UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

		WASHINGTON, D.C. 20460

OFFICE OF CHEMICAL SAFETY

AND POLLUTION PREVENTION

May 25, 2010

MEMORANDUM

SUBJECT:	Review of Product Characterization and Human Health Data for
Plant- Incorporated Protectant Bacillus thuringiensis (Bt) eCry3.1Ab
insect control protein and the genetic material necessary for its
production in Event 5307 maize (Zea mays) [EPA Reg. No. 67979-EUP-I] in
support for an Experimental Use Permit and Temporary Exemption from the
Requirement of a Tolerance [Petition No. 9F7561]; Decision Number:
409084, DP Barcode:  367108; submitted by Syngenta Seeds, Inc. – Field
Crops – NAFTA.

FROM:	Annabel Waggoner, Environmental Protection Specialist	[signed]

		Microbial Pesticides Branch, Biopesticides and

		Pollution Prevention Division (7511P)

THROUGH:	John L. Kough, Ph.D., Biologist					[signed]

	Microbial Pesticides Branch, Biopesticides and

	Pollution Prevention Division (7511P)

TO:	Mike Mendelsohn, Senior Regulatory Action Leader

	Microbial Pesticides Branch, Biopesticides and

	Pollution Prevention Division (7511P)

ACTION REQUESTED: To review product characterization and human health
data submitted by Syngenta Seeds, Inc.-Field Crops – NAFTA, in support
for an Experimental Use Permit and a temporary tolerance exemption for
Bt eCry3.1Ab insect control protein expressed in Event 5307 maize.

CONCLUSION:

The product characterization, toxicological and allergenicity data
support the finding that there is a reasonable certainty that no harm
will result from aggregate exposure to the U.S. population, including
infants and children, to the eCry3.1Ab protein and the genetic material
necessary for its production in Event 5307 maize. This includes all
anticipated dietary exposures and all other exposures for which there is
reliable information. Therefore, the product characterization and human
health data submitted for eCry3.1Ab protein are sufficient to support an
Experimental Use Permit and a temporary exemption from the requirement
of a tolerance.

DATA REVIEW RECORD:

Active Ingredient:	Bacillus thuringiensis eCry3.1Ab insecticidal protein
and the genetic material necessary for its production in corn (via
plasmid vector PV-ZMIR245)

Product Name:	Event 5307 maize [EPA Reg. No. 67979-EUP-I]

Company Name:	Syngenta Seeds, Inc. – Field Crops - NAFTA

ID No: 	      	67979

Decision Number:        409084

DP Barcode: 	367108

MRID No:

Product Characterization Data

477347-01	Characterization and Safety of eCry3.1Ab Protein and Corn
Plants Derived from Event 5307

477347-02 	Molecular characterization of Event 5307 maize

477347-03	Comparison of eCry3.1Ab protein produced in Event 5307-derived
maize plants and eCry3.1Ab protein produced in recombinant Escherichia
coli

477347-04  	Characterization of Test Substance ECRY3.1AB-0208 and
Certificate of Analysis

477347-05	Bioactivity of Test Substance ECRY3.1AB-0208

477347-07	Evaluation of Transgenic Protein Levels in Multiple
Generations of Plants Derived from Transformation Event 5307 Maize

Human Health Data

477539-01	ECRY3.1AB-0208: Single-dose Oral (Gavage) Toxicity Study in
Mice with a 14-Day Observation

	Period

477347-09	eCry3.1Ab: Assessment of amino acid sequence homology with
known toxins

477347-10	eCry3.1Ab: Assessment of amino acid sequence homology with
known or putative allergens

477347-11	In vitro digestibility of eCry3.1Ab protein as contained in
test substance ECRY3.1AB-0208 and event 5307 maize under simulated
mammalian gastric conditions

477347-12	Phosphomannose isomerase (Entrez Database Accession No
AAA24109): Assessment of amino acid sequence homology with known toxins

477347-13	Phosphomannose isomerase (Entrez Database Accession No
AAA24109): Assessment of amino acid

	sequence homology with known or putative allergens

480384-01	Supplemental Information for Study SSB-024-08: In Vitro
Digestibility of eCry3.1Ab Protein as Contained in Test Substance
ECRY3.1AB-0208 and in 5307 Maize Under Simulated Mammalian Gastric
Conditions [EPA MRID 47734711]

BACKGROUND:

Based on amino acid sequence similarity and crystal structures, known
Cry proteins have a similar three-dimensional structure comprised of
three domains, Domain I, II and III (Nakamura et al., 1990; Li et al.,
1991; Ge et al., 1991; Honee et al., 1991). The toxin portions of Cry
proteins are characterized by having five conserved blocks (CB) across
their amino acid sequence. These are numbered CB1 to CB5 from the N-
terminus to the C-terminus (Hofte and Whiteley, 1989). The sequences
preceding and following these conserved blocks are highly variable and
are designated as variable regions V1 to V6.

Syngenta Seeds, Inc. – Field Crops - NAFTA developed Event 5307 maize
(Zea mays) through Agrobacterium-mediated transformation (via plasmid
vector PV-ZMIR245) to express eCry3.1Ab protein for use as a
plant-incorporated protectant (PIP).  This proposed PIP is a chimeric
Bacillus thuringiensis protein, composed of portions of Cry1Ab and
modified Cry3A proteins.  The eCry3.1Ab protein was genetically
engineered via exchanging the variable regions (V1 to V6) between the
mCry3A and the Cry1Ab proteins for enhanced toxicity against western
corn rootworm (WCR, Diabrotica virgifera).  The eCry3.1Ab protein
consists of a fusion between the N-terminus (Domain I, Domain II, and a
portion of Domain III) of mCry3 A and the C-terminus (a portion of
Domain III and variable region 6) of Cry1Ab. The eCry3.1Ab protein is
654 amino acid residues in size and is approximately 73.7 kDa.

Event 5307 corn also contains the pmi gene, which was introduced along
with the eCry3.1Ab protein via the same PV-ZMIR245 transformation
vector.  The gene represents the manA gene from Escherichia coli and
encodes the enzyme phosphomannose isomerase (PMI), which was employed as
a selectable marker during the process of regenerating plant material
following transformation (Negrotto, et al., 2000).

Syngenta Seeds, Inc. is applying for an experimental use permit (EUP) to
conduct field testing on Event 5307 corn, hybrids thereof, and non-PIP
corn.   The proposed planting under the EUP will take place in 28 states
and Puerto Rico for a total of 14,619 acres over two years (7311 acres
in 2010 and 7308 acres in 2011).  The proposed planting also includes
field testing Event 5307 maize, as a combination PIP product, with one
or more of the following previously registered PIP corn events:  Bt11,
DAS-59122-7, MIR162, MIR604, and TC1507.

Event Bt11 produces Bt Cry1Ab protein that protects against European
corn borer (Ostrinia nubilalis) and is currently registered for use as a
PIP (US EPA, 2001).

DAS-59122-7 produces Cry34Ab1 and Cry35Ab1 proteins derived from the Bt
strain PS149B1, to protect against coleopteran pests (corn rootworm) and
is currently registered for use as a PIP (US EPA, 2005b).

