[Federal Register Volume 64, Number 183 (Wednesday, September 22, 1999)]
[Rules and Regulations]
[Pages 51245-51248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24694]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300918; FRL-6381-7]
RIN 2070-AB78
2,6-Diisopropylnapthalene; Temporary Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the biochemical pesticide
2,6-diisopropylnapthalene (2,6-DIPN) when applied/used to inhibit
sprouting in potatoes held in storage. Platte Chemical Company
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996 requesting
the temporary tolerance exemption. This regulation eliminates the need
to establish a maximum permissible level for residues of 2,6-DIPN. The
temporary tolerance exemption will expire on September 22, 2000.
DATES: This regulation is effective September 22, 1999. Objections and
requests for hearings, identified by docket control number OPP-300918,
must be received by EPA on or before November 22, 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 under Unit VIII. To ensure proper receipt
by EPA, your objections and hearing requests must identify docket
control number OPP-300918 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Driss Benmhend, c/o Product
Manager (PM) 90, Biopesticides and Pollution Prevention Division
(7511C), Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460; telephone number: (703-308-9525); and e-mail address:
benmhend.driss@epa.gov.
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:
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Examples of
Categories NAICS Potentially
Affected Entities
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Potato Processors 311 Food manufacturing
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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-300918. 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, 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 (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 25, 1998 (63 FR 65204) (FRL-
6039-7), EPA issued a notice pursuant to section 408 of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the
filing of a pesticide tolerance petition by Platte Chemical Company,
419 18th Street, Greeley, CO 80632. This notice included a summary of
the petition prepared by the petitioner Platte Chemical Company. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of 2,6-DIPN.
New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
[[Page 51246]]
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to
mean that ``there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .'' Additionally, section 408(b)(2)(D) requires that the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
1. Acute toxicity. Technical 2,6-DIPN exhibits low acute toxicity.
It is a toxicity category IV biopesticide. The rat oral LD50
is greater than 5,000 milligrams/kilograms (mg/kg), the rabbit dermal
LD50 is greater than 5,000 mg/kg, and the rat inhalation
LC50 is greater than 2.60 mg/L at the maximum attainable
condition. In addition, 2,6-DIPN is not a skin sensitizer in guinea
pigs, shows no dermal irritation at 72 hours in rabbits, and shows
minimal ocular irritation in rabbits. The end use formulation is the
same as the technical formulation; it contains no intentionally added
inert ingredients.
2. Genotoxicity. Short-term assays for genotoxicity consisting of a
bacterial reverse mutation assay (Ames test), an in vivo/in vitro
unscheduled DNA synthesis in rat primary hepatocyte cultures at two
time points, and an in vivo mouse micronucleus assay have been
conducted for 2,6-DIPN. These studies show a lack of genotoxicity for
2,6-DIPN.
3. Other tests. No additional mammalian toxicology testing has been
conducted. Platte requested a waiver from the requirement to submit
further mammalian toxicology studies on the basis of the favorable
toxicological profile for 2,6-DIPN, the low residues observed in
treated potatoes, the specific plant growth regulator mode of action,
and the confined nature of the proposed use. No data were found in the
literature that would indicate 2,6-DIPN has any adverse effect on
mammals. No incidents of hypersensitivity or any other adverse effects
have been observed in individuals handling the material over the past 6
years.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
Any dietary exposure resulting from applications made under an
experimental use permit (EUP) would be through potato consumption and
animal products in which animals are fed potato feed stocks.
1. Food. Residues in treated potatoes have been shown to be low
(average residue was 0.08 ppm 90 days after treatment). Residues would
be expected to continue to decline after potatoes are removed from
storage and before consumption. Cooking and/or processing would be
expected to further lower the residue level in consumed potatoes or
potato products
2. Drinking water exposure. Since 2,6-DIPN would only be used in
commercial storage warehouses, there is little if any potential for
drinking water exposure.
B. Other Non-Occupational Exposure
The EUP would only cover use for direct application to potatoes
when stored in commercial warehouses. There are currently no other
registered uses of 2,6-DIPN. Non-dietary exposure to 2,6-DIPN via lawn
care, topical treatments, etc., will not occur. Thus, the potential for
non-occupational exposure to the general population is virtually non-
existent.
V. Cumulative Effects
EPA also is required to consider the potential for cumulative
effects of 2,6-DIPN and other substances that have a common mechanism
of toxicity. Consideration of a common mode of toxicity is not
appropriate, given that there is no indication of mammalian toxicity of
2,6-DIPN and no information that indicates toxic effects, if any, would
be cumulative with any other compounds. Since, 2,6-DIPN does not
exhibit a toxic mode of action in the target plant, it is appropriate
to consider only the potential risks of 2,6-DIPN in this exposure
assessment.
VI. Determination of Safety for U.S. Population, Infants and
Children
Since there are no anticipated residues in drinking water or from
other non-occupational sources, and no reliable information exists on
cumulative effects due to a common mechanism of toxicity, the aggregate
exposure to 2,6-DIPN is adequately represented by the dietary route.
The lack of toxicity of 2,6-DIPN has been demonstrated by the results
of acute toxicity testing in mammals in which 2,6-DIPN caused no
adverse effects when dosed orally, dermally, and via inhalation at the
limit dose for each study. Anticipated residues in consumed potatoes
are low. Moreover, 2,6-DIPN exhibits close structural and chemical
similarity to other plant-based, naturally occurring methyl and
isopropyl naphthalene. Thus, the dietary exposure to 2,6-DIPN should
pose negligible risks to human health. Based on the lack of toxicity
and low exposure, there is a reasonable certainty that no harm to
infants, children, or adults will result from aggregate exposure to
2,6-DIPN residues. Exempting 2,6-DIPN from the requirement of a
tolerance should pose no significant risk to humans or the environment.
VII. Other Considerations
A. Analytical Method
An analytical method for residues is not applicable, as this
proposes an exemption from the requirement of a tolerance.
B. Codex Maximum Residue Level
No Codex maximum residue levels are established for residues of
2,6-DIPN in or on any food or feed crop. There are no other established
U.S. tolerances or
[[Page 51247]]
exemptions from tolerances for 2,6-DIPN food or feed crops in the
United States. The Agency has classified 2,6-DIPN as a biochemical
pesticide.
VIII. 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-300918 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 November
22, 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) as well as other requirements set forth
in 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
Room 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 (202) 260-4865.
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 judgment
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 (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
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 VIII.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 number OPP-300918, 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: opp-docket@epa.gov. 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 5.1/6.1 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).
IX. Regulatory Assessment Requirements
This final rule establishes a temporary tolerance/exemption under
section 408(d) of the FFDCA 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). 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
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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(b)(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 on the basis of a petition under FFDCA section 408(d), such
as the a temporary tolerance/exemption 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.
X. 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: September 15, 1999.
Marcia E. Mulkey,
Director, 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.
2. Section 180.1208 is added to subpart D to read as follows:
Sec. 180.1208 2,6-Diisopropylnapthalene; temporary exemption from the
requirement of a tolerance.
2,6-Diisopropylnapthalene is temporarily exempt from the
requirement of a tolerance when used to inhibit sprouting in potatoes
held in storage in accordance with the Experimental Use Permit 034704-
EUP-13. The temporary exemption from the requirement of a tolerance
will expire on September 22, 2000.
[FR Doc. 99-24694 Filed 9-21-99; 8:45 am]
BILLING CODE 6560-50-F
