Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of silica, amorphous, fumed (crystalline free) (CAS Reg. No. 112945–52–5) also known as silicon dioxide fumed amorphous when used as an inert ingredient when applied to animals. Cabot Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act (FQPA) 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 silica, amorphous, fumed (crystalline free). By law, EPA is required to reassess 66% or about 6,400 of the tolerances in existence on August 2, 1996, by August 2002. Upon publication of this final rule, one tolerance reassesment for the existing tolerance exemption in 40 CFR 180.1001(c) for silicon dioxide fumed amorphous will be counted toward the August 2002 review deadline of FFDCA section 408(q), as amended by FQPA in 1996.
This regulation is effective May 15, 2002. Objections and requests for hearings, identified by docket control number OPP–2002–0031, must be received on or before July 15, 2002.
Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VIII. of the
By mail: Treva Alston, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308–8373; e-mail address: Treva.Alston@epa.gov.
You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
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 the table could also be affected. The North American
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In the
The petition requested that 40 CFR 180.1001(e) be amended by establishing an exemption from the requirement of a tolerance for residues of silica, amorphous, fumed (crystalline free).
Section 408(b)(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(b)(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. Section 408(b)(2)(C) 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.
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 ploymers 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.
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. Silica, amorphous, fumed (crystalline free) is composed of oxygen and silicon, the most abundant and second-most abundant elements in the earth's crust, respectively. Silicon almost always occurs in combination with oxygen, and a number of naturally-occurring minerals (such as quartz) are pure, or nearly pure, silicon dioxide. Silica can be divided into two types: crystalline and amorphous. The major toxicological hazard of crystalline silica is through the inhalation route of exposure. Silicosis and/or cancer can result from long-term inhalation of the crystalline form (such as crystalline quartz). However, exposure to amorphous forms of silica is not associated with silicosis or cancer. In fact, IARC (International Agency for Research on Cancer) has classified crystalline forms of silica when inhaled from occupational exposures as Group I, carcinogenic to humans. The IARC has classified amorphous forms of silica as Group 3, not classifiable as to its carcinogenicity to humans. Silica, amorphous, fumed (crystalline free) is a manufactured product. Chemically and physically it is similar to diatomateous earth.
The petitioner submitted to the Agency four acute toxicity studies (acute oral LD
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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 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.
Silica, amorphous, fumed (crystalline free) is composed of oxygen and silicon, which are the most abundant and second-most abundant elements in the earth's crust respectively. Silicon almost always occurs in combination with oxygen, and there are a number of naturally-occurring forms. For this reason, EPA has considered that silica, amorphous, fumed (crystalline free) could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure is possible.
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It is highly likely that silica, amorphous, fumed (crystalline free) can be used in and around the home. Given its high molecular weight (645,000 daltons), it is unlikely that it could be absorbed through the skin in sufficient amounts to cause toxicity in a residential setting. Given the nature of silica, amorphous, fumed (crystalline free) and its anticipated uses, the Agency has examined residential inhalation exposures using a screening approach. There are no concerns for inhalation exposures typical of those found in a residential scenario.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify or revoke a tolerance or tolerance exemption, the Agency considers “available information” concerning the cumulative effects of a particular chemical's residues and ”other substances that have a common mechanism of toxicity.” Silica, amorphous, fumed (crystalline free) has demonstrated a lack of toxicity, and thus is unlikely to share a common mechanism of toxicity with any other substances.
FFDCA section 408 provides that EPA shall apply an additional tenfold 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 data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of silica, amorphous, fumed (crystalline free), EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Silica, amorphous, fumed (crystalline free) has a demonstrated lack of toxicity. The acute toxicity studies are toxicity category IV. The mutagenicity studies are negative. Silica, amorphous, fumed (crystalline free) is not classifiable, as to its carcinogenicity however, given its amorphous nature, it is not expected to pose a carcinogenic risk. Silicas are considered to be inert when ingested, and due to the high molecular weight it is unlikely to be absorbed through the skin. There should be no concerns for human health, whether the exposure is acute, subchronic, or chronic by any route. Thus, based on the very low toxicity of silica, amorphous, fumed (crystalline free), the Agency has determined that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of silica, amorphous, fumed (crystalline free) and that a tolerance is not necessary.
There is no available evidence that silica, amorphous, fumed (crystalline free) is an endocrine disruptor.
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.
There is an existing exemption from the requirement of a tolerance under 40 CFR 180.1001(c) for use as flow control, anticaking, and carrier agent.
The Agency is not aware of any country requiring a tolerance for silica, amorphous, fumed (crystalline free) nor have any CODEX Maximum Residue
Based on the information in this preamble, EPA concludes that there is a reasonable certainty of no harm from aggregate exposure to residues of silica, amorphous, fumed (crystalline free). Accordingly, EPA finds that exempting silica, amorphous, fumed (crystalline free) from the requirement of a tolerance will be safe.
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. EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP–2002–0031 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 July 15, 2002.
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Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260–4865.
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EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305–5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a 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(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
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
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346(a) and 374.
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