E6-13082. Copper Sulfate Pentahydrate; Tolerance Exemption in or on Various Food and Feed Commodities

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes a tolerance exemption for residues of copper sulfate pentahydrate when applied in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses, poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding.

DATES:

This regulation is effective August 11, 2006. Objections and requests for hearings must be received on or before October 10, 2006, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES:

EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2005-0314. All documents in the docket are listed on the regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Marshall Swindell, Antimicrobials Division (7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/​ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2005-0314 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before October 10, 2006.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2005-0314, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket telephone number is [phone].

II. Background and Statutory Findings

In the Federal Register of December 21, 2005 (70 FR 75807) (FRL-7748-3), EPA issued a notice pursuant to section 408(d)(2) of Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-107) announcing the filing of a pesticide petition (PP 5F6982), by ArchAngel, LLC, 636 Hampshire St., Suite 208, Quincy, IL 62301. EPA did not receive any public comments in response to this petition. The petition requested that 40 CFR part 180 be amended to exempt from the requirement of a tolerance residues of the bactericide/fungicide copper sulfate pentahydrate when applied as a bactericide/fungicide in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses, poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding. Various copper containing substances, including copper sulfate pentahydrate, have been exempted from tolerance requirements for numerous uses. 40 CFR 180.1021 exempts the listed copper compounds when applied, among other things, to growing crops as well as shellfish, meat, milk, poultry, eggs, and irrigated crops.

Section 408(c)(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(c)(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. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which 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.

III. 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 sulfate pentahydrate are discussed in this unit.

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 (including humans) and plants. Copper is found naturally in the food we eat including fruits, vegetables, meats and seafood. It is found in the water we drink, the air we breathe and in our bodies themselves. Some of the environmental copper is due to direct modification of the environment by man such as mining and smelting of the natural ore. It is one of the elements found essential to life. The National Academy of Science establishes recommended daily allowances (RDAs) of vitamins and minerals for the diet. The RDA for copper ranges from approximately 400 micrograms per day (μg/d) in young children to 900 μg/d in adults. Additionally, over-the-counter dietary supplements containing copper at levels ranging from 0.33 milligram (mg) to 3 mg are available for individuals with low levels of copper. The copper ion is present in the adult human body with nearly two-thirds of the body copper content located in the skeleton and muscle. The liver is the primary organ for the maintenance of plasma copper concentrations.

Oral ingestion of excessive amounts of the copper ion from pesticidal uses including the proposed use is unlikely. Copper compounds are irritating to the gastric mucosa. Ingestion of large amounts of copper results in prompt emesis. This protective reflex reduces the amount of copper ion available for absorption into the human body. Additionally, at high levels humans are also sensitive to the taste of copper. Because of this organoleptic property, oral ingestions would also serve to limit high doses.

Only a small percentage of ingested copper is absorbed, and most of the absorbed copper is excreted. The human body appears to have efficient mechanisms in place to regulate total body copper. The copper ion occurs naturally in food and the metabolism of copper is well understood. The Agency has conducted a risk assessment in connection with the development and issuance of the Reregistration Eligibility Decision Document for Copper (EPA-HQ-OPP-2005-0558; Human Health Chapter). No endpoints of toxicology concern were identified for risk assessment purposes for a number of reasons. One of the foremost of these is the fact that copper is a required nutritional element for both plants and animals. Indeed, current available data and literature studies indicate that there is a greater risk from the deficiency of copper intake than from excess intake. Copper also occurs naturally in a number of food items including fruits, vegetables, meats and seafood. Although there is little known about the minimum levels of dietary copper necessary to cause evidence of adverse effect, this situation is likely due to the existence of an effective homeostatic mechanism that is involved in the dietary intake of copper and that protects man from excess body copper. Given that copper is ubiquitous and is routinely consumed as part of the daily diet, it is unlikely that with the current exposure pattern there would be any long term adverse effects.

Finally, sulfate has little toxic effect and is routinely used in medicine as a cathartic when combined with magnesium or sodium, the only adverse manifestation from this use being dehydration if water intake is concurrently limited.

IV. 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 ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide chemicals, the Agency considers the toxicity of the chemical in conjunction with possible exposure to residues of the chemical through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure, an exemption from the requirement of a tolerance may be established.

A. Dietary Exposure

Copper is ubiquitous in nature and is a necessary nutritional element for both animals (including humans) and plants. It is one of several elements found essential to life. The human body must have copper to stay healthy. In fact, for a variety of biochemical processes in the body to operate normally, copper must be part of our daily diet. Copper is needed for certain critical enzymes to function in the body. Actually, too little copper in the body can actually lead to disease.

