Based on the results of the antisapstain modeling, runoff from antisapstain treating facilities will exceed acute high risk, restricted use, and endangered species LOCs for freshwater fish, freshwater invertebrates, and aquatic plants.  Chronic risks cannot be assessed at this time due to a lack of chronic toxicity data.

	The model used to estimate exposure from antisapstain uses is intended as a Tier I screening model, and, as such, has inherent assumptions and uncertainties that may result in over- or under-estimation of exposure levels.  Since the model is only intended as a screening-level model, further refinement of the model is necessary to more accurately assess risks from the antisapstain uses of 2-phenylphenol.  Table 22 summarizes the ecotoxicity endpoints used in the risk assessment.

Table 22.  Ecotoxicity endpoints used in the Risk Assessment

Guideline	Species	Value	Toxicity category	Status of Guideline

850.2100/71-1

Avian acute oral	Northern bobwhite	LD50 = 1000 mg/kg	Slightly toxic Fulfilled

850.2200/71-2a	Northern bobwhite	LC50 > 5620 ppm	Practically non-toxic Fulfilled

850.2200/71-2b	Mallard duck	LC 50 . 5620 ppm	Practically non-toxic Fulfilled

850.1075/72-1a	Bluegill sunfish	LC50= 4.6 mg/L	Moderately toxic Fulfilled

850.1075/72-1c	Rainbow trout	LC50 = 4.0 m g/L	Moderately toxic	Fulfilled

850.1010/72-2	Water flea	EC50 = 2.51 mg/L	Moderately toxic	Fulfilled

850.1075/72-3a Marine/estuarine fish acute

Data gap

850.1025/72-3b	Eastern oyster – shell deposition	EC50 = 3.89 mg/L Moderately toxic	Fulfilled

850.1035/72-3c	Mysid	LC50 = 0.32 mg/L	Highly toxic	Fulfilled

850.1300/72-4a

Fish early life-stage

Data gap

850.1400/72-4b

Aquatic invertebrate life-cycle

Data gap

850.4225/122-1a  Seedling emergence in rice, Tier I	Rice	At 1000 mg/L, percent emergence was decreased 7%, shoot length was decreased by 4% (with 10% mortality), and shoot dry weight was decreased by 2%.  	N/A Fulfilled

850.4225/122-1b  Vegetative vigor in rice, Tier I	Rice	At 1000 mg/L, slight decreases in shoot length (5%) early in the study, and a slight decrease in dry weight (2%) by the end of the study.	N/A	Fulfilled

850.4400/123-2

Aquatic vascular plant toxicity	Duckweed	EC50 = 6.2 mg/L	N/A	Not fulfilled (supplemental study)

850.5400/123-2

Algal toxicity on 4 species

Freshwater green alga

Freshwater diatom

Marine diatom

Blue-green alga

EC50 1.39 mg/L

EC50 = 1.9 mg/L

EC50 = 6.4 mg/L

EC50 = 2.3 mg/L

N/A

Fulfilled

3.  	  SEQ CHAPTER \h \r 1 Listed Species Consideration

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated habitat.  Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.  To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 CFR 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004).  After the Agency’s screening-level risk assessment is performed, if any of the Agency’s Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co-occur in the area of the proposed pesticide use.  If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken.  The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

	For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).  Chemicals in these categories therefore do not undergo a full screening-level risk assessment, and are considered to fall under a no effect determination.  The active ingredient uses of 2-phenylphenol and salts, with the exception of the antisapstain wood preservation use, fall into this category.  Using Tier I screening modeling to assess potential exposure from antisapstain wood preservation uses of 2-phenylphenol, risks to Listed Species are indicated.  Since the model is only intended as a screening-level model, and, as such, has inherent uncertainties and limitations which may result in inaccurate exposure estimations, further refinement of the model is necessary before any regulatory action is taken regarding the antisapstain uses of 2-phenylphenol.  Additionally, impacts from the antisapstain use could potentially be mitigated with precautions to prevent leaching and runoff when wood is stored outdoors.  Due to these circumstances, the Agency defers making a determination for the antisapstain uses of 2-phenylphenol until additional data and modeling refinements are available.  At that time, the environmental exposure assessment of the antisapstain use of 2-phenylphenol will be revised, and the risks to Listed Species will be reconsidered.

IV.  	Risk Management, Reregistration, and Tolerance Reassessment Decision  XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision"

	A.  	Determination of Reregistration Eligibility   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision: A. Determination of Reregistration Eligibility" \i

	Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data concerning an active ingredient, whether or not products containing the active ingredient are eligible for reregistration.  The Agency has previously identified and required the submission of the generic (i.e., active ingredient-specific) data required to support reregistration of products containing OPP and salts as an active ingredient.  The Agency has completed its review of these generic data, and has determined that the data are sufficient to support reregistration of all supported products containing OPP and salts.

	The Agency has completed its assessment of the dietary, occupational, drinking water, and ecological risks associated with the use of pesticide products containing the active ingredient OPP and salts.  The Agency has determined that OPP containing products are eligible for reregistration provided that: (i) current data gaps and confirmatory data needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted; and (iii) label amendments are made to reflect these measures where necessary.  Appendix A summarizes the uses of OPP that are eligible for reregistration.  Appendix B identifies the generic data requirements that the Agency reviewed as part of its determination of reregistration eligibility of OPP and lists the submitted studies that the Agency found acceptable.  Data gaps are identified as generic data requirements that have not been satisfied with acceptable data.

	Based on its evaluation of OPP and salts, the Agency has determined that OPP products, unless formulated and used as specified in this document, would present risks inconsistent with FIFRA.  Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this document, the Agency may take regulatory action to address the risk concerns from the use of OPP.  If all changes outlined in this document are incorporated into the product formulations, then all current risks for OPP and its salts will be substantially mitigated for the purposes of this determination.  Once an Endangered Species assessment is completed, further changes to these registrations may be necessary as explained in Section III of this document.

	B.  	Public Comments and Responses   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision: B. Public Comments and Responses" \i

	Through the Agency’s public participation process, EPA worked with stakeholders and the public to reach the regulatory decisions for OPP and salts.  During the public comment period on the risk assessments, which closed on June 26, 2006, the Agency received comments from the Department of Pesticide Regulation (California), American Mushroom Institute, the Northwest Horticultural Council and Dow Chemical/Lanxess (joint comment) in response to EPA’s draft risk assessment (RA) for OPP and salts.  The comments submitted by these registrants are related to toxicology, tolerances, and post-harvest application.  The Agency’s responses to these comments are available in the public docket at   HYPERLINK "http://www.regulations.gov"  www.regulations.gov , docket # EPA-HQ-OPP-2006-0154 and are incorporated into the risk assessment and revised chapters.

	C.  	Regulatory Position   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:C. Regulatory Posistion" \i

		1.	Food Quality Protection Act Findings   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision: C. Regulatory Position: 1. Food Quality Protection Act Findings"

			a.  	“Risk Cup” Determination   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision: C. Regulatory Position: 1. Food Quality Protection Act Findings: a. "Risk Cup" Determination"

	As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with OPP and salts.   The Agency has concluded that the tolerance exemption for the use of Na-OPP as an inert ingredient and OPP as a food contact sanitizer, as well as the existing tolerances for OPP and Na-OPP for their post-harvest use, meet the FQPA safety standards and that the risk from dietary (food sources only) exposure is within the “risk cup.”  An aggregate assessment was conducted for exposures through food and residential exposure.  The Agency has determined that the human health risks from these combined exposures are within acceptable levels.  In reaching this determination, EPA has considered the available information on the special sensitivity of infants and children, as well as aggregate exposure from food and water.

			b.  	Determination of Safety to U.S.  Population   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:C. Regulatory Position: 1. Food Quality Protection Act Findings: b. Determination of Safety to U.S. Population"

	As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with OPP and salts.  The Agency has determined that the established tolerance exemption for Na-OPP as an inert ingredient and OPP as a food contact sanitizer, as well as the existing tolerance for OPP and Na-OPP for their post-harvest use meets the safety standards under the FQPA amendments to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will result to the general population or any subgroup from the use of OPP.  In reaching this conclusion, the Agency has considered all available information on the toxicity, use practices and exposure scenarios, and the environmental behavior of OPP.

The acute and chronic aggregate risk assessments generally include only dietary (direct, indirect, and inert exposures) and drinking water exposures.  As there is no acute dietary endpoint selected for OPP and drinking water exposure is not of concern, an acute aggregate dietary assessment was not performed for OPP.  The chronic aggregate assessment included chronic dietary exposures from the direct food, indirect food, and inert uses from OPP.  The chronic aggregate risk estimate associated with OPP and salts are well below the Agency’s level of concern.

	The short- and intermediate-term aggregate assessments were conducted for adults and children that could be exposed to OPP and OPP salt residues from the use of products in non-occupational environments.  For short-term aggregate risk to adults, the average dietary exposure was aggregated with short-term oral and inhalation exposures that occur from mopping, wiping, and air deodorizer uses for the short-term incidental oral and inhalation residential exposures and the results were below the Agency’s level of concern.  The short-term aggregate risk to children is above the target MOE of 100 and is therefore not of concern.  Dermal aggregate risk is assessed separately as the effect was different for this route of exposure.  Dermal exposure to adults also showed no risk of concern as well as dermal exposure to children.  There are no intermediate-term residential scenarios identified for adults while the risk estimate for children was below the Agency’s level of concern.  The exception to the prior is for adult and child dermal post-application exposures to textile OPP residues (which alone are of concern to the Agency), and which were not included into the aggregate assessment as this alone would make aggregate risk of concern.

			c.  	Determination of Safety to Infants and Children   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:C. Regulatory Position: 1. Food Quality Protection Act Findings: c. Determination of Safety to Infants and Children "

	EPA has determined that the established tolerance exemption for Na-OPP as an inert ingredient and OPP as a food contact sanitizer, as well as the existing tolerances for OPP and Na-OPP for their post-harvest use, with amendments and changes as specified in this document, meet the safety standards under the FQPA amendments to section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children.  The safety determination for infants and children considers factors of the toxicity, use practices, and environmental behavior noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of Na-OPP residues in this population subgroup.

	No Special FQPA Safety Factor is necessary to protect the safety of infants and children.  In determining whether or not infants and children are particularly susceptible to toxic effects from OPP and salts residues, the Agency considered the completeness of the database for developmental and reproductive effects, the nature of the effects observed, and other information.  The FQPA Safety Factor has been removed (i.e., reduced to 1X) for orthophenylphenol and salts based on the available developmental toxicity and reproductive toxicity studies for OPP that are considered acceptable and that show no evidence of increased toxicity to offspring at the same or lower doses as those causing parental/systemic toxicity or evidence of more severe toxicity relative to parental/systemic toxicity.

Cumulative Risks

Risks summarized in this document are those that result only from the use of OPP and salts.  The Food Quality Protection Act (FQPA) requires that 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.”  The reason for consideration of other substances is due to the possibility that low-level exposures to multiple chemical substances that cause a common toxic effect by a common toxic mechanism could lead to the same adverse health effect, as would a higher level of exposure to any of the substances individually.  Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for OPP and salts.  For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at     HYPERLINK "http://www.epa.gov/pesticides/cumulative/"  http://www.epa.gov/pesticides/cumulative/ .

Endocrine Disruptor Effects

EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate."  Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system.  EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potential effects in wildlife.  For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations.  As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

When the appropriate screening and/or testing protocols being considered under the Agency’s EDSP have been developed, OPP and salts may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

		2.	Tolerance Reassessment Summary   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:C. Regulatory Position: 2. Tolerance Summary" \i

OPP currently has one inert ingredient (Na-OPP) exemption from the requirement of a tolerance for residues as required under the Food Quality Protection Act (FQPA) section 408.  Taking into consideration all available information on sodium o-phenylphenate, it has been determined that there is reasonable certainty that no harm to any population subgroup will result from aggregate exposure to sodium o-phenylphenate when used as an inert ingredient in pesticide formulations when considering dietary exposure and all other non-occupational sources of pesticide exposure for which there is reliable information.  Therefore, it is recommended that the one exemption from the requirement of a tolerance established for residues of sodium o-phenylphenate under 40 CFR part 180.920, when used as a preservative at not more than 0.1% of the pesticide formulation and applied before edible portions of plants begin to form, can be considered reassessed as safe under section 408(q) of the FFDCA.

Orthophenylphenol has been used in food-contact surface sanitizing solutions with a tolerance exemption specified in 40 CFR 180.940 (c).  Residues for OPP are exempt from the requirement of a tolerance when used in accordance with good manufacturing practice as ingredients in an antimicrobial pesticide formulation, provided that the substance is applied on a semi-permanent or permanent food-contact surface (other than being applied on food packaging) with adequate draining before contact with food.  OPP has a limitation for the ready-to-use end-use concentration not to exceed 400 ppm for food processing equipment and utensils.  The Agency will be proposing a change to the 40 CFR 180.940(c) to establish a maximum of 4200 ppm for the end-use concentration of OPP, rather than the current limitation of 400 ppm.  The Agency assessed the maximum application rate of 4200 ppm for OPP (as listed on the labels), although the current tolerance exemption has a limitation of 400 ppm.  This assessment indicated that risks are not of concern for any subpopulations.

In addition, tolerances (40 CFR Part 180.129) were established for the residues of orthophenylphenol and its sodium salt.  The tolerances were established for the fungicidal post-harvest application of these chemicals: Raw agricultural commodities (RAC) including: apple, cantaloupe, carrot, cherry, citrus, citron, cucumber, grapefruit, kiwifruit, kumquat, lemon, lime, nectarine, orange, bell pepper, peach, pear, pineapple, plum, prune, sweet potato, tangerine, tomato.  Since the establishment of these tolerances all use sites have been cancelled with the exception of citrus and pear.  Therefore, the tolerances remaining are 10 ppm for citrus and 25 ppm for pear while all others are to be revoked.

Also, the Agency believes that the establishment of a tolerance on mushrooms under 40 CFR 180.129 is necessary.  The limit would be determined once a petition for establishing the tolerance is received by the Agency and reviewed.

The existing tolerances, exemption from the requirement of a tolerance, and those tolerances to be revoked are summarized in Table 23.

