Docket Number EPA-HQ-OPP-20 14

- 0199 www.regulations.gov



## Bosca li d Preliminary Work Plan Registration Review : Initial Docket Case Number 7039
November 2014

Approve d by:

## :p Ric h ard P
. Ke igw in , Jr . Director Pes ti ci d e Re

- evalu ation Divi sion

D ate :

### Boscalid Preliminary Work Plan - Table of Contents

OVERVIEW
. .... . ... . ... .. .. .. .. .. .. .. .. ....... .. ...... .. .......... .. .... . .. .. .. .. . .. .. .. .. .. . .. .. .. ................ .. . ... . ..... .............. 4 ANTICIPATED DATA NEEDS
...................................................................... .. ................ .. .......... 5 STATUTORY AND REGULATORY AUTHORITY
.................................... . .............................. 6 CHEMICAL FACTS
.. ... .. .. ....................... .......... ... ......... . .......... .. ......... .. .. .. . .. ..... .. .. .. .. . .. .. ............... 7 USE AND USAGE INFORMATION
. .. ... .. ..'
........ .. .. ... . . ... ... ...................... .............. . ...................... 7 RECENT ACT IONS
.. .. ... . .. .. . . . .. .. .. .. .. .. .. .. ... . ... .. ... . .. .. .. .. .. .. . ... . .. .. .. .. .. .. .. . .. . .. .. .. .. . .. .. .. . .. .. .. .. . ... ............ 9 ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW
...... .. ..... .. .. .. . .. .. .. .. .. . 9 TIMELINE
.......................................................................................................................... .. .. .. .. .. 11 NEXT STEPS
............ .. .............. ... . .. .. ....... ...... ... ....... ........................................................ . ...... .. .. . 11 Appendix -Additional Areas Considered in the Boscalid Registration Review
......................... 12

References : This Preliminary Work Pl an summari zes the Environmental Protection Agency's current position based on the fo ll ow i ng documents:

1
. Registration Review: Problem Formulation for Environmental Fate, Ecological Risk , Endangered Species, and Human Health Drinking Water Exposure Assessments for Boscalid. Catherine Aubee , Katrina White. October 29, 2014. 2. Boscalid. Human Health Assessment Scoping Document in Support of Registration Review. Barry O'Keefe, Cassi Walls, Steve Funk, Myron Ottley. September 11,2014. 3. Boscalid: Tier 1 Review of Human Incidents. Shana Recore, Elizabet h Evans. June 25, 2014. 4. BEAD Chemical Profile (BCP) for Registration Review: Boscalid (1 28008)
. Leonard Yourman, Jihad Alsadek, Michelle Ranville. June 02,2014. 5
. Boscalid 

### (128008) Screening Level Usage Analysis (SLUA). February 14,2014.
26. Environmental Fate and Effects Division (EFED) Label Data Report: Boscalid (1 28008). June 18,2014. 7. HED Master Label Report: Boscalid (128008). June 18 ,2014. These and other supporting documents for the boscalid registration review case may be found in the docket EPA-HQ-O PP-2014-0199 at http: //www. regulations.gov.

3OVERVIEW The docket for boscalid is now open, initiating the fust public comment period for this registration review (docket number EPA-HQ -OPP-201 4 -0199). Boscalid, 3- pyridinecarboxamide, 2-chloro-N-(4'-chloro[l, 1'-biphenyl]-2-yl), is a carboxamide fungicide registered fo r the control of several economically important diseases, including gray mold on several crops, white mold on potato and beans, and lettuce drop. It is registered on numerous agricultural and orchard crops, and as a seed treatment. It is also registered for use on golf course turf, gardens, residential fruit and nut trees, ornamentals, including shr ubs and bushes, and on tomato plants meant to be transplanted into home ga rden s . Boscalid may be formulated as a single active ingredient pesticide o r co - formulated with the fungicides pyraclostrobin and chlorothalonil a nd with the insecticide lambda-c yhalothrin. Applications can be made with ground, aerial, airblast, chemigation, hand held, or seed treatment equipment. This Preliminary Work
.Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about boscalid, highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeli ne for completing the registration review for boscalid. The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends, by sharing this information in the docket, to inform the public of what it knows about boscalid and what types of new data or other information would 

