### 1 OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460



### October 5 , 2015

PC Code: 028201

MEMORANDUM DP Barcode: 429136

S UBJECT : Propanil : EFED Response to Public Comments Regarding the Registration

Review Problem Formulation : Docket ID# EPA

- HQ

- OPP

- 2015

- 0052

.

FROM: Ryan Mroz, Biologist He Zhong, Ph.D., Biologist

Environmental Risk Branch I Environmental Fate and Effects Division (7507P)

THRU: Sujatha Sankula, P h.D., Branch Chief Greg Orrick, R isk A ssessment P rocess L eader

Environmental Risk Branch I Environmental Fate and Effects Division (7507P)

TO: Leigh Rimmer, Chemical Review Manager Cathryn Britton, Team Leader Kevin Costello, Branch Chief

Risk Management and Implementation Branch II

Pesticide Re

- evaluation Division (7508P)

Attached please find the Environmental Fate and Effects Division (EFED)’s response to public comments on the problem formulation for the r egistration r eview of p ropanil (Do cket ID No.: EPA

- HQ

- OPP

- 2015

- 0052 ). Comments were received from the following stakeholders and are addressed in this response:

• RiceCo, LLC (RCLLC)

– The Principal Registrant of propanil

• California Rice Commission (CRC)

• City of Sacramento Department of Ut ilities (CSDU)

• USA Rice Federation (USARF)

• Center for Biological Diversity (CBD)

EFED generally uses an outline format to address the comments (comment followed by EFED response). The names of the submitters are abbreviated for ease of reference (see above). Some comments are provided verbatim in italic font whereas others are summarized. Full comment documents can be found

in the Docket

.

### 2 Response to Public Comments Regarding the Problem Formulation for the Registration Review of Propanil

1

. Pro panil’s importance , acreage treated
, and u sage data ( CRC, RCLLC, USARF

, and CSDU )

.

EFED Response: The Agency acknowledges the importance of propanil usage in rice production and appreciates the clarification of the use, usage and acreage treated

. The information is helpful for the propanil Registration Review ecological risk assessment

. Since the assessment is based on the label,

t he Agency is encouraging the registrant (RCLLC) to clarify all uses for other States in addition to California on the labels, especially the maximum single application rate ( lbs a.i. /acre ), the maximum number of applications per year, the minimum re

- application interval and the maximum annual application rate ( lbs a.i. /acre/year ).

2. T he a dditional data needs for pollinator s ( USA RF
, CRC, and RCLLC )

.

USA RF : Rice is a self

- pollinating crop. Bees and other pollinators are not a fixture in rice fields. As such, USA Rice believes that EPA’s workplan calling for several honey bee and nectar toxicity studies is unnecessary and would tie up resources better used on other data gathering.

CRC: Impacts on honeybees are not an issue from rice farming practices. The registrant has the ability to comply with the data req uirements, while our role is to provide information to assist with the final decision. Rice is a self

- pollinated crop, it is not a cross pollinated crop like maize, and does not rely wind or insects for pollination. Pollen shed and pollination occurs right before, or as, the flower opens in the

mid

- morning hours. The flowers open for a short period, the anthers dehisce, and then flowers close, leaving the anthers outside the flower. Flowering and pollination usually takes place in mid

- July through

mid

- Augus t in California. This is not the period when managed bees under contract pollination are pollinating crops such as almonds during late winter to early spring

RCLLC: Propanil exhibits very low toxicity in honey bees. The EPA categorizes pesticides as "toxi c to bees" if they cause greater than 50% mortality in adult bees exposed up to 11 micrograms per bee, which technically speaking means that the LD5o is less than 11 micrograms/bee. Available data indicate that the contact LD50 for Propanil is greater than 100 micrograms/bee and the oral LD50 for Propanil is greater than 94 micrograms/bee. Similarly, the contact LD50 for 3,4

- DCA is greater than 100 micrograms/bee and the oral LD50 is greater than 1,600 micrograms/bee. Additionally, it is believed that

there have not been any adverse incidents involving Propanil and bees. EPA collects reports of toxicity incidents involving honey bees from the public, state regulatory agencies and from the adverse effects reporting obligations of registrants of pesticides. Ri ceCo believes that in the entire history of the use of Propanil on millions of rice acres in the United States for over 5 decades there has not been a reported adverse incident involving bees. That is consistent with the recent report by the USDA (Attracti veness of Agricultural Crops to Pollinating Bees for the Collection of Nectar and/or Pollen, 2015, USDA at p.18) confirming that rice is not attractive to pollinating bees. That is to be expected because when Propanil is applied, there are no flowers to at tract bees.

EFED Response: The Agency has recently implemented the Pollinator Risk Assessment

Framework 1

. Honey bees are also used as a surrogate species for all terrestrial invertebrates including Apis and non

- Apis bees and other insect pollinators. The Agency evaluates multiple lines of evidence in determining which data to be used to inform the various tiers of refinement that may be required to

1 http://www2.epa.gov/sites/production/files/2014

- 06/documents/pollinator_risk_assessment_guidance_06_19_14.pdf

### 3 support risk management decisions. Currently, t he only data available to assess the potential risk from propanil to bees is an acute contact study with a non

- definitive endpoint. Although honeybees may not be a fixture in rice fields, exposure to other insect pollinators adjacent to rice fields is possible from propanil usage. In addition, propanil toxicity against other life stages of the pollinator is

unknown

. Therefore, additio nal pollinator studies are necessary.

3

. Monitoring d ata and m odel usages ( CSDU and CRC )

.

