[Federal Register: October 4, 2006 (Volume 71, Number 192)]
[Rules and Regulations]
[Page 58514-58518]
[DOCID:fr04oc06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0670; FRL-8092-7]

Flumetsulam; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
flumetsulam in or on beans (dry). Dow AgroSciences LLC requested this
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective October 4, 2006. Objections and
requests for hearings must be received on or before December 4, 2006,
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-2006-0670. All documents in the
docket are listed in the index for the docket. 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 Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Phil Errico, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural

producer, food manufacturer, or pesticide manufacturer. Potentially
affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 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.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the 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-2006-0670 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 December 4, 2006.
    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-2006-0670, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 25, 2006 (71 FR 50412) (FRL-8084-
8), 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
7F4851) by Dow AgroSciences LLC, 9330 Zionville Road, Indianapolis, IN
46268-1054. The petition requested that 40 CFR 180.468 be amended by
establishing a tolerance for residues of the herbicide flumetsulam, N-
(2,6-difluorophenyl)-5-methyl-(1,2,4)-triazolo-[1,5-a]-pyrimidine-2-
sulfonamide, in or on beans (dry) at 0.05 parts per million (ppm). That
notice included a summary of the petition prepared by the registrant.
There were no comments received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    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. EPA has sufficient data to assess the hazards and to make
a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of flumetsulam on
beans (dry) at 0.05 ppm 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 toxic effects caused by flumetsulam as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov
, Docket OPP-2004-0317.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable

risk, the dose at which no adverse effects are observed (the NOAEL)
from the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    A summary of the toxicological endpoints for flumetsulam used for
human risk assessment is discussed in the docket OPP-2004-0317, for the
Notice published in the Federal Register of September 24, 2004 (69 FR
57281-57284) (FRL-7680-7).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.468) for the residues of flumetsulam, in or on
a variety of raw agricultural commodities, including field corn grain,
fodder, and forage, and soybean. Risk assessments were conducted by EPA
to assess dietary exposures from flumetsulam in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
flumetsulam; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: Tolerance level residue values, 100% crop treated, and the
highest estimated chronic drinking water concentration were used.
    iii. Cancer. Flumetsulam is classified as a ``Group E'' pesticide
(evidence of non-carcinogenicity to humans).
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for flumetsulam in drinking
water. Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of flumetsulam.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentrations in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
flumetsulam for chronic exposures are estimated to be 0.59 parts per
billion (ppb) for surface water and 0.823 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Flumetsulam is not registered for use on any sites that would
result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to flumetsulam and any other
substances and flumetsulam does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that flumetsulam has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative
.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. 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 safety
factor value based on the use of traditional uncertainty factors and/or
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. Neither acceptable
Developmental Toxicity Studies in rats or rabbits revealed increased
susceptibility of the fetus to flumetsulam after in utero exposure.
Similarly, the results of the Two Generation Reproduction Study did not
indicate an increased susceptibility to flumetsulam in utero or during
postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for
Flumetsulam and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. EPA determined
that the 10X SF to protect infants and children may be reduce to 1X.
The FQPA factor is reduced to 1X because:
    i. There is a complete toxicity data base for flumetsulam;
    ii. Toxicity studies with flumetsulam showed no evidence of
increased sensitivity in the young; and
    iii. Exposure data are complete or are estimated based on data that
reasonably accounts for potential exposures. The exposure assessment
was found to

reasonably account for potential exposures because the dietary food
exposure assessment utilizes proposed tolerance level residues and 100%
crop treatment information for all commodities and the dietary drinking
water assessment utilizes values generated by model and associated
modeling parameters which are designed to provide health protective,
high-end estimates of water concentrations.

E. Aggregate Risks and Determination of Safety

    1. Acute dietary risk. No acute hazards were identified following a
single oral exposure (dose) of flumetsulam. No effects in the
developmental toxicity studies in the rabbit or rat were attributed to
a single oral exposure during gestation. Therefore, Flumetsulam is not
expected to pose an acute risk.
    2. Chronic dietary risk. Using the exposure assumptions described
in this unit for chronic exposure, EPA has concluded that exposure to
flumetsulam from food will utilize < 1% of the cPAD for the U.S.
population, all infant and children population subgroups, and women of
childbearing age (females 13 - 49 years old). In addition, there is
potential for chronic dietary exposure to Flumetsulam in drinking
water. After quantitatively incorporating the modeled Estimated
Drinking Water Concentrations (EDWC) for surface water (0.59 ppb) and
ground water (0.82 ppb), the chronic aggregated dietary exposure does
not exceed 1% of the cPAD, and is well below the Agency's Level of
Concern.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Flumetsulam is not registered for use on any sites that would
result in residential exposure. Therefore, calculation of short-term
aggregate risk is not appropriate.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Flumetsulam is not registered for use on any sites that would
result in residential exposure. Therefore, calculation of intermediate-
term aggregate risk is not appropriate.
    5. Aggregate cancer risk for U.S. population. Flumetsulam is
classified as a ``Group E'', i.e., there is evidence of non-
carcinogenicity for humans. Consequently, the conduct of a cancer risk
assessment is not appropriate.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to Flumetsulam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The available analytical enforcement method (GC/MS method) is
considered adequate for tolerance enforcement of Flumetsulam in plant
commodities. The method is available, and has been submitted for
inclusion in the Pesticide Analytical Manual. In the mean time, 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 Flumetsulam; therefore, no questions of compatibility with
U.S. tolerances exist.

V. Conclusion

    Therefore, the tolerance is established for residues of
flumetsulam, N-(2,6-difluorophenyl)-5-methyl-(1,2,4)-triazolo-[1,5-a]-
pyrimidine-2-sulfonamide, in or on beans (dry) at 0.05 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 due to its lack of
significance, 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). 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., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of

regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This rule will not
have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: September 25, 2006.
Lois Rossi,
Director, Registration Division, Office 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 180.468 is amended by alphabetically adding the commodity to
the table in the undesignated text to read as follows:

Sec. 180.468  Flumetsulam: tolerances for residues.

* * * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Beans (dry)....................................                     0.05
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-16271 Filed 10-3-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3405-3406]
[FR Doc No: 2023-00972]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2019-0292; FRL-10585-01-OMS]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Survey To Improve Economic Analysis of Surface Water Quality
Changes (New)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), ``Survey to Improve Economic
Analysis of Surface Water Quality Changes'' (EPA ICR Number 2588.01,
OMB Control Number 2090-NEW) to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a request for approval of a new collection.
Public comments were previously requested via the Federal Register on
September 29, 2021, during a 60-day comment period. This notice allows
for an additional 30 days for public comments.

DATES: Comments may be submitted on or before February 21, 2023.

ADDRESSES: Submit your comments to EPA, referencing Docket ID No. EPA-
HQ-OA-2019-0292 online using www.regulations.gov (our preferred
method), by email to [email protected], or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI), or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
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.

FOR FURTHER INFORMATION CONTACT: Chris Moore, AO/OP/NCEE, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: This is a request for approval of a new
collection. An agency may not conduct or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.
    Public comments were previously requested via the Federal Register
on September 29, 2021, during a 60-day comment period (86 FR 53960).
This notice allows for an additional 30 days for public comments.
Supporting documents, which explain in detail the information that the
EPA will be collecting, are available in the public docket for this
ICR. The docket can be viewed online at www.regulations.gov or in
person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution
Ave. NW, Washington, DC. The telephone number for the Docket Center is
202-566-1744. For additional information about EPA's public docket,
visit http://www.epa.gov/dockets.
    Abstract: Researchers and analysts in EPA's Office of Research and
Development (ORD), Office of Water (OW), and National Center for
Environmental Economics (NCEE) are collaborating to improve EPA's
ability to perform benefit cost analysis on changes in surface water
quality (lakes, rivers, and streams). We are requesting approval to
conduct a survey that will provide data critical to that effort. A
number of non-market valuation methods can be used to estimate the
economic benefits of improving environmental quality, but they often
require more time and resources than federal agencies have to complete
the regulatory impact analysis. Benefit transfer can provide reasonably
accurate estimates of economic benefits under certain conditions with
fewer resources and far less time. Federal agencies rely on benefit
transfer often when analyzing the economic impacts of environmental
regulation. In conducting benefit cost analyses of surface water
regulations, however, it has become apparent that there is a lack of
data on some features of policy analysis that have forced analysts to
make assumptions about the relationships between a number of factors.
This information collection is necessary to provide insight on those
relationships and improve the EPA's and other federal agencies' ability
to perform benefit transfer in regulatory analysis.
    Analysts in the Office of Policy, the Office of Water, and the
Office of Research and Development have begun work on an integrated
hydrological and economic model that will be capable of estimating
benefits for a wide range of surface water regulations. The data
collected with this survey will inform that effort. Analysts elsewhere
in the EPA and other federal agencies may also be able to use the
results of this study to improve benefit transfer in other
applications. The survey will be administered electronically to a
probability-based internet panel. An internet-based survey mode
provides several advantages in efficiency and accuracy over other
collection modes. It is also necessary to meet several of our research
objectives described in the ICR Supporting Statement. Participation in
the survey will be voluntary and the identity of the participants will
be kept confidential.
    Form numbers: EPA Form 5800-078, A Survey on Water Quality in
Rivers, Lakes, and Streams.
    Respondents/affected entities: Eligible respondents for this survey
will be U.S. civilian, non-institutionalized individuals, age 18 years
and older.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 6120 (total).
    Frequency of response: One-time collection.
    Total estimated burden: 2,040 hours.
    Total estimated cost: $637,122. There are no capital or operation
and maintenance costs associated with this collection.
    Changes in the estimates: This is a new collection. The survey is a
one-time data collection activity.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2023-00972 Filed 1-18-23; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

	Date:	3-JAN-08

	Subject:	Spirodiclofen.  Petition for Registration for Use on Hops.  Summary of Analytical Chemistry and Residue Data.  Petition Number 7E7204.

DP#:	346760	Decision Number:	378132

PC Code:	124871	MRID No:	47105301

40 CFR 180	608

Chemical Class:	tetronic acid insecticide

	From:	Mohsen Sahafeyan, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

Through:	George F. Kramer, Ph.D., Senior Chemist

		RAB1/HED (7509P)

	To:	Susan Stanton, Risk Manager Reviewer, RD

		Daniel Rosenblatt, Risk Manager, RD

This document was originally prepared under contract by Dynamac Corporation (1910 Sedwick Road, Building 100, Suite B, Durham, NC 27713; submitted 09/12/2007).  The document has been reviewed by HED and revised to reflect current Office of Pesticide Programs (OPP) policies.

 Executive Summary

Spirodiclofen is a tetronic acid acaricide registered in the U.S. for use on fruit and nut crops for the control of mites and other damaging insects.  Permanent tolerances are established for spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate) on grapes, citrus fruits, pome fruits, stone fruits and the tree nut crop groups at 0.10-2.0 ppm, and on processed commodities from these crops at 0.60-20 ppm [40 CFR §180.608(a)].  Tolerances are also established for the combined residues of spirodiclofen and its free enol metabolite, BAJ 2510 (3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one), in/on livestock commodities at 0.01-0.10 ppm.

Spirodiclofen is currently registered to Bayer CropScience as a 2.0 lb/gal flowable concentrate formulation (FlC, Envidor® 2 SC Miticide, EPA Reg. No. 264-831) for use as a single broadcast foliar application to grapes and fruit and nut trees at rates of 0.19-0.53 lb ai/A with preharvest intervals (PHIs) of 14 days for grapes and 7 days for all other crops.  Interregional Research Project No. 4 (IR-4) is proposing the use of spirodiclofen (FlC) on hops as a single foliar-directed application at 0.28-0.39 lb ai/A with a PHI of 14 days.  Applications are restricted to the use of ground equipment in a minimum of 50 gal/A.  In conjunction with this use, IR-4 is proposing the following permanent tolerance for spirodiclofen.

