United States Chemical Safety September 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Methyloxazolidines Registration Review: Final Work Plan September 2012Docket Number: EPA-HQ-OPP-2012-0007 'INWw.regulations.gov



## Methyloxazolidines Registration Review: Final Work Plan September 

## 2012

Case# 3095

Approved By:



### Date:

2 of 13Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

3 of 13 Methyloxazolidines Registration Review Team

Human Health & Environmental Effects William Hazel Jenny Tao Timothy Dole Jonathan Chen Srinivas Gowda James Breithaupt Zo ё Layton
Risk Management Seiichi Murasaki Lance Wormell

Office of General Counsel Philip Ross

________________________________________ Supporting documents for the Methyloxazolidines Ca se may be found in the registration review docket EPA-HQ-OPP-2012-0007 located on the internet at www.regulations.gov

.Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

4 of 13 Introduction This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of Methyl oxazolidines (Case 3095). Th e work plan includes the expected registration review timeline. The work plan also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document which was posted in the Methyloxazolidines registration review docket, a nd any other comments concerning the initial docket postings. The Summary Docu ment 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 Methyloxazolidines Preliminary Work Plan (PWP) (PC Code 114801) was published on March 28, 2012 and the 60-day comment period ended on May 29, 2012. The Preliminary Work Plan document is available on www.regul ations.gov docket numb er EPA-HQ-OPP-2012-0007.
The Methyloxazolidines Case (Case 3095) contains tw o active ingredients, 4,4- dimethyloxazolidine (DMO) (PC Code 114801) and 3,4,4-trimethyloxazolidine (PC Code 114802). DMO is the only active ingredient in the case with registered products. 3,4,4- trimethyloxazolidine was not supported during reregi stration and, because no currently registered products contain 3,4,4-trimethyloxazo lidine as an active ingredient, will not be addressed in this registration review.
The first product containing 4,4-Dimethyloxazo lidine (DMO) (PC Code 114801) as an active ingredient was registered in the United St ates in 1982. Currently, there are six products containing DMO as an active ingred ient registered with EPA. DM O is registered for use as a material preservative for protection against mi crobial deterioration a nd as a microbiocide and bacteriostat additive in indus trial processes and water system s. EPA does not maintain a tolerance or exemption from the requirement of a tolerance for residues for DMO. During registration review, the Agency will determine if any toleran ces or exemptions from the requirement of a tolerance are needed for registered uses.
DMO is rapidly hydrolyzed to formaldehyde (H CHO) and 2-amino-2-methyl-1-propanol (AMP, CAS No. 124-68-5) in water. Because EPA believes that DMO releases formaldehyde (HCHO) under certain conditions, this Registration Review al so addresses potential risks associated with formaldehyde exposure from DMO use. Produc ts containing formaldehyde as an active ingredient will be evaluated under Registrati on Review Case 0556. EPA’s formaldehyde RED is available in the formaldehyde public docket at http://www.regulations.gov in docket number EPA-HQ-OPP-2008-0121.Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

5 of 13 The Agency completed a Reregistration Eligibil ity Decision (RED) for 4,4-Dimethyloxazolidine in 1996.
Comments Received on the Preliminary Work Plan
The Agency received four sets of comments during the public commen t period on the initial docket, summarized below. In the PWP, the Ag ency solicited comments on specific topics: environmental justice, water body impairment, trade irritants, and structur e activity relationships. No comments or information were received du ring the public comment period concerning these issues.
The Dow Chemical Company (Dow), Troy Cor poration (Troy), Physicians Committee for Responsible Medicine (PCRM), and the FIFR A Endangered Species Task Force (FESTF) submitted comments regarding the data anticipated to be called in to support the registration review of DMO. More details of the comme nts and agency responses are provided in “Methyloxazolidines Environmental Effects and Fate Registration Revi ew Scoping Document - Office of Pesticide Program’s Response to Public Comments” and “4.4-Dimethyloxazolidine (DMO): Responses to the Human Hea lth Comments”, located in the docket.
Several commenters expressed concern about the work plan presentation of anticipated data requirements including additional formalde hyde studies. The Agency acknowledges the comments received on formaldehyde and has adjusted the anticipated data needs table to reflect that no new data on formaldehyde are required at this time, pending the Integrated Risk Information System (IRIS) response to the r ecommendations of the National Academy of Sciences (NAS) peer review of the formaldehyde re-assessment.

