[Federal Register Volume 88, Number 35 (Wednesday, February 22, 2023)]
[Notices]
[Pages 10910-10911]
[FR Doc No: 2023-03643]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2022-0577]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number 1625-0027

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting an extension
of its approval for the following collection of information: 1625-0027,
Vessel Documentation; without change. Our ICR describes the information
we seek to collect from the public. Review and comments by OIRA ensure
we only impose paperwork burdens commensurate with our performance of
duties.

DATES: You may submit comments to the Coast Guard and OIRA on or before
March 24, 2023.

ADDRESSES: Comments to the Coast Guard should be submitted using the
Federal eRulemaking Portal at https://www.regulations.gov. Search for
docket number [USCG-2022-0577]. Written comments and recommendations to
OIRA for the proposed information collection should be sent within 30
days of publication of this notice to https://www.reginfo.gov/public/do/PRAMain.
    Find this particular information collection by selecting
``Currently under 30-day Review--Open for Public Comments'' or by using
the search function.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-6P), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: A.L. Craig, Office of Privacy
Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>, for questions
on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. 3501 et seq., chapter 35, as amended. An ICR is an
application to OIRA seeking the approval, extension, or renewal of a
Coast Guard collection of information (Collection). The ICR contains
information describing the Collection's purpose, the Collection's
likely burden on the affected public, an explanation of the necessity
of the Collection, and other important information describing the
Collection. There is one ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) the practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2022-0577], and must be received by March 24,
2023.

Submitting Comments

    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, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://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.
    We accept anonymous comments. All comments to the Coast Guard will
be posted without change to https://www.regulations.gov and will
include any personal information you have provided. For more about
privacy and submissions to the Coast Guard in response to this
document, see DHS's eRulemaking System of Records notice (85 FR 14226,
March 11, 2020). For more about privacy and submissions to OIRA in
response to this document, see the https://www.reginfo.gov, comment-
submission web page. OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each
ICR. An OMB Notice of Action on each ICR will become available via a
hyperlink in the OMB Control Number: 1625-0027.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (87 FR 68511, November 15,
2022) required by 44 U.S.C. 3506(c)(2). That notice elicited no
comments. Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Vessel Documentation.
    OMB Control Number: 1625-0027.
    Summary: The information collected will be used to establish the
eligibility of a vessel to: (a) be documented as a ``vessel of the
United States,'' (b) engage in a particular trade, and/or (c) become
the object of a preferred ship's mortgage. The information collected
concerns citizenship of owner/applicant and build, tonnage and markings
of a vessel.
    Need: 46 U.S.C. chapters 121, 123, 125 and 313 requires the
documentation of vessels. A Certificate of Documentation is required
for the operation of a vessel in certain trades, serves as evidence of
vessel nationality and permits a vessel to be subject to preferred
mortgages.
    Forms:
     CG-1258, Application for Initial, Exchange, or Replacement
of Certificate of Documentation; Redocumentation with optional
attachments.
     CG-1261, Builder's Certification and First Transfer of
Title.
     CG-1270, Certificate of Documentation.
     CG-1280, Vessel Renewal Notification Application for
Renewal.
     CG-1330, Certificate of Ownership of Vessel.
     CG-1332, General Index or Abstract of Title.
     CG-1340, Bill of Sale.
     CG-1356, Bill of Sale by Government Entity Pursuant to
Court Order of Administrative Degree of Forfeiture.
     CG-4593, Application, Consent, and Approval for Withdrawal
of Application for Documentation or Exchange of Certificate of
Documentation.
     CG-5542, Optional Application for Filing.
     CG-7042, Authorization for Credit Card Transactions.

