Docket Number: EPA-HQ-OPP-2011-0482 www.regulations.gov



## Ancymidol Summary Document Registration Review: Initial Docket
June 20113 

### TABLE OF CONTENTS

Page No.

I. Preliminary Work Plan (PWP)

................................................. 4

II. Fact Sheet

.................................................................................... 10

III. Summary of Data Gaps

............................................................. 13

______________________ __________________

Please Note

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency's current position based on the following documents:

1. Registration Review – Preliminary Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Dr inking Water Exposur e Assessments for Ancymidol , dated March 28, 2011.

2. Ancymidol. Human Health Assessment Sc oping Document in Support of Registration
Review , dated June 7, 2011.

3. Ancymidol Review of Human Incidents . March 1, 2011.

4. Chemical Profile for Regi stration Review: Ancymidol . November 19, 2010.

5. Ancymidol: California Department of Pesticide Regulation Usage Data . July 20, 2010.

Additional supporting documents for ancymidol ma y be found in the an cymidol registration
review docket located on the internet at: www.regulations.gov4 I. Preliminary Work Plan – Ancymidol

Introduction :

The Food Quality Protection Act (FQP A) of 1996 mandated a registration review program. All pesticides sold or distributed in the United States generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when 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 change, all registered pesticides continue to meet the statutory standard of no unreasonabl e adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/.

The Agency is implementing the registration revi ew 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 th e FIFRA standard for registration. 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 whatit knows about the pesticide and what additional risk analyses and data or information it belie ves 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 de velop and commit to a final work plan and schedule for the registration review of ancymidol.

Ancymidol is a plant growth regulator registered for treating container-grown herbaceous plants, ornamental woody shrubs, and bedding plants grown in greenhouses and other plant bedding areas for commercial production. There are no f ood/feed or residential uses of products containing this active ingredient. Growth regulator effects produced by ancymidol are the result of inhibition of gibberellin bios ynthesis. Since gibberellin pr omotes growth, treatment with ancymidol induces a more compact growth form by suppressing growth between nodes. Ancymidol was subject to a Rere gistration Eligibility Decision (RED), which was completed in
June 1995.

Anticipated Risk Assessment and Data Needs :

The Agency anticipates updating and revising th e ecological risk assessment, including an endangered species risk assessment, for the outd oor uses of ancymidol. EPA believes that the existing qualitative human health assessment for ancymidol is ade quate to support its registration review. Below is a summary of the issues releva nt to the registration re view of ancymidol and the data the Agency anticipates requiring:5 Ecological Risk:

• The most recent ecological risk assessment for ancymidol was completed in 1995 in support of the RED.

• EPA intends to conduct an ecological risk assessment for the outdoor uses only of ancymidol during registration review. Th e Agency believes that labeled indoor uses of ancymidol ( i.e., greenhouse, including seed tr eatment, and interiorscape)
would not result in sufficient environmenta l exposure to necess itate an ecological
risk assessment.

• The planned assessment would incor porate the most up-to-date modeling methodologies, updated assessment endpoi nts, and data submitted under the anticipated registration review data call-in.

• The Agency has not conducted an ecol ogical risk assessment that supports a complete endangered species determinati on for ancymidol. The ecological risk assessment planned during registration revi ew will allow the Agency to determine whether ancymidol’s use has “no effect” or “may affect” federally listed threatened or endangered species (listed 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 w ill consult with the U.S. Fish and Wildlife Service (FWS) and/or National Marine Fish eries Service (NMFS) (the Services), as appropriate.

• Data gaps exist in the environmental fate and toxicity databases for ancymidol. In the ecological risk assessment complete d for the 1995 RED, the Agency concluded that, because of the limited treated acr eage, minor use sites (e.g., ornamental flowers and shrubs), and low toxicity cited in the submitted studies, adverse effects to birds, mammals, aquatic organisms and non-target plants were expected to be minimal. Accordingly, no additional ecologi cal data were required at that time. However, based on current environmenta l fate and ecological risk assessment standards, data are anticipa ted to be needed for the registration review assessment of ancymidol.

• Current formulations with labeled outdoor uses for spray, drench, and chemigation applications do not specify maximum app lication rates per plant type. Maximum annual application rates per pot size, or application ra tes per growing season where appropriate, on a chemical weight basis must be specified for the Agency to conduct an ecological risk assessment for all outdoor uses; a maximum number of sequential applications per plant type must also be defined.6 • The Agency anticipates requiring th e following environmental fate and environmental effects data during regist ration review to support an ecological assessment, including an endangered speci es assessment, of the outdoor uses of ancymidol:

o Guideline (GLN) No. 835. 2240 – Photodegradation in Water

o GLN No. 835.2410 – Photodegradation in Soil

o GLN No. 835.4100 – Aerobic Soil Metabolism

o GLN No. 835.4200 – Anaerobic Soil Metabolism

o GLN No. 835.4300 – Aerobic Aquatic Metabolism

o GLN No. 835.4400 – Anaerobic Aquatic Metabolism

o GLN No. 835.6100 – Terrestrial Field Dissipation

o GLN No. 835.6200 – Environmental Chem istry Analytical Methods for
Residues in Water and Sediment a nd Independent Laboratory Validation

o GLN No. 850.2100 – Avian Oral Toxicity (passerine and waterfowl or upland game)

o GLN No. 850.2200 – Avian Dietary Toxicity Test (waterfowl)

o GLN No. 850.2300 – Avian Reproducti on Test (waterfowl and upland game species)

o GLN No. 850.1025 – Oyster Acute Toxicity Test

o GLN No. 850.1035 – Mysid Acute Toxicity Test

o GLN No. 850.1045 – Penaeid Acute Toxicity Test

o GLN No. 850.1055 – Bivalve Ac ute Toxicity Test

o GLN No. 850.1075 – Fish Acute Toxi city Test (Freshwater)

o GLN No. 850.1075 – Fish Acute Toxici ty Test (Estuarine/Marine)

o GLN No. 850.1300 – Daphnid Ch ronic Toxicity Test

o GLN No. 850.1400 – Fish Early-Life St age Toxicity Test (Freshwater)

o GLN No. 850.4100 – Nontarget Area P hytotoxicity Tier II, Seedling Emergence 1

o GLN No. 850.4150 – Nontarget Area P hytotoxicity Tier II, Vegetative Vigor 1

o GLN No. 850.5400 – Nontarget Area Phyt otoxicity Tier II, Aquatic Plant Growth (Algal Plants) 1

• Please refer to Registration Review – Preliminar y Problem Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Ancymidol dated March 28, 2011, located in the docket,
for a detailed discussion of these anti cipated risk assessment and data needs.

1 A Tier II study is expected to be required. The DCI expect ed to be issued will provide that a Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct and submission of a Tier II study as well.7 Human Health Risk:

• The most recent human health risk a ssessment was completed in 1995 in support
of the RED. This assessment evalua ted occupational exposures only, as no
food/feed or residential uses are registered for ancymidol.

• The Agency has evaluated the status of the human health assessments for ancymidol and determined that no additional human health exposure or hazard information are required to support the registration review of ancymidol.

• Please refer to the Ancymidol. Human Health Assessment Scoping Document in Support of Registration Review , dated June 7, 2011, located in the docket, for a detailed discussion of the anticipated ri sk assessment and data needs for human
health.

Endocrine Disruptor Screening Program :

As required by FFDCA section 408(p ), ancymidol is subject to th e endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 screen 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 pest icide active ingredients and 9 inert ingredients. Ancymidol is not among the group of 58 pesticide active ingredient s on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issu e future EDSP orders/data callins, requiring the submission of ED SP screening assays for ancymidol. For further information on the status of the EDSP, the policies and procedur es, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screen ing battery, please visit our website: http://www.epa.gov/endo/

.8 Timeline :

EPA has created the following estimated timeline for the completion of the ancymidol registration review.

Registration Review for Ancymidol – Pr ojected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Co mment Period 2011 – June
Close Public Comment 2011 – August Case Development
Final Work Plan 2011 – November
Issue DCI 2012 – July – Sept.
Data Submission 2014 – July – Sept. Open Public Comment Period for Draft Risk Assessments 2016 – Jan. – March
Close Public Comment Period 2016 – April – June Registration Review Decision Open Public Comment Period for Proposed Registration Review
Decision 2016 – July – Sept.

Close Public Comment Period 2016 – Oct. – Dec. Registration Review Decision and Begin Post-Decision Follow-up 2017 Total (years) 6

Guidance for Commenters :

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manner prior to issuing a fina l work plan (FWP) for ancymidol.

Trade Irritants :

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

Water Quality :

Ancymidol is not identified as a cause of impa irment for any water bodies listed as impaired under section 303(d) of the Clean Water Act 2 . In addition, no Tota l Maximum Daily Loads (TMDL) have been developed for ancymidol 3 . More information on im paired water bodies and

2 http://iaspub.epa.gov/tmdl_waters10/attains _nation_cy.cause_detail_30 3d?p_cause_group_id=885

3 http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant_detail ?p_pollutant_group_id=885&p_ pollutant_group_name=PESTIC IDES9 TMDLs can be found on the Agency’s website 4 . The Agency invites submission 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 Procedur e: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process 5 in order to ensure they can be us ed quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice :

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to ancymidol , compared to the general population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to th e general population.

