UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES, AND

TOXIC SUBSTANCES

			PC Code:	 098301

			DB barcode: 299865

MEMORANDUM

March 2, 2007

Subject:	EFED Response to Public Comments for Aldicarb IRED:

	Docket ID# Opp-2005-0163-0176

To:	Bob McNally, Branch Chief

	Ann Overstreet, Team Leader

	Sherrie Kinard, Chemical Review Manager

Special Review Branch

Special Review and Reregistration Division

From:		Jonathan Angier

		Jeannette Martinez

		Donna Randall

Environmental Risk Branch II

Environmental Fate and Effects Division

Through:	Dana Spatz, RAPL

Tom Bailey, Ph.D, Branch Chief, ERB II,

Environmental Fate and Effects Division

Attached are  EFED’s responses to Bayer Crop Science’s refined
terrestrial and aquatic risk assessment (submitted March, 2006) and
public comments (submitted January, 2007) on the EFED risk assessment
dated September 2006.

Bayer Crop Science presented refined terrestrial and aquatic risk
assessments which used a revised (“refined”) PRZM-EXAMS model
currently used by EFED.  The PRZM-EXAMS model as revised by BCS utilized
putative region-specific soil degradation values, different soil
incorporation efficiencies, and different rainfall pattern assumptions.
The refined risk assessment submitted by BCS also incorporated a new
terrestrial model, GranPARAM, which claims to account for expected bird
behavior (specifically, ‘preferences’ for consuming grit over
granules).  In our response, the Agency will focus on the major
assumptions and supporting data Bayer used in developing their
assessment and model, and critically evaluate whether or not those
assumptions are adequately supported for use in an ecological risk
assessment, and ultimately for a risk management decision.

(1) Agency’s comments regarding BCS’ “Refined Wildlife Risk
Assessment”

As modeled in GranPARAM, birds ingest granules and grit by choice only,
either randomly or non-randomly. The fact that birds incidentally ingest
granules by foraging on soil invertebrates or insects is not accounted
for in the model. According to the Wildlife Exposure Factor Handbook (US
EPA, 1993. Vol. I of II), incidental soil ingestion varies greatly among
types of birds, and for some species makes up a large percentage of
their daily food intake. Some examples of percent ingestion of soil in
diet (dry weight) for birds that visit aldicarb treated fields are: <2%
for mallard duck, 8.2% for Canada goose, and 10.4 % for American
woodcock. Incidental soil ingestion is too important a pathway to be
neglected when assessing risk to birds from aldicarb use. The Agency’s
deterministic model accounts for incidental soil ingestion, among other
exposure pathways.

Furthermore, GranPARAM does not account for the fact that granules
dissolve in water, thus, becoming available to birds via drinking water
uptake (puddles formed on fields containing dissolved aldicarb), nor
does it account for food sources such as soil invertebrates and insects
carrying dissolved aldicarb residues on their membranes and exoskeleton.
Other important routes of exposure ignored by the model include
ingestion of contaminated plant material. The Agency’s deterministic
model indirectly considers all of these exposure pathways with the LD50
ft2 calculation.

Although granular aldicarb also poses risk to mammals, GranPARAM does
not address risks to this group of organisms.  Acute and chronic
exposure via drinking water uptake (puddle water) and food sources, such
as mentioned for birds above, must also be addressed for mammals. In
addition to these routes of exposure, incidental soil ingestion is also
a factor that must be accounted for. Some examples of percent ingestion
of soil in mammalian diets are: 2.4% for meadow vole, 2.8% for red fox,
and 9.4 % for raccoon.

According to BCS’ sensitivity analysis, the most important input
parameter in GranPARAM is the attractiveness of aldicarb granules
compared to grit (1 to 1000). This preference factor was derived from a
laboratory study with one bird species, the house sparrow, where birds
were given a choice to select food from trays with differently colored
granules (one of them containing gypsum and, therefore, resembling
aldicarb formulations). The Agency questions whether the house sparrow
and its preference for grit over aldicarb granules are suitably
representative of all relevant avian species. Food –stuff preference
is an important issue for the Agency. Furthermore, birds are curious
creatures and when presented with the opportunity in the field, may
instinctively peck at food-like objects on the ground, which is
significant given that a single granule of aldicarb will kill a small
bird.

BCS proposed a risk categorization scheme which has not been vetted by
the Agency or Services as acceptable in the risk assessment process.
Further, an adjective risk categorization scheme for risk is deemed
unnecessary according to EFED science policy (Ecological Risk
Description, April 24, 2003) even where the likelihood of integration of
exposure and effects can be summarized based on quantitative
distributions. Agency LOCs have been vetted before the SAP, and have
relevance to risk managers who relate them to risk management
determinations of unreasonable adverse effect.  Likewise the Services
have an understanding of how LOCs relate to risk determinations, whereas
the above arbitrary risk categorizations have not been determined to
relate to current regulatory interpretation.

(2) Agency’s comments regarding BCS’ “Refined Aquatic Risk
Assessment”

Our response to Bayer CropScience’s (2006) aquatic probabilistic risk
assessment (PRA) focuses on the key issue that most accounts for the
differences in conclusions drawn by the Agency in its ecological risk
assessment (May 2006) and those drawn by Bayer in its aquatic PRA.
Although there are differences between the methods EFED would use in
performing an aquatic PRA and those used by Bayer, these differences
have much less influence on the results and conclusions than the choice
of aquatic and soil metabolism inputs for the PRZM/EXAMS modeling.  The
choice of inputs by Bayer CropScience results in considerably different
exposure distributions than those used in the deterministic assessment
for the same crops, scenarios, application rates, application dates, and
incorporation efficiencies.  For example, as shown in the table below
with crops and scenarios modeled by both Bayer and EFED, the 90th
percentile peak and 21-d values calculated by Bayer CropScience were 8
percent lower (Pecan, Georgia, 99% incorporation, peak EEC) to 94.7
percent lower (Cotton, Mississippi, 99% incorporation, 21-d EEC) than
values determined by EFED.  Aquatic and soil half-life values used by
EFED follow the standard acceptable practice for calculation of these
parameters (PRZMEXAMS (ver. 3.12 and 2.98.04)) based on the available
number, type, and range of data
(http://www.epa.gov/oppefed1/models/water/input_guidance2_28_02.htm).
For more of a discussion about regional aerobic soil half-lives, see
also response to comments below.

Comparison of 90th percentile peak and 21-d EEC values

Crop and Scenario	Application Rate

(lb a.i./A)	Incorporation

Eff. %	Bayer CropScience (2006) PRA	EPA Deterministic (May and November,
2006)

	Peak	21-d	Aerobic soil half-life (days)	Peak	21-d	Aerobic soil
half-life (days)

Citrus FL	4.95	99	0.19	0.07	18.25	0.64	0.41	55

Citrus FL	4.95	85

9.6	6.0	55

Pecan GA	10.05	99	0.77	0.31	39.54	2.6	1.7	55

Pecan GA	10.05	85	11.4	4.7	39.54	12.0	11.4	55

Cotton MS (1 app)	4.05	99	0.34	0.16	18.25	4.0	3.0	55

Cotton MS (1 app)	4.05	85	7.1	3.4	18.25	28.0	26.6	55

	Bayer CropScience (2006)	EPA Deterministic (May and November 2006)

Aerobic aquatic metabolism	5 days	12 days

Anaerobic aquatic metabolism	5 days	24 days

CAM (FL citrus)	1	8

Bayer claims to have used region-specific soil degradation rates in the
PRZM/EXAMS model.  However, the Agency believes this may only be
significant for crops grown specifically on those soils evaluated.
There is actually greater variability in soils within regions than there
is between ‘representative’ soils from different regions. Therefore,
variability in degradation rates based upon individual soils from a
region will also yield a wide range of degradation rates.  Unless it can
be shown that faster degradation rates can be applied to most soils in
that region upon which the relevant crops are grown, it is not
sufficiently protective to apply differing soil degradation rates for
different regions.

