United States Chemical Safety March 2011 Environmental Protection and Pollution Prevention Agency (7510P)



# p-chloro-m-cresol & sodium p-chloro-m-cresolate Summary Document Registration Review: Initial Docket March 2011Docket Numbers: EPA-HQ-OPP-2011-0071, EPA-HQ-OPP-2011-0073 www.regulations.gov



## p-chloro-m-cresol & 

## sodium p-chloro-m-cresolate Summary Document Registration Review: Initial Docket March 2011

Case # 

## 3046 & 

## 5011

Approved By:

oan Harrigan- relly Director, Antimicrobials Division

Date:



## rl

20f22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov


### TABLE OF CONTENTS

p-chloro-m-cresol and sodium p-chloro-m -cresolate Registra tion Review Team ...............4 I. Preliminary Work Plan .....................................................................................................5 II. Fact Sheet ......................................................................................................................12 III. Summary of Anticipated Data Requirements ..............................................................16 IV. Use Pattern Appendices ...............................................................................................17

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Please Note

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency's current position based on the following documents:

1. Summary of Product Chemistry, Environmenta l Fate, and Ecotoxicity Data for the pchloro-m-Cresol and Sodium p-chloro-m-Cresolate Registration Review Decision Document. March 11, 2011

2. Summary of Human Health Effects Data for the p-chloro-m-cresol and Sodium p-chlorom-cresolate Registration Review D ecision Document. February 18, 2011

Additional supporting documents may be found in the registration review docket EPA-HQ-OPP2011-0071 for the p-chloro-m-cresol Case and in the registration review docket EPA-HQ-OPP2011-0073 for the sodium p-chloro-m-cresolate Case, both located on the internet at www.regulations.gov

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p-chloro-m-cresol and sodium p-chloro-m -cresolate Registration Review Team

Human Health & Environmental Effects Nathan Mottl Srinivas Gowda

Risk Management Seiichi Murasaki Lance Wormell

Office of General Counsel Philip Ross

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I. Preliminary Work Plan -- p-chloro-m-cres ol and sodium p-chloro-m-cresolate

Introduction:

The Food Quality Protection Act (F QPA) of 1996 mandated a regist ration review program. All pesticides distributed or sold in the United St ates generally must be registered by the U.S. Environmental Protection Agency (USEPA, EPA, or the Agency ) based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The regist ration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet th e statutory standard of no unreas onable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency pe riodically reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/

. The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. The Agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the Agency’s opportunity to state whatit knows about the pesticide and what additional risk analyses and data or information it belie ves are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the p-chloro-m-cresol and sodium p-chloro-m-cresolate cases.

The current registration review cases include two chemicals: p-chloro-m-cresol (case 3046, PC Code 064206) and its salt, sodium p-chloro-m-c resolate (case 5011, PC Code 064205). Because sodium p-chloro-m-cresolate rapidl y protonates in water to form p-chloro-m-cresol, data will be bridged between sodium p-chloro-m-cresolate pr oducts and the technical product for p-chloro-mcresol.

The first product containing 4- chloro-3-cresol (p-chloro-m-cr esol or PCMC) (PC Code 064206) as an active ingredient was regi stered in the United States in 1968. Currently, there are three active products registered with EPA. PCMC is registered for use to control slime-forming bacteria, yeasts, and fungi in industrial preserva tives including oil recovery drilling muds/packer fluids, adhesives, coatings, emulsions, leathe r processing liquors and leather products, metal working fluids, and paints. PCMC has a use cl assification as a materi al preservative and currently does not have a pesticide tolerance or exemptions from the requirement of a tolerance. PCMC is cleared by the Food and Drug Administra tion (FDA) as an indirect food additive and formulated into adhesives (21 CFR 175.105), and paper and paperboard components (176.180,176.200, 176.210). The Agency completed a Reregistration Eligibility Decision (RED) for pchloro-m-cresol in 1996. Since the completion of the risk assessments for the RED, PCMC has been registered for disinfectant uses for industr ial, hospital, household, institutional, and hard surface disinfection. During registration review, th e Agency will determine if any tolerances or exemptions from the requirement of a toleran ce are needed for the registered uses.

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The first product containing sodium p-chloro-m -cresolate (Na PCMC) (PC Code 064205) as an active ingredient was registered in the United States in 2000. Current ly, there are six active products registered with EPA. Registered uses for Na PCMC ar e the same as uses of PCMC (i.e., Na PCMC is registered for use as a di sinfectant for industrial, hospital, household, institutional, and hard surface disinfection and as a material preserva tive to control slimeforming bacteria, yeasts, and fungi in oil rec overy drilling muds/packer fluids, adhesives, coatings, emulsions, leather pr ocessing liquors and leather produc ts, metal working fluids, and paints). Na PCMC currently does not have a pesticide tolerance or exemptions from the requirement of a tolerance. The Agency will determine if any tolerances or exemptions from the requirement of a tolerance are needed for regi stered uses of Na PCMC during registration review. The Agency did not identify any F DA clearances for Na PC MC. A RED was not completed for sodium p-chloro-m-cresolate beca use it was registered af ter November 1, 1984.