     CG-7043, Abstract of Title/Certified COD Request.
    Why is the Coast Guard proposing to add two new forms: The Coast
Guard is adding optional forms CG-1330 and CG-1332 to provide a
standardized means of delivering information about documented U.S.
vessels. A Certificate of Ownership of Vessel (CG-1332) provides the
name and official number of a vessel, name and address of the last
owner of record, the Certificate of Documentation expiration date, any
outstanding mortgages, preferred mortgages, and notice of lien.
Additionally, it lists any pending application and or instruments
filed. A General Index or Abstract of Title (CG-1330) contains
information concerning build, ownership, and encumbrances or liens
filed and recorded against a vessel.
    Respondents: Owners/builders of yachts and commercial vessels of at
least 5 net tons.
    Frequency: Annually, and on occasion.
    Hour Burden Estimate: The estimated burden has increased from
50,844 hours to 84,443 hours, due to an increase in the estimated
number of responses. In addition, the estimated burden has increased by
5,883 hours, due to the addition of two new optional forms--CG-1330,
Certificate of Ownership of Vessel and CG-1332, General Index or
Abstract of Title. The total estimated burden is 90,326 hours.
    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. chapter
35, as amended.

    Dated: January 24, 2023.
Kathleen Claffie,
Chief, Office of Privacy Management, U.S. Coast Guard.
[FR Doc. 2023-03643 Filed 2-21-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]
[Page 33708-33714]
[DOCID:fr13jn08-17]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0596; FRL-8367-7]

(Z)-7,8-epoxy-2-methyloctadecane (Disparlure); Exemption from the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the (Z)-7,8-epoxy-2-methyloctadecane on
all food and feed crops when used to treat trees, shrubs, and pastures
resulting in unintentional spray and drift from application as well as
unintentional

spray and drift to non-target vegetation including non-food, food, and
feed crops. Aberdeen Road Company d/b/a Hercon Environmental submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of (Z)-7,8-epoxy-2-methyloctadecane. This active
ingredient (AI) is also known as Disparlure.

DATES: This regulation is effective June 13, 2008. Objections and
requests for hearings must be received on or before August 12, 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-2007-0596. 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:  Andrew Bryceland, Biopesticides and
Pollution Prevention Division (7511P), 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:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I 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 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, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. 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-2007-0596 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 on or before August 12, 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 your copies, identified by docket ID
number EPA-HQ-OPP-2007-0596, 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. Background and Statutory Findings

    In the Federal Register of August 1, 2007 (72 FR 42070) (FRL-8141-
5), 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 tolerance
petition (PP 6F7141) by Aberdeen Road Company d/b/a Hercon
Environmental, P.O. Box 453, Emigsville, PA 17318-0435. The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of (Z)-7,8-epoxy-2-
methyloctadecane. This notice included a summary of the petition
prepared by the petitioner Aberdeen Road Company d/b/a Hercon
Environmental.
    There was only one comment received in response to the notice of
filing. The commenter suggested that there should not be an exemption
for (Z)-7,8-epoxy-2-methyloctadane because the commenter felt that
``plants should not have to grow with toxic chemicals on them;'' that
the Agency ``is not protecting the public health of the American public
which is dying from all kinds of cancers;'' and further of not properly
evaluating pesticides in general.
    Agency Response: (Z)-7,8-epoxy-2-methyloctadecane is a naturally

