### Docket Numbers : Ferbam EPA-HQ-OPP-2015-0567 Thiram EPA-HQ-OPP-20 15-0433 www.regulations.gov



# Ferbam and Thiram Final Work Plan Registration Review Ferbam Case Number 8000 Thiram Case Number 0122

March 2016

Approved by:

# Yu-~aran Director Pesticide Re-evaluation Division

Date: 

# 0}tSltS

### INTRODUCTION This is the Environmental Protection Agency ' s (EPA or the Agency) Final Work Plan (FWP) for the registration review of ferbam and thiram. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the ferbam (EPAHQ-OPP-20 15-0567) and thiram registration review dockets (EPA-HQ-OPP-20 15-0433). Ferbam and thiram are dimethyldithiocarbamate fungicides

. EPA will assess ferbam and thiram together during registration review , because ferbam rapidly degrades to the more persistent thiram

. Ferbam is primarily registered for use on grapefruits and oranges in Florida to control scab disease. It is also used to control anthracnose disease on mangoes in Florida (as a special local need registration). Other agricultural use sites for ferbam include: apples , citrus , cranberries, pears, peaches, and nectarines. There are no non-agricultural use sites for ferbam

. Thiram is registered for use on apples , strawberries , peaches , and nectarines. A tolerance without US registration is established for avocado , and banana/plantain use . It is also registered as a seed treatment (non-food use). Thiram is labeled for use on non-bearing trees, shrubs , nursery stock, and ornamentals as an animal repellent to protect crops from damage by rabbits , rodents , and deer. Thiram is also registered for non-agricultural use on golf course turf tees and greens. The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide , and Rodenticide Act (FIFRA), and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration

. Changes in science , public policy , and pesticide use practices occur over time. The registration review program is intended to make sure that , as the ability to assess risk evolves and as policies and practices change , all registered pesticides continue to meet the statutory standard. The public phase of regi stration review begins when the initial docket is opened for each case. Information on this program is provided on the Agency ' s website. 1
The FWP begins with any updates since the PWP was issued. Next is a summary of substanti ve comments received during the public comment period for the PWP concerning anticipated data needs , expected risk assessments , or the estimated timeline identified in the PWP , and a summary of the Agency ' s responses to those comments
. This section is followed by registration re view planned data needs, risk assessments expected to be conducted , and the projected registration review timelines for ferbam and thiram

. Lastly , there is a discussion of next steps
. 

### UPDATES SINCE THE PWP WAS ISSUE D The PWP for ferbam and thiram indicated that thiram is registered for use on avocado in the U. S

. During the 60-day public comment period, the Thiram Task Force commented that the tolerance for avocado is for imported avocadoes only. There are no U.S. registrations for thiram on avocado

. The FWP reflects this correction

.

1 http ://www2

.epa.gov/pes ticid e -reeva luation 2

### SUMMARY O F CO MMEN T S AN D AGENCY RE SPO NSES During the 60-day public comment period for the ferbam and thiram PWP , which opened on October 2 , 2015 and closed on December I , 2015 , the Agency received two public comments for ferbam , and 4 public comments for thiram

. Public comments for ferbam were submitted from VJP Consulting on behalf ofTaminco US Inc. , a registrant , and the Center for Biological Diversity (CBD). VJP Consulting noted that Taminco did not receive a data call-in (DCI) for ferbam for crop field trials in apples , but Taminco plans to bridge to apple trials conducted with both thiram and ziram supported by comparative peach trials with ferbam , ziram , and thiram. CBD commented on EPA ' s duty to complete threatened and endangered (listed) species assessment and consult with the U.S. Fish and Wildlife Service (FWS) , and the National Marine Fisheries Service (NMFS) (together, the Services) , on ferbam

. Public comments for thiram were submitted from the Thiram Task Force , the FIFRA Endangered Species Task Force (FESTF), the Physicians Committee for Responsible Medicine (PCRM) , and from CBD. The comments from the Thiram Task Force addressed data requirements , and the import tolerance for avocado. The comment from FESTF identified MacDermid Agricultural Solutions as a FESTF member, which is entitled to rely on FESTF data for endangered species risk assessments
. PCRM recommends using the OECD Test Guideline 223 (TG223) instead of EPA Guideline 850.2100 for the acute avian oral sequential dose study , in the interest of reducing the numbers of animals tested. CBD ' s comments focused on EPA's duty to consult with the Services on the registration review of thiram in accordance with the Endangered Species Act (ESA)

. None of the comments addressed the timeline described in the PWP , or the planned ecological and human health risk assessments. In the PWP , EPA also solicited comments on the specific topics of environmental justice , water quality concerns , and trade irritants , but no comments or information were received on those issues. This section summarizes the submitted public comments , and provides the Agency ' s response . Public comments in their entirety are located in the dockets EPA-HQ-OPP-20 15-0567 (ferbam) and EPA

-HQ-OPP-20 15-0433 (thiram). For a more detailed response , please refer to the documents titled 

### Thiram : Response to Comments on the EFED Problem Formulationfor Registration Review and 

### Thiram : Response to Comments on the Human Health Risk Scoping Do cum ent in Support of Registration Review, which are also located in the thiram docket. 