Other Information :

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining the risk assessments, incl uding any species-specific ecological effects determinations. The Agency is interested in receiving the following information:

1. confirmation on the following label information;

a. sites of application
b. formulations

c. application methods and equipment
d. maximum application rates in units rela ted to mass per unit area of treatment

zone

e. frequency of application, applicati on intervals and maximum number of applications per season
f. geographic limitations on use
2. use or potential use distri bution (e.g., acreage and geogr aphical distribution of relevant crops);
3. use history;
4. median and 90 th percentile reported use rates (lbs. a.i./acre) from usage data – national, state, and county;
5. application timing (date of first applica tion and application intervals) by crop – national, state and county;
6. sub-county crop location data;
7. directly acquired county-level usage data (not derived from state level data);

a. maximum reported use rate (lbs. a.i. /acre) from usage data – county

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

5 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm10 b. median and 90 th percentile number of applications – county

c. total pounds per year – county
d. the year the pesticide was last us ed in the county/sub-county area

e. the years in which the pesticide was applied in the county/sub-county area
8. typical interval (days);
9. state or local use restrictions and
10. ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency.

Next Steps :

After the 60-day comment period closes, the Ag ency will review and respond to any comments received in a timely manner, and then issu e its Final Work Plan (FWP) for ancymidol.

II. FACT SHEET

Background Information :

• Ancymidol PC code: 108601, CAS No.: 12771-68-5.

• Registration review case number: 3017.

• Technical registrants: SePRO Co rporation; Fine Agrochemicals.

• The first ancymidol pesticide product was registered for use in the U.S. in 1973.

• The RED for ancymidol was completed in June 1995.

• Ancymidol product reregistration is complete , and the mitigation specified in the 1995
RED is on current labels.

• There are currently three e nd-use products and two tec hnical products registered.

• There are no tolerances for use of ancymi dol in or on food crops under 40 CFR § 180.

• Pesticide Re-evaluation Divi sion Chemical Review Mana ger: Eric Miederhoff, miederhoff.eric@epa.gov.

• Registration Division Contact: Tony Kish, kish.tony@epa.gov

.

Use & Usage Information : (For additional details, please refer to the Appendix A, SLUA, and Chemical Profile documents in the ancymidol docket.)

• Ancymidol, in the pyrimidine chemical class, is a plant growth regulator registered for treating container-grown herbaceous plants , ornamental woody shrubs, and bedding plants grown in greenhouses and other plan t bedding areas for commercial production.

• Ancymidol is formulated as a soluble concentr ate (solid) or as an emusifiable concentrate (liquid). It may be applied by drip irrigati on, spray, to pots or c ontainerized soil, or by
drench foliar and seed treatments. The am ount of active ingredient required for an optimum growth response depends on pot size , stage of growth, me thod of application, season, and varietal response.11 • The available agricultural us age data for ancymidol in nurseries/greenhouses only indicated that less than 20 pounds active ingredient per year were used nationwide for the years 1999, 2002, 2004, and 2006.

Recent and Pending Actions :

• There are currently no new us e applications under evaluation.

Ecological Risk Assessment Status :

The following are key findings of the most recen t ecological risk assessment for ancymidol.
Please refer to the Registration Review – Preliminary Problem Formulation for the Environmental Fate, Ecological Risk, Endange red Species, and Drinking Water Exposure Assessments for Ancymidol dated March 28, 2011, located in the docket, for a detailed discussion of the ecological risk assessment.

• The most recent ecological risk assessment for ancymidol was completed in 1995 in support of the RED. This assessment identi fied minimal adverse effects to listed and nonlisted fish, aquatic invertebra tes, aquatic plants, birds, mammals, beneficial insects, and terrestrial plants from the nursery use of ancymidol on containe rized plants only. However, this determination was based on an incomplete data set (i.e., effects data on terrestrial plants and chroni c effects data for all species were not available) and unspecified maximum application rates.

Human Health Risk Assessment Status :

The following are key findings of the most recent human health risk assessments for ancymidol.
Please refer to the Ancymidol. Human Health Assessment Scoping Document in Support of Registration Review , dated June 7, 2011, located in the docket, for a detailed discussion of the
human health risk assessment.

• The most recent human health risk assessm ent for ancymidol was completed in 1995 in support of the RED.

Hazard Characterization:

• Ancymidol has low acute oral a nd dermal toxicities (Toxicity Category III for oral and IV for dermal exposure). Ancymidol is a mild eye and skin irritant (Toxicity Category III and IV, respectively). Ancymidol has low acu te inhalation toxicity (Toxicity Category III). It is not a dermal sensitizer.

Dietary (Food and Water):

• Ancymidol is not registered for use on agricultural commodities intended for human consumption. Additionally, concentrations in drinking water are expected to be minimal12 since the primary use of ancymidol occurs i ndoors. Therefore, a dietary assessment was
not conducted for the 1995 RED.