Hop, dried cones	30 ppm

The nature of spirodiclofen residues in fruit and nut crops is adequately understood based on the available apple, orange, lemon, grapefruit and grape metabolism studies and the results of newly submitted and reviewed apple and grape processing studies (T. Bloem, D341847, 10-OCT-07).  HED concludes the following:  (1) citrus fruit, pome fruit, stone fruit, and tree nut - the residue of concern for risk assessment and tolerance enforcement is spirodiclofen per se and (2) grape - the residue of concern for tolerance enforcement is spirodiclofen per se and residues of concern for risk assessment are spirodiclofen and BAJ 2510.  Since the grape processing study demonstrated degradation of spirodiclofen to BAJ 2510, HED is requesting that the petitioner submit an orange processing study monitoring for residues of spirodiclofen, BAJ 2510, 3-OH-enol, and 4-OH-enol.  Pending the submission of these data, human-health risk assessments should assume default processing factors for all processed commodities excluding the processed commodities for apple and grape.   For the current petition on hops, no additional plant metabolism data are required and the residue of concern is spirodiclofen per se.

As the proposed use on hops does not include any regulated livestock feedstuffs, issues pertaining to livestock metabolism, analytical methods and storage stability data for animal commodities, and residues in livestock commodities are not relevant to the current petition.

→ 313 and 99 →71 ion transitions and deuterated spirodiclofen as an internal standard.  The validated limit of quantitation (LOQ) is 0.01 ppm for spirodiclofen in/on citrus fruits, stone fruits, pome fruits, nutmeats and almond hulls.  This method has undergone a successful independent laboratory validation (ILV) trial, and has been reviewed by the Analytical Chemistry Branch (ACB).  ACB determined that the method would be adequate for tolerance enforcement provided that a revised copy of the method was submitted incorporating the changes and clarifications recommended by ACB (D308566, E. Kolbe, 5/18/05).

cartridges and analyzed by LC/MS/MS using the m/z 411→313 ion transition and external standards.  The method was adequately validated in conjunction with the analysis of field trial samples.  The lowest level of method validation (LLMV) was 0.05 ppm, and the statistically calculated LOQ was 0.05 ppm and the calculated limit of detection (LOD) was 0.02 ppm.

In conjunction with the field trials, adequate storage stability data were submitted indicating that spirodiclofen is stable at -20ºC in dried hops for up to 15.3 months of storage.  These data adequately support the maximum frozen storage interval (15.9 months) from the U.S. field trials.

Adequate field trial data on hops are available from 3 trials conducted in the U.S. in Zones 11 and 12 during 2004.  In each trial, spirodiclofen (2 lb/gal FlC) was applied to hops as a single foliar-directed application at 0.387-0.412 lb ai/A (1x rate) during cone development and maturation.  Applications were made using ground equipment at volumes of 43-175 gal/A, and did not include the use of any spray adjuvants.  The resulting residues of spirodiclofen were 1.97-13.1 ppm in/on 6 samples of dried hop cones harvested 21 days after treatment (DAT) and 2.85-5.72 ppm in/on 6 samples harvested at 28 DAT.  Average spirodiclofen residues were 6.42 and 3.99 ppm at 21 and 28 DAT, respectively.

The petitioner also submitted supplemental hops field trial data from 8 trials conducted in Germany during 2003 and 2004.  In each of these trials, spirodiclofen (240 g/L FlC) was applied to hops as a single foliar application at 0.34-0.43 kg ai/ha (0.30-0.38 lb ai/A, ~1x proposed U.S. rate) during cone development and maturation (BBCH 71-87), using ground equipment at volumes of 2100-3547 L/ha (225-380 gal/A).  Residues of spirodiclofen were 3.9-24.0 ppm in/on 8 samples of dried hops harvested at the proposed PHI of 14 days.  Residues were 3.9-10.9 ppm in/on 4 samples by 21 DAT and 3.1-10.0 ppm in/on 6 samples by 28 DAT.  Average residues were 11.6, 7.23, and 7.07 ppm at 14, 21 and 28 DAT, respectively, indicating that residues declined slowly from 14-28 DAT.

As there are no regulated processed commodities associated with hops, no processing studies are required for this petition.  Data pertaining to residues in rotational crops are also not required as hops are a perennial crop.

  SEQ CHAPTER \h \r 1 Regulatory Recommendations and Residue Chemistry Deficiencies

No deficiencies were noted in the subject petition that would preclude establishing a permanent tolerance for spirodiclofen residues on dried hops.  Although adequate U.S. field trial data are available supporting a minimum PHI of either 21 or 28 days, IR-4 is requesting a 14-day PHI for hops in order to harmonize the U.S. and German use patterns.  In addition, IR-4 is requesting a 30-ppm tolerance on dried hop cones to harmonize with the established German maximum residue limit (MRL).  Considering similarity in climatic conditions between the hops growing regions in the U.S. and Germany and the German MRL of 30 ppm being higher than the maximum residue values from the other two submitted field trial data sets having similar application rates, but longer PHIs (21 and 28 day), HED recommends establishing a permanent tolerance for spirodiclofen on hops at 30 ppm to promote free trade between NAFTA and non-NAFTA countries.  A human-health risk assessment for spirodiclofen is forthcoming.

Background

Spirodiclofen is a member of a new class of chemicals called tetronic acid insecticides (MOA Group 23).  These compounds are acaricides that also have insecticidal activity at higher doses.  Their mode of action is through the inhibition of lipid biosynthesis, which inhibits the younger insect’s ability to develop through the various growth stages and the ability of adults to reproduce.

Interregional Research Project 4 has submitted a petition (PP#7E7204) proposing the use of spirodiclofen on hops for control of two-spotted spider mites.  Although IR-4 has conducted the required hops field trials in the U.S., they proposed harmonizing the U.S. use pattern and tolerance with the existing use pattern and tolerance in Germany.  This proposal was reviewed by chemistry science advisory council (ChemSAC) (meeting of 2/28/07).

Table 1.	Spirodiclofen Compound Nomenclature.

Compound

Common name	Spirodiclofen

Company experimental name	BAJ2740

IUPAC name	3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutyrate

CAS name	3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate

CAS registry number	148477-71-8

End-use product (EP)	2 lb/gal FlC (ENVIDOR® 2 SC Miticide; EPA Reg. No. 264-831)

Table 2.	Physicochemical Properties of Spirodiclofen.

