Docket Number: EPA-HQ-OPP-2010-0240 www.regulations.gov

United States Chemical Safety June 2010

Environmental Protection and Pollution Prevention Agency (7510P)



# Xylenol Summary Document: Registration ReviewDocket Number: EPA-HQ-OPP-2010-0240 www.regulations.gov



### TABLE OF CONTENTS

Xylenol Registration Review Team ................................................................................. 4

I. PRELIMINARY WORK PLAN – XYLENOL .......................................................... 5

II. FACT SHEET ............................................................................................................ 13

III. GLOSSARY of TERMS & ABBREVIATIONS ................................................... 16 IV. Appendix A ................................................................................................................ 18

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Xylenol Registration Review Team

Human Health & Environmental Effects

William Hazel Najm Shamim

Risk Management

Eliza Blair

Lance Wormell

Office of General Counsel Philip Ross

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I. PRELIMINARY WORK PLAN – XYLENOL

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a re gistration review program. All pesticides distributed or sold in the United States generally must be registered by the U.S. Environmental Protec tion Agency (USEPA, 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 di rected on product labe ling. 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 unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pestic ide use practices will occur over time. Through the registration review program, the Agency periodically r eevaluates pesticides 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/

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The Agency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to de termine whether it continues to meet the FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of re gistration 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 believes are needed to make a registrati on review decision. After reviewing and responding to comments and data received in the docket during th is initial comment period, the Agency will develop and commit to a final work plan and schedule for the registration review of Xylenol.

Xylenol (PC Code 086804) shares its si ngle registered product, Gallex, with another active ingredient, M- Cresol (PC Code 022102). M-Cr esol is being considered separately under registration review Case #4027 in docket ID EPA-HQ-OPP-2010-0244.

Gallex contains M-Cresol at a concentration of 0.466%, and Xy lenol at a concentration of 0.463%. This product is used to selectively ki ll bacterial galls in orchard and greenhouse trees and ornamentals such as apple, filbert, pear, walnut, and olive tr ees, as well as roses

and willows.

A pesticide product containing Xylenol wa s first registered in 1980. A combined RED was issued for M-Cresol and Xylenol in September 1994. The RED can be located

at: http://www.epa.gov/pesticides /reregistration/status.htm

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Risk Assessment Status & Anticipated Data Needs

Human Health Risk Assessment Status and Anticipated Data Needs

Based on a review of the complete risk assessment that was performed for the 1994 m-Cresol and Xylenol RED and the combin ed human health databases for m-Cresol and Xylenol, the Agency anticipates that no a dditional toxicity and exposure data will be needed for the registration review of this case. Additionally, based on Xylenol’s low concentration in Gallex, limited use patterns, low total volume of use, and limited exposure due to Personal Prot ective Equipment (PPE) requirements on the label, the Agency believes that dietary, drinking wa ter, occupational, and residential exposure

scenarios and risk assessments are not need ed; the very conservative risk assessments performed in the 1994 RED are considered sufficient for registration review.

Further information are available in “2,4-Xylenol: Human Health Effects Scoping Document for the Registration Review Decision”, dated May 17, 2010.

Dietary and Drinking Water Assessment

Xylenol has no registered food uses and no tolerances or tolerance exemptions for use in food. The Gallex label specifies that plan ts should be treated “w hen rain is unlikely for several days”, and that fruit and nuts from treated plants are not to be used for food and feed purposes. Use of Gallex in the greenhou se and in the field is not expected to result in human dietary exposure to resi dues in food. Additionally, because of low

volume of use and the aforementioned label rest rictions, it is not expected to result in contamination of drinking water; however, the Agency may still conduct a drinking water assessment based on the results of the hydrol ysis study requested in the environmental

fate section.

Occupational and Resi dential Assessment

An occupational and/or residential expos ure assessment is required for an active ingredient if (1) certain toxico logical criteria are triggered and (2) there is potential exposure to handlers (mixers, loaders, applicators, etc.) during use.

