UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

Cyprodinil: Response to Public Comments on EPA’s Proposed Registration of the New Use

tree nuts, crop group 14

- 12 (Docket ID: EPA

- HQ

- OPP

- 201 5

- 0180 )

Summary

This document summarizes the U.S. Environmental Protection Agency's (the Agency, EPA)

responses to public comments received through the public notification of the receipt of the

application for new uses for cyprodinil on tree nuts, crop group 14

- 12; except almond, except

pistachio

.

On April 15 th , 2015, EPA published a notice of receipt in the Federal Register for Pesticide

Product Registration ; Receipt of A pplication for new uses

. The Notice for the proposed new

use s announced a public comment period of 30 days; two comments were received on the notice

of receipt

.

Both comments were submitted by the Center for Food Safety. The first comment provided

information and cited abstracts. The other comments were outlined in a document submitted by

the Center for Food Safety. The agency’s review and r esponses are summarized in this

document.

Summary of Comments on Applications to Register Pesticide Products Containing

Cyprodinil

Comments from: Center for Food Safety Document ID: EPA

- HQ

- OPP

- 2015

- 0180

- 0005

I. **EPA MUST**  **CRITICALLY ASSESS**  **THE IMPACTS**  **OF THE**  **PROPOSED NEW** 

**SYSTEMIC** FUNGICIDES ON POLLINATOR HEALTH

• In evaluating the applications for use of cyprodinil

, EPA must critically assess the

potential adverse effects from the uses of this systemic fungicides on honey bees and

other pollinators. Because of its systemic nature, cyprodinil poses similar dangers as the

currently widely

- used neonicotinoid pesticide s, for which EPA has recently moved up

registration review in order to better assess this toxic chemica ls’ impacts on pollinator

health.

• The additional proposed outdoor uses of this systemic fungicide would create another

stressor to honey bees and other pollinators, and further threaten the health of these

precarious species.Page 2 of 6

• Outstanding data gaps and studies on systemic fungicides and their impacts on honey

bees and pollinators dictate that EPA cannot register the proposed pesticide products

and their uses unconditionally under Section 3(c)(5) of FIFRA, but can only consider

them for conditional registration under Section 3(c)(7) of FIFRA.

EPAs Response:



### • Cyprodinil is practically non

- toxic to adult honey bees on an acute contact basis, and no

effects were observed in the oral toxicity study at the highest tested dose.

• EPA published its Pollinator Framework in 2014, which describes the studies to be used in

a tiered updated risk assessment approach. The enhanced approaches for pollinator risk

assessment will permit EPA to evaluate larval safety as well as chronic exposure. If

suggested by the new baseline data, the framework may also call for colony

- level data.

• EPA is currently developing an approach for implementing the new bee testing

r equirements in the context of three types of reg ulatory actions including Registration

Review of existing pesticides, registration of new pesticide uses, and registration of

pesticides containing new active ingredients. In cases where the Tier I bee data was not

required as part of an already

- issued Registration Review DCI, decisions on when to issue

a subsequent DCI for the missing Tier 1 data will be prioritized based on the chemical’s

potential for both bee exposure and effects. Based on a lack of t oxicity to adult bees from

the acute oral and acute contact routes of exposure, cyprodinil is not among the chemicals

prioritized for issuance of a subsequent DCI at present.

• EPA is currently engaged in a rulemaking effort to codify the Tier I studies outlined in the

Pollinator Framework.

• Existing data for cyprodinil do not suggest that mitigation for honey bees are necessary on

the product labels

• EPA has concluded that FIFRA section 3(c)(5) finding is supported, based on all factors

and th e decision standards under FIFRA.

II. EPA MUST CONSIDER THE ECONOMIC IMPACTS AND ADVERSE

EFFECTS ON U.S. AGRICULTURE STEMMING FROM THE

PROPOSED USE OF CYPRODINIL

• Effects on U.S agriculture economy, and on honey bees and other terrestrial

invertebrates, including native bees and other vital pollinator species whose existence

is the backbone of the U.S. agricultural economy.

• Given the uncertainties and initial results that point to significant acute hazards, the

propose applications for new uses present unreasonable adverse effects to bee species,

pollinators, and other beneficial organisms.

EPAs Response:

• The cyprodinil new uses are not expected to result in toxic effects to individual adult

honey bees resulting from acute oral and acute contact toxic ity based on the data

available to characterize the toxicity to adult honey bees. Due to its practically non

toxic classification to honey bee on an acute contact basis, cyprodinil is not expected toPage 3 of 6

adversely impact beekeepers or agricultural interests w ho depend on them. Therefore,

t he Agency does not believe cyprodinil would pose adverse economic effects on the U.S

agricultural market or environment.

