27793 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Notices which is provisional and subject to evolution, is that no more than 6 months from the completion of 6 × coverage of the sequence for a singlegenome project, the data will be released on the JGI web site or to a publicly accessible database with no use restrictions. For microbial community projects, the JGI will conduct normal QA/ QC assessments on the sequence output ( at approximately 2 × coverage), then discuss with the proposer( s) and with BER staff the extent to which sequencing will be continued to achieve a satisfactory genomic `` view'' of the selected microbial community. From the time of initiation of this discussion, not more than 6 months will be permitted to elapse before unconditional release of these data. BER is fully aware that some ambiguity remains in the precise initiation of this `` embargo'' period but stresses its intention and commitment to the rapid release, without any use restrictions, of this data into publicly accessible databases. Upon selection of a nominated microbial sequencing target, BER expects that Principal Investigators will collaborate with the JGI by providing high quality, high MW genomic DNA for library construction as well as assisting in annotating the draft sequence data until a sufficiently complete annotation is achieved ( understanding that this will be sensitive to hypothetical gene predictions and the usual uncertainties of annotation). Following data acquisition and annotation, DOE expects that those whose nominations have been sequenced will make good faith efforts to publish in the open scientific literature the results of their subsequent work, including both the genome sequences of the organisms sequenced under this notice as well as the annotation. ( BER also expects the Principal Investigator of a selected effort to either deposit a culture of the microbe or consortium into a publicly accessible collection or repository, or make it available directly so others can have access). These parties are encouraged to create process and costeffective partnerships that will maximize data production and analysis, data dissemination, and progress towards understanding basic biological mechanisms that can further the aims of this effort. Additionally, it must be explicitly understood that DOE will provide an assembled and computationally annotated draft ( roughly 6 × ; carried out in a paired end sequencing approach) sequence of the microbe( s) selected, but that research using that sequence data should be funded from separate sources and/ or separate solicitations. Finally, there is no commitment to finish a given drafted sequence, although this option may be considered at a later time. Submission Information: Interested parties should submit a brief white paper to either of the foci given above, consisting of not more than 5 pages of narrative exclusive of attachments ( which are discouraged) responding to each of the specific criteria set forth. Electronic submission ( to joanne. corcoran@ science. doe. gov and daniel. drell@ science. doe. gov) is strongly encouraged. It is expected that the Principal Investigator will serve as the main point of contact for additional information on the nominated microbe. Nominations must contain a very short abstract or project summary and a cover page with the name of the applicant, mailing address, phone, fax, and email. The nomination should include 2 page curriculum vitae of the key investigators; letters of intent from collaborators ( suggesting the size of the interested community) are permitted. Nominations will be reviewed relative to the scope and research needs of the BER relevant programs cited above. A brief response to each nomination will be provided electronically following merit and programmatic reviews. Other useful Web sites include: DOE JGI Microbial Sequencing Priorities for FY2003   http:// www. ornl. gov/ microbialgenomes/ seq2003. html Microbial Genome Program Home Page   http:// www. sc. doe. gov/ ober/ microbial. html DOE Joint Genome Institute Microbial Web Page   http:// www. jgi. doe. gov/ JGI_ microbial/ html/ GenBank Home Page   http:// www. ncbi. nlm. nih. gov/ Human Genome Home Page   http:// www. ornl. gov/ hgmis DOE Genomes to Life   http:// DOEGenomestoLife. org DOE Natural and Accelerated Bioremediation Research ( NABIR) Program   http:// www. lbl. gov/ nabir Biotechnology Investigations   Ocean Margins Program   http:// www. sc. doe. gov/ ober/ GC/ omp. html Issued in Washington, DC, May 14, 2003.

John Rodney Clark,

Associate Director of Science for Resource Management. [ FR Doc. 03   12715 Filed 5   20   03; 8: 45 am]

BILLING CODE 6450   01   P ENVIRONMENTAL PROTECTION AGENCY [ OW   2003   0026, FRL   7501   4]

Agency Information Collection Activities: Proposed Collection; Comment Request; National Water Quality Inventory Reports ( Clean Water Act Sections 305( b), 303( d), 314( a), and 106( e))

