[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3544-3548]
[FR Doc No: 2019-01920]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0021; Notice 2]

Gillig, LLC, Denial of Petition for Decision of Inconsequential
Noncompliance

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

ACTION: Denial of petition.

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SUMMARY: Gillig LLC (Gillig) has determined that certain model year
(MY) 1997-2016 Gillig Low Floor buses do not fully comply with Federal
Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, Reflective
Devices, and Associated Equipment. Gillig filed a noncompliance report
dated February 24, 2017. Gillig also petitioned NHTSA on March 24,
2017, and supplemented its petition on May 10, 2017, for a decision
that the subject noncompliance is inconsequential as it relates to
motor vehicle safety.

FOR FURTHER INFORMATION CONTACT:
    Leroy Angeles, Office of Vehicle Safety Compliance, NHTSA,
telephone<PHONE_NUMBER>, facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Overview

    Gillig LLC (Gillig) has determined that certain model year (MY)
1997-2016 Gillig Low Floor buses do not fully comply with paragraph
S<IP_ADDRESS>.1 of FMVSS No. 108, Lamps, Reflective Devices, and Associated
Equipment (49 CFR 571.108). Gillig filed a noncompliance report dated
February 24, 2017, pursuant to 49 CFR part 573, Defect and
Noncompliance Responsibility and Reports. As stated in the
noncompliance report, turn signal lights that do not meet the
requirements of the standard may not be sufficiently visible to other
drivers or pedestrians, potentially increasing the risk of a crash.
Gillig also petitioned NHTSA on March 24, 2017, and supplemented its
petition on May 10, 2017, for an exemption from the notification and
remedy requirements of 49 U.S.C. Chapter 301 on the basis that this
noncompliance is inconsequential as it relates to motor vehicle safety,
pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556.
    Notice of receipt of the petition was published with a 30-day
public comment period, on October 4, 2017, in the Federal Register (82
FR 46346). No comments were received.

II. Buses Involved

    Approximately 17,138 MY 1997-2016 Gillig Low Floor buses,
manufactured between December 31, 1997, and February 3, 2017, are
potentially involved.

III. Noncompliance

    Gillig stated that it installed six different generations of turn
signal assemblies in the subject buses; however, after receiving two
complaints that their Generation 7 turn signal assemblies were not
sufficiently visible, Gillig and the turn signal manufacturer went back
and tested the previous generations to see if they met the requirements
of FMVSS No. 108. Test

results for generations 1 through 6 of the turn signal assemblies
showed that they do not meet all the minimum photometry requirements of
paragraph S<IP_ADDRESS>.1 of FMVSS No. 108.

IV. Rule Text

    Paragraph S<IP_ADDRESS>.1 of FMVSS No. 108 includes the requirements
relevant to this petition:

     When tested according to the procedure of S14.2.1, each
front turn signal lamp must be designed to conform to the base
photometry requirements plus any applicable multipliers as shown in
Tables VI-a and VI-b for the number of lamp compartments or
individual lamps and the type of vehicle it is installed on.

