[Federal Register Volume 61, Number 116 (Friday, June 14, 1996)]
[Proposed Rules]
[Pages 30204-30207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15200]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP5F4545, FAP6H5737/P663; FRL-5375-5]
Quizalofop-P Ethyl Ester; Pesticide Tolerance and Maximum Residue
Level
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a tolerance for the residues of the
herbicide quizalofop (2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy])-
propanoic acid], and quizalofop ethyl [ethyl-(2-[4-(6-chloroquinoxalin-
2-yl) oxy)phenoxy)propanoate), all expressed as quizalofop ethyl in or
on the raw agricultural commodity canola seed at 1.0 part per million
(ppm) and to establish a maximum residue limit for quizalofop ethyl on
canola meal at 1.5 ppm. E.I. DuPont de Nemours Company submitted
petitions pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA)
requesting these regulations to establish certain maximum permissible
residue levels for residues of the herbicide.
DATES: Comments, identified by the docket control number [PP PP5F4545,
FAP6H5737/P663], must be received on or before July 15, 1996.
ADDRESSES: By mail, submit written comments 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 comments to Rm. 1132, CM #2,
1921 Jefferson-Davis Hwy., Arlington, VA 22202. Comments and data may
also be submitted to OPP by sending electronic mail (e-mail) to: docket@epamail.epa.gov. Electronic comments must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. Comments and data will also be accepted on disks in Word
Perfect 5.1 file format or ASCII file format. All comments and data in
electronic form must be identified by the docket number [PP 5F4545, FAP
6H5737/P663]. Electronic comments on this proposed rule may be filed
online at many Federal Depository Libraries. Additional information on
electronic submissions can be found in the ``SUPPLEMENTARY
INFORMATION'' section of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). Information so marked will
not be disclosed except in accordance with procedures set forth in 40
CFR part 2. A copy of the comment 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. All
written comments will be available for public notice. All written
comments will be available for public inspection in Rm. 1132 at the
Virginia address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager (PM-25), Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location, telephone number, and e-mail address: Rm.
241, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-
6027; e-mail: taylor.robert@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued notices published in the Federal
Register of February 1, 1996 (61 FR 3696) (FRL-4994-3), which announced
that E.I. Du Pont de Nemours Company, Agricultural Products, Walkers
Mill, Barley Mill Plaza, P.O. Box 80038, Wilmington, DE 19880-0038, had
submitted pesticide petition (PP) 5F4545 to EPA proposing to amend 40
CFR 180.441 by establishing tolerances for residues of the herbicide
quizalof [2-4-(6-chloroquinoxalin-2-yl)oxylphenoxy)propanic acid] and
quizalofop ethyl(ethyl-2-[4,(6-chloroxyunoxalin-2-
yl)oxy)phenoxy]propanonate), all expressed as quizalofop ethyl in or on
foliage of legume vegetables (except soybean) at 3.0 ppm and on canola
seed at 2.0 ppm. DuPont also submitted a
[[Page 30205]]
feed/food additive petition (FAP) 6F5737 proposing to amend 40 CFR
185.5250 by establishing tolerances for the combined residues of the
herbicide quizalof [2-[4-(6-chloroquinoxalin-2-yl)oxylphenyl)propanic
acide] and quizalofopethyl(ethyl-2-[4,(6chloroxyunoxalin-2-
yl)oxy)phenoxy]propanonate), all expressed as quizalofop ethyl in or on
the food commodities canola, meal at 3.0 ppm and canola, oil at 0.1 ppm
and to amend 40 CFR 186.5250 by establishing tolerances for the
combined residues of the herbicide quizalof [2-[4-(6-chloroquinoxalin-
2-yl)oxylphenyl)propanic acide] and quizalofop ethyl(ethyl-2-[4,(6-
choroxyunoxalin-2-yl)oxy)phenoxy]propanonate), all expressed as
quizalofop ethyl in or on the feed commodity canola, meal at 3.0 ppm.
There were no comments or requests for referral to an advisory
committee received in response to these notices of filing.
During the course of the review of the PP 5F4545, the Agency
determined that the filing notice had several errors in the chemical
name, that the proposed listing for foliage of legume vegetables
(except soybeans) was not necessary since it duplicated a listing under
PP 3F4268 (final rule published elsewhere in today's Federal Register)
and should be deleted from PP 5F4545. The Agency also determined that
the proposed tolerance for canola, seed at 2.0 was higher than
necessary. The petitioner subsequently submitted a revised section F
deleting the listing for foliage of legume vegetables, and proposing
the establishment of a tolerance for the combined residues of the
herbicide quizalofop ethyl 2-[4-(6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoic acid), and quizalofop ethyl (ethyl-2-[4-(6-
chloroquinoxalin-2-yl)oxy)phenoxy] propanoate, all expressed as
quizalofop ethyl in on the raw agricultural commodity canola, seed at
1.0 ppm.