1. Food. The main source of copper for infants, children, and adults, regardless of age, is the diet. Copper is typically present in mineral rich foods like vegetables (potato, legumes (beans and peas), nuts (peanuts and pecans), grains (wheat and rye), fruits (peaches and raisins), and chocolate in levels that range from 0.3 to 3.9 ppm. A single day's diet may contain 10 mg or more of copper. The daily recommended allowance of copper for adult nutritional needs is 2 mg. It is not likely that the approval of this petition would significantly increase exposure over that of the existing levels of copper.

2. Drinking water exposure. Copper is a natural element found in the earth's crust. As a result, most of the world's surface water and ground water that is used for drinking purposes contains copper. The actual amount varies from region to region, depending on how much is present in the earth, but in almost all cases the amount of copper in water is extremely low. Naturally occurring copper in drinking water is safe for human consumption, even in rare instances where it is at levels high enough to impart a metallic taste to the water. Residues of copper in drinking water are regulated under the Safe Drinking Water Act. A Maximum Contaminant Level Goal of 1.3 ppm has been set by the Agency for copper. According to the National Research Council's Committee on Copper in Drinking Water, this level is “set at a concentration at which no known or expected adverse health effects occur and for which there is an adequate margin of safety.” The Agency believes that this level of protection would not cause any potential health problems, i.e. stomach and intestinal distress, liver and kidney damage and anemia. It is not likely that the approval of this petition would significantly increase exposure over that of the existing levels of copper.

B. Other Non-Occupational Exposure

Copper compounds have many uses on crops (food as well as non-food) and ornamentals as a fungicide.

Dermal exposure. Given the prevalence of copper in the environment, no significant dermal exposure increase above current levels would be expected from the non-occupational use of copper sulfate pentahydrate.

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 indicated that air levels of copper are much lower. The Agency does not expect the air concentrations of copper to be significantly affected by the use of copper sulfate pentahydrate.

V. 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 including copper sulfate pentahydrate. For the purposes of this tolerance action, EPA has not assumed that copper compounds have a common mechanism of toxicity with other substances.

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

Copper sulfate pentahydrate is considered as Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA). EPA has also exempted various copper compounds from the requirement of a tolerance when used as aquatic herbicides (40 CFR 180.1021). Copper compounds, including copper sulfate pentahydrate, are also exempt from the requirements of a tolerance when applied to growing crops when used as a plant fungicide in accordance with good agricultural practices (40 CFR 180.1021).

1. U.S. population. Copper is a component of the human diet and an essential element. In addition, no acute or chronic dietary end points were selected because no endpoints of toxicological concerns have been identified for risk assessment purposes. Use of copper sulfate pentahydrate is not expected to increase the amount of copper in the diet as a result of its use on growing crops and post harvest use.

2. Infants and children. Copper is also a component of the diet of infants and children and also an essential element of their diet. Since no endpoints of concern have been identified, EPA has not conducted a quantitative risk assessment for copper sulfate pentahydrate. The Agency has also determined that the special FQPA safety factor to protect infants and children was not needed since there are no toxicity endpoints or uncertainty surrounding exposure.

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 sulfate pentahydrate residues.

VII. Other Considerations

A. Analytical Method

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

B. Existing Tolerance Exemptions

Copper sulfate pentahydrate has been exempted from the requirement of a tolerance under 40 CFR 180.1021 (c) when applied to growing crops or to raw agricultural commodities after harvest.

C. International Tolerances

The Agency is not aware of any country requiring a tolerance for copper sulfate pentahydrate nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

VIII. Conclusions

Based on the information contained in the document, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of copper sulfate pentahydrate. According, EPA finds that the exemption for residues in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses and poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding will be safe.

IX. Statutory and Executive Order Reviews

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). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). 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) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 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. The Agency hereby certifies that this rule will not have significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

X. Congressional Review Act

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 this final rule in the Federal Register. This final rule 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, copper sulfate pentahydrate

Dated: August 3, 2006.

Frank Sanders,

Director, Antimicrobials 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. 321(q), 346a and 371.

2. Section 180.1021 is amended by revising paragraph (c) to read as follows:

§ 180.1021

Copper; exemption from the requirement of a tolerance.

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(c) Copper sulfate pentahydrate (CAS Reg. No. 7758-99-8) is exempt from the requirement of a tolerance when applied as a fungicide to growing crops or to raw agricultural commodities after harvest, and as a bactericide/fungicide in or on meat, fat and meat by-products of cattle, sheep, hogs, goats, horses and poultry, milk and eggs when applied as a bactericide/fungicide to animal premises and bedding.

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