Docket Number EPA-HQ-OPP

- 2008-0802 www.regulations.gov



# 2-EEEBC (Debacarb) Proposed Interim Registration Review Decision Case Number 4031

March 2015

Approved by: 

# 6b \ )(;LLc\- 

# e**V:tU-l( U...'\** **AA ~**  Richard P. Keigwin , Jr. Director Pesticide Re-evaluation Division

Date: 

## -3 · - lh**-- ~61<)** 

### Table of Contents Contents I. INTRODUCTION

................... . .. .. ... . ... . .................. .. .. . ... .. ....................................................... 3 II. U SE AN D USAGE

.............. . .. .. .. .. .. .. .......................... . .... . ....................................................... 4 III

. SCIENT IFIC ASSESSMENTS

.. . ..................... .. ........................ ................................ ............. 5 A. Human Health ......................................................................................................................... 5 B. Ecological

..................... .. ...... ............... ..................... ..... ... ....... ................................. ............... 5 1

. RiskConclu sions

.................. . ... . .............................................................................................. 5 Terrestrial Assessmen/

............... . .. .. .. . ............. ... .......................................... .................. ............... 5 Mammals and Bird s ...................... . .. .. ... .. .. . ............... . .. .. ... . ... . ......................................... .. ............ 5 Plants

..................................... . ... . ... . ... . ............................... . ........................................................... 6 Aquatic Assessment

.................. ..... . ...... : ...... .. ...... . ...... .. ........ . ............ .............................. ............ .. 

### 6 Fis h and Invertebrate s .
.. ........... .............. .. .. .................. ...... .............................................. ...... . ...... 6 Plants ............................................................................................................................................. 6 2. Ecological Incid ents

.. . .. .. ............ ................ .................... . . ..... .......... .. ........... 6 C. Endangered Species Assessment.

.............................. . . ... . . ..................... . .. . . .. . . ... 6 D. Endocrine Disrupter Screening Program
.............................................................. . .. .. .. .. .. . ....... ? IV. PROPOSED INTERIM REGIS T RATION REVIEW DECISION

. .. .. .. .. .. ..... .. ....... . ........ .. ... .. 8 V. NEXT STEPS AND T I ME LINE

....... ......................... .......... ................................... ..... ....... .. 1 0 Appendix A: Summary of Actions Taken for Deba c arb
.............................................................. 1 1 Appendix B: Debacarb Label Table

.. . ..................................... . .............. ........................... .......... .. 11

All relevant documents supporting this proposed decision may be found in the debacarb docket at EP A-HQ-OPP-2008-0802.

2

### I. INTRODUCTION

This document is the Environmental Protection Agency's (EPA or the Agency) Proposed Interim Registration Review Decision for 2EEEBC ( debacarb) (case 4031 , PC 115001) and is being issued pur suant to 40 CFR sec tions 155.56 and 155.58. A registrati on review decision is the Agency's determination whether a pesticide meets , or does not meet , the standard for registration in the Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA). The Agency may issue , when i t determines it to be appropriate , an Interim Registration Review Decision before completing a registration review. Among other things, the Interim Registration Review Decision may: 1) require new risk mitigation measures; 2) impose interim risk mitigation measures; 3) identify data or information required to complete the review; and 4) include schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further information on debacarb, additional documents can be found in EPA's public docket (EPA-HQ-OPP-2008-0802) at www.regulations.gov.
FIFRA , as amended by the Food Quality Protection Act (FQPA) of 1996 , mandated the continuous review of existing pesticides. A ll pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonab l e adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluat es pesticides to make sure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided as www.epa.gov/ oppsrrd 1 / registration review /

. In 2006 , the Agency implemented the registration review program pursuant to FIFRA section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.
Debacarb is a fungicide registered for u se to prevent and treat certain fungal diseases in ornamental trees. It was first registered in 1993 and is currently registered for use as a tree injection. Debacarb is registered for commercial and residential use. Debacarb was first registered in 1993 , and therefore was not subject to reregistration. Only pe s ticides registered after November 1984 were subject to reregistration.
Pursuant to 40 CFR section 155.50 , EPA formally initiated registration review for debacarb (case 4031 ). The following list highlights s ignific ant events that have occurred during the registration review of debacarb and cites documents that can be found in EPA's public docket, EPA-HQ -OPP-2008-0802, acce ssed at www.regulations.gov:

• December 17, 2008

- Publication of debacarb Preliminary Work Plan ( PWP) for a 60-day public comment period. The PWP was accompanied by the Scoping Document and Problem Formulation.

