2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA or the Agency ) Final Work Plan (FWP) for the registration review of buprofezin

. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP) , which was posted in buprofezin ’s registration review docket (EPA

- HQ

- OPP

- 2012

- 0373 ). Buprofezin is an insect growth regulator registered

for use against a variet y of homopteran pests (e.g., cicadas, whiteflies, plant lice, mealy bugs, leafhoppers, and scale insects). There are no registered residential/homeowner uses and buprofezin products are used primarily in agricultural areas on various food and feed crops, ornamentals, and trees.

The Agency is implementing the registration review program pursuant to Section 3(g) of the 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 registration review program is intended to make sure that, as the ability to assess risk evolves and as policie s 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.

Informatio n 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 of the Agency’s response s to th o se comments

. This section is followed by buprofezin ’s registration review planned data needs, risk assessments expected to be conducted

, and the projected registration review timeline. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

This FWP identifies data gaps (snap bean field trial data (guideline 860.1500) and orange processing data (guideline 860.1520) ) which were inadvertently omitted from the data needs

section of the PWP

. The FWP also identifies the requirement of a WP formulation when conducting cucurbit and lettuce crop field trials and a DF formulation for stone fruit crop field

trials. The PWP also contained a radiovalidation of livestock enforcement analytical method data requi rement which is no longer being required by the Agency. Additionally, o n November 21, 2012 , an addendum to the HED scoping document was finalized. This addendum listed one residue chemistry data requirement (lemon field trial data, three trials (guideline 860.1500) ),

which was omitted from the Scoping document signed on 4/17/2012. This residue chemistry requirement was captured in the PWP and therefore this addendum does not result in a change to the data requirement listing. No additional updates on buprofezin have been made since the

PWP.

1 http://www.epa.gov/oppsrrd1/registration_review/3 SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60

- day public comment period on the Buprofezin Preliminary Work Plan , which opened on July 06, 2012 and closed on September 10, 201 2 , the Agency received ten public

comments from academic institutions. The comments submitted to the Agency discussed the benefits of buprofezin in agriculture for several crops (including vegetables, citrus, vineyards,

tomatoes, cotton, coffee, papaya, pistachios, tree fruit and pome fruit). The submitted comments provided information with regard to the use, maximum residue levels ( MRLs ) , distribution, and application of buprofezin. None of the submitted comments address ed the timeli ne described in

th e PWP, the data requirements, or the planned ecological and human health risk assessments. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns, and trade irritants

. The Agency received one commen t regarding the potential classification of buprofezin as a trade irritant

.

All p ublic comments are located in the docket, EPA

- HQ

- OPP

- 2012

- 0373

. The Agency ’s response to the public comments can be found in the Response to Buprofezin Preliminary Work

Pl an comments

.

Comments submitted by nine universities in EPA

- HQ

- OPP

- 2012

- 0373

- 0008

- 16.

1. Comment: The Agency received ten comments from nine universities, which provided information regarding the use, MRLs, distribution (e.g. acreage and geographical distribution of relevant use sites) , and application of buprofezin. These comments stressed the importance of buprofezin in IPM practices throughout the United States and its agricultural significance to various commodities and geographic areas.

Response: The Agency understands the significance of buprofezin as an effective tool to the grower community. The information about buprofezin use, MRL s , distribution (e.g. acreage and geographical distribution of relevant use si tes)

, application and other supporting information will be taken into consideration during the registration review process.

Comment submitted by University of Hawaii at Manoa in EPA

- HQ

- OPP

- 2012

- 0373

- 0011

.

2

. Comment: T he Agency received a comment from the University of Hawaii with regard to the potential for buprofezin being classified as a potential ‘trade irritant’ based on disparities

between US tolerances and some MRLs.

Response: Buprofezin tolerances will be re

- evaluated during the registration r eview process and attempts will be made by the Agency to harmonize buprofezin tolerance s and MRLs with

those of other countries

.

Public comments and EPA responses in their entirety are located in the docket, EPA

- HQ

- OPP

2012

- 0373

.4 PLANNED DATA NEED S

The table below summarizes the planned data needs for buprofezin based on the Problem Formulation for the Environmental Fate, Ecological Risk, and Endangered Species in Support of the Registration Review of Buprofezin and the Buprofezin: Human Health Risk Scoping Document in Support of Registration Review

. The FWP identifies the requirement of a WP formulation when conducting cucurbit and lettuce crop field trials and a DF formulation for stone
fruit crop field trials. The FWP also includes the resi due chemistry field trial data for snap beans and magnitude of residue study for oranges . Additionally, the FWP no longer requires a radiovalidation of livestock enforcement analytical method . Other than these changes, t he planned data needs have not chan ged from what was included in the PWP

.