Parameter	Value	Reference

Melting point	94.8ºC	DP# 315459, S. Mathur, 4/20/05

pH	4.2

	Density (20ºC)	1.29 g/cm3

	Water solubility (20ºC at pH 4)	50μg/L

	Solvent solubility (g/L at 20°C)	n-heptane

xylene

dichloromethane

2-propanol

1-octanol

polyethylene glycol

acetone

ethyl acetate

acetonitrile

dimethylsulfoxide	20

>250

>250

47

44

24

>250

>250

>250

75

	Vapor pressure (20ºC)	3 x 10-7 Pa

	Dissociation constant, pKa	Not determinable due to the instability in aqueous solutions at >pH 4

	Octanol/water partition coefficient, Log(KOW) at pH 4 and 20ºC	5.83

	UV/visible absorption spectrum	λmax = 201 nm:  Not expected to absorb UV at λ >350 nm

860.1200 Directions for Use

A 2 lb/gal FlC formulation of spirodiclofen (ENVIDOR® 2 SC Miticide; EPA Reg. No. 264-831) is currently registered to Bayer for use as broadcast foliar applications to citrus fruits, pome fruits, stone fruits, grapes, and tree nuts.  IR-4 is proposing the use of this 2 lb/gal FlC on hops for the control of two-spotted spider mites (Tetranychus urticae).  An example label was provided, and the proposed use directions are summarized below in Table 3.

Table 3.  Summary of Directions for Use of Spirodiclofen.

Applic. Timing, Type, and Equip.	Formulation

[EPA Reg. No.]	Applic. Rate

(lb ai/A)	Max. No. Applic. per Season	Max. Seasonal Applic. Rate

(lb ai/A)	PHI

(days)	Use Directions and Limitations 1

Hops

Single foliar application at the early stages of mite infestation;  Ground equipment	2 lb/gal FlC

[264-831]	0.28-0.39	1	0.39	14	Apply in a minimum of 50 gal/A using conventional ground airblast spray

1	Do not apply through any type of irrigation equipment or using aerial equipment.

Conclusions.  The label directions are adequate to allow evaluation of the residue data relative to the proposed use.  Although samples from the U.S. field trials were collected at 21 and 28 DAT, IR-4 is requesting a 14-day PHI in order to harmonize the U.S. and German use patterns.  In addition to the U.S. field trials, IR-4 has provided summaries from eight field trials conducted on hops in Germany at 0.30-0.38 lb ai/A (~1x rate) with harvest intervals of 14, 21 and 28 DAT.  As residue levels in/on dried hops were similar between the U.S. and German field trials at 21 and 28 DAT, HED will accept the use of the 14-DAT residue data from Germany to support the proposed use directions on hops in the U.S.

860.1300 Nature of the Residue – Plants

PP#2F6469, DP# D285249, T. Bloem, 4/18/05

The nature of spirodiclofen residues in fruit and nut crops is adequately understood based on the available apple, orange, lemon, grapefruit and grape metabolism studies and the results of newly submitted and reviewed apple and grape processing studies (T. Bloem, D341847, 10-OCT-07). These studies indicate that the metabolism of spirodiclofen in fruit crops involves the following steps:  cleavage of the ester linkage to form the free enol metabolite (BAJ 2510); hydroxylation of BAJ 2510 on the cyclohexyl ring to form 3-OH-enol and 4-OH-enol metabolites; and cleavage of the enol ring structure to form 2,4-dichloro-mandelic acid-cyclohexylester, which undergoes hydroxylation/conjugation and further degradation to yield 2,4-dichloro-mandelic acid (free and conjugated).  The recently submitted grape processing study indicates that residues of spirodiclofen degrade to BAJ 2510 during processing of grapes to juice, juice concentrate, jelly and raisin.

 identified:  BAJ 2510 (≤2% TRR), 3-OH-enol (≤3% TRR), 4-OH-enol (<1% TRR), 2,4-dichloro-mandelic acid-cyclohexylester compounds (free and conjugated; ≤9% TRR), and 2,4-dichloro-mandelic acid (free and conjugate; ≤12% TRR).

HED concludes the following:  (1) citrus fruit, pome fruit, stone fruit, and tree nut - the residue of concern for risk assessment and tolerance enforcement is spirodiclofen per se and (2) grape - the residue of concern for tolerance enforcement is spirodiclofen per se and residues of concern for risk assessment are spirodiclofen and BAJ 2510 (T. Bloem, D341847, 10-OCT-07).  HED has requested data demonstrating the stability of BAJ 2510, 3-OH-enol, and 4-OH-enol in/on grape juice and raisins when stored frozen for 70 days and submission of an orange processing study monitoring for residues of spirodiclofen, BAJ 2510, 3-OH-enol, and 4-OH-enol.  Pending the submission of these data, human-health risk assessments should assume default processing factors for all processed commodities excluding the processed commodities for apple and grape.   For the current petition on hops, no additional plant metabolism data are required and the residue of concern is spirodiclofen, per se.

Conclusions.  As hops are a minor crop, the available metabolism data will be used to support the use on hops.  However, additional plant metabolism data may be required in the future for crop uses other than fruits.  For purposes of this tolerance petition, HED concludes that the residue of concern in/on dried hops consists of spirodiclofen per se.

860.1300 Nature of the Residue - Livestock

As there are no livestock feedstuffs associated with hops, data requirements for livestock metabolism are not relevant to this tolerance petition.

860.1340 Residue Analytical Methods

PP#2F6469, DP# D285249, T. Bloem, 4/18/05

DP# 318055, T.  Bloem, 6/1/05

Enforcement method.  Bayer has proposed a LC/MS/MS method (Report No. 109351) for enforcing tolerances of spirodiclofen in/on plant commodities.  With the exception of nutmeats and oil, residues are extracted with ACN:water (2:1), filtered, and acidified with HCl.  For nutmeats, residues are extracted sequentially with ACN:water (2:1, acidified with 20% aqueous cysteine HCl) and acetone:DCM (1:2).  The filtrates are combined, and residues in the lower organic layer are concentrated, reconstituted in hexane and partitioned into ACN.

With the exception of nutmeat and almond hull samples, residues are then cleaned up using an ENVI-carb cartridge eluted with DCM.  Residues from hulls are cleaned using an NH2 cartridge eluted with ACN, and residues from nutmeats are analyzed without further clean up.  Purified residues are determined by LC/MS/MS analysis with electrospray ionization in the positive-ion single-reaction monitoring mode.  The m/z 411→ 313 and 99 →71 ion transitions are monitored for spirodiclofen, and deuterated spirodiclofen is used as an internal standard.  The validated LOQ is 0.01 ppm for spirodiclofen in/on citrus fruits, stone fruits, pome fruits, nutmeats and almond hulls.