Documents associated with the registration revi ew of p-chloro-m-cresol can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2011-0071. Do cuments associated with the registration review of sodium p-chlo ro-m-cresolate can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2011-0073. Below is a summary of the issues relevant to the registration review cases.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessment, for all uses of p-chloro-m-cresol and sodium pchloro-m-cresolate. The Agency anticipates the n eed to conduct a human health risk assessment. The Agency anticipates needing additional data to conduct the registration review for p-chlorom-cresol and sodium p-chloro-m-cresolate.

Ecological Risk:

• No ecological risk assessments were performed for p-chloro-m-cresol or sodium pchloro-m-cresolate due to limited ind oor use patterns and low likelihood of environmental exposure. Because of the poten tial for environmental exposure if material preservatives pass through waste water trea tment plants (WWTPs) and are discharged into terrestrial and aquatic environments, the Agency will conduct ecological and environmental fate risk assessments for material preservative uses.

• The Agency has not conducted risk assessm ents that support a complete endangered species determination for p-chloro-m-cresol or sodium p-chloro-m-cresolate. The ecological risk assessments planned during re gistration review will allow the Agency to determine whether the use of p-chloro-m-creso l or sodium p-chloro-m-cresolate has 'no effect' or 'may affect' federall y listed threatened or endange red species (listed species) or their designated critical hab itats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated cr itical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

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• The Agency anticipates the need to require the following additional ecological data to conduct the registration review of p-chloro-m-cresol and sodium p-chloro-m-cresolate.

850.5400 -- Algal Toxicity Tier II us ing freshwater green alga, Selenastrum capricornutum

• The Agency anticipates the need to require the following additional environmental fate data to conduct the registra tion review of p-chloro-m-cresol and sodium p-chloro-mcresolate.

835.2120 -- Hydrolysis 835.2240 -- Photodegradation in water 850.6800 -- Modified activated sludge , respiration inhibition test 835.1110 -- Activated Sludge Sorption Isotherm 835.3110 -- Ready Biodegradability

• For more information, please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the p-chloro -m-Cresol and Sodium p- chloro-m-Cresolate Registration Review Decision Document , located in the docket.

Human Health Risk:

• Assessments to support sodium p-chloro-m-creso late’s initial regist ration in 2000 utilized the same toxicity, chemistry, and exposure data used in support of the p-chloro-m-cresol RED in 1996. Because the PCMC RED was pre-FQPA, the Agency expects new risk assessments will be necessary. Furthermore, risk assessments must be performed for the disinfectant and leather product uses for both p-chloro-m-cresol and sodium p-chloro-mcresolate.

• The Agency anticipates the need to require the following additional human health data to conduct the registration review of p-chloro-m-cresol and sodium p-chloro-m-cresolate.

870.3465 -- 90-day inhalati on toxicity (rat) 870.3700 -- Developmental t oxicity study (rabbit) 870.3800 -- Reproduction and fertility effects 875.1100 -- Dermal outdoor exposure 875.1200 -- Dermal indoor exposure 875.1300 -- Inhalation outdoor exposure 875.1400 -- Inhalation indoor exposure 875.1600 -- Application exposure data reporting and calculations 875.1700 -- Product use information 875.2300 -- Indoor surface residue dissipation 875.2500 -- Inhalation exposure 875.2700 -- Product use information 875.2900 -- Data reporti ng and calculations 875.3000 -- Nondietary ingestion exposure

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• For more information, please refer to Summary of Human Health Effects Data for the pchloro-m-cresol and Sodium p-chloro-m-cre solate Registration Review Decision Document , located in the docket.

Product Chemistry:

• The Agency does not anticipate the need to require additional product chemistry data for the registration review at this time.

• For more information, please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the p-chloro -m-Cresol and Sodium p- chloro-m-Cresolate Registration Review Decision Document , located in the docket.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. As part of its most recent re gistration decision, EPA re viewed these data and selected the most sensitive endpoi nts for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), p-chloro-m-cresol and sodium p-chloro-m-cresolate are subject to th e endocrine screening pa rt of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. P-chloro-mcresol and sodium p-chloro-m-cresolate are not among the group of 58 pesticide active ingredients on the initi al list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/dat a call-ins, requiring the submission of EDSP

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screening assays for p-chloro-m-cresol and sodium p-chloro-m-cresolate. For further information on the status of the EDSP, the polic ies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, pl ease visit our website: http://www.epa.gov/endo/

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Timeline

EPA has created the following estimated timelin e for the completion of the p-chloro-m-cresol and sodium p-chloro-m-creso late registration review:

Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket March 2011 Close Public Comment Period for Docket May 2011 Phase 2: Case Development Develop Final Work Plan (FWP) September 2011 Issue DCI September 2012 Data Submission September 2016 Open Public Comment Period for Prelim inary Risk Assessments March 2017 Close Public Comment Period for Preliminary Risk Assessments June 2017 Phase 3: Registration Review Decision Open Public Comment Period for Propos ed Reg. Review Decision September 2018 Close Public Comment Period for Proposed Reg. Review Decision December 2018 Final Decision and Begin Post-Decision Follow-up 2019 Total (years) 8

Guidance for Commenters: The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency will carefully consider all comments as well as any additional information or data provided in a timely manner prior to issuing a final work plan for the p-chloro-m-creso l and sodium p-chlorom-cresolate registration review cases.

