1 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR)

1. Identification of the Information Collection 1( a). Title of the Information Collection Title: Tolerance Petitions for Pesticides on Food/ Feed Crops and New Inert Ingredients EPA ICR No. 0597.09 OMB Control No. 2070 0024 1( b). Short Characterization/ Abstract The use of pesticides to increase crop production often results in pesticide residues in or on the crop. To protect the public health from unsafe pesticide residues, the Environmental Protection Agency ( EPA) sets limits on the nature and level of residues permitted pursuant to section 408 of the Federal Food, Drug and Cosmetic Act ( FFDCA) ( Attachment A). A pesticide may not be used on food or feed crops unless the Agency has established a tolerance ( maximum residue limit) for the pesticide residues on that crop, or established an exemption from the requirement to have a tolerance.

Under the law, EPA is responsible for ensuring that the maximum residue levels likely to be found in or on food/ feed are safe for human consumption through a careful review and evaluation of residue chemistry and toxicology data. In addition, EPA must ensure that adequate enforcement of the tolerance can be achieved through the testing of submitted analytical methods. If the data are adequate for EPA to determine that there is a reasonable certainty that no harm will result from aggregate exposure, the Agency will establish the tolerance or grant an exemption from the requirement of a tolerance.

There are basically three types of tolerance actions:

( 1) Permanent tolerance ( or an exemption from the requirement for a permanent tolerance) for residues which would result from a pesticide use registered under FIFRA. These tolerances can be established for raw and processed foods and they can address both active and inert ingredients in pesticides. The vast majority of these actions are taken in response to petitions, but the Agency may also initiate such actions.

( 2) Temporary tolerance ( or an exemption from the requirement for a temporary tolerance) to permit the sale of commodities containing residues resulting from authorized experimental use of an unregistered pesticide. In the absence of such a tolerance or exemption, all such commodities must be destroyed. In submitting an application for Experimental Use Permit ( EUP), the applicant may also request that the Agency establish a tolerance or an exemption from the tolerance requirement. This ICR does not cover EUP related tolerance information collection activities, which are covered by the ICR entitled, AApplication for Experimental Use Permit ( EUP) to Ship and Use a Pesticide for Experimental Purposes Only@ ( OMB Control # 2070 0040, EPA ICR No. 276). 2 ( 3) Time limited tolerance ( or an exemption there from) to permit the sale of commodities containing residues resulting from a pesticide whose use was authorized under Section 18 of FIFRA. Under FIFRA ' 18, EPA may allow States to use a pesticide for an unregistered use for a limited time if EPA determines that emergency conditions exist. FQPA requires EPA to establish tolerances to cover all pesticide residues in food, even residues resulting from emergency uses. Although the Agency initiates these tolerance actions, these actions are taken in response to petitions for the Agency to issue an action under FIFRA ' 18. This ICR does not cover information collection related to FIFRA ' 18 tolerance activities, which is collected under the ICR entitled, AApplication and Summary Report for an Emergency Exemption for Pesticides@ ( OMB Control # 2070 0032, EPA ICR No. 596).

This ICR only applies to the information collection activities associated with the submission of a petition for a tolerance action. While EPA is authorized to set pesticide tolerances, the Food and Drug Administration ( FDA) is responsible for their enforcement. Food or feed commodities found to contain pesticide residues in excess of established tolerances are considered adulterated, and are subject to seizure by FDA, and may result in civil penalties.

2. Need For and Use of the Collection 2( a). Need/ Authority for the Collection The tolerances for pesticide residues in food or feed are set primarily under the authority of section 408 of the Federal Food, Drug and Cosmetic Act ( FFDCA), as amended. The Agency takes these tolerance actions either on its own initiative pursuant to FFDCA ' 408( e) or in response to a petition filed pursuant to FFDCA ' 408( d). The regulations covering tolerances are contained in Title 40 of the Code of Federal Regulations ( CFR) Part 180. Actual listings of individual tolerances by chemical are also found in Part 180 ( Attachment B).

Under FFDCA ' 408( d), any person may file a petition with EPA, proposing the issuance of a regulation establishing, modifying, or revoking ( a) a tolerance for a pesticide chemical residue in or on food, or ( b) an exemption from the requirement to have a tolerance for such residue. The Agency publishes a notice of receipt for such petitions in order to provide an opportunity for public comment on the request, and then either issues a final regulation, or a notice denying the petitioner= s request. FFDCA ' 408( d)( 4) directs the Agency to issue a final regulation establishing, modifying, or revoke a tolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of a tolerance, or issue an order denying the petition.

Under FFDCA ' 408( e), at any time the Agency may issue a regulation establishing, modifying, suspending, or revoking ( a) a tolerance for a pesticide chemical residue in or on food, or ( b) an exemption from the requirement to have a tolerance for such residue. When initiating such actions, FFDCA ' 408( e)( 2) requires the Agency to issue a notice of proposed rulemaking to provide an opportunity for public comment. 3 The Food Quality Protection Act of 1996 ( FQPA), which amended the two primary statutes regulating pesticides, i. e., FFDCA and the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA), requires that tolerances be set at a level to ensure that there be Aa reasonable certainty that no harm will result from aggregate exposure.@ Among other things, FQPA requires EPA to consider a number of factors when setting such tolerances or registering pesticide products, including:

( 1) special protection for infants and children;

( 2) aggregate exposure and risk from foods and other known sources, such as drinking water and household pesticide use;

( 3) consideration of common mechanisms of toxicity ( some chemicals have different molecular structures but cause deleterious effects in the same manner); and,

( 4) consideration of endocrine disruptor effects.

The collection of information covered by this ICR is needed to ensure that the statutory requirements related to tolerances can be met by the public and EPA. Food or feed commodities found to contain residues of a pesticide without or in excess of established tolerances are considered adulterated, and are subject to seizure by FDA, and may result in civil penalties.

