[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45828-45834]
[FR Doc No: 2019-18820]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2016-0065]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Request for
Comment; Defect and Noncompliance Reporting and Notification

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted below is being forwarded to the Office of Management and
Budget (OMB) for review and comment. The ICR describes the nature of
the information collections and their expected burden. The Federal
Register Notice with a 60-day comment period was published on June 12,
2019.

DATES: Comments must be submitted to OMB on or before September 30,
2019.

ADDRESSES: Send comments to the Office of Information and Regulatory
Affairs, OMB, Attention: NHTSA Desk Officer, 725 17th Street NW,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Stephen Hench, Office of Chief Counsel
(NCC-0100), Room W41-229, NHTSA, 1200 New Jersey Avenue SE, Washington,
DC 20590. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. OMB has promulgated regulations describing what must be
included in such a document. Under OMB's regulation, see 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) 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) 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) How to enhance the quality, utility, and clarity of the
information to be collected; and
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including 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.
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Defect and Noncompliance Reporting and Notification.
    Type of Request: Renewal of a currently approved information
collection.
    Type of Review Requested: Regular.
    OMB Control Number: 2127-0004.
    Affected Public: Businesses or individuals.
    Abstract: The 60-day notice for this information collection
received two (2) comments. One of those comments appears to have been
placed on the incorrect docket. The other comment received was
submitted by The Alliance of Automobile Manufacturers (Alliance). The
Alliance offered comments on the scope of, and burdens associated with,
the collection as it relates to the Takata Coordinated Remedy Program.
A summary of these comments is below with the corresponding burden
estimates, along with the agency's response.
    This collection covers the information collection requirements
found within various statutory provisions of the Motor Vehicle Safety
Act of 1966 (Act), 49 U.S.C. 30101, et seq., that address and require
manufacturer notifications to NHTSA of safety-related defects and
failures to comply with Federal Motor Vehicle Safety Standards (FMVSS)
in motor vehicles and motor vehicle equipment, as well as the provision
of particular information related to the ensuing owner and dealer
notifications and free remedy campaigns that follow those
notifications. The sections of the Act imposing these requirements
include 49 U.S.C. 30118, 30119, 30120, and 30166. Many of these
requirements are implemented through, and addressed with more
specificity in, 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports (part 573) and 49 CFR 577, Defect and
Noncompliance Notification (part 577).
    Pursuant to the Act, motor vehicle and motor vehicle equipment
manufacturers are obligated to notify, and then provide various
information and documents to, NHTSA in the event a safety defect or
noncompliance with FMVSS is identified in products they manufactured.
See 49 U.S.C. 30118(b) and 49 CFR 573.6. Manufacturers are further
required to notify owners, purchasers, dealers, and distributors about
the safety defect or noncompliance. See 49 U.S.C. 30118(b), 30120(a);
49 CFR 577.7, 577.13. Manufacturers are required to provide to NHTSA
copies of communications pertaining to recall campaigns that they issue
to owners, purchasers, dealers, and distributors. See 49 U.S.C.
30166(f); 49 CFR 573.6(c)(10).
    Manufacturers are also required to file with NHTSA a plan
explaining how they intend to reimburse owners and purchasers who paid
to have their products remedied before being notified of the safety
defect or noncompliance, and explain that plan in the notifications
they issue to owners and purchasers about the safety defect or
noncompliance. See 49 U.S.C. 30120(d) and 49 CFR 573.13. Manufacturers
are further required to keep lists of the respective owners,
purchasers, dealers, distributors, lessors, and lessees of the products
determined to be defective or noncompliant and involved in a recall
campaign, and are required to provide NHTSA with a minimum of six
quarterly reports reporting on the progress of their recall campaigns.
See 49 CFR 573.8 and 573.7, respectively.
    The Act and Part 573 also contain numerous information collection
requirements specific to tire recall and remedy campaigns. These
requirements relate to the proper disposal of recalled tires, including
a requirement that the manufacturer conducting the tire recall submit a
plan and provide specific instructions to certain persons (such as
dealers and distributors) addressing that disposal, and a requirement
that those persons report back to the manufacturer certain deviations
from the plan. See 49 U.S.C. 30120(d) and 49 CFR 573.6(c)(9). The
regulations also require that manufacturers report to NHTSA intentional
and knowing sales or leases of defective or noncompliant tires.
    49 U.S.C. 30166(n) and its implementing regulation found at 49 CFR
573.10 mandate that anyone who knowingly and willfully sells or leases
for use on a motor vehicle a defective tire or a tire that is not
compliant with FMVSS, and with actual knowledge that the tire
manufacturer has notified its dealers of the defect or noncompliance as
required under the Act, is required to report that sale or lease to
NHTSA no more than five working days after the person to whom the tire
was sold or leased takes possession of it.
    Pursuant to its safety authorities, NHTSA is continuing its
oversight of recalls of unprecedented complexity involving Takata air
bag inflators.\1\ Under the Coordinated Remedy Program established to
address this major issue, and the associated Coordinated Remedy Order
as amended on December 9, 2016 (the ``ACRO''), manufacturers issue
supplemental owner communications utilizing non-traditional means.\2\
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    \1\ See generally ``Takata Recall Spotlight,'' https://www.nhtsa.gov/equipment/takata-recall-spotlight.
    \2\ See generally ``Notice of Coordinated Remedy Program
Proceeding for the Replacement of Certain Takata Air Bag Inflator,''
available at https://www.regulations.gov/docket?D=NHTSA-2015-0055.
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    Estimated Burden: NHTSA previously estimated an annual burden of
36,070 hours associated with this collection (of which 456 hours was
contemplated for conducting supplemental recall communications under
administrative order to achieve completion of the Takata recalls),
$155,450,329 (of which $27,836,329 is contemplated for conducting
supplemental recall communications under administrative order to
achieve completion of the Takata recalls), and 274 respondents per year
(19 vehicle manufacturers conducting supplemental recall communications
under administrative order to achieve completion of the Takata
recalls).\3\ Our prior estimates of the burden hours and cost
associated with the requirements currently covered by this information
collection require adjustment as follows.
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    \3\ See 82 FR 60789, 60790 (December 22, 2017).
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    Based on current information, we estimate 249 distinct
manufacturers filing an average of 988 Part 573 Safety Recall Reports
each year. This is a change from our previous estimate of 963 Part 573
Safety Recall Reports filed by 274 manufacturers each year. In
addition, with reference to the metric associated with NHTSA's Vehicle
Identification Number (VIN) Look-up Tool regulation, see 49 CFR 573.15,
we continue to estimate it takes the 17 major passenger-vehicle
manufacturers (those that produce more than 25,000 vehicles annually)
additional burden hours to complete these Reports to NHTSA, as explored
in more detail below. See 82 FR 60789 (December 22, 2017). Between 2015
and 2018, the major passenger-vehicle manufacturers conducted an
average of 316 recalls annually.
    We continue to estimate that maintenance of the required owner,
purchaser, dealer, and distributors lists requires 8 hours a year per
manufacturer. We also continue to

