0715]
RIN 1625-AA00

Safety Zone; Blasting, Delaware River

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
on the waters of the Tinicum Range, Eddystone Range, Chester Range, and
Marcus Hook Range, in the Delaware River from December 1, 2016 to March
15, 2016. The safety zone would temporarily restrict vessel traffic
from transiting or anchoring in a portion of the Delaware River while
rock blasting, dredging, and rock removal operations are being
conducted to facilitate the Delaware River Main Channel Deepening
project for the main navigational channel of the Delaware River. This
action is needed to protect personnel, vessels, and the marine
environment from potential hazards created by rock blasting, dredging,
and rock removal operations. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before September 30, 2016.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0715 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
rulemaking, call or email MST1 Thomas Simkins, Sector Delaware Bay
Waterways Management Division, U.S. Coast Guard; telephone 215-271-
4889, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    The Army Corps of Engineers (ACOE) is sponsoring a project, termed
``The Deepening,'' in which dredging operations are taking place in the
Delaware River and Bay navigational channel deepening the channel to 45
feet. The project goal is to maintain a minimum depth of 45 feet to
accommodate larger vessel traffic entering the Sector Delaware Bay
Zone. The upcoming portion of the project requires the deepening of the
Delaware River from Tiniucm Range, south, through Marcus Hook Rang, in
which the topography consist of mostly rock bottom. To satisfy the
minimum project depth of 45 feet the ACOE has hired Great Lakes
Dredging Company to perform rock blasting operations, dredging, and
removal of rock in Tinicum Range, Eddystone Range, Chester Range, and
Marcus Hook Range, in the Delaware River from December 1, 2016, to
March 15, 2017. The Captain of the Port, Delaware Bay, has determined
that potential hazards associated with rock blasting, dredging, and
rock removal operations, will be a safety concern for anyone within 500
yards of rock blasting, dredging, and rock removal operations. This
proposed rule is needed to protect personnel, vessels, and the marine
environment in the navigable waters within the operational area.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 500-yard radius of rock blasting,
dredging, and rock removal operations. The Coast Guard proposes this
rulemaking under authority in 33 U.S.C. 1231; 33 CFR 1.05-1 and 160.5;
and Department of Homeland Security Delegation No. 0170.1.

III. Discussion of Proposed Rule

    This proposed rule would establish a safety zone from December 1,
2016, through March 15, 2017. The safety zone would cover all navigable
waters in the Delaware River within 500 yards of vessels and machinery
being used by personnel to conduct rock blasting, dredging, and rock
removal. The duration of the zone is intended to protect personnel,
vessels, and the marine environment in these navigable waters while
operations are being conducted.
    For the duration of the project, in the vicinity of the rock
blasting, rock removal, and dredging operation, one side of the main
navigational channel will be closed due to the drill boat APACHE being
unable to relocate for vessel traffic while conducting rock blasting
and removal operations. Additionally there is a potential for blasted
rock to be within the navigational channel causing a navigational
safety hazard for vessels transiting the safety zone. Vessels wishing
to transit the safety zone in the main navigational channel may do so
if they can make satisfactory passing arrangements with drill boat
APACHE, dredge TEXAS, or dredge NEW YORK in accordance with the
navigational rules in 33 CFR subchapter E via VHF-FM channel 13 at
least 30 minutes prior to arrival. If vessels are unable to make
satisfactory passing arrangements with the drill boat APACHE, dredge
TEXAS, or dredge NEW YORK they may request permission from the Captain
of the Port, or his designated representative, on VHF-FM channel 16.
All vessels must operate at the minimum safe speed necessary to
maintain steerage and reduce wake.
    No vessels may transit through the safety zone during times of
explosives detonation. During rock blasting detonation, vessels would
be required to maintain a 500 yard distance from the drill boat APACHE.
The drill boat APACHE will make broadcasts, via VHF-FM channels 13 and
16, at 15 minutes, 5 minutes, and 1 minute prior to detonation, as well
as a countdown to detonation on VHF-FM channel 16. The drill boat
APACHE will also raise a red flag signifying when a detonation is
occurring. The 500 yard radius will be secured by a contracted security
vessel on either side of the blast area. Security vessels will ensure
the blasting area is clear prior to explosive detonation. Sector
Delaware Bay will ensure significant notice is given to the maritime
community of dates and times of blasting via broadcast notice to
mariners on VHF-FM channel 16. After every explosive detonation, a
survey will be conducted to ensure the navigational channel is clear
for vessels to transit. The drill boat APACHE will broadcast, via VHF-
FM channels 13 and 16, when the survey has been completed

and the channel is clear to transit. Vessels granted permission to
transit through the safety zone must proceed as directed by the
designated representative of the Captain of the Port, and must contact
the drill boat APACHE, dredge TEXAS, or dredge NEW YORK on VHF-FM
channel 13 to make satisfactory passing arrangements.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the size,
location, duration, and traffic management of the safety zone. The
Coast Guard does not anticipate any significant economic impact because
the safety zone would be enforced in an area and in a manner that does
not conflict with transiting commercial and recreational traffic,
except for the short periods of time when explosive detonation
evolutions are being conducted. The blasting detonations will not occur
more than three times a day. At all other times, at least one side of
the main navigational channel would be open for vessels to transit.
Moreover, the Coast Guard will work in coordination with the pilots to
ensure vessel traffic is limited during the times of detonation and
Broadcast Notice to Mariners are made via VHF-FM marine channels 13 and
16 when blasting operations will occur.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. 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
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to anchor in or
transit the safety zone may be small entities, for the reasons stated
in section IV.A above, this proposed rule would not have a significant
economic impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed 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 proposed rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. 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.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. 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 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This proposed rule involves a safety zone in force from
December 1, 2016, through March 15, 2017, that prohibits entry within
500 yards of vessels and machinery being used by personnel conducting
rock blasting, dredging, and rock removal operations within Tinicum
Range, Eddystone Range, Chester Range, and Marcus Hook Range. It is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction M16475.1D. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your

message can be received without jeopardizing the safety or security of
people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 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 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add temporary Sec.  165.T05-0715 under the undesignated center
heading Fifth Coast Guard District to read as follows:

Sec.  165.T05-0715  Safety Zone; Blasting, Delaware River.