Trade Irritants: Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern. Water Quality: P-chloro-m-cresol and sodium p-chloro-m-cresola te are not identified as causes of impairment for any water bodies listed as impaired under se ction 303(d) of the Clean Water Act, based on

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information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation_cy.cause_detail_303d?p_cause_group_id=885. In addition, no Total Maximum Daily Loads (TMDL) have been developed for p-chloro-mcresol or sodium p-chloro-m-cresola te, based on information provided at http://iaspub.epa.gov/tmdl_waters10/attains_ nation.tmdl_pollutant_de tail?p_pollutant_group_id =885&p_pollutant_group_name=PESTICIDES. More information on impaired wate r bodies and TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Revi ew Risk Assessment and Management Process (see: http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm ), in order to ensure the data can be used quantitatively or qual itatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to p-chloro -m-cresol or sodium p-chloro-m-cresolate compared to the general population. Please comme nt if you are aware of any sub-populations that may have atypical, unusually high expos ure compared to th e general population. Structure Activity Relationships: EPA must rely upon information of appropriate qual ity and reliability for each decision made by the Agency. In the Office of Pesticide Program s (OPP), the evaluation process for a pesticide chemical traditionally begins with the applicant’ s submission of a set of studies conducted with the specific pesticide chemical of interest. The use of the results of such testing (measured data) is a logical, scientifically rigorous proce ss that identifies the physical, chemical, and environmental fate properties of the pesticide, as well as the dose and endpoints at which an adverse effect can occur in various animal species. Today, there is significant interest in alternat ive techniques, i.e., tech niques other than data generation that could significantly inform th e Agency’s decision-making process. Recently, OPP has made increasing use of structure activity relationship (S AR) as part of its regulatory decision-making process. In the SAR process, a chemical's molecular structure is compared to that of other chemicals for which data are available. These structural similarities are then used to make predictive judgments about a chemical’s p hysical, chemical, and bi ological properties. Thus, the chemical’s physical, chemical, and biol ogical properties are a f unction of (or directly related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To develop a QSAR, a selected set of measured da ta on a single physical, chemical, or biological property is used to derive a model (an equatio n) to predict the valu e of that property. Since SAR assessments and QSAR modeling are anothe r set of tools that are available to Agency scientists, OPP has begun a proce ss shift that envisions shifting from the current study-by-study approach to an approach in which the use of pr edicted data, generated us ing validated models, is

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considered along with information from open litera ture and studies specifically generated under Part 161 requirements. All relevant information w ould be considered as pa rt of a weight-of-theevidence evaluation.
At this time, EPA believes that for certain e ndpoints, especially physi cal/chemical and fate properties, that SAR and QSAR might be effect ively utilized to fulfill these data requirements for many antimicrobial pesticide chemicals. Wh en considering biologica l properties, at this time, EPA believes that SAR and QSAR can be mo st effectively utilized in the evaluation of chemicals that exhibit lower toxicity for human h ealth and/or ecotoxicity parameters. This is appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a screening-level assessment procedure rather than multiple tiers of assessments with progressively more data requirements.

If stakeholders believe that submission of predic ted data can fulfill one of the data needs for the p-chloro-m-cresol or sodium p-chloro-m-cresola te cases, then the Agency invites submission of this information. The submitter would be expected to supply a rationale describing the utility of the information and provide documentation on the scientific validity of the information. The determination that the predicted data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission consultation with the Agency is encouraged.

Additional Information: Stakeholders are also specifically asked to provid e available information a nd data that will assist the Agency in refining its risk assessments, including any species-spec ific ecological effects determinations. The Agency is interested in receiving the following information:

1. Confirmation on the following label information:

a. Sites of application b. Formulations

c. Application methods and equipment d. Maximum application rates

e. Frequency of application, applicatio n intervals and maximum number of applications f. Geographic limitations on use 2. Use or potential use distribution 3. Use history 4. Usage/use information for non-agricultura l uses (e.g., materials preservation) 5. Typical application interval 6. State or local use restrictions 7. Ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian and mammalian mortalities) not already reported to the Agency 8. Monitoring data Next Steps: After the 60-day comment period closes in Ma y 2011, the Agency will review and respond to any comments received in a timely manner, and th en issue a Final Work Plan for the p-chloro-mcresol and sodium p-chloro-m-cresolate cases.