3• May 18, 2009 -Final Work Plan (FWP) for debacarb was issued

-- no public comments were received during the 60 -da y comment period for the debacarb PWP; thus, the FWP did not modify the PWP.

o The FWP noted that certain environmental fate and ecotoxicology data were anticipated to be needed for the debacarb registration review to facilitate the risk assessment and support a proposed registration review decision. o The Agency announced that a new human health risk assessment would not be needed for debacarb because of its limited usage and minimal opportunities for exposure.

• August 5, 2013

- Generic Data Call-In (GDCI) for debacarb issued.

o The registrant subsequentl y sought waivers for each of the GDCI data requirements , maintaining that its sales were not s ufficient to justi fy the development of new data. The registrant ultimately provided information to show that the use of debacarb was very limited and proposed that the limited usage would result in very little environmental exposure. The re gistrant also acknowledged that in the absence of new data, it understood that the Agency wou ld make conservative assumptions. The Agency agreed to proceed with this caveat.

• September 24, 2014- The Agency published the Registration Review : Draft Ecological Risk Assessment and Endangered Species Effects Determination/or Debacarb for a 60- day public comment period. One comment was received during the comment period , from the Center for Biological Diversity (C BD ), stating that the E PA s hould move quickly to assemble the needed spatial data to make an informed " no effect" or " may affect" finding for each listed s pecies that will likely overlap with the use of debacarb or come into contact with its environmental degradates. o In response to the comment from CBD, the Agency is working with the U.S

. Fish and Wildlife Service and the Nationa l Marine Fisheries Services (the Services) to develop a process for making risk findings and consultations on li sted species. This process is described in detail below " Endangered Species Assessment."

• March 2015

- The Agency is now publishing the Debacarb Proposed Int e rim Registration Review Decision , in docket number EPA-HQ-OPP-2008-0802 for a 60-da y public comment period. 

### II. USE AND USAGE
Debacarb is a member of th e benzimidazo le class of fungicides. Products containing debacarb are registered for use to prevent and treat certain fungal diseases in ornamental trees. The only currently registered use of debacarb is as a tree injection to ornamental trees. Ther e are three end -u se product regist rations; in one , debacarb is co-formulated with carbendazim. In two others, debacarb is co
- formula ted with carbendazim and imidacloprid or carbendazim and

4abamectin. Debacarb is a carbamate pesticide , but not anN-methyl carbamate (NMC), and is not part of the NMC cumulative assessment. 

### III. SCIENTIFIC ASSESSMENTS
A. Human Health
The Agency announced that a human health risk assessment would not be needed for debacarb because of its limited usage and minimal opportunities for exposure. Debacarb is not used on food plants and no tolerances have been established for its use. B. Ecological
A summary of the Agency's ecological risk assessment is presented below.
Based on the currently registered use pattern , there is a potential for exposures to birds , mamma l s, and insect po ll inators that come into contact with or feed on translocated residues of debacarb in fruit, seeds , foliage, and pollen , and to aquatic organisms exposed to residues from leaf drop and run-off. For a deta il ed discussion of the ecologica l assessment for debacarb, see Registration Review: Draft Ecological Risk Asse s sment and Endangered Species Effects Determinationfor Debacarb dated Augu st 2 7 ,2014 availab le in the p u blic docket EPA-OPP2008-0802, w h ich can be accessed at http://www.regu l atio n s.gov/.
The Agency also completed a screening-level endangered and threatened (listed) species assessment for debacarb for birds , reptiles, terrestrial-phase amphibians , mammals , and terrestrial plants. Because sufficient data were not avai l able to evaluate effects to listed aquatic o rganisms and terrestria l invertebrates, risks of concern cannot be precluded for this group. For the remainder of the taxa , the Agency made No Effects and No Habitat Modification determinat ions for a ll Federally

- listed species within those taxa. Ri s k Conclusions
Terrestrial Assessment
Mammals and Birds
There are limited hazard data for use in conducting a quantitative risk assessment for debacarb. H owever, based on a conservative risk analysis performed using a composite dataset of debacarb and carbendazim (a carbamate fungicide with a similar structure), the use of

5debacarb is not expected to result in ri sks of concern to birds (and the terrestrial-phase amphibians and reptiles for which birds are a surrogat e) and mammals.

