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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

2 I. INTRO D UC T ION

Th i s document i s the E n vironmental Protection Agency's ( E PA o r the Agency) Interim Registration

Review D ecision f

o r cyromazine (Case 7439), w h i ch is being i ssued p u rsuant to 40 C F R sectio n s 1 55.56

a nd 1 5 5

. 5 8

. A re g

i str a tio n review de ci si o n is the Agen c y 's dete r minat

i on of whe t h er a p esti c

i d e

meets, or does not meet, the standard for r egistrati o n in t h e Fed e ral I nsecticide, Fungicide, and

Rodenticide Act (

FIFR A ). The Age n cy may issue, when it d etermines it to be appropr i a te, an

Interim R egistration R e

v iew Decision before c ompleting a r e gistration review. A m ong other

th i n gs, the Interim Regist r ati o n Review Decision may require new risk mitigat i on mea s ures,

im p ose interim r

i sk mitigation measu r e s, i de ntify da t a o r info r mat

i on req u i r ed to com p l

ete the

review, and include s che d u l es for submitting the required da t a, c o nd u cting the new ris k

assessment and completing the r e gistration review. For further information on cyromazine,

additional d ocuments can be fo u nd in EPA's public docket ( EP A

- HQ

- OP P

- 2 00 6

- 0 108) at

www.regulations.gov

.

FIFRA, as amended by the F o od Quality Protection A c t (FQPA) of 1 996, mandated the

continuous review of existing pesticides. All pesticides distributed or sold in the Un i ted States

gener a l l y m u s t be registered by the EPA based on scient i fic data s howing that they will not cause

unreasonab l e r

i s ks t o human he a l t h or to the environment when used as directed on produ c t

l ab e lin g

. T h e re g

i s tration review program i s intended to make sure that, a s the ability to assess and

reduce risk ev o l

ves and as policies a nd practices change, all registered pesticides continue to m e e t

the statutory stan d ard of no unreas o n a b l e adv e rse effects. Changes in science, public policy, and

pesticide use practices will occur o ver tim e

. Through the registration review p r ogram, the Agency

periodic a l l y r e

- ev a l uates p esti c ides to m ake sure that a s these c hanges occur, products in the

marketplace can continue to be us e d safely. Information on this program is p r ovided a t

www.epa.gove/oppsrrd1/registration review/

.

In 2006, the A g

en c y imp l emented the registration review program pursuant to FIFRA s e ction

3(g) a nd w

ill review each r egi s t er e d p e sti c i d e ev e ry 1 5 years to d etermine whether it conti n u es t o

m eet the F IFRA stand a r d for regi s t r ation.

Cyromazine is an insect growth regulating triazine insecticide which exerts its effects by inhibiting

chitin synthesis. Cyromazine is currently registered for use on several crops, o rnamentals and

livestock commodities (including livest o ck premises) for c ontrol of a variety of fly pests, maggots,

fly larvae, and leaf miners. Cyromazine is formulated as a wettable powder, soluble concentrate and

granular. It is also registered for use as a feed through for horses and chickens to control fly pests in

their manure and as a seed treatment for bulb onions for the onion maggots . There are no

cyromazine products registered for residential use. Cyromazine was first registered as a pesticide in

1993, and therefore was not subject to reregistration. The followin g timeline highlights significant

cyromazine registration review documents and actions that can be found in the public docket under

EPA

- HQ

- OPP

- 2006

- 0108, which can be accessed through http://www.regulations.gov/

.

• March 28, 2007

- The Agency published the Cyromazine Summary Document , dated March 23,

2007 in d ocket number EPA

- HQ

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- 2006

- 01 08 for a 60

- day public comment peri od.

The Summary Document included the Agency’s Preliminary Work Plan for Cyromazine

, in

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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

3 2007

, and the Registration Review Scoping Document for Human Health Assessment

, dated March

21, 2007. The Agency received six comments during the public comment period, which

were addressed in the Final Work Plan.

• September 7, 2007

- Cyromazine Final Work Plan for Registration Review d ated August 21,

2007 posted to the docket. The Cyromazine Final Work Plan con fir med that the Agency

would conduct a comprehensive human health and ecological risk assessment during the

Registration Review process, in addition to providing responses to the six comments that

were received d uring the public comment period for the Cyromazine Summary Document.

• September 17, 2008

- E PA i ssued t h e G e n eric D a t a C al l

- I n (DCI) f

o r cyromazine. Data

requirements included: U V / v isible absorption (GLN 830.7050); oyster acute toxicity

( GLN 850. 1 025); mysid chronic toxicity (GLN 8 5 0 .135 0 ); and inh a

l ation toxicity (GLN

870

. 346 5).

• Ma r ch 7, 2 0 13

- The Agency publi s hed the Preliminary Ecological Risk Assessment for the

Registration Review of Cyromazine

, dated J an uary 24, 2013 and the Human Health Risk

Assessment for Registration Review

, dated Ja n uary 31, 2013 for a 60

- d a y p ubl i c c o m m e nt p eri o d.

• May 6, 2013

– One comment was submitted by Syngenta which contained information

regarding the ecological fate and effects of cyromazine. Syngenta also submit ted an acute

neurotoxicity stud y (ACN study).

• July 23, 2014

- The Agency published the Cyromazine Proposed Interim Registration

Review Decision for a 60

- day public comment period, in addition the Environmental Fate

and Effects Division's Response to Pub lic Comments on the Registration Review Preliminary Risk

Assessment for Cyromazine , dated March 26, 2014 and the Cyromazine: Human Health Risk

Assessment for Registration Review , dated February 17, 2014 in the public docket, EPA

- HQ

OP P

- 2 0 0 6

- 0108, which can b e accessed th r ou g h http://www.regulations.gov/

• December 2014

– The Agency is now publishing the Cyromazine Interim

Registration Review Decision on regulation s

. gov under docket number E P A

- H Q

-

OP P

- 200 6

- 01 08.

