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                              Isopropyl Myristate
                                       
                   Tetradecanoic acid, 1 - methylethyl ester
                               PC Code : 000207
                                       
                                       
                                       
                                       

   
	U.S. Environmental Protection Agency
	Office of Pesticide Programs
                Biopesticides and Pollution Prevention Division
                                       
                                       
                                August 24, 2011
	
                              TABLE OF CONTENTS 
                                       
                                       
       I.         EXECUTIVE SUMMARY ....................................................................5
   II.       ACTIVE INGREDIENT OVERVIEW ......................................................7
   II.       REGULATORY BACKGROUND ...........................................................8
   A. Classification .......................................................................................8 
   B.    Food Clearances and Tolerances ...............................................................8
    IV.      RISK ASSESSMENT ...............................................................................8
   A. Active Ingredient Characterization ............................................................8
   B. Human Health Assessment .......................................................................8
        1.             Toxicology .....................................................................................8
        2.             Dose Response Assessment ................................................................11
            Drinking Water Exposure and Risk Characterization..............................11
        3.             Occupational, Residential, School and Day Care Exposure and Risk Characterization............................................................................11
        4.             Aggregate Exposure from Multiple Routes Including Dermal, Oral, and
             Inhalation ...................................................................................12
        5.             Cumulative Effects ........................................................................12
        6.             Risk Characterization ....................................................................12
   C. Environmental Assessment ......................................................................12
        1. Ecological Hazards.........................................................................12
        2. Environmental Fate and Ground Water Data ......................................13
        3. Ecological Exposure and Risk Characterization ....................................13
        4. Endangered Species Assessment ........................................................13
    Product Performance/ Efficacy Data ........................................................14
      V.      RISK MANAGEMENT DECISION ...........................................................14
   A. Determination of Eligibility for Registration ..................................................14
   B. Regulatory Decision .................................................................................14
   C. Environmental Justice ..............................................................................14
    VI.      ACTIONS REQUIRED BY REGISTRANTS ....................................................15
   A. Reporting of Adverse Effects ........................................................................15
   VII.  APPENDIX A.  Data Requirements (40 CFR Part 158) ........................................15
 VIII. APPENDIX B. Product Specific Information ........................................................22
   IX.    APPENDIX C.  References .............................................................................22
       X.   APPENDIX D. Bibliography.........................................................................23      
      XI.    GLOSSARY OF ACRONYMS AND ABBREVIATIONS.................................. 28
       
            BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM


                         Office of Pesticide Programs
                   Biopesticides and Pollution Prevention Division
                      Biochemical Pesticides Branch (BPB)
                                       

Branch Chief
Linda A. Hollis, M.S.

Health Effects
Angela Gonzales, Biologist 

Product Performance
Clara Fuentes, Entomologist 

Environmental Effects 
Miachel Rexrode, Ph.D., Senior Biologist

Product Chemistry 
Jacob Moore, Chemist
 
Regulatory Action Leader
Cheryl Greene
I.	EXECUTIVE SUMMARY:
Isopropyl myristate is a pesticidal active ingredient intended for formulation into end-use insecticidal products that are intended to kill ticks on cats and dogs.  Isopropyl myristate is a clear, odorless liquid produced from the reaction of myristic acid and isopropyl alcohol. Myristic acid is a naturally occurring fatty acid found in plants, plant oils and animal fats including the nutmeg tree, palm oil, coconut oil, butterfat and sperm whale oil. Isopropyl alcohol, commonly known as rubbing alcohol, is a secondary alcohol produced and used since the 1920s in chemical experimentation and since 1957 in cosmetic, pharmaceutical and household products.  
Isopropyl myristate is commercially synthesized for use as a flavoring agent in a wide range of foods including baked goods and desserts. It is used in over 900 cosmetic and personal care products at concentrations ranging from 0.00008-78%. Such products include face powders, liquid makeup, beauty creams, body sprays, aftershave, deodorants, lotions, and hand sanitizers. Isopropyl myristate is also used as a carrier or solvent in a variety of pharmaceutical therapies that require good precutaneous absorption. Such products include hair rinses for killing and controlling head lice and transdermal patches for delivery of pain management drugs and antibiotics. 
 The Agency's assessment of risks, hazards and benefits associated with isopropyl myristate is based on data submitted on the unregistered technical active ingredient formulated into the single end-use product containing isopropyl myristate as an active ingredient.  
The Biopesticides and Pollution Prevention Division (BPPD) has determined that the data submitted for Product Chemistry, Tier I Acute Toxicity, Ecological Effects and Environmental Fate for isopropyl myristate satisfy current guideline requirements. The Agency notes, however, that if the intended end-use applications result in different exposures to humans than is anticipated, then the registrant may be required to address additional data requirements in future submissions. Based on this information, the Agency has determined that use of isopropyl myristate as an active ingredient in end-use pesticide products to kill ticks on cats and dogs will have No Effect on threatened and/or endangered species. The mode of action of the active ingredient is desiccation; the chemical dissolves the wax on the cuticle or exoskeleton of the insect which causes the insect to dry out or desiccate.   
Based on the acute toxicity data submitted for isopropyl myristate, the Agency classifies the active ingredient as a toxicity category II out of four categories with category I being the most toxic and category IV being the least toxic. EPA has no concerns about non-target organisms exposed to isopropyl myristate in accordance with approved label directions. There are no concerns for any threatened or endangered species. Given that isopropyl myristate is a lower toxicity substance and the potential for exposure to the environment is insignificant or unlikely, EPA concludes, based on the use pattern, that it is in the best interests of the public and the environment to issue the registration for isopropyl myristate.
The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data and information in support of the requirements for granting registration under Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). We have determined that the data/information submitted adequately satisfy current guideline requirements (see 40 CFR Subpart U § 158.2000). 
On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for the public to participate in major registration decisions. According to this new policy, EPA intends to provide a public comment period prior to making a registration decision for, at minimum, the following types of applications: new active ingredient, first food use, first outdoor use, first residential use; and any registration decisions for which the Agency believes there may be substantial public interest.  

