[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17132-17135]
[FR Doc No: 2011-7191]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0017]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary National
Retail Food Regulatory Program Standards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by April
27, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0621.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Voluntary National Retail Food Regulatory Program Standards--(OMB
Control Number 0910-0621)--Extension

    The Program Standards define nine essential elements of an
effective regulatory program for retail food establishments, establish
basic quality control criteria for each element, and provide a means of
recognition for those state, local, and tribal regulatory programs that
meet the Program Standards. The program elements addressed by the
Program Standards are as follows: (1) Regulatory foundation, (2)
trained regulatory staff, (3) inspection program based on Hazard
Analysis and Critical Control Point (HACCP) principles, (4) uniform
inspection program, (5) foodborne illness and food defense preparedness
and response, (6) compliance and enforcement, (7) industry and
community relations, (8) program support and resources, and (9) program
assessment. Each standard includes a list of records needed to document
compliance with the standard (referred to in the Program Standards
document as ``quality records'') and has one or more corresponding
appendices that contain forms and worksheets to facilitate the
collection of information needed to assess the retail food regulatory
program against that standard. The respondents are State, local and
tribal government Agencies. Regulatory Agencies may use existing,
available records or may choose to develop and use alternate forms and
worksheets that capture the same information.
    In the course of their normal activities, state, local, and tribal

regulatory Agencies already collect and keep on file many of the
records needed as quality records to document compliance with each of
the Program Standards. Although the detail and format in which this
information is collected and recorded may vary by jurisdiction, records
that are kept as a usual and customary part of normal Agency activities
include inspection records, written quality assurance procedures and
records of quality assurance checks, staff training certificates and
other training records, a log or database of food-related illness or
injury complaints, records of investigations resulting from such
complaints, an inventory of inspection equipment, records of outside
audits, and records of outreach efforts (e.g., meeting agendas and
minutes, documentation of food safety education activities). No new
recordkeeping burden is associated with these existing records, which
are already a part of usual and customary program recordkeeping
activities by state, local, and tribal regulatory Agencies, and which
can serve as quality records under the Program Standards.
    State, local, and tribal regulatory Agencies that enroll in the
Program Standards and seek listing in the FDA National Registry are
required to report to FDA on the completion of the following three
management tasks outlined in the Program Standards: (1) Conducting a
program self assessment, (2) conducting a baseline survey of the
regulated industry, and (3) obtaining an independent outside audit
(verification audit). The results are reported to FDA on Form FDA 3519,
``FDA National Registry Report'' and Form FDA 3520, ``Permission to
Publish in National Registry.'' These forms are located in Appendix I
of the Program Standards document. If a regulatory Agency follows all
the recordkeeping recommendations in the individual standards and their
appendices, it will have all the information needed to complete the
forms.
    In April 2010, the Conference for Food Protection approved changes
to the Program Standards. The changes have been incorporated into a
draft 2011 revision, which will be available at: http://www.fda.gov/retailfoodprotection. One change was to provide an extension of time
for completion of the three management tasks. Another change was the
inclusion of clarifying language in Standard 9 that a jurisdiction may
use its inspection data to conduct its study of risk factor occurrence.
Although this was always the intent in Standard 9, it was not clear to
jurisdictions that this was a viable option.
    FDA analyzed whether incorporation of these changes alters its
estimate of the recordkeeping and reporting burdens. FDA concluded that
the changes will lessen the annual recordkeeping burden estimate
because the management tasks will be conducted on a less frequent basis
annually. Thus, based on its experience with the Program Standards over
the past 3 years, FDA has reduced its estimate of the hours per record
to 94.29, from the previously estimated 157 hours per record in 2008.
The reduced recordkeeping burden hour estimates are shown in table 1 of
this document. FDA notes that jurisdictions that choose to analyze
their inspection data per the Standard 9 criteria will enjoy a less
resource intensive method for tracking risk factor trends over time.
However, the Agency has not reduced its estimate of 333 hours for
Standard 9 shown in table 2 of this document. The Agency will consider
reducing this estimate in a future information collection request based
on supporting data it expects to receive in the future from
participating jurisdictions. The two noted changes had no effect on the
reporting burden hour estimates shown in table 2 of this document.

Recordkeeping

    FDA's recordkeeping burden estimate includes time required for a
State, local, or tribal Agency to review the instructions in the
Program Standards, compile information from existing sources, and
create any records recommended in the Program Standards that are not
already kept in the normal course of the Agency's usual and customary
activities. Worksheets (Appendices) are provided to assist in this
compilation. In estimating the time needed for the program self-
assessment (Program Standards 1-8, shown in table 1 of this document),
FDA considered responses from four state and three local jurisdictions
that participated in an FDA Program Standards Pilot study. Table 2 of
this document shows the estimated recordkeeping burden for the
completion of the baseline data collection and table 3 of this document
shows the estimated recordkeeping burden for the verification audit.
    In the Federal Register of January 12, 2011 (76 FR 2124), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received six comment letters in response
to the notice. One comment was generally supportive of the necessity of
the information collection and its practical utility. Five letters
contained comments outside the scope of the four collections of
information topics on which the notice solicits comments and thus, will
not be addressed here.
    FDA estimates the burden for this collection of information as
follows:

                                            Table 1--Self Assessment
----------------------------------------------------------------------------------------------------------------
                  Standard                                Recordkeeping activity               Hours per record
----------------------------------------------------------------------------------------------------------------
No. 1. Regulatory Foundation................  Self Assessment: (Appendix A) Completion of                   16
                                               worksheet recording results of evaluations
                                               and comparison on worksheets \1\.
No. 2. Trained Regulatory Staff.............  Self Assessment: (Appendix B-2 and B-4)\1\                    19.3
                                               Completion of the Center for Food Protection
                                               Field Training Manual and Documentation of
                                               Successful Completion--Field Training
                                               Process; completion of summary worksheet of
                                               each employee training records \2\.
No. 3. Hazard Analysis and Critical Control   Self Assessment: (Appendix C \1\) Completion                   4
 Point.                                        of worksheet documentation.
No. 4. Uniform Inspection Program...........  Self Assessment: (Appendix D \1\) Completion                  19
                                               of worksheet documentation of jurisdiction's
                                               quality assurance procedures \2\.
No. 5. Foodborne Illness Investigation......  Self Assessment: (Appendix E \1\) Completion                   5
                                               of worksheet documentation.
No. 6. Compliance Enforcement...............  Self Assessment: (Appendix F \1\) Selection                   19
                                               and review of 20 to 70 establishment files @
                                               25 minutes per file. Estimate is based on a
                                               mean number of 45. Completion of worksheet.
No. 7. Industry & Community Relations.......  Self Assessment: (Appendix G \1\) Completion                   2
                                               of worksheet.

No. 8. Program Support and Resources........  Self Assessment: (Appendix H \1\) Selection                    8
                                               and review of establishment files.
    Subtotal................................  ..............................................                92.3
----------------------------------------------------------------------------------------------------------------
\1\ Or comparable documentation.
\2\ Estimates will vary depending on number of regulated food establishments and the number of inspectors
  employed by the jurisdiction.

                                        Table 2--Baseline Data Collection
----------------------------------------------------------------------------------------------------------------
                  Standard                                Recordkeeping activity               Hours per record
----------------------------------------------------------------------------------------------------------------
No. 9. Program Assessment...................  Baseline Data Collection (Appendices I & J)                    333
                                               Selection and inspection of randomly selected
                                               statistical sample of 9 to 87 establishments
                                               from each of 9 facility types \1\.
----------------------------------------------------------------------------------------------------------------
\1\ Calculation based on mean sample size of 39 and average FDA inspection time for each establishment type.
  Estimates will vary depending on number of regulated food establishments within a jurisdiction and the number
  of inspectors employed by the jurisdiction.

                                           Table 3--Verification Audit
----------------------------------------------------------------------------------------------------------------
                  Standard                                Recordkeeping activity               Hours per record
----------------------------------------------------------------------------------------------------------------
No. 9.......................................  Verification Audit (Appendices I & J) \1\.....               46.15
----------------------------------------------------------------------------------------------------------------
\1\ We estimate that no more than 50% of time spent to complete self assessment of all 9 Standards is spent
  completing verification audit worksheets. Time will be considerably less if less than 9 standards require
  verification audits.

    Thus, FDA estimates the recordkeeping burden for this collection of
information as follows:

                                                   Table 4--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average burden
                    FDA Worksheets \2\                         Number of      Number of records     Total annual    per recordkeeping     Total hours
                                                             recordkeepers     per recordkeeper       records           (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Appendices A-J...........................................                500                  1                500              94.29             47,145
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................             47,145
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Or comparable documentation.

    FDA bases its estimates of the number of recordkeepers and the
hours per record on its experience with the Program Standards over the
past 3 years. FDA estimates that approximately 500 regulatory
jurisdictions will participate in the Program Standards. There are
approximately 3,000 jurisdictions in the United States and its
territories that have retail food regulatory programs. Enrollment in
the Program Standards is voluntary and, therefore, FDA does not expect
all jurisdictions to participate.
    FDA bases its estimate of the hours per record on the recordkeeping
estimates for the management tasks of self assessment, baseline data
collection, and verification audit (tables 1, 2, and 3 of this
document) that enrolled jurisdictions must perform, a total of 471.45
hours (92.3 + 333 + 46.15 = 471.45). As noted, based on its experience
with the Program Standards over the past 3 years, FDA has reduced its
estimate of the number of recordkeeping hours that enrolled
jurisdictions will perform annually to 94.29, from the previously
estimated 157 hours per record in 2008. FDA estimates that, annually,
500 recordkeepers will spend 94.29 hours performing the required
recordkeeping for a total of 47,145 hours.

Reporting

    FDA requires regulatory jurisdictions that participate in the
Program Standards to submit two forms annually: Form FDA 3519, ``FDA
National Registry Report,'' and Form FDA 3520, ``Permission to Publish
in National Registry.'' Form FDA 3519 requires the name and address of
the jurisdiction; completion dates for the self assessment, baseline
survey (original and update), and verification audit; names of the
person(s) who completed the self-assessment, verification audit,
baseline survey, baseline survey update, and action plan; signature of
the program manager; and date the form was completed. Form FDA 3520
requires the name of the jurisdiction, completion date of the self
assessment, date of the verification audit report, name of the auditor,
signature and title of the official completing the form, and date the
form was completed.
    The reporting burden in table 5 of this document includes only the
time necessary to fill out and send the forms, as compiling the
underlying information (including self-assessment reports, baseline
surveys, outside audits, and supporting documentation) is accounted for
under the recordkeeping estimates in table 1 of this document.
    FDA estimates the reporting burden for this collection of
information as follows:

                                                     Table 5--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                           Average burden
                       Form FDA No.                            Number of        responses per       Total annual     per response (in     Total hours
                                                              respondents         respondent        respondents         Hours) \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
3519.....................................................                500                  1                500               1/60                 50
3520.....................................................                500                  1                500               1/60                 50
CFP Training Plan and Log................................                500                  3              1,500               1/60                150
    Total................................................  .................  .................  .................  .................                250
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in the format ``[number of minutes per response]/60''.