Residential:

• Ancymidol is not registered for use in resi dential settings. Ther efore, a residential exposure risk assessment was not conducted for the 1995 RED.

Occupational :

• Given the low toxicity of ancymidol and lo w application rates, the Agency conducted a qualitative occupational risk assessment and c oncluded potential risk s to workers to be insignificant.

Aggregate:

• Ancymidol is not registered for use on agricultural commodities intended for human consumption or for use in residential setti ngs. Therefore, an aggregate exposure risk
assessment was not conducted for the 1995 RED.

Cumulative:

• The Agency has not determined whether ancymidol shares a common mechanism of toxicity with other chemical s ubstances. If, in the future, th e Agency determines that new information on ancymidol indicates a shared m echanism of toxicity with other chemicals, the Agency will revisit the need for including ancymidol in a cumulative risk assessment.

Incidents :

Ecological:

• The Ecological Incident Information System (EIIS) and the Avian Incident Monitoring System (AIMS) were consulted for reports of ecological incident s associated with ancymidol. No incidents involving ancy midol were found in these databases.

Human Health:

• No ancymidol human incidents were repor ted in the Office of Pesticide Programs Incident Data System (IDS) since 2002.

Tolerances and International Harmonization :

• There are no food/feed uses of ancymidol, thus no tolerances or exemptions from tolerances are necessary for ancymidol.13 Data Call-In Status :

• Generic data call-ins (GDCI-108601-17067 and GDCI-108601-17395) were issued in February and September 1993, respectively. A ll of these data requirements have been
fulfilled.

Labels :

• The labels for ancymidol can be obtained from the Pesticide Product Label System (PPLS) website at: http://oaspub.epa.gov/ pestlabl/ppls.home

.

Ancymidol Registrations as of April 29, 2011

Registration No. Product Name Company Name

67690-2 A-Rest Solution SePRO Corporation

67690-5 A-Rest Technical SePRO Corporation

67690-41 A-Rest Seed Treatment SePRO Corporation

62097-22 Abide Fine Agrochemicals, Ltd.

62097-23 Ancymidol Technical Fine Agrochemicals, Ltd.

III. Summary of Data Gaps

The table below summarizes the anticipated data requirements for ancymidol. The Agency anticipates requiring the following envi ronmental fate and environmental effects data during registration review to s upport an ecological assessment of the outdoor uses of ancymidol.
Please refer to Registration Review – Preliminary Probl em Formulation for the Environmental Fate, Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for Ancymidol for a detailed discussion of these antic ipated risk assessment and data needs.

Guideline
Number Study Title Test
Material Estimated
Timeframe

835.2240 Photodegradation in Water TGAI 12

835.2410 Photodegradation in Soil TGAI 12

835.4100 Aerobic Soil Metabolism TGAI 24

835.4200 Anaerobic Soil Metabolism TGAI 24

835.4300 Aerobic Aquatic Metabolism TGAI 24

835.4400 Anaerobic Aquatic Metabolism TGAI 2414 Guideline
Number Study Title Test
Material Estimated
Timeframe

835.6100 Terrestrial Field Dissipation TGAI 24

835.6200 Environmental Chemistry Analytical Methods
for Residues in Water and Sediment and Independent Laboratory Validation TGAI 12

850.2100 Avian Oral Toxicity (p asserine and waterfowl or upland game) TGAI 6 12

850.2200 Avian Dietary Toxicity Test (waterfowl) TGAI 12

850.2300 Avian Reproduction Test (waterfowl and upland game species) TGAI 24

850.1025 Acute Toxicity Estuarine/Marine Organisms (Oyster) TGAI 12

850.1035 Mysid Acute Toxicity Test TGAI 12

850.1045 Penaeid Acute Toxicity Test TGAI 12

850.1055 Bivalve Acute Toxicity Test TGAI 12

850.1075 Freshwater Fish Toxicity (Estuarine/Marine) TGAI 12

850.1075 Freshwater Fish Toxic ity (Freshwater) TGAI 12

850.1300 Daphnid Chronic Toxicity Test TGAI 12

850.1400 Fish Early-Life Stage Toxicity Test (Freshwater) TGAI 12

850.4100 Nontarget Area Phytotoxic ity Tier II, Seedling Emergence 7 TEP 8 12

850.4150 Nontarget Area Phytotoxicity Tier II, Vegetative Vigor 7 TEP 12

850.5400 Nontarget Area Phytotoxic ity Tier II, Aquatic Plant Growth (Algal Plants) 7 TEP 12

6 Technical Grade Active Ingredient (TGAI).

7 A Tier II study is expected to be required. The DCI expe cted to be issued will provide that a Tier I plant study may be conducted in lieu of a Tier II study with the understanding that any adverse effects observed by the Tier I study would necessitate conduct and submission of a Tier II study as well.

8 Typical End-use Product (TEP)