Consistent with the policy of making registration actions more transparent, isopropyl myristate and the end-use product containing isopropyl myristate as an active ingredient (RESULTIX(TM), EPA Registration Number 86865-1) was subject to a 30-day comment period as a "new active ingredient". During this comment period, no comments were received on the Agency's preliminary decision to register. Therefore, the Agency maintains that, based upon the risk assessment and information submitted in support of registration of RESULTIX(TM), it is in the best interest of the public and the environment to issue the registration for this pesticide product. The basis for this decision can be found in the risk assessment for isopropyl myristate which is characterized throughout this BRAD.
II.		ACTIVE INGREDIENT OVERVIEW
   Common Name: 			Isopropyl Myristate 
      Chemical Names: 	     		Tetradecanoic acid isopropyl ester
					     Myristic acid isopropyl ester 

   Trade & Other Names: 
   Tetradecanoic acid, 1 - methylethyl ester			Chemical/Systemic name 
   Isopropyl myristate								Other Common name
   Starfol ISOPROPYL MYRISTATE					Trade name
   Kessco Isopropyl myristate95					Trade name 
   Stepan D-50									 Trade name
   RESULTIX(TM)									Trade name 
      CAS Registry Number: 	110-27-0
   OPP Chemical Code: 	000207
   Type of Pesticide: Biochemical Pesticide/Insecticide 
Molecular formula:	C17H34O2 
Molecular Weight:   270.46g/mol