MIR162 produces Bt Vip3Aa20 insecticidal protein and is currently
registered for use as a PIP that protects against feeding damage caused
by many lepidopteran insect pests:  Spodoptera frugiperda (fall
armyworm), Pseudaletia unipunctata (armyworm), Spodoptera exigua (beet
armyworm), Helicoverpa zea (corn earworm/cotton bollworm), Agrotis
ipsilon (black cutworm), and Striacosta albicosta (western bean cutworm)
(US EPA, 2009).

MIR604 produces a modified Bt mCry3A protein to protect against corn
rootworm (CRW) larval feeding and is currently registered for use as a
PIP (US EPA, 2007).

TC1507 produces Bt Cry1F protein to selectively control larvae of the
European corn borer (O. nubilalis) and other lepidopteran insect pests
and is currently registered for use as a PIP (US EPA, 2005a)

To satisfy the data requirements specific for the EUP for eCry3.1Ab,
Syngenta Seeds, Inc. has submitted product characterization, toxicity,
and allergenicity data, which are reviewed in this report.   The
registrant also submitted additional data for PMI to be reviewed in this
report- specifically an updated amino acid similarity assessment of PMI
to known toxins and allergens, which will supersede the previously
reviewed PMI data.

RECOMMENDATION:

The product characterization and human health data submitted for
eCry3.1Ab as expressed in Event 5307 maize [EPA Reg. No. 67979-EUP-I]
are sufficient to support an Experimental Use Permit and a temporary
exemption from the requirement of a tolerance.

There are a few studies classified as “SUPPLEMENTAL” but sufficient
for the purposes of the EUP and satisfy the data needed to support the
preliminary safety assessment.  However, if the registrant pursues a
Sec. 3 Registration of eCry3.1Ab expressed in Event 5307 maize for use
as a PIP, additional data would be needed to complete the eCry3.1Ab
database.  Details of these studies and recommendations are provided
below:

MRID No. 477347-11 and 480384-01

The provisional enzyme kinetic analysis of a previously conducted in
vitro digestibility study in SGF for the microbial-derived and the
plant-derived eCry3.1Ab test substances showed rapid pepsin degradation
rates  (DT50= <1 minute and DT50= <2 minutes, respectively). However,
the combination of the original in vitro digestibility study and
supplemental information are only sufficient to support the data needs
for the EUP request because these degradation rates are an estimated
range of values and based on a comparison of the degradation rate with
other non-allergenic proteins.  There is no exact quantified endpoint
for the DT50 endpoint to report.

Therefore, if the registrant submits an application for a Sec. 3
registration for Event 5307 maize expressing eCry3.1Ab protein, the
Agency recommends conducting an appropriately designed in vitro
digestibility study of eCry3.1Ab test substances in SGF utilizing the
kinetic approach with the inclusion of additional data points in between
the first two minutes of the assay.  This study will serve as final
confirmation of the rapid digestibility of eCry3A.1Ab protein in pepsin
by providing earlier data points to plot the exact degradation rate of
the protein.

 The Agency also recognizes that collecting enough data points early in
the decay curve is difficult (because the pepsinolysis reaction is
difficult to stop for rapidly degraded proteins), therefore, it is also
recommended the registrant consult with the Agency in a pre-registration
meeting to address the data needs for the Sec.3 registration.

The registrant should be prepared to provide data to verify  the buffer
ionic strength effect on other proteins to the Agency.

MRID No. 477347-07

The study establishing field protein expression levels in 5307 corn
tissues and plants, the study is supplemental.  This study was a
preliminary greenhouse experiment and contained limited data points of
the protein expression and used a minimal sample size of eCry3.1Ab in
Event 5307 corn.  It does provide useful information for establishing
the consistency of expression of eCry3.1Ab and PMI protein
concentrations across four generations of Event 5307 maize (VT-R1
stages), but does not include quantification of eCry3.1Ab protein levels
expressed in various plant tissues and the whole corn plant, which is
necessary to determine exposure for non-target organisms, for IRM dose
levels, and dietary exposure estimates.  However, these data do not
affect the findings of the safety assessment for the proposed EUP.

This data requirement can be addressed in the Sec. 3 Registration of
eCry3.1Ab.  It is recommended that a field study be conducted to
determine the protein concentrations of eCry3.1Ab and PMI in various
plants tissues at multiple stages of plant growth development  (using
multiple geographic locations and a sufficient number of replicates for
the plant samples to ensure statistical validity). The study should also
include the following:

1) Protein concentration values should include:  the mean, range, and
standard deviations) and reported on a dry weight basis (µg protein/g
tissue).  An appendix should be submitted to contain the results of the
individual samples to serve

 as the basis of calculating the mean and range.

2) The number of samples collected should be statistically valid to
represent a range of field conditions at various geographic regions
where the product is expected to be grown.

	3)  Standard curve data for the ELISA should be included.

4) The calculation method for determining the dry weight conversion
factor from the fresh weight tissue samples; and

	5) Identification of the specific seed line and lot utilized as the
test material with number of plants used in analysis, field sites and
replicates.

Temporary Exemption from the Requirement of a Tolerance [Petition No.
9F7561]

In conjunction with the EUP, Syngenta Seeds, Inc. – Field Crops- NAFTA
has submitted a petition for a temporary exemption from the requirement
of a tolerance pursuant to section 408(d)(1) of the Federal Food, Drug,
and Cosmetic Act with respect to the plant-incorporated protectant
eCry3.1Ab Bacillus thuringiensis insect control protein and the genetic
material necessary for its production in food and feed commodities of
field corn, sweet corn, and popcorn.  The genetic material necessary for
the production of the plant-incorporated protectant active ingredients
are the nucleic acids (DNA, RNA) which comprise genetic material
encoding these proteins and their regulatory regions.  The genetic
material (nucleic acids) that are part of any plant-incorporated
protectant are exempt from the requirement of a tolerance [40 CFR
174.507, effective Apr. 25, 2007].   An exemption from the requirement
of a tolerance has been established for PMI in all crops when used as a
plant-incorporated protectant inert ingredient [see 40 CFR 180.1252,
effective May 14, 2004].

Existing exemptions from the requirement of a tolerance has been
established for Cry1Ab protein in food and mCry3A protein in maize when
used as plant-incorporated protectants [see 40 CFR 174.511, effective
Apr. 25, 2007 and 40 CFR 174.506, effective Apr. 25, 2007,
respectively].

Preliminary Safety Assessment

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA
defines “safe” to mean that “there is a reasonable certainty that
no harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.” This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section 408(b)(2)(C) of the FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to “ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue”… Additionally, section 408(b)(2)(D) of the FFDCA
requires that the Agency consider “available information concerning
the cumulative effects of a particular pesticide's residues and other
substances that have a common mechanism of toxicity.” EPA performs a
number of analyses to determine the risks from aggregate exposure to
pesticide residues. First, EPA determines the toxicity of pesticides.
Second, EPA examines exposure to the pesticide through food, drinking
water, and through other exposures that occur as a result of pesticide
use in residential settings.