AGENCY: Environmental Protection Agency ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that EPA is planning to submit the following continuing Information Collection Request ( ICR) to the Office of Management and Budget ( OMB): National Water Quality Inventory Reports ( Clean Water Act Sections 305( b), 303( d), 314( a), and 106( e)); EPA ICR Number 1560.07, OMB Control Number 2040   0071, expiring on July 31, 2003. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below. DATES: Comments must be submitted on or before July 21, 2003. ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: John Wilson, Assessment and Watershed Protection Division, Office of Water, Mail Code: 4503T, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202   566   2385; fax number: 202   566   1331; e mail address: Wilson. John@ epa. gov. SUPPLEMENTARY INFORMATION: EPA has established a public docket for this ICR under Docket ID number OW   2003   0026, which is available for public viewing at the Water Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the Water Docket is ( 202) 566   2426. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public VerDate Jan< 31> 2003 15: 43 May 20, 2003 Jkt 200001 PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MYN1. SGM 21MYN1 27794 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Notices docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 60 days of this notice, and according to the following detailed instructions: Submit your comments to EPA online using EDOCKET ( our preferred method), by e mail to owdocket epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Water Docket, Mail Code 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to http:// www. epa. gov./ edocket. Affected entities: Entities potentially affected by this action are States, Territories and Tribes with Clean Water Act ( CWA) responsibilities. Title: National Water Quality Inventory Reports ( Clean Water Act Sections 305( b), 303( d), 314( a), and 106( e)). ( OMB Control Number 2040   0071; EPA ICR Number 1560.07 expiring 07/ 31/ 2003. Abstract: Section 303( d) of the Clean Water Act requires States to identify and rank waters which cannot meet water quality standards ( WQS) following the implementation of technology based controls. Under section 303( d), States are also required to establish total maximum daily loads ( TMDLs) for listed waters not meeting standards as a result of pollutant discharges. In developing the section 303( d) lists, States are required to consider various sources of water quality related data and information, including the section 305( b) State water quality reports. The section 305( b) reports contain information on the extent of water quality degradation, the pollutants and sources affecting water quality, and State progress in controlling water pollution. EPA's Assessment and Watershed Protection Division ( AWPD) works with its Regional counterparts to review and approve or disapprove State section 303( d) lists and TMDLs from 56 respondents ( the 50 States, the District of Columbia, and the five Territories). Section 303( d) specifically requires States to develop lists and TMDLs `` from time to time'' and EPA to review and approve or disapprove the lists and the TMDLs. EPA also collects State 305( b) reports from 59 respondents ( the 50 States, the District of Columbia, five Territories, and 3 River Basin commissions). This announcement includes the reapproval of current, ongoing activities related to 305( b) and 303( d) reporting and TMDL development for the period of August 1, 2003 through July 31, 2006. During the period covered by this ICR renewal, respondents will: complete their 2004 305( b) reports and 2004 303( d) lists; complete their 2006 305( b) reports and 2006 303( d) lists; transmit annual electronic updates of their 305( b) databases in 2003 through 2006; and continue to develop TMDLs according to their established schedules. EPA will prepare two biennial Reports to Congress: one in 2003 and one in 2005, and EPA will review TMDL submissions from respondents. The respondent community for 305( b) reporting consists of 50 States, the District of Columbia, 5 Territories ( Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands), and 3 River Basin Commissions. The Ohio River Valley Sanitation Commission, the Delaware River Basin Commission, and the Interstate Sanitation Commission have jurisdiction over basins that lie in multiple States. Indian Tribes are exempt from the 305( b) reporting requirement, but some Tribes choose to participate as a way of presenting assessments and water quality issues to the public and Congress. One Tribe or Tribal Group prepared 305( b) reports in 1996 and 1997. However, since Tribal 305( b) reporting is a voluntary effort, it is not included in the burden estimates for this ICR. The respondent community for 303( d) activities consists of 50 States, the District of Columbia, and 5 Territories ( Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands). Although Indian Tribes are not exempt from 303( d) requirements, there is not a process currently in place to designate them for this purpose. Further, very few Tribes have established water quality standards, and EPA is currently in the process of preparing standards where they are needed. Therefore, we assume that there would be no burden to Indian Tribes over the period covered by this ICR for 303( d) activities. The burden of specific activities that States undertake as part of their 305( b) and 303( d) programs are derived from an ongoing project among EPA, States and other interested stakeholders to develop a tool for estimating the States' resource needs for State water quality management programs. This project has developed the State Water Quality Management Workload Model ( SWQMWM), which estimates and sums the workload involved in more than one hundred activities or tasks comprising a State water quality management program. Over twenty States have contributed information about their activities that became the basis for the model. According to the SWQMWM, the States will carry out the following activities or tasks to meet the 305( b) and 303( d) reporting requirements: watershed characterization; modeling and analysis; development of a TMDL document for public review; public outreach; formal public participation; tracking; planning; legal support; etc. In general, respondents have conducted each of these reporting and record keeping activities for past 305( b) and 303( d) reporting cycles and thus have staff and procedures in place to continue their 305( b) and 303( d) reporting programs. The burden associated with these tasks is estimated in this ICR to include the total number of TMDLs that may be submitted during the period covered by this ICR. The biennial frequency of the collection is mandated by section 305( b)( 1) of the CWA. Section 305( b) originally required respondents to submit water quality reports on an annual basis. In 1977, the annual requirement was amended to a biennial requirement in the CWA. EPA has determined that abbreviated reporting for hard copy 305( b) reports, combined with annual electronic reporting using respondent databases, will meet the CWA reporting requirements while reducing burden to respondents. The biennial period with annual electronic reporting ensures that information needed for analysis and water program decisions is reasonably current, yet abbreviated reporting requirements provides respondents with sufficient time to prepare the reports.

VerDate Jan< 31> 2003 15: 43 May 20, 2003 Jkt 200001 PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MYN1. SGM 21MYN1 27795 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Notices An 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 numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The EPA would like to solicit comments to: ( i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; ( ii) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ( iii) Enhance the quality, utility, and clarity of the information to be collected; and ( iv) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e. g., permitting electronic submission of responses. Burden Statement: Burden 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. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. For current 305( b) and 303( d) reporting activities, the primary source we use in estimating burden for tasks to be performed by States is the State Water Quality Management Workload Model ( SWQMWM), which estimates and sums the workload involved in more than one hundred activities or tasks comprising a State water quality management program. The average annual burden per respondent for current 305( b) ( 59 respondents) and 303( d)( 56 respondents) reporting activities is 6,491 hours and the total annual burden to all respondents is 372,403 hours. The table below displays a summary of the burden estimates.

AVERAGE OF ANNUAL BURDEN FOR 305( B) AND 303( D) REPORTING ACTIVITIES Activity Number of respondents Total annual burden 1. Review regs and guidance for 305( b) & 303( d) .................................................................................................. 59 7,434 2. Plan and coordinate data acquisition and compile and screen data for assessments ...................................... 59 65,490 3. Development and submission of complete 305( b) report and response to EPA comments ............................. 59 83,013 4. Develop, review and update 303( d) listing and de listing methodology ............................................................. 56 46,536 5. Prepare 303( d) list ( includes identifying waters, setting priorities, and schedules) ............................................ 56 123,648 6. Required public outreach for 303( d) list .............................................................................................................. 56 14,840 7. Submission of 303( d) list to EPA and response to EPA comments ................................................................... 56 12,208 8. Prepare annual electronic updates ..................................................................................................................... 59 19,234 9. Implement enhanced benefit cost of WQS ......................................................................................................... 59 40,710 Total .............................................................................................................................................................. 413,113 The additional burden for States to assess the costs and benefits of achieving water quality standards depends on the level of detail and sophistication that the States choose to provide as well as factors such as the number of impaired waters in the State, the State's diversity of water resources, and the intensity of use of those resources. The estimate of the burden associated with the enhanced benefit cost analysis, resulting in an average increase in State burden of 690 hours annually. We use a separate analysis to estimate the burden associated with current TMDL development. Based on estimates of the number of TMDLs per year ( 4,000), the total average current burden associated with developing TMDLs under the current 303( d) program is estimated to be 59,409 hours per respondent, and the total annual burden for all 56 respondents is estimated to be 3,326,904 hours. To estimate respondent costs, we applied an average fully loaded cost per hour to the burden estimates. This fully loaded hourly labor rate represents the total cost for obtaining an hour's worth of work, and includes: direct salary paid, paid or accrued vacation, paid or accrued sick leave, cost of other fringe benefits ( e. g., health, pension, etc.), general training, indirect expenses such as professional support ( e. g., clerical, accounting, supervisory, etc.), office space, utilities, telephone service, equipment ( e. g., fax machines, basic computing needs such as hardware and software, etc.), etc. The average annual cost to each respondent for current 305( b) and 303( d) reporting ( including the enhanced benefit cost activities) is estimated to be $ 298,227. The total annual costs imposed on all 59 respondents is estimated to be $ 17,156,583. Average annual respondent costs for current TMDL development is estimated at $ 2,467,256 per respondent and $ 138,166,323 for all 56 respondents. Agency burden estimates are based on EPA's prior experience in developing 305( b) and 303( d) guidance, preparing the Report to Congress, providing technical support to respondents, and reviewing and approving/ disapproving 303( d) lists and TMDL submissions. The hourly cost estimates were calculated for a technical federal position, Grade 10 Step 7 effective as of January 2003 ($ 22.49 per hour). The total costs are based upon an overhead rate of 110 percent. The average annual Agency burden for 305( b) and 303( d) reporting activities is estimated at 9,089 hours at a cost of $ 456,774. The cost of the Agency's additional burden to develop new guidance required by States to improve their estimates of the benefits and costs of achieving WQS is estimated at approximately $ 300,000 which would be incurred during 2004 and 2005. Over the 3 year period of this ICR, the annual cost would be $ 100,000 which translates into a burden of 2,117 hours annually. The annual average Agency burden and costs for TMDL review is 11,200 hours and $ 528,976.

