Docket Number; EPA–HQ–OPP–2010-0004 

www.regulations.gov 

 

United States Chemical Safety August 2010 

Environmental Protection and Pollution Prevention 

Agency (7510P)

1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane 

(CTAC) 

Final Work Plan Registration Review 

August 2010 
Docket Number; EP A-HQ-OPP-20 1 0-0004 

www.regulations.gov 

Docket Number: EPA-HQ-OPP-2010-0004 

1-(3-chloroallyl)-3,5,7-triaza-l-azoniaadamantane 

(CTAC) Final Work Plan 

Registration Review Case 3069 

Approved By: 

I!Irector, Mn~~ AntImIcrobials DIVIsIon 

Date: 

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Docket Number; EPA-HQ-OPP-2010-0004 

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TABLE OF CONTENTS

1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane (CTAC) Registration Review Team....................... 4

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

II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN............................................. 6

III. RISK ASSESSMENT AND DATA NEEDS ........................................................................................ 8

IV. TIMELINE ........................................................................................................................................... 14

V. GLOSSARY of TERMS & ABBREVIATIONS ................................................................................. 15
Docket Number; EPA-HQ-OPP-2010-0004 

www.regulations.gov 

1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane (CTAC) Registration Review 

Team

Human Health & Environmental Effects 

Timothy Dole 

Srinivas Gowda 

Risk Management

Rebecca von dem Hagen 

Lance Wormell 

Office of General Counsel

Philip Ross 

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Docket Number; EPA-HQ-OPP-2010-0004 

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I. INTRODUCTION 

This is the Environmental Protection Agency’s (EPA or “the Agency”) Final 

Work Plan (FWP) for the registration review of 1-(3-chloroallyl)-3,5,7-triaza-1-

azoniaadamantane (CTAC). The work plan includes the expected registration review 

timeline. The work plan also addresses public comments received concerning the 

Preliminary Work Plan (PWP) in the Summary Document which was posted in the 

CTAC registration review docket, and any other comments concerning the initial docket 

postings. The Summary Document provided information on what EPA knows about the 

pesticide and what additional risk analyses and data or information the Agency believes 

are needed to make a registration 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 determine whether it continues to meet the 

FIFRA standard for registration. Changes in science, public policy and pesticide use 

practices will occur over time. 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 that 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 CTAC Preliminary Work Plan (PWP) 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-2010-0004. 

CTAC is a formaldehyde (HCHO) releasing biocide. Therefore, this registration 

review case also addresses potential exposure to HCHO resulting from the use of CTAC. 

However, this registration review case does not address possible aggregate risks from 

HCHO. When the HCHO registration review case is at the stage in which a risk 

assessment is conducted, aggregate risks from HCHO derived from the use of CTAC will 

be considered at that time. The Agency issued a Reregistration Eligibility Decision 

(RED) document for formaldehyde in 2008 to address potential risks associated with 

formaldehyde. The formaldehyde RED did not include potential exposure to HCHO 

resulting from the use of products containing CTAC as an active ingredient. 

 The Office of Pesticide Programs (OPP) developed the formaldehyde inhalation 

non-cancer toxicological endpoint used in the 2008 formaldehyde RED through the 

established reregistration process, which includes stakeholder consultation and public 

comment. However, the result has not been subjected to an inter-agency review or 

external peer review. Because of time constraints imposed by statutory deadline, OPP 

could not consider all available peer reviewed science (for example, the intentional 

human dosing toxicity studies). Thus, this value (10 ppb residential and 100ppb 

occupational) should be considered an interim value, developed solely for the purposes of 

the RED and subject to future revision and subsequent peer review and should not be 

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Docket Number; EPA-HQ-OPP-2010-0004 

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used in other contexts as EPA's opinion of the best available science on the non-cancer 

effects of formaldehyde. 

The Agency has formed a work group that is charged with developing a 

harmonized non-cancer hazard characterization document for formaldehyde. The 

Agency intends to use this non-cancer information when assessing the risks associated 

with the antimicrobial uses of CTAC and other formaldehyde releasers. In the near term, 

the antimicrobial uses will also be assessed for cancer risks in the same manner as 

presented in the formaldehyde RED (i.e., a range of cancer risks using the Chemical 

Industry Institute of Toxicology [CIIT] model and the existing Integrated Risk 

Information System [IRIS] unit risk). Once the IRIS update of the formaldehyde cancer 

unit risk is available, the Agency will adopt that value in our risk assessments. The 

formaldehyde risk assessments are available on EPA’s Pesticide Docket at: 

www.regulations.gov. The docket number is EPA-HQ-OPP-2008-0121. 

