E9-19193. Carbon Black; 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 for residues of carbon black (CAS Reg. No. 1333-86-4) under 40 CFR 180.920 when used as an inert ingredient (colorant) in pesticide formulations applied to seeds used to grow agricultural and horticultural crops. Becker Underwood, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of carbon black.

DATES:

This regulation is effective August 12, 2009. Objections and requests for hearings must be received on or before October 13, 2009, 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-2009-0129. All documents in the docket are listed in the docket index available at http://www.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 in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open 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:

Elizabeth Fertich, 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. 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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/​ecfr.

C. Can I File an Objection or Hearing Request?

Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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-2009-0129 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 13, 2009.

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-2009-0129, 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 Facility'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 May 6, 2009 (74 FR 20947) (FRL-8412-7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170), announcing the filing of a pesticide petition (PP 8E7484) by Becker Underwood, Inc., 801 Dayton Ave., P.O. Box 667, Ames, IA 50010. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of carbon black when used as an inert ingredient (colorant) in pesticide formulations applied to seeds used to grow agricultural and horticultural crops. That notice included a summary of the petition prepared by the petitioner. There were no comments received in response to the notice of filing.

Section 408(b)(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(b)(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. Section 408(b)(2)(C) of FFDCA 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. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

IV. 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 carbon black are discussed in this unit.

Based on the limited systemic toxicity, carbon black is not expected to pose a hazard when used for its proposed use pattern as an inert ingredient (colorant) in pesticide formulations applied to seeds used to grow agricultural and horticultural crops. Six acute toxicity studies were submitted by the petitioner to support this action. The results indicate that carbon black is very low in toxicity. The acute oral toxicity of carbon black to rats and the acute dermal toxicity to rabbits are both low. The lethal dose (LD)₅₀ for both was determined to be greater than 5,050 milligrams/kilogram (mg/kg) and the EPA Toxicity Category is IV. The acute inhalation toxicity to rats was also low with a lethal concentration (LC)₅₀ of greater than 2.54 mg/Liter (L) and the toxicity category is IV. Acute eye and dermal irritation to rabbits were both rated as non-irritating with a Toxicity category of IV. A skin sensitization study on guinea pigs determined that carbon black is not a dermal sensitizer.

The toxicity of carbon black is summarized in a 2005 Tolerance Reassessment Document (http://www.epa.gov/​opprd001/​inerts/​carbonblack.pdf). No systemic toxicity was identified in a chronic toxicity/carcinogenicity study in mice and rats fed carbon black at doses up to 1,000 mg/kg/day for 2 years (Gandhi, 2005). No developmental or reproductive studies were identified in this report for carbon black. However, there was no evidence of effects on reproductive organs observed in a 2 year, long term study in rats. The lack of systemic toxicity identified at doses up to 1,000 mg/kg/day in the 2 year chronic toxicity study also supports the lack of developmental and reproductive effects. It has also been determined that assays for mutagenicity are negative for carbon black. No neurotoxicity information is available, however, no neurological effects were observed in any of the available studies. There is no evidence of carcinogenicity by oral route. However, there is some evidence of lung tumors in occupational exposure scenarios via inhalation route.

V. Aggregate Exposures

In examining aggregate exposure, section 408 of FFDCA 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).

Residential exposures (inhalation and dermal) are not expected since there are no existing or proposed residential uses. Dietary exposure (food and drinking water) to carbon black is not expected since it is a solid, insoluble particle that adsorbs to the seed surface only. It is not likely that it will be absorbed into the seed and translocated to the plant and harvested plant parts. In addition, carbon black has limited toxicity, therefore no harm is expected.

As stated above, no hazard was identified for dietary and residential exposures to carbon black. Therefore, no aggregate risk assessments were performed. For carbon black, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate given the lack of human health concerns, associated with the exposure to carbon black when used as an inert ingredient (colorant) in pesticide formulations applied to seed used to grow agricultural and horticultural crops.

