Inert Ingredients; Proposed Revocation of Tolerance Exemptions 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 exemptions from the requirement of a tolerance for residues of certain inert ingredients because there are insufficient data to make the determination of safety required by FFDCA section 408(b)(2), or because they are redundant and, therefore, are not necessary. In addition, EPA has identified substances within certain of these tolerance exemptions that meet the definition of low-risk polymers and is proposing to establish new tolerance exemptions for them. The revocation actions proposed in this document contribute 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 actions proposed in this document pertain to the proposed revocation of 129 tolerance exemptions which would be counted as tolerance reassessment toward the August 2006 review deadline.

DATES:

Comments must be received on or before July 3, 2006.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2006-0230, 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 (7502C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPP Regulatory Public Docket, Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., 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.
• Important Note: OPP will be moving to a new location the first week of May 2006. As a result, from Friday, April 28 to Friday, May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any deliveries at the Crystal Mall #2 address and this facility will be closed to the public. Beginning on May 8, 2006, the OPP Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will be accepted in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. The mail code for the mailing address will change to (7502P), but will otherwise remain the same. The OPP Regulatory Public Docket telephone number and hours of operation will remain the same after the move.

Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2006-0230. 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 Web site 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 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 in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the OPP Regulatory Public Docket at the location identified under “Delivery” and “Important Note.” The hours of operation for 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 (7505C), 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:

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. 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.

B. What Should I Consider as I Prepare My Comments for EPA?

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns, and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

1. Revocation because of insufficient data. 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. EPA is proposing to revoke 129 inert ingredient tolerance exemptions because insufficient data are available to the Agency to make the safety determination required by FFDCA section 408(c)(2).

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 these inert ingredients 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 proposing to revoke the inert ingredient tolerance exemptions 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 . In some cases, the full OECD SIDS may not have been necessary because EPA has available a limited number of studies and information on some of the inert ingredients in question (e.g., acute toxicity studies). In other cases, the limited toxicity information available to the Agency may 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.

The Agency is proposing to revoke one other inert ingredient because it does not have sufficient data, as discussed earlier. The inert ingredient's two tolerance exemptions in 40 CFR 180.1001(c) and (e) were inadvertently removed from the CFR between the 1999 and 2003 editions. Since that time, 180.1001(c) and (e) have been renamed as 40 CFR 180.910 and 189.930, respectively. These tolerance exemptions were omitted from the CFR by mistake, therefore, they are considered to be active tolerance exemptions under 40 CFR 180.910 and 180.930 that are subject to reassessment as required by the FFDCA section 408(q). The tolerance exemption under 40 CFR 180.910 reads as follows: “α-Alkyl(C₁₂-C₁₅ )-ω- hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; the poly(oxyethylene) content averages 3 moles.” The name of the tolerance exemption under 40 CFR 180.930 differs slightly but not substantively, and reads as follows: “α-Alkyl (C₁₂-C₁₅ )-ω-hydroxypoly(oxyethylene) sulfate and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts; the poly(oxyethylene) content averages 3 moles.” As stated in this unit, this inert ingredient does not has sufficient data and EPA is proposing to revoke the tolerance exemptions in 40 CFR 180.910 and 180.930.

In summary, the safety finding required by FFDCA section 408(b)(2) cannot be made for certain inert ingredient tolerance exemptions due to insufficient data. Therefore, EPA is proposing to revoke under FFDCA section 408(e)(1) the tolerance exemptions identified at the end of this document under 40 CFR 180.910, 180.920, 180.930, and 180.940, with the revocations effective 2 years after the date of publication of the final rule in the Federal Register.

