Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

United States Preventi on, Pesticides March 2010
Environmental Protection and Toxic Substances Agency (7510P)



# Thymol Summary Document: Registration ReviewDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

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### TABLE OF CONTENTS

Thymol Registration Review Team ................................................................................. 4 I. PRELIMINARY WORK PLAN – Thymol ................................................................ 5

II. FACT SHEET ............................................................................................................ 15

III. GLOSSARY of TERMS & ABBREVIATIONS ................................................... 19

IV. APPENDIX A ............................................................................................................ 21Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

4 of 34 Thymol Registration Review Team

Human Health & Environmental Effects

Nathan Mottl

Jacob S. Moore

Srinivas Gowda

Risk Management

Monisha Harris

Lance Wormell Andrew Bryceland

Office of General Counsel Philip RossDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

5 of 34 I. PRELIMINARY WORK PLAN – THYMOL

Introduction

The Food Quality Protection Act (FQPA) of 1996 mandated the registration 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 pesticide use practices will occur over time. Through the registration review program, th e Agency periodically reevaluate s 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 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 Thymol.

Thymol (PC Code 080402), also known as 2-isopropyl-5-methylphenol, is an organic phenol compound derived from thyme oil of plant, Thymus vulgaris (thyme) is produced synthetically from m-cresol. Thymol is an antimicrobial pesticide registered

for limited use in indoor and outdoor reside ntial, indoor non-food, indoor medical and

terrestrial non-food site s. Thymol is registered for use in bathroom premises/hard surfaces, household/domestic dwellings, hos pital/medical institu tions, HVAC systems, schools, and nursing homes. Thymol is also re gistered for use as a biochemical pesticide to control Varroa mites in bee hives, and as a conventional pesticide repellent against tree squirrels, voles, dogs, and cats. Thymol was fi rst registered in the United States in 1964. In September of 1993, the EPA issued a Reregistration Eligibility Decision (RED) for thymol. In January 2006, a Biopesticide Registration Action Do cument (BRAD) was completed for the new use of suppression of mites in honeybee colonies. EPA also registered a new antimicrobial use of thym ol on heating, ventilation and air conditioning (HVAC) air ducts in 2004. In addition, an exem ption from the requirement of a tolerance for honey and honeycombs was published in the Federal Register on January 18, 2006 (71 FR 2889–2895).Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

6 of 34 The concentration of thymol in the 11 registered active products ranges from 0.035% to 74.09% active ingred ient (AI). There is cu rrently no manufacturing use product containing thymol.

A review of existing Agency registration and reregistration in formation indicates these additional highlights:

• The FDA considers thymol, thyme esse ntial oil, and thyme (spice) as Generally Recognized as Safe (G RAS) for use in foods, 21 CFR 182.20.

• Thymol, thyme essential oil, and thyme (spice) are used in human food.

• Thymol is also widely dist ributed as a food additive.

• The Agency previously waived many of the existing toxicity data requirements in the RED; see the Tymol RED.

• There is negligible human exposure to t hymol as a result of pesticidal use patterns based on the low use rate and lo w frequency of application; see page 8 of the Thymol RED.

• Thymol degrades rapidly in the environment to elemental constituents by normal biological, physical, and/or chemical processes.

• Once in the body, thymol is excreted rapidly.

Risk Assessment Status & Anticipated Data Needs

Human Health Risk Assessment Status and Anticipated Data Needs

The Agency has reviewed the hazard and exposure databases for the thymol registration review case. As a result of this review, the Agen cy does not expect that data or risk assessments will be needed to assess dermal, dietary, drinking water or incidental oral exposures. However, inhalation exposur e may result from the application/use of thymol via pressure sprayers, aerosols, airl ess sprayers; pump-up ga rden type sprayers, ULV (ultra low volume) and mist generating sprayers (foggers). Therefore, the Agency anticipates needing additional inhalation and mutagenicity to xicity studies; upon review of these data, EPA will revisit the need for exposure data and an inhalation exposure risk

assessment.

Dietary and Drinking Wa ter Exposure and Risk

Dietary Food Exposure

Thymol is found naturally in food stu ffs such as lime honey and cooking herbs and/or food stuffs derived from cranberry a nd mandarin and tangerine oils. Thymol is also added to food stuffs commonly consum ed by humans such as ice cream, nonalcoholic beverages, candy, baked goods, and chewing gum. It is FDA-approved when used as a synthetic flavoring (21 CFR 172.515) , a preservative and indirect food additive of adhesives (21 CFR 172.105) and the sour ce plant (thyme), from which thymol isDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

7 of 34 extracted is acknowledged by FDA as gene rally recognized as safe (GRAS)(21 CFR 182.10, 21 CFR 182.20).

