Docket Number; EPA–HQ–OPP–2010-0005 www.regulations.gov

United States Chemi cal Safety August 2010

Environmental Protection and Pollution Prevention Agency (7510P)



# Decyl Isononyl Dimethyl Ammonium

Chloride (DIDAC) Final Work Plan Registration Review August 2010Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

3 

### TABLE OF CONTENTS

Decyl Isononyl Dimethyl Ammonium Chloride (DIDAC) Registration Review Team........... 4

I. INTRODUCTION ................................................................................................................ ..... 5

II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN.............................. 5

III. RISK ASSESSMEN T AND DATA NEEDS......................................................................... 6

IV. TIMELINE ................................................................................................................... ......... 15

V. GLOSSARY of TERMS & ABBREVIATIONS.................................................................. 16Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

4 Decyl Isononyl Dimethyl A mmonium Chloride (DIDAC) Registration Review Team

Human Health & Environmental Effects

Tim McMahon

Srinivas Gowda

Risk Management

Monisha Harris

Lance Wormell

Office of General Counsel Philip RossDocket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

5 I. INTRODUCTION

This is the Environmental Protection Ag ency’s (EPA or “the Agency”) Final Work Plan (FWP) for the registration revi ew of Decyl Isononyl Dimethyl Ammonium Chloride (DIDAC). The work plan includes the expected registration review timeline. The work plan also addresses public co mments received concerning the Preliminary Work Plan (PWP) in the Summary Docu ment which was posted in the DIDAC registration review docket, and any othe r comments concerning the initial docket postings. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses a nd data or information the Agency believes are needed to make a regist ration review decision.

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. Changes in science, public policy and pesticide use practices will occur over time. The registra tion review program is intended to make sure that, as the ability to assess risk evolve s and as policies and practices change, all registered pesticides continue to meet th at statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/

.

The DIDAC Preliminary Work Plan was published March 31, 2010. The 90-day comment period ended on June 1, 2010. The Preliminary Work Plan document is

available on www.regulations.gov , docket number EPA-HQ-OPP-2010-0005.

DIDAC (PC Code 069207) is known by the trade name Bardac 2180. Bardac 2180 is also known by the chemical name of isoba rdac. DIDAC is considered structurally similar to Didecyl Dimethyl Ammonium Ch loride (DDAC) (PC Code 069149) and data developed for DDAC were used to support th e initial registration of DIDAC in 1995. DDAC, as well as Alkyl Dimethyl Ethyl Am monium Bromide, Octyl Decyl Dimethyl Ammonium Chloride, and Dioctyl Dimethyl A mmonium Chloride are structurally similar and are collectively referred to as the Group I "quaternary compounds" or "quats" as published in PR Notice 88-2 on 2/26/88. Ther efore, the Agency will continue to use

information from the DDAC database to support the DIDAC registration review. Because DIDAC was first regi stered after November 1, 1984, a reregistration eligibility decision (RED) was not issued. A RED was issued in 2006 for DDAC.

II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN

EPA received no comments during the pub lic comment period on the initial docket, described below. In the PWP, EP A also solicited comments on three specific topics: environmental justice; water body impairment; and trad e irritants. No comments or information were received during the public comment period concerning these issues.Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

6 Therefore, the data needs, work plan and timeline described in the Preliminary Work Plan remain as they were presented in itially. Further, this document makes final the work plan for the DIDAC registration review process.

III. RISK ASSESSMENT AND DATA NEEDS

Human Health Risk Assessment Status and Anticipated Data Needs

The Agency reviewed the hazard an d exposure databases for the DIDAC registration review case and an ticipates that additional toxi city and exposure studies will be needed for registration review. Th e Agency will need to conduct occupational

inhalation and dermal risk assessments ba sed on exposure to DIDAC through use in antifouling coatings. The Agency will need to conduct a dietary assessment based on indirect dietary exposure. There will also be a need for drinking water assessment of DIDAC based on the materials preservative s, and industrial slimicides use in recirculating cooling water towers and pape r mills that potentia lly pass through waste water treatment plants and may be discharged into terrestr ial and aquatic environments.