Tolerances Currently Listed Under 40 CFR

Table 23.  Tolerance Reassessment Summary of OPP

Expression	Commodity	Current Tolerance	Tolerance Reassessment	Use

Listed Under 40 CFR 180.9201

Sodium o-phenylphenate (Na-OPP)	N/A	Exemption:

Not more than 0.1% of pesticide formulation	Exemption:

Not more than 0.1% of pesticide formulation 	Preservative of formulation

Listed Under 40 CFR 180.940(c)

[1,1’-Biphenyl]-2-ol	N/A	End use concentration not to exceed 400 ppm End use concentration not to exceed 4200 ppm

	food contact sanitizing solutions for food processing equipment and utensils

Listed Under 40 CFR 180.129

 o-Phenylphenol and its sodium salt, sodium o-phenylphenate	Pear	25 ppm 25 ppm

Citrus	10 ppm	10 ppm

Cherry	5 ppm	Revoke

Nectarine	5 ppm	Revoke

Citron	10 ppm	Revoke

Cucumber	10 ppm	Revoke

Grapefruit	10 ppm	Revoke

Kumquat	10 ppm	Revoke

Lime	10 ppm	Revoke

Cantaloupe (edible portion)	10 ppm	Revoke

Sweet orange	10 ppm	Revoke

Bell pepper	10 ppm	Revoke

Pineapple	10 ppm	Revoke

Tangerine	10 ppm	Revoke

Tomato	10 ppm	Revoke

Sweet potato roots	15 ppm	Revoke

Carrot roots	20 ppm	Revoke

Kiwi	20 ppm	Revoke

Peach	20 ppm	Revoke

Plum	20 ppm	Revoke

Prune	20 ppm	Revoke

Apple	25 ppm	Revoke

Cantaloupe (non-edible portion).	125 ppm	Revoke

	1.Residues listed in 40 CFR §180.920 are exempted from the requirement of a tolerance when used as inert ingredients in pesticide formulations when applied to growing crops only.

b.	Codex Harmonization   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:C. Regulatory Position: 2. Tolerance Reassessment: b. Codex Harmonization"

  XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:C. Regulatory Position: 2. Tolerance Reassessment: b. Codex Harmonization"

	Currently there are no Codex MRLs established for OPP and salts.

	D.	Regulatory Rationale   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale"

	The Agency has determined that 2-phenylphenol and salts is eligible for reregistration provided that additional required data confirm this decision, that the risk mitigation measures outlined in this document are adopted, and label amendments are made to reflect these measures.

	The following is a summary of the rationale for managing risks associated with the use of OPP and salts.  Where labeling revisions are warranted, specific language is set forth in the summary tables of Section V of this document.

		1.	Human Health Risk Management   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision: D. Regulatory Rationale: 1. Human Health Risk Management"

			a.	Dietary (Food) Risk Mitigation   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale:1. Human Health Risk Management: a. Dietary (Food) Risk Mitigation"

	For all supported uses, the acute and chronic dietary exposure estimates are below the Agency’s level of concern. Therefore, no risk mitigation measures are required to address exposure to OPP residues in food.

b.	Drinking Water Risk Mitigation   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 1. Human Health Risk Management: b. Drinking Water Risk Mitigation"

2-phenylphenol and its salts are not likely to contaminate surface and ground waters based on its use patterns and fate characteristics. Thus, a drinking water assessment was not conducted. Therefore, no risk mitigation measures are required to address OPP exposure from drinking water.

c.	Residential Risk Mitigation   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 1. Human Health Risk Management: c. Residential Risk Mitigation"

Residential risks from handler and post-application exposure were calculated for short-and intermediate-term dermal, inhalation and incidental oral exposures. All exposure and risk estimates for residential handler scenarios are below the Agency’s level of concern. Therefore, no risk mitigation measures are required for these handler scenarios.

Risks of concern have been identified for several post-application exposure scenarios including children’s dermal exposure to treated clothing and treated diapers and adult’s dermal exposure to treated clothing. The Agency believes that adding clear instructions for washing and rinsing textile items will result in the adequate removal of residues from the treated items and address the Agency’s concerns for this scenario.

In summary, to reduce residential exposure, the Agency has determined that the following mitigation and label changes for specific scenarios are appropriate and required for reregistration eligibility:

-Delete all diaper uses

-Delete all use on non-laundered textiles\items including mattresses, helmets,

  headgear, headphones, face gear, and mouthpieces.

-All labels with laundered textile uses must have directions that indicate that items

   	  must be treated prior to washing and rinsing.

d.	Occupational Risk Mitigation   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 1. Human Health Risk Management: d. Occupational Risk Mitigation"

Handler Exposure

  XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 1. Human Health Risk Management: d. Occupational Risk Mitigation: i. Handler Exposure"

Risks of concern have been identified for several occupational handler scenarios including dermal exposure from: 1. Wiping in commercial/institutional premises, 2. Mopping in medical premises, 3. Liquid pour of the material into textiles (materials preservatives), and 4. Painting through the use of an airless sprayer.  Also, dermal and inhalation risks have been identified for fogging applications in agricultural premises.

Although the total MOEs for dermal exposure from mopping without gloves in medical premises and dermal exposure from the gloved liquid pour of the material into textiles is 78 and below the Agency target of 100, the Agency does not believe mitigation measures for these two uses are required at this time.  This is because the unit exposure data along with the values for the amount used/handled that were selected for estimating the risks were conservative.  For the mopping scenarios, the CMA dermal and inhalation unit exposure values for ungloved mopping were used (71.6 mg/lb a.i. and 2.38 mg/lb a.i., respectively).  For the liquid pour scenarios for materials preservatives, the unit exposure is 0.135 mg/lb ai and the inhalation UE is 0.00346 mg/lb ai).  As a result, the daily dosages calculated for the scenarios assessed are most likely overestimated.  If scenario-specific values were available to the Agency, then the MOEs are expected to be greater than 100 and not of concern to the Agency.

The total calculated MOE (inhalation and dermal) for fogging in agricultural premises for occupational handlers is 98.  Although this MOE is below the Agency target of 100, the Agency is not requiring mitigation since it is a conservative assessment with multiple assumptions.  In addition, the MOE is very close to the target so that EPA doesn't have risk concerns.

In summary, to reduce occupational handler exposure, the Agency has determined that the following mitigation and label changes for specific scenarios are appropriate and required for reregistration eligibility:

-For products with a wiping use in commercial and institutional premises, the percentage of 2-phenylphenol as an active ingredient must be below 63%.  This will result in MOEs that are above the target of 100.

-For products with a paint preservative use (via airless sprayer) the maximum application         rate must be less than 0.33 lb ai/gal (% active ingredient by weight of material being treated) to address risks for workers applying paint.  This will result in MOEs that are above the target of 100.

ii.	Post-Application Risk Mitigation

There is a potential for dermal and inhalation exposure when a worker handles treated metalworking fluids.  This route of exposure occurs after the chemical has been incorporated into the metalworking fluid and a machinist is using/handling this treated end-product and poses a risk of concern.  Also, a risk of concern has been identified in the case of Na-OPP/OPP post-harvest commodity applications, whereby workers performing sorting and packing activities are potentially exposed to Na-OPP/OPP following application.

The short-term dermal risk for pear sorters was reported to be a risk of concern (MOE = 51) when the maximum reported dermal exposure for pear sorters was used.  This risk was calculated with the maximum reported single exposure (out of 15 data points) for pear sorters in a Washington state study.  However, it should be noted that it is unlikely that this level of dermal exposure would persist over the entire short-term exposure duration (i.e., up to 30 days), and is a conservative risk estimate.  Further, the Agency believes the mean exposure is likely to be more representative of the actual exposure to pear sorters for this duration.  Additionally, all dermal risk estimates are calculated with exposures adjusted for the maximum-labeled application rate (2% solution) while the study used was conducted at much lower levels (0.2%).  This necessitated the use of linear extrapolation to the higher rate which may add further conservatism to the assessment.  Therefore this risk calculation is very conservative and the MOE is not of concern.  The short-term dermal risk using the average of dermal exposure for pear sorters (MOE = 120) may be a more appropriate estimate.

	The calculated short-term dermal MOE for the metal working fluid scenario is 54, which is below the Agency’s target of 100, and therefore poses a risk of concern.  In summary, to reduce occupational handler exposure, the Agency has determined that the following mitigation and label changes for specific scenarios are appropriate and required for reregistration eligibility:

-All products used as a metalworking fluid may not exceed a maximum application rate of 0.81 lb ai/gal (% active ingredient by weight of material being treated).  This will result in MOEs that are above the target of 100.

		2.	Environmental Risk Management   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 2. Environmental Risk Mitigation"

Based on the results of the antisapstain modeling, runoff from antisapstain treating facilities will exceed acute high risk, restricted use, and endangered species LOCs for freshwater fish, freshwater invertebrates and aquatic plants.  In order to reduce environmental exposure, those products with an antisapstain use must contain the following language:

"Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the waterway.  Treated lumber stored within 100 feet of a pond, lake, steam, or river must be either covered with plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway.  If a berm or curb is used around the site, it should consist of impermeable material (clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events."

		3.	Listed Species Considerations   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 4. Threatened and Endnagered Species Considerations"

			a.	The Endangered Species Program   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 4. Threatened and Endnagered Species Considerations: a. The Endangered Species Program"

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species or their designated habitat.  Each federal agency is required under the Act to insure that any action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a listed species or result in the destruction or adverse modification of designated critical habitat.  To jeopardize the continued existence of a listed species means "to engage in an action that reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of the species." 50 CFR. 402.02.

To facilitate compliance with the requirements of the Endangered Species Act subsection (a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established procedures to evaluate whether a proposed registration action may directly or indirectly reduce appreciably the likelihood of both the survival and recovery of a listed species in the wild by reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004).  After the Agency’s screening-level risk assessment is performed, if any of the Agency’s Listed Species LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify if any listed or candidate species may co-occur in the area of the proposed pesticide use.  If determined that listed or candidate species may be present in the proposed use areas, further biological assessment is undertaken.  The extent to which listed species may be at risk then determines the need for the development of a more comprehensive consultation package as required by the Endangered Species Act.

	For certain use categories, the Agency assumes there will be minimal environmental exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency - Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB, pg.81).  Chemicals in these categories therefore do not undergo a full screening-level risk assessment, and are considered to fall under a no effect determination.  The active ingredient uses of 2-phenylphenol, with the exception of the antisapstain wood preservation use, fall into this category.  Using Tier I screening modeling to assess potential exposure from antisapstain wood preservation uses of 2-phenylphenol, risks to Listed Species are indicated.  Since the model is only intended as a screening-level model, and, as such, has inherent uncertainties and limitations which may result in inaccurate exposure estimations, further refinement of the model is recommended before any regulatory action is taken regarding the antisapstain uses of 2-phenylphenol.  Additionally, impacts from the antisapstain use could potentially be mitigated with precautions to prevent leaching and runoff when wood is stored outdoors (see General Risk Mitigation, below).  Due to these circumstances, the Agency defers making a determination for the antisapstain uses of 2-phenylphenol until additional data and modeling refinements are available.  At that time, the environmental exposure assessment of the antisapstain use of 2-phenylphenol will be revised, and the risks to Listed Species will be reconsidered.

b. 	General Risk Mitigation   XE "IV. Risk Management, Reregistration, and Tolerance Reassessment Decision:D. Regulatory Rationale: 4. Threatened and Endnagered Species Considerations: b. General Risk Mitigation"

OPP and salts end-use products (EPs) may also contain other registered pesticides.  Although the Agency is not proposing any mitigation measures for products containing OPP or its salts specific to federally listed species, the Agency needs to address potential risks from other end-use products.  Therefore, the Agency requires that users adopt all listed species risk mitigation measures for all active ingredients in the product.  If a product contains multiple active ingredients with conflicting listed species risk mitigation measures, the more stringent measure(s) should be adopted.

V.	What Registrants Need to Do  XE "V. What Registrants Need To Do"

	The Agency has determined that OPP and salts is eligible for reregistration provided that: (i) additional data that the Agency intends to require confirm this decision; and (ii) the risk mitigation measures outlined in this document are adopted, and (iii) label amendments are made to reflect these measures.  The additional data requirements that the Agency intends to obtain will include, among other things, submission of the following:

	For OPP technical grade active ingredient products, the registrant needs to submit the following items:

Within 90 days from receipt of the generic data call in (DCI):

1.  completed response forms to the generic DCI (i.e., DCI response form and requirements status and registrant’s response form); and

	2.  submit any time extension and/or waiver requests with a full written justification.

Within the time limit specified in the generic DCI:

1.  cite any existing generic data which address data requirements or submit new generic data responding to the DCI.

Please contact Rebecca M. Miller at<PHONE_NUMBER> with questions regarding generic reregistration.

By US mail:						By express or courier service:

Document Processing Desk				Document Processing Desk

Rebecca Miller					Rebecca Miller

Office of Pesticide Programs (7510P)		Office of Pesticide Programs (7510P)

U.S. Environmental Protection Agency		U.S. Environmental Protection Agency

1200 Pennsylvania Ave., NW				Room S-4900, One Potomac Yard

Washington, DC 20460-0001				2777 South Crystal Drive

							Arlington, VA 22202

For end use products containing the active ingredient OPP (or Na-OPP/K-OPP), the registrant needs to submit the following items for each product.

Within 90 days from the receipt of the product-specific data call-in (PDCI):

1.  completed response forms to the PDCI (i.e., PDCI response form and requirements status and registrant’s response form); and

2.  submit any time extension or waiver requests with a full written justification.

Within eight months from the receipt of the PDCI:

1.  two copies of the confidential statement of formula (EPA Form 8570-4);

2.  a completed original application for reregistration (EPA Form 8570-1).  Indicate on the form that it is an “application for reregistration”;

3.  five copies of the draft label incorporating all label amendments outlined in Table 23 of this document;

4.  a completed form certifying compliance with data compensation requirements (EPA Form 8570-34); and

5.  if applicable, a completed form certifying compliance with cost share offer requirements (EPA Form 8570-32); and

6.  the product-specific data responding to the PDCI.

	Please contact the product manager, Adam Heyward, at<PHONE_NUMBER> with questions regarding product reregistration and/or the PDCI.  All materials submitted in response to the PDCI should be addressed as follows:

By US mail:						By express or courier service:

Document Processing Desk				Document Processing Desk

Adam Heyward					Adam Heyward

Office of Pesticide Programs (7510P)		Office of Pesticide Programs (7510P)

U.S. Environmental Protection Agency		U.S. Environmental Protection Agency

1200 Pennsylvania Ave., NW				Room S-4900, One Potomac Yard

Washington, DC 20460-0001				2777 South Crystal Drive

							Arlington, VA 22202

A.	Manufacturing Use Products   XE "V. What Registrants Need to Do:A. Manufacturing Use Products"

		1.	Additional Generic Data Requirements   XE "V. What Registrants Need to Do:A. Manufacturing Use Products: 1. Additional Generic Data Requirements"

	The generic database supporting the reregistration of OPP and salts has been reviewed and determined to be substantially complete.  However, the following additional data requirements outlined in Table 24 have been identified by the Agency as confirmatory data requirements.  A generic data call-in will be issued at a later date.

