Registration Review Final Work Plan    Streptomyces lydicus WYEC 108

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REGISTRATION REVIEW OF STREPTOMYCES

 LYDICUS WYEC 108: FINAL WORK PLAN 

 

Case Name: Streptomyces 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 Streptomyces 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 Streptomyces 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 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 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 products1 containing Streptomyces lydicus WYEC 108 as an active 

ingredient. 

 

 

1There 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

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SUMMARY OF COMMENTS AND EPA’S RESPONSES 

 During the 60-day public comment period on the Streptomyces 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 information were received concerning these issues. 

PLANNED DATA NEEDS 

 EPA has identified several Product Analysis (40 CFR 158.2120) data gaps for Streptomyces 

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 

Materiala

Estimated Timeframe 

(months from Receipt of DCIc)

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 

characteristicsb MP; EP 8 months 

830.7000 pH TGAI 8 months 

830.7300 Density TGAI 8 months 

aEP=end-use product; MP=manufacturing-use product; TGAI=technical grade of the active ingredient bRequired when microbial pesticides are packaged in metal, plastic, or paper containers. cDCI=Data Call-in 

 

REGISTRATION REVIEW RISK ASSESSMENTS 

 

 In the Streptomyces 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), Streptomyces lydicus WYEC 108 qualifies for 

exemption from the Endocrine Disruptor Screening Program (EDSP). EPA believes that Streptomyces 

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

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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 Plana 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 

ESTIMATED TOTAL (years): ≈4.5

aThis 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 newly 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 the EDSP; this determination will inform 

EPA’s final Registration Review decision. Additionally, 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.