V. Summary of Gillig's Petition

    Gillig described the subject noncompliance and stated its belief
that the noncompliance is inconsequential as it relates to motor
vehicle safety.
    In support of its petition, Gillig submitted the following
arguments:
    1. Analysis: For front turn signals, the FMVSS No. 108 photometry
requirements provide that ``when tested according to the procedure of
S14.2.1, each front turn signal lamp must be designed to conform to the
base photometry requirements plus any applicable multipliers \1\ for
the number of lamp compartments or individual lamps and the type of
vehicle it is installed on.'' See FMVSS No. 108, S<IP_ADDRESS>.1.
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    \1\ All of the designs of the turn signal assemblies employ a
reflector. Since the spacing from the geometric centroid of the turn
signal to the lighted edge of the lower beam of the headlamp is
greater than 100 mm, a multiplier is not applicable. (FMVSS No. 108,
S<IP_ADDRESS>.3, S<IP_ADDRESS>.4(a)).
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    A front turn signal lamp meets the photometry requirements of FMVSS
No. 108 if it: (1) Meets the minimum photometric intensity (PI)
requirement in each of the five test groups, (2) none of the values for
the individual test points are less than 60% of its own minimum PI
value, and (3) the minimum PI value between test points is not less
than the lower specified minimum value of the two closest adjacent test
points on a horizontal or vertical line. Stated another way, an
individual test point may be up to 40% below its minimum PI value as
long as the group in which it is contained achieves the overall group
minimum PI value. Based on this approach, even if the turn signal did
not meet the minimum photometry requirements at multiple individual
test points, the assembly complies with the standard as long as the
overall light intensity of all the test points included within the
group does not fall below the required minimum value of the group. (See
61 FR 1663; January 23, 1996) (``The photometric requirements for turn
signal lamps may be met at zones or groups of test points, instead of
at individual test points.'')
    Gillig, in concert with Hamsar Diversco (Hamsar), its lighting
supplier, conducted a series of compliance testing for Generations 1 to
6. In order to accurately execute the tests, Hamsar used CAD drawings
of the Gillig Low Floor bus to construct an aluminum test stand
fixture. The test stand precisely matched the orientation and angle at
which the turn signal would have been installed on a Gillig Low Floor
bus. Hamsar then conducted a series of tests measuring the PI output
using samples of each of the available generations of turn signals. A
summary of test data shows:
    (a) For Generations 1 and 2 (the oldest generations), the
assemblies meet the minimum photometric intensity (PI) requirements for
3 of 5 test groups and allowable 60% of minimum PI at 13 of 19
individual test points. The turn signal's overall PI output of 1271
candelas is approximately 25% below the combined minimum requirements
for all 5 groups (1710 candelas).
    (b) For turn signals in Generation 3, the assemblies meet the
minimum PI requirements for 3 of 5 test groups and allowable 60% of
minimum PI at 13 of 19 individual test points. However, the overall PI
output for Generation 3 turn signals of 2506 candelas is 47% greater
than the combined minimum requirements for all 5 groups (1710
candelas).\2\
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    \2\ In addition, the integrated side markers for Generation 3
turn signals were tested and meet all photometric requirements.
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    (c) For turn signals in Generation 4, the assemblies meet the
minimum PI requirements for 3 of 5 test groups and allowable 60% of
minimum PI at 15 of 19 individual test points. However, the overall PI
output for Generation 4 turn signals of 2120 candelas is 24% greater
than the combined minimum requirements for all 5 groups (1710
candelas).
    (d) For turn signals in Generation 5, the assemblies meet the
minimum PI requirements for 2 of 5 test groups and allowable 60% of
minimum PI at 8 of 19 individual test points. However, the overall PI
output for Generation 5 turn signals of 1403 candelas is only 18% below
the combined minimum requirements for all 5 groups (1710 candelas).
    (e) For turn signal assemblies in Generation 6, the assemblies also
meet the minimum photometric intensity for 3 of 5 test groups and
allowable 60% of minimum photometric intensity at 12 of 19 individual
test points. The overall photometric intensity output for Generation 6
turn signals of 4201 candelas is 146% greater than the combined minimum
requirements for all 5 groups (1710 candelas).
    Gillig states that for the test groups in each generation that meet
the PI requirements, the values for those groups well exceed the
minimum values for the group. The PI output for groups exceeding the
minimum values in Generations 1 and 2 achieve 119%-242% of minimum
values. The PI output for Generation 3 turn signals achieve 105%-575%
of minimum values. The PI output for Generation 4 turn signals achieve
109%-386% of minimum values. The PI output for Generation 5 turn
signals achieve 224%-267% of minimum values. Finally, the PI output for
Generation 6 turn signals achieve 114%-1022% of minimum values.
    Gillig further contends that the turn signals are sufficiently
bright and visible overall and there is little if any perceptible
difference in light output when compared with a compliant turn signal.
The comparisons also illustrate how visually similar the performance of
the earlier generations of the assemblies are to the FMVSS No. 108
standard, and why their noncompliance garnered no attention, by Gillig
or its customers, in over twenty years of production.
    2. NHTSA has Previously Granted Petitions Where Lighting Equipment
Did Not Meet the Photometry Requirements: Gillig contends that from its
inception, the Safety Act has included a provision recognizing that
some noncompliances pose little or no safety risk. In applying this
recognition to particular fact situations, Gillig asserts that the
agency considers whether the noncompliance gives rise to ``a
significantly greater risk than . . . in a compliant vehicle.'' See 69
FR 19897-19900 (April 14, 2000).
    Relying on this same principle, Gillig contends that despite the
technical noncompliance with the PI requirements, the light output in
Generation 1-6 turn signals is sufficiently bright and does not create
a greater risk than turn signal assemblies that fully meet the
photometric parameters. Gillig states that NHTSA has considered
deviations from these photometric parameters on numerous occasions,
frequently finding that there is no need for a recall remedy campaign
when there are other factors contributing to the overall brightness of
the equipment.

