[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Proposed Rules]
[Pages 24950-24952]
[FR Doc No: 2018-11645]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0330]
RIN 1625-AA00

Safety Zone; Appomattox River, Hopewell, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
for a marine event on the navigable waters of the Appomattox River at
confluence with the James River in Hopewell, VA. This action is
necessary to provide for the safety of life on these navigable waters
in Hopewell, VA, during a fireworks display on June 30, 2018. This
proposed rulemaking would prohibit persons and vessels from being in
the safety zone unless authorized by the Captain of the Port Hampton
Roads 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 June 7, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2018-0330 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
proposed rulemaking, call or email LCDR Barbara Wilk, Waterways
Management Division Chief, Sector Hampton Roads, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
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 27, 2018, the Hopewell Recreation and Parks Department
notified the Coast Guard that it will be conducting a fireworks display
from approximately 9:30 to 9:45 p.m. on June 30, 2018, to serve as the
city of Hopewell's Fourth of July celebration. The fireworks are to be
launched from a barge in the Appomattox River near City Point.
Potential hazards from firework displays include accidental discharge
of fireworks, dangerous projectiles, and falling hot embers or other
debris. The Captain of the Port Hampton Roads (COTP) has determined
that potential hazards associated with the fireworks to be used in this
display would be a safety concern for anyone within a 234-yard radius
of the barge. The purpose of this rulemaking is to ensure the safety of
vessels and the navigable waters within a 234-yard radius of the
fireworks barge before, during, and after the scheduled event. The
Coast Guard proposes this

rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 9 to 11 p.m. on
June 30, 2018. The safety zone would cover all navigable waters within
234 yards of a barge in the Appomattox River at approximate
coordinates: 37[deg]18'52.20'' N, 077[deg]17'12.52'' W. The duration of
the zone is intended to ensure the safety of vessels and these
navigable waters before, during, and after the scheduled 9:30 to 9:45
p.m. fireworks display. No vessel or person will be permitted to enter
the safety zone without obtaining permission from the COTP or a
designated representative. The regulatory text we are proposing appears
at the end of this document.

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 13771 directs agencies to control
regulatory costs through a budgeting process. 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), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of the Appomattox River at confluence
with the James River in Hopewell, VA, for 2 hours. Moreover, the Coast
Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel
16 about the zone and the rule allows vessels to seek permission on-
scene to enter the zone.

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
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 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 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 contact 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 and Commandant Instruction M16475.1D, 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 lasting 2 hours
that would prohibit entry within 234 yards of a fireworks barge.
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. 01. A preliminary Record of Environmental
Consideration supporting this determination is 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, visit http://www.regulations.gov/privacyNotice.
    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 website'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, 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T05-0330 to read as follows:

Sec.  165.T05-0330  Safety Zone, Appomattox River; Hopewell, VA.

    (a) Definitions. The following definitions apply to this section:
(1) Captain of the Port means the Commander, Sector Hampton Roads.
    (2) Representative means any Coast Guard commissioned, warrant or
petty officer who has been authorized to act on the behalf of the
Captain of the Port.
    (3) Participants mean individuals and vessels involved in the
fireworks display.
    (b) Location. The following area is a safety zone: All navigable
waters in the vicinity of the Appomattox River at confluence with the
James River, within a 234 yard radius of the fireworks display barge in
approximate position 37[deg]18'52.20'' N, 077[deg]17'12.52'' W. (NAD
1983).
    (c) Regulations. (1) Except as provided in paragraph (c)(4) of this
section, all persons are required to comply with the general
regulations governing safety zones of subpart C of this part.
    (2) With the exception of participants, entry into or remaining in
this safety zone is prohibited unless authorized by the Captain of the
Port, Hampton Roads or his designated representatives. All vessels
within this safety zone at the time it is implemented are to depart the
zone immediately.
    (3) The Captain of the Port, Hampton Roads or his representative
can be contacted at telephone number<PHONE_NUMBER>. The Coast Guard
and designated security vessels enforcing the safety zone can be
contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and
channel 16 (156.8 Mhz), or by visual or verbal hailing on-scene.
    (4) This section does not apply to participants and vessels that
are engaged in the following operations:
    (i) Enforcing laws;
    (ii) Servicing aids to navigation, and
    (iii) Emergency response vessels.

