[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12747-12748]
[FR Doc No: 2013-04272]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC13-11-000]

Commission Information Collection Activities (FERC-539); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 U.S.C. 3506(c)(2)(A), the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
currently approved information collection, FERC-539, Gas Pipeline
Certificates: Import/Export Related.

DATES: Comments on the collection of information are due April 26,
2013.

ADDRESSES: You may submit comments (identified by Docket No. IC13-11-
000) by either of the following methods:
     eFiling at Commission's Web Site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: Gas Pipeline Certificates: Import/Export Related.
    OMB Control No.: 1902-0062.
    Type of Request: Three-year extension of the FERC-539 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: Section 3 of the Natural Gas Act (NGA) \1\ provides, in
part, that ``* * * no person shall export any natural gas from the
United States to a foreign country or import any natural gas from a
foreign country without first having secured an order from the
Commission authorizing it to do so.'' The 1992 amendments to Section 3
of the NGA concern importation or exportation from/to a nation which
has a free trade agreement with the United States and requires that
such importation or exportation: (1) Shall be deemed to be a ``first
sale'' (i.e. not a sale for a resale) and (2) shall be deemed to be
consistent with the public interest. Applications for such importation
or exportation should be granted without modification or delay.
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    \1\ 15 U.S.C. 717-717w.
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    Type of Respondents: Facilities proposing to import or export
natural gas.
    Estimate of Annual Burden: \2\ The Commission estimates the total
Public

Reporting Burden for this information collection as:
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    \2\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

                           FERC-539: Gas Pipeline Certificates: Import/Export Related
----------------------------------------------------------------------------------------------------------------
                          Number of responses       Total number of      Average burden hours    Estimated total
 Number of respondents      per respondent             responses             per response         annual burden
(A)                                    (B)           (A) x (B) = (C)                   (D)      (C) x (D)
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                 7                       1                       7                      12            84
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    The total estimated annual cost burden to respondents is $5,880[84
hours * $70/hour \3\ = $5,880].
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    \3\ Average salary (per hour) plus benefits per full-time
equivalent employee.
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: February 19, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-04272 Filed 2-22-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Proposed Rules]
[Pages 30640-30644]
[FR Doc No: 2015-12530]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0230; FRL-9927-02]
RIN 2070-ZA16

Banda de Lupinus albus doce BLAD; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to revoke the current exemption from the
requirement for a tolerance for residues of banda de Lupinus albus doce
(BLAD) in or on all food commodities. In its place, EPA proposes to
establish a tolerance limiting residues of BLAD to 0.005 parts per
million (ppm) in or on almonds, grapes, strawberries and tomatoes. The
Agency is undertaking this action under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: Comments must be received on or before July 28, 2015.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0230, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Director,
Biopesticides and Pollution Prevention Division (7511P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-
7090; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

     Pesticide manufacturing (NAICS code 32532).

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 email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information on 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 preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. This Proposal

A. What is the authority for this action?

    EPA is taking this action under section 408(e) the FFDCA, 21 U.S.C.
346a(e), which allows EPA to initiate a tolerance action under FFDCA
section 408, 21 U.S.C. 346a et seq. FFDCA section 408(b)(2)(A)(i)
allows EPA to establish a tolerance (the legal limit for a pesticide
chemical residue in or on a food) only if EPA determines that the
tolerance is ``safe.'' FFDCA section 408(b)(2)(A)(ii) 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.
    FFDCA section 408(b)(2)(C) 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 . .
.''
    Section 408(c)(2)(A)(ii) contains the same safety standard for
establishing or leaving in effect an exemption from the requirement of
a tolerance. Section 408(c)(2)(A)(i) requires the Agency to modify or
revoke an exemption if the Agency determines it is not safe.
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of FFDCA section 408 and a complete description
of the risk assessment process, see http://www.epa.gov/pesticides/regulating/tolerances.htm.

