Do cket Number EPA-HQ-OPP-2015-0303 www.regulations.gov



# Penoxsulam Preliminary Work Plan

Registration Review: Initial Docket Case Number 7625

Approved by:

Date: 

# September 2015**Ghc-t~** 

## r ·**~qu..-~** 

# , ')} Richard P. Keigwin, Jr. Director Pesticide Re-evaluation Divi sio n

### Penoxsulam Preliminary Work Plan - Tab le of Contents

OVERV IEW
....................................................... . ....... .. ... . ....... ... ................................. ......... ........... 4 ANT IC IP ATED OAT A NEEDS
..... .. .. ...... .......... .............. ...... ........... .. .... . ...... .... . .. .. ....................... 5 STATUTORY AND REGULATORY AUTHORIT Y
................................................................... 5 CHEMICAL FACTS
.. ... ... .. . ... .. ... .. .. .. .. .. ... . .. .. .. .. ... . .. .. .. .. .. .. .. .. ... .. .. ... . .. ... ... . ....... ... . ........................... 6 USE AND USAGE INFORMATION
................................................................. . .. ......................... 6 RE CEN T ACTIONS
................................................... . ... . ...............................................................7 ANT ICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW
.............. ................... ? TIMELINE
............................................................................................................................. . .... .. ! 0 NEXT STEPS
.. .. .. .. .. ... .. ... ....... .. .. ... .. .. .. .. ... . .. .. .. .. ... . .. . .. ... .. . ... .. ... .. .. .. .. . .... ... . .. ... . ... .. ......................... I 0 Appendix

- Additional Areas Considered i n the Penoxsulam Reg istration Rev iew
................. I 1



### References: This Pre liminary Work Plan summarizes th e Environmental Protection Age ncy ' s cmTent position based on th e following documents: 1
. R egistration R evi ew Ecological Risk Assessment for Peno xsufam
. James Wolf , Ph.D. and Rosanna Louie-Juzwiak , RAPL. July 1 7 , 2015. 2. Penoxsulam Human Health Assessment Scoping Docum ent in Support of R eg i s tration R evi ew . Douglas Dotson , Ph.D.; Linnea Hansen , Ph .D.; Zaida Figueroa, M
. S
. Apri l 1 6, 2015. 3. Penoxsulam: Tier I R evie w of Human Incidents . Shanna Recore, Industrial Hygienist; Elizabeth Evans, Env ironmenta l Protection Specia l ist. January 28, 20 1 5. 4. BEAD Chemical Profile (BCP)for R eg istration R evi ew: P e noxsulam (1 19031). Sunil R atn ayake, Bi ologis t ; Sepehr H addad, Environmental Protection Speciali st; Stephen Smearman , Economist. D ecember 4, 20 14.

25. 

### Penoxsulam Screening Level Usage Analysis. J u l y 2 1 , 2014 

### 6. Penoxsufam (1 

### 19031) Label Use Report Package in Support of Registration Review,· September 11, 2014. EFED Table 1 Report 7. 

### Penoxsufam (119031) Label Use Report Package in Support of Registration Review; September 11, 2014. HED Master Table Report
. These and other su pportin g doc umen t s fo r the penoxsu lam registration review case may be found in the docket EPA- H Q -O PP

- 2015-0303 at http ://www . regulations
. gov .