There are n o submitted toxicity data for effects to terre s trial plants. However, based on the use pattern, exposure to non-target plants is not considered likely and will not be assessed. Aquatic Assessment
The potential for expos ure to aquatic organisms from res idues of debacarb in leaves , fruits , and seeds of treated trees that fall into adjacent water bodies was previously acknowledged, but was not considered to be a s ignificant route of exposure at the time the Problem Formulation was completed. Although the Agency did require the submiss ion of certain environmental fate data and aquatic toxicity studies fo r debacarb , as noted previously, the Agency agreed to waive those data requirements and use conservative parameters to assess the impacts of debacarb use on aquatic organism s. What we know about the s cope of use and the nature of debacarb informs the Agency's assessment. A limited numb er of trees are treated with debaca rb eac h year. Despite these small numbers , if many trees were treated in the same location at around the same time of year, and in close proximity to waterbodies, there is a potential for shed leaves to introduce debacarb into these bodi es of water , wheth er through leaves falling directl y into the water , or through run-off that could carry residues from fallen leaves into the water. W e are uncertain as to what proportion of the injected debacarb residue s would migrate to the foliage or other plant parts. Because the target pests for debacarb include various types of cankers in the bark or other woody or stem portions of th e plant, at least some of debacarb residue s would have to res ide there rather than in foliage.


### 1. Ecological Incidents
Reviews of the Eco lo g i ca l Incident Information System (E ll S, version 2. 1 ), the A vi an Incident Monitoring System (A IMS ) 1

, and the Incident Data System ( IDS ) were conducted on June 19 ,20 14. There were no reported ecological incidents assoc iat ed with debacarb ; however , as with other chemica l s, give n the limited reporting of incidents, the absence of incident reports cannot be construed as the absence of inc idents.


### C. Endangered Species Assessment
Since direct adverse effects are not expected for birds , reptiles , terrestrial-phase amphibians, and mammals , the EPA makes a No Effects determination for all Federally-listed species within these groups and a No Habi tat Modification determination for all designated critical habitats associated with these species for the currently registered uses of debacarb. Effects and habitat modification determinations cannot be made for listed aquatic organisms and terrestrial invertebrates at this time.

1http: //www.abcbirds.org/abcprograms/ policy /toxins/ a im s/ aims / login.cfm?CFI D = 11304823 I &CFTOKEN=924 3482



### 6Consistent with EPA's responsibility under the Endangered Species Act (ESA), the

**Agen~y** will evaluate risks to all federally listed threatened and endangered ( li sted) species from registered uses of pesticides in accordance with the Joint Interim Approaches developed to implement the recommendations of the April 2013 National Academy of Sciences (N AS) report , Assessing Risks to Endangered and Threatened Species from Pesticides. The NAS report2 outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the ESA and FIFRA. EPA will address concerns specific to debacarb in connection with the de velopment of its final registration re view decision for debacarb.
In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries Services (the Services), and the U.S. Departm ent of Agriculture released a white paper containing a summary of their joint Interim Approaches for assessing ri sks to listed species from pesticides. These Int er im Approaches were developed jointly by the agencies in response to the NAS recommendations, and reflect a common approach to risk assessment s hared by the agencies as a way of addressing scientific differences between the EPA and the Services. Detail s of the joint Interim Approaches are contained in the November 1 , 2013 white paper , Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendation s ofthe National Academy of Sciences April2013 Report. 3
Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat , the ecological risk assessment supporting thi s lnterim Registration Review Decision for debacarb does not contain a complete ESA analy sis, including effects determinations for specific listed species or d esignated critical habitat. While the agencies continue to develop a common method for ESA analysis, the preliminary risk assessm ent for the registrati on review of debacarb describes the level of ESA analysis completed for this particular registration review case. This assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists, once the scientific methods being developed by the agencies have been fully vetted. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for listed species and their designated critical habitats, these methods will be applied to subsequent analyses of debacarb as part of completing this registration review.
D. Endocrine Disruptor Screening Program
As required by F I FRA and FFDCA , EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Co llectively , these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology , organ weights, estrus cyclicity , sexua l maturation , fertility, pregnancy rates,

