Document ID: EPA-HQ-OPP-2009-0101-0011
Agency: epa
Document Type: Rule
Title: Bacillus thuringiensis Cry1A.105 Protein; Time Limited Exemption From the Requirement of a Tolerance; Correction
Posted Date: 2009-08-07T04:00Z

[Federal Register: August 7, 2009 (Volume 74, Number 151)]
[Rules and Regulations]               
[Page 39540-39543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au09-3]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2009-0101; FRL-8428-7]

 
Bacillus thuringiensis Cry1A.105 Protein; Time Limited Exemption 
From the Requirement of a Tolerance; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule, correction.

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SUMMARY: On May 20, 2009 EPA published a Final Rule that established an 
18-month, time-limited exemption from the requirement of a tolerance 
for residues of the Bacillus thuringiensis Cry1A.105 protein in or on 
the food and feed commodities cotton seed, cotton seed oil, cotton seed 
meal, cotton hay, cotton hulls, cotton forage and cotton gin byproducts 
when used as a plant-incorporated protectant. Subsequent to the 
publication of the May 20, 2009 Final Rule, the Agency identified an 
error in the Analytical Methods section of that Rule's preamble. 
Through this action, EPA is republishing the tolerance exemption with a 
new effective date and opportunity to request a hearing, and a 
corrected Analytical Methods section. The conditions of the

[[Page 39541]]

time-limited tolerance exemption as established on May 20, 2009 are 
unchanged: the time-limited tolerance exemption expires and is revoked 
on November 22, 2010.

DATES: This regulation is effective August 7, 2009. Objections and 
requests for hearings must be received on or before October 6, 2009 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0101. All documents in the 
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: 703-308-8263; e-mail address: greenway.denise@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 174 through the 
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2009-0101 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before October 6, 2009.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2009-0101, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 4, 2009 (74 FR 9395) (FRL-8403-5), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 
9F7521) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 
63167. The petition requested that 40 CFR part 174 be amended by 
establishing a time-limited exemption from the requirement of a 
tolerance for residues of the plant-incorporated protectant Bacillus 
thuringiensis Cry1A.105 protein, in or on the food and feed commodities 
cotton seed, cotton seed oil, cotton seed meal, cotton hay, cotton 
hulls, cotton forage and cotton gin byproducts. This notice included a 
summary of the petition prepared by the petitioner Monsanto Company. 
This petition was submitted to deal with a small amount -- less than an 
acre -- of an unauthorized, genetically-engineered cotton variety 
containing an unregistered plant-incorporated protectant - the 
Cry1A.105 protein -- that was inadvertently harvested along with 54 
acres of a commercially-available, genetically-engineered cotton 
variety. (http://www.epa.gov/pesticides/biopesticides/pips/btcotton_
statement.html). In response to EPA's notice announcing the filing of 
pesticide petition 9F7521, one comment was received and was addressed 
in the May 20, 2009, Final Rule, in which EPA presented its rationale 
for establishing an 18-month time-limited exemption from the 
requirement of a tolerance.
    Subsequent to the publication of the May 20, 2009 regulation, the 
Agency identified an error in the Analytical Methods section of the 
Rule's preamble (Unit VII.B.). Specifically, the text in the Analytical 
Methods section of the preamble to the May 20, 2009 Final Rule 
erroneously stated that the Polymerase Chain Reaction (PCR) method 
analyzed for Bacillus thuringiensis Cry1A.105 protein. In fact, the PCR 
method analyzes for Bacillus thuringiensis

[[Page 39542]]

Cry1A.105 DNA. This action corrects that error. This action also 
establishes a new effective date and opportunity to request a hearing. 
The conditions of the time-limited tolerance exemption as established 
on May 20, 2009 are unchanged: it still expires and is revoked on 
November 22, 2010. See Section VII.B., below, for the subject 
correction to the Analytical Methods section.
    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 section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, 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, section 408(b)(2)(D) of FFDCA 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 section 408(b)(2)(D) of FFDCA, 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.
    For a more extensive discussion, see the Final Rule of May 20, 2009 
(74 FR 23635, FRL-8417-3).

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA 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).

A. Dietary Exposure

      Food. See the Final Rule of May 20, 2009 (74 FR 23635, FRL-8417-
3).

 B. Other Non-Occupational Exposure

     Dermal and inhalation exposure. See the Final Rule of May 20, 2009 
(74 FR 23635), (FRL-8417-3).

V. Cumulative Effects

    See the Final Rule of May 20, 2009 (74 FR 23635), (FRL-8417-3).

VI. Determination of Safety for U.S. Population, Infants and Children

    See the Final Rule of May 20, 2009 (74 FR 23635), (FRL-8417-3).

VII. Other Considerations

A. Endocrine Disruptors

    See the Final Rule of May 20, 2009 (74 FR 23635), (FRL-8417-3).

B. Analytical Method

    A Polymerase Chain Reaction (PCR) method for the detection and (in 
the context of a tolerance exemption) measurement of the Bacillus 
thuringiensis Cry1A.105 DNA in cotton has been submitted (MRID 477497-
01).

C. Codex Maximum Residue Level

    See the Final Rule of May 20, 2009 (74 FR 23635, FRL-8417-3).

VIII. Conclusions

    See the Final Rule of May 20, 2009 (74 FR 23635, FRL-8417-3).

 IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of FFDCA 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 final rule has been exempted from review under 
Executive Order 12866, this final rule 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 final rule 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 section 408(d) of FFDCA, 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 final rule 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 section 408(n)(4) of FFDCA. 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).
    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 of 1995

[[Page 39543]]

(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule 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: July 27, 2009.
W. Michael McDavit,
Acting Director, Biopesticides and Pollution Prevention Division, 
Office of Pesticide Programs.

0
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: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 174.502 is revised to read as follows:

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

    (a) Residues of Bacillus thuringiensis Cry1A.105 protein in or on 
the food and feed commodities of corn; corn, field, flour; corn, field, 
forage; corn, field, grain; corn, field, grits; corn, field, meal; 
corn, field, refined oil; corn, field, stover; corn, sweet, forage; 
corn, sweet, kernel plus cob with husk removed; corn, sweet, stover; 
and corn, pop, grain and corn, pop, stover are exempt from the 
requirement of a tolerance when the Bacillus thuringiensis Cry1A.105 
protein is used as a plant-incorporated protectant in these food and 
feed corn commodities.
    (b) A time-limited exemption from the requirement of a tolerance is 
established for residues of Bacillus thuringiensis Cry1A.105 protein in 
or on the food and feed commodities of cotton; cotton, forage; cotton, 
gin byproducts; cotton, hay; cotton, hulls; cotton, meal; cotton, 
refined oil; and cotton, undelinted seed when the Bacillus 
thuringiensis Cry1A.105 protein is used as a plant-incorporated 
protectant in these food and feed cotton commodities. The exemption 
from the requirement of a tolerance expires and is revoked on November 
22, 2010.
[FR Doc. E9-18860 Filed 8-6-09; 8:45 am]

BILLING CODE 6560-50-S