80 FR 25946 - Bacillus thuringiensis Cry1A.105 Protein in Soybean; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 87 (May 6, 2015)

Page Range		25946-25950
FR Document		2015-10624

This regulation establishes an exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis (B.t.) Cry1A.105 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. Cry1A.105 protein in or on soybean.

Federal Register, Volume 80 Issue 87 (Wednesday, May 6, 2015)

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Rules and Regulations]
[Pages 25946-25950]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-10624]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2014-0454; FRL-9926-23]

Bacillus thuringiensis Cry1A.105 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.)
Cry1A.105 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

[[Page 25947]]

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.
Cry1A.105 protein in or on soybean.

DATES: This regulation is effective May 6, 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 http://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 http://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:

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
http://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: http://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 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.

II. Background and Statutory Findings

In the Federal Register initially on October 24, 2014 (79 FR 63596)
(FRL-9916-03) and then again on December 17, 2014 (79 FR 75111) (FRL-
9918-90), 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 4F8275) by Monsanto Company, 800 North Lindbergh Blvd.,
St. Louis, MO 63167. The petition requested that 40 CFR part 174 be
amended by establishing an exemption from the requirement of a
tolerance for residues of the B.t. Cry1A.105 protein in or on all food
commodities. That document referenced a summary of the petition
prepared by the petitioner Monsanto Company, which is available in the
docket, http://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. Cry1A.105 protein 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

[[Page 25948]]

``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. Cry1A.105 protein.
Further, amino acid sequence comparisons showed no similarities between
the B.t. Cry1A.105 protein and known toxic proteins in protein
databases. In addition, the B.t. Cry1A.105 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. Cry1A.105 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. Cry1A.105 protein in the identified
soybean commodities.
Since the PIP is a protein, allergenic potential was also
considered. 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. Cry1A.105 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. Cry1A.105 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. Cry1A.105 protein was rapidly digested
in less than 30 seconds in simulated mammalian gastric fluid containing
pepsin.
4. Glycosylation. The B.t. Cry1A.105 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. Cry1A.105 protein to be a
food allergen is minimal.
The information on the safety of the pure B.t. Cry1A.105 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.
Cry1A.105 protein residue, and exposure from non-occupational sources.
Oral exposure may occur at very low levels from ingestion of corn 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. Cry1A.105 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. Cry1A.105 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. Cry1A.105 protein does not act through a toxic mode
of action, nor does the B.t. Cry1A.105 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 (FQPA SF). In applying this provision, EPA either retains
the default value of 10X or uses a different additional safety factor
when reliable data available to EPA support the choice of a different
factor.
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. Cry1A.105 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.

[[Page 25949]]

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. Cry1A.105
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. Cry1A.105
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 ``B.t. 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.
Cry1A.105 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
an exemption for the B.t. Cry1A.105 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. Cry1A.105 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.
Cry1A.105 protein in or on soybean when the protein is used as a PIP in
soybean. In addition, the Agency is removing the existing paragraph (b)
contained in section 174.502 because that tolerance has expired.

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.

[[Page 25950]]

Dated: April 22, 2015.
Jack 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. In Sec. 174.502, revise paragraph (b) to read as follows:

Sec. 174.502 Bacillus thuringiensis Cry1A.105 protein; exemption from
the requirement of a tolerance.

* * * * *
(b) Residues of Bacillus thuringiensis Cry1A.105 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. 2015-10624 Filed 5-5-15; 8:45 am]
BILLING CODE 6560-50-P

