[Federal Register Volume 86, Number 64 (Tuesday, April 6, 2021)]
[Proposed Rules]
[Pages 17755-17757]
[FR Doc No: 2021-06398]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0170]
RIN 1625-AA00

Safety Zone; Sabine River, Orange, TX

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain navigable waters of the Sabine River, extending the
entire width of the river, adjacent to the public boat ramp located in
Orange, TX. The safety zone is necessary to protect persons and vessels
from hazards associated with a high-speed boat race competition in
Orange, TX. Entry of vessels or persons into this zone would be
prohibited unless authorized by the Captain of the Port Marine Safety
Unit Port Arthur or a designated representative. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 21, 2021.

ADDRESSES: You may submit comments identified by docket number USCG-
2021-0170 using the Federal eRulemaking Portal at https://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
proposed rulemaking, call or email Mr. Scott Whalen, Marine Safety Unit
Port Arthur, U.S. Coast Guard; telephone<PHONE_NUMBER>, 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

II. Background, Purpose, and Legal Basis

    On March 18, 2021, the City of Orange, TX notified the Coast Guard
that it will be sponsoring high speed boat races from 8:30 a.m. to 6
p.m. on May 22 and 23, 2021, adjacent to the public boat ramp in
Orange, TX. The Captain of the Port Port Arthur (COTP)

has determined that potential hazards associated with high speed boat
races would be a safety concern for spectator craft and vessels in the
vicinity of these race events.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters of the Sabine River adjacent to the public
boat ramp in Orange, TX before, during, and after the scheduled event.
The Coast Guard is proposing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 7:30 a.m. on
May 22, 2021 through 6 p.m. on May 23, 2021. The safety zone would be
enforced from 7:30 a.m. to 6 p.m. on both the 22nd and the 23rd. The
safety zone would cover all navigable waters of the Sabine River,
extending the entire width of the river, adjacent to the public boat
ramp located in Orange, TX bounded to the north by the Orange Public
Wharf and latitude 30[deg]05'50'' N and to the south at latitude
30[deg]05'33'' N. The duration of the safety zone is intended to
protect participants, spectators, and other persons and vessels, in the
navigable waters of the Sabine River during high-speed boat races and
will include breaks and opportunity for vessels to transit through the
regulated area.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. They will be available on VHF-FM or by telephone.
    The COTP or a designated representative may prohibit or control the
movement of all vessels in the zone. The COTP or a designated
representative may terminate the operation of any vessel at any time it
is deemed necessary for the protection of life or property. The COTP or
a designated representative may terminate enforcement of the safety
zone at the conclusion of the event.

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. 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 (OMB).
    This regulatory action determination is based on the proposed size,
location and duration of the rule. The safety zone will encompass a
less than half-mile stretch of the Sabine River for eight hours on each
of two days. The Coast Guard will notify the public by issuing Local
Notice to Mariners (LNM), and/or Marine Safety Information Bulletin
(MSIB) and Broadcast Notice to Mariners via VHF-FM radio and the rule
will allow vessels to seek permission to enter the zone during
scheduled breaks.

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 transit the
temporary 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 rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    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 call or email 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 proposed 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 would 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 proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

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 Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination

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 that would last
8 hours on each of two days and that would prohibit entry on less than
a half-mile stretch of the Sabine River in Orange, TX. Normally such
actions are categorically excluded from further review under paragraph
L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01,
Rev. 1. A preliminary Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble. 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 call or email 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 https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, call or email the person
in the FOR FURTHER INFORMATION CONTACT section of this document for
alternate instructions.
    We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have
provided. For more about privacy and submissions in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020).
    Documents mentioned in this NPRM as being available in the docket,
and public comments, will be in our online docket at https://www.regulations.gov and can be viewed by following that website's
instructions. We review all comments received, but we will only post
comments that address the topic of the proposed rule. We may choose not
to post off-topic, inappropriate, or duplicate comments that we
receive. 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 is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREA AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 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 Sec.  165.T08-0170 to read as follows:

Sec.  165.T08-0170   Safety Zone; Sabine River, Orange, Texas.