Gallex is applied with a paintbrush by hand but the label instructions for a 24- hour re-entry interval and the requirement th at handlers wear certa in personal protective equipment (PPE) – long-sleeved shirt and pant s, shoes and socks, chemical-resistant gloves, and protective eyewear – are consider ed sufficient to protect workers from the localized irritation effects of exposure to Xylenol. The Agency does not anticipate needing to perform an occupational or resident ial applicator assessment for this chemical.

Tolerances

Xylenol has no registered food uses and no tolerances or tolerance exemptions for

use in food.

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Aggregate/Cumulative Exposure & Risk

In examining aggregate exposure, EP A takes into account the available and reliable information concerning exposures to pesticide residues in food and drinking water, as well as non-occupati onal pesticide exposures. An aggregate risk assessment is not needed for Xylenol because the only two potential routes of exposure to Xylenol are occupational and residential applications, neith er of which is expected to result in significant exposure or to require risk assessment.

Section 408(b)(2)(D)(v) of FFDCA require s that, when considering whether to establish, modify, or revoke a tolerance, th e Agency consider “available information” concerning the cumulative effects of a part icular pesticide's residues and “other

substances that have a common mechanism of toxicity.” EPA has not yet determined whether Xylenol has a common mechanism with other compounds; consequently, a cumulative assessment will not be performed at this time.

Anticipated Human Health Data Needs:

The Agency considers its database for all human health risk assessments for Xylenol sufficient at this time. No furthe r human health data needs are anticipated.

Further information is available in “ 2,4-Xylenol: Human Health Effects Scoping Document for the Registration Review Decision,” dated May 17, 2010.

Anticipated Physical/ Chemic al Property Data Needs

All product chemistry data requirements have been fulfilled for the active ingredient Xylenol. Therefore, the Agency does not anticipate needing additional product chemistry data at this time.

Further information is available in “2,4-Xylenol: Product Chemistry/ Environmental Fate and Eco-Effect s Scoping Document”, dated May 10, 2010.

Anticipated Environmental Fate and Ecotoxi city Risk Assessment and Data Needs

The Agency has reviewed the environmental fate and ecological hazard databases for Xylenol. Based on its review, EPA believes ri sk assessments are needed to ensure that the Xylenol registration review case meets FI FRA standards. The Agency will complete the environmental fate and ecological hazard risk assessments presented below.

Further information and detailed justificat ions for the studies that are anticipated as being needed are available in th e document titled “2,4-Xylenol: Product Chemistry/Environmental Fate and Eco-Effects Scoping Document”, dated May 10,

2010.

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Environmental Fate and Transport

The 1994 combined RED for M-Cresol and Xylenol waived all environmental fate and ecotoxicity data needs for both ch emicals due to their low concentration, low total volume of use, and limited use pattern. However, results from available computer models are inconsistent on the predicted biod egradability of Xylenol and the length of time that it may persist in the environment. Because of this, the Agency anticipates needing a hydrolysis study to confirm Xylenol’s degradation rate:

o (GLN 835.2120) Hydrolysis

Ecological Effects / Ectoxicity

As mentioned above, all ecot oxicity data needs have previously been waived. However, due to some uncertainty regardi ng Xylenol’s environmental fate, the Agency anticipates needing a hydrolysis study for use in the ecotoxic ity risk assessment. If the hydrolysis study shows that Xylenol does not break down readily, further data regarding its effects may be needed. Base on the resu lts of the hydrolysis study, the Agency will determine whether it needs the following studies:

o (GLN 850.2100) Acute avian oral

o (GLN 850.2200) Acute avia n dietary, bobwhite quail

o (GLN 850.1075) Acute fish, rainbow trout

o (GLN 850.1010) Acute aquatic invertebrate, Daphnia Magna

Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species determination for Xylenol . The ecological risk assessment planned during registration review will allow the Agency to determine whether Xylenol use has “no effect” or “may affect” federally liste d threatened or endangered species (listed species) or their designated critical habita ts. 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 Services (the Services), as appropriate.

Incidents:

A search of the Office of Pesticide Programs Incident Database yielded no reported incidents for Xylenol.