occurring substance produced by the female gypsy moth (Lymantria
dispar) as a pheromone to attract the male gypsy moth. The activity of
this pesticide is specific to the Gypsy moth, and when applied to
forests, it confuses the male gypsy moth searching for a mate; this
reduces the moth population's ability to successfully reproduce itself
without killing individuals in the population. The Agency's assessment
of the naturally occurring pheromone's specific, non-toxic mode of
action, its low acute toxicity and exposure profiles (see Unit III.),
and its intended non-food uses indicate negligible dietary risks
associated with the unintended application of (Z)-7,8-epoxy-2-
methyloctadecane to areas adjacent to agricultural areas (Refs. 2 and
3).
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require 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....
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues '' and ``other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    The AI, (Z)-7,8-epoxy-2-methyloctadecane (also known as
Disparlure), is an aliphatic hydrocarbon compound containing 19 carbons
and a single epoxide bond. It is a naturally occurring lepidopteran
pheromone produced by female gypsy moths (Lymantria dispar) to attract
males. When used as a pesticide, the pheromone is intended to disrupt
mating by disorienting males during their in-flight search for females.
(Z)-7,8-epoxy-2-methyloctadecane was registered by the Agency in 1986
as a non-food use pesticide to lower the incidences of gypsy moth
mating in residential, municipal, and shade tree areas; recreational
areas such as campgrounds, golf courses, parks and parkways; ornamental
and shade tree forest planting; shelter belts, rights of way and other
easements. While (Z)-7,8-epoxy-3-methyloctadecane is not intended to be
sprayed directly on food or feed crops, the Agency has expressed
concern that there may be a potential for regular and significant
exposure from residues of the pesticide on food and feed crops as a
result of unintentional spray or drift. Therefore, at the
recommendation of the Agency, a request to establish an exemption for
the requirement of a tolerance has been made by the applicant.
    This tolerance exemption is supported by toxicity data on a
structurally related substance, epoxylated soybean oil (ESO), in
anticipation of frequent and significant exposure to food and feed
crops near treated areas. All the data normally required to support a
tolerance exemption are not available for (Z)-7,8-epoxy-2-
methyloctadecane; therefore, the data on ESO was submitted to address
concerns about inadvertent residues on food or feed crops. The Agency
has agreed to consider the toxicity data on epoxylated soybean oil,
since it is chemically similar to (Z)-7,8-epoxy-2-methyloctadecane
(Disparlure), and the data requirements normally required for a food
use can support an assessment of potential dietary risks associated
with possible residues of the pesticide from spray drift (Refs. 1, 2
and 3).
    Historically the AI, (Z)-7,8-epoxy-2-methyloctadecane, has been
used as a non food use pesticide and, therefore, no data that address
the data requirements required by the Agency in support of food use
pesticides have been generated using this AI. Therefore, in order to
satisfy these data requirements and address the issue of whether or not
food and feed crops that are inadvertently affected by residues of (Z)-
7,8-epoxy-2-methyloctadecane are safe, the Agency has bridged from
toxicity data generated on a structurally related substance, epoxylated
soybean oil, to both satisfy the food use toxicity data requirements
for (Z)-7,8-epoxy-2-methyloctadecane and to conduct a risk assessment.
As stated in this Unit, data normally required for a food use can
support an assessment of potential dietary risks associated with
possible residues of the pesticide from spray drift (Refs. 1 and 3).
    ESO is a compound that is structurally related to (Z)-7,8-epoxy-2-
methyloctadecane and has already been fully assessed by the Agency as
an inert ingredient. ESO and (Z)-7,8-epoxy-2-methyloctadecane are
similar, from a structural perspective, in that both compounds contain
one or more epoxide bonds, thus the basis for the Agency's decision to
allow the bridging of toxicity data from ESO to (Z)-7,8-epoxy-2-
methyloctadecane. Epoxide bonds are three-membered rings, made up of 2
carbons and 1 oxygen, bonded together in a triangular shape. The
epoxide bond is very unstable in the environment and this instability
makes the bond very reactive such that it reacts to whatever is in the
environment (i.e. proteins, nucleophiles) (Refs. 3 and 4). This
information is key in determining the potential risks to the (Z)-7,8-
epoxy-2-methyloctadecane compound since it is the reactive epoxide
groups in both compounds that mostly contribute to the toxicological
activity itself (Refs. 3 and 4). Epoxides in general are formed outside
of the body (environmental epoxides) or they are synthesized in the
body. Environmental epoxides are generally less toxic than epoxides
that are synthesized in the body (Refs. 3 and 4). Both epoxides behave
in the environment in the same way. The epoxide content of (Z)-7,8-
epoxy-2-methyloctadecane is double that of ESO. While this information
does suggest that (Z)-7,8-epoxy-2-methyloctadecane could be more
reactive than ESO, this potential toxicity is essentially attributed to
the fact that (Z)-7,8-epoxy-2-methyloctadecane has more epoxide groups
(16%) than ESO (8%). Even