(3) Agency’s Response to Bayer’s Comments on the September 2006
Aldicarb Ecological Risk Assessment

Bayer Crop Science comment: “Available monitoring data and incident
reports were also examined to see if these lines of evidence supported
the predictions of the refined exposure and risk assessments. Only two
incidents in aquatic ecosystems involving aldicarb have been documented
since it was first used in 1970. Several factors call into question the
reliability of these incident reports. Both incidents occurred at a time
of year when aldicarb would not have been used for one of the crops
associated with the incidents. Aldicarb was one of several compounds
detected during the incidents. Thus, it cannot be conclusively
identified as the compound that caused the adverse effects.”

Agency response: Reporting of wildlife kills is voluntary in the United
States.  Therefore, it cannot be concluded that low numbers of
ecological incident reports in the Agency’s database indicate low
ecological risk. The incidents cited above may reflect enhanced
discharge of tainted groundwater into surface water, which is typically
observed soon after a storm event (e.g., the tailing limb of a storm
hydrograph).  This may explain why these incidents occurred “at a time
of year when aldicarb would not have been used for one of the crops
associated with the incidents” and why other compounds were also
detected. Toxicity tests performed by the registrant indicate the
potential for chronic reproductive effects in fish and aquatic
invertebrates, and the chronic EEC values as estimated using PRZM-EXAMS
for different crops and application rates suggest potential chronic risk
to these organisms (EFED ERA, 2006). Chronic risk quotients exceed the
Agency LOC of 1.0 for all crops and application rates modeled for
freshwater fish (and freshwater invertebrates and estuarine/marine
invertebrates).  Documented cases of chronic reproductive effects in
fish (and invertebrates) are not available because there is currently no
system for monitoring or assessing such effects in the field.  If the
registrant is aware of such monitoring efforts that have shown no
effects, we urge the registrant to submit that information to the Agency
for consideration.

BCS comment: Surface water monitoring data are available from the
National Water

Quality Assessment Program (NAWQA), the California Surface Water
Monitoring Database, and the Beaver Creek, Tennessee monitoring study.
Of 5,530 samples collected by NAWQA, 13 (0.2%) had detectable
concentrations of aldicarb residues (aldicarb, aldicarb sulfoxide,
aldicarb sulfone). Twelve of these samples are suspect because only one
aldicarb carbamate compound was detected, or little to no use of
aldicarb occurred in the area near where the samples were taken.

Agency response: The NAWQA sampling regimen is not targeted for aldicarb
detections, and samples are obtained far too infrequently (approximately
once every two weeks) to expect many detections; random periodic
sampling is not likely to detect aldicarb in surface water except by
chance.  Samples would have to be obtained frequently (especially during
and soon after application), and specifically during and after the first
moderate-to-large storm event following application.  Indeed, given the
sporadic, non-targeted nature of the NAWQA samples, a detection rate of
0.2% would indicate that aldicarb residues are in fact a potential issue
– and almost certainly no ‘peak’ values will have been included in
the NAWQA database. The presence of only one aldicarb degradate in a
sample in no way indicates an absence of aldicarb.  Not all forms
(parent, sulfoxide, sulfone) need to be present in every sample to
verify detection.

BCS comment: The California Surface Water Monitoring Database contains
three

samples with detectable concentrations of aldicarb residues. Aldicarb
and aldicarb sulfoxide concentrations of 0.12 and 0.28 µg/L,
respectively, were measured at the San Joaquin River Hill Ferry sampling
station in Stanislaus County. The aldicarb concentration of 0.12 µg/L
is well below the freshwater invertebrate LC10 for the most sensitive 1%
of species. Follow-up sampling at this site found no detectable
concentrations of aldicarb or aldicarb sulfoxide, and one detectable
concentration of

aldicarb sulfone (0.05 µg/L). One sample collected at the Turlock
Irrigation District Drain #5 site showed a detectable concentration of
aldicarb sulfone (0.26 µg/L), but not aldicarb or aldicarb sulfoxide.

Agency response: Again, the presence of any of the 3 toxic compounds
indicates a positive detection.

BCS comment: BCS has several concerns about using data from the Beaver
Creek monitoring study, and it was demonstrated in the refined
assessment that Beaver Creek represents a worst case scenario for an
atypical environment (see Section 5.2.2 in Moore et al., 2006a). Samples
were predominantly taken from drainage ditches at the edge of
agricultural fields. These ditches go dry after most storm events (see
photographs in Figures 2 and 3). Samples were taken at the field edge
would typically show the highest concentration, samples further
downstream would produce lower concentrations because of dilution from
parts of the watershed not associated with treated agricultural fields.
Samples taken further downstream, in an environment capable of
supporting aquatic biota, would be more representative of a typical
environment. Such data are unavailable for the Beaver Creek watershed.

Agency response: To reiterate from previous Responses to Comments
(January 2005, May 2005, August 2005, November 2005, August 2006), the
fact that samples can be obtained from the Beaver Creek site only when
there is runoff from the treated field actually makes this a more
accurate benchmark for off-site concentrations than random stream
samples.  Although there would likely be some downstream dilution within
the receiving water body, a concentrated plume originating from a
treated site would retain some of its form (and chemical load) for some
distance downstream, with attenuation depending upon stream flow rates
and channel turbulence.  In addition, there may be successive aldicarb
inputs along that same stream channel from other sources within the same
watershed.

BCS comment: RQs for saltwater invertebrates exceeded 0.5 for cotton,
pecans and soybeans. Considering that these acute RQs were calculated
for worst-case exposure scenarios (maximum application rate, banded
application leaving 15% of product on the surface, high rainfall and
storm intensity) and used conservative toxicity benchmarks, it is not
surprising that refinements to the exposure and toxicity
characterizations would result in much lower estimates of acute risk.

Agency response: The assertion that RQs were calculated for worst-case
exposure scenarios is misleading.  PRZM-EXAMS uses historical (30-year)
weather data, not “high rainfall and storm intensity” data, so
weather inputs utilized by PRZM-EXAMS reflect the variability in weather
(particularly rainfall) that actually occurred at or near the site over
a 30-year period.  This helps ‘average-out’ the effect of weather;
high rainfall and storm intensity in one year is likely countered by low
rainfall and intensity in another year over that same (30-year) time
period. Maximum application rates are used specifically in an attempt to
model upper bound exposure, since these application amounts are allowed
according to the label.  Banded applications were also used for the same
reasons, as they are permitted on the label for these crops.  However,
scenarios were also run that accounted for ‘average’ use rates, and
with higher incorporation rates (99%, vs. 85% for banded applications);
nevertheless, EECs obtained by EFED were still higher than those cited
by BCS (see Table, above).

BCS comments: The results of these [refined] risk assessments indicate
that aldicarb poses de minimis or low risk to aquatic life and wildlife
for the vast majority of areas where the pesticide is currently or could
potentially be used. The few scenarios that indicated elevated risk
(e.g., banded application to cotton, peanuts and pecans in southeastern
US region, banded application to potatoes in Pacific region) represent
minor uses for aldicarb. The record of wildlife and fish kill incidents
and field study results are consistent with the low level of risk
predicted by the refined assessments.

Agency response: When all these uses are summed, they appear to account
for at least 2-3% of total uses.  While this may seem to be a small
percentage, these uses still need to be considered – especially as
they represent some of the most sensitive scenarios.

BCS comments: The Agency’s stated rationale for requiring these
[plant] studies is “because of potential phytotoxic effects (delayed
emergence and plant stand) identified by the registrant on the label.”
It is further explained that terrestrial and aquatic plant testing are
typically not required for non-herbicides unless there is evidence of
potential phytotoxicity at use rates based on label warning statements
or from other lines of evidence.

Agency response: There is evidence in the literature (Kennedy, 2002)
that application of aldicarb in excess of label rate (0.0138 kg
a.i./container) causes delayed emergence response in pearl millet. Such
excess concentrations may stem from concentrated runoff from fields
where applications occurred at or below the maximum label application
rate. Concentrated runoff, originating from a treated site (as
demonstrated at Beaver Creek site), may move off-field and receive
successive aldicarb inputs along the way before reaching non-target
sites where listed species occur.