    For example, the agency granted a petition by General Motors \3\
where its turn signals met the photometry requirements in 3 of 4 test
groups and produced, on average, 90% of the required PI output. For the
three complying groups of turn signals, the assemblies exceeded the
light intensity requirements by at least 20%.
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    \3\ 61 FR 1663-1664 (January 22, 1996).
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    Gillig further states that the agency granted similar petitions for
inconsequential noncompliance where the product did not meet the
photometric intensity requirements.\4\
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    \4\ 78 FR 46000 (July 30, 2013); 55 FR 37602 (September 12,
1990); 61 FR 1663 (January 22, 1996).
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    Here, Gillig asserts that because the PI output of the compliant
test groups within Generations 3, 4 and 6 exceeds the candela
requirements by a substantial margin, a range of 24%-146% above, the
additional candela offsets the overall performance of the turn
signals.\5\
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    \5\ 63 FR 70179 (December 18, 1998); 61 FR 1663-1664 (January
22, 1996).
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    Gillig observes that in some instances, involving reduced
photometric output, NHTSA has denied the petition on the basis that the
condition created a measurable impact on the driver's ability to see
objects on or above the road.\6\ In contrast, according to Gillig, the
only indication of such an impact involves the Generation 7 assemblies
for which Gillig is in the process of conducting a recall remedy
campaign. Gillig states that there is no indication that the deviation
in performance for Generations 1-6 has led to any difficulty in seeing
and responding to the turn signals, and as supported by the field
history, the turn signal assemblies have operated successfully for
years and in some cases decades.
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    \6\ 66 FR 38340 (July 23, 2001).
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    Gillig states that the agency has long considered changes in light
output in the range presented here as being visually imperceptible to
vehicle occupants or other drivers.\7\ Gillig also states that the
agency has noted that turn signals, unlike headlamps, do not affect
road illumination so that a reduced amount of light output would not,
by itself, create an increased risk to the public.\8\
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    \7\ 59 FR 65428 (December 19, 1994).
    \8\ 66 FR 38341 (July 23, 2001).
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    Finally, according to Gillig, the environment in which the Gillig
turn signals are used diminishes any potential risk to safety. Gillig
explains that because the buses in which the subject turn signals are
installed are predominantly public transit buses, they are managed by
fleet operators and undergo regular maintenance and reviews by skilled
technicians.\9\ Part of that process includes a pre-trip inspection.
That protocol requires a review of the bus's operating systems,
including a review of the turn signals. Consequently, according to
Gillig, if the photometric intensity of the Generations 1-6 lights were
inadequate, trained professional service personnel and drivers would
have identified this over the years, and in some cases, decades of pre-
trip inspections.\10\ Gillig states it has never received a complaint,
notice or report related to visibility concerns with the Generation 1-6
turn signals, underscoring the overall visibility of the turn signals.
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    \9\ According to Gillig, the typical life cycle for a public
transit bus is either 12 years or 500,000 miles, meaning that the
majority of the vehicles with Generation 1-6 turn signals may no
longer be in service. However, arguments that only a small number of
vehicles or items of motor vehicle equipment are affected by a
noncompliance do not justify granting an inconsequentiality
petition.
    \10\ 64 FR 44575 (August 16, 1999).
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    Gillig concludes by stating that the subject noncompliance is
inconsequential as it relates to motor vehicle safety, and that its
petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    3. Supplemental Petition: In April 2017, and as part of its ongoing
quality review process, Gillig contracted with an independent lighting
certification laboratory (Calcoast-ITL) to conduct a series of
additional compliance tests for the turn signals included in
Generations 1-6. In order to accurately execute the testing, CAD
drawings of the front of the Gillig Low Floor bus were used to
construct an aluminum test stand fixture. The test stand precisely
matched the orientation and angles at which the right and left front
turn signals would have been installed on the bus. The laboratory then
conducted a series of tests measuring the PI output using samples of
each of the available generations of turn signals. The testing was
certified to have been conducted in accordance with the FMVSS 108 Test
Procedure (TP-108-13). A summary of the test data provides:
    (a) For Generations 1 and 2 (the oldest generations), the
assemblies meet the minimum photometric intensity (PI) requirements for
3 of 5 test groups and allowable 60% of minimum PI at 13 of 19
individual test points. The turn signal's overall PI output of 1364
candelas is approximately 20% below the combined minimum requirements
for all 5 groups (1710 candelas).
    (b) For turn signals in Generation 3, the assemblies meet the
minimum PI requirements for 3 of 5 test groups and allowable 60% of
minimum PI at 15 of 19 individual test points. However, the overall PI
output for Generation 3 turn signals of 2387 candelas is 40% greater
than the combined minimum requirements for all 5 groups (1710
candelas).\11\
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    \11\ In addition, the integrated side markers for Generation 3
turn signals were tested and meet all photometric requirements.
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    (c) For turn signals in Generation 4, the assemblies meet the
minimum PI requirements for 4 of 5 test groups and allowable 60% of
minimum PI at 15 of 19 individual test points. However, the overall PI
output for Generation 4 turn signals of 3307 candelas is 93% greater
than the combined minimum requirements for all 5 groups (1710
candelas).
    (d) For turn signals in Generation 5, the assemblies meet the
minimum PI requirements for 2 of 5 test groups and allowable 60% of
minimum PI at 12 of 19 individual test points. However, the overall PI
output for Generation 5 turn signals of 2385 candelas is only 39% below
the combined minimum requirements for all 5 groups (1710 candelas).
    (e) For turn signal assemblies in Generation 6, the assemblies also
meet the minimum photometric intensity for 4 of 5 test groups and
allowable 60% of minimum photometric intensity at 17 of 19 individual
test points. The overall photometric intensity output for Generation 6
turn signals of 5655 candelas is 231% greater than the combined minimum
requirements for all 5 groups (1710 candelas).
    Thus, the new PI output for groups that exceed the minimum values
are:
     Generations 1 and 2 achieve 122%-267% of minimum values.
     Generation 3 achieves 192%-428% of minimum values.
     Generation 4 achieves 125%-598% of minimum values.
     Generation 5 achieves 367%-445% of minimum values.
     Generation 6 achieves 143%-1185% of minimum values.
    As a result, according to Gillig, the groups that exceed the
minimum values in each lamp compensate for the groups that are below
the minimums to the extent that the overall PI outputs of the most
recent four generation of lights (Generations 3-6) significantly exceed
the overall PI output required for a front turn signal lamp (1710
candelas).
    As part of Gillig's supplemental petition, it included a video
which shows a side-by-side comparison of

Generation 1-6 turn signal assemblies with a newer generation of turn
signal that exceeds all FMVSS No. 108 minimum requirements for
photometry. Gillig says that the comparisons were performed with the
lights in their various generations installed on the same bus as it was
driven through a turning maneuver (filmed indoors to control ambient
lighting throughout the comparisons). Gillig believes that it is
evident from the multiple angles in the video that the lights from
Generation 1-6 are so bright and large that they are virtually
indistinguishable from the newer version.
    Gillig's complete petition and all supporting documents are
available by logging onto the Federal Docket Management System (FDMS)
website at: https://www.regulations.gov and following the online search
instructions to locate the docket number listed in the heading of this
notice.

