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Rule

Inert ingredients: Denial of Pesticide Petitions 2E6491 (N-Acyl Sarcosines and Sodium N-Acyl Sarcosinates), 7E4810 (Crezasin), and 7E4811 (Mival)

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Information about this document as published in the Federal Register.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is denying three petitions to amend or establish exemptions from pesticide tolerances because insufficient data were available to the Agency to make the safety finding of FFDCA section 408(c)(2): PP 2E6491 submitted by Hampshire Chemical Corporation to amend the inert ingredient tolerance exemption under 40 CFR 180.1207 for certain N-acyl sarcosines and sodium N-acyl sarcosinates, and PP 7E4810 (Crezasin) and PP 7E4811 (Mival) submitted by Globe Tech Industries Corporation to establish an inert ingredient tolerance exemption under § 180.920.

DATES:

This regulation is effective February 8, 2008. Objections and requests for hearings must be received on or before April 8, 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-2002-0201. 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 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 (703) 305-5805.

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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: (703) 308-2857; e-mail address: martin.kathleen@epa.gov.

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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, those engaged in the following activities:

  • Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
  • Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
  • Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
  • Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be Start Printed Page 7473affected 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 EPA's tolerance regulations at 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, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. 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-2002-0201 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 as required by 40 CFR part 178 on or before April 8, 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 this copy, identified by docket ID number EPA-HQ-OPP-2002-0201, 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 (703) 305-5805.

II. Background

A. What Action is the Agency Taking?

1. Denial of Pesticide Petition 2E6491 (N-Acyl Sarcosines and Sodium N-Acyl Sarcosinates).

In December 1999, EPA established exemptions from the requirement of a tolerance at 40 CFR 180.1207 for residues of certain N-acyl sarcosines and sodium N-acyl sarcosinates when used as inert ingredients (surfactants) at levels not to exceed 10% in pesticide formulations containing glyphosate (64 FR 68044; December 6, 1999). The specific N-acyl sarcosines and sodium N-acyl sarcosinates were: N-oleoyl sarcosine (CAS 110-25-8); N-stearoyl sarcosine (CAS 142-48-3); N-lauroyl sarcosine (CAS 97-78-9); N-myristoyl sarcosine (CAS 52558-73-3); N-cocoyl sarcosine mixture (CAS 68411-97-2); N-methyl-N-(1-oxo-9-octodecenyl) glycine (CAS 3624-77-9); N-methyl-N-(1-oxooctadecyl) glycine (CAS 5136-55-0); N-methyl-N-(1-oxododecyl) glycine (CAS 137-16-6); N-methyl-N-(1-oxotetradecyl glycine (CAS 30364-51-3); and N-cocoyl sarcosine sodium salt mixture (CAS 61791-59-1).

In the Federal Register of September 18, 2002 (67 FR 58799) (FRL-7194-5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 2E6491) by Hampshire Chemical Corporation. The petition requested that 40 CFR 180.1207, which pertains to the N-acyl sarcosines and sodium N-acyl sarcosinates listed in the previous paragraph, be amended to add pesticide formulations containing the active ingredients 2,4-D, atrazine, dicamba, and glufosinate ammonium; the existing tolerance exemption is limited to formulations containing glyphosate. No comments were received in response to the notice of filing.

In evaluating the petitioner's request (PP 2E6491), EPA determined that significant and important data were missing from the petitioner's submission. First, certain data submitted by the petitioner (e.g., acute, subchronic, and chronic toxicity) are inadequate and not acceptable. The data are unpublished, and no basic quality information (in compliance with Good Laboratory Practices) is provided, including when the studies were conducted. Second, the submitter did not provide adequate developmental and reproductive toxicity data. In making the FFDCA safety determination, EPA considers the validity, completeness, and reliability of the data that are available to the Agency (FFDCA sections 408(b)(2)(D) and 408(c)(2)(B)), and the available information concerning the special susceptibility of infants and children. If reproductive and developmental toxicity data are not available, or if such information is not available in the open literature, screening level reproductive and developmental toxicity data may be acceptable for assessing the special susceptibility of infants and children. For the sarcosines, EPA communicated with the petitioner regarding the developmental/reproductive toxicity data gap; no further information or data were received.

Because the safety finding, as required under FFDCA section 408(c)(2), could not be made due to insufficient data, EPA is denying the petitioner's request to amend the existing tolerance exemption for the N-acyl sarcosines and sodium N-acyl sarcosinates.

2. Denial of Pesticide Petitions 7E4810 (Crezasin) and 7E4811 (Mival).

In the Federal Register of December 2, 1997 (62 FR 63940) (FRL-5751-9), EPA issued two notices pursuant to section 408 of FFDCA, 21 U.S.C. 346a announcing the filing of pesticide petitions (PP 7E4810 and PP 7E4811) by Globe Tech Industries Corporation. The petitions requested that EPA establish inert ingredient tolerance exemptions under 40 CFR 180.920 for the use of Crezasin (PP 7E4810) and Mival (PP 7E4811) in pesticide formulations used on growing crops only.

In evaluating the petitioner's requests, EPA determined that significant and important data in the petitioner's submission were inadequate and not acceptable, including the residue chemistry and the description of the chemicals' product chemistry data. EPA has been unable to contact or locate the petitioner, Globe Tech Corporation, about the data deficiencies. In making the FFDCA safety determination, EPA considers the validity, completeness, and reliability of the data that are available to the Agency (FFDCA section 408(b)(2)(D) and 408(c)(2)(B)). Because the safety finding required under FFDCA section 408(b)(2) could not be Start Printed Page 7474made due to insufficient data, EPA is denying the petitioner's request to establish inert ingredient tolerance exemptions under 40 CFR 180.920 for the use of Crezasin (PP 7E4810) and Mival (PP 7E4811).

B. What is the Agency's Authority for Taking this Action?

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 exemption 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.”

III. Objections and Hearing Requests

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. Although the procedures in those regulations require some modification to reflect the amendments made to FFDCA by FQPA, 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.

A. What Do I Need to Do to File an Objection or Request a Hearing?

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 ID number EPA-HQ-OPP-2002-0201 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 April 8, 2008.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., 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 III.A., you should also send a copy of your request to Public Information and Records Integrity Branch (PIRIB) for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number EPA-HQ-OPP-2002-0201, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502P), 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 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.

B. 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).

IV. Statutory and Executive Order Reviews

This final rule denies a request to amend an exemption from tolerance under FFDCA section 408(d). 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 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. 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 Start Printed Page 7475levels 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 (59 FR 22951, 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.

V. 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).

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List of Subjects in 40 CFR Part 180

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Dated: January 28, 2008.

Marty Monell,

Acting Director, Office of Pesticide Programs.

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[FR Doc. E8-2175 Filed 2-7-08; 8:45 am]

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