[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)]
[Proposed Rules]
[Pages 53347-53348]
[FR Doc No: 2019-21643]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2016-D-2343]

Hazard Analysis and Risk-Based Preventive Controls for Human
Food; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of another draft chapter of a multichapter
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food.'' This multichapter draft guidance
is intended to explain our current thinking on how to comply with the
requirements for hazard analysis and risk-based preventive controls
under our rule entitled ``Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food.'' The
newly available draft chapter is entitled ``Chapter 14--Recall Plan.''

DATES: Submit either electronic or written comments on the draft
guidance by February 4, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you

do not wish to be made available to the public, submit the comment as a
written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive
Controls for Human Food.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Food Safety (HFS-300), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send one self-addressed adhesive label to assist that office
in processing your requests. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. FSMA enables FDA to focus more
on preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production.
    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with
requirements for hazard analysis and risk-based preventive controls for
establishments that are required to register as food facilities under
our regulations in 21 CFR part 1, subpart H, in accordance with section
415 of the FD&C Act (21 U.S.C. 350d). We have established regulations
to implement these requirements within part 117 (21 CFR part 117).
    In the Federal Register of August 24, 2016 (81 FR 57816), we
announced the availability of several chapters (Chapters 1-5) of a
multichapter draft guidance for industry entitled ``Hazard Analysis and
Risk-Based Preventive Controls for Human Food.'' In the Federal
Register of August 31, 2017 (82 FR 41364), and January 25, 2018 (83 FR
3449), we announced the availability of additional chapters (Chapter 6
and Chapter 15, respectively). We now are announcing the availability
of an additional draft chapter of this multichapter guidance for
industry.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on ``Current
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
    The multichapter draft guidance for industry is intended to explain
our current thinking on how to comply with the requirements for hazard
analysis and risk-based preventive controls under part 117, principally
in subparts C and G. The chapter that we are announcing in this
document is entitled ``Chapter 14--Recall Plan.'' We intend to announce
the availability for public comment of additional chapters of the draft
guidance as we complete them.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 117 have been approved under OMB
control number 0910-0751.

IV. Electronic Access

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

    Dated: September 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21643 Filed 10-4-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 89 (Tuesday, May 9, 2023)]
[Rules and Regulations]
[Page 29835]
[FR Doc No: 2023-09542]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2019-0508; FRL-7261-05-OCSPP]
RIN 2070-AK54

Notification of Submission to the Secretary of Agriculture;
Pesticides; Exemptions of Certain Plant-Incorporated Protectants (PIPs)
Derived From Newer Technologies; Draft Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification of submission to the Secretary of Agriculture.

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SUMMARY: This document notifies the public as required by the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA
Administrator has forwarded to the Secretary of the United States
Department of Agriculture (USDA) a draft regulatory document entitled
``Pesticides; Exemptions of Certain Plant-Incorporated Protectants
(PIPs) Derived from Newer Technologies; Final Rule.'' The draft
regulatory document is not available to the public until after it has
been signed and made available by EPA.

DATES: Notification effective as of May 1, 2023.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2019-0508, is available at
https://www.regulations.gov. That docket contains historical
information and this Federal Register document; it does not contain the
draft final rule.

FOR FURTHER INFORMATION CONTACT: Amanda Pierce, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. What action is EPA taking?

    FIFRA section 25(a)(2)(B) requires the EPA Administrator to provide
the Secretary of USDA with a copy of any draft final rule at least 30
days before signing it in final form for publication in the Federal
Register. The draft final rule is not available to the public until
after it has been signed by EPA. If the Secretary of USDA comments in
writing regarding the draft final rule within 15 days after receiving
it, the EPA Administrator shall include the comments of the Secretary
of USDA, if requested by the Secretary of USDA, and the EPA
Administrator's response to those comments with the final rule that
publishes in the Federal Register. If the Secretary of USDA does not
comment in writing within 15 days after receiving the draft final rule,
then the EPA Administrator may sign the final rule for publication in
the Federal Register any time after the 15-day period.

II. Do any statutory and Executive Order reviews apply to this
notification?

    No. This document is merely a notification of submission to the
Secretary of USDA. As such, none of the regulatory assessment
requirements apply to this document.

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Plant-incorporated
protectants, Reporting, and recordkeeping requirements.

    Dated: May 1, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-09542 Filed 5-8-23; 8:45 am]
BILLING CODE 6560-50-P


	U. S. ENVIRONMENTAL PROTECTION AGENCY

	WASHINGTON, DC 20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM							PC Code No. 129106

DP Barcode: D323681

Date:  September 20, 2006

SUBJECT:	IR-4 Tolerance Petition for Cymoxanil (Tanos®) Use on Grapes and Hops

TO:		Shaja Brothers, Risk Manager Reviewer

Daniel Rosenblat, Risk Manager

Registration Division (7505P)

FROM:	Dirk Young, Ph.D., Environmental Engineer

Thomas Steeger, Ph.D., Senior Scientist

Environmental Fate and Effects Division (7507P)

THROUGH:	Elizabeth Behl, Chief

Environmental Risk Branch IV/EFED (7507P)