3OVERVIEW The docket for penoxsulam is now open, initiating the first public comment period for this registration review (docket number EPA-HQ-OPP-2015-0303). Penoxsulam is an herbicide belonging to the triazolopyrimidine su lf onamide fami ly. Members of this family, like those in the imid azolinone and sulfonylurea herbicide families, work by inhibiting the activity of the enzyme acetolactate synthase (ALS). Penoxsulam is a systemic herbicide applied as a postemergence treatment for selective contro l of annual grasses, sedges, and broad leaf weeds in agricultural and non-agricultural use s ites. lt is also used for control of vegetation in l akes, ponds, canals and reservoirs. This Preliminary Work Plan (PWP) document explains what EPA's Office of Pesticide Programs knows about penoxsulam, 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 timeline for completing the registration review for penoxsulam. The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The Agency intends , by sharing this infotmation in the docket, to infonn the public of what it knows about penoxsu lam and what types of new data or other information would be helpful for the Agency to receive as it moves toward a decision on penoxsulam. The Agenc y encourages all interested stakeholders to review the PWP and Append ix and to provide comments and additional information that will help the Agency's decision-making 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 ld ers could in clude: enviromnental non-profit or interest groups; pesticide manufacturers; agricultural labor or cormnodity groups; commercial , institutional , residential, and other users of pesticides; or the public at large. The Agency i s re leasing a Preliminary Risk Assessment (PRA) for ecological risk concurrent with the PWP. Rather than providing a Problem Formulation for planning the eco l ogical risk assessment for penoxsulam , as is usual for docket openings, the Agency has already completed a preliminary ecological risk assessment. This PRA is included in the penoxsulam registration review docket, and the Agency is requesting comments on the PRA as well as the PWP during the docket open in g comme nt period. The Agency ant icipates completing a pollinator risk assessment for penoxsulam after considering data from pollinator studies it antic ipates requirin g for the penoxsulam registration review. The Preliminary Work Plan begins by listing the ant ic ip ated data needs for penoxsulam. Next , it discusses the statutory and regulatory authority for registration review. The n the document provides chemical facts , use and usage information , recent actions , infonnation on the anticipated risk assessments , and a projected registration review timeline for penoxsulam. Finall y, the Appendix to this document includes identification and discussion of some areas that are considered generally in registration review along w ith some add iti onal chemica l case-specific information.



### 4ANTICIPATED DATA NEE DS Table 1 below summarizes anticipated data needs for penoxsulam. For additional di sc u ssio n of the antic ipated data ne eds, see the 

### Registration Review Ecological Risk Assessment for Penoxsu/am and 

### Penoxsu/am. Human Health Assessment Scoping Document in Support of Registration R eview
. Table 

### 1: Anticipated Data Needs for the Penoxsulam Registration Review Estimated Guideline Timeframe Number Study Title Test Material (Mo nth s from receipt of DCI) Non-guideline Acute oral toxicity to larval honey bees TGAI 12

(OECD 237) Non-guideline Chronic oral toxi c ity to adult h oney bees 1 TGAI 12 Non-guidel in e Chronic o ral toxicity to larval honey bees 1 TGAI 12 Non-guideline Field trial of residues in pollen and nectar 1 TEP 24 No n- guidel in e Semi-field te sting for pollinator 1 TEP 24 850.3040 Field testing for pollinators TEP 24 TGAJ 

### = teclmical grad e active mgred1ent; TEP 

### = typtcal end-use product. STATUTORY AND REGULATORY AUTHORITY The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All pe sticide s distributed or so ld in the Un ited States (U.S.) generally must be registered by the Environmental Protection Agency (EPA or the Agency), ba sed on sc ientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product lab eli ng . The registration review program is intended to make sure that, as the ab ili ty to assess risk evolves and as policies and practices change, all registered pesticide s continue to meet the s tatutory standard o f no unreasonable adverse effects to human health or the environment. Changes in sc ience, pub li c policy, and pe st ic i de u se practic es will occur over time. Through the registration review program , the Agency periodi call y reevaluates pesticides to make sure that as change occurs, products in the marketplace can be used safel y . Information o n this program is provided on EPA's website. 2 The Agency i s implementing the registration review program pursuant to Section 3(g) of th e Federal Insecticide , Fungicide, and Roden ticide Act (FIFRA), and wi ll review each r egistered pesti cide every 15 years to determine whether it continues to meet the FIFRA s tandard for regi s tration
. The regulations govern ing registration review begin at 40 CFR 155.40. The Agency w ill consider benefits information and data as required by FIFRA. The public phase of registration rev iew begins when the initial docket is opened for each case. Th e docket is the
1 Guidance for these studies can be found at: http ://www2
. epa . gov /po llin a tor-pro t ec ti on/ po llin a tor-ri sk

- asscss m ent
guid an ce . 2 http ://www .epa.gov /opps rrd ! /r eg istr at io n r ev ie w / 5Agency'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 registration review decision. 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 rev iew of penox s u l am . 