During the course of the review of FAP 6H5767, the Agency noted
that there were several errors in the filing notice, including the
designation of the petition number, the filing notice should have read
6H5737 instead of 6F5737. The Agency also determined that food additive
tolerances were not necessary for canola, oil or canola, meal and that
a section 701 maximum residue level (MRL) instead of a section 409 feed
additive tolerance was needed for canola meal. The petitioner
subsequently submitted a revised section F proposing the establishment
of a maximum residue limit (MRL) for the combined residues of the
herbicide quizalofop ethyl 2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)
propanoic acid), and quizalofop ethyl (ethyl-2-[6-chloroquinoxalin-2-
yl)oxy)phenoxy]propanoate, all expressed as quizalofop ethyl in or on
canola meal at 1.5 ppm.
In the Federal Register of June 14, 1995 (60 FR 31300) (FRL-4944-
2), EPA issued a revised policy concerning when section 409 food and
feed additive tolerances were needed to prevent the adulteration of
foods and animal feeds. Under EPA's revised policy, a section 409
tolerance is necessary for pesticide residues in processed food when it
is likely that the level of some residues of the pesticide will exceed
the section 408 tolerance level in ``ready to eat'' processed food. Of
particular relevance to the quizalofop ethyl feed additive tolerance is
EPA`s decision to interpret the term ``ready to eat'' processed food as
food ready for consumption ``as is'' without further preparation. For
foods that are found to be not ``ready to eat,'' EPA takes into account
the dilution of residues that occurs in preparing a ``ready to eat''
food.
EPA has determined that canola meal is not a ``ready to eat''
animal feed. EPA has found no evidence that canola meal is feed to
livestock as a stand-alone feedstock. Rather, canola meal is used as an
ingredient in animal feeds. The section 408 tolerance for quizalofop
ethyl on canola seed is 1.0 ppm. The highest average field trial (HAFT)
residue found in canola was 0.65 ppm. A processing study showed that
the concentration factor for canola meal was 2.3X. Thus, given this
information, it is likely that quizalofop ethyl residues of 1.5 ppm
(0.65 x 2.3) could occur in canola meal. However, to project what
residues are likely in ``ready to eat'' animal feed containing canola
meal the 1.5 ppm level must be divided by 4 to allow for dilution
occurring when canola meal is added to other feedstuffs. Once this
dilution is taken into account, the maximum residue level of quizalofop
ethyl in animal feed would be 0.375 (1.5 ppm/4=0.375 ppm). Since this
is below the section 408 tolerance level, animal feed containing such
residue levels would not be adulterated, and no section 409 feed
additive tolerance is needed.
To aid in the efficient enforcement of the Act, EPA is proposing to
establish a maximum residue limit (MRL) for quizalofop ethyl residues
in canola meal. The MRL will reflect the maximum residue of quizalofop
ethyl in processed foods consistent with a legal level of such residues
being present in canola and the use of good manufacturing practices.
See 21 U.S.C. 542(a)(2)(c) and rules published December 6, 1995 (60 FR
62366) (FRL-4971-7), and February 29, 1996 (61 FR 7734) (FRL-4996-2),
regarding imidacloprid. Processed food not in compliance with an
applicable MRL will be deemed adulterated under section 402. Taking
into account the degree to which quizalofop ethyl may concentrate
during processing using good manufacturing processes (2.3) and the
level of residues expected in canola (0.65 ppm), EPA proposes a MRL of
1.5 ppm for canola meal. For purposes of enforcement of the MRL, the
same analytical method used for enforcement of the section 408
regulations, should be used.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data submitted in support of these
petitions is discussed under a final rule regarding PP 3F4268 and FAP
5H5720, published elsewhere in today's issue of the Federal Register.
Based on the NOEL of 0.9 mg/kg/bwt/day in the 2-year rat feeding
study, and using a hundredfold uncertainty factor, the reference dose
(RfD) for quazalofop ethyl is calculated to be 0.009 mg/kg/bwt/day. The
theoretical maximum residue contribution (TMRC) is 0.000478 mg/kg/bwt/
day for existing tolerances for the overall U.S. population. The
current action will increase the TMRC by less than 0.000077 mg/kg/bwt/
day. These tolerances and previously established tolerances utilize a
total of 6.8 % of the RfD for the overall U.S. populations, with all
exposure coming from published uses. For U.S. subgroup populations,
non-nursing infants and children aged 1 to 6 years, the current action
and previously established tolerances utilize, respectively a total of
18.842 percent and 11.98 percent of the RfD, with all exposure coming
from previously established tolerances, assuming that residue levels
are at the established tolerances and that 100 percent of the crop is
tested.
