Docket Number EPA-HQ-OPP-2015-0568 www.regulations.gov



# Ziram Final Work Plan Registration Review

Case Number 800 1

March 2015

Approved by:

Date: Yu- T g Guilaran, P.E. Dire or Pesticide Re-evaluation Division

·- Steve Knizner Director Antimicrobials DivisionINTRODUCTION This is the Environmental Protection Agency ' s (EPA or the Agency) Final Work Plan (FWP) for the registration review of ziram

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the ziram registration review docket (EPA-HQ-OPP-2015-0568). Ziram has both conventional pesticide uses and antimicrobial uses. As a conventional fungicide , ziram is registered for use on various f ruits , nuts , and vegetables , including almond , apple , apricot, peach, pear, pecan , and tomato
. Ziram is also registered for use in non-agricultural areas , including Christmas tree plantations , conifers , and ornamentals

. As an antimicrobial , ziram is also registered as a mold inhibitor, preservative , and short-term spoilage protectant in the following products: latex paint, paper and paperboard, paper coatings , water reduc ed industrial materials , adhesives , industrial yarns and fabrics , and dried films. Ferbam (PC code 034801 , a related dithiocarbamate) and ziram have a common degradate

- thiram (PC code 079801 )

. Ferbam and thiram also have pesticidal uses and EPA is conducting separate , concurrent, registration reviews for ferbam , thiram , and ziram. The Agenc y 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 registration 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 substantive 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 timeline for ziram. Lastly , there is a discussion of next steps. UPDATES SINCE THE PWP WAS ISSUED There have been no additional updates on ziram since the PWP
. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment period for the ziram PWP , which opened on October 2 , 2015 and closed on December 1 , 2015 , the Agency received four public comments
. Two comments came from VJP Consulting on behalf of the Ziram Task Force and Taminco US Inc. , a technic al registrant. The other comments came from the Center for Biological Diversity (CBD) and the San Francisco Bay Regional Water Quality Control Board

.

1 http ://www2

.epa. gov/pe sticide-reevaluation 2

### The Ziram Task Force asked the Agency to reconsi der the need for pollinator studies , as ziram exhibits very low toxicity to honeybees. Taminco US Inc
. stated that it intends to fully participate in the registration review process for ziram, and will provide relevant information if needed

. CBD commented on EPA's obligations under the Endangered Species Act (ESA). The San Francisco Bay Regional Water Quality Control Board requested that EPA consider zinc , a degradate released from ziram in water, in its review. The Board argued that zinc can be released in urban runoff, and there are Total Maximum Daily Loads (TMDLs) for zinc

. The comments did not result in changes to the agency ' s planned data requirements , risk assessments , or registration review timeline

. In the PWP , EPA also solicited comments on the specific topics of environmental justice and trade irritants , but no comments or information were received on those issues

. Public comments , and EPA ' s responses in their entirety are located in the docket, EPA-HQ-OPP20 15-0568

. Summarized public comments and Agency responses related to the anticipated ecological risk assessment or data needs are in the Ziram : Response to Comm ent s on the EF ED Problem Formulationfor Registration Review. 

### Summarized below are public comments that addressed the anticipated registration review data needs , risk assessments , or timeline , or are of a broader regulatory nature.
Comments submitted by the Ziram Task Force in EPA -HQ-OPP-2015-0568-00 12 . 1. Comment: V JP Consulting, Inc, on behalf of the Ziram Task Force, reques ted that EPA reconsider th e need for additionalpollinator studiesfor z iram, s in ce e xisting data indicat es ve r y low tox icity to honeybees. In addition, there are no reported adverse incident s involving ziram and be es. 

### Response : EPA thanks the Ziram Task Force for their comments. At this time , the full suite of Tier 1 honeybee data are still needed for ziram in order to assess the need for higher tier honeybee testing

. In accordance with EPA ' s 2014 guidance for Assessing Pesticide Risk to Bees (available at http: //www.epa . gov/pesticides/science/efed/policy guidance/team authors/terrestrial biology te ch team/guidanceassessingpesticiderisk2bees.pdf) , EPA will consider waiving Tier 2 and Tier 3 honeybee testing for ziram once it has received Tier 1 honeybee data, and has completed Tier 1 pollinator screening. The Ziram Task Force is not expected to conduct Tier 2 or Tier 3 honeybee testing f or ziram until a determination has been made by EPA that Tier 2 and Tier 3 honeybee data are needed

.