2 http : //www.nap.edu/catalog/18344/ assessing-risks-to-endangered

- and

- threatened-species-from-pesticides

1 http: //www.epa.gov/espp/20 13 / nas.html

7reproductive los s, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth , developmental and reproductive effects in different taxonomic groups. As part of its mo st rece nt registration decision for debacarb , EPA reviewe d these data and se lected the mo st se n siti ve endpo ints for relevant risk assess men t scenarios from t h e existing hazard database. However , as required by FFDCA sect ion 408(p ), debacarb is subject to the endocrine sc reening part of the Endocrin e D i srupter Screeni n g Program (ED SP).
EPA has developed the EDSP to determine w hether certain substances (including pesticide active and ot her ingredients) may have an effect in human s or wildlife similar to an effect produced by a "nat urally occurring estrogen, or other s uch endocrine effects as the Administr ator may designate." The E DSP employs a two-tiered app roach to making the statutorily required determina t io n s
. Tier 1 consists of a battery of 1 1 sc reening assays to ident ify the potential of a chem i ca l sub stance to inte ract with th e est rogen , andro ge n , or thyroi d ( E, A, or T) hormonal systems. C h e micals that go through Tier 1 sc reening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where E PA wi ll determine which, if any, of th e Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effect s caused by the substance, and establish a d ose -response rel ations hip between the do se and theE, A , or T effect.
Under FFDCA section 408(p ), the Agency must screen all pesticid e chemicals. Between October 2 009 and February 2010, EPA iss u ed test orde r s/data call

- in s for the first group of67 c hemicals, which contains 58 pesticide activ e in g re dients and 9 inert ingredient s. A second li st of c hemicals identifi ed for EDSP screening was published on June 14 , 2013 4 and includes some pesticides scheduled for Reg i st ration Revi ew and chemicals found in water. Ne ither of these li sts sho uld be construed as a list of known or likely endocr ine d i srupters. Debacarb does not appear on either li st. For furthe r informati on on the status of the E D SP, the policies and pro cedures , the li sts of chemicals , futur e l ists, the test guidelines and the T ier 1 screening batt ery, p l ease vis i t our website. 5

In this prop osed interim decision , EPA is making no human hea l th or env ironmental safety findings assoc i ated with th e EDSP screening of debacarb. Before comp l etin g this Registration Re view, the Agency will make an EDSP FF DC A secti on 408(p ) d etermination. 

### IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION
A. Risk Mitigation and Regulatory Rationale
As dis cussed above, there are significant uncertainties in t h e assessment of risks pos e d by the use of debacarb for aquatic organisms and terrestrial inv ert e brate s (incl udin g po llinators). The Agency b e li eves there are simple modification s to the label in g of debacarb products that can reduce both the uncertainty and the risks.

4 See http: //www.regulat ions.gov/# ! documentDetaii:D = EPA-HO-OPPT-2009-0477

- 0074 for the final second li st of chemicals. 5 http: //www.epa.gov / endo/

8Aquatic Organis m s
To address concerns that leaf drop can introduce debacarb residues into aquatic resourc es at concentrations that could pose excess risk to aquatic organisms, the Agency is proposing that label lan guage be implemented to limit the us e of debacarb products to trees that are at le ast 20 feet away from waterbodies (lakes, ponds , streams , etc.)
Terrestrial Inverteb rates
To address concerns that terrestrial insect pollinators could be exposed to harmful concentrations of debacarb in pollen and/or nectar , the Agency is proposing to prohibit the use of debacarb on trees until after bloom. One debacarb product, co-formulated with carbendazim and abamectin, already bears l abeling that restricts application to the time after bloom only.
B. Tolerance Amendments
Debacarb is not u sed on food or feed crop s and no tolerances have been established. C. Endangered Species
As noted above , this Proposed Interim R eg istration Review Decision for debacarb does not contain a comp lete ESA anal ys i s. However , th e Agency has compl e t e d a part i a l ESA anal ysis and is making a no effect determination under the ESA for direct and indirect advers e effects to li sted birds , reptiles , terrestrial