Adequate validation data, a successful ILV trial, and radiovalidation data are available for the proposed enforcement method.  The method has also been reviewed by ACB, without conducting a laboratory trial.  ACB determined that the method would be adequate for tolerance enforcement provided that a revised copy of the method was submitted incorporating the changes and clarifications recommended by ACB (D308566, E. Kolbe, 5/18/05).

and quantified using the m/z 411→313 ion transition and external standards.  The LLMV was 0.05 ppm, and the statistically calculated LOQ and LOD were 0.05 ppm and 0.02 ppm, respectively.  The above method was adequately validated prior to and in conjunction with the analysis of field trial samples.

Conclusions.  The LC/MS/MS method used in the field trials is adequate for determining residues of spirodiclofen in/on dried hops.  Given the similarity between the data collection method and the LC/MS/MS enforcement method (nutmeats), the enforcement method will be adequate for regulating residues in/on dried hops.

860.1360 Multiresidue Methods

  SEQ CHAPTER \h \r 1 45696517.der, T. Bloem, 8/18/04

Spirodiclofen and BAJ 2510 were screened through the FDA MRM testing protocols.  As both compounds are not N-methylcarbamates, naturally fluorescent, acids, phenols or substituted ureas, Protocols, A, B, and G were not performed.  Protocol C modules DG1 and DG10 (gas chromatography/electron-capture detector, GC/ECD) gave acceptable results for BAJ 2510 and spirodiclofen.  Using fortified orange samples, acceptable recoveries of spirodiclofen were attained through Protocols D (80-103%) and E (54-77%).  Using fortified ground beef samples, unacceptable recoveries of spirodiclofen were attainted through protocol F (16-30%).  BAJ 2510 was not recovered through the Florisil clean-up column, and therefore, gave unacceptable recoveries for Protocol D (fortified orange samples) and F (fortified ground beef samples).  Since BAJ 2510 was not recovered through Protocol D, Protocol E was not tested.  These data have been forwarded to FDA for evaluation (DP# D308565, T. Bloem, 9/29/04).

860.1380 Storage Stability

45696606.der2, T. Bloem, 9/22/04

Adequate data are available indicating that spirodiclofen is stable at <-15ºC for up to 13.3 months in peaches and grapes, 10 months in prunes and almond hulls, and 7.6 months in raisins, dried apples, and fruit juice concentrates (apple and grape).  However, spirodiclofen residues were shown to decline by 26% in almond nutmeats over 13.5 months of storage.

In conjunction with the hops field trials, a storage stability study was conducted using control samples of dried hop cones fortified with spirodiclofen at 0.10 ppm.  The fortified samples were stored under the same conditions as the field trial samples.  At the end of the analytical phase of the study, the stored sample was analyzed in triplicate along with a control sample and a freshly fortified sample.  The average corrected recovery from the stored samples was 102%, indicating that spirodiclofen is stable in dried hops at -20ºC for up to 460 days (15.1 months).

In the hops field trials conducted in the U.S., samples of dried hops were stored at -20ºC for 470-476 days (15.6 months) prior to analysis.

Conclusions.  The submitted storage stability data on hops are adequate and support the storage intervals and conditions incurred by the field trial samples.

860.1400 Water, Fish, and Irrigated Crops

There are no registered uses that are relevant to this guideline topic.

860.1460 Food Handling

There are no registered uses that are relevant to this guideline topic.

860.1480 Meat, Milk, Poultry, and Eggs

As there are no livestock feedstuffs associated with the proposed use on hops, data requirements pertaining to meat, milk, poultry, and eggs are not relevant to this tolerance petition.

860.1500 Crop Field Trials

47105301.der (hops)

To support the use of spirodiclofen (FlC) on hops in the U.S., IR-4 has submitted field data from three trials conducted in the U.S. during 2004.  In Section G of the submitted petition, IR-4 also provided the German review of the data from eight field trials conducted in Germany during 2003-2004.    SEQ CHAPTER \h \r 1 The results from these tests are discussed below and the residue data are summarized in Table 4.

Table 4.	Summary of Residue Data from Crop Field Trials with Spirodiclofen (FlC).

Crop matrix	Total Applic. Rate  (lb ai/A)	PHI (days)	Residue Levels (ppm) 1

	n	Min.	Max.	HAFT 2	Median	Mean	Std. Dev.

Hops,  proposed U.S. use rate - 0.39 lb ai/A with 14-day PHI

U.S. Field Trial Data (2004)

Dried hop cones	0.39-0.41	21	6	1.97	13.1	13.0	4.26	6.42	5.16

28	6	2.85	5.72	4.83	3.90	3.99	0.982

German Field Trial Data (2003-2004)

Dried hop cones	0.30-0.39	14	8	3.9	24.0	24.0	10.65	11.60	6.62

21-22	4	3.9	10.9	10.9	7.05	7.23	2.89

28	6	3.1	10.0	10.0	8.15	7.07	2.85

1	The method LOQ is 0.05 ppm for residues of spirodiclofen in dried hops.

2	HAFT = Highest average field trial result.

U.S. Field Trials.  In 3 field trials conducted during 2004 in Zones 11 and 12, spirodiclofen (2 lb/gal FlC) was applied to hops as a single foliar-directed application at 0.387-0.412 lb ai/A (1x rate) during cone development and maturation.  Applications were made using ground equipment at volumes of 43-175 gal/A, and did not include the use of any spray adjuvants.  Duplicate control and treated samples of mature fresh hop cones were collected from each test site at 21 and 28 DAT, and dried within one day of harvest using commercial dryers.  In one field trial, additional samples were also collected at 6 and 14 DAT to assess residue decline.  Samples of dried hop cones were stored frozen for up to 15.6 months prior to analysis, and a concurrent storage stability study was conducted supporting the stability of spirodiclofen in hops at -20ºC for up to 15.1 months.