The Environmental Fate and Effects Division (EFED) has reviewed the Inter-Region 4 (IR-4)  tolerance petition (DP Barcode D271572) for use of cymoxanil (Tanos®) on grapes (east of the Rocky Mountains) and hops to control downy mildew (Plasmopara viticola). Tanos® is a formulated endproduct containing 25% famoxadone (PC Code 113202) and 25% cymoxanil. Based on cymoxanil alone, the maximum proposed application rate for grapes is 0.25 lb a.i./acre with a maximum of 10 applications; the maximum proposed application rate for hops is 6 applications of 0.25 lbs a.i./A..  The reapplication interval is 7 days.  The maximum annual rate of cymoxanil alone on grapes is 2.5 lb a.i./acre while the maximum annual rate on hops is 1.5 lbs a.i./A.

The newly proposed application rates are higher than those evaluated in the previous Section 3 registration for the use of cymoxanil on potatoes (DP Barcode D233366) and for the initial IR-4 tolerance petition for use of cymoxanil (Curzate 60 DF) on hops (DP Barcode D271572).  Based on environmental fate and ecological effect data contained in the original Section 3 and on estimates of terrestrial and aquatic exposure generated using the newly proposed application rates, neither acute nor chronic levels of concern (LOCs) are exceeded for aquatic animals.   There is substantial uncertainty introduced into the assessment due to the lack of data on foliar dissipation rates.  If the rate is significantly lower than 35 days (default value), for example 2 days, risk estimates are below both acute and chronic risk levels of concern all non-target animals except mammals where chronic risk LOC is exceeded.  However, if the default foliar dissipation half-life (35 days) is used for terrestrial assessments, the chronic risk LOC is exceeded for both birds and mammals.

In the previous Section 3, cymoxanil was expected to pose negligible risks to terrestrial and aquatic animals on both an acute and chronic exposure basis.  Although no chronic levels of concern were exceeded for animals, the chronic reproductive toxicity endpoints (reduced number of young) in birds, fish and aquatic invertebrates were sufficient to trigger future studies to examine the endocrine disrupting potential of this compound.  Although the newly proposed application rates are higher than those previously assessed, the generally low acute toxicity of the chemical combined with the chemical’s rapid degradation, reduced risk estimates below levels of concern when less conservative estimates of the foliar dissipation half-life were considered.  Since no magnitude of residue data have been reviewed to substantiate the potentially rapid dissipation of cymoxanil from foliar surfaces, there is uncertainty regarding the potential for chronic risk.

EFED is uncertain about the ecological effects of cymoxanil when it is used in combination with famoxadone as is the case with Tanos®   In 2003, a Section 3 registration of famoxadone (DP Barcode D276071) noted that technical grade cymoxanil is less toxic than famoxadone to fish on an acute exposure basis.  Famoxadone is very highly toxic to fish and aquatic invertebrates on an acute exposure basis and the end-use product, Tanos® 50DF, appears to be at least as toxic as famoxadone to rainbow trout (Oncorhynchus mykiss).  Famoxodone is practically nontoxic to birds on both an acute oral and subacute dietary exposure basis.  End-product testing with birds indicated that cymoxanil/famoxadone combined is practically nontoxic to birds on an acute oral exposure basis; however, the end product tested did not contain the same ratio of cymoxanil/famoxadone as that of Tanos® 50DF.

EFED recommends that the label restrictions imposed for the previous registration be maintained for this tolerance petition as well.  For further details on the environmental fate and ecological effects of cymoxanil, please refer to DP Barcode D233366, a portion of which is attached.

Environmental Fate Assessment

For a more thorough review of the environmental fate of cymoxanil, the reader is referred to  the ecclogical risk assessment written in support of the Section 3 registration (DP Barcode D233366).  Cymoxanil is expected to degrade quickly in the environment.  Cymoxanil hydrolyzes rapidly under both alkaline and neutral media, but is stable to hydrolysis at pH 5.  Cymoxanil photodegrades quickly in aqueous media, and is very susceptible to aerobic and anaerobic biodegradation.

The major degradates observed in the hydrolysis and photolysis in water studies, were not observed in large amounts in the aerobic soil metabolism study.  These degradation products are expected to be more likely to occur in surface waters after runoff events.

In aerobic soil metabolism studies conducted in foreign soils, various degradates were detected and identified.  The distribution and concentration of such degradates was dependent on the soil types.  In most cases, the degradates comprised a small fraction of the applied material, or were quickly degraded further.  In metabolism studies conducted in domestic soils, with the exception of carbon dioxide, no single degradate exceeded 10% of the applied material.

The lack of persistence predicted by the laboratory studies is confirmed in the field.  The reported half-lives of cymoxanil at both an Elkton, MD test site, and at a Madera, CA test site were short and ranged between 1 to 9 days.  Additionally, no detections of cymoxanil were observed during the field dissipation studies below the 0 to 15 cm soil depth at any of the test intervals.