B. What action is the Agency taking?

    EPA, on its own initiative under FFDCA section 408(c)(1)(B), is
proposing to revoke the existing exemption from the requirement of a
tolerance for residues of the fungicide BLAD in or on all food
commodities as established in the Federal Register of March 22, 2013
(78 FR 17600) (FRL-9380-6). In addition, EPA is proposing to establish
a tolerance under FFDCA section 408(e) for residues of the fungicide
BLAD, in or on almonds, grapes, strawberries, and tomatoes at the level
of detection of 0.005 ppm.
    EPA is taking this action in response to concerns that were raised
by the Federal Drug Administration (FDA) about the potential
allergenicity of BLAD for peanut-sensitive individuals following EPA's
promulgation of the tolerance exemption of BLAD on all food
commodities. Based on the potential uncertainty raised by those
concerns, EPA sought additional data from the petitioner and reexamined
the safety of the BLAD tolerance exemption. Following an assessment of
the additional data that was provided, EPA has concluded that the
available data supports establishing a more limited tolerance at the
level of detection on specific commodities.

III. Regulatory Background

    In the Federal Register of March 22, 2013, EPA established a
tolerance exemption for residues of BLAD in or on all food commodities
when applied as a fungicide and used in accordance with label
directions and good agricultural practices. EPA established this
tolerance exemption following the receipt of a petition from Consumo Em
Verde S.A, Biotecnologia De Plantas, Parque Technologico de Cantanhede
(CEV) in 2012. All of the data requirements to support the exemption
from the requirement of a tolerance were fulfilled, and following an
assessment of all available data, EPA concluded that there was a
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
BLAD.
    Following EPA's establishment of a tolerance exemption for residues
of BLAD on all food commodities, FDA raised concerns about the
potential allergenicity of the BLAD protein for peanut-sensitive
individuals. EPA's original review of the data in support of the
establishment of a tolerance exemption had considered BLAD's potential
allergenicity and concluded that the use of BLAD as pesticide would not
result in any meaningful exposure to human health and the environment
based on the following considerations. First, because lupines are
commonly used in human and animal nutrition as a food and feed, EPA
concluded that any dietary contribution from use of BLAD as a pesticide
would be relatively limited. Second, the weight of evidence regarding
the BLAD protein suggested low risk for allergenicity concerns upon
application of the criteria set by the Codex Alimentarius (2003) and
the Food and Agricultural Organizations of the United Nations/World
Health Organization (FAO/WHO) (2001):
     Amino acid homology: Having an amino acid residue
similarity of greater than 35% over a sequence of 80 amino acids of a
known allergenic protein (Ara h 1). Residues 5 to 169 in BLAD exhibit a
58% sequence homology when compared to residues 148 to 312 in Ara h 1,
which is similar to other legume seed storage proteins;
     Having one or more sets of more than 6 contiguous amino
acid residues that are identical to amino acids of a known allergenic
protein. BLAD contains only one stretch of contiguous amino acid
residues identical to Ara h 1; as a comparison there are 2 in lupine
and bean vicilin, 3 in pea and broad bean vicilin, and 5 in soybeans.
This observation suggests a more likely presence of IgE recognition
epitopes on the vicilins rather than on BLAD;
     Serum cross-reactivity to known allergens: Moneret-Vautrin
et al., 1999 found that although peanut-lupine cross-reactivity
allergenic potential is high, it presumably corresponds to lupine
[gamma]-conglutin and not to lupine [beta]-conglutin, the precursor of
BLAD;
     Pepsin resistance: BLAD is readily degraded by proteolytic
enzymes and
     Expression levels: Using immunological methods, residual
levels of BLAD were not detectable 18 hours after application to
tomatoes, relative to controls.
    This information was used by the EPA to conclude that BLAD is not
likely to be an allergen.
    Nonetheless, FDA expressed concerns about the potential
allergenicity of BLAD because lupine is known to incite food allergy in
sensitive individuals and because of reports of cross-reactivity to
lupine protein in peanut sensitive

individuals. In response to these newly raised concerns, EPA decided to
investigate further the issues raised by FDA and seek additional data,
including a skin prick (in vivo) test on Ara h 1 peanut/lupine
sensitive individuals and an in vitro immunological testing on serum
from Ara h 1 peanut/lupine sensitive individuals. The focus on Ara h 1
sensitive individuals is due to the similarity of the [beta]-conglutin
parent molecule of BLAD to the Ara h 1 allergen and reports of cross
reactivity in peanut-sensitive individuals to lupine protein.
    In addition, EPA required residue chemistry field trials conducted
on crops listed on the proposed pesticide label using PROBLAD PLUS, the
end-use pesticide containing the BLAD protein, at label rates and
exaggerated application rates (5X) to establish a rate of decline and
residue levels of BLAD on crops tested. Upon receipt of all the new
information, EPA reexamined the safety of BLAD.