Respondent Total Annual Burden: 3,740,017 hours per year.

VerDate Jan< 31> 2003 16: 48 May 20, 2003 Jkt 200001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MYN1. SGM 21MYN1 27796 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Notices Annual Costs: $ 155,322,906 per year.

Agency Total Annual Burden: 22,406 hours per year. Annual Costs: $ 1,085,750 per year.

Dated: May 15, 2003. Diane C. Regas, Director, Office of Wetlands, Oceans and Watersheds. [ FR Doc. 03   12759 Filed 5   20   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OAR   2003   0070, FRL   7501   7]

Agency Information Collection Activities: Proposed Collection; Comment Request; The SunWise School Program AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that EPA is planning to submit the following continuing Information Collection Request ( ICR) to the Office of Management and Budget ( OMB): The SunWise School Program, Global Programs Division, EPA ICR No. 1904.01, expiration date: 11/ 30/ 03. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the continuing information collection as described below. DATES: Comments must be submitted on or before July 21, 2003. ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Kristin Kenausis, Office of Atmospheric Programs, Global Programs Division, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW. ( 6205J), Washington, DC 20460, ( 202) 564   2289, kenausis. kristin@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has established a public docket for this ICR under Docket ID number OAR   2003   0070, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for Air and Radiation Docket is ( 202) 566   1744. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA within 60 days of this notice, and according to the following detailed instructions: Submit your comments to EPA online using EDOCKET ( our preferred method), by email to a and r Docket@ epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, Air and Radiation Docket, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov./ edocket. Affected entities: Entities potentially affected by this action are elementary and middle school students, parents, and teachers ( SIC Div. I: Group 8211). Title: SunWise School Program; ( OMB Control Number 2060   0439; EPA ICR No. 1904.01, expiring on 11/ 30/ 03). Abstract: The goal of the SunWise School Program is to teach children and their care givers how to protect themselves from overexposure to the sun. The SunWise School Program recognizes the challenge of measuring the progress and evaluating the effectiveness of an environmental and public health education program where the ultimate goal is to reduce risk and improve public health. Therefore, the continual and careful evaluation of program effectiveness through a variety of means, including data from pre and post intervention surveys, tracking and monitoring of classroom activities and school policies, and advisory board meetings, is necessary to monitor progress and refine the program. Surveys to be developed and administered include: ( 1) Student survey to identify current sun safety knowledge and behaviors among students; ( 2) Parent survey to compare findings with those of their children as well as to draw comparisons with the benchmarks established in other national surveys; and ( 3) Teacher questionnaire for measuring their receptivity to the educational component of the Program. The data will be analyzed and results will indicate the Program's effect on participants' sun protection attitudes and behaviors. Responses to the collection of information are voluntary. All responses to the collection of information remain anonymous and confidential. An 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 numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. Burden Statement: The annual public reporting and record keeping burden for this collection of information is estimated to average .5 hours per response.

Number to be surveyed annually Total Hours Burden Rate per hour ($) Total Cost ( D= B* C)

( A) ( B) ( C) ( D)

3,000 Students ............................................................................................................................. 3,000 ........................ ........................ 1,000 Teachers ............................................................................................................................ 500 $ 36.88 $ 18,440.00 VerDate Jan< 31> 2003 15: 43 May 20, 2003 Jkt 200001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 21MYN1. SGM 21MYN1


[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Page 39645]
[FR Doc No: 2017-17644]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: National
Flight Data Center Web Portal

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew a previously approved
information collection. National Flight Data Center (NFDC) Web Portal
forms are used to collect aeronautical information, detailing the
physical description and operational status of all components of the
National Airspace System (NAS).

DATES: Written comments should be submitted by September 20, 2017.

ADDRESSES: Interested persons are invited to submit written comments on
the proposed information collection to the Office of Information and
Regulatory Affairs, Office of Management and Budget. Comments should be
addressed to the attention of the Desk Officer, Department of
Transportation/FAA, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

FOR FURTHER INFORMATION CONTACT: Barbara Hall by email at:
<EMAIL_ADDRESS>Phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0754.
    Title: National Flight Data Center Web Portal.
    Form Numbers: FAA Form 7900-1, 7900-2, 7900-3, 7900-4, 7900-7.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on April 5, 2017 (82 FR 16658). There were no comments.
The National Flight Data Center (NFDC) is the authoritative government
source for collecting, validating, storing, maintaining, and
disseminating aeronautical data concerning the United States and its
territories to support real-time aviation activities. The information
collected ensures the safe and efficient navigation of the national
airspace. The information collected is maintained in the National
Airspace System Resources (NASR) database which serves as the official
repository for NAS data and is provided to government, military, and
private producers of aeronautical charts, publications, and flight
management systems. The FAA is no longer collecting the information
that was previously collected using Form 7900-5 or 7900-6.
    Respondents: Approximately 5,173 representatives of U.S. public
airports, U.S. privately-owned instrument landing systems, and non-
Federal weather systems.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 40 minutes.
    Estimated Total Annual Burden: 2,107 hours.