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II. Fact Sheet

Background Information - p-chloro-m-cresol:

• Active Ingredient: 4-chloro-3-cresol (p-chloro-m-cresol)

• Case number: 3046

• PC Code: 064206

• CAS number: 59-50-7

• Technical registrants: LANXESS Corporation

• First approved for use in a registered product: 1968

• PCMC has a use classification as a material preservative and curren tly does not have a pesticide tolerance or exemptions from the re quirement of a tolerance. PCMC is cleared by the Food and Drug Administration (FDA) as an indirect food additive and formulated into adhesives (21 CFR 175.105), and pa per and paperboard components (176.180, 176.200, 176.210). During registration review, the Agency will determine if any tolerances or exemptions from the require ment of a tolerance are needed for the registered uses.

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, murasaki.seiichi@epa.gov

• Antimicrobials Division Product Manager (P M): Jacqueline Campbell-McFarlane, campbell-mcfarlan e.jacqueline@epa.gov

• Chemical Structure:

Background Information - sodium p-chloro-m-cresolate:

• Active Ingredient: sodium p-chloro-m-cresolate

• Case number: 5011

• PC Code: 064205

• CAS number: 15733-22-9

• Technical registrants: LANXESS Corporation

• First approved for use in a registered product: 2000

• Na PCMC currently does not have a pestic ide tolerance or exemptions from the requirement of a tolerance. The Agency did not identify any FDA clearances for Na PCMC. The Agency will determine if a ny tolerances or exemptions from the requirement of a tolerance are needed for regi stered uses of Na PCMC during registration review.

• Antimicrobials Division Chemical Review Manager (CRM): Seiichi Murasaki, murasaki.seiichi@epa.gov

• Antimicrobials Division Product Manager (PM): Wanda Henson, henson.wanda@epa.gov

• Chemical Structure:

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Use & Usage Information:

• PCMC and Na PCMC are registered for use as disinfectants for industrial, hospital, household, institutional, and hard surface disinf ection and as material preservatives to control slime-forming bacteria , yeasts, and fungi in oil r ecovery drilling muds/packer fluids, adhesives, coatings, emulsions, leat her processing liquors and leather products, metal working fluids, and paints. Ecological Risk Assessment Status:

Please refer to Summary of Product Chemistry, Environm ental Fate, and Ecotoxicity Data for the p-chloro-m-Cresol and Sodi um p-chloro-m-Cresolate Re gistration Review Decision Document , located in the docket, for a detailed disc ussion of the ecological risk assessments.

• Toxicity studies indicate PCMC is slightly t oxic to birds, highly toxic to freshwater fish, and moderately toxic to aquatic invertebrates.

• Ecological and environmental fate risk asse ssments were not conducted on the currently registered use patterns. Mate rial preservatives may potenti ally pass through waste water treatment plants (WWTPs) and be discharged into terrestrial and a quatic environments. The Agency will conduct ecological and environm ental fate risk assessments for material preservative uses because of the potential for environmental exposure. To support the planned risk assessments during registrati on review, the Agency anticipates requiring additional environmental fate and toxicity data.

Human Health Risk Assessment Status:The following are key findings of the recent human health risk assessments for p-chloro-mcresol and sodium p-chloro-m-cresolate. Please refer to Summary of Human Health Effects Data for the p-chloro-m-cresol and Sodium p-chloro -m-cresolate Registra tion Review Decision Document , located in the docket, for a detailed discu ssion of the human health risk assessment.
Hazard Characterization:

• Since Na PCMC rapidly protonates in wate r to form PCMC, data , including toxicity studies, are bridged between Na PCMC products and the te chnical product for PCMC.

• PCMC exhibits low to moderate acute oral toxicity (toxicity category III and IV) based on acute oral and dermal studies in animals. PCMC was identified as corrosive to the eye and skin (Category I). Because PCMC is corrosive on skin and will, therefore, damage the sensitive respiratory mucosa if i nhaled, the rat inhalation study was waived.

• The carcinogenic potential of PCMC has been classified as Group D, not classifiable as to human carcinogenicity.

• Possible reproductive and deve lopmental effects resulting from chronic exposure to certain uses (e.g., metalworking fluids) will be examined in the planned risk assessments during registration review. Dietary (Food and Water):

• Although categorized for non-food use, the Ag ency anticipates th e need to conduct dietary exposure and risk assessments becau se of possible indirect dietary exposure

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resulting from migration of residues from pesticidal sources (e.g., adhesives, cements, coatings, food contact paper, a nd lubricant oils ) into food.

• The Agency will also assess potential acute and chronic indirect ingestion exposure estimates resulting from kitchen surf ace disinfectant and detergent uses.