    Dated: May 24, 2018.
Richard J. Wester,
Captain of the Port, Hampton Roads.
[FR Doc. 2018-11645 Filed 5-30-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: May 23, 2007 (Volume 72, Number 99)]
[Rules and Regulations]
[Page 28871-28877]
[DOCID:fr23my07-14]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0820; FRL-8131-4]

Coumaphos; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
coumaphos in or on honey and honeycomb. Interregional Research Project
4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 23, 2007. Objections and
requests for hearings must be received on or before July 23, 2007, 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-2006-0820. 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 web site 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: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail<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 the 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-2006-0820 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 23, 2007.
    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-2006-0820, by one of
the followingmethods:
     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 October 18, 2006 (71 FR 61465) (FRL-
8097-9), 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
2E6504) by Interregional Research Project 4 (IR-4), Rutgers,
The State University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR 180.189 be
amended by establishing a tolerance for residues of the insecticide
coumaphos (O,O -diethyl O -3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl
phosphorothioate) and its oxygen analog (O,O -diethyl O -3-chloro-4-
methyl-2-oxo-2H-1-benzopyran-7-yl phosphate) in or on honey at 0.10
parts per million (ppm) and honeycomb at 100 ppm. That notice
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available to the public in the docket, http://www.regulations.gov.
 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 has
determined tolerance levels for honey and honeycomb should be modified.
The reason for these changes is explained in Unit V. EPA is also
deleting the established tolerances in Sec. 180.189(b) for honey and
honeycomb that are no longer needed. The tolerance deletions under
Sec. 180.189(b) are time-limited tolerances established under section
18 emergency exemptions that are superceded by the establishment of
general tolerances for coumaphos under Sec. 180.189(a).

III. Aggregate Risk Assessment and Determination of Safety

    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. . .
.'' These provisions were added to the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors
specified in 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
for residues of coumaphos (O,O -diethyl O -3-chloro-4-methyl-2-oxo-2H-
1-benzopyran-7-yl phosphorothioate) and its oxygen analog ( O,O -
diethyl O -3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate) on
honey at 0.15 ppm and honeycomb at 45 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. Specific information on the studies received and the nature
of the adverse effects caused by coumaphos as well as the NOAEL and the
LOAEL from the toxicity studies can be found in the Reregistration
Eligibility Decision (RED) for coumaphos (http://www.epa.gov/oppsrrd1/REDs/0018.pdf
), the Reregistration Eligibility Decision Addendum and

FQPA Tolerance Reassessment Progress Report (TRED) for coumaphos
(http://www.epa.gov/oppsrrd1/REDs/0018tred.pdf) and at

http://www.regulations.gov in document Coumaphos: Human Health Risk Assessment

for Proposed Use on Honey and Honeycomb page 11 in Docket ID EPA-HQ-
OPP-2006-0820.
    The mammalian toxicology database for coumaphos is complete. Acute
toxicity studies in rats and rabbits; an acute delayed neurotoxicity
study in hens; subchronic oral and dermal studies in rats; chronic/
carcinogenicity studies in rats, mice, and dogs; developmental toxicity
studies in rats and rabbits; a 2-generation study in rats; mutagenicity
studies; and a metabolism study were discussed and considered in the
Reregistration Eligibility Decision (RED) for coumaphos (http://www.epa.gov/oppsrrd1/REDs/0018.pdf
). Acute and subchronic neurotoxicity

studies in rats were received subsequent to the RED and were considered
in the RED Addendum and FQPA Tolerance Reassessment Progress Report
(TRED) for coumaphos (http://www.epa.gov/oppsrrd1/REDs/0018tred.pdf).

