[Federal Register Volume 60, Number 234 (Wednesday, December 6, 1995)]
[Proposed Rules]
[Pages 62361-62364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29734]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300405; FRL-4987-4]
RIN 2070-AC18
Maleic Hydrazide, Oryzalin, Hexazinone, Streptomycin; Tolerance
Actions
AGENCY: Environmental Protection Agency (EPA).
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 Decision (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
[[Page 62362]]
subject to this proposed rule, EPA is proposing to revoke various
tolerances for maleic hydrazide, oryzalin, and hexazinone. This
document also proposes to delete as surplusage the term ``negligible''
from a regulation on streptomycin.
DATES: EPA must receive written comments, identified by the OPP
document control number [OPP-300405], on or before February 5, 1996.
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.
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-300405]. No Confidential Business Information
(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: Jeff Morris, 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. Telephone: (703)-308-8029; e-mail:
morris.jeffrey@epamail.epa.gov.
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 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 the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) 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 or whether 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, based on more recent data, 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 revoking tolerances or
exemptions from the requirement of tolerances is set forth in 40 CFR
parts 177 through 180. The Administrator of EPA, or any person by
petition, may initiate an action proposing to establish, amend, revoke,
or exempt a tolerance for a pesticide registered for food uses. 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, and the Agency then publishes its
final determination regarding the specific tolerance actions.
II. Chemical-Specific Information and Proposed Actions
A. Maleic Hydrazide
1. Regulatory history. In 1952, USDA registered maleic hydrazide
for use as a growth regulator. EPA issued a Registration Standard for
maleic hydrazide in 1988. In 1992, EPA issued a Data Call-In (DCI)
notice for maleic hydrazide and the potassium salt of maleic hydrazide
that required data to address ecological effects, environmental fate,
and residue chemistry data gaps. EPA published a RED for maleic
hydrazide in June 1994 that reflects a reassessment of all data
submitted to date in response to the Registration Standard and the 1992
DCI. The RED also conditions the maleic hydrazide reregistration on the
cranberry tolerance revocation proposed in this document. Persons
interested in the details of this reassessment are referred to the
maleic hydrazide RED (NTIS #PB88-236849).
2. Current proposal. EPA proposes to revoke the 15-ppm tolerance
for maleic hydrazide residues in or on cranberries, as listed in 40 CFR
180.175(b). EPA is proposing this action for two reasons: (1) The
registrant is not supporting the use of maleic hydrazide on this
commodity, and end-use maleic hydrazide labels do not list cranberries
as a registered use (Two States, Massachusetts and New Jersey, had
FIFRA section 24(c) (Special Local Need) registrations for the use of
maleic hydrazide on cranberries in 1984 and 1985; EPA cancelled those
registrations in 1991, and EPA believes that since 1992 there has been
little or no usage of maleic hydrazide on cranberries in those States.)
Therefore, no residues of maleic hydrazide are expected in or on
cranberries, making a cranberry tolerance unnecessary. (2) Also, EPA
does not have adequate nature-of-the-residue data to determine that the
cranberry tolerance for maleic hydrazide is protective of the public
health. A tolerance under section 408 of the Federal Food, Drug, and
Cosmetic Act requires a finding that the tolerance will protect the
public health, and to make such a finding for the established cranberry
tolerance in 40 CFR 180.175(b), EPA needs adequate data on the nature
of the residue (see 40 CFR part 158 for guidance on data requirements).
To date, the Agency has not received these data.
If during the comment period of this proposed rule no party
indicates that it will support the use of maleic hydrazide on
cranberries by providing the necessary data, EPA will issue a final
rule revoking the tolerance.
B. Oryzalin
1. Regulatory history. Oryzalin was first registered in the United
States in 1974 for use as a preemergence herbicide in fruit and nut
crops, vineyards, orchards, forest areas, noncrop areas, and
agricultural crops. In
[[Page 62363]]
1987, EPA issued a Registration Standard for oryzalin that evaluated
the studies submitted to that date. EPA issued a DCI for oryzalin in
1991 requiring additional phytotoxicity data, plant and animal
analytical methods, and nondietary exposure data. The January 27, 1995
RED for oryzalin reflects a reassessment of all data submitted in
response to the Registration Standard and the DCI. The RED also
conditions the oryzalin reregistration on the tolerance actions
proposed in this document. The Agency refers persons interested in this
reassessment to the oryzalin RED (NTIS publication #PB90-174137).
2. Current proposal. EPA proposes to revoke the tolerances for
oryzalin residues in or on the following commodities listed in 40 CFR
180.304(a): cottonseed, .05 ppm; grain, barley, .05 ppm; grain, wheat,
.05 ppm; peas (succulent), .05 ppm; potatoes, .05 ppm; and soybeans, .1
ppm. EPA is proposing this action because the registrant is not
supporting the use of oryzalin on these commodities, and end-use
oryzalin labels do not list these commodities as registered uses (these
have not been registered uses since before publication of the the 1987
registration standard). As a result, residues of oryzalin in or on
these commodities are not expected; therefore, the tolerances are not
necessary.
EPA previously issued a proposal to remove the above-named
commodities from 40 CFR 180.304(a). (See the Federal Register of
January 18, 1995 (60 FR 3611).) That proposal is superseded by this
document.
EPA has sufficient data to ascertain the adequacy of the
established tolerances listed 40 CFR 180.304(a) for the above-named
commodities. However, if no party indicates support for the use of
oryzalin on these commodities during the comment period of this
proposed rule, EPA will issue a final rule revoking the tolerances.
