D ocket Number EPA- HQ -O PP-2014

- 0 77 1

www

. regulations.gov



## Dikegulac Sodium Preliminary Work Plan

Registration Review : Initial Docket

Case Number 3061

A p proved 

### by:

D ate: 

## December 2014

## ~QNOL.P~~~ Ric h ar d P. Ke i gwin, J r.
D irector

P estici d e R e- e va l ua ti o n Divi s i o n2 

### Dikegulac Sodium Preliminary Wo rk Plan – Table of Contents

OVERVIEW

.............................................................................................................................. ..... 3

ANTICIPATED DATA NEEDS ................................................................................................... 4

STATUTORY AND REGULATORY AUTHORITY .................................................................... 5

CHEMICAL FACTS ....................................................................................................................... 5

USE AND USAGE INFORMATION ............................................................................................ 6

RECENT ACTIONS ...................................................................................................................... 7

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW ................................. 7

TIMELINE

.............................................................................................................................. ....... 9

NEXT STEPS

.............................................................................................................................. . 10 Appendix – Additional Areas Considered in the Dikegulac Sodium Registration Review ........... 11

References:

This Preliminary Work Plan summarizes the En vironmental Protection Agency's current position based on the following documents:

1. EFED Registration Review Proble m Formulation for Dikegulac-sodium . Arnold, Elyssa. October, 27

2014.

2. Dikegulac Sodium. Human Health Scoping Document and Preliminary Risk Assessment. Bobowiec, Bridgett. September 10, 2014.

3. BEAD Chemical Profile for Registration Review: Dikegulac Sodium (109601). Chen, Carl. November 17, 2014.

These and other supporting documents for the dike gulac sodium registration review case may be found in the docket EPA- HQ-OPP-2014-0771 at http://www.regulations.gov

.3 OVERVIEW

The docket for dikegulac sodium is now open, initiating the first public comment period for this registration review (docket number EPA-HQ-OPP-201 4-0771). Dikegulac-sodium is a plant growth regulator that was first registered in 1978. It is registered for use on ornamentals, nursery crops, and trees to reduce growth, flowering, and/or fruit set. There are residential uses of dikegulac sodium. Three end-use products containing dikegulac-sodium are currently registered for use in the United States. Dikegulac-sodium was previously assesse d at the time of the development of the Reregistration Eligibility Decision (RED) in 2007. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Progra ms knows about dikegulac sodium, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing the registration review for dikegulac sodium.

The registration review process was designed to incl ude a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about dike gulac sodium and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on dikegulac sodium. The Agency encourages all interested st akeholders to review the PWP and Appendix and to provide comments and additional information that will help the Agency’s decision-making process for this chemical. In addition to general areas on which persons may wish to comment,

there are some areas identified in the PWP and A ppendix about which the Agency specifically seeks

comments and information. Interested stakeholders could include: environmental non-profit or interest groups; pesticide manufacturers; agricu ltural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large.

The Preliminary Work Plan begins by listing the an ticipated data needs for dikegulac sodium. Next, it discusses the statutory and regulatory authori ty for Registration Review. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timeline for dike gulac sodium. Finally, the Appendix to this document includes identification and discussion of some areas that are considered generally in Registration Review along with some additional chemical case-specific information.4 ANTICIPATED DATA NEEDS

Table 1 below summarizes anticipated data needs for dikegulac sodium. For additional discussion of the anticipated data needs, see the EFED Registration Review Proble m Formulation for Dikegulac-sodium.