Public Commen t s

One comment was submitted to the Agency by the Center for Biological Diversity during the 60

- day

public comment period for the Cyromazine Proposed Interim Registration Review Decision . The

Center for Biological Diversity’s comment addressed the Agency’s responsibilities under the

Endangered Species Act (ESA). T he C enter for Biological Diversity’s comment is summarized

below along with the Agency’s response . The Center for Biological Diversity’s comment in its

entirety is located in the docket, EPA

- HQ

- OPP

- 20 06

- 01 08 accessible at www.regulations.gov

. Comment S ubmitted by the Center for Biological Diversity in EPA

- HQ

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- 2006

- 0108

- 0045

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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

4 Comment: The Center for Biological Diversity’s (CBD) comments focus on the EPA’s independent duty under the

Endangered Species Act (ESA) to consult with the U.S. Fish and Wildlife Service and the National Marine

Fisheries Service (the Services) on the reg istration review of cyromazine.

Response: EPA has reviewed the comments from for cyromazine 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 r ecommendations of the April 2013 National Academy of Sciences

(NAS) report. EPA will address concerns specific to cyromazine in connection with the

development of its registration review decision for cyromazine.

In November 2013, 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

National Academy of Sciences’ (NAS) recommendations and reflect a common approach to risk

assessment shared by the agencies as a way of addressing scientific diff erences between the EPA and

the Services. The NAS report outlines recommendations on specific scientific and technical issues

related to the development of pesticide risk assessments that EPA and the Services must conduct in

connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

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, and held a stakeholder workshop in April 2014, allowing additional

opportunities for stakehold ers to comment on the Interim Approaches. 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 R eview decisions. The details of the joint Interim Approaches are contained in the

white paper “Interim Approaches for National

- Level Pesticide Endangered Species Act Assessments

Based on the Recommend ations of the National Academy of Sciences April 2013 Report,” dated

November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the Interim

Approaches to assess the potential risks of pesticides to listed spec ies and their designated critical

habitat, the ecological risk assessment supporting this Interim Registration Review Decision for

cyromazine does not contain a complete ESA analysis that includes effects determinations for

specific listed species or desig nated critical habitat. Although EPA has not yet completed effects

determinations for specific species or habitats, for this preliminary assessment EPA conducted a

screening

- level assessment for all taxa of non

- target wildlife and plants that assumes for the sake of

the assessment that listed species and designated critical habitats may be present in the vicinity of the

application of cyromazine. This screening level assessment will allow EPA to focus its future

evaluations on the types of species where th e potential for effects exists once the scientific methods

being developed by the agencies have been fully vetted. While the agencies continue to develop a

common method for ESA analysis, the regulatory section of the Interim Registration Review

Decision d ocument will describe the level of ESA analysis completed for this particular registration

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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

5 necessary to complete risk assessments for endangered and threatened (list ed) species and their

designated critical habitats, these methods will be applied to subsequent analyses for cyromazine as

part of completing this registration review.

II. SCIENTIFIC ASSESSMENT

A. Human Health Risk Assessment

Since the publication of the Cyromazine Preliminary Risk Assessment an ACN study has bee n

submit t ed by Syngenta. Su b mi s sion of the ACN data, and other updates led to several changes

in the human health risk assessment including the following.

• Est a blishing an acute dietary endpoint

• Revision of the chronic dietary endpoint

• Revision of the safety factors for dietary risk assessment

• Revision of safety factors for occupational risk assessment

• Est a blishing an inciden ta l oral endpoint (for use in bystander assessment )

• Estimates of bystander risk ( v ia spray drift

)

• Revision of occupation a l risk estimates based upon updated inputs

A summary of the Agency's human health risk assessment is presented b elo w

. For detailed

discussions of all aspects of the human health risk assessment, see the Cyromazine : Human Health

Risk Assessment for Registration Review

, dated Feb. 27, 2014 available in the public docket under EP A

HQ- OPP

- 2006

- 0108, which can be accessed at www.regulations.gov.

1

. Human He a

l th Risk Summary

Dietary Exposure

Rev i sions to the dietary analysis were incorporated into the revised screening

- leve l human health

analysis

. Exposure to cyroma z in e

, through food and dri n king water, to the highest exposed

population subgroup, (children 1

- 2 years) was estimated to be 18% of the acute population

adjusted dose (aP A D

) and 8.2% of the chronic p opulation adjusted dose (cPAD) which is l ess

than the level of concern ( LOC ) of 100% of the PA D

. For the gener a l population, dietary

exposure to cyromazine (food + drinking water) i s estimated to be 7.5% of the aPAD, 3.8% of

the cP A D

.

Residential and Aggregate Exposure

Cyromazine products are not registered for residential use. However, the Agency considered

potential residential exposure that may result from off

- target movement of cyromazine, also referred

to as a "bystander exposure assessment". The Agency estimated potential bystander risk (dietary,

hand

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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

6 turf assessments. The Agency identified no risks of concern to bystanders from either aerial or

ground application scenarios, (MOEs were estimated at 100,000 and 140,000 respectively) where

margins of exposure (MOEs) were greater than the LOC of 100. The Agency did not aggregate

bystander exposure with dietary exposures, therefore, aggregate risk is considered equal to acute

dietary (food + drinking water) which does not represent a risk of concern

Cumulative

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common

mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to

cyromazine and any other substances and cyromazine does not appear to produ ce a toxic metabolite

produced by other substances. For the purposes of this tolerance action, therefore, EPA has not

assumed that cyromazine has a common mechanism of toxicity with other substances. For

information regarding EPA’s efforts to determine whi ch chemicals have a common mechanism of

toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released

by EPA’s Office of Pesticide Programs concerning common mechanism determinations and

procedures for cumulating eff ects from substances found to have a common mechanism on EPA’s

website at http://www.epa.gov/pesticides/cumulative/

.