    FDA bases its estimates of the number of respondents and the hours
per response on its experience with the Program Standards over the past
3 years. As explained previously in this document, FDA estimates that
500 regulatory jurisdictions will enroll in the Program Standards. FDA
estimates a total of 12 minutes annually for each enrolled jurisdiction
to complete both forms. FDA bases its estimate on the small number of
data elements on the two forms and the ease of availability of the
information. FDA estimates that, annually, 500 regulatory jurisdictions
will submit one Form FDA 3519 for a total of 500 annual responses. Each
submission is estimated to take 0.1 hour per response for a total of 50
hours. FDA estimates that, annually, 500 regulatory jurisdictions will
submit one Form FDA 3520 for a total of 500 annual responses. Each of
these submissions is estimated to take 0.1 hour per response for a
total of 50 hours. FDA estimates that, annually, 500 regulatory
jurisdictions will submit three requests for documentation of
successful completion of staff training using the CFP Training Plan and
Log for a total of 1,500 annual responses. Each submission is estimated
to take 0.1 hour per response for a total of 150 hours. Thus, the total
reporting burden for this information collection is 250 hours.

    Dated: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7191 Filed 3-25-11; 8:45 am]
BILLING CODE 4160-01-P


December 16, 2003 Mr. Ronald W. Gore Chief, Air Quality Division Department of Environmental Management P. O. Box 301463 Montgomery, AL 36130 7861 Dear Mr. Gore:

I am writing to update you on the status of our work to repropose the best available retrofit technology ( BART) provisions of the Regional Haze Rule, to outline the planned schedule, and to encourage you to move forward with planning for implementation of BART. I also want to thank you for the work you have done to this point, especially gathering and submitting preliminary data on the BART source population.

As you may know, on May 24, 2002, the U. S. Court of Appeals for the D. C. Circuit issued a decision in American Corn Growers et al. v. EPA 291 F. 3d 1 ( D. C. Cir. 2002) that invalidated part of our Regional Haze Rule. As a result, we are reproposing both that portion of the Regional Haze Rule and the proposed guidelines for BART determinations ( Proposed Guidelines for Best Available Retrofit Technology Determinations Under the Regional Haze Regulations, 66 FR 38108, July 20, 2001).

We have recently published a proposed consent decree establishing a schedule for action on the BART rule provisions and guidelines. If finalized, the consent decree would require us to publish a proposed rulemaking package addressing these issues in the Federal Register by April 15, 2004. The proposal will include issues in the Regional Haze Rule and the BART guidelines. We intend to publish the final rulemaking package in the Federal Register by April 2005. We have accelerated the schedule for this rulemaking as much as possible.

Our rulemaking effort will address concerns that the Court raised about the cumulative nature of the air quality analysis necessary both to determine which of a States's or Tribe's BART eligible sources should be subject to a BART review and to evaluate the degree of visibility improvement from individual sources that potential BART controls would provide. It will also address the Court's concern that we did not include a mechanism by which States could exempt individual sources from BART determinations.

The Court did not remand any portion of the process for determining which sources are BART eligible. Therefore, we do not intend to make significant changes to the source identification process laid out in Section II ( How to Identify BART Eligible Sources) of the proposed BART guidelines. Thus, you should continue to work on the important step of 2 identifying BART eligible sources. In addition, once you have identified BART eligible sources, you should begin both the process of determining which BART eligible sources will be subject to BART, as well as the process of identifying available retrofit control measures and their costs.

More specifically, I encourage you to proceed with the following steps:

( 1) Identify BART eligible sources: many States have already provided a draft list of BART eligible sources. Additional work may be necessary to produce a final list.

( 2) For each BART eligible source, begin the engineering analysis. You should identify the possible levels of control based on the best system of continuous emissions control technology taking into account the following factors:

 costs of compliance;  the energy and non air quality environmental impacts;  any pollution control equipment in use at the source;  the remaining useful life of the source; and The engineering analysis in a BART determination was not addressed by the Court. Therefore, I believe that it is appropriate for you to proceed with your engineering review for BART eligible sources. Specifically, for each source in each of the 26 possible source categories, you should begin to assess compliance costs, environmental impacts, in use control equipment, and remaining useful life of the source. Given that this review could take some time, I encourage you to begin this work now.

Thank you for your interest in this important matter, and for all of the good work that you have done and continue to do. If you have any questions, please contact Kathy Kaufman of my staff at ( 919) 541 0102 or Todd Hawes of my staff at ( 919) 541 5591.