EPA is planning to hold two identical public meetings about this proposed action on inert ingredient tolerance exemptions with insufficient data for reassessment. EPA will review its reassessment progress for inert ingredients, describe the Agency's data finding efforts, discuss data needs and the screening level studies that may suffice, and other topics that may prove useful to those who are considering developing data in support of these inert ingredients. Both identical public meetings will be held on Tuesday, May 23, 2006, at the Office of Pesticide Program's new office building located at One Potomac Yard, 2777 S. Crystal Dr., Arlington, VA, 22202. The first meeting will be held from 9 a.m. to 11 a.m. and the second meeting will be from 1 p.m. to 3 p.m. In order to ensure adequate space for attendees, the Agency requests an RSVP from those who are interested in attending the public meetings. Please RSVP to Karen Angulo at either (703) 306-0404 or angulo.karen@epa.gov, and indicate whether you prefer the morning or afternoon meeting and the number of attendees in your group. The formal announcement of these public meetings appears elsewhere in this issue of the Federal Register.

2. Five new tolerance exemptions for polymer chemicals—i. Exemptions. Several of the tolerance exemptions discussed in this unit include numerous chemicals. While EPA does not have sufficient data to make the safety finding for all of the chemicals within these multi-chemical exemptions, EPA has identified certain chemicals within these exemptions that meet the criteria specified in accordance with the Toxic Substances Control Act for defining a low-risk polymer under 40 CFR 723.250. Polymers that are eligible for exemption under 40 CFR 723.250 will not present an unreasonable risk of injury to human health and the environment. Therefore, EPA is proposing to establish five tolerance exemptions under 40 CFR 180.960.

ii. Cumulative effects from substances with a common mechanism of toxicity. 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 these chemicals and any other substances and these chemicals do not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that these chemicals have 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 Web site at http://www.epa.gov/pesticides/cumulative .

iii. Determination of safety for U.S. population, infants and children. Dietary (food and drinking water) and residential risks are not of concern for chemicals that meet the criteria specified for defining a low-risk polymer in 40 CFR 723.250. Therefore, EPA finds that exempting these polymer chemicals in 40 CFR 180.960 will be safe for the general population including infants and children.

iv. Analytical enforcement methodology. An analytical method is not required for the new tolerance exemption for enforcement purposes because the Agency is establishing an exemption from the requirement of a tolerance.

3. Revocations for administrative reasons. The Agency has identified seven tolerance exemptions that can be revoked for administrative reasons, as described in this unit.

i. The Agency has determined that two tolerance exemptions describe chemicals and substances that do not exist, and can be revoked on the date of publication of the final rule in the Federal Register.

a. The first exemption is “Ethyl vinyl acetate (CAS Reg. No. 24937-78-8)” under 40 CFR 180.930. This chemical name is wrong; the correct name associated with this CAS Reg. No. is “Ethylene, polymer with vinyl acetate.” This CAS Reg. No. already has a tolerance exemption under 40 CFR 180.960 (polymers), therefore, the tolerance exemption under 40 CFR 180.930 is unnecessary and can be revoked.

b. The second exemption is for “α-(Methylene (4-(1,1,3,3-tetramethylbutyl)-o-phenylene)bis-ω-hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene oxide per hydroxyl group.” This name is in error because it describes a chemical that does not exist. Therefore, the tolerance exemption under 40 CFR 180.930 can be revoked.

ii. The Agency has identified five tolerance exemptions that can be revoked because they are redundant. These redundant tolerance exemptions are unnecessary and can be revoked on the date of publication of the final rule in the Federal Register.

a. The tolerance exemption “Sodium mono- and dimethyl naphthalenesulfonate; molecular weight (in amu) 245-260” under 40 CFR 180.920 is unnecessary because there is an identically named exemption in 40 CFR 180.910.

b. The tolerance exemptions “Sodium butyl naphthalenesulfonate” under 40 CFR 180.920 and 180.930 can be revoked because they are included in the broader tolerance exemptions “Sodium mono-, di-, and tributyl naphthalenesulfonates” in 40 CFR 180.910 and 180.930.

c. Similarly, the two tolerance exemptions called “α-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles of ethylene oxide; ...” under 40 CFR 180.910 and 180.930 can be revoked because they are included in the broader tolerance exemptions that are also in 40 CFR 180.910 and 180.930 that have “α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of ethylene oxide;....”

