[Federal Register Volume 61, Number 138 (Wednesday, July 17, 1996)]
[Proposed Rules]
[Pages 37233-37236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18183]
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ENVRIONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186
[PP 4F4313 and FAP 4H5687/P670, FRL-5374-1]
RIN 2070-AC18
Cyfluthrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish permanent tolerances for residues of
the pyrethroid cyfluthrin in or on the raw agricultural commodities
(RACs) group citrus, fruits; to withdraw the proposed food/feed
additive petition for citrus oil, dried pulp, and molasses and to
establish a maximum residue limit for cyfluthrin on citrus oil and
dried pulp. Bayer Corporation (formerly Miles, Inc.) submitted
petitions pursuant to the Federal Food, Drug, and Cosmetic Act (FFDCA)
requesting these regulations to establish certain maximum permissible
levels for residues of the insecticide.
DATES: Comments, identified by the docket control number [PP 4F4313 and
FAP 4H5687/P670], must be received on or before August 16, 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 Highway, Arlington, VA 22202.
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 inspection in Rm. 1132 at
the address given above, from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to: [email protected]. 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 WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [PP 4F4313 and FAP 4H5687/P670]. Electronic comments on
this proposed 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: George T. LaRocca, Product
Manager (PM) 13, 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.
200, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202. (703)
305-6100.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Register of July 13, 1994 (59 FR 35717), which announced that
Miles Corp. had submitted pesticide petition PP 4F4313 and food/feed
additive petition (FAP) 4H5687 to EPA. Pesticide petition 4F4313
requests that the Administrator, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), amend
40 CFR 180.436 by establishing tolerances for residues of the
insecticide cyfluthrin, [cyano[4-fluoro-3-phenoxyphenyl]-methyl-3-[2,2-
dicloroethenyl]-2,2-dimethylcyclopropanecarboxylate] in or on the raw
agricultural commodities group citrus, fruits at 0.2 parts per millions
(PPM).
Food/feed additive petition 4H5687 requests that the Administrator,
pursuant to section 409(b) of the FFDCA (21 U.S.C. 348), amend 40 CFR
parts 185 and 186 by establishing food/feed additive regulations for
cyfluthrin in or on the processed food commodity citrus oil at 1.0 ppm,
and the feed commodities citrus dried pulp at 1.0 ppm and citrus
molasses at 0.5 ppm.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
On May 2, 1996, Miles Corp. requested that the proposed food/feed
additive regulation (4H5687) for citrus oil, citrus dried pulp, and
citrus molasses under section 409 of FFDCA be withdrawn and proposed
establishment of a maximum residue level (MRL) for citrus oil and
citrus dried pulp at 0.3 ppm under section 701 of FFDCA. The request to
withdraw the feed additive petition for citrus molasses was submitted
in response to EPA's determination that citrus molasses is no longer
considered a significant feed item. See EPA's final 860 Series Residue
Chemistry Guidelines (860.1000) published as public drafts on August
25, 1995 (60 FR 44343) (formerly Table II of Subdivision O, Residue
Chemistry, of the Pesticide Assessment Guidelines).
The request to withdraw the food/feed additive petition under
section 409 for citrus oil and citrus dried pulp and instead propose to
establish a MRL for citrus oil and citrus dried pulp under section 701
was submitted in response to EPA's policy changes regarding when
pesticide residues concentrate in processed food and whether a
particular processed food is considered ``ready to eat.'' In June 1995
(60 FR 31300, June 14, 1995), EPA issued a revised policy concerning
when section 409 food and feed additive tolerances were needed to
[[Page 37234]]
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/feed. Of particular relevance to the proposed
food/feed additive regulation for citrus oil and dried pulp is EPA's
decision to interpret the term ``ready to eat'' processed food/feed as
food ready for consumption ``as is'' without further preparation. For
foods/feeds 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/feed.
Under the revised policy, EPA has determined that citrus fruit oil
and dried citrus pulp are not ``ready to eat'' food or animal feed
commodities. Citrus oil is not consumed ``as is'' but used as a
flavoring in other foods. Likewise EPA has found no evidence that dried
citrus pulp is fed to livestock as a stand-along feed stock. Rather
dried citrus pulp is used as an ingredient in animal feeds. As such,
dried citrus pulp can constitute up to 25% of animal feed.