Sincerely,

Lydia N. Wegman Director Air Quality Strategies and Standards Division cc: John Hornback 3 LETTERS SENT TO THE FOLLOWING:

Mr. Ron Gore Chief, Air Quality Division Alabama Dept. of Environmental Management P. O. Box 301463 Montgomery, AL 36130 1463 Telephone: ( 334) 271 7861 Fax: ( 334) 279 3044 E Mail: rwg@ adem. state. al. us Mr. Tom Chapple Director, Air & Water Quality Division Alaska Dept. of Environmental Conservation 555 Cordova Street Anchorage, AK 99501 Telephone: ( 907) 269 7508 Fax: ( 907) 269 3098 E Mail: tom_ chapple@ dec. state. ak. us Ms. Nancy Wrona Director, Air Quality Division Arizona Dept. of Environmental Quality 3033 North Central Avenue 5th Floor Phoenix, AZ 85012 Telephone: ( 602) 207 2308 Fax: ( 602) 207 2366 E mail: wrona. nancy@ ev. state. az. us Mr. Keith Michaels Chief, Air Division Arkansas Dept. of Environmental Quality 8001 National Drive, P. O. Box 8913 Little Rock, AR 72219 8913 Telephone: ( 501) 682 0730 Fax: ( 501) 682 0753 E mail: michaels@ adeq. state. ar. us Ms. Catherine Witherspoon Executive Officer California Air Resources Board 1001 I Street P. O. Box 2815 4 Sacramento, CA 95812 Telephone: ( 916) 445 4383 Fax: ( 916) 322 6003 E Mail: cwithers@ arb. ca. gov Ms. Margie Perkins Director, Air Pollution Control Division B 1 Colorado Dept. of Health and Environment 4300 Cherry Creek Drive South Denver, CO 80246 Telephone: ( 303) 692 3115 Fax: ( 303) 782 5493 E mail: margie. perkins@ state. co. us Ms. Anne Gobin InterimChief, Bureau of Air Management Connecticut Dept. of Environmental Protection 79 Elm Street Hartford, CT 06106 Telephone: ( 860) 424 3026 Fax: ( 860) 424 4063 E mail: gobin. anne@ po. state. ct. us Mr. Ali Mirzakhalili Administrator, Air Quality Management Section. Division of Air and Waste Mgmt Delaware Dept. of Natural Resources and Environmental Control 156 South State Street Dover, DE 19901 Telephone: ( 302) 739 4791 Fax: ( 302) 739 3106 E Mail: amirzakhali@ state. de. us Mr. Donald Wambsgans II Program Manager, Air Resources Management Division D. C. Department of Health 51 N Street, N. E. Washington, DC 20002 Telephone: ( 202) 535 2250 Fax: ( 202) 535 1371 E mail: don. wambsgans@ dc. gov Mr. Michael Cooke Director, Air Resources Management 5 Florida Dept. of Environmental Protection Mail Station 5500 2600 Blair Stone Road Tallahassee, FL 32399 2400 Telephone: ( 850) 488 0114 Fax: ( 850) 922 6979 E Mail: michael. cooke@ dep. state. fl. us Mr. Ronald Methier Chief, Air Protection Branch Environmental Protection Division Georgia Dept. of Natural Resources 4244 International Parkway Suite 120 Atlanta, GA 30354 3906 Telephone: ( 404) 363 7000 Fax: ( 404) 363 7100 E Mail: ron_ methier@ mail. dnr. state. ga. us Mr. Wilfred Nagamine Chief, Clean Air Branch Hawaii Dept. of Health 919 Ala Moana Blvd., Room 203 P. O. Box 3378 Honolulu, HI 96801 Telephone: ( 808) 586 4200 Fax: ( 808) 586 4359 E Mail: nmasuda@ emb. health. state. hi. us Mr. Martin Bauer Administrator, Air Quality Division Idaho Dept. of Environmental Quality 1410 North Hilton, 3rd Floor Boise, ID 83706 Telephone: ( 208) 373 0440 Fax: ( 208) 373 0154 E Mail: mbauer@ deq. state. id. us Mr. David Kolaz Chief, Bureau of Air Illinois Environmental Protection Agency 1021 North Grand Avenue East P. O. Box 19276 Springfield, IL 62794 9276 Telephone: ( 217) 785 4140 6 Fax: ( 217) 782 2465 E Mail: dkolaz@ epa. state. il. us Ms. Janet McCabe Assistant Commissioner, Office of Air Management Indiana Dept. of Environmental Management 100 N. Senate Avenue Indianapolis, IN 46206 6015 Telephone: ( 317) 232 5586 Fax: ( 317) 233 5917 E Mail: jmccabe@ dem. state. in. us Ms. Catharine Fitzsimmons Chief, Air Quality Bureau Iowa Dept. of Natural