estimate it takes a major passenger-vehicle manufacturer 40 hours to
complete each notification report to NHTSA, and it takes all other
manufacturers 4 hours. Accordingly, we estimate the annual burden hours
related to the reporting to NHTSA of a safety defect or noncompliance
for the 17 major passenger vehicle-manufacturers to be 12,640 hours
annually (316 notices x 40 hours/report), and that all other
manufacturers require a total of 2,688 hours annually (672 notices x 4
hours/report) to file their notices. Thus, the estimated annual burden
hours related to the reporting to NHTSA of a safety defect or
noncompliance is 17,320 hours (12,640 hours + 2,688 hours) + (249 MFRs
x 8 hours to maintain purchaser lists).\4\
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    \4\ For more information about how we derived these and certain
other estimates, please see 81 FR 70269 (October 11, 2016).
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    We continue to estimate that an additional 40 hours will be needed
to account for major passenger-vehicle manufacturers adding details to
Part 573 Safety Recall Reports relating to the intended schedule for
notifying its dealers and distributors, and tailoring its notifications
to dealers and distributors in accordance with the requirements of 49
CFR 577.13. An additional 2 hours will be needed to account for this
obligation in other manufacturers' Safety Recall Reports. This burden
is estimated at 13,984 hours annually (672 notices x 2 hours/
notification) + (316 notices x 40 hours/notification).
    49 U.S.C. 30166(f) requires manufacturers to provide to the Agency
copies of all communications regarding defects and noncompliances sent
to owners, purchasers, and dealerships. Manufacturers must index these
communications by the year, make, and model of the vehicle as well as
provide a concise summary of the subject of the communication. We
continue to estimate this burden requires 3 hours for each vehicle
recall for the 17 major passenger-vehicle manufacturers, and 30 minutes
for all other manufacturers for each vehicle recall. This totals an
estimated 1,284 hours annually (316 recalls x 3 hours for the 17 major
passenger-vehicle manufacturers) + (672 recalls x .5 for all other
manufacturers).
    In the event a manufacturer supplied the defective or noncompliant
product to independent dealers through independent distributors, that
manufacturer is required to include in its notifications to those
distributors an instruction that the distributors are then to provide
copies of the manufacturer's notification of the defect or
noncompliance to all known distributors or retail outlets further down
the distribution chain within five working days. See 49 CFR
577.7(c)(2)(iv). As a practical matter, this requirement would only
apply to equipment manufacturers, since vehicle manufacturers generally
sell and lease vehicles through a dealer network, and not through
independent distributors. We believe our previous estimate of 87
equipment recalls per year needs to be adjusted to 91 equipment recalls
per year to better reflect recent data. We have estimated the burden
associated with these notifications (identifying retail outlets, making
copies of the manufacturer's notice, and mailing) to be 5 hours per
recall campaign. Assuming an average of 3 distributors per equipment
item, which is a liberal estimate given that many equipment
manufacturers do not use independent distributors, the total number of
burden hours associated with this third-party notification requirement
is approximately 1,365 hours per year (91 recalls x 3 distributors x 5
hours).
    As for the burden linked with a manufacturer's preparation of and
notification concerning its reimbursement for pre-notification
remedies, we continue to estimate that the preparation of a
reimbursement plan takes approximately 4 hours annually. We also
continue to estimate that an additional 1.5 hours per year is spent by
the 17 major passenger-vehicle manufacturers adapting the plan to
particular defect and noncompliance notifications to NHTSA and adding
tailored language about the plan to a particular safety recall's owner
notification letters, while an additional .5 hours per year is spent on
this task by all other manufacturers. And we continue to estimate that
an additional 12 hours annually is spent disseminating plan
information, for a total of 4,794 annual burden hours ((249 MFRs x 4
hours to prepare plan) + (316 recalls x 1.5 hours tailoring plan for
each recall) + (672 recalls x .5 hours) + (249 MFRs x 12 hours to
disseminate plan information)).
    The Safety Act and 49 CFR part 573 also contain numerous
information collection requirements specific to tire recall and remedy
campaigns, as well as a statutory and regulatory reporting requirement
that anyone who knowingly and intentionally sells or leases a defective
or noncompliant tire notify NHTSA of that activity.
    Manufacturers are required to include specific information related
to tire disposal in the notifications they provide NHTSA concerning
identification of a safety defect or noncompliance with FMVSS in their
tires, as well as in the notifications they issue to their dealers or
other tire outlets participating in the recall campaign. See 49 CFR
573.6(c)(9). We believe our previous estimate of 12 tire recalls per
year needs to be adjusted to 11 tire recalls per year to better reflect
recent data. We continue to estimate that the inclusion of this
additional information will require an additional two hours of effort
beyond the subtotal above associated with non-tire recall campaigns.
This additional effort consists of one hour for the NHTSA notification
and one hour for the dealer notification for a total of 22 burden hours
(11 tire recalls a year x 2 hours per recall).
    Manufacturer-owned or controlled dealers are required to notify the
manufacturer and provide certain information should they deviate from
the manufacturer's disposal plan. Consistent with our previous
analysis, we continue to ascribe zero burden hours to this requirement
since to date no such reports have been provided, and our original
expectation that dealers would comply with manufacturers' plans has
proven accurate.
    Accordingly, we estimate 22 burden hours a year will be spent
complying with the tire recall campaign requirements found in 49 CFR
573.6(c)(9).
    The agency continues to estimate 1 burden hour annually will be
spent preparing and submitting reports of a defective or noncompliant
tire being intentionally sold or leased under 49 U.S.C. 30166(n) and
its implementing regulation at 49 CFR 573.10.
    We continue to expect that nine vehicle manufacturers, who did not
operate VIN-based recalls lookup systems prior to August 2013, incur
certain recurring burdens on an annual basis. We continue to estimate
that 100 burden hours will be spent on system and database
administrator support. These 100 burden hours include: Backup data
management and monitoring; database management, updates, and log
management; and data transfer, archiving, quality assurance, and
cleanup procedures. We continue to estimate another 100 burden hours
will be incurred on web/application developer support. These burdens
include: Operating system and security patch management; application/
web server management; and application server system and log files
management. We continue to estimate these burdens will total 1,800
hours each year (9 MFRs x 200 hours). We also continue to estimate the
recurring costs of these burden hours will be $30,000 per

