oxytetracycline Proposed Tolerance 4/95
Date: Wed, 19 Apr 1995 08:45:43 -0400
To: Multiple recipients of list <firstname.lastname@example.org>
Subject: Potassium Oleate, Oxytetracycline, and S-ethyl
X-Comment: U.S. EPA FEDERAL REGISTER PESTICIDE documents
[Federal Register: April 19, 1995]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Potassium Oleate, Oxytetracycline, and S-ethyl
diisobutylthiocarbamate; Proposed Tolerance Actions
AGENCY: Environmental Protection Agency (EPA or ``the Agency'')
ACTION: Proposed rule.
SUMMARY: For each of the pesticides subject to the actions listed in
this proposed rule, EPA has completed the reregistration process and
issued a Reregistration Eligibility Document (RED). In the
reregistration process, all information to support a pesticide's
continued registration is reviewed for adequacy and, when needed,
supplemented with new scientific studies. Based on the RED tolerance
assessments for the pesticide chemicals subject to this proposed rule,
EPA is proposing the following actions: to delete the term potassium
oleate from the tolerance exemption for ``potassium oleate and related
C<INF>12-C<INF>18 fatty acid potassium salts,'' to increase the
tolerance for oxytetracycline on peaches, and for the tolerance ``S-
ethyl diisobutylthiocarbamate,'' to change the chemical name to the
common name ``butylate'', to delete certain terms, and to change
commodity definitions to accord with Table II of Subdivision O.
DATES: Written comments, identified by the OPP document control number
, must be received on or before May 19, 1995.
ADDRESSES: By mail, submit comments to: Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person,
deliver comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
FOR FURTHER INFORMATION CONTACT: By mail: Special Review and
Reregistration Division (7508W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location: Special Review Branch,
Crystal Station #1, 3rd floor, 2800 Crystal Drive, Arlington, VA 22202.
The contacts for the specific chemicals are: Ben Chambliss
(oxytetracycline), (703) 308-8174, David Chen (potassium oleate), (703)
308-8017, Paul Parsons (butylate), (703) 308-8037.
I. Legal Authorization
The Federal Food, Drug, and Cosmetic Act (FFDCA) [21 U.S.C. 301 et
seq.] authorizes the establishment of tolerances (maximum legal residue
levels) and exemptions from the [[Page 19557]] requirement of a
tolerance for residues of pesticide chemicals in or on raw agricultural
commodities pursuant to section 408 [21 U.S.C. 346(a)]. Without such
tolerances or exemptions, a food containing pesticide residues is
considered to be ``adulterated'' under section 402 of the FFDCA, and
hence may not legally be moved in interstate commerce [21 U.S.C. 342].
To establish a tolerance or an exemption under section 408 of the
FFDCA, EPA must make a finding that the promulgation of the rule would
``protect the public health'' [21 U.S.C. 346a(b)]. For a pesticide to
be sold and distributed the pesticide must not only have appropriate
tolerances under the FFDCA, but also must be registered under the
Federal Insecticide, Fungicide, and Rodenticide Act [FIFRA, 7 U.S.C.
136 et seq.].
In 1988, Congress amended FIFRA and required EPA to review and
reassess the potential hazards arising from currently registered uses
of pesticides registered prior to November 1, 1984. As part of this
process, the Agency must determine whether a pesticide is eligible for
reregistration and if any subsequent actions are required to fully
attain reregistration status. EPA has chosen to include in the
reregistration process a reassessment of existing tolerances or
exemptions from the need for a tolerance. Through this reassessment
process, EPA can determine whether a tolerance must be amended,
revoked, or established, or whether an exemption from the requirement
of one or more tolerances must be amended or is necessary.
The procedure for establishing, amending, or repealing tolerances
or exemptions from the requirement of tolerances is set forth in the
Code of Federal Regulations 40 CFR parts 177 through 180. Pursuant to
40 CFR 180.32, EPA is proposing the amendment of the following
tolerances. The Administrator of EPA or any person may initiate an
action proposing to establish, amend, revoke, or exempt a tolerance for
a pesticide registered for food uses. The proposal must explain the
grounds for such a proposed action and will be published as a public
notice. Each petition or request for a new tolerance, an amendment to
an existing tolerance, or a new exemption from the requirement of a
tolerance must be accompanied by a fee. Current Agency policy on
tolerance actions identified during the reregistration process is to
waive the payment of fees if the tolerance action concerns revision or
revocation of an established tolerance, or if the proposed exemption
from the requirement of a tolerance requires the concurrent revocation
of an approved tolerance. Comments submitted in response to the
Agency's published proposals are reviewed; the Agency then publishes
its final determination regarding the specific tolerance actions.
