[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Rules and Regulations]
[Pages 39889-39891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19458]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR PART 180
[PP 4F4291/R2265; FRL-5387-5]
RIN 2070-AB78
Cypermethrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a time limited tolerance for residues of
the insecticide Cypermethrin[()-alpha-cyano-(3
phenoxyphenyl)methyl ()cis,trans-3-(2,2-dichloroethyenyl)-
2,2-dimethylcyclopropane carboxylate] in or on the brassica crop
groups, head and stem brassica at 2.0 parts per million (ppm) and leafy
brassicas at 14.0 ppm. The regulation to establish a maximum
permissible level for residues of the insectide was requested in a
petition submitted by FMC Corp., Agricultural Chemicals Group, 1735
Market St., Philadelphia, PA 19103.
EFFECTIVE DATE: This regulation became effective July 25, 1996.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4291/R2265], may be submitted to:
Hearing Clerk (A-110), Environmental Protection Agency, Rm. M3708, 401
M St., SW., Washington, DC 20460. A copy of any objections and hearing
requests filed with the Hearing Clerk should be identified by the
document control number and submitted 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 copy of objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202. Fees accompanying objections shall be labeled ``Tolerance
Petition Fees'' and forwarded to: EPA Headquarters Accounting
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh,
PA 15251. An electronic copy of objections and hearing requests filed
with the Hearing Clerk may be submitted to OPP by sending electronic
mail(e-mail) to: opp-docket@epamail.epa.gov.
[[Page 39890]]
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 file format
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket number [PP4F4291/R2265]. 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. Additional
information on electronic submissions can be found below in this
document.
FOR FURTHER INFORMATION CONTACT: By mail: George 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.
204, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)
305-6100, e-mail: larocca.george@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice published in the Federal
Register of July 13, 1994 (59 FR 35717), which announced that FMC
Corp., Agricultural Chemicals Group, 1735 Market St., Philadelphia, PA
19103, had submitted pesticide petition (PP) 4F4291 to EPA requesting
that the Administrator, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish tolerances
for the residues of the insecticide cypermethrin [()alpha-
cyano-(3-phenoxyphenyl) methyl()cis,trans-3-(2,2-
dichloroethenenyl)-2,2 dimethylcyclopropanecarboxylate], in or on the
brassica crop groups, head and stem brassicas at 2.0 parts per million
(ppm) and leafy brassicas at 14.0 ppm.
No comments were received in response to the notice of filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicological data considered in support of
tolerance for cypermethrin (PP 4F3011) are discussed in detail in the
Federal Register publication of October 20, 1993 (58 FR 54092).
A chronic dietary exposure analysis was performed using a Reference
Dose (RfD) of 0.01 mg/kg body weight/day based on a no-observed-effect-
level (NOEL) of 1.0 mg/kg body weight/day from an oral dosing study in
dogs and a 100-fold uncertainty factor. The endpoint of concern in this
study was gastrointestinal tract disturbance. Using tolerance level
residues and 100% crop treatment information, the Theoretical Maximum
Residue Contribution (TMRC) from established tolerances and the current
action is estimated at 3.7 x 10-3 mg/kg body weight/day and
utilizes 37% of the RfD for the US population. The TMRC for non-
hispanic others, the subgroup population most highly exposed, is
estimated at 7.2 x 10-3 mg/kg body weight/day and utilizes 72% of
the RfD. In general, EPA has no cause for concern if total chronic
dietary exposure for established and new tolerances is less than the
RfD.