VI. NHTSA Analysis

    As part of Gillig's petition, Gillig submitted third-party
compliance test reports which indicated that the turn signal lamps
failed to meet the turn signal lamp photometry requirements in Table VI
of FMVSS No. 108 as outlined below:
     Generation 1 and 2 turn signal lamps--
    [cir] Two out of the five groups failed to meet the group minimum
photometric intensity.
    [cir] Six out of the nineteen test points fell below 60% of the
minimum requirement (the values ranged from 32% to 49% of the minimum
requirement).
     Generation 3 turn signal lamps--
    [cir] Two out of the five groups failed to meet the group minimum
photometric intensity.
    [cir] Four out of the nineteen test points fell below 60% of the
minimum requirement (the values ranged from 40% to 53% of the minimum
requirement).
     Generation 4 turn signal lamps--
    [cir] Two out of the five groups failed to meet the group minimum
photometric intensity.
    [cir] Four out of the nineteen test points fell below 60% of the
minimum requirement (the values ranged from 41% to 50% of the minimum
requirement).
     Generation 5 turn signal lamps--
    [cir] Three out of the five groups failed to meet the group minimum
photometric intensity.
    [cir] Seven out of the nineteen test points fell below 60% of the
minimum requirement (the values ranged from 14% to 55% of the minimum
requirement).
     Generation 6 turn signal lamps--
    [cir] Two out of the five groups failed to meet the minimum
photometric intensity.
    [cir] Two out of the nineteen test points fell below 60% of the
minimum requirement (the values ranged from 30% to 50% of the minimum
requirement).
    The above summary indicates that the turn signal lamps in these
vehicles are noncompliant.
    According to Gillig, the assemblies were certified as compliant
using an axis of reference that did not correspond to the actual
orientation of the lighting as installed on the bus. Gillig's petition
concerns the ability of the lamps to meet FMVSS No. 108 for certain
test points when tested at their final installation angle.
    NHTSA does not find Gillig's arguments persuasive that the
noncompliant light output from the installed lamps is inconsequential
to safety, as explained below:
    Consistent with what was previously stated in 63 FR 1663 (January
23, 1996), NHTSA herein reiterates that the photometric requirements
for turn signal lamps may be met at zones or groups of test points,
instead of at individual test points as long as each individual test
point is at least 60% of the minimum requirement. However, Gillig
attempted to justify the noncompliance by pointing to the sum of all
group minimums. Overall photometric intensity output, as described in
Gillig's petition, is not defined by FMVSS No. 108 as the cumulative
value of group minimums. Rather, FMVSS No. 108 per Table VI-a footnote
1 permits a test point in a group to be less than the minimum required
value, if and only if it is also not less than 60% of the minimum and
the group minimum can be still met when adjacent test points within the
group make up the difference. A group failing to meet the group minimum
requirements is a noncompliance. In addition, it should also be noted
that if a test point in a group has a value that is less than 60% of
the minimum required value, then it is also non-compliant. The lamps as
installed in Gillig's buses do not meet minimums and therefore will
provide insufficient output to signal appropriately to motorists and
pedestrians. The need for safety for this requirement is to have a
vehicle's turn signal be clearly visible at all zones/groups.
    Furthermore, based on NHTSA's review of the submitted test reports,
it appears that the turn signal lamps subject to the petition were not
tested for visibility in their installed position. Having insufficient
visibility would create a potentially unsafe condition if other
motorists or pedestrians could not see the turn signal as intended by
the standard.
    NHTSA reviewed Gillig's referenced inconsequential non-compliance
petitions used to support its petition and found them to be
unpersuasive. 61 FR 1663-1664 (January 22, 1996) showed failed
photometric values of 10% below the minimum and 78 FR 46000 (July 30,
2013) showed photometric values of 4% below the lower limit, both of
which are supported by 55 FR 37602 (September 12, 1990) and ``Driver
Perception of Just Noticeable Differences of Automotive Signal Lamp
Intensities'' (DOT HS 808 209, September 1994) where a reduction of 25%
of luminous intensity is required before the human eye can detect the
difference between two lamps. 55 FR 37602 (September 12, 1990) and
``Driver Perception of Just Noticeable Differences of Automotive Signal
Lamp Intensities'' (DOT HS 808 209, September 1994) does not apply to
Gillig's petition since each generation contained a failing group
ranging from 41% to 77% below the required group minimum. 63 FR 70179
(December 18, 1998) is unpersuasive as this pertains to stop lamps
which have different activation requirements than turn signal lamps and
more than one light source will always be illuminated, as opposed to
turn signal lamps. 66 FR 38341 (July 23, 2001) is irrelevant because
the term ``less critical'' does not necessarily mean it does not impact
safety. 64 FR 44575 (August 16, 1999) is irrelevant because replacement
of a turn signal bulb will restore optimal performance to the turn
signal assembly and a more rigorous maintenance schedule is intended to
compensate for an improper turn signal bulb outage indicator.

VII. NHTSA's Decision

    In consideration of the foregoing, NHTSA finds that Gillig has not
met its burden of persuasion that the FMVSS No. 108 noncompliance is
inconsequential as it relates to motor vehicle safety. Accordingly,
Gillig's petition is hereby denied and Gillig is obligated to provide
notification of, and a remedy for, that noncompliance under 49 U.S.C.
30118 through 30120.

    Authority: (49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8)

Jeffrey Mark Giuseppe,
Associate Administrator for Enforcement.
[FR Doc. 2019-01920 Filed 2-11-19; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)]
[Notices]
[Pages 26539-26540]
[FR Doc No: 2016-10313]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of the Commission's staff may attend the following
meetings related to the transmission planning activities of the New
York Independent System Operator, Inc.