Dietary and Drinking Water Assessment

Dietary Exposure

Because DIDAC products are registered fo r use in/on agricultural premises and equipment and food handling/storage establishm ent premises and equipment, there is the potential for dietary exposure to DIDAC through indirect food c ontact. A dietary

assessment was conducted for DDAC for the 2006 DDAC RED. No risk of concern was identified in the RED; however, confirmatory data were required. Based on the review of the confirmatory data, the Agency anticipates reviewing the dietary risk assessment used to support the 2006 DDAC RED and, if necessary , will update the asse ssment to address potential exposure to DIDAC.

Drinking Water Exposure

DIDAC end-use registrations that could pot entially impact wate r are registrations for use as an algaecide and for control of al gal and bacterial slimes in once-through water cooling towers, and pulp and paper mills. The current indoor uses of DIDAC are expected to result in minimal residues in dr inking water supplied by residential wells or municipal sources because re-circulating wate r cooling towers are expected to have infrequent discharges and the effluents from recirculating cooling to wers are regulated by NPDES permits.

Tolerances

Quaternary ammonium compounds have a tolerance exemption in 40 CFR 180.940 (a) as a food contact sanitizer for use in public eating places, in dairy processing equipment, and in food processing plants on equipment and utensils and (c) as a food contact sanitizer for use in food proce ssing plants on equipment and utensils.Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

7 Aggregate and Cumulative Exposure

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-occupationa l pesticide exposures. Base d on current use patterns, an aggregate risk assessment will be needed for DIDAC for dietary (food and drinking water) and residential exposure.

Section 40(b)(2)(D)(v) of FFDCA requi res that, when considering whether to establish, modify, or revoke a tolerance, th e Agency considers “available information” concerning the cumulative effects of a part icular pesticide’s residues and “other

substances that have a common mechanism of toxicity. The Agency has not made a common mechanism of toxicity determin ation for DIDAC or other quaternary ammonium compounds and DIDAC does not appear to produce a toxic metabolite produced by other substances. For the purposes of this regi stration review, therefore, a cumulative assessment for DIDAC will not be performed at this time.

Occupational and Resi dential Assessment

The Agency reviewed all available data associated with DIDAC and DDAC and has determined that the currently registered uses of DIDAC may result in residential and occupational exposure. Exposure and risk assessments were conducted for DDAC to support the 2006 DDAC RED. The Agency an ticipates updating these assessments as appropriate to include all registered uses of DIDAC including those such as the antifoulant coating use that we re not applicable for DDAC an d, thus, not included in the 2006 assessment. The Agency anticipates n eeding exposure studies to properly assess exposure to DIDAC in antifouling coatings.

Anticipated Human Health Data Needs

The Agency anticipates needing the follo wing toxicity and exposure studies to assess the DIDAC registration review case:

Anticipated Human Health Toxicity Data Needs

o (GLN 870.3465) 90-day Inha lation Toxicity Study

Anticipated Occupational/Resid ential Exposure Data Needs

As noted in the DDAC RED, “The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure data available from the Chemical Manufacturers Association (CMA) data base . Therefore, the Agency is requiring confirmatory data to support the uses assessed with the CM A exposure data within this

risk assessment. The risk assessment also noted that many of the use parameters (e.g., amount handled and duration of use) were ba sed on professional judgments. Therefore, descriptions of human activi ties associated with the uses assessed are required as confirmatory.” Based on the review of the confirmatory data, the Agency anticipatesDocket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

8 reviewing the occupational/r esidential exposure assessmen t used to support the 2006 DDAC RED and, if necessary, will update th e assessment to address potential exposure

to DIDAC.

