ICR 2311.02

 Attachment D

2014 Section 18 ICR Consultation Questions/Responses:

1) Please provide your official contact information below:

CA: Margaret Reiff, Environmental Program Manager I

California Department of Pesticide Regulation

Pesticide Registration Branch

1001 I Street, P.O. Box 4015

Sacramento, California 95812-4015

Phone: (916) 445-5977

Margaret.Reiff@cdpr.ca.gov

TX: Dale R. Scott

Coordinator for Pesticide Product Evaluation and Registration

Texas Department of Agriculture

PO Box 12847

Austin, TX 78711

(512) 936-2535

Dale.scott@TexasAgriculture.gov

2) Publicly Available Data

a. Is the data that the Agency seeks available from any public source, or 

already collected by another office at EPA or by another agency? 

CA: Some of the general data the Agency seeks, such as crop economics, pest 

definition, FQPA status, and alternative methods of control is available 

(in part) from public sources accessible through the internet.

TX: Because a Section 18 registration can be an unregistered pesticide, the data 

is not always publically available or has not been previously submitted to 

EPA. In the cases where the product is registered for another use by EPA, 

the data would be available. However, much of the data is collected 

directly from the pesticide manufacturer. This data includes the 

Ecological Toxicity data, the Environmental Fate data, as well as residue 

data. Other data such as efficacy data is collected from either the 

company or universities, or both. 

b. If yes, where can you find the data? (Does your answer indicate a true 

duplication, or does the input indicate that certain data elements are 

available, but that they do not meet our data needs very well?)

CA: If the data is not considered confidential, it is available in the public 

sector. Examples of this would include the USDA National Agricultural 

Statistics Service (NASS) data, State/County Crop Reports, State/Federal 

pesticide label databases, University Extension and scientific publications. 
However, how this data is interpreted and used is specific to each 

emergency situation being dealt with for the chemical/crop in question. 

Therefore, it is best to have the section 18 applicant submit the data in the 

context of the emergency explanation. EPA can then use these resources 

as verification.

Confidential data may be possible to obtain from a registrant.

TX: If a pesticide has been submitted to EPA for registration, much of the data 

can be taken from the EPA Risk Assessment. If the pesticide is 

unregistered, the data will have to come from either the manufacturer or 

other sources.

3) Frequency of Collection

a. Can the Agency collect the information less frequently and still produce the 

same outcome?

CA: Emergency Exemption information is collected once when the state 

submits a section 18 to U.S. EPA for approval. Less frequent collection is 

not possible in this regard. Additionally, the follow up reporting of 

pesticide use information once the section 18 expires is important to this 

process; the frequency of which should not be reduced.

However, in the case of repeating section 18’s, the recertification 

provision of the section 18 regulations is a good example of reduced 

information producing the same outcome. Emergencies that are likely to 

continue into the future may be re-certified in subsequent years with a 

reduced application package. This greatly reduces duplication and 

streamlines the application process in most of these cases where the 

emergency situation is identical to the previous year(s). Additional 

information may be required to confirm the severity of the emergency and 

any alternatives that may have been registered since the original 

application.

TX: The data is specific to the Section 18 registration in most cases, therefore 

is not collected multiple times.

4) Clarity of Instructions

a. The ICR is intended to require that respondents provide certain data so that 

the Agency can utilize them. Based on the instructions (regulations, PR 

Notices, etc.), is it clear what you are required to do and how to submit such 

data? If not, what suggestions do you have to clarify the instructions?

CA: Yes. The Pesticide Regulatory Education Program (PREP), in 

conjunction with U.S. EPA, University of California Davis, and State Lead 

Agencies developed a Section 18 Online Training Tool which clarifies the 

application information in detail 

(http://www.epa.gov/pesticides/regulating/section18_training/). This

assists requesting State, tribal, and federal agencies in determining 

situations where it is appropriate to submit a Section 18 application, and 
when doing so, to submit a robust Section 18 package that is as complete 

and accurate as possible to facilitate a timely and effective review by EPA. 

Other stakeholders in this process also find this tool helps to better 

understand the purposes and processes of the Section 18 program.

TX: Yes

b. Do you understand that you are required to maintain records? 

CA: Yes

TX: Yes

c. Considering that there is no required submission format, is it difficult to 

submit information in ways that are clear, logical and easy to complete?

CA: An application format was provided in the November 8, 2001 U.S. EPA 

document titled, Emergency Exemptions Under Section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide Act, Instructions for Submission 

of Emergency Exemption Applications which helped organize the 

required information and is an excellent base to work from. The March 

28, 2006 revisions to 40 CFR part 166 provided more detail and structure 

for what EPA is looking for relative to economic loss information. The 

PREP Section 18 Online Training Tool clarifies the application 

information further. The difficulty encountered is in gathering the 

economic loss information because it is not always available to that level 

of detail. However, once obtained, formatting is not an issue.