Several comments referred to available studies that might be used to satisfy requirements, and in the response to comments documents, the Agen cy outlined the clarification necessary (e.g., methodology, substance concentrations) be fore the studies can be updated.
The Agency has revisited the anticipated data ne eds and has refined the test substances for the studies necessary to complete the risk assessments required for this registration review. The work plan and timeline described in the PWP remain as they were presented initially. Further, this document makes final the work plan for the Me thyloxazolidines registra tion review process.
Anticipated Risk Assessments and Data Needs
The Agency will conduct a comprehensive ecologi cal risk assessment, including an endangered species risk assessment, for all uses of 4,4- Dimethyloxazolidine. The Agency will conduct a human health risk assessment. The Agency e xpects to require additi onal data for use in conducting the registration review for 4,4-Dimethyloxazolidine.
Ecological Risk Asse ssment Status and Anticipated Data Needs

• No ecological risk assessment has been performed for 4,4-Dimethyloxazolidine.

• The Agency anticipates the need to require th e following additional ecological data for use in conducting the registration review of 4,4-Dimethyloxazolidine.Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

6 of 13 850.3300 1 -- Activated Sludge Respiration Inhibition test 850.2100 1,2 -- Avian acute oral toxicity test 850.1075 1,3 -- Fish acute toxicity (freshwater) 850.1400 1,4 -- Fish early-life stage toxicity test (freshwater) 850.1010 1,5 -- Aquatic invertebrate acute toxicity, freshwater daphnids 850.1300 1,5 -- Daphnid chronic toxicity test 850.1075 1 -- Fish acute toxicity (estuarine/marine) 850.1035 1 -- Mysid acute toxicity test 850.1025 1,6 -- Mollusk acute toxicity (shell deposition) 850.1055 1,6 -- Mollusk acute toxicity (embryo/larval) 850.1350 1,7 -- Mysid chronic tox - aquatic invertebrate life-cycle (saltwater) 850.4225 1 -- Seedling emergence, Tier II - rice 850.4400 1 -- Aquatic plant toxicology test using Lemna spp. 850.4500 1,8 -- Algal Toxicity Tier II – marine diatom, freshwater diatom, green algae 850.4550 1,8 -- Algal Toxicity Ti er II – Cyanobacteria

• The Agency anticipates the need to require th e following additional environmental fate data for use in conducting the registration review of 4,4-Dimethyloxazolidine. 835.1110 -- Activated Sludge Sorption Isotherm 835.4300 1 -- Aerobic aquatic metabolism 835.4400 1 -- Anaerobic aquatic metabolism 835.3110 1,9 -- Ready Biodegradability 835.3220 1,9 -- Porous Pot Test 835.3280 1,9 -- Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 835.3240 1,9 -- Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units

• For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Methyloxazolidines , located in the docket.

1 Results needed for the major degradate of concern, AMP.
2 Results needed using bobwhite quail.
3 Results needed using most sensitiv e species (i.e., bluegill sunfish).
4 Results needed using same species as used in acute toxicity test (i.e., bluegill sunfish).
5 Results needed using Daphnia magna

. 6 Only one mollusk acute toxicity study, either embryo/larv al or shell deposition, is anticipated to be required.
7 Results needed using Americamysis bahia

