99-27399. Metolachlor; Extension of Tolerance for Emergency Exemptions

[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Rules and Regulations]
[Pages 56678-56681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27399]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300934; FRL-6386-1]
RIN 2070-AB78


Metolachlor; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends time-limited tolerances for the 
combined residues of the herbicide metolachlor and its metabolites in 
or on spinach at 0.3 part per million (ppm) for an additional 19\1/2\-
month period and grass forage at 10 ppm and grass hay at 0.2 ppm for an 
additional 2-year period. These tolerances will expire and be revoked 
on December 31, 2001. 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 
spinach and grass grown for seed. Section 408(l)(6) of the Federal 
Food, Drug, and Cosmetic Act

[[Page 56679]]

(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 the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA).

DATES: This regulation is effective October 21, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300934, 
must be received by EPA on or before December 20, 1999.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit III. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300934 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: [phone]; and e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person.  The Agency has established an official record for 
this action under docket control number OPP-300934. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2 (CM #2), 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is [phone].

II. Background and Statutory Findings

    EPA issued a final rule, published in the Federal Register of 
November 29, 1996 (61 FR 60617) (FRL-5574-7), which announced that on 
its own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as 
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 
104-170) it established a time-limited tolerance for the combined 
residues of metolachlor and its metabolites in or on spinach at 0.3 
ppm, with an expiration date of November 15, 1998. This tolerance was 
then extended in the Federal Register of December 2, 1998 (63 FR 66435) 
(FRL-6038-4) to have an expiration date of May 15, 2000.
    EPA issued another final rule, published in the Federal Register of 
September 11, 1998 (63 FR 48586) (FRL-6017-9), which announced that on 
its own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as 
amended by the FQPA (Public Law 104-170) it established time-limited 
tolerances for the combined residues of metolachlor and its metabolites 
in or on grass forage at 10.0 ppm and grass hay at 0.2 ppm, with an 
expiration date of December 31, 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 the FIFRA. Such tolerances 
can be established without providing notice or period for public 
comment.
    EPA received a request to extend the use of metolachlor on spinach 
for this year's growing season due to the continuing emergency with 
weeds in spinach. This emergency condition was primarily brought about 
by the loss of the product Antor 4E (diethatyl ethyl), an herbicide 
that was used on spinach. As Antor 4E is no longer manufactured and 
stocks have been exhaused since 1993, spinach growers are in need of a 
product to effectively control weeds in spinach fields.
    EPA received a request to extend the use of metolachlor on grass 
grown for seed for this year's growing season because the situation 
continues to remain an emergency. Due to the cancellation of herbicide 
uses in recent years, shifts in weed populations and development of 
resistance, combined with restrictions on open field burning, growers 
of grasses grown for seed in Oregon are no longer able to adequately 
control weeds. Significant economic losses are expected if these weeds 
are not adequately controlled, as the grass seed becomes contaminated 
with weed seed and does not meet certification requirements to be 
marketed.
    After having reviewed these submissions, EPA concurs that emergency 
conditions exist. EPA has authorized under FIFRA section 18 the use of 
metolachlor on spinach for the control of weeds in Arizona, Colorado, 
Maryland, New Jersey, Oklahoma, Texas, Virginia, and Wisconsin and the 
use of metolachlor on grass grown for seed for the control of weeds in 
Oregon.
    EPA assessed the potential risks presented by residues of 
metolachlor in or on spinach, grass forage and grass hay. In doing so, 
EPA considered the

[[Page 56680]]

safety standard in FFDCA section 408(b)(2), and decided that the 
necessary tolerances under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. The data and other 
relevant material have been evaluated and discussed in the final rules 
of November 29, 1996 (61 FR 60617) and September 11, 1998 (63 FR 
48586). Based on the 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 tolerance for spinach is extended for an additional 19\1/2\-
month period and the time-limited tolerances for grass forage and grass 
hay are extended for an additional 2-year period. EPA will publish a 
document in the Federal Register to remove the revoked tolerances from 
the Code of Federal Regulations (CFR). Although these tolerances will 
expire and be revoked on December 31, 2001, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerances remaining in or on spinach, grass forage, 
and grass hay after that date 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.

III. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300934 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before December 
20, 1999.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is [phone].
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at [phone], by e-mail at [e-mail], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit III.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-300934, 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 or 
by courier, bring a copy to the location of the PIRIB described in Unit 
I.B.2. You may also send an electronic copy of your request via e-mail 
to: [e-mail]. Please use an ASCII file format and avoid 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 6.1/8.0 file format or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IV. Regulatory Assessment Requirements

    This final rule establishes tolerances under section 408(l)(6) of 
the FFDCA. The Office of Management and Budget (OMB) has exempted these 
types of

[[Page 56681]]

actions from review under Executive Order 12866, entitled Regulatory 
Planning and Review (58 FR 51735, October 4, 1993). 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) (Public Law 104-4). Nor does it require prior consultation with 
State, local, and tribal government officials as specified by Executive 
Order 12875, entitled Enhancing the Intergovernmental Partnership (58 
FR 58093, October 28, 1993) and Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19,1998), or special consideration of environmental justice 
related issues under 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). The Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 12612, entitled Federalism (52 FR 41685, October 30, 
1987). This action directly regulates growers, food processors, food 
handlers and food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of the Federal Food, Drug, and 
Cosmetic Act, 21 U.S.C. 346a(n)(4). This action does not involve any 
technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). In addition, since 
tolerances and exemptions that are established under FFDCA section 
408(l)(6), such as the tolerances in this final rule, do not require 
the issuance of a proposed rule, the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

V. 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 to 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 this 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: October 6, 1999.

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. 321(q), 346(a) and 371.

Sec. 180.368  [Amended]

    2. In Sec. 180.368, by amending paragraph (b) by changing the date 
for grass forage and grass hay from ``12/31/99'' to read ``12/31/01'' 
and by changing the date for spinach from ``5/15/00'' to read ``12/31/
01''.

[FR Doc. 99-27399 Filed 10-20-99; 8:45 am]
BILLING CODE 6560-50-F