Occupational Exposure

Occupational risks from cyromazine were r e vised with updated inp u ts and revised uncertainty

factors. Estimates of risk fo r handlers (i.e., those who mix/load or apply pest i c i des ) were a ssessed

and de t ermi n ed not to be a risk concern (MOEs > 99). Pos t

- a p plication r i sks to workers (i.e.,

those who work in an area previously treated with a pesticid e ) were not quantitatively assessed

be c a use (i) t h e low vapor pressure of cyromazine would p r ec l ude signifi c

a n t inhalation exposure;

a n d

, (ii) restri ct e d entr y intervals (REI) established under the wor k er protection sta n dard ( W P S )

adequately addresses the low dermal t o xi c ity of cyr o mazine.

Human Health Incidents

At the time of the Cyromazine Scoping document development in 2007

, the Agency searched for

incidents associated with cyromazine in its Human Health Incident Data Sy stem; the National

Institute for Occupational Safety and Health Sentinel Event Notification System for Occupational

Risks (N IOSH SENSOR

) pesticides program (1998 thru 2003) ; and

, the Poison Control Center

Data (1993 thru 2005) . One incide nt was recorded in the Poison Control D atabase , which reported

an individual had experienced an occupational exposure that resulted in mild (unknown) symptoms

because the individual did not visit a HCF . No recommendations are being made based on the

limit ed availability of information and because there were no reports located in the Incident

Data System

Food T o l er a nc e s

The Agency has d e termin e d that curr e nt tolerances f o r residues of cyromazine in or on certain

commodities e stabli s hed under 40 CFR § 180.41 4 (a) should be revised in order to harmonize with

Codex maximum resi d ue lim i t (MRL) a n d C a nad i an MR L s. T h e Agency h a s also de t ermin e d thatDocket Number EPA

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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

7 tolerances for cyromazine in / on certain crops should be est a bl i sh e d for indirect or inadv e r tent

residues of cyromazine from the application of c y romazi n e to manure which is then a pplied as a

soil amendment to fi e ld s

. For harmonization of cyromazine toleranc e s with Codex and Canada

MRLs, see Tab l e 4.0.1 Cyromazine Revised US Tolerances

, and for toler a nc e s for indirect and inadvertent

cyromazine r esid u es see Ta b l e 4.0.2, Tolerance S ummary for Cyromazine found i n Cyromazine: Human Health

Risk Assessment for Registration Review, dated Feb. 27, 2014. The Agency will pursue harmonizing

tolerances and establishing tolerances for indirect or inadvertent residues during regi s tr a tion

review.

B

. Ecolo g i cal Risk Asses s m ent

Following the issua n c e of the cyromazine p r eliminary risk assessment, the Agency received

c o m m ents and information from the technical registrant r e ga r ding the ecological fate and effe c ts

of cyromazine. The Ag e n c y addressed and/or incorporated Sy n genta's comments a n d

information i n its ecological an a l y s i s of cyromazine in i t s document, Environmental Fate and Effects

Division's Response to Public Comments on the Registration Review Preliminary Risk Assessment for Cyromazin e, dated

March 26, 2014 whi c h can be found in the public docket : (EPA

- HQ

- O P P

- 2006

- 0 1 08) that can

be accessed on http://www.regulations.gov/

.

In the registration review for cyromazine, the Agency identified no risks of concern for aquatic

animals, and found that risks to plants are uncertain. Potential risks to birds were identified from

cyromazine use on potatoes, its use as manure treatment (which is then applied to soil as an

amendment), and its use as an onion seed treatment. Potential risks to mammals were associated

with cyromazine use as a manure treatment, and its use as an onion seed treatment. Potential risks

could not be excluded for terrestrial invertebrates from the agricultural uses of cyromazine. A

summary of these findings and risk estimates is presented below.

The Agency also completed a screening

- level threatened and endangered (listed ) species assessment

for cyromazine and identified potential effects to several taxa (birds, mammals , reptiles, amphibians,

terrestrial invertebrates, terrestrial and semi

- aquatic plants ). The Agency is currently working with

its federal counterparts and other stakeholders to implement an interim approach for assessing

potential risk to listed species and their designated critical habitats. Once, the scientific methods

necessary to complete risk assessments for listed species and their designated critical habitats are

finalized, the Agency will complete its listed species assessment for cyromazine . As such, only

screening

- level risks to listed species will be enumerated here. Risk to listed species will not be

characterized herein.

1. Ecologica l Exposure and Risk Summary

Cyromazine is stable to both hydrolysis and photolysis and displays a low vapor pressure.

Laboratory half

- life information indicates that in aerobic soil cyromazine half

- life ranged from 107

- 142 days, which was c onfirmed with field dissipation data where cyromazine half

- life ranged from

93

- 240 days. Cyroma zine is highly water

- soluble and considered mobile, but also persistent.

Additional details associated with the characterization of the ecological risk can be found in the

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8 Birds

Based upon comments received on the preliminary risk assessment, EPA revised several of the

inputs to its terrestrial risk assessment. The revised analysis identified no acute or chronic LOC

exceedances for avian species from the agricultural uses of cyromazine (RQs < 0.01), with the

exception of cyromazine use on potatoes. Slight LOC exceedances from the potato use were

identified for small birds (20g) consuming short grass where the acute RQ= 0.1 (which is below the

non

- listed LOC of 0.5 but not below the listed LOC of0.1) and the ch ronic RQ=1.39, which

exceeds the LOC of 1 . Bird s also serve as a surrogate for terrestrial phase amphibians and reptiles.