• On the other hand, c yprodinil provides many benefits. Since , cyprodinil is an anilo

pyrimidine (methionine biosynthesis) acting as a methionine inhibitor in fungi, the

Fungicide Resistance Action Committee (FRAC, 2015) 1 classifies cyprodinil as a

Group 9

, AP fungicide s

. Cyprodinil is typically used as one of the fungicides in rotation

to manage alternaria late blight in pistachio (e.g., UC Pest Management Guidelines,

2014) 2 and wou ld likely be used as one component of a program to manage alte rnaria

late blight of tree nuts, crop group 14

- 12

. Alternaria blight is difficult to control,

causing lower quality and production of a pistachio crop significantly by causing nut

staining, early defoliation and, in some cases, moldy nuts, and requires a combination of

management approaches. Some pistachio growers estimate a $1,000 per acr e loss due to

shell staining and lower nut quality resulted from Alternaria infestations

( www.ucanr.edu ) 3

. Resistance of Alternaria spp. to Group 11 and 7 fungicides has

been detected in some pistachio orchards 2

. Late blight is a problem in orchards

irrigated by sprinklers or flooding, with low soil infiltration, and where humidity can be

high and dew formation frequent during late August and September. As with most

fungicides used to manage late blight, application o f cyprodinil in orchards begin

around or at bloom which in almonds coincide with the presence of honey bees

. In

addition to chemical sprays, cultural practices are important for managing alternaria late

blight on tree nuts, crop group 14

- 12

. When used in rotation with other pest

management tools, studies have demonstrated the usefulness of cyprodinil as an

effective fungicide for controlling alternaria late blight caused by isolates of A. alternata

and its potential to help avoid or delay fu ngicide resistance development in certain

pathogens (Crop Protection, 2015) 4

.

• In summary, the registration of cyprodinil for use on tree nuts, crop group 14

- 12 would

add an additional pest management against alternaria late blight, but there are several

effective alternatives currently registered that can be used to manage the disease.

Therefore, use of cyprodinil on tree nuts, crop group 14

- 12 could offer benefits to the

U.S agriculture and economy by sustaining the commodities it has been effec tive in

treating and adding to the current fungi pest management practices available for tree nut

uses. This in turn could be advantageous to the U.S economy and agriculture . The

effects cyprodinil may have on agriculture and the economy as it relates to honey bees

and other pollinator species will be addressed in the bullet below.

• The Agency is actively assessing potential impacts to honey bees generally as part of

the Agency's registration review program for currently registered or existing pesticides.

This allows the Agency to focus on chemicals with potentially higher risk and to

1 FRAC. 2014. Fungicide Resistance Action Committee Code List: Fungicides Sorted by Mode of Action. http://www.frac.info/docs/default

- source/publications/frac

code

- list/frac

- co de

- list

- 2015

- finalC2AD7AA36764.pdf?sfvrsn=4

2 UC Pest Management Guidelines. 2014. Pistachio Alternaria Late Blight

. University of California Extension. http://www.ipm.ucdavis.edu/PMG/r605100411.html

3 Kearney Agricultural Research and Extension Center. 2016. Alternaria Blight. University of California Division of Agriculture and Natural Resources.

http://kare.ucanr.edu/programs/Plant_Pathology/Alternaria_Late_Blight/

4 H.F Avenot and T.J. Michailides. 2015. Detection of isolates of Alternaria alternata with multipl e

- resistance to fludioxonil, cyprodinil, boscalid and pyraclostrobin in California pistachio

orchards. University of California Davis. http://www.sciencedirect.com/science/a rticle/pii/S0261219415301125Page 4 of 6

address any issues that arise from them, resulting in the greatest potential benefits for

non

- target species

. Previous Agency evaluations indicate that cyprodinil does not pose

a significant risks to bees. Since the application rates for each proposed new use have

not increased and the maximum annual application remains unchanged, similar risk

conclusions are expected by the Agency . Therefore, cyprodinil is not among the

chemicals prioritized for issuance of a subsequent DCI at present.

III. EPA MUST CONSIDER THE POTENTIAL ADVERSE EFFECTS ON

ORGANISMS, SOIL HEALTH AND U.S. AGRICULTURE

STEMMING FROM THE PROPOSED USE OF CYPRODINIL

• EPA must critically assess the potential adverse effects on beneficial soil organisms,

soil health and their interrelated impacts on U.S. agriculture.

EPAs Response:

• At this time, EPA’s ecological toxicity database for cyprodinil is complete, according to

current requirements and approaches. However, EPA does not require hazard data on earth

worms. EPA relies upon test data for a number of representative species and will calculate

risk information for these species as a surrogate for other taxonomic groups. Alt hough the

risk assessment for cyprodinil indicates there are a certain number of levels of concern , the

exceedance is generally small. Further, compared to other commercially available

effective fungicides, the risks for cyprodinil are very modest and mitigated in a manner

consistent with the EPA’s Label Review Manual and 40 C.F.R. 156.

IV. EPA MUST CONSULT ON THE POTENTIAL IMPACTS OF THE

PROPOSED PESTICIDE PRODUCTS AS REQUIRED UNDER THE

ESA

• EPA must comply with the agency’s duty under the ESA and consult the expert

agencies on the potential effects of three active ingredients on listed species or their

critical habitats.

