[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: [email protected].
    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: [email protected].
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:
    [email protected].


    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