2( b). Practical Utility/ Users of the Data The FQPA directs the Agency to consider aggregate exposures from dietary and nonoccupational sources when assessing the risks of a chemical and setting tolerances. In addition to dietary exposure, such sources as drinking water and residential lawn care use need to be considered. EPA must make the statutory determination that the resulting pesticide residues in food or feed will result in a reasonable certainty of no harm effects of human health from aggregate exposure through dietary, non occupational, and drinking water routes of exposure before establishing the tolerance.

EPA is applying the FQPA standard to all tolerances for newly registered chemicals and food uses. In addition, FQPA has set a schedule for reassessing all 10,000 existing tolerances under this new standard by 2006. FQPA did not provide for a phase in period for many of the new requirements which had not previously been a part of EPA= s risk assessment process.

EPA does not require registrants to submit any additional information under this ICR in order for the Agency to determine that there is a reasonable certainty that no harm will result from aggregate exposure. However, Section 408 of FFDCA requires petitioners submit Aan information summary of the petition and of the data, information and arguments submitted or cited in support of the petition.@ FQPA requires EPA to consider additional information in order to make the necessary regulatory decisions. Shortly after the enactment of FQPA, EPA encouraged petitioners who previously submitted data prior to enactment of the law to supplement their original submissions with additional information to aid the Agency= s decisionmaking process in light of its new statutory mandates. To allow for the most efficient processing and review of tolerance petitions, the Agency provided a description of the types of information 4 that EPA considers helpful in the appendices to Pesticide Registration ( PR) Notice No. 97 1 ( Attachment D). 1 EPA continues to encourage petitioners to submit supplemental information with their petitions to help EPA determine whether there is a reasonable certainty that no harm will result from aggregate exposure.

EPA uses the data to make decisions about the tolerance petitions. The Agency= s risk managers review, among other things, the regulatory aspects of each petition and coordinate scientific review of the supporting data. Agency residue chemists and toxicologists review all the applicable data. As a result of these reviews, EPA is able to make the statutory determination that the resulting pesticide residues in food or feed will not cause unreasonable adverse dietary effects on human health.

3. Non Duplication, Consultations, and Other Collection Criteria 3( a). Non duplication To avoid potential overlap between the requirement of developing data in support of a tolerance petition and the development of data required for the registration of a pesticide under FIFRA, EPA allows the use of data required to support a tolerance petition that are already archived in EPA records for use as part of a FIFRA registration of a pesticide to be used in a like manner and in the same use pattern.

3( b). Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA published a Federal Register Notice on November 16, 2005 ( 70 FR 69548) ( Attachment I) and provided a 60 day public notice and comment period. The Agency received no public comments regarding the potential conditions for requiring and processing submitted information. EPA also consulted, their comments are set forth below.

1 PR Notice 97 1 applies to most applicants with registration applications, non crop destruct experimental use permit applications, and tolerance or tolerance exemption petitions pending within the Agency. It also applies to most future applicants seeking new or amended pesticide registrations and all actions involving synthetic chemicals, antimicrobial, biochemical and microbial pesticides. 3( c). Consultations 5 In addition to the public notice that EPA published in the Federal Register concerning the renewal of this ICR, the Agency consulted, as required under 5 CFR 1320.8( d)( 1), with stakeholders who actively interact with the Agency through the use of this collection instrument. EPA staff contacted three relevant stakeholders and asked them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR. EPA consulted with the following individuals:

Daniel Kunkel, Ph. D. IR 4 Program, Rutgers University 732 932 9575 Greg Watson Syngenta Regulatory Affairs 336 632 2993 Russell Schneider Monsanto 202 383 2866 Each of the respondents indicated that the cost estimates were comparable to current costs. One respondent indicated that the inflationary cost increase is acceptable. A copy of the questions EPA asked as part of the consultations are listed in Attachment G; the stakeholder responses are included in Attachment H.

3( d). Effects of Less Frequent Collection Not applicable. This activity is conducted only once per " event," so a less frequent collection is not possible.

3( e). General Guidelines Due to the statutory mandate for the permanent retention of supporting chemistry and toxicological data related to pesticides, the data included in petitions must be maintained for the life of the pesticide. This mandate exceeds the PRA guideline that records be retained for no more than three years.

OMB= s regulations require agencies to provide a statement indicating whether the proposed 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 an explanation of the decision ( 5 CFR 1320.5( a)( iii)( E)). Registrants have the option to electronically submit underlying study data required by the Agency in support of the tolerance petition process. Under this option, petitioners need only submit 2 two paper copies if they submit the required study data in Adobe Acrobat Portable Document Format ( PDF) on a compact disc. EPA staff have become familiar with the electronic submission process and the technology, and OPP believes this option is allowing the Agency to achieve operating efficiencies in the regulation of pesticides through the promotion and facilitation of the electronic 6 submission process, including the delivery, review, data interchange capability and archiving of data supporting the petitions. Under this option, the time normally required for OPP to complete its review of the data should be shortened, thereby allowing faster regulatory decision making.

The Agency believes that petitioners have become familiar with the electronic submission process and the technology, and they are able to prepare their data submissions in less time. OPP expects that petitioners are spending less time and money preparing copies and sending their submissions using the hybrid paper electronic submission option, and are benefiting from the efficiencies that EPA expects to experience during data reviews.

At this time of this renewal, OPP is not offering a fully electronic submission option. OPP is, however, beginning the process of defining requirements for electronic submission of studies as well as other elements of applications and petitions. This includes efforts to develop information technology approaches that adequately protect FIFRA Confidential Business Information submitted over the Internet. In the interim, please see EPA= s Electronic Submission Interim Guidance documents ( Attachment E).

3( f). Confidentiality Trade secret or confidential business information ( CBI) is frequently submitted to the EPA in this program because submissions usually include the manufacturing process, product formulation, and supporting data. When such information is provided to the Agency, the information is protected from disclosure under FIFRA Section 10. CBI data submitted to the EPA is handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual.