### CHEMICAL FACTS Table 2 provides a summary of the chemical facts for penoxsulam. 

### Table 2: Chemical Facts for Penoxsu l am PC code 11903 1 Case Number 7625 CAS Number 219714-96-2 Year first registered 2004 Pesticide Type Herbicide Chemical class Triazolopyrimidine sulfonamide Reregistration Eligibi lity Because it was registered after November 1984, penoxsulam was Decision (RED) not subject to reregi stration
. Tolerance Reassessment Not applicable. Because it was registered after November 1984 , Eligibility Deci s ion penoxsulam has not undergone tolerance reassessment. (TRED) Cumulative group Not applicable. Penoxsulam has not been identified as a member of a cumulative group that shares a common mechanism of toxicity to humans. 40 CFR Citation Tolerances for penoxsulam are established in 40 CFR 

### § 180.605. Dual

- use Pe noxsulam is reg i s tered for conventional pesticidal use s only and has no registered antimicrobial or biop es ticidal uses. Non

- pesticidal uses There are no identified non-pesticidal u ses of penoxsulam. Pesticide Re-evaluation Bonnie Adler, adle r. bonnie @ epa . gov , 703-308-8523 Divi sio n , Chemical Review Manager Registration Division , Heather Garvie, garv i e.heather@epa
. gov , 703-308

- 0034 Product Manager 

### USE AND USAGE I NFORMATION Table 3 summarizes the use and usage information for p enoxs ulam. Please see the BEAD Chemical Profile (BCP)for Registration Review: Penoxsulam ( 11903 1) in the registration review docket for more details. 

### Tab le 3: Penoxs u lam Use and Usage Information Summary of Use Penoxsulam belongs to the triazolopyrimidine sulfonamide family. It is registered for use as a post
- emergence treatment to control annual grasses, sedges, and broadleaf weeds in 

### 6Table 3 : Penoxsulam Use and Usage Information agricultural and non-agricultural use sites. 

### It is also registered for use on residential sites. Use Si tes Uses include dry- and wet
- seeded ri ce, turf, tree nuts , grapes , non bearing fruit trees, and aquatic use sites
. Summary of Usage From 2005-2012 , average annual u sage was approximately 6 , 500 pounds active in gredient (a.i.) on approximate ly 207 , 000 acres treated. Usage increased during that time, most noticeably from 2010 to 2011. Rice accounts for the majority of agricultural usage. Formulation Type(s) So lub le / emul s i fiab le concentrate and granu l ar fon nul ations. May be co - formu l ated with other h erbic id es and w ith fertilizer. Application Method(s) Ground spreaders, aerial sprayers. Techn ical Registrant(s) D ow Agrosciences No. of Registrations 5 1 Secti o n 3 products 3 Restricted Use No Guidance for Commenters: Data are n eeded for u sage on turf , l awns, l akes, ponds, canals, non-bearing trees, con ifers, eucal yptus, and non-cropland , in terms of pounds a.i
. used annuall y (ideally for the last several years). Data al so are needed for each of th ese s i tes on indi vi du al an d maximum annual application rates, number of applications/ year, minimum retreatment intervals , and application tim ing. RECENT AND P EN DING ACTIONS There are several new uses pending for penoxsu l am . These include uses on pome fruit group 11- 10; stone fruit group 12-12; small fruit vine climbing subgroup l3-07F; olive; pomegranate; and tree nut group 14- 1 2. ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW The most recent comprehensive human h ealth risk assessment fo r penoxsulam was completed on April 9 , 2009 to evalu ate proposed new uses on grapes and tree nuts. T he most recent eco l ogical ri sk assessme nt was comp l eted Jul y 17, 2015 for regis tration review
. Findings and conclusions from th ese risk assessments are summarized in the Registration R e view Ecological Risk Assessment for Penoxsulam and th e Penoxsulam Human Health Ass essment Scoping Document in Support of Registration Review. At thi s time, th e Agency is issuing a prelim inary ecological risk assessment based on the currentl y avai lab l e data and prio r assessments. The assessment does not include comprehensive data for pote nt ial r isk to honey bees
. During registration review, the Agency antic i pates the need to conduct a comprehensive revised eco log i cal risk assessmen t , in cluding an endangered species

3 Section 3 product labels can be obtained from t he Pesticide Product Label System (PPLS) w eb s ite (http: //oaspub
.epa .gov / pestlabVppls.home). 7assessment and an assess m ent o f ri sks to po lli nators, for all u ses of penoxsulam. For human health , EPA antici p ates the need to conduct revised aggregate, residenti a l , and occupational risk assessments during registration review. Human health risk assessments wi ll be conducted to assess the proposed new u ses. Ta bl e 4 below s umm arizes th e anti c ipated registration review ri s k assessments b ased on the EFE D PRA an d H ED Scoping D oc ument. 