VI. 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 carbon black and any other substances and carbon black does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has not assumed that carbon black 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/​.

VII. Safety Factor for Infants and Children

Section 408 of the FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X or uses a different additional safety factor when reliable data supports the choice of a different factor.

The toxicity database is sufficient for carbon black and potential exposure is adequately characterized given the low toxicity of the chemical. In terms of hazard, there are low concerns and no residual uncertainties regarding prenatal and/or postnatal toxicity. “Carbon black has low subchronic and chronic toxicities. Although no developmental or reproductive studies, per se, were identified, long-term studies have not demonstrated any effects on the reproductive organs of male or female rats. Additionally, the poor to nil absorption of carbon black as demonstrated by the lack of significant adverse effects by the oral route even at high doses would mitigate any concerns” (Gandhi, 2005). No acute or subchronic neurotoxicity studies are available, but there were no signs of neurological effects observed in the database at doses up to 1,000 mg/kg/day. Therefore, the Agency concluded that these studies are not required. Based on this information, there is no concern at this time for increased sensitivity to infants and children to carbon black when used as an inert ingredient in pesticide formulations as a colorant for pesticides applied as seed treatment to seed used to grow agricultural and horticultural crops and a safety factor analysis has not been used to assess risk.

Further, given the limited exposure potential based on the proposed use and limited systemic toxicity, a safety factor analysis has not been used to assess the risks resulting from the inert pesticidal use of carbon black. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children.

VIII. Determination of Safety for U.S. Population

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 inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient 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 to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Residues of concern are not anticipated for dietary exposure (food and drinking water) or for residential exposure (dermal and inhalation) from the use of carbon black for the proposed use pattern as an inert ingredient in pesticide products. As discussed above, EPA expects aggregate exposure to carbon black to pose no appreciable dietary risk given that the data on carbon black shows a lack of systemic toxicity at doses up to 1,000 mg/kg/day. In addition, dietary exposure is not expected since carbon black is a solid, insoluble particle that adsorbs to the seed surface only. It is not likely that it will be absorbed into the seed and translocated to the plant and harvested plant parts. Also, carbon black will be used in very small amounts as a colorant for pesticides applied as a seed treatment to seed used to grow agricultural and horticultural crops. Based on the available exposure and toxicity information, a safety factor analysis has not been used to assess the risks resulting from the inert pesticidal use of carbon black.

Taking into consideration all available information on carbon black, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to carbon black. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of carbon black when used as an inert ingredient (colorant) in pesticide formulations applied to seeds used to grow agricultural and horticultural crops can be considered safe under section 408 of the FFDCA.

IX. Other Considerations

A. Endocrine Disruptors

EPA is required under FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

When additional appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, carbon black may be subjected to further screening and/or testing to better characterize effects related to endocrine disruption.

B. Analytical Method(s)

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.

C. Existing Exemptions

Currently, carbon black is exempted from tolerance requirements in pesticide formulations applied to animals when used as a colorant/pigment in animal tags (40 CFR 180.930).

D. International Tolerances

The Agency is not aware of any country requiring a tolerance for carbon black nor have any CODEX Maximum Residue Levels been established for any food crops at this time.

X. Conclusions

Therefore, an exemption from the requirement of a tolerance is established for carbon black (CAS Reg. No. 1333-86-4) when used as an inert ingredient (colorant) in pesticide formulations applied to seed used to grow agricultural and horticultural crops.

XI. Statutory and Executive Order Reviews

This final rule establishes an exemption from the requirement of 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, entitled 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 9, 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).

XII. 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: July 31, 2009.

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 § 180.920, the table is amended by adding alphabetically the following inert ingredient to read as follows:

§ 180.920

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

Inert ingredients	Limits	Uses
*         *         *         *         *         *         *
Carbon Black (CAS Reg. No. 1333-86-4)	For seed treatment use only	Colorant.
*         *         *         *         *         *         *