EPAs Response :

• The Agency has been working collaboratively and actively with the United States Fish

and Wildlife Service (USFWS) and the National Marine Fisheries Service (NMFS or

“Services”) to design a framework for efficiently completing the consultation process for

pesticide actions in accordance with the Endangered Species Act (ESA). The Agency is

focusing most of its resources for assessing impacts to listed species on the Agency's

registration review program for currently registered or existing pesticides. This allows

the Agency to focus on chemicals with higher risk, resulting in the greatest potential

benefits for listed species. The EPA believes that, as a general matter, currently

registered and existing pesticides may present a greater degree of risk to listed speciesPage 5 of 6

than most new chemistries and new uses coming to market, and th at it is therefore

environmentally preferable in most circumstances for the EPA to assess the impacts of

existing pesticides sooner in the process than newer pesticides that are designed to

compete with more risky alternatives. The Agency does not believe the environment or

the public would be best served by delaying the approval of the new use Tree Nut Crop

Group 14

- 12 (except almond and pistachio) on the already registered active ingredient

c yprodinil given its low toxicity profile as explained in the next bullets

. Additionally, the

EPA has also negotiated with our partner agencies to phase

- in interim scientific

approaches over time. In November 2013, EPA, USFWS, NMFS, and the US

Department of Agricul ture (USDA) released a white paper containing a summary of

their joint interim approaches for assessing risks to listed species from pesticides. These

interim approaches were developed jointly by the agencies in response to the National

Academy of Sciences (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. Details of the joint interim approaches are contained in the

November 1

, 2013 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 . The EPA, USFWS and NMFS are continuing

to develop and work toward implementation of the interim approaches to assess the

potential risks of pesticides to listed species and their designated critical habitat, and

will apply these approaches to initial consultations and, based upon the experience

gained with these approaches as well as any new science that may develop, modify

procedures as appropriate.

• With respect to the evaluation of cyprodinil specifically and as explained in this

document, current data indicate that the ecological risks presented by uses of cyprodinil

are generally low. Cyprodinil was granted classification as a Reduced Risk pesticide.

This means that compared to existing conventional pesticides such as

organophosphates, carbamates and pyrethroids, its presents characteristics that may

inclu de lower impact on human health, lower toxicity to non

- target organisms, low

potential for groundwater contamination, low pest resistance potential and compatibility

with Integrated Pest Management practices. Although the level of concern has been

exceede d for the non

- target organisms list below in the next bullet, the Agency uses

conservative exposure estimates to determine potential risk to non

- target organisms and

mitigation of potential risk is achieved through the risk management process, which

includ es label and use restrictions. To the extent that the EPA receives new information

indicating that cyprodinil may pose a greater risk to listed species than indicated by the

existing scientific database for this pesticide, the EPA will re

- evaluate the term s of

registration and determine whether use restrictions to protect listed species are

necessary.

• Based on the ecological assessment conducted for tree nut crop group 14

- 12, EPA

concluded that no increased risk for the new uses from what was determined for

previously granted uses when label mitigations are included. Cyprodinil poses an acute

and chronic risk to species of aquatic organisms including freshwater invertebrates and

ma rine/estuarine invertebrates living in the water column and in the benthic zone.Page 6 of 6

Existing product labels for cyprodinil contain mitigations to reduce aquatic exposures (1)

vegetative filter strips and (2) buffer zones. Such mitigation measures are design ed to

minimize the potential exposure of cyprodinil

- treated areas to water bodies and include

the requirement of buffer zones for both aerial and ground applications, vegetative buffer

strips, spray drift reduction advisory, surface and ground water adviso ries, and

environmental hazard warnings. Given the cyprodinil risk assessment is conservative,

the buffers zones and label restrictions are established to minimize risk and are

considered appropriate risk mitigation measures.

V. EPA SHOULD ALLOW OPPORTUNITY FOR SUBSTANTIVE

PUBLIC COMMENT ON THE AGENCY’S DECISION

- MAKING

DOCUMENTS, INCLUDING RISK ASSESSMENTS AND ANY OTHER

SUPPORTING DOCUMENTATION

• EPA should give the public and interested parties an opportunity to give substantive

input into EPA’s decision

- making process by publishing and allowing for comments on

the registrants’ application materials, EPA’s risk assessments, and EPA’s proposed

registration decisions prior to issuing EPA’s final decis ions.

EPAs Response:

• EPA now provides several ways for public participation in the pesticide registration

process. In response to President Obama’s directive on transparency and open

government, EPA’s Pesticide Program explored opportunities for expanding the

openness of the process, and accordingly in October of 2009 began implementing a

public participation process for certain registration actions. By establishing this process,

the Agency has increased opportunities for the public to comment on risk assessments

and proposed registration actions. Both EPA and the public benefit from a public

participation process because the public helps to inform the risk assessment and risk

management processes associated with registration.

• Further

, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA )

§ 3(c)(4)

, the agency is required to publish a notice of receipt for all applications for

pesticides containing “any new active ingredient or if [the application] would entail a

changed use pattern. ” For the current new use, tree nut crop group 14

- 12 we made the

notice of receipt available for public comments as required. This document is the

response to comments received on that notice. Further, EPA publishes a Notice of

Filing for tolerance petitions for food uses. Such a public notice was prepared in this

case. These notices address the necessary approaches for transparency called for

und er FIFRA and the Administrative Procedures Ac t.