The risk assessment noted deficiencies in the surrogate dermal and inhalation exposure data available from the Chemical Manufacturers Association (CMA) database. Therefore, the Agency is requiring confirmatory data to support the uses assessed with the CMA 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 based on professional judgments. Therefore, descriptions of human activities associated with the uses assessed are required as confirmatory.  Appropriate air monitoring data in the manufacturing setting may be required dependent on the results of the inhalation toxicity study.

	Table 24.  Confirmatory Data Requirements for Reregistration

Guideline Study Name	New OPPTS Guideline No.	Old Guideline No.

Fish Early Life-Stage Toxicity	850.1300 	72-4a

Aquatic Invertebrate Life-Cycle Toxicity	850.1400	72-4b

Marine/Estuarine Fish Acute Toxicity	850.1075	72-3a

Aquatic Vascular Plant Toxicity	850.4400	123-2

Acute inhalation toxicity - Rat	870.1300	81-3

Acute Eye Irritation - Rabbit	870.2400	81-4

Migration Study for Plastics and Polymers	Special Study	Special Study

Indoor Inhalation Exposure and Applicator Exposure Monitoring Data Reporting	875.1400 and 875.1600	234 and 236

Indoor Dermal Exposure and Applicator Exposure Monitoring Data Reporting 875.1200 and 875.1600	233 and 236

Descriptions of Human Activity	875.2800	133-1

		2.  	Labeling for Technical and Manufacturing Use Products   XE "V. What Registrants Need to Do:A. Manufacturing Use Products: 2. Labeling for Technical and Manufacturing Use Products"

	To ensure compliance with FIFRA, technical and manufacturing use product (MP) labeling should be revised to comply with all current EPA regulations, PR Notices and applicable policies.

	B.  	End-Use Products   XE "V. What Registrants Need to Do:B. End-Use Products"

		1.   Additional Product-Specific and Efficacy Data Requirements tc \l3 "1.   Additional Product-Specific and Efficacy Data Requirements

	Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made.  Registrants must review previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies.  If a registrant believes that previously submitted data meet current testing standards, then the study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product.

A product-specific data call-in, outlining data requirements, will be sent to registrants at a later date.  The PDCI will be based upon current efficacy-related requirements for antimicrobial pesticide products, claims, or patterns of use.  A summary of these requirements can be found on the Agency’s Antimicrobials Science Policy website at   HYPERLINK "http://www.epa.gov/oppad001/sciencepolicy.htm"  http://www.epa.gov/oppad001/sciencepolicy.htm .

2. Labeling for End-Use Products

Labeling changes are necessary to implement measures outlined in Section IV above. Specific language to incorporate these changes is specified in Table 25.

Registrants may generally distribute and sell products bearing old labels/labeling for 26 months from the date of the issuance of this Reregistration Eligibility Decision document. Persons other than the registrant may generally distribute or sell such products for 52 months from the approval of labels reflecting the mitigation described in this RED.  However, existing stocks time frames will be established case-by-case, depending on the number of products involved, the number of label changes, and other factors. Refer to “Existing Stocks of Pesticide Products; Statement of Policy,” Federal Register, Volume 56, No. 123, June 26, 1991.

a. 	Label Changes Summary Table

In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The following table describes how language on the labels should be amended.

Table 25.  Labeling Changes Summary Table

Summary of Labeling Changes for OPP and its Salts

Description	Amended Labeling Language	Placement on Label

Delete use on diapers

Use Directions

Delete all use on non-laundered textiles\items including mattresses, helmets, headgear, headphones, facegear, and mouthpieces.

Use Directions

Laundry Use	Clarify language to ensure use requires washing and rinsing prior to wearing clothing	Use Directions

Environmental Hazards Statements Required by the RED

	All OPP-containing products with an antisapstain use must contain the following language:

"Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the waterway.  Treated lumber stored within 100 feet of a pond, lake, steam, or river must be either covered with plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway.  If a berm or curb is used around the site, it should consist of impermeable material (clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events." Precautionary Statements

Formulation Restrictions	Use: wiping in the commercial/institutional premises-

maximum of 63.0 % active ingredient	Use Directions

Application Restrictions	Use: paint preservative-

maximum application rate of 0.33 (% active ingredient by weight of material being treated). 	Use Directions

Application Restrictions	Use: metalworking fluids-

maximum application rate of 0.81 (% active ingredient by weight of material being treated).  	Use Directions

2-Phenylphenol & Salts RED

VI. APPENDICES  XE "VI. Appendices"

  SEQ CHAPTER \h \r 1 Appendix A:  Table of Use Patterns for OPP and Salts

Use Site	Formulation/ EPA Reg No.	Method of Application	Application Rate/ No. of applications	Use Limitations

Agricultural premises and equipment

Mushroom Farms and Premises	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

1043-26	Sponge, mop, spray	 ½ oz per gallon of water.  10 minute contact time.	Preclean all surfaces with soap and water.  Use between crops and on non-food contact areas

Greenhouse Premises, Tools and Equipment.	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

1043-26	Sponge, mop, spray	Spray, mop, sponge:  ½ oz per gallon of water.  10 minute contact time.	Preclean all surfaces with soap and water.

Rinse all surfaces with a potable water rinse and allow to air day prior to reuse.

Cattle, Swine and Poultry Farms and Premises and Equipment

Cattle, Swine and Poultry Farms and Premises and Equipment	Soluble Concentrate

211-25

211-36

303-223

464-70

464-616

3862-179

3862-180

39967-3

49403-21

1043-26

6836-252

6836-253

303-225

1043-91

1043-118

49403-6

49403-23

66171-1

66171-2

70627-6	Sponge, mop, spray or fogger

	Spray, mop, sponge:  ½-1 oz per gallon of water.  10 minute contact time.	Preclean all surfaces with soap and water.  Do not use in food contact areas.

Fogging:  do not remain in treated area. Allow two hours after fogging before re-entry.  Remove or protect all food an packaging materials.  Treated food contact areas should be scrubbed with a suitable cleaner and rinsed with potable water.

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000 cubic feet.

Ready to Use

10088-105

70263-1

70263-2

70263-3

11694-99

44446-67

70263-4

70263-5

	Spray	Spray until covered with mist.  10 minute contact time.	Preclean all surfaces with soap and water.  Do not use in food contact areas.

Hatcheries, Setters, and Chick Processing Facilities                              	Soluble Concentrate

211-25

211-36

464-70

464-616

3862-179

3862-180

39967-3

49403-21

1043-26

6836-252

6836-253

70627-6

	Sponge, mop, spray or fogger	Spray, mop, sponge ½-1 oz per gallon of water.  10 minute contact time.	Preclean all surfaces with soap and water. Do not use in food contact areas.

Fogging:  do not remain in treated area. Allow two hours after fogging before re-entry.  Remove or protect all food an packaging materials.  Treated food contact areas should be scrubbed with a suitable cleaner and rinsed with potable water.

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000 cubic feet.

	Egg Washing treatments (Hatching)	Soluble Concentrate

464-70

464-616

39967-3

49403-21

66171-1

66171-2	Immersion, automatic water system, foaming or fogging	½ oz per gallon of water.  Use at 78 – 110 degrees F

	Trucks and other Vehicles	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

6836-252

6836-253

303-225

303-223

1043-91

66171-1

66171-2

70627-6	Sponge, mop, spray	Spray, mop, sponge ½-1 oz per gallon of water.  10 minute contact time.	None

	Ready to Use

211-32

10088-105

70263-1

70263-2

70263-4

70263-5	Spray	Spray until covered with mist.  10 minute contact time. None

Shoebath sanitizer

	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

6836-252

6836-253

66171-1

66171-2

70627-6	Open vessel

	½-1 oz per gallon of water.

	None

	Ready to Use

706-69

3862-104

70263-5

	Spray	Spray until covered with mist.

Allow to air dry	Preclean shoes before applying

Food Handling/storage establishments premises and equipment

Fruit and Vegetable rinses (Citrus and pears ONLY)	Soluble Concentrate (solid and liquid)

464-70

464-616

49403-21

39967-3

464-78

2792-28

2792-32

8764-1

8764-16

8764-24

33354-2

39967-20

43410-9

43553-20

57227-7

64864-45

	Dip tank, Mechanical spray or foam machine	Citrus:  1 gallon of ingredient per 9-90 gallons of water.  A pH of 11-12 should be maintained.  Maximum 1 minute contact time.  Rinse with Potable water.

Wax emulsions:  1 gallon to 40 gallons of emulsion.  1 gallon of emulsion per 10,000 lbs of fruit.  Do not rinse.

	Note: EPA Reg No. 8764-1, 33354-2, 43410-9 and 43553-20 all have unapproved or cancelled fruits and vegetables on their labels.  Orthophenylphenol is no longer approved for use on Apples, Cantaloupes, Carrots, Cherries, Cucumbers, Peaches, Peppers, Pineapples, Plums, Sweet Potatoes and Tomatoes.

Tolerance for citrus, 10ppm

Tolerance for Pears, 25ppm

	Pears:  1 gallon per 9-80 gallons of water. A pH of 11 should be maintained.  Maximum 1 minute contact time.  Rinse with Potable water.

	Food Processing Plant Non-food Handling Areas	Ready to Use

464-70

464-616

39967-3

49403-21

10088-105

44446-67

	Spray	Spray until covered with mist.  10 minute contact time.	Rinse all surfaces with a potable water rinse and allow to air day prior to reuse.

	Soluble Concentrate

1043-92

34810-8

70627-6

	Sponge, mop, spray	Spray, mop, sponge ½-1 oz per gallon of water.  10 minute contact time.	Rinse all surfaces with a potable water rinse and allow to air day prior to reuse.

Eating Establishment Food Handling Areas (Non-food contact)	Ready to Use

211-32

464-70

464-616

49403-21

39967-3

498-194

706-69

2296-101

10088-105

33176-6

44446-67

69658-3

70627-6

	Spray, Sponge	Spray or sponge until damp.  10 minute contact time. Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

Not for use on utensils, glassware and dishes

	Soluble Concentrate

211-25

211-36

	Sponge, mop, spray	Spray, mop, sponge ½ oz per gallon of water.  10 minute contact time	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

Not for use on utensils, glassware and dishes

Commercial, institutional and industrial premises and equipment

Industrial and Institutional equipment and buildings, non porous, non food contact surfaces

Industrial and Institutional equipment and buildings, non porous, non food contact surfaces

Industrial and Institutional equipment and buildings, non porous, non food contact surfaces	Soluble Concentrate 211-25

211-36

464-70

464-616

675-19

675-43

39967-3

49403-21

1043-26

6836-252

6836-253

303-225

303-223

1043-91

1043-92

1043-115

1043-117

1043-118

3862-179

3862-180

5741-6

34810-8

34810-16

34810-19

34810-28

46851-5

49403-6

49403-23

66171-1

66171-2

70627-6

	Sponge, mop, spray or fogger	Spray, mop, sponge ½-2 oz per gallon of water.  10 minute contact time.	Preclean all surfaces with soap and water. Do not use in food contact areas.

Fogging:  do not remain in treated area. Allow two hours after fogging before re-entry.  Remove or protect all food an packaging materials.  Treated food contact areas should be scrubbed with a suitable cleaner and rinsed with potable water.

Preclean all surfaces with soap and water. Do not use in food contact areas.

Fogging:  do not remain in treated area. Allow two hours after fogging before re-entry.  Remove or protect all food an packaging materials.  Treated food contact areas should be scrubbed with a suitable cleaner and rinsed with potable water.

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000 cubic feet.

Ready to Use

1270-237

70263-1

70263-2

70263-3

70263-4

70263-5

211-32

7405-51

498-134

498-180

498-154

706-69

1043-19

2296-101

3862-104

5741-22

10807-177

10807-178

11694-98

11694-99

33176-5

33176-6

34810-21

44446-67

55195-3

56392-4

69658-3

70627-14

	Spray, Sponge

	Spray or sponge until damp.  10 minute contact time.

	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

	Soluble Powder

34810-29	Sponge, mop	Mop, sponge ½ oz per gallon of water.  10 minute contact time.	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

	Impregnated Wipe

46851-10

55195-4	Wipe	Thoroughly wet surface.  10 minute contact time.	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

Residential and public access premises

Household/Domestic Dwellings indoor premises

Household/Domestic Dwellings indoor premises	Soluble Concentrate

211-25

211-36

464-70

464-616

49403-21

39967-3

6836-253

777-60

49403-6

49403-23	Sponge, mop, spray	Spray, mop, sponge ½-2 oz per gallon of water.  10 minute contact time.	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

Not for use on utensils, glassware and dishes

	Ready to Use

10088-105

498-134

498-180

498-154

706-69

777-27

777-73

1043-19

5741-22

11694-99

33176-5

33176-6

44446-67

69658-3

70263-4

70627-14	Spray

	Spray until covered with mist.  10 minute contact time.

	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

Not for use on utensils, glassware and dishes

	Impregnated Wipe

46851-10

55195-4	Wipe	Thoroughly wet surface.  10 minute contact time.	Treated food contact areas should be thoroughly cleaned and rinsed with potable water.

Not for use on utensils, glassware and dishes

	Ready to use

4822-479	Spray	For spot use, cracks, crevices and baseboards.  Spray until wet and allow to air dry.	Do not spray up in into air.  Apply to non-food contact areas only.

Household/Domestic Dwellings outdoor premises and equipment (roofs, decks, fences)	Soluble Concentrate

71240-1	Tank type chemical sprayer	 6 oz. per 104 oz. of water AND 18 oz. of bleach.  Makes one gallon. Liberally wet roof, wait five minutes then rinse well.	No for interior use.

Carpets	Soluble Concentrate

464-70

464-616

49403-21

39967-3

70263-5

70263-7	Soak, approved cleaning machine	1-4 oz per gallon of water.

Allow carpet to air dry	None

Garbage Cans

Garbage Cans

	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

6836-253

777-60

40510-5

66171-1

66171-2

3862-179

3862-180	Sponge, mop, spray	Spray, mop, sponge ½-2 oz per gallon of water.  10 minute contact time.	None

	Ready to Use

10088-105

8284-7

211-32

498-134

498-180

706-69

777-73

3862-104

5741-22

10807-177

10807-178

11694-98

11694-99

33176-5

55195-3

56392-4

69658-3

70263-4

70263-5

70627-14	Spray	Spray until covered with mist.  10 minute contact time. None

Animal Kennels and Sleeping Quarters

Animal Kennels and Sleeping Quarters

	Soluble Concentrate

211-25

211-36

464-70

464-616

39967-3

49403-21

1043-26

3862-179

6836-252

6836-253

303-225

49403-6

66171-1

66171-2

70627-6	Sponge, mop, spray or fogger	Spray, mop, sponge ½-1 oz per gallon of water.  10 minute contact time.

Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000 cubic feet.	Preclean all surfaces with soap and water.

Fogging:  do not remain in treated area. Allow two hours after fogging before re-entry.  Remove or protect all food an packaging materials.  Treated food contact areas should be scrubbed with a suitable cleaner and rinsed with potable water.

	Ready to Use

10088-105

70263-1

70263-2

70263-3

70263-5

211-32

498-134

498-180

498-154

33176-5

44446-67

70263-4

	Spray	Spray until covered with mist.  10 minute contact time.	None

Laundry Starch	Soluble Concentrate

464-78

464-616

39967-3

49403-21

	Open pour	0.025-0.2% by weight of formulation	To preserve liquid during shelf life and use life.

Laundry (household/coin operated)	Soluble Concentrate

464-70

464-616

39967-3

49403-21

777-60	Open Pour	4 oz per load of laundry.	None

Diaper Pails (empty) 	Ready to Use

464-70

464-616

39967-3

49403-21

498-134

498-180

33176-5

70627-14	Spray	Spray until covered with mist.  10 minute contact time.  None

Bathrooms, Urinals and Chemical toilets

Bathrooms, Urinals and Chemical toilets	Ready to Use

1207-237

8284-7

211-32

464-70

464-616

39967-3

49403-21

7405-51

498-134

498-180

498-154

706-69

777-27

777-73

2296-101

10807-177

10807-178

33176-5

44446-67

55195-3

56392-1

56392-2

56392-4

69658-3

70263-4

70627-14	Spray, Sponge

	Spray or sponge until damp.  10 minute contact time.

	None

None

	Soluble Concentrate

211-25

211-36

464-78

3862-179

6836-252

6836-253

777-60

34810-8

34810-16

34810-19

40510-5

49403-6

66171-1

66171-2

70627-6

70263-5

	Sponge, mop, spray	Spray, mop, sponge ½-2 oz per gallon of water.  10 minute contact time.

Soluble Powder

34810-29	Sponge, mop	Mop, sponge ½ oz per gallon of water.  10 minute contact time.	None

Air conditioning cooling coils	Soluble Concentrate

464-70

464-616

39967-3

49403-21

5741-6

	Spray or approved applicator	2 oz per gallon of water	None

Air conditioning Ducts	Ready to Use

464-70

464-616

39967-3

49403-21

70263-5

	Spray or approved applicator	Spray areas until thoroughly moist.  10-20 minute contact time.	Follow industry standards for cleanliness and mechanical inspections prior to using this product.

Medical premises and equipment

Hospitals and dental office equipment and premises (noncritical items)

Hospitals and dental office equipment and premises (noncritical items)

Hospitals and dental office equipment and premises (noncritical items) Ready to Use

464-70

464-616

39967-3

49403-21

1207-237

10088-105

211-32

7405-51

498-134

498-180

498-154

706-69

1043-19

5741-22

10807-177

10807-178

11694-98

11694-99

33176-5

33176-6

34810-21

34810-22

44446-67

55195-3

56392-1

Ready to Use

56392-2

56392-4

69658-3

70263-4

70263-5

	Spray

Spray	Spray until covered with mist.  10 minute contact time. Wipe off excess.

Spray until covered with mist.  10 minute contact time. Wipe off excess. 	None

None

	Soluble Concentrate

211-25

211-36

211-62

675-19

675-21

675-43

3862-179

3862-180

6836-252

6836-253

303-225

303-223

1043-87

1043-91

1043-92

1043-115

1043-117

5741-6

34810-8

34810-16

34810-19

34810-28

34810-31

46851-1

46851-5

49403-6

49403-23

66171-1

66171-2

70627-6	Sponge, mop, spray

	Spray, mop, sponge ½-4 oz per gallon of water.  10 minute contact time.

	None

	Soluble Powder

34810-29	Sponge, mop	Mop, sponge ½ oz per gallon of water.  10 minute contact time.	None

	Impregnated Wipe

46851-10

55195-4	Wipe	Thoroughly wet surface.  10 minute contact time.	None

Laundry	Soluble Concentrate

675-19	Open Pour	Add 1 cup to 17 gallons of water.	See label

	Soluble Concentrate

3862-179	Open pour	Soak in 1 oz per gallong of water for 10 minutes

	Household Sickrooms	Ready to Use

464-70

464-616

49403-21

39967-3

3862-104

70263-5	Spray	Spray until covered with mist.  10 minute contact time. Wipe off excess.	None

Hospital and Dental Critical Items

	Soluble Concentrate

211-25

211-36

464-70

464-616

675-19

675-43

39967-3

49403-21

675-21

1043-114

1043-115

1043-117

2212-17

46851-1	Soak, approved cleaning machine

	1/2- 4oz per gallon. 10-20 minute contact time.

	May be used in an ultrasonic cleaning system.  See individual labels.

For interim decontamination prior to terminal cleaning and sterilization.

If instruments are to be in contact with solution for more than 20 minutes, add 1g of NAHC03 per quart of solution, dissolve completely. Also add 2 oz. of Isopropyl alcohol per quart of solution.  See individual labels.

	Soluble Powder

34810-29	Soak	½ oz per gallon of water.  10 minute contact time.	For interim decontamination prior to terminal cleaning and sterilization.

Barber Shop and Salon equipment and premises

Barber Shop and Salon equipment and premises	Soluble Concentrate

211-25

211-36

211-62

303-223

464-70

464-616

3862-179

3862-180

39967-3

49403-21

954-13

10088-105

33176-5

33176-6

62296-1

65596-1

66171-1

66171-2

70627-6

	Soak or spray

	1-4 oz. per gallon of water.

Wet surfaces to be disinfected.  10 minute contact time

	None

	Ready to use

498-194

954-10

211-32

	Spray	Wet surfaces to be disinfected.  10 minute contact time	None

Veterinary Hospitals and premises

Veterinary Hospitals and premises

 	Soluble Concentrate

211-25

211-36

211-62

464-70

464-616

39967-3

49403-21

675-21

1043-26

6836-252

6836-253

303-225

303-223

3862-179

1043-87

1043-91

1043-92

1043-118

46851-1

46851-5

49403-6

49403-23

	Sponge, mop, spray or fogger

	Spray, mop, sponge ½-4 oz per gallon of water.  10 minute contact time.	None

	Fogger:  ½ oz per gallon of water. Fog area at 32-64 oz per 1,000 cubic feet.

Ready to Use

498-154

70263-1

70263-2

70263-3

70263-4

211-32

7405-51

498-134

498-180

33176-5

44446-67

56392-1

56392-2

56392-4

70627-6

70263-5

	Spray

	Spray until covered with mist.  10 minute contact time.

	None

	Impregnated Wipe

46851-10

55195-4	Wipe	Thoroughly wet surface.  10 minute contact time.	None

Materials preservatives

Building Materials	Soluble Concentrate

464-126

464-70

464-78

464-616

39967-3

39967-9

39967-11

39967-24

39967-26

49403-21

67869-21

	Open Pour

	0.10-2.8% by weight of product to be preserved.	None

Water based Conveyor Belt Lubricants	Soluble Concentrate 464-70

464-616

39967-3

49403-21

1677-128

1677-130

1677-157	Spray or approved dispenser	0.27-1.25 oz. per gallon of water Spray clean conveyors with a suitable detergent to remove soil and slime build up prior to application

Hides, Leather and Leather products	Soluble Concentrate (solid and liquid), Ready to Use

464-126

464-70

464-78

464-616

49403-21

39967-3

10145-3

10145-4

39967-9

39967-11

39967-23

39967-24

39967-26

67869-24

72136-1	Swab, spray, roller machine or open pour.	Apply thin coat on finished leathers, allow to dry

For open pour:  Dissolve into retanning or fat-liquoring oils prior to application.  Use 1.5-2% active ingredient based upon weight of leather. None

	Ready to Use

10088-105

	Spray	Spray until covered with mist.  10 minute contact time.	None

Paints and Stains	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

464-656

39967-11

39967-24

67869-21	Open Pour, spray 	0.1-2.8% by weight of materials treated.

Add as a concentrated aqueous solution to the formulation.	Per RED mitigation, for products with a painting use applied via airless sprayer the maximum application rate must be less than 0.33 lb ai/gal (% active ingredient by weight of material being treated).

Glues and Adhesives	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-23

39967-26

67869-21	Open Pour	0.1-0.4% by weight of materials treated.

Add as a concentrated aqueous solution to organic portion of the ingredients.	None

Concrete Admixtures

	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

49403-21

39967-3

464-126

464-656

39967-11

39967-23

39967-24

39967-26

67869-21	Open Pour

	0.01-2.8% by weight of the admixture.

Add at a suitable point during the manufacture of the admixture

 	Conversion to a water dilutable alkaline concentrate using sodium hydroxide is recommended.

Mineral Pigment Slurries

	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

464-656

39967-9

39967-23

39967-26

67869-21	Open Pour

	0.025-1.6% by weight of the slurry.

Add at a suitable point during the manufacture, loading/filling or shipment of slurry.

	If needed add caustic to make a water dilutable alkaline concentrate.

Metal Working Fluids	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

49403-21

39967-3

464-126

464-656

39967-9

39967-11

39967-23

39967-24

39967-26

67869-21	Open Pour	0.05-4.0% by weight of diluted concentrate.

Add as a concentrated aqueous solution to the formulation. Add to water-emulsifiable oil concentrate during formulating process.	Per RED mitigation, all products used as a metalworking fluid may not exceed a maximum application rate of 0.81 lb ai/gal (% active ingredient by weight of material being treated).

Inks, Dyes, Tints, Pigments, and Filler Suspensions	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-11

39967-23

39967-24

67869-21	Open Pour	0.018-1.1% by weight of materials treated.

Add as a concentrated aqueous solution to the formulation. Add a suitable point during the manufacture, using dispersing agents if necessary.	None

Cleaning solutions, Wax emulsions, polishes	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

464-656

39967-9

39967-11

39967-23

39967-24

39967-26

67869-21

	Open Pour	0.05-2.3% by weight of materials treated.

Add as a concentrated aqueous solution to the formulation.

Add a suitable point during the manufacture.	None

Textiles and auxiliaries	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-23

39967-24

39967-26

67869-21

	Open Pour	Textiles:  0.15-28.3% by weight of materials treated.

Add as a solution by dissolving in a suitable solvent.

Auxiliaries:  0.05-0.4% by weight of materials treated.

Add as a solution by dissolving in a suitable solvent.	Per RED mitigation, all labels with laundered textile uses must have directions that indicate that items must be treated prior to washing and rinsing.

	Ready to Use

10088-105

	Spray	Spray until covered with mist.  10 minute contact time.	Per RED mitigation, all labels with laundered textile uses must have directions that indicate that items must be treated prior to washing and rinsing.

Paper Slurries and auxiliaries	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-23

39967-24

39967-26

39967-45

67869-21	Open Pour	Paper slurries:  0.07%-0.6% by weight of slurry. 3-6 lbs per 10,00 lbs of slurry.	Add as a solution by dissolving in a suitable solvent.

Non food contact

	Auxiliaries:  0.05-1.7% by weight of materials treated.

	Fire Extinguisher medium	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-26

	Open Pour	0.1-0.4% by weight of solution.

Add a suitable point during the manufacture	None

Ceramic Glazes

	Soluble Concentrate (solid and liquid)

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-9

39967-11

39967-26

67869-21

	Open Pour	0.05-2.8% by weight of glaze or slip formation.

Add to ingredients of formation as they are charged into a ball mill.  None

Photographic solutions	Soluble Concentrate 464-70

464-78

464-616

49403-21

39967-3

464-126

39967-11

67869-21	Open Pour	0.05-0.5% by weight of solution or emulsion.	None

Polymers and Plastic emulsions

	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-11

39967-23

39967-24

67869-21	Open Pour	0.05-1.7% by weight of material to be protected

Add a suitable point during the manufacture	Add as a solution by dissolving in a suitable solvent.

Biopolymers	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

464-126

39967-11

39967-23

67869-21	Open Pour	0.05-1.1% by weight of material to be preserved

Add a suitable point during the manufacture.	None

Latex Dispersions and Emulsions	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

464-656	Open Pour	0.1-1.0% by weight of dispersion or emulsion	None

Drilling Muds	Soluble Concentrate

464-70

464-78

464-616

39967-3

49403-21

39967-24	Open Pour

None

Wood Preservation

Green and or Freshly Cut Lumber, Sapstain control	Soluble Concentrate

464-70

464-616

39967-3

49403-21

1022-564

39967-11

39967-23

57227-1

43553-20

	Dip or Spray	1-4 oz. per gallon of water, 15 second dip or uniformly wet all surfaces	Per RED mitigation, the following language must appear on all products with an antisapstain use:

"Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the waterway.  Treated lumber stored within 100 feet of a pond, lake, steam, or river must be either covered with plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway.  If a berm or curb is used around the site, it should consist of impermeable material (clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events."

Dip tanks and drip aprons must be roofed, paved and drained to prevent dilution and loss of treatment solution.

DO NOT expose treated lumber to rains immediately after treatment. DO NOT float treated lumber in lakes, rivers, streams, or oceans.

	1.0-4.0% by weight of product to be treated.  Use Sodium Hydroxide or another base to make end use product dilutable.

	Swimming Pools

Whirlpool Baths	Soluble Concentrate

211-36

464-70

464-616

49403-21

39967-3

	Open Pour, spray, wipe	1 oz per gallon of water in unit. Start pump and circulate solution for 30-60 seconds. Turn off pump. Drain solution and thoroughly clean the unit and rinse all cleaned surfaces with water.

Other whirlpool components may be sanitized with a 1 oz per gallon solution, 10 minute contact time.	None

Appendix B.  	Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision  XE "VI. Appendices:B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision"

Guide to Appendix B

	Appendix B contains listing of data requirements which support the reregistration for active ingredients within case #3026 (BIT) covered by this RED.  It contains generic data requirements that apply to BIT in all products, including data requirements for which a “typical formulation” is the test substance.

	The data table is organized in the following formats:

	1.	Data Requirement (Columns 1 & 2).  The data requirements are listed in the order in which they appear in 40 CFR part 158.  The reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance, which are available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161<PHONE_NUMBER>.

Guideline Description (Column 3).  Identifies the guideline type.

3.	Use Pattern (Column 4).  This column indicates the standard Antimicrobials Division use patterns categories for which the generic (not product specific) data requirements apply. The number designations are used in Appendix A.