Subsequent to the TRED, a developmental neurotoxicity study and a
comparative cholinesterase study in rats were received; these studies
are discussed in detail at http://www.regulations.gov in document Coumaphos:

Human Health Risk Assessment for Proposed Use on Honey and Honeycomb at
page 11 in Docket ID EPA-HQ-OPP-2006-0820.
    The acute toxicity of coumaphos is high via the oral route of
exposure (Category I), moderate via the inhalation route (Category II),
and slight via the dermal route (Category III). Coumaphos is not a
dermal sensitizer or a dermal irritant.
    Coumaphos, an organophosphate insecticide, primarily affects the
nervous system through cholinesterase (ChE) inhibition. Females are
consistently more sensitive to the cholinergic effects than males. In
the acute oral toxicity studies, female rats are approximately 17 times
more sensitive to the toxic and lethal effects of coumaphos compared to
male rats. In a single dose oral study, female rats had ChE inhibition
and cholinergic symptoms at much lower doses than male rats. In a
short-term (5 days) dermal toxicity study, brain ChE inhibition was the
most sensitive

indication of the toxic effects of coumaphos dermal treatment. In
subchronic and chronic studies in rats, the magnitude of ChE inhibition
in red blood cell and plasma and brain was also more pronounced in
females, compared to males. Coumaphos does not cause delayed
neuropathy. In chronic studies, systemic effects other than cholinergic
toxicity include decreases in body weight gain.
    There was no evidence of malformations or decreases in the number
of pups and/or litter or surviving offspring in any of the
developmental toxicity or reproduction studies. In developmental
toxicity studies in rats and rabbits, no developmental toxicity was
observed, while clinical signs of ChE toxicity were seen in the
maternal animals. In a 2-generation reproduction study, ChE inhibition
was noted in both parents and offspring, with parents more susceptible.
Reproductive toxicity was not observed in this study.
    The developmental neurotoxicity study showed no increased
susceptibility of the young. The maternal ChE activity was inhibited at
both the mid and high does. Consistent with the other mammalian
toxicity studies, female pups were more sensitive to cholinergic
effects than males; at the high dose, female plasma, erythrocyte, and
brain ChE activities were inhibited 27%, 33%, and 8%, respectively, but
only plasma ChE activity was significantly inhibited (30%) at this dose
in males. In the comparative ChE study increased quantitative
susceptibility of the offspring was observed in that ChE inhibition was
seen at a lower dose in neonatal rats, compared to young adult rats.
The relative sensitivities to ChE inhibition at peak inhibition by
coumaphos were measured in neonatal and young adult rats. This
comparative ChE study does demonstrate increased quantitative
susceptibility of the offspring. However, the degree of concern for
this comparative ChE study is low because the effects are well
characterized and there are clear no observed adverse effect levels
(NOAELs) and lowest observed adverse effect levels (LOAELs) for both
neonatal and adult animals. Furthermore, there are no residual
uncertainties for prenatal and/or postnatal toxicity for the
comparative ChE study because the endpoint of concern is the one used
for the acute dietary exposure risk assessment and a more protective
endpoint (based on long term-exposure) is used for chronic dietary
exposure risk assessment.
    Coumaphos is not carcinogenic and is classified as a Group E
chemical, indicating that it is ``Not Likely'' to be carcinogenic in
humans via relevant routes of exposure. This classification is based on
adequate studies in two animal species. No evidence of mutagenicity was
seen in any study.

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 highest dose at which the NOAEL in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which the LOAEL of
concern are identified is sometimes used for risk assessment.
Uncertainty/safety factors (UF) 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 (cPAD) adjusted dose. The aPAD and cPAD are
calculated by dividing the LOC by all applicable uncertainty/safety
factors. Short-term, intermediate, 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 uncertainty/
safety factors is not exceeded.
    For non-threhold risk, 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 used 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 coumpahos used for
human risk assessment can be found at http://www.regulations.gov in document