though there are more reactive epoxide groups that belong to (Z)-7,8-
epoxy-2-methyloctadecane, these reactive epoxides are environmental
epoxides (i.e. found outside the body), and based on the literature,
and as stated in Unit IV., the second paragraph, environmental epoxides
are less toxic than those synthesized in the body (Refs. 3 and 4).
    As stated in this Unit, environmental epoxides, such as (Z)-7,8-
epoxy-2-methyloctadecane react in the environment. When the AI is
released into the environment the epoxide groups of the AI will most
likely interact with nucleophilic sites in the environment, such as
proteins in food, and will not be absorbed in their active form (Refs.
3 and 4). Based on the behavior of environmental epoxides, such as this
AI, the Agency has extrapolated the potential risks (if any) to humans
and animals from consuming food and/or feed commodities the contain
residues of (Z)-7,8-epoxy-2-methyloctadecane as a result of indirect or
unintended spray or drift. The Agency has determined that even if
residues of the AI were to occur on food/feed commodities, the reaction
of epoxides in (Z)-7,8-epoxy-2-methyloctadecane (Disparlure) would in
all probability react with proteins (such as those already found in
foods) during digestion and would not be absorbed in their active form
to cause any toxicological effects (Refs. 3 and 4). Additionally, there
are also a number of ways the body can detoxify epoxides like
Disparlure if they are absorbed in an active form (Ref. 4). These are:
    1. Spontaneous decomposition,
    2. Nonenzymatic reaction with glutathione,
    3. Reaction with glutathione catalyzed by glutathione transferase,
    4. Hydration by epoxide hydrolase, and
    5. Minor mechanisms such as cytochrome P450 hydrolysis (Refs. 3 and
4).
    Further, acute oral toxicity studies on both substances indicated
that their toxicity is low (Toxicity Category IV) which is consistent
with these general characteristics of environmental epoxides.
Therefore, use of toxicity data on ESO to define endpoints for the
assessment of dietary exposure estimates associated with inadvertent
treatment of food or feed crops with (Z)-7,8-epoxy-2-methyloctadecane
(Disparlure) is reasonable. ESO data - including application of maximum
uncertainty factors - define endpoints used in risk characterization
for (Z)-7,8-epoxy-2-methyloctadecane, and data requirements to support
the petition for exemption from the requirement of tolerances for the
AI have been waived by the Agency based on the negligible risks
described in this Unit.

A. Acute Toxicity

    Acute oral toxicity (rat) (OPPTS GLN 870.1100): Based on acute oral
toxicity studies in rats, (Z)-7,8-epoxy-2-methyloctadecane has very low
toxicity and is classified into Toxicity Category IV. No adverse
effects or deaths were seen in rats that received an oral dose of
undiluted (Z)-7,8-epoxy-2-methyloctadecane at 5,000 milligram per
kilogram of bodyweight (mg/kg/bw) (Master Record Identification (MRID)
Number 45529801). ESO also has very low acute oral toxicity lethal dose
(LD)50 > 5,000 mg/kg (Toxicity Category IV; Refs. 2 and 3).

B. Chronic Toxicity and Carcinogenicity (OPPTS GLN 870.3100; 870.4100
and 870.4200)

    Information from The Scientific Panel on Food Additives (European
Commission on Food Safety) was considered which included a two-year
chronic oral toxicity study in rats given diets containing up to 5%
ESO. The no observed adverse effect level (NOAEL) was approximately 140
mg/kg/day and the lowest observed adverse effect level (LOAEL) was
approximately 1,400 mg/kg/day. Observed effects were slight changes in
liver, kidney and uterus weights. The published summary also concluded
that ESO was not carcinogenic when fed to rats. Based on the data, a
tolerable daily intake of 1 mg/kg/day was determined for ESO (Refs. 1,
2, and 3).