BCS comments: While there is potential for seedling emergence effects if
the highest rates are applied directly into the seed furrow of some crop
plants, this scenario is not applicable to exposures of non-target
plants. Nontarget non-crop plants will not have Temik® granules applied
into the seed furrow and the concentration in the soil surrounding seeds
and seedlings of non-target plants will be much lower.

Agency response: Aldicarb may dissolve and become available to plants
via puddles that form off-field, or groundwater that reemerges in
lowland, non-target plant habitats. Because aldicarb is systemic and may
cause hazard to endangered and threatened plants, the Agency needs the
Tier I plant studies to fully characterize risk to these taxa.

 PAGE

 PAGE   3


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64391-64393]
[FR Doc No: 2019-25335]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0085]

Hours of Service of Drivers: National Waste & Recycling
Association; Application for Exemption

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to grant the National Waste &
Recycling Association's (NWRA) request for exemption from the
requirement that short-haul drivers utilizing the records of duty
status (RODS) exception return to their normal work-reporting location
within 12 hours after coming on duty. The exemption enables all NWRA
members' short-haul commercial motor vehicle (CMV) drivers in the waste
and recycling industry to return to their work-reporting location
within 14 hours (instead of the current 12 hours) without losing their
short-haul status. FMCSA has analyzed the exemption application and the
public comments and has determined that the exemption, subject to the
terms and conditions imposed, will achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.

DATES: This exemption is effective November 21, 2019 through November
21, 2024.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division; Telephone:<PHONE_NUMBER>; Email:
<EMAIL_ADDRESS>If you have questions on viewing or submitting material
to the docket, contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, FMCSA-2019-0085 in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
e.t., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews the safety analyses and public comments
submitted, and determines whether granting the exemption would likely
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by the current regulation (49 CFR 381.305). The
Agency's decision must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must specify the effective period (up to 5 years)
and explain its terms and conditions. The exemption may be renewed (49
CFR 381.300(b)).

III. Request for Exemption

    Under FMCSA's current hours-of-service (HOS) rules, drivers are not
required to prepare and maintain records of duty status (RODS) provided
that (among other things) they return to their normal work reporting
location and are released from work within 12 hours after coming on
duty (49 CFR 395.1(e)(1)). A driver who exceeds the12-hour limit loses
the short-haul exception and must immediately prepare RODS for the
entire day, often by means of an electronic logging device (ELD) (49
CFR 395.8(a)(1)(i)).
    NWRA represents approximately 700 publicly traded and privately-
owned local, regional, national and international waste and recycling
companies. These motor carriers operate more than 100,000 waste and
recycling collection trucks and employ an even greater number of
commercial motor vehicle (CMV) drivers. Its drivers routinely qualify
for the short-haul HOS exception in 49 CFR 395.1(e)(1); however, on
occasion, these drivers cannot complete their duty day within 12 hours.
The drivers may exceed the 12-consecutive hour limitation of the short-
haul exception more than 8 times

in any 30-day period due to operating restrictions placed upon the
industry by States and localities, inclement weather, traffic
congestion, and other circumstances beyond their control. Once they
exceed the 8-in-30-day threshold, NWRA member companies must install
electronic logging devices (ELDs) to document driver's duty status (49
CFR 395.8(a)(1)(iii)(A)(1)). Therefore, NWRA's application for a 14-
hour day would help some of its member carriers to avoid the economic
burden of installing ELD's when their drivers occasionally exceed the
8-in-30-day threshold for the ELD mandate.
    NWRA notes that drivers in the asphalt-paving business were granted
a similar exemption [83 FR 3864, Jan. 26, 2018], and that 49 CFR
395.1(e)(1)(ii)(B) reflects a statutory exemption for the ready-mixed
concrete industry. NWRA further notes that FMCSA recently granted one
of its member companies, Waste Management Holdings, Inc., a similar
exemption [83 FR 53940, Oct. 25, 2018]. NWRA argues that granting a
broader exemption would create regulatory consistency across the entire
waste and recycling industry.
    NWRA asserts that waste and recycling carriers have virtually no
record of HOS violations in the Agency's Compliance, Safety,
Accountability (CSA) Safety Measurement System (SMS), nor is there a
history of CSA interventions for HOS non-compliance by these carriers.
NWRA adds that there is no equivalent or greater level of safety that
ELDs would bring to the waste and recycling industry.
    NWRA's application for exemption is available for review in the
docket referenced at the beginning of the notice.

IV. Public Comments

    On March 29, 2019, FMCSA published notice of this application and
requested public comment (84 FR 12019). The Agency received 13 comments
12 supporting the application. Seven of these comments were filed by
waste and recycling-related companies: Republic Services; Waste
Connections; Rumpke Waste and Recycling; Kimble Recycling and Disposal;
Waste Management; Texas Disposal Systems; and the National Demolition
Association. Five individuals also supported the exemption request. One
individual opposed the application.
    The primary reasons cited for supporting the NWRA request include
the following: (1) The HOS of waste and recycling drivers are impacted
by factors outside their control, which means the driver cannot always
return to the work reporting location within the allotted 12 hours; (2)
requiring waste and recycling drivers to log their HOS on an ELD causes
driver distraction; and (3) granting NWRA's application for exemption
is consistent with a number of the Agency's prior exemptions, including
those issued to the National Asphalt Pavement Association and Waste
Management, Inc.
    Regarding the first reason given in support of the exemption,
commenters noted that drivers may exceed the 12-hours on-duty
limitation under the short-haul exemption more than eight times in any
30-day period due to operating restrictions placed upon the industry by
the State, localities, inclement weather, traffic congestion, and other
circumstances beyond their control. With regard to the second reason,
commenters believe that, from a safety perspective, the following
burdens and risks are a concern, particularly for residential, short-
haul drivers: An ELD device which requires interaction by the driver
making frequent duty-status changes, as the trucks stop to pick up
waste, would cause significant distractions; and maneuvering through
residential areas, parking lots, among parked cars, pedestrians, and
other motorists of all types requires the constant, undivided attention
of drivers, both for their own safety and for that of the general
public.
    Commenters further argued that granting a broader exemption to NWRA
member companies--based on prior FMCSA exemptions on this same issue--
would create regulatory consistency across the entire waste and
recycling industry. One individual commenter opposed the application,
stating that the Agency should stop granting exemptions like the one
requested by NWRA.

V. FMCSA Response to Comments

    The Agency agrees with the commenters who support the application
because the exemption would not allow additional driving time during
the work shift or allow driving after the 14th hour from the beginning
of the work shift. In addition, drivers would remain limited by the
weekly 60- or 70-hour limits and the employer must maintain accurate
time records concerning the time the driver reports for work each day,
the total number of hours the driver is on duty each day, and the time
the driver is released from duty each day. The exemption would provide
limited relief from the recordkeeping requirements for HOS for short-
haul drivers who find it necessary to exceed the 12-hour limit, which
impacts the type of HOS records required. The Agency has granted
similar exemptions to the National Asphalt Paving Association [January
26, 2018, (83 FR 3864)], the Motion Picture Association of America
[January 19, 2018, (83 FR 2869)], and Waste Management Holdings, Inc.
[October 25, 2018 83 FR 53940].

VI. FMCSA Decision

    FMCSA has evaluated NWRA's application and the public comments and
determined that it is appropriate to grant the request. Because the
exemption would extend neither the 11-hour driving time allowed during
the work shift nor the 14-hour driving window applicable to all other
truck drivers, there is no reason to believe that the safety
performance of these drivers would be compromised. Drivers would
continue to return to the normal work-reporting location at the end of
each work shift and continue to comply with the weekly HOS limits.
Therefore, the Agency believes that the exempted drivers will likely
achieve a level of safety that is equivalent to or greater than, the
level of safety achieved without the exemption [49 CFR 381.305(a)]. The
exemption will allow drivers for NWRA's member companies to use the
short-haul RODS exception, but with a 14-hour duty period instead of 12
hours.
    The FMCSA emphasizes that absent the exemption, these drivers could
take advantage of the current exemption that allows driver up to eight
days within a 30-consecutive day period to operate beyond the short-
haul limits without incurring the costs of using ELDs. Through this
exemption, motor carriers and drivers will have additional flexibility
to address situations when drivers operate beyond the 12-hour short-
haul limit for more than 8 days during a 30-day period.