IV. Aggregate Risk Assessment and Determination of Safety

A. EPA's Safety Determination

    EPA has evaluated the available toxicity and exposure data and
considered its validity, completeness, and reliability, as well as the
relationship of the results of the studies to human risk. Based upon
that evaluation, EPA concludes that there is a reasonable certainty
that no harm will result to the general population, or to infants and
children, from aggregate exposure to BLAD residues under the tolerance
proposed in this action.
    EPA's assessment of exposures and risks associated with BLAD is
discussed in this unit of the document.

B. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    BLAD is a naturally occurring 20 kilo Dalton (kDa) polypeptide
fragment of [beta]-conglutin, a main storage protein in the flowering
plant sweet lupines (Lupinus albus). BLAD protein is produced by
breakdown of [beta]-conglutin during day 4 to 12 of the germination
process of the sweet lupines. Data submitted and reviewed by the Agency
demonstrate that BLAD operates in a non-toxic manner. BLAD, which is
used as a fungicide, degrades chitin by catalyzing and successfully
removing the N-acetyl-D-glucosamine terminal monomers, resulting in the
destruction of the fungal cells. There is a history of safe use in
human and livestock consumption; however, there may be a potential for
allergenicity with some sensitive populations.
    All of the toxicity data requirements have been fulfilled. EPA has
concluded that the data are acceptable and no additional data are
required. Data on the end-use product, PROBLAD PLUS, containing BLAD as
its active ingredient, did not indicate toxicity endpoints. The
toxicological information showed that PROBLAD PLUS has a low toxicity
profile as noted in the test results for the following studies: Acute
Oral Lowest Dose (LD)50 > 5,000 milligram/kilogram (mg/kg);
Acute Dermal LD50 > 2,000 mg/kg; Acute Inhalation
LC50 > 5.34 milligram/Liter (mg/L); Primary Eye Irritation
was slight; Primary Dermal Irritation was mild to slight; and PROBLAD
PLUS is not a contact dermal sensitizer. Moreover, there are no known
effects on endocrine systems via oral, dermal, or inhalation exposure.
Therefore, the Agency concludes that there are no toxicity risks with
BLAD.
    As noted in Unit III., EPA re-examined the potential allergenicity
of BLAD because of the concern raised about potential sensitivity of
peanut-sensitive individuals. The following observations raised new
questions about the potential for BLAD to pose an allergenicity
concern:
    1. BLAD comprises an internal segment of [beta]-conglutin;
    2. [beta]-conglutin exhibits a relatively strong homology to the
other members of the vicillin family, including well-known allergens
contained in peanuts and soybeans (specifically Ara h 1); and
    3. There are a considerable number of studies concerning the
allergenicity of lupine-derived products.
    EPA then evaluated the reactivity to BLAD in sensitive individuals.
    A Skin Prick Test (SPT) with lupine or peanut extracts in order to
establish a sampling population that was sensitive to lupines and/or
peanuts was submitted to the Agency. The serum from a sensitive
population that tested positive to lupine/peanut exposure through a SPT
was used to evaluate the capacity of cross-reactivity to BLAD in these
sensitive individuals. Negative results to BLAD in IgE-specific in
vitro immunoblot (ELISA) testing on serum from sensitive individuals,
suggest that the compound is non-allergenic to lupine and/or peanut-
sensitive individuals.
    Allergenicity relates to both a sensitizing exposure (sensitization
leading to allergy cannot occur to a protein without a prior exposure)
and a subsequent acute effect if allergy develops (a single exposure in
a sensitive individual will cause a response). The difficulty with
assessing allergenicity relates to determining a threshold level of
exposure below which there is no reasonable expectation of eliciting a
reaction in a sensitive individual. Although the new allergenicity data
suggest that BLAD is not an allergen, the existing exemption from the
requirement of a tolerance allows any amount of residue that might
result from reasonably foreseeable uses of BLAD as a fungicide. In
light of the similarity of BLAD to peanut allergens and documented
allergies to lupines in the literature, the Agency believes the safety
of BLAD also depends on demonstrating no detectable residues, in the
absence of a demonstrated threshold level.
    Specific information on the studies received and EPA's assessment
of them can be found at http://www.regulations.gov in docket ID number
EPA-HQ-OPP-2015-0230.

