2 I NTRODUCTION

This is the Environm ental Protection Agency’s (EPA ) Final Work Plan (FWP) for the

R egistration R eview of the nucleopolyhedroviruses (NPVs) and granuloviruses (GVs). This FWP follows the Preliminary Work Plan (PWP) posted in the R egistration R evie w docket for the

NPVs and GVs (EPA

- HQ

- OPP

- 2011

- 0694). The NPVs and GVs are insecticides regis tered for use against specific insects (e.g., gypsy moth, beet armyworm, and codling moth) in agricultural, forestry, and residential settings, as well as in food/feed processing, packing, and storage areas.

EPA is implementing the R egistration R eview program pursuant to Section 3(g) of the Federal Insecticide, Fungici de, 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 R egistration

R eview 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 of no

unreasonable adverse effects to human health or the environment . The public phase of

R egistration R eview begins when the initial docket is opened for each case. Informatio n on this program is provided on EPA’s website

. 1

The FWP begins with any updates since the PWP was issued. Next , it provides a summary of

substantive comments received , if any, during the public comment period for the PWP concerning anticipated data needs

, expected risk assessments, or the estimated timeline identified

in t he PWP

, and a summary of EPA’s response s to th o se comments

. This section is followed by

the planned data needs, risk assessments expected to be conducted , and the projected

R egistration R eview timeline for the NPVs and GVs

. Lastly, there is a discussion of next steps.

UPDATES SINCE THE PWP WAS ISSUED

In the PWP, EPA indicated that there were several data gaps for the NPVs and GVs and committed to conducting a comprehensive examination of its entire record (e.g., product jackets retired to the Federal Records Center) to solidify data needs. Between the issuance of the PWP on September 30, 2011 and the issuance of this FWP, EPA searched its records and found two
risk assessments 2 that show fulfillment of the following data requirements for celery looper ( Anagrapha falcifera ) NPV:

(1) Acute Oral Toxicity / Pathogenicity (Harmo nized Guideline 885.3050) (2) Acute Pulmonary Toxicity / Pathogenicity (Harmonized Guideline 885.3150) (3) Cell Culture (Harmonized Guideline 885.3500) (4) Avian Oral Toxicity (Harmonized Guideline 885.4050) (5) Wild Mammal Toxicity / Pathogenicity (Harmonized Guideline 885.4 150) (6) Freshwater Fish Toxicity / Pathogenicity (Harmonized Guideline 885.4200)

1 See http://www.epa.gov/oppsrrd1/registration_review/

. 2 EPA, OPP, BPPD Ecological Effects Review . Memorandum written by J.L. Vaughn, Ph.D. and R.I. Rose, Ph.D. dated June 21,

1995.

BPPD Review of Ac ute Oral Toxicology, Revised Manufacturing Process and Quality Control Data Submitted by Biosis, Incorporated for Anagrapha falcifera MNPV . Memorandum from C. Schaffer to L. Hollis dated June 13, 1995.3 (7) Freshwater Aquatic Invertebrate Toxicity / Pathogenicity (Harmonized Guideline 885.4240) (8) Nontarget Plant Testing (Harmonized Guideline 885.4300) (9) Nontarget Insect Testing (Harmonized Guideline 885.4340) (10) Honey Bee Testing (Harmonized Guideline 885.4380)

EPA no longer considers the data listed above to be gaps for celery looper NPV.

Additionally, on a separate but parallel track to this Registration Review , EPA will work with the

curre nt registrant of the celery looper NPV pesticide product, Certis USA, LLC (Certis) , to get a complete response to the following condition outlined in the August 9, 2002 registration notice for CLV LC (EPA Reg. No. 70051

- 41):

“Submit five batch analysis to justify the appropriateness of the visual microscopic counts of polyhedr i on [sic] inclusion bodies by January 8, 2003.”

In the PWP, EPA stated that this condition (Analysis of Samples, Harmonized Guideline 885.1400) was a da ta gap. In looking a t the records more closely, EPA found that Certis

submitted analysis of samples data in response to the August 9, 2002 registration notice, and the

EPA reviewed the se data in 2004. In the 2004 review, EPA con cluded that additional

infor mation was needed from Certi s to fulfill the data requirement

. T his remains a data gap

, and

EPA will inform Certis of this issue through w ritten correspondence by December 2012

.