Table 1: Anticipated Data Needs for the Dikegulac Sodium Registration Review

Guideline

Number 1 Study Title 1 Test Material Estimated

Timeframe

(Months from receipt of DCI)

Anticipated Data Needs for the Parent Dikegulac Sodium

Nonguideline Honey bee acute oral toxicity TGAI 12

Nonguideline Honey bee acute larval toxicity TGAI 12

Nonguideline Honey bee chronic larval toxicity TGAI 12

Nonguideline Honey bee adult chronic 10-day toxicity TGAI 12

TGAI = technical grad e active ingredient

1 On June 27, 2012, EPA announced certain revisions in ha rmonized guideline series 850 – Ecological Effects Tests –

including renumbering and other designat ions or changes for some guideline stud ies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Availab ility” 77 FR 38282, June 27, 2012. http://www.regulations.gov/#!docum entDetail;D=EPA-HQ-OPPT-2009-0154-00285 STATUTORY AND REGULATORY AUTHORITY

The Food Quality Protection A ct (FQPA) of 1996 mandated a registration review program. All pesticides distributed or sold in the United Sta tes (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agen cy), based on scientific data showing that they

will not cause unreasonable risks to human health or the environment wh en used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices chan ge, all registered pesticides continue to meet the statutory standard of no unreasonable adverse e ffects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided on EPA’s website. 2

The Agency is implementing the registration review pr ogram 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. The regulations governing registration review begin at 40 CFR 155.40. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state what it knows about the pesticide and what additional risk an alyses and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for th e registration review of dikegulac sodium.

CHEMICAL FACTS

Table 2 provides a summary of the chemical facts for dikegulac sodium.

Table 2: Chemical Facts for Dikegulac Sodium

PC code 109601

Case Number 3061

CAS Number 52508-35-7 Year first registered 1978 Pesticide Type Plant growth regulator Chemical class Not applicable Reregistration Eligibility Decision (RED) The RED was completed in 2007

Tolerance Reassessment Eligibility Decision (TRED) Not applicable. There are no food uses for dikegulac sodium.

Cumulative group Dikegulac sodium has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation There are no established tolerances for dikegulac sodium.

2 http://www.epa.gov/oppsrrd1/registration_review/6 Table 2: Chemical Facts for Dikegulac Sodium

Dual-use Dikegulac sodium is registered for conventional pesticidal uses only and has no registered antimicrobial or biopesticidal uses. Non-pesticidal uses There are no identified non-pesticidal uses of dikegulac sodium.

Pesticide Re-evaluation Division, Chemical Review Manager Matthew Manupella, manupella.matthew@epa.gov , (703) 347-0411

Registration Division, Product Manager Tony Kish, kish.tony@epa.gov , (703) 308-9443

USE AND USAGE INFORMATION

Table 3 summarizes the use and usage informat ion for dikegulac sodium. Please see the BEAD Chemical Profile for Registration Review: Dikegulac Sodium (109601) in the registration review docket for

more details.

Table 3: Dikegulac Sodium Use and Usage Information

Summary of Use Dikegulac sodium, a plant gr owth regulator, is registered for use on ornamental plants in greenhouses, nurseries, and on landscapes, as well as deciduous evergreen and conifer tree farms. Use Sites Agricultural Use Sites: Dikegulac sodium is registered for use on farms for deciduous evergreen and conifer trees, including

Christmas trees.

Non-Agricultural Use Sites: Dikegulac sodium is registered for use in greenhouses, nurseries, and on landscape trees, hedges, shrubs, groundcovers, flowering plants and other ornamentals. Landscape areas include parks, school campuses, city streets, and similar recreational, institutional, or industrial areas. Summary of Usage EPA reviewed available data sources and found that only the Department of Agriculture National Agricultural Statistics Service reported national use of dikegulac sodium in the nursery and floriculture sector in 2006, where approximately 400 lbs a.i. were applied at an average a.i. rate of 2.057 lbs a.i. per acre. California Department of Pesticide Regula tion, however, reported use of dikegulac sodium in higher amounts in recent years (2008-2012), particularly for landscape maintenance, where an average of 1,400 lbs a.i. were applied annually. Formulation Type(s) Dikegulac sodium is formulated as soluble and emulsifiable concentrates, as well as liquid ready-to-use. Application Method(s) Dikegulac-sodium is app lied as a foliar spray, soil drench, tree trunk injection, or tree trunk spray band Technical Registrant(s) PBI/Gordon Corporation, Arborsystems Inc.7 Table 3: Dikegulac Sodium Use and Usage Information

No. of Registrations 3 Section 3 products 3

Restricted Use No

Guidance for Commenters: The Agency currently does not have certain important information on dikegulac sodium. Obtaining the following information may improve future assessments conducted by the Agency related to the use and importance of dikegulac sodium.