### Ferbam Co mm ents: Comm ents submitted by VJP C on sultin g, In c in EPA-HQ - OPP-20 15-056 7-0009 . 

### 1

. Comment: VJP Consulting , on behalf ofTaminco US Inc., stated that th e y intend tofully participate in the registration review process. They also noted that they were not in receipt of a D C !forferbam requiring crop field trials in apples, butplan to bridge to e xistingpeach datafor ziram and thiram

. Response: EPA is pleased that Taminco intends to fully participate in the registration review process. EPA issued a generic data call-in (GDCI) in support of the reregistration of ferbam in May 2008 (GDCI-034801-26275)

. Taminco was listed as a registrant , and guideline 860.1500-crop field trials (apple) was listed as a data requirement in this DCI. Crop field
3trials for apple were also noted as requirements in past GDCis issued in 1993 (GDCI

-03480 1- 17316) and in 1991 (GDCI-03480 1-16873). Since this requirement was noted in past DCIs , EPA will not require crop field trials in apples as part of the registration review GDCI. Taminco ' s plan to bridge to existing peach field trial data for ziram and thiram to fulfill this requirement is acceptable to EPA

. Taminco should cite/submit the existing peach field trial data as soon as possible. 

### Thiram Comm ents: Comments submitted by th e Thiram Tas k Fo rce in EPA-HQ-OPP-201 5-0433- 0012. 1. Comment: 

### The Thiram Task Force recognizes the need for many of the studies listed as anticipated data needsfor the Thiram Registration Review; however, there are afew studies that the Thiram Task Force would like the Agency to reconsider. A turf transferable residue (JTR) study is not needed. Response: At the registrant's request, EPA has reconsidered the requirement for the TTR study, and has confirmed that the data are necessary. In accordance with the updated (2007) Part 15 8 data requirements of the 40 CFR, TTR data are required for all turf uses that could result in post

-application exposure to treated turf. The guidance for waiving these data was developed considering the conservative nature of the standard/default residue transfer values. The waiver criterion, requiring that MOEs are 10 times greater than the level of concern (LOC), was based on the data used to develop these standard/default residue transfer values. In the case of thiram, the LOC is 1 00; therefore, all MOEs would need to be 1,000 or above in order for the TTR data waiver to be granted. The assessment of thiram' s turf use (golf course) yields an MOE of 850 for children 6 to < 11 years old, which does not meet the criterion ; therefore, the waiver may not be granted. 2. Comment: 

### The Thiram Task Force believes that the Agency should reconsider the need for the pollinator studies identified in the P WP

. The EPA categorizes pesticides as "toxic to bees" 

### if the acute contact 

### LD5o is 

### < 11 11g l bee

. Available data indicate that the contact 

### LD5o for thiram is 7 

### 3

. 72 11g l bee and was considered by the Agency to be practically nontoxic to bees. Additionally , it 

### is not believed that there have been any adverse incidents involving thiram and bees. Response: Although thiram is categorized as practically non-toxic to adult honey bees via acute contact exposure, there is considerable uncertainty regarding the potential effects of the compound on honey bee larval development and survival, as well as potential for chronic effects. Additional data on pollinators are needed to fully characterize the risk associated with thiram use to all developmental stages of honey bees, as sensitivity may vary according to life-stage (adult vs. eggs, larvae, and pupae), length of exposure (acute vs. chronic), and route of exposure (contact vs. oral). As indicated in EPA guidance issued in 2014 2
, assessing risks to bees involves a battery of laboratory-based studies (Tier 1 ). Depending on the

2 USEPA

. 2014. Guidance for Assessing Pesticide Risks to Bees

. Office of Pesticide Programs United States

Environmental Protection Agency, Health Canada Pest Management Regulatory Agency, California Department of Pesticide Regulation. June 19 , 2014. Available at: http: //www .epa.gov/pollinator-protection/ pollinator-riskassessment-guidance 4

### outcome of those studies, semi

-fie ld and fu ll -fie ld studies (Tier II and Tier III) involving whole bee colonies may be req uired to refine the understanding of risk to the whole colony. An absence of reported inc idents does not necessarily equate to an absence of incidents given the nature of incident reporting. Incidents that do not involve acute mortality events can be difficult to identify and are very rarely reported. 3. Comment: The members of the Thiram Task Force hold segmented labelsforfoliar and seed treatment uses. It would be helpful to the Task Force 

### if the FWP could designate which data requirements areforfoliar uses, for seed treatments, and for both. Response: OCSPP 850.4150 , Vegetative Vigor, is applicable to foliar uses only. All other requested ecotoxicity studies app ly to both fo liar uses and seed treatments. 

