[Federal Register Volume 61, Number 150 (Friday, August 2, 1996)]
[Rules and Regulations]
[Pages 40336-40338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19812]
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ARMS CONTROL AND DISARMAMENT AGENCY
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[[Page 40337]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4517/R2270; FRL-5391-4]
RIN 2070-AB78
Phosphinothricin Acetyltransferase (PAT) and the Genetic Material
Necessary for Its Production (Plasmid Vector pZ01502) in Corn;
Exemption from Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of the plant pesticide inert ingredient
phosphinothricin acetyltransferase and the genetic material necessary
for its production (plasmid vector pZ01502) in corn. A request for an
exemption from the requirement of a tolerance was submitted by Northrup
King Company (NK). This regulation eliminates the need to establish a
maximum permissible level for residues of this plant pesticide inert
ingredient in all raw agricultural commodities of field corn, sweet
corn, and popcorn.
EFFECTIVE DATE: Effective on August 2, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
docket number [PP 5E4517/R2270] may be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC. 20460. A copy of any objections and hearing requests
filed with the Hearing Clerk should be identified by the docket number
and submitted to: Public Response and Program Resources Branch, Field
Operations Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St. SW., Washington, Dc 20460.
In person, bring copy of objections and hearing requests to: Rm. 1132,
CM #2, 1921 Jefferson Davis Highway, Arlington, Va. 22202. Fees
accompanying objections shall be labeled ``tolerance Petition Fees''
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(tolerance Fees) P.O. Box 360277M, Pittsburgh, PA 15251.
An electronic copy of objections and hearing requests filed with
the Hearing Clerk may be submiited to OPP by sending electronic mail
to: opp-docket@epamail.epa.gov.
Copies of electronic objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption. Copies of electronic objections and hearing
requests be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All copies of electronic objections and hearing requests
must be identified by the docket number [PP 5E4517/R2270]. No
Confidential Business Information (CBI) should be submitted through e-
mail. Copies electronic objections and hearing requests on this rule
may be filed online at many Federal Depository Libraries. Additional
information on electronic submissions can be found below in this
document.
FOR FURTHER INFORMATION CONTACT: By mail: Michael L. Mendelsohn,
Biopesticides and Pollution Prevention Division (7501W), Office of
Pesticide Programs, U. S. Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20460. Office location and telephone number: 5th
Floor CS, 2800 Crystal Drive, Arlington, VA 22202, (Telephone No. 703-
308-8715); e-mail: mendelsohn.michael@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of October 25, 1995 (60 FR 54689)(FRL-4982-4), which
announced that Northrup King Company, 7500 Olson Memorial Hwy., Golden
valley, MN 55427, had submitted a pesticide petition (PP) 5E4517 to EPA
requesting that the Administrator, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d),
establish an exemption from the requirement of a tolerance for the
plant pesticide inert ingredient phosphinothricin acetyltransferase
(PAT) as produced in corn by the PAT gene and its controlling sequences
as found on plasmid vector pZ01502. EPA has assigned the inert
ingredient of this product the name phosphinothricin acetyltransferase
and the genetic material necessary for its production (plasmid vector
pZ01502) in corn. ``Genetic material necessary for its production''
means the genetic material which comprise (1) genetic material encoding
the phosphinothricin acetyltransferase and (2) its regulatory regions.
``Regulatory regions'' are the genetic material that control the
expression of the genetic material encoding the phosphinothricin
acetyltransferase, such as promoters, terminators, and enhancers. There
were no adverse comments, or requests for referral to an advisory
committee received in response to the notice of filing of the pesticide
petition 5E4517.
Toxicology Assessment
Data regarding the in vitro digestibility of PAT as well as
information on the similarity of the PAT enzyme to other proteins were
cited and submitted. These data support the prediction that the PAT
protein would be non-toxic to humans and have a minimal potential for
allergenicity. Residue chemistry data were therefore not required.
The Agency expects that proteins with no significant amino acid
homology to known mammalian protein toxins and which are readily
inactivated by heat or mild acidic conditions and readily degraded in
an in vitro digestibility assay have little likelihood for displaying
oral toxicity. The in vitro digestibility studies indicate that the PAT
enzyme would be rapidly degraded following ingestion. Further, the PAT
enzyme was shown to have no significant amino acid homology to known
mammalian protein toxins.
Current scientific knowledge suggests that common food allergens
tend to be resistant to degradation by heat, acid, and proteases, are
glycosylated and are present at high concentrations in the food. The in
vitro digestibility studies indicate the PAT protein is rapidly
degraded in the gastric environment and is also readily denatured by
heat or low pH. Thus, the potential for PAT to be a food allergen is
minimal
The genetic material necessary for the production of PAT are the
nucleic acids (DNA) which comprise (1) genetic material encoding the
PAT and (2) its regulatory regions. ``Regulatory regions'' are the
genetic material that control the expression of the genetic material
encoding PAT, such as promoters, terminators, and enhancers. DNA is
common to all forms of plant and animal life and the Agency knows of no
instance where these nucleic acids have been associated with toxic
effects related to their consumption. These ubiquitous nucleic acids as
they appear in the subject active ingredient have been adequately
characterized. Therefore, no mammalian toxicity is anticipated from
dietary exposure to the genetic material necessary for the production
of PAT in corn.
Conclusions
Based on the information considered, the Agency concludes that
establishment of a tolerance is not necessary to protect the public
health. Therefore, the exemption from tolerance is established as set
forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the
[[Page 40338]]
Federal Register, file written objections to the regulation and may
also request a hearing on those objections. Objections and hearing
requests must be filed with the Hearing Clerk, at the address given
above (40 CFR 178.20). A copy of the objections and/or hearing requests
filed with the Hearing Clerk should be submitted to the OPP docket for
this rulemaking. The objections submitted must specify the provisions
of the regulation deemed objectionable and the grounds for the
objections (40 CFR 178.25). Each objection must be accompanied by the
fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, a
summary of any evidence relied upon by the objector as well as the
other materials required by 40 CFR 178.27. A request for a hearing will
be granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issue(s) in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).
EPA has established a record for this rulemaking under docket
number [PP 5E4517/R2271] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
address in ``ADDRESSES'' at the beginning of this document.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act (5
U.S.C. 601-612), the Administrator has determined that regulations
establishing new tolerances or raising tolerance levels or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A statement
containing the factual basis for this certification was published in
the Federal Register of May 4, 1981 (46 FR 24950).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
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 General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 30, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In subpart D, by adding Sec. 180.1175, to read as
Sec. 180.1175 Phosphinothricin acetyltransferase (PAT) and the genetic
material necessary for its production (plasmid vector pZ01502) in corn;
exemption from the requirement of a tolerance.
Phosphinothricin acetyltransferase (PAT) and the genetic material
necessary for its production (plasmid vector pZ01502) in corn is exempt
from the requirement of a tolerance when used as a plant pesticide
inert ingredient in all raw agricultural commodities of field corn,
sweet corn, and popcorn. ``Genetic material necessary for its
production'' means the genetic material which comprise genetic material
encoding the phosphinothricin acetyltransferase and its regulatory
regions. ``Regulatory regions'' are the genetic material that control
the expression of the genetic material encoding the phosphinothricin
acetyltransferase, such as promoters, terminators, and enhancers.
[FR Doc. 96-19812 Filed 8-01-96; 8:45 am]
BILLING CODE 6560-50-F