III.  REGULATORY BACKGROUND
Isopropyl myristate was first registered by EPA on October 31, 1986, as an active ingredient for use in antimicrobial pesticides. By the end of 1987, all products containing isopropyl myristate as an active ingredient were cancelled following a generic data call-in. On December 3, 2009, EPA received an application filed by Piedmont Animal Health, (204 Muirs Chapel Road, Suite 200, Greensboro, NC 27410) to register an end-use product containing isopropyl myristate as an insecticide to kill ticks on cats and dogs. RESULTIX(TM), the end-use product contains 50.0 % isopropyl myristate as an active ingredient. A notice of receipt of this application, allowing for a 30-day comment period, was published in the Federal Register on March 10, 2010 (75FR 28702). No comments were received following this publication.
   A. Classification
Isopropyl myristate is classified as a synthetic substance, not naturally occurring. Moreover, some may question whether its mode of action is actually non-toxic. Nonetheless, on March 27, 2009, the Agency's Biochemical Classification Committee completed a review of isopropyl myristate, which determined that, although the substance is not naturally occurring, it nonetheless is eligible for a reduced set of data requirements, based on a mode of pesticidal action similar to sucrose octanoate, which is a registered biochemical pesticide. 
	B.	Food Clearances/Tolerances 
Currently this active ingredient is not registered on food or feed commodities.  
IV.			RISK ASSESSMENT
A.   Active Ingredient Characterization
Isopropyl myristate is a pesticidal active ingredient intended for formulation into products to kill ticks on cats and dogs. It is a clear, odorless liquid produced from the reaction of myristic acid and isopropyl alcohol. Myristic acid is a naturally occurring fatty acid found in plant and plant oils and animal fats including the nutmeg tree, palm oil, coconut oil, butterfat and sperm whale oil. Isopropyl alcohol, commonly known as rubbing alcohol, is a secondary alcohol produced and used since the 1920's in chemical experimentation, and since 1957 in cosmetic, pharmaceutical and household products. The end-use product (EP) is intended for use on cats and dogs to kill ticks. The mode of action of this active ingredient is physical in that isopropyl myristate de-waxes the cuticle or outer skeleton of the target pest (tick).  Insects such as ticks need waxed cuticles in part to maintain body fluids. Once cuticle wax is destroyed or compromised the insect loses critical body fluids and simply dries up or undergoes desiccation. 
All data requirements have been satisfied per 40 CFR 158.2030 for registration of the end-use product RESULTIX(TM). The data presented in Table 1 of the appendix to this document are a summary of the product chemistry data and information submitted to support the EP, RESULTIX(TM). 
B.	Human Health Assessment
   1. Toxicology 
For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) identified from studies and/or information on file with the Agency. The active ingredient is classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest toxicity and Toxicity Category IV indicates the lowest toxicity. 
   Adequate mammalian toxicology data/information is available to support registration of isopropyl myristate.  All toxicology data requirements for isopropyl myristate have been satisfied.  The Agency has classified isopropyl myristate into Toxicity Category II.
   a.  Acute Toxicity
   Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes and skin, and 3) determine the potential for skin sensitization (allergic contact dermatitis).  
   All data cited by the registrant to satisfy the biochemical pesticide data requirements for isopropyl myristate as an active ingredient were submitted from the open scientific literature. Additional data were obtained using the Hazardous Substances Database (HSDB) from the National Library of Medicine. Data submitted to satisfy the one registered product show that isopropyl myristate has low acute oral, acute dermal and acute inhalation toxicity. An additional acute inhalation toxicity study from the HSDB (2011) indicates no mortality or significant adverse effects when rats were exposed to an aerosol formulation containing 4.7% isopropyl myristate (9.7 mg/L) for four 15-minute periods. Several eye irritation studies conducted on rabbits indicate that the chemical is nonirritating to minimally irritating.  Studies on the dermal irritation of isopropyl myristate have yielded mixed results. The majority of these studies indicate that the chemical is minimally irritating when applied to rabbits. One study showed severe irritation in rabbits, moderate irritation in guinea pigs and mild irritation in rats. The Agency has conservatively classified isopropyl myristate into toxicity category II on a scale of IV for dermal irritation based on the results of this study. The results of the other studies demonstrate that the chemical is only mildly irritating and meets the Agency's classification of a toxicity category II active ingredient. The active ingredient is not considered to be a skin sensitizer. 
   For additional information regarding acute toxicity data requirements, refer to Table 2 in Appendix A of this document. 
   b.  Subchronic Toxicity
   Subchronic data are required to determine a no-observed-effect-level (NOEL) and any toxic effects associated with repeated or continuous exposure to a test substance for a period of ninety days.  
	90-Day Oral
   In a 28-day non-guideline oral toxicity study, Wistar rats were exposed to the end-use product (RESULTIX(TM)) via gavage once per day for five days a week at 0, 100, 500 or 1000 mg/kg bw. No treatment-related mortality or adverse effects were observed. Hyperplasia of the fore stomach mucosa was recorded in all the test groups, including the control group. The injury was reversible following the 14-day recovery period. The NOAEL is >= 1000 mg/kg bw; the LOAEL could not be determined (no adverse effects at the highest dose tested). (HSDB, 2011). Repeat human oral exposure is not expected based on the use pattern; isopropyl myristate is not food-use and will be applied dermally to cats and dogs to kill ticks.    
	90-Day Dermal
   In a 28-day non-guideline dermal toxicity study, Landrace-Duroc pigs were exposed to the end-use product (RESULTIX(TM)) every three days. The applied doses were equivalent to 0, 20.31-33.89, 59.62-94.43, or 196.3-321.3 mg/kg bw.  No mortality or adverse treatment related effects were observed.  At the highest dose, there was a slight increase in male pituitary weights and there was an equivocal increase in female adrenal weights. These changes were not detected by the end of the 14-day recovery period. These observations may be treatment-related, but are not considered toxicologically significant due to the lack of associated findings or changes in the evaluated toxicological parameters. The NOAEL is >= 196.3-321.3 mg/kg bw and the LOAEL could not be determined as no adverse effects were identified at the highest dose tested.  Prolonged dermal exposure to the human skin is not expected as the end-use product is not intended to be purposely applied directly to the skin.
	90-Day Inhalation
   In a 13-week inhalation study, guinea pigs were exposed for three one-hour periods every day to an aerosol formulation containing 16-20% isopropyl myristate at 0, 63.3, or 224 mg/m[3]. At four weeks, half of the animals were sacrificed. One female died during the course of the study from unknown causes. There was an increase in absolute and relative lung weights in the treated animals compared to the control animals. No other adverse treatment-related effects were observed during gross necropsy and histology in the animals that were sacrificed at four weeks and 13 weeks.   
   In a 13-week inhalation study, cynomolgus monkeys were exposed for three one-hour periods every day to the same formulation used in the guinea pig study (above) at 0, 5.3, 8.4, 33.6, or 37.0 mg/m[3]. During the study, coughing and wheezing were observed and there was a bloody nasal discharge in two of the animals exposed to the 8.4 mg/m[3] dose. Accumulations of macrophages within the bronchiolar and alveolar walls were observed and were dose-related in treated monkeys. No other adverse treatment-related effects were noted.
   Significant repeat inhalation exposure is unlikely based on the use pattern and low volatility of the active ingredient (<1 Torr at 20º C).
   For additional information regarding subchronic toxicity data requirements, refer to Table 2 in Appendix A of this document. 
   c.  Developmental Toxicity 
   Developmental toxicity data on technical grade active ingredients are a standard requirement for the registration of pesticide active ingredients.  As described above, products containing isopropyl myristate, are commonly used by the general population, including human females. Due to the lack of reported adverse effects to humans females from the use of these products, the Agency is not requiring these data at this time.  
   d.  Mutagenicity
   Results were negative in an Ames mutagenicity assay with and without metabolic activation using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 at concentrations of 4, 20, 100, 500 and 2500 ug/plate. In a similar Ames assay, results were negative using the same S. typhimurium strains with and without metabolic activation at a concentration of 50 mg/mL. Isopropyl myristate was non-mutagenic in these assays. 
   Data from an in vitro mammalian mutagenicity assay are unavailable. But, significant human exposure is unlikely; isopropyl myristate is not structurally related to a known mutagen and does not belong to a chemical class of compounds containing a known mutagen.  Refer to Table 2 for product-specific information.
   e. Effects on the Endocrine System
   As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine related effects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.
   Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain post-application agricultural scenarios. This list should not be construed as a list of known or likely endocrine disruptors.
   Isopropyl myristate is not among the group of 58 pesticide active ingredients on the initial list to be screened under the EDSP. Under FFDCA section 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/.
   A. Dose Response Assessment
       No relevant toxicological endpoints were identified; therefore, a dose response assessment is not required           for this pesticidal active ingredient. 
   B. Drinking Water Exposure and Risk Characterization
      Based on the use pattern of isopropyl myristate as a contact pesticide to kill ticks on cats and dogs, pesticide       residues in drinking water are not expected when products containing isopropyl myristate are used                      according to label instructions. Pesticide application to pets is generally considered by the Agency to be an         indoor use pattern; therefore, isopropyl myristate residues in drinking water are highly unlikely.   
   C. Occupational, Residential, School and Day Care Exposure and Risk Characterization
   a. Occupational Exposure and Risk Characterization
   An occupational exposure assessment was not conducted for isopropyl myristate. Based on the use pattern and toxicity data available to the Agency, anticipated exposure is not likely to result in unreasonable risk to humans including animal health care professionals and animal grooming professionals.  No relevant toxicological endpoints were identified and significant exposure in an occupational setting is not expected.  
   A. Residential, School and Day Care Exposure and Risk Characterization
   A residential, school and day care exposure assessment was not conducted for isopropyl myristate. Based on the use pattern, school and day care exposures are unlikely. Although the product will be used in residential settings, based on the use pattern and toxicity data available to the Agency, anticipated exposure is not likely to result in unreasonable risk to humans. No relevant toxicological endpoints were identified and significant exposure in a residential setting is not expected.  
   B. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation
   There is reasonable certainty that no harm to the U.S. population will result from aggregate exposure to isopropyl myristate. This includes all exposures for which there is reliable information. The Agency arrived at this conclusion isopropyl myristate's highly specific mode of action as a topical insecticide limited to use on cats and dogs, its low toxicity to mammalian systems and the intended non-food use. The risk from aggregate exposure (via oral, dermal and inhalation exposures) is negligible. The Agency has conservatively classified isopropyl myristate into toxicity category II for possible eye irritation. The Agency will mitigate the potential for eye irritation through product labeling language.   
   C. Cumulative Effects
   EPA has considered the potential for cumulative effects of isopropyl myristate and other substances in relation to a common mechanism of toxicity. However, because of its highly specific mode of action as a topical insecticide limited to use on cats and dogs, its low toxicity to mammalian systems and the intended non-food use, the Agency does not expect any cumulative or incremental effects from exposure to residues of isopropyl myristate.   
   D. Risk Characterization
   The Agency considered human exposure to isopropyl myristate in light of the relevant safety factors in FIFRA. A determination has been made that no unreasonable adverse effects to the U.S. population in general, and to infants and children in particular, will result from the use of isopropyl myristate when label instructions are followed. 
   E. Environmental Assessment 
Ecological Hazards  
The Agency has evaluated the potential for toxicity of isopropyl myristate and the end-use products to aquatic and terrestrial ecosystems and concludes that the potential for exposure to the environment is insignificant or unlikely. Isopropyl myristate will be formulated into products that will be applied to dog and cats as a topical spray treatment to kill ticks and is not expected to impact nontarget species because of limited exposure due to its indoor use pattern. Therefore, Non Target Organisms and Environmental Fate Data Requirements were waived based on the rationales below. The Agency is requiring that the end-use product label carry environmental hazard information regarding potential toxicity to aquatic organisms and to prevent accidental release to aquatic environments and water bodies. 