    (a) Location. The following area is a safety zone: All navigable
waters of the Sabine River, extending the entire width of the river,
adjacent to the public boat ramp located in Orange, TX bounded to the
north by the Orange Public Wharf and latitude 30[deg]05'50'' N and to
the south at latitude 30[deg]05'33'' N. The duration of the safety zone
is intended to protect participants, spectators, and other persons and
vessels, in the navigable waters of the Sabine River during high-speed
boat races and will include breaks and opportunity for vessels to
transit through the regulated area.
    (b) Effective period. This section is effective from 10 a.m.
through 6 p.m. on May 22, 2021 and May 23, 2021.
    (c) Enforcement periods. This section will be enforced from 10 a.m.
through 6 p.m. daily.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry of vessels or persons into this zone
is prohibited unless authorized by the Captain of the Port Marine
Safety Unit Port Arthur (COTP) or a designated representative. They may
be contacted on VHF-FM channel 13 or 16, or by phone at by telephone at
409-719-5070.
    (2) The COTP or a designated representative may forbid and control
the movement of all vessels in the regulated area. When hailed or
signaled by an official patrol vessel, a vessel shall come to an
immediate stop and comply with the directions given. Failure to do so
may result in expulsion from the area, citation for failure to comply,
or both.
    (3) The COTP or a designated representative may terminate the event
or the operation of any vessel at any time it is deemed necessary for
the protection of life or property.
    (4) The COTP or a designated representative will terminate
enforcement of the special local regulations at the conclusion of the
event.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any changes in the dates and times of
enforcement through Local Notice to Mariners (LNMs), Broadcast Notices
to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs)
as appropriate.

    Dated: March 23, 2021.
Molly A. Wike,
Captain, U.S. Coast Guard, Captain of the Port, Marine Safety Zone Port
Arthur.
[FR Doc. 2021-06398 Filed 4-5-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]
[Page 33692-33695]
[DOCID:fr13jn08-13]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2008-N-0310]

Medical Devices; Medical Device Reporting; Baseline Reports

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its medical
device reporting regulations to remove a requirement for baseline
reports that the agency deems no longer necessary. Currently,
manufacturers provide baseline reports to FDA that include the FDA
product code and the premarket approval or premarket notification
number. Because most of the information in these baseline reports is
also submitted to FDA in individual adverse event reports, FDA is
removing the requirement for baseline reports. The removal of this
requirement will eliminate unnecessary duplication and reduce the
manufacturer's reporting burden. FDA is amending the regulation in
accordance with its direct final rule procedures. Elsewhere in this
issue of the Federal Register, we are publishing a companion proposed
rule under FDA's usual procedures for notice and comment to provide a
procedural framework to finalize the rule in the event we receive a
significant adverse comment and withdraw this direct final rule.

DATES: This rule is effective October 27, 2008. Submit written or
electronic

comments by August 27, 2008. If we receive no significant adverse
comments within the specified comment period, we intend to publish a
document confirming the effective date of the final rule in the Federal
Register within 30 days after the comment period on this direct final
rule ends. If we receive any timely significant adverse comment, we
will withdraw this final rule in part or in whole by publication of a
document in the Federal Register within 30 days after the comment
period ends.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0310, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see section IX of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Howard A. Press, Center for Devices
and Radiological Health (HFZ-530), Food and Drug Administration, 1350
Piccard Dr, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of the Rule?