The proposed section 408 tolerance for cyfluthrin on citrus is 0.2
ppm. The highest average residue found in crop field trials for
cyfluthrin on citrus fruits was 0.06 ppm. A processing study showed
that in producing citrus oil and dried pulp residues concentrated 530%
(a concentration factor of 5.3x). Thus with this information it is
likely that cyfluthrin residues of 0.32 ppm (0.06 x 5.3) could occur in
citrus oil and dried pulp. However to project what residues are likely
in ``ready to eat'' food or animal feed containing citrus oil and dried
citrus pulp the 0.32 ppm must be divided by 238 for citrus oil and 3
for dried citrus pulp to allow for dilution occurring when citrus oil
and dried citrus pulp is added to other ingredients in the preparation
of food and animal feed respectively. Once these dilutions are taken
into account (0.32 divided by 238) and (0.32 divided by 3) the likely
residues of cyfluthrin in food and animal feed would not be expected to
exceed 0.001 ppm for citrus oil (or < 0.01 ppm which is the limit of
detection of the analytical method) and 0.11 for dried citrus pulp.
Since these levels are below the 408 tolerance level (0.2 ppm) food and
animal feed would not be adulterated and no section 409 tolerances are
needed. However since residues could be present in the not ``ready to
eat'' commodities at levels (0.32 ppm) appreciably higher than the 0.2
ppm RAC tolerance, section 701 MRL's are being proposed. A section 701
MRL represents the highest level of pesticide residue in a not ``ready
to eat'' processed commodity that is consistent with the requirements
in 21 U.S.C. 342(a)(2)(C) that the pesticide be applied in accordance
with the section 408 tolerance and that good manufacturing processes be
used.
EPA will compute the MRL by multiplying the highest average residue
found in the raw commodity in field trials by the concentration factor
determined in processing studies using good manufacturing practices. As
noted above, the highest average residue from the cyfluthrin fields
trials is 0.06 ppm and the concentration factor for processing is 5.3x.
Multiplying 0.06 by 5.3 yields a product of 0.318 ppm. EPA believes it
is appropriate to round 0.318 ppm and proposes 0.3 ppm as MRL for
cyfluthrin residues in citrus oil and dried citrus pulp. For purposes
of enforcement of the MRL, the same analytical method used for
enforcement of the section 408 tolerances should be used.
EPA is proposing to place this MRL in existing parts 185 and 186 of
title 40 of the Code of Federal Regulations (CFR) rather than creating
a new part of title 40. Currently, 40 CFR parts 185 and 186 contain
section 409 food and feed additive tolerances organized by pesticide.
EPA believes it will be clearer to the regulated community and to
enforcement personnel if all regulations pertaining to residue levels
of a pesticide in food and animal feeds are located in the same part of
the CFR. Because EPA is respectively proposing to expand the type of
regulation that would be included in part 185 and 186, EPA proposes
modifying the titles of parts 185 and 186 to ``Pesticides in Food and
Pesticides in Animal Feeds'' to reflect these changes.
The science data submitted in support of the petitions and other
relevant material have been reviewed. The toxicological and metabolism
data considered in support of this tolerance are discussed in detail in
a related document published in the Federal Register of March 15, 1996
(61 FR 10678).
A chronic dietary exposure/risk assessment was performed for
cyfluthrin using a Reference Dose (RfD) of 0.025 mg/kg bwt/day, based
on a No Observed Effect Level (NOEL) of 50 ppm (2.5 mg/kg bwt/day) and
an uncertainty factor of 100. The NOEL was determined in a 2-year rat
feeding study. The endpoint effects of concern were decreased body
weights in males and inflammation of the kidneys in females at the LEL
of 150 ppm (6.2 mg/kg/day). The current estimated dietary exposure for
the U.S. population resulting from established tolerances is 0.002907
mg/kg/bwt day, which represents 11.6% of the RfD and 0.00662 mg/kg/day,
which represents 26.4% of the RfD for children (1-6 years old), the
subgroup population exposed to the highest risk. The current action
will increase exposure to 0.003268 mg/kg/day or 13% of the RfD and
0.007605 mg/kg/day or 30.4% of the RfD respectively. Generally
speaking, EPA has no cause for concern if total residue contribution
for published and proposed tolerances is less than the RfD. EPA
concludes that the chronic dietary risk of cyfluthrin, as estimated by
the dietary risk assessment, does not appear to be of concern.
Because there was a sign of developmental effects seen in animal
studies, the Agency used the rabbit developmental toxicity study (with
a NOEL of 20 mg/kg/day to assess acute dietary exposure and determine a
margin of exposure (MOE) for the overall U.S. population and certain
subgroups. Since the toxicological end-point pertains to developmental
toxicity, the population group of concern for this analysis is women
aged 13 and above, the subgroup which most closely approximates women
of child-bearing age. The MOE is calculated as the ratio of the NOEL to
the exposure. For this analysis, the Agency calculated the MOE for
women ages 13 and above to be 666. Generally speaking, MOE's greater
than 100 for data derived from animal studies are generally not of
concern.
The metabolism of cyfluthrin in plants and livestocks for this use
is adequately understood. The residues of concern is cyfluthrin.
