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Maleic Hydrazide, Oryzalin, Hexazinone, Streptomycin; Tolerance Actions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: December 6, 1995 (Volume 60, Number 234)]
[Proposed Rules]               
[Page 62361-62364]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06de95-27]

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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.

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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

 
 

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