    In the Federal Register of December 11, 1995 (60 FR 63578), FDA
published a final rule revising part 803 (21 CFR part 803) and
requiring medical device manufacturers to submit certain reports
relating to adverse events, including a requirement under Sec.  803.55
to submit baseline reports on FDA Form 3417 or an electronic
equivalent. Section 803.55 requires manufacturers to submit baseline
reports when the manufacturer submits the first adverse event report
under Sec.  803.50 for a device model. In addition, Sec.  803.55
requires annual updates of each baseline report.
    The baseline report includes address information for the reporting
and manufacturing site for the device, device identifiers, the basis
for marketing for the device (e.g., the 510(k) number or PMA number),
the FDA product code, the shelf life of the device (if applicable) and
the expected life of the device, the number of devices distributed each
year, and the method used to calculate that number. In the Federal
Register of July 31, 1996 (61 FR 39868), FDA stayed the requirement for
manufacturers to submit information on the number of devices
distributed each year and the method used to calculate that number,
because of questions raised about the feasibility of obtaining such
information and the usefulness of such information once submitted to
FDA.
    With the requirement for these two data elements stayed, the data
submitted in baseline reports largely overlapped with the data
submitted in individual adverse event reports. That is, FDA had access
to much of the information included in baseline reports through the
individual adverse event reports submitted on the MedWatch mandatory
reporting form (FDA Form 3500A). Two notable exceptions were the basis
for marketing and the FDA product code, data elements that were
included in the baseline reports but were not included in the FDA Form
3500A and its instructions.
    The basis for marketing and the FDA product code were, however,
subsequently incorporated into the FDA Form 3500A and its instructions.
In the Federal Register of December 27, 2004 (69 FR 77256), FDA
announced proposed modifications to FDA Form 3500A, which included
adding an entry for the basis for marketing (PMA or 510(k) number). In
the Federal Register of December 7, 2005 (70 FR 72843), FDA announced
that the Office of Management and Budget approved these modifications
under the Paperwork Reduction Act of 1995. FDA also modified the
instructions for FDA Form 3500A to state that manufacturers use the FDA
product code when completing the entry for ``Common Device Name'' on
FDA Form 3500A.
    With the addition of these two data elements (basis for marketing
and FDA product code) to FDA Form 3500A and its instructions, the
information submitted in FDA Form 3500A largely replicates the
information submitted in baseline reports. As a result, the agency
deems the baseline reporting requirement in Sec.  803.55 no longer
necessary. The agency believes that removing Sec.  803.55 will reduce
the reporting burden for manufacturers without impairing the agency's
receipt of device adverse event information.

II. What Does This Direct Final Rulemaking Do?

    In this direct final rule, FDA is removing Sec.  803.55, which
requires manufacturers to submit a baseline report when they submit the
first report under Sec.  803.50 involving a device model and provide
annual updates thereafter. In addition, this direct final rule makes
conforming amendments to Sec. Sec.  803.1(a), 803.10(c), and 803.58(b)
to remove references to baseline reports and to Sec.  803.55. Finally,
this direct final rule removes the terms ``device family'' and ``shelf
life'' from the definitions in Sec.  803.3 because these terms are used
only in the context of baseline reports.

III. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial changes to existing regulations. We
anticipate no significant adverse comment.
    Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule that is identical to the direct final rule. The companion
proposed rule provides a procedural framework within which the rule may
be finalized in the event the direct final rule is withdrawn because of
any significant adverse comment. The comment period for this direct
final rule runs concurrently with the comment period of the companion
proposed rule. Any comments received in response to the companion
proposed rule will also be considered as

comments regarding this direct final rule.
    We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
final rule before its effective date by publication of a notice in the
Federal Register within 30 days after the comment period ends. A
significant adverse comment is defined as a comment that explains why
the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553). Comments that are frivolous, insubstantial, or outside the scope
of the rule will not be considered significant or adverse under this
procedure. For example, a comment recommending an additional change to
the rule will not be considered a significant adverse comment, unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
    If we withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.

IV. What is the Legal Authority for This Rule?

    FDA is issuing this direct final rule under the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).

V. What is the Environmental Impact of This Rule?

    The agency has determined under 21 CFR 25.30(h) and (i) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. What is the Economic Impact of This Rule?

    FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this direct final rule is not a significant regulatory action as
defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The direct final rule amends the existing medical
device reporting regulation to remove Sec.  803.55, which requires that
manufacturers submit baseline reports, and makes conforming amendments
to Sec. Sec.  803.1(a), 803.3, 803.10(c), and 803.58(b) to remove
references to baseline reports and to Sec.  803.55 and to remove the
terms ``device family'' and ``shelf life.'' This final rule does not
impose any new requirements but instead removes a reporting requirement
for manufacturers that FDA deems no longer necessary. The agency
certifies that the final rule will not have a significant economic
impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

VII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?

    This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not
required.

VIII. What are the Federalism Impacts of This Rule?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies 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. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

IX. How Do You Submit Comments on This Rule?

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments or
submissions will be accepted by FDA only through FDMS at http://
www.regulations.gov.