VII. Terms and Conditions for the Exemption

     Drivers for member companies of the National Waste &
Recycling Association must have a copy of this notice or equivalent
signed FMCSA exemption document in their possession while operating
under the terms of the exemption. The exemption document must be
presented to law enforcement officials upon request.
     Drivers for NWRA member companies must return to the work
reporting location and be released from work within 14 consecutive
hours.
     NWRA member companies must maintain accurate time records
concerning the time the driver reports for work each day, the total
number of

hours the driver is on duty each day, and, the time the driver is
released from duty each day.

Extent of the Exemption

    This exemption is limited to the provisions of 49 CFR
395.1(e)(1)(ii) and is available only to drivers for companies that are
members of NWRA. These drivers must comply will all other applicable
provisions of the FMCSRs.

Preemption

    In accordance with 49 U.S.C. 31315(d), during the period this
exemption is in effect, no State shall enforce any law or regulation
that conflicts with or is inconsistent with this exemption with respect
to a firm or person operating under the exemption.

Notification to FMCSA

    Any NWRA member company utilizing this exemption must notify FMCSA
within 5 business days of any accident (as defined in 49 CFR 390.5),
involving any of the motor carrier's CMVs operating under the terms of
this exemption. The notification must include the following
information:
    (a) Identity of the exemption: ``National Waste & Recycling
Association;''
    (b) Name of operating motor carrier;
    (c) Date of the accident;
    (d) City or town, and State, in which the accident occurred, or
closest to the accident scene;
    (e) Driver's name and license number;
    (f) Vehicle number and State license number;
    (g) Number of individuals suffering physical injury;
    (h) Number of fatalities;
    (i) The police-reported cause of the accident;
    (j) Whether the driver was cited for violation of any traffic laws,
motor carrier safety regulations; and
    (k) The driver's total driving time and total on-duty time period
prior to the accident.
    Reports filed under this provision shall be emailed to
[email protected]
Termination
    FMCSA does not believe the drivers covered by this exemption will
experience any deterioration of their safety record.
    Interested parties or organizations possessing information that
would otherwise show that any or all of these motor carriers are not
achieving the requisite statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any information submitted and,
if safety is being compromised or if the continuation of this exemption
is inconsistent with 49 U.S.C. 31315(b)(4) and 31136(e), FMCSA will
immediately take steps to revoke the exemption of the company and
drivers in question.

    Issued on: November 15, 2019.
Jim Mullen,
Deputy Administrator.
[FR Doc. 2019-25335 Filed 11-20-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: October 2, 2006 (Volume 71, Number 190)]
[Notices]
[Page 58025-58026]
[DOCID:fr02oc06-135]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54487; File No. SR-FICC-2005-17]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Order Approving Proposed Rule Change Relating to Assumption of Blind
Brokered Fails by Its Government Securities Division

 September 22, 2006.

I. Introduction

    On September 30, 2005, the Fixed Income Clearing Corporation
(``FICC'') filed with the Securities and Exchange Commission
(``Commission'') and on November 28, 2005, amended proposed rule change
SR-FICC-2005-17 pursuant to Section 19(b)(1) of the Securities Exchange
Act of 1934 (``Act'').\1\ Notice of the proposal was published in the
Federal Register on March 8, 2006.\2\ On August 15, 2006, FICC filed an
amendment to the proposed rule change.\3\ No comment letters were
received. For the reasons discussed below, the Commission is approving
the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 53396 (March 2, 2006),
71 FR 11694.
    \3\ The August 15, 2006, amendment, as noted below, is not
substantive and did not require republication of notice.
---------------------------------------------------------------------------

II. Description

    The purpose of the proposed rule change is to clarify the practice
of the Government Securities Division (``GSD'') of FICC of assuming
certain blind brokered repo fails and of obtaining financing as
necessary in connection with such assumptions. The settlement of the
start leg of a same-day starting repo has always been and continues to
be processed outside of the GSD. In the evening of the day of a same-
day starting brokered repo, FICC will assume responsibility from the
broker for the settlement of such start leg if the repo dealer has not
delivered securities to the broker to start the repo (i.e., the start
leg has failed). This may involve FICC's receipt of securities from the
repo dealer for redelivery to the reverse repo dealer or FICC's netting
or pairing off of the settlement obligation arising from the start leg
against the settlement obligation arising from the close leg of the
same or another repo.
    FICC will also assume a blind brokered repo fail that arises in the
close leg of a blind brokered repo transaction. For example, if the
start leg of the transaction settles outside of FICC in normal course
but one side of the close leg does not compare (for any reason that
would cause a trade to not compare such as the erroneous submission of
trade data), the broker will have a net settlement position at FICC
rather than netting flat. If that transaction fails to settle, FICC
will assume the broker's fail.
    FICC assumes the fails in these instances in order to decrease risk
to itself and to its members.\4\ By assuming the fail, FICC removes the
broker, which acts as an intermediary and which expects to net out of
every transaction and not have a settlement position, from the
settlement process.\5\ FICC is therefore adding a provision to its
Rules to expressly provide for its practice of assuming blind broker
repo fails and therefore to make its Rules consistent with its current
and longstanding practice.\6\
---------------------------------------------------------------------------

    \4\ FICC has engaged in the practice of assuming broker fails
since the inception of its blind brokered repo service.
    \5\ FICC filed its August 15, 2006, amendment to the proposed
rule change to make explicit its policy that in all cases where FICC
assumes a fail from a broker, the counterparty remains responsible
for its obligations with respect to the transaction.
    \6\ Specifically, new Section 5, ``Assumption of Blind Brokered
Fails,'' is being added to GSD Rule 19.
---------------------------------------------------------------------------

    In the assumption of such broker fails, the need for financing
might arise, such as in the situation where the repo dealer delivers
securities near the close of the securities Fedwire and the broker is
unable to redeliver them to the reverse repo dealer. The GSD's Rules
already contain a provision, Section 8 of Rule 12, that addresses the
GSD's need to obtain financing in general. This provision contemplates
the need for financing in order to allow the GSD to facilitate
securities settlement generally. It is important to note that such
financing is part of the GSD's normal course of business, and the GSD's
ability to obtain such financing is necessary for

it to be able to complete securities settlement. Section 8 of Rule 12
provides that if FICC deems it appropriate to obtain financing to
provide its securities settlement services, FICC may create security
interests in eligible netting securities delivered by a netting member
in order to obtain such financing. The provision requires that members
not take any action to adversely affect this process. The provision
also states that such security interests may be created to obtain
financing in an amount greater than the obligation of a member to FICC
relating to such eligible netting securities. Thus, clearing fund
securities may also be used to collateralize such financing. Also,
Section III.C of the GSD's fee structure provides the formula that the
GSD uses to charge members for the cost of any financing obtained by
GSD.
    FICC interprets Section 8 of Rule 12 and Section III.C. to apply to
financing that might arise because of FICC's assumption of blind
brokered fails. FICC does not believe that actual changes to this rule
is necessary for this clarification.

III. Discussion

    Section 17A(b)(3)(F) of the Act requires that the rules of a
clearing agency be designed to promote the prompt and accurate
clearance and settlement of transactions and to assure the safeguarding
of securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.\7\ The Commission finds
that FICC's proposed rule change is consistent with this requirement
because the change, which is designed to clarify FICC's practice of
assuming failed blind brokered repo transactions, will facilitate the
settlement of blind brokered repo fails and as such will facilitate the
prompt and accurate clearance and settlement of these transactions. By
facilitating the settlement of these fails, FICC will also reduce
settlement risk, which will better enable it to assure the safeguarding
of securities and funds which are in FICC's custody or control or for
which it is responsible.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change, as amended, is consistent with the requirements
of the Act and in particular Section 17A of the Act and the rules and
regulations thereunder.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\8\ that the proposed rule change, as amended, (File No. SR-FICC-
2005-17) be and hereby is approved.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).