. 8 Since the opening of this docket, the Agency has posted the availability of Final Algal Toxicity guidelines. The Public 850.5400 guideline has been split and renumbered as 850.4500 Algal Toxicity and 850.4550 Cyanobacteria ( Anabaena flos-aquae ). http://www.epa.gov/ocspp/pubs/frs/publi cations/Test_Guidelines/series850.htm
9 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these four biodegradation tests would be anticipated to be required. If the ASRI test EC50 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 EC50 is greater than 20 mg/L, then the applicant would c hoose 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-2012-0007 www.regulations.gov

7 of 13 Human Health Risk Assessment Status and Anticipated Data Needs

• No human health risk assessment has been performed for 4,4-Dimethyloxazolidine.
Dietary Assessment

• Dietary (food) exposure to DMO or AMP could potentially occu r, since materials preserved with DMO could potentially cont act food directly or be used to manufacture food contact materials, leading to exposure to the pa rent compound and AMP. Dietary (food) risk assessments are expected to be necessary unless all use sites on all product labels are limited to nonfood contact.

• Material preservative uses of dimethyloxazolidine may lead to contamination of human and livestock drinking water through the discharge of wa ste water. Dimethyloxazolidine and/or its degradates could potentially pass through wastewater treatment plants (WWTPs). The contaminating substance is expected to be la rgely AMP (the stable hydrolytic and metabolic product of the parent compound). The Agency w ill determine the need for a dietary drinking water risk assessment following the submission a nd review of environmental fate data that are anticipated to be required.

Tolerances and Intern ational Harmonization

• EPA does not maintain a tolerance or exemption from the requirement of a tolerance for residues for DMO. During registration review, the Agency will determine if any tolerances or exemptions from the requirement of a to lerance are needed for registered uses.
Occupational and Residen tial Assessment and Risk

• Dimethyloxazolidine, AMP, and HCHO all pose potential worker dermal and inhalation exposure concerns during open- pour activities, painting, and metal-working. Detailed use information and results from exposure and small chamber studies are anticipated as being needed for use in estimating occupational exposure to DMO or its metabolites during manufacture of preserved mate rials and treatment and use of other liquids. Scenarios expected to be needed to be assessed include: (1) open-pour li quids during material preservation and oil field treatments, (2) usi ng treated metal-working fluids, and (3) painting with treated paints (Airle ss spray and brush/roller).

• Detailed use information and results from sma ll chamber studies are anticipated as needed for use in estimating residential exposure to DM O or its metabolites fr om materials preserved or treated with DMO (e.g., liquid soaps, fa bric cleaning and care products, water-based cleaning products, paints, adhe sives, printing supplies, polis hes, and textile emulsions). Scenarios expected to be needed to be assessed include: (1) usi ng treated surface cleaners and laundry detergents, (2) painting w ith treated paints (Airless spra y and brush/roller), and (3) toddlers playing on floors cleaned with treated surface cleaners.Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

8 of 13 Aggregate and Cumulative Exposure and Risk

• In examining aggregate exposure, EPA take s into account the available and reliable information concerning exposures to resi dues in food and drinking water, and nonoccupational pesticide exposures. If the result s of the environmental fate data that are anticipated to be required indica te that a drinking water asse ssment is necessary, then the Agency anticipates the need to conduct an ag gregate assessment for residential and dietary exposure to DMO and its residues of concern (AMP and HCHO).

• EPA does not have, at this time, available data to determine whether 4,4- Dimethyloxazolidine has a common mechanism of t oxicity with other substances or how to include this pesticide in a cumulative risk assessment.

• For the purposes of this Registratio n Review, EPA has assumed that 4,4- Dimethyloxazolidine does not ha ve a common mechanism of toxicity with other substances when used as an antimicrobial as registered.
Human Health Anticipated Data Needs

• The Agency anticipates the need to require the following additional human health data for use in conducting the registration review of 4,4-Dimethyloxazolidine.