The New York Independent System Operator, Inc. Joint Electric System
Planning Working Group and Transmission Planning Advisory Meeting

May 5, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=bic_espwg&directory=2016-05-05.

The New York Independent System Operator, Inc. Business Issues
Committee Meeting

May 18, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=bic&directory=2016-05-18.

The New York Independent System Operator, Inc. Operating Committee
Meeting

May 19, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=oc&directory=2016-05-19.

The New York Independent System Operator, Inc. Management Committee
Meeting

May 25, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/committees/documents.jsp?com=mc&directory=2016-05-25.
    The discussions at the meetings described above may address matters
at issue in the following proceedings:
    New York Independent System Operator, Inc., Docket No. ER13-102.
    New York Independent System Operator, Inc., Docket No. ER15-2059.
    New York Independent System Operator, Inc., Docket No. ER16-120.
    New York Independent System Operator, Inc., Docket No. ER13-1942.
    New York Transco, LLC, Docket No. ER15-572.
    New York Independent System Operator, Inc., Docket No. ER16-966.
    For more information, contact James Eason, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: April 27, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-10313 Filed 5-2-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Rules and Regulations]
[Page 28488-28492]
[DOCID:fr21my10-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0663; FRL-8824-9]

Silver Nitrate; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of silver nitrate (CAS Reg. No. 7761-88-8)
when used as an inert ingredient under 40 CFR 180.910 as stabilizer at
a maximum of 0.06% by weight in pesticide formulations as post-harvest
treatment for potatoes to control sprouting. Wagner Regulatory
Associates on behalf of Pimi Agro CleanTech, Ltd. submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting establishment of an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of silver nitrate.

DATES: This regulation is effective May 21, 2010. Objections and
requests for hearings must be received on or before July 20, 2010, 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-2009-0663. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., 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 (703)
305-5805.

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

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://
www.gpoaccess.gov/ecfr

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, and any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2009-0663 in the subject line on the first page of
your submission. All objections and requests for a hearing must be in
writing, and must be received by the Hearing Clerk on or before [date
60 days after date of publication in the Federal Register]. Addresses
for mail and hand delivery of objections and hearing requests are
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2009-0663 by one following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Exemption

    In the Federal Register of October 7, 2009 (74 FR 5159) (FRL-8792-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 9E7584) by
Wagner Regulatory Associates on behalf of Pimi Agro CleanTech, Ltd.,
P.O.Box. 117, Hutzot Alonim 30049, Israel. The petition requested that
40 CFR 180.910 be amended establishing an exemption from the
requirement of a tolerance for residues of silver nitrate (CAS Reg. No.
7761-88-8) when used as an inert ingredient stabilizer at 0.06% by
weight in pesticide formulations applied to

potatoes as a post-harvest treatment to control sprouting. That notice
referenced a summary of the petition prepared by Wagner Regulatory
Associates on behalf of Pimi Agro CleanTech, the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply no
toxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the 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 chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), 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 silver nitrate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with silver nitrate
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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 silver nitrate are discussed in this
unit.
    The following provides a brief summary of the risk assessment and
conclusions for the Agency's review of silver nitrate. The Agency's
full decision document for this action is available in the Agency's
electronic docket (regulations.gov) under the docket number EPA-HQ-OPP-
2009-0663.
    Silver nitrate is a water soluble inorganic salt that readily
dissociates into the silver cation and the nitrate/nitrite anion.
Nitrate and nitrite are naturally occurring inorganic ions which are
part of the nitrogen cycle. Nitrate is a natural constituent of soil
and vegetation. Nitrate is also a normal metabolite in mammals. Nitrate
in soil, ground water and surface water are derived mainly from
mineralization of soil organic matter as well as from application of
mineral fertilizers.
    The EPA IRIS lists an oral RfD for chronic noncarcinogenic health
effects for nitrate (as nitrate nitrogen) based on early clinical signs
of methemoglobinemia in excess of 10% (0-3 months old infant's
formula).
    Silver ions and preparations containing silver in an ionic state
have been used for over a century for medicinal and bactericidal
purposes. Because of its bactericidal properties, silver has been used
as a topical treatment for burns, as a treatment for venereal diseases,
as an ingredient in cosmetic formulation, in the sanitation of swimming
pools and hot tubs/spas, and cleansing of hard surfaces in various food
handling. Silver has also been used in dentistry (as amalgams and as an
ingredient in mouth washes), in acupuncture, jewelry making, and
photography. Silver can be found in electroplating as well as in paints
and in water purification systems.
    The toxicity of silver is well understood based on epidemiological
data from humans, toxicology data in animals, and documented
information on the metabolism of silver in mammalian species. These
studies show that the effect of concern for silver is argyria, a bluish
discoloration of the skin. Argyria, while a permanent condition, is a
cosmetic condition. The function of the skin as an organ is not
compromised and the resulting discoloration is not associated with
systemic toxicity. Information regarding the toxicity of silver is
discussed in detail in the recent rulemaking establishing an exemption
from tolerance for silver used as a surface sanitizing solution in the
Federal Register published on June 10, 2009 (74 FR 27447; FRL-8412-1).