Even though cymoxanil was reported to be mobile in four soils tested, EFED believes that cymoxanil does not pose a threat to ground waters.  Cymoxanil is not expected to persist in soils due to the chemical’s susceptibility to microbial-mediated degradation.  The four minor degradates of these processes appear to be only weakly adsorbed to soils, and are also predicted to be short lived and of little concern to the fate assessment.  Furthermore, EFED believes that cymoxanil is not likely to persist in surface waters because it is vulnerable to both hydrolysis in alkaline and neutral media, and to aqueous photolysis.

Ecological Effects Assessment

For a more comprehensive assessment of the ecological effects of cymoxanil, the reader is referred to the ecological risk assessment written in support of the Section 3 registration (DP Barcode D233366).  Cymoxanil is practically nontoxic to birds on both an acute exposure (LD50 > 2,250 mg/kg) and subacute dietary exposure (LC50 > 5,620 mg/kg of diet) basis; chronic toxicity in birds (NOAEC = 100 mg/kg) included reductions in the number of eggs laid, number of viable embryos, number of normal hatchlings, number of 14-day survivors and reductions in hatchling weight.  Cymoxanil was only slightly toxic (LD50 = 760 mg/kg) to mammals on an acute exposure basis; chronic toxicity in mammals (NOAEC=6.5 mg/kg) included reductions in first-generation pup viability.  Cymoxanil is practically nontoxic to bees (LD50 > 25) and earthworms (LC50 = 2,208) on an acute exposure basis.  Additionally, cymoxanil is slightly toxic to freshwater and marine fish (LC50 range 29 - 91 mg/L) and invertebrates (EC50 range: 27 - 47 mg/L).  Chronic toxicity testing in freshwater (NOEC = 0.00098 mg/L) and marine fish (NOEC = 0.094 mg/L) reduced growth and survival.  Chronic toxicity testing in freshwater (NOEC = 0.067 mg/L) and marine (NOEC = 1.70 mg/L) invertebrates reduced survival, growth and reproduction (number of young produced per female).

Aquatic Exposure Assessment

Estimated environmental concentrations for surface water were derived using GENEEC 2 (Appendix A).  Peak, 1-in-10 year 21-day and 60-day average concentrations are 8.8, 1.8 and 0.63 µg/L, respectively, for aerial applications at the maximum proposed rate.

Terrestrial Exposure Assessment

Estimated environmental concentrations for terrestrial exposure were derived using TREX (Version 1.2.3).  The initial Section 3 assessment relied on a foliar dissipation half-life of 2 days based on the upper 90th percentile aerobic soil metabolism half-life; however, without magnitude of residue data with which to estimate foliar dissipation half-lives, the current OPP policy is to utilize a default half-life of 35 days.  Since cymoxanil appears to be susceptible to both biotic and abiotic (aqueous photolysis t½=1.8 days; hydrolysis at pH 7 t½=1.4 days), the use of the 35-day default value is likely highly conservative.  Therefore, estimated environmental concentrations on terrestrial forage items are calculated based both on the 35-day default foliar dissipation half-life and assuming a half-life roughly an order of magnitude lower.  Output from TREX can be found in Appendix B.

Ecological Risk Characterization

Estimation

Following the methodologies described in the initial risk assessment, risk quotients (RQs) were calculated for the proposed use of cymoxanil on grapes and hops and compared to acute and chronic risk levels of concern (LOCs).  Since cymoxanil is practically nontoxic to birds and mammals on an acute oral exposure basis and is also practically nontoxic to birds on a subacute dietary exposure basis [where median lethal doses and concentrations exceeded the maximum concentration tested], acute risk to terrestrial animals is not quantified.  At the maximum application rate for hops and grapes and using a default foliar dissipation half-life of 35 days, dietary-based RQ values exceed the chronic risk LOC for birds foraging on short grass (RQ=3.5), tall grass (RQ=1.6) and broadleaf plants/small insects (RQ=2.0) (Appendix B) at the maximum proposed application rate for grapes.  Application rates would have to be reduced to 0.07 lbs a.i./acre to get RQ values below the chronic risk LOC if 10 applications are made with a 7-day reapplication interval.  Alternatively, if the reapplication interval is extended to 35 days and the number of applications is reduced to two, then RQ values would fall below the chronic risk LOC for birds if 0.25 lbs a.i./A is used per application.

Similarly, for mammals, the default 35-day foliar dissipation half-life results in exceedances of the chronic risk LOC for animals foraging on short grass (RQ=2.7), tall grass (RQ=1.2) and broadleaf plants/small insects (RQ=1.5) (Appendix B).  To get mammalian RQ values below the chronic risk LOC, the reapplication interval would have to be extended to 32 days or the number of applications per year would have to be reduced two [as opposed to 10].  Alternatively, if the maximum application rate was reduced to 0.09 lbs a.i/acre, RQ values would fall below the chronic risk LOC.

For aquatic animals, neither acute nor chronic RQ values exceed any level of concern (Table 2) and thus the likelihood of adverse effects to aquatic animals from the proposed use of cymoxanil on hops and grapes is considered low.

  SEQ CHAPTER \h \r 1 Table 2: Risk Quotients for aquatic organisms based on toxicity values and EEC values based on the GENEEC 2 model.

