[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