Nancy M. Morris,
Secretary.
[FR Doc. E6-16109 Filed 9-29-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Rules and Regulations]
[Pages 75253-75254]
[FR Doc No: 2013-29448]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2013-0060; FRL-9903-98-Region 6]

Approval and Promulgation of Implementation Plans; New Mexico;
Prevention of Significant Deterioration; Greenhouse Gas Plantwide
Applicability Limit Permitting Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving portions of one revision to the New Mexico
State Implementation Plan (SIP) submitted by the New Mexico Environment
Department (NMED) to EPA on January 8, 2013. The January 8, 2013,
submittal adopted revisions to the New Mexico Prevention of Significant
Deterioration (PSD) plantwide applicability limit (PAL) permitting
provisions to enable the NMED to issue PALs to greenhouse gas (GHG)
emitting sources. EPA is approving the January 8, 2013, SIP revision to
the New Mexico PSD permitting program as consistent with federal
requirements for PSD permitting. EPA is taking no action on the portion
of the January 8, 2013, SIP revision that relates to the provisions of
EPA's July 20, 2011, GHG Biomass Deferral Rule. EPA is taking this
final action under section 110 and part C of the Clean Air Act (CAA or
the Act). EPA is not approving these rules within the exterior
boundaries of a reservation or other areas within any Tribal Nation's
jurisdiction.

DATES: This final rule will be effective January 10, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R06-OAR-2013-0060. All documents in the docket are listed in
the http://www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., Confidential Business
Information or other information the disclosure of which is restricted
by statute. Certain other material, such as copyrighted material, will
be publicly available only in hard copy. Publicly available docket
materials are available either electronically at http://www.regulations.gov or in hard copy at the Air Permits Section (6PD-R),
Please schedule an appointment with the person listed in the FOR
FURTHER INFORMATION CONTACT paragraph below or Mr. Bill Deese at 214-
665-7253.

FOR FURTHER INFORMATION CONTACT: Ms. Adina Wiley, Air Permits Section
(6PD-R), telephone<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background for This Final Action
II. Final Action
III. Statutory and Executive Order Reviews

I. Background for This Final Action

    On August 23, 2013, EPA proposed approval of the January 13, 2013,
submitted revisions to 20.2.74 NMAC into the New Mexico SIP. See 78 FR
52473. Our proposed rulemaking provided our preliminary determination
that the January 13, 2013, revisions to the New Mexico PSD permitting
program are substantively similar to the federal requirements for the
permitting of GHG-emitting sources subject to PSD. Our proposal
demonstrated that the submitted revisions to <IP_ADDRESS>(AZ)(1) and
<IP_ADDRESS>0 NMAC appropriately revised the New Mexico PSD PAL
permitting requirements to provide the NMED the authority to issue GHG
PALs, consistent with EPA's Tailoring Rule Step 3 for GHG PALs. Our
analysis also demonstrated that non-substantive revisions adopted at
<IP_ADDRESS>(AZ)(1), (2), (2)(b), (3), (4), and (5) NMAC to correct
typographical errors are also approvable as revisions to the New Mexico
SIP.
    We accepted comments on this proposed rulemaking through September
23, 2013. No comments were received. Therefore, EPA is finalizing the
rule as proposed.

II. Final Action

    EPA is approving portions of the January 8, 2013, submitted
revisions to 20.2.74 NMAC into the New Mexico SIP which provide the
NMED the authority to issue GHG PALs in the New Mexico PSD program. EPA
has determined that the January 8, 2013, revisions to 20.2.74 NMAC are
approvable because they were adopted and submitted in accordance with
the CAA and EPA regulations regarding PSD permitting for GHGs.
Therefore, under section 110 and part C of the Act, and for the reasons
stated in our proposed rulemaking, EPA approves the following revisions
to the New Mexico SIP:
     Substantive revisions to <IP_ADDRESS>(AZ)(1) NMAC
establishing GHG PAL permitting requirements,
     Non-substantive revisions to <IP_ADDRESS>(AZ)(1), (2),
(2)(b), (3), (4), and (5) NMAC to correct formatting, and
     Substantive revisions to <IP_ADDRESS>0 NMAC establishing the
GHG PAL permitting requirements.
    EPA is taking no action at this time on the submitted revisions to
<IP_ADDRESS>(AZ)(2)(a) NMAC. The DC Circuit Court issued an order to
vacate EPA's Biomass Deferral Rule on July 12, 2013.
    EPA is not approving these rules within the exterior boundaries of
a reservation or other areas within any Tribal Nation's jurisdiction.

III. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and

     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified
by Executive Order 13175 (65 FR 67249, November 9, 2000), because the
SIP is not approved to apply in Indian country located in the state,
and EPA notes that it will not impose substantial direct costs on
tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action 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 the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by February 10, 2014. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposed of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: November 25, 2013.
Ron Curry,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart GG--New Mexico

0
2. Section 52.1620(c) is amended by revising the entry for Part 74
under the first table titled ``EPA Approved New Mexico Regulations'' to
read as follows:

Sec.  52.1620  Identification of plan.

* * * * *
    (c) * * *

                                       EPA Approved New Mexico Regulations
----------------------------------------------------------------------------------------------------------------
                                                          State
                                                        approval/
         State Citation              Title/Subject      effective    EPA approval date           Comments
                                                           date
----------------------------------------------------------------------------------------------------------------
          New Mexico Administrative Code (NMAC) Title 20--Environment Protection Chapter 2--Air Quality
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Part 74.........................  Permits--Prevention     1/8/2013  12/11/2013.........  Revisions to
                                   of Significant                   [Insert FR page       <IP_ADDRESS>3(A) NMAC
                                   Deterioration.                    number where         submitted 5/23/2011,
                                                                     document begins].    effective 6/3/2011,
                                                                                are NOT part of SIP.
                                                                                <IP_ADDRESS>3 NMAC
                                                                                submitted 12/1/2010,
                                                                                effective 1/1/2011,
                                                                                remains SIP approved
                                                                                (6/20/2011, 76 FR
                                                                                43149).
                                                                                Revisions to
                                                                                <IP_ADDRESS>(AZ)(2)(a)
                                                                                NMAC submitted 1/8/
                                                                                2013, effective 2/6/
                                                                                2013, are NOT part of
                                                                                SIP.
                                                                                <IP_ADDRESS>(AZ)(2)(a)
                                                                                NMAC submitted 5/23/
                                                                                2011, effective 6/3/
                                                                                2011, remains SIP
                                                                                approved.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-29448 Filed 12-10-13; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF

PREVENTION, PESTICIDES, AND

TOXIC SUBSTANCES

			PC Code:	098301

			DP barcode: 	D344325

MEMORANDUM	September 14, 2007

Subject:	ADDENDUM to:  Aldicarb - Ecological risk results for alternative application rate and incorporation efficiencies

To:	Robert McNally, Branch Chief

	Anne Overstreet, Team Leader

Special Review Branch

Special Review and Reregistration Division

From:		Dana Spatz, Chief (acting)

Environmental Risk Branch II

Environmental Fate and Effects Division

In response to your request, the following addendum gives the risk quotients for birds and mammals exposed to aldicarb applied at maximum application rates and 99 percent granule incorporation efficiency.  This analysis will help to characterize the aldicarb ecological risk assessment.  Note that the risk quotients for aquatic species for this scenario were previously provided in a memo to you dated August 25, 2006 (D331981).

