[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17717-17720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9373]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300463; FRL-5597-3]
RIN No. 2070-AB78


Phosphinothricin Acetyltransferase and the Genetic Material 
Necessary for Its Production in All Plants; Exemption From the 
Requirement of a Tolerance On All Raw Agricultural Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for residues of the plant-pesticide inert ingredients 
Phosphinothricin Acetyltransferase (PAT) and the genetic material 
necessary for its production in all plants when used as plant-
pesticides in or on all raw agricultural commodities (RACs). Dekalb 
Genetics Corporation submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality 
Protection Act of l996 (FQPA) requesting the exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of this plant-
pesticides in or on all RACS.

EFFECTIVE DATE: This regulation becomes effective on April 11, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300463], may be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
docket control 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. A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically to the OPP by sending 
electronic mail (e-mail) to: <a href="/cdn-cgi/l/email-protection#503f20207d343f333b3524103520313d31393c7e3520317e373f26"><span class="__cf_email__" data-cfemail="a0cfd0d08dc4cfc3cbc5d4e0c5d0c1cdc1c9cc8ec5d0c18ec7cfd6">[email protected]</span></a>.
    Copies of objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Copies of objections and hearing requests will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All copies of objections and hearing requests in electronic 
form must be identified by the docket control number [OPP-300463]. No 
Confidential Business Information (CBI) should be submitted through e- 
mail. Electronic copies of objections and hearing requests on this rule 
may be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found in Unit VIII. of 
this preamble.

FOR FURTHER INFORMATION CONTACT: By mail: Mike Mendelsohn, 
Biopesticides and Pollution Prevention Division, Office of Pesticide 
Programs, U. S. Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: 5th Floor CS, 2800 Crystal Drive, Arlington, VA 22202, (703)-
308-8715); email: <a href="/cdn-cgi/l/email-protection#ed8088838988819e828583c380848688ad889d8c808c8481c3889d8cc38a829b"><span class="__cf_email__" data-cfemail="610c040f05040d120e090f4f0c080a04210411000c00080d4f0411004f060e17">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 1996 
(62 FR 3682)(FRL-5380-2), EPA issued a notice pursuant to section 
408(d) of FFDCA, 21 U.S.C. 346a(d) announcing the filing of a pesticide 
petition for an exemption from the requirement for a tolerance by 
Dekalb Genetics Corporation (Dekalb), 3100 Sycamore Road, Dekalb, IL 
60115. The notice contained a summary of the petition prepared by the 
petitioner and this summary contained conclusions and arguments to 
support its conclusion that the petition complied with the FQPA (Pub. 
L. 104-170). The petition requested that an exemption from the 
requirement of a tolerance be established for the plant-pesticides PAT 
and the genetic material necessary for its production in plants in or 
on all raw agricultural commodities (RACS). There were no comments or 
requests for referral to an advisory committee received in response to 
the notice of filing. The data submitted in the petition and other 
relevant material have been evaluated. The toxicology and other data 
listed below were considered in support of this exemption from the 
requirement of a tolerance.

I. Toxicological Profile

    The data submitted regarding potential health effects of PAT 
include information on the characterization of the expressed protein in 
corn, the acute oral toxicity of PAT, and in vitro digestibility 
studies of the protein. The results of these studies were determined 
applicable to evaluate human risk and the validity, completeness, and 
reliability of the available data from the studies were considered.
    The acute oral toxicity test of bacterially-derived PAT protein 
showed no test substance related deaths at a dose of 2,500 milligrams 
per kilogram (mg/kg). Residue chemistry data were not required for a 
human health effects assessment of the subject plant-pesticide inert 
ingredients because of the lack of mammalian toxicity. Both (1) 
available information concerning the dietary