manufacturer.\5\ Furthermore, we continue to estimate that the total
cost to the industry from these recurring expenses will total $270,000,
on an annual basis (9 MFRs x $30,000).
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    \5\ $8,000 (for data center hosting for the physical server) +
$12,000 (for system and database administrator support) + $10,000
(for web/application developer support) = $30,000.
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    Changes to 49 CFR part 573 in 2013 required 27 manufacturers to
update each recalled vehicle's repair status no less than every 7 days,
for 15 years from the date the VIN is known to be included in the
recall. This ongoing requirement to update the status of a VIN for 15
years continues to add a recurring burden on top of the one-time burden
to implement and operate these online search tools. We continue to
estimate that 8 affected motorcycle manufacturers will make recalled
VINs available for an average of 2 recalls each year and 19 affected
passenger-vehicle manufacturers will make recalled VINs available for
an average of 8 recalls each year. We believe it will take no more than
1 hour, and potentially less with automated systems, to update the VIN
status of vehicles that have been remedied under the manufacturer's
remedy program. We continue to estimate this will require 8,736 burden
hours per year (1 hour x 2 recalls x 52 weeks x 8 MFRs + 1 hour x 8
recalls x 52 weeks x 19 MFRs) to support the requirement to update the
recalls completion status of each VIN in a recall at least weekly for
15 years.
    As the number of Part 573 Recall Reports has increased in recent
years, so has the number of quarterly reports that track the completion
of safety recalls. Our previous estimate of 4,498 quarterly reports
received annually is now revised upwards to 5,512 quarter reports
received annually. We continue to estimate it takes manufacturers 1
hour to gather the pertinent information for each quarterly report, and
10 additional hours for the 17 major passenger-vehicle manufacturers to
submit electronic reports. We therefore now estimate that the quarterly
reporting burden pursuant to Part 573 totals 5,682 hours ((5,512
quarterly reports x 1 hour/report) + (17 MFRs x 10 hours for electronic
submission)).
    We continue to estimate a small burden of 2 hours annually in order
to set up a manufacturer's online recalls portal account with the
pertinent contact information and maintaining/updating their account
information as needed. We estimate this will require a total of 498
hours annually (2 hours x 249 MFRs).
    We continue to estimate that 20 percent of Part 573 reports will
involve a change or addition regarding recall components, and that at
two hours per amended report, this totals 396 burden hours per year
(988 recalls x .20 = 193 recalls; 198 x 2 = 396 hours).
    As to the requirement that manufacturers notify NHTSA in the event
of a bankruptcy, we expect this notification to take an estimated 2
hours to draft and submit to NHTSA. We continue to estimate that only
10 manufacturers might submit such a notice to NHTSA each year, so we
calculate the total burden at 20 hours (10 MFRs x 2 hours).
    We continue to estimate that it takes the 17 major passenger-
vehicle manufacturers an average of 11 hours to draft their
notification letters, submit them to NHTSA for review, and then
finalize them for mailing to their affected owners and purchasers. We
also continue to estimate it takes 8 hours for all other manufacturers
to perform this task. Accordingly, we estimate that the 49 CFR part 577
requirements result in 8,852 burden hours annually (11 hours per recall
x 316 recalls per year) + (8 hours per recall x 672 recalls per year).
    The burden estimate associated with the regulation that requires
interim owner notifications within 60 days of filing a Part 573 Safety
Recall Report must be revised upward. We previously calculated that
about 12 percent of past recalls require an interim notification
mailing, but recent trends show that 13 percent of recalls require an
interim owner notification mailing. We continue to estimate the
preparation of an interim notification can take up to 10 hours. We
therefore estimate that 1,250 burden hours are associated with the 60-
day interim notification requirement (963 recalls x .13 = 125 recalls;
125 recalls times 10 hours per recall = 1,250 hours).
    As for costs associated with notifying owners and purchasers of
recalls, to reflect an increase in postage rates, we are revising our
estimate of the cost of first-class mail notification to $1.53 per
notification, on average. This cost estimate includes the costs of
printing and mailing, as well as the costs vehicle manufacturers may
pay to third-party vendors to acquire the names and addresses of the
current registered owners from state and territory departments of motor
vehicles. In reviewing recent recall figures, we determined that an
estimated 51.4 million letters are mailed yearly totaling $78,642,000
($1.53 per letter x 51,400,000 letters). The requirement in 49 CFR part
577 for a manufacturer to notify their affected customers within 60
days would add an additional $10,223,460 (51,400,000 letters x .13
requiring interim owner notifications = 6,682,000 letters; 6,682,000 x
$1.53 = $10,023,000). In total, we estimate that the current 49 CFR
part 577 requirements cost manufacturers a total of $88,865,460
annually ($78,642,000 for owner notification letters + $10,223,460 for
interim notification letters = $88,865,460).
    As discussed above, to address the scope and complexity of the
Takata recalls, NHTSA issued the ACRO, which requires affected vehicle
manufacturers to conduct supplemental owner notification efforts in
coordination with NHTSA and the Independent Monitor of Takata. On
December 23, 2016, the Monitor, in consultation with NHTSA, issued
Coordinated Communications Recommendations for vehicle owner outreach
(``CCRs''), which includes a recommendation that vehicle manufacturers
provide at least one form of consumer outreach per month for vehicles
in a launched recall campaign (i.e., a recall where parts are
available) until the vehicle is remedied (unless otherwise accounted
for as scrapped, stolen, exported, or otherwise unreachable under
certain procedures in the ACRO). See CCRs ] 1(b); ACRO ]] 45-46. The
Monitor also recommended that manufacturers utilize at least three non-
traditional means of communication (e.g., postcards; email; telephone
calls; text message; social media) as part of their overall outreach
strategy. See CCRs ] 1(a). And the Monitor recommended including
certain content in these communications, including certain safety-risk
information. See id. ] 2. If a vehicle manufacturer does not wish to
follow the Monitor's recommendations, the ACRO permits the manufacturer
to propose an alternative communication strategy to NHTSA and the
Monitor. ACRO ] 42.
    As noted above, two comments were submitted in response to the 60-
day notice of this information collection. One of those comments
appears to have been placed on the incorrect docket. The other comment,
filed by The Alliance (which also attached two previously filed
comments regarding this collection), responded to several facets of the
notice that touch on two primary issues: (1) The extent to which
various provisions of the ACRO are subject to the PRA (and whether the
investigatory exception applies to the PRA in this context); and (2)
the accuracy of the agency's burden estimate. The Alliance commented
that it believes that NHTSA should account for additional cost burdens
under the

ACRO beyond the monthly outreach recommended under the CCRs. See
Comments (Aug. 12, 2019) at 2-4. The Alliance also commented that NHTSA
underestimated the costs associated with this monthly outreach, and
that NHTSA should provide separate burden estimates for each category
of outreach and compare those burdens with ``evidence of
effectiveness.'' See id. at 2, 5. In addition, The Alliance commented
that NHTSA should account for Monitor-conducted surveys and other
activities, and provide ``information justifying the practical
utility'' of supplemental non-traditional outreach. See id. at 5. The
Alliance further commented that it disagrees with NHTSA's discounting
of its cost estimates based on vehicle manufacturer settlement
agreements in multi-district litigation proceedings. Id.
    As to the extent to which various provision of the ACRO in addition
to the CCRs described above are subject to the PRA, The Alliance
previously commented that the investigatory exception to the PRA
applies `` `only after a case file or equivalent is opened with respect
to a particular party . . . and only with respect to `an administrative
action, investigation or audit involving an agency against specific
individuals or entities.' '' Comments (Jan. 22, 2018) at 2 (quoting 5
CFR 1320.4(a)(2), (c)). The Alliance's position is that ``if there is
any relevant investigation,'' it is an investigation against Takata--
not the affected automakers, because they ``are not the target'' of the
investigation. Id. Therefore, the Alliance believes NHTSA should
account for burdens associated with other provisions of the ACRO,
beyond the monthly-outreach recommendations in the CCRs. See id. at 3-
4.
    NHTSA is not persuaded that it should deviate from its approach.
The plain meaning of the statute specifically exempts collections of
information ``during the conduct of . . . an administrative action,
investigation, or audit involving an agency against specific
individuals or entities.'' 44 U.S.C. 3518(c)(1)(B)(ii) (emphasis
added); 5 CFR 1320.4(a)(2), 1320.3(c). NHTSA's investigation is clearly
directed at ``specific individuals or entities''--both Takata and the
19 specifically named vehicle manufacturers that installed defective
Takata inflators. See Opening Resume for EA15-001.\6\ Indeed, the
Coordinated Remedy Order did not originally contain numerous vehicle
manufacturers that were, subsequently, added to the Program.\7\ After
an expansion of the recalls in light of new information, NHTSA
specifically added seven ``newly affected'' vehicle manufacturers to
the Coordinated Remedy Program in its Third Amendment to the
Coordinated Remedy Order. See ACRO ]] 8, 10, 31.\8\
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    \6\ https://static.nhtsa.gov/odi/inv/2015/INOA-EA15001-4970.PDF.
    \7\ The ``original affected manufacturers'' were: BMW of North
America, LLC; FCA US, LLC; Daimler Trucks North America, LLC;
Daimler Vans USA, LLC; Ford Motor Company; General Motors, LLC;
American Honda Motor Company; Mazda North American Operations;
Mitsubishi Motors North America, Inc.; Nissan North America, Inc.;
Subaru of America, Inc.; and Toyota Motor Engineering and
Manufacturing.
    \8\ These newly affected manufacturers were: Ferrari North
America, Inc.; Jaguar Land Rover North America, LLC; McLaren
Automotive, Ltd.; Mercedes-Benz US, LLC; Tesla Motors, Inc.;
Volkswagen Group of America, Inc.; and, based on a Memorandum of
Understanding with the Agency, Karma Automotive (as to certain
Fisker vehicles).
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    Thus, contrary to Alliance and Global's suggestion, these orders
are not generalized so as to apply broadly ``to a category of
individuals or entities, such as a class of licensees or an industry''
under the PRA. See Comments (January 22, 2018) at 2 (citing 5 CFR
1320.4(c)). Rather, the orders are limited to specific vehicle
manufacturers the Agency has identified as affected by the Takata air
bag recalls. See also Shell Oil Co. v. Babbitt, 945 F. Supp. 792, 806
(D. Del. 1996) (rejecting argument that agency's investigations were
limited to subjects covered in forms agency uses for routine inquiries,
noting it is untenable to ``to limit [the agency] in a way that would
seriously curtail its investigative efforts and in a way Congress never
intended in passing'' an agency statute and the PRA); id. at 805-06
(observing a ``long line of cases recognizing that an administrative
agency's authority when it requests records and undertakes
investigatory functions related to its responsibilities is very
broad''); Lonsdale v. United States, 919 F.2d 1440, 1445 (10th Cir.
1990) (recognizing courts holding that PRA is inapplicable to forms
requesting information issued in investigation against an individual to
determine tax liability); Pitts v. Commissioner of Internal Revenue,
T.C. Memo 2010-101, 10 (May 6, 2010) (rejecting interpretation that PRA
applies to tax collection due-process hearings because the hearings
involve a ``category of individuals'' asked to submit a form).
    In sum, NHTSA is conducting an ongoing administrative action and
investigation into particular parties--both Takata and the specifically
enumerated affected vehicle manufacturers--as governed by the Takata
Coordinated Remedy Program. The Program is constructed and implemented
through various Agency orders (principally the Coordinated Remedy Order
and amendments) directed specifically at a discrete, finite number of
entities, including only those vehicle manufacturers affected by the
Takata recalls. Accordingly, NHTSA's responses to comments and its
burden estimates are limited to the monthly-outreach recommendation in
the CCRs.
    Furthermore, to the burden estimate, NHTSA acknowledges the ``wide
variety of outreach methods contemplated by the ACRO,'' and agrees with
the Alliance's recognition that estimating per-VIN outreach cost is a
difficult task given that outreach populations change and, with those
changes, the methods necessary to engage those populations also
changes. See Comments (Jan. 22, 2018) at 4; Comments (Aug. 12, 2019).
The Alliance notes that costs of outreach per VIN may have increased as
the recalls have progressed. Comments (Aug. 12, 2019) at 2. The
Alliance also states that NHTSA should separately estimate the burdens
for each category of outreach and compare the burden with the
outreach's effectiveness. Id.
    The CCR provisions recommend ``[e]ngaging in outreach specific to
the Takata airbag recall employing at least three'' methods of non-
traditional outreach, ``to ensure that each vehicle in a launched
campaign receives at least one form of outreach per month until the
vehicle is repaired'' (unless the vehicle can otherwise be accounted
for as set forth in the ACRO). CCRs at 1 (emphases in original). Thus,
the CCRs provide manufacturers wide latitude, and what specific
outreach methods a vehicle manufacturer employs is the vehicle
manufacturer's decision.\9\ The CCRs do not state that vehicle
manufacturers must engage in, e.g., canvassing when the remaining
recalled vehicle population reaches a certain threshold. NHTSA and the
Independent Monitor have simply identified for vehicle manufacturers
potential ways to achieve high completion rates for certain vehicle
populations.
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    \9\ If a vehicle manufacturer does not wish to follow the
Monitor's recommendations, the ACRO permits the manufacturer to
propose an alternative communication strategy to NHTSA and the
Monitor. ACRO ] 42.
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    NHTSA recognizes that as vehicles are repaired, the harder-to-reach
owners comprise a larger portion of the remaining unrepaired
population, and that as manufacturers adopt more intensive outreach
methods, outreach may prove more expensive. NHTSA also notes, however,
that while certain forms of non-traditional outreach may be more
expensive than others (such as