Dietary food risks of concern are not anticipated for the use of thymol as a pesticide for all registered uses; theref ore, a dietary food assessment will not be performed.

Dietary Drinking Water Exposure

Risks to thymol residues in drinking wa ter are not expected since outdoor use is limited and thymol is GRAS therefore, rel ease to drinking water sources is unlikely. Therefore, a dietary drinking water assessment will not be performed.

Tolerances

The following exemptions have been established for the use of thymol: 1) an exemption from the requirement of a tolera nce has been established for residues of thymol (as present in thyme oil) in or on food commodities when applied/used in/on public eating places, dairy processing equipmen t, and/or food processing equipment and utensils (FRL-8404-4); and 2) an exemption fr om the requirement of a tolerance has been established for residues of thymol in or on honey and honeycomb when used in accordance with good agricultura l practices (40 CFR 180.1240).

Aggregate and Cumulative Exposure and 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, and non-occupational pe sticide exposures. Dietary (f ood and drinking water) risks of concern are not anticipated for thymol. F DA considers thymol GRAS for use in foods and drinking water. Risks asso ciated with thymol exposures are expected to be minimal through dermal and oral based on limited eviden ce of any subchronic or chronic systemic effects through the oral routes of exposure. Therefore, an aggregate assessment will not

be needed.

Section 408(b)(2)(D)(v) of FFDCA requi res 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 thymol has a common mechanism with other compounds, consequently a cumulative assessment will not be performed at this time.

Occupational and Residen tial Assessment and Risk

The Agency reviewed all available data associated with thymol and has determined that the currently registered us es of thymol may resu lt in residential and occupational exposure. EPA expects dermal occupational and/or residential exposuresDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

8 of 34 will likely be minimized based on the label use directions, PPE (e.g. gloves), dilution, and lack of systemic toxicity. Therefore, no additional dermal risk assessments are anticipated as being needed for registration review. The Agency will determine the need for occupational and/or residential inhalation risk assessments based on the results of the inhalation toxicity study which the Agency anticipates needing as part of registration

review.

The Biopesticides and Pollution Prevention Division (BPPD) does not anticipate the need for additional studies for thymol to support the use in bee hives. This bee hive use is the only biochemical use for this active ingredient.

Anticipated Human Health Data Needs

The Agency anticipates requiring the following data for thymol.

Anticipated Human Health Toxicity Data Needs

• (GLN 870.5915) In vivo sister chromosome exchange assay

• (GLN 870.5900) In vitro sister chromosome exchange assay

• (GLN 870.5375) In vitro mammalian chromosomal aberration test; and

• (GLN 870.5550) Unscheduled DNA synthesis, and

• (GLN 870.3465) 90-day inha lation toxicity study

Anticipated Occupational/Resid ential Exposure Data Needs

• (GLN 875.1400) Inhalation Exposure Indoor

• (GLN 875.1600) Application Exposure Monitoring Data Reporting; and

• (GLN 875.1700) Product Use Data

Further information and detailed justificati ons for studies that are expected to be needed are available in “Summary of Hu man Health Effects Data for the Thymol Registration Review Decision Do cument,” dated March 23, 2010.

Anticipated Physical/Chemical Property Data Needs

All product chemistry data requirement s have been fulfilled for thymol. Therefore, it is anticipated that additional pr oduct chemistry data will not be needed for thymol.

Environmental Fate and Ecological Risk A ssessment Status and Anticipated Data

Needs

The Agency reviewed the environmental fate and ecological hazard databases for thymol. The Agency has waived all envir onmental fate data requirements for thymol because of the relatively non-toxic nature of thymol, and its limited uses around

residential areas. All of the ecotoxicity data requirements for thymol have been waived by the Agency because the ecotoxicity status is so well known for this active ingredient.

Available data from literature reviews show that thymol is not toxic to aquatic organisms.Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

9 of 34 Based on thymol’s natural occurrence, current use pa tterns, toxicity data, low/non-toxicity, very low environmental e xposure, and the lack of reported adverse effects information, the Agency does not anti cipate conducting an environmental fate or ecological risk assessment for thymol. In addition, no environmental fate or ecological data are anticipated as being need ed for this registration review.