# be helpful for the Agency to receive as it moves toward a decision on boscalid. The Agency encourages all interested sta keholder s to review the PWP and Appendix and to provide comments and additional informat ion that will help the Agency ' s decisionmaking process for this chemical. In addition to general areas on which persons may wish to comment, there are some areas identified in the PWP and Appendix about which the Agency specifically seeks comments and information. Interested stakeho lders could include: environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or th e public at large. The Preliminary Wor k Plan begins by list ing the anticipated data needs for boscalid. Next, it discusses the statutory and regulato ry authority for Registration Review. Then the document provides chemical facts, use and usage information, recent actions, the anticipated risk assessments, and a projected registration review timel in e for boscalid. Finally , the Appendix to this document includes identification and discussion of some areas that are considered generally in Registration Review along with some addition al chemical case-specific info rmation.

4ANTICIPATED DATA NEEDS Tab le 1 below summarizes anticipated data needs for boscalid. For additional discussion of the anticipated data needs , see the Registration Review: Problem Formulationfor Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure As s essmentsfor Boscalid and Boscalid. Human Health Assessment Scoping Document in Support of Registra t ion Review. Table 1: Anti cipated Data Needs for the Boscalid Registration Review Estimated Guide line Study Title1 Timeframe Number 1 Test Material (Months from receip t of DCI) Anticipated Data Needs for Boscalid 835.4100 Aerobic s oil metabolism TGAI 24 835.4400 Anaerobic aq uatic metabolism TGAI 24 Acute toxicity fre s hwater invertebrates - 850.10 1 0 daphnids (with boscalid alone and repre sentative TGAI , TEP 12-24 end

-use products) 850.1035 Acute toxicity estuarine and marine organisms TGAJ 

### 12 (mysid) 850.1350 Aquatic in vertebrate li f e cycle ( s altwater) TGAI 12 850
. 1400 Fish early-life (e stuar ine/marine) TGAI 12 850
. 1500 F ish li fe cycle (freshwater) TGAI 24 850.4150 Vegetative vigo r (cabbage only) TEP 12 Env i ro nmenta l Chemi s try Method s and 850.6100 Independent Laboratory val idat io n fo r water , TGAI 12 sedi m ent , and soil for analys is of boscalid No n- Chro ni c sediment toxicity with Chironomus GDLN dilutus, Hyalella azteca, and Leptocheirus TGAI 

### 24 plumulosus 870.3465 90 -Day inhalat ion TGAI 24 T GAI

- t e chmca l g rad e active m g r

edt e nt ; 1 EP

- typtcal e nd-us e produ ct

' O n .June 27,2012 , EPA announ ced certain rev is ion s in harmonized guideline series 850

- Eco log ical Effe cts Tests
- inc luding renumbering and/or removal of the Tier d es ig nati o ns fo r some g uid e lin e studies . S ee ''F inal Test Guideline s; OCS PP 850 Se ries ; Notice of Availabili ty " 77 FR 382 8 2, Jun e 27 , 20 12
. http ://www . r eg ulatio ns.gov/# ! doc ume ntDeta ii: D = EP A-H O

-O PPT

-2009

- 0 1 54- 002 8

5STATUTORY AND REGULATORY AUTHORI T Y The F ood Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pesticides d i stributed or sold in the United States (U.S.) generally must be registered by the Environmental Protec ti on Agency (EPA or the Agency), based on scientific dat a showing th at they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change , a ll registered pesticides cont i nue to meet the statutory st andard of no unreasonable adverse effects to human health or the environment. Changes i n science , public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically reevaluates pesticides to make sure that as change occurs, products in the market place can be used safely. Information on this program is provided on EPA ' s website. 2 The Agency i s implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide , Fungicide, and Rodenticide Act (FIFRA) , and will review each registered pesti c ide every 15 years to determine whether it continues to meet the FIFRA standard for registration
. The regulations governing registration review begin at 40 CFR 155
.40
. The Agency will cons ider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docke t is opened for each case. The docket is the Agency ' s opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a reg i stration review decis i on . After reviewing and responding to comments and data received in the docket during this initial comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for the registration review of boscalid.