canvassing), such outreach may not be occurring on a monthly basis, nor
for all affected VINs. Balancing these considerations, NHTSA is
revising its estimate of the cost of monthly outreach upward to $10/VIN
per month, and welcomes further comment on the particular combination
of outreach methods in which manufacturers are engaging on a monthly
basis and associated costs therewith. In addition, although The
Alliance does not specifically comment on the burden hours associated
with non-traditional outreach,\10\ NHTSA recognizes that as the recalls
progress and there is more frequent implementation of more-intensive
outreach methods, the associated burden hours may also increase.
Accordingly, NHTSA is also revising its estimate of the monthly burden
upward from 2 hours to 10 hours to prepare and administer non-
traditional outreach. NHTSA welcomes any additional insights from The
Alliance regarding the specifics of its members' outreach costs and
burdens.
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    \10\ In its August 12, 2019 comments, The Alliance notes the
burden associated with monthly outreach ``[v]aries widely among
manufacturers, but includes multi-OEM canvassing activities that are
very labor intensive.'' Id. at 4.
---------------------------------------------------------------------------

    As to the effectiveness and ``practical utility'' of outreach under
the CCRs, this is in part reflected in the 2017 State of the Takata
Airbag Recalls report from the Independent Monitor.\11\ Notably,
completion percentages for recalls of the oldest vehicles under the
Takata Coordinated Remedy Program avoided a ``leveling off'' in
completion percentage typically observed for recall campaigns involving
vehicles 10 years or older, and this can be attributed to, at least in
part, the ACRO and associated CCRs.\12\ Another example is the
completion percentages for Priority Group 4 vehicles which, for the
first two quarters, were triple that of the completion percentages for
recall campaigns launched prior to Coordinated Remedy Order in their
first two quarters.\13\ And a further example can be seen in completion
percentages in the first six quarters for Priority Group 4 vehicles,
which were twice as high compared to completion percentages in the
first six quarters for vehicles with recall campaigns that were already
underway before the Coordinated Remedy Order.\14\ As noted in the
Monitor's report, those campaigns ``achieved in just two quarters what
previously took more than five.'' \15\ The Monitor's recent Update on
the State of the Takata Airbag Recalls further discusses the efficacy
of outreach, including an observation that most 2017 focus-group
participants indicated that contact for a reminder regarding a serious,
urgent safety risk should occur at least weekly, with almost two-thirds
of survey respondents indicating several notifications each month would
be appropriate.\16\
---------------------------------------------------------------------------

    \11\ This report is available at https://www.nhtsa.gov/recall-spotlight/state-takata-recalls.
    \12\ See State of the Takata Airbag Recalls at 66, fig.37.
    \13\ See id. at 68, fig.39. Recall campaigns for Priority Group
4 vehicles were scheduled to launch March 31, 2017--after the ACRO
and CCRs were issued. Most recall campaigns launched at that time.
As noted in the Independent Monitor's report, before the issuance of
the ACRO and the CCRs, recall campaigns ``used mainly infrequent,
letter-only communication.'' See id. at 67.
    \14\ Again, recall campaigns for Priority Group 4 vehicles were
scheduled to launch March 31, 2017--after the ACRO and CCRs were
issued. Most recall campaigns launched at that time. Note that
Priority Group 4 data for quarters 3 through 6 consist of data from
one vehicle manufacturer, which launched its Priority Group 5
campaign early (and therefore, at the time of the report, had six
quarters of data).
    \15\ See id. at 69, fig.40.
    \16\ Update on the State of the Takata Airbag Recalls (2018) at
14, fig.9, available at http://www.nhtsa.gov/sites/nhtsa.dot.gov/files/documents/update_on_the_state_of_the_takata_airbag_recalls.v2.pdf. The Agency
and the Independent Monitor have been and remain open to sharing
information about the efficacy of certain methods of outreach to
better guide vehicle manufacturers in executing their recall
campaigns.
---------------------------------------------------------------------------

    Maintaining such momentum--through mechanisms such as monthly
outreach--is vital to the success of the recalls. And this is a goal in
which Congress continues to take significant interest, including at a
hearing on the issue on March 20, 2018. The Takata Monitor testified at
that hearing: ``Vehicle manufacturers using frequent, multi-channel
outreach have seen completion percentages nearly twice as high as rates
for vehicle manufacturers using traditional letter outreach, when
targeting similarly situated vehicles over the same period of time.''
\17\ Two vehicle manufacturers likewise testified about their use of
innovative outreach strategies to reach consumers and convince them to
come in for a free repair.\18\
---------------------------------------------------------------------------

    \17\ Written Testimony of John D. Buretta, Independent Monitor,
https://www.commerce.senate.gov/public/index.cfm/hearings?ID=EAE03543-B332-480F-8390-B301E8F79CBB.
    \18\ Written testimony of Rick Schostek, Honda North America;
Written Testimony of Desi Ujkashevic, Ford Motor Company, https://www.commerce.senate.gov/public/index.cfm/hearings?ID=EAE03543-B332-480F-8390-B301E8F79CBB.
---------------------------------------------------------------------------

    As to accounting for Monitor-conducted surveys and other
activities, as a general matter, monitors are ``an independent third-
party, not an employee or agent of the corporation or of the
Government.'' \19\ Moreover, for the reasons described above, any such
``collection of information'' is subject to the PRA's investigatory
exception. Additionally, it should be noted that such research was not
a prerequisite to the implementation of the monthly-outreach provisions
in the CCRs. As NHTSA previously observed in its notices, various other
sources served as the bases for this recommendation.\20\
---------------------------------------------------------------------------

    \19\ https://www.justice.gov/usam/criminal-resource-manual-163-selection-and-use-monitors.
    \20\ See 82 FR 45941, 45945 & ns.5--6 (Oct. 2, 2017); 82 FR
60789, 60794 & n.6 (Dec. 22, 2017).
---------------------------------------------------------------------------