Based on the limited use patterns, very low exposure levels, the chemical's natural occurrence in the environment, common use as a food item, lack of reported adverse effects information, and very low/non-toxi city potential of thymol, the Agency anticipates concluding that the registered us es of thymol will have “no effect” (NE) on endangered or threatened terr estrial or aquatic species, or their designated critical habitats, as listed by the U.S. Fish a nd Wildlife Service (USFWS) and the National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS). EPA anticipates conducting no further analysis of potential risks to endangered or threatened species unless public comments provide additional information that would alter the Agency's current position that thymol will have "no effect" on such species or their designated critical habitat.

Further information on the en vironmental fate and ecological risk assessment is available in the document titled, Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Thymol Regi stration Review Decision Document, dated
March 23, 2010.

Incidents:

A search of the OPP Incident Data Syst em (IDS) revealed no reported incidents for thymol.

Timeline:

EPA has created the following estimated timeline for the completion of the thymol registration review:

Anticipated Schedule

Activities Estimated Month/Year
Phase 1: Opening the docket
Open Public Comment Period for Thymol Docket March 2010
Close Public Comment Period May 2010
Phase 2: Case Development

Develop Final Work Plan (FWP) September 2010
Issue DCI September 2011
Data Submission September 2015
Open Public Comment Period for Preliminary Risk Assessments March 2016Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

10 of 34 Close Public Comment Period June 2016

Phase 3: Registration Review Decision
Open Public Comment Period for Propos ed Reg. Review Decision September 2016

Close Public Comment Period December 2016
Final Decision and Begin Post-Decision Follow-up 2017
Total (years) 7Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

11 of 34 Guidance for Respondents:

The public is invited to co mment on EPA’s preliminary registration review work plan and rationale. The Agency will caref ully consider all comments as well as any

additional information or data provided in a timely manner pr ior to issuing a final work plan for the thymol registration review 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 (MRL s) 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

Thymol is 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 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 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 factor s, may have atypical, unusually high exposure to thymol compared to the general populat ion. Please comment if you are aware of any sub-populations that may have atypical, unusua lly high exposure compared to the general population.Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

12 of 34 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 th e 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 valu e 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 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 predicted data can fulfill one of the data needs for thymol, then the Agency invites s ubmission 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.Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

13 of 34 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 testing 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.

Thymol 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 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/.

Additional Information

Stakeholders are also specifically asked to provide available information and data in the following areas:

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 distributionDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

14 of 34 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, the Agency will review and respond to any comments received in a timely manner, a nd then issue a Final Work Plan for thymol.Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

15 of 34 II. FACT SHEET

Background Information

• Chemical Name: Thymol

• Common Names: 5-Methyl -2-isopropyl-1-phenol 5-Methyl-2-(1-methylethyl)phenol

• Registration review case number: 3143

• PC Code: 080402

• CAS#: 89-83-8

• There are no technical registrants for ac tive products of Thym ol. The following registrants have end use products cont aining thymol: Melaleuca Inc., OHSO Clean, Inc., and Wexford Labs, Inc.; Chem icals LAIF, Exosect Limited, and Vita (Europe) Limited; and MCB L.L.C.

• First approved for use in a registered product: 1964

• Eleven active registrations

• Antimicrobials Division Chemical Revi ew Manager (CRM): Monisha Harris, harris.monisha@epa.gov

• Antimicrobials Division Product Mana ger (PM): Jacqueline CampbellMcFarlane, campbell-mcfarlane.jacqueline@epa.gov

Chemical Structure:

Use & Usage Information

• Type of Pesticide: repellant, bacteriostat, fungi cide/fungistat, disinfectant, mildewstat, tuberculocide, a nd virucide (antimicrobial).

• Antimicrobial Use Sites:

o food handling/storage esta blishments premises

o commercial, institutional and i ndustrial premises and equipment

 day cares, nurseries, fitness gyms, and spas

 HVAC system and ducts

o residential and public access premises

 animal repellent

 kitchen and food storage areas

o medical premises and equipmentDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

16 of 34  intensive care, emergency rooms, nurseries, and dental operations

 veterinary; chiropractic and physiotherapy clinics

• Biopesticide Use Site:

o registered for use for the contro l of Varroa mites in bee hives.

• Registered for use in indoor and outd oor residential, indoor non-food, indoor

medical and terrestr ial non-food sites.