3Comm ents submitted by CBD in EPA -HQ-OPP-2015-0568-0010 . 2. Comment : CBD ' s comments focus on the EPA ' s duty to consult with the U.S. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration revie w of ziram in accordance with ESA. CBD ' s comments mention developing endangered species risk assessments, and evaluation of effects on endangered and threatened (listed) species, and their designated critical habitat. Response : EPA has reviewed the comments from CBD on the registration review docket opening for ziram 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 ofthe April2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to ziram in connection with the development of its final registration review decision for ziram. 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 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. 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 April 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 April2013 Report" 3
, 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 formulation supporting this FWP for ziram does 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

2 http ://www.nap.edu/catalog.php?record_id=18344 3 http: / /www.epa.gov/espp/20 13 /nas.html

4ecological problem formulation document for ziram, EPA described the screening

-level risk assessment to determine the potential effects of ziram 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 ofthe application of ziram

. 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 ziram will describe the level of ESA analysis completed for this particular registration review case. 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 for ziram as part of completing this registration review

.
Comm ents submitted by the San Francisco Bay Regional W ater Quality Control Board in EPA-HQ-O PP-20 15-0568-00 11. 3. Comment: The San Francisco Bay Regional Water Quality Control Board noted that ziram is used in many urban products such as paint , and degrades rapidly in water , releasing zinc
. Use of ziram-containingproducts could leach zinc into urban runoff. The Board requested that EPA consider zinc as a degradate in its review, and update its procedure for identifying whether a pesticide is a cause of water quality impairment by : 1) reviewing all §303(d) listings, not just pesticide listings, and 2) include all degradates and metals in the pesticide. Response: EPA appreciates the Water Board's comment. EPA routinely assesses all pesticide degradates of concern and will continue to include degradates in its process for identifying if a pesticide is a cause of water quality impairment. Zinc, however, was not identified as a degradate of concern for ziram. Levels of zinc that can form in the environment from applications of ziram are negligible relative to background levels. When the degradate of concern is a metal, EPA will focus on metal-impaired waters within the use areas ofthe pesticide active ingredient. Land cover data will be used to indicate if an ingredient's use areas is within the watershed. The relevance of §303d listings and TMDLs for metals outside the active ingredient's use area is uncertain due to natural occurrences or non -pesticidal activities such as mmmg.

5PLANNED D ATA NEED S Table 1 below summarizes the planned data needs for ziram based on the Registration Review : Preliminary Problem Formulationfor Environmental Fate, Ecological Risk , Endangered Species, and Human Health Drinking Water Exposure Assessments for Ziram, Ziram Scoping Document , and Ziram: Response to Comments on the EFED Problem Formulationfor Registration Review
. The planned data needs have not changed from what was included in the PWP
. Table 1 : Planned Data N eeds for the Ziram Registration Rev iew

,. Estimated Guideline Study Title4 Timeframe Number 4 Test Material (Months from receipt ofDCI) Anticipated Data Nee d s for the Pa rent (Ziram) 835.3110 5 • 6 •7 835.3220 5 •7 • 8 Wastewater treatment plant biodegradation TGAI 12 83 5 .3240 5 ,7· 9 tests 835.3280 5 • 7 • 10 835.4300 1 1 Aerobic aquatic metabolism 12 TGAI 24 850.2100 1 3 Avian oral toxicity (passerine species) TGAI 12

4 On June 27,2012, EPA announced certain revisions in harmonized guideline series 850

- Ecological Effects Tests

- including renumbering and other designations or changes for some guideline studies. See "Fi nal Test Guidelines ; OCSPP 850 Series; Notice of Availability" 77 FR 38282 , June 27, 2012. http ://www.regulations

.gov/# !documentDetail;D=EPA-HQ

- OPPT

-2009-0154-0028 5 These data are triggered by the antimicrobial uses of ziram and were also required of sodium and potassium

dimethyldithiocarbamate salts in a separate registration review case. The data could potentially be bridged between any of these three compounds. 6 EPA has a published fmal guideline for this study : http: //www.regulations.gov/# !documentDetail;D=EPA-HQOPPT-2009-0152-0003

. 7 The results of the Activated Sludge Respiration Inhibition Test (ASRI) , GLN 850

. 3300, will determine which of

the four biodegradation tests is/are required

. If the ASRI test EC50 is less than or equal to 20 mg/L , then either the (i) Biodegradation in Activated Sludge Study , GLN 835 .32 80 or (ii) Simulation Test- Aerobic Sewage Treatment: A

. Activated Sludge Units, GLN 835

. 3240 , or (iii) the Porous Pot Test, GLN 835.3220 is required

. If the ASRI test EC50 is greater than 20 mg/L , then the registrant must conduct either : (i) Ready Biodegradabi li ty or (ii) a) Biodegradation in Activated Sludge, or b) Simulation Test- Aerobic Sewage Treatment: A

