oxytetracycline Tolerance Actions 6/95
[Federal Register: July 5, 1995 (Volume 60, Number 128)]
40 CFR Part 180
Potassium Oleate, Oxytetracycline, and S-Ethyl Diisobutylthiocarbamate;
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: EPA on its own inititative is revising 40 CFR 180.232,
180.337, and 180.1068 to change some chemical expressions, increase
certain tolerances, revise certain commodity definitions, and delete
certain terms. For each of the pesticides subject to this rule, EPA has
completed the reregistration process and issued a Reregistration
Eligibility Document. These actions are taken as a result of EPA's
reregistration process involving these chemicals.
EFFECTIVE DATE: This regulation becomes effective July 5, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [OPP-300385A], may be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. 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. 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: firstname.lastname@example.org. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number
[OPP-300385A]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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: Ben Chambliss, Special Review
and Reregistration Division (7508W), Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Special Review Branch, Crystal Station #1, 3rd Floor, 2800
Crystal Drive, Arlington, VA 22202, (703)-308-8174; e-mail:
SUPPLEMENTARY INFORMATION: In the Federal Register of April 19, 1995
(60 FR 19556), EPA issued a propose rule in which it stated that for
each of the pesticides subject to the actions listed in the proposed
rule, EPA had completed the reregistration process and issued a
Reregistration Eligibility Document (RED). In the reregistration
process, all continued registrations were reviewed for adequacy and,
when needed, supplemented with new scientific studies. Based on the RED
tolerance assessments for the pesticide chemicals subject to this rule,
EPA is taking the following actions: deleting the term "potassium
oleate" from the tolerance exemption for C12-C18 fatty acid
potassium salts (40 CFR 180.1068); increasing a tolerance for
oxytetracycline on peaches (40 CFR 180.337); and changing the chemical
name of "S-ethyl diisobutylthiocarbamate" (40 CFR 180.232) to the
common name "butylate", deleting certain terms from the section, and
changing commodity definitions in the section.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
The data submitted with the proposal and other relevant material
have been evaluated and discussed in the proposed rule. Based on the
data and information considered, the Agency concludes that the
amendments will protect the public health. Therefore, the amendments
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 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 docket
number [OPP-300385A] (including objections and hearing requests
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 Room 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.
Written objections and hearing requests, identified by the document
control number [OPP-300385A], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
A copy of electronic objections and hearing requests filed with the
Hearing Clerk 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 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 objections and hearing requests 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
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).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: June 27, 1995.
Lois A. Rossi,
Director, Special Review and Reregistration Division, Office of
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.232 is revised to read as follows:
Sec. 180.232 Butylate; tolerances for residues.
Tolerances are established for the herbicide butylate in or on the
raw agricultural commodities corn, field, grain; corn, pop, grain;
corn, sweet (kernels, plus cob with husk removed); corn, field, fodder; corn,
field, forage; corn, pop, forage; and corn, sweet, forage at 0.1 part
3. Section 180.337 is revised to read as follows:
Sec. 180.337 Oxytetracycline; tolerance for residues.
Tolerances are established for residues of the pesticide
oxytetracycline in or on the following raw agricultural commodities:
4. Section 180.1068 is revised to read as follows:
Sec. 180.1068 C12-C18 fatty acid potassium salts; exemption
from the requirement of a tolerance.
C12-C18 fatty acids (saturated and unsaturated) potassium
salts are exempted from the requirement of a tolerance for residues in
or on all raw agricultural commodities when used in accordance with
good agricultural practice.