• Thymol has uses as an antiseptic, loca l anesthetic, cooling agent, and as a preservative. It is found in liniments , lip balms, toothpaste, and mouthwash.

• Thymol as a conventional pesticide is re gistered for use as a repellent for tree squirrels, voles, dogs, and cats.

• Thyme is used as a food seasoning ingred ient, and is generally recognized as a safe (GRAS) natural seasoning by the Food and Drug Administration (FDA) (21 CFR 182.10).

• Thymol is also added to food stuffs commonly consumed by humans such as ice cream, non-alcoholic beverages, candy, baked goods, and chewing gum.

Recent Regulatory Actions

There are no recent regulatory actions for thymol. A reregistration eligibility decision (RED) was issued in September 1993. http://www.epa.gov/pesticides /reregistration/status.htm

Human Health Risk Assessment Status

The Agency has reviewed the hazard and exposure databases for the thymol registration and review case a nd anticipates that additional mutagenicity studies and a 90- day inhalation toxicity study will be needed for registration review. Further information and detailed justifications for studies that are expected to be need ed are available in “Summary of Human Health Effects Data fo r the Thymol Registration Review Decision
Document,” dated March 23, 2010.

Environmental Fate & Ecologi cal Risk Assessment Status

The Agency does not anticipate conducting further analyses of environmental fate and ecological risk or requir ing additional data based on t hymol’s natural occurrence, current use patterns, toxicity data, low/non- toxicity, very low environmental exposure, and the lack of reported adverse effects information.

Further information on the en vironmental fate and ecological risk assessment is available in the document titled, “Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Thymol Regist ration Review Decision Document,” dated
March 23, 2010.Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

17 of 34 Tolerances

The following exemptions have been established for the use of thymol: 1) an exemption from the requirement of a tolera nce has been established for residues of thymol (as present in thyme oil) in or on food commodities when applied/used in/on public eating places, dairy processing equipmen t, and/or food processing equipment and utensils(in the Federal Register of (Mar ch 25, 2009)(74FR12613)(FRL-8404-4)); and 2) an exemption from the requirement of a tole rance has been established for residues of thymol in or on honey and honeycomb when used in accordance with good agricultural practices (40 CFR 180.1240).

Data Call-In Status

The Agency anticipates requiring additional data to complete a risk assessment during the registration re view of this case.

Labels

There are 11 registered pr oducts that contain thymol. There are currently seven antimicrobial products, three biopesticide pr oducts, and one repellent product registered by the EPA containing thymol as an active ingredient. The EPA Registration Numbers are provided in Tables 1, 2, and 3 below. Fo r future reference, during registration review a list of product registration numbers will be in cluded in the docket. Product registration labels may be obtained from the Pesticid e Product Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

.

Table 1. Registered Active Antimi crobial Products of Thymol (AD)

Registration # Registration Name Company Name Formulation Type % of Active Ingredient

34810-18 Thymo-Cide Wexford Labs, Inc. Soluble Concentrate 13.00

34810-25 Ready To Use Thymo-Cide Wexford Labs, Inc. Ready-to-Use

Solution 0.051

66251-2 SBT 2 To 1 Concentrate Melale uca Inc. Soluble Concentrate 0.092

84683-1 Benefect Broad Spectrum

Disinfectant OHSO Clean, Inc. Ready-to-Use

Solution 0.23

84683-2 Benefect Biocide A.D. OHSO Clean, Inc. Ready-to-Use

Solution 0.23

84683-3 Benefect Botanical Daily Cleaner Disinfectant Spray OHSO Clean, Inc. Pressurized Liquid 0.05

84683-4 Benefect Botanical Daily

Cleaner Disinfectant Towelette OHSO Clean, Inc. Impregnated

Materials 0.05Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

18 of 34 Table 2. Registered Active Biopes ticide Products of Thymol (BPPD)

Registration # Registration Name Company Name Formulation Type % of Active Ingredient

73291-1 Api Life Var Chemicals LAIF Pelleted/Tableted 74.09

79442-11 ExomiteTM-Pro Exosect Limited Dust 6

79671-1 Apiguard Vita (Europe)

Limited Microencapsulated 25

Table 3. Registered Active Repellent or Feeding Depre ssant Products of Thymol (RD)

Registration # Registration Name Company Name Formulation Type % of Active Ingredient

81117-1 Ro-Pel® Tree Squirrel, Vole, Dog, And Cat Repellent MCB L.L.C. Ready-to-Use

