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



# o-Benzyl-p-Chlorophenol Registration Review: Final Work Plan December 2011Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov



### o-Benzyl-p-Chlorophenol Registration Review: Final Work Plan December 2011

Case # 2045

Approved By :

J an Harrigan-Farrelly

irector, Antimicrobials Division

Date: 

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### 15Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

3 of 15 o-Benzyl-p-Chlorophenol Registration Review Team

Human Health & Environmental Effects Nathan Mottl Najm Shamim

Risk Management Rebecca von dem Hagen Lance Wormell

Office of General Counsel Phil Ross

________________________________________ Supporting documents for the o-Benzyl-p-Chlorophe nol Case may be found in the registration review docket EPA-HQ-OPP-2011-0423 located on the internet at www.regulations.gov

.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

4 of 15 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of o-benz yl-p-chlorophenol (Case 2045). The work plan includes the expected registration review time line. The work plan also addresses public comments received concerning the Preliminary Wo rk Plan (PWP) in the Summary Document which was posted in the o-benzyl-p-chloropheno l registration review docket, and any other comments concerning the initial docket postings. The Summary Do cument provided information on what EPA knows about the pesticide and what additional risk analyses and data or information the Agency believes are needed to make a registration review decision.

The Agency is implementing the registration 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. Changes in science, public policy an d pesticide use practices will occur over time. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practi ces change, all registered pestic ides continue to meet that statutory standard. The public pha se of registration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/ registration_review/.

The o-Benzyl-p-Chlorophenol Case (Case Numb er 2045) includes three active ingredients, obenzyl-p-chlorophenol (PC Code 062201) and its salts, potassium o-benzyl-p-chlorophenol (PC Code 062202) and sodium o-benzyl-p-chloroph enol (PC Code 062203). The first product containing o-benzyl-p-chlorophenol as an active ingred ient was registered in the United States in 1948. Currently, there are 38 o-benzyl-p-chlorop henol, 3 potassium o-benzyl-p-chlorophenol, and 5 sodium o-benzyl-p-chlorophenol products registered with the EPA.

O-benzyl-p-chlorophenol and salts products are registered as disi nfectants, fungicides/fungistats, tuberculocides, sanitizers, viruci des, bacteriocides/bacteriostats, microbiocides/microbiostats and algaecides. O-benzyl-p-chlorophe nol and salts products are regist ered for use as hard non porous surface disinfectants and deodorizers in agricult ural premises and equipment, commercial, institutional and industrial premises, food hand ling processing equipment and premises, and residential and public access areas such as horse stables, meat and poul try processing plants, mushroom houses, greenhouses, households, and an imal kennels. O-benzyl-p-chlorophenol and salts are also registered for use as hard non porous surface disinfectant in medical areas and equipment such as non conductive floors, beds, wall and floors and to pre-clean instruments and other medical equipment prior to terminal steril ization. In addition, th e technical product is registered for use as a material preservative in metalworking fluids, rubber goods, leather, textiles, upholstery fabrics, and carpets. The technical product and two additional end-use products are registered for use in water treatmen t systems such as air washers, recirculating cooling water towers, sewage systems, greas e traps, drains, and human drinking water equipment. The material preservative uses are not listed on any end-use pr oduct labels. There is one sodium o-benzyl-p-chloropheno l end-use product registered fo r use in recirculating coolingDocket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

5 of 15 water systems and air washers. EPA has established tolerances under 40 CFR § 180.940(c) 1 for o-benzyl-p-chlorophenol’s use in food processing equipment and utensils not to exceed 320 ppm. FDA has cleared o-benzyl-p-chlor ophenol as an indirect additi ve in food contact sanitizing solutions (21 CFR §178.1010) that can be used fo r food processing equipment and utensils.

The o-benzyl-p-chlorophenol Preliminary Work Plan (PWP) was published on June 29, 2011 and the 60-day comment period ended on August 29, 2011. Documents associated with the registration review of o-benz yl-p-chlorophenol and salts can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2011-0423. The Agency completed a Reregistration Eligibility Decision (RED) for o-benzyl-p-chl orophenol and salts in 1995.

