[Federal Register Volume 63, Number 72 (Wednesday, April 15, 1998)]
[Rules and Regulations]
[Pages 18326-18329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10013]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300623; FRL-5773-9]
2070-AB78


Canola Oil; Exemption from the 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 canola oil, i.e., low erucic acid rapeseed 
oil (containing no more than 2% erucic acid), when used as an 
insecticide in or on all food commodities. W. Neudorff GmbH KG 
submitted a petition to the EPA under the Federal Food, Drug and 
Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act 
(FQPA) of 1996 requesting the exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of this insecticide in or on all food 
commodities.
EFFECTIVE DATE: This regulation is effective April 15, 1998. Objections 
and requests for hearings must be received on or before June 15, 1998.
ADDRESSES:  Written objections and hearing requests, identified by the 
docket control number [OPP-300623], 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 [OPP-300623] and submitted to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division (7502C), 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. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
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 will also be accepted on 
disks in WordPerfect 5.1 or 6.1 file format or ASCII file format. All 
copies of electronic objections and hearing requests must be identified 
by the docket control number [OPP-300623]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Copies of 
electronic objections and hearing requests on this rule may be filed 
online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Susanne Cerrelli, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511W), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460, Office location and telephone 
number and e-mail address: CS1 Rm. 5-W31, 2800 Crystal Drive, 
Arlington, VA, 703-308-8077, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: W. Neudorff GmbH KG, c/o Walter G. Telarek, 
PC, 1008 Riva Ridge Drive, Great Falls, VA, has requested in pesticide 
petition PP 7F4804 the establishment of an exemption from the 
requirement of a tolerance for residues of canola oil. A notice of 
filing (FRL-5597-6) was published in the Federal Register (62 FR 17812) 
on April 11, 1997, and the notice announced that the comment period 
would end on May 11, 1997; no comments were received. This exemption 
from the requirement of a tolerance will permit the marketing of raw 
agricultural commodities when treated in accordance with EPA Reg No. 
67702-U, which is being issued under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), as amended (Pub. L. 95-396, 92 
Stat. 819; 7 U.S.C. 136). The data submitted in the petition and all 
other relevant material have been evaluated. The following is a summary 
of EPA's findings regarding this petition.

I. Product Identity

    NEU 1160 Vegetable Oil Insecticide (EPA file symbol No. 067702-U) 
is the first pesticide product containing low erucic acid rapeseed oil 
as the active ingredient. The rapeseed oil in this product contains 
less than 2% erucic acid and conforms with 21 CFR 184.1555(c). Canola 
oil is the common name of this active ingredient. Canola oil is the 
full refined edible oil obtained from certain varieties of plants, i.e. 
Brassica campetris, or B. napus, of the family Cruciferae.

II. Risk Assessment and Statutory Findings

    New section 408(c)(2)(a)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(ii) 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. Section 408(c)(2)(b) requires 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***.'' 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 
scientific data and other relevant information in support of this 
action and considered its validity, completeness, reliability, and 
relationship 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. 
Data waivers were requested for acute oral, dermal, inhalation, and eye 
toxicity, dermal sensitization, genotoxicity, reproductive and 
developmental toxicity, subchronic (90-day) oral and inhalation 
toxicity, and teratogenicity. The waivers were accepted based on the 
long history of use of canola as an edible fat and oil in food without 
any indication of deleterious effects; its low toxicity; its natural 
occurrence as an oil extracted from plants; its low erucic acid (less 
than 2%) content; its conformity with 21 CFR 184.1555(c); and its 
classification by FDA as ``generally recognized as safe'' (GRAS) for 
use as an edible fat or oil in human food. Available toxicity data on 
vegetable oils from the open literature and the Reregistration 
Eligibility Decision document for Flower and Vegetable Oils (EPA 738-R-
93-031) support this finding.

 IV. Residue Chemistry

    A waiver was requested and granted for the following residue data 
requirements: (1) Magnitude of residue anticipated at the time of 
harvest, and (2) method used to determine the residue. These are waived 
based on the rationale presented in Unit III of this preamble.

