Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Octanal,

[Federal Register: September 30, 2004 (Volume 69, Number 189)]

[Rules and Regulations]

[Page 58299-58304]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr30se04-14]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0298; FRL-7678-7]

Octanal; 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 octanal on growing crops or raw agricultural commodities (RAC) when used as an inert ingredient in pesticide formulations applied to growing crops, RAC after harvest, or to animals. Firmenich 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 octanal.

DATES: This regulation is effective September 30, 2004. Objections and requests for hearings must be received on or before November 29, 2004.

ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number OPP-2004-0298. All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket. Although

listed in the index, some information is not publicly available, i.e., 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 electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460- 0001; telephone number: (703) 308-8033; e-mail address: campbell.princess@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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 111)

      Animal production (NAICS 112)

      Food manufacturing (NAICS 311)

      Pesticide manufacturing (NAICS 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.

   2. How Can I Access Electronic Copies of this Document and Other Related Information?

      In addition to using EDOCKET (http://www.epa.gov/edocket/) you may

      access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180

      is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

2. Background and Statutory Findings

   In the Federal Register of December 20, 2000 (65 FR 79834) (FRL- 6751-9), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (6E4757) by Firmenich, P.O. 5880, Princeton, NJ 08543.

   Firmenich requested that octanal, also known as caprylic aldehyde, or 1-octanal, be approved for use as an inert ingredient in pesticide formulations applied to growing crops, RACs after harvest, or to animals at an amount that was not to exceed 0.2% of the formulated product. This notice included a summary of the petition prepared by the petitioner Firmenich.

   The petition requested that 40 CFR 180.1001, (c) and (e), newly re- designated as Sec. 180.910 and Sec. 180.930 April 28, 2004 (69 FR 23113) (FRL-7335-4), be amended by establishing an exemption from the requirement of a tolerance for residues of octanal, (CAS Registration No. 124-13-0). There were no comments received in response to the notice of filing.

   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

   [[Page 58300]]

   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.

3. 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 octanal are discussed in this unit.

   1. Toxicity data

      Table 1 below summarizes the toxicological aspects of octanal (C8aldehyde), and its surrogates, heptanal (C7 aldehyde) and nonanal (C9aldehyde). All three chemicals belong to a group of short-chained linear (unbranched) aliphatic acyclic aldehydes. Based on their structural similarities, and the fact that studies indicate that these aldehydes are biochemically similar, toxicity data can be used almost interchangeably as surrogate data for these three substances. These aliphatic aldehydes are oxidized in the body to form the corresponding fatty acids. Thus, the corresponding fatty acids, octanoic and nonanoic acid, which are essentially metabolites of the original aldehyde can also be used as surrogate data. The Agency used the surrogate data from heptanal, nonanal, octanoic acid, and nonanoic acid as discussed in table 1 below, to supplement the available information on octanal.

      Table 1.--Comparative Toxicity Data for Octanal, Heptanal, and Nonanal

      Study Type

      Octanal

      Heptanal

      Nonanal

      Acute oral toxicity - rat

      LD50 = 5.63 mL/kg

      *LD50 > 5,000 mg/kg LD50 > 5,000 mg/kg *LD50 = 4,616 mg/kg....

      Acute dermal toxicity - rabbit

      *LD50 = 5,207 mg/kg *LD50 > 5,000 mg/kg *LD50 > 5,000 mg/kg

      Acute eye irritation - rabbit

      0.01 mL is irritating, NA

      NA 0.5 mL severe burn

      Acute dermal irritation - rabbit At 0.5 mL moderate NA

      NA dermal reaction (irritant)

      14 day dermal (5 days per week for NA

      In this single dose Rabbit/New Zealand two weeks with a two week recovery

      study, at 500 mg/kg/ White M/F period)

      day there was local NOAEL thSt., NW., Washington, DC 20005. 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) 564-6255.

      2. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2004-0298, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

   2. When Will the Agency Grant a Request for a Hearing?

      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).

10. 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. In addition, the Agency has determined that this action will not have a substantial direct effect

    [[Page 58304]]

    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.

11. 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.

    Dated: September 23, 2004. Lois Rossi, Director, Registration Division, Office of Pesticide Programs.

    0 Therefore, 40 CFR chapter I is amended as follows:

    PART 180--[AMENDED]

    0 1. The authority citation for part 180 continues to read as follows:

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

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

    Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.

    * * * * *

    Inert Ingredients

    Limits

    Uses

    * * * * * 1-Octanal (CAS Reg. No. 124-13- Not more than 0.2% Odor masking agent 0)

    of the pesticide formulation * * * * *

    0 3. In Sec. 180.930, the table is amended by adding alphabetically the following inert ingredient to read as follows:

    Sec. 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance.

    * * * * *

    Inert Ingredients

    Limits

    Uses

    * * * * * 1-Octanal (CAS Reg. No. 124-13- Not more than 0.2% Odor masking agent 0)

    of the pesticide formulation * * * * *

    [FR Doc. 04-21937 Filed 9-29-04; 8:45 am]

    BILLING CODE 6560-50-S