### Table 4 : Anticipated Risk Assessments for the Penoxsulam Registration Review Type of Risk Assessment Conduct? Notes Ecological and,Environmental Fate Ecological (species to be 

### y Th e PRA f o r eco logical risk is b ei ng posted to the assessed include terrestria l docket along with th is PWP. When data th at are and aquatic organisms) , anti cipated to be required fo r registr a ti o n rev i ew are including en dan gered species received, the Agency expects to be able to co n du ct an assessment for honey be es. Incidents Will c h eck for For a discussion of reported ecological in cidents for upd ates penoxsulam, seepage 1 9 of the EFED PRA. 

### Human Health 1 Dietary Food N The most recent dietary risk assessment is adeq uate to support registration review. Drinkin g water 

### y New u ses wi ll warrant a n ew drinking water assessme nt , and findin gs will be addressed in the registration review dec ision -makin g as app ropriate. Occup ation a l Handlers (mixers , loader s , 

### y Updated occupational handler assess m ents w ill be applicators) conducted to re fl ect a ll th e registered u ses and c urre nt occupational exposu re policies. Post-application 

### y No dermal e ndp o int has b ee n identified , so no dermal occup atio n al post
- applic ation assessme nt is planned. I f th e Agency's volatili zation screening tool or data from th e Agricultural Reentry Task Force indi cate that analyses of occupat ional post
- applicati on inhalation expos ures are n eeded , th ey will b e includ ed 

### in the registration review risk assessment for penoxsulam
.



### 8Type of Risk Assessment Condu ct? Notes Residential Handlers 

### y No short

- term dermal endpoint has been identified , so a quantitative dern1al residential handler exposure assessment is not planned. Residential inhalation handler exposures were previously assessed, and are not of concern . The Agency will conduct a residential handler assessment for the aquatic use; how ever, no risks of concern are anticipated
. Post-application 

### y The Agency previously conducted re s idential postapplication asse ssments for the turf and aquatic use s. The ri sk estimates were not of concern. However, during registration review , thes e assessments will be updated as needed based on revised inputs , assumptions, and SOPs. The Agency also will consider the potential for residential post-app lication exposure through spray drift and vo latilization. Other Aggregate 

### y HED will conduct a new aggregate risk assessment that will be based on any policy changes and potential update s to points of departure. Cumulative N P e noxsulam is not a member of a cumulative group with a common mechanism of toxicity to humans. Therefore no cumulative ri sk assessment is planned. Tolerances N Per the Scoping Document, the Agency expects to revise the tolerance expression for p e noxsulam at 40 CFR § 180.605. Incidents Will check for For a discussion of reported human incident s for updates penoxsulam , see page 11 of the Scoping Document and Penoxsulam: Tier I Review of Human Incidents
. Based on the low fr equency and low severity of incident cases reported for penoxsulam, there does not appear to be a concern at this time that would warrant further investigation. The Agency will continue to monitor incid ent information. Gu i dance for Commenters: Additional eco logical information reque ste d for this registration review, and of particular interest to EPA, is de scribed below
.
• Ecological incident s (non

- target plant damage and avian, fish, reptilian , amphibian and mammalian mortalities) not already reported to the Agency. • Water quality monitoring data (see Appendix for further details).