    As to discounting our cost estimates based on vehicle
manufacturers' settlement agreements in multi-district litigation
proceedings, The Alliance's position is essentially that the ACRO
predates the MDL settlement, and that ``[t]he settling companies would
have set aside more than $1Billion to comply with [the] ACRO, even if
there had been no MDL settlement.'' \21\ Comments (Aug. 12, 2019) at 5.
The Agency disagrees that this dictates a change in its approach. While
the ACRO predates the MDL settlements, the agency must, on an ongoing
basis, consider all attendant circumstances and be forward-looking in
estimating the costs associated with its initiatives--consistent with
the forward-looking purpose of its statute: ``to reduce traffic
accidents and deaths and injuries resulting from traffic accidents.''
49. U.S.C. 30101; see id. 30118(c)(1) (notification of vehicle owners
of a defect); id. 30119 (notification procedures); id. 30120(d)
(manufacturer's remedy program).
---------------------------------------------------------------------------

    \21\ Those manufacturers are Toyota; Subaru; Nissan; BMW; Mazda;
Honda; and Ford. See generally In re: Takata Airbag Products Liab.
Litig., 14-cv-24009, MDL No. 2599 (S.D. Fla.). Our 60-day notice
only accounted for six vehicle manufacturers that have entered into
settlement agreements--there are seven.
---------------------------------------------------------------------------

    At present, settling vehicle manufacturers have already chosen to
enter into these settlement agreements, and looking forward, these
vehicle manufacturers must comply with its terms--including provisions
for enhanced outreach efforts. It is appropriate that NHTSA's burden
estimate discounts for enhanced outreach that will occur regardless of
the ACRO. In fact, the Agency's view is that outreach conducted under
the settlements appear to satisfy the minimum recommendations of the
ACRO and CCRs. The Alliance's comments that costs associated with the
ACRO were considered when executing the settlement agreements, or that
manufacturers would have set aside those funds to comply with the ACRO
in the absence of a settlement, do not affect this. But for NHTSA's
ACRO, as NHTSA is presently submitting its information-collection
renewal, settling

MDL vehicle manufacturers would still conduct outreach that would
satisfy the ACRO's requirements--and therefore the monthly outreach
under the ACRO is not a marginal ``burden'' for those vehicle
manufacturers for which the Agency must account in this collection.
    To account for the progression of the recalls since its last
notice, NHTSA is revising its previous estimates associated with this
part of the collection. NHTSA continues to estimate a yearly average of
19 manufacturers will be issuing monthly supplemental communications
over the next three years pursuant to the ACRO and the CCRs.
Manufacturers may satisfy the CCRs through third-party vendors (which
have been utilized by many manufacturers), in-house strategies, or some
combination thereof. NHTSA estimates the cost for supplemental
communications at $10.00 per VIN per month.
    The volume of outreach required by the ACRO and the CCRs (and the
costs associated with that outreach) is a function of the number of
unrepaired vehicles that are in a launched campaign and are not
otherwise accounted for as scrapped, stolen, exported, or otherwise
unreachable. The schedule in Paragraph 35 of the ACRO delineates the
expected remedy completion rate, by quarter, of vehicles in a launched
remedy campaign.
    Utilizing these variables, we now estimate an initial annualized
cost over the next three years of $1,018,882,470 per year, with an
annualized discount of $541,833,140 to account for outreach conducted
pursuant to the MDL settlement agreements by seven vehicle
manufacturers, for a net annualized cost of $477,049,330. NHTSA
estimates that manufacturers will take an average of 10 hours each
month drafting or customizing supplemental recall communications
utilizing non-traditional means, submitting them to NHTSA for review,
and finalizing them to send to affected owners and purchasers. NHTSA
therefore estimates that 2280 burden hours annually are associated with
issuing these supplemental recall communications, with an annualized
discount of 840 hours to account for outreach conducted pursuant to the
MDL settlement agreements by seven vehicle manufacturers, for a net
annualized burden of 1440 hours.
    Because of the forgoing burden estimates, we are revising the
burden estimate associated with this collection. The 49 CFR part 573
and 49 CFR part 577 requirements found in today's notice will require
66,004 hours each year. NHTSA estimates the labor cost for compiling
and submitting the required information under 49 CFR parts 573 and 577
to be $33.98 per hour using the Bureau of Labor's mean hourly wage
estimate for technical writers in the motor vehicle manufacturing
industry (Standard Occupational Classification # 27-3042).\22\ NHTSA
thus estimates that it will cost vehicle manufacturers $2,242,815.92 in
wage costs to comply with the Part 573 and 577 requirements. The Bureau
of Labor Statistics estimates that for private industry workers, wages
represent 70.1% of total compensation.\23\ Therefore, the total labor
cost associated with the hourly burden is estimated to be $3,199,453.
Accordingly, manufacturers impacted by 49 CFR part 573 and 49 CFR part
577 requirements will incur a recurring annual cost estimated at
$92,334,913 total.
---------------------------------------------------------------------------

    \22\ National Industry-Specific Occupational Employment and Wage
Estimates NAICS 336100--Motor Vehicle Manufacturing, May 2018,
https://www.bls.gov/oes/current/naics4_336100.htm#47-0000, last
accessed August 26, 2019; US Office of Management and Budget.
Standard Occupation Classification Manual, 2018.
    \23\ Employer Costs for Employee Compensation-March 2019,
https://www.bls.gov/news.release/pdf/ecec.pdf, last accessed August
26, 2019.
---------------------------------------------------------------------------

    The burden estimate in this collection contemplated for conducting
supplemental recall communications under administrative order to
achieve completion of the Takata recalls is 1440 hours each year. That
administrative order contemplates impacted manufacturers incurring an
annual cost estimated at $477,049,330. NHTSA also estimates the labor
cost for compiling and submitting the required information to be $35.28
per hour using the Bureau of Labor's mean hourly wage estimate for
Media and Communications Workers in the motor vehicle manufacturing
industry (Standard Occupational Classification #27-3000).\24\ Assuming
that 1440 hours per year would be associated with issuing supplemental
recall communications, at an average cost of $35.28 per hour, NHTSA
estimates vehicle manufacturers will incur $50,803.20 (1440 hours x
$35.28) annually in wage costs. The Bureau of Labor Statistics
estimates that for private industry workers, wages represent 70.1% of
total compensation.\25\ Therefore, the total labor cost associated with
the hourly burden of supplemental recall communications is estimated to
be $72,472.47.
---------------------------------------------------------------------------

    \24\ National Industry-Specific Occupational Employment and Wage
Estimates NAICS 336100--Motor Vehicle Manufacturing, May 2018,
https://www.bls.gov/oes/current/naics4_336100.htm#47-0000, last
accessed August 26, 2019; US Office of Management and Budget.
Standard Occupation Classification Manual, 2018.
    \25\ Employer Costs for Employee Compensation-March 2019,
https://www.bls.gov/news.release/pdf/ecec.pdf, last accessed August
26, 2019.
---------------------------------------------------------------------------

    Therefore, in total, we estimate the burden associated with this
collection to be 67,444 hours each year, with a recurring annual cost
estimated at $569,456,715.47.
    Estimated Number of Respondents--NHTSA estimates that there will be
approximately 249 manufacturers per year filing defect or noncompliance
reports and completing the other information collection
responsibilities associated with those filings. NHTSA estimates there
will be an average of 19 manufacturers each year conducting
supplemental nontraditional monthly outreach pursuant to administrative
order in an enforcement action associated with the Takata recalls.

Jeffrey Giuseppe,
Associate Administrator for Enforcement.
[FR Doc. 2019-18820 Filed 8-29-19; 8:45 am]18820
 BILLING CODE 4910-59-P


EMISSION SOURCES  MAXIMUM ALLOWABLE EMISSION RATES Permit Number 8714 This table lists the maximum allowable emission rates for all sources of air contaminants on the applicant's property covered by this permit.