Species	Acute toxicity

(ppm)	Chronic toxicity NOEC

(ppm)	EEC

Peak

(ppm)	EEC

21-day Ave.

(ppm)	EEC

60-Day Ave.

(ppm)	Acute RQ

	Chronic RQ

Bluegill

Lepomis macrochirus 	29	n/a	0.009	n/a	n/a

	<0.01	--

Waterflea

Daphnia magna	27	0.067	0.009	0.0018	n/a

	<0.01	0.20

Mysid

Mysidopsis bahia	>44.4	1.7	0.009	0.0018	n/a

	<0.01	0.00

Rainbow  trout

Oncorhynchus mykis	n/a	0.00098	n/a	n/a	0.0006	n/a	0.61

Sheepshead

Cyprinodon variegates

>47.5

0.0942

n/a

n/a

0.0006

<0.01

0.01

Daphnia

Daphnia magna	n/a	0.067	n/a	0.0018	n/a	0.03	0.03

Duckweed

Lemna gibba	>100	n/a	0.009	n/a	n/a	<0.01	--

Navicula pelliculosa	0.202	n/a	0.009	n/a	n/a	0.04	--

Risk Discussion

	The likelihood of either acute or chronic risk to aquatic animals from the proposed use of cymoxanil on hops and grapes is considered low.  Additionally, the likelihood of acute risk to birds or mammals from cymoxanil is also considered low.  However, based on a default 35-day foliar dissipation half-life for cymoxanil on avian and mammalian forage items, the chronic risk level of concern is exceeded for terrestrial animals.

μg/L), estuarine/marine fish (96-hr LC50=49 μg/L), freshwater invertebrates (48-hr EC50=11.8 μg/L) and estuarine/marine invertebrates (EC50=1.6 μg/L); famoxodone is highly toxic to aquatic plants (EC50=13 μg/L).  Toxicity testing of the formulated product itself (MRID 449463-02) failed to establish a 96-hr LC50 (LC50<44.6 μg famoxodone/L).  For more information on the ecological effects of famoxodone, see DP Barcode D276071.

The likelihood of chronic effects from cymoxanil on terrestrial mammals is uncertain primarily because of the lack of data on a foliar dissipation half-life.  However, birds appear to be more sensitive to famoxodone (NOAEC=46 mg/kg diet than cymoxanil (NOAEC=100 mg/kg diet) but mammals appear to more sensitive to cymoxanil (NOAEC 6.5 mg/kg diet) compared to famoxodone (NOAEC=40 mg/kg diet).  Given the exceedances with cymoxanil alone using a 35-day foliar dissipation value, it is likely that the formulated product will exceed the chronic risk LOC.

As stated previously, the default foliar dissipation value of 35 days is considered conservative given the limited persistence of cymoxanil in the environment.  The 2-day foliar dissipation value used in the previous assessments of cymoxanil is more consistent with the abiotic and biotic degradation half-lives observed in laboratory studies but is not supported by magnitude of residue studies.  If chronic risk quotients for terrestrial animals had been based on a 2-day foliar dissipation half-life, then RQ values would not have exceeded the chronic risk LOC for birds; however, RQ values would have exceeded the chronic risk LOC for all-sized mammals feeding on a range of forage items.

  SEQ CHAPTER \h \r 1 Federally Threatened and Endangered (Listed) Species Concerns

 tc "4.2.4.  Federally Threatened and Endangered (Listed) Species Concerns " \l 3

	Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated habitat.  Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.  To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species."

	To facilitate compliance with the requirements of the Endangered Species Act subsection (a)(2), the Environmental Protection Agency Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004).  After the Agency’s screening-level risk assessment is conducted, if any of the Agency’s listed species LOCs are exceeded for either direct or indirect effects, an analysis is conducted to determine if any listed or candidate species may co-occur in the area of the proposed pesticide use or areas downstream or downwind that could be contaminated from drift or runoff/erosion.  If determined that listed or candidate species may be present in the proposed action areas, further biological assessment is undertaken.  The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

	The federal action addressed herein is the proposed IR-4 registration of pesticide product that contains the active ingredient cymoxanil for use on grapes (east of the Rocky Mountains) and hops.

Action Area  tc "<IP_ADDRESS>.  Action Area " \l 4

	For listed species assessment purposes, the action area is considered to be the area affected directly or indirectly by the Federal action and not merely the immediate area involved in the action.  At the initial screening level, the risk assessment considers broadly described taxonomic groups and so conservatively assumes that listed species within those broad groups are collocated with the pesticide treatment area.  This means that terrestrial plants and wildlife are assumed to be located adjacent to the treated site and aquatic organisms are assumed to be located in a surface water that is the treated site.  The assessment also assumes that the listed species are located within an assumed area which has the relatively highest potential exposure to the pesticide, and that exposures are likely to decrease with distance from the treatment area.  The use characterization section of this risk assessment presents the pesticide use sites that are used to establish initial collocation of species with treatment areas.