CSDU: In recent years, surface water monitoring programs in our region have detected propanil and its degradate 3,4

- dichloroaniline (3,4

- DCA) in the Sacramento River, both upstream and in the very reach that includes water treatment plant intakes. Both propanil and a major degradate

- 3,4

- dichloroaniline (3,4

- DCA)

- have been detected in the Sacramento River watershed on more than 100 occasions at

concentrations up to 47 1Jg/L

. Recent monitoring by the USGS on the Sacramento River at Freeport showed that 3,4

- DCA was detected in nearly every sample, that propanil degradation is likely the source of most 3,4

- DCA in the watershed, and that concentrations of the degra date were often three or more times the concentration of propanil.

We understand that EPA is developing an update to the model it uses to estimate surface water concentrations of rice pesticides, the Pesticides in Flooded Agriculture Model (PFAM). We enc ourage EPA to use the updated version of PFAM in its propanil risk assessments if possible. Whether or not the updated version of PFAM is ready for use for this risk assessment, EPA s hould draw on the more detailed scientific understanding of the relations hip between rice pesticide use and downstream drinking water intakes that it has gained through the PFAM update effort.

Since propanil monitoring is ongoing in our region, when EPA initiates work on its risk assessment, we request that EPA obtain the most recent California monitoring data from the California Water Board CEDEN database, California Department of Pesticide Reg ulations' Surface Water Monitoring database, and the U.S. Geological Survey National Water

- Quality Assessment Program database. These databases will probably contain the data we mentioned above. (We understand that EPA routinely downloads data from these t hree government databases.). We request that EPA also contact the California Central Valley Regional Water Quality Control Board's Irrigated Lands Program, which may have additional data that have not yet been uploaded into CEDEN.

CRC: The California rice industry has a long history of managing water quality programs dating back over 30 years. The California Department of Pesticide Regulation (CDPR) monitored propanil in surface water during 1987, 1988, 1998 and 2001. Starting in 2003, all agriculture in t he Central Valley began surface water monitoring under a conditional program to evaluate discharges from irrigated lands. The conditional program has evolved to permanent regulation implemented through waste discharge requirements with orders approved in 2 014. Under the conditional program, the CRC monitored propanil at our established core sites and one river location patterning the monitoring after the thiobencarb schedule. Propanil monitoring took place from 2006 to 2008 using the EPA 8081A(w) method wit h the reporting limit of 0.05 μg/L

... The CRC has resumed propanil monitoring as regular rotation under the current waste discharge requirements in 2015.

EFED Response: The Agency appreciates the data and resources provided by the commentators. The Agency will use the most recent aquatic models, such as P FAM , SWCC and PRZM

- GW and review

all available monitoring data collected by federal and state agencies such as the U.S. Geological Survey (USGS)

, National Water Quality Assessment (NAWQA) Data Warehouse and California Environmental Data Exchange Network (CEDEN) for propanil and its degradate 3,4

- DCA for the Registration Review ecological risk assessment and drinking water assessment

.

### 4 4. Consultation with the Services (CBD)

.

C BD : “ EPA has an independent duty under the Endangered Species Act to consult with the U.S. Fish and Wildlife Service and National Marine Fisheries Service on the [Registration Review] of propanil ” and its

end

- use product labels including making “defensible “Not Likely to Adversely Affect” and “Likely to Adversely Affect” determinations as a prerequisite for defensible “Jeopardy” and “No Jeopardy” determinations,” assessing the “adverse impacts of propanil in critical habitat,” and following the new Interim Appro aches based on recommendations of the National Academy of Science that include a spatial analysis at Step 1 and geographic restrictions on product labels to protect critical habitat at Steps 2 and 3.

EFED Response: EPA has reviewed the comments from CBD o n the problem formulation for the registration review of propanil and plans to address many of the concerns raised by CBD as part of the implementation plan for assessing the risks of pesticides to listed species based on the recommendations of the April 2 013 National Academy of Sciences (NAS) report. EPA will address concerns specific to propanil in connection with the development of its registration review decision

for propanil

.

The NAS report, available at http://www.nap.edu/catalog.php?record_id=18344 , outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that are compliant with the Endangered Species Act and the Federa l Insecticide, Fungicide, and Rodenticide Act. In November, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (collectively, the Services), and the U.S. Department of Agriculture (USDA), released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. 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 EPA and the Services. The joint Interim Approaches were released prior to the stakeholder workshop held on November 15, 2013. EPA presented the joint Interim Approaches at the Decembe r 2013 PPDC and SFIREG meetings, allowing additional opportunities for stakeholders to comment on the Interim Approaches. The Agencies are considering public comments on the Interim Approaches prior to implementing them. The Agencies intend to jointly im plement these approaches as part of a phased iterative process. EPA will refine its listed species risk assessments based on these interim approaches. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches for Na tional

- Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013, available at http://www.epa.gov/ espp/2013/nas.html

.

EPA plans to follow the March 2013 stakeholder engagement paper (“Enhancing Stakeholder Input in the Pesticide Registration Review and ESA Consultation Processes and Development of Economically and Technologically Feasible Reasonable a nd Prudent Alternatives”) to identify the appropriate time for initiation of consultation, either formal or informal, with the Services. The stakeholder engagement paper, jointly developed by the EPA, USDA, and the Services and available

at http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

- OPP

- 2012

- 0442

- 0038 , allows for early

interaction with the Services under informal consultation. EPA and the Services acknow ledge that early interaction as part of informal consultation may result in refinements to EPA’s effects determinations that can improve the efficiency of the ESA compliance process. For example, EPA may involve the Services at the earliest stages of regi stration review. In general, EPA plans to initiate formal ESA consultation, if necessary, at the final decision stage in the registration review process. Consulting later in the process allows the EPA to develop more refined ecological risk assessments

### 5 a nd to engage stakeholders in discussions that should result in more focused consultation packages that may include risk mitigation for listed species.