Product Characterization Profile

An eCry3.1Ab Bacillus thuringiensis (Bt) insect control protein was
produced in Event 5307 maize (Zea mays) through Agrobacterium-mediated
transformation (via plasmid vector PV-ZMIR245) for use as a
plant-incorporated protectant (PIP).  This proposed PIP is a chimeric
Bacillus thuringiensis protein, composed of portions of Cry1Ab and
modified Cry3A proteins.  The eCry3.1Ab protein was genetically
engineered via exchanging the variable regions (V1 to V6) between the
mCry3A and the Cry1Ab proteins for enhanced toxicity against western
corn rootworm (WCR, Diabrotica virgifera).  The eCry3.1Ab protein
consists of a fusion between the N-terminus (Domain I, Domain II, and a
portion of Domain III) of mCry3 A and the C-terminus (a portion of
Domain III and variable region 6) of Cry1Ab. The eCry3.1Ab protein is
654 amino acid residues in size and is approximately 73.7 kDa.  The pmi
gene, which was introduced along with the eCry3.1Ab protein via the same
PV-ZMIR245 transformation vector, encodes the enzyme phosphomannose
isomerase (PMI), which is employed as a selectable marker during the
process of regenerating plant material following transformation.  The
PMI protein is a common enzyme involved in carbohydrate metabolism to
allow for selection of transformants in cell culture, by only allowing
transformed corn cells to utilize mannose as a sole carbon source, while
corn cells lacking the pmi gene fail to grow (Negrotto, et al. 2000).

The ecry3.1Ab expression cassette consisted of the ecry3.lAb coding
region regulated by a cestrum yellow leaf curling virus promoter (CMP)
and a nopaline synthase (NOS) polyadenylation sequence. The pmi
expression cassette consisted of the pmi coding region regulated by a Z.
mays polyubiquitin promoter (ZmUbilnt) and the NOS polyadenylation
sequence. Southern blot analyses and DNA sequencing indicate that one
full length copy of each of the eCry3.1Ab and pmi genes were integrated
into the maize genome, without the backbone sequences from
transformation plasmid PV-ZMIR245 plasmid.   Therefore, the overall
integrity of the insert and the contiguousness of the functional
elements were confirmed.

Data have been submitted demonstrating the protein equivalency of
plant-expressed eCry3.1Ab protein and its respective protein test
substances, expressed in recombinant E. coli (ECRY3.1AB-0208) for use as
a surrogate in toxicity experiments based on  similar biochemical and
functional characteristics (see MRID No. 477347-03).

Toxicological Profile

Consistent with section 408(b) (2) (D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

1.   Mammalian Toxicity and Allergenicity Assessment

Syngenta has submitted acute oral toxicity data demonstrating the lack
of mammalian toxicity at high levels of exposure to the pure eCry3.1Ab
protein.  These data demonstrate the safety of the product at a level
well above maximum possible exposure levels that are reasonably
anticipated in the crop.  Basing this conclusion on acute oral toxicity
data without requiring further toxicity testing and residue data is
similar to the Agency position regarding toxicity testing and the
requirement of residue data for the microbial Bacillus thuringiensis
products from which this plant-incorporated protectant was derived (See
40 CFR Sec. 158.740(b)(2)(i)). For microbial products, further toxicity
testing and residue data are triggered by significant adverse acute
effects in studies such as the mouse oral toxicity study, to verify and
quantify the observed adverse effects and clarify the source of these
effects (Tiers II & III).

An acute oral toxicity study in mice (MRID No. 477539-01) indicated that
eCry3.1Ab is non-toxic. Two groups of ten male and ten female mice were
orally dosed (via gavage) with 2,000 milligrams/kilograms bodyweight
(eCry3.1Ab protein mg/kg bwt) of the ECRY3.1AB0208 test substance, the
microbial-produced eCry3.1Ab protein.  All treated animals gained weight
and had no test material-related clinical signs and no test
material-related findings at necropsy.  Since there were no significant
differences between the test and control groups related to the oral
administration of ECRY3.1AB-0208 test material; the eCry3.1Ab protein
does not appear to cause any significant adverse effects at an exposure
level of up to 2000 mg/kg bodyweight and supports the finding that the
eCry3.1Ab protein would be non-toxic to mammals.

When proteins are toxic, they are known to act via acute mechanisms and
at very low dose levels (Sjoblad, Roy D., et al., “Toxicological
Considerations for Protein Components of Biological Pesticide
Products,” Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Therefore, since no acute effects were shown to be caused by eCry3.1Ab,
even at relatively high dose levels, the eCry3.1Ab protein is not
considered toxic.  Further, amino acid sequence comparisons showed no
similarities between the eCry3.1Ab protein and known toxic proteins in
protein databases that would raise a safety concern.

Since eCry3.1Ab is a protein, allergenic sensitivities were considered.
Currently, no definitive tests exist for determining the allergenic
potential of novel proteins.  Therefore, EPA uses a “weight-of-the
evidence” approach where the following factors are considered: source
of the trait; amino acid sequence similarity with known allergens;
prevalence in food; and biochemical properties of the protein, including
in vitro digestibility in simulated gastric fluid (SGF), and
glycosylation (as recommended by CAC, 2003).  Current scientific
knowledge suggests that common food allergens tend to be resistant to
degradation by acid and proteases; may be glycosylated; and present at
high concentrations in the food.

Source of the trait.  Bacillus thuringiensis is not considered to be a
source of allergenic proteins.

Amino acid sequence.  A comparison of the amino acid sequence of
eCry3.1Ab with known allergens showed no significant overall sequence
similarity or identity at the level of eight contiguous amino acid
residues.

Prevalence in food.  Preliminary expression level analysis of eCry.1Ab
protein is present at relatively low levels.  Dietary exposure is
expected to be correspondingly low.  Expression in Event 5307 leaf is
<35 ppm; root is <6 ppm; pollen is < 0.15 ppm.  Thus, the expression has
been shown to be in the parts per million range.

Digestibility.  The eCry3.1Ab protein was rapidly digested in simulated
mammalian gastric fluid containing pepsin at a pH of 1.2 at 37°C.  The
enzyme kinetic analysis estimated the degradation rate as less than one
minute for eCry3.1Ab protein.

Glycosylation.  The eCry3.1Ab protein expressed in corn was shown not to
be glycosylated.

Conclusion.  Considering all of the available information, EPA has
concluded that the potential for eCry3.1Ab to be a food allergen is
minimal.

2) Aggregate Exposures

In examining aggregate exposure, EPA considers available information
concerning exposures from the pesticide residue in food and all other
non- occupational exposures, including drinking water from ground water
or surface water and exposure through pesticide use in gardens, lawns,
or buildings (residential and other indoor uses).