### Co mm ents submitted by FE STF in EPA -HQ-OPP-2015-0433 -0010 . 4. Comment: MacDermid Agricultural Solutions, Inc., a technical registrant , is a FESTF member and is entitled to rely on the FESTF data

. Response: The Agency thanks FESTF for its comment , and wi ll consider the FESTF data during the thiram registration review. 

### Comm ents submitted by the PCRM in EPA -HQ-OPP-2015-0433-0013. 5

. Comment: PCRM has identified acute avian oral toxicity datafor a passerine species via Extoxnet (http :// extoxnet. orst. edu /

pips /thiram. htm)

. The stated LD5o is > I 00 mg /

kg in redwinged blackbirds

. 

## If additional data are needed , PCRM recommends using the OECD Test Guideline 223 (TG223) instead of EPA Guideline 850

. 2IOO in the interest of reducing the numbers of animals used. Response: EPA will review the red-winged blackbird study referenced by PCRM if it is submitted to the Agency for that purpose. However, EPA notes that a limit dose of 100 mg/kg is unlikely to be sufficient for risk assessment. EPA will accept TG223 studies in place of850.2100 studies under the conditions laid out in EPA's 2011 Guidance for Classifying Studies Conducted Using the OECD Test Guideline 223 (TG223) (Acute Avian Oral Sequential Dose Study) (http: / /www.epa . gov/pesticide

- science-and

-assessing

-pesticiderisks/guidance-classifying-studies-conducted-u si ng-oecd). 

### Comm ents that Address Both Ferbam and Thiram: Comm ents submitted by CBD in EPA-HQ-OPP-2015-0567 -0008 (ferbam docket) , and in EPA -HQ-OPP-2015-0433-0011 (thiram docket). 1. 

### Comment : CBD 's comments focus on the EPA ' s duty to consult with the Services on the registration review of ferbam and thiram in accordance with the ESA. CBD 's comments mention developing listed species risk assessments, and evaluation of effects on listed species, and their designated critical habitat

. 5Response: EPA has reviewed the comments from CBD on the registration review docket openings for ferbam and thiram, and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to ferbam and thiram in connection with the development of the final registration review decisions for ferbam and thiram. In November 2013, the EPA, along with the Services and the USDA, released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the agencies in response to the NAS report 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. The N AS report 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. The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops in April2014 and October 2014, and in April2015, allowing additional opportunities for stakeholders to comment on the Interim Approaches

. Additional workshops are planned to enhance stakeholder involvement. As part of a phased , iterative process for developing the Interim Approaches , the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming registration review decisions. The details of the joint Interim Approaches are contained in the white paper "Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report, " dated November 1 , 2013. 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 problem formulations supporting the FWPs for ferbam and thiram do not describe the specific ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. In the ecological problem formulation documents for ferbam and thiram, EPA described the screening-level risk assessment to determine the potential effects offerbam and thiram on all taxa of non-target wildlife and plants, which will assume that listed species and their designated critical habitats may be present in the vicinity of the application of ferbam and thiram. This screening-level 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. While the agencies continue to develop a common method for ESA analysis, the planned screening-level risk assessment for the registration review of ferbam and thiram will describe the level of ESA analysis completed for these particular registration review cases. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for listed species

6

### and their designated critical habitats, these methods will be applied to subsequent analyses for ferbam and thiram as part of completing these registration reviews. PLANNED D ATA NEE D S 

### Table 1 below summarizes the planned data needs for thiram. Since ferbam degrades to thiram in the environment, EPA intends to bridge data from thiram to assess ferbam. Therefore , there are no anticipated data needs for ferbam for registration review 

### per se. The planned data needs are based on the 

### Registration Review : Preliminary Problem Formulationfor Environmental Fate, Ecological Risk , Endangered Species, and Human Health Drinking Water Exposure A ssessmentsfor Ferbam and Thiram , the 

