Bacillus thuringiensis Cry2Ab2 Protein in Soybean; Exemption From the Requirement of a Tolerance, 25601-25604 [2015-10493]
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Federal Register / Vol. 80, No. 86 / Tuesday, May 5, 2015 / Rules and Regulations
11. Indian Tribal Governments
This rule does not have tribal
implications under Executive Order
13175, Consultation and Coordination
with Indian Tribal Governments,
because it does 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.
12. Energy Effects
This rule is not a ‘‘significant energy
action’’ under Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use.
13. Technical Standards
This rule does not use technical
standards. Therefore, we did not
consider the use of voluntary consensus
standards.
14. Environment
We have analyzed this rule under
Department of Homeland Security
Management Directive 023–01 and
Commandant Instruction M16475.lD,
which guide the Coast Guard in
complying with the National
Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321–4370f), and
have determined that this action is one
of a category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves the
establishment of a temporary security
zone near Chambers Bay Golf Course in
South Puget Sound, University Place,
WA. This rule is categorically excluded
from further review under paragraph
34(g) of Figure 2–1 of the Commandant
Instruction. An environmental analysis
checklist supporting this determination
and a Categorical Exclusion
Determination are available in the
docket where indicated under
ADDRESSES. We seek any comments or
information that may lead to the
discovery of a significant environmental
impact from this rule.
rljohnson on DSK3VPTVN1PROD with RULES
List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for part 165
continues to read as follows:
40 CFR Part 174
■
Authority: 33 U.S.C. 1231; 50 U.S.C. 191;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 0170.1.
15:13 May 04, 2015
Jkt 235001
[EPA–HQ–OPP–2014–0454; FRL–9925–85]
Bacillus thuringiensis Cry2Ab2 Protein
in Soybean; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
■
AGENCY:
§ 165.T13.281 Security Zone; U.S. Open
Golf Championship, South Puget Sound;
University Place, WA.
SUMMARY:
2. Add temporary § 165.T13–281 to
read as follows:
(a) Location. This temporary security
zone is established in all waters
encompassed by the following points:
47°12′50″ N., 122°35′25″ W.; thence
southerly to 47°11′14″ N., 122°35′50″
W.; thence easterly to the shoreline at
47°11′14″ N., 122°35′03″ W.; thence
northerly along the shoreline to
47°12′49″ N., 122°34′39″ W.; thence
westerly back to the point of origin.
(b) Regulations. In accordance with
the general regulations in 33 CFR part
165, subpart D, no person or vessel may
enter or remain in the security zone
created by this section without the
permission of the Captain of the Port or
his Designated Representative.
Designated Representatives are Coast
Guard Personnel authorized by the
Captain of the Port to grant persons or
vessels permission to enter or remain in
the security zone created by this section.
See 33 CFR part 165, subpart D, for
additional information and
requirements. Vessels wishing to enter
the zone must request permission for
entry by contacting the Joint Harbor
Operations Center at (206) 217–6001, or
the on-scene patrol craft via VHF–FM
Ch 13. If permission for entry is granted
vessels must proceed at a minimum
speed for safe navigation.
(c) Enforcement period. This rule will
be enforced from 6 a.m. on June 14,
2015, until 11 p.m. on June 22, 2015,
unless canceled sooner by the Captain
of the Port.
Dated: April 22, 2015.
M.W. Raymond,
Captain, U.S. Coast Guard, Captain of the
Port, Puget Sound.
[FR Doc. 2015–10488 Filed 5–4–15; 8:45 am]
BILLING CODE 9110–04–P
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
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This regulation establishes an
exemption from the requirement of a
tolerance for residues of the Bacillus
thuringiensis (B.t.) Cry2Ab2 protein in
or on soybean when the protein is used
as a plant-incorporated protectant (PIP)
in soybean. Monsanto Company
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of B.t. Cry2Ab2 protein in
or on soybean.