Comments Received on the Preliminary Work Plan

The Agency received two comments during the p ublic comment period on the initial docket, described below. One comment resulted in a change to the anticipa ted human health data requirements. Based on the comment submitte d by Physicians Committee for Responsible Medicine, the Agency intends to accept either a multigeneration or an extended one-generation reproduction and fertility effects study (870.3800) to support the risk assessments planned for registration review instead of a multigenera tion reproduction and fert ility effects study (870.3800), as discussed below. In the PWP, the Agency solicited commen ts on specific topics: environmental justice, water body impairment, trade irritants, and structure activity relationships. No comments or information were received du ring the public comment period concerning these issues.

Comment: The Physicians Committee for Responsible Medicine (PCRM) commented that conducting the special study for dermal sensitization antici pated as being required in the PWP “raises serious ethical and scientif ic concerns.” The commenters state that based on research, including a 1986 patch test, researchers found that “different doses of sensitizing substances in ge neral induce variable expressions in the human population, making the identification of a sensitization threshold that can pr otect all populations extremely difficult from human data, much less from the animal study the agency proposes to require.” Also, the commenter suggests the Agency utilize cell-based alternatives. They urge the Agency to re quest a Local Lymph Node Assay (LLNA) in place of the currently anticipated study because of the assay’s animal welfare advantages.

PCRM submitted multiple studies from the litera ture that could be utilized by the Agency for the anticipated Immunotoxicity ( 870.7800) and Multigeneration Reproduction and Fertility Effects (870.3800) st udies. If the studies on th e reproductive effects of obenzyl-p-chlorophenol do not satisfy the Multigeneration Reproduction and Fertility Effects data gap, the commenter argues that the effects will be evident in the first generation; therefore, a on e-generation test should be required instead of a multigeneration test.

1 Tolerance listed in 40 CFR § 180.940(c) is for Phenol, 4-chloro-2-(phenylmethyl)-, an alternative name for obenzyl-p-chlorophenol, CAS Reg. No. 120-32-1. This tolerance only applies only to o-benzyl-p-chlorophenol, not the potassium and sodium salts.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

6 of 15 Response: As noted in the Summary of Human Health Effects Data for the o-Benzyl-pChlorophenol (OBPC) Registratio n Review Decision Document ,, a dermal sensitization study using multiple concentrations of o-benz yl-p-chlorophenol is anticipated as being being required based on the us e of this chemical in textiles, upholstery fabrics, and carpets where repeated dermal contact will occur. This study is necessary for the planned human health risk assessment because ther e is a known positive dermal sensitization response observed in the traditional guinea pig test the Agency requires for all pesticide registrations. The available animal data do not establish a concentra tion to quantitatively assess dermal sensitization for human hea lth risk assessment. The published study of Stern et al. (1991) utilized mice in the ear swellin g assay, which is not an acceptable assay for the Agency to assess dermal sensitization. The Stern et al. study also utilized dermabrasion, which the Agency considers unacceptable in studies involving dermal application of test materials.

Currently, there are no validated in vitro or cell-based assays that the Agency can use to determine dermal sensitization potential or potency. The Local Lymph Node Assay (LLNA), which is stated in the OCSPP 870.2600 guideline as one of the acceptable assays for dermal sensitization assessment may not be appropriate for strong dermal irritants such as o-benzyl-p-chlorophenol, a nd also only measures the induction phase of dermal sensitization.

Based on a preliminary review of the 1986 human patch test study by Sonnex and Rycroft mentioned in PCRM's letter, the study does not provide sufficient information to fulfill the data requirement; therefore, the Agency continues to anticipate the need to require a quantitative dermal sensitization st udy. The Agency will consider all submitted information during the registrati on review risk assessments.