B. 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.

C. When do These Actions Become Effective?

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

i. 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.

ii. 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.

2. EPA is proposing the establishment of new tolerance exemptions under 40 CFR 180.960 effective on the date of publication of the final rule in the Federal Register.

3. EPA is proposing to revoke for administrative reasons the redundant and incorrect tolerance exemptions identified in this document under 40 CFR 180.910, 180.920, and 180.930 effective on the date of publication of the final rule in the Federal Register.

D. 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 proposes to revoke 129 inert ingredient tolerance exemptions, which will be counted in a final rule as a tolerance reassessment toward the August 2006 review deadline under FFDCA section 408(q), as amended by FQPA in 1996.

III. Are the Proposed Actions Consistent with International Obligations?

The tolerance revocation in this proposal 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://www.epa.gov/fedrgstr .

IV. Statutory and Executive Order Reviews

This proposed rule establishes 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 proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed 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 proposed 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).

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 pesticides listed in this proposed rule, the Agency hereby certifies that this proposed 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 proposed rule). Furthermore, for the pesticides named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the EPA's previous analysis. Any comments about the Agency's determination should be submitted to EPA along with comments on the proposal, and will be addressed prior to issuing a final rule.

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 proposed 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 proposed 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 proposed 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 proposed rule.

List of Subjects in 40 CFR Part 180

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

Therefore, it is proposed that 40 CFR chapter I be 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 § 180.910, the table is amended by removing the following entries:

a. α-Alkyl (C₉-C₁₈-ω-hydroxypoly(oxyethylene) with poly(oxyethylene) content of 2-30 moles.

b. α-(p-Alkylphenyl)-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of alkylphenol (alkyl is a mixture of propylene tetramer and pentamer isomers and averages C₁₃) with 6 moles of ethylene oxide.

c. α-Alkyl (C₆-C₁₄ )-ω-hydroxypoly(oxypropylene) block copolymer with polyoxyethylene; polyoxypropylene content is 1-3 moles; polyoxyethylene content is 4-12 moles; average molecular weight (in amu) is approximately 635.

d. α-(p-tert-Butylphenyl)-ω-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 4-12 moles.

e. α-(o, p-Dinonylphenyl)-ω-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 nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4-14 moles.

f. α-(o, p-Dinonylphenyl)-ω-hydroxypoly (oxyethylene) produced by condensation of 1 mole of dinonylphenol (nonyl group is a propylene trimer isomer) with an average of 4-14 or 140-160 moles of ethylene oxide.

g. Dodecylbenzenesulfonic acid, amine salts.

h. α-(p-Dodecylphenyl)-ω-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 30-70.

i. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the ethylene oxide content averages 3.5, 10, or 30 moles.

j. α-Lauryl-ω-hydroxypoly(oxyethylene), average molecular weight (in amu) of 600.

k. α-Lauryl-ω-hydroxypoly(oxyethylene) sulfate, sodium salt; the poly(oxyethylene) content is 3-4 moles.

l. Manganous oxide.

m. α-(p-Nonylphenyl)-ω-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 nonyl group is a propylene trimer isomer and the poly (oxyethylene) content averages 4-14 moles or 30 moles.

n. α-(p-Nonylphenyl)-ω-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4 moles.

o. Polyglyceryl phthalate ester of coconut oil fatty acids.

p. Poly(methylene-p-tert-butylphenoxy)- poly(oxyethylene) ethanol; the poly(oxyethylene) content averages 4-12 moles.

q. Poly(methylene-p-nonylphenoxy)poly(oxyethylene) ethanol; the poly(oxyethylene) content averages 4-12 moles.

r. Secondary alkyl (C₁₁-C₁₅ ) poly(oxyethylene) acetate, sodium salt; the ethylene oxide content averages 5 moles.

s. Sodium diisobutylnapthalenesulfonate.