    (a) Regulated area. The following area is a safety zone: all the
waters of the Delaware River within 500 yards of the drill boat or
dredges performing rock blasting, rock removal, and dredging
operations, in the Delaware River between the southern end of Marcus
Hook Range to the eastern end of Tinicum Range.
    (b) Regulations. The general safety zone regulations in Sec.
165.23 apply to the safety zone created by this temporary section,
Sec.  165.T05-0715.
    (1) All vessels and persons are prohibited from entering into or
moving within the safety zone unless authorized by the Captain of the
Port, Delaware Bay, or by his designated representative.
    (2) Vessels wishing to transit the safety zone, described in
paragraph (a) of this section, in the main navigational channel, may do
so if they can make satisfactory passing arrangements with the drill
boat APACHE, dredge TEXAS, or dredge NEW YORK in accordance with the
Navigational Rules in 33 CFR subchapter E via VHF-FM channel 13 at
least 30 minutes prior to arrival. If vessels are unable to make
satisfactory passing arrangements with the drill boat APACHE, dredge
TEXAS, or dredge NEW YORK, they may request permission from the Captain
of the Port, or his designated representative, on VHF-FM channel 16.
    (3) No vessels may transit through the safety zone during times of
explosives detonation. During rock blasting detonation, vessels are
required to maintain a 500 yard distance from the drill boat APACHE.
The drill boat APACHE will make broadcasts, via VHF-FM channels 13 and
16, at 15 minutes, 5 minutes, and 1 minute prior to detonation, as well
as a countdown to detonation on VHF-FM channel 16. The drill boat
APACHE will also raise a red flag signifying when a detonation is
occurring. The 500 yard radius will be secured by contracted security
vessel on either side of the blast area. Security vessel will ensure
the blasting area is clear prior to explosive detonation. Sector
Delaware Bay will ensure significant notice is given to the maritime
community of dates and times of blasting via broadcast notice to
mariners on VHF-FM channel 16.
    (4) After every explosive detonation, a survey will be conducted to
ensure the navigational channel is clear for vessels to transit. The
drill boat APACHE will broadcast, via VHF-FM channels 13 and 16, when
the survey has been completed and the channel is clear to transit.
Vessels granted permission to transit through the safety zone must
proceed as directed by the designated representative of the Captain of
the Port and contact the drill boat APACHE on VHF-FM channel 13 to make
satisfactory passing arrangements in accordance with the navigational
rules in 33 CFR subchapter E.
    (5) This section applies to all vessels except vessels that are
engaged in the following operations: enforcing laws; servicing aids to
navigation, and emergency response vessels.
    (c) Definitions. As used in this section:
    Captain of the Port Delaware Bay means the Commander, U.S. Coast
Guard Sector Delaware Bay, Philadelphia, PA.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Delaware Bay to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (d) Enforcement. The U.S. Coast Guard may be assisted by Federal,
State and local agencies in the patrol and enforcement of the zone.
    (e) Enforcement period. This section will be effective from
December 1, 2016, through March 15, 2017.

    Dated: August 23, 2016.
Benjamin A. Cooper,
Captain, U.S. Coast Guard, Captain of the Port Delaware Bay.
[FR Doc. 2016-20868 Filed 8-30-16; 8:45 am]
 BILLING CODE 9110-04-P


18582 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. The EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. DATES: Comments must be received in writing by May 16, 2003. ADDRESSES: Written comments should be mailed to Kristeen Gaffney, Acting Chief, Permits and Technical Assessment Branch, Mailcode 3AP11, U. S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the documents relevant to this action are available for public inspection during normal business hours at the Air Protection Division, U. S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103 and District of Columbia Department of Public Health, Air Quality Division, 51 N Street, NE., Washington, DC 20002. FOR FURTHER INFORMATION CONTACT: Paresh R. Pandya, ( 215) 814   2167, or by e mail at pandya. perry@ epa. gov. SUPPLEMENTARY INFORMATION: For further information, please see the information provided in the direct final action, with the same title, that is located in the `` Rules and Regulations'' section of this Federal Register publication.

Dated: April 9, 2003. James W. Newsom, Acting Regional Administrator, Region III. [ FR Doc. 03   9344 Filed 4   15   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0125; FRL   7302   3]

Indoxacarb; Proposed Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Proposed rule.

SUMMARY: This document proposes to establish a temporary tolerance for combined residues of Indoxacarb, ( S) methyl 7 chloro 2,5 dihydro 2 [[( methoxy carbonyl) [ 4( trifluor omethoxy) phenyl] amino] carbonyl] indeno[ 1,2 e][ 1,3,4] oxadiazine 4a( 3H) carboxylate + its R enantiomer [( R) methyl 7 chloro 2,5 dihydro 2 [[( methoxycarbonyl)[ 4( trifluoro methoxy) phenyl] amino] carbonyl] indeno [ 1,2 e][ 1,3,4] oxadiazine 4a( 3H) carboxylate in or on peaches under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). This action is in response to university extension specialists, DuPont Crop Protection, and EPA's combined efforts to generate the information necessary for use of the reduced risk pesticide, Indoxacarb, on peaches for control of oriental fruit moth and plum cuculio. This proposed temporary tolerance supports a non crop destruct experimental use permit ( EUP) under section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of Indoxacarb on peaches in Georgia, Michigan, New Jersey, Pennsylvania, South Carolina, and West Virginia. This regulation proposes to establish a maximum permissible level for residues of Indoxacarb in this food commodity pursuant to section 408( e) of FFDCA, as amended by FQPA. DATES: Comments, identified by docket ID number OPP   2003   0125, must be received on or before May 1, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Rita Kumar, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8291; e mail address: kumar. rita@ epa. gov.

