Docket Number: EPA-HQ-OPP-2010-0214 www.regulations.gov



## Pyridaben Summary Document Registration Review: Initial Docket September 20103 of 14 

### TABLE OF CONTENTS

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 11

______________________ __________________

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 Ecological Risk and Drinking Water Exposure Assessments for Pyridaben. August 26, 2010.

2. Pyridaben. Human Health Assessment Scoping Document in Support of Registration Review. May 21, 2010.

3. Pyridaben: Review of Hu man Incidents. May 20, 2010.

4. Screening Level Use Analysis (SL UA) for Pyridaben. October 19, 2009.

5. Appendix A for Pyridaben. July 6, 2009.

Supporting documents for Pyridaben may be found in the docket (EPA-HQ-OPP-2010-0214) located on the internet at www.regulations.gov.4 of 14 I. Preliminary Work Plan – Pyridaben

Introduction:

The Food Quality Protection Act of 1996 mandated a registration review program. All pesticides
sold or distributed in the United States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), based on scientific data showing that they will not

cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intende d 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 unreasonable adverse eff ects 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 Ag ency periodically reevaluates pest icides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/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), a nd 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 what it 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 pyridaben.

Pyridaben was first registered in 1996 and is used as a miticide/insecticide in orchards and vineyards. Pyridaben is formul ated as both wettable powder and as an aqueous solution. There are no residential uses for pyrid aben. Tolerances for pyridaben are established under 40 CFR
180.494 for residues that result from agricultural uses.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting a comprehens ive ecological risk assessment, including an endangered species assessment, for all uses of pyridaben. A drinking water assessment will be conducted in order to support future human health risk assessments. Below is a summary of the issues relevant to the registra tion review proce ss of pyridaben.5 of 14 Ecological Risk:

• The most recent ecological risk assessment for pyridaben was completed in 2004 for uses on strawberries, hops, tropical fruits, and stone fruits.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for pyridaben. The ecological risk assessment planned during registration review will allow the Agency to determine whether pyridaben’s use has “no effect” or “may affect” federally listed threat ened or endangered sp ecies (listed species) or their designated critical ha bitats. When an assessment c oncludes that a pesticide’s use “may affect” a listed species or its designate d critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

• Based upon the use pattern and the current data base, the Agency anticipates requiring the following environmental fate a nd ecological effects data in order to conduct a complete ecological risk assessment, including an e ndangered species assessment, for all uses:

o GLN 835.4100 Aerobic Soil Metabolism

o GLN 835.4300 Aerobic Aquatic Metabolism

o GLN 835.4400 Anaerobic Aquatic Metabolism

o GLN 835.6100 Frozen Storage Stability

o GLN 835.6200 Environmental Chemistry An alytical Method and Independent Laboratory Validation for Residues in Water (see 40 CFR § 158.1300 note 7)

o GLN 835.6100 Environmental Chemistry An alytical Method and Independent Laboratory Validation for Residues in Soil (see 40 CFR § 158.1300 note 7)

o GLN 850.1710 Bioconcentration in oysters

o GLN 850.1850 Aquatic food chain transfer

o GLN 850.3040 Field testing for pollinators

o GLN 850.1075 Estuarine/Marine Fi sh Acute Toxicity Test

o GLN 850.1400 Saltwater fish early-life stage test

o GLN 850.1350 Estuarine/Marine in vertebrate life cycle test

o GLN 850.1735 Whole sediment: acute freshwater invertebrates

o Special Study Whole sediment: chronic freshwater invertebrates

o GLN 850.4100 Terrestrial Plant Toxicity Test, Tier II: Seedling Emergence

o GLN 850.4150 Terrestrial Plant Toxicity Test, Tier II: Vegetative Vigor

o GLN 850.5400 Aquatic Plant Toxici ty Test, Tier II: Algae

o GLN 850.4400 Aquatic Plant Toxicity Te st, Tier II: Vascular Plants Registrants may opt to conduct a Tier I studies (GLN 850.4100, 4150, 5400, 4400) in lieu of a Tier II, with the und erstanding that any adverse effects (even if <25%) will necessitate a Tier II study. A Tier II study will enable the Agency to conduct an endangered species assessment for nontarget plants.6 of 14 • Please refer to the document, Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Water Assessments for Pyridaben, dated August 26, 2010, located in the docket for a detailed disc ussion of the anticipated risk assessment

and data needs.