3( g). Sensitive Questions Not applicable. No information of a sensitive or private nature is requested in this information collection activity.

4. The Respondents and the Information Requested 4( a). Respondents/ NAICS Codes Respondents to this information collection activity include anyone who files a petition asking the Agency to take a specific tolerance action. Although such petitions typically come from those businesses engaged in the manufacturing of pesticides, the Agency may also receive petitions from other entities, including the Interregional Research Project No. 4 ( IR 4), third party registrants, grower groups, importers or other governments, and concerned citizens.

Although it is impossible to identify all the North American Industrial Classification System ( NAICS) codes for all of the potential respondents, the NAICS code for the most frequent type of respondent is: 7 Respondent Category NAICS code Examples of potentially affected entities Pesticide and other agricultural chemical manufacturing 325320 Individuals or entities engaged in activities related to the registration of a pesticide product.

4( b). Information Requested ( i) Data Items, Including Record Keeping Requirements In addition to a cover letter and fee, a tolerance petition must include the following nine parts:

Chemical identity The name, chemical identity, and composition of the pesticide chemical. If the pesticide chemical is an ingredient of a pesticide, the complete quantitative formula of the resulting pesticide product should be submitted. The submission of this information does not restrict the application of any tolerance or exemption granted to the specific formula( s) submitted.

Chemical use The amount, frequency, and time of application of the pesticide chemical.

Safety reports Include reports of investigations made with respect to the safety of the pesticide chemical. These reports should include, when necessary, detailed data derived from appropriate animal or other biological experiments in which the methods used and the results obtained are clearly set forth.

Residue test results The results of tests on the amount of residue remaining, including description of the analytical method used. ( See 40 CFR 180.34 for further information about residue tests.)

Residue removal Practicable methods for removing residue that exceeds any proposed tolerance. 8 Proposed tolerance Proposed tolerances for the pesticidal chemical if specific tolerances are being proposed.

Grounds for petition Reasonable grounds in support of the petition.

Supplemental information Analysis of factors relevant to the provisions of FQPA Summary An informative summary of the petition or application, including a summary of the supporting data, information, accompanying rationales, and a statement providing permission to publish such summary. This summary should indicate how approval of the petition will meet the statutory determination required of Areasonable certainty of no harm.@

There are no forms associated with this information collection. The data compiled should be submitted as separate sections, suitably identified. If data have already been submitted with an earlier application, the petitioner may incorporate it by reference in the present petition. The petition must be submitted in triplicate. The petitioner must also show that the pesticide is already registered for the related food or feed use, or that an application for the registration of a pesticide for the related food or feed use has been submitted pursuant to FIFRA section 3 ( Attachment C).

( ii) Respondent Activities In order for a tolerance to be established for a pesticide product, a respondent ( petitioner) must do the following:

Review regulations Read applicable FFDCA provisions and related tolerance regulations;

Prepare information Prepare supplemental information to aid Agency decision making concerning a tolerance petition, as encouraged by the Agency and outlined in Pesticide Registration Notice 97 1 ( Attachment D).

If necessary, this may involve:

  conducting additional toxicological or residue chemistry studies   developing analytical methods Prepare correspondence Generate petition correspondence, including preparing an informative summary to be published in the Federal Register;

Review Agency comment If applicable, read any Agency notice of petition deficiency;

Respond to Agency comment Submit supplemental information or petition, or request that 9 petition be filed as submitted; and Maintain records Store, file and maintain the information submitted.

5. The Information Collected  Agency Activities, Collection Methodology, and Information Management 5( a) Agency Activities Upon receipt of a tolerance petition, EPA performs the following activities:

Log Receipt Log petition and associated fee.

Review petition Screen petition, fee, and supporting data for completeness and acceptability; resolve any deficiencies with petitioner.

Prepare Federal Register notice Upon acceptance, publish notice of filing in Federal Register.

Review data Review supporting residue chemistry, toxicology data and other assessments received.

Test analytical methods Test proposed analytical methods in EPA laboratories, if they are new or modified.

Integrate review Integrate data reviews and determine adequacy; resolve any deficiencies with petitioner, make registration decision.

Prepare decision document Prepare decision document, Federal Register Notice with rule establishing the tolerance( s) or exemption( s).

Maintain records Record all actions and decisions in official records.

5( b). Collection Methodology and Management Specific studies submitted as part of petition are catalogued and archived as they are received. When the Agency review is complete, the remaining portions of the petition record, including correspondence subsequent to filing and all reviews, notices, and other materials created by EPA in the course of its review, are catalogued and archived. All petition materials are retained permanently.

5( c). Small Entity Flexibility At times, small entities seek a tolerance or an exemption from the requirement of a tolerance for pesticide residues resulting from registered uses. These actions are usually initiated for minor crop uses for which the pesticide registrant is unwilling to seek a tolerance or for residues on commodities which are not grown in the United States and therefore for which there 10 is no U. S. registrant, such as import tolerances. In such cases, the EPA can reduce the burden and cost to small entities by adjusting the range of data requirements to be commensurate with the extent of pesticide use. The Agency also uses this type of regulatory flexibility to set tolerances for residues on commodities which are not grown in the United States.

5( d). Collection Schedule Not applicable. This is not a scheduled collection. A petition is required only once for each raw or processed commodity on which the pesticide is used.

6. Estimating the Burden and Cost of the Collection 6( a). Estimating Respondent Burden The respondent burden reflected in this ICR is for petition requests for new tolerance actions. This ICR does not reflect burden associated with the Agency= s pesticide tolerance reassessment program. The bulk of tolerance reassessment activities are conducted through the reregistration program. As a result, the respondent burden associated with the FQPA standards for tolerance reassessment activities have been estimated as part of the Data Generation for Pesticide Reregistration ICR ( OMB No. 2070 0107; EPA ICR No. 1504) for active ingredients, and are not included in this ICR.