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. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS Code 111)   Animal production ( NAICS Code 112)   Food manufacturing ( NAICS Code 311)   Pesticide manufacturing ( NAICS Code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0125. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00027 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18583 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2003   0125. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2003   0125. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID Number OPP   2003   0125. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA., Attention: Docket ID Number OPP   2003   0125. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI To the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible.

VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18584 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the proposed rule or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background and Statutory Findings EPA, in cooperation with DuPont Crop Protection and university extension specialists, under section 408( e) of the FFDCA, 21 U. S. C. 346a, is proposing to establish a tolerance for combined residues of the insecticide Indoxacarb, in or on peaches at 10.0 parts per million ( ppm). This action is in response to university extension specialists, DuPont, and EPA's combined efforts to generate the information necessary for registration of the reduced risk pesticide, Indoxacarb, on peaches for control of oriental fruit moth and plum cuculio. This proposed temporary tolerance supports a noncrop destruct experimental use permit ( EUP) under section 5 of FIFRA authorizing use of Indoxacarb on peaches in Georgia, Michigan, New Jersey, Pennsylvania, South Carolina, and West Virginia. Section 5 of FIFRA authorizes EPA to issue an experimental use permit for a pesticide. This provision was not amended by FQPA. EPA has established regulations governing such experimental use permits in 40 CFR part 172. Section 408( r) of FFDCA authorizes EPA to issue temporary tolerances for pesticide residues from FIFRA experimental use permits. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for a tolerance for combined residues of Indoxacarb on peaches at 10.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by Indoxacarb are discussed in Table 1 of this unit as well as the no observed adverse effect level ( NOAEL) and the lowest observedadverse effect level ( LOAEL) from the toxicity studies reviewed.

TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90   Day oral toxicity rodents DPX MP062 NOAEL = M 3.1 mg/ kg/ day F 2.1 mg/ kg/ day LOAEL = M 6.0 mg/ kg/ day, F 3.8 mg/ kg/ day based on decreased body weight, body weight gain, food consumption and food efficiency.

870.3150 90   Day oral toxicity in nonrodents DPX JW062 NOAEL = 5.0 mg/ kg/ day LOAEL = 19 mg/ kg/ day based on hemolytic anemia, as indicated by decrease in HGB, RBCs; increases in platelets, increased reticulocytes; and secondary histopathologic findings indicative of blood breakdown ( pigment in Kupffer cells, renal tubular epithelium, and spleen and bone marrow macrophages); increase in splenic EMH; and RBC hyperplasia in bone marrow in dogs.

870.3200 21/ 28   Day dermal toxicity DPX MP062 NOAEL = 2,000 mg/ kg/ day LOAEL = > 2,000 mg/ kg/ day in rats. DPX MP062 NOAEL = 50 mg/ kg/ day LOAEL = 500 mg/ kg/ day based on decreased body weights, body weight gains, food consumption, and food efficiency in F*, and changes in hematology parameters ( increased reticulocytes), the spleen ( increased absolute and relative weight M* only, gross discoloration), clinical signs of toxicity in both sexes in rats.

VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18585 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.3700 Prenatal developmental in rodents DPX MP062 Maternal NOAEL = 2.0 mg/ kg/ day LOAEL = 4.0 mg/ kg/ day based on decreased mean body weights, body weight gains, food consumption. Developmental NOAEL = 2.0 mg/ kg/ day LOAEL = 4.0 mg/ kg/ day based on decreased fetal weights. DPX JW062 Maternal NOAEL = 10 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on mortality, clinical signs, and decreased mean body weights, body weight gains, and food consumption. Developmental NOAEL = 10 mg/ kg/ day LOAEL = 100 mg/ kg/ day based on decreased numbers of live fetuses/ litter. DPX JW062 Maternal NOAEL = 1.1 mg/ kg/ day LOAEL = 2.2 mg/ kg/ day based on decreased mean body weights, body weight gains, food consumption, and food efficiency. Developmental NOAEL = 1.1 kg/ day LOAEL = 2.2 mg/ kg/ day based on decreased fetal body weights.

870.3700 Prenatal developmental in nonrodents DPX JW062  rabbits Maternal NOAEL = 500 mg/ kg/ day LOAEL = 1,000 mg/ kg/ day based on slight decreases in maternal body weight gain and food consumption. Developmental NOAEL = 500 mg/ kg/ day LOAEL = 1,000 mg/ kg/ day based on decreased fetal body weights and reduced ossification of the sternebrae.

870.3800 Reproduction and fertility effects DPX JW062 Parental/ Systemic NOAEL = 1.5 mg/ kg/ day LOAEL = 4.4 mg/ kg/ day based on decreased body weights, body weight gains, and food consumption of F0 females, and increased spleen weights in the F0 and F1 females Reproductive NOAEL = 6.4 mg/ kg/ day LOAEL = 6.4 mg/ kg/ day Offspring NOAEL = 1.5 mg/ kg/ day LOAEL = 4.4 mg/ kg/ day based on decrease in the body weights of the F1 pups during lactation.