[[Page 17718]]

consumption patterns of consumers (and major identifiable subgroups of 
consumers including infants and children) and (2) safety factors which, 
in the opinion of experts qualified by scientific training and 
experience to evaluate the safety of food additives, are generally 
recognized as appropriate for the use of animal experimentation data 
were not evaluated because the lack of mammalian toxicity at high 
levels of exposure demonstrate the safety of the product at levels 
above possible maximum exposure levels. This is similar to the Agency 
position regarding toxicity and the requirement of residue data for the 
microbial Bacillus thuringiensis. [See 40 CFR 158.740(b).] For 
microbial products, further toxicity testing to verify the observed 
effects and clarify the source of the effects (Tiers II and III) and 
residue data are triggered by significant acute effects in studies such 
as the mouse oral toxicity study.
    The acute oral toxicity data submitted support the prediction that 
the PAT protein would be non-toxic to humans. When proteins are toxic, 
they are known to act via acute mechanisms and at very low dose levels 
[Sjoblad, Roy D., et al. ``Toxicological Considerations for Protein 
Components of Biological Pesticide Products,'' Regulatory Toxicology 
and Pharmacology 15, 3-9 (1992)]. Therefore, since no effects were 
shown to be caused by the plant-pesticides, even at relatively high 
dose levels, the PAT delta-endotoxin protein is not considered toxic.
    Adequate information was submitted to show that the PAT test 
material derived from microbial cultures was biochemically and, 
functionally similar to the proteins produced by the plant-pesticide 
inert ingredient in corn. Production of microbially produced protein 
was chosen in order to obtain sufficient material for testing. In 
addition, the in vitro digestibility studies indicate the proteins 
would be rapidly degraded following ingestion.
    The genetic material necessary for the production of the plant-
pesticides active and inert ingredients are the nucleic acids (DNA) 
which comprise (1) genetic material encoding these proteins and (2) 
their regulatory regions. ``Regulatory regions'' are the genetic 
material that control the expression of the genetic material encoding 
the proteins, 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 as a component of food. These 
ubiquitous nucleic acids as they appear in the subject plant-pesticide 
inert ingredient has been adequately characterized by the applicant. 
Therefore, no mammalian toxicity is anticipated from dietary exposure 
to the genetic material necessary for the production of the subject 
active and inert plant pesticidal ingredients.

II. Sensitivity of Subgroups

    The Agency has considered available information on the variability 
of the sensitivities of major identifiable subgroups of consumers 
including infants and children and the physiological differences 
between infants and children and adults and effects of in utero 
exposure to the plant-pesticides. Since PAT is a protein, allergenic 
sensitivities were considered. 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. Data has been submitted which demonstrate 
that the PAT protein is rapidly degraded by gastric fluid in vitro and 
is non-glycosylated. Thus, the potential for the PAT protein to be a 
food allergen is minimal.

III. Cumulative Effects

    The Agency has considered available information on the cumulative 
effects of such residues and other substances that have a common mode 
of toxicity. These considerations included the cumulative effects on 
infants and children of such residues and other substances with a 
common mechanism of toxicity. Because there is no indication of 
mammalian toxicity to these plant-pesticides, there are no cumulative 
effects.

IV. Aggregate Exposures

    The Agency has 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 tolerances or exemptions in effect 
for the plant-pesticides chemical residue, and exposure from non-
occupational sources. Exposure via the skin or inhalation is not likely 
since the plant-pesticides are contained within plant cells which 
essentially eliminates these exposure routes or reduces these exposure 
routes to negligible. Oral exposure, at very low levels, may occur from 
ingestion of processed corn products and drinking water. However a lack 
of mammalian toxicity and the digestibility of the plant-pesticides has 
been demonstrated. At present, the use sites for PAT are all 
agricultural. Therefore, exposure via residential or lawn use to 
infants and children is not expected. Even if negligible exposure 
should occur, the Agency concludes that such exposure would present no 
risk due to the lack of toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (safety) for infants and children in the 
case of threshold effects to account for pre- and post-natal toxicity 
and the completeness of the database unless EPA determines that a 
different margin of exposure (safety) will be safe for infants and 
children. In this instance EPA believes there is reliable data to 
support the conclusion that the plant-pesticides are not toxic to 
mammals, including infants and children, and thus there are no 
threshold effects of concern. As a result, the provision requiring an 
additional margin of exposure does not apply.

V. Endocrine Effects

    EPA does not have any information regarding endocrine effects for 
these kinds of pesticides at this time. The Agency is not requiring 
information on the endocrine effects of these plant-pesticides at this 
time; and Congress allowed 3 years after August 3, 1996, for the Agency 
to implement a screening and testing program with respect to endocrine 
effects.