	(1) Agricultural premises and equipment

	(2) Food handling/ storage establishments premises and equipment

	(3) Commercial, institutional and industrial premises and equipment

	(4) Residential and public access premises

	(5) Medical premises and equipment

	(6) Human water systems

	(7) Materials preservatives

	(8) Industrial processes and water systems

	(9) Antifouling coatings

	(10) Wood preservatives

	(11) Swimming pools

(12) Aquatic areas

4.	Bibliographic Citation (Column 5).  If the Agency has acceptable data in its files, this column list the identify number of each study.  This normally is the Master Record Identification (MRID) number, but may be a “GS” number if no MRID number has been assigned.  Refer to the Bibliography appendix for a complete citation of the study.

TECHNICAL GRADE ACTIVE INGREDIENT (TGAI) DATA REQUIREMENTS	CITATION(S)

New Guideline Number	Old Guideline Number	Study Title	Use Pattern	MRID Number

CHEMISTRY

830.1550	61-1	Product Identity and Composition	All	41609501

41609502

42381901

830.1600 830.1620

830.1650	61-2 A	Starting Materials and Manufacturing Process	All 42097001

42528701

41609502

42381901

830.1670	61-2 B	Formation of Impurities	All	41609501

42381901

41609502

830.1700	62-1	Preliminary Analysis	All	41609501

42381901

41609502

830.1750	62-2	Certification of Limits	All	41609501

42381901

41609502

830.1800	62-3   	Analytical Method	All	41609501

42381901

41609502

830.6302	63-2	Color	All	101697

42381901

41609503

830.6303	63-3	Physical State	All	101697

42381901

41609503

830.6304	63-4	Odor	All	101697

42381901

41609503

830.7200	63-5	Melting Point	All	101697

42381901

41609503

41609504

830.7220	63-6	Boiling Point	All	101697

42381901

41609503

830.7300	63-7	Density	All	101697

42381901

41609503

830.7840

830.7860	63-8	Solubility	All	42441701

42381901

42500201

830.7950	63-9	Vapor Pressure	All	42441702

42381901

41609505

830.7370	63-10	Dissociation Constant in Water	All	42441703

42381901

42500202

41609503

830.7550

830.7560

830.7570	63-11	Partition Coefficient (Octanol/Water)	All	42441704

42381901

830.7000	63-12	pH	All	41609503

830.6313	63-13	Stability	All	42457001

42381901

41609503

830.6314	63-14	Oxidizing/Reducing Action	All	42441703

830.6315	63-15	Flammability	All	42441703

830.6316	63-16	Explodability	All	N/A

830.6317	63-17	Storage Stability	All	42441703

830.7100	63-18	Viscosity	All	N/A

830.6319	63-19   	Miscibility	All	N/A

830.6320	63-20	Corrosion Characteristics 	All	42441703

ECOLOGICAL EFFECTS

850.2100	  71-1	Avian Acute Oral Toxicity Test, TGAI - Quail/duck	All 160150

42500204

850.2200	71-2 A	Avian Acute Dietary, TGAI - Quail	10	160149

42500205

850.2200	71-2 B	Avian Acute Dietary, TGAI – Duck	10	160151

42500206

850.1075	72-1 A      	Fish Acute Toxicity, TGAI – Warmwater species All	156044

110232

850.1075	72-1 C      	Fish Acute Toxicity, TGAI – Coldwater species	10 156044

110232

850.1010	72-2 A	Acute Aquatic Invertebrate Toxicity, TGAI	All	156044

110222

850.1300	72-4 A	Fish Early Life-Stage Toxicity, TGAI	10	Required

850.1400	72-4 B	Aquatic Invertebrate Life-Cycle Toxicity, TGAI	10 Required

850.1075	72-3 A	Marine/Estuarine Fish Acute Toxicity, TGAI	10	Required

850.1025	72-3 B	Marine/Estuarine Bivalve Acute Toxicity, TGAI	10 46751202

850.1035	72-3 B	Marine/Estuarine Invertebrate Acute Toxicity, TGAI	10 46751203

850.4100	122-1	Seedling Emergence Test Using Rice, TEP or TGAI	10 46751207

850.4150	122-1	Vegetative Vigor Test Using Rice, TEP or TGAI	10	46751204

850.4400	123-2	Aquatic Vascular Plant Toxicity, TGAI	10	Required

850.5400	123-2	Algal Toxicity Using Four Species, TGAI	10	45688201

46751205

46751201

46823801

TOXICOLOGY

870.1100	81-1	Acute Oral - Rat	All	43334201

43334204

870.1200	81-2	Acute Dermal - Rabbit	All	78779

870.1300	81-3	Acute Inhalation – Rat	All	Required

870.2400	81-4	Acute Eye Irritation - Rabbit	All	Required

870.2500	81-5	Acute Skin Irritation - Rabbit	All	43334202

870.2600	81-6	Dermal Sensitization	All	43334203

43334205

870.3250	82-2	21-Day Subchronic Dermal	1,2,3,4,5,7,

10, 11	42881901

870.3250	82-3	90 Day Dermal-Rodent	N/A	Reserved

870.3465	82-4*	90-Day Subchronic Inhalation	N/A	Reserved

870.3100	82-1 A	90-Day feeding-Rodent	1,2,7,10,11	40760206

870.3150	82-1 B	90-Day feeding-Non-rodent	1,2,7,10,11	41656401

870.4100	83-1 A	Chronic Toxicity-Rodent	10,11	43954301

870.4100	83-1 B	Chronic Toxicity-Non-rodent	10,11	41656401

870.4200	83-2 A	Oncogenicity-Rat	10,11	43954301

870.4200	83-2 B	Oncogenicity-Mouse	10,11	43545501

870.3700	83-3 A	Prenatal Developmental Toxicity - Rat 	1,2,3,4,5,7,

10,11	92154037

870.3700	83-3 B	Prenatal Developmental Toxicity – Rabbit	1,2,3,4,5,7,

10,11	41925001

41925002

41925003

870.3800	83-4**	Reproduction and fertility effects - Rat 	2,10,11 43928801

870.5100	84-2 A	Bacterial Reverse Mutation Test - Ames	All	92154039

161577

870.5375	84-2 B	In Vitro Mammalian Chromosome Aberration Test	All	161577

	84-4	Other Genotoxic Effects	All	161577

127249

92154038

870.7485	85-1	General Metabolism	10,11	145962

71253

44197601

44197602

870.7600	85-3	Dermal Penetration	10,11	46882301

*For guidelines 82-3 and 82-4, at least one is required to be fulfilled; not both (for both food and non-food uses).

**Only required for food use.

ENVIRONMENTAL FATE

835.2120	161-1	Hydrolysis of Parent and Degradates	All	43994201

43973501

835.2240	161-2	Photodegradation – Water	N/A	Reserved

835.4400	162-3	Anaerobic Aquatic Metabolism	N/A	Reserved

835.4300	162-4	Aerobic Aquatic Metabolism	N/A	Reserved

835.1230	163-1	Leaching and Absorption/desorption	N/A	Reserved

840.1100	164-2	Aquatic Field Dissipation	N/A	Reserved

850.1730	165-4	Bioaccumulation in Fish	N/A	Reserved

850.1950	165-5	Bioaccumulation in Aquatic non-target organisms	N/A Reserved

	168-1 SS	Availability Study/Wood leaching study	10	46601401

OCCUPATIONAL PROTECTION

875.2100	132-1 A	Foliar Residue Dissipation	N/A	Waived

875.2400	133-3	Dermal Passive Exposure	N/A	Waived

41412201

41742601

875.2500	133-4	Inhalation Passive Exposure	N/A	Waived

41412201

41742601

875.1400	234	Estimation of Inhalation Exposure	All	43432901

RESIDUE CHEMISTRY

860.1100	171-2	Chemical Identity	All	41609502

860.1200	171-3	Directions for Use	N/A	Reserved

Migration Study for Plastics

Required

	171-5	Reduction of Residues	N/A	Reserved

860.1300	171-4 A	Nature of Residue – Plants	All	43298301

43537101

	171-4 B	Nature of Residue – Livestock	All	44349301

860.1340	171-4 C	Residue Analytical Method – Plant	All	43384101

43742101

44038501

43996401

	171-4 D	Residue Analytical Method – Livestock	N/A	Reserved

860.1380	171-4 E	Storage Stability	All	43992401

44112001

44182601

860.1460	171-4 I	Magnitude of Residue – Food Handling	N/A	Reserved

860.1480	171-4 J	Magnitude of Residue – Meat/Milk/Poultry/Eggs	N/A Required

860.1500	171-4 K	Magnitude of Residue, Crop Field Trials – Citron, Citrus	N/A	Reserved

Magnitude of Residue, Crop Field Trials – Pear

860.1520	171-4 L	Magnitude of Residue, Processed food/feed – Citron, Citrus	N/A	Reserved

Magnitude of Residue, Processed food/feed – Pear

Appendix C.  Technical Support Documents  XE "VI. Appendices:C. Technical Support Documents"

	Additional documentation in support of this RED is maintained in the OPP docket located in Room S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202, and is open Monday through Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.

	The docket initially contained preliminary risk assessments and related documents as of April 28, 2004.  Sixty days later the first public comment period closed.  The EPA then considered comments and revised the risk assessments.

	All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the Internet at the following site:   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov , docket ID # EPA-HQ-OPP-2006-0154

	These documents include:

Ortho-phenylphenol and orthophenylphenol salts:  AD Preliminary Risk Assessment for the Reregistration Eligibility Decision  (RED) Document , 4/17/06

Evaluation of the Carcinogenic Potential of  Ortho-Phenyelphenol and Sodium Ortho-Phenylphenol, 9/27/05

Ortho Phenylphenol, and its Sodium and Potassium Salts. Dietary Exposure Assessments for the Reregistration Eligibility Decision, 2/24/06

Ecological Hazard and Envrironmental Risk Assessment, 2-Phenylphenol and Salts,  4/10/06

Science Chapter on: Environmental Fate Studies and Environmental Fate Assessment of Orthophenylphenol, 9/20/05

Incident Reports Associated with 2 Phenylphenol & Salts, 5/10/05

Inert Ingredient Dietary and Non-dietary Risk Assessments for O-Phenylphenol and Salts Reregistration Eligibility Document (RED), 2/22/06

2-Phenylphenol, and salts - Conventional Uses:   Revised Occupational and Residential Exposure and Risk Assessment for the Reregistration Eligibility Decision (RED) Document (Case 2575), 10/6/05

Occupational and Residential Exposure Chapter for Ortho-phenylphenol & Ortho-phenylphenol Salts, 4/4/06

Product Chemistry Chapter for OPP and Salts, 2/17/06

Toxicology Disciplinary Chapter for the Re-Registration Eligibility Decision (RED) Risk Assessment, 4/17/06

Appendix D.	Bibliography Citations

MRID STUDIES

Chemistry

MRID 41609501 – Deford, C. (1990) Product Chemistry Data for Dowcide 1 Anti-micro- bial. Unpublished study prepared by Dow Chemicals U.S.A. 74 p.

MRID 41609502 – Deford, C. (1990) Product Chemistry Data for Dowcide A Antimicro- bial. Unpublished study prepared by Dow Chemical U.S.A. 64 p.

MRID 42381901 – Cocciardo, C.; Stroech, K. (1992) Product Chemistry Data Upgrades as Requested in Phase IV Data-Call-In for 2-Phenylphenol (49-155 ortho-Phenylphenol): Lab Project Number: 39967-3. Unpublished study prepared by Bayer Ag. 60 p.

MRID 42097001 – Lickly, L. (1991) O-Phenylphenol: Description of Beginning Materi- als and Manufacturing Process (...): Lab Project Number: Unpub- lished study prepared by The Dow Chemical Co. 6 p.

MRID 42528701 –Lickly, L. (1991) Sodium O-Phenylphenate--Description of Beginning Materials and Manufacturing Process: An amendment. Unpublished study prepared by The Dow Chemical Co. 6 p.

MRID 101697 – Dow Chemical Co. (1969) Dowicide 1 Antimicrobial. Midland, MI: Dow. (Antimicrobial agents, section I-1; also In unpublished submission received Jun 20, 1969 under 464-70; CDL:003397-A)

MRID 41609503 – Deford, C. (1990) Physical and Chemical Characteristics of Dowcide A Antimicrobial. Unpublished study prepared by Dow Chemical U.S.A.. 5 p.

MRID 41609504 – Black, C.; Frurip, D. (1990) Melting Point of Sodium o-Phenyl Phenate (Dehydrated): Lab Project Number: ML-AL 90-020344. Unp- ed study prepared by Dow Chemical U.S.A.. 10 p.

MRID 42441701 – Heimerl, J.; Engel, J. (1992) Solubility of Dowicide 1 Antimicrobial for Registration: Lab Project Number: ML-AL 92-080421. Unpublished study prepared by Dow Chemical USA, Analytical Sciences. 52 p.

MRID 42500201 – Heimeri, J.; Engel, J. (1992) Solubility of Dowicide A Antimicrobial for Registration: Lab Project Number: ML-AL 92-080543. Unpublished study prepared by Dow Chemical, USA, Analytical Sciences. 45 p.

MRID 42441702 – Srivastava, R.; Chakrabarti, A.; Griffin, K. (1992) Vapor Pressure of Ortho-Phenylphenol Measured by the Knudsen-Effusion/Weight Loss Method: Lab Project Number: ML-AL 91-020408. Unpublished study prepared by Dow Chemical USA. 15 p.

MRID 41609505 – Chakrabarti, A. (1990) Vapor Pressure of the Sodium Ortho-phenyl- phenate Measured by the Knudsen-Effusion/Weight Loss Method: Lab Project Number: ML-AL 90-020313. Unpublished study prepared by Dow Chemical U.S.A.. 10 p.

MRID 42441703 – Reim, R. (1992) Dissociation of Dowicide 1 Antimicrobial: Lab Project Number: ML-AL 92-080459. Unpublished study prepared by The Dow Chemical Co. 15 p.

MRID 42500202 – Reim, R. (1992) Dissociation of Dowicide A Antimicrobial: Lab Project Number: ML-AL 92-041093. Unpublished study prepared by Dow Chemical, USA, Analytical Sciences. 15 p.

MRID 42441704 –Heimerl, J. (1992) Octanol/Water Partition Coefficient Determination of Dowicide 1 Antimicrobial for Registration: Lab Project Number: ML-AL 92-080459. Unpublished study prepared by The Dow Chemical Co. 43 p.

MRID 42457001 –Engel, J.; Heimerl, J. (1992) Stability of Dowicide 1 Antimicrobial for Registration: Lab Project Number: ML-AL 92-080398. Unpublished study prepared by Dow Chemical USA. 45 p.