The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect for
the plant-incorporated protectant chemical residue, and exposure from
non-occupational sources. Exposure via the skin or inhalation is not
likely since the plant-incorporated protectant is contained within plant
cells, which essentially eliminates these exposure routes or reduces
these exposure routes to negligible. The amino acid similarity
assessment included similarity to known aeroallergens.  It has been
demonstrated that there is no evidence of occupationally related
respiratory symptoms, based on a health survey on migrant workers after
exposure to Bt pesticides (Berstein et al. 1999).  Exposure via
residential or lawn use to infants and children is also not expected
because the use sites for the eCry3.1Ab protein are all agricultural for
control of insects. Oral exposure, at very low levels may occur from
ingestion of processed corn products and, potentially, drinking water.

However, oral toxicity testing done at a dose of 2 gm/kg showed no
adverse effects. Furthermore, the expected dietary exposure from corn
are several orders of magnitude lower than the amounts of eCry3.1Ab
protein shown to have no toxicity. Therefore, even if negligible
aggregate exposure should occur, the Agency concludes that such exposure
would present no harm due to the lack of mammalian toxicity and the
rapid digestibility demonstrated for the eCry3.1Ab protein.

3)  Cumulative Effects

Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available
information on the cumulative effects of such residues and other
substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity.  Because there is no indication of mammalian toxicity,
resulting from the plant-incorporated protectant, we conclude that there
are no cumulative effects for the eCry3.1Ab protein.

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

A. Toxicity and Allergenicity Conclusions

The data submitted and cited regarding potential health effects for the
eCry3.1Ab protein include the characterization of the expressed
eCry3.1Ab protein in corn, as well as the acute oral toxicity, heat
stability, and in vitro digestibility of the proteins. The results of
these studies were used to evaluate human risk, and the validity,
completeness, and reliability of the available data from the studies
were also considered.

Adequate information was submitted to show that the eCry3.1Ab protein
test material derived from microbial cultures was biochemically and
functionally similar to the protein produced by the plant-incorporated
protectant ingredients in corn.  Microbially produced protein was chosen
in order to obtain sufficient material for testing.

The acute oral toxicity data submitted supports the prediction that the
eCry3.1Ab protein would be non-toxic to humans. As mentioned above, when
proteins are toxic, they are known to act via acute mechanisms and at
very low dose levels (Sjoblad, Roy D., et al. 1992). Since no effects
were shown to be caused by eCry3.1Ab protein, even at relatively high
dose levels (2,000 mg eCry3.1Ab/kg bwt), the eCry3.1Ab protein is not
considered toxic. This is similar to the Agency position regarding
toxicity and the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant was
derived. (See 40 CFR 158.740(b)(2)(i)).   Moreover, eCry3.1Ab showed no
sequence similarity to any known toxin.

Protein residue chemistry data for eCry3.1Ab were not required for a
human health effects assessment of the subject plant-incorporated
protectant ingredients because of the lack of mammalian toxicity.
However, preliminary expression level analysis showed eCry3.1Ab protein
is present at relatively low levels.  Dietary exposure is expected to be
correspondingly low.  Expression in Event 5307 leaf, root, and pollen is
<35 ppm, <6 ppm, and < 0.15 ppm, respectively.

Since eCry3.1Ab is a protein, its potential allergenicity is also
considered as part of the toxicity assessment. Data considered as part
of the allergenicity assessment include that the eCry3.1Ab protein came
from Bacillus thuringiensis which is not a known allergenic source,
showed no sequence similarity to known allergens, was readily degraded
by pepsin, and was not glycosylated when expressed in the plant.
Therefore, there is a reasonable certainty that eCry3.1Ab protein will
not be an allergen.

Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children); nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the eCry3.1Ab protein, as well as the minimal potential to
be a food allergen demonstrate the safety of the product at levels well
above possible maximum exposure levels anticipated in the crop.

B. Infants and Children Risk Conclusions

FFDCA section 408(b)(2)(C) provides that EPA shall assess the available
information about consumption patterns among infants and children,
special susceptibility of infants and children to pesticide chemical
residues and the cumulative effects on infants and children of the
residues and other substances with a common mechanism of toxicity.

In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall
apply an additional tenfold margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA determines
that a different margin of safety will be safe for infants and children.

In this instance, based on all the available information, the Agency
concludes that there is a finding of no toxicity for the eCry3.1Ab
protein and the genetic material necessary for their production. Thus,
there are no threshold effects of concern and, as a result, the
provision requiring an additional margin of safety does not apply.
Further, the provisions of consumption patterns, special susceptibility,
and cumulative effects do not apply.

C. Overall Safety Conclusion

There is a reasonable certainty that no harm will result from aggregate
exposure to the U.S. population, including infants and children, to the
eCry3.1Ab protein and the genetic material necessary for its production.
This includes all anticipated dietary exposures and all other exposures
for which there is reliable information. The Agency has arrived at this
conclusion because, as previously discussed, no toxicity to mammals has
been observed, nor has there been any indication of allergenicity
potential for the plant-incorporated protectant.

5)  Other Considerations

A. Endocrine Disruptors

As required under FFDCA section 408(p), EPA has developed the Endocrine
Disruptor Screening Program (EDSP) to determine whether certain
substances (including pesticide active and other ingredients) may have
an effect in humans or wildlife similar to an effect produced by a
“naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.”  The EDSP employs a two-tiered approach
to making the statutorily required determinations. Tier 1 consists of a
battery of 11 screening assays to identify the potential of a chemical
substance to interact with the estrogen, androgen, or thyroid (E, A, or
T) hormonal systems.  Chemicals that go through Tier 1 screening and are
found to have the potential to interact with E, A, or T hormonal systems
will proceed to the next stage of the EDSP where EPA will determine
which, if any, of the Tier 2 tests are necessary based on the available
data. Tier 2 testing is designed to identify any adverse endocrine
related effects caused by the substance, and establish a dose-response
relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data
call-ins for the first group of 67 chemicals, which contains 58
pesticide active ingredients and 9 inert ingredients.  This list of
chemicals was selected based on the potential for human exposure through
pathways such as food and water, residential activity, and certain
post-application agricultural scenarios.  This list should not be
construed as a list of known or likely endocrine disruptors.

The proposed PIP, eCry3.1Ab insect control protein (as expressed in
Event 5307 maize), is not among the group of 58 pesticide active
ingredients on the initial list to be screened under the EDSP.  Under
FFDCA sec. 408(p) the Agency must screen all pesticide chemicals.
Accordingly, EPA anticipates issuing future EDSP test orders/data
call-ins for all pesticide active ingredients.

For further information on the status of the EDSP, the policies and
procedures, the list of 67 chemicals, the test guidelines and the Tier 1
screening battery, please visit our website:  http://www.epa.gov/endo/.

B. Analytical Method(s)

A method for extraction and two test strip commercial kits to detect
eCry3.1Ab protein via ELISA analysis in corn has been submitted and is
under review by the Agency.

C. Codex Maximum Residue Level

No Codex maximum residue levels exist for the plant-incorporated
protectant Bacillus thuringiensis eCry3.1Ab protein and the genetic
material necessary for its production in corn.