870.4100 Chronic toxicity rodents DPX JW062 NOAEL = M 5, F 2.1 mg/ kg/ day LOAEL = M 10, F 3.6 mg/ kg/ day based on decr. body weight, body weight gain, and food consumption and food efficiency; decreased HCT, HGB and RBC at 6 months in F only. no evidence of carcinogenic potential 870.4100 Chronic toxicity dogs DPX JW062 NOAEL = M 2.3, F 2.4 mg/ kg/ day LOAEL = M 18, F 19 mg/ kg/ day based on decr. HCT, HGB and RBC; increased Heinz bodies and reticulocytes and associated secondary microscopic changes in the liver, kidneys, spleen, and bone marrow; increased absolute and relative liver weights.

870.4200 Carcinogenicity rats DPX JW062 see 870.4100. No evidence of carcinogenicity 870.4300 Carcinogenicity mice DPX JW062 NOAEL = M 2.6, F4.0 mg/ kg/ day LOAEL = M 14, F 20 mg/ kg/ day based on decreased body weight, body weight gain, and food efficiency and clinical signs indicative of neurotoxicity. No evidence of carcinogenicity 870.5100 Gene Mutation DPX MP062 strains TA97a, TA98, TA100 and TA1535 of S. typhimurium and strain WP2( uvrA) of E. coli were negative for mutagenic activity both with and without S9 activation for the concentration range 10   5,000 µ g/ plate DPX JW062 strains TA97a, TA98, TA100 and TA1535 of S. typhimurium and strain WP2( uvrA) of E. coli were negative for mutagenic activity both with and without S9 activation for the concentration range 10   5,000 µ g/ plate.

VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18586 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.5300 Gene Mutation DPX MP062 negative for mutagenic activity for the following concentration ranges: 3.1   250 µ g/ mL ( S9); 3.1   250 µ g/ mL (+ S9) DPX JW062 negative for mutagenic activity for the following concentration ranges: Negative; 100   1,000 µ g/ mL ( S9); 100   1,000 µ g/ mL (+ S9), precipitate   1,000 µ g/ mL 870.5375 Cytogenetics DPX MP062 no evidence of chromosomal aberrations induced by the test article over background for the following concentration ranges: 15.7   1,000 µ g/ mL ( ± S9) DPX JW062 no evidence of chromosomal aberrations induced by the test article over background for the following concentration ranges: 19   300 µ g/ mL ( S9), 19   150 µ g/ mL (+ S9); partial insoluble and cytotoxicity   150 µ g/ mL 870.5395 Cytogenetics DPX MP062 no evidence of mutagenicity for the following dose ranges: 3,000   4,000 mg/ kg  males; 1,000   2,000 mg/ kg  females DPX JW062 no evidence of mutagenicity at 2,500 or 5,000 mg/ kg 870.5550 Other Effects DPX MP062 no evidence of mutagenic activity at the following concentration range: 1.56   200 µ g/ mL; cytotoxicity was seen at concentrations of   100 µ g/ mL DPX JW062 No evidence of mutagenic activity at the following concentration range: 0.1   50 µ g/ mL, cytotoxicity observed at   50 µ g/ mL 870.6200 Acute neurotoxicity screening battery DPX MP062 NOAEL = M 100, F 12.5 mg/ kg LOAEL = M 200 mg/ kg based on decreased body weight gain, decreased food consumption decreased forelimb grip strength, and decreased foot splay. F 50 mg/ kg based on decreased body weight, body weight gain, and food consumption DPX JW062 NOAEL= M > 2,000 mg/ kg = F < 500 mg/ kg LOAEL > M 2,000 mg/ kg F < 500 mg/ kg based on clinical signs, decreased body weight gains and food consumption and FOB effects 870.6200 Subchronic neurotoxicity screening battery DPX MP062 NOAEL = M 0.57, F 0.68 mg/ kg/ day LOAEL = M 5.6, F 3.3 mg/ kg/ day based on decreased body weight and alopecia 870.7485 Metabolism and pharmacokinetics Both DPX MP062 and DPX JW062 were extensively metabolized and the metabolites were eliminated in urine, feces, and bile. The metabolite profile for DPX JW062 was dose dependent and varied quantitatively between males and females. Differences in metabolite profiles were also observed for the different label positions ( indanone and trifluoromethoxyphenyl rings). All biliary metabolites undergo further biotransformation in the gut. The proposed metabolic pathway for both DPX MP062 and DPX JW062 has multiple metabolites bearing one of the two ring structures ( see 870   4100 chronic toxicity rodents above).

B. Toxicological Endpoints The dose at which no adverse effects are observed ( the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor ( SF). For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18587 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for Indoxacarb used for human risk assessment is shown in Table 2 of this unit:

TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR INDOXACARB FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( females 13   50 years of age) NOAEL = 2.0 mg/ kg/ day UF = 100 Acute RfD = 0.02 mg/ kg FQPA SF = 1 aPAD = acute RfD ÷ FQPA SF = 0.02 mg/ kg/ day Developmental rat toxicity study. developmental LOAEL = 4.0 mg/ kg/ day based on decreased fetal body weight.

Acute Dietary general population including infants and children NOAEL = 12.5 mg/ kg UF = 100 Acute RfD = 0.12 mg/ kg FQPA SF = 1 aPAD = acute RfD ÷ FQPA SF = 0.12 mg/ kg/ day Acute oral rat neurotoxicity study. LOAEL = 50 mg/ kg based on decreased body weight and body weight gain in females.