- phase amphibians, and mammals and their designated critica l habitat. See the Draft Ecological Ris k Assessment and Endangered Spec ies Effects Det e rmination for D ebac arb for additional detail s on this determination.
D. Proposed Interim Registration Review Decision
In accordance with 40 CFR Sections 155.56 and 155.58 , the Agency is issuing this Proposed Interim Registration Review Decision. This proposed deci s ion does not consider the EDSP components of this case , and the Agency i s able to consider the ESA component for l ist e d birds , reptiles , terres tria l-phase amphibians , and mammals only. The Agency has made the following Proposed Inte rim Registration Review D ec ision for debacarb at thi s time: (1) no add iti onal data are required at this time , and (2) changes to the affected r egistrations and their labeling are needed.
In this Propos ed Interim Registration R ev i ew Decision, EPA is making no human health or environmental safety findings associated with t he EDSP screening of debacarb , nor is it making a complete endangered species finding. The Agency's fina l regi stration review decision for Debaca r b will d epend upon both the result of an ESA Section 7 consultation with the Services, and an EDSP FFDCA section 408(p) determination.



### 9

### V. NEXT STEPS AND TIMELINE
A. Interim Registration Review Decision
ln accordance with 40 CFR Sections 155.56 and 155.58 , the Agency is issuing this Proposed Interim Registration Review Decision, and placing it in the debacarb registrat ion review docket (EPA-HQ-OPP-2008-0802) for public comment for 60 days. A Federal Register Notice will announce the avai lability of this Proposed Interim Registration Review Decision for debacarb and initiate a 60-day comment period. If there are no significant comments or additional information submitted to the docket during the comment period that leads the Agency to change its decision, EPA will issue 

### an Interim Registration Review Decision for debacarb (case4031).
B. Implementation of Mitigation Measures
Once the Interim Registration Review Decision is issued in final form , registrants are to submit amended labels to the Agency that include the label changes summarized in Appendix B , within 60 days after the issuance of the Interim Registration Review Deci sion. A summary of the mitigation measures discussed in t hi s interim decision are described in Appendix A. Appendix B captures the proposed label changes for debacarb products.

10AppendixA:SummaryofActionstobeTakenforDebacarbRegistrationReviewCase#:4031PCCode:115001ChemicalType:FungicideChemicalFamily:Benzimidazolecarbamate!ModeofInhibitionofformationofspindlefiversatnucleardivision,resultingininhibitionofDNAreplicationAffectedSourceofRouteofExposureDurationofExposureRisk(s)ofConcernAction(s)tobeCqmmentPopulation(s)ExposureTaken./Fish./Residuesin./Habitat./Acute././UseProhibitapplicationtoI./Aquaticwater./SubeChronicrestrictionsreesincloseproximityInvertebrates./Chronicowaterbodies,./Terrestrial./Residuesin./Dietary,contact./Acute././LimittimingProhibitapplicationinvertebratespollenand./Sub-Chronicofapplicationuntilafterbloomincludingotherplant./ChronicpollinatorspartsAppendixB:SummaryofLabelingChangesforDebacarbDescriptionLabelingLanguageforDebacarbEnd-UseProductsPlacementonLabelEndUseProductsUserestriction"Donotapplythisproducttotreeswithin20feetofawaterbody(lakes,ponds,DirectionsforUseunderauserestrictionsstreams,etc.)."headingTimingofapplicationDirectionsforUse"Usefortreemicro-injectionasapost-bloomapplicationonly."underauserestrictionsheading