DATES: This regulation is effective May
5, 2015. Objections and requests for
hearings must be received on or before
July 6, 2015, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0454, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Robert McNally, 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:
BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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Federal Register / Vol. 80, No. 86 / Tuesday, May 5, 2015 / Rules and Regulations
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).
rljohnson on DSK3VPTVN1PROD with RULES
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 174
through the Government Publishing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0454 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before July 6, 2015. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0454, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
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instructions for submitting comments.
Do not submit electronically any
information you consider to be 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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Background and Statutory Findings
In the Federal Register initially on
October 24, 2014 (79 FR 63596) (FRL–
9916–03) and then again January 28,
2015 (80 FR 4527) (FRL–9921–55), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 4F8276) by
Monsanto Company, 800 North
Lindbergh Blvd., St. Louis, MO 63167.
The petition requested an amendment to
40 CFR 174.519 by extending the
current exemption from the requirement
of a tolerance for residues of B.t.
Cry2Ab2 protein in corn and cotton to
all food commodities. That document
referenced a summary of the petition
prepared by the petitioner Monsanto
Company, which is available in the
docket, https://www.regulations.gov. A
comment was received on the October
24, 2014, notice of filing. EPA’s
response to this comment is discussed
in Unit VII.C.
Based on available data, EPA is
amending the existing exemption for
residues of B.t. Cry2Ab2 protein in corn
and cotton to include residues in
soybean rather than all food
commodities as requested. The reasons
for this change are discussed in Unit
VII.D.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
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occupational exposure. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require 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,
FFDCA section 408(b)(2)(D) 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.
III. Toxicological Profile
Consistent with FFDCA section
408(b)(2)(D), 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.
The acute oral toxicity data
demonstrates the lack of mammalian
toxicity at high levels of exposure to the
pure B.t. Cry2Ab2 protein. Further,
amino acid sequence comparisons
showed no similarities between the B.t.
Cry2Ab2 protein and known toxic
proteins in protein databases. In
addition, the B.t. Cry2Ab2 protein was
shown to be substantially degraded by
heat when examined by immunoassay.
This instability to heat would also
lessen the potential dietary exposure to
intact B.t. Cry2Ab2 protein in cooked or
processed foods. These biochemical
features along with the lack of adverse
results in the acute oral toxicity test
support the conclusion that there is a
reasonable certainty no harm from
toxicity will result from dietary
exposure to residues of the B.t. Cry2Ab2
protein in the identified soybean
commodities.
Since this PIP is a protein, allergenic
potential was also considered.
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Currently, no definitive tests for
determining the allergenic potential of
novel proteins exist. Therefore, EPA
uses a weight-of-evidence approach
where the following factors are
considered: Source of the trait; amino
acid sequence comparison with known
allergens; and biochemical properties of
the protein, including in vitro
digestibility in simulated gastric fluid
(SGF) and glycosylation. This approach
is consistent with the approach outlined
in the Annex to the Codex Alimentarius
‘‘Guideline for the Conduct of Food
Safety Assessment of Foods Derived
from Recombinant-DNA Plants.’’ The
allergenicity assessment for the B.t.
Cry2Ab2 protein follows:
1. Source of the trait. Bacillus
thuringiensis is not considered to be a
source of allergenic proteins.
2. Amino acid sequence. A
comparison of the amino acid sequence
of the B.t. Cry2Ab2 protein with known
allergens showed no significant overall
sequence similarity or identity at the
level of eight contiguous amino acid
residues.
3. Digestibility. The B.t. Cry2Ab2
protein was rapidly digested in 15
seconds in simulated mammalian
gastric fluid containing pepsin.
4. Glycosylation. The B.t. Cry2AB2
protein expressed in soybean was
shown not to be glycosylated.
5. Conclusion. Considering all of the
available information, EPA has
concluded that the potential for the B.t.
Cry2Ab2 protein to be a food allergen is
minimal.
The information on the safety of the
pure B.t. Cry2Ab2 protein provides
adequate justification to address
possible exposures in all soybean crops.
IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational 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 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 exemptions in effect for the B.t.
Cry2Ab2 protein residue, and exposure
from non-occupational sources. Oral
exposure may occur at very low levels
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from ingestion of corn, cotton and
soybean products. With respect to
drinking water, since the PIP is
integrated into the plant genome and
based upon EPA’s human health and
environmental assessments for B.t.