Chronic Dietary all populations NOAEL = 2.0 mg/ kg/ day UF = 100 Chronic RfD = 0.02 mg/ kg/ day FQPA SF = 1 cPAD = chronic RfD ÷ FQPA SF = 0.02 mg/ kg/ day 90   day rat subchronic toxicity study, 90   day rat neurotoxicity study, chronic/ carcinogenicity rat study. LOAEL = 3.3 mg/ kg/ day based on decreased body weight, alopecia, body weight gain, food consumption and food efficiency; decreased hematocrit, hemoglobin and red blood cells only at 6 months. 3.3 mg/ kg/ day is the lowest LOAEL of the three studies.

Short Term Oral ( 1   7 days) ( Residential) oral study NOAEL= 2.0 mg/ kg/ day LOC for MOE = 100 ( Residential includes the FQPA SF) Developmental rat toxicity study. Maternal LOAEL = 4.0 mg/ kg/ day based on decreased mean maternal body weights, body weight gains, and food consumption.

Intermediate Term Oral ( 1 week  several months) ( Residential) oral study NOAEL= 2.0 mg/ kg/ day LOC for MOE = 100 ( Residential includes the FQPA SF) 90   day rat subchronic toxicity study. LOAEL = 3.8 mg/ kg/ day based on decreased body weight, body weight gain, food consumption and food efficiency.

Short ( 1   7 days), Intermediate ( 1 week  several months), and Long( several months  lifetime) Term Dermal ( Occupational Residential) dermal study NOAEL= 50 mg/ kg/ day LOC for MOE = 100 ( Occupational) LOC for MOE = 100 ( Residential includes the FQPA SF) 28   day rat dermal toxicity study. LOAEL = 500 mg/ kg/ day based on decreased body weights, body weight gains, food consumption and food efficiency in females, and changes in hematology parameters ( increased reticulocytes), the spleen ( increased absolute and relative weight males only, gross discoloration), and clinical signs of toxicity in both sexes.

Short Term Inhalation ( 1   7 days) ( Occupational/ Residential) oral study NOAEL= 2.0 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Occupational) LOC for MOE = 100 ( Residential includes the FQPA SF) Rat developmental toxicity study. Maternal LOAEL = 4.0 mg/ kg/ day based on decreased mean maternal body weights, body weight gains, and food consumption.

Intermediate Term Inhalation ( 1 week  several months) ( Occupational Residential) oral study NOAEL= 2.0 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Occupational) LOC for MOE = 100 ( Residential includes the FQPA SF) 90   day rat subchronic toxicity study. LOAEL = 3.8 mg/ kg/ day based on decreased body weight, body weight gain, food consumption and food efficiency.

Long Term Inhalation ( several months  lifetime) ( Occupational Residential) oral study NOAEL= 2.0 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Occupational) LOC for MOE = 100 ( Residential includes the FQPA SF) 90   day rat subchronic toxicity study, 90   day rat neurotoxicity study, chronic/ carcinogenicity rat study. LOAEL = 3.3 mg/ kg/ day based on decreased body weight, body weight gain, food consumption and food efficiency; decreased hematocrit, hemoglobin and red blood cells only at 6 months.

VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18588 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR INDOXACARB FOR USE IN HUMAN RISK ASSESSMENT   Continued Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Cancer ( oral, dermal, inhalation) `` not likely'' to be carcinogenic to humans N/ A no evidence of carcinogenicity in either the rat or mouse in acceptable carcinogenicity studies and no evidence of mutagenicity.