t. Sodium dodecylphenoxybenzenedisulfonate.

u. Sodium isopropylisohexylnaphthalenesulfonate.

v. Sodium lauryl glyceryl ether sulfonate.

w. Sodium monoalkyl and dialkyl (C₈-C₁₆ ) phenoxybenzenedisulfonate mixtures containing not less than 70% of the monoalkylated product.

x. Sodium mono- and dimethylnaphthalenesulfonates, molecular weight (in amu) 245-260.

y. Sodium mono-, di-, and tributyl naphthalenesulfonates.

z. Sodium mono-, di-, and triisopropyl naphthalenesulfonate.

aa. Sodium N-oleoyl-N-methyltaurine.

bb. Sodium sulfite.

cc. α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of ethylene oxide: if a blend of products is used, the average range number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 1-14 or 30-70.

dd. α-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 30-70.

ee. Tridecylpoly(oxyethylene) acetate, sodium salt; where the ethylene oxide content averages 6-7 moles.

3. In § 180.920, the table is amended by removing the following entries:

a. α-Alkyl (C₁₂-C₁₈ )-ω-hydroxypoly(oxyethylene) copolymers with poly(oxypropylene); polyoxyethylene content averages 3-12 moles and polyoxypropylene content 2-9 moles.

b. α-Alkyl (C₁₂-C₁₅ )-ω-hydroxypoly(oxyethylene) sulfosuccinate, isopropylamine and N-hydroxyethyl isopropylamine salts of; the poly(oxyethylene) content averages 3-12 moles.

c. α-Alkyl(C₁₀-₁₂ )-ω-hydroxpoly(oxyethylene) poly(oxypropylene) copolymer; poly(oxyethylene) content is 11-15 moles; poly(oxyproplene) content is 1-3 moles.

d. α-Alkyl(C₁₂-C₁₈ )-ω-hydroxypoly (oxyethylene/oxypropylene) hetero polymer in which the oxyethylene content averages 13-17 moles and the oxypropylene content averages 2-6 moles.

e. α-Alkyl (C₁₀-C₁₆ )-ω-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.

f. α-Alkyl (C₁₂-C₁₈ )-ω-hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the oxyethylene content is 8-12 moles and the oxypropylene content is 3-7 moles.

g. α-Alkyl (C₁₂-C₁₅ )-ω-hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 moles.

h. α-Alkyl (C₂₁-C₇₁ )-ω-hydroxypoly (oxyethylene) in which the poly(oxyethylene) content is 2 to 91 moles and molecular weight range from 390 to 5,000.

i. n-Alkyl(C₈-C₁₈ )amine acetate.

j. Amine salts of alkyl (C₈-C₂₄ ) benzenesulfonic acid (butylamine, dimethylaminopropylamine, mono- and diisopropylamine, mono- , di-, and triethanolamine).

k. N-(Aminoethyl) ethanolamine salt of dodecylbenzenesulfonic acid.

l. N, N-Bis[α-ethyl-ω-hydroxypoly(oxyethylene) alkylamine; the poly(oxyethylene) content averages 3 moles; the alkyl groups (C₁₄-C₁₈ ) are derived from tallow, or from soybean or cottonseed oil acids.

m. N, N-Bis(2-hydroxyethyl)alkylamine, where the alkyl groups (C₈-C₁₈ ) are derived from coconut, cottonseed, soya, or tallow acids.

n. N, N-Bis 2-(ω-hydroxypolyoxyethylene) ethyl) alkylamine; the reaction product of 1 mole N, N-bis(2-hydroxyethyl)alkylamine and 3-60 moles of ethylene oxide, where the alkyl group (C₈-C₁₈ ) is derived from coconut, cottonseed, soya, or tallow acids.

o. N, N-Bis-2-(ω-hydroxypolyoxyethylene/polyoxypropylene) ethyl alkylamine; the reaction product of 1 mole of N, N-bis(2-hydroxyethyl alkylamine) and 3-60 moles of ethylene oxide and propylene oxide, where the alkyl group (C₈-C₁₈ ) is derived from coconut, cottonseed soya, or tallow acids.