The LC/MS/MS method used to determine residues of spirodiclofen in/on hops was adequately validated in conjunction with the analysis of field trial samples.  The calculated LOQ and LOD were 0.05 and 0.02 ppm, respectively, and the LLMV was 0.05 ppm.

Following a single foliar-directed application of spirodiclofen (FlC) at 0.387-0.412 lb ai/A, residues of spirodiclofen were 1.97-13.1 ppm in/on 6 samples of dried hop cones harvested 21 DAT and 2.85-5.72 ppm in/on 6 samples of dried hop cones harvested 28 DAT.  Average residues were 6.42 and 3.99 ppm at 21 and 28 DAT, respectively, and the HAFT residues were 13.0 and 4.83 ppm.  In the residue decline trial, average residues in/on hops decline relatively linearly from 6.68 ppm at 6 DAT to 3.59 ppm by 28 DAT.

German Field Trials.   In 8 field trials conducted during 2003 and 2004 in Southern Germany (see Appendix III), a 240 g/L suspension concentrate formulation of spirodiclofen was applied to hops as a single foliar application at 0.34-0.43 kg ai/ha (0.30-0.38 lb ai/A, ~1x U.S. rate) during cone development and maturation (BBCH 71-87).  Applications were made using ground equipment at volumes of 2100-3547 L/ha (225-380 gal/A).  Fresh green hops were harvested at 14 DAT from each trial, and at 21-22 DAT from 4 trials and at 28 DAT from 6 trials.  Green hops were dried to yield a single treated sample of dried hops from each trial at each interval.

The German report did not include information on sample storage conditions or intervals prior to analysis.  Residues were determined using a LC/MS/MS method, but no details of the method were provided.

Following a single foliar application of spirodiclofen (FlC) at 0.30-0.38 lb ai/A (~1x the proposed U.S. use rate), residues of spirodiclofen were 3.9-24.0 ppm in/on 8 samples of dried hops harvested at the proposed PHI of 14 days.  Residues were 3.9-10.9 ppm in/on 4 samples by 21 DAT and 3.1-10.0 ppm in/on 6 samples by 28 DAT.  Average residues were 11.6, 7.23, and 7.07 ppm at 14, 21 and 28 DAT, respectively, indicating that residues declined slowly from 14-28 DAT.

Conclusions.  The three hops field trials conducted in the U.S. are adequate and would support PHIs of either 21 or 28 days, independently from the German field trial data.  An adequate number of trials were conducted on hops in the U.S. in the appropriate geographical regions.  Samples were analyzed for the residues of concern using an adequate method and the samples storage conditions and intervals are supported by the available storage stability data.

However, IR-4 is requesting that the use pattern for hops in the U.S. be harmonized with the use pattern in Germany, which allows for a PHI of 14 days.  Although no residue data for a 14-day PHI are available from the U.S., IR-4 has supplied summaries of German field trials that included harvest intervals of 14, 21, and 28 DAT and were conducted at approximately the same rates as proposed for the U.S.   Average residues in/on hops were 6.42 and 3.99 ppm at 21 and 28 DAT in the U.S. field trials, and were 7.23 and 7.07 ppm at 21 and 28 DAT in the German field trials.  At 14 DAT, average residues were 11.60 ppm in the German field trials.

Considering the similarity in climatic conditions between the hops growing regions in the U.S. and Germany, and the similarity in the residue data from both countries at the 21- and 28-day harvest intervals, ChemSAC recommended in favor of allowing the use of the German field trial data to support the U.S. use pattern and tolerance (meeting 2/28/07).  In order to harmonize with the previously established Germany MRL, HED has decided to set the U.S. tolerance for spirodiclofen on hops at 30 ppm to promote free trade between NAFTA and non-NAFTA countries (for more discussion see section 860.1550 Proposed Tolerances below).

860.1520 Processed Food and Feed

HED does not require residue data for any processed commodities associated with hops.  Therefore, data requirements for processed food and feed are not relevant to this tolerance petition

  SEQ CHAPTER \h \r 1 860.1650 Submittal of Analytical Reference Standards

Analytical reference standards for spirodiclofen are available at the EPA National Pesticide Standard Repository as of 8/8/07.

860.1850-1900 Confined and field Accumulation in Rotational Crops

Because hops are not rotated, no data pertaining to rotational crops are required to support the proposed use.

860.1550 Proposed Tolerances

HED has concluded that the residue of concern in fruit, except grape, and nut crops is spirodiclofen per se, for both the tolerance expression and risk assessment purposes; for grape, the residue of concern for tolerance enforcement is spirodiclofen per se and residues of concern for risk assessment are spirodiclofen and BAJ 2510.  For purposes of this tolerance petition, the residue of concern is parent spirodiclofen.  Permanent tolerances are established for spirodiclofen on grapes, citrus fruits, pome fruits, stone fruits and the tree nut crop groups at 0.1-2.0 ppm, and on processed commodities from these crops at 0.6-20 ppm [40 CFR §180.608(a)(1)].  Tolerances are also established for the combined residues of spirodiclofen and its free enol metabolite BAJ 2510 in/on livestock commodities at 0.01-0.10 ppm [40 CFR §180.608(a)(2)].

Using the Agency’s Guidelines for Setting Pesticide Tolerances Based on Field Trial Data, potential tolerances for dried hops were calculated using the 21- and 28-DAT residue data from the adequate U.S. field trials conducted at a 1x rate.  The calculated tolerances for dried hops harvested at the 21 and 28-day intervals were 35 and 7 ppm, respectively (Appendix I).

However, IR-4 is requesting a minimum PHI of 14 days for hops in order to harmonize the U.S. use directions with the use pattern in Germany.  IR-4 has also requested that the U.S. tolerance on hops be harmonized with the proposed German MRL of 30 ppm (Table 6).

HED calculated a tolerance for spirodiclofen on hops with a PHI of 14 days using field trial data conducted in Germany.  These field trial data were originally submitted to European regulatory authorities in order to establish a German MRL.  Following the guidance used by NAFTA countries (Guideline for Setting Pesticide Tolerances Based on Field Trial Data SOP), the suggested tolerance for this data set would be 45 ppm, which is rounded up from 40.73 ppm (the point estimate of the 99th percentile).  However, the European regulatory community employs different methods for calculating tolerances.  As such, the German MRL was set at 30 ppm, which is above the highest residue value of 24 ppm.  The German MRL of 30 ppm is also higher than the maximum residue values from two other submitted field trial data sets having similar application rates, but longer PHIs (21 and 28 day).  Thus, in order to harmonized with the previously established Germany MRL, HED has decided to set the U.S. tolerance for spirodiclofen on hops at 30 ppm to promote free trade between NAFTA and non-NAFTA countries.

