[Federal Register Volume 63, Number 113 (Friday, June 12, 1998)]
[Rules and Regulations]
[Pages 32134-32136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15743]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300670; FRL-5795-3]
RIN 2070-AB78
Propamocarb hydrochloride; Extension of Tolerances for Emergency
Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule extends time-limited tolerances for residues of the
fungicide propamocarb hydrochloride in or on potatoes at 0.5 part per
million (ppm); fat, meat, meatbyproducts (except kidney and liver) of
cattle, goats, hogs, horses, and sheep; and milk at 0.1 ppm; and
tomatoes at 0.5 ppm; tomato paste at 3 ppm; and tomato puree at 1 ppm
for an additional year and a half. This action is in response to EPA's
granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on potatoes and tomatoes. Section 408(l)(6) of the Federal
Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA.
DATES: This regulation becomes effective June 12, 1998. Objections and
requests for hearings must be received by EPA, on or before August 11,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300670], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations
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Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A
copy of any objections and hearing requests filed with the Hearing
Clerk identified by the docket control number, [OPP-300670], must also
be submitted to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring a copy of objections and hearing
requests to Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections
and hearing requests must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Copies of
electronic objections and hearing requests will also be accepted on
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of
electronic objections and hearing requests must be identified by the
docket control number [OPP-300670]. No Confidential Business
Information (CBI) should be submitted through e-mail. Copies of
electronic objections and hearing requests on this rule may be filed
online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 272, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9364; e-mail:lpemberton@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued final rules, published in the
Federal Register of April 2, 1997 (FR 15615) (FRL-5597-2) and May 16,
1997(FR 26960)(FRL-5717-5), which announced that on its own initiative
and under section 408(e) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6), it
established time-limited tolerances for the residues of propamocarb
hydrochloride in or on potatoes at 0.5 ppm; fat, meat, meat byproducts
(except kidney and liver) of cattle, goats, hogs, horses, and sheep;
and milk at 0.1 ppm with an expiration date of March 15, 1999 and in or
on tomatoes at 0.5 ppm, tomato paste at 3 ppm, and tomato puree at 1
ppm with an expiration date of May 15, 1999. EPA established the
tolerances because section 408(l)(6) of the FFDCA requires EPA to
establish a time-limited tolerance or exemption from the requirement
for a tolerance for pesticide chemical residues in food that will
result from the use of a pesticide under an emergency exemption granted
by EPA under section 18 of FIFRA. Such tolerances can be established
without providing notice or period for public comment.
EPA received a request to extend the use of propamocarb
hydrochloride for this growing season due to continued failure to
control immigrant strains of late blight in tomatoes and potatoes with
registered fungicides. After having reviewed the submissions, EPA
concurs that emergency conditions exist for the states which have
requested this use. EPA has authorized under FIFRA section 18 the use
of propamocarb hydrochloride on for control of late blight in potatoes
and tomatoes.
EPA assessed the potential risks presented by residues of
propamocarb hydrochloride in or on potatoes and tomatoes. In doing so,
EPA considered the new safety standard in FFDCA section 408(b)(2), and
decided that the necessary tolerance under FFDCA section 408(l)(6)
would be consistent with the new safety standard and with FIFRA section
18. The data and other relevant material have been evaluated and
discussed in the final rules of April 2, 1997 and May 16, 1997. Based
on those data and information considered, the Agency reaffirms that
extension of the time-limited tolerances will continue to meet the
requirements of section 408(l)(6). Therefore, the time-limited
tolerances are extended for an additional year and a half. Although
these tolerances will expire and are revoked on September 15, 2000 and
November 15, 2000, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerances
remaining in or on after these dates will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA and the
application occurred prior to the revocation of the tolerances. EPA
will take action to revoke these tolerances earlier if any experience
with, scientific data on, or other relevant information on this
pesticide indicate that the residues are not safe.
I. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by August 11, 1998, file written objections to any
aspect of this 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 issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (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 issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information 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.
II. Public Record and Electronic Submissions
The official record for this rulemaking, as well as the public
version, as described above will be kept
[[Page 32136]]
in paper form. Accordingly, EPA will transfer any copies of 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 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
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
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 copies of 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 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.
III. Regulatory Assessment Requirements
This final rule extends time-limited tolerances that were
previously extended by EPA under FFDCA section 408(d) in response to a
petition submitted to the Agency. The Office of Management and Budget
(OMB) has exempted these types of actions from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). In addition, this final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
IV. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 2, 1998.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is 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.
Sec. 180.499 [Amended]
2. In Sec. 180.499, by amending paragraph (b) by changing the date
``3/15/99'' to read ``9/15/00'' and the date ``May 15, 1999'' to read
``11/15/00''.
[FR Doc. 98-15743 Filed 6-11-98; 8:45 am]
BILLING CODE 6560-50-F