p. Butoxytriethylene glycol phosphate.

q. Cyclohexanol.

r. α-(Di-sec-butyl)phenylpoly(oxypropylene) block polymer with poly(oxyethylene); the poly(oxypropylene) content averages 4 moles, the poly(oxyethylene) content averages 5 to 12 moles, the molecular.

s. Disodium 4-isodecyl sulfosuccinate.

t. Dodecylphenol.

u. α-Dodecylphenol-ω-hydroxypoly(oxyethylene/oxypropylene) hetero polymer where ethylene oxide content is 11-13 moles and oxypropylene content is 14-16 moles, molecular weight (in amu) averages 600 to 965.

v. Isopropylbenzenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts.

w. (3-Lauramidopropyl) trimethylammonium methyl sulfate.

x. Linoleic diethanolamide (CAS Reg. No. 56863-02-6).

y. Methyl bis(2-hydroxyethyl)alkyl ammonium chloride, where the carbon chain (C₈-C₁₈ ) is derived from coconut, cottonseed, soya, or tallow acids.

z. α,α′-[Methylenebis]-4-(1,1,3,3-tetramethylbutyl)-o-phenylene bis[ω-hydroxypoly(oxyethylene)] having 6-7.5 moles of ethylene oxide per hydroxyl group.

aa. Methylnapthalenesulfonic acid—formaldehyde condensate, sodium salt.

bb. Methyl poly(oxyethylene) alkyl ammonium chloride, where the poly(oxyethylene) content is 3-15 moles and the alkyl group (C₈-C₁₈ ) is derived from coconut, cottonseed, soya, or tallow acids.

cc. Methyl violet 2B.

dd. Morpholine salt of dodecylbenzenesulfonic acid.

ee. Napthalenesulfonic acid-formaldehyde condensate, ammonium and sodium salts.

ff. Partial sodium salt of N-lauryl-α-iminodipropionic acid.

gg. Poly(methylene-p-nonylphenoxy)poly(oxypropylene) propanol; the poly(oxy-propylene) content averages 4-12 moles.

hh. Primary n-alkylamines, where the alkyl group (C₈-C₁₈ ) is derived from coconut, cottonseed, soya, or tallow acids.

ii. Sodium butyl naphthalenesulfonate.

jj. Sodium 1,4-dicyclohexyl sulfosuccinate.

kk. Sodium 1,4-dihexyl sulfosuccinate.

ll. Sodium 1,4-diisobutyl sulfosuccinate.

mm. Sodium 1,4-dipentyl sulfosuccinate.

nn. Sodium 1,4-ditridecyl sulfosuccinate.

oo. Sodium mono- and dimethyl naphthalenesulfonate; molecular weight (in amu) 245-260.

pp. Sulfosuccinic acid ester with N-(2,-hydroxy-propyl) oleamide, ammonia and isopropylamine salts of.

qq. Tall oil diesters with polypropylene glycol (CAS Reg. No. 68648-12-4).

rr. N, N, N′, N′′-Tetrakis-(2-hydroxypropyl) ethylenediamine.

ss. α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-ω-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen phosphate esters and the corresponding sodium salts of the phosphate esters; the poly(oxyethylene) content averages 6 to 10 moles.

4. In § 180.930, the table is amended by removing the following entries:

a. α-Alkyl (C₉-C₁₈ )-ω-hydroxypoly(oxyethylene): the poly(oxyethylene) content averages 2-20 moles.

b. α-Alkyl (C₁₂-C₁₅ )-ω-hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the oxyethylene content is 8-13 moles and the oxypropylene content is 7-30 moles.

c. α-Alkyl (C₈ 8-C₁₀) hydroxypoly(oxypropylene) block polymer with polyoxyethylene; polyoxypropylene content averages 3 moles and polyoxyethylene content averages 5-12 moles.