The Agency anticipates needing the data identified below, for DIDAC.

o (GLN 875.1200) Dermal Exposure

o (GLN 875.1400) Inhalation Exposure

o (GLN 875.1600) Applicator Exposur e Monitoring Data Reporting

o (GLN 875.2300) Fabric Leaching Study

o (GLN 875.2300) Surface Wood Wipe Study

o (GLN 875.2800) Description of Human Activity (all uses)

o (GLN 875.2900) Data Repor ting and Calculations

Anticipated Residue Chemistry Data Needs

o (GLN 860.1460) Food Handling* *Dietary-Residues in Food from Treating Countertops with DIDAC (FDA Wipe Study Methodology) (FDA, 2003a and 2003b)

Further information and detailed justificat ions for the studies that are expected to be required are available in “Summary of Human Health Effects Data for the Decyl Isononyl Dimethyl Ammonium Chloride (D IDAC) Registration Review Decision Document,” dated March 26, 2010.

Product Chemistry Status and Anticipated Data Needs

The data submitted pertaining to the physical and chemical characteristics of the active ingredient DIDAC are adequate. All product chemistry data requirements have been fulfilled for the active ingredient DIDAC. Therefore, the Agency does not anticipate the need to require additional product chem istry data for DIDAC at this time.

For further information please refer to the Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Decyl Isononyl Dimethyl Ammonium Chloride Registration Review D ecision Document, dated March 29, 2010.

Environmental Fate and Ecological Risk A ssessment Status and Anticipated Data

Needs

The Agency has evaluated the available e nvironmental fate and ecological effects data on DDAC submitted by the registrant. Wh en DIDAC was first registered in 1995, the Agency concluded that the chemical stru ctures of DDAC and DIDAC are structurally similar; therefore, the environmental fate and ecological effect s studies developed on DDAC will be used to evaluate DIDAC as part of this registration review. The Agency will complete the environmental fate and ecological hazard risk assessments presented

below.

• Environmental fateDocket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

9 • Ecological hazard

• Endangered species assessment

Further information and detailed justificat ion for the studies that are expected to be required are available in the document titled, Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Decyl Isononyl Dimethyl Ammonium Chloride Registration Review D ecision Document, dated March 29, 2010.

Environmental fate and ecological risk assessments have not been conducted for DIDAC. DIDAC uses that have potentia l for environmental exposure are swimming pools water, material preserva tives, industrial slimicides used in recirculating water cooling towers, and paper mills discharges. The Agency needs to conduct environmental fate and ecological risk assessments for swim ming pools water, material preservatives,

and industrial slimicides used in recirculati ng water cooling towers and paper mills that potentially pass through waste water treatmen t plants (WWTPs) and may be discharged into terrestrial and aquatic environments. Also, the Agency needs to conduct an ecological risk assessment for DIDAC used in once-through water cooling towers for control of microbiologi cal growth and that likely would be discharged into effluents and surface waters. The Agency also needs to conduct an ecological risk assessment for DIDAC used in aquatic areas to control or kill slime-forming b acteria, fungi, or algae. In addition, the Agency needs to conduct an ecol ogical risk assessment for DIDAC used in wood preservatives and antifouling coatings. Th erefore, the Agency anticipates requiring

the identified environmental fate and ecotoxic ity data for DIDAC and/or any of its major degradation products that are of potential c oncern for all registered uses of DIDAC.

Anticipated Environmental Fate Data Needs (Indoor Use)

o (GLN 850.6800) modified activated sludge respiration inhibition

o (GLN 835.1110) activated sl udge sorption isotherm

Anticipated Ecological Da ta Needs (Indoor Use)

o (GLN 850.4225) seedling emergence, Ti er II - dose response study on rice (Oryza sativa)

o (GLN 850.4250) vegetative vigor, Ti er II - dose response study on rice (Oryza sativa)

o (GLN 850.4400) aquatic plant growth (a quatic vascular plant toxicity), Tier II - dose response study on floating macrophyte Lemna gibba

o (GLN 850.5400) aquatic plant growth (a lgal toxicity), Tier II - dose response studies on Anabaena flos- aquae (blue-green cyanobacteria), Navicula pelliculosa (freshwater di atom), and Skeletonema costatum (marine diatom)Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

10 Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for Antifoulant Coatings Uses of DIDAC