List of Subjects in 21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
803 is amended as follows:

PART 803--MEDICAL DEVICE REPORTING

0
1. The authority citation for 21 CFR part 803 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

Sec.  803.1  [Amended]

0
2. Section 803.1 is amended in paragraph (a), in the fourth sentence,
by removing the phrase ``and baseline reports''.

Sec.  803.3  [Amended]

0
3. Section 803.3 is amended by removing the definitions for ``Device
family'' and ``Shelf life''.

Sec.  803.10  [Amended]

0
4. Section 803.10 is amended by removing paragraph (c)(3) and
redesignating paragraph (c)(4) as paragraph (c)(3).

Sec.  803.55  [Removed]

0
5. Section 803.55 is removed.

Sec.  803.58  [Amended]

0
6. Section 803.58 is amended in paragraph (b)(1) by removing
``803.55,''.

    Dated: June 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13350 Filed 6-12-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Rules and Regulations]
[Page 27756-27761]
[DOCID:fr14my08-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0149; [FRL-8362-9]

 Cyproconazole; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for the free and
conjugated residues of cyproconazole, [alpha]-(4-chlorophenyl)-[alpha]-
(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol in or on aspirated
grain fractions; field corn, forage, grain and stover; soybean, seed,
forage, hay and oil; wheat, forage, hay, straw, grain, grain, milled by
products; fat of cattle, goat, horse and sheep; and meat byproducts
(except liver) of cattle, goat, horse and sheep. Additionally, this
regulation establishes tolerances for cyproconazole and its metabolite,
[delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-methyl-1H-
1,2,4-triazole-1-hexenoic acid in or on milk and for cyproconazole and
its metabolite, 2-(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-
butane-2,3-diol in or on liver of cattle, goat, hog, horse, and sheep.
Syngenta Crop Protection, Inc., requested this tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective May 14, 2008. Objections and
requests for hearings must be received on or before July 14, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0149. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 those
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to
provide 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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0149 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before July 14, 2008.

    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0149, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of November 22, 2006 (71 FR 67575) (FRL-
8089-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6F7072) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.485 be amended by
establishing tolerances for residues of the fungicide cyproconazole, in
or on the following commodities: Soybean, seed at 0.05 parts per
million (ppm); soybean, forage at 1.0 ppm; soybean, hay at 2.5 ppm;
corn, field, grain at 0.02 ppm; corn, field, forage at 0.6 ppm; corn,
field, stover at 1.5 ppm; wheat, straw at 1.0 ppm; wheat, grain at 0.05
ppm; wheat, forage at 1.0 ppm; wheat, hay at 1.5 ppm; aspirated grain
fractions at 0.6 ppm; cattle, fat at 0.01 ppm; cattle, liver at 0.3
ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts (except liver)
at 0.01 ppm; milk at 0.01 ppm; goat, fat at 0.01 ppm; goat, liver at
0.3 ppm; goat, meat at 0.01 ppm; goat, meat byproducts (except liver)
at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver at 0.3 ppm; hog meat at
0.01 ppm; hog, meat byproducts (except liver) at 0.01 ppm; horse, liver
at 0.3 ppm; horse, meat at 0.01 ppm; horse, meat byproducts (except
liver) at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, kidney at 0.3 ppm;
sheep, meat at 0.01 ppm; and sheep, meat byproducts (except liver) at
0.01 ppm. This notice included a summary of the petition prepared by
Syngenta Crop Protection, Inc., the registrant. Comments were received
on the notice of filing. EPA's response to these comments is discussed
in Unit IV.C.
    Based upon review of the data supporting the petition, EPA
concluded that the preferred chemical name for cyproconazole is
``[alpha]-(4-chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-
triazole-1-ethanol.'' 40 CFR 180.485 is being revised to use this
terminology. Also, EPA determined that the time-limited tolerance
established for soybean seed under 40 CFR 180.485(b) can be deleted
given that a tolerance for soybean seed without time limitation is
being established in section (a).
    Additionally, EPA has determined that, as a result of the
tolerances sought in this petition, a tolerance is needed for the
combined free and conjugated residues of cyproconazole [alpha]-(4-
chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol
and its metabolite [[delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-
[gamma]-methyl-1H-1,2,4-triazole-1-hexenoic acid in or on the
commodity: Milk at 0.02 ppm and that tolerances are needed for the
combined free and conjugated residues of cyproconazole [[alpha]-(4-
chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol
and its metabolite [2-(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-
1-yl-butane-2,3-diol in or on the commodities: Liver of cattle, goat,
horse, and sheep at 0.50 ppm and hog liver at 0.01 ppm.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    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 FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 for the petitioned-for-tolerance.
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.
    Specific information on the studies received and the nature of the
adverse effects caused by cyproconazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the docket
established by this action, which is described under ADDRESSES, and is
identified as ``Cyproconazole: Human-Health Risk Assessment for
Proposed Uses'' in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the NOAEL in the toxicology study identified as appropriate for
use in risk assessment. However, if a NOAEL cannot be determined, the
LOAEL is sometimes used for risk assessment. Uncertainty/safety factors
(UFs) are used in conjunction with the LOC to take into account
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. Safety is assessed for
acute