RQs for terrestrial

- phase amphibians and reptiles were calculated using the Terrestrial Herpetofaunal

Exposure Residue Program Simulation (f

- HERPS), and exceedances were identified for amphibians

from cyromazine use on potatoes where an acute RQ for small (2g) amphibian/reptiles was

estimated to be 0.14, and chronic RQs were estimated at 1.07 and 1.39 (See Appendix C for a table

of LOCs )

. In order to mitigate remaining potential ri sks from use on potatoes

, the application

interval will be increased from 7 days to 17 days

. The increased application interval will reduce

EECs and therefore reduce estimated exceedances at or below the chronic LOC

.

Syngenta commented, and the Agency agreed, that based on typical grower practices, an appropriate

representative onion seed rate is 2

– 4 lbs seed/acre and therefore, EPA used 4 lbs seed/acre in

evaluating potential exposure from the onion seed treatment u se. Avian RQs from the onion seed

use were estimated using (i) the median lethal dose (LD50) per square foot method, where estimated

risk to avian species w as below LOCs (RQs < 0.01); and , (ii) the dietary

- based method, where both

acute and chronic LOC ex ceedances were identified ( acute RQs ranged from 1.45

– 10.19, and the

chronic RQ = 660). These exceedances are further characterized below in Section 3

.

Finally, the Agency also identified potential acute risk to birds from exposure to food sources

contaminate d with cyromazine from application of cyromazine on manure that is then used as a soil

a mendment. Acute risks ranged based upon whether the application is assumed to be of wet

m anure or dry manure (i.e., where the amount of soil amendment per a cre is measured on a weight

basis of excreted m aterial). RQ estimates for “wet” application ranged from below the LOCs to

slightly above the listed species LOC (acute RQs = <0.001

– 0.11). RQ estimates of “dry”

applications ranged from below the LOCs to above the LOCs (acute RQs = 0.01

– 1.14).

Characterization of the conservative assumptions and uncertainties in the soil amendment analysis

and exceedances is provided below in Section 3.

Mammals

Acute risk estimates for mammals from the onion seed treatment use were revised to reflect the

more appropriate seeding rate (i.e., 4 lbs/acre). RQs were estimated using two methods; (i) an LD50

per square foot method, where RQs were below LOCs (RQs < 0.01); and, (ii) a dietary

- based

method, where both acute and chronic RQs exceeded LOCs, (acute RQs ranged from 2.08

– 4.55,

and the chronic RQ = 49.5). However, as discussed below in Section 3, the Agency believes risks

from the onion seed use may be li mited to small and medium mammals and may also be both

temporally and spatially limited

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9 from < LOC

– 0.81 , and a s noted above, characterization of the conservative assumptions and

uncertain ties in the soil amendment analysis is provided below in Section 3.

Ter r e s trial Invertebra t es

With respect to terrestrial invertebrates, the Agency only has acute oral data with adult bees. Given

the mode of action for cyromazine, which targets the larval stage of development, the data on hand

do not provide sufficient information to estimate potential risk. Information available in the open literature or conducted under OECD guidelines, indicate effects to other terrestrial invertebrate

species (such as beetle, bumblebe e, and fruit fly) at levels that are above the single maximum

application rate but that are roughly equivalent to concentrations that may be present in the

environment following se veral a pplications. Based upon the mode of action for cyromazine, the

ability for cyromazine to persist in the environment, and lack of appropriate effects and exposure

data (i.e., data identified under the Agency's new risk assessment framework for bees) , the Agency

cannot preclude potential risk to terrestrial invertebrates at this time

. Therefore, language will be

added to certain cyromazine labels to inform users of potential risks to pollinators, and additional

pollinator data will be required (see S ection IV. Interim Registration Review Decision).

Plants

The Agency also has limited data on cyromazine effects to plants. While some phytotoxicity was

observed for some terrestrial plant species (dicot

- soybean, and monocot

- maize) at concentrations

at or below the labeled application rate, information available from the open l iterature did not

provide a consistent indication that cyromazine causes adverse effects to terres trial plants.

With respect to aquatic plants, based upon the information from the one aquatic non-vascular study

(with green algae), estimated RQs are below LOCs (RQs < 0.01). The Agency does not anticipate

that data with other non

- vascular plants would lead to dissimilar conclusions. Data on vascular

aquatic plants were not avail able

, but again based upon the level at which effects were observed in

the one non

- vascular plant study and estimated environmental concentrations (EECs) from the uses

of cyromazine, risk to aquatic vascular plants is not expected. Ther efore, despite the limited data,

effects to either terrestrial or aquatic plants are considered unlikely.

Fi s h and A q u atic Inver t e b rat e s

For ma n y o f t h e aquatic species examined, definitive acute endpoints were n o t r e ported in the

effects data, a nd t h er e fore, RQs were not calculated. However, bas e d upon a comparison

between lowest reported acute effect and EECs, acute risks to aquatic s pec i es are not expected.

Chronic RQs howe v e r

, were estimated and found to be below LOCs. The Age n c y has also

d et e rmin e d that its conclusion of low potential risk is a p plicab l e to sediment dwelling aquatic

organisms as well.

2. Ec o log i cal Incidents

At the time of the c yromazine e cological p roblem f ormulation document development in 2007

, the

Agency searched its Ecological Incident Information System (E II S), the Avian IncidentDocket Number EPA

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10 Monitoring System (AIMS), and the EPA Incident Data System (IDS) for cyromazine related

adverse ecological incident i nformation. One incident was recorded in the IDS database, dated

2002, which involved the cy romazine product Trigard is classified as a minor incident and involv ed

wildlife

.

3. Risk Characterization

Risks to Birds and Mammals from Onion S eed Use

The Agency considers its risk estimates for the onion seed use conservative for several reasons.