Resources 7900 Hickman Road, Suite 1 Urbandale, IA 50322 Telephone: ( 515) 281 8034 Fax: ( 515) 242 5094 E Mail: catharine. fitzsimmons@ dnr. state. ia. us Mr. Clark Duffy Director, Bureau of Air and Radiation Kansas Dept. of Health and Environment 1000 SW Jackson, Suite 400 Topeka, KS 66612 1367 Telephone: ( 785) 296 1551 Fax: ( 785) 296 1545 E Mail: cduffy@ kdhe. state. ks. us Mr. John Lyons Director, Division for Air Quality Kentucky Dept. for Environmental Protection 803 Schenkel Lane Frankfort, KY 40601 1403 Telephone: ( 502) 573 3382 Fax: ( 502) 573 3787 E Mail: john. lyons@ mail. state. ky. us Ms. Teri Lanoue Administrator, Office of Air Quality and Radiation Louisiana Dept. of Environmental Quality Protection 7290 Bluebonnet Blvd. P. O. Box 82135 Baton Rouge, LA 70884 7 Telephone: ( 225) 765 0256 Fax: ( 225) 765 0222 E Mail: teri_ l@ deq. state. la. us Mr. James Brooks Director, Bureau of Air Quality Maine Dept. of Environmental Protection 17 State House Station Augusta, ME 04333 Telephone: ( 207) 287 2437 Fax: ( 207) 287 7641 E Mail: james. p. brooks@ state. me. us Mr. Thomas Snyder Director, Air and Radiation Management Administration Maryland Dept. of the Environment 1800 Washington Blvd. Baltimore, MD 21230 Telephone: ( 410) 537 3255 Fax: ( 410) 537 3391 E Mail: tsnyder@ mde. state. md. us Ms. Nancy Seidman Director, Bureau of Waste Prevention Massachusetts Dept. of Environmental Protection One Winter Street, 7th Floor Boston, MA 02108 Telephone: ( 617) 292 5500 Fax: ( 617) 292 5858 E Mail: nancy. seidman@ state. ma. us Mr. G. Vinson Hellwig Chief, Air Quality Division Michigan Dept. of Environmental Quality 525 West Allegan Street Constitution Hall, 3rd Floor North P. O. Box 30260 Lansing, MI 48909 7760 Telephone: ( 517) 373 7069 Fax: ( 517) 335 6993 E Mail: hellwigv@ michigan. gov Mr. David Thornton Manager, Policy and Planning Division Minnesota Pollution Control Agency 8 520 Lafayette Road St. Paul, MN 55155 Telephone: ( 651) 296 7265 Fax: ( 651) 297 8676 E Mail: david. thornton@ pca. state. mn. us Mr. Dwight Wylie Chief, Air Division Office of Pollution Control Mississippi Dept. of Environmental Quality P. O. Box 10385 Jackson, MS 39289 0385 Telephone: ( 601) 961 5587 Fax: ( 601) 961 5742 E Mail: Dwight_ wylie@ deq. state. ms. us Ms. Leanne Tippett Director, Air Pollution Control Program Division of Environmental Quality Missouri Dept. of Natural Resources P. O. Box 176 Jefferson City, MO 65102 Telephone: ( 573) 751 4817 Fax: ( 573) 751 2706 E Mail: nrwilst@ mail. dnr. state. mo. us Mr. Don Vidrine Chief, Air and Waste Management Bureau Montana Dept. of Environmental Quality 1520 E. Sixth Avenue P. O. Box 200901 Helena, MT 59620 0901 Telephone: ( 406) 444 2467 Fax: ( 406) 444 1499 E Mail: dvidrine@ state. mt. gov Ms. Shelley Kaderly Director, Air Quality Division Nebraska Dept. of Environmental Quality 1200 N Street, Suite 400 P. O. Box 98922 Lincoln, NE 68509 8922 Telephone: ( 402) 471 4299 Fax: ( 402) 471 2909 E Mail: shelley. kaderly@ ndeq. state. ne. us 9 Ms. Colleen Cripps Chief, Bureau of Air Quality Nevada Division of Environmental Protection 123 West Nye Lane, Room 69 Carson City, NV 89706 Telephone: ( 775) 687 4670, ext. 3065 Fax: ( 775) 687 6396 E Mail: ccripps@ govmail. state. nv. us Mr. Robert Scott Director, Air Resources Division New Hampshire Dept. of Environmental Services 6 Hazen Drive Concord, NH 03301 Telephone: ( 603) 271 1370 Fax: ( 603) 271 1381 E Mail: rscott@ des. state. nh. us Mr. Bill O'Sullivan Director, Office of Air Quality Management New Jersey Dept. of Environmental Protection P. O. Box 418 701 East State Street, 7th Floor West Trenton, NJ 08625 Telephone: ( 609) 984 1484 Fax: ( 609) 777 6369 E Mail:

Ms. Sandra Ely Chief, Air Quality Bureau New Mexico Environmental Protection Division 2048 Galisteo Street Santa Fe, NM 87505 Telephone: ( 505) 827 1494 Fax: ( 505) 827 1523 E Mail: sandra_ ely@ nmenv. state. nm. us Mr. David J. Shaw Acting Director, Division of Air Resources New York Dept. of Environmental Conservation 625 Broadway Albany, NY 12233 3250 Telephone: ( 518) 402 8452 Fax: ( 518) 402 9035 10 E Mail:

Mr. Keith Overcash Director, Division of Air Quality North Carolina Dept. of Environment and Natural Resources 1641 Mail Service Center Raleigh, NC 27699 1641 Telephone: ( 919) 733 3340 Fax: ( 919) 715 7175 E Mail: keith. overcash@ ncmail. net Mr. Terry O'Clair Director, Division of Air Quality North Dakota Dept. of Health 1200 Missouri Avenue, Room 304 Bismarck, ND 58506 Telephone: ( 701) 328 5188 Fax: ( 701) 328 5200 E Mail: toclair@ state. nd. us Mr. Bob Hodanbosi Chief, Division of Air Pollution Control Ohio Environmental Protection Agency 122 South Front Street P. O. Box 1049 Columbus, OH 43216 Telephone: ( 614) 644 2310 Fax: ( 614) 644 3681 E Mail: bob. hodanbosi@ epa. state. oh. us Mr. Eddie Terrill Director, Air Quality Division Oklahoma Dept. of Environmental Quality 707 North Robinson P. O. Box 1677 Oklahoma City, OK 73101 1677 Telephone: ( 405) 702 4156 Fax: ( 405) 702 4101 E Mail: eddie. terrill@ deq. state. ok. us Mr. Andy Ginsburg Administrator, Air Quality Division Oregon Dept. of Environmental Quality 811 SW 6th Avenue, 11th Floor Portland, OR 97204 11 Telephone: ( 503) 229 5359 Fax: ( 503) 229 5675 E Mail: ginsburg. andy@ deq. state. or. us Ms. Joyce Epps Director, Bureau of Air Quality Pennsylvania Dept. of Environmental Protection 400 Market Street, 12th Floor P. O. Box 8468 Harrisburg, PA 17105 Telephone: ( 717) 787 9702 Fax: ( 717) 772 3414 E Mail: jepps@ state. pa. us Mr. Stephen Majkut Chief, Division of Air Resources Rhode Island Dept. of Environmental Management 235 Promenade Street Providence, RI 02908 Telephone: ( 401) 222 2808 Fax: ( 401) 222 2017 E Mail: smajkut@ dem. state. ri. us Mr. James Joy Chief, Bureau of Air Quality South Carolina Dept. of Health and Environmental Control 2600 Bull Street Columbia, SC 29201 1797 Telephone: ( 803) 898 4123 Fax: ( 803) 898 4117 E Mail: joyja@ dhec. sc. gov Mr. Brian Gustafson Administrator, Air Program South Dakota Dept. of Water and Natural Resources 523 E. Capitol Avenue Pierre, SD 57501 Telephone: ( 605) 773 3151 Fax: ( 605) 773 4068 Mr. Barry Stephens Director, Division of Air Pollution Control Tennessee Dept. of Environment and Conservation 401 Church Street, 9th Floor 12 L & C Annex Nashville, TN 37243 1531 Telephone: ( 615) 532 0554 Fax: ( 615) 532 0614 E Mail: barry. stephens@ state. tn. us Mr. Herb Williams Director, Policy and Regulations Division ( MC 205) OEPA, Texas Commission on Environmental Quality 12100 Park 35 Circle P. O. Box 13087 Austin, TX 78753 Telephone: ( 512) 239 5588 Fax: ( 512) 239 4808 E Mail: hwilliam@ tnrcc. state. tx. us Mr. Rick Sprott Director, Division of Air Quality Utah Dept. of Environmental Quality 150 North 1950 West Salt Lake City, UT 84114 Telephone: ( 801) 536 0072 Fax: ( 801) 536 0085 E Mail: rsprott@ utah. gov Mr. Dick Valentinetti Director, Air Pollution Control Division Vermont Dept. of Environmental Quality 103 South Main Street Building 3 South Waterbury, VT 05671 Telephone: ( 802) 241 3840 Fax: ( 802) 241 2590 E Mail: dickv@ dec. anr. state. vt. us Mr. John Daniel Director, Air Division Virginia Dept. of Environmental Quality P. O. Box 10009 Richmond, VA 23240 Telephone: ( 804) 698 4311 Fax: ( 804) 698 4510 Contact: John Daniel, Director E Mail: jmdaniel@ deq. state. va. us 13 Ms. Mary Burg Director, Air Quality Program Washington Dept. of Ecology 300 Desmond Drive P. O. Box 47600 Olympia, WA 98504 Telephone: ( 360) 407 6880 Fax: ( 360) 407 6802 E Mail: mbur461@ ecy. wa. gov Mr. John Benedict Director, Office of Air Quality West Virginia Dept. of Environmental Protection 7012 MacCorkle Avenue, SE Charleston, WV 25304 Telephone: ( 304) 926 3647 Fax: ( 304) 926 3637 E Mail: jbenedict@ mail. dep. state. wv. us Ms. Lloyd Eagan Director, Bureau of Air Management Wisconsin Dept. of Natural Resources 101 S. Webster Street P. O. Box 7921 AM/ 7 Madison, WI 53707 Telephone: ( 608) 266 0603 Fax: ( 608) 267 0560 E Mail: eaganl@ dnr. state. wi. us Mr. Dan Olson Director, Air Quality Division Wyoming Dept. of Environmental Quality 122 West 25th Street Cheyenne, WY 82002 Telephone: ( 307) 777 7391 Fax: ( 307) 777 5616 E Mail: dolson@ missc. state. wy. us


[Federal Register Volume 86, Number 231 (Monday, December 6, 2021)]
[Rules and Regulations]
[Pages 68905-68907]
[FR Doc No: 2021-26365]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0546; Project Identifier MCAI-2021-00387-P;
Amendment 39-21815; AD 2021-23-17]
RIN 2120-AA64

Airworthiness Directives; Hoffmann GmbH & Co. KG Propellers

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2020-25-05
for all Hoffmann GmbH & Co. KG (Hoffmann) model HO-V 72 propellers. AD
2020-25-05 required amending the existing aircraft flight manual (AFM)
with abnormal propeller vibration instructions. AD 2020-25-05 also
required visual inspection and non-destructive test (NDT) inspection of
the propeller hub and, depending on the results of the inspections,
replacement of the propeller hub with a part eligible for installation.
AD 2020-25-05 also required replacement of the propeller hub before
exceeding 30 years since the date of manufacture. This AD was prompted
by reports of cracks at different positions on two affected propeller
hubs and subsequent manufacturer revision of the service information,
which showed that the 30-year life limit of the propeller hub is no
longer needed. This AD requires amending the existing AFM by inserting
abnormal propeller vibration instructions, visual inspection and NDT
inspection of the propeller hub and, depending on the results of the
inspections, replacement of the propeller hub with a part eligible for
installation. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective January 10, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 10,
2022.