    Issued in Washington, DC, on August 15, 2017.
Ronda L. Thompson,
FAA Information Collection Clearance Officer. Performance, Policy &
Records Management Branch, ASP-110.
[FR Doc. 2017-17644 Filed 8-18-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Notices]
[Pages 60871-60872]
[FR Doc No: 2013-23947]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0106; FRL-9401-2]

Pesticide Experimental Use Permits; Notice of Receipt of
Applications; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's receipt of applications requesting
experimental use permits (EUPs). The Agency has determined that the
permits may be of regional and national significance. Therefore,
because of the potential significance, and pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby
providing notice of receipt and is seeking comments on these
applications.

DATES: Comments must be received on or before November 1, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the EUP File Symbol of interest as shown in the body of
this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to those persons who conduct or
sponsor research on pesticides, the Agency has not attempted to
describe all the specific entities that may be affected by this action.

B. What Should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked

will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What action is the Agency taking?

    Under section 5 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136c, EPA can allow manufacturers to
field test pesticides under development. Manufacturers are required to
obtain an EUP before testing new pesticides or new uses of pesticides
if they conduct experimental field tests on 10 acres or more of land or
one acre or more of water. A copy of the applications and any
information submitted is available for public review in the docket
established for these EUP applications. Following the review of the
application and any comments and data received in response to this
solicitation, EPA will decide whether to issue or deny the EUP request,
and if issued, the conditions under which it is to be conducted. Any
issuance of an EUP will be announced in the Federal Register.
    Therefore, pursuant to 40 CFR 172.11(a), the Agency has determined
that the following EUP applications may be of regional and national
significance, and therefore is seeking public comment on the following
EUP applications:
    1. 524-EUP-RNA. (EPA-HQ-OPP-2013-0012). Submitter: Monsanto
Company, 800 N. Lindbergh Blvd., St. Louis, MO 63167. Pesticide
chemical: MON 102100. Type of chemical: Nematicide. Summary of request:
Large scale seed treatment trials on corn, soybean, and cotton. 12.94
pounds (lb.) of active ingredient (a.i.) per year on corn seed, 19.10
lb. of a.i per year on soybeans seed, and 7.46 lb. of a.i. per year on
cotton seed will be used in 208 locations of 20 ft. x 1,000 ft. plots.
Period of treatment is from February 1, 2014, to December 31, 2016.
Treated seed must be dyed to impart an unnatural color to prevent use
for food, feed, or oil purposes. This is a crop-destruct EUP.
    2. 72500-EUP-E. (EPA-HQ-OPP-2013-0546). Submitter: Scimetrics Ltd.
Corp., P.O. Box 1045, Wellington, CO 80549. Pesticide chemical:
Warfarin. Type of chemical: Rodenticide. Summary of request:
Authorization requested to use 0.005% warfarin bait blocks at one or
more test sites in large, fenced areas in Texas. 0.63 lb of warfarin in
12,600 lb of formulated bait. Bait to be applied on 25 lb to 100 lb
amounts in dispensers said to allow feral hogs to access bait while
limiting access by nontarget species. Area covered by treatments not to
exceed 2,471 acres (10 km\3\). Baiting period is projected to last 3
weeks, with dispensers being replenished ``as needed.'' Proposed period
of treatment is from July 1, 2014, to August 31, 2014.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: September 23, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-23947 Filed 10-1-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 9, 2008 (Volume 73, Number 69)]
[Rules and Regulations]
[Page 19147-19150]
[DOCID:fr09ap08-5]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0433; FRL-8357-5]

1-Methylcyclopropene; Amendment to an Exemption from the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an amendment to an exemption from
the requirement of a tolerance for residues of the 1-Methylcyclopropene
(1-MCP) on fruits and vegetables when applied or used outdoors for pre-
harvest treatments. Agrofresh Inc., submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA), requesting an amendment to
the existing 1-MCP exemption from the requirement of a tolerance at 40
CFR 180.1220. This regulation eliminates the need to establish a
maximum permissible level for residues of 1-Methylcyclopropene.

DATES: This regulation is effective April 9, 2008. Objections and
requests for hearings must be received on or before June 9, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0433. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0433 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before June 9, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0433, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One

Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA.
Deliveries are only accepted during the Docket's normal hours of
operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays). Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of August 8, 2007 (72 FR 44520) (FRL-8138-
9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7170) by Agrofresh, Inc., 100 Independence Mall,
Philadelphia, PA 19106-2399. The petition requested that 40 CFR
180.1220 be amended to include residues resulting from outdoor pre-
harvest use of 1-Methylcyclopropene. This notice included a summary of
the petition prepared by the petitioner Agrofresh, Inc. There were no
comments received in response to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue....
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues'' and ``other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    1-Methylcyclopropene (1-MCP) is a plant regulator known for
inhibiting ripening and aging of plants, flowers, fruits, and
vegetables caused by the production of ethylene. 1-MCP acts by blocking
the attachment of ethylene to tissue, and thus, prolonging the life of
the food commodity treated. This mode of action is not relevant in
animals, since ethylene receptors are not present in animal tissues.
    The toxicity profile of 1-MCP has already been assessed by the
Agency for its pesticidal use and in support of the tolerance exemption
for post-harvest use in or on fruits and vegetables. The final rule was
published on July 26, 2002 (67 FR 48796)(FRL-7187-4). Comprehensive
review of studies submitted and risk assessment conducted on 1-MCP with
regard to its toxicity to human health, done in support of the current
petition and the approved tolerance exemption for post-harvest usage,
have all concluded that this compound has a low acute toxicity.
    1. Acute toxicity. 1-MCP exhibits low acute toxicity for all routes
of exposure. It is a category IV for acute oral, dermal, inhalation,
eye and dermal irritations. Moreover, 1-MCP is not a skin sensitizer,
and no hypersensitivity incidents were observed following exposure to
1-MCP.
    2. Genotoxicity. 1-MCP was not mutagenic when tested in several
short-term in vitro/in vivo assays, including a bacterial reverse
mutation assay (Ames test), an in vitro mammalian point mutation assay
in Chinese hamster ovary cells, an in vitro cytogenetics assay in human
lymphocytes and an in vivo mouse micronucleus assay following
inhalation exposure. In addition, 1-MCP is not mutagenic when tested as
a suspension in cell media in the Ames test and in the in vitro mouse
lymphoma forward mutation assay (MRID 444647-10) and is not mutagenic
in the in vivo mouse micronucleus assay (MRID 444747-11) following oral
exposure.
    3. Developmental toxicity. 1-MCP produces no developmental toxicity
when tested in a standard developmental toxicity study in the rat via
inhalation at concentrations up to and including 2.3 milligram active
ingredient/Liter (mg a.i./L) (or 543 mg a.i./kilogram (kg)/day, 6 hour
(hr) exposure/day). The no observed adverse effect level (NOAEL) for
maternal toxicity was 0.24 mg a.i./L (56 mg a.i./kg/day, 6 hr exposure/
day).
    4. Subchronic toxicity. 1-MCP was tested in a 90-day inhalation
study at doses of 0.05, 0.24 and 2.3 mg a.i./kg in the rat. The NOAEL
is 0.05 mg a.i./L (equivalent to 9 to 15 mg a.i./kg/day), based on
minimal to mild effects on spleen and kidney histopathology at 0.24 mg
a.i./L (equivalent to 39 to 66 mg a.i./kg/day). In this study there was
no evidence of neurotoxicity, no effects on the respiratory tract and
no effects on pathology of any endocrine or reproductive organs up to
and including the highest dose tested of 2.3 mg a.i./L (or equivalent
to 380 to 640 mg a.i./kg/day).
    5. AgroFresh (the applicant) submitted a request to waive the
immune response from the testing guidelines. A scientific rationale
based on the current toxicological data submitted on 1-MCP was provided
to address this data requirement. The review of the 3-month inhalation
rat study (mentioned in the previous paragraph) indicates no effects on
thymus weight and no effects on the histopathology of the thymus, bone
marrow or spleen that would be attributed to an impact on the immune
system were seen. There were no effects on white blood cell
differential parameters (including monocytes, lymphocytes, segmented
neutrophils or eosinophils) and no basophils were observed which may be
indicative of an allergic reaction. The Agency concluded that 1-MCP did
not induce dysfunction or inappropriate suppressive responses in
components of the immune system. As a result, the Agency granted the
request to waive immune response from the testing guidelines.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or

buildings (residential and other indoor uses).

A. Dietary Exposure

    1. Food. The primary source for human exposure to 1-MCP will be
from ingestion of raw and processed fruits and vegetables treated with
1-MCP before and after the harvest. Studies submitted, conducted in the
field on apples (MRID 470886-12), maize (MRID 470886-11) and tomatoes
(471082-03), showed residues in treated fruits to be extremely low.
Moreover, harvested apples treated with 1-MCP in storage areas (MRID
456090-02), showed also low residue (average residue was 0.004 part per
million (ppm) using an exaggerated treatment rate of 1,200 parts per
billion (ppb) versus the 1,000 ppb proposed label rate). A worst-case
scenario (using the 0.004 ppm average residue concentration found in
treated apples and assuming that concentration is present in 100% of
the diet regardless of crops treated) indicates that a daily diet of
1.5 kg/day could contain 0.006 mg 1-MCP. For the general population
(assuming an average body weight of 60 kg), this would represent a
daily intake of 0.0001 mg 1-MCP/kg body weight which is 90,000 to
150,000-fold less than the 9-15 mg/kg NOAEL indicated in the 90-day
inhalation study. Residues in other treated commodities are expected to
be similar or even lower since the highest treatment rate is
recommended for apples. Processing would be expected to further lower
the residue levels in processed food commodities.
    2. Drinking water exposure. No significant drinking water exposure
and residues are expected to result from the pesticidal use of 1-MCP
when applied or used as directed on the label and in accordance with
good agricultural practices. Moreover, review of the study for soil
absorption (OPPTS 835.1220), showed that the field use of 1-MCP should
not result in leaching of 1-MCP residues to ground water.

B. Other Non-Occupational Exposure

    There are no residential, school or day care uses proposed for this
product. Since the proposed use pattern is for agricultural food crops,
the potential for non-occupational, non-dietary exposures to 1-MCP by
the general population, including infants and children, is highly
unlikely.
    1. Dermal exposure. Non-occupational dermal exposures to 1-MCP when
used as a plant regulator are expected to be negligible because it is
limited to agricultural use.
    2. Inhalation exposure. Non-occupational inhalation exposures to 1-
MCP when used as a plant regulator are expected to be negligible
because it is limited to agricultural use.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish an exemption from a tolerance, the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues and other substances that
have a common mechanism of toxicity.'' These considerations include the
possible cumulative effects of such residues on infants and children.
    EPA has considered the potential for cumulative effects of 1-MCP
and other substances in relation to a common mechanism of toxicity. 1-
MCP cannot share a common mechanism of toxicity with other substances
because this compound is not toxic to mammalian systems. Thus, section
408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

A. U.S. Population

    There is reasonable certainty that no harm will result from
aggregate exposure to residues of 1-MCP to the U.S. population,
infants, and children. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. The
Agency arrived at this conclusion based on the low level of mammalian
toxicity of 1-MCP and the already widespread exposure to 1-MCP when
used on pre-harvested and post-harvested fruits and vegetable, without
any reported adverse effects on human health. For these reasons, the
Agency has determined that residues of 1-MCP from pre-harvest treatment
of fruits and vegetables are safe, i.e., there is a reasonable
certainty that no harm will result from aggregate exposure to such
residues.

B. Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (also referred to as a margin of safety) for
infants and children in the case of threshold effects to account for
prenatal and postnatal toxicity and the completeness of the database
unless EPA determines that a different margin of exposure will be safe
for infants and children. Margins of exposure are often referred to as
uncertainty or safety factors. In this instance, based on all available
information, the Agency concludes that 1-MCP is non-toxic to mammals,
including infants and children. Because there are no threshold effects
of concern to infants, children, and adults when 1-MCP is used as
labeled, the provision requiring an additional margin of safety does
not apply. As a result, EPA has not used a margin of exposure approach
to assess the safety of 1-MCP.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.''
    1-MCP is not known as an endocrine disruptor nor is it related to
any class of known endocrine disruptors. Thus, there is no impact via
endocrine-related effects on the Agency's safety finding set forth in
this final rule for1-MCP.