870.3465 -- 90-day inhalation toxicity (rat) 870.4300 -- Combined chronic t oxicity/carcinogenicity 875.1100 10 -- Dermal outdoor exposure 875.1300 10 -- Inhalation outdoor exposure 875.1600 10 -- Application exposure data reporting and calculations 875.2300 11,12 -- Indoor surface residue dissipation 875.2500 13 -- Small Chamber Emissions 875.1700 -- Product use information Special Study-- Nature of Residue on Surfaces Special Study-- Migration Study

• For more information, please refer to Methyloxazolidines. Human Health Scoping Document for the Registration Review , located in the docket.

10 Exposure studies are anticipated as being needed for following scenarios: open-pour liquids for material preservation or oil-field treatments; application of preserved paints using brush/roller or airless sprayer; use of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners. If labels are amended to require closed mixing/loading, then any required exposure study for open-pour scenarios can be waived
11 Study is anticipated as being needed for following scenario: post-application exposure to floors and carpets cleaned with preserve d household cleaners.
12 If this anticipated study is required but is not conducted, a default transfer factor of 100% would be expected to be used.
13 Study is anticipated as being needed for the following scenario: post-application inhalation exposure to treated paints.Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

9 of 13 Product Chemistry Anticipated Data Needs

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

• For more information, please refer to Product Chemistry, Environmental Fate, and Ecological Effects Scoping Document in Support of Registration Review of Methyloxazolidines , located in the docket.

Incidents: Ecological:

• No 4,4-Dimethyloxazolidine ecol ogical incidents have been re ported in OPP’s Ecological Incident Information System (EIIS).

Human Health:

• No 4,4-Dimethyloxazolidine human poisoning in cidents have been reported in the OPP Incident Data System (IDS).
Endangered Species The Agency has not conducted a risk assessmen t that supports a complete endangered species determination for 4,4-Dimethyloxazolidine. Th e ecological risk assessment planned during registration review will allow the Agency to determine whether 4,4-Dimethyloxazolidine’s use has 'no effect' or 'may affect' federally listed thre atened or endangered species (listed species) or their designated critical habita ts. 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 Mari ne 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. A human health risk assessment identifying the most sensitive endpoints has not been conducted for the Me thyloxazolidines case. As requi red by FFDCA section 408(p), 4,4- Dimethyloxazolidine is subject 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 effectDocket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

10 of 13 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 scre en all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/dat a call-ins for the firs t group of 67 chemicals, which contains 58 pesticide activ e ingredients and 9 inert ingredients. 4,4-Dimethyloxazolidine is not among the group of 58 pesticide active ingred ients 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 scr eening assays for 4,4-Dimethyloxazolidine. For further information on the status of the EDSP, the policies and procedur es, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening batt ery, please visit our website: http://www.epa.gov/endo/.

Timeline
EPA has created the following estimated timelin e for the completion of the Methyloxazolidines registration review:
Anticipated Schedule Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket Completed March 2012

Close Public Comment Period for Docket Completed May 2012 Phase 2: Case Development Develop Final Work Plan (FWP) Completed September 2012 Issue DCI September 2013 Data Submission September 2015 Open Public Comment Period for Preliminary Risk Assessments March 2017 Close Public Comment Period for Preliminary Risk Assessments April 2017 Phase 3: Registration Review Decision Open Public Comment Period for Proposed Reg. Review Decision September 2017 Close Public Comment Period for Propos ed Reg. Review Decision November 2017 Final Decision and Begin Post -Decision Follow-up March 2018 Total (years) 6Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

11 of 13 Next Steps

A DCI will be developed regarding the data needs listed under the “Risk Assessments and Anticipated Data Needs” section of this document. The Agency expects to issue the DCI in September 2013. Human health and environmental fa te and ecological hazard assessments will be conducted for all uses.Docket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

12 of 13 Summary of Anticipated Data Requirements – 4,4-Dimethyloxazolidine

The table below summarizes anticipated data ne eds for the Methyloxazolidines Case in this document (Final Work Plan), Product Chemistry, Environmenta l Fate, and Ecological Effects Scoping Document in Support of Registra tion Review of Methyloxazolidines, and Methyloxazolidines. Human Health Scoping Document for the Registration Review.