a. 	Acute Toxicity Aquatic Invertebrates (Daphnids)  -  TGAI & EP

A search of available environmental databases for isopropyl myristate did not produce any acute toxicity data for aquatic invertebrates. This compound, however, is lipophilic and has a very low solubility in water (0.014 mg/L). However, isopropyl myristate is also semi volatile suggesting low potential exposure to aquatic organisms. 

b. 	Freshwater Fish Acute Toxicity - TGAI & EP
A search of available environmental data produced one acute fish 96-hour LC50 =100 mg/L that shows that isopropyl myristate is practically non-toxic to fish. This compound is lipophilic and has a very low solubility in water (0.014 mg/L) suggesting low exposure to fish and other aquatic organisms.
  
c.   				Avian Acute Oral and Dietary Toxicity Avian - TGAI & EP
The end-use product is intended to be used indoors and applied as a topical spray to cats and dogs and therefore exposure to birds as a result of this indoor use pattern is unlikely. In the event of label misuse, the potential routes of exposure to birds from the use of the product are inhalation, dermal, and oral. The route of exposure for these two studies is oral (gavage and dietary); the other routes are not applicable. Because the end-use product is a colorless and practically odorless liquid product, it is unlikely that the end-use product would be gastronomically attractive for birds to ingest. Usually toxicity to birds occurs from ingestion of pesticide products that resemble seeds (e.g., granular formulation) or from ingestion of pesticide residues on plant and other food items (insects). Additionally, the container is small (20 mL) and spillage of the colorless fluid would result in minimal amounts present on soil or plant surfaces. Birds are also unlikely to mistake accidental spillage of the end-use product as water, particularly because of the small volume and rapid volatilization of the product. 

d.  	Terrestrial Plant Toxicity Seedling Emergence and Vegetative Vigor - TGAI & EP

The target species for products containing isopropyl myristate are ticks found on domestic cats and dogs. Therefore, direct or indirect application of the end-use product to terrestrial plants is not expected to occur if label instructions are followed.  
e. 	 Nontarget Insect Testing - TGAI & EP
Because isopropyl myristate is used to kill ticks by desiccation (solubilizing the cuticle), it is likely to have the same affect on all insects and other arthropods. However, the Agency believes that the use indoor pattern on domestic cats and dogs, and the limited application (20 ml) precludes contact with nontarget insects, particularly honeybees.  
f.  	Environmental Fate and Groundwater 
The need for environmental fate and groundwater data was not triggered because isopropyl myristate acute toxicity studies did not trigger any additional Tier I studies.  
g. 	 Ecological Exposure and Risk Characterization 
Based on the information submitted in the data waiver requests for nontarget plants and nontarget insects, exposure and risk from the use of isopropyl myristate is not expected to occur for other nontarget organisms.  
h. 	Endangered Species Assessment 
Based on the information discussed above, the Agency has determined that registered use of isopropyl myristate as an active ingredient will have No Effects on threatened and/or endangered species.  When the product is used according to label use directions, there are no concerns for any nontarget organisms.  
D.	Product Performance (Efficacy)
Product performance data must be developed for all pesticides to ensure that pesticide products will perform as intended and that unnecessary pesticide exposure to the environment will not occur as a result of the use of ineffective products. The Agency reserves the right to require, on a case-by- case basis, submission of efficacy data for any pesticide products registered or proposed for registration that are intended to be used to control a pest of significant public health importance and any public health pest defined in FIFRA section 28(d) and section 2(nn). For further guidance on product performance regulatory requirements, refer to Pesticide Registration (PR) Notices 96-7,(http://www.epa.gov/PR _Notices/pr1996-7.pdf), 2002-1 (http://www.ea.gov/PR_Notices/pr2002-1.pdf)  and the Agency's "Explanation of Statutory Framework for Risk-Benefit Balancing for Public Health Pesticides" (http://www.epa.gov/pesticides/health/risk-benefit.htm).
As required by regulation (FIFRA section 28(d) and section 2(nn)) product performance data/information (MRID 479253-17 and MRID 479253-18) were submitted to support the efficacy of the end-use product RESULTIX(TM). The Agency has determined that the submitted data/information submitted in support of the end-use product RESULTIX(TM) satisfies current testing requirements as described at  40CFR 158.2070 for this active ingredient and the end-use product.  
V.	RISK MANAGEMENT DECISION
A.	Determination of Eligibility for Registration 
Section 3(c) (5) of FIFRA provides for the registration of a new active ingredient if it is determined that: (A) its composition warrants proposed claims; (B) its labeling and other materials comply with the requirements of FIFRA; (C) it will perform its intended function without unreasonable adverse effects on the environment; and (D) when used in accordance with widespread and commonly recognized practice, it will not generally cause unreasonable adverse effects on the environment. 
The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by the science assessments supporting products containing isopropyl myristate. Such products are not expected to cause unreasonable adverse effects and [are likely to provide protection, as claimed when used according to label instructions. Therefore, isopropyl myristate as a technical grade active ingredient is eligible for registration for the labeled uses.  
B.	Regulatory Decision
The data submitted fulfill the registration requirements of isopropyl myristate for use as a topical spray treatment for killing ticks on cats and dogs. Refer to Appendix B for product-specific information.
   1. Conditional/Unconditional Registration
   All data requirements are fulfilled, and EPA has determined that unconditional registration of isopropyl myristate Technical Grade Active Ingredient is appropriate.
C. Environmental Justice
EPA seeks to achieve environmental justice -- the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income -- with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or unusually high exposure to isopropyl myristate compared the general population. Please comment if you are aware of any sub-populations that may have atypical or unusually high exposure as compared to the general population. 
For additional information regarding environmental justice issues, please visit EPA's website at http://www.epa.gov/compliance/environmentaljustice/index.html.