Mexican and Codex MRLs have not been established for spirodiclofen (Appendix II), but Canadian MRLs have been established on a number of crops and processed commodities.  No MRLs have been established by Canada, Mexico or Codex for spirodiclofen on hops.  However, Germany is currently using an assessment level (Beurteilungsempfehlungen) of 30 mg/kg to evaluate the safety of spirodiclofen use on hops.

Table 6. 	Tolerance Summary for Spirodiclofen.

Commodity	Proposed Tolerance (ppm)	Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Hop, dried cones	30	30

References

DP Number:	D285249

Subject:	Spirodiclofen in/on Citrus Fruit, Grape, Pome Fruit, Stone Fruit, and Tree Nut Crops.   Summary of Analytical Chemistry and Residue Data.

From:	T. Bloem

To:	D. Kenny

Dated:	4/18/05

MRID(s):	45696504, 45696505, 45696506, 45696507, 45696508, 45696510, 45696513, 45696514, 45696515, 45696516, 45696517, 45696518, 45696519, 45696520, 45696521, 45696601, 45696602, 45696603, 45696604, 45696605, 45696606, 45696611, 45696612, 46028301

DP Number:	D315459

Subject:	Product Chemistry Review of TGAI.  Joint Review with PMRA (NAFTA)

From:	S. Mathur

To:	R. Kumar / D. Kenny

Dated:	4/20/05

MRID(s):	NA

DP Number:	D308566

Subject:	PP# 2F6469.  Review of Proposed Tolerance Enforcement Methods for Spirodiclofen in/on Plant and Livestock Commodities.

From:	E. Kolbe

To:	K. Whitby/ M. Laws

Dated:	5/18/05

MRID(s):	45696514, 45699604, 45696515, 45696603

DP Number:	318055

Subject:	Spirodiclofen.  Results of Petition Method Validation (PMV).

From:	T. Bloem

To:	D. Kenny

Dated:	6/1/05

MRID(s):	None

  SEQ CHAPTER \h \r 1 Attachments:

Appendix I – Tolerance Assessment Calculations

Appendix II – International Residue Limit Status sheet

Appendix III – Residue Data from German Field Trials

Template Version September 2005

Appendix I – Tolerance Assessment Calculations

The Agency’s Guideline for Setting Pesticide Tolerances Based on Field Trial Data was utilized for determining appropriate tolerance levels on dried hop cones.  Residues levels in this commodity were >LOQ in all samples.  The dataset used to calculate tolerances for spirodiclofen residues on hops consisted of U.S. and German field trial data representing applications of the appropriate formulation at ~1x the maximum proposed use rate but at different PHIs (U.S. PHI = 21 and 28 days; German PHI = 14 days).

The datasets for spirodiclofen on hops harvested at 21- and 28-DAT were entered into the tolerance spreadsheet.  The results form the approximate Shaprio-Francia test statistic (Figures I-2 and -4) and visual inspection indicated that mathematically, the residues from samples harvested at 21-DAT are lognormal; lognormality, however, was rejected for residues from samples harvested at 28-DAT.  The calculated tolerance for 21-day and 28-day PHI were respectively 35 and 7 ppm.

HED also calculated a tolerance for spirodiclofen on hops with a PHI of 14 days using field trial data conducted in Germany.  These field trial data were originally submitted to European regulatory authorities in order to establish a German MRL.  Following the guidance used by NAFTA countries (Guideline for Setting Pesticide Tolerances Based on Field Trial Data SOP), the suggested tolerance for this data set would be 45 ppm, which is rounded up from 40.73 ppm (the point estimate of the 99th percentile).  However, the European regulatory community employs different methods for calculating tolerances.  As such, the German MRL was set at 30 ppm, which is above the highest residue value of 24 ppm.  The German MRL of 30 ppm is also higher than the maximum residue values from two other submitted field trial data sets having similar application rates, but longer PHIs (21 and 28 day).  Thus in order to harmonized with the previously established Germany MRL, HED has decided to set the U.S. tolerance for spirodiclofen on hops at 30 ppm to promote free trade between NAFTA and non-NAFTA countries.

Table I-1.	Spirodiclofen Residues in/on Dried Hop Cones, U.S. Field Trial Data.

Regulator:	EPA

Chemical:	Spirodiclofen

Crop:	Hops, dried cones

PHI:	21 days	28 days

App. Rate:	0.39-0.41 lb ai/A

Submitter:	IR-4

MRID Citation:	MRID 41705301

	Residues	Residues

	1.97	2.85

	2.13	3.32

	3.95	3.86

	4.57	3.93

	12.8	4.23

	13.1	5.72

Figure I-1.	Lognormal Probability Plot of Spirodiclofen Residues in/on Dried Hop Cones Harvested at 21 DAT.

Figure I-2.	Data Summary Sheet for Residues of Spirodiclofen in/on Dried Hop Cones at 21 DAT.

 Figure I-3.	Lognormal Probability Plot of Spirodiclofen Residues in/on Dried Hop Cones Harvested at 28 DAT.

Figure I-4.	Data Summary Sheet for Residues of Spirodiclofen in/on Dried Hop Cones at 28 DAT.

Table I-2.	Spirodiclofen Residues in/on Dried Hop Cones, German Field Trial Data (PHI = 14 days).

Regulator:	EPA

Chemical:	spirodiclofen

Crop:	hops

PHI:	14 days

App. Rate:	0.32 - 0.38 lb ai/A

Submitter:	IR-4 (German Study)

	Residues

	17.000

	24.000

	3.900

	5.200

	10.800

	13.900

	7.500

	10.500

Figure I-5.	Lognormal Probability Plot of Spirodiclofen Residues in/on Dried Hop Cones Harvested at 14 DAT (German Study).

Figure I-6.	Data Summary Sheet for Residues of Spirodiclofen in/on Dried Hop Cones at 14 DAT (German Study).