Planned D ata Needs for Buprofezin ’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

835.4300 Aerobic Aquatic Metabolism TGAI or

PAIRA 24

835.6100 Terrestrial field dissipation study 2 TGAI 12

835.6200 Aquatic (sediment) field dissipation study 2 TGAI 12

850.1500 Fish Life Cycle (saltwater) TGAI 24

850.1350 Aquatic Invertebrate life cycle (saltwater) TGAI 12

Special Study Whole Sediment: Chronic toxicity to saltwater

invertebrates

– Examining survival, growth, and reproduction for Leptocheirus plumulosus ( Draft OCSPP 850.1780) TGAI 12

Special Study Whole Sediment: Chronic t oxicity to f reshwater

i nvertebrates

- Examining s urvival, g rowth, and

r eproduction for Chironomus dilutus or C. tentans

. ( Draft OCSPP 850

. 1760) TGAI 12

Special Study Whole Sediment: Chronic t oxicity to f reshwater

i nvertebrates

- Examining s urvival, g rowth, and

r eproduction for Hyaella azteca . ( Draft OCSPP

850.1770 ) TGAI 12

2 See footnote 7 of 40 CFR 835.6100 and 835.6200. EPA anticipates requiring only the environmental chemistry

analytical methods and independent laboratory (ILV) portions of this guideline for soil and wate r, rather than the full field dissipation study. Storage stability data are also required for 835.6100 to upgrade the terrestrial field dissipation study (MRID 44394044, guideline 835.6100).5 Planned D ata Needs for Buprofezin ’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

Special Study Acute honey bee larvae feeding study TGAI 12

860.1500 Magnitude of residue crop field trial s

– cucurbits 3

(WP formulation) TEP 24

860.1500 Magnitude of residue crop field trial s

– lettuce 3

(WP formulation) TEP 24

860.1500 Magnitude of residue crop field trial s

– stone frui t 3

( DF formulation) TEP 24

860.1500 Magnitude of residue crop field trial

– lemon 3 (DF formulation) TEP 24

860.1500 Magnitude of residue crop field trial

– snap bean 3

(SC formulation)

860.1520 Magnitude of residue processed food/feed
Apple 3 processing conducted at 5x TEP 24

860.1520 Magnitude of residue processed food/feed grape 3 processing conducted at 5x TEP 24

860.1520 Magnitude of residue processed food/feed orange 3
processing conducted at 5x TEP 24

870.3465 Sub

- chronic (28/90

- day) inhalation

– rat TGAI 12

The study listed below was previously required as a condition of registration by the Registration Division in connection with the approval of new buprofezin uses on brassica, coffee, green bean and pomegranate. This data requirement will be included in the buprofezin r egistration review generic data

call

- in.
Special Study Developmental Thyroi d study TGAI 24

TGAI = technical grade active ingredient; TEP = typical end

- use product ;

3 Analyses required for all residues for risk assessment (buprof ezin, BF

- 9, BF

- 12, and BF

- 26)6 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, t he Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of buprofezin

. For human health, EPA

will conduct revised dietary and occupational risk assessment s during registration review

. If toxicological endpoints or points of departure are revised based on the data that are required for registration review

, they will be considered in th e new assessment s
, as well as any changes to the standard operating p rocedures or default exposure assumptions

.

The planned assessments have not changed from what was included in the PWP

.

Planned Risk Assessments for Buprofezin ’s Registration Review

Type of Risk Assessment Conduct ? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed

include terrestrial and aquatic organisms ), including endangered species Yes

Incidents Yes For a discussion of buprofezin ’s reported ecological incidents, see page 18 of the Problem Formulation.

Human Health Dietary

Food Yes A new assessment maybe required to incorporate any new residue chemistry data submitted prior to assessment development. Drinking water Yes Occupational Handlers (mixers, loaders, applicators) Yes Occupational assessments may be updated to incorporate any new standard operating procedures and any new toxicity data submitted prior to assessment development. Post

- application Yes

Residential

Handlers No No residential use and no expectation of residential

exposure. Post

- application No

Other Aggregate Yes Aggregate exposure is equal to dietary (food and water) exposure as there are no residential exposures.

Cumulative No A common mechanism of toxicity with other substances has not been identified for buprofezin.

Tolerances Yes Tolerances will be re

- evaluated based on the residue

data submitted and for harmonization with other

countries.

Incidents Yes For a discussion of buprofezin’s reported human incidents, see page 7 of the Scoping Document.7 TIMELINE

EPA has created the following estimated timeline for the completion of buprofezin ’s registration

review

. The projected timeline has not changed since the PWP.

Registration Review for Buprofezin

– Projected Registration Review Timeline

Activities Estimated Date
Opening the Docket Open Docket and 60

- day Public Comment Period July 2012

Close Public Comment Sept. 2012 Case Development

Final Work Plan Dec

. 2012

Issue DCI 2013

– July

– Sept.

Data Submission 2015

– July

– Sept. Open 30

- day Public Comment Period for Draft Risk Assessments 2017

– Jan.

– March

Close Public Comment Period 2017

– Apr.

– June Registration Review Decision Open 60

- day Public Comment Period for Proposed Registration Review

Decision 2017

– July

– Sept.

Close Public Comment Period 2017

– Oct.

– Dec. Registration Review Decision and Begin Post

- Decision Follow

- up 2018 Total (years) 6

NEXT STEPS

As noted previously, the Agency plans to require several environmental fate, ecological effects,

and human health studies for buprofezin through a data call

- in

.