1018-0067 Supporting Statement A.rtf

Supporting Statement A for

Paperwork Reduction Act Submission

OMB Control Number 1018-0067

Approval Procedures for Nontoxic Shot and Shot Coatings

50 CFR 20.134

Terms of Clearance. OMB approved this information collection on February 23, 2007, with the following terms of clearance: In accordance with 5 CFR 1320, prior to the agency’s next submission of this information collection to OMB for approval the agency shall review its regulations and make any necessary revisions to reduce the information required to the extent practicable.

We reviewed our regulations (50 CFR 20.134) for possible reductions in the amount of information we collect to approve nontoxic shot. We believe we collect the minimum information and require the minimum amount of testing necessary for us to determine whether a proposed shot is toxic or nontoxic. We did not make any changes to our regulations based on this review.

When considering approval of a candidate material as nontoxic, we must ensure that it is not hazardous in the environment and that secondary exposure (ingestion of spent shot or its components) is not a hazard to migratory birds. To make that decision, we require each applicant to collect information about the solubility and toxicity of the candidate material. Additionally, for law enforcement purposes, a noninvasive field detection device must be available to distinguish candidate shot from lead shot.

We have not required applicants to conduct live animal testing of any nontoxic shot for the last 10 years. However, if an applicant proposes a new nontoxic shot for approval, we may require the dosing of ducks with lead shot. This testing is necessary to confirm that the dosing methods used by the testers are likely to achieve the desired results. We require testing only on the minimum number of animals for statistical validity. If we reduce this number further, we run an increased risk of approving a shot that is actually toxic.

1. Explain the circumstances that make the collection of information necessary.

This information collection is associated with regulations implementing the Migratory Bird Treaty Act (MBTA) (16 U.S.C. 703 et seq.). The MBTA prohibits the unauthorized take of migratory birds and authorizes the Secretary of the Interior to regulate take of migratory birds in the United States. Under this authority, the Fish and Wildlife Service (Service, we) controls the hunting of migratory game birds through regulations at 50 CFR part 20. In 1991, we banned lead shot for hunting waterfowl and coots in the United States, because of its toxicity to migratory birds and other wildlife. At that time, steel shot was the only available nontoxic alternative. In subsequent years, we have encouraged manufacturers to develop other alternatives for hunting use. The guidelines for approving a candidate material as nontoxic for waterfowl and coot hunting are at 50 CFR 20.134. The information collection requirements found there provide the basis by which the Director of the Service approves or disapproves the nontoxic status of candidate shot materials.

2. Indicate how, by whom, how frequently, and for what purpose the information is to be used. If the information collected will be disseminated to the public or used to support information that will be disseminated to the public, explain how the collection complies with all applicable Information Quality Guidelines.

We do not collect this information on a regular basis, but rather whenever a manufacturer submits an application for approval of a nontoxic shot or shot coating. The regulations at 50 CFR 20.134 outline the application and approval process for new types of nontoxic shot. When considering approval of a candidate material as nontoxic, we must ensure that it is not hazardous in the environment and that secondary exposure (ingestion of spent shot or its components) is not a hazard to migratory birds. To make that decision, we require each applicant to collect information about the solubility and toxicity of the candidate material. Additionally, for law enforcement purposes, a noninvasive field detection device must be available to distinguish candidate shot from lead shot. 50 CFR 20.134 specifies what information we collect and how we use it to determine the shot material’s nontoxic status. This information constitutes the bulk of an application for approval of nontoxic shot.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden [and specifically how this collection meets GPEA requirements.].

Applicants send us automated or electronic risk assessment analysis and modeling.

4. Describe efforts to identify duplication.

There are no other information collections that gather the information we need to determine the nontoxic status of a candidate shot material. Applicants may use previously collected information, thus avoiding unnecessary duplication of risk assessments, toxicity tests, and background information.

5. If the collection of information impacts small businesses or other small entities, describe the methods used to minimize burden.

This collection does not significantly impact small businesses. About 40 percent of the applications are from small entities, which is an average of less than one per year. If a small entity chooses to submit an application, we work closely with the applicant to avoid duplication (see item 4) and reduce the hour/dollar burden as much as possible.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

We only collect this Information when an entity applies for approval of a new nontoxic shot. If the information were not collected, we could not determine if the candidate material is nontoxic; therefore, fewer nontoxic shot materials would be available to hunters. We believe that hunter compliance with nontoxic shot requirements for waterfowl is greater when there are more nontoxic shot alternatives available. Furthermore, increased use of nontoxic shot will enhance protection of migratory waterfowl and their habitats.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

* requiring respondents to report information to the agency more often than quarterly;

* requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;

* requiring respondents to submit more than an original and two copies of any document;

* requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;

* in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;

* requiring the use of a statistical data classification that has not been reviewed and approved by OMB;

* that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

* requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.

There are no special circumstances that would require us to conduct this collection in a manner inconsistent with OMB guidelines.

8. Provide the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice (or in response to a PRA statement) and describe actions taken by the agency in response to these comments.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported. [Please list the names, titles, addresses, and phone numbers of persons contacted.]