VI.		ACTIONS REQUIRED BY REGISTRANTS
Notwithstanding the information stated in the previous paragraph, it should be clearly understood that certain specific data are required to be reported to EPA as a requirement for maintaining the Federal registration for a pesticide product. A brief summary of these types of data are listed below. 
A.  Reporting of Adverse Effects
Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment must be submitted to EPA.
B.REPORTING OF HYPERSENSITIVITY INCIDENTS
Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).
VII.	 APPENDIX A.  Data Requirements (40 CFR Part 158-Subpart U)
*NOTE:  Master Record Identification (MRID) numbers listed in the following tables are representative of supporting data for the original registration of the product containing this active ingredient. Subsequent to this registration, there may be additional MRIDs that support registration of other products containing this active ingredient. 

TABLE 1.  Physical and Chemical Properties for RESULTIX(TM) and isopropyl myristate TGAI[a]
                       Guideline Reference No./Property
                             Description of Result
                                    Methods
830.6302	Color
                                TGAI: colorless
                                 EP: colorless
                               Visual inspection
                                       
830.6303	Physical State
                                 TGAI: liquid
                                  EP: liquid 
                               Visual inspection
830.6304	Odor
                                TGAI: odorless
                                 EP: odorless
                             Olfactory inspection
830.6313	Stability
                                 TGAI: stable
                                  EP: stable 
                        Storage stability studies[b,c]
                                       
830.6315	Flammability
                     TGAI: flash point 164.4°C closed cup
             EP: flash point 85.0°C closed cup; 95.0°C open cup
                    FDA, 16 CFR 1500.3 (c)(6) and 43 (a)[e]
830.6317	Storage Stability
TGAI: No loss of isopropyl myristate and no container leachate components identified.
                                       
                                       
TGAI: Stored in 100 mL carbon steel containers at 25° and 40°C / 60% relative humidity for 48 months.[b]

EP: No loss of isopropyl myristate and no container leachate components identified. 
EP: Stored in 1 oz. and 2 oz. HDPE bottles at 25° and 40°C / 60% relative humidity for 48 months.[c]
830.6319	Miscibility
                              TGAI: not required
EP: Not applicable, the product is not intended for dilution with petroleum solvents.
                                       
830.6320	Corrosion Characteristics
                              TGAI: Not required
                      EP: Not expected to be corrosive. 
                        Storage stability studies[b,c]
830.7000	pH
                             TGAI: not applicable
                              EP: not applicable
         Both the TGAI and EP are not soluble or dispersible in water.
830.7100	Viscosity
                              TGAI: not required 
                              EP: 3.5  -  3.7 cP
                         Storage stability studies[c]
                                       



TABLE 1. (Cont.)   Physical and Chemical Properties for RESULTIX(TM) and isopropyl myristate TGAIa 
                       Guideline Reference No./Property
                             Description of Result
                                    Methods
830.7200	Melting Range
                TGAI: Not applicable, the product is a liquid.
                               EP: not required

830.7220	Boiling Range
                                TGAI: 192.6°C
                               EP: not required
                                 CIR (1982)[f]
830.7300	Density/Relative Density/Bulk Density
                            TGAI: 0.85 to 0.86 g/mL
                             EP: 0.85 to 0.86 g/mL
                                 CIR (1982)[f]
                                       
830.7370	Dissociation Constant in Water
TGAI: Not applicable, the product is not pure active ingredient and is insoluble in water.
                               EP: not required
                                 CIR (1982)[f]
830.7550	Partition Coefficient
                              TGAI: 7.17  -  7.43
                                EP: not required
                                 CIR (1982)[f]
830.7840	Water Solubility
                           TGAI: insoluble in water
                               EP: not required
                                 CIR (1982)[f]
830.7950	Vapor Pressure
                               TGAI: <1 Torr
                               EP: not required
                                 CIR (1982)[g]