While both the LD 50 per f t2 and the dietary

- based exposure assessment assume that the treated seed

is readily available to the bird or mammal , cultural practice for planting bulb onion is to drill seed,

i.e., incorporate the seed into the soil, thereby red ucing availability and potential exposure to birds

and mammals. In addition, the dietary

- based approach reflects the risk that a bird/mammal would

receive from eating an entire day's diet of just cyromazine

- treated onion seed. However, natural

competitio n for food typically would reduce the amount of onion seed that an organism would be

able to access.

The Agency also performed two additional analyses to f urther characterize risk estimates to b i r ds

an d mammals from cyromazine

- treat e d oni o n seed. I n one analysis

, the Agency estimated t he

number of cyromazin e

- treated se e ds an or g anism would need to eat in order to reach LOCs

(tables 1 and 2). In a second analysis the Agency estimated the number of square feet that a bird/mammal w o u ld ne e d t o gle a n in o r d er to reach the no n

- listed LOC. T h a t is, given the

number of onion seeds planted per square foot in onion bulb production, the Agency e s timated

the number of square feet of cr o p l and a bird or mammal w o u l d n e e d to glean of cyr o mazine

t r eated seed in order to rea c h the LOC. (t a b l es 3 and 4 )

.

Table 1. Number of Cyrom a zi n e

- T r eated Onion Seeds Needed to be Co n su m ed to Reach

Acu t e non

- L i s ted LOC

- Birds

M a m m a l S ize A c ute n o n

- li s ted L OC (0. 5 )

Small 55

- 71

Med. 348

- 452

Large 4

, 9 1 1

- 6388

T aken from Table 27 of the Pre liminary R isk Assessment for the Reg

is trat io n Re view o f Cyromazine dated January 24, 2013 and Table 15

of the Environmental Fate and Effect s Divisions Response to Public Comments on the Registration Review Preliminary Risk Assessment for Cyromazine

dated March 26, 2014

.

Table 2. Number of Cyromazine

- Treated Onion Seeds Needed to be Consumed to Reach non

Listed Acute LOC

- Mammals

M a m m a l S ize A c ute n o n

- li s ted L OC (0. 5 )

Small 77

- 100

Med. 281

- 365

Large 3

, 468

- 4510

Taken from Table 27 of the Preliminary Risk Assessment for the Registration Review of Cyromazine dared January 24, 2013 and

Table 15 of the Environmental Fate and Effects Division’s Response to Public Comments on the Registration Review Preliminary Risk

Assessment for Cyromazine dated March 26, 2014.Docket Number EPA

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11 T able 3. Number of Squa r e F e et N e eded t o be Gleaned t o Reach LO C s

- Bir d s

Bird S i ze A c ute n o n

- l i s ted LOC ( 0

. 5)

S m a ll 6

M e d

. 38

L a r ge

. . . 532

- 5 46

Taken from Table 15 o f the Environmental Fate and Effects Division’s Response to Public Comments on the Registration Review Preliminary Risk

Assessment for Cyromazine dated March 26, 2014

.

T able 3. Number of Squa r e F e et N e eded t o be Gleaned t o Reach LO C s

- Mammals

Bird S i ze A c ute n o n

- l i s ted LOC ( 0

. 5)

S m a ll 16

M e d

. 30

L a r ge

. . . 385

- 376

Taken from Ta b le 1 5 of the Environmental Fate and Effects Division’s Response to Public Comments on the Registration Review

Preliminary Risk Assessment for Cyromazine dated March 26, 2014.

The alternative analyses suggest that risk estimates for larger organisms may be less likely than for

small organisms. That is, given variables such as seed incorporation and resource competition, the

likelihood of a small bird consuming 55

- 71 seeds in a day, or gleaning the seeds in a 6 ft2 area (or

equivalent) seems greater than a large bird consuming greater than 3000 seeds or gleaning all the

onion seed from an onion bulb production area greater than 500 ft 2 in a single day. Considering

these differ ent lines of information, the Agency reasons that risks may exist, but may be acute in

nature, and limited to small birds or mammals.

Risks to Birds and Mammals fro m Manure Use

The use of manure to treat an agricultural field is dictated mainly by the nitrogen needs for the crop

to be grown in tha t field, and the type of manure that is being applied. Therefore

, actual practices

for soil amendmen t can vary significantly, making it difficult to accurately estimate potential risk.

When estimating risk from this use, the Agency employed conservative assumptions including ( i )

risk was estimate d based upon potential exposure associated with cyromazine

- treated manure that is

applied wet (i.e., lower c yromazine exposure), and cyromazine

- treated manure that is applied dry

(i.e., higher cyromazine exposure); (ii) risk was estimated assuming no incorporation; (iii) risk was

explored from both the dermal and dietary routes of exposure; and, (iv) risk was es timated by

assuming the organism eats all treated material in a square foot, including all contaminated plant

material and contaminated soil. Therefore, based upon the low exceedances and conservative

assumptions built into the estimate, the Agency belie ves that the overall risk from the soil

a mendment use of c yromazine

- treated manure is low.

C. E n da n g e red Species Assessment

In November 2013, 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 Agricu l ture

(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 agencie s in respon se to theDocket Number EPA

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12 Na tional 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. The NAS report outlines recommendations o n specific scientific and technical issues

related to the development of pesticide risk assessments that EPA and the Services must conduct in

connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on

November 15, 2013. In addition, the EPA p r esent e d the joint Interim Approaches at the December

2013 Pestici d e Program Dialogue Committee (PPDC) and Stat e

- FIFRA I ssues R e search and

Evaluation Group (SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing

additional opp o rtunit i es for stakeh o l d ers to comment on the Interim Approaches. As part of a phased, i t erative pro c ess 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. The details of the joint Interim Approaches are contained in the

white paper "Interim Approaches for National

- Level Pesticide Endangered Species Act

Assessments B a sed on the Recommendations of the National Academy of Sciences April 2013

Report,” dated November 1, 2013.

