### Docket Number EPA-HQ-OPP-2015-0303 www.regulations.gov



## Penoxsulam Final Work Plan Registration Review

Case Number 7625
March 2016

Approved by:

# ~t~~tt;Va}JtL:::-**~** Director Pesticide Re-evaluation Division

Date:

### INTRODUCTION This is the Environmental Protection Agency ' s (EPA or the Agency) Final Work Plan (FWP) for the regi stration review ofpenoxsulam. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in the penoxsulam registration review docket (EPA-HQ-OPP-2015-0303)

. Penoxsulam is an herbicide belonging to the triazolopyrimidine sulfonamide famil y . It is a systemic herbicide applied as a post-emergence treatment for selective control of annual grasses , sedges , and broadleaf weeds in agricultural and non-agricultural use sites. It 

### is also used for control of vegetation in lakes , ponds , canals and reservoirs . The Agency is implementing the registration review program pursuant to Section 3(g) ofthe Federal Insecticide , Fungicide, and Rodenticide Act (FIFRA) , and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. Changes in science , public policy, and pesticide use practices occur over time

. The regi stration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change , all registered pesticides continue to meet the statutory standard. The public phase of registration review begins when the initial docket is opened for each case. Information on this program is provided on the Agency ' s website. 1 

### The FWP begins with any updates since the PWP was issued

. Next is a summary of substantive comments received during the public comment period for the PWP concerning anticipated data needs, expected risk assessments , or the estimated timeline identified in the PWP , and a summary ofthe Agency ' s responses to those comments. This section is followed by registration review planned data needs, risk assessments expected to be conducted , and the projected registration review timeline for penoxsulam

. Lastly , there is a discussion of next steps
. 

### UPDATES SINCE THE PWP WAS ISSUED Updates to penoxsulam since the PWP include the registration ofthe following uses : pome fruit group 11-1 0 ; stone fruit group 12-12 , small vine and climbing subgroup 13-07F (except fuzzy kiwi) , tree nut group 14-12, olive and pomegranate. The petition and label amendment application for these additional food uses for penoxsulam were submitted by Interregional Research Project No
. 4 (IR-4)

. The docket for this action is EPA-HQ-OPP-2014-0879 , which includes the Notice of Filing for the Petition and the Notice of Receipt for the Registration Action, as well as the Final Rule establishing tolerances , which was published in the Federal Register on March 2, 2016. The label was also updated by this action. 

### SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day public comment period on the Penoxsulam Preliminary Work Plan , which opened on September 30 , 2015 and closed on December 1, 2015 , the Agency received 3 public comments
. Comments were submitted by FIFRA Endangered Species Task Force (FESTF) and the Center for Biological Diversity (CBD) and Dow AgroSciences (DAS). DAS comments included typographical errors and data interpretation

. The comments do not have any

1 http :/ /www2

.epa.gov /pesticide-reevaluation 

### 2implications for the anticipated registration review data needs or the registration review timeline described in the PWP, but they are of relevance to the planned ecological and human health risk assessments
. A few public comments are summarized below. Pub lic comments and EPA responses in their entirety, inc luding BEAD's Responses to Commentsfrom Dow AgroSciences on Use and Usage Information in the US. EPA's Penoxsulam Registration Review Docket, are located in docket EPA

-HQ

-OPP

-20 15

-0303. Comments submitted by FESTF in EPA-HQ-OPP-2015-0303-0016. 1

. Comment: In the Preliminary Work Planfor Penoxsulam, the Agency had not completed an endangered species determinationfor whether the uses have "no effect " or "may affect " federally listed species or their designated critical habitats. At such time as an endangered species evaluation is conducted by EPA , the data developed by FESTF, in response to the Agency ' s endangered species data requirements, will address species proximity to penoxsulam uses. FESTF indicated that the technical registrant , Dow AgroSciences , LLC, is a FESTF member and entitled to rely on FESTF data. FESTF also indicated that the data they have previously submitted to the Agency are the best available data necessary to support the anal ysis of Penoxsulam use; listed species locations and potential exposure. They alsofulfill the data requirements indicated in Pesticide Registration Notice 2000-2. EPA Response : EPA thanks FESTF for its comment and will consider all appropriate information as we conduct the regist ration review assessment and make our registration review decision. Comments submitted by Center for Biological Diversity in EPA-HQ-OPP-2015-0303-0018 . 2