II. COMMENTS RECEIVED ON THE PRELIMINARY WORK PLAN 

 EPA received submissions from two commenters during the public comment 

period on the initial docket. The comments address anticipated toxicity, environmental 

fate, and ecological effects data needs. After consideration of these comments, the 

Agency has determined that the following three studies are no longer anticipated as being 

needed to be required: Activated Sludge Sorption Isotherm test (835.1110), Seedling 

Emergence (850.4225), and Vegetative Vigor (850.4250). The submissions received and 

the Agency’s responses are explained below. 

In the PWP, EPA also solicited comments on three specific topics: environmental 

justice, water body impairment, and trade irritants. No comments or information were 

received during the public comment period concerning these issues. The timeline 

described in the Preliminary Work Plan remains as presented initially. Further, this 

document makes final the work plan for the CTAC registration review process. 

Commenter 1 

Anticipated Toxicity Data Needs 

Comment: The commenter suggests that the Agency accept a combined chronic 

toxicity/carcinogenicity study to fulfill both the chronic oral and carcinogenicity 

data requirements because performing a combined study would save over 100 

animals. 

Response: As stated in the PWP, the Agency will accept a combined chronic 

toxicity/carcinogencity study. 

Comment: The commenter encourages the registrant to submit legible study 

reports for GLN 870.3250 90-Day Oral Toxicity to avoid conducting the study 

again, as it is currently being called in through this Registration Review. 

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Response: The Agency has received and will review legible copies of GLN 

870.3250, 90-Day Oral Toxicity. If the studies are determined to be “acceptable” 

during review, then this data requirement will be satisfied. 

Commenter 2 

Comment: The chemical name is misspelled throughout the document. 

Response: The Agency has corrected the spelling from 1-(3-chloroally)-3,5,7 

triaza-1-azoniaadamantane chloride to 1-(3-chloroallyl)-3,5,7-triaza-1-

azoniaadamantane in this Final Work Plan. 

Anticipated Toxicity Data Needs 

Comment: The registrant intends to submit legible copies of studies performed for 

GLN 870.3250 90-Day Oral Toxicity: rodent and non-rodent. 

Response: The Agency has received and will review the legible copies of the 

studies performed for GLN 870.3250. 

Comment: The registrant requests reconsideration of the Chronic 

Toxicity/Oncogenicity data requirement based on the belief that the hazard profile 

for CTAC containing products is sufficient to make this data requirement 

unnecessary: 

 CTAC is largely negative in in vitro genotoxicity studies 

 CTAC is negative in in vivo genotoxicity studies 

 CTAC shows no evidence of pre-neoplatic events in sub-chronic toxicity 

studies in the rat and the dog 

 CTAC demonstrates a high Margin of Safety in various exposure 

 scenarios 

Response: The EPA will evaluate these claims based on the submission and 

review of any data provided to the Agency. Until the EPA is able to evaluate 

these claims, EPA anticipates requiring the Chronic Toxicity/Oncogenicity 

requirement. 

Anticipated Environmental Fate Data Needs 

Comment: An Activated Sludge Sorption Isotherm test (835.1110) does not need 

to be performed on l-(3-Chloroallyl)-3,5,7-Triaza-I-Azoniaadamantane Chloride 

(CTAC) for two reasons. First, the compound is susceptible to hydrolysis, 

particularly at low concentrations relevant to this test procedure. Second, 

sufficient information exists to predict the extent of adsorption on activated 

sludge. 

The hydrolysis kinetics of CTAC have been assessed previously (Gonsior et. al., 

1994). Half-lives for 50 mg/L CTAC ranged from 1.1 to 2.7 days at 25°C over the 

pH range 5 to 9. Thus, the test guideline requirement that mixtures of the test 

substance and activated sludge solids are to be mixed until equilibrium is 

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Docket Number; EPA-HQ-OPP-2010-0004 

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achieved cannot be met since the aqueous concentration of the test substance will 

continually decrease over time in the test system. 