• The Agency will determine the need for a dietary drinking water risk assessment following the submission and review of required environmental fate data.
Residential:

• Assessments of residential risk are planne d for registration review because potential exposure is expected through dermal, inhalati on, and incidental inge stion routes resulting from the use of treated paints, le ather, and household disinfectants. Aggregate:

• An aggregate risk assessment for PCMC/N a PCMC is needed to assess aggregate exposures from dietary sources (food and wate r), residential handler , and post-application exposures for paint. Occupational:

• Assessments of occupational risk are planne d for registration revi ew because potential exposure is expected through dermal and i nhalation routes during open-pour and mixing for materials preservation, oil recover y, leather production, and textile production. Dermal and inhalation exposure ar e also expected to result from the use of treated paints, disinfectants, and metal-working fluids.
Cumulative:

• EPA does not have, at this time, available data to determine whether PCMC/Na PCMC have common mechanisms of toxicity with other substances or how to include these pesticides in a cumulative risk assessment.

• For the purposes of this Registration Revi ew, EPA has assumed that PCMC/Na PCMC do not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.

Incidents: Ecological:

• No p-chloro-m-cresol or sodium p-chloro-m -cresolate ecological incidents have been reported in the Ecological In cident Information System (EIIS), maintained by the Environmental Fate and Effects Division (EFED) of the Agency.
Human Health:

• No p-chloro-m-cresol or sodium p-chloro-m -cresolate human poisoning incidents have been reported in the OPP Incident Data System (IDS).

Tolerances and International Harmonization:

• PCMC has a use classification as a material preservative and curren tly does not have a pesticide tolerance or exemptions from the re quirement of a tolerance. PCMC is cleared

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by the Food and Drug Administration (FDA) as an indirect food additive and formulated into adhesives (21 CFR 175.105), and pa per and paperboard components (176.180, 176.200, 176.210).

• Na PCMC currently does not have a pestic ide tolerance or exemptions from the requirement of a tolerance. The Agency did not identify any FDA clearances for Na PCMC.

• During registration review, the Agency will determine if any tolerances or exemptions from the requirement of a tolerance are n eeded for the registered uses of PCMC/Na PCMC.
Data Call-In Status:

• GDCI-064206-16860 was issued on Oct ober 31, 1991 and GDCI-064206-17313 was issued on September 18, 1993 for PCMC. Requirements for these DCIs have been fulfilled.

• There are no outstanding data call-in (DCI) require ments for Na PCMC.

• The studies identified in the da ta needs section of the curren t document are anticipated to be required to support the registratio n review of PCMC and Na PCMC.

Labels: Registered active products, including EPA registration numbers are provided in Tables 1 and 2 below. For future reference, during registration review a list of product registration numbers will be included in the docket. Produc t registration labels may be obt ained from the Pesticide Product Label System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home

. Table 1. Registered Active Products – p-chloro-m-cresol Registration # Registration Name Company Name Formulation Type % A.I.

39967-8 Preventol ® CMK P ara c hloro m eta c resol (PCMC) LANXESS Corporation Techni cal Chemical Solid 99.9

39967-9 Preventol ® WB LANXESS Corporation Soluble Concentrate 29.6
39967-12 Preventol ® CMK Preservative LANXESS Corporation End Use Product Pellets 99.9

Table 2. Registered Active Produc ts – sodium p-chloro-m-cresolate Registration # Registration Name Company Name Formulation Type % A.I.
39967-21 Preventol CMK-NA LANXESS Corporation Intermediate Solid MUP 71

39967-22 Preventol CMK-NA Preservative LANXESS Corporation Ready-to-Use Solid MUP 71

39967-25 Preventol CMK 40 LANXESS Corporation Soluble Concentrate MUP 46.13
39967-26 Preventol WB Plus LANXESS Corporation Soluble Concentrate 31.9

39967-27 Preventol CMK-NA Preservative Solution LANXESS Corporation Soluble Concentrate MUP 34.5

39967-46 Preventol CT-L LANXESS Corporation Soluble Concentrate 37.3

15 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov
III. Summary of Anticipated Data Requirements – p-chloro-m-cresol

The table below summarizes anticipated data needs for the p-chloro-m-cresol and sodium pchloro-m-cresolate cases in Section I of this document (Preliminary Work Plan), Summary of Product Chemistry, Environmental Fate, and Ecot oxicity Data for the p-chloro-m-Cresol and Sodium p-chloro-m-Cresolate Regi stration Review Decision Document , and Summary of Human Health Effects Data for the p-chloro-m-creso l and Sodium p-chloro-m-cresolate Registration Review Decision Document

. Table 3. Summary of Anticipated Data Requirements

Guideline Number Anticipated Data Requirement Test Material Est. Timeframe (from DCI Receipt in months)
835.2120 Hydrolysis TGAI 12
835.2240 Photodegradation in water TGAI 12