Cry2Ab2 protein (Refs. 1 and 2), the
Agency expects residues in drinking
water to be extremely low or nonexistent.
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 exposure by
these routes to negligible. Exposure to
infants and children via residential or
lawn use is also not expected because
the use sites for the B.t. Cry2Ab2 protein
is agricultural.
V. 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.’’
Since the B.t. Cry2Ab2 protein does
not act through a toxic mode of action,
nor does the B.t. Cry2Ab2 protein
appear to produce a toxic metabolite
produced by other substances, the
protein does not have a common
mechanism of toxicity with other
substances; therefore, the requirements
of section 408(b)(2)(D)(v) do not apply.
VI. Determination of Safety for U.S.
Population, 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
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)
provides that EPA shall apply an
additional tenfold (10X) margin of
exposure (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 exposure (safety) will be safe
for infants and children. This additional
margin of exposure (safety) is commonly
referred to as the Food Quality
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25603
Protection Act Safety Factor. In
applying this provision, EPA either
retains the default value of 10X or uses
a different additional safety factor when
reliable data available to EPA support
the choice of a different factor.
Based on the information discussed in
Unit III., EPA concludes that there are
no threshold effects of concern to
infants, children, or adults from
exposure to the B.t. Cry2Ab2 protein. As
a result, EPA concludes that no
additional margin of exposure (safety) is
necessary to protect infants and
children and that not adding any
additional margin of exposure (safety)
will be safe for infants and children.
Therefore, based on the discussion in
Unit III. and the supporting
documentation, 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 the
B.t. Cry2Ab2 protein in soybean, when
it is used as a plant-incorporated
protectant. Such exposure includes all
anticipated dietary exposures and all
other exposures for which there is
reliable information.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a
protein, derived from a source that is
not known to exert an influence on the
endocrine system. Therefore, the
Agency is not requiring information on
the endocrine effects of the plantincorporated protectant at this time.
B. Analytical Enforcement Methodology
A standard operating procedure for an
enzyme-linked immunosorbent assay for
the detection and quantification of the
B.t. Cry2Ab2 protein in soybean tissue
has been submitted.
C. Response to Comments
EPA received one comment that is
potentially relevant to this petition. The
commenter generally opposed approval
of the use of a Monsanto ‘‘bt pip,’’ but
did not specify any particular PIP or any
particular safety concern. As no specific
basis for denying the petition was
provided, the comment is not being
further considered.
D. Revisions to Petition for Tolerance
Monsanto’s petition requested an
exemption for residues of the B.t.
Cry2Ab2 protein in or on all food and
feed commodities. However, based on
the data provided, the Agency can only
support a safety finding for residues in
or on soybean at this time. Currently,
the Agency does not have adequate
information for a full range of crops for
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an exemption for the B.t. Cry2Ab2
protein in or on all food and feed
commodities.
VIII. Conclusions
There is a reasonable certainty that no
harm will result from aggregate
exposure to the U.S. population,
including infants and children, to
residues of the B.t. Cry2Ab2 protein in
all food and feed commodities of
soybean. 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 discussed in
this unit, no toxicity to mammals has
been observed, nor is there any
indication of allergenicity potential for
the plant-incorporated protectant.
Therefore, an exemption is
established for residues of the B.t.
Cry2Ab2 protein in or on soybean when
the protein is used as a PIP in soybean.
IX. References
rljohnson on DSK3VPTVN1PROD with RULES
1. U.S. EPA. 2014a. Review of Product
Characterization and Human Health Data for
Plant-Incorporated Protectant Bacillus
thuringiensis (Bt) Cry2Ab2 and Cry1A.105
Insect Control Protein and the Genetic
Material Necessary for Its Production in
MON 87751 and the Combined-Trait Insect
Protected Soybeans in Support for an
Experimental Use Permit, Sec. 3 Registration
and Exemptions from the Requirement of a
Tolerance. Memorandum from J. Facey, Ph.D.
through J. Kough, Ph.D. to K. Haymes, Ph.D.,
dated December 23, 2014.