C. Developmental Toxicity (OPPTS GLN 870.3700 and 870.3800)

    The European Food Safety Authority (EFSA) report (2004) also
described a developmental toxicity study in which ESO was given to
pregnant rats during gestation at daily oral doses of 0, 100, 300 or
1,000 mg/kg/day (Ref. 1). No maternal or developmental effects were
noted at any dose level according to the summary submitted (Ref. 3).

D. Reproductive Toxicity (OPPTS GLN 870.3800)

    The EFSA review indicated that ESO was administered daily by oral
gavage to rats at the 100, 300 and 1,000 mg/kg bw/day dose levels for
71 and 15 days before mating in males and females, respectively, until
day 21 post-partum of F1 litters; no toxic effects were noted in
parental animals or their offspring (Ref. 1). Under the experimental
conditions, the highest tested dose of 1,000 mg/kg bw/day was found to
be the NOAEL, and no LOAEL was reported (Ref. 3).

E. Genotoxicity (OPPTS GLN 870.5000; MRID 45309502)

    A bacterial reverse mutation assay using Salmonella typhimurium and
Escherichia coli was conducted on (Z)-7,8-epoxy-2-methyloctadecane with
and without activation. The study concluded that (Z)-7,8-epoxy-2-
methyloctadecane was not mutagenic in bacteria under the conditions of
the study.

F. Hazard Characterization

    In assessing the hazard associated with (Z)-7,8-epoxy-2-
methyloctadecane, its has been characterized in terms of epoxylated
soybean oil. All toxicological effects were observed at or above limit
doses (>=5,000 mg/kg/bw for acute oral toxicity and >=1,000 mg/kg/bw/
day for reproductive, developmental and chronic toxicity studies) (Ref.
3). Based upon the Agency's standard hazard assessment protocol, if
there is an incomplete data set for assessment of developmental
toxicity (studies in two species) and a one-generation reproduction
toxicity study (rather than a multi-generation reproduction study), an
uncertainty factor of 3X is retained for consideration of the
sensitivity of infants and children (Ref. 3). Moreover, there is
uncertainty regarding the structure-activity relationship between
Disparlure and ESO (16% versus 7-8% epoxide by weight, respectively)
and the lack of repeated-dose studies on both substances to adequately
support bridging from ESO data to Disparlure (at least one repeated-
dose study on both substances) for purposes of assessing the dietary
risks associated with use of the mating disruptor (Ref. 3). To account
for this, an additional 10X uncertainty factor is applied (Ref 3).
Therefore, the 1,000 mg/kg/day endpoint was divided by 1,000 for
general population risk characterizations (uncertainty factors of 10X
for interspecies extrapolation, 10X for intraspecies variation, and 10X
for uncertainties regarding bridging from data on a surrogate
substance) to determine a reference dose (RfD) of 1 mg/kg/day; a
population adjusted dose (PAD) of 0.33 mg/kg/day for infants and
children is determined when the FQPA safety factor (3X) is retained
(Ref. 3).
    Comparing this with the maximum estimated exposure for pesticidal
use of Disparlure, the result does not exceed the Agency's level of
concern (LOC) because the estimated exposure is less than 1% of the RfD
(Ref. 3). Based on the behavior of epoxides in the environment and
during ingestion, we conclude that toxicologically significant