SUMMARY OF DATA SUBMITTED:

The submitted studies to support the registrant’s EUP request and
petition for a temporary exemption from the requirement of a tolerance
for eCry3A.1Ab protein as expressed in Event 5307 maize are listed below
with their respective MRID No. and classification (see Table 1).  The
Agency reviewed the submitted studies (including product
characterization, human toxicity, and allergenicity data) and they are
individually summarized in Data Evaluation Reports (DERs).  Each DER
contains the objective, test methods/materials, results and findings,
conclusion, and classification of each study.   This memorandum
represents the Agency’s overall recommendation for Syngenta’s EUP
request based on the summary of data reviewed in each DER (for detailed
information of each study, refer to the DER according to their
respective assigned MRID number).

Table 1. Compilation of Submitted Data and Classification for Event 5307
expressing eCry3.1Ab protein [EPA Reg. No. 67676-EUP-I] in support of
Syngenta’s EUP request.

MRID NO.	STUDY TITLE	CLASSIFICATION

Product Characterization Data

477347-01	Characterization and Safety of eCry3.1Ab Protein and Corn
Plants Derived from Event 5307

	ACCEPTABLE

477347-02	Molecular characterization of Event 5307 maize

	ACCEPTABLE

477347-03	Comparison of eCry3.1Ab protein produced in Event 5307-derived
maize plants and eCry3.1Ab protein produced in recombinant Escherichia
coli

	ACCEPTABLE

477347-04	Characterization of Test Substance ECRY3.1AB-0208 and
Certificate of Analysis

	ACCEPTABLE

477347-05	Bioactivity of Test Substance ECRY3.1AB-0208

	ACCEPTABLE

477347-07	Evaluation of Transgenic Protein Levels in Multiple
Generations of Plants Derived from Transformation Event 5307 Maize

	SUPPLEMENTAL

Toxicity and Allergenicity Data

477539-01	ECRY3.1AB-0208: Single-dose Oral (Gavage) Toxicity Study in
Mice with a 14-Day Observation Period

	ACCEPTABLE

477347-09	eCry3.1Ab: Assessment of amino acid sequence homology with
known toxins

	ACCEPTABLE

477347-10	eCry3.1Ab: Assessment of amino acid sequence homology with
known or putative allergens

	ACCEPTABLE

477347-11	In vitro digestibility of eCry3.1Ab protein as contained in
test substance ECRY3.1AB-0208 and event 5307 maize under simulated
mammalian gastric conditions  	SUPPLEMENTAL

477347-12	Phosphomannose isomerase (Entrez Database Accession No
AAA24109): Assessment of amino acid sequence homology with known toxins

	ACCEPTABLE

477347-13	Phosphomannose isomerase (Entrez Database Accession No
AAA24109): Assessment of amino acid sequence homology with known or
putative allergens	ACCEPTABLE

480384-01	Supplemental Information for Study SSB-024-08: In Vitro
Digestibility of eCry3.1Ab Protein as Contained in Test Substance
ECRY3.1AB-0208 and in 5307 Maize Under Simulated Mammalian Gastric
Conditions [EPA MRID 47734711]	ACCEPTABLE- for the purposes of the EUP

REFERENCES

Bernstein, I.L., Bernstein, J.A., Miller, M., Tierzieva, S., Bernstein,
D.I., Lummus, Z., Selgrade, M.K., Doerfler DL, Seligy VL. (1999) Immune
responses in farm workers after exposure to Bacillus thuringiensis
pesticides. Environ Health Perspect. 107(7):575-82.

CAC (2003) Alinorm 03/34: Joint FAO/WHO Food Standard Programme. Codex
Alimentarius Commission, Twenty-Fifth Session, 30 July 2003. Rome,
Italy. Appendix III: Guideline for Conduct of Food Safety Assessments of
Foods Derived from Recombinant-DNA Plants; Appendix IV: Annex on
Assessment of Possible Allergenicity. CAC, 47–60.

Ge, A., D. Rivers, R. Milne, and D.H. Dean. (1991) Functional Domains of
Bacillus thuringiensis Insecticidal Crystal Proteins. Refinement of
Heliothis virescens and Trichoplusia ni Specificity Domains on Cry1A(c).
J. Biol. Chem. 266: 17954-17958.

Herman R.A., Storer N.A., Gao Y. (2006) Digestion assays in
allergenicity assessment of transgenic proteins.” Environmental Health
Perspectives. 114:1154–1157.

Hofte, H., and Whitley H.R. (1989) Insecticidal Crystal Proteins of
Bacillus thuringiensis.

Microbiol. Rev. 53: 242-255.

Honee, G., D. Convents, J. Van Rie, S. Jansens, M. Peferoen, and B.
Visser. (1991) The C-Terminal Domain of the Toxic Fragment of a Bacillus
thuringiensis Crystal Protein Determines Receptor Binding. Mol.
Microbiol. 5: 2799-2806.

Li, J., J. Carroll, and D.J. Ellar. (1991) Crystal Structure of
Insecticidal δ-Endotoxin from

	Bacillus thuringiensis at 2.5 A resolution. Nature 353: 815-821.

Nakamura, K., K. Oshie, M. Shimizu, Y. Takada, K. Oeda, and H. Ohkawa.
(1990) Construction of Chimeric Insecticidal Proteins Between the
130-kDa and 135-kDa Proteins of Bacillus thuringiensis subsp. aizawai
for Analysis of Structure-Function Relationship. Agric. Biol. Chem. 54:
715-724.

Negrotto, et al. (2000) The use of phosphomannose-isomerase as a
selectable marker to

	recover transgenic maize plants (Zea mays L. via Agrobacterium
transformation). Plant Cell Reports, 19: 798-803.

Sjoblad, R. D., McClintock, J.T., and Engler, R. (1992) Toxicological
Considerations for Protein Components of Biological Pesticide Products,
Reg. Toxicol. Pharmacol. 15(1): 3-9.

US EPA (2001)  Biopesticides Registration Action Document for Bacillus
thuringiensis (Bt)

	Plant-Incorporated Protectants, dated October 2001.  US Environmental
Protection Agency (EPA), Washington, DC.

US EPA (2005a)  Biopesticides Registration Action Document for Bacillus
thuringiensis (Bt)

	Cry1F Plant-Incorporated Protectant, dated August 2005.  US EPA,
Washington, DC.

US EPA (2005b)  Biopesticides Registration Action Document for Bacillus
thuringiensis (Bt)

         Cry34Ab1 and Cry35Ab1 Plant-Incorporated Protectants, dated
October 2005. US EPA, Washington, D.C.

US EPA (2007) Biopesticides Registration Action Document for the
Bacillus thuringiensis (Bt) Modified Cry3A Plant-Incorporated
Protectant, dated March 2007. US EPA, Washington, D.C.