850.6800 Modified activated sludge, respiration inhibition test TGAI 12

835.1110 Activated Sludge Sorption Isotherm TGAI 12
835.3110 Ready Biodegradability TGAI 12

850.5400 Algal Toxicity Tier II using freshwater green alga, Selenastrum capricornutum TGAI 12

870.3465 90-day inhalation toxicity (rat) TGAI 24
870.3700 Developmental toxicity study (rabbit) TGAI 24
870.3800 Reproduction and fertility effects TGAI 48
875.1100 Dermal outdoor exposure TGAI 24
875.1200 Dermal indoor exposure TGAI 24
875.1300 Inhalation outdoor exposure TGAI 24
875.1400 Inhalation indoor exposure TGAI 24

875.1600 Application exposure data reporting and calculations TGAI 12

875.1700 Product use information TGAI 12
875.2300 Indoor surface residue dissipation TGAI 24
875.2500 Inhalation exposure TGAI 24
875.2700 Product use information TGAI 12
875.2800 Description of human activity TGAI 24
875.2900 Data reporting and calculations TGAI 12
875.3000 Nondietary ingestion exposure TGAI 24

16 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov
IV. Use Pattern Appendices Appendix A: Use Patterns – p-chloro-m-cresol

Reg. # Treatment Site / Surface App Method Max Application / Use Rate Use Limitations 39967-8 Industrial adhesives -- -- 39967-8 Leather -- -- 39967-8 Paper products -- -- Not for use in CA

39967-8 Textiles, fibers and cordage -- -- Not for use in CA 39967-8 Metalworking (cutting) fluids -- -- 39967-8 Industrial coatings -- -- Not for use in CA

39967-8 Resin, latex or polymer emulsions -- -- Not for use in CA 39967-8 General hard non-porous surfaces -- -- 39967-8 General hard non-porous surfaces -- --

39967-9 Leather Pour SALTED HIDES: Dilute 1:3 with water and pour onto the salt using a watering can and mix thoroughly; may also be sprayed onto the salt when using a mixer. At least 250-Kg raw hide can be satisfactorily preserved with 100 Kg of salt containing product. RAW HIDES: Add 300 - 500 g per m3 to the water to be used for soaking. PICKLED PELTS: Add 0.2 - 0.5% product, calculated on the weight of the pelts, to the salt solution. Running time approximately 10 minutes. Dilute with 2 - 5 parts water before use. WET BLUES: 0.2 - 0.3% product, based on pelt weight. VEGETABLE TANNAGE: Pit Tannage – Add 50- 100 g product per m3 to vegetable tan float Additions should be diluted 1:2 - 1:3 and should be added gradually while stirring or circulating the float. Drum Tannage - Add 0.3 - 0.5% product (diluted 1:2 - 1:5 and calculated on pelt weight) to vegetable tanning substance. 39967-9 Adhesives and glues -- Effective concentrations .15 - .55%

39967-9 Pigment slurries; materials in the building industry: joint cements, concrete, other materials & auxiliaries -- Effective concentrations .02 - .70%

39967-9 Metalworking (cutting) fluids -- Effective concentrations .1 - 4.0% 39967-9 Materials in the textile industries -- Effective concentrations .15 - .4%

39967-9 Materials in the paper industry: filler, rosin paper, starch slurries, other materials and auxiliaries -- Effective concentrations .15 - .4%

39967-9 Polishing and wax material; Protein solutions; Ceramic glazes; Fire extinguishing materials; -- Effective concentrations .15 - .5%

17 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov

Reg. # Treatment Site / Surface App Method Max Application / Use Rate Use Limitations Cleaning solutions, detergents 39967-12 Adhesives and glues -- Effective concentrations .05 - 1.0%.

39967-12 Joint cements; Polymer dispersions: emulsions -- Effective concentrations .05 - .2%.

39967-12 Leather -- Effective concentrations .1 - .4%.

39967-12 Lubricoolants and mineral oil based products -- Effective concentrations .05 - 6.0%.

39967-12 Materials in the printing industry: inks; fount solutions; printing pastes; other printing materials and auxiliaries -- Effective concentrations .05 - 0.3%.

39967-12 Materials in the building industry: bitumen emulsions; concrete additives; other building materials and auxiliaries -- Effective concentrations .15 - 0.4%.

39967-12 Materials in the coatings industry: dyestuff paste; knifing fillers and plastic putty; casein based coatings; paints; other auxiliaries and coating materials; synthetic resin dispersions -- Effective concentrations .05 - 0.4%.

39967-12 Materials in the paper industry: rosin paper sizes; filler suspensions and coating compounds; starch slurries; pigment slurries; other materials and auxiliaries -- Effective concentrations .05 - 0.3%.

39967-12 Materials in textile industry: spinning preparations; sizes and finishing agents; yarn humidifiers; printing thickeners (solid); printing thickeners (liquid); other materials and auxiliaries -- Effective concentrations .05 - 2.0%.