C. Toxicological Points of Departure/Levels of Concern

    Based on the available toxicity and allergenicity data, the Agency
did not identify any toxicological points of departure or levels of
concern. Nevertheless, due the potential for allergenicity that might
arise under the current exemption due to potentially unlimited exposure
to residues of BLAD, the Agency is relying on data supporting a lack of
exposure to BLAD residues on certain crops. Therefore, the Agency is
conducting a qualitative assessment based on a lack of residues.

D. Exposure Assessment

    1. Dietary exposure from food and feed uses. The dietary exposure
to residues of BLAD via pesticidal use is expected to be negligible as,
based on available residue data, the residues are below the level of
detection.
    Due to the potential for allergenicity, field trials using PROBLAD
PLUS at the product-labeled application rate and an exaggerated
application rate (5X) were submitted in order to determine levels of
potential exposure and the rate of BLAD residue degradation. Those
studies, conducted on grapes, tomatoes and strawberries, showed that
even with multiple consecutive applications at exaggerated application
rates, the residue levels of BLAD will be negligible or non-existent.
Both studies (involving label and exaggerated

application rates) showed similar residue measurements and a similar
pattern with a half-life of about 2 days.
    At label application rates, grape and strawberry samples showed no
detectable residues (< limit of detection (LOD), 0.005 ppm) of BLAD on
day zero; tomato samples showed BLAD residues < limit of quantitation
(LOQ) (0.0062 ppm) on day zero but declined to < LOD levels one day
after application. To ensure the reduction of any available residues, a
one-day pre-harvest interval on PROBLAD PLUS labeling is being
required.
    Additionally, due to the presence of an almond husk and the
subsequent processing of almond nut meats, the pre-harvest use of BLAD
on almonds following good agricultural practices does not represent any
reasonable possibility of resulting in detectable residues on the
edible nut.
    2. Dietary exposure from drinking water. Pesticide residues in
drinking water are not expected because BLAD residues degrade rapidly
in the environment. Specific information on the studies received and
EPA's assessment of them can be found at http://www.regulations.gov in
docket ID number EPA-HQ-OPP-2015-0230.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). BLAD is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found BLAD to share a common mechanism of toxicity with
any other substances, and BLAD does not appear to degrade into any
toxic metabolite or other substance of concern. For the purposes of
this tolerance action, therefore, EPA has assumed that BLAD does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the
establishment of a tolerance or tolerance exemption for a pesticide
chemical residue, EPA shall apply an additional tenfold (10X) margin of
safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure, unless EPA determines that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data are available to support the choice of
a different safety factor.
    As part of its qualitative assessment, the Agency did not use
safety factors for assessing risk; therefore, no additional safety
factor is needed for assessing risk to infants and children. The
available data indicate that BLAD has minimal or no toxicity and is not
an allergen, especially in combination with the data demonstrating a
lack of exposure from application as a pesticide. EPA therefore
concludes that there are no threshold effects of concern to infants,
children, or adults when BLAD is applied as a fungicide and used in
accordance with label directions and good agricultural practices.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on BLAD, EPA
concludes that the potential for allergenicity of BLAD introduces a
reasonable uncertainty concerning the potential for harm to peanut-
sensitive individuals in light of the possibility for unlimited
exposure to BLAD that might be permitted under an unlimited exemption
from the requirement of a tolerance. To address that potential
uncertainty, EPA is proposing to revoke the current tolerance exemption
for BLAD in 40 CFR 180.1319. In its place, and in consideration of
these potential concerns, EPA is proposing to establish a more limited
tolerance of 0.005 ppm for residues of BLAD in or on almonds, grapes,
strawberries, and tomatoes. This is based on crop-specific residue data
on grapes, strawberries, and tomatoes that demonstrates a lack of
residues on those specific crops. Additionally, due to the presence of
an almond husk and the subsequent processing of almond nut meats, the
pre-harvest use of BLAD on almonds following good agricultural
practices does not represent any reasonable possibility of resulting in
detectable residues on the edible nut.
    Therefore, under this more limited scenario, EPA concludes that
there is a reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
the residues of BLAD when it is applied as fungicide to the
specifically noted crops and used in accordance with label directions
and good agricultural practices. Such exposure includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. Based on this information, EPA expects that, when used
according to the proposed label directions, the tolerance for residues
of BLAD on the listed commodities is safe, and no adverse effects such
as allergenic reactions are expected to occur.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Enzyme-Linked Immunosorbent Assay
(ELISA: EASI Method No: RA029 and RA031) is available to enforce the
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for BLAD.