Table 1. Aldicarb: Acute avian RQs for 99 percent incorporation efficiency at maximum application rates

Crop Scenario

Bird Type

Rate

(lbs ai/A)	RQ

(99% incorporated)

Citrus

Broadcast

	Small Bird

Medium Bird

Large Bird

4.95	51.7

8.1

0.57

Cotton

Banded/Sidedress

4” band width

40” row spacing	Small Bird

Medium Bird

Large Bird

4.05	428.5

67.3

4.8

Dry Beans

Banded

6” band width

48” row spacing	Small Bird

Medium Bird

Large Bird

2.1	175.5

27.6

1.9

Sorghum

Banded

2” band width

36” row spacing	Small Bird

Medium Bird

Large Bird

1.05	192.6

30.3

2.1

Peanuts

Banded

6” band width

36” row spacing	Small Bird

Medium Bird

Large Bird

3.0	188.1

29.5

2.1

Pecans

Broadcast

	Small Bird

Medium Bird

Large Bird

10.05	104.9

16.5

1.2

Potatoes

Banded

6” band width

38” row spacing	Small Bird

Medium Bird

Large Bird

3.0	198.5

31.2

2.2

Soybeans

Banded

6” band width

30” row spacing	Small Bird

Medium Bird

Large Bird

3.0	156.7

24.5

1.7

Sugar Beets

Banded

6” band width

22” row spacing	Small Bird

Medium Bird

Large Bird

4.95	189.6

29.8

2.1

Sweet Potatoes

Banded

12” band width

48” row spacing	Small Bird

Medium Bird

Large Bird

3.0	124.8

19.6

1.4

Ornamentals

Broadcast

	Small Bird

Medium Bird

Large Bird

5.0	52.2

8.2

0.58

Mallard duck LD50 = 1 mg/kg- bw

Rat LD50 = 0.9 mg/kg-bw

Table 2. Aldicarb: Acute mammalian RQs for 99 percent incorporation efficiency at maximum application rates

Crop Scenario	Mammal Type

Rate

(lbs ai/A)	RQ

(99% incorporated)

Citrus

Broadcast

	Small Bird

Medium Bird

Large Bird

4.95	17.5

9.2

0.75

Cotton

Banded/Sidedress

4” band width

40” row spacing	Small Bird

Medium Bird

Large Bird

4.05	144.8

76.7

6.2

Dry Beans

Banded

6” band width

48” row spacing	Small Bird

Medium Bird

Large Bird

2.1	59.3

31.4

2.5

Sorghum

Banded

2” band width

36” row spacing	Small Bird

Medium Bird

Large Bird

1.05	65.1

34.5

2.8

Peanuts

Banded

6” band width

36” row spacing	Small Bird

Medium Bird

Large Bird

3.0	63.5

33.7

2.7

Pecans

Broadcast

	Small Bird

Medium Bird

Large Bird

10.05	35.4

18.8

1.5

Potatoes

Banded

6” band width

38” row spacing	Small Bird

Medium Bird

Large Bird

3.0	67

35.5

2.9

Soybeans

Banded

6” band width

30” row spacing	Small Bird

Medium Bird

Large Bird

3.0	53

28

2.3

Sugar Beets

Banded

6” band width

22” row spacing	Small Bird

Medium Bird

Large Bird

4.95	64

33.9

2.7

Sweet Potatoes

Banded

12” band width

48” row spacing	Small Bird

Medium Bird

Large Bird

3.0	42.1

22.3

1.8

Ornamentals

Broadcast

	Small Bird

Medium Bird

Large Bird

5.0	17.6

9.3

0.76

Mallard duck LD50 = 1 mg/kg- bw

Rat LD50 = 0.9 mg/kg-bw

 PAGE

 PAGE   1


[Federal Register: July 18, 2006 (Volume 71, Number 137)]
[Notices]
[Page 40717-40718]
[DOCID:fr18jy06-59]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0606;FRL-8080-5]

Notice of Receipt of a Request for an Amendment to Delete Acid
Copper Chromate (ACC) Uses in Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of request for amendments by registrants to delete
uses in certain pesticide registrations. Section 6(f)(1) of FIFRA
provides that a registrant of a pesticide product may at any time
request that any of its pesticide registrations be amended to delete
one or more uses. FIFRA further provides that, before acting on the
request, EPA must publish a notice of receipt of any request in the
Federal Register.

DATES: Comments must be received on or before August 17, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0606, 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
Building), 2777 S. Crystal Drive, 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 telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0606. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
    Docket. All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Adam Heyward, Antimicrobials Division
(7510P), 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?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by 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. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a

copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public docket. Information
so marked will not be disclosed except in accordance with procedures
set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    This notice announces receipt by the Agency of an application from
the registrant to delete uses in certain pesticide registrations. This
registration is listed in Table 1 of this unit by registration number,
product name, active ingredients, and specific uses deleted:

       Table 1.--Registration With Request for Amendment to Delete Uses in Certain Pesticide Registrations
----------------------------------------------------------------------------------------------------------------
         EPA Registration No.                Product Name          Active Ingredient        Delete from Label
----------------------------------------------------------------------------------------------------------------
3008-60                                ACC 50% Wood             Copper Oxide             All residential uses
                                        Preservative             (14.07%)Chromic
                                                                 Acid(35.46%)
----------------------------------------------------------------------------------------------------------------

    Users of these products who desire continued use on sites being
deleted should contact the applicable registrant before August 17, 2006
to discuss withdrawal of the application for amendment. This 30-day
period will also permit interested members of the public to intercede
with registrants prior to the Agency's approval of the deletion.
    Table 2 of this unit includes the name and address of record for
the registrant of the product listed in Table 1 of this unit, by EPA
company number.

   Table 2.--Registrant Requesting Amendment to Delete Uses in Certain
                         Pesticide Registrations
------------------------------------------------------------------------
              EPA company no.                 Company name and address
------------------------------------------------------------------------
3008                                        Osmose, Inc.980 Ellicott
                                             St.Buffalo, NY 14209-2398
------------------------------------------------------------------------

III. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be amended to delete one or more uses. The Act further provides that,
before acting on the request, EPA must publish a notice of receipt of
any such request in the Federal Register. Thereafter, the Administrator
may approve such a request.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for use deletion must
submit the withdrawal in writing to the person named under FOR FURTHER
INFORMATION CONTACT using the methods in ADDRESSES. The Agency will
consider written withdrawal requests postmarked no later than August
17, 2006.

V. Provisions for Disposition of Existing Stocks

    The registrant is no longer manufacturing or distributing this
product, and has requested no existing stocks provision.

List of Subjects

    Environmental protection, Pesticides and pests, acid copper
chromate, ACC.

    Dated: July 12, 2006.
Frank Sanders,
Director, Antimicrobials Division, Office of Pesticide Programs.
[FR Doc. E6-11342 Filed 7-17-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: August 26, 2009 (Volume 74, Number 164)]
[Rules and Regulations]
[Page 43042-43043]
[DOCID:fr26au09-4]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2009-N-0381]

Advisory Committee; Tobacco Products Scientific Advisory
Committee; Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
Establishment of the Tobacco Products Scientific Advisory Committee.
These actions are needed to implement the Federal Food, Drug, and
Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco
Control Act. Elsewhere in this issue of the Federal Register, FDA is
publishing two separate documents requesting nominations for voting and
non-voting membership on this committee. This document also amends the
agency's regulations to add the Tobacco Products Scientific Advisory
Committee (the committee) to the agency's list of standing advisory
committees.

DATES: This rule is effective August 26, 2009. The committee is being
established and this charter will remain in effect until amended or
terminated by the Commissioner of Food and Drugs (the Commissioner).