9TIME LI NE EPA has created the follow i ng e stimated ti meline for the completion of the p e no xsu lam regi s tration revi ew in Table 5 below. Tab le 5 : Proj ected Penoxsu lam Reg istration Review Timeline Acti vi ties Estimated Date Open ing the Docket Open Docket and 60

- day Pub li c Comment Period 20 IS

- S e ptember Close Public Comment 2015-November Case Development Fin al W o rk P l an 20 16-February Is s u e DC I 20 1 6 Apri l -June Data Submission 2018 April -June 60-day Pub lic Comment Period for Draft Ri s k As sess ment s 4 201 9 October

- December Registration Rev iew Deci s ion 60

-day Pub lic Comment Period for Propo sed Regi stration Rev iew 2020 Ju l y-September D ec ision Re g istration Rev iew Dec i s ion and B egi n Po s t
- Dec is i on Follow-up 2021 January

- March Total (years ) 6 NEXT STEPS After th e 60-day public comment period on the PWP , th e Seeping Document , and the preliminary eco logical ri s k assessment clos es, th e A ge ncy will review and re spond to any comments recei ve d in a timely manner and then iss ue a Final Work Plan f or the regi stration review of penox su lam.

4 The regulations gove m ing R eg is tra ti on Rev iew ge ne rall y require the Agency t o provide a public co mm en t period of at least 30 ca l en d ar da ys f or dra ft ri sk assessmen t s; see 40 CF R Part 1 55.53(c)
. Fo r co nve nti o nal pestic ides, the Agency plans to provide a 60 ca le nd a r day publi c comment period gene rall y for draft ri s k a ssess me nt s . 10

### Appendix

- Additional Areas Considered in the Penoxsulam Registration Review PUBLIC COMMENTS AND FEEDBACK: Guidance for Commenters: The areas b elow highlight topics of spec i al interest to the Agency where your comments, data submissions , or refere nce to sources of additional information could be of parti cu lar use. Trade Irritant s : Through the reg i stration review proces s, the Agency intends to solicit information on trade irritants and, to the extent feasible , take steps toward facilitating irritant resolution. The Agency w ill work to hannonize tolerances and internationa l maximum residue limits (MRLs) and may modify tolerance levels to do so , when po ssib le
. Growers 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 spec ificity as possible regarding the nature of the concern. Water Quality: Penoxsulam is not id entified as a cause of impairment for any water bodies li s t ed as impaired under section 303(d) of th e C lean Water Act. 5 In addition , no Total Maximum Daily Loads (TMDL) h ave been developed for penoxsulam. 6 More information on impaired water bodies and TMDLs can be found at the Agency 's website. 7 The Agency invites submission of water quality data for this pesticide. To the extent possible , data sho uld conform to the quality standards in Appendix A of the OPP Standard Operating Procedur e : Inclusion of Impaire d Water Body and Oth e r Wate r Quality Data in OPP's Registration Review Risk Assessment and Management Process 8 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments. Environm e ntal Justic e : EPA seeks to achieve environmental justice, the fair treatment and meaningful in volvement of all people, regardless of race , color, national origin, or income , in the development , impl ementat ion , and enforceme nt of environmental laws , regulations, and policies. To help address potential environmental ju stice issues , the Agency seeks inf ormation on any groups or segments of the population who, as a result of their locatio n , cultural practices, or other factors , may have atypical, unusually high exposure to penoxsulam compared to the general population. Please comment if you are aware of any sub-populations that may have aty pical, unusually high exposure compared to the general population.

5 http ://iaspub.epa .gov / tmdl waters I0 /attains nation cy.cause detail 303d?p cause group id = 885 6 http: //iaspub.epa.gov / tmdl waters I0/ attains nation.tmdl pollutant detail?p pollutant group id = 885&p pollutant group name= PESTICIDES 7 http ://www.epa.gov/ owow/ tmdll 8 http ://www.epa.gov/oppsrrd ! / registration review / water quality sop.h tm 