C. Trade Considerations

    The revocation of the existing tolerance exemption and
establishment of tolerances for four commodities is a reduction in
allowable residues of BLAD on food. Therefore, EPA intends to provide
notice to the World Trade Organization (WTO) of this proposal in
accordance with its obligations under the WTO's Sanitary and
Phytosanitary Measures Agreement.

VI. Conclusion

    EPA proposes to revoke the existing tolerance exemption for
residues of BLAD in or on all food commodities as established in the
Federal Register of March 22, 2013 under section 408 of the FFDCA due
to potential allergenicity concerns. In its stead, the Agency proposes
to establish a tolerance for residues of BLAD in or on almonds, grapes,
strawberries, and tomatoes at the level of detection of 0.005 ppm based
on BLAD's low toxicity profile, testing that indicated that BLAD is
non-allergenic, and residue data that demonstrated a rapid decline of
BLAD following application at an exaggerated rate. Therefore, EPA is
proposing to establish a tolerance level at the limit of detection for
the analytical method to prevent any exposure to sensitive individuals
from potential residues of BLAD on the treated crops.

VII. Statutory and Executive Order Reviews

    This proposed action would revoke an existing exemption from the
requirement of a tolerance and establish new tolerances under FFDCA
section 408(e). The Office of Management and Budget (OMB) has exempted
tolerance actions from review under Executive Orders 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993), and
13563, entitled Improving Regulation and Regulatory Review (76 FR 3821,
January 21, 2011). As a result, this action is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).
Nor does it require OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997).
    This action does not contain any information collections subject to
OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.); require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
and does not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act (NTTAA)
(15 U.S.C. 272 note).
    This action directly regulates growers, food processors, food
handlers, and food retailers, but it does not regulate State or tribal
governments. Nor does this action alter the relationships or
distribution of power and responsibilities established in the
preemption provisions of FFDCA section 408(n)(4). Therefore, the Agency
has determined that Executive Orders 13132, entitled Federalism (64 FR
43255, August 10, 1999) and 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000) do not apply to this action. In addition, this action does not
impose any enforceable duty, contain any unfunded mandate, or otherwise
significantly or uniquely affect small governments as described in the
Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.),
I certify that this action will not have significant economic impact on
a substantial number of small entities. In making this determination,
the impact of concern is any significant adverse economic impact on
small entities. An agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the action will not impose any requirements on small entities. There
are not a substantial number of small entities affected by this rule.
BLAD, which is currently manufactured only by CEV, is not being used as
a pesticide on food at this time. Therefore, this action will not
impose any requirements or have a significant impact on a substantial
number of small entities. We have therefore concluded that this action
will not impact small entities.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 13, 2015.
Jack Housenger,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
3. Section 180.683 is added to read as follows:

Sec.  180.683  Banda de Lupinus albus doce; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide banda de Lupinus albus doce (BLAD), including its metabolites
and degradates, in or on the commodities in the table below as a result
of the application of BLAD. Compliance with the tolerance levels
specified below is to be determined by measuring only BLAD in or on the
following commodities.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almonds.....................................................       0.005
Grapes......................................................       0.005
Strawberries................................................       0.005
Tomatoes....................................................       0.005
------------------------------------------------------------------------

    (a) Section 18 emergency exemptions. [Reserved]
    (b) Tolerances with regional registrations. [Reserved]
    (c) Indirect or inadvertent residues. [Reserved]

Sec.  180.1319  [Removed and Reserved]

0
3. Remove and reserve Sec.  180.1319.
[FR Doc. 2015-12530 Filed 5-28-15; 8:45 am]
 BILLING CODE P


[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Pages 11789-11790]
[FR Doc No: 2016-04960]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

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

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

March 7, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

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

March 16, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/markets_operations/committees/meeting_materials/index.jsp?com=bic.

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

March 17, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/markets_operations/committees/meeting_materials/index.jsp?com=oc.

The New York Independent System Operator, Inc. Electric System Planning
Working Group Meeting

March 22, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/markets_operations/services/planning/index.jsp.

