Docket Number EP A-HQ-OPP-20 14

-0105 www.regulations.gov



# Formic Acid Final Work Plan Registration Review

Case Number 6073 September 2014

Approved by: Robert McNally, Directo Biopesticides and Pollution Prevention Division
Date:INTRODUCTION This is the Environmental Protection Agency's (EPA or the Agency) Final Work Plan (FWP) for the registration review of formic acid. This work plan addresses public comments received concerning the Preliminary Work Plan (PWP), which was posted in the formic acid registration review docket (EPA-HQ-OPP-2014-0105). Formic acid is currently registered in two products for control of tracheal mites and suppression of V arroa mites in honeybees. 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 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 tirneline identified in t he PWP, and a summary of the Agency ' s responses to those comments. This section is followed by registra t ion review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline for formic acid. Lastly, there is a discussion of next steps. UPDATES SINCE THE PWP WAS ISSUED There are no additional updates on formic acid since the issuance of the PWP. SUMMARY OF COMMENTS AND AGENCY RESPONSES During the 60-day p ublic comment period on the formic acid PWP, which opened on March 28, 2014 , and closed on May 27, 2014 , the Agency did not receive any comments concerning this case. PLANNED DATA NEEDS The planned data needs have not changed from what was included in the formic acid PWP. RISK ASS E SSMENTS FOR REGISTRATION REVIEW As stated in the PWP, no data gaps (anticipated data needs) for formic acid have been identified. The most recent comprehensive risk assessment for formic acid was completed January 28, 1999, in support of the first biochemical registration of formic acid, which also occurred on January 28 , 1999. Because there are no data gaps and no additional information has been 1 http: // www.epa.gov / oppsrrd ! / registration review / 2received by the Agency for this biochemica l pesticide since it was first registered, the Agency does not anticipate the need to conduct a new risk assessment during registration review. TIME LINE EPA has created the following estimated timeline for the completion ofthe formic acid registration review in Table 1, below. This projected timeline has not changed since the PWP. lfable 1: Registration Review for Formic acid

- Projected Registration Review Timeline* Activities Estimated MonthlY ear Opening the Docket Open Docket and 60-Day Public Comment Period March 2014 Close Public Comment Period May 20 14 Case Development Issue F inal Work Plan September 20 14 Issue Data Call-in NIA Data Submission N/A Open 30-Day Public Comment Period for Draft Risk Assessments NI A Close Public Comment Period N/A Registration Review Decision Open 60-Day Public Comment Period for Proposed Registration Review June2015 Decision Close Public Comment Period August 2015 Final Decision December 20 15 Estimated Total (years) 1 year and 9 months

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### * This schedule IS s ubJeCt to rev1s 1 on shou ld unforeseen 1ssues anse dunng the reg1strat10n rev1ew process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time. That Final Work Plan will identify any newly anticipated data needs and set forth a new timeline. NEXT STEPS The Agency plans to issue a Proposed Registration Review Decision for this case in June , 20 15
. At that time, a 60-day public comment period will be opened to accept comments on the Proposed Decision.



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