Solution 0.035Docket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

19 of 34 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 ProgramDocket Number: EPA-HQ-OPP-2010-0002 www.regulations.gov

20 of 34 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-2010-0002www.regulations.gov21 of 34IV. APPENDIX AUse Patterns for THYMOLFood Handling/ Storage Establishments Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsFood Area Premises andEquipment – Indirect FoodContactFood preparation facilities;restaurants and bars;kitchens; cafeterias; foodstorage areas:Non-porous surfaces e.g.countertops, sinks, foodpreparation surfaces.Areas Without Potential forFood ContactFood preparation facilities;restaurants and bars;kitchens; cafeterias; foodstorage areas:Non-porous surfaces e.g.toilet seats, garbage cans,highchairs.Porous and semi-poroussurfaces including carpets,pads, sub-floors, drywall,studding, trim and lumber,other similar constructionReady-to-usesolution84683-184683-3Pressurizedliquid84683-3Spray To clean: Preclean. Shake, applyproduct and wipe away.To disinfect: Shake well and wetsurface with spray. Expose for10 minutes, allow to air dry. Norinsing or wiping is requiredexcept on direct oral, skin orfood contact surfaces whichrequire potable water rinse aftertreatment.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov22 of 34materials.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov23 of 34Food Handling/ Storage Establishments Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsFood Area Premises andEquipment – Indirect FoodContactFood preparation facilities;restaurants and bars;kitchens; cafeterias; foodstorage areas:Non-porous surfaces e.g.countertops, sinks, foodpreparation surfaces.Areas Without Potential forFood ContactFood preparation facilities;restaurants and bars;kitchens; cafeterias; foodstorage areas:Non-porous surfaces e.g.toilet seats, garbage cans,highchairs.Porous and semi-poroussurfaces including carpets,pads, sub-floors, drywall,studding, trim and lumber,other similar constructionmaterials.Impregnatedmaterials84683-4Wipe Wet the surface with wipe.Contact time 10 minutes. Wipeclean.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov24 of 34Commercial, Institutional and Industrial Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsIndoorCommercial/InstitutionalIndustrial Premises/EquipmentSchools - floors, wallsbathroom fixtures, showerroom stallsSolubleconcentrate34810-1834810-19Cloth, mop orbrushUse 1.5 oz of product per 1 galwater. Wet all surfacesthoroughly for at least 10minutes. Remove gross filth andheavy soil before application.IndoorCommercial/InstitutionalIndustrial Premises/EquipmentDay cares; nurseries;fitness gyms; spas:Hard, non-porous surfacese.g. countertops, sinks,toilet seats, constructionmaterials.Porous and semi-poroussurfaces e.g. carpets, pads,sub-floors, drywall,studding, trim and lumber,other constructionmaterials.Ready-to-usesolution84683-184683-3Pressurizedliquid84683-3Spray To clean: Preclean. Shake, applyproduct and wipe away.To disinfect: Shake well and wetsurface with spray. Expose for10 minutes, allow to air dry. Norinsing or wiping is requiredexcept on direct oral, skin orfood contact surfaces whichrequire potable water rinse aftertreatment.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov25 of 34Commercial, Institutional and Industrial Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsIndoorCommercial/InstitutionalIndustrial Premises/EquipmentDay cares; nurseries;fitness gyms; spas:Hard, non-porous surfacese.g. countertops, sinks,toilet seats, constructionmaterials.Porous and semi-poroussurfaces e.g. carpets, pads,sub-floors, drywall,studding, trim and lumber,other constructionmaterials.Impregnatedmaterials84683-4Wipe Wet the surface with wipe.Contact time 10 minutes. Wipeclean.IndoorCommercial/Institutional/Industrial Premises/Equipment(Indoor)HVAC System and DuctsReady-to-usesolution84683-2Brush, mop, wipe,spray, ULV or mistgenerator,atomize/sprayShake well and wet surfaceswith spray. Allow 10 - 20minutes for drying. No rinse orwipe required. Details may varyaccording to application method.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov26 of 34Residential and Public Access PremisesUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsNon-Food IndoorHousehold/Domestic DwellingsContentsHotels and motels; zoosand kennels:Hard, non-porous surfaces-Faucets, sinks, drains,doorknobs, telephones,kitchen appliances, sportsequipment, children’s toys,etc.Solubleconcentrate66251-2Spray Dilute 8.5 oz of product per 8.5oz water. Avoid splashing.To clean: Spray diluted producton area to be cleaned untilthoroughly wet and wipe or rinseaway.To sanitize: Spray dilutedproduct on surface untilthoroughly wet. Let stand 1minute. Wipe or air dry.To disinfect: Preclean. Spraydiluted producton surface untilthoroughly wet. Let stand 10minutes before wiping. Norinsing necessary.