E8-6818. Ferric Citrate; Inert Ingredient; Exemption from the Requirement of a Tolerance

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance under 40 CFR 180.910 for residues of ferric citrate (CAS Reg. No. 2338-05-8) in or on raw agricultural commodities when applied/used as inert ingredients in pesticide formulations. The Shepherd Chemical Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996, requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ferric citrate.

DATES:

This regulation is effective April 2, 2008. Objections and requests for hearings must be received on or before June 2, 2008, 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-2006-0479. To access the electronic docket, go to http://www.regulations.gov, select “Advanced Search,” then “Docket Search.” Insert the docket ID number where indicated and select the “Submit” button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is [phone].

FOR FURTHER INFORMATION CONTACT:

Kathleen Martin, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR part 152. 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 FFDCA, as amended by 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-2006-0479 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 June 2, 2008.

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-2006-0479, 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 Bldg.), 2777 S. Crystal Dr., 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 Facility telephone number is [phone].

II. Background and Statutory Findings

In the Federal Register of June 7, 2006 (71 FR 32955) (FRL-8071-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6E7062) by The Shepherd Chemical Company, 4900 Beech Street; Norwood, OH 45212-2398. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of ferric citrate. No comments were received in response to the notice of filing.

Section 408(c)(2)(A)(i) of 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) of FFDCA 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) of FFDCA, 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) of FFDCA, 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. Provided below in Unit III is a brief summary and conclusions for the Agency's review of ferric citrate. The full Inert Ingredient Decision Document for this action is available on EPA's Electronic Docket at http://www.regulations.gov/​ under docket number EPA-HQ-OPP-2006-0479.

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 ferric citrate is discussed in this unit.

The Agency reviewed the available information on ferric citrate and determined that the toxicity database is sufficient. The toxicity studies summarized below are from the published literature; their full references are provided in the Decision Document. In summary, from what is known about the sulfates of iron (as opposed to the citrate), it appears that ferric citrate is not acutely toxic via the oral route. In subchronic toxicity using mice, no effects were noted at the maximum tolerated dose. In chronic toxicity testing, no effects were seen at 1,200 parts per million (ppm). Ferric citrate has not been shown to be mutagenic or carcinogenic. Finally, no developmental and reproductive effects have been shown.

Acute toxicity. No acute toxicity studies per se were identified for ferric citrate. In 2002 the Agency reassessed the tolerance exemptions for the mineral acids and their salts. Among the chemicals assessed were the iron sulfates. Acute toxicity values included: oral LD₅₀ rat—1,487 to 2,102 milligrams/kilograms (mg/kg); oral LD₅₀ mice—1,520 mg/kg; and dermal LD₅₀ rabbit—2,000 mg/kg. The National Academy of Sciences Institute of Medicine (IOM) discusses reports of acute toxicity resulting from overdoses of medicinal iron, especially in young children. Accidental iron overdose is the most common cause of poisoning deaths in children under six years of age in the U.S. The severity of iron toxicity is related to the amount of elemental iron absorbed. Gastrointestinal (GI) manifestations occur following the ingestion of 20 milligrams/kilograms body weight (mg/kg bw) and systemic toxicity may occur following the ingestion of 60 mg/kg bw. Vomiting and diarrhea characterize the initial stages of iron intoxication while later systemic effects can include those involving the heart, central nervous system, kidney, liver, and blood. IOM reports that in studies with adults, GI effects were seen at 50 milligrams/day (mg/day) of elemental iron; this finding is supported by other studies showing similar effects.

Subchronic toxicity. The open literature reports a study where ferric citrate was administered to mice in drinking water at doses of 0; 0.06; 0.12; 0.25; 0.5; or 1% (which is equivalent to 0; 600; 1,200; 2,500; 5,000; or 10,000 ppm) for 13 weeks. The investigators determined that the maximum tolerated dose is 1,200 ppm.

Mutagenicity. The open literature provides results of Ames testing (with S. typhimurium strains TA92, TA 1535, TA100, TA1537, TA94, and TA98) and chromosomal aberration testing (with Chinese hamster fibroblasts). In the Ames test using 25 milligrams/plate (mg/plate) of ferric citrate (the maximum dose), no significant increases in the number of revertant colonies were detected in any S. typhimurium strains. In the chromosomal aberration testing using 0.5 milligrams/milliLiters (mg/mL) (the maximum dose), polyploidy was observed in 3% of the cells after 48 hours and structural aberration was observed in 1% of the cells after 48 hours; the investigators concluded that these results were negative for chromosomal aberration.

Chronic toxicity. In a study reported in the open literature, ferric citrate was administered to mice in drinking water at doses of 0; 0.06; or 0.12% (which is equivalent to 0; 600 or 1,200 ppm) for 96 weeks. No evidence of chronic toxicity or carcinogenicity was demonstrated in the study.

Developmental and reproductive toxicity. To determine if toxic fetal serum iron levels are reached when maternal serum iron concentrations rise above what the body can homeostatically maintain, investigators dosed pregnant sheep with toxic doses of iron. Specifically, four gravid ewes were dosed with ferric chloride at 2 mg/kg/bw via intravenous administration over 60 minutes; this route was chosen over the oral route because only a small amount of iron is absorbed from the gastrointestinal tract after overdose. A significant rise was observed in the maternal serum iron concentration but not in that of the fetuses. The investigators concluded that the fetus is protected from elevated maternal serum iron concentrations during the third trimester of pregnancy, a period when the fetus acquires most of the iron that it needs during the gestational period.

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 does not have information available to assess the potential for exposure to ferric citrate in consumer products. Nevertheless, given: The natural and ubiquitous occurrence of iron-containing compounds in the environment; iron's known role in human physiology; and its presence in various foods such as beef, soybeans, lentils, and spinach, it is unlikely that residential exposures of concern would result from the use of ferric citrate in nonpesticide products and as an ingredient in pesticide. Therefore, no further aggregate assessment is necessary.

Dietary Exposure Food. EPA estimated dietary exposures for use of ferric citrate as an inert ingredient using DEEM^(tm), or Dietary Exposure Evaluation Model, a generic screening model that assumes that the inert ingredient is used on all commodities and that 100 percent of crops are treated with the inert ingredient. Generic chronic exposure for the overall U.S. population was estimated at 0.12 mg/kg/day.

2. Drinking water exposure. Iron concentrations in groundwater have been reported to range <0.5 to 100 mg/L; higher values have been found in the absence of oxygen and in the presences of organic matter. In surface waters, iron concentrations can vary widely, ranging from 61 to 2,680 milligrams/Liters (mg/L).

V. Cumulative Effects

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to ferric citrate and any other substances and, this material does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that ferric citrate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/​pesticides/​cumulative/​.

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

Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues. Accordingly, EPA finds that exempting from the requirement of a tolerance will be safe.

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. International Tolerances

The Agency is not aware of any country requiring a tolerance for ferric citrate (CAS Reg. No. 2338-05-8), nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

VIII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of FFDCA 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 final rule has been exempted from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., 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).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance 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.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not apply to this final rule. In addition, this final rule does not 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).

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).

IX. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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

Dated: March 21, 2008.

Lois Rossi,

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:

Authority: 21 U.S.C. 321(q), 346a and 371.

2. In §180.910 the table is amended by adding alphabetically the following inert ingredient to read as follows:

§ 180.910

Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.

* * * * *

Inert ingredients	Limits	Uses
*    *    *    *    *    *    *
Ferric Citrate (CAS Reg. No. 2338-05-8)		Stabilizer
*    *    *    *    *    *    *