. Activated Sludge Units, or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes , then no further testin g is required

. If , however , the antimicrobial fails the Ready Biodegradability study, then the (i) Biodegradation in Activated Sludge , or (ii) Simulation Test- Aerobic Sewage Treatment: A. Activated Sludge Units , or (iii) the Porous Pot study is required

. 8 EPA has a published final guideline for this study: http ://www.regulations

. gov/# !documentDetail;D=EPA-HQOPPT-2009-0 152-0024

. 9 EPA has a published final guideline for this study : http ://www .regulations

. gov/# !documentDetaii;D= EPA-HQOPPT-2009-0152-0034

. 10E PA has a published final g uideline for this study: http ://www.regulations.gov/# !documentDetail ; D= EPA-HQOPPT-2009-0152-0036. 11 The se data are triggered by both the agricultural and antimicrobial uses of ziram

. 12 A study (MRID 46045903) for thi s requirement is in review

. Iffound acceptable , this study will not be required

for registration review. 13 These data are triggered by the agricultural uses of ziram. 6Table 1: Planned Data N eeds for the Ziram Regis tration R eviewEstimated Guideline Study Title4 Timeframe Number" Test Material (Months from
' receipt ofDCI)

"'-**~** 850.3040 13 Field testing for po ll inators (tier III) 14 TEP 24 850.3300 5 • 7• 15 orOECD Modified activated sludge respiration test TGAI 12 209 850.4500 11 • 16 Algal toxicity TEP 12 850.4550 11 • 16 Cyanobacteria toxicity TEP 12

875.1200 17 Dermal exposure indoor TGAI 24 875.1400 17 Inhalation exposure indoor TGAI 24 875.2300 1 8 Indoor surface residue study TGAI 12 Non- Honeybee adult acute oral toxicity (tier I) TGAI 12 guideline 11 Non- Honeybee larval acute toxicity (tier I) TGAI 12 guideline 13 Non

- Honeybee adult chronic toxicity (tier I) TGAI 12 guideline 13 Non- Honeybee larvae chronic toxicity (tier I) TGAI 12 guideline 13 Non- Semi-field testing for pollinators-tunnel or TEP 24 guideline 13 colony feeding (tier II) 14 Non- Field trial of residues in pollen and nectar (tier TEP 24 guideline 13 ny 4 Anticipated Data Needs for the Thiram Degradate 850

. 1350 1 1 Mysid chronic toxicity 19 TGAI 12 850.1400 11 Estuarine/marine fish early life-stage toxicity TGAI 12

14 The need for tier II and tier III pollinator studies is contingent upon results of tier I testing and other lines of

evidenc e . 15 EPA published draft guidance under guideline 850.6800 and has since published final guidance for this study

under guideline 850.3300 : http ://www.regulations

.gov/# !documentDetail ;D= EPA-HQ-OPPT-2009-0 154

-0021. OECD Test Guideline 209 can also be used as guidance for this study , available online at http ://www .oecdilibrary

.org/content/book/9789264070080-en. 16 In a Federal Register Notice dated June 27, 2012 , EPA split the Public Draft OPPTS 850

.5400 test guideline into

two te st guidelines : OCSPP 850.4500 and OCSPP 850.4550. See " Final Test Guideline s; OCSPP 850 Series ; Notice ofAvailability" 77 FR 38282 , June 27 , 2012

. http ://www.re gulation s . gov/# !documentDeta il ;D= EPA-HQOPPT

-2009-0154-002 8

. 17 These anticipated data are triggered by the antimicrobial uses of ziram

. The indoor exposure studies are needed to

evalua te occupational handler exposures for: (I) mixing/loading of ziram powder for paint preservation and (2) brush/roller and airless sprayer application of preserved paints

. 18 These anticipated data are triggered by the antimicrobial uses ofziram

. The indoor surface residue study is needed

to evaluate dermal and incidental oral exposures to ziram treated textiles that are used to man ufacture apparel or household items such as towels and blankets. 19 These studies also appear in the thiram problem formulation, but are also deemed important for the risk

as sessment of ziram

. 7Table 1: Planned Data Needs for the Ziram Registration ReviewEstimated Guideline Study Title4 Timeframe Number' Test Material (Months from receipt ofDCI) I Outstanding Data Requirements from GDCI-034805-24513 20 850.4100 Terrestrial plant toxicity--seedling emergence TEP 12 850.4150 Terrestrial plant toxicity--vegetative vigor TEP 12 860.1500 Crop field trials (blackberry) 21 TEP 24 860.1500 Crop field trials (tomato) TEP 24 TGAI = techmcal grade active ingredient; TEP = typ1cal end-use product;