AIR CONTAMINANTS DATA Emission Source Air Contaminant Emission Rates Point No. ( 1) Name ( 2) Name ( 3) lb/ hr TPY( 4)

EPN 102 East Coating Boiler POC 0.67 2.95 EPN 103 West Coating Boiler POC 0.67 2.95 EPN 202 Coating Line II or Line IV VOC 511.06 74.45 ( Stack II)

EPN 204 Carbon Bed Stack VOC 1.73 1.22 EPN 205 Carbon Bed Stack VOC 23.96 0.41 EPN 206 Process Fugitives VOC 0.32 1.39 EPN 210 Reel Cleaning VOC 0.98 0.71 EPN 211 Blade Cleaning VOC 1.43 0.18 ( 1) Emission point identification  either specific equipment designation or emission point number from a plot plan. ( 2) Specific point source names. ( 3) VOC  volatile organic compounds as defined in Title 30 Texas Administrative Code § 101.1 POC  products of combustion including nitrogen oxides, sulfur dioxide, carbon monoxide, VOC, and particulate matter. ( 4) The rate is for a rolling 12 consecutive months.

Dated


[Federal Register: May 28, 2008 (Volume 73, Number 103)]
[Rules and Regulations]
[Page 30492-30498]
[DOCID:fr28my08-12]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0339; FRL-8363-7]

Fluopicolide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
fluopicolide in or on vegetable, root, subgroup 1A, except sugar beet
and carrot; vegetable, leaves of root and tuber, group 2; vegetable,
bulb, group 3-07; and Brassica, head and stem, subgroup 5A.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). In
connection with a request for new uses of the active ingredient,
fluopicolide, the Agency has also evaluated the toxicity and exposure
databases for 2,6-dichlorobenzamide (BAM) which is a common metabolite/
degradate of dichlobenil and fluopicolide. Further characterization of
fluopicolide and its metabolite BAM, will be discussed herein of this
document.

DATES: This regulation is effective May 28, 2008. Objections and
requests for hearings must be received on or before July 28, 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-2007-0339. 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: Barbara Madden, 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 those
engaged in the following activities:
     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 to
provide 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 EPA's tolerance regulations at
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, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. 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-2007-0339 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 as required by 40 CFR part 178 on or
before July 28, 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 this copy, identified by docket ID number
EPA-HQ-OPP-2007-0339, 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. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237) (FRL-8133-
4), 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 petition (PP
7E7172) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.627 be amended by
establishing tolerances for residues of the fungicide fluopicolide,
[2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide], in or on vegetable, root and tuber, group
1 at 0.2 parts per million (ppm); vegetable, leaves of root and tuber,
group 2 at 12.0 ppm; vegetable, bulb, group 3 at 5.0 ppm; chive, fresh
leaves at 5.0 ppm; chive, Chinese, fresh leaves at 5.0 ppm; daylily,
bulb at 5.0 ppm; elegans hosta at 5.0 ppm; fritillaria, bulb at 5.0
ppm; fritillaria, leaves at 5.0 ppm; garlic, serpent, bulb at 5.0 ppm;
kurrat at 5.0 ppm; lady's leek at 5.0 ppm; leek, wild at 5.0 ppm; lily,
bulb at 5.0 ppm; onion, Beltsville bunching at 5.0 ppm; onion, Chinese,
bulb at 5.0 ppm; onion, fresh at 5.0 ppm; onion, macrostem at 5.0 ppm;
onion, pearl at 5.0 ppm; onion, potato, bulb at 5.0 ppm; onion, tree,
tops at 5.0 ppm; shallot, bulb at 5.0 ppm; shallot, fresh leaves at 5.0
ppm; and brassica, head and stem, subgroup 5A at 5.0 ppm. The notice
referenced a summary of the petition prepared by Valent Corporation,
the registrant, which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petitions, EPA has
revised certain proposed tolerance levels and corrected commodity
definitions as follows:
    1. The Agency determined that adequate data are available to
support establishing a tolerance for the bulb vegetable crop group 3-
07. IR-4 petitioned for a tolerance for bulb vegetable group 3 as well
as individual tolerances on chive, fresh leaves; chive, Chinese, fresh
leaves; daylily, bulb; elegans hosta; fritillaria, bulb; fritillaria,
leaves; garlic, serpent, bulb; kurrat; lady's leek; leek, wild; lily,
bulb; onion, Beltsville bunching onion; Chinese, bulb; onion, fresh;
onion, macrostem; onion, pearl; onion, potato, bulb; onion, tree, tops;
shallot, bulb; and shallot, fresh leaves (PP 7E7172). In the Federal
Register of December 7, 2007 (72 FR 69150) (FRL-8340-6), EPA issued a
final rule that revised the crop grouping regulations. As part of this
action, EPA expanded and revised bulb vegetable group 3. Changes to
crop group 3 (bulb vegetable) included adding new commodities, revising
existing subgroups and creating new subgroups (including bulb vegetable
crop group 3-07 consisting of the commodities requested in PP 7E7172
and cultivars, varieties, and/or hybrids of these).
    EPA indicated in the December 7, 2007 final rule as well as the
earlier May 23, 2007 proposed rule (72 FR 28920) that, for existing
petitions for which a notice of filing had been published, the Agency
would attempt to conform these petitions to the rule. Therefore,
consistent with this rule, EPA is establishing tolerances on bulb
vegetable crop group 3-07. Bulb vegetable crop group 3-07 consists of a
variety of commodities for which tolerances were requested in PP
7E7172.
    EPA concludes it is reasonable to revise the petitioned-for
tolerances so that they agree with the recent crop grouping revisions
because:
     i. Although the subgroup includes several new commodities, these
commodities were proposed as individual tolerances and are closely
related minor crops which contribute little to overall dietary or
aggregate exposure and risk;
    ii. Fluopicolide exposure from these added commodities was
considered when EPA conducted the dietary and aggregate risk
assessments supporting this action and
    iii. The representative commodities for the revised subgroup has
not changed.
    2. Based upon review of the data supporting PP 7E7172, EPA has also
revised the tolerance levels for vegetable, root, subgroup 1A, except
sugar beet and carrot to 0.15 ppm; vegetable, leaves of root and tuber,
group 2 to 15.0 ppm; and vegetable, bulb, crop group 3-07 to 7.0 ppm.
EPA revised these tolerance levels based on analyses of the residue
field trial data using the Agency's Tolerance Spreadsheet in accordance
with the Agency's Guidance for Setting Pesticide Tolerances Based on
Field Trial Data Standard Operating Procedure (SOP). EPA has also
determined that it is not appropriate to establish tolerances on sugar
beet and carrot at this time and revised the subgroup tolerance
accordingly.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide fluopicolide residue in or
on a food) only if EPA determines that the tolerance is ``safe.''
Section 408(b)(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 fluopicolide 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. Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
fluopicolide 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 fluopicolide residue.
. . .''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of fluopicolide, [2,6-dichloro-N-[[3-chloro-5-
(trifluoromethyl)-2-pyridinyl]methyl]benzamide] as an indicator of
combined residues of fluopicolide and its metabolite BAM on vegetable,
root, subgroup 1A, except sugar beet and carrot at 0.15 ppm; vegetable,
leaves of root and tuber, group 2 at 15.0 ppm; vegetable, bulb, crop
group 3-07 at 7.0 ppm; and brassica, head and stem, subgroup 5A at 5.0
ppm. EPA's assessment of exposures and risks associated with
establishing tolerances follow.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific

information on the studies received and the nature of the adverse
effects caused by fluopicolide and its metabolite BAM as well as the
no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov in documents entitled Floupicolide: Human
Health Risk Assessment for the Establishment of Tolerances for use on
root vegetables (subgroup 1A), leaves of root and tuber vegetables
(group 2), bulb vegetables (group 3), and head and stem brassica
(subgroup 5A) on pages 29-35; and BAM as a Metabolite/Degradate of
Fluopicolide and Dichlobenil. Human Health Risk Assessment for proposed
uses of Fluopicolide on tuberous and corm vegetables, leafy vegetables
(except brassica), fruiting vegetables, cucurbit vegetables, grapes,
turf, and ornamentals, and for indirect or inadvertent residues on the
rotational crop wheat on pages 54-62. Each of these risk assessments is
contained within in docket ID number EPA-HQ-OPP-2007-0339.
    In general, the toxicology studies conducted on fluopicolide
demonstrate few or no biologically significant toxic effects at
relatively low-dose levels in animal studies and only mild or no toxic
effects at high doses. The subchronic and chronic toxicity studies
showed that the primary effects of fluopicolide are in the liver. The
toxicological database indicates that technical grade fluopicolide has
relatively low acute toxicity. Fluopicolide is not a dermal sensitizer,
primary eye irritant, or primary skin irritant. Fluopicolide is also
not neurotoxic, carcinogenic, nor mutagenic. Fluopicolide is not a
developmental or reproductive toxicant. There is no evidence of
increased susceptibility of rat or rabbit fetuses to in utero or post-
natal exposure to fluopicolide. No toxic effects were observed in
studies in which fluopicolide was administered by the dermal routes of
exposure.
    The rabbit developmental and rat chronic/carcinogenicity studies
were considered co-critical for endpoint selection. The toxicological
profile for fluopicolide suggests that increased durations of exposure
(i.e., 90-day versus chronic) does not significantly increase the
severity of observed effects. The rabbit developmental and rat chronic/
cancer studies were therefore considered for all exposure scenarios.
    BAM is a metabolite and/or environmental degradate of both the
fungicide fluopicolide and the herbicide dichlobenil. Residues of BAM
from uses of both fluopicolide and dichlobenil were considered when
assessing BAM as a metabolite/degradate resulting from proposed uses of
fluopicolide. BAM was assessed separately since there is no common
toxicological effect for BAM and other fluopicolide residues of
concern. The submitted acute and chronic studies on BAM were sufficient
to evaluate human hazard potential. BAM demonstrated moderate acute
toxicity via the oral route of exposure. In subchronic and chronic
toxicity studies, the primary oral effects seen in the rat and dog were
body weight changes. Adverse liver effects were also observed but at
doses of BAM that were higher than those of dichlobenil. There is no
evidence that BAM is either mutagenic or clastogenic nor is there
evidence of endocrine mediated toxicity. BAM is considered to be
neurotoxic. In the absence of carcinogenicity study data for a second
species, the EPA has assumed that BAM's carcinogenic potential is
similar to that of dichlobenil, the parent compound having the greatest
carcinogenicity potential. Dichlobenil is classified as ``group C,
possible human carcinogen.'' Quantification of cancer risk is based on
the reference dose (RfD) approach which requires comparison of the
chronic exposure to the RfD. Using this methodology will adequately
account for all chronic toxic effects, including carcinogenicity,
likely to result from exposure to dichlobenil and therefore to BAM.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-term,
intermediate-term, and chronic-term risks are evaluated by comparing
food, water, and residential exposure to the POD to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded. This latter value is referred to as the Level of
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.

    A summary of the toxicological endpoints for fluopicolide and its
metabolite BAM used for human risk assessment can be found at http://
www.regulations.gov in documents entitled: Fluopicolide Human Health
Risk Assessment for the Establishment of Tolerances for use on root
vegetables (subgroup 1A), leaves of root and tuber vegetables (group
2), bulb vegetables (group 3), and head and stem brassica (subgroup 5A)
on pages 10-11; and BAM as a Metabolite/Degradate of Fluopicolide and
Dichlobenil. Human Health Risk Assessment for proposed uses of
Fluopicolide on root vegetables (subgroup 1A), leaves of root and tuber
vegetables (group 2), bulb vegetables (group 3), and head and stem
brassica (subgroup 5A) on pages 3-4. Each of these risk assessments is
contained within in docket ID number EPA-HQ-OPP-2007-0339.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluopicolide and its metabolite BAM, EPA considered
exposure under the petitioned-for tolerances as well as all existing
fluopicolide and its metabolite BAM tolerances in 40 CFR 180.627 and
the exposures from BAM from existing dichlobenil tolerances under
180.231. EPA assessed dietary exposures from fluopicolide and its
metabolite BAM in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.

    a. Fluopicolide. No effects were identified in the toxicological
studies for fluopicolide; therefore, a quantitative acute dietary
exposure assessment was not conducted.
    b. BAM. In estimating acute dietary exposure to BAM, EPA used food
consumption information from the U.S. Department of Agriculture (USDA)
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by
Individuals (CSFII). As to residue levels in food, maximum residues of
BAM from fluopicolide and dichlobenil field trials on food commodities
with established/pending tolerances were included in the assessment.
The assessments used 100 percent crop treated (PCT) except for apples,
blueberries, cherries, peaches, pears, and raspberries. No livestock
tolerances are established or proposed for either fluopicolide or
dichlobenil.
    ii. Chronic exposure.--a. Fluopicolide. In conducting the chronic
dietary exposure assessment EPA used the food consumption data from the
USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA
assumed all foods for which there are tolerances or for which
tolerances are being established contain tolerance-level residues and
100 PCT.
    b. BAM. In conducting the chronic dietary exposure assessment EPA
used the food consumption data from the USDA 1994-1996 and 1998 CSFII.
As to residue levels in food, EPA assumed, maximum residues of BAM from
fluopicolide and dichlobenil field trials on food commodities with
established/pending tolerances were included in all foods for which
there are tolerances. The assessments used 100 PCT except for apples,
blueberries, cherries, cranberries, peaches, pears, and raspberries. No
livestock tolerances are established or proposed for either
fluopicolide or dichlobenil.
    iii. Cancer. Fluopicolide has been classified as ``not likely to be
carcinogenic to humans.'' Therefore a cancer dietary exposure
assessment was not conducted for the parent fluopicolide. Additionally,
EPA has determined BAM's potential for carcinogenicity is similar to
that of dichlobenil, which is classified as ``group C, possible human
carcinogen.'' Quantification of cancer risk is based on the reference
dose (RfD) approach which requires comparison of the chronic exposure
to the RfD. Using this methodology will adequately account for all
chronic toxic effects, including carcinogenicity, likely to result from
exposure to BAM. Therefore, a separate cancer exposure assessment was
not conducted.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of FFDCA authorizes EPA to use available data and information on the
anticipated residue levels of pesticide residues in food and the actual
levels of pesticide residues that have been measured in food. If EPA
relies on such information, EPA must pursuant to FFDCA section
408(f)(1) require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. For the present action,
EPA will issue such Data Call-Ins as are required by FFDCA section
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be
required to be submitted no later than 5 years from the date of
issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
    a. The data used are reliable and provide a valid basis to show
what percentage of the food derived from such crop is likely to contain
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any
significant subpopulation group.
    c. Data are available on pesticide use and food consumption in a
particular area, the exposure estimate does not understate exposure for
the population in such area. In addition, the Agency must provide for
periodic evaluation of any estimates used. To provide for the periodic
evaluation of the estimate of PCT as required by FFDCA section
408(b)(2)(F), EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    For the BAM acute assessment, maximum PCT estimates were used for
the following commodities: Apples (2.5%), blueberries (2.5%), cherries
(2.5%), peaches (2.5%), pears (2.5%) and raspberries (2.5%).
    For the BAM chronic assessment, average PCT estimates were used for
the following commodities: Apples (1%), blueberries (1%), cherries
(1%), peaches (1%), pears (1%), raspberries (1%) and cranberries (45%).
    EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five percent except for those situations in which
the average PCT is less than one. In those cases <1% is used as the
average and <2.5% is used as the maximum. EPA uses a maximum PCT for
acute dietary risk analysis. The maximum PCT figure is the single
maximum value reported overall from available Federal, State, and
private market survey data on the existing use, across all years, and
rounded up to the nearest multiple of five percent. In most cases, EPA
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary
Market Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent six years.
    The Agency believes that the three conditions listed in this unit
have been met. With respect to Condition a, PCT estimates are derived
from Federal and private market survey data, which are reliable and
have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions b, and c, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which BAM may be
applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fluopicolide in drinking water. These simulation models
take into account data on the physical, and fate/transport
characteristics of fluopicolide. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    No monitoring data were available for fluopicolide or BAM. Drinking
water residues of fluopicolide (parent) were modeled for exposures
resulting from uses on grapes, vegetables, and turf, which are the uses
that are expected to yield the highest estimated environmental
concentrations (EECs).