On August 15, 2008, we published in the Federal Register (73 FR 47963) a notice that we would request that OMB renew approval of our information collection associated with the approval procedures for nontoxic shot and shot coatings. In that notice, we solicited public comments for 60 days, ending October 14, 2008. We did not receive any comments in response to that notice.

We queried four previous applicants for nontoxic shot approval:

Tim Wei Spherical Precision, Inc. 2882A Walnut Avenue Tustin, California 92780-7027 714-544-7777	Ralph Naumann Environmental, Inc. 11307 Clark Mill Road Sweet Home, Oregon 97386-1121 541-367-3522
Greg Smith Olin Corporation 427 North Shamrock Street East Alton, IL 62024 618-258-2817	Kyle Smith 424 Bridgefield Court Wichita, KS 67230 316-841-7119

Two individuals responded to our inquiry and provided the following information:

• Burden estimate. One person replied that the application took about 18 months to complete. This response accounts for all of the time involved, from creation of the shot to testing it and working with a consultant to prepare an application. The other commenter replied that the initial application required about 3,200 manhours to complete, but subsequent applications required 600 to 1,600 hours. Based on these comments, we believe our estimate of an average of 3,200 hours to complete the application is correct.

• Ways to improve the application process (specifically, the type of information collected). One person suggested that if the testing criteria were clearer, it would help. Many complicated technical questions determine the duration and cost of the testing protocols. Fish and Wildlife Service staff work closely with applicants to make the process as easy as possible.

• Whether or not the instructions are clear on how to complete the application process. One person stated that, with the help of the consultant, the process seemed clear. The other commenter stated that the application process is straightforward, but the criteria for testing, reporting, and approval are more difficult to understand. Again, Fish and Wildlife Service staff work closely with applicants to define the issues.

• Nonhour burden cost associated with the application. One person estimated $18,000 for the consultant to test the shot and prepare an application. The other commenter stated that there were substantial subcontracting expenses; e.g., payments for animal testing and blood work including toxicology analyses for metal releases under a wide range of environmental conditions and artificial gizzard experiments. This commenter stated that animal studies routinely cost $20,000 to $30,000, corrosion studies cost about $10,000, and toxicological studies typically cost $10,000. Based on these comments, we increased our estimates for the nonhour cost burden (see item 13).

9. Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

We do not provide any payments or gifts to respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy.

There is no assurance of confidentiality. Once an application is submitted, we publish a summary of the application in the Federal Register as a Notice of Application. The information contained in an application is subject to the Freedom of Information Act.

11. Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

We do not ask questions of a sensitive nature.

12. Provide estimates of the hour burden of the collection of information.

Over the past 11 years, we have received about 10 applications for nontoxic shot approvals, and several of these were repeat applications. We estimate that we will receive one application per year for a total of 3,200 annual burden hours. The hour burden associated with the information collection varies with each applicant and depends significantly on how much already-available information can be applied toward a candidate material. Our hour burden estimate ranges from 80 to 6,400 hours with an average of 3,200 hours per application.

We estimate the total dollar value of the annual burden hours to be $125,920 (3,200 hours x $39.35). Based on Bureau of Labor Statistics 2007 National Occupational Employment and Wage Estimates for the United States (http://www.bls.gov/oes/current/oes_nat.htm#b19-0000), the mean hourly wage for zoologists and biologists is $28.11. We multiplied this wage by 1.4 to account for benefits ($39.35).

13. Provide an estimate of the total annual [nonhour] cost burden to respondents or recordkeepers resulting from the collection of information.

We estimate the total annual nonhour cost burden to respondents to be $25,000. This amount reflects average annual spending to contract out with companies that perform the tests and analyses required for approval of a nontoxic shot material.

14. Provide estimates of annualized costs to the Federal Government.

We estimate the annual cost to the Federal Government to administer this information collection to be $25,597. To determine salary costs, we used the Office of Personnel Management Salary Table 2009-DCB and multiplied the hourly rate for a GS-13, step 8 ($51.37) by 1.5 to account for benefits ($77.06).

Task	Total Annual Hours	Hourly Rate Including Benefits	Total costs
Application Review	24	$77.06	1,849
Prepare Notice of Application	8	$77.06	616
Federal Register printing cost			870
Prepare Draft Environmental Assessment	40	$77.06	3,082
Prepare Proposed Rule	80	$77.06	6,165
Federal Register printing cost			4,350
Prepare Final Environmental Assessment	16	$77.06	1,233
Prepare Final Rule	40	$77.06	3,082
Federal Register printing cost			4,350
Total			$25,597

15. Explain the reasons for any program changes or adjustments.

Based on our experience in administering this program, we adjusted our estimate of the number of responses from two to one, which resulted in a decrease of 3,200 burden hours (from 6,400 to 3,200 hours). We increased our estimate of the nonhour burden cost to $25,000 per application. However, because we decreased the number of responses, the result is a decrease of $9,000 from our previous submittal.

16. For collections of information whose results will be published, outline plans for tabulation and publication.

We do not publish the results of this information collection. We do publish Federal Register documents when we receive an application and when we take final action. These documents summarize the contents of the application.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.

We will display the OMB control number and expiration date on appropriate materials.

18. Certification.

There are no exceptions to the certifications required by 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).