There are no desirable data lacking for this petition.
The nature of the residue in plant and livestock is adequately
understood. An adequate amount of geographically representative crop
field trial residue data were presented which show that the proposed
tolerances should not be exceeded when quizalofop ethyl is formulated
into ASSURE and used as directed. An adequate analytical methodology
(high-pressure liquid chromatography using either ultraviolet or
fluorescence detection) is available for enforcement purposes in Vol.
II of
[[Page 30206]]
the Food and Drug Administration Pesticide Analytical Method (PAM II,
Method I). There are currently no actions pending against the
registration of this chemical. Any secondary residues expected to occur
in eggs, milk, meat, fat, and meat byproducts of cattle, goats, hogs,
horses, sheep, and poultry from this use will be covered by existing
tolerances.
Based on the information cited above, the Agency has determined
that when used in accordance with good agricultural practice, this
ingredient is useful and that the tolerance established by amending 40
CFR part 180 will protect the public health, and the establishment of
the maximum residue level by amending 40 CFR part 186 is consistent
with residue levels permissible in processed foods under 21 U.S.C.
342(a)(2)(C). It is proposed, therefore, that the tolerances be
established as set forth below.
Any person who has registered or submitted an application for
registration a pesticide, under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this document in the Federal Register that this rulemaking proposal
be referred to an Advisory Committee in accordance with section 408 (e)
of the Federal Food, Drug, and Cosmetic Act.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number [PP 5F4545, FAP 6H5720/P663]. All written
comments filed in response to this petition will be available in the
Public Response and Program Resources Branch, at the address given
above from 8 a.m. to 4:30 p.m., Monday through Friday, except legal
holidays.
A record has been established for this rulemaking under docket
number [PP 5F4545, FAP 6H5737/P663](including comments and data
submitted electronically as described below). 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 Rm. 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 can 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 public version,
as described above will be kept in paper form. Accordingly, EPA will
transfer all comments received electronically into printed paper form
as they are received and will place the paper copies in the final
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), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to all the requirements of the Executive Order
(i.e., Regulatory Impact Analysis, review by the Office of Management
and Budget (OMB)). Under section 3(f), the order defines
``significant'' as those actions likely to lead to a rule (1) Having an
annual effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities (also known as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President`s
priorities, or the principles set forth in this Executive Order.
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 a
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 26, 1994).
Pursuant to the terms of this Executive Order, EPA has determined
that this proposed rule is not ``significant'' and therefore not
subject to OMB review.
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 food additive regulations or raising
tolerance levels or food additive regulations or establishing
exemptions from tolerance requirements do not have a significant
economic impact on a substantial number of small entities. A
certification statement containing the factual basis for this
conclusion was published in the Federal Register of May 4, 1981 (46 FR
24950). Because MRLs function similarly to tolerances and food additive
regulations, the establishment of a MRL also does not have a
significant effect on a small number of small entities.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
List of Subjects in 40 CFR Part 186
Environmental protection, Animal feeds, Pesticides and pests.
Dated: May 26, 1996.
James Tompkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180 [AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
b. In 180.441, by revising paragraph (a) to read as follows:
Sec. 180.441 Quizalofop ethyl; tolerances for residues.
(a) Tolerances are established for the combined residues of the
herbicide quizalofop 2-[4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)propanic
acid], and quizalofop ethyl (ethyl 2-(4-((6-chloroquinoxalin-2-
yl)oxy)phenoxy)propanoate, all expressed as quizalofop ethyl, in or on
the raw agricultural commodities:
------------------------------------------------------------------------
Commodities Part per million
------------------------------------------------------------------------
soybeans.................................. 0.05
canola, seed............................. 1.0
------------------------------------------------------------------------
* * * * *
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
[[Page 30207]]
b. In 186.5250, by adding paragraph (c) to read as follows:
Sec. 186.5250 Quizalofop ethyl.
* * * * *
(c) A maximum residue level regulation is established permitting
residues of quizalofop (2-(4-(6-chloroquinoxalin-2-yl)oxy)phenoxy)
propanoic acid) and quizalofop ethyl (ethyl 2-[4-(6-chloroquinoxalin-2-
yl)oxy)phenoxy)-12-propanoate, in or on the following feed resulting
from application of the herbicide to canola.
------------------------------------------------------------------------
Feed Parts per million
------------------------------------------------------------------------
canola, meal.............................. 1.5
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This regulation reflects the maximum level of residues in canola meal
consistent with the use of quizalofop ethyl on canola in conformity
with 180.441 of this chapter and with the use of good manufacturing
practices.
[FR Doc. 96-15200 Filed 6-13-96; 8:45 am]
BILLING CODE 6560-50-F