Since 1995, the Agency has allowed for the use of a single petition to request a tolerance action( s) for a group of similar crops, or " Crop Groupings," rather than submitting individual petitions on a crop by crop basis. In reviewing some of the petitions, it is apparent that many petitioners take advantage of this flexibility, including in the petition requests for several tolerance actions. Some have sought as many as 15 crops per petition, including crop groupings. FQPA amendments allow anyone to submit a petition, where previously only registrants could submit the petition.

Section 408 of FFDCA requires petitioners submit Aan information summary of the petition and of the data, information and arguments submitted or cited in support of the petition.@ FQPA requires EPA to consider additional information in order to make the necessary regulatory decisions. EPA encouraged petitioners who previously submitted data prior to enactment of the law to supplement their original submissions with additional information to aid the Agency= s decision making process in light of its new statutory mandates. To allow for the most efficient processing and review of tolerance petitions, the Agency provided a description of the types of information that EPA considers helpful in the appendices to Pesticide Registration ( PR) Notice No. 97 1 ( Attachment D).

EPA continues to encourage petitioners to develop new and/ or submit any existing supplemental information with their petitions to help EPA determine whether there is a reasonable certainty that no harm will result from aggregate exposure. EPA uses the data to make decisions about the tolerance petitions. The Agency= s risk managers review, among other things, the regulatory aspects of each petition and coordinate scientific review of the supporting data. 11 Agency residue chemists and toxicologists review all the applicable data.

Two types of burden on respondents are considered in this analysis: administrative burden and technical burden. The respondents= administrative burden is defined as the time spent to prepare and submit a petition to the Agency. This burden includes the time spent working with the Agency throughout the petition process, gathering data and supplemental information ( such as the safety reports, residue test data, residue removal data), drafting the grounds for the petition, reviewing and submitting the petition. The technical burden includes the labor needed to actually derive the test data which involves designing the test, performing it, compiling test data and summarizing the results. For the purposes of calculating paperwork burden, only the technical burden related to the documentation of the test results, complying with good laboratory standards in conducting the tests, and storing testing information in files are included in the burden estimates for this ICR.

To quantify the administrative burden, the Agency estimated the amount of labor as a percentage of the total test costs. The Agency assumed that respondents would expend approximately two percent of the total test cost for administrative paperwork burden. This percentage represents an estimate obtained from expert opinion, industry sources, and proprietary data. The Agency assumed that the value of this time is equally divided among management and technical staff members.

The methodology for calculating the technical burden differs from the administrative burden. One third of the total test cost represents labor. Management, technical and clerical comprises the labor staff. A proportional labor rate is used to calculate the number of hours. Approximately 70 percent is technical, 20 percent management, and 10 percent clerical.

As in previous renewal of this information collection request, this current renewal estimates that an average of 150 tolerance petitions will be submitted to the Agency each year for the next three years. The estimate has not changed from the previous ICR. As in the previous renewal, the Agency estimates that the average paperwork burden associated with the submission of a single tolerance petition is 1,726 hours. Assuming that the Agency will receive an average 150 tolerance petitions each year for the next 3 years, the Agency estimates that the overall annual paperwork burden will be 258,900 hours. 12 Table 1 B ANNUAL RESPONDENT BURDEN/ COST ESTIMATES BURDEN HOURS ( per petition) COSTS ( per petition) ACTIVITIES Mgmt. $ 133/ hr Tech. $ 90/ hr Cler. $ 41/ hr Total Hours Total Costs a) Review FFDCA regulations CFR citation; PRN 97 1 25 48 24 97 $ 8,629 b) Conduct Field Trial 252 1,080 25 1,357 $ 131,741 c) Prepare Petition 42 30 116 188 $ 13,042 d) Read Notice of any petition deficiency 1 1 1 3 $ 264 e) Prepare response 2 44 12 58 $ 4,718 f) Maintain information 1 8 14 23 $ 1,427 TOTAL BURDEN 323 1,211 192 1,726 $ 159,821 ANNUAL BURDEN: 1,726 total hours x 150 petitions = 258,900 hours 6( b). Estimating Respondent Costs The overall annual cost associated with this information collection, based on an estimate of 150 petitions per year, is estimated to be $ 23,973,150. For respondents, the value of labor per hour for management, technical, and clerical is $ 133, $ 90, and $ 41, respectively. As part of this ICR renewal, EPA increased its previously estimated labor rates for respondents by using the NASA Gross Domestic Product Inflation Calculator. This is an inflation calculator for adjusting costs from one year to another using the Gross Domestic Product ( GDP) Deflator inflation index. This inflation calculator is based on the inflation rate during the US Government Fiscal Year, which begins on October 1 and ends on September 30. This inflation calculator will compute inflation from 1940 to 2009.

These labor rates are fully loaded and include benefits and overhead costs. Using the Agency= s burden estimate and the fully loaded labor rates, the Agency estimates the applicant costs to be approximately $ 159,821 per response.

ANNUAL COSTS: ( a) Management  323 hours x $ 133 x 150 applicants $ 6,443,850 ( b) Technical  1211 hours x $ 90 x 150 applicants $ 16,348,500 ( c) Clerical  192 hours x $ 41 x 150 applicants $ 1,180,800 TOTAL $ 23,973,150 These labor burden estimates represent the average time and costs. Some tolerance petitions will require less effort and more complicated petitions will require more of each. The 13 analysis assumes that one respondent will generate the data for a given petition. If a consortium takes responsibility for the petition, the burden and cost will be distributed across members of the consortium.

6( c). Estimating Agency Burden and Cost The Agency needs to process, review and document their evaluation of the tolerance petitions. Each year, the Agency may spend 2300 hours for 150 petitions in labor burden. EPA increased its previously estimated labor rates for respondents by using the NASA Gross Domestic Product Inflation Calculator. This is an inflation calculator for adjusting costs from one year to another using the Gross Domestic Product ( GDP) Deflator inflation index. This inflation calculator is based on the inflation rate during the US Government Fiscal Year, which begins on October 1 and ends on September 30. This inflation calculator will compute inflation from 1940 to 2009. Estimates for the Agency's burden are provided below.