Coumaphos: Human Health Risk Assessment for Proposed Use on Honey and
Honeycomb page 15 in Docket ID EPA-HQ-OPP-2006-0820.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to coumaphos, EPA considered exposure under the petitioned-for
tolerances as well as all existing coumaphos tolerances in (40 CFR
180.189). EPA assessed dietary exposures from coumaphos and coumaphos-
oxon 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 one-day or single exposure
    In estimating acute dietary exposure, EPA used food consumption
information from the United States Department of Agriculture's (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, EPA relied upon
anticipated residues incorporating 2002 (USDA) Pesticide Data Program
(PDP) monitoring data for beef and 2004 PDP monitoring data for milk.
Field trial data were used for honey to support the proposed use
pattern. The dietary exposure assessment assumes 100% crop treated for
all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, EPA relied upon anticipated
residues incorporating 2002 USDA PDP monitoring data for beef and 2004
PDP monitoring data for milk. Field trial data were used for honey to
support the proposed use pattern. The dietary exposure assessment
assumes 100% crop treated for all commodities.
    iii. Cancer. Coumaphos is not carcinogenic and is classified as a
Group E chemical, indicating that it is ``Not Likely'' to be
carcinogenic in humans via relevant routes of exposure. Therefore, the
Agency concluded that coumaphos is not expected to pose a carcinogenic
risk and quantification of cancer risk is not required.
    iv. Anticipated residue 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 residues that have been measured in food. If EPA
relies on such information, EPA must pursuant to section 408(f)(1)
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. For the present action,
EPA will issue such data call-ins as are required by section
408(b)(2)(E) and authorized under section 408(f)(1) of the FFDCA. Data
will be required to be

submitted no later than 5 years from the date of issuance of this
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for coumaphos 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
coumaphos. 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
.

    The generic expected environmental concentration (GENEEC) and
screening concentration in groundwater (SCI-GROW) screening models were
used to estimate surface water and ground water concentrations of
coumaphos and its oxygen analog, coumaphoxon. This degradate is
considered in the drinking water assessment, as it was in the
assessment for consumption of food (honey and livestock commodities).
Based on the GENEEC and SCI-GROW models, the estimated environmental
concentrations (EECs) of coumaphos and its oxygen analog, coumaphoxon
for acute exposures are estimated to be 1.86 parts per billion (ppb)
for surface water and 0.17 ppb for ground water. The EECs for chronic
exposures are estimated to be 0.41 ppb for surface water and 0.17 ppb
for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 1.86 ppb was used to
assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 0.41 ppb was used to
assess the contribution to drinking 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).
     Coumaphos 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 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.''
    FQPA (1996) stipulates that when determining the safety of a
pesticide chemical, the EPA shall consider, among other things,
available information concerning the cumulative effects on human health
that may result from dietary, residential, or other non-occupational
exposure to the pesticide chemical and other substances that have a
common mechanism of toxicity. The reason for consideration of other
substances is due to the possibility that low-level exposures to
multiple chemical substances that cause a common toxic effect by a
common mechanism could lead to the same adverse health effect as would
a higher level of exposure to any of the substances individually. A
person exposed to a pesticide at a level that is considered safe may,
in fact, experience harm if that person is also exposed to other
substances that cause a common toxic effect by a mechanism common with
that of the subject pesticide, even if the individual exposure levels
to the other substances are also considered safe.
    The organophosphate pesticides (OPs) were established as the first
common mechanism group by EPA in 1999, based on their shared ability to
bind to and phosphorylate the enzyme acetylcholinesterase in both the
central (brain) and peripheral nervous systems. Coumaphos is an OP
pesticide. In December 2001, the Agency issued the ``Preliminary OP
Cumulative Risk Assessment'', available at http://www.epa.gov/pesticides/cumulative/pra_op_methods.htm.
 In June 2002, the Agency

released its Revised OP CRA, available at http://www.epa.gov/pesticides/cumulative/rra-op/
, which included the cumulative risk due

to the OPs from exposures in food, drinking water, and residential
uses. In August 2006, the Agency issued an update to the 2002 Revised
OP CRA document, which emphasized changes, modifications, and
amendments. With the 2006 update, available at http://www.epa.gov/pesticides/cumulative/2006-op/index.htm
, the Agency has developed a