20 The studies listed in this section were previously required through a generic data call-in issued in November 2014

and are still outstanding. These studies will not be included in the anticipated Registration Review DCI because they are already required through the earlier DCI. 21The tolerance for use ofziram on blackberry has expired

. EPA will work with registrants to remove blackberry

use from the ziram labels

. When blackberry use is removed from all ziram labels, crop field trial data on blackberry will no longer be required. 8RISK ASSESSMENTS FOR REGI ST RATIO N REVIEW During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of ziram

. For human health, EPA will conduct revised dietary, residential, and occupational risk assessments during registration review

. If toxicological endpoints or points of departure are revised based on the data that are 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. Table 2 below summarizes the planned registration review risk assessments for ziram. The planned assessments for ziram have not changed from what was included in the PWP.

9Table 2: Planned Ri sk As ses sments for the Ziram Regi stration Review Ty pe of Risk Ass ess ment Conduct? Notes Ecological and Environmental Fate Comprehensive ecological 

### y A comprehensive ecological risk assessment will be (species to be assessed conducted for ziram. The ziram risk assessment will include terrestrial and aquatic also will rely heavily on the combined thirarnlferbam organisms) , including risk assessment. endangered species Conventional andAntimicrobial: EPA intends to conduct revised ecological risk assessments for both conventional and antimicrobial uses of ziram

. Incidents Will check for For a discussion of reported ecological incidents for updates ziram, see page 17 ofthe Problem Formulation. Human Health Dietary Food 

### y Conventional : Acute and chronic dietary risk assessments were conducted in 2010 to support a tolerance action. Both acute and chronic dietary risks were below the Agency ' s level of concern . EPA anticipates conducting a revised dietary assessment to Drinking water 

### y incorporate updated models and assumptions and any changes to toxicological points of departures or drinking water estimates

. Antimicrobial: The antimicrobial uses of ziram are non -food uses. Any dietary exposure from the antimicrobial uses of ziram are considered to be negligible. Occupa tional Handlers (mixers , loaders , 

### y Conventional : EPA anticipates updating occupational applicators ) exposure and risk assessments based on current policies and exposure assessment methodology. Antimicrobial: Inhalation exposures for the antimicrobial uses may be reevaluated during Post

-application 

### y registration review to incorporate inhalation toxicity data that was submitted since the issuance of the RED. Residenti al

10

### Handlers 

### y Conventional : 

### Conventional uses of ziram are not expected to result in residential exposure , therefore , a residential assessment is not planned for conventional uses during registration review. Antimicrobial: 

### Residential exposure is anticipated from the antimicrobial uses of ziram

. EPA anticipates Post-application 

### y conducting a post-application residential assessment for the anti-microbial uses during registration review. B ystander 

### y Conventional: 

### During registration review , EPA will determine if a residential bystander exposure assessment is needed. Antimicrobial: 

### A bystander exposure assessment is not anticipated for the antimicrobial uses of ziram. Other Aggregate 

### y There are no residential uses associated with the conventional uses of ziram

. Post-application exposures from the antimicrobial industrial yam and fabric use(s) may require aggregation with the dietary exposures if it is determined that ziram treated yams and fabrics are used to manufacture household goods and apparel. Cumulative N 

### Ziram has not been identified as a member of a cumulative group , therefore , no cumulative risk assessment is planned. Tolerance s 

### y Tolerance residue levels for ziram may need to be reexamined during registration review to harmonize with Codex and Canadian MRLs
. Incidents Will check for For a discussion of reported human incidents for updates ziram, see page 1 0 of the Scoping Document and the Ziram: Tier I Rev iew of Human I ncidents.



### 11TIMELINE EPA has created the following estimated timeline for the completion of the ziram registration review in Table 3 below. The projected timeline has been modified since the PWP to include a revised date for the close of the public comment period for the docket opening. Table 3: Projected Ziram Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period September 20 15--completed Close Public Comment December 20 15--completed Case Development Final Work Plan March 20 16--completed Issue DCI May-July 2016 Data Submission May-July 2018 60-day Public Comment Period for Draft Risk September-November 2019 Assessments 22 Registration Review Decision 60-day Public Comment Period for Proposed June-September 2020 Registration Review Decision Registration Review Decision and Begin Post-Decision January-March 2021 Follow-up Total (years) 6
NEXT STEPS As noted previously, the Agency plans to require several environmental fate, ecological effects , and human health studies for ziram through a Data Call- In Notice, expected to be issued in the spring/summer of2016.

22 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
. 12