The nature of cypermethrin residue in plants and animals for this
use is adequately understood. Since the available field residue studies
indicate that there will be low to non-detectable levels of the
metabolite DCVA (3-(2,2-dichloroethyenyl)-2,2 dimethyl-cyclopropane
carboxylic acid) in the terminal residues of some crops and the
toxicity of this metabolite is comparable to the parent compound, the
Agency has concluded that the tolerance expression regulate only the
parent compound cypermethrin and not the metabolite. This determination
is consistent with the International Codex Maximum Residue Limits for
cypermethrin, which includes only the parent compound and will
facilitate enforcement of the tolerance since the current FDA
Multiresidue Methods I and II can detect the parent compound but not
the metabolite. However, since there is a potential for low levels of
this metabolite in some crops, new crop field trials will be required
to include analyses for residues of the parent compound cypermethrin
and metabolite DCVA. The dietary risk assesment will be based on
residues of cypermethrin plus metabolite DCVA for crops with
quantifiable residues of the metabolite DCVA.
There is no reasonable expectation of secondary residues in animal
tissues and milk from this use, since no animal feed items are
associated with the brassica crop group. An adequate analytical method,
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 and is published in
the Pesticide Analytical Manual Vol. II (PAM II).
There currently exists a separate tolerance in 40 CFR 180.418 for
cypermethrin on cabbage at 2.0 ppm. Since the current action is
establishing tolerances on the brassica crop group which includes
cabbage under the head and stem subgroup, the seperate cabbage
tolerance is being deleted.
The Agency issued a conditional registration for cypermethrin for
use on cotton with an expiration date of December 1, 1988 (see the
Federal Register of June 15, 1984 (49 FR 24684), January 9, 1985 (50 FR
1112), and September 27, 1985 (50 FR 39100)). This conditional
registration was subsequently amended to include pecans, lettuce,
cabbage and onions and extended to November 15, 1996. The conditional
registration was amended and extended to allow time for submission and
evaluation of additional environmental effects data. Due to the
conditional status of the registration, tolerances have been
established for cypermethrin on a temporary basis (until November 15,
1997) on cottonseed, pecans, lettuce, cabbage, onions, meat, fat and
meat byproducts of hogs, horses, cattle, goats, sheep and milk to cover
residues expected to be present from use during the period of
conditional registration. To be consistent with the current conditional
registration status for cypermethrin, the Agency is establishing
tolerances for the brassica crop groups with an expiration date of
November 15, 1997, to cover residues expected to be present during the
period of conditional registration.
Residues remaining in or on the above commodities after expiration
of these tolerances will not be considered actionable if the pesticide
is legally applied during the term of and in accordance with provisions
of the conditional registration.
There are presently no actions pending against the continued
registration of this chemical.
This pesticide is considered useful for the purposes for which the
tolerance is sought. Based on the information and data considered, the
Agency has determined that the tolerances established by amending 40
CFR part 180 will protect the public health. Therefore, these
tolerances are established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, 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
[[Page 39891]]
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 a 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).
A record has been established for this rulemaking under the docket
number [PP4F4291/R2265] (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
4:30 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 (7505C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
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.
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.
Pursuant to the requirements of the Regulatory Flexibility Act,
under section 801(a) (1) (A) of the Administrative Procedure Act (APA)
as amended by the Small Business Regulatory Enforcement Fairness Act of
1996, (Pub. L. 104-121, 110 Stat. 847), EPA submitted 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
General Accounting Office prior to publication of the rule in today's
Federal Register. This rule is not a ``major rule'' as defined by
section 804(2) of the APA as amended (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 statement explaining the
factual basis for this certification was published in the Federal
Register of May 4, 1981 (46 FR 24950).
In addition, this action does not impose any enforceable duty, or
contain any ``unfunded mandates'' as described in Title II of the
Unfunded Reform Act of 1995 (Pub. L. 104-4), or require prior
consultation as specified by Executive Order 12875 (58 FR 58093,
October 28,1993), entitled Enhancing the Intergovernmental Partnership,
or special considerations as required by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 25, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By amending Sec. 180.418 in the table therein, by removing the
entry for cabbage and by adding and alphabetically inserting the
following raw agricultural commodities to read as follows:
Sec. 180.418 Cypermethrin; tolerances for residues.
* * * * *
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Parts per
Commodities million
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Brassica head and stem..................................... 2.0
* * * * *
Leafy brassica............................................. 14.0
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[FR Doc. 96-19458 Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F