highly refined and complex cumulative risk assessment for the OPs that
represents the state of the science regarding existing hazard and
exposure data and the models and approaches used. Based upon the
results from the 2006 update, the Agency concluded that the results of
the OP cumulative risk assessment support a reasonable certainty of no
harm finding.
    In both the 2002 revised OP CRA, as well as the 2006 update, the
cumulative dietary risk associated with the use of OP pesticides on
food crops was assessed using residue monitoring data collected by the
USDA PDP and dietary consumption data collected by USDA's Survey of
Food Intakes by Individuals (CSFII). Both assessments relied primarily
on the PDP for residue data; the 2006 update added PDP data collected
in 2002-2004 to the 1994-2001 data used in the 2002 Revised Assessment.
The PDP has been collecting pesticide residue data since 1991,
primarily for purposes of estimating dietary exposure. The program
focuses on high-consumption foods for children and reflects foods
typically available throughout the year. A complete description of the
PDP and all data through 2004 are available online (http://www.ams.usda.gov/science/pdp
). No PDP data on honey currently exist

that could have been used in a cumulative assessment. OP residues in
honey were not included in the PDP data base, in part because honey is
a low-consumption food. A quantitative estimate of honey consumption
over a single day was obtained for the general U.S. population and
subpopulations using the Dietary Exposure Evaluation Model (DEEM-
FCIDTM, Version 2.03), which uses food consumption data from
the USDA's CSFII from 1994-1996 and 1998. Consumption estimates at the
99.9th percentile of exposure range from 21 grams of honey/
day in all infants (< 1 year) to 96 grams/day in adults 50 + years, the
population subgroup who reported the greatest amount of honey consumed.
Estimates of honey consumption for all other subpopulations, including
children 1-2, 3-5, and 6-12 years; youth 13-19 years; females 13-49
years; and adults 20-49 years are within this range.
    Although PDP data on coumaphos data in honey is not available,
monitoring for coumaphos in honey is conducted under the Food and Drug
Administration's (FDA's) Center for Food Safety and Applied Nutrition
(CFSAN) Surveillance Monitoring Program. This monitoring program is
designed primarily for enforcement of EPA pesticide tolerances on
imported foods and domestic foods shipped in interstate commerce. In
this monitoring program, domestic samples are generally collected close
to the point of production in the distribution system. Import samples
are collected at the point of entry into U.S commerce. The emphasis in
sample collection is on the agricultural commodity, which is analyzed
as the unwashed, whole (unpeeled), raw commodity. Processed foods are
also included in the program.

A description of the program and residue data for recent years can be
found online (http://vm.cfsan.fda.gov/~lrd/pestadd.html). Because the

emphasis of this program is not on dietary exposure, it was used in the
2006 cumulative assessment mostly as a semi-quantitative check on the
potential for residues and as support for data from other sources. Data
are available from 1996-2003. Although the Agency has granted emergency
exemptions, starting in 1999, such that the coumaphos strips assessed
in this document have been and continue to be used on beehives in 40-46
states (http://www.epa.gov/opprd001/section18), the FDA has detected

coumaphos in honey only once, in 2003, at levels lower than the level
of quantification. Thus, FDA data indicates that there is a low
expectation of meaningful coumaphos residues in honey.
    EPA does not believe that inclusion of anticipated coumaphos
residues in honey in the OP CRA will significantly modify the
calculated risk. This conclusion is based on three factors. First,
honey is a low consumption food, and, thus, even if honey contained
quantifiable levels of OPs, it would be unlikely to significantly alter
the OP CRA. Second, available monitoring data indicates that, despite
widespread use of coumaphos, residues of coumaphos in honey as consumed
are exceedingly low, if present at all. Finally, a prior risk
assessment for coumaphos indicated that aggregate risk from coumaphos
was essentially unchanged when honey containing levels of coumaphos
residues found in field trials was added to the coumaphos risk
assessment, August 16, 2000 (65 FR 49927) (FRL-6738-3). In the current
assessment, no discernible difference in exposure was observed when
coumaphos residues in honey and beeswax were or were not included in an
aggregate assessment (personal correspondence, S. Piper, January 1,
2007). If coumaphos exposure from honey is insignificant in comparison
to exposure to coumaphos from other uses of the chemical, it
necessarily is insignificant in comparison to exposure to the more than
30 other OPs. For these reasons, EPA concludes that the establishment
of a coumaphos honey tolerance will not raise a concern regarding
cumulative OP exposure.