US EPA (2009) Biopesticides Registration Action Document for Bacillus
thuringiensis (Bt)

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 PAGE

Page   PAGE  2  of   NUMPAGES  14

*THIS REPORT DOES NOT CONTAIN FIFRA CONFIDENTIAL BUSINESS INFORMATION*


[Federal Register Volume 77, Number 102 (Friday, May 25, 2012)]
[Notices]
[Pages 31396-31398]
[FR Doc No: 2012-12710]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0017]

Reports of Injuries to Employees Operating Mechanical Power
Presses; Extension of the Office of Management and Budget's (OMB)
Approval of an Information Collection (Paperwork) Requirement

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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

SUMMARY: OSHA solicits public comments concerning its proposal to
extend OMB approval of the information collection requirement contained
in the Standard on Reports of Injuries to Employees Operating
Mechanical Power Presses (29 CFR 1910.217(g)).

DATES: Comments must be submitted (postmarked, sent, or received) by
July 24, 2012.

ADDRESSES: Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2012-0017,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2012-
0017). All comments, including any

personal information you provide, are placed in the public docket
without change, and may be made available online at http://www.regulations.gov. For further information on submitting comments see
the ``Public Participation'' heading in the section of this notice
titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Theda Kenney or Todd Owen, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information
is in the desired format, reporting burden (time and costs) is minimal,
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (the OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (29 U.S.C. 657). The OSH Act also requires that OSHA obtain
such information with minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of efforts in obtaining information
(29 U.S.C. 657).
    In the event a worker is injured while operating a mechanical power
press, 29 CFR 1910.217(g) requires an employer to provide information
to OSHA regarding the accident within 30 days of the accident. This
information includes the employer's and worker's name(s), workplace
address and location; injury sustained; task being performed when the
injury occurred; number of operators required for the operation and the
number of operators provided with controls and safeguards; cause of the
accident; type of clutch, safeguard(s), and feeding method(s) used; and
means used to actuate the press stroke. OSHA's Directorate of Standards
and Guidance, or the State agency administering a plan approved by the
Assistant Secretary of Labor for Occupational Safety and Health,
collects the information. These reports are a source of up-to-date
information on power press machines. Particularly, this information
identifies the equipment used and conditions associated with these
injuries.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is requesting that OMB extend its approval of the information
collection requirement contained in the Standard on Reports of Injuries
to Employees Operating Mechanical Power Presses (29 CFR 1910.217(g)).
OSHA is proposing to decrease the existing burden hour estimate for the
collection of information requirement specified by the Provision from
13 hours to 9 hours, for a total decrease of 4 hours. This adjustment
is a result of a decline in the number of reports received by OSHA
annually.
    The Agency will summarize the comments submitted in response to
this notice and will include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: Reports of Injuries to Employees Operating Mechanical Power
Presses (29 CFR 1910.217(g)).
    OMB Number: 1218-0070.
    Affected Public: Business or other for-profits; Federal Government;
State, Local, or Tribal Government.
    Number of Respondents: 83.
    Frequency of Response: On occasion.
    Average Time Per Response: Five minutes (.08 hour) for a secretary
to submit the report to OSHA and 15 minutes (.25 hour) for a supervisor
to obtain the information regarding the accident and to prepare the
written report.
    Estimated Total Burden Hours: 9.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on this Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2012-0017). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify your electronic comments
by your name, date, and the docket number so the Agency can attach them
to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the  http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection

and copying at the OSHA Docket Office. Information on using the http://www.regulations.gov Web site to submit comments and access the docket
is available at the Web site's ``User Tips'' link. Contact the OSHA
Docket Office for information about materials not available through the
Web site, and for assistance in using the Internet to locate docket
submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on May 22, 2012.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2012-12710 Filed 5-24-12; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: February 26, 2007 (Volume 72, Number 37)]
[Notices]
[Page 8366]
[DOCID:fr26fe07-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. ER07-523-000]

ColumbiaGrid; Notice of Filing

February 13, 2007.

    Take notice that on February 2, 2007, ColumbiaGrid, acting on
behalf of Avista Corporation and Puget Sound Energy, Inc. tendered for
filing a Planning and Expansion Functional Agreement with an effective
date of April 4, 2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 23, 2007.

Magalie R. Salas,
Secretary.
[FR Doc. E7-3187 Filed 2-23-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 26, 2006 (Volume 71, Number 207)]
[Notices]
[Page 62631]
[DOCID:fr26oc06-74]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension:
    Rule 15c2-12; SEC File No. 270-330; OMB Control No. 3235-0372.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.

Rule 15c2-12 Disclosure Requirements for Municipal Securities

    Rule 15c2-12 (17 CFR 240.15c2-12) under the Securities Exchange Act
of 1934 (15 U.S.C. 78 et. seq.) requires underwriters of municipal
securities: (1) To obtain and review a copy of an official statement
deemed final by an issuer of the securities, except for the omission of
specified information; (2) in non-competitively bid offerings, to make
available, upon request, the most recent preliminary official
statement, if any; (3) to contract with the issuer of the securities,
or its agent, to receive, within specified time periods, sufficient
copies of the issuer's final official statement to comply both with
this rule and any rules of the MSRB; (4) to provide, for a specified
period of time, copies of the final official statement to any potential
customer upon request; (5) before purchasing or selling municipal
securities in connection with an offering, to reasonably determine that
the issuer or other specified person has undertaken, in a written
agreement or contract, for the benefit of holders of such municipal
securities, to provide certain information about the issue or issuer on
a continuing basis to a nationally recognized municipal securities
information repository; and (6) to review the information the issuer of
the municipal security has undertaken to provide prior to recommending
a transaction in the municipal security.
    These disclosure and recordkeeping requirements will ensure that
investors have adequate access to official disclosure documents that
contain details about the value and risks of particular municipal
securities at the time of issuance while the existence of compulsory
repositories will ensure that investors have continued access to terms
and provisions relating to certain static features of those municipal
securities. The provisions of Rule 15c2-12 regarding an issuer's
continuing disclosure requirements assist investors by ensuring that
information about an issue or issuer remains available after the
issuance.
    Municipal offerings of less than $1 million are exempt from the
rule, as are offerings of municipal securities issued in large
denominations that are sold to no more than 35 sophisticated investors,
have short-term maturities, or have short-term tender or put features.
It is estimated that approximately 12,000 brokers, dealers, municipal
securities dealers, issuers of municipal securities, and nationally
recognized municipal securities information repositories will spend a
total of 123,850 hours per year complying with Rule 15c2-12.
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimates of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    The recordkeeping requirement is mandatory to ensure that investors
have access to information about the issuer and particular issues of
municipal securities. This rule does not involve the collection of
confidential information. Please note that an agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid control number.
    Please direct your written comments to (i) Desk Officer for the
Securities and Exchange Commission, Office of Information and
Regulatory Affairs, Office of Management and Budget, Room 10102, New
Executive Office Building, Washington, DC 20503 or by sending an e-mail
to: David<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312 or send
an e-mail to<EMAIL_ADDRESS>Comments must be submitted to OMB
within 60 days of this notice.

