[Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
[Rules and Regulations]
[Pages 41-44]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34702]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300777; FRL-6052-5]
RIN 2070-AB78
Copper-ethylenediamine Complex; Exemption From the Requirement of
a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes an exemption from the requirement of a
tolerance for residues of copper-ethylenediamine complex in or on
potatoes when applied/used in accordance with good agricultural
practice as an active ingredient in pesticide formulations as a
desiccant/harvest aid. The Interregional Research Project Number 4 (IR-
4) submitted a petition to EPA under the Federal Food, Drug and
Cosmetic Act as amended by the Food Quality Protection Act of 1996
(Pub. L. 104-170) requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Copper-ethylenediamine complex in or
on potatoes.
DATES: This regulation is effective February 3, 1999. Objections and
requests for hearings must be received by EPA on or before March 5,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300777], 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 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-300777], 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 (CM #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: [email protected]. 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 file format or ASCII file format. All
copies of electronic objections and hearing requests must be identified
by the docket number [OPP-300777]. 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: Sidney Jackson (PM5),
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: CM #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 305-7610, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of October 29, 1997
(62 FR 56179) (FRL-5749-7), 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 of 1996 announcing the
filing of a pesticide tolerance petition by IR-4. This notice included
a summary of the petition prepared by the Griffin Corporation. There
were no comments received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Copper-ethylenediamine complex.
I. Background and Statutory Authority
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
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 tolerance is ``safe.'' Section 408(b)(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
[[Page 42]]
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...''
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 us in residential settings.
II. Toxicological Profile
Consistent with section 408(b)(2)(D) of 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. The nature of the toxic effects caused by Copper-
ethylenediamine complex are discussed below:
Copper-ethylenediamine complex and copper sulfate pentahydrate are
the active ingredient components of INFERNO Plant
Desiccant, a formulation containing 8% elemental copper. An identical
product, KOMEEN Aquatic Herbicide (EPA Reg. No. 1812-312), is
approved for use in slow moving or quiescent bodies of water including
potable water reservoirs. Copper sulfate pentahydrate is already exempt
from the requirement of a tolerance according to 40 CFR 180.1001(b)(1).
Copper is ubiquitous in nature and is a nutritionally required
element for plants and animals. The National Academy of Science has
established a recommended daily dietary intake for copper. In addition,
humans possess a natural efficient homeostatic mechanism for regulating
copper body levels over a wide range of dietary intake. The toxicity of
the copper ion is well-characterized in the published literature. There
is no evidence of any chronic effects induced by dietary ingestion of
copper unless the intake is of such enormous magnitude that there is a
disruption of the natural homeostatic mechanism for controlling body
levels. Consequently, there is no reason to expect that long-term
exposure to the copper ion in the diet is likely to lead to adverse
health effects.
The EPA toxicology database on copper-ethylenediamine complex shows
this compound has similar toxicological properties to other copper
compounds already exempt from the requirement of a tolerance such as
copper hydroxide and cuprous oxide.
The Agency does not require subchronic, chronic, reproductive or
developmental toxicity studies for the copper salts.
Results of a battery of acute toxicity studies show copper-
ethylenediamine complex (Komeen) is slightly to moderately toxic upon
acute oral, dermal and inhalation exposure, slightly irritating to the
skin and moderately irritating to the eye.
In rats, the acute oral lethal dose (LD) 50 (95%
confidence limits) for Komeen was 498 milligram (mg)/kilogram (kg)
(349-710 mg/kg) for a Toxicity Category II classification.
The acute dermal LD50 in rabbits for Komeen was
determined to be > 2,000 mg/kg (Toxicity Category III).
In acute inhalation studies with Sprague-Dawley rats, the lethal
concentration (LC) 50 (95% confidence limits) for Komeen was
0.81 mg/liter(l) (0.26-1.37 mg/l).
In rabbit studies, Komeen was shown to be moderately irritating to
the eye with all signs of ocular irritation cleared within 10 days of
treatment (Toxicity Category III).
III. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from groundwater or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
A. Dietary Exposure
1. Food. Based on the proposed used pattern of potato vine
desiccation, minimal copper residues are expected to occur in potatoes
and the dietary exposure would be negligible by comparison to the
normal daily intake of copper. A single day's diet may contain 10 mg or
more of copper. The daily recommended allowance of copper for adults
nutritional needs is 2 mg.
Copper levels toxic to plants induce a chlorosis condition which
causes decreased growth and yield before hazardous copper levels are
reached. Since the INFERNO formulation will be
applied to the potato vine above ground, the potato tubers below ground
will not be directly treated. Moreover, copper is naturally found in
several types of food, such as fruits and vegetables, at levels ranging
from 0.3 to 3.9 ppm. The Agency believes that residues of copper, if
any, in potatoes from pesticidal application of copper-ethylenediamine
complex are not likely to exceed these naturally occurring levels.
Additionally, the Agency has waived all residue chemistry study
requirements for copper-ethylenediamine complex since copper is
naturally occurring in plants and it is impossible to distinguish
copper residues resulting from naturally occurring copper or copper-
ethylenediamine complex.
2. Drinking water exposure. Copper is ubiquitous in the environment
and found in natural water. Komeen is registered for use in water
including potable water, livestock watering, fish hatcheries, etc. The
average copper concentration in drinking water is 0.13 ppm. In 1991,
the US EPA established a maximum contamination level (MCL) for copper
in drinking water of 1.3 mg/l. The Agency believes that no impact on
copper levels found naturally in water would occur as a result of
potato vine desiccant use of copper-ethylenediamine complex.
B. Other Non-Occupational Exposure
Copper is registered for use as an aquatic herbicide for outdoor
residential sites. Any contributions to aggregate exposure from this
use would not be expected to be significant.
1. Dermal exposure. No significant dermal exposure would be
expected to result from intended use of copper-ethylenediamine complex.
2. Inhalation exposure. Air concentrations of copper are relatively
low. A study based on several thousand samples assembled by EPA's
Environmental Monitoring Systems Laboratory showed copper levels
ranging from 0.003 to 7.32 micrograms per cubic meter. Other studies
indicate that air levels of copper are much lower. The Agency does not
expect the air concentration of copper to be significantly effected by
the use of copper-ethylenediamine complex on potatoes.
IV. Cumulative Effects
The Agency believes that copper has no significant toxicity to
humans and that no cumulative adverse effects are expected from long-
term exposure to copper salts. No other elements are expected to
produce cumulative toxicity with copper-ethylenediamine complex.
[[Page 43]]
V. Determination of Safety for U.S. Population, Infants and
Children
Copper compounds such as copper sulfate pentahydrate are considered
as Generally Recognized as Safe (GRAS) by the Food and Drug
Administration. EPA has exempted various copper compounds from the
requirement of a tolerance when used as aquatic herbicides (40 CFR
180.1021). Copper compounds are also exempt from the requirement of a
tolerance when applied to growing crops when used as a plant fungicide
in accordance with good agricultural practices (40 CFR 180.1001(b)(1)).
1. U.S. population. Copper is a component of the human diet and an
essential element. Use of copper-ethylenediamine complex is not
expected to increase the amount of copper in the diet as a result of
potato vine desiccation.
2. Infants and children. Infants and children also require copper
in their diets and EPA believes that no special sensitivity for this
population subgroup would be expected as a result of the proposed use.
Because of copper's low toxicity, EPA has not used a safety factor
approach to analyzing the safety of copper-ethylenediamine complex used
a potato vine desiccant. For similar reasons, an additional tenfold
margin of safety is not necessary for the protection of infants and
children.
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm to the general population,
including infants and children, from aggregate exposure to Copper-
ethylenediamine complex residues. Accordingly, EPA finds that exempting
Copper-ethylenediamine complex from the requirement of a tolerance will
be safe.
VI. Other Considerations
A. Endocrine Disruptors
Since copper is required for homeostasis, low copper dietary
exposures would not be expected to result in any adverse endocrine
effects. Moreover, the Agency has no information to suggest that copper
will adversely affect the immune or endocrine systems. The Agency is
not requiring information on the endocrine effects of copper at this
time; Congress has allowed three (3) years after August 3, 1996, for
the Agency to implement a screening program with respect to endocrine
effects.
B. Analytical Method(s)
A practical analytical method for copper-ethylenediamine complex
is not required for crop use since it is expected that no residues will
occur in potatoes. Additionally, the Agency is establishing an
exemption from the requirement of a tolerance without any numeric
limitation; therefore, the Agency is not requiring an analytical method
for enforcement purposes for copper-ethlenediamine complex.
C. Existing Tolerances
There are no existing tolerance(s) for copper-ethylenediamine
complex.
D. International Tolerances
No maximum residue level has been established for copper-
ethylenediamine complex by the Codex Alimentarius Commission.
VII. Objections and Hearing Requests
The new FFDCA 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)and 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 governs 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 Marach 5, 1999, 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 under the ``ADDRESSES'' section (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). 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 tolerance objection fee waivers,
contact James Tompkins, 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. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5697, [email protected]. Requests for waiver of tolerance
objection fees should be sent to James Hollins, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
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). 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). 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.
VIII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300777] (including any comments and data submitted
electronically). 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 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[email protected].
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E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted diredtlly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes an exemption from the tolerance
requirement 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) (Pub.L. 104-4). Nor does it require any
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 additions, since tolerance exemptions that are established on
the basis of a petition under FFDCA section 408(d), such as the
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. Nevertheless, 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.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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 the rule in the Federal Register. This 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: December 21, 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. 180.1001 [Amended]
2. Section 180.1001 in subpart D is amended in paragraph (b)(1), by
adding alphabetically ``copper-ethylenediamine complex,''.
[FR Doc. 98-34702 Filed 12-31-98; 8:45 am]
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