Taxonomic Groups Potentially at Risk  tc "<IP_ADDRESS>. Taxonomic Groups Potentially at Risk " \l 4

	If the assumptions associated with the screening-level action area result in RQs that are below the listed species LOCs, a "no effect" determination conclusion is made with respect to listed species in that taxa, and no further refinement of the action area is necessary.  Furthermore, RQs below the listed species LOCs for a given taxonomic group indicate no concern for indirect effects upon listed species that depend upon the taxonomic group covered by the RQ as a resource.  However, in situations where the screening assumptions lead to RQs in excess of the listed species LOCs for a given taxonomic group, a potential for a "may affect" conclusion exists and may be associated with direct effects on listed species belonging to that taxonomic group or may extend to indirect effects upon listed species that depend upon that taxonomic group as a resource.  In such cases, additional information on the biology of listed species, the locations of these species, and the locations of use sites could be considered to determine the extent to which screening assumptions regarding an action area apply to a particular listed organism.  These subsequent refinement steps could consider how this information would impact the action area for a particular listed organism and may potentially include areas of exposure that are downwind and downstream of the pesticide use site.

	The assessment endpoints used in the screening-level risk assessment include those defined operationally as reduced survival, reproduction, and growth for both aquatic and terrestrial animal species from direct acute and direct chronic exposures.  These assessment endpoints address the standard set forth in the Endangered Species Act requiring federal agencies to ensure that any action they authorize does not reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species.  Risk estimates (i.e., RQs integrating exposure and effects) are calculated for broad-based taxa groups for the screening-level risk assessment and presented in Section 6.

	Listed Species Risk Quotients

 tc "<IP_ADDRESS>.1. Listed Species Risk Quotients " \l 5

	A description of the potential direct effects associated with exposure to cymoxanil is discussed for each of the taxonomic groups below.  Table 2 provides a summary of the direct effects for Federally-listed threatened/endangered species, including the range of RQ values and the acute dose-response slopes used in evaluating the probability of individual effects on listed species.

Table 2.  Summary of direct effects for Federally listed species from agricultural uses.

Listed Species Taxonomic Group of Concern	Direct Effects	Slopea	RQ

Freshwater Fish	Acute: mortality	31	<0.01

Freshwater Invertebrates	Acute: mortality/immobilization	4.5a	<0.01

Estuarine/Marine Fish

	<0.01

Estuarine/Marine Mollusk 	Acute mortality	4.5a	<0.01

Aquatic Plants:

 Vascular

 Non-vascular

no data

no data

—

—

—

—

Birds	Acute: mortality/sublethal	4.5a

	1.9 – 3.5

Mammals	Acute: mortality	4.5a	1.5 – 2.7

Terrestrial Plants:

 Monocots

 Dicots

Acute: no data

Acute: no data

—

—

—

—

aRaw data were not provided so the default value of 4.5 is used.

*Dose-based value.

Freshwater Fish and Amphibians

	No freshwater vertebrate acute toxicity LOCs are exceeded from the proposed use of cymoxanil on grapes and hops

		Freshwater Invertebrates

	No freshwater vertebrate acute toxicity LOCs are exceeded from the proposed use of cymoxanil on grapes and hops

	.

Estuarine/Marine Fish and Invertebrates

	No estuarine/marine vertebrate acute toxicity LOCs are exceeded from the proposed use of cymoxanil on grapes and hops

Aquatic Plants

	No aquatic plant toxicity data were submitted and no useable data were located in the open literature for antimycin; therefore, risks associated with aquatic plant exposure to antimycin are unknown.

Birds

	No acute risk LOCs are exceeded for birds; however, the chronic risk LOC is exceeded for birds when a more conservative value (35 days) is used to estimate the foliar dissipation half-life.  Since birds serve as surrogates for terrestrial-phase amphibans and reptiles, chronic risk to these taxa is also presumed.

Mammals

	No acute risk LOCs are exceeded for mammals; however, the chronic risk LOC is exceeded for mammals when a more conservative value (35 days) is used to estimate the foliar dissipation half-life.

Probit Dose Response Relationship  tc "<IP_ADDRESS>.  Probit Dose Response Relationship " \l 4

Aquatic Listed Species Probability of Effects on Individuals

  tc "<IP_ADDRESS>.1 Aquatic Listed Species Probability of Effects on Individuals " \l 5

	The probability of individual effects at estimated acute RQs above the listed species acute risk LOC was calculated (Appendix D).  The probit slopes used in this analysis were obtained from dose-response relationships used in calculating RQs.  For freshwater fish, the probit dose-response slope is 31 based on the bluegill sunfish (LC50=29 mg a.i.//L; Appendix C), the chance of an individual effect is 1 out of 1x1016.

	The probability of individual effects to the remaining aquatic and terrestrial animals based on a probit dose-response default slope of 4.5 is 1 out of 4 x 108.

Appendix E contains a list of the number of potentially affected Federally-listed endangered and/or threatened species by state based on the LOCATES database.

APPENDIX A Estimated Environmental Concentrations Using FIRST, GENEEC 2 and SCIGROW Models.