B. Regulatory Levels

    The EPA's IRIS lists an oral RfD for chronic noncarcinogenic health
effects for nitrate (as nitrate nitrogen) of 1.6 miligrams/kilogram/day
(mg/kg/day). This RfD is derived from human epidemiological surveys
using a no observed adverse effect level (NOAEL) of 10 mg nitrate-
nitrogen/L (equivalent to 1.6 mg/kg/day) and lowest observable adverse
effect level (LOAEL) of 11-20 mg nitrate-nitrogen/L (equivalent to 1.8-
3.2 mg/kg/day) based on early clinical signs of methemoglobinemia in
excess of 10% (0-3 months old infant's formula).
     Safe exposure levels for silver have been established by several
regulatory Agencies including FDA, OSHA and other offices within EPA
based on the common endpoint argyria and using the same human studies.
Argyria occurs only after chronic exposure. Both the

Secondary Maximum Contamination Level (SMCL) reported by the EPA's
Office of Water and the oral RfD reported under the EPA's IRIS were
determined based on a human biomonitoring study. For the oral exposure
route, the Agency is relying on the drinking water SMCL of 0.1 mg/L
(0.003 mg/kg/day) based on skin discoloration and graying of the whites
of eyes (argyria) and using a safety factor of 3X. The Agency applied
an additional 3x uncertainty factor to further address the lack of a
NOAEL in the study on which this assessment and all regulatory
advisories are set. Thus, a composite database factor of 10X is being
applied yielding a chronic RfD of 0.001 mg/kg/day. This composite
factor of 10X should be sufficient for providing protection from the
non-toxic effects which may result from chronic oral exposure to
silver.

Chronic RfD = 0.003 mg/kg/day / 3 = 0.001 mg/kg/day

    A full discussion of the derivation of the RfD is contained in the
previously-mentioned tolerance exemption action. (June 10, 2009).
    The Agency has concluded that the silver RfD of 0.001 mg/kg/day
would be protective of both the toxic effects of silver and nitrate
because the silver SMCL is nearly 1,000X below the RfD calculated for
nitrate (1.6 mg/kg/day). Therefore, given that silver and nitrate
exposure would be roughly equivalent, a separate human health risk
assessment for nitrate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to silver nitrate, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from silver nitrate in food as follows:
    Residue analysis of whole tuber washed potato samples treated with
silver nitrate showed 0.0085 ppm (equivalent to 0.0085 mg/kg) of
silver.
    Silver nitrate dietary exposure assessment was conducted using the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), Version 2.00. No drinking
water exposure assessment was included in the DEEM run since no outdoor
or potable human drinking water system uses for this proposed use of
silver nitrate. The residues value of 0.0085 ppm (equivalent to 0.0085
mg/kg/day) of silver nitrate and an empirical processing factor of 6.5
for dry potatoes were used in this assessment. However, default
processing factors were used for potato, tuber with or without peel.
The use of the default processing factors for potato, tuber
overestimates exposure to these commodities.
    Recently, EPA assessed chronic dietary exposure from the use of
silver as a food contact sanitizer. (June 10, 2009). The dietary
assessment was only completed for chronic routes end point of concern
because the end point of concern that has been identified is based on
argyria, one that occurs only after chronic exposure. For dietary
exposures from this product being used on countertops, the Incidental
Dietary Residential Exposure Assessment Model, (IDREAMTM)
incorporates consumption data from United State Department of
Agriculture (USDA) Continuing Surveys of Food Intakes by Individuals
(CSFII), 1994-1996 and 1998. The 1994-1996, 98 data are based on the
reported consumption of more than 20,000 individuals over two non-
consecutive survey days.
    2. Dietary exposure from drinking water There are no outdoor or
potable human drinking water system uses for this proposed use of
silver. In addition, the uses identified as indoor hard surface
applications will result in minimal, if any, runoff of silver into the
surface water. The use of silver as a food contact surface sanitizer
will result in minimal, if any, runoff of silver into the surface
water. This use will result in an insignificant contribution to
drinking water exposures. In addition to sanitization, silver is
registered as an active ingredient in water filters. The bacteriostatic
water filters are impregnated with silver and may result in residues in
the drinking water supply. However, the levels of available residues
resulting from impregnated water filters are much less when in
comparison to the amount of residues that will be available for intake
when silver-containing liquid concentrates are used. As a result, any
drinking water exposures from the new use of silver are assumed to be
negligible. Additionally, any drinking water risks from impregnated
filters are assumed to be represented by the dietary risks resulting
from hard surface sanitization. The Agency believes that an assessment
of any potential risks resulting from silver in drinking water is not
warranted at this time.
    Therefore, based on the proposed uses of silver, the Agency
believes that risks resulting from silver in drinking water will be
negligible and as assessment is not warranted at this time.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in
food or in drinking water. Exposures may occur during and after
application on hard surfaces (e.g., floors). Each route of exposure
(incidental oral, dermal, inhalation) is considered where appropriate.
The risks to handlers are quantitatively assessed based on the nature
of the chemical. There are no adverse toxicological consequences
(systemic or irritation) resulting from contact with silver other than
skin discoloration. Residential exposures are short-term (<30 days) and
intermediate-term (1-6 months) in nature. As supported in the
toxicological discussion, however, silver ion produces only cosmetic
effects and only as a result of chronic exposures. In addition,
incidental ingestion (hand to mouth behavior of a child on a treated
floor) as well as dermal exposures resulting from a child contacting a
freshly cleaned floor is considered short-term in duration.
    Based on the fact that silver will exist in the ionic form, which
does not volatilize, any post application inhalation exposures to
vapors are expected to be negligible. Essentially, there are no
toxicological consequences (systematic or irritation) resulting from
contact with silver other than discoloration.
    Other non-pesticidal industrial uses of silver include, but are not
limited to, photography, cosmetics, sunscreens, manufacture of inks and
dyes, mirror production, and in jewelry. All these uses may result in
exposures via the dermal route, which over a chronic duration, may
cause skin discoloration. However, dermal exposures resulting from
these uses are not appropriate to include in this aggregate exposure
assessment. Systemic uptake and distribution of silver does not occur
via the dermal route. The specific uses of silver that were considered
for this aggregate assessment include the cleansing of hard surfaces in
various food handling, institutional, medical and residential premises.
    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.''
    EPA has not found silver nitrate to share a common mechanism of
toxicity with any other substances, and silver nitrate does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
silver nitrate does not have 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 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 extensive data and
analysis on silver's toxicity in the historical data/literature and
regulatory advisories established by other Federal Agencies, which do
not indicate an increased susceptibility of children to the toxic
effects of silver. A National Toxicology Program (NTP) developmental
toxicity study concluded that the NOAEL recorded for developmental
toxicity in rats receiving gavages doses of silver acetate was greater
than 100 mg/kg/day when the test material was administered on gestation
day 6 through 19. No increase in susceptibility was apparent in this
study. Furthermore, silver nitrate has been used for decades to treat
neonatal conjunctivitis. Finally, there is no reason to believe that
the effects that are observed following the administration of silver
would warrant additional safety factors for children. The skin is the
target organ and deposition of silver should not be age dependent.
Moreover, because EPA believes that the available biomonitoring studies
adequately characterize variability in human sensitivity, EPA is not
applying an intra-species uncertainty factor in deriving the chronic
RfD for silver.
    3. Conclusion. Although EPA is not applying an inter-species
uncertainty factor (because of reliance on human data) or an intra-
species uncertainty factor (because human sensitivity has been
adequately characterized), EPA is retaining the 10X FQPA safety factor
in assessing oral risk to address the fact that the dose used to
determine the chronic RfD showed effects from silver (argyria). In
making its determination regarding the appropriate safety factors for
evaluating the risk of silver, EPA took into account that argyria is
not a toxic effect, there is no evidence of increased sensitivity in
the young from exposure to silver, and the exposure assessment for
silver is very conservative.