For use in this registration revi ew, the following ecological effects and environmental fate data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.1045: Acute Penaeid; 850.1300: Daphnid chronic toxicity test; 850.1350: Mysid chronic toxicity test - Aquatic invertebrate life cycle 850.1400: Fish early-life stage toxicity studies 850.4225: Seedling emergence 850.4250: Vegetative vigor 850.4400: Aquatic plant growth usi ng floating macrophyte Lemna gibba 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II 850.1735: Whole sediment, acute invertebrates (freshwater) 850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailability /biomagnifications, toxicity tests 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Special leaching study (ASTM 6903-07) None: (Special study) Monitoring of repr esentative U. S. waters (residue of concern)

Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for

Outdoor Wood Preservative Uses of DIDAC

For DIDAC registered for treatment of wood products used in outdoor scenarios (e.g., decks, decking materials, aquatic uses ), the Agency antici pates requiring the following data in order to conduct the e nvironmental fate and ecological risk assessments, including an endangered species assessment. However, note that expected data needs may depend on factors such as the quantities of DIDAC (and/or majorDocket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

11 degradates or metabolites) leaching from w ood; the types of chemical(s) leaching from wood (e.g., parent compound, major degradat es or metabolites); the outdoor use scenarios in which DIDAC-treated wood may be used; and the Agency's evaluation of leaching data along with the available use, effects, and exposure information for DIDAC:

Anticipated Ecological Effects and Environmental Fate Study Needs 1

For use in this registration revi ew, the following ecological effects and environmental fate data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.4225: Seedling emergence 850.4250: Vegetative vigor 850.4400: Aquatic plant growth usi ng floating macrophyte Lemna gibba 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1045: Acute Penaeid 850.1300: Daphnid chronic toxicity test 850.1350: Mysid chronic toxicity test 850.1400: Fish early-life stage toxicity studies 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailability /biomagnifications, toxicity tests 850.1735: Whole sediment, acute invertebrates (freshwater) 850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.3020: Honeybee acute contact LD 50 850.3030: Honey Bee Toxicity of Residues on Foliage 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number

835.4200: Anaerobic soil metabolism 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Soil leac hing from wood study (AWPA E20-04) None: (Special study) Monitoring of repr esentative U. S. waters (residue of concern)

1 Test material for anticipated studies would depend in part on what chemicals are leaching from DIDACtreated wood.Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

12 Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for Aquatic Areas Use Pattern of DIDAC

For use in this registration revi ew, the following ecological effects and environmental data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.1300 Aquatic invertebrate chronic NOAEC using Daphnia magna 850.1350 Aquatic invertebrate chronic NOAEC using mysid shrimp 850.1400: Fish early-life stage and a quatic invertebrate life-cycle 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.4225: Seedling emergence 850.4250: Vegetative vigor dose response test using rice 850.4400: Aquatic plant growth using floa ting macrophyte Lemna gibba - Tier II 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1045: Acute Penaeid 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailabil ity/biomagnification/toxicity tests 850.1735: Whole sediment, acute invertebrates (freshwater) 850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Monitoring of repr esentative U. S. waters (residue of concern)

Anticipated Ecological Effects and Envi ronmental Fate Data Requirements for Once-Through Cooling Water Systems Use Pattern of DIDAC

DIDAC is intended for use in once-thr ough industrial cooling water systems in which the water is not re-used, and is released after a single cycle through the system, and therefore, the Agency anticipates requiring the followi ng data in order to conduct the environmental fate and ecological risk a ssessments, including an endangered species

assessment.Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

13 Anticipated Ecological Effects and Environmental Fate Study Needs

For use in this registration revi ew, the following ecological effects and environmental data are anticipated as being needed:

Anticipated Ecological Effects Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 850.1300 Aquatic invertebrate chronic NOAEC using Daphnia magna 850.1350 Aquatic invertebrate chronic NOAEC using mysid shrimp 850.1400: Fish early-life stage and aquati c invertebrate life-cycle studies 850.4225: Seedling emergence 850.4400: Aquatic plant growth using floa ting macrophyte Lemna gibba - Tier II 850.5400: Aquatic plant growth (algal a nd aquatic plant to xicity) - Tier II