FIRST MODEL (Drinking Water Concentrations using Index Reservoir Scenario)

   RUN No.   1 FOR Cymoxanil        ON   Grapes        * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  %CROPPED INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)     AREA    (IN)

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

   .250(   .274)  10   7        .3  780.0   AERIAL(16.0)  87.0      .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

      2.00        2           1.40    1.80-  223.20     .00       1.39

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0 DEC 12, 2005

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

             11.717                       .060

GENEEC 2 (Environmental Concentrations)

AERIAL

   RUN No.   1 FOR Cymoxanil        ON   Grapes        * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  NO-SPRAY INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)   ZONE(FT)  (IN)

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

   .250(   .274)  10   7        .3  780.0   AERL_B( 13.0)    .0    .0

   FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)   RAIN/RUNOFF   (POND)     (POND-EFF)    (POND)     (POND)

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

      2.00        2           1.40    1.80-  223.20     .00       1.39

   GENERIC EECs (IN MICROGRAMS/LITER (PPB))     Version 2.0 Aug 1, 2001

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

       PEAK      MAX 4 DAY     MAX 21 DAY    MAX 60 DAY    MAX 90 DAY

       GEEC      AVG GEEC       AVG GEEC      AVG GEEC      AVG GEEC

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

        7.95        5.65          1.62           .57           .38

GROUND

   RUN No.   2 FOR Cymoxanil        ON   Grapes        * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  NO-SPRAY INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)   ZONE(FT)  (IN)

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

   .250(   .274)  10   7        .3  780.0   GRHIFI(  6.6)    .0    .0

   FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)   RAIN/RUNOFF   (POND)     (POND-EFF)    (POND)     (POND)

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

      2.00        2           1.40    1.80-  223.20     .00       1.39

   GENERIC EECs (IN MICROGRAMS/LITER (PPB))     Version 2.0 Aug 1, 2001

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

       PEAK      MAX 4 DAY     MAX 21 DAY    MAX 60 DAY    MAX 90 DAY

       GEEC      AVG GEEC       AVG GEEC      AVG GEEC      AVG GEEC

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

        7.78        5.47          1.56           .55           .37

SCIGROW (Groundwater Concentrations)

Appendix B  TREX Model Output with Foliar Dissipation Half-life of 2.0 Days.

TREX Output with Foliar Dissipation Half-life of 35 Days.

APPENDIX C  PROBIT ANALYSIS (LOG10) OF BLUEGILL SUNFISH MORTALITY AFTER 96-HR Cymoxanil EXPOSURE (441807-18 7

                                        Probit Procedure

                            Iteration History for Parameter Estimates

                 Iter    Ridge    Loglikelihood       Intercept     Log10(DOSE)

                    0        0       -34.657359               0               0

                    1        0       -15.136711    -4.011072953    2.6600722052

                    2        0       -10.372624    -6.820867501    4.5752892208

                    3        0       -8.1433154    -10.00696525    6.7784080513

                    4        0       -7.2809497    -13.26496173    9.0441355425

                    5        0       -7.0317841    -16.09609085    11.000246522

                    6        0       -6.9620761    -18.49883412    12.648536961

                    7        0       -6.9411854    -20.60399811    14.088943641

                    8        0       -6.9346346    -22.49770029    15.384040828

                    9        0       -6.9325203    -24.23342099    16.570990537

                   10        0        -6.931824    -25.84567195    17.673477962

                   11        0       -6.9315914    -27.35801204    18.707634606

                   12        0       -6.9315127    -28.78733018    19.685016375

                   13        0       -6.9314859    -30.14621494    20.614233879

                   14        0       -6.9314767    -31.44434696    21.501907687

                   15        0       -6.9314735    -32.68936205    22.353259522

                   16        0       -6.9314724     -33.8874106    23.172495189

                   17        0        -6.931472    -35.04353432    23.963062286

                   18        0       -6.9314719    -36.16192814     24.72782935

                   19        0       -6.9314718    -37.24612739    25.469213884

                   20        0       -6.9314718    -38.29914488    26.189276059

                   21        0       -6.9314718    -39.32357319    26.889788718

                   22        0       -6.9314718     -40.3216627    27.572290686

                   23        0       -6.9314718    -41.29538163    28.238127847

                   24        0       -6.9314718    -42.24646353    28.888485617

                   25        0       -6.9314718    -43.17644436    29.524414298

                   26        0       -6.9314718    -44.08669259    30.146849665

                   27        0       -6.9314718    -44.97843109    30.756627919

                   28        0       -6.9314718    -44.97843109    30.756627919

                                       Model Information

                             Data Set                        WORK.B

                             Events Variable               RESPONSE

                             Trials Variable                      N

                             Number of Observations               5

                             Number of Events                    35

                             Number of Trials                    50

                             Name of Distribution            Normal

                             Log Likelihood            -6.931471806

                             Number of Observations Read           6

                             Number of Observations Used           5

                             Number of Events                     35

                             Number of Trials                     50

PROBIT ANALYSIS (LOG10) OF BLUEGILL SUNFISH MORTALITY AFTER 96-HR Cymoxanil EXPOSURE (441807-18 8

                                        Probit Procedure

                                     Parameter Information

                                     Parameter    Effect

                                     Intercept    Intercept

                                     DOSE         DOSE

                        Last Evaluation of the Negative of the Gradient

                                      Intercept   Log10(DOSE)

                                   2.062335E-11  1.892886E-11

                          Last Evaluation of the Negative of the Hessian

                                             Intercept   Log10(DOSE)

                             Intercept     6.366197724  9.3099148058

                             Log10(DOSE)  9.3099148058  13.614800773

           Algorithm converged.