ADDRESSES: For service information identified in this final rule,
contact Hoffmann GmbH & Co. KG, K[uuml]pferlingstrasse 9, 83022,
Rosenheim, Germany; phone: +49 0 8031 1878 0; email: prop.com">[email protected]prop.com; website: prop.com">https://hoffmann-prop.com. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 1200 District Avenue, Burlington, MA 01803. For
information on the availability of this material at the FAA, call (781)
238-7759. It is also available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0546.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0546; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, the mandatory
continuing airworthiness information (MCAI), any comments received, and
other information. The address for Docket Operations is Document
Operations, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2020-25-05, Amendment 39-21347 (85 FR
78702, December 7, 2020), (AD 2020-25-05). AD 2020-25-05 applied to all
Hoffmann model HO-V 72 propellers. The NPRM published in the Federal
Register on July 6, 2021 (86 FR 35416). The NPRM was prompted by
reports of cracks at different positions on two affected propeller hubs
and subsequent manufacturer revision of the service information, which
showed that the 30-year life limit of the propeller hub is no longer
needed. In the NPRM, the FAA proposed to continue to require amending
the existing AFM with abnormal propeller vibration instructions. In the
NPRM, the FAA also proposed to continue to require visual inspection
and NDT inspection of the propeller hub and, depending on the results
of the inspections, replacement of the propeller hub with a part
eligible for installation. The FAA is issuing this AD to address the
unsafe condition on these products.
    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, has
issued EASA AD 2020-0226R1, dated March 31, 2021

(referred to after this as ``the MCAI''), to address the unsafe
condition on these products. The MCAI states:

    Cracks have been reported at different positions on two affected
parts, both installed on Slingsby T67 ``Firefly'' aeroplanes. One
crack was found during scheduled inspection, the other crack during
an unscheduled inspection after abnormal vibrations occurred. Both
cases are under investigation by Hoffmann Propeller.
    This condition, if not detected and corrected, could lead to in-
flight propeller detachment, possibly resulting in damage to the
airplane and/or injury to persons on the ground.
    To address this potential unsafe condition, Hoffmann issued the
SB, providing applicable instructions.
    For the reasons described above, EASA issued Emergency AD 2020-
0226-E to require inspections of affected parts and, depending on
findings, replacement, and introduces a life limit for affected
parts. That [EASA] AD also required, for certain aeroplanes,
amendment of the applicable Aircraft Flight Manual (AFM).
    Since that [EASA] AD was issued, recent analyses of inspection
results showed that the life limit of 30 years is no longer
necessary and Hoffmann Propeller issued Revision D of the SB
accordingly.
    This [EASA] AD is revised to delete the life limit and to
introduce a clarification for corrective action(s) during overhaul
in paragraph (6) [of EASA AD].

    You may obtain further information by examining the MCAI in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0546.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from one individual commenter. The
individual commenter supported the NPRM without change.

Clarification of Required Actions

    The FAA revised paragraph (g), Required Actions, of this AD by
clarifying that the propeller hub must be replaced with a part eligible
for installation if any crack is detected during an overhaul
inspection.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety requires adopting the AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. This AD is adopted as proposed in the
NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Hoffmann Propeller GmbH & Co. KG Service Bulletin
SB E53, Rev. D, dated February 18, 2021. The service bulletin describes
procedures for visual and NDT inspections of the propeller hub for
cracks. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in ADDRESSES.

Costs of Compliance

    The FAA estimates that this AD affects 35 propellers installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Amend AFM.............................  1 work-hour x $85 per                 $0             $85          $2,975
                                         hour = $85.
Visually inspect propeller hub........  1 work-hour x $85 per                  0              85           2,975
                                         hour = $85.
NDT inspect propeller hub.............  8 work-hours x $85 per                 0             680          23,800
                                         hour = $680.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary
replacements that would be required based on the results of the
mandated inspections. The FAA has no way of determining the number of
aircraft that might need this replacement:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Replace propeller hub.........................  5 work-hours x $85 per hour =             $1,600          $2,025
                                                 $425.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive 2020-25-05, Amendment 39-21347 (85
FR 78702, December 7, 2020); and
0
b. Adding the following new airworthiness directive:

2021-23-17 Hoffmann GmbH & Co. KG: Amendment 39-21815; Docket No.
FAA-2021-0546; Project Identifier MCAI-2021-00387-P.

(a) Effective Date

    This airworthiness directive (AD) is effective January 10, 2022.

(b) Affected ADs

    This AD replaces AD 2020-25-05, Amendment 39-21347 (85 FR 78702,
December 7, 2020).

(c) Applicability

    This AD applies to all Hoffmann GmbH & Co. KG model HO-V 72
propellers.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6114, Propeller Hub
Section.