. Comment: The Center for Biological Diversity's (CBD) comments focus on the EPA ' s duty to consult with the US. Fish and Wildlife Service and the National Marine Fisheries Service (the Services) on the registration review of penoxsulam in accordance with the Endangered Species Act (ESA). The CBD comments mention various aspects of the risk assessmentprocess, including use of the best available data to develop endangered species risk assessments, and evaluation of effects on endangered and t hreatened species and their designated critical habitat. CBD also expresses concern regarding the rigor of the Agency's preliminary determinations regarding the effects of penoxsulam on endangered and threatened (listed) species and their designated critical habitatfor the penoxsulam registration review
. EPA Response: EPA has reviewed the comments from CBD on the Penoxsulam Preliminary Work Plan and plans to add ress many ofthe concerns raised by CBD as part ofthe implementation plan for assessing the risks ofpesticides to listed species based on the recommendations ofthe April2013 National Academy of Sciences (NAS) report. EPA will address concerns specific to penoxsulam in connection with the development of its final registration review decision for penoxsulam. The NAS report outlines recommendations on specific scientific and technical issues related to the development ofpesticide risk assessments that EPA and the Services must conduct in
3connection with their obligations under the ESA and FIFRA. At this time, EPA has not fully developed its risk assessment process for listed species. In November 2013 , the EPA, along with the Services and the U.S. Department of Agriculture, released a summary oftheirjoint Interim Approaches for assessing risks to listed species from pesticides (see the white paper "Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations ofthe National Academy of Sciences April2013 Report," available at http: //www .epa.gov/espp/2013 /nas.html )

. The Interim Approaches were developed jointly by the agencies in response to the NAS recommendations and reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings. The agencies also held stakeholder workshops in April and October 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. Additional workshops are planned to enhance stakeholder involvement. As part of a phased , iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. Comments submitted by Dow AgroSciences (DAS) in EPA-HQ-OPP-2015-0303-0015. 3. Comment: A summary of the screening level estimates of agricultural uses of penoxsulam is presented in Table 2 which includesplums / prunes as crops. This entry should be deleted since penoxsulam is not currently registered in plums orprunes. EPA Response : The Agency thanks DAS for calling our attention to the fact that penoxsulam was not previously registered for use on, "bearing" plums/ prunes. This use was updated on March 2, 2016 and the registered use is now on the technical and end use label (Registration No. 62719-612) for "nonbearing" fruit trees including plums and fresh prune . PLANNED DATA NEEDS Table 1 below summarizes the planned data needs for penoxsulam based on the Registration Review Ecological RiskAssessment for Penoxsulam and the Penoxsulam Human Health Assessment Scoping Document in Support of Registration Review
. The planned data needs have not changed from what was included in the PWP.

4Table 1: Planned Data Need s for the Penoxsulam Registration Review Estimated Guideline Study Title2 Timeframe Number-2 Test Material (Months from receipt ofDCI) Non-guideline Acute oral toxicity to larval honey bees TGAI 12

(OECD 237) Non-guide! ine Chronic oral toxicity to adult honey bees 3 TGAI 12 Non-guideline Chronic oral toxicity to larval honey bee s 3 TGAI 12 Non-guideline Field trial of residues in pollen and**necta ·**  4 TEP 24 Non-guide line Semi-field testing for pollinator3A TEP 24 850.3040 Field testing for pollinators4 TEP 24 TGAI = techmcal grade acttve mgredtent; TEP = typtcal end-use product RISK ASSESSMENTS FOR REGISTRATION REVIEW During registration review and after data are received and reviewed , the Agency will update the risk assessment only for honey bees for all uses ofpenoxsulam. The most recent risk assessment will not be revised , except for honey bee information

. For human health, EPA will conduct residential and occupational risk assessments during registration review and possibly a dietary risk assessment. If toxicological endpoints or points of departure are revised based on data received during registration review, they will be considered in the new assessments, as well as any changes to the standard operating procedures or default exposure assumptions. Table 2 below summarizes the anticipated registration review risk assessments based on the Registration Review Ecological RiskAssessment for Penoxsulam and Penoxsulam Human Health Assessment Scoping Document in Support of Registration Review ; the planned assessments have not changed from what was included in the PWP.