FOR FURTHER INFORMATION CONTACT: Erik P. Mettler, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm.
4324, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The committee was established under 21
U.S.C. 387q, as added by section 917 of the Family Smoking Prevention
and Tobacco Control Act (Public Law 111-31). The committee is also
governed by part 14 (21 CFR part 14), Public Law 92-463 (5 U.S.C.
app.), and the Federal Advisory Committee Act, which sets forth
standards for the formation and use of advisory committees. The
committee advises the Commissioner or designee in discharging
responsibilities as they relate to the regulation of tobacco products.
    The committee reviews and evaluates safety, dependence, and health
issues relating to tobacco products and provides appropriate advice,
information, and recommendations to the Commissioner.
    Specifically, the committee will submit reports and recommendations
on tobacco-related topics, including the following:
     The impact of the use of menthol in cigarettes on the
public health, including such use among children, African Americans,
Hispanics and other racial and ethnic minorities;
     The nature and impact of the use of dissolvable tobacco
products on the public health, including such use on children;
     The effects of the alteration of nicotine yields from
tobacco products and whether there is a threshold level below which
nicotine yields do not product dependence on the tobacco product
involved; and
     Any application submitted by a manufacturer for a modified
risk tobacco product.
    The committee may provide recommendations to the Secretary of
Health and Human Services regarding any regulations to be issued under
the Federal Food, Drug, and Cosmetic Act and may review any
applications for new tobacco products or petitions for exemption under
section 906(e) of the Family Smoking Prevention and Tobacco Control
Act. The committee may consider and provide recommendations on any
other matter as provided in the Family Smoking Prevention and Tobacco
Control Act.
     The committee shall consist of 12 members including the Chair.
Members and the Chair are selected by the Commissioner or designee from
among individuals knowledgeable in the fields of medicine, medical
ethics, science, or technology involving the manufacture, evaluation,
or use of tobacco products. Members will be invited to serve for
overlapping terms of up to 4 years. Almost all non-Federal members of
this committee serve as Special Government Employees. The committee
shall include nine technically qualified voting members, selected by
the Commissioner or designee. The nine voting members shall be
physicians, dentists, scientists, or health care professionals
practicing in the area of oncology, pulmonology, cardiology,
toxicology, pharmacology, addiction, or any other relevant specialty.
One member shall be an officer or employee of a State or local
government or of the Federal Government. The final voting member shall
be a representative of the general public. In addition to the voting
members, the committee shall include three nonvoting members who are
identified with industry interests. These members shall include one
representative of the tobacco manufacturing industry, one
representative of the interests of tobacco growers, and one
representative of the interests of the small business tobacco
manufacturing industry. This final position can be filled on a
rotating, sequential basis by representatives of different small
business tobacco manufacturers based on areas of expertise relevant to
the topics being considered by the committee.
    The Commissioner or designee shall designate one of the voting
members of the committee to serve as chairperson.
    As added by section 917 of the Family Smoking Prevention and
Tobacco Control Act, 21 U.S.C. 387q(d)(3) provides that section 14 of
the Federal Advisory Committee Act does not apply to this committee.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e),
the agency finds good cause to dispense with notice and public comment
procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary
and are not in the public interest as this final rule merely amends the
information in Sec.  14.100 to reflect the establishment of the
committee.
    Therefore the agency is amending Sec.  14.100(a) as set forth in
the regulatory text of this document.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended to read as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for 21 CFR part 14 continues to read as
follows:

    Authority:  5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155.

0
2. In Sec.  14.100, add paragraph (a)(5) to read as follows:

Sec.  14.100  List of standing advisory committees.

* * * * *
    (a) * * *
    (5) Tobacco Products Scientific Advisory Committee.
    (i) Date Established: August 12, 2009.
    (ii) Function: The committee reviews and evaluates safety,
dependence, and health issues relating to tobacco products and provides
appropriate advice, information, and recommendations to the
Commissioner of Food and Drugs. Specifically, the committee will submit
reports and recommendations on tobacco-related topics, including: The
impact of the use of menthol in cigarettes on the public health,
including such use among children, African Americans, Hispanics and
other racial and ethnic minorities; the nature and impact of the use of
dissolvable tobacco products on the public health, including such use
on children; the effects of the alteration of nicotine yields from
tobacco products and whether there is a threshold level below which
nicotine yields do not produce dependence on the tobacco product
involved; and any application submitted by a manufacturer for a
modified risk tobacco product. The committee may provide
recommendations to the Secretary of Health and Human Services regarding
any regulations to be issued under the Federal Food, Drug, and Cosmetic
Act and may review any applications for new tobacco products or
petitions for exemption under section 906(e) of the Family Smoking
Prevention and Tobacco Control Act. The committee may consider and
provide recommendations on any other matter as provided in the Family
Smoking Prevention and Tobacco Control Act.
* * * * *

    Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20485 Filed 8-26-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]
[Page 8879-8881]
[DOCID:fr15fe08-62]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0077]

Agency Information Collection Activities; Proposed Collection;
Comment Request; MedWatch: The Food and Drug Administration Medical
Products Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the present MedWatch Forms
3500 and 3500A (also known as MedWatch reporting forms) having an OMB
expiration date of October 31, 2008. These forms are presently used to
report to the agency about adverse events, product problems, and
medication/device use errors that occur with FDA regulated products,
including drugs, biologicals, medical devices, special nutritional
products, dietary supplements, and non-prescription (over-the-counter
(OTC)) human drug products marketed without an approved application.

DATES: Submit written or electronic comments on the collection of
information by April 15, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the

collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

MedWatch: The FDA Medical Products Reporting Program, Form FDA 3500 and
Form FDA 3500A--(OMB Control Number 0910-0291)--Extension

    Under sections 505, 512, 513, 515, and 903 of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 360b, 360c, 360e, and
393), and section 351 of the Public Health Service Act (42 U.S.C. 262),
FDA has the responsibility to ensure the safety and effectiveness of
drugs, biologics, and devices. Under section 502(a) of the act (21
U.S.C. 352(a)), a drug or device is misbranded if its labeling is false
or misleading. Under section 502(f)(1) of the act it is misbranded if
it fails to bear adequate warnings, and under section 502(j), it is
misbranded if it is dangerous to health when used as directed in its
labeling.
    Under section 4 of the Dietary Supplement Health and Education Act
of 1994 (Public Law 103-417), 21 U.S.C. 342 is amended so that FDA must
bear the burden of proof to show a dietary supplement is unsafe.

    To carry out its responsibilities, the agency needs to be informed
whenever an adverse event, product problem, or error with use of a
medication or device occurs. Only if FDA is provided with such
information will the agency be able to evaluate the risk, if any,
associated with the product, and take whatever action is necessary to
reduce or eliminate the public's exposure to the risk through
regulatory action. To ensure the marketing of safe and effective
products, certain adverse events must be reported. Requirements
regarding mandatory reporting of adverse events or product problems
have been codified in parts 310, 314, 600, and 803 (21 CFR 310, 314,
600, and 803), specifically Sec. Sec.  310.305, 314.80, 314.98, 600.80,
803.30, 803.50, 803.53, and 803.56.
    Two forms are available from the agency in order to implement these
provisions for reporting of adverse events, product problems, and
medication/device use errors for FDA regulated products such as
medications, devices, biologics, special nutritional products,
cosmetics, dietary supplements, and non-prescription (OTC) human drug
products marketed without an approved application, as well as any other
products that are regulated by FDA. Form FDA 3500 may be used by health
care professionals and the public for voluntary (i.e., not mandated by
law or regulation) reporting. Form FDA 3500A is used by industry for
mandatory reporting (i.e., required by law or regulation).
    Respondents to this collection of information are health care
professionals, hospitals and other user-facilities (e.g., nursing
homes, etc.), consumers, manufacturers of biological and drug products
or medical devices, and importers.

I. Use of Form FDA 3500 (Voluntary Version)

    The voluntary version of the form is used to submit all reports not
mandated by Federal law or regulation. Individual health professionals
are not required by law or regulation to submit reports to the agency
or the manufacturer, with the exception of certain adverse reactions
following immunization with vaccines as mandated by the National
Childhood Vaccine Injury Act of 1986 (Public Law 99-660). Those
mandatory reports are not submitted to FDA on the 3500 or 3500A forms,
but are submitted to the joint FDA/Centers for Disease Control and
Prevention Vaccines Adverse Event Reporting System (VAERS) on the
VAERS-1 form (see: http://www.vaers.hhs.gov/pdf/vaers_form.pdf).

    Hospitals are not required by Federal law or regulation to submit
reports associated with drug products, biological products, or special
nutritional products. However, hospitals and other user facilities are
required by Federal law to report medical device-related deaths and
serious injuries.

II. Use of Form FDA 3500A (Mandatory Version)

A. Drug and Biologic Products

    In sections 505(j) and 704 of the act (21 U.S.C. 374), Congress has
required that important safety information relating to all human
prescription drug products be made available to FDA so that it can take
appropriate action to protect the public health when necessary. Section
702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA
for enforcement of the act. These statutory requirements regarding
mandatory reporting have been codified by FDA under parts 310 and 314
(drugs) and 600 (biologics). Parts 310, 314, and 600 mandate the use of
FDA Form 3500A for reporting to FDA on adverse events that occur with
drugs and biologics.
    Manufacturers whose name (under section 403(e)(1) of the act (21
U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed
in the United States are required to report adverse reactions
associated with use of the dietary supplement to FDA (the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Public Law
109-462)).