residues will not result (refer to Unit III.; Refs. 3 and 4). Even when
the maximum potential for inadvertent residues from the non-food uses
of this pesticide are compared with the most conservative estimate of
hazard, there is reasonable certainty that no harm will result to the
U.S. population from exposure to this pesticide when used according to
label instructions (Ref. 3). In the event that a food-use is requested,
the Agency would require repeated-dose studies such as a 90-day
subchronic feeding study (OPPTS 870.3100) and a prenatal developmental
toxicity study (OPPTS 870.3700) on Disparlure.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    In general, the epoxide (oxirane ring formed by an oxygen and two
carbon atoms) is the reactive group in (Z)-7,8-epoxy-2-methyloctadecane
and other epoxides, and is expected to contribute the most to
biological or toxicological activity of (Z)-7,8-epoxy-2-
methyloctadecane (Ref. 4; see Ref. 3). The unstable oxirane ring can
open and react with DNA, protein, or other nucleophilic substances.
This means that if (Z)-7,8-epoxy-2-methyloctadecane were to be ingested
then most likely the epoxide would react with the proteins in food
during digestion (i.e. it would be digested). As stated in the
literature (deBethizy and Hayes (Ref. 4), epoxides formed in animals
are apparently more toxic than those present in the environment because
they react with proteins and DNA in the animal's tissue (Refs. 3 and
4). If the AI were to result on food/feed commodities, the epoxide or
reactive group of that AI is more likely to break down and react with
nucleophiles and proteins that are found in food and would not be
absorbed in their active form (Refs. 3 and 4). However, even if they
are absorbed in their active form, epoxides can be detoxified in the
human body via:
    1. Spontaneous decomposition,
    2. Nonenzymatic reaction with glutathione,
    3. Reaction with glutathione catalyzed by glutathione transferase,
    4. Hydration by epoxide hydrolase, and
    5. Minor mechanisms such as cytochrome P450 hydrolysis (Ref.s 3 and
4).
    In general, these considerations are expected to reduce the
potential risk.

A. Dietary Exposure

    In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and on all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    Given the use pattern of this AI, residues of the AI on food/feed
crops as a result of unintentional spray or drift, as stated throughout
this document, is not expected. However, the Agency has determined that
even if residues of the AI were to occur on food/feed commodities, the
reactive groups of the active would not be absorbed in their active
form to cause any toxicological effects. While it is reasonable to
assume that no toxicological effects would occur given the unliklihood
of absorption and the low toxicity of the AI, the EPA has further
examined the potential for dietary exposure from unintentional spray or
drift and absorption and has estimated the potential risks (if any) to
humans, including infants and children, from the consumption of food
commodities that have been inadvertently treated with the AI. Assuming
that dietary exposure has occurred the Agency considered potential
exposure estimates for two representative scenarios including pasture
grass and apple orchards.
    1. Food -- i. Apples. The Agency used apples as one representative
in conducting its food assessment since apples are a significant
commodity by a sensitive subpopulation (infants and children). For the
apple exposure analysis, the Agency obtained a kg apples/A value from
U.S. Department of Agriculture (USDA) statistics and used the worst-
case application rate of 60 grams (g) (Z)-7,8-epoxy-2-methyloctadecane/
Acre (A) (two applications of 30 g/A per season) for an apple orchard
(unintentional application). The maximum potential concentration of
(Z)-7,8-epoxy-2-methyloctadecane was estimated to be 6 mg/AI/kg of
apples (i.e., 6 parts per million (ppm); Ref 3). This 6 ppm value is an
overestimate because its determination assumes: All the (Z)-7,8-epoxy-
2-methyloctadecane is directly applied to an apple orchard (a misuse)
and all of the AI applied will be on or in the apples (not sticking to
foliage or other inedible plant parts). (Z)-7,8-epoxy-2-
methyloctadecane residues are also likely to be reduced by their
reactivity, the AI's physical/chemical properties, and washing or
processing treated apples before their consumption (Ref. 3).
    Based on the amount of the AI/kg of crop it was determined that the
amount of (Z)-7,8-epoxy-2-methyloctadecane consumed from treated apples
for the general population, children, and adults would be 0.005, 0.03
and 0.002 mg/A.I./kg/bw per day, respectively (Ref. 3). As noted in the
introduction to this Unit IV. Aggregate Exposures, by the time
Disparlure-treated apples are consumed, the epoxides in the AI are
likely to have broken down or reacted with nucleophiles such as
proteins in the apples and would not be absorbed in their active form
(Refs. 3 and 4).
    ii. Pasture. A pasture grass exposure analysis was presented in the
applicant's petition, which was based on maximum recommended single
application rates (30 g/AI/A) and a model for estimating potential
exposure for grazing cattle (described at http://www.epa.gov/oppefed1/
ecorisk_ders/toera_analysis_exp.htm). The largest estimate was
determined to be 0.14 mg Disparlure/kg cattle body weight per day (Ref.
3). This estimate of the potential exposure was based on the assumption
that all the Disparlure applied to an acre of short grass would be
consumed as if the AI was intentionally applied to the pasture rather
than drifting from a nearby treated area (Ref. 3). A more realistic
assumption in the exposure analysis was that 10% or less of the pasture
grass would be impacted by spray drift, thereby reducing the exposure
estimate to 0.014 mg Disparlure/kg cattle bw/day (Ref. 3). Also,
applications in any given area would not be done more than one or two
days each year which further reduces the potential exposure to cattle.
As noted in the second paragraph of Unit IV., the metabolic pathways
that break down epoxides in animals are expected to further reduce the
potential for dietary exposure preventing detection or bioaccumulation
of Disparlure residues in cattle feeding on inadvertently treated
pasture grass. Therefore, a dietary assessment for meat, milk and meat
by-products was not conducted by the Agency (Ref 3).
    2. Drinking water exposure. Exposure to residues of (Z)-7,8-epoxy-
2-methyloctadecane in consumed drinking water is unlikely because of
the reactivity of such epoxides in the environment (see discussion
under Unit IV. Aggregate Exposure; Refs. 3 and 4),