With respect to PCRM's comments on the immu notoxicity and reproduc tive toxicity data requirements, the Agency encourages the regi strants to submit these studies in response to the data call-in associated with this regi stration review. At that time, the Agency will review the information to determine if the requirements for immunotoxicity and reproductive toxicity data are ad equately met. The Agency agrees with PCRM that an extended one-generation reproductive and fertility effects study will provide the Agency with sufficient information to support the hum an health risk assessment planned for the o-benzyl-p-chlorophenol registration review. The Agency will accept a multigeneration or an extended one-generation reproductiv e and fertility effect s study (870.3800) The “Anticipated Human Health Data Needs” secti on in this FWP has been updated to reflect this change. .

Comment: The technical registrant of o-be nzyl-p-chlorophenol submitted a comment stating that the company intends to subm it a request for deletion of the material preservative use of o-benzyl-p-chlorophe nol in metalworking fluids, rubber goods, leather, textiles, upholstery fa brics and carpets. Lanxess beli eves that the removal of these uses will result in changes to the data requirements anticipated for this registration review. The registrant also believes th e need for the immunoxicity study currentlyDocket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

7 of 15 anticipated as required should be reevaluated and the registrant states that they would like to discuss this further with the Agency.

In addition, the registrant not ed that several of the da ta justifications in the Product chemistry, Environmental Fate and Eco-ef fects Scoping Document for Registration Review of: Ortho-Benzyl-Para-Chlo rophenol and Sodium and Potassium Salts state that the anticipated data is triggered by o-benzyl-p -chlorophenol’s use as a wood preservative. However, this chemical is not registered as a wood preservative.

Response: Upon receipt of the registrant’s request to terminate o-benzyl-p-chlorophenol’s use as a material preservative in metalwor king fluids, rubber goods, leather, textiles, upholstery fabrics and carpets, the Agency will initiate the use termination process pursuant to FIFRA Section 6(f). Should th ese use terminations become final and effective, the Agency expects that the an ticipated data needs will change. Until the Cancellation Order is complete, the Agency cont inues to anticipate the need to require the data as described in the PWP. The Agen cy is willing to discuss the anticipated immunotoxicity data requirement and encourages the registrant to request a meeting with the Agency.

In regards to the comment on the study justifications included in the Product chemistry, Environmental Fate and Eco-effects Scopi ng Document for Registration Review of: Ortho-Benzyl-Para-Chlorophenol and Sodium and Potassium Salts , the Agency has confirmed that o-benzyl-p-chlorophenol is no t registered for use as a wood preservative and that the references in th e Scoping Document were erro rs. The study justifications will be updated to reference th e correct uses that trigger the data requirements.

The comments did not affect the work plan and timeline described in the PWP and they remain as they were presented initially in the PWP. Further, this document makes final the work plan for the o-benzyl-p-chlorophenol registration review process.

Anticipated Risk Assessments 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 o-benzyl-p-chlorophenol and salts. The Agency anticipates the need to conduc t a human health risk assessment. The Agency anticipates needing additional data for use in co nducting the registration review for o-benzyl-pchlorophenol.

Ecological Risk Assessment Stat us and Anticipated Data Needs

 A quantitative environmental risk assessm ent was not performed for o-benzyl-pchlorophenol for the 1995 RED because at that time the Agency antici pated that potential release into the environment would be re gulated under the NPDES program and would not result in significant exposure to wildlife.

 The Agency anticipates the need to require the following additional ecological data for use in conducting the registration review of o-benzyl-p-chlorophenol and salts.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

8 of 15 850.1010 -- Aquatic invertebrate acute toxicity, freshwater daphnids 850.1025 -- Oyster acute toxicity test 2
850.1055 -- Bivalve acute tox la rval (embryo/larval) 2 850.1035 -- Mysid acute toxicity test 850.1300 -- Daphnid chronic toxicity test 850.1400 -- Fish early-life stage to xicity test (freshwater) 850.5400 -- Algal Toxicity Tier I an d Tier II (green algae) 850.1710 -- Aquatic Bioavailability/Bio magnification: Oyster BCF 850.1730 -- Aquatic Bioavailability/B iomagnification: Fish BCF

 The Agency anticipates the need to require the following additional environmental fate data for use in conducting the registration re view of o-benzyl-p-chlorophenol and salts.