* The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique to the FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.564) for the combined residues of Indoxacarb, in or on a variety of raw agricultural commodities. Including tolerances already established for: alfalfa, forage at 10 ppm; alfalfa, hay at 50 ppm; apple at 1.0 ppm; apple, wet pomace at 3.0 ppm; brassica, head and stem, subgroup at 5.0 ppm; cattle, goat, horse, sheep, and hog fat at 1.5 ppm; cattle, goat, horse, sheep, and hog meat at 0.05 ppm; cattle, goat, horse, sheep , and hog meat byproducts at 0.03 ppm; corn, sweet, forage at 10 ppm; corn, sweet, kernel plus cob with husk removed at 0.02 ppm; corn, sweet stover at 15 ppm; cotton gin byproducts at 15 ppm; cotton, undelinted seed at 2.0 ppm; lettuce, head at 4.0 ppm; lettuce, head at 5.0 ppm; lettuce, leaf at 10.0 ppm; milk at 0.15 ppm; and milk, fat at 4.0 ppm; peanut at 0.01 ppm; peanut, hay at 40 ppm; pear at 0.20 ppm; potato at 0.01 ppm; soybean, seed at 0.8 ppm; soybean, aspirated grain fractions at 45 ppm; and vegetables, fruiting, group at 0.50 ppm. Risk assessments were conducted by EPA to assess dietary exposures from Indoxacarb in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model ( DEEM   ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989   1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: An acute Tier 2 ( partially refined analysis) dietary assessment was performed with use of anticipated residues ( ARs) from field trial data, processing factors ( where applicable), and assumed 100% crop treated ( CT) for all crops. ARs for meat, milk, poultry, and eggs ( MMPE) raw agricultural commodities ( RACs) were calculated also. ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEM   analysis evaluated the individual food consumption as reported by respondents in the USDA1989   1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Chronic exposure estimates are expressed in mg/ kg bw/ day and as a percent of the cPAD. The chronic dietary assessment assumed tolerance level residues, DEEM   default processing factors, assumed 100% CT for all crops other than peaches, and 1% CT for the peach EUP ( 300 acres)( Tier 1). iii. Cancer. There is no evidence for mutagenicity and there is no evidence of carcinogenicity in either the rat or mouse. Indoxacarb has been classified as `` not likely to be carcinogenic in humans'' by the Agency; therefore, no carcinogenic dietary risk analysis was performed. iv. Anticipated residue and percent crop treated ( PCT) information. Section 408( b)( 2)( E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408( b)( 2)( E) of the FFDCA, EPA will issue a data call in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408( b)( 2)( F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408( b)( 2)( F) of the FFDCA, EPA may require registrants to submit data on PCT. The Agency used PCT information as follows: Dietary exposure estimates were based on 1% PCT for peaches. This PCT of 1% was based on the fact that the 2   year experimental use permit was issued for only 300 acres of peaches to be treated annually, which amounts to 0.2% of the total peach acreage in the United States. The reason for using 1% instead of 0.2% is to allow for any uncertainties in the residue evaluation. Before making this tolerance permanent, reevaluation of dietary exposure will be performed using all available information. Other commodities were assumed to be 100% treated. The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA finds that the PCT information described 1% for Indoxacarb used on peaches is reliable and has a valid basis. A 2   year EUP has been issued for this use, which will allow for use of Indoxacarb on 300 acres of peaches in some eastern states. Before the use can be expanded for treatment of greater than 300 acres per year, permission from the Agency must be obtained. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18589 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which Indoxacarb may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for Indoxacarb in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of Indoxacarb. The Agency uses the Generic Estimated Environmental Concentration ( GENEEC) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and SCIGROW ( screening concentration in ground water), which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model) for a screening level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a percent reference dose (% RfD) or percent population adjusted dose (% PAD). Instead, drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to Indoxacarb they are further discussed in the aggregate risk sections below. Based on the PRZM/ EXAMS and SCIGROW models the estimated environmental concentrations ( EECs) of Indoxacarb for acute exposures are estimated to be 13.7 parts per billion ( ppb) for surface water and 0.02 ppb for ground water. The EECs for chronic exposures are estimated to be 3.7 ppb for surface water and 0.02 ppb for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Indoxacarb is not registered for use on any sites that would result in residential exposure. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether Indoxacarb has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, Indoxacarb does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that Indoxacarb has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. There is no evidence for either qualitative or quantitative susceptibility. In all developmental studies, the developmental endpoint occurs at the maternal LOAEL or above. Although there is no rabbit developmental toxicity study with indoxacarb, a study is not required since: ( 1) studies both using methyl cellulose comparing JW062 in the rabbit and rat demonstrate that the toxicity profiles for the rat and rabbit are similar and that the rat is the more sensitive species; ( 2) range finding studies in the rat comparing indoxacarb and JW062 indicate that the maternal and external developmental toxicity are comparable; ( 3) a dietary developmental toxicity study in the rat with JW062 had comparable toxicity to the gavage indoxacarb rat developmental toxicity study. Developmental toxicity only occurred at levels at or above maternal toxicity. The reproduction toxicity study with JW062 can be used to satisfy the requirement for an indoxacarb study because: 1) systemic toxicity is at similar doses and of similar magnitude to that observed in subchronic feeding studies with both indoxacarb and JW062; 2) based on the data base, the HIARC determined that there was support for using data from dietary studies conducted with JW062 to satisfy the data requirements for indoxacarb. The Agency has required a developmental neurotoxicity study as confirmatory data due to:   Clinical signs of neurotoxicity in several studies, males and females, mice and rats, at some doses that do not cause mortality;   Signs of neurotoxicity in the acute neurotoxicity study rat with indoxacarb ( males and females), no mortality in males at neurotoxic doses;

VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18590 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules   Clinical signs of neurotoxicity in the 90   day toxicity study rat indoxacarb ( females), mortality;   Clinical signs of neurotoxicity in the 90   day toxicity study mouse with the racemic mixture, JW062 ( males and females), no mortality in females at neurotoxic doses, mortality in males;   Clinical signs of neurotoxicity in the 18 month carcinogenicity study mouse with JW062 ( males and females) high and mid dose, mortality at the high but no mortality at the mid dose; and   Clinical signs of neurotoxicity in the developmental toxicity study rat with JW062 ( using methyl cellulose as the vehicle), at doses causing mortality. 3. Conclusion. The Agency concluded that the FQPA safety factor could be reducecd to 1X for Indoxacarb because:   There is no indication of quantitative or qualitative increased susceptibility of rats or rabbits to in utero and/ or postnatal exposure;   The requirement of a developmental neurotoxicity study is not based on the criteria reflecting special concern for the developing fetuses or young which are generally used for requiring a DNT study  and a safety factor ( e. g.: neuropathy in adult animals; CNS malformations following prenatal exposure; brain weight or sexual maturation changes in offspring; and/ or functional changes in offspring)  and therefore does not warrant an FQPA safety factor; and   The dietary ( food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children   There are no registered residential uses at the current time. E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates drinking water level of comparison ( DWLOCs) which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water [ e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and groundwater are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to Indoxacarb will occupy 12% of the aPAD for the U. S. population, 69% of the aPAD for females 13 years and older, 67% of the aPAD for infants less than 1 year old and 36% of the aPAD for children 1 to 2 years old. In addition, there is potential for acute dietary exposure to Indoxacarb in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPad, as shown in Table 3 of this unit:

TABLE 3.   AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO INDOXACARB Population Subgroup aPAD ( mg/ kg) % aPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Acute DWLOC ( ppb)