2. U.S. EPA. 2014b. Environmental Risk
Assessment for the FIFRA Section 3 Seed
Increase Registration of the PlantIncorporated Protectant (PIP), Bacillus
thuringiensis (Bt) Cry1A.105 and Cry2Ab2
Insect Control Proteins and the Genetic
Material (PV–GMIR13196) Necessary for
Their Production in Event MON 87751
Soybean. Memorandum from I. You, Ph.D.
through S. Borges to K. Haymes, Ph.D., dated
December 16, 2014.
X. Statutory and Executive Order
Reviews
This action establishes an exemption
from the requirement of a tolerance
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, 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), or Executive
Order 13045, entitled ‘‘Protection of
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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., nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemption in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999), and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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
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Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 174
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: April 22, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 174—[AMENDED]
1. The authority citation for part 174
continues to read as follows:
■
Authority: 7 U.S.C. 136–136y; 21 U.S.C.
346a and 371.
2. § 174.519 is revised to read as
follows:
■
§ 174.519 Bacillus thuringiensis Cry2Ab2
protein; exemption from the requirement of
a tolerance.
(a) Residues of Bacillus thuringiensis
Cry2Ab2 protein in or on corn or cotton
are exempt from the requirement of a
tolerance when used as a plantincorporated protectant in the food and
feed commodities of corn; corn, field;
corn, sweet; corn, pop; and cotton seed,
cotton oil, cotton meal, cotton hay,
cotton hulls, cotton forage, and cotton
gin byproducts.
(b) Residues of Bacillus thuringiensis
Cry2Ab2 protein in or on soybean are
exempt from the requirement of a
tolerance when used as a plantincorporated protectant in the food and
feed commodities of soybean.
[FR Doc. 2015–10493 Filed 5–4–15; 8:45 am]
BILLING CODE 6560–50–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 90
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Travelers’ Information Stations
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Commission.
ACTION: Final rule.
AGENCY:
In this document, the
Commission amends its rules pertaining
to public safety Travelers’ Information
Stations (TIS), which Public Safety
Pool-eligible entities operate to transmit
noncommercial, travel-related
information over AM band frequencies
to motorists on a localized basis. One
SUMMARY:
E:\FR\FM\05MYR1.SGM
05MYR1
]]>Agencies
[Federal Register Volume 80, Number 86 (Tuesday, May 5, 2015)]
[Rules and Regulations]
[Pages 25601-25604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10493]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 174
[EPA-HQ-OPP-2014-0454; FRL-9925-85]
Bacillus thuringiensis Cry2Ab2 Protein in Soybean; Exemption From
the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus thuringiensis (B.t.)
Cry2Ab2 protein in or on soybean when the protein is used as a plant-
incorporated protectant (PIP) in soybean. Monsanto Company submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of B.t. Cry2Ab2 protein in or on soybean.
DATES: This regulation is effective May 5, 2015. Objections and
requests for hearings must be received on or before July 6, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0454, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Robert McNally, 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: BPPDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 25602]]
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. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 174 through the Government Publishing Office's e-CFR site at
https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0454 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 6, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0454, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be 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 https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register initially on October 24, 2014 (79 FR 63596)
(FRL-9916-03) and then again January 28, 2015 (80 FR 4527) (FRL-9921-
55), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 4F8276) by Monsanto Company, 800 North Lindbergh Blvd.,
St. Louis, MO 63167. The petition requested an amendment to 40 CFR
174.519 by extending the current exemption from the requirement of a
tolerance for residues of B.t. Cry2Ab2 protein in corn and cotton to
all food commodities. That document referenced a summary of the
petition prepared by the petitioner Monsanto Company, which is
available in the docket, https://www.regulations.gov. A comment was
received on the October 24, 2014, notice of filing. EPA's response to
this comment is discussed in Unit VII.C.