Table 2 B ANNUAL AGENCY BURDEN/ COST ESTIMATES BURDEN HOURS ( per year) COSTS ( per year) COLLECTION ACTIVITIES Mgmt. $ 101/ hr Tech. $ 74/ hr Cler. $ 35/ hr Total Hours Total Costs a) Log petition and associated fee 0 8 0 8 $ 592 b) Screen petition request for completeness 1 2 0 3 $ 249 c) Draft and publish Federal Register notice 1 4 0 5 $ 397 d) Review Residue Chemistry and Toxicology data 200 1,642 3 1845 $ 141,813 e) Verify new analytical methods in EPA Lab. and resolve any deficiencies 34 223 1 258 $ 19,971 f) Integrate Data Reviews 67 100 2 169 $ 14,237 g) Prepare decision document and Federal Register Notice 4 4 2 10 $ 770 h) Record actions in official records. 0 0 2 2 $ 70 TOTAL BURDEN 307 1983 10 2300 $ 170,099 ( a) Management  307 hours x $ 101 x 150 petitioners $ 4,651,050 ( b) Technical  1,983 hours x $ 74 x 150 petitioners $ 22,011,300 ( c) Clerical  10 hours x $ 35 x 150 petitioners $ 52,500 TOTAL $ 26,714,850 14 6( d). Bottom Line Burden Hours And Cost Tables Table 3 B MASTER TABLE: Total Annual Burden Hours and Costs Annual Burden Hours Annual Costs Total Annual petitions per petition Total per petition Total Respondents ( Petitioners) 150 1726 258,900 $ 159,821 $ 23,973,150 Agency 150 2300 345,000 $ 170,099 $ 26,714,850 6( e). Reasons for Change in Burden Respondent costs for this ICR have increased due to inflationary adjustments in labor rates for both respondents and Agency personnel. As a result, there is an increase of $ 537,450 in the estimated total annual respondent cost ( from $ 23,435,700 to $ 23,973,150).

6( f). Burden Statement The total estimated annual respondent paperwork burden to comply with this information collection activity is 258,900 hours. According to the Paperwork Reduction Act, Aburden@ means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection, it is the time reading the regulations, planning the necessary data collection activities, conducting tests, analyzing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data. The agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears at the beginning and the end of this document. In addition OMB control numbers for EPA= s regulations, after initial display in the final rule, are listed in 40 CFR part 9 ( Attachment F).

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under docket ID No. EPA HQ OPP 2005 0291, which is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1801 S. Bell St., Arlington, VA. The Docket Public Reading Room is open from 8: 30 a. m. to 4: 00 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Docket is ( 703) 305 5805. An electronic version of the public docket is available through Federal eRulemaking Portal, http:// www. regulations. gov. Follow the online instructions for viewing documents and submitting comments. You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the docket ID No. EPA HQ OPP 2005 0291 and OMB control number 2070 0024 in any correspondence. Attachments List All of the attachments listed below can be found in the docket for this ICR ( unless otherwise noted); accessible electronically through www. Regulations. gov . On the main page, select Advanced Search from the menu bar at the top and select Docket Search. Enter the Docket ID Number, EPA HQ OPP 2005 0291 in the Docket ID field. Click on the Submit button. From the results page, you will be able to link to the docket view or directly open select documents found in the docket.

ATTACHMENT A: FFDCA Sections 402, 406, 408, and 409 ( 21 U. S. C. Sections 342, 346, 346a, and 348, respectively).

ATTACHMENT B: 40 CFR Parts 180.7 through 180.41  Tolerances and Exemptions from Tolerances for Pesticide Chemicals in or on Raw Agricultural Commodities.

ATTACHMENT C: FIFRA Section 3 ( 7 U. S. C. 136a).

ATTACHMENT D: PR Notice 97 1  Agency Actions under the Requirements of the Food Quality Protection Act.

ATTACHMENT E: Electronic Submission Interim Guidance Documents  available electronically at http:// www. epa. gov/ oppfead1/ eds/ esr_ guidance. htm.

ATTACHMENT F: Display Related to OMB Control # 2070 0024  Listings of Related Regulations in 40 CFR 9.1.

ATTACHMENT G: List of Consultation Questions ATTACHMENT H: Response to EPA on ICR Burden Consultation ( Record of Consultation Correspondence)

ATTACHMENT I: First Federal Register Notice  70 FR 69548  Tolerance Petitions for Pesticides on Food/ Feed Crops and New Inert Ingredients; Renewal of Pesticide Information Collection Activities and Request for Comments ( published November 16, 2005).


[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Notices]
[Pages 47291-47296]
[FR Doc No: 2011-19833]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0192]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemption from the diabetes mellitus
standard; request for comments.

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SUMMARY: FMCSA announces receipt of applications from 33 individuals
for exemption from the prohibition against persons with insulin-treated
diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in
interstate commerce. If granted, the exemptions would enable these
individuals with ITDM to operate CMVs in interstate commerce.

DATES: Comments must be received on or before September 6, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0192 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' The statute also allows the Agency to renew
exemptions at the end of the 2-year period. The 33 individuals listed
in this notice have recently requested such an exemption from the
diabetes prohibition in 49 CFR 391.41(b)(3), which applies to drivers
of CMVs in interstate commerce. Accordingly, the Agency will evaluate
the qualifications of each applicant to determine whether granting the
exemption will achieve the required level of safety mandated by the
statutes.

Qualifications of Applicants

Michael J. Alexander

    Mr. Alexander, age 33, has had ITDM since 2011. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Alexander understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a Commercial Motor Vehicle (CMV) safely.
Mr. Alexander meets the requirements of the vision standard at 49 CFR
391.41(b)(10). His optometrist examined him in 2011 and certified that
he does not have diabetic retinopathy. He holds a Class E operator's
license from Missouri.