Human Health Risk:

• The most recent human health risk assessm ent for pyridaben was completed in 2005 for use on hops, tropical fruits, strawberries, and stone fruits.

• Based on the current use pattern, the Agency an ticipates requiring the following data in order to support a human health risk assessment for pyridaben:

o GLN 870.7800 Immunotoxicity

• Following submission of the additional toxicolo gical data, the Agency plans to update the human health toxicity profile.

• As part of registration review, a new diet ary risk assessment should be conducted which
utilizes the most current version of the Di etary Exposure Evaluation Model software with the Food Commodity Intake Database.

• The most recent Tier 1 drinking water e xposure assessment was completed in 2004. A new drinking water assessment will be c onducted to support the anticipated dietary exposure assessments of pyridab en in registration review.

• The livestock dietary burdens should be r eassessed to evaluate potential secondary residues of pyridaben and its metabolites in/on livestock commodities due to of feed items with pyridaben residues resulting fr om the established food/feed commodities.

• An updated occupational exposure and risk asse ssment for all uses will be conducted to support registration review. This updated ri sk assessment will consider any revised toxicity endpoints or expos ure assessment methodologies.

• The pyridaben tolerance expression ( 40 CFR 180.494) will be reviewed during registration review to ensure that it appropr iately covers the metabolites and degradates of pyridaben and that it specifics the re sidues to be measured for each commodity.

• Please refer to the document, Pyridaben. Human Health Assessment Scoping Document in Support of Registration Review, dated May 21, 2010, located in the docket for a detailed discussion of the anticipated risk assessment needs for human health.7 of 14 Other Data Needs:

• GLN 830.7050 UV/Visible Light Ab sorption – this study is a new data requirement under 40 CFR part 158 (Product Chemistry Data Requi rements) for registration of a pesticide (food and non-food uses). The Agency antici pates requiring this study to obtain basic information about the compound’s identity/com position and the wavelengths at which the compound may be susceptible to photochemical degradation.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EP A has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (inc luding pesticide active and other ingredients) may have an effect in humans or wildlife si milar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered ap proach to making the statutorily required

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the 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 quantitative relationship betw een the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticid e active ingredients and 9 inert ingredients.
This list of chemicals was selected based on th e potential for human exposure through pathways such as food and water, residen tial activity, and certain post-applic ation agricultural scenarios.

This list should not be construed as a lis t of known or likely endocrine disruptors.

Pyridaben is not among the group of 58 pesticide active ingredients on th e initial list to be
screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticipates i ssuing future EDSP orders/data call-ins for all Registration Review cases, including those for which EPA has already opened a Registration Review docket for a pestic ide active ingredient.

For further information on the status of the ED SP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, pleas e visit our website: http://www.epa.gov/endo/

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Timeline:

EPA has created the following estimated ti meline for the completion of the pyridaben registration review.8 of 14 Registration Review for Pyridaben – Pr ojected Registration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Co mment Period 2010 – September

Close Public Comment 2010 – November Case Development

Final Work Plan 2011 – February

Issue DCI 2011 – Oct. – Dec.

Data Submission 2013 – Oct. – Dec. Open Public Comment Period for Preliminary Risk Assessments 2015 – April – June

Close Public Comment Period 2015 – July – Sept. Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2015 – Oct. – Dec.

Close Public Comment Period 2016 – Jan. – March Final Registration Review Decision a nd Begin Post-Decision Follow-up 2016 Total (years) 6

Guidance for Commenters:

The public is invited to comme nt on EPA’s preliminary regist ration review work plan and rationale. The Agency will carefully consid er all comments as well as any additional information or data provided in a timely manner pr ior to issuing a final wo rk plan for pyridaben.

