[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: [email protected].

[[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: [email protected].

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
                                                                        
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Leafy brassica.............................................         14.0
                                                                        
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[FR Doc. 96-19458 Filed 7-30-96; 8:45 am]
BILLING CODE 6560-50-F