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

March 30, 2016, 10:00 a.m.-4:00 p.m. (EST)

    The above-referenced meeting will be via web conference and
teleconference.
    The above-referenced meeting is open to stakeholders.
    Further information may be found at: http://www.nyiso.com/public/markets_operations/committees/meeting_materials/index.jsp?com=mc.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

New York Independent System Operator, Inc., Docket No. ER13-102.
New York Independent System Operator, Inc., Docket No. ER15-2059.
New York Independent System Operator, Inc., Docket No. ER16-120.
New York Independent System Operator, Inc., Docket No. ER13-1942.
New York Transco, LLC, Docket No. ER15-572.
New York Independent System Operator, Inc., Docket No. ER16-966.

    For more information, contact James Eason, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: March 1, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-04960 Filed 3-4-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Rules and Regulations]
[Page 19-21]
[DOCID:fr03ja06-7]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2005-MT-0002, FRL-8012-8]

Approval and Promulgation of Air Quality Implementation Plans;
Montana; Revisions to the Emergency Episode Avoidance Plan; Direct
Final Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: EPA is taking direct final action approving State
Implementation Plan (SIP) revisions submitted by the State of Montana
on August 2, 2004. The revisions are to the State's Emergency Episode
Avoidance Plan (EEAP). The intended effect of this action is to make
federally enforceable those provisions that EPA is approving. This
action is being taken under section 110 of the Clean Air Act.

DATES: This rule is effective on March 6, 2006, without further notice,
unless EPA receives adverse comment by February 2, 2006. If adverse
comment is received, EPA will publish a timely withdrawal of the direct
final rule in the Federal Register informing the public that the rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
OAR-2005-MT-0002 by one of the following methods:
     http://www.regulations.gov. Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>and<EMAIL_ADDRESS>
     Fax:<PHONE_NUMBER> (please alert the individual listed in
the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
     Mail: Richard R. Long, Director, Air and Radiation
Program, Environmental Protection Agency (EPA), Region 8, Mailcode 8P-
AR, 999 18th Street, Suite 200, Denver, Colorado 80202-2466.
     Hand Delivery: Richard R. Long, Director, Air and
Radiation Program, Environmental Protection Agency (EPA), Region 8,
Mailcode 8P-AR, 999 18th Street, Suite 300, Denver, Colorado 80202-
2466. Such deliveries are only accepted Monday through Friday, 8 a.m.
to 4:55 p.m., excluding federal holidays. Special arrangements should
be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R08-OAR-
2005-MT-0002. EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online 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 http://www.regulations.gov

or e-mail. The http://www.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
http://www.regulations.gov, your e-mail address will be automatically captured

and included as part of the comment that is placed in the public 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. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

For additional instructions on submitting comments, go to Section I.
General Information of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: 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., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the Air and

Radiation Program, Environmental Protection Agency (EPA), Region 8, 999
18th Street, Suite 300, Denver, Colorado 80202-2466. EPA requests that
if at all possible, you contact the individual listed in the FOR
FURTHER INFORMATION CONTACT section to view the hard copy of the
docket. You may view the hard copy of the docket Monday through Friday,
8 a.m. to 4 p.m., excluding federal holidays.

FOR FURTHER INFORMATION CONTACT: Laurie Ostrand, Air and Radiation
Program, Mailcode 8P-AR, Environmental Protection Agency (EPA), Region
8, 999 18th Street, Suite 200, Denver, Colorado 80202-2466, (303) 312-
6437<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
II. Background
III. EPA's Review of the State of Montana's August 2, 2004 submittal
IV. Final Action
V. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, or our mean or refer to the United States
Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.
    (iv) The words State or Montana mean the State of Montana, unless
the context indicates otherwise.

I. General Information

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

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or el-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 to 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:
    a. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions--The agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part of section number.
    c. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.

    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    h. Make sure to submit your comments by the comment period deadline
identified.

II. Background

    On August 2, 2004, the Governor submitted a SIP revision that
contains amendments to the Montana Emergency Episode Avoidance Plan
(EEAP). The EEAP fulfills the requirements of 40 CFR part 51, subpart H
which requires a plan to prevent ambient concentrations of air
pollutants from reaching levels that may endanger public health and
welfare.