Based on available data, EPA is amending the existing exemption for
residues of B.t. Cry2Ab2 protein in corn and cotton to include residues
in soybean rather than all food commodities as requested. The reasons
for this change are discussed in Unit VII.D.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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, FFDCA section 408(b)(2)(D) 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.
III. Toxicological Profile
Consistent with FFDCA section 408(b)(2)(D), 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.
The acute oral toxicity data demonstrates the lack of mammalian
toxicity at high levels of exposure to the pure B.t. Cry2Ab2 protein.
Further, amino acid sequence comparisons showed no similarities between
the B.t. Cry2Ab2 protein and known toxic proteins in protein databases.
In addition, the B.t. Cry2Ab2 protein was shown to be substantially
degraded by heat when examined by immunoassay. This instability to heat
would also lessen the potential dietary exposure to intact B.t. Cry2Ab2
protein in cooked or processed foods. These biochemical features along
with the lack of adverse results in the acute oral toxicity test
support the conclusion that there is a reasonable certainty no harm
from toxicity will result from dietary exposure to residues of the B.t.
Cry2Ab2 protein in the identified soybean commodities.
Since this PIP is a protein, allergenic potential was also
considered.
[[Page 25603]]
Currently, no definitive tests for determining the allergenic potential
of novel proteins exist. Therefore, EPA uses a weight-of-evidence
approach where the following factors are considered: Source of the
trait; amino acid sequence comparison with known allergens; and
biochemical properties of the protein, including in vitro digestibility
in simulated gastric fluid (SGF) and glycosylation. This approach is
consistent with the approach outlined in the Annex to the Codex
Alimentarius ``Guideline for the Conduct of Food Safety Assessment of
Foods Derived from Recombinant-DNA Plants.'' The allergenicity
assessment for the B.t. Cry2Ab2 protein follows:
1. Source of the trait. Bacillus thuringiensis is not considered to
be a source of allergenic proteins.
2. Amino acid sequence. A comparison of the amino acid sequence of
the B.t. Cry2Ab2 protein with known allergens showed no significant
overall sequence similarity or identity at the level of eight
contiguous amino acid residues.
3. Digestibility. The B.t. Cry2Ab2 protein was rapidly digested in
15 seconds in simulated mammalian gastric fluid containing pepsin.
4. Glycosylation. The B.t. Cry2AB2 protein expressed in soybean was
shown not to be glycosylated.
5. Conclusion. Considering all of the available information, EPA
has concluded that the potential for the B.t. Cry2Ab2 protein to be a
food allergen is minimal.
The information on the safety of the pure B.t. Cry2Ab2 protein
provides adequate justification to address possible exposures in all
soybean crops.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider 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 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 exemptions in effect for the B.t.
Cry2Ab2 protein residue, and exposure from non-occupational sources.
Oral exposure may occur at very low levels from ingestion of corn,
cotton and soybean products. With respect to drinking water, since the
PIP is integrated into the plant genome and based upon EPA's human
health and environmental assessments for B.t. Cry2Ab2 protein (Refs. 1
and 2), the Agency expects residues in drinking water to be extremely
low or non-existent.
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 exposure by
these routes to negligible. Exposure to infants and children via
residential or lawn use is also not expected because the use sites for
the B.t. Cry2Ab2 protein is agricultural.
V. 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.''
Since the B.t. Cry2Ab2 protein does not act through a toxic mode of
action, nor does the B.t. Cry2Ab2 protein appear to produce a toxic
metabolite produced by other substances, the protein does not have a
common mechanism of toxicity with other substances; therefore, the
requirements of section 408(b)(2)(D)(v) do not apply.
VI. Determination of Safety for U.S. Population, 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 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) provides that EPA shall apply an additional
tenfold (10X) margin of exposure (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 exposure (safety) will
be safe for infants and children. This additional margin of exposure
(safety) is commonly referred to as the Food Quality Protection Act
Safety Factor. In applying this provision, EPA either retains the
default value of 10X or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
Based on the information discussed in Unit III., EPA concludes that
there are no threshold effects of concern to infants, children, or
adults from exposure to the B.t. Cry2Ab2 protein. As a result, EPA
concludes that no additional margin of exposure (safety) is necessary
to protect infants and children and that not adding any additional
margin of exposure (safety) will be safe for infants and children.