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months from DCI Receipt)

850.3300 14 Activated Sludge Respiration Inhibition test AMP 24

850.2100 14,15 Avian acute oral toxicity test AMP 12

850.1075 14,16 Fish acute toxicity (freshwater) AMP 12

850.1400 14,17 Fish early-life stage toxicity test (freshwater) AMP 12

850.1010 14,18 Aquatic invertebrate ac ute toxicity, freshwater daphnids AMP 12

850.1300 14,18 Daphnid chronic toxicity test AMP 12

850.1075 14 Fish acute toxicity (estuarine/marine) AMP 12

850.1035 14 Mysid acute toxicity test AMP 12

850.1025 14 Mollusk acute toxicity (shell deposition) AMP 12

850.1055 14 Mollusk acute toxicity (embryo/larval) AMP 12

850.1350 14,19 Mysid chronic tox - aquatic invertebrate lifecycle (saltwater) AMP 12

850.4225 14 Seedling emergence, Tier II - rice AMP 12

850.4400 14 Aquatic plant toxicology test using Lemna spp. AMP 12

850.4500 14,20 Algal Toxicity Tier II -- marine diatom, freshwater diatom, green algae AMP 12

850.4550 14,20 Algal Toxicity Tier II – Cyanobacteria AMP 12
835.1110 Activated Sludge Sorption Isotherm TGAI 24

14 Results needed for the major degradate of concern, AMP.
15 Results needed using bobwhite quail.
16 Results needed using most sensitiv e species (i.e., bluegill sunfish).
17 Results needed using same species as used in acute toxicity test (i.e., bluegill sunfish).
18 Results needed using Daphnia magna

. 19 Results needed using Americamysis bahia

. 20 Since the opening of this docket, the Agency has posted the availability of Final Algal Toxicity guidelines. The Public 850.5400 guideline has been split and renumbered as 850.4500 Algal Toxicity and 850.4550 Cyanobacteria ( Anabaena flos-aquae ). http://www.epa.gov/ocspp/pubs/frs/publi cations/Test_Guidelines/series850.htmDocket Number: EPA-HQ-OPP-2012-0007 www.regulations.gov

13 of 13 835.4300 14 Aerobic aquatic metabolism AMP 24

835.4400 14 Anaerobic aquatic metabolism AMP 24

835.3110 14,21 Ready Biodegradability AMP 24

835.3220 14

, 21 Porous Pot Test AMP 24

835.3280 14,21 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater AMP 24

835.3240 14,21 Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units AMP 24

870.3465 90-day inhalation toxicity (rat) DMO 24
870.4300 Combined chronic toxicity/carcinogenicity DMO 48

875.1100 22 Dermal outdoor exposure DMO 24

875.1300 22 Inhalation outdoor exposure DMO 24

875.1600 22 Application exposure data reporting and calculations DMO 24

875.2300 23,24 Indoor surface residue dissipation DMO 24

875.2500 25 Small Chamber Emissions DMO 24

875.1700 Product use information DMO 12
Special Study Nature of Residue on Surfaces DMO 24
Special Study Migration Study DMO 24

21 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these four biodegradation tests would be anticipated to be required. If the ASRI test EC50 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 EC50 is greater than 20 mg/L, then the applicant would c hoose 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.
22 Exposure studies are anticipated as being needed for following scenarios: open-pour liquids for material preservation or oil-field treatments; application of preserved paints using brush/roller or airless sprayer; use of treated metalworking fluids; and trigger sprayer, wipe, and mop application of preserved cleaners. If labels are amended to require closed mixing/loading, then any required exposure study for open-pour scenarios can be waived
23 Study is anticipated as being needed for following scenario: post-application exposure to floors and carpets cleaned with preserve d household cleaners.
24 If this anticipated study is required but is not conducted, a default transfer factor of 100% would be expected to be used.
25 Study is anticipated as being needed for the following scenario: post-application inhalation exposure to treated paints.