SUMMARY OF COMMENTS AND EPA RESPONSES

During the 60

- day public comment period on the NPVs and GVs PWP , which opened on September 30, 2011

, and closed on November 29, 2011

, EPA received no p ublic comments. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality conc erns, and trade irritants, but no comments or information were received on those

issues.4 PLANNED DATA NEEDS

The table below summarizes the planned data needs for the NPVs and GVs based on EPA ’s risk

assessment memoranda and other references associated with the insect viruses. 3

Planned D ata Needs for the Registration Review of the NPVs and GVs

Harmonized

Guideline Number Study Title Test

Material Estimated

Timeframe

(Months from Receipt of DCI)

Corn Earworm NPV, Beet Armyworm NPV, and Codling Moth GV

885.1250 Deposition of a Sample in a Nationally Recognized Culture Collection TGAI 8 months

Douglas

- fir Tussock Moth NPV and Gypsy Moth NPV

885.1200 Manufacturing Process TGAI & EP

8 months 885.1250 Deposition of a Sample in a Nationally Recognized Culture Collection TGAI

885.1300 Discussion of Formation of Unintentional Ingredients TGAI & EP

885.1400 Analysis of Samples TGAI & EP

Indian Meal Moth GV

885.1200 Manufacturing Process TGAI & EP

8 months 885.1250 Deposition of a Sample in a Nationally Recognized Culture Collection TGAI

885.1300 Discussion of Formation of Unintentional Ingredients TGAI & EP

Celery Looper NPV

885.1250 Deposition of a Sample in a Nationally Recognized Culture Collection TGAI

8 months 885.1400 Analysis of Samples TGAI & EP

830.6313 Stability to Normal and Elevated Temperatures,

Metals and Metal Ions TGAI

830.6317 Storage Stability TGAI & EP 16 months
TGAI = technical grade of the active ingredient ; EP = end

- use pesticide product

3 See the “Bibliography” section of the PWP, as well as the two risk assessments mentioned in footnote #2 of this document. Also see the discussion in “Updates Since T he PWP Was Issued” for a listing of data that were previously identified as anticipated data needs but which are no longer needed by EPA for celery looper NPV.5 RISK ASSESSMENTS FOR REGISTRATION REVIEW

During R egistration R eview, EPA will (1) conduct an endangered species assessment for all uses

of the NPVs and GVs; (2) revise/update the product analysis assessments for douglas

- fir tussock moth NPV, gypsy moth NPV, indian meal moth GV

, and celery looper NPV; and (3) determine

whether , pursuant to Section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act, the NPVs

and GVs qualify for exemption from the Endocrine Disruptor Screening Program (EDSP)

. EPA

believes that the NPVs and GVs are likely not endocrine disruptors; as such, EPA may exempt

them from the EDSP (if exempted, an order will be issued).

TIMELINE

EPA has created the following estimated timeline for the completion of the R egistration R eview

for the NPVs and GVs

.

Registration Review for the NPVs and GVs

– Projected Registration Review Timeline

Activities Estimated Month/Year Opening the Docket Open Docket and 60

- day Public Comment Period for NPVs and GVs September 2011

– Completed

Close Public Comment Period November 2011

– Completed Case Development

Issue Final Work Plan September 2012

– Completed

Issue D ata Call

- in September 2013

Data Submission January 2015 Open 30

- day Public Comment Period for Draft Risk Assessments July 201 6

Close Public Comment Period August 201 6 Registration Review Decision Open 60

- day Public Comment Period for Proposed Registration

Review D ecision December 2016

Close Public C omment P eriod February 2017 Registration Review D ecision and Begin P ost

- d ecision F ollow

- up March 2017 Total ( years ) * 5 .5
* This schedule is subject to revision should unforeseen issues arise during the Registration R eview process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended FWP will be issued at that

time. That F WP will identify any newly planned data needs and set forth a new timeline.

NEXT STEPS

As noted previously, EPA plans to require several product analysis studies for the NPVs and GVs likely through a data call

- in, expected to be issued in September 2013 , and will work with Certis to fully address a condition of its CLV LC (EPA Reg. No. 70051

- 41) registration

. EP A believes that the NPVs and GVs are likely not endocrine disruptors; as such, EPA may exempt them from the EDSP (if exempted, an order will be issued). If the NPVs and GVs are exempted pursuant to FFDCA section 408(p)(4) by the end of September 2016 , EPA anticipates issuing a Proposed Registration Review Decision for public comment in December 2016.