and chronic risks by comparing aggregate exposure to the pesticide to
the acute population adjusted dose (aPAD) and chronic population
adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the
LOC by all applicable UFs. Short-term, intermediate-term, and long-term
risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the margin of exposure (MOE) called for by the product of
all applicable UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for cyproconazole used for
human risk assessment can be found at http://www.regulations.gov in
document ``Cyproconazole Human Health Risk Assessment for Proposed Uses
on Corn, Soybean and Wheat'' in docket ID number EPA-HQ-OPP-2008-0149.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to cyproconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing cyproconazole
tolerances in 40 CFR 180.485. EPA assessed dietary exposures from
cyproconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    In estimating acute dietary exposure, EPA used food consumption
information from the U.S. Department of Agriculture (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA assumed all foods for which
there are tolerances were treated and contain tolerance-level residues.
    ii. Chronic exposure. In conducting this chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996,
or 1998 CSFII. As to residue levels in food, EPA assumed all foods for
which there are tolerances were treated and contain tolerance-level
residues.
    iii. Cancer. Cyproconazole has been classified by the Agency as
``Not Likely to be Carcinogenic to Humans''. The decision was based on
the weight of evidence that supports a non-genotoxic mitogenic mode of
action for cyproconazole. Therefore, a cancer dietary exposure
assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for cyproconazole 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 environmental
fate characteristics of cyproconazole. Further information regarding
EPA drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated environmental concentrations (EECs) of cyproconazole for
acute exposures are estimated to be 1.14 parts per billion (ppb) for
surface water and 0.05 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.11 ppb for surface water and 0.05 ppb
for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
     Cyproconazole is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding for cyproconazole and any other
substance. Other than as discussed below for the cyproconazole
metabolite 1,2,4-triazole for the purposes of this tolerance action,
therefore, EPA has assumed that cyproconazole does not have 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 policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
    Cyproconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole and two
triazole conjugates (triazole alanine and triazole acetic acid). To
support existing tolerances and to establish new tolerances for
triazole-derivative pesticides, including cyproconazole, EPA conducted
a human health risk assessment for exposure to 1,2,4-triazole, triazole
alanine, and triazole acetic acid resulting from the use of all current
and pending uses of any triazole-derived fungicide. The risk assessment
is a highly conservative, screening-level evaluation in terms of
hazards associated with common metabolites (e.g., use of a maximum
combination of uncertainty factors) and potential dietary and non-
dietary exposures (i.e., high end estimates of both dietary and non-
dietary exposures). In addition, the Agency retained the additional 10X
FQPA safety factor for the protection of infants and children. The
assessment includes evaluations of risks for various subgroups,
including those comprised of infants and children. The Agency's
complete risk assessment is found in the propiconazole reregistration
docket at http://www.regulations.gov (docket ID EPA-HQ-OPP-2005-0497).
An addendum to the risk assessment, ``Dietary Exposure Assessments for
the Common Triazole Metabolites 1,2,4-triazole, Triazolylalanine,
Triazolylacetic Acid and Triazolyl Pyruvic Acid; Updated to Include New
Uses of Fenbuconazole, Ipconazole, Metconazole, Tebuconazole, and
Uniconazole'' can be found at http://www.regulations.gov in docket ID
