Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Inert ingredient with insufficient data for reassessment; tolerance exemption revocation,

[Federal Register: June 7, 2006 (Volume 71, Number 109)]

[Proposed Rules]

[Page 32895-32899]

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

[DOCID:fr07jn06-35]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0493; FRL-8072-4]

Inert Ingredient; Revocation of a Tolerance Exemption with Insufficient Data for Reassessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes under section 408(e)(1) of the Federal Food, Drug, and Cosmetic Act (FFDCA) to revoke the existing exemption from the requirement of a tolerance for residues of one inert ingredient because there are insufficient data to make the determination of safety required by FFDCA section 408(b)(2). The inert ingredient tolerance exemption under 40 CFR 180.920 is ``[alpha]-Alkyl (C10-C16)-[omega]-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; the poly(oxyethylene) content averages 3-20 moles.'' The revocation action in this document contributes towards the Agency's tolerance reassessment requirements under FFDCA section 408(q), as amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by August 2006 to reassess the tolerances that were in existence on August 2, 1996. The regulatory action in this document pertains to the revocation of one tolerance exemption which is counted as tolerance reassessment toward the August 2006 review deadline.

DATES: Comments must be received on or before July 7, 2006.

ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0493, 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 Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP- 2006-0493. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e- mail. The Federal regulations.gov website is an ``anonymous access'' system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If

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you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index. Although listed in the index, some information is not publicly available, e.g., 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 OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8811; e-mail address: leifer.kerry@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 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 Unit II. 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. Background and Statutory Findings

   1. What Action is the Agency Taking?

      On May 3, 2006, EPA published a proposed rule in the Federal Register (71 FR 25993; FRL-8060-9) to revoke exemptions from the requirement of a tolerance for certain inert ingredients used in pesticide products. Unfortunately, one inert ingredient tolerance exemption was inadvertently omitted from this Federal Register proposed rule: ``[alpha]-Alkyl (C10-C16)-[omega]- hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; the poly(oxyethylene) content averages 3-20 moles.'' Therefore, in this proposed rule, EPA is proposing to revoke this one inert ingredient tolerance exemption because sufficient data are not available to the Agency to make the safety determination required by FFDCA section 408(c)(2). As described in the Federal Register of May 3, 2006, described in this unit, EPA is now in the process of reassessing all inert ingredient exemptions from the requirement of a tolerance (``tolerance exemptions'') established prior to August 2, 1996, as required by FFDCA section 408(q). Under FFDCA section 408(q), tolerance reassessment may lead to regulatory action under FFDCA section 408(e)(1). When taking action under FFDCA section 408(e)(1), EPA may leave a tolerance exemption in effect only if the Agency determines that the tolerance exemption is safe. As is the case for the inert ingredient tolerance exemptions identified in the May 3 Federal Register, EPA has insufficient data available to make the safety determination required by FFDCA section 408(c)(2) for this one inert ingredient and is proposing to revoke the tolerance exemption.

      In making the FFDCA reassessment 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 the available information concerning the special susceptibility of infants and children (including developmental effects from in utero exposure), FFDCA section 408 (b)(2)(C). Data gaps exist for this inert ingredient in areas critical to reassessment. Without these data, the assessment of possible effects to infants and children cannot be made. Thus, EPA has insufficient data to make the safety finding of FFDCA section 408(c)(2) and is revoking the inert ingredient tolerance exemption identified in this document.

      In developing risk assessment documents for inert ingredient tolerance exemptions, EPA currently reviews data submitted to the Agency as well as information from reputable, publicly available sources. For example, studies may be available in professional (peer- reviewed) journals, and chemical assessments may be available on the Internet from U.S. Government agencies (e.g., EPA, the Agency for Toxic Substances and Disease Registry, National Institutes of Health, Food and Drug Administration (FDA)) and international organizations (e.g., World Health Organization, Organization for Economic Cooperation and Development (OECD)). In some cases, representatives from chemical and pesticide manufacturing industry associations endeavored to locate data to support reassessment of surfactant chemicals. Nonetheless, sufficient valid and reliable data were not available to make the requisite FFDCA safety finding.

      EPA could not have made the requisite FFDCA safety finding unless, at the very least, a set of basic toxicity studies had been available to the Agency. It is possible that the tests agreed to under OECD's Screening Information Data Set (SIDS) program would have sufficed. Especially important to inert ingredient reassessment is an acceptable repeat-dose study. The preferred test for repeat-dose toxicity is the ``Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test'' (OECD Test Guideline 422). More information about the OECD SIDS and EPA's High Production Volume (HPV) programs is found at http://www.epa.gov /oppt/chemrtk/ sidsappb.htm.

      For the inert ingredient subject to this proposed rule and the inert ingredients identified in the May 3 Federal Register, the full OECD SIDS may not have been necessary in some cases because EPA has available a limited number of studies and information on the inert ingredient in question (e.g., acute toxicity studies). In other cases, the limited toxicity information available to the Agency may

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      indicate a need for further testing. EPA always recommends that parties interested in supporting an inert ingredient consult with the Agency prior to embarking on a testing strategy in order to determine existing data gaps and if testing certain chemicals within a multi-chemical exemption would serve to represent the entire exemption.