C. Hexazinone
1. Regulatory history. EPA first registered hexazinone in 1975 for
use as a broad-spectrum herbicide for general weed control. In 1982,
EPA issued an initial Registration Standard for hexazinone, and in 1988
EPA issued a second Registration Standard. The 1988 Standard summarized
available data supporting the registration of hexazinone products and
required additional product chemistry, residue chemistry, toxicology,
ecological effects, and environmental fate data. The January 27, 1995
RED for hexazinone represents an assessment of the data required by the
Registration Standards. The RED also conditions the hexazinone
reregistration on the tolerance actions proposed in this document.
Persons interested in this reassessment should contact NTIS (telephone
no. 703-487-4650) for a copy of the hexazinone RED.
2. Current proposal. EPA proposes to revoke the tolerances for
hexazinone residues in or on the following commodities in 40 CFR
180.396: eggs, .1 ppm; poultry, fat, .1 ppm; poultry, meat, .1 ppm;
poultry, mbyp, .1 ppm; pineapple, fodder, 5 ppm; and pineapple, forage,
5 ppm.
EPA is proposing to revoke the egg and poultry tolerances because
the maximum residue expected in poultry tissues would be .005 ppm, an
order of magnitude below the limit of detection for hexazinone
metabolites, resulting in no detectible residues. Therefore, tolerances
are not needed for hexazinone residues in or on eggs and poultry. The
pineapple fodder and forage tolerances are proposed for revocation
because EPA no longer regulates pineapple fodder and forage as raw
agricultural commodities (since the Agency does not consider pineapple
fodder and forage to be produced in significant quantities to warrant
regulation).
If no valid objections are raised during the comment period
following this proposed rule, EPA will issue a final rule revoking the
tolerances.
D. Streptomycin
1. Regulatory history. Streptomycin has been used in the United
States since the 1940s to treat bacterial infections in humans and was
first registered as a pesticide in 1955. At that time, it was used
primarily as a bactericide/fungicide on selected agricultural and
nonagricultural crops. Other uses include seed treatment, residential
use, and as an aquarium algaecide. In 1988, EPA issued a Registration
Standard for streptomycin requiring data to support the registered uses
regulated under FIFRA.
EPA issued a RED for streptomycin on September 30, 1992, reflecting
a reassessment of all data submitted in response to the Registration
Standard. The RED also conditions the streptomycin reregistration on
the tolerance action proposed in this document. Persons interested in
this reassessment should contact NTIS (telephone no. 703-487-4650) for
a copy of the streptomycin RED.
2. Current proposal. EPA proposes to delete ``negligible'' from 40
CFR 180.245 because in this case the term ``negligible'' is surplusage.
III. Public Comment Procedures
EPA invites interested persons to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by February 5, 1996. Comments must bear a notation
indicating the document control number. Three copies of the comments
should be submitted to either location listed under ADDRESSES at the
beginning of this document.
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). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with the CBI deleted,
also must be submitted for inclusion in the public record. EPA may
publicly disclose without prior notice information not marked
confidential.
Any person who has registered or submitted an application for
registration of a pesticide under FIFRA, as amended, that contains any
of the ingredients listed herein may request within 30 days after
publication of this document in the Federal Register that this
rulemaking 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 4:30
p.m., Monday through Friday, except for legal holidays.
A record has been established for this rulemaking under docket
number [OPP-300405] (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 Mall #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.
[[Page 62364]]
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 address in ADDRESSES at the beginning of
this document.
IV. Regulatory Assessment Requirements
To satisfy requirements for analysis specified by Executive Order
12866, the Regulatory Flexibility Act, the Paperwork Reduction Act, and
the Unfunded Mandates Reform Act, EPA has analyzed the impacts of this
proposal.
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, Oct. 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, EPA has determined
that this rule is not a ``significant regulatory action,'' because it
does not meet any of the regulatory-significance criteria listed above.
B. Regulatory Flexibility Act
EPA has reviewed this proposed rule under the Regulatory
Flexibility Act of 1980 (Pub. L. 96-354; 94 Stat. 1164, 5 U.S.C. 601 et
seq.) and 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 Flexibility Act.
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.
D. Unfunded Mandates Reform Act
This proposed rule contains no Federal mandates under Title II of
the Unfunded Mandates Reform Act of 1995, Pub. L. 104-4, for State,
local, or tribal governments or the private sector, because it would
not impose enforceable duties on them.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 30, 1995.
Jack E. Housenger,
Chief, Special Review Branch, Special Review and Reregistration
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.
2. In Sec. 180.175, by removing paragraph (b) and designating it as
``reserved'' as follows:
Sec. 180.175 Maleic hydrazide; tolerances for residues.
* * * * *
(b) [Reserved]
Sec. 180.245 [Amended]
3. By amending Sec. 180.245 Streptomycin; tolerances for residues,
by removing the term ``negligible'' from the text.
Sec. 180.304 [Amended]
4. In Sec. 180.304 Oryzalin; tolerances for residues by amending
paragraph (a) in the table therein by removing the entries for
cottonseed; grain, barley; grain, wheat; peas (succulent); potatoes;
and soybeans.
Sec. 180.396 [Amended]
5. In Sec. 180.396 Hexazinone; tolerances for residues by amending
paragraph (a) in the table therein by removing the entries for eggs;
poultry, fat; poultry, mbyp; poultry, meat; pineapple, fodder; and
pineapple, forage.
[FR Doc. 95-29734 Filed 12-5-95; 8:45 am]
BILLING CODE 6560-50-F