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov27 of 34Residential and Public Access PremisesUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsNon-Food Indoor/OutdoorHousehold/Domestic DwellingsOutdoor premisesTree squirrel, vole, dog, catrepellent for use on outdoorstructures and surfacessuch as brown bark oftrees, fences, poles, decks,planters, siding, garbagecans, furniture, seeds andbulbsReady-to-usesolution81171-1Spray, brush Use a sprayer capable ofdelivering a coarse droplet spray(such as a tank sprayer). Sprayall surfaces to the point ofrunoff, or treat by painting witha brush. Make a secondapplication in 24 days toimprove effectiveness.Using rubber gloves, place seedsor bulbs in a plastic or metalcontainer and spray untilthoroughly soaked. Allow to dry.Repeat application in areas ofhigh animal pressure. Then plantin normal manner.Use at full strength; do not dilute or mix this productwith any other chemical.Apply to dry surfaces. Product may damagepainted/stained surfaces, fabrics, and plastics; test asmall area first to determine suitability for use.Do not use this product attemperatures <32° F or> 900° F.Do not use mist blowers or ultra- low volumeapplication equipment to apply this product.Do not apply product on rainy, snowy or windy days,or if precipitation is predicted within the next 24 hours.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov28 of 34Residential and Public Access PremisesUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsIndirect Food ContactHousehold/Domestic DwellingsKitchens, food storageareas:Hard, non-porous surfacese.g. countertops, sinks,food preparation surfacesNon-food IndoorHousehold/Domestic DwellingsContentsHard, non-porous surfacese.g. toilet seats, pethabitats, garbage cans,children’s toys, highchairs,sports equipment,construction materialsPorous and semi-poroussurfaces including carpets,pads, sub-floors, drywall,studding, trim and lumber,other constructionmaterialsReady-to-usesolution84683-184683-3Pressurizedliquid84683-3Spray To clean: Preclean. Shake, applyproduct and wipe away.To disinfect: Shake well and wetsurface with spray. Expose for10 minutes, allow to air dry. Norinsing or wiping is requiredexcept on direct oral, skin orfood contact surfaces whichrequire potable water rinse aftertreatment.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov29 of 34Residential and Public Access PremisesUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsIndirect Food ContactHousehold/Domestic DwellingsKitchens, food storageareas:Hard, non-porous surfacese.g. countertops, sinks,food preparation surfacesNon-food IndoorHousehold/Domestic DwellingsContentsHard, non-porous surfacese.g. toilet seats, pethabitats, garbage cans,children’s toys, highchairs,sports equipment,construction materialsPorous and semi-poroussurfaces including carpets,pads, sub-floors, drywall,studding, trim and lumber,other constructionmaterialsImpregnatedmaterials84683-4Wipe Wet the surface with wipe.Contact time 10 minutes. Wipeclean.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov30 of 34Medical Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHospital/Medical InstitutionsNon-Critical PremisesHospitals, health carefacilities, nursing homes -floors, walls bathroomfixtures, shower room stallsSolubleconcentrate34810-1834810-19Cloth, mop orbrushUse 1.5 oz of product per 1 galwater. Wet all surfacesthoroughly for at least 10minutes. Remove gross filth andheavy soil before application.Special instructions forsurfaces/objects soiled withblood/body fluids which maycontain HIV.I (AIDS VIRUS).Contact time 1 minute. Forlightly soiled areas wipe offvisual soil/clean with productand disinfect with secondapplication. For large spills thecontaminated areas should beflooded with product beforecleaning, then decontaminatedwith fresh product.This product is not to be used as a terminalsterilant/high level disinfectant on any surface orinstrument that (1) is introduced directly into thehuman body, either into or in contact with thebloodstream or normally sterile areas of the body, or(2) contacts intact mucous membranes but which doesnot ordinarily penetrate the blood barrier or otherwiseenter normally sterileareas of the body.