2

INTRODUCTION

This is the Environmental 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 variety 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 policies and practices change, all registered pesticides continue to meet the statutory standard. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency’s website1

.

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 responses to those 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 requirement which is no longer being required by the Agency. Additionally, on 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, 2012, 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 addressed the timeline described in 

the 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 comment regarding the potential 

classification of buprofezin as a trade irritant. 

All public 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 

Plan 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, MRLs, distribution (e.g. acreage 

and geographical distribution of relevant use sites), 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: The 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 review process 

and attempts will be made by the Agency to harmonize buprofezin tolerances and MRLs with 

those of other countries. 

Public comments and EPA responses in their entirety are located in the docket, EPA-HQ-OPP2012-0373. 
4

PLANNED DATA NEEDS

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 residue 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, the 

planned data needs have not changed from what was included in the PWP.

Planned Data 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 study2TGAI 12

835.6200 Aquatic (sediment) field dissipation study2TGAI 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 toxicity to freshwater 

invertebrates - Examining survival, growth, and 

reproduction for Chironomus dilutus or C. tentans. 

(Draft OCSPP 850.1760)

TGAI 12

Special 

Study

Whole Sediment: Chronic toxicity to freshwater 

invertebrates - Examining survival, growth, and 

reproduction 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 water, 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 Data 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 trials – cucurbits3

(WP formulation) TEP 24

860.1500

Magnitude of residue crop field trials – lettuce3

(WP formulation) TEP 24

860.1500

Magnitude of residue crop field trials – stone fruit

3

(DF formulation) TEP 24

860.1500

Magnitude of residue crop field trial – lemon3 (DF 

formulation) TEP 24

860.1500 Magnitude of residue crop field trial – snap bean3

(SC formulation)

860.1520

Magnitude of residue processed food/feed

Apple3 processing conducted at 5x TEP 24

860.1520

Magnitude of residue processed food/feed grape3

processing conducted at 5x TEP 24

860.1520

Magnitude of residue processed food/feed orange3

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 registration review generic data 

call-in.

Special 

Study Developmental Thyroid study TGAI 24

TGAI = technical grade active ingredient; TEP = typical end-use product;

 3 Analyses required for all residues for risk assessment (buprofezin, BF-9, BF-12, and BF-26)
6

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the 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 assessments 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 the new assessments, as well as any changes to the

standard operating procedures 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 

Post-application No exposure.

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.