EcoTox

ACC232113.  Batchelder, T.L., and W. M. McCarty.  1977.  Toxicity of Dowicide A to Daphnids.  Unpublished data.  Conducted by Environmental Sciences Research, Dow Chemical Co., and submitted by Dow Chemical Co.

MRID 42500204 – Campbell, S.M. and M. Jaber.  1992.  Sodium o-phenylphenalte (DOWICIDE A):  An Acute Oral Toxicity Study with the Northern Bobwhite.  Unpublished data.  Conducted by Wildlife International for the Dow Chemical Co.

MRID 42500205 – Campbell, S.M., and S.P. Lynn.  1992.  Sodium o-phenylphenate (DOWICIDE A): A Dietary LC50 Study with the Northern Bobwhite.  Unpublished data.  Conducted by Wildlife International for the Dow Chemical Co.

MRID 42500206 – Campbell, S.M., and M Jaber.  1992.  Sodium o-phenylphenate (DOWICIDE A): A Dietary LC50 Study with the Mallard.  Unpublished data.  Conducted by Wildlife International for the Dow Chemical Co.

MRID 45688201 – Hicks, S. 2002.  Ortho-phenyl Phenol: Growth Inhibition Test with Green Alga, Selenastrum capricornutum.  Unpublished data.  Conducted by ABC Laboratories for The Dow Chemical Co.

MRID 160150 – Grimes, J. (1986) Ortho-phenylphenol Technical: An Acute Oral Toxi- city Study with the Mallard: Final Report: Project No. 103-248. Unpublished study prepared by Wildlife International Ltd. 18 p.

MRID 160149 – Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 Study with the Bobwhite: Final Report: Project No. 103-246. Un- published study prepared by Wildlife International Ltd. 17 p.

MRID 160151 – Grimes, J. (1986) Ortho-phenylphenol Technical: A Dietary LC50 Study with the Mallard: Final Report: Project No. 103-247. Un- published study prepared by Wildlife International Ltd. 18 p.

MRID 156044 – Dill, D.; Milazzo, D.; Bartlett, E.; et al. (1985) Evaluation of the Toxicity of Dowicide 1 Antimicrobial, Technical O-Phenyl- phenol, to Representative Aquatic Organisms: ES-811. Unpub- lished study prepared by Dow Chemical U S A. 17 p.

MRID 110232 – Bentley, R. (1975) Acute Toxicity of Dowicide CO to Bluegill ... and Rainbow Trout ...: GH-RC 62. (Unpublished study re- ceived Aug 25, 1976 under 464-126; prepared by Bionomics, EG & G Environmental Consultants, submitted by Dow Chemical U.S.A., Midland, MI; CDL:233706-A)

MRID 110222 – Batchelder, T.; McCarty, W. (1977) Toxicity of Dowicide A to Daph- nids: ES-154. (Unpublished study received Oct 28, 1977 under 464-78; submitted by Dow Chemical U.S.A., Midland, MI; CDL: 232113-A)

MRID 46751202 – Cafarella, M. (2006) OPP/SOPP - Acute Toxicity to Eastern Oyster (Crassostrea virginica) Under Flow-Through Conditions. Project Number: 12550/6382, 050368. Unpublished study prepared by Springborn Bionomics. 60 p.

MRID 46751203 – Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to Mysids (Americamysis bahia) Under Flow - Through Conditions. Project Number: 12550/6383, 050369. Unpublished study prepared by Springborn Bionomics. 61 p.

MRID 46751207 –Teixeira, D. (2006) OPP/SOPP - Determination of Effects on Seedling Emergence of Rice (Oryza sativa). Project Number: 12550/6384, 050370. Unpublished study prepared by Springborn Smithers Laboratories. 60 p.

MRID46751204 – Teixeira, D. (2006) OPP/SOPP - Determination of Effects on Vegetative Vigor of Rice (Oryza sativa). Project Number: 12550/6385, 050371. Unpublished study prepared by Springborn Bionomics. 61 p.

MRID 46751205 – Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Freshwater Diatom (Navicula pelliculosa). Project Number: 12550/6388, 050374. Unpublished study prepared by Springborn Bionomics. 63 p.

MRID 46751201 – Hoberg, J. (2006) OPP/SOPP - Acute Toxicity to the Marine Diatom, Skeletonema costatum, Under Static Conditions. Project Number: 12550/6389, 050375. Unpublished study prepared by Springborn Bionomics. 68 p.

MRID 46823801 – Hoberg, J. (2006) OPP/SOPP - Growth Inhibition Test with Freshwater Blue-Green Alga (Anabaena flos-aquae). Project Number: 12550/6387, 050373. Unpublished study prepared by Springborn Smithers Laboratories. 66 p.

Environmental Fate

MRID 43994201 – The Hydrolysis of o-Phenylphenol in Buffered Solution: SJ Gonsior, 1996, Study ID#: ES 3034, Performing Lab: The Environmental Chemistry Research Laboratory, The Dow Chemical company, Midland, Michigan 48674

MRID 43973501 – Dullau (1990) Preventol O Extra Hydrolysis Study: (Ortho-phenylphenol): Lab Project Number: G 89/0056/02 LEV: ZF-DZA/OAL: K2011-0058701-95E. Unpublished study prepared by Bayer AG. 162 p.

MRID 46601401 – Davis, J.; Gonsior, S. (2005) Ortho-Phenylphenol, Sodium Salt: Determination of the Leaching Rate from Wood Following a Simulated Sapstain Treatment. Project Number: 051089. Unpublished study prepared by The Dow Chemical Co. 31 p.

Toxicology

MRID 43334201 – Gilbert, K.; Crissman, J. (1994):  Dowicide 1 Antimicrobial: Acute Oral Toxicity study in Fischer 344 Rats: Lab Project Number: K/001024/057A: K/001024/057A2: K/001024/057A3. Unpublished study prepared by Dow Chemical Co. 53 p.

MRID 43334202 – Gilbert, K. (1994): Dowicide 1 Antimicrobial: Primary Dermal Irritation study in New Zealand White Rabbits: Lab Project Number: K/001024/057B. Unpublished study prepared by Dow Chemical Co. 18 p.

MRID 43334203 – Gilbert, K. (1994):  Dowicide 1 Antimicrobial: Dermal Sensitization Potential in the Hartley Albino Guinea Pig: Lab Project Number: K/001024/057E. Unpublished study prepared by Dow Chemical Co. 16 p.

MRID 43334204 – Gilbert, K.; Stebbins, K. (1994): Dowicide A Antimicrobial: Acute Oral Toxicity study in Fischer 344 Rats: Lab Project Number: K/001024/014A: K/001024/014A2. Unpublished study prepared by Dow Chemical Co. 78 p.

MRID 43334205 – Gilbert, K. (1994):  Dowicide A Antimicrobial: Dermal Sensitization Potential in the Hartley Albino Guinea Pig: Lab Project Number: K/001025/014E. Unpublished study prepared by Dow Chemical Co. 16 p.

MRID 40760206 – Iguchi, S.; Takahashi, H.; Fujii, T.; et al. (1984): Subchronic Toxicity of o-Phenolphenol (OPP) by Food Administration to Rats. Unpublished translation of Ann. Rept. Tokyo Res. Lab. 35: 407- 415. 29 p.

MRID 41925001 – Zablotny, C.L., et al. (1991):  Ortho-phenylphenol (OPP):  13-Day Range Finding Oral Gavage Study in New Zealand White Rabbits.  The Toxicology Research Laboratory, Midland, MI.  Study ID K-001-24-043.

MRID 41925002 – Zablotny, C.L., et al. (1991):  Ortho-phenylphenol (OPP):  Gavage Teratology Probe Study in New Zealand White Rabbits.  The Toxicology Research Laboratory, Midland, MI.  Study ID K-001-24-044.

MRID 41925003 – Zablotny, C.L., et al. (1991):  Ortho-phenylphenol (OPP):  Gavage Teratology Study in New Zealand White Rabbits.  The Toxicology Research Laboratory, Midland, MI.  Study ID K-001-24-045.

MRID 43928801 – Eigenberg, D.; Lake, S. (1995):  A Two-Generation Dietary Reproduction

 Study in Sprague-Dawley Rats Using Technical Grade ortho-Phenylphenol:

Lab Project Number: 93-672-VX: 7788. Unpublished study prepared by Bayer Corp. 1213 p.

MRID 42881901 – Zempel, J.A. and J.R. Szabo (1993): Ortho-Phenylphenol:  21-Day Repeated Dermal Dose Study of Systemic Toxicity in Fischer 344 Rats.  Health and Environmental Sciences- Texas, Freeport, Texas.  Study ID K-001024-056.

MRID 43954301 – Wahle, B.S. and W.R. Christenson (1996): Technical Grade ortho-PHENYLPHENOL:  A Combined Chronic Toxicity/ Oncogenicity Study in the Rat.  Bayer Corporation, Stillwell, KS.  Study ID 92-272-SC.

MRID 44832201 – Wahle, B.S. and W.R. Christenson (1996): Supplemental Submission to Bayer Toxicology Report No. 7908 (EPA MRID 43954301).  Bayer Corporation, Stillwell, KS.  Study ID 92-272-SC.

MRID 44852701 – Wahle, B.S. and W.R. Christenson (1996): Supplemental Submission to Bayer Toxicology Report No. 7908 (EPA MRID 43954301).  Bayer Corporation, Stillwell, KS.  Study ID 92-272-SC.

MRID 43545501 –   SEQ CHAPTER \h \r 1 Quast, J.F. and McGuirk, R.J. (1995): Ortho-phenylphenol: Two Year Dietary Chronic Toxicity/Carcinogenicity Study in B6C3F1 mice. Study conducted by Dow Chemical Company, Midland, Michigan and Freeport Texas for Dow Chemical Company, Midland, Michigan and Miles Inc., Stillwell, KS.

MRID 46882301 –    SEQ CHAPTER \h \r 1 Timchalk, C. (1996) 14C-Orthophenylphenol: Pharmacokinetics following dermal application in male human volunteers. Unpublished report No. HET-K-001024-064 from Dow Chemical Co., Midland, Michigan, USA. Submitted to WHO by Leng Associates, Midland, Michigan, USA.

MRID 92154037 – John, J.S. et al. (1978, reformatted 1990):  Phase 3 Reformat of MRID 00067616/ 164362:  The Effect(s) of Orally Administered Orthophenylphenol on Rat Embryonal and Fetal Development.  Toxicology Research Laboratory, Midland, MI.  Study ID HET K-0001024-33 (R).

MRID 78779 – Carreon, R.E.; New, M.A. (1981) Dowicide(TM) 1: Acute Percutaneous Absorption Potential: HET K-1024-(37). (Unpublished study received Jun 18, 1981 under 464-70; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:245514-A)

MRID 41656401 – Cosse, P.; Stebbins, K.; Stott, W.; et al. (1990) Ortho-phenylphen- ol: Palatability/Probe, Four-week and One-year Oral Toxicity Studies in Beagle Dogs: Lab Project Number: K-001024-038: K-001024-038A: K-001024-039. Unpublished study prepared by Dow Chemical Co., Health and Environmental Sciences. 321 p.

MRID 92154039 – Brusick, D. (1990) Dow Chemical U S A Phase 3 Reformat of MRID 00073282 and Related MRIDs 00079551. Mutagenicity of Ortho-Phenylphenol: LBI Project No. 2547. Prepared by Litton Bionetics, Inc. 11 p.

MRID 161577 – US Public Health Service, National Institutes of Health (1986) NTP Technical Report on the Toxicology and Carcinogenesis Studies of Ortho-phenylphenol (CAS No. 90-43-7) Alone and with 7,12-Di- methylbenz(a)anthracene (CAS No. 57-97-6) in Swiss CD-1 Mice: (Dermal Studies). NIH Publication No. 86-2557. 144 p.

MRID 127249 – Reitz, R.; Fox, T.; Quast, J.; et al. (1983) Follow-up Studies of the Effects of Orthophenylphenol ... and Sodium Orthophenyl- phenol ... on the Urinary Tract of F344 Rats: HET K-1025-(11). (Unpublished study received Mar 28, 1983 under 464-70; sub- mitted by Dow Chemical U.S.A., Midland, MI; CDL:249835-A)

MRID 92154038 – Deford, C. (1990) Dow Chemical U S A Phase 3 Summary of MRID 00127249. Biochemical Factors Involved in the Effects of Orthophenylphenol (OPP) and Sodium Orthophenylphenol (SOPP) on the Urinary Tract of Male F344 Rats. Prepared by Dow Chemical Company. 6 p.

MRID 145962 – Reitz, R.; Fox, T.; Quast, J.; et al. (1983) Molecular mechanisms involved in the toxicity of orthophenylphenol and its sodium salt. Chem.-Biol. Interactions 43:99-119.

MRID 71253 – Savides, M.C.; Oehme, F.W. (1980) Urinary metabolism of orally administered~ortho~-phenyl phenol in dogs and cats. Toxicology 17:355-363. (Also~In~unpublished submission received Feb 12, 1981 under 464-70; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:244358-A)

MRID 44197601 – Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade ortho-Phenylphenol: A Special Subchronic Dietary Study to Examine the Mechanism of Urinary Bladder Carcinogenesis in the Male Rat: Lab Project Number: 92-972-MS: 8042. Unpublished study prepared by Bayer Corp. and University of Nebraska Medical Center. 47 p.

MRID 44197602 – Christenson, W.; Wahle, B.; Cohen, S. (1996) Technical Grade ortho-Phenylphenol: A Special Subchronic Dietary Study to Examine the Mechanism of Urinary Bladder Carcinogenesis in the Male Rat: Supplement: Lab Project Number: 92-972-MS: 8042-1. Unpublished study prepared by Bayer Corp. and University of Nebraska Medical Center. 11 p.

Residue Chemistry

MRID 41609502 – Deford, C. (1990) Product Chemistry Data for Dowcide A Antimicro- bial. Unpublished study prepared by Dow Chemical U.S.A. 64 p.

MRID 43298301 – Wu, D. (1994) Metabolism of (carbon 14) Sodium Ortho-Phenylphenate (SOPP) in Stored Oranges: Nature of the Residue in Plants: Lab Project Number: XBL/93011: RPT00165. Unpublished study prepared by XenoBiotic Lab., Inc. 150 p.

MRID 43537101 – Wu, D. (1995) Metabolism of (carbon 14)Sodium Ortho-Phenylphenate (SOPP) in Stored Pears: Nature of the Residue in Plants: Lab Project Number: 93013: RPT00211. Unpublished study prepared by XenoBiotic Labs., Inc. 209 p.

MRID 44349301 – Thalacker, F. (1997) Nature of the Residue of (carbon-14)-Orthophenylphenol in Lactating Goats: Final Report: Lab Project Number: CHW 6578-105: AM-066: MILKG2S2.XLS. Unpublished study prepared by Corning Hazleton Inc. 160 p.

