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. USE AND USAGE ................... ........ ....................................................................................... 4 

III. SCIENTIFIC ASSESSMENTS ............................................................................................... 5 

A. Human Health ......................................................................................................................... 5 

B. Ecological ................................................................................................................................ 5 

1. RiskConclusions ..................................................................................................................... 5 

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

Mammals and Birds ................................ ...................................................................................... 5 

Plants ............................................................................................................................................. 6 

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

Fish and Invertebrates ................................ ................................................................................... 6 

Plants ............................................................................................................................................. 6 

2. Ecological Incidents ..... .. ............ ................ .................... ....... ....................... 6 

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

D. Endocrine Disrupter Screening Program ....................................................................... .......... ? 

IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION ..... .... ................................ 8 

V. NEXT STEPS AND TIMELINE .................................................................................. ......... 1 0 

Appendix A: Summary of Actions Taken for Debacarb .............................................................. 11 

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. 

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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 pursuant to 40 CFR sections 155.56 and 155.58. A registration 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 it 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. All 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 unreasonable adverse effects. Changes in science, public 

policy, and pesticide use practices will occur over time. Through the registration review 

program, the Agency periodically re-evaluates 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/oppsrrd1/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 use 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 pesticides 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 significant 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, accessed 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. 

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• May 18, 2009 -Final Work Plan (FWP) for debacarb was issued -- no public comments 

were received during the 60-day 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 subsequently sought waivers for each of the GDCI data 

requirements, maintaining that its sales were not sufficient to justify 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 registrant also 

acknowledged that in the absence of new data, it understood that the Agency 

would 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 (CBD), stating that the EPA should move quickly 

to assemble the needed spatial data to make an informed "no effect" or "may affect" finding 

for each listed species 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 National Marine Fisheries Services (the Services) to 

develop a process for making risk findings and consultations on listed species. 

This process is described in detail below "Endangered Species Assessment." 

• March 2015- The Agency is now publishing the Debacarb Proposed Interim 

Registration Review Decision, in docket number EPA-HQ-OPP-2008-0802 for a 60-day 

public comment period. 

II. USE AND USAGE 

Debacarb is a member of the benzimidazole 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. There are 

three end-use product registrations; in one, debacarb is co-formulated with carbendazim. In two 

others, debacarb is co-formulated with carbendazim and imidacloprid or carbendazim and 

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abamectin. 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, 

mammals, and insect pollinators 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 detailed discussion of the ecological assessment for debacarb, see 

Registration Review: Draft Ecological Risk Assessment and Endangered Species Effects 

Determination for Debacarb dated August 27,2014 available in the public docket EPA-OPP2008-0802, which can be accessed at http://www.regulations.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 available to evaluate effects to listed aquatic 

organisms and terrestrial 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 

determinations for all Federally-listed species within those taxa. 

Risk Conclusions 

Terrestrial Assessment 

Mammals and Birds 

There are limited hazard data for use in conducting a quantitative risk assessment for 

debacarb. However, 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 

5 
debacarb is not expected to result in risks of concern to birds (and the terrestrial-phase 

amphibians and reptiles for which birds are a surrogate) and mammals. 

There are no submitted toxicity data for effects to terrestrial 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 exposure to aquatic organisms from residues 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 significant route of exposure at the time the 

Problem Formulation was completed. Although the Agency did require the submission of certain 

environmental fate data and aquatic toxicity studies for 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 organisms. 

What we know about the scope of use and the nature of debacarb informs the Agency's 

assessment. A limited number of trees are treated with debacarb each 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 bodies of water, whether through leaves falling directly into the water, or through run-off 

that could carry residues from fallen leaves into the water. We are uncertain as to what 

proportion of the injected debacarb residues 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 the plant, at least some of debacarb residues would have to reside there rather 

than in foliage. 

1. Ecological Incidents 

Reviews of the Ecological Incident Information System (EllS, version 2. 1 ), the A vi an 

Incident Monitoring System (AIMS) 1

, and the Incident Data System (IDS) were conducted on 

June 19,20 14. There were no reported ecological incidents associated with debacarb; however, 

as with other chemicals, given the limited reporting of incidents, the absence of incident reports 

cannot be construed as the absence of incidents. 

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 Habitat 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. 

1

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

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

Agen~y will evaluate risks to all federally listed threatened and endangered (listed) 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 development of its final registration review decision for debacarb. 

In November 2013, EPA, the U.S. Fish and Wildlife Service, National Marine Fisheries 

Services (the Services), and the U.S. Department of Agriculture released a white paper 

containing a summary of their joint Interim Approaches for assessing risks to listed species from 

pesticides. These Interim Approaches were developed jointly by the agencies in response to the 

NAS recommendations, and reflect a common approach to risk assessment shared by the 

agencies as a way of addressing scientific differences between the EPA and the Services. Details 

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 

Recommendations 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 this lnterim Registration 

Review Decision for debacarb does not contain a complete ESA analysis, including effects 

determinations for specific listed species or designated critical habitat. While the agencies 

continue to develop a common method for ESA analysis, the preliminary risk assessment for the 

registration 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 FIFRA and FFDCA, EPA reviews numerous studies to assess potential 

adverse outcomes from exposure to chemicals. Collectively, 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, sexual 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 