VI. Conclusion

    There is a reasonable certainty that no harm will result from 
aggregate exposure to the U. S. population, including infants and 
children, to the PAT protein and the genetic material necessary for its 
production. 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 above, no toxicity to 
mammals has been observed for the plant-pesticides. As a result, EPA 
establishes an exemption from tolerance requirements pursuant to FFDCA 
section 408(j)(3) for PAT and the genetic material necessary for its 
production in all plants.
    Phosphinothiricin Acetyltransferase (PAT) and the genetic material 
necessary for its production in all plants are exempt from the 
requirement of a tolerance when used as plant-pesticide inert 
ingredients in all plant raw agricultural commodities. ``Genetic 
material necessary for its production'' means the genetic material 
which comprise (1) genetic material encoding the PAT protein and (2) 
its regulatory regions. ``Regulatory regions'' are the genetic material 
that control the

[[Page 17719]]

expression of the genetic material encoding the PAT protein, such as 
promoters, terminators, and enhancers.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d) as 
was provided in the old section 408 and in section 409. However, the 
period for filing objections is 60 days, rather than 30 days. EPA 
currently has procedural regulations which governs the submission of 
objections and hearing requests. These regulations will require some 
modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law. 0
    Any person may, by June 10, 1997, file written objections to any 
aspect of this 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 under the ``ADDRESSES'' section (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, and a summary of 
any evidence relied upon by the objector (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 a genuine and 
substantial issue of fact; there is a 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). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as CBI. Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2. A copy 
of the information that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential may 
be disclosed publicly by EPA without prior notice.

VIII. Public Docket

    A record has been established for this rulemaking under docket 
control number [OPP-300463]. A public version of this record, which 
does not include any information claimed as CBI, is available for 
inspection from 8:30 a.m. to 4 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. The 
official record for this rulemaking, as well as the public version, as 
described above, is kept in paper form. Accordingly, in the event there 
are objections and hearing requests, 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. The official rulemaking record is the paper 
record maintained at the Virginia address in ADDRESSES at the beginning 
of this document.

IX. Regulatory Assessment Requirements

    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 subject to 
approval under 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 mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, l993), or special considerations as required by Executive 
Order 12898 (59 FR 7629, February 16, l994).
    Because exemptions from the requirement of a tolerance established 
on the basis of a petition under section 408(d) of FFDCA do not require 
issuance of a proposed rule, the regulatory flexibility analysis 
requirements of the Regulatory Flexibility Act (RFA), 5 U.S.C. 604(a), 
do not apply. Prior to the recent amendment of the FFDCA, EPA had 
treated such rulemakings as subject to the RFA; however, the amendments 
to the FFDCA clarify that no proposal is required for such rulemakings 
and hence that the RFA is inapplicable. Nonetheless, the Agency has 
previously assessed whether establishing tolerances or exemptions from 
tolerance, raising tolerance levels, or expanding exemptions adversely 
impact small entities and concluded as a generic matter, that there is 
no adverse impact (46 FR 24950)(May 4, 1981).
    Pursuant to 5 U.S.C. 801(a)(1)(A), 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 25, 1997.

Daniel M. Barolo,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I 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. Section 180.1151 is revised to read as follows:


Sec. 180.1151  Phosphinothricin Acetyltransferase (PAT) and the genetic 
material necessary for its production all plants; exemption from the 
requirement of a tolerance.

    Phosphinothricin Acetyltransferase (PAT) and the genetic material 
necessary for its production in all plants are exempt from the 
requirement of a tolerance when used as plant-pesticide inert 
ingredients in all plant raw agricultural commodities. ``Genetic 
material necessary for its production'' means the genetic material 
which comprise genetic material encoding the PAT protein and its 
regulatory regions. ``Regulatory regions'' are the genetic material 
that control the expression of the genetic material encoding the PAT 
protein, such as promoters, terminators, and enhancers.

[[Page 17720]]

Sec. 180.1175 [Removed]

    3. Section 180.1175 is removed.

[FR Doc. 97-9373 Filed 4-10-97; 8:45 am]
BILLING CODE 6560-50-F


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