Larry E. Baumgartner

    Mr. Baumgartner, 59, has had ITDM since 2004. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Baumgartner understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Baumgartner meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His ophthalmologist examined him in 2011 and
certified that he has stable nonproliferative diabetic retinopathy. He
holds a Class A Commercial Driver's License (CDL) from Colorado.

Stanley R. Boots

    Mr. Boots, 56, has had ITDM since 2005. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Boots understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Boots meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Carl D. Braddock

    Mr. Braddock, 57, has had ITDM since 2011. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Braddock understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Braddock meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Nebraska.

Dean A. Chamberlin

    Mr. Chamberlin, 37, has had ITDM since 1997. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Chamberlin understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely.
    Mr. Chamberlin meets the requirements of the vision standard at 49
CFR 391.41(b)(10). His optometrist examined him in 2011 and certified
that he does not have diabetic retinopathy. He holds a Class O
operator's license from Nebraska.

Michael W. Conner

    Mr. Conner, 56, has had ITDM since 2009. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Conner understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Conner meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Illinois.

Edna R. Contreras

    Ms. Contreras, 42, has had ITDM since 2011. Her endocrinologist
examined her in 2011 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Contreras understands diabetes
management and monitoring, has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Contreras meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2011 and certified that she does not have
diabetic retinopathy. She holds a Class B CDL from Indiana.

Craig E. Cusick

    Mr. Cusick, 34, has had ITDM since 2008. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Cusick understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Cusick meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from
California.

Ronald D. Fatka

    Mr. Fatka, 56, has had ITDM since approximately 10 years ago. His
endocrinologist examined him in 2011 and certified that he has had no
severe hypoglycemic reactions resulting in loss of consciousness,
requiring the assistance of another person, or resulting in impaired
cognitive function

that occurred without warning in the past 12 months and no recurrent (2
or more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Fatka understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Fatka meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Iowa.

Robert M. Fleming

    Mr. Fleming, 57, has had ITDM since 1974. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Fleming understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Fleming meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
South Dakota.

David W. Hammons

    Mr. Hammons, 39, has had ITDM since 2010. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hammons understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hammons meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class D Chauffer's license from
Louisiana.

Frank B. Hernandez

    Mr. Hernandez, 58, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Hernandez understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hernandez meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Jeffrey D. Horsey

    Mr. Horsey, 53, has had ITDM since 2008. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Horsey understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Horsey meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Delaware.

Dale A. Iverson

    Mr. Iverson, 55, has had ITDM since 2009. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Iverson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Iverson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from Utah.

John H. Krastel

    Mr. Krastel, 66, has had ITDM since 2009. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Krastel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Krastel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Iowa.

Joshua L. Kroetch

    Mr. Kroetch, 30, has had ITDM since 1985. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Kroetch understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Kroetch meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2010 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Minnesota.

Larry D. Lilley

    Mr. Lilley, 66, has had ITDM since 2005. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Lilley understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Lilley meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2010

and certified that he does not have diabetic retinopathy. He holds a
Class B CDL from Texas.

Edward J. Linhart

    Mr. Linhart, 52, has had ITDM since 2008. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Linhart understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Linhart meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Massachusetts.

Larry D. Matson

    Mr. Matson, 38, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Matson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Matson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Montana.

Michael L. O'Clair

    Mr. O'Clair, 52, has had ITDM since 2009. His endocrinologist
examined him in 2010 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. O'Clair understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. O'Clair meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Maine.

David W. Payne

    Mr. Payne, 44, has had ITDM since 1973. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Payne understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Payne meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
Kansas.

Matthew B. Rhodes

    Mr. Rhodes, 23, has had ITDM since 2008. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Rhodes understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Rhodes meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class D operator's
license from Connecticut.

Jim B. Robertson, II

    Mr. Robertson, 59, has had ITDM since 1998. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Robertson understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Robertson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Kentucky.

Donald M. Rush, Jr.

    Mr. Rush, 35, has had ITDM since 2010. His endocrinologist examined
him in 2011 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Rush understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Rush meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His optometrist examined him
in 2011 and certified that he does not have diabetic retinopathy. He
holds a Class A CDL from Georgia.

Barry A. Sircy

    Mr. Sircy, 52, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Sircy understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Sircy meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Kentucky.

Andre M. St. Pierre

    Mr. St. Pierre, 28, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. St. Pierre understands diabetes
management and monitoring,

has stable control of his diabetes using insulin, and is able to drive
a CMV safely. Mr. St. Pierre meets the requirements of the vision
standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in
2011 and certified that he does not have diabetic retinopathy. He holds
a Class A CDL from Arizona.

John S. Starchevich

    Mr. Starchevich, 71, has had ITDM since 2009. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Starchevich understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Starchevich meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Michael B. Tortora

    Mr. Tortora, 22, has had ITDM since 2006. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Tortora understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Tortora meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Connecticut.

Gregory J. Vigil

    Mr. Vigil, 52, has had ITDM over 10 years. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Vigil understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Vigil meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from New
Mexico.

Charlotte C. Watson

    Ms. Watson, 57, has had ITDM since 2007. Her endocrinologist
examined her in 2011 and certified that she has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
Her endocrinologist certifies that Ms. Watson understands diabetes
management and monitoring, has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Watson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2011 and certified that she does not have
diabetic retinopathy. She holds a Class C operator's license from
California.

Wayne W. Wenzel

    Mr. Wenzel, 67, has had ITDM since 2010. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wenzel understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wenzel meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2011 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Minnesota.

