[Federal Register Volume 63, Number 241 (Wednesday, December 16, 1998)]
[Rules and Regulations]
[Pages 69205-69208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-33117]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300765; FRL 6048-5]
RIN 2070-AB78


Copper Ammonium 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 ammonium complex in or on raw 
agricultural commodities when used in accordance with good agricultural 
practices as an active ingredient in pesticide formulations applied to 
growing crops. Chemical Specialties, Inc., 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 this 
tolerance exemption.

DATES: This regulation is effective December 16, 1998. Objections and 
requests for hearings must be received by EPA on or before February 16, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the

[[Page 69206]]

docket control number [OPP-300765], 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-300765], must also be submitted to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [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 or ASCII file format. All copies of 
electronic objections and hearing requests must be identified by the 
docket number [OPP-300765]. 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: Cynthia Giles-Parker, 
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: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, 703-305-7740; e-mail: giles-
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 12, 1998 (63 
FR 3211) (FRL-5797-7), EPA issued a notice pursuant to section 408 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) 
announcing the filing of a pesticide petition by Chemical Specialties, 
Inc., One Woodlawn Green, Suite 250, Charlotte, NC 28217. This notice 
included a summary of the petition prepared by the petitioner Chemical 
Specialties, Inc. 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 ammonium complex.

I. Risk Assessment and Statutory Findings

    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 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 use 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 
ammonium complex are discussed below:
    1. Acute toxicity. The acute oral LD50 for a 31.4% 
solution of copper ammonium complex is 2,055 milligrams/kilogram (mg/
kg). Accordingly, the acute oral toxicity of copper ammonium complex is 
relatively low.
    2. Genotoxicity, reproductive and developmental toxicity, 
subchronic toxicity and chronic toxicity. Copper is ubiquitous in 
nature, found naturally in most foods and essential for the well-being 
of humans: the copper ion is present in the adult human body at levels 
of 80-150 mg. 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 any subchronic, 
developmental, reproductive or chronic adverse effects. Finally, the 
toxicity profile of copper ammonium complex should not significantly 
differ from the numerous other copper compounds which are already 
exempted from the requirement of a tolerance.

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. Copper is naturally found in several types of food, such 
as fruits and vegetables, at levels ranging from 0.3-3.9 ppm. These 
levels are much higher than the levels of copper, if any, that may 
occur from the pesticidal application of copper ammonium complex. 
Copper levels in plants, subsequent to the application of copper 
ammonium complex or other copper salts, are minimized since high copper 
levels induce an imbalance with iron which causes plant dwarfing, 
stunted roots and decreased growth and yields. These effects appear 
before significant copper buildup takes place. The Agency has waived 
all residue chemistry studies for copper ammonium complex since copper 
is an essential trace element critical for the propogration of plants; 
copper is found in many foods; and it is impossible to distinguish 
copper residues resulting from naturally

[[Page 69207]]

occuring copper or copper ammonium complex.
    2. Drinking water exposure. The average copper concentration in 
drinking water is 0.13 ppm. This concentration is substantially below 
the drinking water standard of 1 ppm.

B. Other Non-Occupational Exposure

     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 0.003-7.32 g/m3. Other studies 
indicate that air levels of copper are much lower.

IV. Cumulative Effects

    Copper has no significant toxicity to humans. Accordingly, the 
Agency believes that there is no reason to expect any cumulative 
effects from the use of copper ammonium complex on food crops.

V. Determination of Safety for U.S. Population, Infants and 
Children

    Several copper compounds, such as the copper salts of fatty acids 
and copper sulfate, are currently approved for use on food crops. Since 
copper ammonium complex is a substitute for these copper compounds, and 
under use-conditions, releases equivalent amounts of copper, no 
increases in dietary exposure will occur from the use of copper 
ammonium complex on food crops. Moreover, copper is an essential trace 
element for which the National Academy of Sciences has issued a 
recommended daily allowance of 0.5-1.0 mg/day for infants, 1.0-2.0 mg/
day for small children and 2.0-3.0 mg/day for adolescents and adults. 
Furthermore, since copper has no significant toxicity and EPA has 
therefore not used a margin of safety approach to assess any risk posed 
by copper, the requirement pertaining to an additional margin of safety 
for infants and children is not applicable to EPA's safety 
determination for this tolerance exemption. Because use of copper 
ammonium complex is unlikely to pose a dietary risk under reasonably 
foreseeable circumstances, EPA concludes that there is a reasonable 
certainty of no harm from aggregate exposure to copper ammonium complex 
residues. Accordingly, EPA finds that exempting copper ammonium complex 
from the requirement of a tolerance will be safe.

VI. Other Considerations

A. Endocrine Disruptors

    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 3 years after August 3, 1996, for the Agency to implement a 
screening program with respect to endocrine effects.

B. Analytical Method(s)

    The Agency is establishing an exemption from the requirement of a 
tolerance without any numeric limitation; therefore, the Agency has 
concluded that an analytical method is not required for enforcement 
purposes for copper ammonium complex.

C. Existing Tolerances

    There are no existing tolerances for copper ammonium complex.

D. International Tolerances

     No maximum residue level has been established for copper ammonium 
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 February 16, 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) or a request for a fee waiver, as noted in 40 CFR 
180.33(m). 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-300765]. 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 Rm. 119 of the Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing request, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the Virginia address in 
ADDRESSES at the beginning of this document.

[[Page 69208]]

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). 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 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 section 408(d) of the 
FFDCA, 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 to 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 1, 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:

Sec. 180.1001 [Amended]

    Authority: 21 U.S.C. 346a and 371.


    2. In Sec. 180.1001, by adding ``copper ammonium complex'' 
immediately after ``copper acetate,'' in paragraph (b)(1).

[FR Doc. 98-33117 Filed 12-15-98; 8:45 am]
BILLING CODE 6560-50-F