Therefore, based on the discussion in Unit III. and the supporting
documentation, 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 the B.t. Cry2Ab2
protein in soybean, when it is used as a plant-incorporated protectant.
Such exposure includes all anticipated dietary exposures and all other
exposures for which there is reliable information.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active ingredient is a protein, derived from a
source that is not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of the plant-incorporated protectant at this time.
B. Analytical Enforcement Methodology
A standard operating procedure for an enzyme-linked immunosorbent
assay for the detection and quantification of the B.t. Cry2Ab2 protein
in soybean tissue has been submitted.
C. Response to Comments
EPA received one comment that is potentially relevant to this
petition. The commenter generally opposed approval of the use of a
Monsanto ``bt pip,'' but did not specify any particular PIP or any
particular safety concern. As no specific basis for denying the
petition was provided, the comment is not being further considered.
D. Revisions to Petition for Tolerance
Monsanto's petition requested an exemption for residues of the B.t.
Cry2Ab2 protein in or on all food and feed commodities. However, based
on the data provided, the Agency can only support a safety finding for
residues in or on soybean at this time. Currently, the Agency does not
have adequate information for a full range of crops for
[[Page 25604]]
an exemption for the B.t. Cry2Ab2 protein in or on all food and feed
commodities.
VIII. Conclusions
There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to residues of the B.t. Cry2Ab2 protein in all food and feed
commodities of soybean. 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 discussed in this
unit, no toxicity to mammals has been observed, nor is there any
indication of allergenicity potential for the plant-incorporated
protectant.
Therefore, an exemption is established for residues of the B.t.
Cry2Ab2 protein in or on soybean when the protein is used as a PIP in
soybean.
IX. References
1. U.S. EPA. 2014a. Review of Product Characterization and Human
Health Data for Plant-Incorporated Protectant Bacillus thuringiensis
(Bt) Cry2Ab2 and Cry1A.105 Insect Control Protein and the Genetic
Material Necessary for Its Production in MON 87751 and the Combined-
Trait Insect Protected Soybeans in Support for an Experimental Use
Permit, Sec. 3 Registration and Exemptions from the Requirement of a
Tolerance. Memorandum from J. Facey, Ph.D. through J. Kough, Ph.D.
to K. Haymes, Ph.D., dated December 23, 2014.
2. U.S. EPA. 2014b. Environmental Risk Assessment for the FIFRA
Section 3 Seed Increase Registration of the Plant-Incorporated
Protectant (PIP), Bacillus thuringiensis (Bt) Cry1A.105 and Cry2Ab2
Insect Control Proteins and the Genetic Material (PV-GMIR13196)
Necessary for Their Production in Event MON 87751 Soybean.
Memorandum from I. You, Ph.D. through S. Borges to K. Haymes, Ph.D.,
dated December 16, 2014.
X. Statutory and Executive Order Reviews
This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, 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), or 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., nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 174
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 22, 2015.
Jack E. Housenger,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 174--[AMENDED]
0
1. The authority citation for part 174 continues to read as follows:
Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.
0
2. Sec. 174.519 is revised to read as follows:
Sec. 174.519 Bacillus thuringiensis Cry2Ab2 protein; exemption from
the requirement of a tolerance.
(a) Residues of Bacillus thuringiensis Cry2Ab2 protein in or on
corn or cotton are exempt from the requirement of a tolerance when used
as a plant-incorporated protectant in the food and feed commodities of
corn; corn, field; corn, sweet; corn, pop; and cotton seed, cotton oil,
cotton meal, cotton hay, cotton hulls, cotton forage, and cotton gin
byproducts.
(b) Residues of Bacillus thuringiensis Cry2Ab2 protein in or on
soybean are exempt from the requirement of a tolerance when used as a
plant-incorporated protectant in the food and feed commodities of
soybean.
[FR Doc. 2015-10493 Filed 5-4-15; 8:45 am]
BILLING CODE 6560-50-P