                                     Goodness-of-Fit Tests

                 Statistic                         Value       DF    Pr > ChiSq

                 Pearson Chi-Square               0.0000        3        1.0000

                 L.R.    Chi-Square               0.0000        3        1.0000

                                   Response-Covariate Profile

                                 Response Levels               2

                                 Number of Covariate Values    5

Since the chi-square is small (p > 0.1000), fiducial limits will be calculated using a t value

of  1.96.

                                  Type III Analysis of Effects

                                                       Wald

                       Effect              DF    Chi-Square    Pr > ChiSq

                       Log10(DOSE)          1        0.0000        0.9999

PROBIT ANALYSIS (LOG10) OF BLUEGILL SUNFISH MORTALITY AFTER 96-HR Cymoxanil EXPOSURE (441807-18 9

                                        Probit Procedure

                                 Analysis of Parameter Estimates

                                      Standard   95% Confidence     Chi-

              Parameter   DF Estimate    Error       Limits       Square Pr > ChiSq

              Intercept    1 -44.9784 337438.9  -661413 661323.1    0.00     0.9999

              Log10(DOSE)  1  30.7566 230743.5  -452218 452279.8    0.00     0.9999

                                   Estimated Covariance Matrix

                                             Intercept   Log10(DOSE)

                             Intercept<PHONE_NUMBER>83  -77861836687

                             Log10(DOSE)  -77861836687<PHONE_NUMBER>7

                        Probit Model in Terms of Tolerance Distribution

                                            MU         SIGMA

                                      1.462398    0.03251332

                                   Estimated Covariance Matrix

                                    for Tolerance Parameters

                                                 MU             SIGMA

                            MU             0.000166          0.000011

                            SIGMA          0.000011      59498.249046

PROBIT ANALYSIS (LOG10) OF BLUEGILL SUNFISH MORTALITY AFTER 96-HR Cymoxanil EXPOSURE (441807-1 10

                                        Probit Procedure

                                 Probit Analysis on Log10(DOSE)

                  Probability          Log10(DOSE)       95% Fiducial Limits

                         0.01              1.38676        .             .

                         0.02              1.39562        .             .

                         0.03              1.40125        .             .

                         0.04              1.40548        .             .

                         0.05              1.40892        .             .

                         0.06              1.41185        .             .

                         0.07              1.41442        .             .

                         0.08              1.41671        .             .

                         0.09              1.41881        .             .

                         0.10              1.42073        .             .

                         0.15              1.42870        .             .

                         0.20              1.43503        .             .

                         0.25              1.44047        .             .

                         0.30              1.44535        .             .

                         0.35              1.44987        .             .

                         0.40              1.45416        .             .

                         0.45              1.45831        .             .

                         0.50              1.46240        .             .

                         0.55              1.46648        .             .

                         0.60              1.47064        .             .

                         0.65              1.47493        .             .

                         0.70              1.47945        .             .

                         0.75              1.48433        .             .

                         0.80              1.48976        .             .

                         0.85              1.49610        .             .

                         0.90              1.50407        .             .

                         0.91              1.50599        .             .

                         0.92              1.50808        .             .

                         0.93              1.51038        .             .

                         0.94              1.51295        .             .

                         0.95              1.51588        .             .

                         0.96              1.51932        .             .

                         0.97              1.52355        .             .

                         0.98              1.52917        .             .

                         0.99              1.53804        .             .

PROBIT ANALYSIS (LOG10) OF BLUEGILL SUNFISH MORTALITY AFTER 96-HR Cymoxanil EXPOSURE (441807-1 11

                                        Probit Procedure

                                     Probit Analysis on DOSE

                      Probability          DOSE       95% Fiducial Limits

                             0.01      24.36468        .             .

                             0.02      24.86702        .             .

                             0.03      25.19110        .             .

                             0.04      25.43767        .             .

                             0.05      25.64002        .             .

                             0.06      25.81352        .             .

                             0.07      25.96660        .             .

                             0.08      26.10444        .             .

                             0.09      26.23044        .             .

                             0.10      26.34696        .             .

                             0.15      26.83491        .             .

                             0.20      27.22915        .             .

                             0.25      27.57199        .             .

                             0.30      27.88355        .             .

                             0.35      28.17539        .             .

                             0.40      28.45515        .             .

                             0.45      28.72846        .             .

                             0.50      29.00000        .             .

                             0.55      29.27411        .             .

                             0.60      29.55529        .             .

                             0.65      29.84874        .             .

                             0.70      30.16116        .             .

                             0.75      30.50197        .             .

                             0.80      30.88602        .             .

                             0.85      31.33978        .             .

