Milestones for Implementing Insect Repellent Rule 

Months after promulgation o

Task/Event 1 2 3 4 5 6 7 8 9 10 11 12 

1 d 60 d 150 d 240 d 330 d 1 yr 

EPA holds workshop to provide 

information to producers of 

currently exempted insect 

repellents. 

1. Milestone #1: Producers 

decide whether to commit to 

pursue registration; submit 

“official letter” committing to 

apply for registration. 

2. EPA continues discussions 

with producers and responds to 

letters. 

3. OPP notifies OECA about 

producers who do not commit to 

registration, and those that intend 

to seek registration. 

4. Milestone #2: Producers who 

commit to registration submit 

registration applications. 

5. OPP notifies OECA about 

producers who do not submit 

applications. 

6. EPA reviews and accepts 

applications to market within the 

exemption while seeking 

registration. 

7. OPP notifies OECA about 

producers whose applications are 

unacceptable. 

8. Milestone #3: Producers begin 

using new labels on products 

released for shipment. 

9. EPA initiates enforcement 

action against producers who do 

not use new labels. 

10. Producers who commit to 

seek registration begin to identify 

laboratories to develop efficacy 

data. 

11. Milestones #4, 5, 6, 7: a t 1
year, 2 years, 3 years and 4 years: 

Notify EPA of progress toward 

registration (letter). 

12. Milestone #8: Final 

application process. 

13. OPP notifies OECA about 

producers who do not complete 

the registration process. 

14. Exemption expires and 

disappears [5 years]. 

OPP = Office of Pesticide Programs OECA = Office of Enforcement and Compliance Assurance Milestones 5 - 8 are off scale. This timeline begins with the date of promulgation of the final rule (becomes effective 60 days after publication). Our estregistration. At the workshop, EPA discusses the Small Business Guidance (required by SBREFA). The discussions will focus on thre

• Decision to commit to registering a currently exempted insect repellent product • Process for seeking a registration from EPA • Laboratory search and protocol review 

Applicant = red EPA = green Enforcement = yellow Search for and contract with a testing facility = blue Producers deciding to market an inset repellent within the exemption must meet all eight milestones to remain exempted. 

can take enforcement action. 

1. Milestone #1: Producers submit of a letter of intent to pursue registration. Failure to meet this milestone would ca

product, and sale or distribution of the product would be prohibited, unless the product were otherwise exempt. Thenter the market as an exempted product after Milestone 1 has passed. After that time, the producer would seek a application. 

2. EPA responds to the letter, by either email or a phone call. EPA believes that a meeting or teleconference would b

web. The Small Entity Compliance Guidance will contain an example of the generic label that would be expectedgather-up all their information for their discussions with EPA. 

3. Enforcement action can be initiated. 
4. Milestone #2: Producers who commit to registration submit registration application, which include an application 

should also be submitted. Note: There may be a few producers with sufficient information that could move direct

5. Enforcement action can be initiated. 6. EPA reviews the application package (CSF and draft label with generic statements). EPA would review the CSF, 

review the draft generic label, and, as appropriate, would modify the generic label statements to be product-specifi

acknowledgement that their label, as modified, is acceptable. EPA assign a tracking number. (The tracking numbeX is the individual product number. So, for company “999999”, the tracking number for their first product would b

7. Enforcement action can be initiated. 8. Milestone #3: Producers have 6 months to transition to the new label. After 6 months, all product released for shi

coordinate with selling establishments to assure that selling establishments do not have large stocks of older-labele

9. Enforcement action can be initiated. 10. As soon as a producer decides to pursue registration they can begin the process of securing a contract with a testin

applications. 

11. Letter describing progress toward registration on a yearly basis. This is not intended to be a lengthy letter, and nee

contract with laboratory was signed, date testing occurred, dates of Human Studies Review Board meetings on the 

12. Producer submits a new label with a protection time [date + 4.5 year]. Agency reviews and converts the tracking n13. Enforcement action can be initiated. 14. Once the exemption has expired, EPA can remove the text and milestones for the transition from CFR.