TX: Although there is no required submission format, §40 CFR lays out the 

requirements that must be included in each submission. TDA does not 

have any problems with the submission procedure.

d. Are there forms associated with this process? Do you use them? Are they 

clear, logical, and easy to complete?

CA: See previous question. We do use what formats are available. Our state 

has elaborated on the 2001 EPA form.

TX: There are no forms for Section 18 submissions.

5) Electronic Reporting and Record Keeping

The Government Paperwork Elimination Act requires agencies make available to 

the public electronic reporting alternatives to paper-based submissions by 2003, 

unless there is a strong reason for not doing so. One such reason is that, at the 

present time, the Agency is unable to ensure the security of CBI that might be 

transmitted over the internet.

a. What do you think about electronic alternatives to paper-based records and 

data submissions? Current electronic reporting alternatives include the use 

of web forms/XML based submissions via the Agency’s internet site and 
magnetic media-based submissions, e.g., diskette, CD_ROM, etc. Would you 

be interested in pursuing electronic reporting?

CA: Yes, to the point that it coincides with our Departments capabilities.

TX: Yes

b. Are you keeping records electronically? If yes, in what format?

CA: In California, we do maintain electronic files of most of the Section 18 

documents that are submitted to the Agency, in addition to paper-based 

records. Large volumes of data are submitted to the Agency via overnight 

mail and not kept electronically, unless the registrant has submitted them 

on CD. Our electronic files for Section 18’s are kept in Microsoft Word, 

Excel, Power Point, and Adobe Acrobat. Database information is kept in 

Oracle 11G with the application written in cold fusion 9.

TX: TDA currently keeps copies of all documents on our system. Most 

documents are either in Microsoft Word or pdf formats.

c. Although the Agency does not offer an electronic reporting option because of 

CBI-related security concerns at this time:

i. Would you be more inclined to submit CBI on diskette (CD or DVD) 

than on paper?

CA: We do not have an inclination at this time.

TX: Yes

ii. What benefits would electronic submission bring you in terms of 

burden reduction or greater efficiency in compiling the information?

CA: It would increase efficiency, reduce workload, and streamline 

paperwork. It would also facilitate a quicker response to 

information requests and the sharing of information between 

entities. In the case of repeat Section 18’s, being able to recall an 

electronic version of previous documents and emails increases the 

efficiency of project completion.

TX: By allowing electronic submission, it would cut down on the cost 

and amount of paperwork and the cost of courier service. It would 

also allow for the submissions to be sent and reviewed in a timelier 

manner.

6) Burden and Costs

a. Are the labor rates accurate? CA: Yes TX: No response

b. The Agency assumes there is no capital cost associated with this activity. Is 

that correct? CA: Yes TX: Correct
c. Bearing in mind that the burden and cost estimates include only burden 

hours and costs associated with the paperwork involved with this ICR, e.g., 

the ICR does not include estimated burden hours and costs for conducting 

studies, are the estimated burden hours and labor rates accurate? If you 

provide burden and cost estimates that are substantially different from 

EPA’s, please provide and explanation of how you arrived at your estimates.

CA: Yes, we agree these figures are accurate for the standard section 18 

request. It should be noted that there are times when a section 18 

emergency situation is credible but the economic information to support 

the emergency is limited. In these situations, the “burden hours” can 

increase significantly (>120) in order to obtain as much data as possible 

to satisfy EPA’s review.

TX: No Response

d. Are there other costs that should be accounted for that may have been 

missed?

CA: Not that we are aware of.

TX: No response

7) Miscellaneous – Response to Emergency Exemption Process Revisions

a. How has the streamlined application process impacted your division as it 

pertains to the following:

i. Recertification of certain repeat emergency exemptions?

CA: See question #2. It has greatly reduced the amount of time needed 

to submit the request in subsequent years.

TX: These submissions are submitted to EPA in a more efficient 

manner. Because the emergency and the need for the pesticide 

use still exists, TDA is able to get the submission to EPA in a 

timely manner. It also cuts down on the duplication of documents 

submitted.

ii. The criteria used to determine when a potential emergency condition 

is expected to cause a significant economic loss and the data 

requirements used to document the loss?

CA: The clarification of these criteria has been helpful. It provided 

more detail and structure to what EPA is looking for with this type 

of information. At the same time, it is often difficult to find data to 

support the three-tiered economic analysis process, especially for 

those crops that are ultra minor, such as fresh figs, where this level 

of detail has not been recorded. In an effort to comply with as 

much of this level of detail as possible a considerable amount of 

“burden hours” are expended.
TX: The streamlined significant economic loss requirements allows for 

quick calculations for determining whether TDA should spend 

resources pursuing a section 18 or if the submission is not going to 

qualify based upon the economic loss data. 

b. Has the application and review process for submitting repeat emergency 

exemptions improved since the regulation went into effect March 28, 2006? 

CA: Yes

TX: I have only been involved in Product Registrations since 2009. 

However, from discussions with other staff members, the 

application and review process has improved with the new 

regulation.