All toxicology data requirements have been satisfied per 40 CFR 158.2050.  The data presented in Table 1 below are a summary of the toxicity data and selected endpoints for isopropyl myristate.    Table 2. Mammalian Toxicology Data and Selected Endpoints for isopropyl myristate (40 CFR § 158.2050)
                           Study/OCSPP Guideline No.
                                  Results[1]
                         Toxicity Category/Description
                                     MRID
Acute oral toxicity (rat)
(870.1100)
                              LD50 > 13.6 g/kg
                                      IV
                                   47925309
                                   48348202
Acute dermal toxicity (rabbit)	
(870.1200)
                              LD50 = 5000 mg/kg 
                                      III
                                   47925309
                                   48348202
                                  HSDB, 2011
Acute inhalation toxicity	 (rat)
(870.1300)
                            LC50 > 33-41 mg/L[2]
                                      IV
                                   47925309
                                   48348202
                                  HSDB, 2011
Primary eye irritation (rabbit)	
(870.2400)
                             Minimally irritating
                                      III
                                   47925309
                                   48348202
                                  HSDB, 2011
Primary dermal irritation (rabbit, guinea pig, rat)
(870.2500)
                      Minimally - severely irritating[3]
                                      II
                                   47925309
                                   48348202
                                  HSDB, 2011
Dermal sensitization (guinea pig)
(870.2600)
                               Not a sensitizer
                                      N/A
                                   47925309
                                   48348202
                                  HSDB, 2011
Hypersensitivity incidents
(885.3400)
                               Must be reported
                                      N/A
                                      N/A
90-Day oral toxicity 
(870.3100)
Repeat human oral exposure is not expected based on the use pattern.  

A 28-day non-guideline oral toxicity study was submitted on the EP but is classified as unacceptable due to deficiencies in the study.  

A 28-day oral toxicity study conducted in rats at 0, 100, 500 or 1000 mg/kg bw-day resulted in a NOAEL of >= 1000 mg/kg bw.  The LOAEL could not be determined (no adverse effects at the highest dose tested). 3   
                                       
                                       
                                   47925315
                                       
                                       
                                  HSDB, 2011
90-Day dermal toxicity (pig)
(870.3250)
No purposeful application to the human skin based on use pattern.  Prolonged dermal exposure is not expected.

A 28-day non-guideline dermal toxicity study in pigs was submitted on the EP.  The dermal LOAEL could not be determined (no adverse effects at the highest dose tested) and the NOAEL >= 196.3-321.3 mg/kg bw. 3    
                                       
                                   48348201
                                       
                                       
                                       
                                   47925316
90-Day inhalation toxicity
(870.3465)
No likelihood of significant repeat inhalation exposure based on use pattern and low volatility of the active ingredient.

A 13-week inhalation study conducted in guinea pigs with an aerosol formulation containing 16-20% isopropyl myristate at 0, 63.3, or 224 mg/m[3] resulted in increased absolute and relative lung weights.  No other treatment-related effects were observed. 
A 13-week inhalation study conducted in cynomolgus monkeys with the same formulation at 0, 5.3, 8.4, 33.6, or 37.0 mg/m[3] resulted in accumulations of macrophages within the bronchiolar and alveolar walls that were dose-related in treated monkeys.  No other treatment-related effects were noted.  
                                       
                                   47925309
                                       
                                   48348201
                                       
                                  HSDB, 2011
Mutagenicity-bacterial reverse mutation test (Ames)
(870.5100)
Negative at 4, 20, 100, 500, 2500 ug/plate with and without metabolic activation in Salmonella typhimurium.  
                                       
                                  HSDB, 2011
Mutagenicity-in vitro mammalian cell assay (870.5300 and 870.5375)
No data were submitted.  However, significant human exposure is unlikely; isopropyl myristate is not structurally related to a known mutagen and does not belong to a chemical class of compounds containing a known mutagen.  

A life-time dermal carcinogenicity study conducted in mice at 10%, 50% and 100% isopropyl myristate diluted in acetone resulted in no difference in skin tumor frequency when compared to controls.    
                                       
                                   48348201
                                       
                                       
                                       
                                       
                                       
                                   47925309
                                  HSDB, 2011
                                       
                                       

Developmental toxicity
 (870.3700)
No data submitted.  However, significant exposure to female humans is unlikely based on use pattern and low volatility.  
                                       
                                   47925309
                                   48348201



Table 2. Mammalian Toxicology Data Requirements for RESULTIX(TM) (40 CFR § 158.2050)
                           Study/OCSPP Guideline No.
                                    Results
                         Toxicity Category/Description
                                     MRID
Acute oral toxicity (rat)
(870.1100)
No data were submitted for the EP.  Based on reported LD50 values for the active and inert ingredients, the estimated LD50 > 4,800 mg/kg 
                                      III
                                   47925309
Acute dermal toxicity (rat and rabbit)	
(870.1200)
                        LD50 > 5,050 mg/kg (rabbit)
                                       
                          LD50 > 5,050 mg/kg (rat)
                                      IV
                                   47925310
                                       
                                   47925311
Acute inhalation toxicity	 (rat)
(870.1300)
No data were submitted for the EP.  Based on reported LD50 values for the active and inert ingredients, the estimated LD50 = 2.7 mg/L
                                      IV
                                   47925309
Primary eye irritation (rabbit)	
(870.2400)
                             Minimally irritating
                                      IV
                                       
                                   47925312
Primary dermal irritation (rabbit)
(870.2500)
                                 Nonirritating
                                      IV
                                   47925313
Dermal sensitization  (guinea pig)
(870.2600)
                               Not a sensitizer
                                       
                                   47925314
Hypersensitivity incidents
(885.3400)
                               Must be reported
                                       
                                       

VIII. APPENDIX B.
For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX.	APPENDIX C.
REFERENCES
Environmental Canada (EC). 2008. Screening Assessment for the Challenge Decamethylcyclo-pentasiloxane (D5).  Excerpt only.  http://www.ec.gc.ca/substances/ese/eng/challenge/batch2/batch2_541-02-6_en.pdf
Office of Environmental Health Hazard Assessment for the State of California (OEHHA).2007. Toxicity Data Review. Decamethylcyclopentasiloxane (D5). Excerpt only. http://www.arb.ca.gov/toxics/dryclean/oehhad5review.pdf
(FDA Inactive Ingredients Database, 2011).
(Household Products Database, 2010)
X. Appendix D.
  BIBLIOGRAPHY