### 11ENDANGERED SPECIES: Consis tent with EPA's responsibility under the Endangered S p ecies Act (ESA), the Agency will evaluate risks to federally li sted threatened and endangered (listed) spec ies from registered u ses of pesticides in accordance with the Joint I nterim Approac h es developed to implement the recommendations of the April 2013 National Academy of Sc iences (NAS) report, Assessing Risks to Endangered and Threatened Species from Pesticides. Th e NAS report outli nes recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services mu st conduct in connection with the ir ob li gat io ns under the ESA and FIFRA. EPA w ill address concerns spec ifi c to penoxsulam in connection with the development of it s fi nal registration review dec is i on for penoxsulam. In November 20 1 3, EPA, the U.S. Fish and Wildlife Service, Nat ional Marine F i sheries (the Services), and US D A released a white paper containing a summary of theirjoint Interim Approach es for assess in g risks to li sted species from pesticides. These Interim Approaches we re developed jointly by the agencies in respo nse to the NAS recommendations , and reflect a common approach to risk assessment shared by the agencies as a way of address in g sc ientific differences between the EPA and the Services. Details of the joint Interim Approac hes are contain ed in th e November 1 , 20 1 3 white paper, Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report. Given that the agencies are continuing to develop and work toward impl ementation of the Interim Ap proac hes to assess the potential risks of pesticides to listed species and their des i gnated cr iti cal hab itat, thi s eco logical p rob lem form ul ation s upp orting the Preliminary Work Plan for penoxsulam does not describe the spec ifi c ESA analysis, including effects determinations for specific listed species or designated critical habitat, to be conducted during registration review. While the agencies continue to develop a common method fo r ESA anal ys is, the planned ri sk assessment for the registration review of penoxsulam wi ll describe the level of ESA analysis comp leted fo r th i s particular registration rev i ew case . This assessment will a ll ow EPA to focus its future evalu ations on the types of species where th e potential for effects exists, once the scienti fic methods b eing developed by the agencies have been fully vetted
. Once th e age ncies h ave fully deve l oped and implemented the scientific methods necessary to comp lete risk assessments fo r li sted spec ies and their designated c riti cal habitats, these methods w ill be applied to subse qu ent analyses of penoxsulam as part of comp letin g thi s registration review. ENDOCRINE DISRUPTOR SCREENING PROGRAM: As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals . Co ll ecti vely, these stud ies in clude acute, subchronic and chronic toxicity , including assessments of carcinogenicity, neurotoxicity , deve l opmental, reproductive, and general or systemic toxicity. These studies include endpo int s which may be suscept ible to endocri ne influence, includin g effects on endocrine target organ histopathology , organ we i ghts, estru s cyclic ity, sexu al maturat ion , fert ili ty, pregnancy rates, reproductive l oss, and sex ratios in offspring. For ecological hazard assessme nts, EPA evaluates ac ute tests and chronic studies that assess growth, developmental and reproductive effects in different 12taxonomic groups. As part of its reregistration decision for penoxsulam , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the exi stin g hazard database. However, as required by FFDCA section 408(p) , penoxsulam is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). EPA has developed the EDSP to determine whether certain substances ( in cluding pesticide acti ve and other ingredients) may have an effect in humans or w ildli fe sim il ar to an effect produced by a "naturally occurring estrogen , or other such endocrine effects as the Administrator may designate." The EDSP emp l oys a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screenin g assays to identify the potential of a chemical substance to interact with the estrogen, androgen , or thyroid 

### (E , A, or T) hormonal systems. Chem ical s that go through Tier 1 screening and are found to have the potential to interact w ith E, A, or T ho1monal 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 avail able data. Tier 2 testing i s designed to identify any adverse endocrine-related effects caused by the substance, and establish a dose-response relationship between the dose and theE, A, or T effect. Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 20 I 0, EPA issued test orders/ data call-ins for the first group of 67 chemicals , which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14 , 2013 and includes some pesti c ides schedu led for registration review and chemicals found in water. Neither of these li sts shou ld be construed as a li st of known or likely endocrine disrupters. Penoxsulam is not included either list. For further information on the status of the EDSP, the policies and procedures, the lists of chem icals , future lists, the test guidelines and the Tier 1 screening battery , please v i sit our webs i te. 9 HUMAN STUDIES: Occupational Past penoxsulam risk assessments rely in part on data from studies in which adult human subjects were intentionally 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 such as the Pesticide Handlers Exposure Database (PHED) and the Agricu ltural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies support ing these multi-pesticide generic exposure databases, and has found no clear and convincing evidence that the conduct of any of them was either fundame nt ally unethical or significantly deficient relative to th e ethical standards prevailing at the time the research was conducted
. All applicab l e requirements of EPA's Rule for the Protection ofHuman Subjects ofResearch (40 CFR Part 26) have been satisfied , and there i s no regulatory barrier to continued reliance on these studies.

9 http ://www.epa .gov/ endo / 13