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reproductive loss, 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 most recent registration decision for debacarb, EPA 

reviewed these data and selected the most sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database. However, as required by FFDCA section 408(p ), 

debacarb is subject to the endocrine screening part of the Endocrine Disrupter Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including 

pesticide active and other ingredients) may have an effect in humans or wildlife similar to an 

effect produced by a "naturally occurring estrogen, or other such endocrine effects as the 

Administrator may designate." The EDSP employs a two-tiered approach to making the 

statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify 

the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or 

T) hormonal systems. Chemicals that go through Tier 1 screening 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 EPA will determine which, if any, of the Tier 2 tests are necessary based on the available 

data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the 

substance, and establish a dose-response relationship between the dose and theE, A, or T effect. 

Under FFDCA section 408(p ), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of 

chemicals identified for EDSP screening was published on June 14, 20134 and includes some 

pesticides scheduled for Registration Review and chemicals found in water. Neither of these 

lists should be construed as a list of known or likely endocrine disrupters. Debacarb does not 

appear on either list. For further information on the status of the EDSP, the policies and 

procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, 

please visit our website. 5 

In this proposed interim decision, EPA is making no human health or environmental 

safety findings associated with the EDSP screening of debacarb. Before completing this 

Registration Review, the Agency will make an EDSP FFDCA section 408(p) determination. 

IV. PROPOSED INTERIM REGISTRATION REVIEW DECISION 

A. Risk Mitigation and Regulatory Rationale 

As discussed above, there are significant uncertainties in the assessment of risks posed by 

the use of debacarb for aquatic organisms and terrestrial invertebrates (including pollinators). 

The Agency believes there are simple modifications to the labeling of debacarb products that can 

reduce both the uncertainty and the risks. 

4 See http://www.regulations.gov/#!documentDetaii:D=EPA-HO-OPPT-2009-0477-0074 for the final second list of 

chemicals. 

5 http://www.epa.gov/endo/ 

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Aquatic Organisms 

To address concerns that leaf drop can introduce debacarb residues into aquatic resources 

at concentrations that could pose excess risk to aquatic organisms, the Agency is proposing that 

label language be implemented to limit the use of debacarb products to trees that are at least 20 

feet away from waterbodies (lakes, ponds, streams, etc.) 

Terrestrial Invertebrates 

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 labeling that restricts application to the time after bloom only. 

B. Tolerance Amendments 

Debacarb is not used on food or feed crops and no tolerances have been established. 

C. Endangered Species 

As noted above, this Proposed Interim Registration Review Decision for debacarb does 

not contain a complete ESA analysis. However, the Agency has completed a partial ESA 

analysis and is making a no effect determination under the ESA for direct and indirect adverse 

effects to listed birds, reptiles, terrestrial-phase amphibians, and mammals and their designated 

critical habitat. See the Draft Ecological Risk Assessment and Endangered Species Effects 

Determination for Debacarb for additional details 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 decision does not consider the 

EDSP components of this case, and the Agency is able to consider the ESA component for listed 

birds, reptiles, terrestrial-phase amphibians, and mammals only. The Agency has made the 

following Proposed Interim Registration Review Decision for debacarb at this time: (1) no 

additional data are required at this time, and (2) changes to the affected registrations and their 

labeling are needed. 

In this Proposed Interim Registration Review Decision, EPA is making no human health 

or environmental safety findings associated with the EDSP screening of debacarb, nor is it 

making a complete endangered species finding. The Agency's final registration review decision 

for Debacarb will depend upon both the result of an ESA Section 7 consultation with the 

Services, and an EDSP FFDCA section 408(p) determination. 

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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 registration 

review docket (EPA-HQ-OPP-2008-0802) for public comment for 60 days. A Federal Register 

Notice will announce the availability 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 Decision. A summary of 

the mitigation measures discussed in this interim decision are described in Appendix A. 

Appendix B captures the proposed label changes for debacarb products. 

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Appendix A: Summary of Actions to be Taken for Debacarb 

Registration Review Case#: 4031 

PC Code: 115001 

Chemical Type: Fungicide 

Chemical Family: Benzimidazole carbamate 

!Mode of Inhibition of formation of spindle fivers at nuclear division, resulting in inhibition of DNA replication 

Affected Source of Route of Exposure Duration of Exposure Risk(s) of Concern Action( s) to be 

Population( s) Exposure Taken 

./ Fish ./ Residues in ./ Habitat ./ Acute ./ ./ Use ./ Aquatic water ./ SubeChronic restrictions 

Invertebrates ./ Chronic 

,./ Terrestrial ./ Residues in ./ Dietary, contact ./ Acute ./ ./ Limit timing 

invertebrates pollen and ./ Sub-Chronic of application 

including other plant ./ Chronic 

pollinators parts 

Appendix B: Summary of Labeling Changes for Debacarb 

Description Labeling Language for Debacarb End-Use Products 

End Use Products 

Use restriction 

"Do not apply this product to trees within 20 feet of a waterbody (lakes, ponds, 

Direct

under 

streams, etc.)." headin

Timing of application Direct

"Use for tree micro-injection as a post-bloom application only." under 

headin