III. EPA's Review of the State of Montana's August 25, 2004 Submittal

    The August 2, 2004 revisions to Montana's EEAP are substantive and
administrative in nature. The substantive changes are in the priority
classification of Air Quality Control Regions (AQCRs). Priority
classifications are based on recent ambient concentrations. In the
August 2004 EEAP submittal, Montana used the three most recent years of
ambient data (2000, 2001 and 2002) to revise the priority
classification of all AQCRs to priority III for all pollutants (sulfur
dioxide (SO2), carbon monoxide (CO), particulate matter (PM-
10) nitrogen dioxide (NO2), and ozone (O3)).
Previously the Helena and Missoula AQCR were classified as priority II
for particulate matter (PM-10) and the remainder of the state was
classified as Priority III for SO2, CO, PM-10,
NO2 and O3.
    It should be noted that Montana experienced exceedences of the PM-
10 NAAQS in 2000. These exceedences were caused by natural events
(wildfires) and Montana has not included these exceedence values for
purposes of determining priority classifications for the state. We
believe it is acceptable for Montana to not include the data from the
natural events for two reasons. First, Montana has an EPA-approved
Natural Events Action Plan (NEAP) to address ambient air quality
problems caused by wildfires. Second, Montana is retaining its
Emergency Episode Action Stages for SO2, PM-10 and CO
because areas in the state have previously been classified as Priority
I or II for these pollutants.
    Montana has also made administrative changes to the EEAP. We
believe the administrative changes are not substantive. Some of the
administrative changes clarify aspects of the plan and others are
changes in writing style.

IV. Final Action

    EPA is approving Montana's Emergency Episode Avoidance Plan
submitted on August 2, 2004.
    EPA is publishing this rule without prior proposal because the
Agency views this as a noncontroversial amendment and anticipates no
adverse comments; we are merely approving administrative changes to
Montana's air rules. However, in the ``Proposed Rules'' section of
today's Federal Register publication, EPA is publishing a separate
document that will serve as the proposal to approve the SIP revision if
adverse comments are filed. This rule will be effective March 6, 2006,
without further notice unless the Agency receives adverse comments by
February 2, 2006. If the EPA receives adverse comments, EPA will
publish a timely withdrawal in the Federal Register informing the
public that the rule will not take effect. EPA will address all public
comments in a subsequent final rule based on the proposed rule. The EPA
will not institute a second comment period on this action. Any parties
interested in commenting must do so at this time. Please note that if
EPA receives adverse comment on an amendment, paragraph, or section of
this rule and if that provision may be severed from the remainder of
the rule, EPA may adopt as final those provisions of the rule that are
not the subject of an adverse comment.
    Section 110(l) of the Clean Air Act states that a SIP revision
cannot be approved if the revision would interfere with any applicable
requirement concerning attainment and reasonable further progress
towards attainment of the NAAQS or any other applicable requirements of
the Act. The Montana SIP revision that is the subject of this document
does not interfere with the maintenance of the NAAQS or any other
applicable requirement of the Act. The August 2, 2004 submittal is a
plan to prevent ambient concentrations of air pollutants from reaching
levels that may endanger public health and welfare. Therefore, section
110(l) requirements are satisfied.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it 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).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state rule
implementing a Federal standard, and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus

standards (VCS), EPA has no authority to disapprove a SIP submission
for failure to use VCS. It would thus be inconsistent with applicable
law for EPA, when it reviews a SIP submission, to use VCS in place of a
SIP submission that otherwise satisfies the provisions of the Clean Air
Act. Thus, the requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    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 rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of 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 March 6, 2006. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: December 7, 2005.
Kerrigan G. Clough,
Acting Regional Administrator, Region 8.

0
40 CFR part 52 is amended to read as follows:

PART 52--[AMENDED]

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

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

Subpart BB--Montana

0
2. Section 52.1371 is amended by revising the introductory text and
revising the entries ``Helena Intrastate AQCR 142'' and ``Missoula
Intrastate AQCR 144'' in the table to read as follows:

Sec.  52.1371  Classification of regions.

    The Montana Emergency Episode Avoidance Plan was revised with an
August 2, 2004 submittal by the Governor. The August 2, 2004 Emergency
Episode Avoidance Plan classified the Air Quality Control Regions
(AQCR) as follows:

----------------------------------------------------------------------------------------------------------------
                                                                     Pollutant
   Air quality control regions   -------------------------------------------------------------------------------
             (AQCR)                 Particulate                      Nitrogen         Carbon
                                      matter       Sulfur  oxide      dioxide        monoxide          Ozone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Helena Intrastate AQCR 142......             III             III             III             III             III

                                                  * * * * * * *
Missoula Intrastate AQCR 144....             III             III             III             III             III
----------------------------------------------------------------------------------------------------------------

[FR Doc. 05-24366 Filed 12-30-05; 8:45 am]

BILLING CODE 6560-50-P