[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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[[Page 18327]]
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