    October 16, 2006.
Nancy M. Morris,
Secretary.
 [FR Doc. E6-17929 Filed 10-25-06; 8:45 am]

BILLING CODE 8011-01-P


EXECUTIVE SUMMARY

On June 7, 2011, the Federal Advisory Council on Occupational Safety and
Health (FACOSH) tasked its Training Subcommittee with developing
occupational safety and health (OSH) training guidelines that would
achieve consistency at all staff levels across the Federal Government
for training requirements contained in 29 CFR Part 1960. The guidelines
are designed to provide training that is tailored to the broad set of
responsibilities and duties that are applicable for a given staff level.
 Agencies can utilize the guidance to identify and address deficiencies
and gaps in their OSH training programs. The following recommendations
for FACOSH, as well as the attached Training Guidelines (Appendix A) and
the generic training Standard Operating Procedures (Appendix B) are the
product of the subcommittee’s effort.

ISSUE

To achieve consistent safety and health training across the Federal
Government, there is a need for uniform OSH training guidelines at all
staff levels.

RECOMMENDATIONS

1A)	The Secretary should direct OSHA to develop and issue Occupational
Safety and Health (OSH) training guidelines for federal agencies. The
guidelines should:

Establish a fundamental baseline of OSH training elements that federal
agencies should use when developing and providing training for federal
employees.

Address the frequency and duration of required OSH training.

Identify a method or means of assuring that federal agencies provide
employees with required OSH training and that the employees understand
the OSH training that they receive.

Give agencies latitude to implement the most effective and efficient
methods of delivering required OSH training.

Require agency heads to develop and implement a program for evaluating
the effectiveness of their OSH training and training delivery methods.

Include a sample Standard Operating Procedure to aid agencies with the
implementation of the OSH training guidelines.

1B)	The Secretary should direct OSHA to revise 29 CFR Part 1960: 1) for
agencies to provide employees with annual OSH training that covers new
or emerging hazards as well as issues of importance to a given agency or
job task/function and 2) to  make the failure to provide annual OSH
training citable by OSHA.

1C)	The Secretary should direct OSHA to send a memorandum to the
Designated Agency Safety and Health Officials (DASHOs) announcing the
issuance of OSH training guidelines for federal agencies.  The memo
should encourage DASHOs to utilize safety and health experts from
whatever source available when developing OSH training, including but
not limited to other agencies, professional groups, consultants,
universities, labor organizations, and safety and health committees.

1D)	The Secretary should correspond with agency heads emphasizing their
responsibility to provide employees with OSH training consistent with
the revised standards of 29 CFR 1960.

2A)	The Secretary should send a memorandum to the Director of the Office
of Personnel Management (OPM) requesting that OPM training orientation,
training resources, and the OPM Federal Training Policy Handbook include
OSH information and materials for supervisors, managers, and executives
that will enable them to implement the OSH programs of their agencies.
Such orientation should include coverage of Section 19 of the
Occupational Safety and Health Act of 1970, Executive Order 12196, and
the requirements of 29 CFR 1960.

2B)	The Secretary should request that OPM distribute OSHA training
requirements by: 1) posting them to the OPM website, and 2)
communicating them to agency heads, human resource departments, and
Employee Assistance Programs.

2C)	The Secretary should request that OPM update the section of the OPM
Federal Training Policy Handbook titled, Supervisory, Managerial, and
Executive Development Federally Mandated Training, to include OSH
training time-frames for all employees and for supervisors.

3A)	The Secretary should direct OSHA to monitor agencies’ OSH training
programs through inspections and evaluations.  During monitoring
activities, OSHA should verify that employee training records are
retrievable and clearly identifiable as meeting the requirements of 29
CFR 1960.

3B)	The Secretary should direct OSHA to include a requirement in the
annual report for agency heads to provide written summaries of their OSH
training and self-evaluations, including: 1) evidence verifying that OSH
training was developed in accordance with the requirements set forth in
29 CFR 1960 and EO 12196; 2) a list of the training conducted,  3)
information pertaining to the matrix the agency used to evaluate the
effectiveness of its OSH training and training delivery methods; and 4)
documentation of the funding allocated to OSH.

3C)	The Secretary should direct OSHA to widely publicize the new
reporting requirements for training to the DASHOs and safety and health
managers, prior to including it in the annual report request.

APPENDIX A

The following list contains the names of FACOSH members, Technical
Experts, and OSHA staff who actively participated on the Training
Subcommittee during its analysis of safety and health training
requirements for all staff levels of federal agencies.

FACOSH Members

Dennis Bushta, Deputy Director, Office of Administration, U.S.
Environmental Protection Agency

Deborah Kleinberg, Counsel, Seafarers International Union, AGLIWD

William Kojola, MS, Industrial Hygienist, Safety and Health Department,
AFL-CIO

Milagro “Milly” Rodriguez, Occupational Health and Safety
Specialist, AFGE

Technical Experts

Craig Brown, Senior Industrial Hygienist, U.S. Department of Veteran
Affairs

Henry Cleveland, Program Analyst, U.S. Department of Veteran Affairs

Edward Collier, U.S. Environmental Protection Agency

Cathie Cronin, Director, Office of Training and Educational Development,
Occupational Safety and Health Administration, U.S. Department of Labor

Chesha Gartmon, Program Manager, U.S. Department of the Treasury

Brian Marcyjanik, General Safety Program Manager, U.S. Department of
Veteran Affairs

Brenda Miller, Senior Safety Advisor, U.S. Department of the Army

Lynn M. O'Brien, CP-12 Program Administrator, U.S. Department of the
Army

Daniel Pubal, Safety and Occupational Health Manager, Federal Aviation
Administration

David Smith, Manager, Occupational Safety and Health Program, U.S.
Department of Energy

Howard Wilson, Deputy Director, Safety, Health and Environmental
Management Division, U.S. Environmental Protection Agency

David Wynn, Industrial Hygienist, Safety, Health and Environmental
Management Division, U.S. Environmental Protection Agency

OSHA Staff

Francis Yebesi, Director, Office of Federal Agency Programs,
Occupational Safety and Health Administration, U.S. Department of Labor

Mikki Holmes, Supervisor, Office of Federal Agency Programs,
Occupational Safety and Health Administration, U.S. Department of Labor

Mandi Dermer, Program Analyst, Office of Federal Agency Programs,
Occupational Safety and Health Administration, U.S. Department of Labor

 PAGE

	   PAGE  2  of   NUMPAGES  6

Recommendations for Consideration by the Secretary of Labor on Uniform
Occupational Safety and Health Training Guidelines for the Federal
Government

Prepared by the

Federal Advisory Council on Occupational Safety and Health

(FACOSH)