Given that the agencies are co n tinuing to develop and work toward implementation of the

Interim Approaches to assess the potential risks of pesticides to l i st e d s p ecies and their designated

critical habitat, the ecological risk assessment supporting th is Interim R e gistrati o n Review Dec i

si o n

for c y romazine does not contain a complete ESA analysis that includes effects determinations f o r specific listed species or designated critic a l habitat. A l though EPA has not yet completed effects

de t erminations for specific species or habitats, for this preliminary assessment E P A conducted a

screenin g

-level assessment for all taxa of no n

- target wildlife and plants that assumes for the sake

of the assessment that listed species and designated critic a l habitats may be present in the vicinity

of the application o f cyromazine. This screenin g

- le v e l assessment will allow EPA to focus its

futu r e evaluations on the types of species where the potential for effects exists once the scientific

methods being deve l o ped by the agencies have been fully vetted. While the agencies continue to

develop a common method for ESA analysis, the regulatory section of the In t e rim R e gistration

Review Decision document will describe the level of ESA analysis completed for this particular

r egist r ation review cas e

. Once the agencies have fully developed and implemented the scientific

methods ne c essary to complete risk assessments for endangered and threatened (listed) species

and their designated critical habitats, these methods will be applied to subsequent analyses for

cyromazine as part of completing this registration review.

D. Endoc r

ine Disrupter Screening P r ogram

As required by FIFRA and the Federal Food Drug and Cosmetic Act (FFDCA), EPA reviews

numer o us studies to assess potential adverse out c o m es from exposure to chemicals. Collectively,

these studies include acute, s ubchronic and chronic toxicity, including assessments of

carcinogenicity, neurotoxicity, developmental, reproductive, and gen e ral or s y stemic toxicity.

These studies include endpoints that may be susceptible to endocrine influence, including e ffects

on endocrine target organ histopathology, o r gan weights, estrus cyclicity, sexual maturation,

fertility, pregnancy rates, reproductive l oss, and sex ratios in offspring. F or ecological hazardDocket Number EPA

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13 assessments, EPA evaluates acute tests and chronic st u dies that assess growth, developmental and

reproductive effects in differe n t taxonomic groups. As part of its most recent registration

decision for cyromazine, EPA reviewed these data and selected the m ost sensitive end p oints for

relevant risk assessment scenarios from the existing hazard database. However, as required by

FFDCA secti o n 4 0 8(p), cyromazine is subject to the endocrine screening part of the Endocrine

Disrupter Screening Pr o g ram ( EDSP ).

EPA has developed the EDSP to determine whether certain substances (including pesticides and

other active 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

- ti ered 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. Chem icals 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 availa ble data. Tier 2 testing is designed to identify any

adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship

between the dose and the E, A, or T effect.

Und e r FFDCA section 408(p), the Agency must sc r een all pesticide chemicals. Between October

2009 and February 2010, EPA issued t e st orders/data call

- ins for the fir st group of 67 chemica l s

, which contains 58 p esticide active ingredients and 9 inert ingredients. A sec o nd list of chemicals

identified for EDSP s c reeni n g was published on June 1 4

, 2013 a nd includes some p e sticides

scheduled for registrati o n review and chemic a l s found in water. Neither of these lists should be

construed as a list of known or likely endocrine disrupters.

Cyromazine is on list two. List two represents the next set of chemicals for which EPA intends to

issue test orders/DCI in the near future. In the interim, EPA is making no human health or

environmental safety f

in di n gs a ssociated with the EDSP scr e ening of cyromazine . Before

completing this registration review, the Agency will make an EDSP FFDCA section 408(p)

determination for cyromazine

.

III. USE AND USAGE/BENEFITS

Because the estimated risks to birds and mammals from the onion seed treatment use is high, the

Agency investigated the potential benefits from that use. The Agency referred to printed sources,

and solicited information from individuals with USDA who have specific knowledge in onion bulb

production. Onion bulb acreage does not represent a significant area in the United States, totaling

approximately 125,000 acres, where California, (approximately 18,000 acres) Idaho- Eastern Oregon

(approximately 20,000 ac res) and Washington (approximately 24,000 acres) represent the leading

states in onion production. Cyromazine is reportedly used to combat the larvae of the onion

maggot, Delia antiqua (Meigen), which is the primary insect pest in bulb production. Foliar

applications are reportedly not effective at controlling the adult onion maggot, as it is a very active

fly, therefore, soil or seed treatments are reportedly needed to control these soil

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14 Cyrom a zine has been used by itself, as well as i n conjunction with other compounds. Cyromazine

use in onion bulb production has reportedly declined over time and currently it is not considered the

first choice for protection from onion seed maggot. Currently, other compounds (neonicotinoids)

are the p referred treatment for onion seed maggot. However, since the onion seed maggot has

demonstrated development of resistance to insecticides, such as organophosphates and carbamates,

entomologists believe the continue d availability of cyromazine is valuable for resistance management

in bulb onion production where maggots are pests . (See Characterization of Cyromazine Use as a Seed

Treatment for Commercial Bulb Onions ; dated April 7, 2014, available in the public docket under EPA

HQ

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- 0108, which can be accessed at www.reglations.gov ).

IV. INTERIM REGISTRATION REVIEW DECISION

A. Tolerance Amendments

T he Agency will pursue changes to the cyromazine tolerances to harmonize with CODEX and

Canadian MRLs and to establish tolerances for indirect and inadvertent residues of cyromazine

during registration review. For the harmonization of the cyromazine tolerance s (which wi ll be

harmonized with Codex and Canada MR Ls ) , see Table 4.0.1 Cyromazine Revised US Tolerances

,

a nd for tolerances for indirect and inadvertent cyromazine residues

, see Table 4.0.2, Tolerance

Summary for Cyromazine found in Cyromazine : Human Health Risk Assessment for Registration Review , dated

Feb. 27, 2014.