E. Aggregate Risks and Determination of Safety

     Determination of safety section. EPA determines whether acute and
chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute population adjusted dose (aPAD) and
chronic population adjusted dose (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate point of
departures (PODs) to ensure that an adequate margin of exposure (MOE)
exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from 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,
silver nitrate is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into
account exposure estimates from chronic dietary consumption of food and
from the use of silver as a food contact sanitizer. Using the exposure
assumptions described in this unit for chronic exposure and the use
limitations of not more than 0.06% by weight in pesticide formulations,
the chronic dietary exposure from food to silver nitrate is 20% of the
cPAD for the U.S. population and 63.8.6% of the cPAD for children 1-2
years old, the most highly exposed population subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Because no short-term adverse effect was identified, silver nitrate
is not expected to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Because no intermediate-term adverse effect was identified, silver
nitrate is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to silver nitrate.
    6. 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 silver nitrate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes
since the Agency is not establishing a numerical tolerance for residue
of silver nitrate in or on any food commodities. EPA is establishing a
limitation on the amount of silver nitrate that may be used in
pesticide formulations. That limitation will be enforced through the
pesticide registration process under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will
not register any pesticide for sale or distribution that contains
greater than 0.06% of silver nitrate by weight in the pesticide
formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.

    Option 1: If there is NO relevant international standard, use this:

     The Agency is not aware of any country requiring a tolerance for
silver nitrate nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.

VI. Conclusions

     Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180. 910 for silver nitrate 7761-88-8) when
used as an inert -ingredient (stabilizer at no more than 0.06% by
weight) in pesticide formulations applied to potatoes as a post-harvest
treatment to control sprouting.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled 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).

VIII. 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 12, 2010.
Lois Rossi,
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 Sec. 180.910, the table is amended by adding alphabetically
the following inert ingredient to read as follows:

Sec.  180.910  Inert ingredients used pre-harvest and post-harvest;
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Silver Nitrate (Cas Reg. No.      For use on          stabilizer
 7761-88-8)                        potatoes as post-
                                   harvest treatment
                                   to control
                                   sprouting at no
                                   more than 0.06%
                                   by weight in
                                   pesticide
                                   formulations
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-12116 Filed 5-20-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Notices]
[Page 76357-76360]
[DOCID:fr23de05-125]

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Part II

Environmental Protection Agency

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Fifty-Seventh Report of the TSCA Interagency Testing Committee to the
Administrator of the Environmental Protection Agency; Receipt of Report
and Request for Comments; Notice

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2005-0062; FRL-7751-8]

Fifty-Seventh Report of the TSCA Interagency Testing Committee to
the Administrator of the Environmental Protection Agency; Receipt of
Report and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its Fifty-Seventh Report to the
Administrator of EPA on November 22, 2005. In the 57th ITC
Report, which is included with this notice, there are no changes to the
TSCA section 4(e) Priority Testing List published in the
56th ITC Report in the Federal Register of October 24, 2005.
As stated in the 56th ITC Report, it was the ITC's intention
to provide in this 57th ITC Report a data-availability study
of the high production volume (HPV) chemicals in the 2002 Inventory
Update Rule (IUR). The study of the HPV chemicals in the 2002 IUR may
be made available after the ITC has had an opportunity to review
comments received on the study of the HPV chemicals described in the
56th ITC Report. In addition, the ITC needs additional time
to review information submitted from the International Tungsten
Industry Association, the Indium Corporation of America, and the
Vanadium Producers and Reclaimers Association, as well as data on
tungsten, indium, and vanadium compounds submitted in response to TSCA
section 8(a) Preliminary Assessment Information Reporting (PAIR) rules.