and the AI is not directly applied to water. Therefore, drinking water
exposure is not expected to pose any quantifiable risks due to a lack
of residues of toxicological concern.

B. Other Non-Occupational Exposure

    There are no residential, school, or day care uses proposed for
(Z)-7,8-epoxy-2-methyloctadecane (Disparlure). Since the proposed use
is for agricultural non-food crops the potential for non-occupational,
non-dietary exposures to (Z)-7,8-epoxy-2-methyloctadecane by the
general population, including infants and prolonged inhalation exposure
to non-sticking flakes in unlikely (Ref. 2).

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish an exemption from 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.'' These considerations include the possible
cumulative effects of such residues on infants and children. EPA has
considered the potential for cumulative effects of (Z)-7,8-epoxy-2-
methyloctadecane and other substances in relation to common mechanism
of toxicity. Common mechanisms of toxicity are not relevant to a
consideration of cumulative exposure to (Z)-7,8-epoxy-2-
methyloctadecane because it is not toxic to mammalian systems. Because,
since Disparlure is an environmental epoxides (formed outside the body)
which are generally considered less toxic than epoxides synthesized
inside the body (Ref. 4). The reactive epoxide in Disparlure's
structure would most likely react with proteins in food during
digestion and would not be absorbed in their active form to induce
toxicological effects (Ref. 4). There are also a number of ways the
body can detoxify epoxides like Disparlure if they are absorbed in an
active form (Ref. 4). Also the acute oral toxicity study on Disparlure
indicated that the toxicity is low (Toxicity Category IV). Thus, the
Agency does not expect any cumulative or incremental effects from
exposure to residues of (Z)-7,8-epoxy-2-methyloctadecane when applied/
used as directed on the label and in accordance with good agricultural
practices. Additionally, when comparing the most conservative estimate
of hazard to the maximum potential for inadvertent residues from the
non-food uses of Disparlure, the result does not exceed the Agency's
LOC (i.e.: Estimated exposure is less than 1% of the RfD; Ref. 3).
Margins of Exposure (MOE) based on estimated exposure and hazard (the
140 mg/kg/day NOAEL from a chronic toxicity study in rats) range from
4,600 to 65,000 (Ref. 3). When the resulting MOE is greater than 100,
the Agency's LOC is not exceeded and there is reasonable certainty of
no harm to human health (Ref. 3).