 Current usage information (pounds a.i. applied, average a.i. rate of application and number of application) on all sites.

 Geographic distribution of dikegulac sodium use in the U.S.

RECENT ACTIONS

There are no recent actions for dikegulac sodium.

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW

The most recent comprehensive human health and ecological risk assessments for dikegulac sodium were completed in 2006 in preparation for the Re registration Eligibility Decision. Findings and

conclusions from these risk assessments are summarized in the Dikegulac Sodium: Human Health Scoping Document and Preliminary Risk Assessment and the EFED Registration Revi ew Problem Formulation for Dikegulac-sodium.

During registration review, the Ag ency anticipates the need for additional data to allow for a more comprehensive evaluation of potential effects to honey bees. For human health, no new data are expected to be required to support the registration re view of this pesticide. There are no hazards associated with dikegulac sodium at doses relevant to humans; therefore, a qualitative approach to risk assessment is appropriate. The Dikegulac Sodium Human Health Scoping Document and Preliminary

Risk Assessment is expected to serve as the preliminary risk assessment for the purpose of registration

review. EPA believes that there are no human health risks associated with the currently registered uses of dikegulac sodium.

Table 4 below summarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document.

3 Section 3 product labels can be obtained from th e Pesticide Product Label System (PPLS) website

(http://oaspub.epa.gov/ pestlabl/ppls.home).8 Table 4: Anticipated Risk Asse ssments for the Dikegulac Sodium Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms) No Ecological risk conclusions in the RED are unchanged

and will not be reassessed. The RED determined that all potential risks to aquatic organisms and plants were below the Agency’s level of concern (LOC). All potential risks to terrestrial organisms were also below the Agency’s LOC, except for semi-aquatic non-listed and listed plants. However, a more comprehensive evaluation of potential effects to honey bees is anticipated. Risks to federally listed species will be

reevaluated.

Incidents Will check for updates As of July 2014, there were no ecological incidents reported in EIIS or AIMS for dikegulac-sodium. There

were also no minor incident s reported in aggregate incident reports.

Human Health Dietary Food No Dikegulac sodium does not have any agricultural or food production uses, as such it is designated and

classified as a “non-food” use chemical. Based on the low hazard concern from the available studies, no endpoints of toxicological concern have been identified. Due to the hazard profile drinking water assessments are not needed. In addition, because dikegulac sodium is not used on any agricultural food and/or feed

commodities and is classified as a “non-food” use chemical and metabolized to non-toxic substances; a dietary risk assessment is not required. Drinking water No

Occupational Handlers (mixers, loaders, applicators) No While there are uses that could result in occupational handler and post-application exposure, due to the (very) low systemic toxicity of dikegulac sodium, a quantitative occupational risk assessment is not warranted for any type, or duration of exposure. Post-application No

Residential Handlers No Dikegulac sodium is used in small quantities by the professional landscaping industry, and is not marketed to homeowners. Residential post application exposure is possible from occupational application to residential use sites however, due to the (very) low systemic toxicity of dikegulac sodium, a residential quantitative risk assessment is not warranted for any type, or duration of exposure. Post-application No

Other9 Aggregate No Evaluates the combined risk from dietary and residential exposures. Cumulative No Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding with dikegulac sodium. Dikegulac sodium does not appear to produce a toxic metabolite produced by other substances. Tolerances No There are no tolerances to be assessed for dikegulac

sodium.

