FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Cyfluthrin Index Page
Cyfluthrin (Bayer; ex Miles). July 17, 1996. Pesticide Tolerance. Proposed Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/July/Day-17/pr-803DIR/pr-803.html
[Federal Register: July 17, 1996 (Volume 61, Number 138)] [Proposed Rules]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.
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: 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.
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 2512f 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 11.612f the RfD and 0.00662 mg/kg/day, which
represents 26.412f 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 1312f the RfD and 0.007605 mg/kg/day or 30.412f 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]
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) * * *
Citrus, fruits............... 0.2 None
[[Page 37236]]
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.
Commodities Parts per million
(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.
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.
Commodities Parts per million
(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.