                                     MRID
                              Citation Reference


78632
Institut Francais de Recherches et Essais Biologiques (19??) A Study of the Irritant and Cough Provoking Potential of Ru 15 525 in the Guinea Pig and the Beagle: I.F.R.E.B.-R 760363. (Unpublished study received on unknown date under unknown admin. no.; submitted by McLaughlin, Gormley, King Co., Minneapolis, Minn.; CDL:238269-L) 
90603
Union Camp Corporation (19??) Material Safety Data Sheet: Unimate 605. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repellent Corp., Savannah, Ga.; CDL:232894-C) 
90604
Union Camp Corporation (1976) Unimate Fatty Esters for Use in Cosmetics. Wayne, N.J.: Union Camp. (Product specifications, Jun; also In unpublished submission received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repellent Corp., Savannah, Ga.; CDL:232894-D) 
90606
Bio-Toxicology Laboratories, Incorporated (19??) Summary & Conclusions of Toxicity Data: Unimate 605 B 8126. Summary of studies 232895-B through 232895-D. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repel- lent Corp., Savannah, Ga.; CDL:232895-A) 
90614
Bio-Toxicology Laboratories, Incorporated (19??) Draize Eye Irritation Study: Unimate 605 B 8126. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repel- lent Corp., Savannah, Ga.; CDL:232895-B) 
90615
Bio-Toxicology Laboratories, Incorporated (19??) Primary Irritation Study: Unimate 605 B 8126. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repel- lent Corp., Savannah, Ga.; CDL:232895-C) 
90616
Bio-Toxicology Laboratories, Incorporated (19??) Acute Oral Toxicity Study: Unimate 605 B 8126. (Unpublished study received Feb 21, 1978 under 40195-1; submitted by Reaenge Insect Repellent Corp., Savannah, Ga.; CDL:232895-D) 
123292
Weil, C.; Scala, R. (1971) Study of intra- and interlaboratory variability in the results of rabbit eye and skin irritation tests. Toxicology and Applied Pharmacology 19:276-360. (Also In unpublished submission received Sep 16, 1982 under 3134-23; submitted by Evsco Pharmaceutical Co., Bulna, NJ; CDL:248947-A) 
5000045
Stenbaeck, F. (1977) Local and systemic effects of commonly used cutaneous agents: Lifetime studies of 16 compounds in mice and rabbits. Acta Pharmacologica et Toxicologica 41(5):417-431. 
5004319
Stenback, F.; Shubik, P. (1974) Lack of toxicity and carcinogenicity of some commonly used cutaneous agents. Toxicology and Applied Pharmacology 30:7-13. 
47811700
Piedmont Animal Health (2009) Submission of Product Chemistry and Toxicity Data in Support of the Petition for Tolerance of (Inert Ingredient). Transmittal of 1 Study.
47811701
Phillips, S. (2009) Chemistry and Toxicological Information for (Inert Ingredient). Unpublished study prepared by Piedmont Animal Health. 83 p.
47925300
Piedmont Animal Health (2009) Submission of Product Chemistry, Toxicity, and Environmental Fate Data in Support of the Application for Registration of RESULTIX(TM) Transmittal of 20 Studies.
47925301
Phillips, S. (2009) Miscellaneous Chemistry Information: RESULTIX(TM). Unpublished study prepared by Piedmont Animal Health. 77 p.
47925302
Ballard, T. (2009) Determination of the Percent Active Ingredient and Impurities in Five Batches of Isopropyl Myristate Technical Grade Active Material: (RESULTIX(TM)). Project Number: 09/0033, PAH/09/0057. Unpublished study prepared by En-Cas Analytical Laboratories. 107 p.
47925303
Omoruan, P. (2005) The Forced Degradation Study for Isopropyl Myristate Drug Substance and Isopropyl Myristate Solution (50% w/w) by GC: (RESULTIX(TM)). Project Number: PED/AR/014/0105/R0. Unpublished Study Prepared by Patheon, Inc. 79 p.
47925304
Carr, G. (2009) Storage Stability of Isopropyl Myristate Manufacturing-Use Product at 25 degrees Celsius and 40 degrees Celsius in Carbon Steel Containers for up to 48 Months: RESULTIX(TM). Project Number: PED/SP/019/0706/R1. Unpublished study prepared by Patheon. 41 p.
47925305
Kaminsky, M. (2007) Isopropyl myristate Solution: Flammability/Flash Point: (RESULTIX(TM)). Project Number: 10633/07. Unpublished study prepared by Stillmeadow, Inc. 9 p.
47925306
Serrano, S. (2007) Analysis of Extractables and Leachables in HDPE Bottles and PP Caps Used to Package the Isopropyl Myristate D5 Formulation (Feasibility Study): (RESULTIX(TM)).  Project Number: R061229B. Unpublished study prepared by Guidelines, Inc. 47 p.
47925307
Serrano, S. (2007) Photostability Protocol, Testing Schedule and Results for Isopropyl Myristate Solution (50% w/w), ANDA: (RESULTIX(TM)). Project Number: PED/SP/022/0107/R0. Unpublished Study Prepared by Patheon, Inc. 10 p.
47925308
Carr, G. (2007) An Investigation of the UV/Visible Absorbance Properties of Isopropyl Myristate 50% Solution, Isopropyl Myristate and Cyclomethicone: (RESULTIX(TM)). Project Number: PED/MIS/024/0307/R0. Unpublished Study Prepared by Patheon, Inc. 14 p.
47925309
Phillips, S. (2009) Miscellaneous Toxicology Information: (RESULTIX(TM)). Unpublished study prepared by Piedmont Animal Health. 315 p.
47925310
Kuhn, J. (2002) Piedmont Pediculicide 2: Final Report: Acute Dermal Toxicity Study in Rabbits. Project Number: 7205/02. Unpublished study prepared by Stillmeadow, Inc. 31 p.
47925311
Kuhn, J. (2002) Piedmont Pediculocide 2: Final Report: Acute Dermal Toxicity Study in Rats: Final Report. Project Number: 7204/02. Unpublished study prepared by Stillmeadow, Inc. 33 p.
47925312
Kuhn, J. (2002) Piedmont Pediculicide 1: Final Report: Acute Eye Irritation Study in Rabbits. Project Number: 7089/02. Unpublished study prepared by Stillmeadow, Inc. 16 p.
47925313
Kuhn, J. (2002) Piedmont Pediculocide 1: Final Report: Acute Dermal Irritation Study in Rabbits. Project Number: 7090/02. Unpublished study prepared by Stillmeadow, Inc. 11 p.
47925314
Kuhn, J. (2009) RESULTIX(TM) Tick Spray: Final Report: Skin Sensitization Study in Guinea Pigs. Project Number: 13304/09. Unpublished study prepared by Stillmeadow, Inc. 16 p.
47925315
Goldenthal, E. (2003) 28-Day Oral Toxicity Study in Rats with a 14-Day Recovery: RESULTIX(TM). Project Number: 1016/001. Unpublished study prepared by MPI Research, Inc. 603 p.
47925316
Goldenthal, E. (2003) 28-Day Dermal Toxicity Study in Pigs with a 14-Day Recovery: RESULTIX(TM). Project Number: 1016/002. Unpublished study prepared by MPI Research, Inc. 442 p.
47925317
Young, D. (2009) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate (ISOPROPYL MYRISTATE) Tick Spray against Rhipicephalus sanguineus and Dermacentor variabilis on Dogs. Project Number: PAH/09/0036. Unpublished study prepared by Young Veterinary Research Services. 19 p.
47925318
Young, D. (2009) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate (ISOPROPYL MYRISTATE) Tick Spray against Rhipicephalus sanuineus and Dermacentor variabilis on Cats. Project Number: PAH/09/0065. Unpublished study prepared by Young Veterinary Research Services. 18 p.
47925319
Garg, D. (2005) Pharmacokinetic, Safety and Tolerance Study of RESULTZ Pediculicide Rinse in Pediatric Subjects with Pediculosis Capitis. Project Number: 04/123941/108. Unpublished study prepared by Hill Top Research, Inc. 103 p.
47925320
Phillips, S. (2009) Environmental Fate Information: RESULTIX(TM). Unpublished study prepared by Piedmont Animal Health. 76 p.
48132300
Piedmont Animal Health LLC (2010) Submission of Product Chemistry Data in Support of the Application for Registration of RESULTIX(TM). Transmittal of 1 Study.
48132301
Chastain, L. (2010) Stability Study of RESULTIX(TM) 1 oz. and 2 oz. Bottles: Interim Report (6 Month). Project Number: 9/066, 09/0066. Unpublished study prepared by Span Packaging Services, LLC. 14 p.
48348200
Piedmont Animal Health, LLC (2011) Submission of Toxicity Data in Support of the Application for Registration of RESULTIX(TM) End-Use Product. Transmittal of 4 Studies.
48348201
Phillips, S.; Barer, G. (2011) Discussion of Submitted Information: (RESULTIX(TM) End-Use Product). Unpublished study prepared by Piedmont Animal Health. 67 p.
48348202
Phillips, S.; Barer, G. (2011) Published Articles Concerning the Safety of Myristic Acid and its Derivatives, Including Isopropyl Myristate. Unpublished study prepared by Piedmont Animal Health. 123 p.
48348203
Young, D. (2011) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate (ISOPROPYL MYRISTATE) Tick Spray against Rhipicephalus sanguineus and Dermacentor variabilis on Dogs: Amended Final Report. Project Number: PAH/09/0036. Unpublished study prepared by Young Veterinary Research Services. 83 p.
48348204
Young, D. (2011) Pivotal Study to Determine Safety and Efficacy of Isopropyl Myristate (ISOPROPYL MYRISTATE) Tick Spray Against Rhipicephalus sanguineus and Dermacentor variabilis on Cats: Amended Final Report. Project Number: PAH/09/0065. Unpublished study prepared by Young Veterinary Research Services. 85 p.
48491400
Piedmont Animal Health LLC (2011) Submission of Product Chemistry Data in Support of the Registration of RESULTIX(TM). Transmittal of 1 Study.
48491401
Chastain, L. (2010) Final Report (12 Month) Stability Study of RESULTIX(TM) 1 oz and 2 oz Bottles. Project Number: PAH/09/0066. Unpublished study prepared by Span Packaging Services, LLC. 14 p.




