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copper-ethylenediamine complex Tolerance Requirement Exemption 12/98

 

[Federal Register: January 4, 1999 (Volume 64, Number 1)]
[Rules and Regulations]               
[Page 41-44]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja99-21]

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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: 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 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: 
jackson.sidney@epamail.epa.gov.

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<greek-T><greek-M> Plant 
Desiccant, a formulation containing 8% elemental copper. An identical 
product, KOMEEN<Register> 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) <INF>50</INF> (95% 
confidence limits) for Komeen was 498 milligram (mg)/kilogram (kg) 
(349-710 mg/kg) for a Toxicity Category II classification.
    The acute dermal LD<INF>50</INF> 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) <INF>50</INF> (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<greek-T><greek-M> 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, tompkins.jim@epa.gov. 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:
    opp-docket@epa.gov.



[[Page 44]]


    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]
BILLING CODE 6560-50-F