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Timeline:

The Agency has created the following estimated timeline for the completion of the Xylenol registration review:

Activities Estimated Month/Year

Phase 1: Opening the docket
Open Public Comment Period for Xylenol Docket June 2010

Close Public Comment Period August 2010
Phase 2: Case Development

Develop Final Work Plan (FWP) December 2010

Issue DCI December 2011

Data Submission December 2013
Open Public Comment Period for Preliminary Risk Assessments June 2015

Close Public Comment Period September 2015

Phase 3: Registration Review Decision
Open Public Comment Period for Propos ed Reg. Review Decision December 2015

Close Public Comment Period March 2016 Final Decision and Begin Post-Decision Follow-up 2016 Total (years) 6

Guidance for Commenters:

The public is invited to co mment on EPA’s preliminary registration review workplan and rationale. The Agency will consider all comments as well as any additional information or data provided in a timely manne r prior to issuing a fi nal work plan for the Xylenol case.

Trade Irritants

Through the registration review process, th e Agency intends to solicit information on trade irritants and, to the extent feasible , take steps toward facilitating irritant

resolution. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key export ma rkets, providing as much specificity as possible regarding the nature of the concern.

Water Quality

Xylenol are not identified as a cause of impairment for any 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/attain s_nation_cy.cause_detail_303d?p_cause_grou p_id=885 . In addition, no Total Maximum Daily Loads (TMDL) have been developed

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for [insert pesticide], based on information provided at http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant _detail?p_pollutant_gr oup_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 extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Im paired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment 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 qualitatively in pesticide risk assessments.

Environmental Justice

EPA seeks to achieve environmental justi ce, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcemen t of environmental laws, regulations, and policies. To help address potential envir onmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factor s, may have atypical, unusually high exposure to Xylenol, compared to the general populati on. Please comment if you are aware of any sub-populations that may have atypical, unusua lly high exposure compared to the general population.

Endocrine Disruptor Screening Program

As required under FFDCA section 408(p) , EPA has developed the Endocrine Disruptor Screening Program (EDSP) to dete rmine whether certain substances (including pesticide active and other ingred ients) may have an effect in humans or wildlife similar to an effect produced by a “natur ally occurring estrogen, or othe r such endocrine effects as the Administrator may designate.” The ED SP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substa nce 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 the potential to inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP wher e EPA will determine which, if any, of the Tier 2 tests are necessary based on the avai lable data. Tier 2 te sting is designed to identify any adverse endocrine related eff ects caused by the substance, and establish a dose-response relationship between th e 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 c ontains 58 pesticide ac tive ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

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Xylenol is not among the group of 58 pesticid e active ingredients on the initial list

to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide chemicals. Accordingly, EPA anticip ates issuing future EDSP test orders/data call-ins for all pesticide active ingredients.

For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our

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

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Structure Activity Relationships

EPA must rely upon information of appropr iate quality and reliability for each decision made by the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide chemical traditionally begins with the appli cant’s submission of a

set of studies conducted with th e specific pesticide chemical of interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous process that identifies the physical, chemical, and environmen tal fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species.

Today, there is significant interest in a lternative techniques, i.e., techniques other than data generation that could significan tly inform the Agency’s decision-making process. Recently, OPP has made increasing use of structure activity relationship (SAR) as part of its regulatory d ecision-making process. In the SAR process, a chemical's molecular structure is compared to that of other chemicals fo r which data are available.

These structural similarities are then us ed to make predictive judgments about a chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, chemical, and biological propertie s are a function of (o r directly related to) the chemical’s molecular structure. Quantitative SAR is re ferred to as QSAR. To develop a QSAR, a selected set of measured data on a single phys ical, chemical, or bi ological property is used to derive a model (an equation) to predict the value of that property.

Since SAR assessments and QSAR modeli ng are another set of tools that are available to Agency scientists, OPP has begun a process shift that envisions shifting from the current study-by-study appro ach to an approach in which the use of predicted data, generated using validated models, is cons idered along with information from open literature and studies specifi cally generated under Part 161 requirements. All relevant information would be considered as part of a weight-of-the-evidence evaluation.