Appendix II - International Tolerances.

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愀Ĥ摧এrࠀ√ Proposed tolerance

 Reevaluated tolerance

 Other	Date:  12/09/2007

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

√ No Codex proposal step 6 or above

 No Codex proposal step 6 or above for the crops requested	Petition Numbers: 7E7204

DP Number:  	346760

Other Identifier:

Residue definition (step 8/CXL): NA	Reviewer/Branch:  M. Sahafeyan/RAB1

	Residue definition:  Spirodiclofen

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

Hops, dried cones	30

	Limits for Canada	Limits for Mexico

 No Limits

√ No Limits for the crops requested	√  No Limits

  No Limits for the crops requested

Residue definition: N/A.

There is a label for use on stone fruit, pome fruit, and grapes.	Residue definition: NA

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

	Notes/Special Instructions: S.Funk, 12/10/2007.

Appendix III – German Field Trail Data on Hops.

Table III- 1.	Residues of Spirodiclofen in/on Dried Hops From German Field Trials Conducted during 2003 and 2004.

Location/year	Variety	Application Type	Growth stage	Rate	Volume	Matrix PHI (days)	Residues (ppm)

kg ai/ha	lb ai/A	l/ha	gal/A

	Gebrontshausen, Germany  2003	Perle	Foliar Directed	BBCH 84/87	0.36 0.32	3300	353	dried cones	14	17.0

Gebrontshausen, Germany  2003	Hallertauer Tradition	Foliar Directed	BBCH 84/87	0.36	0.32	3300	353	dried cones	14	24.0

Tettnang, Germany  2003 	Spalter Hopfen	Foliar Directed	BBCH 79	0.34 0.30	3109	333	dried cones	14	3.9

	21	3.9

	28	3.1

Tettnang, Germany  2003	Hallertauer Mittelfruh	Foliar Directed	BBCH 79 0.39	0.35	3547	380	dried cones	14	5.2

	21	6.6

	28	4.0

Gebrontshausen, Germany  2004	Hallertauer Tradition	Foliar Directed	BBCH 71/79	0.43	0.38

	2100	225	dried cones	14	10.8

	28	10.0

Tettnang, Germany 2004	Hallertauer Mittelfruh	Foliar Directed	BBCH 75/79 0.43	0.38

	2100	225	dried cones	14	13.9

	28	9.0

Gebrontshausen, Germany  2004	Perle	Foliar Directed	BBCH 71/75	0.43	0.38 2100	225	dried cones	14	7.5

	22	7.5

	28	8.8

Tettnang, Germany  2004	Spalter Hopfen	Foliar Directed	BBCH 75/79	0.43 0.38	2100	225	dried cones	14	10.5

	21	10.9

	28	7.5

Spirodiclofen	Summary of Analytical Chemistry and Residue Data	DP#:  346760

PC Code: 124871

Page   PAGE  1  of   NUMPAGES  20


[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Pages 34715-34716]
[FR Doc No: 2017-15633]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81178; File No. SR-MRX-2017-08]

Self-Regulatory Organizations; Nasdaq MRX, LLC; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Adopt Rule 912

July 20, 2017.
    On June 9, 2017, Nasdaq MRX, Inc. (``MRX'' or the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt Rule 912 (Consolidated Audit Trail--Fee
Dispute Resolution). The proposed rule change was published for

comment in the Federal Register on June 23, 2017.\3\ The Commission
received no comment letters on the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 80966 (June 19, 2017),
82 FR 28702 (``Notice'').
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change. The
proposed rule change would establish the procedures for resolving
potential disputes related to CAT Fees charged to Industry Members.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates September 21, 2017, as the date by which the
Commission should either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File
Number SR-MRX-2017-08).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-15633 Filed 7-25-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 10, 2009 (Volume 74, Number 216)]
[Proposed Rules]
[Page 57978-57979]
[DOCID:fr10no09-28]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2005-AL-0002-200924; FRL-8979-7]

Approval and Promulgation of Implementation Plans: Alabama:
Proposed Approval of Revisions to the Visible Emissions Rule and
Alternative Proposed Disapproval of Revisions to the Visible Emissions
Rule; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: EPA is announcing an extension of the public comment period
for the proposed rule entitled ``Approval and Promulgation of
Implementation Plans; Alabama: Proposed Approval of Revisions to the
Visible Emissions Rule and Alternative Proposed Disapproval of
Revisions to the Visible Emissions Rule.'' The proposed rule was
initially published in the Federal Register on October 2, 2009. Written
comments on the proposed rule were to be submitted to EPA on or before
November 16, 2009 (45-day comment period). EPA is extending the public
comment period until December 16, 2009.

DATES: The comment period for the proposed rule published on October 2,
2009 (74 FR 50930), is extended. Comments must be received on or before
December 16, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2005-AL-0002, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2005-AL-0002,'' Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street, SW., Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through

Friday, 8:30 to 4:30, excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. ``EPA-R04-OAR-
2005-AL-0002.'' EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit through http:/
/www.regulations.gov or e-mail, information that you consider to be CBI
or otherwise protected. The http://www.regulations.gov Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2005-AL-0002. All documents in the
docket are listed on the http://www.regulations.gov index. Although
listed in the index, some information is not publicly available, i.e.,
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 either electronically
through http://www.regulations.gov or in hard copy at the Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. EPA requests that, if
at all possible, you contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to schedule your inspection. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Ms. Lynorae Benjamin, Chief,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, Region 4, U.S. Environmental Protection
Agency, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The
telephone number is<PHONE_NUMBER>. Ms. Benjamin can also be reached
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The proposed rule was signed by the Acting
Regional Administrator on September 10, 2009, and published in the
Federal Register on October 2, 2009 (74 FR 50930). The proposed action
provided a 45-day public comment period. EPA has received a request for
an additional 15 days to comment on the proposed rule from one
requester, and 90 days from another requester. EPA has considered these
requests and has decided to extend the comment period an additional 30
days until December 16, 2009.

    Dated: November 2, 2009.
Beverly H. Banister,
Acting Regional Administrator, Region 4.
[FR Doc. E9-27045 Filed 11-9-09; 8:45 am]

BILLING CODE 6560-50-P