EPA-HQ-OPP-2008-0149.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') 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 database on toxicity and exposure unless EPA
determines based on reliable data that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the FQPA safety factor. In applying this
provision, EPA either retains the default value of 10X when reliable
data do not support the choice of a different factor, or, if reliable
data are available, EPA uses a different additional FQPA safety factor
value based on the use of traditional UFs and/or special FQPA safety
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility in the developmental study in rats or in the
2-generation reproduction study in rat. There is no concern for the
increased susceptibility in the New Zealand white (NZW) rabbit study
since clear NOAELs/LOAELs were established for maternal and
developmental toxicities and malformations were observed at doses
higher than the dose that produced marginal maternal toxicity. The
concern is low for the increased susceptibility in the Chinchilla
rabbit study since the incidences of hydrocephaly were low, there was
no dose response, high concentration of the vehicle (CMC) used, and the
hydrocephaly was not seen at the same doses in the NZW strain of
rabbit. Therefore, there is no residual uncertainty for prenatal and/or
postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for cyproconazole is complete.
    ii. There is no indication that cyproconazole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. Although there is qualitative evidence of increased
susceptibility in the prenatal developmental studies in rats and
rabbits, EPA did not identify any residual uncertainties after
establishing toxicity endpoints and selecting traditional UFs to be
used in the risk assessment of cyproconazole.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated (CT) and tolerance-level residues. Conservative
ground water and surface water modeling estimates were used. There are
no residential uses of cyproconazole.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to cyproconazole will occupy 3% of the aPAD for the population group
(females 13-49 years old).
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
cyproconazole from food and water will utilize 13% of the cPAD for the
population group (children 1 - 2 years old). There are no residential
uses for cyproconazole that result in chronic residential exposure to
cyproconazole.
    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).
    Cyproconazole 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.
    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).
    Cyproconazole 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
LOC.
    5. Aggregate cancer risk for U.S. population. Cancer risk is
expected to be negligible because EPA concluded that cyproconazole is
not likely to be a human carcinogen.
    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 or to infants and children from aggregate
exposure to cyproconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Method AM-0842-0790-0 for determining cyproconazole in plant
commodities is an improved version of the current enforcement, which
allows for use of either Nitrogen-Phosphorous Detection (NPD) or Mass-
Selective Detection (MSD). As this method is superior to the current
enforcement method, it will be forwarded to FDA to either replace or
supplement the existing tolerance enforcement method for plant
commodities. The liguid chromotography with tandem mass spectrometry
(LC-MS/MS) method (Syngenta Method RAM 499/01) for determining
cyproconazole in livestock commodities has undergone a successful
Independent Laboratory Validation (ILV) trial and radiovalidation
trial. Therefore, a copy of the method will be forwarded to the
Analytical Chemistry Branch for evaluation as an enforcement method.
The methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>    As metabolites in liver and in milk need to be included in the
tolerance expression, enforcement methods will be required for these
residues. Methods have been sent to the Analytical Chemistry Branch for
evaluation.