MRID 43384101 –Harsy, S. (1994) Validation of Method for Determination of o-Phenylphenol Residues in Pears: Lab Project Number: HWI 6524-106. Unpublished study prepared by Hazleton Wisconsin, Inc. 36 p.

MRID 43742101 – Harsy, S. (1995) Validation of Method for Determination of o-Phenylphenol Residues in Pears: Addendum No. 1 to the Final Report: Lab Project Number: HWI 6524-106. Unpublished study prepared by Hazleton Wisconsin, Inc. 13 p.

MRID 44038501 – Harsy, S. (1996) Validation of Methods for Determination of o-Phenylphenol Residues and Phenylhydroquinone Residues in Citrus: Addendum No.1 to the Final Report: Lab Project Number: HWI 6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 14 p.

MRID 43996401 – Harsy, S. (1996) Validation of Methods for Determination of o-Phenylphenol Residues and Phenylhydroquinone Residues in Citrus: Final Report: Lab Project Number: HWI 6524-107. Unpublished study prepared by Hazleton Wisconsin, Inc. 89 p.

MRID 43992401 – Johnson, G.; Strickland, M. (1996) Storage Stability of Orthophenylphenol and Phenylhydroquinone Residues in/on Raw Orange, Grapefruit, Lemon Fruit and Processed Orange Products: Final Report: Lab Project Number: CCQC 94-06: 101-009: HWI 6578-104. Unpublished study prepared by Western EcoSystems Technology (WEST, Inc.); Research for Hire; and Wm. J. Englar & Associates, Inc. 178 p.

MRID 44112001 – Johnson, G.; Strickland, M. (1996) Storage Stability of Orthophenylphenol and Phenylhydroquinone Residues in/on Raw Orange, Grapefruit, Lemon Fruit, and Processed Orange Products: Addendum 1 to the Final Report: Lab Project Number: 101-009: R289505: CCQC 94-06. Unpublished study prepared by Western EcoSystems Technology (WEST, Inc.); Research for Hire; and Corning Hazleton. 42 p.

MRID 44182601 – Johnson, G.; Strickland, M. (1996) Storage Stability of Orthophenylphenol and Phenylhydroquinone Residues in/on Raw Orange, Grapefruit, Lemon Fruit and Processed Orange Products Addendum 2 to the Final Report (MRID 43992401): Lab Project Number: 101-009: R289505: CCQC 94-06. Unpublished study prepared by Western EcoSystems Technology. 33 p.

Human Exposure

MRID 45524304 – Bestari et al., 1999 Measurement and Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber (Phase III).  (Task force #73154).

MRID 41412201 – Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association Antimicrobial Exposure Assessment Study: Lab Project ID: Q626. Unpublished study prepared by Univ. of Iowa, Insti- tute of Agricultural Medicine and Occupational Health. 209 p. Has different statistics when compared to 41742601 and 41761201.

MRID 41742601 – Popendorf, W.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association Antimicrobial Exposure Assessment: Lab Project Number: Q626. Unpublished study prepared by The Univ. of Iowa. 209 p.

MRID 43432901 – Maxey, S.; Murphy, P. (1994) Evaluation of Post-Application Exposures to Sodium o-Phenylphenate Tetrahydrate/ o-Phenylphenol to Workers During Post-Harvest Activities at Pear and Citrus Fruit Packaging Facilities: Lab Project Number: HEH2.1-1-174(39). Unpublished study prepared by Dow Chemical Co. 180 p.

OPEN LITERATURE

EcoTox

Bentley, R.E.  1975.  Acute Toxicity of Dowicide Co to the Bluegill and Rainbow Trout.  Unpublished data.  Conducted by Bionomics EG&G Environmental Consultants for The Dow Chemical Co.

Blair, R.M., H. Fang, W.S. Branham, B.S. Hass, S.L. Dial, C.L. Moland, W. Tong, L. Shi, R. Perkins, and D. M. Sheehan.  2000.  The Estrogenic Receptor Relative Binding Affinities of 188 Natural and Xenochemicals:  Structural Diversity of Ligands.  Toxicol Sci 54; 138-53.

Broderius, S. J., M.D. Kahl, and M.D. Hoglund.  1995.  Use of Joint Toxic Response to Define the Primary Mode of Toxic Action for Diverse Industrial Organic Chemicals.  Environ Toxicol Chem 14(9): 1591-1605.

Davis, H. C.  1961.  Effects of Some Pesticides on Eggs and Larvae of Oysters (Crassostrea virginica) and Clams (Venus mercenaria).  Commer Fish Rev 23(12): 18-23.

Davoren, M., and A. M. Fogarty.  2005.  Ecotoxicological Evaluation of the Biocidal Agents Sodium o-Phenylphenol, sodium o-Benzyl-p-Chlorophenol, and sodium p-Tertiary Amylphenol.  Ecotox and Environ Safety 60: 203-212.

Hu, J., and T. Aizawa.  2003.  Quantitative Structure-Activity Relationships for Estrogen Receptor Binding Affinitiy of Phenolic Chemicals. Water Res 37: 1213-22.

Kuhn, R., M. Pattard, K. Pernak, and A. Winter.  1989.  Results of the Harmful Effects of Selected Water Pollutants (Anilines, Phenols, Aliphatic Compounds) to Daphnia magna.  Water Res 23(4): 495-499.

McCann, J.  1973.  Fish Toxicity Laboratory Report on Dowicide A, Test No. 640.  Unpublished data.  Conducted by the Animal Biology Laboratory, EPA-PR, ARC, Beltsville, MD.

Miller, D., B. B. Wheals, N. Beresford, and J. P. Sumpter.  2001.  Estrogenic Activity of Phenolic Additives Determined by an In Vitro Yeast Bioassay.  Environ Health Perspec 109(2); 133-38.

Routledge, E. J., and J. P. Sumpter.  1997.  Structural Features of Alkylphenolic Chemicals Associated with Estrogenic Activity.  J Biol Chem 272(6): 3280-88.

Schmeider, P.K., M.A. Tapper, J.S. Denny, R.C. Kolanzyk, B.R. Sheedy, T.R. Henry, and G. D. Veith.  2004.  Use of Trout Liver Slices to Enhance Mechanistic Interpretation of Estrogen Receptor Binding for Cost-Effective Prioritization of Chemicals within Large Inventories.  Environ. Sci. Technol. 38: 6333-6342.

Schmeider, P., M. Tapper, A. Linnum, J. Denny, R. Kolanzyk,  and R. Johnson.  2000.  Optimization of a Precision-Cut Trout Liver Tissue Slice Assay as a Screen for Vitellogenin Induction:  Comparison of Slice Incubation Techniques.  Aquat. Toxicol. 49: 251-268.

Toxicology

  SEQ CHAPTER \h \r 1 Brunsman, L. 2005. Orthophenylphenol: Qualitative Risk Assessment Based on CDF(F-344)/BR Rat and B6C3F1 Albino Mouse Dietary Studies. May 19, 2005, TXR No. 0053394.

Bartels, M.J., McNett, D.A., Timchalk, C., Mendrala, A.L., Christenson, W.R., Sangha, G.K., Brzak, K.A., Shabrang, S.N. (1998): Comparative metabolism of ortho-phenylphenol in mouse, rat, and man. Xenobiotica 28(6): 579-594.

  SEQ CHAPTER \h \r 1 Kolachana, P. et al. (1991): Metabolism of phenylhydroquinone by prostaglandin (H) synthase: possible implications in o-phenylphenol carcinogenesis. Carcinogenesis 12(1): 145-149.

  SEQ CHAPTER \h \r 1 Niho, N et al. (2002): Dose- and time-response studies of sodium o-phenylphenate urinary bladder carcinogenicity in rats. Food and Chemical Toxicology 40: 715-722.

  SEQ CHAPTER \h \r 1 Ozawa, S. et al. (2000): Metabolic activation of o-phenylphenol to a major cytotoxic metabolite, phenylhydroquinone: role of human CYP1A2 and rat CYP2C11/CYP2E1. Xenobiotica 30(10): 1005-1017

  SEQ CHAPTER \h \r 1 Reitz, R.H. et al. (1983): Molecular mechanisms involved in the Toxicity of Orthophenylphenol and its Sodium salt. Chem.-Biol. Interactions 43: 99-119.

Department for Environment, Food, and Rural Affairs, Pesticide Safety Directorate (1993): Evaluation of Fully Approved or Provisionally Approved Products: Evaluation on 2-Phenyl Phenol.

Environmental Fate

Hazard Substances Databank (HSDB), A Database of the National Library of Medicine’s TOXNET System.

K. Verschwren, 1996; Handbook of Environmental Data on Organic Chemicals, 3rd.

Edition, Van Nostrand, NY,  pp 536

RC Gore et al.  J. Assoc. Official Analytical Chemists, 1971, Volume 54, pp 1042-82

J. Suzuki et al.;  Bull Environ Contam. Toxicol,  1990, Volume 45,  pp 512 and M.

Sarakha et al.;  Chemophere, 1989, volume 18, pp 1391)

L. Krumenacker, 1995; Kirk-Othmer Encyclopedia of Chem. And Technol., 4th Edition, John Wiley, NY, Volume 13, pp 1004

W.M Meylan, and PH Howard, 1993; Chemosphere, Volume 26, pp 2293.

AW Garrison, 1969 Analytical Studies of Textile Wastes, Presented to Division of Drinking Water/ Air/ Waste Chem. American Chemical Society)

TR Tallin, 1975; Polytech. Inst., Volume 390, pp 107

SJ Gonsior, J. Agri. Food Chem, 1984, Volume 34, pp 593

Human Exposure

Cinalli, Christina, et al. A Laboratory Method to Determine the Retention of Liquids on the Surface of Hands.  Exposure Evaluation Division. September 1992.

National Institute for Occupational Safety and Health (NIOSH): Criteria for a Recommended Standard-Occupational Exposure to Metalworking Fluids.  Department of Health and Human Services (DHHS) NIOSH Publication #98-102 (1998).

WEBSITES

Dietary

FDA, 2003a.  “Guidance For Industry: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations.  Final Guidance.” April, 2003.    HYPERLINK http://www.cfsan.fda.gov/~dms/opa2pmnc.html. http://www.cfsan.fda.gov/~dms/opa2pmnc.html.   Last accessed June 9, 2003.

FDA, 2003b.  “Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions.”  January, 1993.    HYPERLINK http://www.cfsan.fda.gov/~dms/opa-cg3a.html. http://www.cfsan.fda.gov/~dms/opa-cg3a.html.   Last accessed June 9, 2003

EcoTox

Addinsoft, 2004.  XLSTAT v7.5.    HYPERLINK "http://www.xlstat.com"  http://www.xlstat.com .

Toxicology

IPCS, 1999: Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment: 2-phenylphenol and its sodium salt. Available at:   HYPERLINK "http://www.inchem.org/documents/jmpr/jmpmono/v99pr08.htm"  www.inchem.org/documents/jmpr/jmpmono/v99pr08.htm

Human Exposure

SIMetric, 2005.  Mass, Weight, Density, or Specific Gravity of Bulk Materials.    HYPERLINK "http://www.simetric.co.uk/si_materials.htm"  http://www.simetric.co.uk/si_materials.htm  , last accessed June 2005.

Whatman, 2005.  Whatman Absorbent Sinks.    HYPERLINK "http://www.whatman.com/products/?pageID=7.32.42"  http://www.whatman.com/products/?pageID=7.32.42  , Accessed March 2005.

INTERNAL DOCUMENTS

Dietary

EPA, 1997.  “Exposure Factors Handbook, Volume III: Activity Factors.”  EPA/600/P-95/002Fc August 1997.

EPA, 1999.  “Available Information on Assessing Exposure from Pesticides, A User’s Guide.”     HYPERLINK http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf.  Last accessed June 9, 2003.

Human Exposure

USEPA.  1997.  Standard Operating Procedures (SOPs) for Residential Exposure Assessments.  EPA Office of Pesticide Programs(Human Health Effects Division (HED). Dated December 18, 1997.

USEPA.  1997a.  Exposure Factors Handbook. Volume I-II.  Office of Research and Development.  Washington, D.C.  EPA/600/P-95/002Fa.

USEPA 1997b. Risk Analysis for Microban Additive (B( (Triclosan or Irgason DP300) Treated Toys for Infants. Memorandum from Winston Dang, USEPA to Frank Sanders and William Jordan, USEPA.  Dated February 27, 1997.

USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from the Pesticide Handler Exposure Database Version 1.1.   Washington, DC:  U.S. Environmental Protection Agency.

USEPA.  1999.  Evaluation of Chemical Manufacturers Association Antimicrobial Exposure Assessment Study.  Memorandum from Siroos Mostaghimi, Ph.D., USEPA, to Julie Fairfax,

USEPA.  Dated November 4, 1999.  DP Barcode D247642. (HED(s Science Advisory council for Exposure Policy #009.  Agricultural Default Daily Acres Treated.  April 1, 1999).

USEPA.  2000.  Residential SOPs.  EPA Office of Pesticide Programs(Human Health Effects Division. Dated April 5, 2000.

USEPA.  2001.  HED Science Advisory Council for Exposure. Policy Update, November 12.  Recommended Revisions to the Standard Operating Procedures (SOPs) for Residential Exposure Assessment, February 22, 2001.

Environmental Fate

USEPA, A. Najm Shamim, and Kathryn Montague,  2005 (memorandum); Review on the

Determination of the Leaching Rate of NA-OPP From Wood Following A Simulated

Sapstain Treatment (DP Bar Code: 319656)

Appendix E. Generic Data Call-In

The Agency intends to issue a Generic Data Call-In at a later date.   XE "VI. Appendices:E. Generic Data Call-In"  Appendix F. Product Specific Data Call-In

The Agency intends to issue a Product Specific Data Call-In at a later date.

Appendix G.  ANTIMICROBIAL DIVISION'S BATCHING OF PRODUCTS CONTAINING Phenylphenol and Salts AS THE ACTIVE INGREDIENT FOR MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION

	In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregistration of products containing any of the active ingredients in the Reregistration Case Phenylphenol and Salts, the Agency has batched products which can be considered similar for purposes of acute toxicity.  Factors considered in the sorting process include each product's active and inert ingredients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling (e.g., signal word, use classification, precautionary labeling).  Note that the Agency is not describing batched products as "substantially similar," since they may not have similar use patterns.

	Using available information, batching has been accomplished by the process described in the preceding paragraph.  Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product should the need arise.

	Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute toxicological studies to represent all the products within that batch.  It is the registrants' option to participate in the process with all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute toxicological studies for each of their own products.  If a registrant chooses to generate the data for a batch, he/she must use one of the products within the batch as the test material.  If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by today's standards (see partial list of acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission and acceptance of the acute toxicity data.  The Agency must approve any new or canceled formulations (that were presented to the Agency after the completion of the RED) before data derived from them can be used to cover other products in a batch.  Regardless of whether new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration Number.  If more than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF.

	In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-In Notice and its attachments appended to the RED.  The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90 days of receipt.  The first form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product.  The second form, "Requirements Status and Registrant's Response," lists the product specific data required for each product, including the standard six acute toxicity tests.  A registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend on someone else to do so.  If a registrant supplies the data to support a batch of products, he/she must select one of the following options:  Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6).  If a registrant depends on another's data, he/she must choose among:  Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6).  If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6.  However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies.

	If a registrant would like to have the batching status of a product reconsidered, he/she needs to submit detailed information on the product, including a detailed rationale for the inclusion of the product into a batch.  An MSDS for each "inert" ingredient should be included where possible.  However, registrants and manufacturers should realize that the more unusual their formulation is, the less likely it is to be able to batch that product.

	119 products were found which contain o-phenylphenol or one of its salts as an active ingredient.  These products have been placed into 22 batches and a "No Batch" category in accordance with the active and inert ingredients and type of formulation.  Any product in a batch may cite new or previously submitted acute toxicity data (if it meets current Agency standards) from any other product in the same batch, except as specified below:

•	In Batch 1, Reg. Nos. 39967-20 and 40510-5 each must cite its own eye irritation study.

•	In Batch 2, each product must cite its own data or data conducted on Reg. No. 464-78, 464-616, or 39967-24.

•	In Batch 3, each product must cite its own data or data conducted on Reg. No. 464-656 or 57227-7.

•	In Batch 4, each product must cite its own eye irritation and skin irritation studies.

•	In Batch 5, each product must cite its own data or data conducted on Reg. No. 64864-54.

•	In Batch 9, each product must cite its own data or data conducted on Reg. No. 3862-178.

•	In Batch 10, each product must cite its own data or data conducted on Reg. No. 303-225.

•	In Batch 11, each product must cite its own data or data conducted on Reg. No. 66171-1.

•	In Batch 12, each product must cite its own data or data conducted on Reg. No. 211-25.

•	In Batch 13, each product must cite its own data or data conducted on Reg. No. 3862-179.

•	In Batch 14, for eye irritation data, each product must cite its own study or a study conducted on Reg. No. 70263-7.

•	In Batch 15, each product must cite its own eye irritation study.

•	In Batch 19, each product must cite its own eye irritation study.

•	In Batch 20, each product must cite its own eye irritation study.

•	In Batch 21, each product must cite its own data or data conducted on Reg. No. 70263-2.

•	In Batch 22, each product must cite its own data or data conducted on Reg. No. 70263-1.

	In the No Batch category, each product must cite its own data.  I.e., registrants of these products may only cite data obtained from the specific product itself to support the acute toxicity data requirements for that product.

	If a product can be assumed corrosive to the skin or has pH less than 2 or greater than 11.5, then if the registrant requests a data waiver for eye or skin irritation (or both), the study can be waived.  Acute Toxicity Category I will then be assigned for eye or skin irritation (or both), and the applicable precautionary wording (including the signal word DANGER) will be required on the product label.

Batch 1	EPA Reg. No.	% Active Ingredient

	464-70	o-Phenylphenol   99.5

	464-126	o-Phenylphenol   99.5

	39967-3	o-Phenylphenol   99.9

	39967-11	o-Phenylphenol   99.9

	39967-20*	Sodium o-phenylphenate   99

	40510-5*	Sodium o-phenylphenate   97

	49403-21	o-Phenylphenol   99.5

*Reg. Nos. 39967-20 and 40510-5 each must cite its own eye irritation study.

Batch 2	EPA Reg. No.	% Active Ingredient

Each Batch 2 product must cite its own data or data conducted on Reg. No. 464-78, 464-616, or 39967-24.	464-78	Sodium o-phenylphenate   71.7

	464-616	o-Phenylphenol   63

	39967-24	Sodium o-phenylphenate   71.7

	39967-45	Potassium o-phenylphenate   55.6

Batch 3	EPA Reg. No.	% Active Ingredient

Each Batch 3 product must cite its own data or data conducted on Reg. No. 464-656 or 57227-7.	464-656	Sodium o-phenylphenate   25.3

	1022-564	Sodium o-phenylphenate   23

	39967-23	Sodium o-phenylphenate   20

	57227-1	Sodium o-phenylphenate   23

	57227-7	Sodium o-phenylphenate   22.6

	67869-24	Sodium o-phenylphenate  20

Batch 4	EPA Reg. No.	% Active Ingredient

Each Batch 4 product must cite its own eye and skin irritation studies. 2792-28	Sodium o-phenylphenate   14.5

	2792-32	Sodium o-phenylphenate   14.5

Batch 5	EPA Reg. No.	% Active Ingredient

Each Batch 5 product must cite its own data or data conducted on Reg. No. 64864-54.	33354-2	Sodium o-phenylphenate   14.15

	64864-45	Sodium o-phenylphenate   13

	64864-54	Sodium o-phenylphenate   14.52

Batch 6	EPA Reg. No.	% Active Ingredient

	6836-252	o-Phenylphenol   9.5

o-Benzyl-p-chlorophenol   9.5

	70627-6	o-Phenylphenol   10.5

o-Benzyl-p-chlorophenol   10.5

Batch 7	EPA Reg. No.	% Active Ingredient

	1043-87	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

	1043-114*	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

	1043-115	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

	1043-117	p-tert-Amylphenol   7.66

o-Phenylphenol   9.09

*Not including "Enzyme Presoak" component.

Batch 8	EPA Reg. No.	% Active Ingredient

	1043-91	o-Phenylphenol   7.7

p-tert-Amylphenol   7.6

	1043-92	o-Phenylphenol   7.7

p-tert-Amylphenol   7.6

Batch 9	EPA Reg. No.	% Active Ingredient

Each Batch 9 product must cite its own data or data conducted on Reg. No. 3862-178.	3862-178	o-Benzyl-p-chlorophenol   6.5

p-tert-Amylphenol   10

o-Phenylphenol   6

	3862-180	o-Benzyl-p-chlorophenol   5.06

p-tert-Amylphenol   7.78

o-Phenylphenol   4.67

Batch 10	EPA Reg. No.	% Active Ingredient

Each Batch 10 product must cite its own data or data conducted on Reg. No. 303-225.	303-223	o-Benzyl-p-chlorophenol   5.32

p-tert-Amylphenol   1.81

o-Phenylphenol   3.55

	303-225	o-Benzyl-p-chlorophenol   10.6

p-tert-Amylphenol   3.62

o-Phenylphenol   7.06

Batch 11	EPA Reg. No.	% Active Ingredient

Each Batch 11 product must cite its own data or data conducted on Reg. No. 66171-1.	66171-1	o-Benzyl-p-chlorophenol   6

p-tert-Amylphenol   4

o-Phenylphenol   11

	66171-2	o-Benzyl-p-chlorophenol   3

p-tert-Amylphenol   2

o-Phenylphenol   5.5

 Batch 12	EPA Reg. No.	% Active Ingredient

Each Batch 12 product must cite its own data or data conducted on Reg. No. 211-25.	211-25	Potassium o-benzyl-p-chlorophenate   8.03

Potassium p-tert-Amylphenate   4.3

Potassium o-Phenylphenate   6.28

	211-36	Sodium o-benzyl-p-chlorophenate   4.4

Sodium p-tert-Amylphenate   2.49

Sodium o-Phenylphenate   2.82

Batch 13	EPA Reg. No.	% Active Ingredient

Each Batch 13 product must cite its own data or data conducted on Reg. No. 3862-179.	2212-17	o-Benzyl-p-chlorophenol   3.8

p-tert-Amylphenol   3.74

o-Phenylphenol   2.35

	3862-179	o-Benzyl-p-chlorophenol   3

p-tert-Amylphenol   5.25

o-Phenylphenol   3

Batch 14	EPA Reg. No.	% Active Ingredient

For eye irritation data, each Batch 14 product must cite its own study or a study conducted on Reg. No. 70263-7.	49403-6 o-Benzyl-p-chlorophenol   5

p-tert-Amylphenol   1.25

o-Phenylphenol   4.25

	70263-7	o-Benzyl-p-chlorophenol   4.9

p-tert-Amylphenol   1.2

o-Phenylphenol   4.02

Batch 15	EPA Reg. No.	% Active Ingredient

Each Batch 15 product must cite its own eye irritation study.	706-69 Ethanol   49.95

p-tert-Amylphenol   .045

o-Phenylphenol   .176

	1270-237	Ethanol   66.825

p-tert-Amylphenol   .054

o-Phenylphenol   .216

	3862-104	p-tert-Amylphenol   .02

o-Phenylphenol   .08

	7405-51	Ethanol   53.72

p-tert-Amylphenol   .03

o-Phenylphenol   .1

	10088-104	Ethanol   53.46

p-tert-Amylphenol   .044

o-Phenylphenol   .176

	10088-105	Ethanol   69

p-tert-Amylphenol   .058

o-Phenylphenol   .249

	10807-177	Ethanol   61.348

p-tert-Amylphenol   .045

o-Phenylphenol   .177

	10807-178	Ethanol   67

p-tert-Amylphenol   .045

o-Phenylphenol   .177

	44446-67	Ethanol   53

p-tert-Amylphenol   .046

o-Phenylphenol   .199

Batch 16	EPA Reg. No.	% Active Ingredient

	55195-3	Glutaraldehyde   .275

p-tert-Amylphenol   .0027

o-Phenylphenol   .0137

	55195-4	Glutaraldehyde   .275

p-tert-Amylphenol   .0028

o-Phenylphenol   .0138

Batch 17	EPA Reg. No.	% Active Ingredient

	46851-5	o-Phenylphenol   .28

o-Benzyl-p-chlorophenol   .03

	46851-10	o-Phenylphenol   .28

o-Benzyl-p-chlorophenol   .03

Batch 18	EPA Reg. No.	% Active Ingredient

	211-32	o-Phenylphenol   .21

Ethanol   69.623

	56392-2	o-Phenylphenol   .12

Ethanol   66.6

	56392-4	o-Phenylphenol   .12

Ethanol   69.1

Batch 19	EPA Reg. No.	% Active Ingredient

Each Batch 19 product must cite its own eye irritation study.	11694-98 o-Phenylphenol   .19

Ethanol   68

	11694-99	o-Phenylphenol   .19

Ethanol   68

Batch 20	EPA Reg. No.	% Active Ingredient

Each Batch 20 product must cite its own eye irritation study.	498-134 o-Phenylphenol   .1

Ethanol   63.2

	498-194	o-Phenylphenol   .1

Ethanol   63.2

Batch 21	EPA Reg. No.	% Active Ingredient

Each Batch 21 product must cite its own data or data conducted on Reg. No. 70263-2.	70263-2	o-Phenylphenol  .22

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride monohydrate   .7

N-Octyl bicycloheptene dicarboximide   .33

Piperonyl butoxide   .2

Pyrethrins   .1

Bromine   .04

	70263-3	o-Phenylphenol   .22

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride monohydrate   .7

N-Octyl bicycloheptene dicarboximide   .33

Piperonyl butoxide   .2

Pyrethrins   .1

Batch 22	EPA Reg. No.	% Active Ingredient

Each Batch 22 product must cite its own data or data conducted on Reg. No. 70263-1.	70263-1	o-Phenylphenol   .22

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride monohydrate   .7

Bromine   .04

	70263-5	o-Phenylphenol   .22

Diisobutylphenoxyethoxy ethyl dimethyl benzyl ammonium chloride monohydrate   .7

No Batch	EPA Reg. No.	% Active Ingredient

Each

“No Batch” product must cite its own data.	211-62	o-Phenylphenol   8.085

o-Benzyl-p-chlorophenol   6.65

	498-180	o-Phenylphenol   .1

Isopropanol   55

	675-19	o-Phenylphenol   2.8

o-Benzyl-p-chlorophenol   2.7

	675-21	o-Phenylphenol   15

p-tert-Amylphenol   6.3

	675-43	o-Phenylphenol   10.63

o-Benzyl-p-chlorophenol   5.11

	777-27	o-Phenylphenol   .42

	777-60	o-Phenylphenol   .78

Pine oil   15

	777-73	o-Phenylphenol   .07

	954-10	o-Phenylphenol   .41

Isopropanol   45.63

	954-13	o-Phenylphenol   1.65

o-Benzyl-p-chlorophenol   5

	1043-19	o-Phenylphenol   .041

o-Benzyl-p-chlorophenol   .077

p-tert-Amylphenol   .074

Ethanol   53.096

Alkyl* dimethyl benzyl ammonium chloride

*(60%C14, 30%C16, 5%C18, 5%C12)   .042

Alkyl* dimethyl ethylbenzyl ammonium chloride

*(50%C12, 30%C14, 17%C16, 3%C18)   .042

	1043-26	o-Phenylphenol   10

o-Benzyl-p-chlorophenol   8.5

p-tert-Amylphenol   2

	1043-118	o-Phenylphenol   .5

o-Benzyl-p-chlorophenol   6.4

p-tert-Amylphenol   3

	1677-128	o-Phenylphenol   1.5

o-Benzyl-p-chlorophenol   1.4

	1677-130	o-Phenylphenol   7.5

o-Benzyl-p-chlorophenol   7.4

	1677-157	o-Phenylphenol   3

o-Benzyl-p-chlorophenol   2.85

	2296-101	o-Phenylphenol   .05

	3862-177	o-Phenylphenol   12

o-Benzyl-p-chlorophenol   10

p-tert-Amylphenol   4

	4822-479	o-Phenylphenol   .1

Piperonyl butoxide   .25

Pyrethrins   .1

Permethrin   .2

	5741-6	o-Phenylphenol   6.13

	5741-22	o-Phenylphenol   .051

o-Benzyl-p-chlorophenol   .071

Ethanol   64

	6836-253*	o-Phenylphenol   4.75

o-Benzyl-p-chlorophenol   4.75

	8284-7	Sodium o-phenylphenate   .31

	8764-1	Sodium o-phenylphenate   25

	8764-16	Sodium o-phenylphenate   24

	8764-24	Sodium o-phenylphenate   1

	10145-3	o-Phenylphenol   10.95

	10145-4	o-Phenylphenol   3.92

	33176-5	o-Phenylphenol   .25

Ethanol   44.25

Alkyl* dimethyl benzyl ammonium chloride

*(50%C14, 40%C12, 10%C16)   .33

	33176-6	o-Phenylphenol   .1