Chemical properties for CTAC indicate that adsorption of the test substance to 

activated sludge will be of minimal importance in a wastewater treatment plant 

(WWTP). The water solubility of CTAC is ± 50% by weight at 20°C. The 

octanol/water partition coefficient is very low (log Kow = -2), consistent with the 

high water solubility. A log Koc = 2.5 was estimated using the OECD 121 

guideline "Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage 

Sludge using High Performance Liquid Chromatography (HPLC)" [Gonsior et. 

al., 2002]. This log Koc value is consistent with the high water solubility and low 

log Kow, confirming the position that adsorption of CTAC to sewage sludge will 

be of minor importance in assessing the fate of the substance in a wastewater 

treatment plant. In addition, CTAC is readily biodegradable (Gonsior and 

Goodwin, 2000). Thus, CTAC will be susceptible to both rapid hydrolysis and 

biodegradation in a WWTP. 

Response: The Agency concurs; an Activated Sludge Sorption Isotherm study 

(835.1110) is not needed and that corresponding anticipated study requirement 

has been removed from this work plan. 

Anticipated Ecological Effects Data Needs 

Comment: The registrant believes that the Seedling Emergence and Vegetative 

Vigor studies requirements are inappropriate for CTAC containing products. Due 

to the uses of CTAC, primarily in formulated or finished products at low 

concentrations, this material will not enter terrestrial systems and therefore will be 

unavailable to partition into soil. Following use, most CTAC residues will enter 

the wastewater system and be removed in wastewater treatment plants by both 

biodegradation and hydrolysis. Since it is unlikely that terrestrial non-target plants 

will be exposed to CTAC due to its use patterns, additional testing on terrestrial 

non-target plants should not be necessary. 

Response: The Agency concurs; Seedling Emergence (850.4225) and Vegetative 

Vigor (850.4250) studies are not needed and those corresponding anticipated 

study requirements have been removed from this work plan. 

III. RISK ASSESSMENT AND DATA NEEDS 

Human Health Risk Assessment Status 

 The Agency has reviewed the hazard and exposure databases for the CTAC 

registration review case. As a result of this review, EPA believes risk assessments are 

needed to ensure that the CTAC registration review case meets the FIFRA and FFDCA 

standards. Because CTAC releases formaldehyde it will also be necessary to assess 

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formaldehyde exposures. The Agency will complete the human health risk assessments 

presented below. 

 Dietary (Food) Risk Assessment - Indirect dietary (food) exposure resulting 

from the use of CTAC in food packaging materials. 

 Residential Handler Risk Assessment - Dermal and inhalation exposure to 

CTAC and inhalation exposure to formaldehyde during the use of treated 

paints and general purpose cleaners. Residential inhalation exposure to 

formaldehyde during the use of CTAC treated laundry detergents. 

 Residential Post-Application Risk Assessment - Incidental oral and incidental 

dermal exposure from wearing clothing made from textiles treated with 

finishing fluids preserved with CTAC. 

 Occupational Handler Risk Assessment - Occupational dermal and inhalation 

exposure to CTAC and inhalation exposure to formaldehyde during the open 

pour addition of CTAC powder for materials preservation, oil products, pulp 

and paper production and textile production. Occupational dermal and 

inhalation exposure to CTAC and inhalation exposure to formaldehyde during 

the use of CTAC treated metal working fluids and preserved paints. 

Dietary and Drinking Water Exposure and Risk

Dietary Food Exposure 

CTAC is FDA-approved for use as an indirect food additive in adhesives and 

components of coatings (21 CFR 175.015); paper and paperboard board components (21 

CFR 176.170 & 21 CFR 176.180); and polyurethane resins in contact with bulk 

quantities of dry foods (21 CFR 177.1680). These uses may result in indirect dietary 

food exposure. However, they were not assessed in the 1995 CTAC RED. Therefore, an 

indirect dietary (food) exposure risk assessment is needed in support of this registration 

review. 

Dietary Drinking Water Exposure 

 The registered uses of CTAC are not likely to result in contamination of surface 

water and ground water and as a result drinking water exposure is not expected. 

However, the need for a dietary drinking water exposure assessment for CTAC will be 

determined upon review of environmental fate data, which the Agency anticipates 

requiring. The Agency anticipates that environmental fate data will be useful to 

determine if CTAC can pass through waste-water treatment facilities into drinking water 

or migrate into residential groundwater wells as a result of its current use patterns. 

Therefore, the need for a dietary drinking water assessment will be revisited upon 

submission and review of the environmental fate data that are anticipated as being 

needed. 