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 nature of the concern.

Water Quality:

Pyridaben is not identifie d as a cause of impairment for a ny water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=88

5 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for pyridaben, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES . More information on impaired water bodies and

TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the exte nt possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e: Inclusion of Impaired9 of 14 Water Body and Other Water Quality Data in OPP’s Regist ration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ) in order to ensure they can be used quantitatively or qualitati vely 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, regulations, 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 pyridabe n, 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 the general population.

Other Information:

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining the ecological and human h ealth risk assessments, including any speciesspecific effects determinations. The Agency is interested in receiving the following information:

1. suggestions from stakeholders on ways to reduce non-target organism exposures to pyridaben

2. confirmation on the following label information

a. maximum application rates

b. geographic limitations on use

3. use or potential use distri bution (e.g., acreage and geogr aphical distribution of relevant crop)

4. use history

5. median and 90 th percentile reported use rates (lbs. a.i./acre) from usage data – national, state, and county

6. application timing (date of first applica tion and application intervals) by crop – national, state and municipality

7. sub-municipality crop location data

8. directly acquired municipali ty-level usage data (not de rived from state level data)

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

b. percent crop treated – county

c. median and 90 th percentile number of applications – county

d. total pounds per year – county

e. the year the pesticide was last us ed in the county/sub-county area

f. the years in which the pesticide was applied in the county/sub-county area

9. state or local use restrictions10 of 14 10. ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency

11. monitoring data

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 issue its Final Work Plan (FWP) for the pyridaben registration review.11 of 14 II. FACT SHEET

Background Information :

• Pyridaben PC Code: 129105, CAS#: 96489-71-3

• Technical registrant: Nissan Chemical Industries, Ltd (EPA Company No. 33906)

• First registered for use in 1996; ther efore not subject to Reregistration.

• There are eleven active FIFRA section 3 regi strations and six special local need 24c registrations.

• Pesticide Re-evaluation Divi sion Chemical Review Manage r (CRM): Carissa Cyran cyran.carissa@epa.gov

• Registration Division Co ntact: Richard Gebken gebken.richard@epa.gov

Use & Usage Information: (For additional details, please refer to the Appendix A document in the pyridaben docket.)

• Pyridaben is a miticide/insecticide applied to tr ee nuts, pistachio, apple, pear, citrus fruits, grape, apricot, cherry, nectarine, peach, pl um, prune, plumcot, cr anberry, ornamentals, strawberries, hops, tropical fruit, and greenhouse-grown tomatoes.

• Pyridaben is formulated as both a wetta ble powder and as an aqueous solution.

• Approximately 50,000 pounds of pyridaben were used annually between 2001- 2007.

Recent Actions:

• A section 24c special local needs (SLN) for th e use of pyridaben on p ears in four counties in Washington was granted in May 2010. Th is SLN allows a higher rate on pears.

Ecological Risk Assessment Status :

The following are key findings of the most recen t ecological risk assessments for pyridaben. Please refer to the document, Registration Review – Preliminary Problem Formulation for the Ecological Risk and Drinking Wate r Assessments for Pyridaben , located in the docket for a

detailed discussion of the ecological risk assessment.

• Pyridaben (parent only), at the maximum uses rates on strawberries, hops, tropical fruit, and stone fruit, exceeded acute and chronic ri sk levels of concern (LOC) for freshwater fish and invertebrates, acute risk for estuarin e/marine fish and invertebrates, and chronic

risk for birds and mammals.

• The avian acute LOC’s were not exceeded.12 of 14 • Bioconcentration of pyridaben in the food chain has been identified as a potential

concern.

Human Health Risk Assessment Status:

The following are key findings of the most recent human health risk assessments for pyridaben. Please refer to the document, Pyridaben. Human Health Assessment Scoping Document in Support of Registration Review

, located in the docket for a de tailed discussion of the human

health risk assessment.

