Registration Review Final Work Plan Streptomyces lydicus WYEC 108 EPA

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### REGISTRATION REVIEW OF S TREPTOMYCES LYDICUS WYEC 108: FINAL WORK PLAN

Case Name: S treptomyces lydicus WYEC 108 Case No : 6088 PC Code: 006327 Docket: EPA-HQ-OPP-2014-0608 Registrant: Novozymes BioAg

INTRODUCTION

This is the U.S. Environmental Protection Agency’s (EPA) Final Work Plan (FWP) for the Registration Review of S treptomyces lydicus WYEC 108. This FWP follows the Preliminary Work Plan (PWP) which was posted in the public docket (EPA-HQ-OPP-2014-0608) on September 24, 2014 (79 FR 57092). Products containing of S treptomyces lydicus WYEC 108 are registered for use as a microbial fungicide on a broad array of food and nonfood agricultural and residential use sites.

EPA is implementing the Registration Review pr ogram 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 o ccur 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 that statutory standard of no unreasonable adverse effects to human health or the environment. The public phase of Registration Review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/registration_review/.

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 the PWP, and a summary of the EPA's responses to those comments. This section is followed by the anticipated 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

Since the PWP was issued in September 2014 (U.S. EPA 2014), there have been no changes to the registrations of pesticide products 1 

### containing S treptomyces lydicus WYEC 108 as an active ingredient.

1 There are three registered products containing Streptomyces lydicus WYEC 108 as an active ingredient: EPA Reg. No 73314-1, 73314-2, and 73314-4.Registration Review Final Work Plan Streptomyces lydicus WYEC 108 EPA

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### SUMMARY OF COMMENTS AND EPA’S RESPONSES

During the 60-day public comment period on the S treptomyces lydicus WYEC 108 PWP (docket opened on September 24, 2014 and closed on November 24, 2014), EPA received no public comments. In the PWP, EPA specifically solicited comments on: environmental justice, water quality concerns, and trade irritants; no comments or info rmation were received concerning these issues.

PLANNED DATA NEEDS

EPA has identified several Product Analysis (40 CFR 158.2120) data gaps for S treptomyces lydicus WYEC 108. These are discussed in the PWP (U.S. EPA 2014; available at regulations.gov) and summarized in Table 1.

Table 1 Planned Data Needs for Case 6088— Streptomyces lydicus WYEC 108
Harmonized

Guideline Number Study Title Test Material a Estimated Timeframe (months from Receipt of DCI c )

830.6302 Color TGAI 8 months

830.6304 Odor TGAI 8 months

830.6313 Stability to normal and elevated temperatures, metals, and metal ions TGAI 8 months

830.6320 Corrosion characteristics b MP; EP 8 months

830.7000 pH TGAI 8 months 830.7300 Density TGAI 8 months

a EP=end-use product; MP=manufacturing-use product; TGAI=t echnical grade of the active ingredient

b Required when microbial pesticides are packaged in metal, plastic, or paper containers.

c DCI=Data Call-in



### REGISTRATION REVIEW RISK ASSESSMENTS

In the S treptomyces lydicus WYEC 108 PWP, EPA stated that it plans to conduct an ecological risk assessment to determine whether use of Streptomyces lydicus WYEC 108 will have “no effect” or “may affect” federally listed threatened or endangered species (listed species) and/or their designated critical habitat (see, U.S. EPA 2014, p.10). No other risks assessments are planned.

In addition, EPA will determine, whether, pursuant, whether, pursuant to Section 408(p)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA), S treptomyces lydicus WYEC 108 qualifies for exemption from the Endocrine Disruptor Scr eening Program (EDSP). EPA believes that S treptomyces lydicus WYEC 108 is likely not an endocrine disruptor; as such, EPA may exempt it from EDSP. If it is exempted, then EPA will issue an order.Registration Review Final Work Plan Streptomyces lydicus WYEC 108 EPA

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### TIMELINE

The projected timeline for the completion of the Registration Review for Streptomyces lydicus WYEC 108 is provided in Table 2.

Table 2 Registration Review for Streptomyces lydicus WYEC 108: Projected Registration Review Timeline

Activities Estimated Month Year

Docket Opening Open Docket and 60-Day Public Comment Period for Streptomyces lydicus WYEC 108 September 24, 2014: Completed

Close Public Comment Period November 24, 2014: Completed

Case Development

Issue Final Work Plan a March 2015: Completed Issue Data Call-in May 2016 Data Submission January 2017 Open 30-Day Public Comment Period for Draft Risk Assessments June 2017

Close Public Comment Period July 2017

Registration Review Decision Open 60-Day Public Comment Period for Proposed Registration Review Decision November 2017

Close Public Comment Period January 2018 Registration Review Final Decision and Begin Postdecision Follow-up February 2018

E STIMATED T OTAL (years): ≈ 4.5

a This schedule is subject to revision should unforeseen issues arise during the Registration Review

process. If an issue arises (e.g., failure to acquire an EDSP exemption), an amended FWP may be issued at that time. That FWP will identify any ne wly anticipated data needs and set forth a new timeline.



### NEXT STEPS

As noted previously, EPA will determine whether, pursuant to FFDCA Section 408(p)(4), Streptomyces lydicus WYEC 108 qualifies for exemption from t he EDSP; this determination will inform EPA’s final Registration Review decision. Addi tionally, EPA intends to conduct an ecological risk assessment that would support a complete endangered species determination.

REFERENCE

U.S. EPA. 2014. Preliminary Work Plan and Summary Document for Registration Review: Streptomyces lydicus WYEC 108. U.S. Environmental Protection Agency Office of Pesticide Programs. September 23, 2014. 22 pp. Available through regulations.gov.