At this time, EPA believes that for cert ain endpoints, especially physical/chemical and fate properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals. When c onsidering biological properties, at this time, EPA believes that SAR and QSAR can be most effectively

utilized in the evaluation of ch emicals that exhibit lower toxi city for human health and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity

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chemicals can be stream-lined, i.e., a screen ing-level assessment pr ocedure rather than multiple tiers of assessments with pr ogressively more data requirements.

If stakeholders believe that submission of pr edicted data can fulfill one of the data needs for Xylenol, then the Agency invites submission of this information. The submitter would be expected to supply a rationale desc ribing the utility of the information and provide documentation on the scie ntific validity of the info rmation. The determination that the predicted data fulfills the data require ment would be at the sole discretion of the Agency. Pre-submission consultation with the Agency is encouraged.

Additional Information

Stakeholders are also specifically asked to provide available information and data that will assist the Agency in refining the ecological and human health risk assessments. The Agency is interested in obtaining the following information regarding the use of Xylenol:

1. Confirmation on the following label information:

a. Sites of application

b. Formulations

c. Application methods and equipment

d. Maximum application rates

e. Frequency of application, app lication intervals and maximum number of applications

f. Geographic limitations on use

2. Use or potential use distribution

3. Use history

4. Usage/use information for non-agricultural uses (e.g., materials preservation)

5. Typical application interval

6. State or local use restrictions

7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and mammalian mo rtalities) not already reported to the Agency

8. Monitoring data

9. Structure Activity Relationships

Next Steps:

After the 60-day comment period closes, th e Agency will review and respond to any comments received in a timely manner, and then issue a Final Work Plan for Xylenol.

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II. FACT SHEET

Background Information

• Xylenol registration re view case number: 4098

• Alternate names: 2,4-Xylenol

• PC Code: 086804

• CAS#: 105-67-9

• Technical registrant: AgBioChem, Inc.

• First approved for use in a registered product: 1980

• RED issued (jointly with M-Cresol) in September 1994

• Antimicrobials Division Chemical Revi ew Manager (CRM): Eliza Blair, blair.eliza@epa.gov

• Registration Division Product Manager (PM): Mary Waller

Chemical Structure:

Use & Usage Information

• One product in combination with M-Cresol (Product name: Gallex)

• Gallex is painted directly onto bacterial galls in fruit, nut & ornamental trees.

• Personal Protective Equipment (PPE) required on label:

o Long-sleeved shirt & long pants

o Shoes and socks

o Chemical-resistant gloves

o Protective eyewear

Recent Regulatory Actions

A joint RED was issued for M-Cresol and Xylenol in September 1994.

Human Health Risk Assessment Status

The Agency has reviewed the hazard and exposure databases for the Xylenol registration review case and considers them sufficient for registration review. The Agency anticipates that no additional toxic ity and exposure studies will be needed, and toxicological and occupational risk assessments need not be performed.

Further information is available in “ 2,4-Xylenol: Human Health Effects Scoping Document for the Registration Review Decision”, dated May 17, 2010.

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Product Chemistry Database Status

The Agency has reviewed the product chemistry database for the Xylenol registration review case and an ticipates that no additional product chemistry data will be needed for registration review.

Further information is available in “2,4-Xylenol: Product Chemistry/ Environmental Fate and Eco-Effect s Scoping Document”, dated May 10, 2010.

Environmental Fate & Ecologi cal Risk Assessment Status

The Agency has reviewed the environmen tal fate and ecotoxicity databases for the Xylenol case and anticipates needing addi tional environmental fate and ecotoxicity data for the registration revi ew of this chemical.

The Agency has not conducted a risk assessment that supports a complete endangered species determination for Xylenol . The ecological risk assessment planned during registration review will allow the Agency to determine whether Xylenol use has “no effect” or “may affect” federally liste d threatened or endangered species (listed species) or their designated critical habita ts. 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 Services (the Services), as appropriate.