B. Analytical Method

    Through this action, the Agency proposes to establish an exemption
from the requirement of a tolerance for 1-MCP when used on fruit and
vegetable crops. For the very same reasons that support the granting of
this tolerance exemption, the Agency has concluded that an analytical
method is not required for enforcement purposes for these proposed uses
of 1-MCP.

C. Codex Maximum Residue Level

    There are no codex maximum residue levels established for 1-MCP.

VIII. Conclusions

    The Agency does not expect any human health concerns from exposure
to residues of 1-MCP when applied or used as directed on the label and
in accordance with good agricultural practices. The data submitted by
applicant and reviewed by the Agency support the petition for an
exemption from the requirement of a tolerance, for 1-MCP on pre-
harvested fruits and vegetable, when the product is applied or used as
directed on the label.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under

Executive Order 12866, this final rule is not subject to Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 31, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1220 is revised to read as follows:

Sec.  180.1220  1-Methylcyclopropene; exemption from the requirement of
a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of the 1-Methylcyclopropene in or on fruits and vegetables
when:
    (a) Used as a post harvest plant growth regulator, i.e., for the
purpose of inhibiting the effects of ethylene.
    (b) Applied or used outdoors for pre-harvest treatments.
[FR Doc. E8-7458 Filed 4-8-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51073-51076]
[FR Doc No: 2012-20711]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67680; File No. SR-Phlx-2012-106]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing of Proposed Rule Change To Modify Exchange Rule 3307 To
Institute a Five Millisecond Delay in the Execution Time of Marketable
Orders on NASDAQ OMX PSX

August 17, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 9, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or ``Exchange'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify Exchange Rule 3307 to institute a
five millisecond delay in the execution time of marketable orders on
NASDAQ OMX PSX (``PSX''). The Exchange proposes to implement the
proposed rule change within 30 days of Commission approval. The text of
the proposed rule change is available at http://nasdaqomxphlx.cchwallstreet.com/nasdaqomxphlx/phlx, at Phlx's principal
office and at the Commission's Public Reference room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to modify Exchange Rule
3307 to institute a five millisecond delay in the execution time of
marketable orders. The proposal will be implemented initially on a one-
year pilot basis with respect to the trading of securities listed on
the NASDAQ Stock Market (``Tape C Securities''). The Exchange
introduced PSX, which features a unique price/size/pro-rata execution
algorithm, in order to encourage market participants to display more
liquidity in a transparent market environment. As among equally priced
orders on the PSX book, PSX allocates execution opportunities in
proportion to the size of the posted order, rather than its time of
entry. Thus, the Exchange's market model is intended to deemphasize the
importance of speed in realizing trading opportunities.
    Although PSX has enjoyed a measure of success, the Exchange is
concerned that slower liquidity providers that post on PSX are
sometimes subject to suboptimal executions due to disparities in the
speed with which market participants are able to react to market

information. Thus, in a circumstance where a broker posts a large order
on PSX and changes in market conditions render the price of the order
stale, a market participant with superior capabilities to process
information may be able to route an order before the broker can change
its price, thereby obtaining a fill at a price that is out of line with
the price that will prevail in the market generally once the changes in
the market conditions are fully digested. While the potential for a
posted order to interact with orders entered by market participants
with faster reaction capabilities responding to short-term
information--sometimes referred to as ``toxic order flow''--exists on
all markets, the larger posted sizes and pro rata allocation model on
PSX may make the impact more pronounced, since fills are allocated
among all market participants posting orders at a particular price.
    It should also be noted that liquidity providers face asymmetric
risks as compared with firms that seek to access liquidity
opportunistically. To illustrate this point, consider the following
example. Firm A is providing liquidity in 1,000 securities while Firm B
is seeking opportunistically to access liquidity if it perceives a
quote is mispriced. Both firms receive information (e.g., index market
data from a futures market) simultaneously that causes both to re-
evaluate the fair value of all 1,000 securities quoted by Firm A. Firm
A immediately seeks to update its quotes to reflect the change in fair
value, while Firm B seeks to access those quotes before they are
updated. If Firm B's orders are able to access a quote before it is
updated, Firm A faces the risk of executing at stale prices in up to
1,000 securities. If, on the other hand, Firm A's updates are processed
before Firm B's orders, Firm B faces the opportunity cost of failing to
execute at the opportunistic price, but otherwise has no exposure as a
result of its relative latency. As this illustrates, the risk of being
technologically inferior is substantially higher for liquidity
providers (Firm A is exposed to up to 1,000 mispriced executions) than
for liquidity removers (Firm B has no executions).
    In an effort to address these issues, the Exchange is proposing to
institute a five millisecond delay in the time between when a
marketable order is received by the PSX system and when it is presented
for execution against the PSX book.\3\ No information about the receipt
of an incoming marketable order will be provided to any market
participant before the order is presented for execution.\4\ However,
any updates or cancellations of resting orders that are received during
the five millisecond period will be processed before the incoming order
is presented for execution. After an order has been presented for
execution, any unexecuted shares will be cancelled back to the member,
routed, or posted to the book as applicable. As is the case with all
orders on PSX, any price improvement will be allocated to the party
that entered the incoming order. If the incoming order becomes non-
marketable while it is being held, it will nevertheless continue to be
held until the end of the five-millisecond period. In addition, the
market participant entering the order may not cancel or modify it until
the order has been presented at the end of the period.
---------------------------------------------------------------------------

    \3\ Post-only orders and non-marketable orders with a time-in-
force other than ``Immediate-or-Cancel'' will not be subject to the
five millisecond delay.
    \4\ Because the incoming order will not be presented for
execution against the resting quote until after the end of the five
millisecond period, and no market participants will receive notice
of the existence of the order during that time, the delay will not
cause any compliance issues under SEC Rule 602(b), 17 CFR
242.602(b).
---------------------------------------------------------------------------

    With the change, the overall processing time for incoming
marketable orders will still be extremely rapid--in most cases, about
5.075 milliseconds--and will be faster than the processing time for
several existing exchange markets. However, the Exchange believes that
the additional time will be sufficient to allow liquidity providers to
make adjustments if they believe them to be warranted. Accordingly, the
change will ``level the playing field'' between liquidity providers and
opportunistic traders, consistent with the Exchange's goal of making
PSX a market that rewards investors for the size of their trading
interest rather than the speed of their trading algorithms.
    Although the proposal will allow liquidity providers to adjust
their quotes during the delay period after an order is received by PSX,
the Exchange does not believe that the proposal presents any issues
under the provisions of SEC Rule 602(b),\5\ generally known as the
``firm quote rule.'' Subject to certain exceptions, paragraph (b)(2) of
the rule provides:
---------------------------------------------------------------------------

    \5\ 17 CFR 242.602(b).