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov31 of 34Medical Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHospital Critical ItemsHospital Semi-Critical ItemsSolubleConcentrate34810-1834810-19Wipe, pour For lightly soiled areas wipe offvisual soil/clean with product,and disinfect surface with asecond application. For largespills the contaminated areasshould be flooded with theproduct before cleaning, thendecontaminated with product.Special instructions forsurfaces/objects soiled withblood/body fluids which maycontain HIV.I (AIDS VIRUS).Contact time 1 minute. Forlightly soiled areas wipe offvisual soil/clean with productand disinfect with secondapplication. For large spills thecontaminated areas should beflooded with product beforecleaning, then decontaminatedwith fresh product.This product is not to be used as a terminalsterilant/high level disinfectant on any surface orinstrument that (1) is introduced directly into thehuman body, either into or in contact with thebloodstream or normally sterile areas of the body, or(2) contacts intact mucous membranes but which doesnot ordinarily penetrate the blood barrier or otherwiseenter normally sterileareas of the body.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov32 of 34Medical Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHospital/Medical InstitutionsCritical premisesHard, non-porous sur6rs, inoperating rooms, intensivecare, nurseries, emergencyareas, dental operatories,EMS, and other emergencyresponse areas, for workingsurfaces, stainless steel,chrome, glass and vinyl.Ready-to-usesolution34810-2234810-25Cloth, brush,immersionWet all hard surfacesthoroughly. Expose for at least10 minutes before drying with acloth. Remove gross filth andheavy soil before application.Special instructions forsurfaces/objects soiled withblood/body fluids which maycontain HIV.I (AIDS VIRUS).Contact time 1 minute. Forlightly soiled areas wipe offvisual soil/clean with productand disinfect with secondapplication. For large spills thecontaminated areas should beflooded with product beforecleaning, then decontaminatewith fresh product.Do not mix with other cleaners. Do not mix with othercleaners.This product is not to be used as a terminalsterilant/high level disinfectant on any surface orinstrument that (1) is introduced directly into thehuman body, either into or in contact with thebloodstream or normally sterile areas of the body, or(2) contacts intact mucous membranes but which doesnot ordinarily penetrate the blood barrier or otherwiseenter normally sterileareas of the body.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov33 of 34Medical Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHospital /Medical InstitutionsNon-critical PremisesHospitals; nursing homes;medical veterinary anddental offices; healthprofessional, chiropractic& physiotherapy clinics.Hard, non-porous surfacese.g. countertops, sinks,toilet seats, garbage cans,prostheses and orthotics,construction materialsPorous and semi-poroussurfaces e.g. carpets, pads,sub-floors, drywall,studding, trim and lumber,other constructionmaterialsReady-to-usesolution84683-184683-3Pressurizedliquid84683-3Spray To clean: Preclean. Shake, applyproduct and wipe away.To disinfect: Shake well and wetsurface with spray. Expose for10 minutes, allow to air dry. Norinsing or wiping is requiredexcept on direct oral, skin orfood contact surfaces whichrequire potable water rinse aftertreatment.Special instructions forsurfaces/objects soiled withblood/body fluids which maycontain HIV.I (AIDS VIRUS).Contact time 1 minute. Forlightly soiled areas wipe offvisual soil/clean with productand disinfect with secondapplication. For large spills thecontaminated areas should beflooded with product beforecleaning, then decontaminatedwith fresh product.This product is not to be used as a terminalsterilant/high level disinfectant on any surface orinstrument that (1) is introduced directly into thehuman body, either into or in contact with thebloodstream or normally sterile areas of the body, or(2) contacts intact mucous membranes but which doesnot ordinarily penetrate the blood barrier or otherwiseenter normally sterileareas of the body.Docket Number: EPA-HQ-OPP-2010-0002www.regulations.gov34 of 34Medical Premises and EquipmentUse Site Formulation Method ofApplicationApplication Rate/ No. ofapplicationsUse LimitationsHospital /Medical InstitutionsNon-critical PremisesHospitals; nursing homes;medical veterinary anddental offices; healthprofessional, chiropractic& physiotherapy clinics.Hard, non-porous surfacese.g. countertops, sinks,toilet seats, garbage cans,prostheses and orthotics,construction materialsPorous and semi-poroussurfaces e.g. carpets, pads,sub-floors, drywall,studding, trim and lumber,other constructionmaterialsImpregnatedmaterials84683-4Wipe Wet the surface with wipe.Contact time 10 minutes. Wipeclean.