B. Risk Mitigation Measures and Rationale

1. Risk Management for Onion Seed Use

As discussed in this document, the Agency believes that the potential risk to small birds and

mammals from the onion seed us e of cyromazine exists but that the use of cyromazine on onion

seed represents certain benefits. To address potential ecological risks from cyromazine, certain

changes to cyromazine labels will be made. This conclusion is based upon (i) the lack of adverse

ecological incident information associated with cyromazine; (ii) the alternative analyses that suggest

that potential risk may be acute, and relevant to small birds and mammals; (iii) risk may be spatially

and temporally limited; and (iv) availability of cyromazine as a component of onion bulb production

as a means of countering pesticide resistance by the onion maggot larvae . T he following statement

must be added to cyromazine labels (i.e., cyromazine labels registered for use on onion seed).

“Treated seeds exposed on soil surface may be hazardous to wildlife; cover or collect treated

seeds that are spilled during loading and in areas such as row ends.”

2. Risk Management for Terrestrial Invertebrates and Pollinators

As noted above, b a sed upon available information

, the Agency cannot p r eclude po t ential risk s to

bees or other terrestrial invertebrates. Conversely, without pollinator data, the Agency cannot

assess potential exposure or hazard from cyromazine and develop appropriate risk mitigation

measures. The refore, the Agency intend s to require pollinator data ( listed below) , consistent with

the Agenc y’s new pollinator risk assessment framework, to better a ssess potential risks to bees.Docket Number EPA

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15

 Acute oral toxicity to adult honey bees (Non

- guideline, OECD TG 213)

 Acute oral toxicity to larval honey bees (Non

- guideline, OECD TG 237)

 Chronic oral toxicity to larval honey bees (Non

- guideline)

 Honey bee toxicity of residues on foliage (Guideline 850.3030)

 Field tria l of residues in pollen and nectar (Non

- guideline)

 Semi

- field testing for pollinator (Non

- guideline, OECD Guidance 75)

 Field testing for pollinators (Guideline 850.3040)

While data are being gen erated and reviewed, changes will be made to cyromazine labels to inform

users of potential risks to developing bees. The new l anguage to be added to cyromazine labels is

considered advisory, and so the “Protec tion of Pollinators” box will added to relevant labels (i.e.,

cyromazine products labeled for direct application to an agricultural crop) , and the cyromazine bee

language will be placed in the “Pollinator Protection” box along with other advisory lan guage for

pollinator s

. The Agency believes that in the absence of pollinator data to inform a chemical

- specific

pollinator risk assessment and mitigation measures, providing information t o inform the pesticide

user of the potential effects of a product is appropriate

. (See Appendix B. Cyromazine Label Table

, for additional label description )

.

In the “Protection of Pollinators” box, the following language will be added.

“Cyromazine acts as a growth regulator, affecting the molting process of target pests , and

therefore, may have an effect on bee larvae, but not on adult bees. Exposure to adult bees,

either through overspray or contact with residues may lead to effects to bee larvae.”

3. Risk Management for Potato Use

Based on revised inputs to the ecological risk analysis (e.g., revised toxicity endpoint and terrestrial

half

- life information), LOC exceedances for mammals from cyromazine use on potatoes was

removed. However, the revised ecological risk analysis estimat ed chronic avian LOC exceedances

(RQ = 1.39)

. To address this, the application interval for cyromazine use on potato will be increased

from 7 days to 17 days. The remaining chronic LOC exceedance (chronic RQ = 1.39) to birds will

result in RQs that are be low the Agency’s LOC with the increase d a pplication interval . (See t he

Preliminary Ecological Risk Assessment for the Registration Review of Cyromazine dated January 24, 2013

, pages 3 and 61

. )

4. Risk Management for Reduction of Spray Drift

In addition, all cyromazine products label ed for direct application to an agricultural crop must be

changed to specify use of foliar application technology (to all agricultural use s of cyromazine ) that

will deliver mediu m

- coarse or larger s pray droplets as defined in the American Society of

Agric u l tural and Biologic a l Engineers standard ANSI / ASAE S572. 1

.

C

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Interim Registration Review Decision for Reg i stra t ion Revie w ; Case 7439

16 In accordance with 40 CFR Sections 155.56 and 155.58, the Agency is issuing this Interim

Registration Review Decision for cyromazine. Except for the EDSP and ESA components in this

case, the Agency has made the following Interim Regis tration Review Decision : (1) cyromazine does

not represent human health risks of concern; (2) cyromazine represents limited potential ecological

risks; (3) considering the characterization of the ecological risks and the benefits of cyromazine

, that

these ecological risks are acceptable; (4) the Agency intends to change the affected registrations and

their labeling to address these ecolo gical risks (see Appendix B: Cyromazine Label Table); and, (5)

the Agency intends to issue a Data Call

- In to require additional pollinator data, which will be used to

assess the effects of cyromazine on pollinators (see Appendix A Summary of Registration R eview

Mitigation and Data Requirements for Cyromazine).

In this i nterim r egistration r eview d ecision, EPA is making no human health o r environmental safety

fin dings associated with the EDSP screening of cyromazine, nor is it making a complete endangered

species finding. The Agency's final registration review decision for cyromazine w ill depend upon

the result of an ESA Section 7 consultation with the Services, and an EDSP FFDCA section 408(p)

determination.