835.2120 -- Hydrolysis 835.2240 -- Photodegradation in water 835.1110 -- Activated Sludge Sorption Isotherm 850.6800 – Modified activated sludge , respiration inhibition test 3 835.3110 -- Ready biodegradability 3
835.3220 -- Porous Pot Test 3
835.3280 -- Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 3
835.3240 -- Simulation Test - Aerobic Sewage Treatment: A. Activated Sludge Units 3 For more information, please refer to Revised Product chemistry, Environmental Fate and Eco-effects Sc oping Document for Registration Review of: Ortho-Benzyl-Para-Chlorophenol and Sodium and Potassium Salts , located in the docket.

Human Health Risk Assessment St atus and Anticipated Data Needs

 The most recent human health risk assessmen t for o-benzyl-p-chlorophenol and salts was completed in support of the 1995 RED.

Dietary Assessment

 The Agency anticipates the need to conduct a dietary (food) risk assessment for o-benzylp-chlorophenol based on indirect exposure to surface cleaners and a dietary (drinking water) assessment based on the potential fo r o-benzyl-p-chlorophe nol to pass through

2 The anticipated DCI will give registrants the option to undertake testing for either 850.1025 or 850.1055.
3 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant would choose to conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the an timicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

9 of 15 waste water treatment plants.

 A dietary risk assessment was not conducted for the 1995 RED because at that time the U.S. Department of Agriculture and the EP A determined that disinfectants requiring a potable water rinse, when a pplied to surfaces in federally inspected meat, poultry, and egg processing plants, do not present diet ary exposure risks (USDA, FSIS publication #1419, "List of Proprietary Substances a nd Nonfood Compounds"). EPA now conducts dietary risk assessments for disinfectant us es even when a potable rinse is employed. This decision is a result of recent behavioral research that supports that not all consumers carry out a potable water rinse. To further support the need for a dietary risk assessment, it has also been concluded that potab le water rinses are not effici ent at removing residues to a negligible level, and in fact remain on th e surface and may result in human exposure. This change is also a result of the 19 96 signing of the Food Quality Protection Act (FQPA).

Tolerances and Intern ational Harmonization

 EPA has established tolerances under 40 CFR § 180.940(c) 4 for o-benzyl-pchlorophenol’s use in food processing equi pment and utensils not to exceed 320 ppm. FDA has cleared o-benzyl-p-chlorophenol as an indirect additive in food contact sanitizing solutions (21 CFR §178.1010) that can be used for food processing equipment and utensils.

Occupational and Residen tial Assessment and Risk

 The Agency anticipates the need to conduct occupational and reside ntial human health risk assessments for the registration review of o-benzyl-p-chlorophenol. The Agency anticipates that occupationa l handler exposure may occu r through application of obenzyl-p-chlorophenol as disinfectant with a we t-mist fogger. Dermal and incidental oral postapplication exposure may also occur from children crawling on treated floors, or hand-to-mouth exposure from counter tops and floors.

 Occupational and occupational post-applic ation exposure risk assessments were performed for the 1995 RED.

 As a result of the 1995 RED, EPA intended to require application exposure data to confirm that application of o-benzyl-p-chlor ophenol in a fogging device would not pose unreasonable risks to workers through dermal or inhalation exposure. The Agency determined that until the data were receive d, full-face respiratory protection as well as complete dissipation of the mist and thor ough ventilation of the enclosed area before reentering a treated area would be specified for all o-benzyl-p -chlorophenol fogging products. Amended labels reflecting the label changes outlined in the RED were submitted by registrants along with the information required through the post-RED product-specific data call-in (P DCI); therefore, EPA reregister ed the products. However,

4 Tolerance listed in 40 CFR § 180.940(c) is for Phenol, 4-chloro-2-(phenylmethyl)-, an alternative name for obenzyl-p-chlorophenol, CAS Reg. No. 120-32-1. This tolerance only applies only to o-benzyl-p-chlorophenol, not the potassium and sodium salts.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

10 of 15 a post-RED generic data call-in for o-benz yl-p-chlorophenol was never issued and application exposure data have not yet been re quired. The Agency expects to require these data through registration review.