(e) Unsafe Condition

    This AD was prompted by reports of cracks at different positions
on two affected propeller hubs. The FAA is issuing this AD to
prevent failure of the propeller hub. The unsafe condition, if not
addressed, could result in release of the propeller, damage to the
airplane, and injury to persons on the ground.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    (1) Before the next flight after December 22, 2020 (the
effective date of AD 2020-25-05), amend the existing aircraft flight
manual by inserting the procedure: ``Abnormal propeller vibrations:
As applicable, reduce engine RPM.''
    (2) Before the next flight after the effective date of this AD,
and thereafter, before the next flight after any flight where
abnormal propeller vibrations have been experienced, visually
inspect propeller hub HO-V 72 ( ) ( )-( )-( ) for cracks using
paragraph 2.1 of Hoffmann Propeller GmbH & Co. KG Service Bulletin
SB E53, Rev. D, dated February 18, 2021 (the SB).
    (3) Within 20 flight hours after the effective date of this AD,
perform a non-destructive test (NDT) inspection of propeller hub HO-
V 72 ( ) ( )-( )-( ) using paragraph 2.3 of the SB.
    (4) During each overhaul of propeller hub HO-V 72 ( ) ( )-( )-(
) after the effective date of this AD, perform an NDT inspection
using paragraph 2.3 of the SB.
    (5) If, during any inspection required by paragraph (g)(2), (3),
or (4) of this AD, any crack is detected, replace propeller hub HO-V
72 ( ) ( )-( )-( ) with a part eligible for installation.

(h) Definition

    For the purpose of this AD, a ``part eligible for installation''
is a propeller hub HO-V 72 ( ) ( )-( )-( ) with zero hours time
since new or a propeller hub HO-V 72 ( ) ( )-( )-( ) that has passed
an NDT inspection using paragraph 2.3 of the SB.

(i) Non-Required Actions

    (1) Sending the propeller to Hoffmann for investigation, as
contained in paragraph 2.1 of the SB, is not required by this AD.
    (2) Reporting propeller hubs with cracks to Hoffmann, as
contained in paragraph 2.3 of the SB, is not required by this AD.

(j) Credit for Previous Actions

    You may take credit for the initial visual inspection and NDT
inspection of the propeller hub required by paragraphs (g)(2), (3),
and (4) of this AD if you performed any of these actions before the
effective date of this AD using Hoffmann Propeller GmbH & Co. KG SB
E53, Rev. A, dated October 9, 2020; Rev. B, dated October 14, 2020;
or Rev. C, dated December 9, 2020.

(k) Special Flight Permit

    A special flight permit may be issued in accordance with 14 CFR
21.197 and 21.199 to operate the airplane to a service facility to
perform the NDT inspection. Special flight permits are prohibited to
perform the visual inspection of the propeller hub.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (m)(1) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    (1) For more information about this AD, contact Michael Schwetz,
Aviation Safety Engineer, Boston ACO Branch, FAA, 1200 District
Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: (781) 238-
7199; email: [email protected].
    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2020-0226R1, dated March 31, 2021, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0546.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Hoffmann Propeller GmbH & Co. KG (Hoffmann) Service Bulletin
SB E53, Rev. D, dated February 18, 2021.
    (ii) [Reserved]
    (3) For Hoffmann service information identified in this AD,
contact Hoffmann GmbH & Co. KG, K[uuml]pferlingstrasse 9, 83022,
Rosenheim, Germany; phone: +49 0 8031 1878 0; email: prop.com">[email protected]prop.com; website: prop.com">https://hoffmann-prop.com.
    (4) You may view this service information at FAA, Airworthiness
Products Section, Operational Safety Branch, 1200 District Avenue,
Burlington, MA 01803. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 4, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-26365 Filed 12-3-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: February 9, 2010 (Volume 75, Number 26)]
[Notices]
[Page 6386-6387]
[DOCID:fr09fe10-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0832; FRL-8810-5]

Pesticide Products; Registration Applications for a New Active
Ingredient Chemical; Demiditraz

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has received applications to register pesticide products
containing active ingredients not included in any previously registered
pesticide products. Pursuant to the provisions of section 3(c)(4) of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is
hereby providing notice of receipt and opportunity to comment on these
applications.

DATES: Comments must be received on or before March 11, 2010.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0832, 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 Facility'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>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0832. EPA's policy is that all comments

received will be included in the docket without change and may be made
available on-line at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., 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 either 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 hours of
operation of this Docket Facility are 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: BeWanda Alexander, Registration
Division (7505P), Office of Pesticide Programs, 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. 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 e-mail. 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.

II. Registration Applications

    EPA has received applications to register pesticide products
containing active ingredients not included in any previously registered
pesticide products. Pursuant to the provisions of section 3(c)(4) of
FIFRA, EPA is hereby providing notice of receipt and opportunity to
comment on these applications. Notice of receipt of these applications
does not imply a decision by the Agency on these applications.
    1. File Symbol: 1007-OL. Applicant: Pfizer, Inc., 7000 Portage Rd.,
KZO 300-403 SW., Kalamazoo, MI 49001. Product name: Demiditraz
Technical. Active ingredient: Insecticide and Demiditraz at 100%.
Proposed classification/Use: None.
     2. File Symbol: 1007-OA. Applicant: Pfizer, Inc., 7000 Portage
Rd., KZO 300-403 SW., Kalamazoo, MI 49001. Product name: CA Acaricide.
Active ingredient: Insecticide and Demiditraz at 17.5%. Proposed
classification/Use: Spot on treatment for dogs.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: January 28, 2010.
 Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2010-2826 Filed 2-8-10; 8:45 am]
BILLING CODE 6560-50-S