Further information and detailed justificat ions for the studies that are anticipated as being needed are available in “2,4-Xyle nol: Product Chemistry/Environmental Fate and Eco-Effects Scoping Document”, dated May 10, 2010.

Tolerances

There are no tolerances or exemp tions from tolerances for Xylenol.

Data Call-In Status

A joint RED was issued for Xylenol and M-Cresol in September 1994. A Generic Data Call-In (GDCI) for each chemical was issued in January 1989 (data requirements satisfied). A Product-Specific Data Call-In (PDCI) for each chemical was issued in November 1994 (data requirements satisfied). The Agency anticipates needing additional data to complete a risk assessm ent during Registration Review.

Labels

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There is one product registered for Xyle nol. The EPA Registration Number is provided in Table 2 below. Product registration labels may be obtained from the Pesticide Product Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

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Table 2. Registered product containing Xylenol

EPA Reg.

No. Product Name Formulation Type Percent Active Ingredient Registrant

40230-2 Gallex RTU

solution 0.463% AgBioChem, Inc.

Incidents

A search of the Office of Pesticide Programs Incident Database yielded no reported incidents for Xylenol.

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III. GLOSSARY of TERMS & ABBREVIATIONS

ai Active Ingredient AR Anticipated Residue ASTM American Society for Testing and Materials

AWPA American Wood Preserver’s Association

CFR Code of Federal Regulations cPAD Chronic Population Adjusted Dose

CSF Confidential Statement of Formula CSFII USDA Continuing Surveys for Food Intake by Individuals

DCI Data Call-In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DNT Developmental Neurotoxicity DWLOC Drinking Water Level of Comparison

EC Emulsifiable Concentrate Formulation EDWC Estimated Drinking Water Concentration

EEC Estimated Environmental Concentration EPA Environmental Protection Agency

EUP End-Use Product FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery GENEEC Tier I Surface Water Computer Model

IR Index Reservoir

LC 50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD 50 Median Lethal Dose. A statistically deri ved single dose that can be expected to

cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.

LOC Level of Concern

LOAEL Lowest Observed Adverse Effect Level μg/g Micrograms Per Gram μg/L Micrograms Per Liter mg/kg/day Milligram Per Kilogram Per Day mg/L Milligrams Per Liter MOE Margin of Exposure

MRID Master Record Identifi cation (number). EPA's system of recording and tracking

submitted studies. MUP Manufacturing-Use Product

NA Not Applicable NAWQA USGS National Ambient Water Quality Assessment NPDES National Pollutant Discharge Elimination System

NR Not Required

NOAEL No Observed Adverse Effect Level

OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pesticides and Toxic Substances PAD Population Adjusted Dose PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area

PDP USDA Pesticide Data Program

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17 of 18 PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval ppb Parts Per Billion

PPE Personal Protective Equipment

ppm Parts Per Million PRZM/EXAMS Tier II Surface Water Computer Model Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer

Risk Model RAC Raw Agriculture Commodity RED Reregistration Eligibility Decision

REI Restricted Entry Interval

RfD Reference Dose RQ Risk Quotient SCI-GROW Tier I Ground Water Computer Model

SAP Science Advisory Panel SF Safety Factor

SLN Special Local Need (Registrati ons Under Section 24©) of FIFRA) TGAI Technical Grade Active Ingredient

TEP Typical End-Use Product USDA United States Department of Agriculture UF Uncertainty Factor

WPS Worker Protection StandardDocket Number: EPA-HQ-OPP-2010-0240www.regulations.govIV.Appendix AUse SiteFormulationMethod ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsOrchards and GreenhousesBacterial disease controlin fruit & nut trees, vines,and ornamentalsEmulsifiableconcentratePaint directlyonto surfaceApply when rain isunlikely for several days.Cut off major portion of allgalls larger than a baseballand allow to dry 1 or moredays before treatment.Paint onto gall and cutsurfaces plus 1⁄2 inch ofhealthy bark. Worksolution into cracks andcrevices with brush.Examine after 4-6 monthsand retreat if live galls arefound.Apply to non-edible organs only. Do not usefruit or nuts from treated plants for food orfeed purposes.18 of 18