2 On June 27, 20 12 , EPA announced certain revisions in harmonized guideline series 850

- Ecological Effects Tests

- including renumbering and other designations or changes for some guideline studies

. See "Final Test Guidelines; OCSPP 850 Series; Notice of Availability " 77 FR 38282, June 27, 2012. http ://www .regulations

. gov/E PA-HQ-OPPT-2009-0 154-0028 3Guidance for these studies can be found at: http ://www2.epa

.gov/pollinator-protection/pollinator-risk-assessmentguidance

. 4 Pending review of lower Tier studies. 5

### Tab le 2: Planned Risk Assessments for the Penoxsulam Registration Review Type of Risk Assessment Conduct? Notes Ecological and Environmental Fate Comprehensive ecological 

### y The PRA for ecological risk was posted to the docket (species to be assessed along with the PWP
. When data required for include terrestrial and aquatic registration review are received, the Agency expects organisms) , including to be able to conduct an assessment for honey bees

. endangered species Incidents Will check for For a discussion ofreported ecological incidents for updates penoxsulam , see page 19 ofthe Registration Review Ecological RiskAssessment for Penoxs ulam

. 

### Human Health Dietary Food N The most recent dietary risk assessment is adequate to support registration review. However, a dietary assessment would be conducted ifthere were unanticipated changes to dietary endpoints/safety factors or a new drinking water assessment. Drinking water N A new drinking water assessment will not be conducted in the registration review process unless any new use registration requests submitted to EPA warrant it. Occupational Handlers (mixers , loaders , 

### y Updated occupational handler assessments will be applicators) conducted to reflect all the registered uses and current occupational exposure policies. Post-application 

### y No dermal endpoint has been identified , so no dermal occupational post-application assessment is planned

. If the Agency ' s volatilization screening tool or data from the Agricultural Reentry Task Force indicate that analyses of occupational post-application inhalation exposures are needed, they will be included in the registration review risk assessment for penoxsulam. Residential Handlers 

### y No short-term dermal endpoint has been identified , so a quantitative dermal 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; however, no risks of concern are anticipated.

6Post-application 

### y The Agency previously conducted residential postapplication assessments for the turf and aquatic uses . The risk estimates were not of concern . However, during registration review, these assessments will be updated as needed based on revised inputs, assumptions, and SOPs. The Agency also will consider the potential for residential post-application exposure through spray drift and volatilization. Other Aggregate 

### y HED will conduct a new aggregate risk assessment that will be based on any policy changes and potential updates to points of departure. Cumulative N Penoxsulam is not a member of a cumulative group with a common mechanism of toxicity to humans. Therefore no cumulative risk assessment is planned. Tolerances N Per the Scoping Document, the Agency expects to revise the tolerance expression for penoxsulam at 40 CFR 

### § 180

.605. Incidents Will check for For a discussion of reported human incidents for updates penoxsulam, see page 11 ofPenoxsulam Human Health Assessment Scoping Document in Support of Registration Review and the Penoxsulam : Tier I Review of Human Incidents

.


### TIMELINE EPA has created the following estimated timeline for the completion ofthe penoxsulam registration review in Table 3 below. The projected timeline has not changed since the PWP. 

### Table 3: Registration Review for Penoxsulam- Projected Registration Review Timeline Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period September 2015

- Completed Close Public Comment December 2015

- Completed Case Development Final Work Plan March 2016

- Completed Issue DCI June 2016 Data Submission June 2018 60-day Public Comment Period for Draft Risk Assessments 5 December 2019 Registration Review Decision

5 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 ; see 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
. 7

### Table 3: Registration Review for Penoxsulam- Projected Registration Review Timeline Activities Estimated Date 60-day Public Comment Period for Proposed Registration Review September 2020 Decision Registration Review Decision and Begin Post-Decision Follow-up March 2021 Total (years) 6 

### NEXT STEPS As noted previously , the Agency plans to require several ecological effects studies for penoxsulam through a Data Call-In Notice , expected to be issued by June 2016

.



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