[Federal Register Volume 62, Number 148 (Friday, August 1, 1997)]
[Rules and Regulations]
[Pages 41283-41286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20361]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300524; FRL-5734-7]
RIN 2070-AB78
Copper Octanoate; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for the fungicide copper octanoate (CAS Reg. No. 20543-
04-8, PC Code 23306) when used in accordance with good agricultural
practice as an active ingredient in pesticide formulations applied to
growing crops. The petitioner, W. Neudorff GmbH KG requested this
tolerance exemption under the Federal Food, Drug and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (Pub. L.
104-170) in pesticide petition 6F4734.
DATES: This regulation is effective August 1, 1997. Objections and
requests for hearings must be received by EPA on or before September
30, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300524], 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-300524], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), 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. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300524]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of 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) 308-305-7740, e-mail:
giles-parker. [email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of January 15, 1997
(62 FR 2154)(FRL-5580-4), EPA, issued a notice pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346(a)(d) announcing the filing of a pesticide petition (PP) 6F4734
proposing to amend the 40 CFR part 180 by establishing an exemption
from the requirement of a tolerance for copper octanoate in or on all
raw agricultural commodities when applied to growing crops. This notice
included a summary of the petition prepared by W. Neudorff GmbHKG
(``Neudorff''), the registrant. There were no comments received in
response to the notice of filing.
The petition requested that 40 CFR 180.1001(b)(1) be amended by
adding copper octanoate to the list of copper compounds which are
exempt from the requirement of a tolerance.
I. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of Copper
Octanoate and to make a determination, consistent with section
408(b)(2), for an exemption from tolerance requirements for Copper
Octanoate. EPA's assessment of the data associated with establishing
the tolerance exemption follows.
A. Product and Residue Chemistry
1. Product chemistry. Copper octanoate, is a copper salt of a fatty
acid. Copper octanoate is biodegraded first by water hydrolysis into
the copper ion and fatty acid components, and then the fatty acids are
further degraded by two carbon units at a time until they eventually
degrade to water and CO2.
2. Magnitude of the residue anticipated at the time of harvest and
method used to determine the residue. No residues are expected at the
time of harvest on crops treated with copper
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octanoate, because rainwater readily washes copper octanoate off
plants, and this chemical is biodegraded by water hydrolysis into its
copper ion and fatty acid components, and then the fatty acids are
further degraded by two carbon units at a time until they eventually
degrade to water and CO2. In addition, the physio-chemical
properties of soils naturally modify copper ion availability, and when
soils are adjusted/limed to the pH required for normal crop production,
the effect is to reduce copper availability to the crop. Furthermore,
toxic copper levels in plants induce an imbalance with iron which
causes plant dwarfing, stunted roots and decreased growth and yields,
which effects appear before significant copper buildup occurs, and
consequently acts as a warning which prevents excess application of
copper compounds to food/feed crops. Last, even if residues were to
remain on plants, the copper ion is a trace element, or micronutrient,
essential for the growth and well being of higher plants and animals,
including man. Therefore, the amount of this chemical proposed for
application to plants is highly unlikely to cause harm to plants or
animals or to leave excess residues on the plants.
3. Analytical method for detecting and measuring the levels of the
pesticide residue are not needed. The Agency proposes to establish
exemptions from the requirement of a tolerance without any numerical
limitation; therefore, the Agency has concluded that analytical methods
are not required for enforcement purposes for copper octanoate.
B. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. The nature of the toxic
effects caused by Copper Octanoate are discussed below.
1. Acute toxicity. Results of studies conducted on a concentrate
product containing copper octanoate and for which Neudorff has applied
for registration indicate that this chemical has low acute toxicities.
The following outlines the results of the acute toxicity studies:
a. An oral LD50 rat study. Male and female rats were
orally administered single doses of undiluted test material at a dose
level of 2,000 milligrams (mg)/kilogram(kg) mg/kg. The estimated acute
oral LD50 for copper octanoate 10% copper fatty acids was >
2,000 mg/kg for the sexes combined.
b. A dermal LD50 rat study. Male and female rats
received a dermal application of undiluted test material at a mg/kg
(limit dose) for 24 hours. The acute dermal LD50 for Copper
octanoate (10% copper fatty acid) in male and female rats was > 2,000
mg/kg.
c. Inhalation LC50 rat study. Groups of rats were
exposed to an aerosol concentration of 0.38 mg/L NEU 1140 F for 4
hours. There were no mortalities and clinical signs observed. The acute
inhalation LC50 was > 0.38 mg/L (the highest achievable
concentration) in both sexes of rats. Since no mortality and clinical
signs occured at the highest achievable concentration of 0.38 mg/L, NEU
1140 F was classified as Toxicity Category III for inhalation.
d. Primary rabbit eye irritation study. Approximately 0.1 ml of
test material was instilled into the conjunctival sac of one eye of
three male rabbits. The other eye served as an untreated control.
