2311.02_Attachment E

EPA ICR No. 2311.02 -- Attachment E

2014 Section 24(c) ICR Consultation Questions:

1. Please provide your official contact information below:

CA: John E. Inouye

Senior Environmental Scientist (Specialist)

California Department of Pesticide Regulation

Pesticide Registration Branch

1001 I Street, P.O. Box 4015

Sacramento, California 95812-4015

Phone: (916) 324-3538

[email protected]

TX: Dale R. Scott

Coordinator for Pesticide Product Evaluation and Registration

Texas Department of Agriculture

PO Box 12847

Austin, TX 78711

(512) 936-2535

[email protected]

2. Publicly Available Data

   1. Is the data that Agency seeks available from any public source, or already collected by another office at EPA or by another agency?

CA: Yes

TX: In most cases, the requested pesticide for the 24(c) registration already has a Section 3 registration with EPA. Some of the data requested by the EPA Risk Integration, Minor Use, and Emergency Response Branch has already been collected as part of the Section 3 data, which includes tolerance information. However, efficacy data is specific to the Section 24(c) registration and has not been previously collected by EPA.

2. 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 special local need (SLN) situation being dealt with for the chemical/crop in question. Therefore, it is best to have the SLN 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: The tolerance data is published in §40 CFR.

3. Frequency of Collection

   1. Can the Agency collect the information less frequently and still produce the same outcome?

CA: Special local need information is collected once when the state approves the registration and then submits it to U.S. EPA for approval. Less frequent collection is not possible in this regard. However, five year expiration dates could be omitted with the same outcome.

TX: The data is specific to a particular 24(c) registration. The data is only collected upon the state requesting the registration.

4. Clarity of Instructions

   1. 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/TX:Yes

2. Do you understand that you are required to maintain records? CA//TX: Yes

3. 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/TX: No

4. Are there forms associated with this process? Do you use them? Are they clear, logical, and easy to complete?

CA: Yes/Yes/Yes

TX: Yes, the requesting company along with the State Lead Agency is required to submit an EPA form 8570-25 with the registration packet. The forms are clear, logical and easy to complete.

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.

1. 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: I believe electronic submissions are a good idea. It would be faster, more efficient, and cost savings (postal) for the states.

As long as security is addressed, it is something our Department is interested in.

TX: The Texas Department of Agriculture (TDA) would welcome the ability to submit electronic submissions for 24(c) registrations. This option is not available to the agency at this time.

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

CA: Yes. We keep data on file mainly as paper, with some electronic format. Electronically, it’s stored on CDs.

TX: TDA currently keeps copies of all documents on our system. Most documents are either in Microsoft Word or pdf formats.

3. Although the Agency does not offer an electronic reporting option because of CBI-related security concerns at this time:

   1. Would you be more inclined to submit CBI on diskette (CD or DVD) than on paper?

CA: At this point in time we don’t submit CBI for SLNs to EPA. If this type of information is required, we have the data owner of CBI submit it directly to EPA.

TX: Yes

2. What benefits would electronic submission bring you in terms of burden reduction or greater efficiency in compiling the information?

CA: It would be faster, more efficient, and cost savings (postal) for the states.

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

   1. Are the labor rates accurate? CA: Yes TX: N/A

2. The Agency assumes there is no capital cost associated with this activity. Is that correct? CA: Yes TX: Correct

3. 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, for the most part the cost estimates should be fairly close. There are situations in which we may have to spend additional time in gathering and reviewing data to justify an SLN.

TX: No response

4. Are there other costs that should be accounted for that may have been missed?

CA: Yes, the additional cost in maintaining the new requirement for SLNs to have expiration dates. The cost involves:

• The registrant to submit in a timely manner a request to extend the expiration date.

• The registrant must address alternative pesticides (re-justifying SLN).

• The registrant must submit new labels with the new expiration date.

• The State must review this data/ information to extend the SLN.

• The State must send the appropriate correspondence to EPA addressing the extension of the SLN.

• If registrant is late in submitting for an extension of SLN, registrant must submit a new SLN application to the State.

  • The State must use staff to:

    • Process the intake mail.

    • If new data is submitted, we’ll have staff index the data for evaluation.

    • Staff has to review the data and/or information justifying the SLN.

• The State must send the appropriate correspondence to EPA addressing the extension of the SLN.

Overall the burden of tracking and making sure the SLN expiration data is not exceeded becomes an overall burden and additional cost on the State regulatory program, SLN registrants, and grower community.

TX: No response

7. Miscellaneous – Response to Emergency Exemption Process Revisions

   1. How has the streamlined application process impacted your division as it pertains to the following:

      1. Recertification of certain repeat emergency exemptions?

      2. 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?

   2. Has the application and review process for submitting repeat emergency exemptions improved since the regulation went into effect March 28, 2006?

CA/TX: Not Applicable.