                                       
  

 XI.    GLOSSARY OF ACRONYMS AND ABBREVIATIONS
      
   a.i.	Active Ingredient
   BPPD	Biopesticides and Pollution Prevention Division
   BRAD	Biopesticide Registration Action Document
   CFR	Code of Federal Regulations
   
   cm[3] 	cubic centimeter
   CSF	Confidential Statement of Formula
   °C 	degrees Celsius
   EDSP	Endocrine Disruptor Screening Program
   EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee
   EPA	Environmental Protection Agency (the "Agency")
   FFDCA	Federal Food, Drug, and Cosmetic Act
   FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act
   FQPA 	Food Quality Protection Act
   FR	Federal Register
   g 	gram
   kg	kilogram
   L                   liter
   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, or inhalation). It is expressed as a weight of 
   	substance per unit weight of animal (e.g., mg/kg).
   MRID No.	Master Record Identification Number
   mg	milligram
   mL	milliliter
   MP	manufacturing-use product
   MPCA	microbial pest control agent
   NE	"No Effect"
   NIOSH 	National Institute for Occupational Safety and Health
   OPP	Office of Pesticide Programs
   OPPTS 	Office of Prevention, Pesticides, and Toxic Substances
   PCR	polymerase chain reaction 
   PPE 	personal protective equipment
       TGAI 	   technical grade of the active ingredient
 
 
 
