[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)]
[Rules and Regulations]
[Pages 3601-3603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01519]



40 CFR Part 174

[EPA-HQ-OPP-2017-0401; FRL-9972-62]

Bacillus thuringiensis Cry51Aa2.834_16; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of the Cry51Aa2.834_16 protein derived from 
Bacillus thuringiensis in or on cotton, when used as a plant-
incorporated protectant. Monsanto Company submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting this 
exemption from the requirement of a tolerance. This regulation 
eliminates the need under FFDCA to establish a maximum permissible 
level for such residues.

DATES: This regulation is effective January 26, 2018. Objections and 
requests for hearings must be received on or before March 27, 2018, 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-2017-0401, 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: 


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 Printing 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-2017-0401 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 
March 27, 2018. 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-2017-0401, 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 
     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

    In the Federal Register of October 23, 2017 (82 FR 49020 (FRL-9967-
370)), EPA issued notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
7F8566) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 
63167. The petition requested that 40 CFR part 174 be amended by 
establishing permanent exemption from the requirement of a tolerance 
for the plant-pesticide Bacillus thuringiensis Cry51Aa2.834_16 protein 
in or on cotton. A summary of the petition prepared by the petitioner 
Monsanto Company, is available in the docket via http://www.regulations.gov. There were no comments received in response to the 
    One modification has been made to the original request for a 
tolerance exemption: EPA changed ``plant-pesticide'' to ``plant-
incorporated protectant'', to align with the Agency's vocabulary, which 
is published in 40 CFR part 174.3.

[[Page 3602]]

III. Final Rule

A. EPA's Safety Determination

    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 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 or tolerance exemption 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 EPA consider ``available information concerning the 
cumulative effects of [a particular pesticide's] . . . residues and 
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on 
Cry51Aa2.834_16 and considered its validity, completeness, and 
reliability, as well as the relationship of this information to human 
risk. A full explanation of the data upon which EPA relied and its risk 
assessment based on that data can be found within the document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Assessment of the Plant-
Incorporated Protectant Bacillus thuringiensis Cry51Aa2.834_16.'' This 
document, as well as other relevant information, is available in the 
docket for this action as described under ADDRESSES.
    Based upon available data, EPA concludes that the Cry51Aa2.834_16 
protein, which is a modified version of the wild-type Cry51Aa2 protein 
derived from Bacillus thuringiensis, does not show evidence of 
toxicity. Moreover, the source is not allergenic, nor is there any 
significant similarity between the Cry51Aa2.834_16 protein and known 
toxins and allergens. In addition, the Cry51Aa2.834_16 protein readily 
digests in simulated gastric fluids and therefore cumulative, chronic, 
and acute effects are unlikely.
    Given the lack of toxicity or allergenicity of the Cry51Aa2.834_16 
protein, the Agency has not identified any toxicological endpoints for 
assessing risk. Consequently, the Agency's assessment of exposure is 
qualitative. In addition, due to the lack of any threshold effects, EPA 
has determined that the provision to retain a 10X safety factor for the 
protection of infants and children does not apply. Similarly, the lack 
of any toxic mode of action or toxic metabolites means that the 
provision requiring an assessment of cumulative effects does not apply.
    Oral exposure to Cry51Aa2.834_16 may occur from ingestion of 
cotton-derived foods, such as refined, bleached, and deodorized (RBD) 
cottonseed oil. Based on the lack of adverse effects and the rapid 
digestibility of the protein, however, the Agency does not anticipate 
any risk from reasonably foreseeable levels of exposure. Residues in 
drinking water may theoretically be present because cotton PIP plant 
stubble may release modified Cry51Aa2.834_16 protein into ground water 
upon decay. However, the protein would not be expected to survive in 
the soil due to microbial degradation, adherence to soil components, 
and removal upon drinking water treatment procedures. In addition, oral 
toxicity testing showed no adverse effects. Moreover, because the PIP 
is currently only proposed to be used only in plants grown for 
commercial use, the Agency does not anticipate residential exposures. 
In the event that future uses are sold for residential use, the Agency 
does not expect there to be residential, non-occupational dermal or 
inhalation exposures, due to containment of the Cry51Aa2.834_16 protein 
within the plant.
    Based on the lack of any evidence of adverse effects in the 
toxicological database, dietary exposure to the Cry51Aa2.834_16 protein 
is not anticipated to pose any harm to the U.S. population. 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 residues of the Cry51Aa2.834_16 protein derived from 
Bacillus thuringiensis. Therefore, an exemption from the requirement of 
a tolerance is established for residues of the plant-incorporated 
protectant Bacillus thuringiensis Cry51Aa2.834_16 protein in or on 

B. Analytical Enforcement Methodology

    An analytical method is not required because the lack of adverse 
effects makes enforcement and monitoring of residues unnecessary to 
ensure food safety.

IV. 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 EPA. 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 tolerance 
exemption in this action, 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA has determined that 
Executive Order 13132, entitled

[[Page 3603]]

``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 EPA's 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).

V. 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: December 28, 2017.
Hayley Hughes,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


1. The authority citation for part 174 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.

2. Add Sec.  174.539 to subpart W to read as follows:

Sec.  174.539  Cry51Aa2.834_16 protein; exemption from the requirement 
of a tolerance.

    Residues of the Cry51Aa2.834_16 protein, which is a modified 
protein derived from the Cry51Aa2 protein of Bacillus thuringiensis, in 
or on cotton are exempt from the requirement of a tolerance, when the 
Cry51Aa2.834_16 protein is used as a plant-incorporated protectant.

[FR Doc. 2018-01519 Filed 1-25-18; 8:45 am]