VI. Determination of Safety for U.S. Population, Infants and Children

    1. U.S. population. The Agency has determined that there is
reasonable certainty that no harm will result to the U.S. Population
from aggregated exposure to residues of (Z)-7,8-epoxy-2-
methyloctadecane. This includes all dietary exposures and other
exposures for which there is reliable information. The Agency has
arrived at this conclusion based on the chemicals low acute toxicity,
it is a naturally occurring lepidopteran pheromone produced by female
gypsy moths (Lymantria dispar), is similar in chemical structure to
compounds of low chronic toxicity (ESO), and has a very low potential
for human exposure. (Ref. 2).
    2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold MOE for infants and children in the case of
threshold effects. Margins of exposure are often referred to as
uncertainty or safety factors, and are used to account for potential
prenatal and postnatal toxicity and any lack of completeness of the
database. Based on available data and other information, EPA may
determine that a different MOE will define a level of concern for
infants and children or that a MOE approach is not appropriate. Based
on all the available information the Agency reviewed on (Z)-7,8-epoxy-
2-methyloctadecane, including a lack of threshold effects, the Agency
concluded that (Z)-7,8-epoxy-2-methyloctadecane is practically non-
toxic to mammals, including infants and children. Since there are no
effects of concern, the provision requiring an additional margin of
safety does not apply.

VII. Other Considerations

A. Endocrine Disruptors

    There is no evidence to suggest that (Z)-7,8-epoxy-2-
methyloctadecane functions in a manner similar to any known hormone, or
that it acts as an endocrine disrupter.

B. Analytical Method

    Because this is an exemption from the requirement of a tolerance
without numerical limitations, no analytical method is required.

C. Codex Maximum Residue Level

    There are no CODEX maximum residue levels for residues for (Z)-7,8-
epoxy-2-methyloctadecane for unintentional spray or drift from
application when treating trees and shrubs along or within pastures, as
well as unintentional spray and drift to non-target vegetation
including native and ornamental species, and food and feed crops.

VIII. Conclusions

    Based on the low toxicity in animal testing, and the expected low
exposure to humans, no risk to human health is expected from use of the
chemical on food crops.

IX. References

    1. EFSA. (2004) Opinion of the Scientific Panel on Food Additives,
Flavorings, Processing Aids and Materials in Contact with Food (AFC) on
a request from the Commission related to the use of Epoxidized soybean
oil in food contact materials. EFSA Journal 64: 1-17.
    2. Gonzales, A. (June 27, 2007) USEPA Memorandum - Tolerance
Exemption Petition Review for (Z)-7,8-epoxy-2-methyloctadecane.
    3. Gardner, R. & A. Gonzales (January 8, 2008) USEPA Memorandum -
Dietary Risk Considerations Supporting a Petition for Exemption from
the Requirement of a Tolerance for (Z)-7,8-epoxy-2-methyloctadecane.
    4. de Bethizy, J.D., and J.R. Hayes. 2001. ``Metabolism:
Determinant of Toxicity'' Ch. 3 in Principles and Methods of
Toxicology, 4th Edition. A.W. Hayes, ed. Taylor & Francis.
Philadelphia, PA. pp. 123-124.

 X. 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 final rule has been
exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition,
this final 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).

XI. 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 30, 2008.
Marty Monell,
Acting Director, 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 180.1283 is added to subpart D to read as follows:

Sec.  180.1283  (Z)-7,8-epoxy-2-methyloctadecane (Disparlure);
exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of (Z)-7,8-epoxy-2-methyloctadecane on all food and feed crops
that occur when it is used to treat trees, shrubs, and pastures and
such use results in unintentional spray and drift to non-target
vegetation including non-food, food, and feed crops. This active
ingredient is also known as Disparlure.
[FR Doc. E8-13232 Filed 6-12-08; 8:45 am]

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