### Ferbam Scoping Document, and the 

### Thiram

. Human Health Assessment Scoping Document in Support of Registration Review. The planned data needs have not changed from what was included in the PWP.
Table 1: Planned Data Needs fo r th e T hi ram R egistratio n Rev iew Estimated Guideline Study Title3 Timeframe Number' Test Material (Months from receipt ofDCI) " Anticipated Data Needs for Thiram 875.2100 Turf transferable residue study TGAI 12 870.3465 28-day inhalation study TGAl 24 850

. 1350 Mysid chronic toxicity TGAl 12 850

. 1400 Estuarine/marine fish early-life stage toxicity TGAl 12 Algal toxicity (fresh water diatom Na vic ula 850.4500 p e lliculosa and marine diatom Ske leton ema TGAl 12 costatum) 850.4550 Cyanobacteria toxicity TGAI 12 850.2100 Avian acute toxicity (passerine species) TGAI 12 850.4100 Seedling emergence TGAl 12 850.4150 Vegetative Vigor TGAl 12

Non- Honey bee adult acute oral toxicity (Tier I) TGAI 12 guideline4 Non- Honey bee larvae acute toxicity (Tier I) TGAl 12 guideline4 Non- Honey bee adult chronic oral toxicity (Tier I) TGAl 12 guideline4 Non- Honey bee larvae chronic toxicity (Tier I) TGAl 12 guideline 4

3 On Jun e 27 , 2012 , EPA announced certain revisions in harmonized guideline serie s 850

- Ec ological Effect s Te sts

- including renumberin g and other designations or change s for some guideline studi es. See "F inal Test Guidelines ; OCSPP 850 Series ; Notice of Availability " 77 FR 38282 , June 27 , 201 2. http ://www. reg ul ation s . go v/# !doc umentDetaii ; D=E PA- HQ-OPPT-2 009-0 15 4 -002 8 4 Tier 2 and 3 studie s are conditional on the outcome of the s creenin g -level asse ss ment for terrestrial invertebrate s

bas ed on Tier I studie s of individual bees

. 7Table 1: Planned Data Need s for the Thiram Regi s tration R ev iew Estimated Guideline Study Title3 Timefram e Numberl Test Material (Months from receipt ofDC I) Non- Semi-fie ld testing for pollinators (tunnel or TEP 24 guideline4 colony feeding studies (Tier 2) Non

- Field trial of re s idue s in pollen and nectar (Tier 2) TEP 24 g uideline 4 850.3040 4 Fie ld testing for po llinators (Tier 3) TEP 24 Outstanding Data Requirements from GDCI-034801-26275 (Ferbam) 860.1500 5 Crop field trials (app le) TEP 24 TGAI = techmca l grade active mg redient ; T EP = typical end

-use product RISK ASSE S SMENTS FOR REGISTRAT ION REVIEW 

### During registration review , the Agency will conduct a comprehensive eco logical risk assessment , including an endangered species assessment, for all u ses of ferbam and thiram. For human health , EPA wi ll co nduct revised di etary and occup atio nal risk assessments for ferbam. EPA will conduct revised dietary, res idential, and occup ational ris k assessments for thiram during registration review. If toxicological endpoints or points of departure are revised based on the data that are anticipated to be required for registration review, they will be considered in the new assessments , as well as any changes to the standard operating procedures or default exposure assumptions. Tables 2 and 3 below summarize the planned registration review risk assessments based on the combined ferbam/thiram EFED Prob lem Formul ation, and the ferbam and thiram HED Scoping Documents

. The planned assessments have not changed from what was included in the PWP

. T able 2 : Planned Ri sk A ss ess ments for the Ferbam Regi s tration Review T y pe of Ri sk Ass ess ment Conduct ? Notes 

### Ecological and Environmental Fate Comprehensive ecological 

### y Thiram , a major transformation product of (species to be assessed ferbam , will be assessed with ferbam. include terrestrial and aquatic organisms) , including endangered species Incidents Will check for For a discussion of reported ecological updates inc idents for ferbam , see page 21 of the Probl em Formulation. 

### Human Health

5 It is po s sible to bridge crop field trial data for apple for ferbam , ziram , and thiram

. 