    [E]ach responsible broker or dealer shall be obligated to
execute any order to buy or sell a subject security, other than an
odd-lot order, presented to it by another broker or dealer, or any
other person belonging to a category of persons with whom such
responsible broker or dealer customarily deals, at a price at least
as favorable to such buyer or seller as the responsible broker's or
dealer's published bid or published offer (exclusive of any
commission, commission equivalent or differential customarily
charged by such responsible broker or dealer in connection with
execution of any such order) in any amount up to its published
---------------------------------------------------------------------------
quotation size.

    However, paragraph (b)(3) provides that ``[n]o responsible broker
or dealer shall be obligated to execute a transaction for any subject
security as provided in paragraph (b)(2) of this section if * * *
[b]efore the order sought to be executed is presented, such responsible
broker or dealer has communicated to its exchange or association
pursuant to paragraph (b)(1) of this section, a revised bid or offer.''
The application of these provisions to the proposed rule change hinges
on the word ``presented'': if an order executable against a quote is
presented to a broker-dealer, it must be executed unless a revised
quote has been communicated to the exchange before the order is
presented. The rule does not define the term ``presented,'' nor do the
relevant proposing and adopting releases shed extensive light on its
interpretation.\6\ The relevant dictionary definition of ``present''--
to ``show or offer (something) for others to scrutinize or consider''
\7\--suggests the need for awareness of a recipient of the thing that
is presented. As a matter of logic, moreover, a broker-dealer should
not be held responsible for executing an order of which it is not
aware. Indeed, this would appear to be the purpose of the exception
provided by paragraph (b)(3): a broker-dealer that has updated its
quote before receiving a previously marketable order should not be
required to provide an execution against its prior quote. Because, in
the case of the proposed rule change, an incoming order will not
attempt to execute until after the end of the five millisecond period,
and no market participants will receive notice of the existence of the
order during that time, the Exchange believes that it would be contrary
to the purpose of this exception if a broker-dealer were required to
honor its prior quote merely because the Exchange was temporarily
holding an order of which the broker-dealer had no awareness.
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 12670 (July 29, 1976),
41 FR 32856 (August 5, 1976); Securities Exchange Act Release No.
13626 (June 14, 1977), 42 FR 32418 (June 24, 1977); Securities
Exchange Act Release No. 14415 (January 26, 1978), 43 FR 4342
(February 1, 1978).
    \7\ See www.oxforddictionaries.com.
---------------------------------------------------------------------------

    Under Regulation NMS, a trading center that displays an ``automated
quotation'' must ``immediately and

automatically'' execute an incoming order that is ``marked as
immediate-or- cancel,'' up to the full size of the displayed
quotation.\8\ Moreover, the Commission stated that ``immediately''
means that ``a trading center's systems should provide the fastest
response possible without any programmed delay.'' \9\ Thus, although
PSX's response time will remain extremely rapid, the Exchange will mark
PSX's quotations for Tape C Securities as ``manual quotations'' within
the meaning of Regulation NMS. The Exchange notes, however, that in
adopting Regulation NMS, the Commission ``emphasize[d] that adoption of
Rule 611\10\ in no way lessens a broker-dealer's duty of best
execution.* * * The duty of best execution requires broker-dealers to
execute customers' trades at the most favorable terms reasonably
available under the circumstances, i.e., at the best reasonably
available price.'' Accordingly, it is the Exchange's belief that market
participants will be required to consider the price, size,
accessibility, and cost of PSX's quotations in determining whether they
have satisfied their best execution obligations.
---------------------------------------------------------------------------

    \8\ 17 CFR 242.600(b)(3).
    \9\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37519 (June 29, 2005) (File No. S7-10-04).
    \10\ 17 CFR 242.611. Rule 611 provides that trading centers must
establish, maintain, and enforce written policies and procedures
that are reasonably designed to prevent trade-throughs on that
trading center of protected quotations in NMS stocks.
---------------------------------------------------------------------------

    The Exchange proposes adopting the change on a one-year pilot basis
with respect to Tape C Securities only. This approach will allow the
Exchange to compare trading patterns and market performance with
respect to stocks subject to the pilot and those that are not. Based on
this information, the Exchange will determine whether to expand the
pilot, seek permanent approval for it, or allow it to lapse. The
Exchange has selected Tape C Securities for the pilot because it
believes that PSX's overall share volumes in Tape C (roughly comparable
to its volumes for Tape A Securities and higher than for Tape B
Securities \11\) and its percentage market share (higher than for Tape
A Securities) will provide more useful data for assessing the
effectiveness of the pilot. The Exchange reserves the right to submit a
proposed rule change prior to the end of the pilot period in order to
make such changes as it believes warranted.
---------------------------------------------------------------------------

