Docket Number EPA-HQ-OPP-2015-0693 

www.regulations.gov 

p-Menthane-3,8-diol (PMD) 

PC Code: 011550 

Registration Review Final Work Plan 

June 2016 

Case #6017 

Approved by: 

Robert McNall , Directo I 

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 p-methane-3,8-diol (PMD). This work plan addresses public comments 

received concerning the Preliminary Work Plan (PWP), which was posted in the PMD 

registration review docket (EPA-HQ-OPP-20 15-0693). PMD is currently registered in four enduse products (EPs) for outdoor, residential non-food use as an insect repellent to be applied to 

exposed human skin and clothing. 

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 timeline 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 PMD. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED 

There are no additional updates on PMD since the issuance of the PWP. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES 

During the 60-day public comment period on the PMD PWP, which opened on January 11, 2016, 

and closed on March 11 , 2016, 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 PMD PWP. 

RISK ASSESSMENTS FOR REGISTRATION REVIEW 

As stated in the PWP, no data gaps (anticipated data needs) for PMD have been identified. The 

most recent comprehensive risk assessment for PMD was completed on February 26, 1999, in 

support of the first biochemical registration ofPMD, which occurred in May, 2000. Because 

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https://www.epa.gov/pesticide-reevaluation/registration-review-process 

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there are no data gaps for PMD, and no additional information has been received on this 

biochemical 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 PMD registration 

review in Table 1, below. This projected timeline has not changed since the PWP. 

Table 1: Registration Review for p-Methane-3,8-diol (PMD) -

Projected Registration Review Timeline 

Activities Estimated MonthlY ear 

Opening the Docket 

Open Docket and 60-Day Public Comment Period December 2015 

Close Public Comment Period February 201 6 

Case Development 

Issue Final Work Plan June 2016 

Issue Data Call-in N/A 

Data Submission N/A 

Open 30-Day Public Comment Period for Draft Risk Assessments N/A 

Close Public Comment Period N/A 

Registration Review Decision 

Open 60-Day Public Comment Period for Proposed Registration Review December 20 16 

Decision 

Close Public Comment Period February 20 17 

Final Decision June 2017 

Estimated Total (years) 1 year and 6 months* . . * Th1s schedule IS subject to rev1s1on should un foreseen 1ssues anse durmg the reg1strat1on rev1ew process. In the 

event an issue arises, such as the fa ilure to acquire an EDSP exemption, an amended Final Work Plan will be issued 

at that time. That Final Work Plan wi ll 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 December, 

2016. At that time, a 60-day public comment period will be opened to accept comments on the 

Proposed Decision. 

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