Adequate analytical methodology (Gas liquid chromatography with an
electron capture detector) is available for enforcement purposes. The
enforcement methodology has been submitted to the Food and Drug
Administration for publication in the Pesticide Analytical Manual Vol.
II (PAM II). Because of the long lead time for publication of the
method in PAM II, the analytical methodology is being made available in
the interim to anyone interested in pesticide enforcement when
requested from Calvin Furlow, Public Response and Program Resource
Branch, Field Operations Division (7506C), Office of Pesticide
Programs, U.S. Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 1132,
CM #2, 1921 Jefferson-Davis Hwy., Arlington, VA 22202, (703) 305-5232.
The established tolerances for residues of cyfluthrin in/on eggs,
milk, fat, meat and meat by-products of cattle,
[[Page 37235]]
goats, hogs, horses, sheep and poultry are adequate to cover secondary
residues resulting from the proposed use as delinated in 40 CFR
180.6(a)(2).
There are presently no actions pending against the continued
registration of this chemical.
The pesticide is considered useful for the purpose for which the
tolerances are sought. Based on the information and data considered,
the Agency concludes that the establishment of the proposed tolerances
will protect the public health and proposed MRLs are consistent with 21
U.S.C. 342 (a)(c). Therefore, it is proposed that the tolerances be
established as set forth below.
Any person who has registered or submitted an application for
registration of 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 notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA. Interested persons are invited to submit written comments on
the proposed regulation. Comments must bear a notation indicating the
document control number, [PP 4F4313/FAP 4H5687/P670]. All written
comments filed in response to this petition will be available in the
Public Responses 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 the docket
number [PP 4F4313/FAP 4H5687/P670] (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 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 1B2,
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 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.
The Office of Management and Budget has exempted this document from
the requirement of review pursuant to Executive Order 12866.
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.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review. 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 1993), entitled ``Enhancing the Intergovernmental
Partnership,'' or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 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 certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950). EPA has treated
regulations similar to the establishment of tolerances as also not
having a significant economic impact on substantial number of small
entities. Therefore, the proposed MRL is not expected to have such
impact.
List of Subjects in 40 CFR Parts 180, 185, and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 19, 1996.
Stephen L. Johnson,
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 Sec. 180.436(a), by adding and alphabetically inserting the
following entry in the table therein to read as follows:
Sec. 180.436 Cyfluthrin; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodities Parts per million Expiration date
------------------------------------------------------------------------
* * * * * * *
Citrus, fruits............... 0.2 None
[[Page 37236]]
* * * * * * *
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* * * * *
PART 185--PESTICIDES IN FOOD
2. In part 185:
a. The authority citation for part 185 is revised to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
b. By revising the part heading for part 185 to read as set forth
above.
c. In Sec. 185.1250, by adding paragraph (b) to read as follows:
Sec. 185.1250 Cyfluthrin.
* * * * *
(b)(1) A maximum residue level regulation is established for
residues of the insecticide cyfluthrin, [cyano[4-fluoro-3-
phenoxyphenyl]-methyl-3-[2,2-dicloroethenyl]-2,2-
dimethylcyclopropanecarboxylate] in or on the following food
commodities:
------------------------------------------------------------------------
Commodities Parts per million
------------------------------------------------------------------------
Citrus oil..................................... 0.3
------------------------------------------------------------------------
(2) This regulation reflects the maximum level of residues in
citrus oil consistent with use of cyfluthrin on citrus, fruits in
conformity with Sec. 180.436 of this chapter and with the use of good
manufacturing practices.
* * * * *
PART 186 -- [AMENDED]
3. In part 186:
a. The authority citation for part 186 is revised to read as
follows:
Authority: 21 U.S.C. 342, 348, and 701.
b. In Sec. 186.1250, by adding paragraph (b), to read as follows:
Sec. 186.1250 Cyfluthrin.
* * * * *
(b)(1) A maximum residue level regulation is established for
residues of the insecticide cyfluthrin, [cyano[4-fluoro-3-
phenoxyphenyl]-methyl-3-[2,2-dicloroethenyl]-2,2-
dimethylcyclopropanecarboxylate] in or on the following feed
commodities:
------------------------------------------------------------------------
Commodities Parts per million
------------------------------------------------------------------------
Citrus, dried pulp............................. 0.3
------------------------------------------------------------------------
(2) This regulation reflects the maximum level of residues in
citrus, dried pulp consistent with use of cyfluthrin on citrus, fruits
in conformity with Sec. 180.436 of this chapter and with the use of
good manufacturing practices.
* * * * *
[FR Doc. 96-18183 Filed 7-15-96; 8:45 am]
BILLING CODE 6560-50-F