850.1045: Acute Penaeid 850.1500: Fish (freshwater and/or estuarin e/marine species) life cycle study 850.1710: Oyster BCF

850.1730: Fish BCF 850.1850: Aquatic organism bioavailabil ity/biomagnification/toxicity tests 850.1735: Whole sediment, acute invertebrates (freshwater) 850.1740: Whole sediment; acute inve rtebrates (estuarine/marine) 850.1950: Field testing for aquatic organisms (estuarine/marine) 850.2300: Avian reproductive studies with bobwhite quail and/or mallard duck 850.4250: Vegetative vigor dose response test using rice – Tier II (Oryza sativa) 850.4300: Terrestrial Plants Field Study 850.4450: Aquatic Plants Field Study None: (Special study) Whole sediment - chronic invertebrates (freshwater and/or estuarine/marine)

Anticipated Environmental Fate Data Needs (Outdoor Use) : Guideline Description of Anticipated Data Requirement

Number 835.1110: Activated sludge sorption isotherm

850.6800: Modified activated slud ge, respiration inhibition 835.6200: Aquatic (sediment) Field Dissipation None: (Special study) Monitoring of repr esentative U. S. waters (residue of concern)

Endangered Species

The Agency has not conducted a risk assessment that supports a complete endangered species determination. The eco logical risk assessment planned during registration review will allow the Agency to determine whether use of DIDAC has “no effect” or “may affect” federally listed threat ened or endangered sp ecies (listed species) or their designated critical ha bitats. When an assessment c oncludes that a pesticide’s useDocket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

14 “may affect” a listed species or its designate d critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Service (the Services), as appropriate.

Incidents:

As discussed in the DDAC RED, there were many reported incidents associated with exposure to end-use products containing quats. However, as also noted, for the available incident information, it was difficult to differentiate the specific members of the quats involved in each incident. Therefor e, all the quats are discussed together.

Most of the incidents are re lated to irritation. Allergic type reactions have also been reported in some incidents. Symptoms associated with eye irritation are the most commonly reported associated with quaternary ammonium e xposure. The most common symptoms reported for cases of ocular e xposure were eye irritation/burning, eye pain, conjunctivitis, swelling eye and swelling of eyelid. The most common symptoms reported for cases of inhalation exposure were respiratory irritati on/burning, irritation to mouth/throat/nose, coughing/c hoking, chest pain, di sorientation, dizziness, shortness of breath. The most common symptoms reported for cases of dermal exposure were skin irritation/burning, rash, itching, and blistering. Allergic t ype reactions including hives and allergic contact dermatitis, have also been reported. Although oral exposure is considered a minor route of exposure for qua ts use, irritation to mouth/throat/nose, vomiting/nausea/abdominal pain, dizziness, and headache have been reported in the cases of ingestion.Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

15 IV. TIMELINE

The EPA has created the following estimated timeline for the completion of the DIDAC registration review case. The Agency anticipates requiring additional data and residential, occupational and ecological exposure assessments for this registration review

case.

Anticipated Schedule

Activities Estimated

Month/Year Phase 1: Opening the docket
Open Public Comment Period for DI DAC Docket Completed March 2010
Close Public Comment Period Completed June 2010
Phase 2: Case Development

Develop Final Work Plan (FWP) August 2010
Issue DCI September 2011
Data Submission September 2015
Open Public Comment Period for Preliminary Risk Assessments March 2016

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) 7

Next Steps

The Agency plans to develop a Data Call-In for this pesticide and expects to issue it in September 2011.Docket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

16 V. GLOSSARY of TERMS & ABBREVIATIONS

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

AWPA American Wood Preserver’s Association

CBI Confidential Business Information 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

EP End use Product 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 DoseDocket Number; EPA-HQ-OPP-2010-0005 www.regulations.gov

17 PAIRA Pure Active Ingredient Radiolabelled PCA Percent Crop Area PDP USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data

PHI Preharvest Interval phr Pounds Per Hundred 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 RTU Ready to Use 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 Standard