Aggregate and Cumulative Exposure and Risk

 The Agency has not conducted an aggregate risk assessment for o-benzyl-p-chlorophenol and salts.

 EPA does not have, at this time, availabl e data to determine whether o-benzyl-pchlorophenol has a common mechanism of toxi city with other substances or how to include this pesticide in a cumulative risk assessment. For the purposes of this Registration Review, EPA has assumed that o-benzyl-p-chlorophenol does not have a common mechanism of toxicity with other subs tances when used as an antimicrobial as registered.

Anticipated Human Health Data Needs

 The Agency anticipates the need to require the following additional human health data for use in the registration review of o-benzyl-p-chlor ophenol and salts.

Special Study -- Skin (dermal) sensitization 870.3465 -- 90-day inhalati on toxicity (rat) 870.3800 -- Reproduction and fertility effects (multigeneration or extended one- generation) - rat 870.7800 -- Immunotoxicity 875.1200 -- Dermal indoor exposure 875.1400 -- Inhalation indoor exposure 875.1600 -- Application exposure data reporting and calculations 875.1700 -- Product use information 875.2800 -- Description of human activity 875.2300 -- Indoor surface residue dissipation 875.2500 -- Inhalation exposure 875.3000 -- Nondietary ingestion exposure

 For more information, including information on the use patterns triggering each data requirement, please refer to Summary of Human Health Effe cts Data for the o-Benzyl-pChlorophenol (OBPC) Registratio n Review Decision Document , located in the docket.

Product Chemistry Data Needs

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

o For more information, please refer to Product chemistry, Environmental Fate and Eco-effects Scoping Document for Regist ration Review of: Ortho-Benzyl-ParaChlorophenol and Sodium and Potassium Salts , located in the docket.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

11 of 15 Incidents:

Ecological:

 There are no reported incidences in the Agen cy’s Ecological Incidence Information System (EIIS) regarding o-benzyl-p -chlorophenol and salts.

Human Health:

 The OPP Incident Data System (IDS) has repo rted 122 human incidents attributable to obenzyl-p-chlorophenol. Most of th e incidents are classified as moderate incidents. Severe dermal irritation and allergic type reactions were reported. The symptoms included skin depigmentation, itching, pain, swollen, blister, hives, and erythema. Reported symptoms related to inhalation exposures included nasa l irritation, ulcerated nasal membranes, burning throat, blisters in throat, hoarse coughing, s hortness of breath, coughi ng, dyspnea, chest pain, and chest tightness.

 Acute systemic effects for workers included nausea, dizziness, stomach ache, headache, vertigo, and soft stool. For longer exposures over 6-months, workers complained of no or low appetite, weakness, and liver damage. Seve re autoimmune thrombocytopenia, red skin rashes, nose/mouth bleeding, aplastic an emia and leukemia was also reported.

 One incident that raised a reproductive c oncern, involved a pregnant woman. The baby was born 6 weeks early with too much fluid in the abdomen. The baby died as a result.
Endangered Species

The Agency has not conducted a risk assessmen t that supports a complete endangered species determination for o-benzyl-p-chlorophenol and salts. The ecological risk assessment planned during registration review will allow the Agency to determine whether o-benzyl-p-chlorophenol and salts’ use has 'no effect' or 'may affect' federally listed threatened or endangered species (listed species) or their designated critical ha bitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

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 e ndpoints 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 the 1995 Reregist ration Eligibility Decision for o-benzyl-p-Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

12 of 15 chlorophenol and salts, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the exis ting hazard database. However, as required by FFDCA section 408(p), o-benzyl-p-c hlorophenol and salts are subjec t to the endocrine screening part 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 67 chemicals, which contains 58 pest icide active ingredients and 9 inert ingredients. O-benzyl-pchlorophenol and salts are not among the group of 58 pesticide active ingr edients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP screening assays for obenzyl-p-chlorophenol and salts. For further information on the st atus of the EDSP, the policies and procedures, the list of 67 chemicals, future li sts, the test guidelines and the Tier 1 screening battery, please visit our webs ite: http://www.epa.gov/endo/.