### 8

### Dietary Food 

### y The RED acute and chronic dietary risk Drinking water 

### y assessments did not identify risks of concern . A new dietary risk assessment may need to be conducted if there are changes to toxicological endpoints or safety factors or changes to estimated drinking water concentrations

. Occupational Handlers (mixers , loaders , 

### y The revised RED occupational risk assessment applicators) identified post-application risks of concern. A Post-application 

### y new occupational handler and post-application risk assessment may be needed to incorporate changes to toxicological points of departures or changes to risk assessment policy. Residential Handlers N 

### There are no registered residential uses of Post-application N 

### ferbam , therefore , a residential exposure assessment is not needed for registration revtew. Bystander 

### y During registration review , the agency will determine if a residential bystander assessment is needed for ferbam

. Other Aggregate N 

### Evaluates the combined risk from dietary and residential exposures. Since there are no residential uses for ferbam , an aggregate risk assessment includes only dietary exposure. Cumulative N 

### Ferbam has not been identified as a member of a cumulative group with a common mechanism oftoxicity and therefore , no cumulative assessment is planned. Tolerances 

### y During registration review , the Agency anticipates updating the tolerance expression residue levels to determine if further harmonization can be achieved. The agenc y may reevaluate the tolerance levels for ferbam if new field trial data is received. The Agency may also consider converting the tolerances for the dimethyl dithiocarbamates (thiram , ziram , and ferbam) and the ethylene bisdithiocarbamates (EBDCs) to being expressed as carbon disulfide equi v alents. Incidents Will check for For a discussion of reported human incidents updates for ferbam , see page 10 of the Scoping Document and the 

### Ferbam : Ti er I ( Scoping ) Review of Human In cid ents and Epidemiology.

9

### Tabl e 3 : Plann ed Risk Ass ess ments for th e Thiram Reg istrati on Review Ty pe of Risk Assess ment Conduct ? Notes 

### Ecological and Environmental Fate Comprehensive ecological 

### y Thiram is a major transformation product of ferbam , (species to be assessed EPA intends to assess thiram with ferbam

. include terrestrial and aquatic organisms), including endangered species Incidents Will check for For a discussion of reported ecological incidents for updates thiram , see page 21 of the Problem Formulation. 

### Human Health Dietary Food 

### y A new dietary assessment is anticipated for Drinking water 

### y registration review to incorporate any changes to toxicological PODs or uncertainty factors (UFs), methodologies or updated drinking water estimates. Occupational Handlers (mixers , loaders , 

### y The Agency anticipates updating the occupational risk applicators) assessment during registration review to incorporate Post-application 

### y any revised toxicological PODs , current policies or exposure assessment methodologies

. Residential Handlers 

### y The Agency anticipates revising the residential Post-application 

### y exposure risk assessment during registration review to incorporate the required chemical-specific TTR data. The Agency will evaluate the need for spray drift and volatilization risk assessments for thiram during registration review. Other Aggregate 

### y Evaluates the combined risk from dietary and residential exposures. A revised aggregate exposure risk assessment may be necessary during registration review to incorporate any potential changes to the dietary or residential assessments. Cumulative 

### N EPA has not made a common mechanism of toxicity finding as to thiram and any other substances and thiram does not appear to produce a toxic metabolite produced by other substances.

10

### Tolerances 

### y During registration review, the Agency anticipates examining the tolerance residue levels to determine if further harmonization can be achieved. The Agency may also consider converting the tolerances for the dimethyl dithiocarbamates (thiram , ziram, and ferbam) and the ethylene bis-dithiocarbamates (EBDCs) to being expressed as carbon disulfide equivalents. Incidents Will check for For a discussion of reported human incidents for updates thiram, see page 11 of the Scoping Document and the 

### Thiram : Tier I Review ofHuman Incidents and Epidemiology. TIMELINE EPA has created the following estimated timeline for the completion of the ferbam and thiram registration review in Table 4 below. The projected timeline has not changed since the PWP.
Table 4: Projected Ferbam and Thiram Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period October 2015

- Completed Close Public Comment December 2015

- Completed Case Development Final Work Plan March 2016

- Completed Issue DCI 6 

### 2016

- April- June Data Submission 2018

- April- June 60-day Public Comment Period for Draft Risk Assessments7 

### 2019

- Oct- Dec Registration Review Decision 60-day Public Comment Period for Proposed 2020

- July

- Sept. Registration Review Decision Registration Review Decision and Begin Post-Decision 2021 Follow-up Total (years) 6

6 There are no data requirements for ferbam ; therefore , a DCI will not be issued. However, s ince data will be

bridged from thiram or ziram to assess ferbam , the three registration review cases are on the same projected registration review timeline. 7 The regulations governing Registration Review generally require the Agency to provide a public comment period

of at least 30 calendar days for draft risk assessments ; see 40 CFR Part 155

.53(c). For conventional pesticides , the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 11

### NEXT STEPS As noted previously , the Agency plans to require certain ecological effects and human health studies for thiram through a DCI, expected to be issued in spring/summer 2016

.

12