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 Review 

 

 

Docket 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 

3 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

Xylenol Registration Review Team 

Human Health & Environmental Effects 

William Hazel 

Najm Shamim 

Risk Management

Eliza Blair 

Lance Wormell 

Office of General Counsel

Philip Ross 

4 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

I. PRELIMINARY WORK PLAN – XYLENOL

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review 

program. All pesticides distributed or sold in the United States generally must be 

registered by the U.S. Environmental Protection 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 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 unreasonable 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 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 at 

http://www.epa.gov/oppsrrd1/registration_review/. 

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 determine 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 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 

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 and commit to a final work plan and schedule for the 

registration review of Xylenol. 

 Xylenol (PC Code 086804) shares its single registered product, Gallex, with 

another active ingredient, M-Cresol (PC Code 022102). M-Cresol 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 Xylenol at a concentration of 

0.463%. This product is used to selectively kill bacterial galls in orchard and greenhouse 

trees and ornamentals such as apple, filbert, pear, walnut, and olive trees, as well as roses 

and willows. 

 A pesticide product containing Xylenol was 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. 

5 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

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 combined human health databases for m-Cresol 

and Xylenol, the Agency anticipates that no additional 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 Protective Equipment (PPE) requirements on the label, the 

Agency believes that dietary, drinking water, occupational, and residential exposure 

scenarios and risk assessments are not needed; 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 plants should be treated “when 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 greenhouse and in the field is not expected to 

result in human dietary exposure to residues in food. Additionally, because of low 

volume of use and the aforementioned label restrictions, 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 hydrolysis study requested in the environmental 

fate section. 

Occupational and Residential Assessment

 An occupational and/or residential exposure assessment is required for an active 

ingredient if (1) certain toxicological 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 that handlers wear certain personal protective 

equipment (PPE) – long-sleeved shirt and pants, shoes and socks, chemical-resistant 

gloves, and protective eyewear – are considered sufficient to protect workers from the 

localized irritation effects of exposure to Xylenol. The Agency does not anticipate 

needing to perform an occupational or residential applicator assessment for this chemical. 

Tolerances

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

use in food. 

6 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

Aggregate/Cumulative Exposure & Risk

 In examining aggregate exposure, EPA takes into account the available and 

reliable information concerning exposures to pesticide residues in food and drinking 

water, as well as non-occupational 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, neither of which is expected to result in 

significant exposure or to require risk assessment. 

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to 

establish, modify, or revoke a tolerance, the Agency consider “available information” 

concerning the cumulative effects of a particular 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 further 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/ Chemical 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-Effects Scoping Document”, dated May 10, 2010. 

Anticipated Environmental Fate and Ecotoxicity Risk Assessment and Data Needs 

The Agency has reviewed the environmental fate and ecological hazard databases 

for Xylenol. Based on its review, EPA believes risk assessments are needed to ensure that 

the Xylenol registration review case meets FIFRA standards. The Agency will complete 

the environmental fate and ecological hazard risk assessments presented below. 

Further information and detailed justifications for the studies that are anticipated 

as being needed are available in the document titled “2,4-Xylenol: Product 

Chemistry/Environmental Fate and Eco-Effects Scoping Document”, dated May 10, 

2010. 

7 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

Environmental Fate and Transport 

 The 1994 combined RED for M-Cresol and Xylenol waived all environmental 

fate and ecotoxicity data needs for both chemicals 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 biodegradability 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 ecotoxicity data needs have previously been waived. 

However, due to some uncertainty regarding Xylenol’s environmental fate, the Agency 

anticipates needing a hydrolysis study for use in the ecotoxicity 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 results 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 avian 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 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 

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. 

8 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

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 Proposed 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 comment 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 manner prior to issuing a final work plan for the 

Xylenol case. 

Trade Irritants 

Through the registration review process, the 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 markets, 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/attains_nation_cy.cause_detail_303d?p_cause_grou

p_id=885. In addition, no Total Maximum Daily Loads (TMDL) have been developed 

9 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

for [insert pesticide], based on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_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 Impaired Water Body and Other Water Quality Data in OPP’s 

Registration Review Risk Assessment and Management Process (see: 

http://www.epa.gov/oppsrrd1/registration_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 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 

information on any groups or segments of the population who, as a result of their 

location, cultural practices, or other factors, may have atypical, unusually high exposure 

to Xylenol, compared to the general population. Please comment if you are aware of any 

sub-populations that may have atypical, unusually 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 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 endocrine effects as 

the Administrator may designate.” The EDSP 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 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 the 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. 