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Tolerances

CTAC is permitted for use as an inert ingredient in non-food use pesticide 

products (40 CFR Part 180). CTAC is also exempt from the requirement of a tolerance 

when used as an inert ingredient as a preservative at 0.14% by weight (wt) or less of 

pesticide formulations (40 CFR 180.920). 

There are no tolerances or exemptions from tolerances for the use of CTAC as an 

active ingredient and no registered food uses. As previously mentioned, CTAC is FDAapproved for use as an indirect food additive in adhesives and components of coatings, 

paper and paperboard components and polyurethane resins in contact with bulk quantities 

of dry foods. 

It is noted that exemptions and regulations for food additives under Section 409 of 

the Federal Food, Drug, and Cosmetic Act (FFDCA) do not relieve the registrant of 

meeting the standard under Section 408 as amended by the Food Quality Protection Act 

(FQPA), when the active ingredient is subject to regulation as a food-use pesticide under 

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Under Section 408, a 

determination of safety for residues of a pesticide that may be in food is required, and as 

defined in Section 408(b)(2)(A)(ii), “that there is a reasonable certainty that no harm will 

result from aggregate exposure to the pesticide chemical residue, including all anticipated 

dietary exposures and all other exposures for which there is reliable information.” EPA 

will be performing risk assessments to determine if tolerances or exemptions from 

tolerances will be needed to support the existing registered uses of CTAC. 

Aggregate and Cumulative Exposure and 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 

may be needed for CTAC if it is determined that drinking water exposure could occur 

based on the environmental fate data. This assessment would consist of the aggregation 

of the indirect dietary food exposure from CTAC residues in treated food packaging and 

the exposure that would occur from CTAC residues in drinking water. If it is determined 

that an aggregate assessment is needed, the need for including residential incidental oral, 

dermal and inhalation exposures in the aggregate assessment will be determined when the 

toxicity data that are anticipated as being required are completed and added to the 

database for use in endpoint selection. Therefore, the need for an aggregate assessment 

will be revisited upon submission and review of the environmental fate data and human 

toxicology data that are anticipated as being required. 

 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 CTAC has a common mechanism with other compounds; consequently, a 

cumulative assessment will not be performed at this time. 

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 It should be noted that this registration review case does not address aggregate 

exposure from HCHO. When the HCHO registration review case is at the point at which 

a risk assessment is to be conducted, aggregate exposure from HCHO will be assessed 

and the need for a cumulative HCHO assessment also will be addressed at that time. 

Occupational and Residential Exposure and Risk

 The Agency reviewed all available data associated with CTAC and has 

determined that the currently registered uses of CTAC may result in residential and 

occupational exposure. Therefore, the Agency will conduct residential (handler and postapplication) and occupational (handler) risk assessments to assess possible dermal, 

inhalation, incidental oral and incidental dermal exposure to CTAC and possible 

inhalation exposure to HCHO. 

Dermal exposure may possibly lead to dermal sensitization. During its review the 

Agency has identified dermal sensitization in open literature studies. This literature may 

be reviewed during the registration review process. If the Agency decides to rely on this 

open literature study, the Agency will make sure it meets all applicable standards that 

apply to human study ethics. Formaldehyde has been identified as one of the major 

allergens in the cosmetic related allergic contact dermatitis (Groot,et al, 1988 and Storrs, 

et al. 1989). Although the individuals involved in these incidents may have been exposed 

to different types of allergens, the Agency cannot rule out the possibility that CTAC may 

be related to the cosmetic related allergic contact dermatitis. It is also not known if the 

contact dermatitis is due to exposure to the CTAC parent or if it is due to exposure to the 

formaldehyde released by the parent. In a patch test study (Zug et. al., 2009) of 4,454 

patients who had suspected contact dermatitis, 10.3% had positive reactions to 

Quaternium 15 and 9% had positive reactions to formaldehyde. Quaternium 15 was 

among the 4 most positive allergens with the top three being nickel sulfate (19.0%), 

balsam of Peru (11.9%) and fragrance mix (11.5%). 

Anticipated Human Health Data Needs 

The Agency anticipates that the following toxicity and exposure data will be 

needed to conduct residential (handler and post-application) and occupational (handler) 

exposure risk assessments for the registered uses of CTAC. 