39967-12 Materials in the photo industry: gelatin; other materials and auxiliaries -- Effective concentrations .05 - 0.2%.

39967-12 Materials in the oil industry: biopolymers, solid (xanthan, starch, galactomannan, etc.); Biopolymers, liquid (drilling muds); other materials and auxiliaries -- Effective concentrations .05 - 2.0%.

39967-12 Materials and auxiliaries in the leather industry -- Effective concentrations 0.1 - 0.3%.

39967-12 Polishing and wax material; protein solutions; cleaning solutions, detergents; ceramic glazes; fire extinguishing materials; cosmetic and toiletry raw materials; industrial lubricants -- Effective concentrations .05 - 1.0%.

18 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov
Appendix B: Use Patterns – so dium p-chloro-m-cresolate Reg. # Treatment Site / Surface App Method Max Application / Use Rate Use Limitations

39967-21 Industrial, Hospital, Household, Institutional, and Hard Surface Disinfectants. Industrial, Hospital, Household, Institutional, and Hard Surface Disinfection. Industrial, Hospital, Household, Institutional, and Hard Surface Disinfection. Industrial Preservatives for Leather/Leather Products, Polymer/Resin/Latex Emulsions, Coatings, Paints, Specialty Industrial Products, Materials in the Building Industry (concrete additives/masonry and joint cements), Adhesives, Glues, Metalworking/Cutting Fluids, Materials in the Paper Industry (wet end additives, industrial processing chemicals), Textiles, Materials in the Photographic Industry, Thickeners (starch, cellulose, guar, etc.), Air Filter Oils, Starches, Clay Sl urries, Slurries, Printing Inks, Graphite, and Hard Surface Treatment Products (polishes, waxes, ceramic glazes).

39967-22 Animal and synthetic adhesives and glues Metered 0.15-2.00% by weight during manufacture

39967-22 Acrylic, Polyvinylacetate (PVA), Vinyl/Acrylic, Styrene Butadiene (SBR Latex) dispersons and emulsions Metered 0.15-0.40% by weight during manufacture

39967-22 Pickle solutions and pickled hides, Chrome leather (calculated on pelt weight), Leather pasting adhesives, Leather pigment finishes Metered 0.10-0.65% by weight during manufacture

39967-22 Straight oils (Mineral-oil based), Soluble oils (oil emulsions, aqueous), Semi-synthetic (emulsions, aqueous), Synthetic (solutions) Metered 0.08-0.50% by weight during manufacture

39967-22 Straight oils (Mineral-oil based), Soluble oils (oil emulsions, aqueous), Semi-synthetic (emulsions, aqueous), Synthetic (solutions) Metered 1.6-5.00% by weight during manufacture

39967-22 Inks, fount solutions, printing pastes, other related printing Metered 0.10-0.50% by weight during manufacture

19 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov

Reg. # Treatment Site / Surface App Method Max Application / Use Rate Use Limitations materials

39967-22 Joint cements, Concrete additives, other related materials Metered 0.15-0.65% by weight during manufacture

39967-22 Dyestuff paste, knifing fillers and plastic putty, casein based coatings, paints, other auxiliaries and coating materials, synthetic resin dispersions. Metered 0.15-0.65% by weight during manufacture

39967-22 Rosin paper sizes, filler suspensions and coating compounds, starch slurries, pigment slurries, other related materials and auxiliaries. Metered 0.10-0.50% by weight during manufacture

39967-22 Printing thickeners, yarn humidifiers, finishing agents and other related materials Metered 0.15-4.00% by weight during manufacture

39967-22 Solid Biopolymers (xanthan, starch, galactomannan, etc.), Liquid Biopolymers (drilling muds) Metered 0.15-4.00% by weight during manufacture

39967-22 Polishing and wax material Protein solutions Ceramic glazes Fire extinguishing materials Cleaning solutions, detergents Metered 0.15-0.50% by weight during manufacture

39967-22 (Kaolin-, Calcium carbonateTalcum-,lron oxide etc.), Kaolin slurries, Calcium carbonate slurries, Talcum slurries, Iron oxide slurries Metered 0.02-0.125% by weight during manufacture

39967-25 Animal and synthetic adhesives and glues Metered 0.25-0.90 % by weight during manufacture

39967-25 Acrylic, Polyvinylacetate (PVA), Vinyl/Acrylic, Styrene Butadiene (SBR Latex) dispersons and emulsions Metered 0.25-0.60% by weight during manufacture

39967-25 Pickle solutions and pickled hides, Chrome leather (calculated on pelt weight), Leather pasting adhesives, Leather pigment finishes Metered 0.25-1.00% by weight during manufacture

39967-25 Straight oils (Mineral-oil based), Soluble oils (oil emulsions, aqueous), Semi-synthetic (emulsions, aqueous), Synthetic (solutions) Metered 0.125-0.75% by weight during manufacture

