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 the PWP, and a 

summary of the Agency's responses to those comments. This section is followed by registration 

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 public 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 ASSESSMENTS 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 

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http://www.epa.gov/oppsrrd !/registration review/ 

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received by the Agency for this biochemical 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 of the 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 2014 

Case Development 

Issue Final Work Plan September 20 14 

Issue Data Call-in NIA 

Data Submission N/A 

Open 30-Day Public Comment Period for Draft Risk Assessments NIA 

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 2015 

Estimated Total (years) 1 year and 9 months .. * This schedule IS subJeCt to rev1s1on should 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 

time line. 

NEXT STEPS 

The Agency plans to issue a Proposed Registration Review Decision for this case in June, 2015. 

At that time, a 60-day public comment period will be opened to accept comments on the 

Proposed Decision. 

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