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. This list of chemicals was selected based on the potential for human 

exposure through pathways such as food and water, residential activity, and certain postapplication agricultural scenarios. This list should not be construed as a list of known or 

likely endocrine disruptors. 

10 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

Xylenol is not among the group of 58 pesticide 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 anticipates 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/. 

Structure Activity Relationships 

EPA must rely upon information of appropriate 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 applicant’s submission of a 

set of studies conducted with the 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 environmental 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 alternative techniques, i.e., techniques other 

than data generation that could significantly inform the Agency’s decision-making 

process. Recently, OPP has made increasing use of structure activity relationship (SAR) 

as part of its regulatory decision-making process. In the SAR process, a chemical's 

molecular structure is compared to that of other chemicals for which data are available. 

These structural similarities are then used to make predictive judgments about a 

chemical’s physical, chemical, and biological properties. Thus, the chemical’s physical, 

chemical, and biological properties are a function of (or directly related to) the chemical’s 

molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a 

selected set of measured data on a single physical, chemical, or biological property is 

used to derive a model (an equation) to predict the value of that property. 

 Since SAR assessments and QSAR modeling 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 approach to an approach in which the use of predicted data, 

generated using validated models, is considered along with information from open 

literature and studies specifically 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 certain 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 considering biological 

properties, at this time, EPA believes that SAR and QSAR can be most effectively 

utilized in the evaluation of chemicals that exhibit lower toxicity for human health and/or 

ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity 

11 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than 

multiple tiers of assessments with progressively more data requirements. 

If stakeholders believe that submission of predicted 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 describing the utility of the information and 

provide documentation on the scientific validity of the information. The determination 

that the predicted data fulfills the data requirement 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, application 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 mortalities) not already reported 

to the Agency 

8. Monitoring data 

9. Structure Activity Relationships 

Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any 

comments received in a timely manner, and then issue a Final Work Plan for Xylenol. 

12 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

II. FACT SHEET 

Background Information

• Xylenol registration review 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 Review 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 toxicity 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. 

13 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

Product Chemistry Database Status

The Agency has reviewed the product chemistry database for the Xylenol 

registration review case and anticipates 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-Effects Scoping Document”, dated May 10, 2010. 

Environmental Fate & Ecological Risk Assessment Status

 The Agency has reviewed the environmental fate and ecotoxicity databases for 

the Xylenol case and anticipates needing additional environmental fate and ecotoxicity 

data for the registration review 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 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 

will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries 

Services (the Services), as appropriate. 

Further information and detailed justifications for the studies that are anticipated 

as being needed are available in “2,4-Xylenol: Product Chemistry/Environmental Fate 

and Eco-Effects Scoping Document”, dated May 10, 2010. 

Tolerances 

There are no tolerances or exemptions 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 assessment during Registration Review. 

Labels 

14 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

There is one product registered for Xylenol. 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. 

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. 

15 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

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 

LC50 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. 

LD50 Median Lethal Dose. A statistically derived 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 Identification (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 

16 of 18 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov 

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 

Q1* 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 (Registrations 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 Standard 
Docket Number: EPA-HQ-OPP-2010-0240 

www.regulations.gov

IV. Appendix A

Use Site Formulation Method of 

Application 

Application Rate/ No. of 

applications 

Use L

Orchards and Greenhouses Bacterial disease control in fruit & nut trees, vines, and ornamentals 

Emulsifiable concentrate 

Paint directly onto surface 

Apply when rain is unlikely for several days. Cut off major portion of all galls larger than a baseball and allow to dry 1 or more days before treatment. Paint onto gall and cut surfaces plus 1⁄2 inch of healthy bark. Work solution into cracks and crevices with brush. Examine after 4-6 months and retreat if live galls are found. 

Apply to non-edible fruit or nuts from trfeed purposes. 

18 of 18