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 data base 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 uncertainty/safety factors and/or special FQPA safety
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of
increased qualitative or quantitative susceptibility of the offspring
in the developmental, reproduction, or developmental neurotoxicity
studies. Increased quantitative susceptibility of the offspring was
observed in the comparative ChE study in that ChE inhibition was seen
at a lower dose in neonatal rats, compared to young adult rats. The
degree of concern for this comparative ChE study is low because the
effects are well characterized and there are clear NOAELs and LOAELs
for both neonatal and adult animals. Furthermore, there are no residual
uncertainties for pre- and/or postnatal toxicity for the comparative
ChE study because the endpoint of concern is the one used for the acute
dietary exposure risk assessment and a more protective endpoint (based
on long-term exposure) is used for chronic dietary exposure risk
assessment.
    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 coumaphos is complete.
    ii. As discussed in Unit III.D.2., there are no residual
uncertainties regarding prenatal or postnatal toxicity or increased
sensitivity of the young.
    iii. There are no residual uncertainties identified in the exposure
data bases. The dietary food exposure assessments were performed based
on 100% crop treated and using reliable data (USDA PDP data for meat
and milk and field trial data for honey) and will not underestimate the
exposure and risk. Conservative ground water and surface water modeling
estimates were used. These assessments will not underestimate the
exposure and risks posed by coumaphos.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide aPAD and cPAD. The aPAD and cPAD
are calculated by dividing the LOC by all applicable uncertainty/safety
factors. 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 uncertainty/safety factors 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 coumaphos will occupy 15% of the aPAD for the U.S. population and
38% of the aPAD for all infants (<  1 year), the most highly exposed
population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to coumaphos
from food and water will utilize 6% of cPAD for the U.S. population and
13% of the cPAD for all infants (<  1 year), the most highly exposed
population subgroup. There are no residential uses for coumaphos that
result in chronic residential exposure to coumaphos.
    3. Short-term and Intermediate-term risk. Short-term and
intermediate aggregate exposure takes into account residential exposure
plus chronic exposure to food and water (considered to be a background
exposure level). Coumaphos 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. Aggregate cancer risk for U.S. population. Coumaphos is not
carcinogenic and is classified as a Group E chemical, indicating that
it is ``Not Likely'' to be carcinogenic in humans via relevant routes
of exposure. This classification is based on adequate studies in two
animal species. Coumaphos is not expected to pose a cancer risk.
    5. 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 coumaphos residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography/mass
spectroscopy/ mass spectroscopy (LC/MS/MS) is available to enforce the
tolerance expression. The method 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>
B. International Residue Limits

    There are no CODEX, Canadian, or Mexican maximum residue limits
(MRLs) for residues of coumaphos in honey or honeycomb. Therefore,
harmonization with international tolerances is not an issue for this
action.

C. Response to Comments

    Several comments were received from a private citizen objecting to
establishment of tolerances. The Agency has received similar comments
from this commenter on numerous previous occasions. Refer to Federal
Register June 30, 2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70
FR 1354) (FRL-7691-4) and, October 29, 2004 (69 FR 63096) (FRL-7681-9)
for the Agency's response to these objections.

V. Conclusion

    Based upon review of the residue field trial data supporting the
petition, EPA has determined tolerance levels for honey and honeycomb
should be modified and tolerances levels should be 0.15 ppm for honey
and 45 ppm for honeycomb.
    Therefore, tolerance are established for residues of coumaphos (O,O
-diethyl O -3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl
phosphorothioate and its oxygen analog ( O,O -diethyl O -3-chloro-4-
methyl-2-oxo-2H-1-benzopyran-7-yl phosphate) on honey at 0.15 ppm and
honeycomb at 45 ppm.

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) (Pub. L.
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), Pub. L. 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 15, 2007.
Daniel J. Rosenblatt,
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 180.189 is amended by alphabetically adding commodities to
the table in paragraph (a), and in paragraph (b), the text and table
are removed and the paragraph is reserved to read as follows:

Sec.  180.189  Coumaphos; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Honey..........................................                     0.15
------------------------------------------------------------------------
Honeycomb                                                           45.0
                                * * * * *
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-9813 Filed 5-22-07; 8:45 am]

BILLING CODE 6560-50-S