V. NEXT STEPS AND TIMELINE

A. Implementation of Mitigation Measures and Issuance of Required Data

A mended label(s) that include the risk mitigation measures required in this interim decision

document must be submitted to the Agency for approval within 60 days following issuance of th is

Interim Registration Review Decision in final form. A summary of the required mitigation measures

and data requirements are described in Appendix A, and anticipated changes to labels are described

in Appendix B.

B. Data Requirements

In order to assess potential risks to pollinators, t he Agency will issue a DCI for data gaps

identified in the cyromazine pollinator database as described in the “ Risk Management for

Terrestrial Invertebrates and Pollinators ” section above (IV.B.2).

C. Final Registration Review Decision

EPA will make a final registration review decision for cyromazine after ESA Section 7 consultation

with the Services and an EDSP FFDCA section 408(p) determination has been made.Docket Number EPA

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17 Appendix A: Summary of Registration Review Mitigation and D ata R equirements for Cyromazine

Registration Review Case # 7439: PC Code: 121301

Chemical Names: Cyromazine

Chemical Type: Insect Growth Regulator

Chemical Family: Triazine

Mode of Action: Chitin Inhibitor 

## Cyromazine Mitigation

Affected

Population(s) Source of

Exposure Route of Exposure Duration of

Exposure Risk(s) of Concern Action(s)

Taken Mitigation

Birds (small) Foliar

application

to potato dietary Acute/chronic Acute RQ = 0.1 /

1.39 Increase

interval

between

applications

&

Droplet Size

Restriction Increase Application

Interval:

Require a minimum of 17

days between cyromazine

applications to potatoes.

Drop Size Restriction:

Require medium coarse or

larger spray droplet size for

foliar applications.

Birds and

mammals Onion

seed

treatment dietary Acute/chronic Birds acute RQ =

1.45

– 10.19

Birds chronic RQ

= 660

Mammals acute =

2.08

– 4.55

Mammals chronic

= 49.5 Label language See Appendix B. Label Table

Bees and other

insect pollinators Foliar

application

to

agricultural

sites dietary Acute N/A Label language See Appendix B. Label Table



## Cyromazine Data Requirements

Number Data Requirement Guideline Number

1. Acute oral toxicity to adult honey bees Non

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18 2. Acute oral toxicity to larval honey bees Non

- guideline, OECD TG 237

3. Chronic oral toxicity to larval honey bees Non

- guideline

4. Honey bee toxicity of residues on foliage Guideline Number 850.3030

5. Field trail of residues in pollen and nectar Non

- guideline

6. Semi

- field testing for pollinator Non

- guideline, OECD Guidance 75

7. Field testing for pollinators Guideline 850.3040



### Appendix B: Cyromazine Label Table

Summary of Labeling Changes for Cyromazine

Description Amended Labeling Language for Cyromazine Use Products Placement on Label

End Use Products

Medium coarse or larger spray

droplet size requirements for all

foliar applications “When making foliar applications of this product (aerial or ground), use spray

nozzles that will deliver medium course or larger spray droplets as defined in

the American Society Agricultural and Biolog ical Engineers (ASABE) standard

ANSI/ASAE S572.1(March 2009).” Mixing and Application Instructions

Change to the current label

language The current minimum 7 day application interval, must be changed to indicate a

minimum 17 day application interval. Dire ctions for Use

New label language, (for

cyromazine labels which are

intended for use to treat onion

seed “Treated seeds exposed on soil surface may be hazardous to wildlife ; cover or collect treated seeds that are spilled during loading and in areas such as row

ends.” Directions for Use

New label language Addition of the “Protection of Pollinators” box to products that are labeled for

direct application to agricultural crops. Placed on the label after between the

Environmental Hazards section and

the Directions for Use section.

New label language “Cyromazine act s as a growth regulator, a ffecting the molting process of target

pests, and therefore, may have an effect on b ee larvae, but not adult bees.

Exposure to adult bees, either through overspray or contact with residues may

lead to effects to bee larvae.” Inside the “Protection of

Pollinators ” box (see below)Docket Number EPA

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19 

# PROTECTION OF POLLINATORS

“Cyromazine acts as a growth regulator, affecting the

molting process of target pests, and therefore, may have an

effect on bee larvae, but not on adult bees. Exposure to

adult bees, either through overspray or contact with

residues may lead to effects to bee larvae.”

Bees and other insect pollinators will forage on plants when they flower, shed pollen, or produce

nectar.

Bees and other insect pollinators can be exposed to this pesticide from:

o Direct contact during foliar applications, or contact with residues on plant surfa ces after

foliar applications

o Ingestion of residues in nectar and pollen when the pesticide is applied as a seed

treatment, soil, tree injection, as well as foliar applications.

When U sing T his P roduct, Applicators Should T ake S teps To:

o Minimize exposure of this product to bees and other insect pollinators when they are

foraging on pollinator attractive plants around the application site.

o Minimize drift of this product on to beehives or to off

- site pollinator attractive habitat.

Drift o f this product onto beehives or off

- site to pollinator attractive habitat can result in

bee kills.

Information on protecting bees and other insect pollinators may be found at the Pesticide

Environmental Stewardship website at:

http://pesticidestewardship.o rg/PollinatorProtection/Pages/default.aspx.

Pesticide incidents (for example, bee kills) should immediately be reported to the state/tribal lead

agency. For contact information for your state, go to: www.aapco.org/officials.html. Pesticide

incidents s hould also be reported to the National Pesticide Information Center at:

www.npic.orst.edu or directly to EPA at: beekill@epa.govDocket Number EPA

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20 

### Appendix C: Levels of Concern (LOC) for Ecological Risk Assessment

Taxa Non

- Listed Species LOC Listed Species LOC

Acute Chronic

Birds and Wild Mammals 0.5 1 0.1

Aquatic Animals 0.5 1 0.05

Plants 1 1 1

Terrestrial Invertebrates 0.4 1 0.05 (interim)