Timeline

EPA has created the following estimated time line for the completion of the o-benzyl-pchlorophenol registration review:

Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket Completed June 2011 Close Public Comment Peri od for Docket Completed August 2011 Phase 2: Case Development Develop Final Work Plan (FWP) Completed December 2011 Issue DCI December 2012 Data Submission December 2014 Open Public Comment Period for Preliminary Risk Assessments June 2016Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

13 of 15 Close Public Comment Period for Pre liminary Risk Assessments July 2016 Phase 3: Registration Review Decision Open Public Comment Period for Propos ed Reg. Review Decision December 2016 Close Public Comment Period for Proposed Reg. Review Decision February 2017 Final Decision and Begin Post-Decision Follow-up 2017 Total (years) 6

Next Steps

A DCI will be developed regarding the data needs listed under the “Anticipated Risk Assessments and Data Needs” section of this doc ument. The Agency expects to issue the DCI in December 2012. Human health and ecological risk assessments will be conducted for all uses.Docket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

14 of 15 Summary of Anticipated Data Requi rements – o-Benzyl-p-Chlorophenol

The table below summarizes anticipated data need s for the registration review of o-benzyl-pchlorophenol.

Table 1. Summary of Anticipated Data Requirements – o-Benzyl-p-Chlorophenol

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months from DCI Receipt)
Special Study Skin (Dermal) Sensitization TGAI 12

870.3465 90-day Inhalation Toxicity TGAI 24

870.3800 Reproduction and Fertility Effects (multigeneration or extended one-generation) TGAI 24

870.7800 Immunotoxicity TGAI 24
875.1200 Dermal Exposure – Indoor TGAI 24
875.1400 Inhalation Exposure - Indoor TGAI 24
875.1600 Data Reporting and Calculations TGAI 24

875.1700 Product Use Information (Handler) TGAI 12
875.2800 Product Use Information (Postapplication) TGAI 12
875.2300 Indoor Surface Residue Dissipation TGAI 12
875.2500 Inhalation Exposure TGAI 24
875.3000 Non-dietary Ingestion TGAI 12
835.2120 Hydrolysis TGAI 12
835.2240 Photodegradation in water TGAI 12
835.1110 Activated Sludge Sorption Isotherm TGAI 12

850.6800 Modified activated sludge, respiration inhibition
test 5 TGAI 12

5 The results of the Activated Sludge Respiration Inhibitio n Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant would choose to conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge UnitsDocket Number: EPA-HQ-OPP-2011-0423 www.regulations.gov

15 of 15

835.3110 Ready Biodegradability 5 TGAI 12

835.3220 Porous Pot Test 5 TGAI 12

835.3240 Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units 5 TGAI 12

835.3280 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 5 TGAI 12

850.1010 Aquatic invertebrate acute toxicity, freshwater daphnids TGAI 12

850.1025 Oyster acute toxicity test 6 or TGAI 12

850.1055 Bivalve acute tox larval 4 (embryo/larval) TGAI 12
850.1035 Mysid acute toxicity test TGAI 12
850.1300 Daphnid chronic toxicity test TGAI 18
850.1400 Fish early-life stage toxic ity test (freshwater) TGAI 18
850.5400 Algal Toxicity Tier I and Tier II (green algae) TGAI 12

850.1710 Aquatic Bioavailability/Biomagnification: Oyster BCF TGAI 18

850.1730 Aquatic Bioavailability/Biomagnification: Fish BCF TGAI 18

or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the an timicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.
6 The anticipated DCI will give registrants the option to undertake testing for either 850.1025 or 850.1055.