DATES: Comments must be received on or before January 23, 2006.

ADDRESSES: Comments, identified by docket identification (ID) number
EPA-HQ-OPPT-2005-0062, may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division (7408M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This notice is directed to the public in general. It may, however,
be of particular interest to you if you manufacture (defined by statute
to include import) and/or process TSCA-covered chemicals and you may be
identified by the North American Industrial Classification System
(NAICS) codes 325 and 32411. Because this notice is directed to the
general public and other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
interested in this action. 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket ID number EPA-HQ-OPPT-2005-0062. The official
public docket consists of the documents specifically referenced in this
action, any public comments received, and other information related to
this action. Although a part of the official docket, the public docket
does not include Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. The official
public docket is the collection of materials that is available for
public viewing at the EPA Docket Center, Rm. B102-Reading Room, EPA
West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket
Center is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The EPA Docket Center Reading Room telephone
number is<PHONE_NUMBER>, and the telephone number for the OPPT Docket,
which is located in EPA Docket Center, is<PHONE_NUMBER>.
    2. Electronic access. 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 additional information about the ITC at http://www.epa.gov/opptintr/.

itc/ or through the web site for the Office of Prevention, Pesticides
and Toxic Substances (OPPTS) at http://www.epa.gov/opptsfrs/home/opptsim.htm/
.

    EDOCKET, EPA's electronic public docket and comment system was
replaced on November 25, 2005, by an enhanced federal-wide electronic
docket management and comment system located at http://www.regulations.gov/.
 Follow the on-line instructions.

    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public

comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or

delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
    1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.

Once in the system, select ``search,'' and then key in docket ID number
EPA-HQ-OPPT-2005-0062. The system is an ``anonymous access'' system,
which means EPA will not know your identity, e-mail address, or other
contact information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to<EMAIL_ADDRESS>
Attention: Docket ID Number EPA-HQ-OPPT-2005-0062. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
EPA-HQ-OPPT-2005-0062. The DCO is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
DCO is<PHONE_NUMBER>.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    We invite you to provide your views and comments on the
57th ITC Report. You may find the following suggestions
helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. Provide specific examples to illustrate your concerns.
    5. Make sure to submit your comments by the deadline in this
notice.
    6. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

II. Background

    TSCA (15 U.S.C. 260l et seq.) authorizes the Administrator of EPA
to promulgate regulations under TSCA section 4(a) requiring testing of
chemicals and chemical groups in order to develop data relevant to
determining the risks that such chemicals and chemical groups may
present to health or the environment. Section 4(e) of TSCA established
the ITC to recommend chemicals and chemical groups to the Administrator
of EPA for priority testing consideration. Section 4(e) of TSCA directs
the ITC to revise the TSCA section 4(e) Priority Testing List at least
every 6 months.

A. The ITC's 57th Report

    In this 57th ITC Report to the Administrator of EPA,
there are no changes to the TSCA section 4(e) Priority Testing List
published in the 56th ITC Report in the Federal Register of
October 24, 2005 (70 FR 61520) (FRL-7739-9) (http://www.epa.gov/fedrgstr/EPA-TOX/2005/October/Day-24/t21197.htm
). As stated in the

56th ITC Report, it was the ITC's intention to

provide in this 57th ITC Report a data-availability study of
HPV chemicals in the 2002 IUR. The study of the HPV chemicals in the
2002 IUR may be made available after the ITC has had an opportunity to
review comments received on the study of the HPV chemicals described in
the 56th ITC Report. In addition, the ITC needs additional
time to review information submitted from the International Tungsten
Industry Association, the Indium Corporation of America, and the
Vanadium Producers and Reclaimers Association, as well as data on
tungsten, indium, and vanadium compounds submitted in response to TSCA
section 8(a) PAIR rules.

B. Status of the Priority Testing List

    There are no changes to the TSCA section 4(e) Priority Testing List
published in the 56\th\ ITC Report.

List of Subjects

    Environmental protection, Chemicals, Hazardous substances.

    Dated: December 16, 2005.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.

Fifty-Seventh Report of the TSCA Interagency Testing Committee to the
Administrator, U.S. Environmental Protection Agency

    In this 57\th\ Interagency Testing Committee (ITC) Report to the
Administrator of EPA, there are no changes to the Toxic Substances
Control Act (TSCA) section 4(e) Priority Testing List published in the
56\th\ ITC Report in the Federal Register of October 24, 2005 (70 FR
61520) (FRL-7739-9) (http://www.epa.gov/fedrgstr/EPA-TOX/2005/October/Day-24/t21197.htm
). As stated in the 56\th\ ITC Report, it was the

ITC's intention to provide in this 57\th\ ITC Report a data-
availability study of the high production volume (HPV) chemicals in the
2002 Inventory Update Rule (IUR). The study of the HPV chemicals in the
2002 IUR may be made available after the ITC has had an opportunity to
review comments received on the study of the HPV chemicals described in
the 56\th\ ITC Report. In addition, the ITC needs additional time to
review information submitted from the International Tungsten Industry
Association, the Indium Corporation of America, and the Vanadium
Producers and Reclaimers Association, as well as data on tungsten,
indium, and vanadium compounds submitted in response to TSCA section
8(a) Preliminary Assessment Information Reporting (PAIR) rules.

[FR Doc. 05-24410 Filed 12-22-05; 8:45 am]

BILLING CODE 6560-50-S