2 http :// www. epa.gov/ op p s rrd I/regi s tration _review/ 6CHEMICAL FACTS Tab le 2 provides a summary of the chemical facts for boscalid. Table 2: Chemical Facts for Boscalid PC code 128008 Case Number 7039 CAS Number 18842 5-85-6 Year first registered 2003 Pesticide Type Fungicide Chemical class Carboxamide (or anilide) Reregistration Eligibi lity Because it was registered after November 1 984, boscalid was not Decision subjec t to reregistration. Tolerance Reassessment Because it was registered after November 1984, boscalid was not Eligibility Decision subject to to lerance reassessment. (TRED) Cumul ative group No t applicab le. Boscalid has not been identified as a member of a cumulative group that shares a common mechanism of toxicity. 40 CFR Citation Tolerances for boscalid are established in 40 CFR § 180.589
. Dual-use Boscalid is registered for conventional pesticida l uses only and has no registered antim icrob ial or b i opesticidal uses. Non -p esticidal uses There are no identified non-pesticidal uses of bosca li d. Pes ticide Re

- evalua tion Maria Rivera Piansay Division, Chemical Piansay.maria@epa.gov Review Manager (703)308-8063 Regis tration Division, Shaja J oyner ProductManager Joyner
. shaja@epa
. gov (703)308

- 3194 USE AND USAGE I NFORM ATION Table 3 summarizes the use and usage information for boscalid. Please see the BEAD Chemical Profile for Registration Review: Boscalid , 128008 in the registration review docket for more details Table 3 : Boscalid Use and Usage Information

Summary of Use Boscalid i s a succ inate dehydrogenase inhibitor (SDHI) fungicide of the same chemical group as fluopyram and penthiopyrad and wo rks by di srupting the mitochondrial activity of fungi to inhibit respiration. Use Sites Agricultural Use Sites: Boscalid i s registered for numerous ag ricultural use sites including: berries, bulb vegetables, carrots , artichoke, grapes, ci trus, nut trees , pome fruits, stone frui ts , tropical fru its, gi nger, hops , cress, turmeric , cucurbits, eggp l ant, toma t oes, persimmon, Brassica leafy vegetables, root crops, beans, alfalfa, canola, 7

### Table 3: Boscalid Use and Usage Information celery, cotton, peanuts, sunflower , sp in ac h, st rawberries, turnip greens, and soybeans. 

### Non-agricultural Use Sites: Boscalid registered non-agricultural use si tes include: ornamentals, golf courses, and fru it and nut trees. Summary of Usage 

### Agricultural Usage: Based on private market usage data from 2004-2012 , usage averaged approximately 410,000 pounds a.i. applied annually on approximately 1. 9 million <"\Cres treated. 

### Non-agricultural Usage: There were 26 ,000 lbs. of boscalid used by professional s on turf and ornamentals in 2011. Older data show minimal reported usage data of 3,000 lbs. a.i. (2004) and 4 , 000 lbs. a.i. (2006) on go lf courses . Formula tion Type(s) Water dispersible granules , emulsifiable concentrate, t1owable concentrate, soluble concentrate, ready- to-use solution, and so lubl e concentrate / solid. Applicat ion Method(s) Application is via multiple, fo li ar and broadcast sprays. Technical Registrant(s) BASF Corporation Number of Registrations Twelve Section 3 1 and 3 (24c) registrations Restricted Use No 1 Section 3 product labels can. be obtained from the Pesticide Product Label System (PPLS) website (http: //oaspub. epa .gov/ pestlbl/ppls
. home) 

### Guidance for Commenters : Additional areas of use and usage related information requested for this registration review, and of particular intere st to EPA , are described below.

