[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: 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 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: parker.cynthia@epamail.epa.gov.
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