      In summary, the safety finding required by FFDCA section 408(b)(2) cannot be made for the one inert ingredient tolerance exemption due to insufficient data. Therefore, EPA is revoking under FFDCA section 408(e)(1) the tolerance exemption identified at the end of this document under 40 CFR 180.920 with the revocation effective 2 years after the date of publication of the final rule in the Federal Register.

      The inert ingredient tolerance exemption that is the subject of this revocation proposal is found in 40 CFR 180.920 and reads as follows: ``[alpha]-Alkyl (C10-C16)-[omega]- hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; the poly(oxyethylene) content averages 3-20 moles.'' It is noted that the chemical described in this tolerance exemption is included in a broader tolerance exemption also found in 40 CFR 180.920 that was proposed for revocation for insufficient data in the May 3 Federal Register, which reads as follows: ``[alpha]-Alkyl (C10-C16)-[omega]-hydroxypoly (oxyethylene)poly (oxypropylene) mixture of di- and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; the combined poly(oxyethylene) poly(oxypropylene) content averages 3-20 moles.'' The public has had an opportunity to comment on the proposed revocation of the broader tolerance exemption since May 3. Because the public has had an opportunity since May 3 to comment on the broader exemption that encompasses this more narrow tolerance exemption, a 30-day comment period is provided for this proposed revocation of the more narrow tolerance exemption.

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

      A ``tolerance'' represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ``adulterated'' under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under FFDCA, but also must be registered under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States.

   3. When do These Actions Become Effective?

      EPA is revoking the tolerance exemption identified in this proposed rule that has insufficient data effective 2 years after the date of publication of the final rule in the Federal Register. Any commodities listed in this rule treated with pesticide products containing the inert ingredient and in the channels of trade following the tolerance revocation shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residues of this pesticide chemical in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that:

      1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA.

      2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.

   4. What is the Contribution to Tolerance Reassessment?

      By law, EPA is required by August 2006 to reassess the tolerances and exemptions from tolerances that were in existence on August 2, 1996. This document revokes one inert ingredient tolerance exemption, which counts as a tolerance reassessment toward the August 2006 review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

3. Are the Actions Consistent with International Obligations?

   The tolerance revocation in this rule is not discriminatory and is designed to ensure that both domestically produced and imported foods meet the food safety standard established by FFDCA. The same food safety standards apply to domestically produced and imported foods.

   EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. It is EPA's policy to harmonize U.S. tolerances with Codex MRLs to the extent possible, provided that the MRLs achieve the level of protection required under FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual Reregistration Eligibility Decision (RED) documents. EPA has developed guidance concerning submissions for import tolerance support which was published in the Federal Register of June 1, 2000 (65 FR 35069) (FRL-6559-3). This guidance will be made available to interested persons. Electronic copies are available on the Internet at http://www.epa.gov. On the Home

   Page select ``Laws, Regulations, and Dockets,'' then select ``Regulations and Proposed Rules'' and then look up the entry for this document under ``Federal Register--Environmental Documents.'' You can also go directly to the ``Federal Register'' listings at http://

   http://www.epa.gov/fedrgstr.

4. Statutory and Executive Order Reviews

   The Office of Management and Budget (OMB) has exempted this type of action 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 rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44

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   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).

   Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency previously assessed whether establishment of tolerances, exemptions from tolerances, raising of tolerance levels, expansion of exemptions, or revocations might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. These analyses for tolerance establishments and modifications, and for tolerance revocations were published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticide chemical listed in this rule, the Agency hereby certifies that this action will not have a significant negative economic impact on a substantial number of small entities. Specifically, the Agency has concluded in a memorandum dated May 25, 2001 that for import tolerance revocation there is a negligible joint probability of certain defined conditions holding simultaneously which would indicate an RFA/Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) concern and require more analysis. (This Agency document is available in the docket of this rule). Furthermore, for the pesticide chemical named in this rule, the Agency knows of no extraordinary circumstances that exist as to the present rule that would change the EPA's previous analysis.

   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 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 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 section 408(n)(4) of FFDCA. 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.

   List of Subjects in 40 CFR Part 180

   Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

   Dated: May 31, 2006. Donald R. Stubbs, Acting 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 Sec. 180.920, the table is amended by revising the entry in the table to read as follows:

      Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.

      Inert Ingredients

      Limits

      Uses

      * * * * * [alpha]-Alkyl (C10-C16)-[omega]-hydroxypoly(oxyethylene)

      Expires June 9, 2008 Surfactant; related mixture of dihydrogen phosphate and monohydrogen phosphate

      adjuvants of esters and the corresponding ammonium, calcium, magnesium,

      surfactants monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; the poly(oxyethylene) content averages 3-20 moles........................................................ * * * * *

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      [FR Doc. E6-8826 Filed 6-6-06; 8:45 am]

      BILLING CODE 6560-50-S