39967-25 Straight oils (Mineral-oil based), Soluble oils (oil emulsions, aqueous), Semi-synthetic (emulsions, aqueous), Synthetic (solutions) Metered 2.5-15.0% by weight during manufacture

39967-25 Inks, fount solutions, printing pastes, other related printing Metered 0.25-0.75% by weight during manufacture

20 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov

Reg. # Treatment Site / Surface App Method Max Application / Use Rate Use Limitations materials

39967-25 Joint cements, Concrete additives, other related materials Metered 0.25-1.00% by weight during manufacture

39967-25 Dyestuff paste, knifing fillers and plastic putty, casein based coatings, paints, other auxiliaries and coating materials, synthetic resin dispersions. Metered 0.25-1.00% by weight during manufacture

39967-25 Rosin paper sizes, filler suspensions and coating compounds, starch slurries, pigment slurries, other related materials and auxiliaries. Metered 0.25-0.75% by weight during manufacture

39967-25 Printing thickeners, yarn humidifiers, finishing agents and other related materials Metered 0.25-0.60% by weight during manufacture

39967-25 Solid Biopolymers (xanthan, starch, galactomannan, etc.), Liquid Biopolymers (drilling muds) Metered 0.30-0.75% by weight during manufacture

39967-25 Polishing and wax material Protein solutions Ceramic glazes Fire extinguishing materials Cleaning solutions, detergents Metered 0.25-2.50% by weight during manufacture

39967-25 (Kaolin-, Calcium carbonateTalcum-,lron oxide etc.), Kaolin slurries, Calcium carbonate slurries, Talcum slurries, Iron oxide slurries Metered 0.03-0.20% by weight during manufacture

39967-26 Joint cements, Concrete additives, other related materials Metered 0.20-0.70% by weight during manufacture

39967-26 Pickle solutions and pickled hides, Chrome leather (calculated on pelt weight), Leather pasting adhesives, Leather pigment finishes Metered 0.2-1.00% by weight during manufacture product should be diluted 1:3 with water before incorporation.

39967-26 Soaking raw hides, Vegetable tannage Metered 50-500g per cubic meter product should be diluted 1:3 with water before incorporation.

39967-27 Animal and synthetic adhesives and glues Metered 0.35-1.20% by weight during manufacture

39967-27 Acrylic, Polyvinylacetate (PVA), Vinyl/Acrylic, Styrene Butadiene (SBR Latex) dispersons and emulsions Metered 0.35-0.80% by weight during manufacture

39967-27 Pickle solutions and pickled hides, Chrome leather (calculated on pelt weight), Leather pasting Metered 0.35-1.40% by weight during manufacture

21 of 22Docket Numbers: EPA-HQ- OPP-2011-0071, EPA- HQ-OPP-2011-0073 www.regulations.gov

22 of 22 Reg. # Treatment Site / Surface App Method Max Application / Use Rate Use Limitations adhesives, Leather pigment finishes

39967-27 Straight oils (Mineral-oil based), Soluble oils (oil emulsions, aqueous), Semi-synthetic (emulsions, aqueous), Synthetic (solutions) Metered 0.25-1.5% by weight during manufacture

39967-27 Straight oils (Mineral-oil based), Soluble oils (oil emulsions, aqueous), Semi-synthetic (emulsions, aqueous), Synthetic (solutions) Metered 4.00-15.0% by weight during manufacture

39967-27 Inks, fount solutions, printing pastes, other related printing materials Metered 0.35-1.00% by weight during manufacture

39967-27 Joint cements, Concrete additives, other related materials Metered 0.35-1.40% by weight during manufacture

39967-27 Dyestuff paste, knifing fillers and plastic putty, casein based coatings, paints, other auxiliaries and coating materials, synthetic resin dispersions. Metered 0.35-1.30% by weight during manufacture

39967-27 Rosin paper sizes, filler suspensions and coating compounds, starch slurries, pigment slurries, other related materials and auxiliaries. Metered 0.35-1.00% by weight during manufacture

39967-27 Printing thickeners, yarn humidifiers, finishing agents and other related materials Metered 0.35-0.80% by weight during manufacture

39967-27 Solid Biopolymers (xanthan, starch, galactomannan, etc.), Liquid Biopolymers (drilling muds) Metered 0.40-1.00% by weight during manufacture

39967-27 Polishing and wax material Protein solutions Ceramic glazes Fire extinguishing materials Cleaning solutions, detergents Metered 0.35-1.20% by weight during manufacture

39967-27 (Kaolin-, Calcium carbonateTalcum-,lron oxide etc.), Kaolin slurries, Calcium carbonate slurries, Talcum slurries, Iron oxide slurries Metered 0.05-0.30% by weight during manufacture

39967-46 Pickle solutions and pickled hides, Chrome leather (calculated on pelt weight), Leather pasting adhesives, Leather pigment finishes Metered 0.2-0.5% by weight during manufacture product should be diluted with 2 to 5 parts water before incorporation.