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V. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures. The primary 
non-food sources of exposure the Agency considers include drinking 
water or groundwater, and exposure through pesticide use in gardens, 
lawns, or buildings (residential and other indoor uses).
     Dietary exposure of canola oil via food consumption exists due to 
its use as a fat and oil in food. Residues from use of the biochemical 
pesticide, canola oil, are expected to increase the current dietary 
exposures only minimally because the application rates for canola are 
very low. In addition, because the current uses of low erucic acid 
canola oil have low toxicity, the Agency has determined that the 
aggregate dietary risk from adding the pesticidal uses of canola would 
be minimal.
     Exposure by the inhalation route would be negligible because 
canola oil has low volatility, and the maximum concentration applied to 
plants is 2% canola oil. In summary, the potential aggregate exposure, 
derived from non-dietary and non-occupational exposure, should be 
minimal.

 VI. Cumulative Effects

     Canola oil shares a common dietary metabolic disposition with 
other edible fats and oils. Canola oil and other cooking grade oils 
have been used for many years without reported toxicity. These fats and 
oils are not known to cause any direct toxic effects when part of a 
balanced diet.

VII. Endocrine Disruptors

    The Agency has no information to suggest that canola oil has any 
effect on the immune and endocrine systems. The Agency is not requiring 
information on the endocrine effects of this biochemical pesticide at 
this time; Congress has allowed 3 years after August 3, 1996, for the 
Agency to implement a screening program with respect to endocrine 
effects. Nevertheless, the above discussion on exposure from all 
sources combined with the low toxicity of canola oil would indicate 
such testing would not be necessary.

VIII. Safety Determination for U.S. Population, Infants and 
Children

    Based on the information discussed in Unit V of this preamble, EPA 
concludes that there is reasonable certainty that no harm will result 
from aggregate exposure to the U.S. population, including infants and 
children, to residues of canola oil. 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 in Unit III of this preamble, the toxicity of canola oil to 
mammals is very low and under reasonably foreseeable circumstances it 
does not pose a risk. FFDCA section 408 provides that EPA shall apply 
an additional ten-fold 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. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, the 
Agency believes there is reliable data to support the conclusion that 
canola oil is practically non-toxic to mammals, including infants and 
children, and, thus, there are no threshold effects; therefore, EPA has 
not used a margin of exposure (safety) approach to assess the safety of 
canola oil. As a result, the provision requiring an additional margin 
of exposure (safety) does not apply.

IX. Other Considerations

    1. Analytical method. The Agency proposes to establish an exemption 
from the requirement of a tolerance without any numerical limitation; 
therefore, an analytical method is not required for enforcement 
purposes for canola oil residues.
    2. Codex maximum residue level. There are no CODEX tolerances nor 
international tolerance exemptions established for canola oil at this 
time.

X. Conclusion

    Based on the information discussed above, EPA establishes an 
exemption from the requirement of a tolerance for Canola oil (low 
erucic acid rapeseed oil containing no more than 2% erucic acid). This 
exemption from the requirement of a tolerance will be revoked if any 
experience with or scientific data on this pesticide indicate that the 
tolerance is not safe.

XI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance exemption regulation issued by 
EPA under new section 408(e) as was provided in the old section 408. 
However, the period for filing objections is 60 days, rather than 30 
days. EPA currently has procedural regulations which govern 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.
    Any person adversely affected by this regulation may, by June 15, 
1998, 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, 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 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). 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.

XII. Public Docket and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300623] (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

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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 119 of the Public Information and Records Integrity 
Branch, Information Resources and Services Division (7502C), 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 
Virginia address in ``ADDRESSES'' at the beginning of this document.

XIII. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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). 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., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any 
prior consultation as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993), or special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629), February 16, 
1994), or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerance exemptions that are established on the 
basis of a petition under FFDCA section 408(d), 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. Nevertheless, the Agency previously assessed 
whether establishing tolerances, exemptions from tolerances, raising 
tolerance levels or expanding exemptions might adversely impact small 
entities and concluded, as a generic matter, that there is no adverse 
economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950) was provided to the Chief Counsel for Advocacy of the Small 
Business.

XIV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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 the rule in the 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: April 3, 1998.

Marcia E. Mulkey,

Director, Office of Pesticide Programs.

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 180.1194 is added to read as follows:


Sec. 180.1194   Canola oil; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical pesticide, canola oil, conforming to the 
following definition when used as an insecticide, in or on all food 
commodities: Canola oil, also known as low erucic rapeseed oil, is the 
fully refined, bleached, and deodorized edible oil obtained from 
certain varieties of Brassica Napus or B. Campestris of the family 
Cruciferae. Canola oil contains no more than 2 percent erucic acid.

[FR Doc. 98-10013 Filed 4-14-98; 8:45 am]
BILLING CODE 6560-50-F