    \11\ Tape A Securities are listed on the New York Stock Exchange
and Tape B Securities are listed on NYSE MKT and other ``regional''
exchanges.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \12\ in general, and furthers the objectives of Section
6(b)(5) of the Act \13\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers. The Exchange believes that the
rule change will promote these goals by providing broker-dealers and
investors that post liquidity with a better opportunity to adjust the
prices of their orders to reflect changed market circumstances, thereby
enhancing their ability to avoid so-called toxic order flow. The
Exchange believes that firms willing to provide liquidity in large
numbers of stocks provide benefits to investors and listed companies by
supporting active markets in those stocks and dampening volatility.
Specifically, the Exchange believes that widespread quoting activity
benefits retail and institutional investors that have longer investment
horizons and do not calibrate their purchases or sales to intraday
variations in prices. As discussed above, however, as a firm becomes
active in providing liquidity in a larger number of stocks, it faces
greater challenges in ensuring that its quoted prices are up-to-date.
If firms that wish to actively quote are unable to mitigate the
asymmetric risks created by opportunistic traders, they are likely to
decrease their quoting activity, rather than incur losses. Accordingly,
the Exchange believes that it is appropriate to adopt the proposed rule
change as a means to assist liquidity providers in mitigating these
risks, and thereby encourage greater levels of liquidity provision in a
wider range of stocks.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange does not believe that the proposal is unfairly
discriminatory. Although the change may be seen as diminishing the
ability of opportunistic traders to access quotes before they are
updated to reflect changed market information, the Exchange believes
that the anticipated benefits of the proposal in supporting liquidity
provision and the interests of investors with longer trading horizons
outweigh the potentially diminished profit opportunities for traders
with shorter trading horizons. Moreover, because the Exchange's market
share is small, the change will have little effect on the ability of
traders to continue trading actively with a short-term focus on
numerous other venues.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. Although the change will delay
the execution time for incoming marketable orders, the Exchange
believes that the extremely fast overall processing time of 5.075
milliseconds should not be considered a burden on the ability of market
participants to compete for order executions. Moreover, the Exchange
believes that the change is appropriate in furtherance of the purposes
of the Act because it will help liquidity providers to mitigate the
asymmetric risks associated with opportunistic traders. The Exchange
further believes that any burden on the ability of opportunistic
traders to realize short-term trading opportunities on the Exchange
will be minimal, because such opportunities will continue to exist on
other trading venues. Moreover, the Exchange believes that any such
burden will be outweighed by the benefits that it seeks to provide to
support liquidity provision and the interests of investors with longer-
term trading horizons.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) by order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2012-106 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-Phlx-2012-106. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-Phlx-2012-106 and should be
submitted on or before September 13, 2012.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-20711 Filed 8-22-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67552-67553]
[FR Doc No: 2020-23485]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0862]

Captain Neill's Seafood, Inc.: Final Debarment Order

AGENCY: Food and Drug Administration

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Capt. Neill's Seafood, Inc. (Capt. Neill's or the Company) for a period
of 5 years from importing articles of food or offering such articles
for importation into the United States. FDA bases this order on a
finding that Capt. Neill's was convicted, as defined in the FD&C Act,
of a felony count under Federal law for conduct relating to the
importation into the United States of an article of food. The Company
was given notice of the proposed permanent debarment and an opportunity
to request a hearing within the timeframe prescribed by regulation. As
of 30 days after receipt of the notice (July 13, 2020), Capt. Neill's
has not responded. Capt. Neill's failure to respond and request a
hearing constitutes a waiver of the Company's right to a hearing
concerning this matter.

DATES: This order is effective October 23, 2020.

ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029), Division
of Enforcement, Office of Strategic Planning and Operational Policy,
Office of Regulatory Affairs, Food and Drug Administration, 12420
Parklawn Dr., Rockville, MD 20857 or at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C))
permits FDA to debar an individual from importing an article of food or
offering such an article

for import into the United States if FDA finds, as required by section
306(b)(3)(A) of the FD&C Act, that the individual has been convicted of
a felony for conduct relating to the importation into the United States
of any food.
    On January 9, 2020, Capt. Neill's was convicted as defined in
section 306(l)(1)(B) of the FD&C Act, in the U.S. District Court for
the Eastern District of North Carolina, when the court accepted the
Company's plea of guilty and entered judgment against it for the
offense of violating the Lacey Act and Aiding and Abetting. This
offense was in violation of 16 U.S.C. 3372(d)(1), 3373(d)(3)(A)(i) and
(ii), and 18 U.S.C. 2.
    FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As contained in the Indictment, filed on June
26, 2019, Capt. Neill's is a North Carolina corporation in the business
of purchasing, processing, packaging, transporting, and selling seafood
and seafood products, including crab meat from domestically harvested
Atlantic blue crab, and products made from Atlantic blue crab. From as
early as January 1, 2012 and continuing through December 31, 2015,
Capt. Neill's purchased foreign crab meat from South American and Asia.
Capt. Neill's employees repacked the foreign crab meat into containers
labeled ``Product of USA.'' Capt. Neill's employees then knowingly sold
those containers of foreign crab meat as jumbo domestically harvested
blue crab to customers. During the relevant time frame, Capt. Neill's
sold approximately 200,536 pounds of crab meat falsely labeled
``Product of USA'' with a total retail market value of $4,082,841.
    As a result of this conviction FDA sent Capt. Neill's, by certified
mail on May 6, 2020, a notice proposing to debar him for a period of 5
years from importing articles of food or offering such articles for
import into the United States. The proposal was based on a finding
under section 306(b)(1)(C) of the FD&C Act that Capt. Neill's felony
conviction of violating the Lacey Act and Aiding and Abetting in
violation 16 U.S.C. 3372(d)(1), 3373(d)(3)(A)(i) and (ii), and 18 U.S.C
2, constitutes conduct relating to the importation into the United
States of an article of food because the offense involved Capt. Neill's
employees falsely labeling crabmeat that was imported from foreign
countries and purporting that the crabmeat was a ``Product of USA.''
    The proposal was also based on a determination, after consideration
of the relevant factors set forth in section 306(c)(3) of the FD&C Act,
that Capt. Neill's should be subject to a 5-year period of debarment.
The proposal also offered Capt. Neill's an opportunity to request a
hearing, providing the Company 30 days from the date of receipt of the
letter in which to file the request, and advised Capt. Neill's that
failure to request a hearing constituted a waiver of the opportunity
for a hearing and of any contentions concerning this action. Capt.
Neill's failed to respond within the timeframe prescribed by regulation
and has, therefore, waived the Company's opportunity for a hearing and
waived any contentions concerning Capt. Neill's debarment (21 CFR part
12).

II. Findings and Order

    Therefore, the Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Capt.
Neill's has been convicted of a felony count under Federal law for
conduct relating to the importation into the United States of an
article of food and that the Company is subject to a 5-year period of
debarment.
    As a result of the foregoing finding, Capt. Neill's is debarred for
a period of 5 years from importing articles of food or offering such
articles for import into the United States, effective (see DATES).
Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the
importing or offering for import into the United States of an article
of food by, with the assistance of, or at the direction of Capt.
Neill's Seafood, Inc. is a prohibited act.
    Any application by Capt. Neill's for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2020-N-0862 and sent to the Dockets Management Staff (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20.
    Publicly available submissions will be placed in the docket and
will be viewable at http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23485 Filed 10-22-20; 8:45 am]
BILLING CODE 4164-01-P