U. S. Population 0.12 7 13.7 0.02 3,700 Females 13 + 0.02 69 13.7 0.02 180 All infants less than 1 year 0.12 67 13.7 0.02 400 Children 1 to 2 0.12 36 13.7 0.02 760 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to Indoxacarb from food will utilize 30% of the cPAD for the U. S. population, 29% of the cPAD for infants less than 1 year old and 79% of the cPAD for children 1 to 2 years old. There are no residential uses for Indoxacarb that result in chronic residential exposure to Indoxacarb. Based the use pattern, chronic residential exposure to residues of Indoxacarb is not expected. In addition, there is potential for chronic dietary exposure to Indoxacarb in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18591 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules TABLE 4.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO INDOXACARB Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. Population 0.02 30 3.7 0.02 490 All infants less than 1 year old 0.02 29 3.7 0.02 140 Children 1 to 2 0.02 79 3.7 0.02 43 3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Indoxacarb is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Indoxacarb is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. Aggregate cancer risk for U. S. population. There is no evidence for mutagenicity and there is no evidence of carcinogenicity in either the rat or mouse. Indoxacarb has been classified as `` not likely to be carcinogenic in humans'' by the Agency; therefore, Indoxacarb is not expected to pose carcinogenic risk when used as directed. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to Indoxacarb residues.

IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology ( high performance liquid chromatography HPLC/ UV Method AMR 2712   93) is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PRRIB, IRSD ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: ( 703) 305   5229; e mail address: furlow. calvin@ epa. gov. B. International Residue Limits There are no established or proposed Codex, Canadian, or Mexican maximum residue limits ( MRLs) for residues of indoxacarb; therefore, international harmonization is not an issue at this time.

V. Conclusion A 15   day comment period is being allowed for this proposed rule because of the speed of growth and the pest pressure, and the Agency's desire to be suportive of efforts by peach growers and researchers to find alternatives to organophosphates for control of oriental fruit moth and plum curculio in peaches. Additionally, the Agency feels that there is strong evidence in support of the safety of this proposed action. Therefore, a temporary tolerance for 3 years is proposed for combined residues of Indoxacarb, ( S) methyl 7 chloro 2,5 dihydro 2[[( methoxy carbonyl) [ 4 ( trifluoromethoxy) phenyl] amino] carbonyl] indeno[ 1,2 e][ 1,3,4] oxadiazine 4a( 3H) carboxylate + its R enantiomer] ( R) methyl 7 chloro 2,5 dihydro 2 [[( methoxycarbonyl)[ 4( trifluoro methoxy) phenyl] amino] carbonyl] indeno [ 1,2 e][ 1,3,4] oxadiazine 4a( 3H) carboxylate in peaches at 10.0 ppm.

VI. Statutory and Executive Order Reviews This proposed rule is establishing a tolerance under section 408( d) of the FFDCA. EPA is proposing this regulation in cooperation with Research Extension Specialists at the University of Georgia, Rutgers University, Clemson University, Pennsylvania State University, Michigan State University, University of West Virginia, and DuPont de Nemours and Company. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this proposed rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on 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 Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is VerDate Jan< 31> 2003 15: 26 Apr 15, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 E:\ FR\ FM\ 16APP1. SGM 16APP1 18592 Federal Register / Vol. 68, No. 73 / Wednesday, April 16, 2003 / Proposed Rules defined in the Executive order to include regulations that 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.'' This proposed rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, 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.'' This proposed rule will not have substantial direct effects on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: April 10, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs. [ FR Doc. 03   9340 Filed 4   15   03; 8: 45 a. m.]

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[Federal Register Volume 84, Number 85 (Thursday, May 2, 2019)]
[Notices]
[Pages 18850-18851]
[FR Doc No: 2019-08897]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0001]

Preparation for International Cooperation on Cosmetics Regulation
Thirteenth Annual Meeting; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``International
Cooperation on Cosmetics Regulation (ICCR)--Preparation for ICCR-13
Meeting.'' The purpose of the public meeting is to invite public input
on various topics pertaining to the regulation of cosmetics. We may use
this input to help us prepare for the ICCR-13 meeting that will be held
July 9 to 11, 2019, in Montreal, Canada.

DATES: The public meeting will be held on June 5, 2019, from 2 p.m. to
4 p.m. See the SUPPLEMENTARY INFORMATION section for registration date
and information.

ADDRESSES: The public meeting will be held at the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr., Wiley Auditorium (first floor), College Park, MD 20740.

FOR FURTHER INFORMATION CONTACT: Jonathan Hicks, Office of Cosmetics
and Colors, Food and Drug Administration, 5001 Campus Dr. (HFS-125),
College Park, MD 20740,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The intention of the ICCR multilateral framework is to pave the way
for the removal of regulatory obstacles to international trade while
maintaining global consumer protection. The purpose of the meeting is
to invite public input on various topics pertaining to the regulation
of cosmetics. We may use this input to help us prepare for the ICCR-13
meeting that will be held July 9 to 11, 2019, in Montreal, Canada.
    ICCR is a voluntary international group of cosmetics regulatory
authorities from Brazil, Canada, the European Union, Japan, and the
United States of America. These regulatory authority members will
engage in constructive dialogue with their relevant cosmetics industry
trade associations and public advocacy groups. Currently, the ICCR
members are: The Brazilian Health Surveillance Agency; Health Canada;
the European Commission Directorate-General for Internal Market,
Industry, Entrepreneurship, and Small and Medium-sized Enterprises; the
Ministry of Health, Labor, and Welfare of Japan; and FDA. All decisions
are made by consensus and will be compatible with the laws, policies,
rules, regulations, and directives of the respective administrations
and governments. Members will implement and/or promote actions or
documents within their own jurisdictions and seek convergence of
regulatory policies and practices. Successful implementation will need
input from stakeholders.