Incidents Will check for updates As of September 2014, there are no incident cases reported for dikegulac sodium in either the Main or Aggregate Incident Data System (IDS) module, Poison Control Centers (PCCs), California Department of Pesticide Regulation, National Pesticide Information Center (NPIC) and National Institute of Occupational Safety and Health’s Sentinel Event Notification System for Occupational Risks.

TIMELINE

EPA has created the following estimated timelin e for the completion of the dikegulac sodium registration review in Table 5 below.

Table 5: Projected dikegulac sodi um Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period December 2014 Close Public Comment February 2015 Case Development Final Work Plan June 2015 Issue DCI July-September 2015 Data Submission July-September 2016 60-day Public Comment Period for Draft Risk

Assessments 4 January-March 2017

Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision June-September 2017

Registration Review Decision and Begin Post-Decision Follow-up January-March 2018

Total (years) 4 years

4 The regulations governing Registration Review generally requ ire the Agency to provide a public comment period of at

least 30 calendar days for draft risk assessments; see 40 CF R Part 155.53(c). For conventional pesticides, the Agency plans to provide a 60 calendar day public commen t period generally for draft risk assessments.10 NEXT STEPS

After the 60-day public comment period closes, the Agency will review and respond to any comments received in a timely manner and then is sue a Final Work Plan for the registration review of dikegulac sodium.11 

### Appendix – Additional Areas Considered in the Dikegulac Sodium Registration Review

PUBLIC COMMENTS AND FEEDBACK:

Guidance for Commenters: The areas below highlight topics of special interest to the Agency where your comments, data submissions, or referen ce to sources of additional information could be of particular use.

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilit ating irritant resolution. The Agency will work to

harmonize tolerances and international maximum residue limits (MRLs) and may modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern. Because dikegulac sodium is not registered for foo d/feed uses in the U.S., it has no U.S. tolerances; therefore, the Agency does not antici pate any trade irritant issues for it.

Water Quality:

Dikegulac sodium is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. 5 In addition, no Total Maximum Daily Loads (TMDL) have been developed for dikegulac sodium. 6 More information on impaired water bodies and TMDLs can be found at the Agency’s website. 7 The Agency invites su bmission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and

Other Water Quality Data in OPP’s Registration Re view Risk Assessment and Management Process 8 in order to ensure they can be used quantitatively or qua litatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks in formation on any groups or segments of the population who, as a result of their location, cultur al practices, or other factors, may have atypical, unusually high exposure to dikegulac sodium compared to the general population. Please comment if you are aware of any sub-populati ons that may have atypical, unusually high exposure compared to the general population.

5 http://iaspub.epa.gov/tm dl_waters10/attains_nation_cy.cause _detail_303d?p_cause_group_id=885

6 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmd l_pollutant_detail?p_pollutant _group_id=885&p_pollutant_g roup_name=PESTICIDES

7 http://www.epa.gov/owow/tmdl/

8 http://www.epa.gov/oppsrrd1/registrat ion_review/water_quality_sop.htm12 ENDANGERED SPECIES:

A risk assessment that supports a complete en dangered species determination has not been conducted for dikegulac sodium. The ecological ri sk assessment planned during registration review will allow the Agency to determine whether use of di kegulac sodium has “no effect” or “may affect” federally listed threatened or endangered species (lis ted species) or their designated critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

ENDOCRINE DISRUPTOR SCREENING PROGRAM:

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collective ly, these studies include acute, subchronic and chronic toxicity, including assessments of carc inogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including eff ects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, 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 reregistration decision for dikegulac sodium, 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), dikegulac sodium is subject to the endocrine screening part of the Endocrine Disruptor 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 endocr ine effects as the Administrator may designate.” The EDSP employs a two-tiered approach to maki ng 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 th e 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 the E, A, or T effect.

Under FFDCA section 408(p), the Agency must scr een all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 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, 2013 9 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 disruptors.

9 See http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0477-0074 for the final second list of

chemicals.13 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. 10

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