Shaun M. Wheeler

    Mr. Wheeler, 40, has had ITDM since 1999. His endocrinologist
examined him in 2011 and certified that he has had no severe
hypoglycemic reactions resulting in loss of consciousness, requiring
the assistance of another person, or resulting in impaired cognitive
function that occurred without warning in the past 12 months and no
recurrent (2 or more) severe hypoglycemic episodes in the last 5 years.
His endocrinologist certifies that Mr. Wheeler understands diabetes
management and monitoring, has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wheeler meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2011 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Connecticut.

James J. Wolf, Jr.

    Mr. Wolf, 56, has had ITDM since 2010. His endocrinologist examined
him in 2011 and certified that he has had no severe hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the last 5 years. His
endocrinologist certifies that Mr. Wolf understands diabetes management
and monitoring, has stable control of his diabetes using insulin, and
is able to drive a CMV safely. Mr. Wolf meets the requirements of the
vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined
him in 2011 and certified that he does not have diabetic retinopathy.
He holds a Class A CDL from Pennsylvania.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of business on the closing date indicated in the date section
of the notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users requires
the Secretary to revise its diabetes exemption program established on
September 3, 2003 (68 FR 52441).\1\ The revision must provide for
individual assessment of drivers with diabetes mellitus, and be
consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 notice as a ``final
rule.'' However, the 2003 notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) Elimination of the requirement for 3
years of

experience operating CMVs while being treated with insulin; and (2)
establishment of a specified minimum period of insulin use to
demonstrate stable control of diabetes before being allowed to operate
a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 U.S.C. 31136(e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary.
    The FMCSA concluded that all of the operating, monitoring and
medical requirements set out in the September 3, 2003 notice, except as
modified, were in compliance with section 4129(d). Therefore, all of
the requirements set out in the September 3, 2003 notice, except as
modified by the notice in the Federal Register on November 8, 2005 (70
FR 67777), remain in effect.

    Issued on: July 28, 2011.
Larry W. Minor,
Associate Administrator Office, of Policy.
[FR Doc. 2011-19833 Filed 8-3-11; 8:45 am]
BILLING CODE


[Federal Register Volume 82, Number 35 (Thursday, February 23, 2017)]
[Rules and Regulations]
[Pages 11401-11403]
[FR Doc No: 2017-03499]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 82, No. 35 / Thursday, February 23, 2017 /
Rules and Regulations

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2017-0032]
RIN 1625-AA08

Special Local Regulation; Black Warrior River; Tuscaloosa, AL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary special local
regulation on the Black Warrior River extending the entire width of the
river from mile marker 339.0 to mile marker 341.5 in Tuscaloosa, AL.
The special local regulation is needed to protect the persons
participating in the NCAA Collegiate Rowing Competition marine event.
This rulemaking restricts transit into, through and within the
regulated area unless specifically authorized by the Captain of the
Port Mobile.

DATES: This rule is effective from 7 a.m. until noon on February 25,
2017.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-0032 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Fannie L. Wilks, Sector Mobile, Waterways Management
Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
event sponsors informed the U.S. Coast Guard of the marine event on
January 3, 2017. After gathering all necessary information, including
safety needs related to this event, the Coast Guard determined that the
related special local regulation is necessary during this event. At
this time, it would be impracticable to complete the full notice and
comment process because this special local regulation must be
established on February 25, 2017.
    We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for making this temporary rule
effective less than 30 days after publication in the Federal Register.
For the same reasons discussed in the preceding paragraph, waiting for
a 30 day notice period to run would be impracticable.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. The Captain of the Port Mobile (COTP) has determined that
potential hazards associated with the rowing event on February 25, 2017
will be a safety concern for anyone within the area of the Black
Warrior River between mile marker 339.0 and mile marker 341.5. This
rule is needed to protect participants, spectators, and other persons
and vessels during the rowing event on navigable waters.

IV. Discussion of the Rule

    This rule establishes a special local regulation on February 25,
2017, which will be enforced between the hours of 7 a.m. and noon. The
special local regulation takes place on the Black Warrior River between
mile marker 339.0 and mile marker 341.5, extending the entire width of
the navigable channel. The duration of the regulation is intended to
protect participants, spectators, and other persons and vessels before,
during, and after the rowing event. No vessel or person will be
permitted to enter, transit within or through, or exit the regulated
area without obtaining permission from the COTP or a designated
representative. Spectator vessels desiring to enter, transit through or
within, or exit the regulated area may request permission to do so from
the Patrol Commander. When permitted to transit the area vessels must
follow restrictions within the regulated area as directed by the Coast
Guard, and must operate at a minimum safe navigation speed in a manner
which will not endanger participants in the regulated area or any other
vessels.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This rule has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, it has not been reviewed by the Office of Management and
Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the regulation. The special
local regulation will take place on a 2.5 mile stretch of navigable

waterway, during a short duration of five hours on the Black Warrior
River from mile marker 339.0 to 341.5 on February 25, 2017, which is a
time of year experiencing lower than normal traffic. Moreover, the
Coast Guard will issue Broadcast Notices to Mariners via VHF-FM marine
channel 16 about the regulation so that waterway users may plan
accordingly for transits during this restriction. The rule also allows
vessels to seek permission from the COTP Mobile or a designated
representative to enter the regulated area.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a special local regulation lasting for five hours on the
Black Warrior River between mile marker 339.0 and mile marker 341.5. It
is categorically excluded from further review under paragraph 34(h) of
Figure 2-1 of the Commandant Instruction. An environmental analysis
checklist supporting this determination and a Categorical Exclusion
Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Add Sec.  100.35T08-0032 to read as follows:

Sec.  100.35T08-0032  Special Local Regulation; Black Warrior River;
Tuscaloosa, AL.

    (a) Regulated area. All navigable waters of the Black Warrior River
between mile marker 339.0 and mile marker 341.5, Tuscaloosa, AL.
    (b) Period of enforcement. This rule will be enforced from 7 a.m.
until noon on February 25, 2017.
    (c) Special local regulations. (1) Entry into, transit within or
through, or exit from this area is prohibited unless authorized by the
Captain of the Port Mobile (COTP) or the designated Patrol Commander.
The Coast Guard will patrol the regulated area under the direction of a
designated Coast Guard Patrol Commander. The Patrol Commander may be
contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign ``PATCOM''.
    (2) All persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast

Guard, state, or local law enforcement and sponsor provided vessels
assigned or approved by the Captain of the Port (COTP) Mobile to patrol
the regulated area.
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer will be operated at a minimum safe navigation
speed in a manner which will not endanger participants in the regulated
area or any other vessels.
    (4) No spectator vessel shall anchor, block, loiter, or impede the
through transit of participants or official patrol vessels in the
regulated area during the effective dates and times, unless cleared for
entry by or through an official patrol vessel.
    (5) The patrol commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both.
    (6) Any spectator vessel may anchor outside the regulated area, but
may not anchor in, block, or loiter in a navigable channel. Spectator
vessels may be moored to a waterfront facility within the regulated
area in such a way that they shall not interfere with the progress of
the event. Such mooring must be complete at least 30 minutes prior to
the establishment of the regulated area and remain moored through the
duration of the event.
    (7) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (8) The Patrol Commander will terminate enforcement of the special
local regulations at the conclusion of the event.
    (d) Informational Broadcasts. The COTP Mobile or a designated
representative will inform the public through broadcast notices to
mariners of the enforcement period for the regulated area as well as
any changes in the date and times of enforcement.

    Dated: January 25, 2017.
J.H. Snowden,
Captain, U.S. Coast Guard, Captain of the Port Mobile.
[FR Doc. 2017-03499 Filed 2-22-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 47 (Friday, March 10, 2023)]
[Rules and Regulations]
[Pages 14916-14918]
[FR Doc No: 2023-04865]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0163]
RIN 1625-AA00

Safety Zone; Missouri River Mile Markers 175.5-176.5, Jefferson
City, MO

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters in the Missouri River at Mile Marker (MM) 175.5 to
176.5. The safety zone is needed to protect personnel, vessels, and the
marine environment from all potential hazards associated with
electrical line work. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Sector Upper Mississippi River (COTP) or a designated representative.

DATES: This rule is effective from March 13, 2023, until March 24,
2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2023-0163 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MSTC Nathaniel Dibley, Sector Upper Mississippi River
Waterways Management Division, U.S. Coast Guard; telephone 314-269-
2550, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of The Port Sector Upper Mississippi River
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this temporary safety zone immediately to protect personnel,
vessels, and the marine environment from potential hazards created by
the electrical work and lack sufficient time to provide a reasonable
comment period and then consider those comments before issuing the
rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
contrary to the public interest because immediate action is needed to
respond to the potential safety hazards associated with the ongoing
construction work.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper
Mississippi River (COTP) has determined that potential hazards
associated with electrical line work will be a safety concern for
anyone operating or transiting within the Missouri River from MM 175.5-
176.5. This rule is needed to protect personnel, vessels, and the
marine environment in the navigable waters within the safety zone while
electrical line work is being conducted.

IV. Discussion of the Rule

    Electrical line work will be occurring near MM 175.5-176.5
beginning March 13, 2023. The safety zone is designed to protect
waterway users until work is complete.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard (USCG) assigned to units under
the operational control of USCG Sector Upper Mississippi River. To seek
permission to enter, contact the COTP or a designated representative
via VHF-FM channel 16, or through USCG Sector Upper Mississippi River
at<PHONE_NUMBER>. Persons and vessels permitted to enter the safety zone
must comply with all lawful orders or directions issued by the COTP or
designated representative. The COTP or a designated representative will
inform the public of the effective period for the safety zone as well
as any changes in the dates and times of enforcement, as well as
reductions in the size of the safety zone as conditions improve,
through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners
(BNMs), and/or Safety Marine Information Broadcast (SMIB), as
appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on a safety zone
located on the Missouri River at MM 175.5-176.5, near Jefferson City,
MO. The Safety Zone is expected to be active only during the hours of 9
a.m. through 4 p.m., or only when work is being conducted, every day
until March 24, 2023.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended,

requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator because the zone will be enforced only when
work is being conducted.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone encompassing the width of the Upper Mississippi River at MM
139.5-139.2. It is categorically excluded from further review under
paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine Safety, Navigation (water), Reporting and
recordkeeping requirements, Security Measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T08-0163 to read as follows:

Sec.  165.T08-0163  Safety Zone; Missouri River, Mile Markers 175.5-
176.5, Jefferson City, MO.

    (a) Location. The following area is a safety zone: all navigable
waters within Missouri Mile Markers (MM) 175.5-176.5.
    (b) Enforcement period. This section will be subject to enforcement
from March 13, 2023, through March 24, 2023.
    (c) Regulations. (1) In accordance with the general safety zone
regulations in Sec.  165.23, entry of persons or vessels into this
safety zone described in paragraph (a) of this section is prohibited
unless authorized by the COTP or a designated representative. A
designated representative is a commissioned, warrant, or petty officer
of the U.S. Coast Guard (USCG) assigned to units under the operational
control of USCG Sector Upper Mississippi River.
    (2) To seek permission to enter, contact the COTP or a designated
representative via VHF-FM channel 16, or through USCG Sector Upper
Mississippi River at<PHONE_NUMBER>. Persons and vessels permitted to
enter the safety zone must comply with all lawful orders or directions
issued by the COTP or designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public of the effective period for the
safety zone as well as any changes in the dates and times of
enforcement, as well as reductions in size or scope of the safety zone
as ice or flood conditions improve, through Local Notice to Mariners
(LNMs), Broadcast Notices to Mariners (BNMs), and/or Safety Marine
Information Broadcast (SMIB) as appropriate.

    Dated: March 3, 2023.
A.R. Bender,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper Mississippi
River.
[FR Doc. 2023-04865 Filed 3-9-23; 8:45 am]
BILLING CODE 9110-04-P