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[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 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: 

[[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 
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 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, 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. 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]

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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.

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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
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