• Confirmation of the following label information: sites of application; formulations; application methods and equipment; maximum application rates; frequency of application, app li cation intervals, and maximum number of applications per season; and geographic limitations on use . • The labels for products with EPA Reg. Nos. 7969-197 and 7969-199, and SD090006 p rovide a maximum single application rate and a maximum number of applications per crop cycle or season; however, a maximum application rate per acre per year is not provided. Particularly for some vegetable crops, it i s uncertain whether the chemical may be applied during multiple crop cycles in the same year. A maximum annual application rate per acre or a maximum number of seasons per year is needed to permit estimation of the maximum amount that may be app li ed to a given field during one year. The Agency will work with the regis trant to address this issue. • Some labels do not include a minimum retreatment interval. The Agency will work with the re gi st ran t to address this issue. • Some use instruc tions are provided on a product basis rather than an a.i. basis. If a different product containing boscalid is used on the same site within the year or crop cycle, the user may ha ve difficulty complying with lim its to the total amount of boscalid he can use in one


### 8year or season in a given area. The Agency will work with the registrant to address this ISSUe. • Use distribution 

### (e .g. , acreage and geographical distribution of relevant use sites). • Median and 90 1 h percentile reported use rates (lbs ai/ A) from usage data- national, state, and county. • Typical application timing (date of first application and application intervals)

- national, state, and county. • Pounds of active ingredient applied, percent crop tre ated, and application rates on crops that are not captured in the BEAD Chemical Profile (e.g., lentil , triticale, and grasses) • Reports of resistance to this fungicide appear to be increasi ng. Additional information on the occurrence of resistance to boscalid or other SDHI fungicides would b e useful in establishing benefits and developing resistance management language. • Foreign technical registrants not listed above who supply technical boscalid to the US market. RECENT ACTIONS The most recent risk assessment for boscalid was conducted in 20 13 for numerous new uses ( 040506 3, B. O'Keefe, 08/22/2013). The review of the proposed new uses ofboscalid on herb subgroup 19A and dill seed is pending (No tice of Filing can be found on the docket at docket id: EPA-HQ -OPP-2013-0798)
. EFED also conducted recent environmental fate and eco logical risk assessments for the proposed new uses ofboscalid (see USEPA, 2010, 0363523,2013, 0405817+, 2014c). ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW The most recent dietary (food and drinking water) exposure assessment for boscalid was completed on 06/24/2013 us ing the Dietary Exposure Evaluation Model. Residential and occupational handler and post-application risk assessments were conducted around the same time. New assessments are not anticipated during registration review. The most recent ecologica l and environmental fate risk assessment was completed in 2003 (USEPA, 2003, 0278387). Findings and conclusions from these risk assessments are summarized in Registration Review: Preliminary Problem Formulation for Environmental Fate, Eco lo g ical Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Boscalid and Boscalid. Human Health Assessment Seeping Document in Support of Registration Review, which can be found 

### in th e docket for registration review. During registration review, the Agency anticipates th e need to conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of boscalid. If toxicological endpoint s or points of departure are revised based on the data that are anticipated to be required for registration review, they will be considered in any new assessments, as well 

## as any changes to the standard operating procedures or default exposure assumptions. Table 4 below summarizes the anticipated registration review risk assessments based on the EFED Problem Formulation and HED Scoping Document.


### 9

### Table 4: Anticipated R i sk Assessments for the Boscalid Regi s t ration Review T ype of Risk Assessment Conduct? Notes Ecological and Environmental Fate C o mprehensive ecolog i cal y T he Agency w ill conduct a comprehensive eco logical (species to be assessed risk assessments for the parent boscalid , including an include terrestri al and aquatic endangered species assessment. organisms) , including end angered species Inc i dents W ill check for For a discussion of reported ecological incidents for updates boscalid , see page 21 of the Problem Formulation. 

### Human Health Di etary Food N A new dietary (food) risk assessment is not anticipated to be needed during registration rev i ew . Drinking water N A new drinking water risk assessment i s not anticipated to be needed during registration review unless there are significant increases to the drinking water exposure es ti mates . O ccupat ional Handlers (mixers, loaders, N A new occupational handler risk assessment is not app licators) anticipated t o be needed during reg i strat i on review. However, if new subchronic inhalation data yield a different endpoint or a more sensitive POD, then an assessment may be needed. Po st-application N A new occupational post-application exposure is not anti c ipated to be needed during registration review. Res iden tial H andlers N New residential handler exposure is not anticipated to be needed during reg i s tration rev i ew unless new subchronic inhal ation data yield a d ifferent endpoint and a more sens iti ve POD
. P o st
- applica t i on y During registration review, the Agency will determine t he need for drift and volatilization assessments for bys tanders. Other Aggregate N A new aggregate assessment is not anticipated to be needed unless there are changes in endpoints, PODs , or other components of aggregate risk. Cumulative N EPA has not made a common mechanism of toxicity finding for bosca li d and any other substances; and boscali d does no t appear to produce a toxic metabolite produced by other substances. 10Table 4: Anticipated Risk Assessments for the Boscalid Registration Review Type of Risk Assessment Conduct? Notes To lerances 

### y EPA will evaluate the possibility of harmoniz ing to lerances with Canadian and Codex MRLs. Incidents Will check for For a di scuss i on of reported human inc iden ts for updates boscalid, see p ages 1 1

- 12 of the Seeping Document and the Boscalid: Tier 1 Review of Human Incidents
.


### . . Guidance for Commenters: Add 1 t10nal ecological information requested for th1 s registration review, and of particul ar in terest to EPA, i s desc ribed below.
• Ecological incidents (non-target plan t damage and avian, fish, reptilian, amph ibian a nd mammalian mortali ties) not already repo rted to the Agency. • Water quali ty monitoring data (see Appendix for further de tails). 

### TIMELINE EPA h as created the following es timated timeline for the completion of the boscalid registration review in Tab le 5 below. Table 5: Projected Boscalid Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60

-day Public Commen t Period 20 14- D ecember Close Public Comment 2015

- February Case Development Final Work Plan 20 1 5

- May Issue DCI 2015

- Ju ly - September Data Submission 2017

- July

- September 60-day Pub lic Comment Period for Draft Risk 2019- January- March Assessments 1 Registration Review D ecis i on 60

- day Public Comment Period for Proposed 2019- October

- December Registrati on Rev iew Decision Registration Review Decision and Begin Post

- Decision 2020 Follow-up To t al (years) 6

'The regulations governing registration review generally require the Agency to provide a public comment period of at least 30 calendar days for draft risk assessments; s ee 40 CFR Part 155
. 53(c)
. For conventional pesticides , the Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. NEXT STEPS After the 60

-day public comment period closes, the Agency will review and respond to any comments rece ived in a time ly manner and then issue a Fina l Work Plan for the registration rev iew of boscalid. 11