Drinking water residues for BAM were modeled for exposures resulting
from the use currently registered on dichlobenil for control of
nutsedge. This use is expected to yield the highest EECs for BAM.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW), the estimated drinking water concentrations (EDWCs) of
fluopicolide for acute exposures are estimated to be 26.81 parts per
billion (ppb) for surface water and 0.64 ppb for ground water. Chronic
exposures are estimated to be 8.34 ppb for surface water and 0.64 ppb
for ground water. Based on the PRZM/EXAMS and SCI-GROW models, the
EDWCs of BAM for acute exposures are estimated to be 20.9 ppb for
surface water and 56.2 for ground water. Chronic exposures are
estimated to be 8.61 ppb for surface water and 56.2 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment for BAM, the water concentration value of 56.2 ppb was used
to assess the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 8.34 ppb and 56.2 were
used to assess the contribution to drinking water for fluopicolide and
BAM, respectively.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Fluopicolide is currently registered for the following uses that
could result in residential exposures: Residential turf grass and
recreational sites.The labels do not prohibit homeowners from using
these products; therefore, residential handlers may receive short-term
dermal and inhalation exposure to fluopicolide when mixing, loading and
applying the formulations. Dermal exposure is likely for adults and
children entering treated lawns. Toddlers may also experience exposure
via incidental non-dietary ingestion during postapplication activities
on treated turf.
     EPA assessed residential exposure for fluopicolide using the
following assumptions:
    i. Handler exposure scenarios resulting from residential lawn
applicators were assessed for 1. mix/load and spot application of
liquid formulation (low-pressure hand sprayer), and 2. mix/load and
broadcast application of liquid formulation (garden hose-end sprayer).
    Post-application exposure scenarios resulting from lawn treatment
were assessed for 1. adult and toddler postapplication dermal exposure,
2. toddlers' incidental ingestion of pesticide residues on lawns from
hand-to-mouth transfer, 3. toddlers' object-to-mouth transfer from
mouthing of pesticide-treated turfgrass, and 4. toddlers' incidental
ingestion of soil from pesticide-treated residential areas. There are
short and intermediate term exposures for fluopicolide.
    BAM exposure estimates are based on fluopicolide use only since the
use pattern for dichlobenil is not expected to result in scenarios with
significant residential/non-occupational exposure. Exposure to BAM from
fluopicolide uses on residential turfgrass and recreational sites, such
as golf courses, has been evaluated. Residential handler exposure was
not evaluated because the metabolite BAM is believed to form slowly in
plants and soil after the product containing the parent (fluopicolide)
has been applied.
     EPA assessed residential exposure for BAM using the following
assumptions:
    ii. Post-application exposure scenarios resulting from lawn
treatment were assessed for 1. adult and toddler postapplication dermal
exposure, 2. toddlers' incidental ingestion of pesticide residues on
lawns from hand-to-mouth transfer, 3. toddlers' object-to-mouth
transfer from mouthing of pesticide-treated turfgrass, and 4. toddlers'
incidental ingestion of soil from pesticide-treated residential areas.
Short and intermediate term exposures for fluopicolide are expected.

    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluopicolide (parent) and
its metabolite BAM, and any other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that fluopicolide
(parent) and its metabolite BAM has a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rat or rabbit fetuses or pups to in utero
or post-natal exposure to fluopicolide.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for fluopicolide is complete.
    ii. There is no indication that fluopicolide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluopicolide results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to fluopicolide in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral

exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by fluopicolide.
    BAM: EPA is retaining the 10X FQPA SF for BAM for those exposure
scenarios that do not rely on dichlobenil toxicity data. These
scenarios are acute dietary for the general population including
infants and children, females 13-49 years of age, chronic dietary, and
incidental oral non-dietary. This is due to the incompleteness of the
data base with regard to the systemic neurotoxic potential of BAM,
including olfactory toxicity via the oral route of exposure.
    For the dermal and inhalation routes of exposures, for which the
Agency is relying on dichlobenil toxicity data. EPA has reduced the
FQPA SF for BAM toxicity to 1X. The reasons for this are that, based on
a comparison of toxicity via the intraperitoneal route of exposure,
higher doses of BAM are needed to induce levels of olfactory toxicity
that are similar to those caused by dichlobenil (Brandt et al. 1990;
Brittebo et al. 1991; Eriksson and Brittebo 1995). Olfactory toxicity
was the endpoint chosen for these exposure scenarios.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-term, intermediate-term, and
chronic-term risks are evaluated by comparing the estimated aggregate
food, water, and residential exposure to the POD to ensure that the MOE
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
fluopicolide is not expected to pose an acute risk. Using the exposure
assumptions discussed in this unit for acute exposure, the acute
dietary exposure from food and water to BAM will occupy 28% of the aPAD
for all infants <1 year old and females 13-49 years old, the population
groups receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fluopicolide from food and water will utilize 11% of the cPAD for
children 1-2 years old, and chronic exposure to BAM from food and water
will utilize 93% of the cPAD for all infants <1 year old, the
population group receiving the greatest exposure. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of fluopicolide and its
metabolite is not expected.
    3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account short-term and
intermediate-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Fluopicolide is currently registered for uses that could result in
short and intermediate term residential exposure and the Agency has
determined that it is appropriate to aggregate chronic exposure through
food and water with short-term and intermediate-term residential
exposures to fluopicolide. Using the exposure assumptions described in
this unit for short-term and intermediate-term exposures, EPA has
concluded the combined short-term and intermediate-term food, water,
and residential exposures aggregated for fluopicolide result in
aggregate MOEs of 300 for children 1-2 years.
    As discussed in the unit for short-term and intermediate-term
exposures, exposures to BAM may result based on use of fluopicolide
only since the use pattens for dichlobenil are not expected to result
in scenarios with significant residential/non-occupational exposure.
Exposure to BAM from fluopicolide uses on residential turfgrass and
recreational sites, such as golf courses, has been evaluated. The
Agency has determined that it is appropriate to aggregate chronic
exposure through food and water with short and intermediate term
residential exposures to BAM. Using the exposure assumptions described
in this unit for short-term and intermediate-term exposures for BAM,
EPA has concluded the combined short and intermediate term food, water,
and residential exposures aggregated result in aggregate MOEs of 3200
for all infants <1 year old and 5,400 for children 1-2 years old.
    4. Aggregate cancer risk for U.S. population. Fluopicolide has been
classified as ``not likely to be carcinogenic to humans.'' As such, an
estimate of cancer risk is not warranted for parent fluopicolide.
    EPA has determined BAM's potential for carcinogenicity is similar
to that of dichlobenil, which is classified as ``group C, possible
human carcinogen.'' Quantification of cancer risk is based on the RfD
approach which requires comparison of the chronic exposure to the RfD.
Therefore, the chronic risks discussed in Unit III.E.2. are considered
protective of both non-cancer and cancer effects.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluopicolide and its metabolite BAM residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography mass
spectrometry ((LC/MS/MS) method, Method RM-43C-2) is available to
enforce the tolerance expression for fluopicolide. Enforcement
methodology (LC/MS/MS Method, Methods 00782, 00782/M001, 00782/M002,
and 00782/M003) is available to adequately enforce the tolerance
expression for BAM. The methods may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) or
tolerances have been established for fluopicolide.

V. Conclusion

    Therefore, tolerances are established for residues of fluopicolide,
[2,6-dichloro-N-[[3-chloro-5-(trifluoromethyl)-2-
pyridinyl]methyl]benzamide] as an indicator of combined residues of
fluopicolide and its metabolite BAM on vegetable, root, subgroup 1A,
except sugar beet and carrot at 0.15 ppm; vegetable, leaves of root and
tuber, group 2 at 15.0 ppm; vegetable, bulb, crop group 3-07 at 7.0
ppm; and brassica, head and stem, subgroup 5A at 5.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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).

VII. 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: May 14, 2008.
Donald Stubbs,
Acting Director, Registration 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 180.627 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.627  Fluopicolide; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                 Commodity                                            Parts per million
----------------------------------------------------------------------------------------------------------------
Brassica, head and stem, subgroup 5A......                                                                   5.0
                                                    * * * * *
Vegetable, bulb, crop group 3-07..........                                                                   7.0
                                                    * * * * *
Vegetable, leaves of root and tuber, group                                                                  15.0
 2........................................
Vegetable, root, subgroup 1A, except sugar                                                                  0.15
 beet and carrot..........................
                                                    * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. E8-11853 Filed 5-27-08; 8:45 am]

BILLING CODE 6560-50-S