II. Chemical-Specific Information and Proposed Actions
A. Potassium Oleate: Deletion of Term
1. Regulatory background. Prior to March 1989, the Agency
classified potassium salts of fatty acids [C<INF>12-C<INF>18 saturated
and unsaturated fatty acids], potassium laureate, potassium myristate,
potassium oleate, and potassium ricinoleate as separate active
ingredients. In March 1989, the Agency decided to treat all potassium
salts of fatty acids, and all combinations of these chemicals, as a
single active ingredient because these active ingredients tend to exist
as mixtures in pesticide products. In May 1992, EPA revisited its March
1989 decision. EPA concluded that for registration purposes only
potassium salts of C<INF>12-C<INF>18, saturated and unsaturated fatty
acids, would be treated as a single active ingredient and that any
other chain length (either shorter or longer) should be considered to
be a different active ingredient.
Because of the generally low toxicity of potassium salts and the
acceptability of naturally occurring fatty acids in food, in 1982 EPA
determined that a tolerance is not needed to protect the public health
and established an exemption from the requirement of a tolerance for
potassium oleate and related salts of fatty acids (47 FR 1379).
2. Proposed action. Currently, under 40 CFR 180.1068, EPA has
established exemptions from the requirement of tolerances for potassium
oleate and related C<INF>12-C<INF>18 fatty acids of potassium salts for
residues in or on all raw agricultural commodities. Because EPA now
treats all C<INF>12-C<INF>18 fatty acids of potassium salts as a single
active ingredient, and potassium oleate is a C<INF>18-fatty acid, a
separate term for potassium oleate is no longer needed. Therefore, EPA
proposes that the term potassium oleate be deleted from 40 CFR
B. Oxytetracycline: Amendment of the Tolerance on Peaches
1. Regulatory background. Tolerances of 0.35 and 0.1 ppm currently
exist for the bactericide/fungicide oxytetracycline in or on pears and
peaches, respectively, from foliar treatment or injection (40 CFR
180.337), The Agency's 1988 Registration Standard for oxytetracycline
concluded that EPA had adequate data to support registered uses on
pears and peaches, including nectarines. However, an evaluation of
available data indicate that residue uptake in peaches could exceed the
existing 0.1 ppm tolerance level but would be less than 0.35 ppm.
Therefore, EPA is proposing that the oxytetracycline tolerance for
peaches be increased from 0.1 ppm to 0.35 ppm.
To determine whether a 0.35 ppm tolerance level is protective of
the public health, EPA considered the following information:
a. A 2-year chronic feeding study in Osborne-Mendel rats with a No
Observed Effect Level (NOEL) of 3,000 ppm, approximately 150 milligrams
(mg)/kilogram (kg)/day (highest dose tested).
b. A 2-year chronic feeding study in Sprague-Dawley rats with a
NOEL of 1,000 ppm, approximately 50 mg/kg/day (highest dose tested).
c. A 2-year chronic feeding study in dogs with a NOEL of 10,000
ppm, approximately 250 mg/kg/day (highest dose tested).
d. A mouse developmental toxicity study with a NOEL for maternal
and developmental toxicity at 2,100 mg/kg (highest dose tested).
e. A dog study, undertaken to evaluate antimicrobial resistance to
oxytetracycline, with a NOEL of 2 ppm (approximately 0.05 mg/kg/day).
In December of 1988, EPA completed a review of the available data
for oxytetracycline and concluded that there is no evidence of
carcinogenic effects in either the mouse or the rat study.
The reference dose (RfD) is established at 0.005 mg/kg/body weight
per day based on a NOEL of 0.05 mg/kg body weight per day from the dog
feeding study. An uncertainty factor of 10 to account for intraspecies
variability was used.
The theoretical maximum residue contribution (TMRC) from existing
tolerances is 0.000268 mg/kg/day; the proposed increase in the
tolerance would contribute 0.000054 mg/kg/day. Existing tolerances and
the proposed increase to the tolerance on peaches would utilize 5.35
percent of the RfD. The most highly exposed subgroup, non-nursing
infants (less than 1 year old), had a TMRC of 0.001391 mg/kg/day,
utilizing 27.81 percent of the RfD. The Agency believes that exposure
at these levels carries no appreciable risk.
The nature of the residue is adequately understood and an adequate
analytical method, a microbiological assay, is available for
enforcement purposes. [[Page 19558]]
2. Proposed action. Based on the data and information presented
above, the Agency is proposing that the tolerance for peaches be
increased from 0.1 to 0.35 ppm. In proposing this action, EPA believes
that the tolerance level of 0.35 ppm for oxytetracycline residues in or
on peaches is protective of the public health.
C. Amendment to 40 CFR 180.232
1. Background. EPA has determined, as explained in the
Reregistration Eligibility Document issued September 1993, that there
are sufficient data to support the adequacy of the established S-ethyl
diisobutylthiocarbamate tolerances listed in 40 CFR 180.232.
2. Proposed action. By this document, EPA proposes the following
a. Amend the name S-ethyl diisobutylthiocarbamate in 40 CFR 180.232
to the common name ``Butylate'' so that the tolerance regulation may be
more easily located.
b. Delete the term ``negligible residues'' in the tolerance entry
because the regulation specifies a tolerance level.
c. Amend the commodity definitions listed in 40 CFR 180.232 to read
as follows to conform to commodity definitions currently used by EPA:
i. ``Corn grain (including popcorn)'' is proposed to be revised to
``Corn, field, grain'' and ``Corn, pop, grain.''
ii. ``Fresh corn including sweet corn (kernels plus cob with husk
removed)'' is proposed to be revised to ``Corn, sweet (kernels plus cob
with husk removed).''
iii. ``Corn forage and fodder including sweet corn, field corn, and
popcorn'' is proposed to be revised to ``Corn, field, fodder''; ``Corn,
field, forage''; ``Corn, pop, fodder''; ``Corn, pop, forage''; and
``Corn, sweet, forage.''
III. Public Comment Procedures
Interested persons are invited to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by May 19, 1995. Comments must bear a notation indicating
the document control number. Three copies of the comments should be
submitted to either location listed under the ADDRESSES unit of this
Information submitted as a comment concerning this document may be
claimed confidential by marking any 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 a 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.
Any person who has registered or submitted an application for
registration of a pesticide, under FIFRA as amended, which contains any
of the ingredients listed herein, may request within 30 days after
publication of this document in the Federal Register that this proposal
be referred to an Advisory Committee in accordance with section 408(e)
of the FFDCA.
Documents considered and relied upon by EPA pertaining to this
action, and all written comments filed pursuant to this proposed rule,
will be available for public inspection in Rm. 1132, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA between 8 a.m. and 4 p.m.,
Monday through Friday, except public holidays. Any person who has
registered, or who has submitted an application for registration under
FIFRA of any of the pesticide chemicals listed in this proposed rule,
may request that this proposal be referred to an advisory committee.
Such a request must be made within 30 days of the publication of this
proposal. To satisfy requirements for analysis specified by Executive
Order 12866 and the Regulatory Flexibility Act, EPA has analyzed the
impacts of this proposal. This analysis is available for public
inspection in Rm. 1132 at the Virginia address given above.
IV. Regulatory Assessment Requirements
A. 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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; 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, it has been
determined that this proposed rule is not a ``significant regulatory
action,'' because it does not meet any of the regulatory-significance
criteria listed above.
B. Regulatory Flexibility Act
This proposed rule has been reviewed under the Regulatory
Flexibility Act of 1980 [Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.] and EPA has determined that it will not have a significant
economic impact on a substantial number of small businesses, small
governments, or small organizations.
Accordingly, I certify that this proposed rule does not require a
separate regulatory flexibility analysis under the Regulatory
C. Paperwork Reduction Act
This proposed regulatory action does not contain any information
collection requirements subject to review by OMB under the Paperwork
Reduction Act of 1980, 44 U.S.C. 3501 et seq.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: April 7, 1995.
Acting Director, Special Review and Reregistration Division, Office of
Therefore, it is proposed that 40 CFR part 180 be amended as
1. The authority citation for part 180 would continue to read as
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 per million.
3. Section 180.337 is revised to read as follows: [[Page 19559]]
Sec. 180.337 Oxytetracycline; tolerances for residues.
Tolerances are established for residues of the pesticide
oxytetracycline in or on the following raw agricultural commodities:
Commodity Parts per million
4. Section 180.1068 is revised to read as follows:
Sec. 180.1068 C<INF>12-C<INF>18 fatty acid potassium salts; exemption
from the requirement of a tolerance.
C<INF>12-C<INF>18 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.
[FR Doc. 95-9534 Filed 4-18-95; 8:45 am]
BILLING CODE 6560-50-F