### Appendix- Additional Areas Considered in the Boscalid Registration Review PUBLIC COMMENTS AND FEEDBACK : G uidance for Comm enters: The areas below highlight topics of specia l intere st to the Agency where your comment s, data submissions, or refe rence to sources of additional information could be of particular use. Trade Irritant s: T hroug h the reg i stration review process, the Age n cy intends to solicit information on trade irritants and, to th e extent feasible, take step s toward facilitating irritant resolution. The Agency w ill work to harmonize toleranc es and international maximum re si du e limits (MRLs) and may modify toleran ce level s to do so, when possible. G rowers and other stakeholders are asked to comment on any trade irritant issues resulting from lack ofMRLs or disparities between U.S. tolerances and MRLs in key export markets , providing as much specificity as possible re garding the nature of the concern . Water Quality: Bo scalid i s not identified as a cause of impairment for any water bodi es li sted as impaired under section 303(d) of the C lean Water Act. 3 In addition , no Total Maximum Daily Loads (TMDL) have been developed for boscalid
. More inf ormation on impaired water bodies and TM DL s can be found at the Agency's website. 4 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: Inclusion of Impaired Water Body and Other Water Quality Data in OP P 's Registration Review Risk Assessment and Management Proc ess 5 in order to ensure they can be used quantitatively or qualita t ively in pesticide risk assessments. Env ironmental Justice: EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development , implementation, and enforc ement of envi ronmental laws, regulations, and policies. To help address potential e nviro nmental justice i ss ue s, the Agency seeks inf ormation on any groups o r segments of the population who, as a resu lt of their location, cultural practices, or other factors, may have atypica l, unusually h igh exposure to boscalid compared to the general population. Please co mment if you are awa re of any sub-populations that may have atypical, unusually high exposure compared to the general p opul ation
. 

### ENDANGERED SPECIES:

3 http: //ias pub. epa.gov / tmdl waters I0/attains nation cy .causc detail 303d?p cause group id= 885 4 http: //www.epa.gov / owow/tmdl/ s http: //www.epa.gov/ oppsrrd 1/registration rev iew/ water quality sop.htm 12A risk assessment that supports a complete endangered species determination has not been conducted for boscalid. The ecological risk assessment planned during registration review will allow the Agency to determine whether use of boscalid has "no effect'' or "may affect" federally listed threatened or endangered spec ies (listed species) or th eir designated critical habitats. 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 Service (the Services), as appropriate. ENDOCRINE DISRUPTOR SCREENING PROGRAM: As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these st udies include acute, subchronic and chronic tox icity , including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be sus ceptible to endocrine infl uence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss , and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxono mic groups. As part of its most recent registration decision for boscalid, EPA reviewed these data and selected the most sensitive endpoints for relevant ris k assessment scenarios from the existing hazard database. However, as required b y FFDCA section 408(p ), boscalid is subject to the endocrine s creening part of the Endocrine Disrupter Screening Program (EDSP). EPA has developed the EDS P to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." The EDSP employs a two -tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 

### .1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing i s designed to identify any adverse endocrine-related effects caused by the substance, and establish a dose-response relations hip 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 tes t orders/data call-ins for the first group of 67 chemicals, which contains 58 pes ticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14 , 2013 6 and includes some pesticides scheduled for registration review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disrupters.

6 See http :/ / www.regulations.gov/#!doc um entDetaii;D=EPA-HQ-OPPT-2009 -0477-0074 for the final second list of chemicals. 13For further information on the status ofthe EDSP , the policies and procedures , the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery , please visit our website. 7 HUMAN STUDIES: Occupational and R es idential Past boscalid risk a ssessments rely in part on data from studies in which adult human subjects were intentionall y exposed to a pesticide to determine their dermal and inhalation exposure. Many such studies, involving exposure to many different pesticides , comprise generic pesticide exposure databases suc h as the Pesticide Handlers Exposure Database (PHED), the Agricultural Reentry Task Force (ARTF) Database, and the Outdoor Res idential Exposure Task Force (ORETF) Database. EPA has rev iewed all the studies supporting these multi-pestic ide generic exposure databases , and has found no clear and convincing evidence that the conduct of any of them was either fundamentally unethical or significantly deficient relative to the ethical standards prevailin g at the time the research was conducted. All applicable requirements of EPA's Rule for the Protection of Human Subjects of Research (40 CFR Part 26) have been s atisfied , and there i s no regulatory barrier to continued reliance on these studies.

7 http: //www.epa.gov/ endo/ 14