25946 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations

B. Analytical Enforcement Methodology Populations’’ (59 FR 7629, February 16, Dated: April 28, 2015.
A standard operating procedure for an 1994). Robert McNally,
enzyme-linked immunosorbent assay for Since tolerances and exemptions that Director, Biopesticides and Pollution
are established on the basis of a petition Prevention Division, Office of Pesticide
the detection and quantification of Programs.
spinach defensin proteins SoD2 and under FFDCA section 408(d), such as
SoD7 in citrus plant tissue has been the exemption in this final rule, do not Therefore, 40 CFR chapter I is
judged useful for its intended purpose. require the issuance of a proposed rule, amended as follows:
the requirements of the Regulatory
C. Response to Comments PART 174—[AMENDED]
Flexibility Act (RFA) (5 U.S.C. 601 et
EPA received one comment relevant seq.), do not apply. ■ 1. The authority citation for part 174
to this petition. The comment supports continues to read as follows:
This action directly regulates growers,
this tolerance exemption and therefore
food processors, food handlers, and food Authority: 21 U.S.C. 321(q), 346a and 371.
warrants no response.
retailers, not States or tribes, nor does
this action alter the relationships or ■ 2. Add § 174.535 to subpart W to read
VIII. Conclusion
as follows:
The Agency concludes that there is a distribution of power and
reasonable certainty that no harm will responsibilities established by Congress § 174.535 Spinach Defensin proteins;
result to the U.S. population, including in the preemption provisions of FFDCA temporary exemption from the requirement
section 408(n)(4). As such, the Agency of a tolerance.
infants and children, from aggregate
exposure residues of spinach defensin has determined that this action will not (a) Residues of the defensin protein
SoD2 and SoD7 proteins in or on citrus. have a substantial direct effect on States SoD2 derived from spinach (Spinacia
This includes all anticipated dietary or tribal governments, on the oleracea L.) in or on citrus food
exposures and all other exposures for relationship between the national commodities are temporarily exempt
which there is reliable information. The government and the States or tribal from the requirement of a tolerance
Agency has arrived at this conclusion governments, or on the distribution of when used as a plant-incorporated
because, as discussed previously no power and responsibilities among the protectant in citrus plants in accordance
toxicity to mammals has been observed, various levels of government or between with the terms of Experimental Use
nor is there any indication of the Federal Government and Indian Permit No. 88232–EUP–1. This
allergenicity potential for the plant- tribes. Thus, the Agency has determined temporary exemption from the
incorporated protectant. that Executive Order 13132, entitled requirement of a tolerance expires on
Therefore, an exemption is ‘‘Federalism’’ (64 FR 43255, August 10, April 18, 2018.
1999) and Executive Order 13175, (b) Residues of the defensin protein
established for residues of spinach
entitled ‘‘Consultation and Coordination SoD7 derived from spinach (Spinacia
defensin SoD2 and SoD7 proteins in or
with Indian Tribal Governments’’ (65 FR oleracea L.) in or on citrus food
on citrus when the protein is used as a
67249, November 9, 2000) do not apply commodities are temporarily exempt
PIP in citrus plants.
to this action. In addition, this action from the requirement of a tolerance
IX. Statutory and Executive Order does not impose any enforceable duty or when used as a plant-incorporated
Reviews contain any unfunded mandate as protectant in citrus plants in accordance
This action establishes a temporary described under Title II of the Unfunded with the terms of Experimental Use
exemption from the requirement of a Mandates Reform Act (UMRA) (2 U.S.C. Permit No. 88232–EUP–1. This
tolerance under FFDCA section 408(d) 1501 et seq.). temporary exemption from the
in response to a petition submitted to requirement of a tolerance expires on
This action does not involve any April 18, 2018.
the Agency. The Office of Management technical standards that would require
and Budget (OMB) has exempted these [FR Doc. 2015–10486 Filed 5–5–15; 8:45 am]
Agency consideration of voluntary
types of actions from review under consensus standards pursuant to section BILLING CODE 6560–50–P
Executive Order 12866, entitled 12(d) of the National Technology
‘‘Regulatory Planning and Review’’ (58 Transfer and Advancement Act
FR 51735, October 4, 1993). Because ENVIRONMENTAL PROTECTION
(NTTAA) (15 U.S.C. 272 note). AGENCY
this action has been exempted from
review under Executive Order 12866, X. Congressional Review Act
40 CFR Part 174
this action is not subject to Executive
Order 13211, entitled ‘‘Actions Pursuant to the Congressional Review [EPA–HQ–OPP–2014–0454; FRL–9926–23]
Concerning Regulations That Act (5 U.S.C. 801 et seq.), EPA will
Significantly Affect Energy Supply, submit a report containing this rule and Bacillus thuringiensis Cry1A.105
Distribution, or Use’’ (66 FR 28355, May other required information to the U.S. Protein in Soybean; Exemption From
22, 2001) or Executive Order 13045, Senate, the U.S. House of the Requirement of a Tolerance
entitled ‘‘Protection of Children from Representatives, and the Comptroller
General of the United States prior to AGENCY: Environmental Protection
Environmental Health Risks and Safety Agency (EPA).
Risks’’ (62 FR 19885, April 23, 1997). publication of the rule in the Federal
Register. This action is not a ‘‘major ACTION: Final rule.
This action does not contain any
information collections subject to OMB rule’’ as defined by 5 U.S.C. 804(2). SUMMARY: This regulation establishes an
approval under the Paperwork List of Subjects in 40 CFR Part 174 exemption from the requirement of a
tkelley on DSK3SPTVN1PROD with RULES