Application of NEU 1140 F caused irritation of conjunctivae in all
rabbits which was reversible within 48 hours. The study demonstrated
that NEU 1140 F produces transient ocular irritation in rabbits.
e. Primary rabbit skin irritation study. Test material, 0.5 g,
moistened with 0.5 ml of 0.5% distilled water was applied to a clipped
skin area of three rabbits for 4 hours. The study demonstrated that
copper ocatnoate is non-irritating to the rabbit skin.
f. Dermal sensitization guinea pig study. In a Maximization Test,
20 guinea pigs received 3 intradermal injections of 0.5% NEU 1140 F in
distilled water and an epidermal application of undiluted test material
during the induction phase. During the challenge phase, a topical
appication of 50% test substance concentraton in distilled water was
administered to animals. The study showed that NEU1140 is a non-
sensitizer of skin in female guinea pigs.
2. Genotoxicity, reproductive and developmental toxicity,
subchronic toxicity, and chronic toxicity. There is adequate
information available to characterize the toxicity of the copper ion.
Copper is ubiquitous in nature and is a necessary nutritional element
for both animals and plants. It is 1 of 26 elements found essential to
life. The copper ion is present in the adult human body at levels of
80-150 mg. Oral ingestion of excessive amounts of the copper ion from
pesticidal uses is unlikely; copper compounds are irritating to the
gastric mucosa and emesis usually occurs promptly, thereby reducing the
amount of copper ion available for absorption into the human body. Only
a small percentage of ingested copper is absorbed, and most of the
absorbed copper is excreted. In view of the facts that the copper ion
occurs naturally in most foods and the metabolism of copper is well
understood, there is no reason to expect that long-term exposure to the
copper ion in the diet is likely to pose the risks of chronic or sub-
chronic adverse effects. It is unlikely that the toxicity profile for
copper octanoate would differ significantly from the numerous other
copper compounds which are already exempted from the requirement of a
tolerance.
C. Aggregate Exposure
As part of the hazard assessment process, the Agency reviews the
available toxicological database to determine the endpoints of concern
for acute and chronic dietary exposure; and short, intermediate and
chronic term occupational and residential exposure. In the case of
copper octanoate the Agency only reviewed acute toxicity data on the
end-use product formulations, since information currently available to
the Agency indicates that there is no significant toxicity from
exposure to copper octanoate that lasts from 1 day to several months.
The Agency has exempted from the requirement of a tolerance other
compounds similar to copper octanoate, such as the, copper salts of
fatty acids that include: copper oleate, copper lineolate and copper
acetate which are listed in 40 CFR 1011(b)(1). Therefore, no risk
assessments are required for any exposure scenarios.
After taking into account the factors set forth in section
408(b)(2)(D), EPA concludes that copper does not present a dietary risk
under reasonably forseeable circumstances. Accordingly, EPA concludes
that there is a reasonable certainty that no harm will result to
consumers, including infants and children, from aggregate exposure to
copper. Because copper has no significant toxicity EPA has not assessed
its risk using a margin of safety approach and, therefore, the
requirement pertaining to an additional safety factor for infants and
children is not applicable to EPA's safety determination for this
exemption.
D. Existing Tolerances
1. Existing tolerances or tolerance exemptions. EPA has not
established a tolerance or an exemption from the requirement for a
tolerance for this chemical. However, EPA has promulgated a tolerance
exemption for a group of similar copper-based chemicals, i.e., Bordeaux
mixture, copper acetate, basic copper carbonate (malachite), copper
hydroxide, copper-
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lime mixtures, copper linoleate, copper oleate, copper oxychloride,
copper sulfate basic, copper sulfate monohydrate, copper sulfate
pentahydrate, copper-zinc chromate, cupric oxide, and cuprous oxide
(two of these chemicals are copper salts of fatty acids), when they are
applied to growing crops in accordance with good agricultural practice.
See 40 CFR 180.1001(b)(1). In addition, EPA has promulgated a tolerance
exemption for copper residues in meat, milk, poultry, eggs, fish, and
irrigated crops when they result from the use of certain copper
compounds, i.e., copper sulfate, basic copper carbonate, copper
triethanolamine, copper monoethanolamine, and cuprous oxide, at certain
sites. See 40 FR 180.1021. The common basis for EPA's tolerance
exemptions for the compounds in these two classes of copper compounds
appears to be the fact that the copper ion is the entity responsible
for their fungicidal action, and there is adequate data on the copper
ion upon which EPA can make judgments about its potential for causing
unreasonable adverse effects to humans or the environment.
2. International tolerances. No maximum residue level has been
established for this substance by the Codex Alimentarius Commission.
II. Conclusion
Therefore, an exemption from requirement of a tolerance is
established for copper octanoate in pesticide formulations applied to
growing crops.
III. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (1)(6) 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 govern 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 September 30, 1997, 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 above (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). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (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 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 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
Confidential Business Information (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.
regulation issued by EPA under new section 408(e) and (l)(6) as was
provided in the old section 408 and in section 409. However, the period
for filing objections is 60 days, rather than
IV. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300524] (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 1132 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above 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 rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
V. Regulatory Assessment Requirements
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 any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or 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 addition, since these tolerances and 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 has
previously assessed whether establishing
[[Page 41286]]
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.
VI. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's 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: July 24, 1997.
Stephen L. Johnson,
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
Sec. 180.1001 [Amended]
2. In Sec. 180.1001, Exemptions from the requirement of a
tolerance, by adding and alphabetically inserting copper octanoate in
paragraph (b)(1).
[FR Doc. 97-20361 Filed 7-31-97; 8:45 am]
BILLING CODE 6560-50-F