B. Medical Device Products

    Section 519 of the act (21 U.S.C. 360i) requires manufacturers and
importers of devices intended for human use to establish and maintain
records, make reports, and provide information as the Secretary of
Health and Human Services may by regulation reasonably require to
assure that such devices are not adulterated or misbranded and to
otherwise assure their safety and effectiveness. The Safe Medical
Device Act of 1990 (Public Law 91-4243), signed into law on November
28, 1990, amends section 519 of the act. The amendment requires that
user facilities such as hospitals, nursing homes, ambulatory surgical
facilities, and outpatient treatment facilities report deaths related
to medical devices to FDA and to the manufacturer, if known. Serious
illnesses and injuries are to be reported to the manufacturer or to FDA
if the manufacturer is not known. These statutory requirements
regarding mandatory reporting have been codified by FDA under part 803.
Part 803 mandates the use of FDA Form 3500A for reporting to FDA on
medical devices.
    The Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
(Public Law 107-250), signed into law October 26, 2002, amended section
519 of the act. The amendment (section 303 of MDUFMA) required FDA to
revise the MedWatch forms ``to facilitate the reporting of information
* * *relating to reprocessed single-use devices, including the name of
the reprocessor and whether the device has been reused.''
    Under section 303 of the FDA Amendments Act of 2007 (Public Law
110-85), FDA must share reports for Humanitarian Device Exemption (HDE)
devices. To facilitate sharing the appropriate reports, it would be
helpful to obtain the HDE number in the present section G, box 5, on
page 2 of FDA Form 3500A.

III. Proposed Modifications to Forms

    The proposed extension to Form FDA 3500 and Form FDA 3500A will
only have changes in the form instructions to reflect the range of
reportable products and provide clarity of reporting. The previous
forms changes (2005-2008) allow reporters to better utilize available
space for data entry and offer voluntary reporters the opportunity to
clearly describe the suspected adverse event, product problem or error,
and provide better quality safety-related data for agency evaluation.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            No. of       Annual Frequency  per     Total Annual         Hours per
                     FDA Center                          Respondents            Response            Responses           Response          Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CBER/CDER
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Form 3500                                                      22,955                    1               22,955                 0.6             13,773

  Form 3500A (Sec.  Sec.   310.305, 314.80, 314.98,                 600                  579.9            347,940                 1.1            382,734
   and 600.80)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Form 3500                                                       3,433                    1                3,433                 0.6              2,060
  Form 3500A (Part 803)                                           1,935                   33               63,855                 1.0             63,855
--------------------------------------------------------------------------------------------------------------------------------------------------------
CFSAN
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Form 3500                                                         847                    1                  847                 0.6                508
  Form 3500A                                                          0                    0                    0                 1.0                  0
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form 3500                                                                                16,341
Form 3500A                                                                                446,589
Total                                                                                462,930
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\CBER (Center for Biologics Evaluation and Research), CDER (Center for Drug Evaluation and Research), CDRH (Center for Devices and Radiological
  Health), and CFSAN (Center for Food Safety and Applied Nutrition). FDA Form 3500 is for voluntary reporting; FDA Form 3500A is for mandatory
  reporting.

    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

    Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2821 Filed 2-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71527-71528]
[FR Doc No: 2019-28164]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Annual Random Controlled Substances Testing Percentage Rate for
Calendar Year 2020

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

ACTION: Notice of program change.

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

SUMMARY: The FMCSA announces that it is increasing the minimum annual
percentage rate for random controlled substances testing for drivers of
commercial motor vehicles (CMVs) requiring a commercial driver's
license (CDL) from the current rate of 25 percent of the average number
of driver positions to 50 percent of the average number of driver
positions, effective in calendar year 2020. The FMCSA Administrator
must increase the minimum annual random testing percentage rate when
the data received under the reporting requirements for any calendar
year indicate that the reported positive rate is equal to or greater
than 1.0 percent. Based on the results of the 2018 FMCSA Drug and
Alcohol Testing Survey, the positive rate for controlled substances
random testing increased to 1.0 percent. Therefore, the Agency will
increase the controlled substances minimum annual percentage rate for
random controlled substances testing to 50 percent of the average
number of driver positions.

DATES: Beginning January 1, 2020, the minimum annual percentage rate
for random controlled substances testing, for drivers of commercial
motor vehicles (CMVs) requiring a commercial driver's license (CDL),
will be 50 percent.

FOR FURTHER INFORMATION CONTACT: Mr. Juan Moya, Drug and Alcohol
Program Manager, Compliance Division, Federal Motor Carrier Safety
Administration, 1200 New Jersey Avenue SE, Washington, DC 20590, 202-
366-4844 or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The final rule titled, ``Controlled Substances and Alcohol Use and
Testing,'' published August 17, 2001, (66 FR 43097), established the
process by which the Agency determines whether the minimum annual
percentage rate for random controlled substances testing should be
increased or decreased. The final rule included a provision indicating
that the decision on whether to increase or decrease the percentage
rate would be based upon the motor carrier industry's overall positive
random controlled substance test rate, as reported by motor carrier
employers to FMCSA, pursuant to 49 CFR 382.403. Under this performance-
based system, when the minimum annual percentage rate for random
controlled substances testing is 25 percent, and the data received
under the reporting requirements for any calendar year indicate that
the reported positive rate is equal to or greater than 1 percent, the
FMCSA Administrator will increase the minimum annual percentage rate
for random controlled substances to 50 percent for all driver positions
(49 CFR 382.305(h)). The new annual random testing percentage rate
would then apply starting January 1 of the following calendar year.
    In accordance with 49 CFR 382.403, each calendar year FMCSA
requires motor carriers selected for the survey to submit their DOT
drug and alcohol testing program results. Selected motor carriers are
responsible for ensuring the completeness, accuracy, and timeliness of
the data submitted. The survey requires motor carriers to provide
information to the Agency on the number of random tests conducted and
the corresponding positive rates.
    For the 2018 survey, forms were sent to 4,480 randomly selected
motor carriers. Of these forms, 1,908 were completed and returned to
FMCSA, resulting in usable data from 1,552 carriers (comprising of
300,635 CDL drivers) for random controlled substance testing.
Respondents providing non-usable data represent entities that are out
of business, exempt, have no testing program in place, or belong to
consortia that did not test any drivers for the carrier during 2018.
    The estimated positive random controlled substance test rate in
2018 is 1 percent. The 95-percent confidence interval for this estimate
ranges from 0.9 to 1.1 percent. In other words, if the survey were to
be replicated, it would be expected that the confidence interval
derived from each replication would contain the true usage rate in 95
out of 100 surveys. For 2016 and 2017, the estimated positive usage
rate for drugs was estimated to be 0.7 percent and 0.8 percent,
respectively. A more detailed discussion of the 2018 drug and alcohol
testing survey results can be found in the Analysis Brief included in
the docket for this Notice.

Part 382 Compliance

    Based on the 2018 survey results, the estimated percentage of
subject motor carriers with random controlled substance and alcohol
testing programs in place is 94 percent, and the estimated percentage
of all CDL drivers participating in such programs is 99 percent. FMCSA
estimates there are 3.2 million CDL holders operating in interstate
commerce and 1 million CDL holders operating in intrastate commerce.
With this population, at least 1.05 million random controlled
substances tests would be conducted with an annual random testing rate
of 25 percent of all driving positions. At a 50 percent annual random
testing rate, approximately 2.1 million random controlled substances
tests will need to be conducted in calendar year 2020.
    The new minimum annual percentage rate for random drug testing will
be effective January 1, 2020. This change reflects the increased
positive test rate and will result in an estimated $50 to 70 million
increase in costs to the industry by requiring that more drivers be
tested.

Minimum Annual Percentage Rates for Random Controlled Substances
Testing for 2020

    Beginning January 1, 2020, the minimum annual percentage rate for
random controlled substances testing is 50 percent of the average
number of driver positions. The minimum annual percentage rate for
random alcohol testing will remain at 10 percent.

    Issued on: December 20, 2019.
Elaine L. Chao,
Secretary.
[FR Doc. 2019-28164 Filed 12-26-19; 8:45 am]
 BILLING CODE 4910-EX-P