Reduction Act (PRA) (44 U.S.C. 3501 et tolerance for residues of the Bacillus
seq.), nor does it require any special Environmental protection, thuringiensis (B.t.) Cry1A.105 protein in
considerations under Executive Order Administrative practice and procedure, or on soybean when the protein is used
12898, entitled ‘‘Federal Actions to Agricultural commodities, Pesticides as a plant-incorporated protectant (PIP)
Address Environmental Justice in and pests, Reporting and recordkeeping in soybean. Monsanto Company
Minority Populations and Low-Income requirements. submitted a petition to EPA under the

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Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Rules and Regulations 25947

Federal Food, Drug, and Cosmetic Act B. How can I get electronic access to II. Background and Statutory Findings
(FFDCA), requesting an exemption from other related information?
the requirement of a tolerance. This In the Federal Register initially on
regulation eliminates the need to You may access a frequently updated October 24, 2014 (79 FR 63596) (FRL–
establish a maximum permissible level electronic version of 40 CFR part 174 9916–03) and then again on December
for residues of B.t. Cry1A.105 protein in through the Government Publishing 17, 2014 (79 FR 75111) (FRL–9918–90),
or on soybean. Office’s e-CFR site at http:// EPA issued a document pursuant to
www.ecfr.gov/cgi-bin/text- FFDCA section 408(d)(3), 21 U.S.C.
DATES: This regulation is effective May 346a(d)(3), announcing the filing of a
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
6, 2015. Objections and requests for 40tab_02.tpl. pesticide tolerance petition (PP 4F8275)
hearings must be received on or before by Monsanto Company, 800 North
July 6, 2015, and must be filed in C. How can I file an objection or hearing Lindbergh Blvd., St. Louis, MO 63167.
accordance with the instructions request? The petition requested that 40 CFR part
provided in 40 CFR part 178 (see also 174 be amended by establishing an
Unit I.C. of the SUPPLEMENTARY Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an exemption from the requirement of a
INFORMATION). tolerance for residues of the B.t.
objection to any aspect of this regulation
ADDRESSES: The docket for this action, and may also request a hearing on those Cry1A.105 protein in or on all food
identified by docket identification (ID) objections. You must file your objection commodities. That document referenced
number EPA–HQ–OPP–2014–0454, is or request a hearing on this regulation a summary of the petition prepared by
available at http://www.regulations.gov in accordance with the instructions the petitioner Monsanto Company,
or at the Office of Pesticide Programs provided in 40 CFR part 178. To ensure which is available in the docket,
Regulatory Public Docket (OPP Docket) proper receipt by EPA, you must http://www.regulations.gov. A comment
in the Environmental Protection Agency identify docket ID number EPA–HQ– was received on the October 24, 2014,
Docket Center (EPA/DC), West William OPP–2014–0454 in the subject line on notice of filing. EPA’s response to this
Jefferson Clinton Bldg., Rm. 3334, 1301 the first page of your submission. All comment is discussed in Unit VII.C.
Constitution Ave. NW., Washington, DC objections and requests for a hearing Based on available data, EPA is
20460–0001. The Public Reading Room must be in writing, and must be amending the existing exemption for
is open from 8:30 a.m. to 4:30 p.m., received by the Hearing Clerk on or residues of B.t. Cry1A.105 protein to
Monday through Friday, excluding legal before July 6, 2015. Addresses for mail include residues in soybean rather than
holidays. The telephone number for the and hand delivery of objections and all food commodities as requested. The
Public Reading Room is (202) 566–1744, hearing requests are provided in 40 CFR reasons for this change are discussed in
and the telephone number for the OPP 178.25(b). Unit VII.D.