[Federal Register Volume 83, Number 170 (Friday, August 31, 2018)]
[Notices]
[Pages 44622-44623]
[FR Doc No: 2018-18954]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2017-0640; FRL-9982-92-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Producers, Registrants and Applicants of
Pesticides and Pesticide Devices Under Section 8 of the Federal
Insecticide, Fungicide, and Rodenticide Act (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Producers, Registrants and
Applicants of Pesticides and Pesticide Devices under Section 8 of the
Federal Insecticide, Fungicide, and Rodenticide Act (EPA ICR Number
0143.13, OMB Control Number 2070-0028), to the Office of Management and
Budget (OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a proposed extension of the ICR, which is
currently approved through September 30, 2018. Public comments were
previously requested via the Federal Register on February 13, 2018
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may not conduct or sponsor and a person is not required to respond to a
collection of information unless it

displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before October 1,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2017-0640 to (1) EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Michelle Stevenson, Office of
Compliance, Monitoring, Assistance, and Media Programs Division,
Pesticides, Waste & Toxics Branch (2225A), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, EPA West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Producers of pesticides and pesticide devices must
maintain certain records with respect to their operations and make such
records available for inspection and copying as specified in Section 8
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
in regulations at 40 CFR part 169. This information collection is
mandatory under FIFRA Section 8. It is used by the Agency to determine
compliance with FIFRA.
    Form Numbers: None.
    Respondents/affected entities: Producers of pesticides and
pesticide devices for sale or distribution in or exported to the United
States.
    Respondent's obligation to respond: Mandatory (40 CFR 169).
    Estimated number of respondents: 28,566 (total).
    Frequency of response: Annually.
    Total estimated burden: 57,132 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $7,545,424 (per year), which includes no
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an increase of 28,238 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is due to an adjustment in the
estimates of the number of respondents.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-18954 Filed 8-30-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10948-10949]
[FR Doc No: 2021-03673]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Number: PR12-20-001.
    Applicants: NorthWestern Corporation.
    Description: Tariff filing per 284.123(b)(1)/.: Rate Certification
in Compliance with Docket No. CP11-76-000 under PR12-20.
    Filed Date: 2/16/2021.
    Accession Number:<PHONE_NUMBER>00.
    Comments/Protests Due: 5 p.m. ET 3/9/2021.

    Docket Numbers: RP21-482-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2021-02-12 Non-Conforming
Negotiated Rate Amendment to be effective 2/13/2021.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5073.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-483-000.
    Applicants: TransCameron Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Changes Normal filing 2021 Mar
to be effective 3/16/2021.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5075.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-484-000.
    Applicants: TransCameron Pipeline, LLC.
    Description: Petition for Limited Waiver of TransCameron Pipeline,
LLC, under RP21-484.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5117.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-485-000.
    Applicants: ANR Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Short Notice Start-Up to be
effective 3/15/2021.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5122.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-486-000.
    Applicants: Empire Pipeline, Inc.
    Description: Compliance filing Refund Report Per Settlement in
RP18-940.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5125.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-487-000.
    Applicants: Northern Natural Gas Company.
    Description: Sec.  4(d) Rate Filing: 20210212 Negotiated Rate to be
effective 2/12/2021.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5170.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-488-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreements--Koch & Citadel to be effective 2/11/2021.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5239.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-489-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2021-02-12 Negotiated Rate
Agreement and Amendment to be effective 2/12/2021.
    Filed Date: 2/12/21.
    Accession Number: 20210212-5253.
    Comments Due: 5 p.m. ET 2/24/21.

    Docket Numbers: RP21-490-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 2.15.21 Negotiated Rates--
Mieco LLC H-7080-89 to be effective 2/13/2021.
    Filed Date: 2/16/21.
    Accession Number: 20210216-5009.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: RP21-491-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Capacity
Release Agreement--2/15/2021 to be effective 2/15/2021.
    Filed Date: 2/16/21.
    Accession Number: 20210216-5143.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: RP21-492-000.
    Applicants: Guardian Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreement--Morgan Stanley Extension to be effective 2/12/2021.

    Filed Date: 2/16/21.
    Accession Number: 20210216-5201.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: RP21-493-000.
    Applicants: Viking Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreement--World Fuel VR1048 Extension to be effective 2/12/2021.
    Filed Date: 2/16/21.
    Accession Number: 20210216-5217.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: RP21-494-000.
    Applicants: Viking Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreement--World Fuel VR1050 & VR1051 to be effective 2/13/2021.
    Filed Date: 2/16/21.
    Accession Number: 20210216-5257.
    Comments Due: 5 p.m. ET 3/1/21.

    Docket Numbers: RP21-495-000.
    Applicants: Midwestern Gas Transmission Company.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate PAL
Agreement--Exelon Generation Company, LLC to be effective 2/14/2021.
    Filed Date: 2/16/21.
    Accession Number: 20210216-5272.
    Comments Due: 5 p.m. ET 3/1/21.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at:
    http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: February 17, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-03673 Filed 2-22-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Rules and Regulations]
[Page 51975]
[FR Doc No: 2019-20981]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2019-0584]

Special Local Regulation; Clearwater Super Boat National
Championship, Gulf of Mexico; Clearwater Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce special local regulations for the
Clearwater Super Boat National Championship on September 29, 2019, to
provide for the safety of life on navigable waterways during this
event. Our regulation for Clearwater Super Boat National Championship
identifies the regulated area for this event in Clearwater Beach, FL.
During the enforcement period, no persons or vessels will be permitted
in the Race Area without permission of the Captain of the Port St.
Petersburg (COTP), unless they are authorized race participants. If
permission is granted by the COTP, all persons and vessels receiving
such permission must comply with the instructions of the COTP or a
designated representative. Also during the enforcement period all
vessels in the Spectator Area are to be anchored or operating at a ``no
wake speed''.

DATES: The regulations in 33 CFR 100.721 will be enforced from 11:30
a.m. until 4 p.m. on September 29, 2019.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Marine Science Technician First
Class Michael Shackleford, Sector St. Petersburg Prevention Department,
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce special local
regulations in 33 CFR 100.721 for the Clearwater Super Boat National
Championship regulated area from 11:30 a.m. to 4 p.m. on September 29,
2019. This action is being taken to provide for the safety of life on
navigable waterways during this event. Our regulation for the
Clearwater Super Boat National Championship, Sec.  100.721, specifies
the location of the regulated area for the event which encompasses
portions of the Gulf of Mexico. During the enforcement period only
authorized race participants will be permitted to enter, transit
through, anchor in, or remain in the Race Area. If you are an
authorized operator of a vessel in the Race Area you must comply with
the instructions of the Captain of the Port or a designated
representative. On-scene designated representatives will direct
spectator vessels to the Spectator Area and are to be anchored or
operating at a ``no wake speed'' during the enforcement period. Persons
or vessels wishing to obtain authorization to enter or remain within
the regulated areas may contact the COTP by telephone at<PHONE_NUMBER>
or a designated representative via VHF radio on channel 16.
    In addition to this notice of enforcement in the Federal Register,
the Coast Guard plans to provide notification of this enforcement
period via Broadcast Notice to Mariners.

    Dated: September 16, 2019.
Matthew A. Thompson,
Captain, U.S. Coast Guard, Captain of the Port St. Petersburg.
[FR Doc. 2019-20981 Filed 9-27-19; 11:15 am]
BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 202 (Friday, October 18, 2019)]
[Notices]
[Page 55951]
[FR Doc No: 2019-22793]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-77-000]

Painted Hills Wind Holdings, LLC; Supplemental Notice That
Initial Market-Based Rate Filing Includes Request for Blanket Section
204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Painted Hills Wind Holdings, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 31, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-22793 Filed 10-17-19; 8:45 am]
BILLING CODE 6717-01-P