Anticipated Toxicity Data Needs

 (GLN 870.3250) 90-Day Oral Toxicity- rodent and non-rodent 

 (GLN 870.3700) Developmental Toxicity- non-rodent 

 (GLN 870.3465) 90-Day Inhalation- rat 

 (GLN 870.3800) Reproductive Study- oral 

 (GLN 870.4100) Chronic Oral- rodent* 

 (GLN 870.4200) Carcinogenicity*

* A combined chronic toxicity/carcinogenicity study (OPPT 870.4300) can fulfill both the 

chronic oral and carcinogenicity data requirements.

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Anticipated Residential and Occupational Handler Exposure Data Needs

 (GLN 875.1200) Dermal Exposure 

 (GLN 875.1400) Inhalation Exposure 

 (GLN 875.1600) Data Reporting/Calculations 

 (GLN 875.1700) Product Use Information 

 (Non-Guideline Study) Textile Leaching Study 

Anticipated Physical/Chemical Property Data Needs 

All product chemistry data requirements have been fulfilled for CTAC. 

Therefore, it is anticipated that additional product chemistry data will not be needed for 

CTAC. 

Environmental Fate and Ecological Risk Assessment Status 

The Agency reviewed the environmental fate and ecological hazard databases for 

CTAC. Based on its review, EPA believes risk assessments are needed to ensure that the 

CTAC registration review case meets the 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 expected to be required are 

available in the document titled “Summary of Product Chemistry, Environmental Fate, 

and Ecotoxicity Data for the CTAC Registration Review Decision Document,” dated 

March 23, 2010. 

 Environmental fate 

 Ecological hazard 

 Endangered species assessment 

Environmental fate and ecological risk assessments have not been conducted for 

CTAC. The use of CTAC as a materials preservative could potentially result in 

environmental exposure. These uses may result in waste water treatment plant (WWTP) 

discharges into terrestrial and aquatic environments. Therefore, the Agency will conduct 

environmental fate and ecological risk assessments to assess environmental exposure 

resulting from possible discharges into terrestrial and aquatic environments. The Agency 

anticipates that environmental fate and ecological data will be needed to conduct these 

assessments. 

Anticipated Environmental Fate and Ecological Data Needs 

The Agency anticipates conducting environmental fate and ecological risk 

assessments for CTAC based on its use as a materials preservative. The use of CTAC as 

a materials preservative could potentially result in CTAC passing through waste water 

treatment plants (WWTPs), which may then be discharged into terrestrial and/or aquatic 

environments. Therefore, the Agency anticipates needing environmental fate and 

ecological toxicity data for CTAC. Should the Agency determine at a later date that it 

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needs additional data on this active ingredient or on any of its degradates about which the 

Agency may have concern, the Agency will require such data. The environmental fate 

and ecological toxicity data listed below are anticipated as being needed to conduct 

environmental fate and ecological risk assessments. 

Anticipated Environmental Fate Data Needs

 (GLN 835.2240) Photodegradation in Water 

 (GLN 835.3110) Ready Biodegradability 

Anticipated Ecological Data Needs

 (GLN 850.4400) Aquatic Plant Growth (aquatic vascular plant toxicity), Tier 

 II dose response study on floating macrophyte (Lemna gibba) 

 (GLN 850.5400) Aquatic Plant Growth (algal toxicity), Tier II dose response 

 studies on Anabaena flos-aquae (blue-green cyanobacteria), Navicula 

 pelliculosa (freshwater diatom), and Skeletonema costatum (marine diatom) 

Endangered Species 

The Agency has not conducted a risk assessment that supports a complete 

endangered species determination for CTAC. The ecological risk assessment planned 

during registration review will allow the Agency to determine whether use of CTAC 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 

Service (the Services), as appropriate. 

Incidents

No CTAC specific incidents have been reported in the OPP Incident Data System 

(IDS). CTAC (as Quaternium-15) has been used as a preservative in cosmetics and it has 

been reported as one of the potential causes of allergic contact dermatitis in consumers of 

cosmetics (Groot,et al, 1988; Storrs, et al. 1989; and O'Reilly and Murphy, 1996). 

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IV. TIMELINE 

The EPA has created the following estimated timeline for the completion of the 

CTAC registration review case. The Agency anticipates requiring additional data and 

residential, occupational, environmental fate 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 CTAC Docket March 2010 – complete

Close Public Comment Period June 2010 – complete 

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 Proposed 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. 

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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 

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 

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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 

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 

RTU Ready to Use 

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