Docket is (703) 305–5805. Please review In addition to filing an objection or Section 408(c)(2)(A)(i) of FFDCA
the visitor instructions and additional hearing request with the Hearing Clerk allows EPA to establish an exemption
information about the docket available as described in 40 CFR part 178, please from the requirement for a tolerance (the
at http://www.epa.gov/dockets. submit a copy of the filing (excluding legal limit for a pesticide chemical
FOR FURTHER INFORMATION CONTACT: any Confidential Business Information residue in or on a food) only if EPA
Robert McNally, Biopesticides and (CBI)) for inclusion in the public docket. determines that the exemption is ‘‘safe.’’
Pollution Prevention Division (7511P), Information not marked confidential Section 408(c)(2)(A)(ii) of FFDCA
Office of Pesticide Programs, pursuant to 40 CFR part 2 may be defines ‘‘safe’’ to mean that ‘‘there is a
Environmental Protection Agency, 1200 disclosed publicly by EPA without prior reasonable certainty that no harm will
Pennsylvania Ave. NW., Washington, notice. Submit the non-CBI copy of your result from aggregate exposure to the
DC 20460–0001; main telephone objection or hearing request, identified pesticide chemical residue, including
number: (703) 305–7090; email address: by docket ID number EPA–HQ–OPP– all anticipated dietary exposures and all
BPPDFRNotices@epa.gov. 2014–0454, by one of the following other exposures for which there is
SUPPLEMENTARY INFORMATION: methods: reliable information.’’ This includes
• Federal eRulemaking Portal: http:// exposure through drinking water and in
I. General Information residential settings, but does not include
www.regulations.gov. Follow the online
A. Does this action apply to me? instructions for submitting comments. occupational exposure. Pursuant to
Do not submit electronically any FFDCA section 408(c)(2)(B), in
You may be potentially affected by establishing or maintaining in effect an
information you consider to be CBI or
this action if you are an agricultural exemption from the requirement of a
other information whose disclosure is
producer, food manufacturer, or tolerance, EPA must take into account
restricted by statute.
pesticide manufacturer. The following the factors set forth in FFDCA section
list of North American Industrial • Mail: OPP Docket, Environmental 408(b)(2)(C), which require EPA to give
Classification System (NAICS) codes is Protection Agency Docket Center (EPA/ special consideration to exposure of
not intended to be exhaustive, but rather DC), (28221T), 1200 Pennsylvania Ave. infants and children to the pesticide
provides a guide to help readers NW., Washington, DC 20460–0001. chemical residue in establishing a
determine whether this document • Hand Delivery: To make special tolerance and to ‘‘ensure that there is a
applies to them. Potentially affected arrangements for hand delivery or reasonable certainty that no harm will
entities may include: delivery of boxed information, please result to infants and children from
• Crop production (NAICS code 111). follow the instructions at http:// aggregate exposure to the pesticide
tkelley on DSK3SPTVN1PROD with RULES

• Animal production (NAICS code www.epa.gov/dockets/contacts.html. chemical residue. . . .’’
112). Additional instructions on Additionally, FFDCA section
• Food manufacturing (NAICS code commenting or visiting the docket, 408(b)(2)(D) requires that the Agency
311). along with more information about consider ‘‘available information
• Pesticide manufacturing (NAICS dockets generally, is available at concerning the cumulative effects of a
code 32532). http://www.epa.gov/dockets. particular pesticide’s residues’’ and

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This regulation is effective May 6, 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).
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
FR Citation		80 FR 25946
CFR Associated		Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements