[Federal Register Volume 61, Number 70 (Wednesday, April 10, 1996)]
[Proposed Rules]
[Pages 15915-15917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8942]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300421; FRL-5361-3]
RIN 2070-AB18
2-Bromo-2-Nitro-1,3-Propanediol; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes that residues of 2-bromo-2-nitro-1,3-
propanediol (CAS Reg. No. 52-51-7) be exempted from the requirement of
a tolerance when used at levels not to exceed 0.04% as an inert
ingredient (preservative) in pesticide formulations applied to growing
crops, raw agricultural commodities after harvest, and animals. This
proposed regulation was requested by Kennedy Consultants Inc. on behalf
of Knoll Pharmaceuticals, Knoll Microcheck, pursuant to the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments, identified by the docket control number [OPP-300421],
must be received on or before May 10, 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 deliver comments to: Rm. 1132, Crystal
Mall CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
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 will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the Virginia 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 electronically 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 in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number, [OPP-300421]. No CBI should be submitted through e-
mail. 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: Amelia M. Acierto,
Registration Support Branch, Registration Division (7505W), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: 2800 Crystal Drive, North Tower, Arlington, VA, (703)308-8375,
e-mail: acierto.amelia@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: Kennedy Consultants Inc., 13 ``C'' Street,
Suite G, Laurel, MD 20707 on behalf of Knoll Pharmaceuticals, Knoll
Microcheck has submitted pesticide petition (PP) 0E03904 to EPA
requesting that the Administrator, pursuant to section 408(e) of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(e), propose to
amend 40 CFR 180.1001(c) and (e) by establishing an exemption from the
requirement of a tolerance for 2-bromo-2-nitro-1,3-propanediol when
used as an antimicrobial in-can preservative in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals.
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
[[Page 15916]]
The data submitted in the petition and other relevant material have
been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), the Agency set forth a list of studies which would generally be
used to evaluate the risks posed by the presence of an inert ingredient
in a pesticide formulation. However, where it can be determined without
that data that the inert ingredient will present minimal or no risk,
the Agency generally does not require some or all of the listed studies
to rule on the proposed tolerance or exemption from the requirement of
a tolerance for an inert ingredient. The Agency has decided that no
data, in addition to that described below, for 2-bromo-2-nitro-1,3-
propanediol will need to be submitted. The rationale for this decision
is described below:
1. An acute rat oral toxicity study with an acute oral LD50 of
1.138 g/kg (0.146) for male rats and 1.138 g/kg
(0.013) for female rats.
2. An acute rat inhalation toxicity study with a 3.5-hour
inhalation LC50 of >5.0 mg/L/hr.
3. A rabbit eye irritation study with irritancy score of 0.43
classifying 2-bromo-2-nitro-1,3-propanediol as a moderate eye irritant.
4. A rat dermal developmental toxicity study with maternal no
observe effect level (NOEL) >40 mg/kg/day (HDT) considering 2-bromo-2-
nitro-1,3-propanediol as a severe dermal irritant in rats.
5. A rabbit primary dermal irritation study indicating that 2-
bromo-2-nitro-1,3-propanediol is a moderate skin irritant.
6. An acute rabbit dermal toxicity study with dermal LD50 of
>2 g/kg.
7. A guinea pig dermal sensitization study which suggests that 2-
bromo-2-nitro-1,3-propanediol is a skin sensitizer for a 13%
formulation.
8. A rabbit developmental effects study with a NOEL for maternal
toxicity of 40 mg/kg/day and developmental toxicity NOEL of 40 mg/kg/
day; lowest effect level (LEL) for maternal toxicity of 80 mg/kg/day
with a LEL for developmental toxicity of 80 mg/kg/day.
9. Mutagenicity studies including in vitro/in vivo in mouse
erythrocytes (micronucleus assay), chromosomal abberation test in human
lymphocytes, Salmonella typhimurium plate (Ames) tests with and without
activation were negative.
10. The two generation rat reproduction study (drinking water) with
a systemic NOEL of 25 mg/kg/day and lowest effect level (LEL) of 70 mg/
kg/day; reproduction NOEL of 70 mg/kg/day and LEL of 200 mg/kg/day;
developmental NOEL of 25 mg/kg/day and LEL of 70 mg/kg/day.
11. A 2-year rat (drinking water) carcinogenicity study with
asystemic NOEL of 10 mg/kg/day and LEL of 40 mg/kg/day finding 2-bromo-
2-nitro-1,3-propanediol to be not carcinogenic.
12. A 13-week rat gavage study with a NOEL of 20 mg/kg/day and LEL
of 80 mg/kg/day.
13. A 13-week dog gavage study with NOEL of 8 mg/kg/day and LEL of
20 mg/kg/day.
The reference dose (RfD) for 2-bromo-2-nitro-1,3-propanediol based
on the 2-year chronic study (drinking water) in rats with a NOEL of 10
mg/kg/day and using an uncertainty factor of 100 is calculated to be
0.1 mg/kg of body weight (bwt)/day. The estimated worst-case
theoretical maximum residue contribution (TMRC) resulting from this
action will be 0.000024 mg/kg/bwt/day for the overall U.S. population
and represents 0.024 percent of the RfD.
Based upon the above information and review of its use, EPA has
found that, when used in accordance with good agricultural practice,
this ingredient is useful and a tolerance is not necessary to protect
the public health. Therefore, EPA proposes that the exemption from the
requirement of a tolerance 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 document in the Federal Register that this proposal be referred
to an Advisory Committee in accordance with section 408(e) of FFDCA.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
docket control number, [OPP-300421]. All written comments filed in
response to this petition will be available in the Public Response 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 docket
number [OPP-300421] (including comments and data 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 MallCM #2, 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 all comments 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 Virginia address in ``ADDRESSES '' at
the beginning of this document.
The Office of Management and Budget has exempted this proposed rule
from the requirements of section 3 of Executive Order 12866.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-3 54, 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
recordkeeping requirements.
Dated: March 29, 1996
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be 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.
[[Page 15917]]
2. In Sec. 180.1001 the table in paragraph (c) and paragraph (e) is
amended by adding alphabetically the inert ingredient 2-bromo-2-nitro-
1,3-propanediol (CAS Reg. No. 52-51-7), to read as follows:
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(c) * * *
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Inert Ingredients Limits Uses
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* * * * * * *
2-Bromo-2-nitro-1,3- Not more than Preservative
propanediol (CAS Reg. No. 52- 0.04 percent by
51-7). weight of
pesticide
formulation.
* * * * * * *
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(e) * * *
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Inert Ingredients Limits Uses
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* * * * * * *
2-Bromo-2-nitro-1,3- Not more than Preservative
propanediol (CAS Reg. No. 52- 0.04 percent by
51-7). weight of
pesticide
formulation.
* * * * * * *
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[FR Doc. 96-8942 Filed 4-9-96; 8:45 am]
BILLING CODE 6560-50-F