II. Topics for Discussion at the Public Meeting

    We will make the agenda for the public meeting available on the
internet at https://www.fda.gov/Cosmetics/InternationalActivities/ICCR/default.htm. Depending on the number of requests for oral
presentations, we intend to have an agenda available by May 29, 2019.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, send registration
information (including your name, title, affiliation, address, email,
and telephone), to Jonathan Hicks by May 22, 2019. If you would like to
listen to the meeting by phone, please submit a request for a dial-in
number by May 22, 2019 (see FOR FURTHER INFORMATION CONTACT). If you
need special accommodations due to a disability, please contact
Jonathan Hicks by May 29, 2019.
    Requests for Oral Presentations: If you wish to present, you should
notify Jonathan Hicks by May 22, 2019, and submit a brief statement of
the general nature of the presentation: What you wish to present, your
name, title, affiliation, address, email, and telephone, and indicate
the approximate amount of time needed to make your presentation. You
may wish to present proposals for future ICCR agenda items, data,
information, or views, in person or in writing, on issues pending at
the

public meeting or a topic related to a previous meeting. There will be
no presentations by phone. Time allotted for oral presentations may be
limited to 10 minutes or less for each presenter, depending on the
number of requests received.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20850.

    Dated: April 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08897 Filed 5-1-19; 8:45 am]
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[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)]
[Proposed Rules]
[Pages 3445-3446]
[FR Doc No: 2018-01297]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2017-D-5225]

Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Foreign Supplier Verification Programs for Importers of Food for
Humans and Animals.'' The draft guidance, once finalized, will provide
our thinking on how importers of human or animal food can comply with
the regulation on foreign supplier verification programs (FSVPs) issued
on November 27, 2015.

DATES: Submit either electronic or written comments on the draft
guidance by May 25, 2018 to ensure that the Agency considers your
comments on this draft guidance before it completes a final version of
the guidance,

ADDRESSES: You may submit comments on any guidance at any time as
follows.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2017-D-5225 for ``Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals: Guidance for Industry.''
Received comments 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 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 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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Outreach and Information Center (HFS-009), Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740. Send one self-addressed adhesive
label to assist that office in processing your requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Office of
Compliance (HFS-600), Center for Food Safety and Applied Nutrition,
5001 Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 27, 2015 (80 FR 74226), we
issued a final rule adopting a regulation on foreign supplier
verification programs (FSVPs) for importers of food for humans and
animals (FSVP final rule). The FSVP final rule implements section 301
of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
which enables the Agency to better protect public health by helping to
ensure the safety and security of the food supply.
    Section 301 of FSMA added section 805 to the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) to require persons who
import food into the United States to perform risk-based foreign
supplier verification activities. In addition to directing FDA to issue
regulations on the content of FSVPs, section 805 directs FDA to issue
guidance to assist importers in developing FSVPs.
    In accordance with section 805 of the FD&C Act, we are announcing
the availability of a draft guidance for industry entitled ``Foreign
Supplier Verification Programs for Importers of Food for Humans and
Animals.'' The draft guidance, once finalized, will provide our
thinking on how to comply with the FSVP regulation, including, but not
limited to, requirements to analyze the hazards in food, evaluate a
potential foreign supplier's performance and the risk posed by a food,
and determine and conduct appropriate foreign supplier verification
activities. The draft guidance also addresses how importers can meet
the modified FSVP requirements for importers of dietary supplements,
very small importers, importers of food from certain small foreign
suppliers, and importers of food from countries whose food safety
systems we have officially recognized as comparable or determined to be
equivalent to that of the United States.
    The draft guidance reflects interpretations regarding two matters
addressed in the preamble to the FSVP final rule that differ from the
interpretations expressed there. First, the draft guidance reflects an
interpretation that is different from our statement in the preamble to
the FSVP final rule that waxing and cooling raw agricultural
commodities, when done by a packing operation for purposes of storage
or transport, may be considered a packing activity (see 80 FR 74226 at
74236 (Comment/Response 14)). Instead, the draft guidance states that
such activities may be packing activities and/or holding activities,
depending on the circumstances. This change reflects our revised
thinking regarding the classification of waxing, which we now consider
may be incidental to holding (not packing) under certain circumstances
(see ``Classification of Activities as Harvesting, Packing, Holding, or
Manufacturing/Processing for Farms and Facilities: Draft Guidance for
Industry'' (81 FR 58421, August 25, 2016) available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517575.pdf). Second, the
draft guidance reflects an interpretation that differs from our
statement in the preamble to the FSVP final rule that there may be
circumstances in which hazards that may be intentionally introduced by
acts of terrorism may present a known or reasonably foreseeable hazard,
such that importers may need to address these hazards as part of their
supplier verification activities (see 80 FR 74226 at 74281 (Comment/
Response 174)). That statement assumed that importers would consider
such hazards in their hazard analyses. In the draft guidance, we
clarify that importers are not required under the FSVP regulation to
consider in their hazard analysis hazards that are intentionally
introduced to cause wide scale public health harm. Instead, importers
should consider warning letters or other enforcement action taken by
FDA against foreign suppliers for violation of FDA's regulation on
intentional adulteration (in 21 CFR part 121) as part of their
evaluation of potential suppliers under 21 CFR 1.505 in the FSVP
regulation. Our prior statements were incorrect and we hereby withdraw
them. We further explain our thinking on these matters in the FSVP
draft guidance.

II. Significance of Guidance

    This level 1 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 current thinking of FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You may use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This draft guidance is not subject to Executive Order 12866.

III. 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
collections of information in 21 CFR part 1, subpart L, have been
approved under OMB control number 0910-0752.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the draft guidance.

    Dated: January 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01297 Filed 1-24-18; 8:45 am]
BILLING CODE 4164-01-P