B. International Residue Limits

    There are no established or proposed Canadian or Codex maximum
residue limits (MRLs) for cyproconazole on food or feed crops. Mexico
has established tolerances for cyproconazole at 0.05 ppm in barley and
wheat grain, which is equivalent to the recommended U.S. tolerance for
wheat grain. Therefore, there are generally no questions about the
compatibility of the proposed tolerances with international tolerances.
However, EPA notes that Japan has established numerous tolerances for
cyproconazole, including MRLs on wheat (0.2 ppm), corn (0.1 ppm), and
soybeans (0.05 ppm).

C. Response to Comment

    Comments were received on the notice of filing. EPA has responded
to similar comments from the commenter on previous occasions. Refer to
Federal Register cites: 70 FR 37686 (June 30, 2005); 70 FR 1354
(January 7, 2005); and 69 FR 63083 (October 29, 2004).

V. Conclusion

    Therefore, the tolerance is established for free and conjugated
residues of

cyproconazole, [alpha]-(4-chlorophenyl)-[alpha]-(1-cyclopropylethyl)-
1H-1,2,4-triazole-1-ethanol in or on the following commodities at the
indicated tolerance levels in parts per million.
    Aspirated grain fractions . . . 2.5
    Corn, field, forage, . . . 0.60
    Corn, field, grain . . . 0.01
    Corn, field, stover . . . 1.2
    Fat of cattle, goat, horse and sheep. . . 0.01
    Meat byproducts (except liver) of cattle, goat, horse and sheep . .
.0.01
    Soybean, seed . . . 0.05
    Soybean, forage . . . 1.0
    Soybean hay . . .3.0
    Soybean, oil . . . 0.10
    Wheat, forage . . . 0.80
    Wheat, hay . . . 1.3
    Wheat, straw . . . 0.90
    Wheat, grain . . . 0.05
    Wheat, grain, milled byproducts . . . 0.10
    A tolerance is also established for the combined free and
conjugated residues of cyproconazole [[alpha]-(4-chlorophenyl)-[alpha]-
(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol] and its metabolite
[[delta]-(4-chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-methyl-1H-
1,2,4-triazole-1-hexenoic acid in or on the following commodity:
    Milk. . . 0.02
    Also, tolerances are established for the combined free and
conjugated residues of cyproconazole [alpha]-(4-chlorophenyl)-[alpha]-
(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol and its metabolite [2-
(4-chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butane-2,3-diol in
or on the following commodities:
    Liver of cattle, goat, horse, and sheep . . . 0.50
    Hog liver . . . 0.01

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., 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).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final 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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection. Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 6, 2008.
Deborah McCall,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.485 is amended by revising paragraph (a) and removing
the text from paragraph (b) and reserving to read as follows:

Sec.  180.485  Cyproconazole; tolerances for residues.

    (a) General. (1) Tolerances are established for the free and
conjugated residues of the fungicide cyproconazole, [alpha]-(4-
chlorophenyl)-[alpha]-(1-cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol,
in or on the following food commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Aspirated grain fractions............................                2.5
Cattle, fat..........................................               0.01
Cattle, meat byproducts (except liver)...............               0.01
Coffee bean, green (Imported)\1\.....................                0.1
Corn, field, forage..................................               0.60
Corn, field, grain...................................               0.01
Corn, field, stover..................................                1.2
Goat, fat............................................               0.01
Goat, meat byproducts (except liver).................               0.01
Horse, fat...........................................               0.01
Horse, meat byproducts (except liver)................               0.01
Sheep, fat...........................................               0.01
Sheep, meat byproducts (except liver)................               0.01
Soybean, forage......................................                1.0
Soybean, hay.........................................                3.0
Soybean, oil.........................................               0.10
Soybean, seed........................................               0.05
Wheat, forage........................................               0.80
Wheat, grain.........................................               0.05
Wheat, grain, milled byproducts......................               0.10
Wheat, hay...........................................                1.3
Wheat, straw.........................................               0.90
------------------------------------------------------------------------
\1\There are no U.S. registrations as of February 15, 2008 for use on
  coffee bean.

    (2) A tolerance is established for the combined free and conjugated
residues

of cyproconazole [alpha]-(4-chlorophenyl)-[alpha]-(1-cyclopropylethyl)-
1H-1,2,4-triazole-1-ethanol] and its metabolite [[delta]-(4-
chlorophenyl)-[beta],[delta]-dihydroxy-[gamma]-methyl-1H-1,2,4-
triazole-1-hexenoic acid in or on the following commodity:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Milk.................................................               0.02
------------------------------------------------------------------------

    (3) Tolerances are established for the combined free and conjugated
residues of cyproconazole [alpha]-(4-chlorophenyl)-[alpha]-(1-
cyclopropylethyl)-1H-1,2,4-triazole-1-ethanol and its metabolite 2-(4-
chlorophenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butane-2,3-diol in or
on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, liver........................................               0.50
Goat, liver..........................................               0.50
Hog, liver...........................................               0.01
Horse, liver.........................................               0.50
Sheep, liver.........................................               0.50
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *

[FR Doc. E8-10829 Filed 5-13-08; 8:45 am]

BILLING CODE 6560-50-S