                             0.90      31.92019        .             .

                             0.91      32.06198        .             .

                             0.92      32.21674        .             .

                             0.93      32.38776        .             .

                             0.94      32.57983        .             .

                             0.95      32.80029        .             .

                             0.96      33.06120        .             .

                             0.97      33.38480        .             .

                             0.98      33.81989        .             .

                             0.99      34.51718        .             .

APPENDIX D.  Probit Dose-Response

APPENDIX E.  List of Potentially Affected Endangered and/or Threatened Species.

	Species Counts by State for Indicated Crops

	No species were excluded.

	Minimum of 1 Acre.

	All Medium Types Reported

	grapes, hops, hops (irrigated)

	AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV,

	NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY

	Alabama

	The taxa Amphibian has 2 species co-occurring with indicated crops.

	The taxa Bird has 4 species co-occurring with indicated crops.

	The taxa Mammal has 4 species co-occurring with indicated crops.

	The taxa Reptile has 5 species co-occurring with indicated crops.

	Arizona

	The taxa Amphibian has 2 species co-occurring with indicated crops.

	The taxa Bird has 8 species co-occurring with indicated crops.

	The taxa Mammal has 9 species co-occurring with indicated crops.

	The taxa Reptile has 2 species co-occurring with indicated crops.

	Arkansas

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	California

	The taxa Amphibian has 6 species co-occurring with indicated crops.

	The taxa Bird has 15 species co-occurring with indicated crops.

	The taxa Mammal has 20 species co-occurring with indicated crops.

	The taxa Reptile has 8 species co-occurring with indicated crops.

	Colorado

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	Connecticut

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Delaware

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Florida

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 9 species co-occurring with indicated crops.

	The taxa Mammal has 7 species co-occurring with indicated crops.

	The taxa Reptile has 10 species co-occurring with indicated crops.

	Georgia

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 5 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	The taxa Reptile has 2 species co-occurring with indicated crops.

	Hawaii

	The taxa Bird has 25 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 2 species co-occurring with indicated crops.

	Idaho

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 4 species co-occurring with indicated crops.

	Illinois

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	Indiana

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Iowa

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Kansas

	The taxa Bird has 4 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	Kentucky

	The taxa Bird has 7 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	Louisiana

	The taxa Bird has 5 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 7 species co-occurring with indicated crops.

	Maine

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Maryland

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Massachusetts

	The taxa Bird has 4 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 2 species co-occurring with indicated crops.

	Michigan

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Minnesota

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	Mississippi

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 6 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	The taxa Reptile has 7 species co-occurring with indicated crops.

	Missouri

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	Montana

	The taxa Bird has 1 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	Nebraska

	The taxa Bird has 4 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Nevada

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	New Hampshire

	The taxa Bird has 1 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	New Jersey

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	New Mexico

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 7 species co-occurring with indicated crops.

	The taxa Mammal has 5 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	New York

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	North Carolina

	The taxa Bird has 5 species co-occurring with indicated crops.

	The taxa Mammal has 4 species co-occurring with indicated crops.

	The taxa Reptile has 5 species co-occurring with indicated crops.

	North Dakota

	The taxa Bird has 1 species co-occurring with indicated crops.

	Ohio

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	The taxa Reptile has 2 species co-occurring with indicated crops.

	Oklahoma

	The taxa Bird has 7 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	Oregon

	The taxa Bird has 5 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Pennsylvania

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Rhode Island

	The taxa Bird has 1 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	South Carolina

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 5 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	The taxa Reptile has 5 species co-occurring with indicated crops.

	South Dakota

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Tennessee

	The taxa Bird has 4 species co-occurring with indicated crops.

	The taxa Mammal has 3 species co-occurring with indicated crops.

	Texas

	The taxa Amphibian has 4 species co-occurring with indicated crops.

	The taxa Bird has 13 species co-occurring with indicated crops.

	The taxa Mammal has 5 species co-occurring with indicated crops.

	The taxa Reptile has 6 species co-occurring with indicated crops.

	Utah

	The taxa Bird has 3 species co-occurring with indicated crops.

	The taxa Mammal has 2 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Vermont

	The taxa Bird has 1 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

	Virginia

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 2 species co-occurring with indicated crops.

	The taxa Mammal has 5 species co-occurring with indicated crops.

	The taxa Reptile has 1 species co-occurring with indicated crops.

	Washington

	The taxa Bird has 5 species co-occurring with indicated crops.

	The taxa Mammal has 4 species co-occurring with indicated crops.

	West Virginia

	The taxa Amphibian has 1 species co-occurring with indicated crops.

	The taxa Bird has 1 species co-occurring with indicated crops.

	The taxa Mammal has 4 species co-occurring with indicated crops.

	Wisconsin

	The taxa Bird has 4 species co-occurring with indicated crops.

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ꐓ[ᘀThe taxa Mammal has 2 species co-occurring with indicated crops.

	Wyoming

	The taxa Bird has 1 species co-occurring with indicated crops.

	The taxa Mammal has 1 species co-occurring with indicated crops.

 50 C.F.R. § 402.02

 PAGE  6