Hazard Characterization:

• An acute neurotoxicity study in rats showed possible neurotoxic effects at the higher
tested doses. A subchronic neurotoxicit y study showed no evidence of neurotoxic

effects.

• Carcinogenicity studies for pyridaben do not demonstrate any evidence of cancer, thus

the chemical is classified as “Not Li kely to Be Carcinogenic to Humans.”

Dietary (Food and Drinking Water):

• The most recent acute and chronic diet ary (food and drinking water) exposure assessments were completed in 2005 and were below the Agency’s level of concern for the general U.S. population and all populat ion subgroups examined, thus there are no dietary risks.

Residential:

• There are no residential uses for or exposures to pyridaben; therefor e, a residential risk
assessment has not been conducted.

Aggregate:

• Aggregate risks are calculated from combined dietary and residential exposures. Since
there are no residential uses of pyridaben, aggregate risks are equivalent to dietary risks and are below the Agency’s level of concern.

Occupational :

• An occupational exposure assessment ha s been conducted for wettable powder formulations and showed no risks above the Agency’s level of concern with combined (dermal and inhalation) margins of exposur e (MOEs) from 110-600 for applicators and 1,700-36,000 for mixer/loaders.13 of 14 • An occupational exposure assessment has b een conducted for postapplication dermal exposure and showed no risks above the Agency’s level of concern with MOEs from

100-790.

• Postapplication inhalation exposure and risk was not quantitatively assessed. The12 hour re-entry interval (REI), as required in the Worker Protection Standard, is on the current

labels.

• Past pyridaben risk assessments rely in part on data from studies in which adult human subjects were intentionally exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, invo lving exposure to many different pesticides, comprise generic pesticide exposure database s such as the Pestic ide Handlers Exposure Database (PHED) and the Agricultural Reen try Task Force (ARTF) Database. EPA has reviewed all the studies supporting these multi- pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relativ e to the ethical standards prevailing at the time the research was conducte d. All applicable re quirements of EPA’s

Rule for the Protection of Hu man Subjects of Research ( 40 CFR Part 26) have been satisfied, and there is no re gulatory barrier to continue d reliance on these studies.

Cumulative

• The Agency has not determined whether pyridaben shares a common mechanism of toxicity with other chemical s ubstances. If, in the future, th e Agency determines that new information on pyridaben is available that could potentially impact a cumulative risk assessment and result in a risk of concern, the Agency will revisit a cumulative risk

assessment.

Incidents:

• The Office of Pesticide Programs Incident Data System (IDS) was reviewed for reports of pyridaben human incidents. Based on the low number and severity classification (i.e., 11 cases, classified as either low or moderate severity), th ere does not appear to be a
concern at this time that would wa rrant further investigation.

• No ecological incidents have been reported fr om 2002 to the present associated with the use of pyridaben.

Data Call-In Status:

• No DCIs have been issued for pyridaben.14 of 14 Tolerances and International Harmonization:

• Tolerances are established under 40 CF R 180.494 for residues that result from agricultural uses.

• The permanent tolerance expression for all commodities is in terms of the parent only for plant commodities, and parent plus the me tabolites PB-7, and PB-9 for livestock

commodities.

• Where possible, EPA encourages the harmoni zation of U.S. tolerances and Maximum Residue Limits (MRLs) in key export mark ets. A table noting the U.S. tolerances, Canadian MRLs, and Codex MRLs for pyrid aben is located in the Human Health Assessment Scoping Document in Support of Registration Review. The Agency will work to harmonize tolerances/MRLs, wher e possible, during registration review.

Labels :

• The labels for pyridaben (EPA Reg. Nos. 33906-16, 33906-19, 33906-20, 33906-21, 33906-22, 33906-23, 33906-24, 81880-3, 81880-4, 81880-5, and 81880-7) can be obtained from the Pesticide Product Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.home

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