d. α-Alkyl (C₆-C₁₄ )-ω-hydroxypoly(oxypropylene) block copolymer with polyoxyethylene; polyoxypropylene content is 1-3 moles; polyoxyethylene content is 7-9 moles; average molecular weight (in amu) approximately 635.

e. α-(p-Alkylphenyl)-ω-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of alkylphenol (alkyl is a mixture of propylene tetramer and pentamer isomers and averages C₁₃) with 6 moles of ethylene oxide.

f. Amine salts of alkyl (C₈-C₂₄ ) benzenesulfonic acid (butylamine; dimethylamino propylamine; mono- and diisopropyl- amine; and mono- , di-, and triethanolamine).

g. α-(p-tert-Butylphenyl)-ω-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 4-12 moles.

h. α-(o, p-Dinonylphenyl)-ω-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 nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4-14 moles.

i. α-(o, p-Dinonylphenyl)-ω-hydroxypoly(oxyethylene), produced by the condensation of 1 mole of dinonylphenol (nonyl group is a propylene trimer isomer) with an average of 4-14 moles of ethylene oxide.

j. Dodecylbenzenesulfonic acid, amine salts.

k. α-(p-Dodecylphenyl)-ω-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a propylene tetramer isomer) with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 30-70 moles.

l. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the ethylene oxide content averages 3.5, 10, or 30 moles.

m. Ethyl vinyl acetate (CAS Reg. No. 24937-78-8).

n. α-Lauryl-ω-hydroxypoly(oxyethylene), average molecular weight (in amu) of 600.

o. α-Lauryl-ω-hydroxypoly(oxyethylene), sulfate, sodium salt; the poly(oxyethylene) content is 3-4 moles.

p. Manganous oxide.

q. α-(Methylene (4-(1,1,3,3-tetramethylbutyl)-o-phenylene)bis-ω-hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene oxide per hydroxyl group.

r. Mono-, di-, and trimethylnapthalenesulfonic acids-formaldehyde condensates, sodium salts.

s. Naphthalenesulfonic acid and its sodium salt.

t. α-(p-Nonylphenyl)-ω-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 nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4-14 moles.

u. α-(p-Nonylphenyl)-ω-hydroxypoly(oxyethylene) sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4 moles.

v. α-(p-Nonylphenyl)-ω-hydroxypoly(oxyethylene) sulfate, and its ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts; the nonyl group is a propylene trimer isomer and the poly(oxyethylene) content averages 4-14 or 30-90 moles of ethyiene oxide.

w. Polyglyceryl phthalate esters of coconut oil fatty acids.

x. Poly(methylene-p tert-butylphenoxy)poly(oxyethylene) ethanol; the poly(oxyethylene) content averages 4-12 moles.

y. Poly(methylene-p-nonylphenoxy)poly(oxyethylene) ethanol; the poly(oxyethylene) content averages 4-12 moles.

z. Poly(methylene-p-nonylphenoxy)poly(oxypropylene) propanol; the poly(oxypropylene) content averages 4-12 moles.

aa. Secondary alkyl (C₁₁-C₁₅ ) poly(oxyethylene) acetate, sodium salt; the ethylene oxide content averages 5 moles.

bb. Sodium butylnaphthalenesulfonate.

cc. Sodium diisobutylnaphthalenesulfonate.

dd. Sodium isopropylisohexylnaphthalenesulfonate.

ee. Sodium isopropylnaphthalenesulfonate.

ff. Sodium monoalkyl and diakyl (C₈-C₁₃ ) phenoxybenzenedisulfonate mixtures containing not less than 70% of the monoalkylated product.

gg. Sodium mono- and dimethylnaphthalenesulfonate, molecular weight (in amu) 245-260.

hh. Sodium mono-, di-, and tributylnaphthalenesulfonates.

ii. Sodium N-oleoyl-N-methyl taurine.

jj. α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p (1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of ethylene oxide: if a blend of products is used, the average range number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 1-14 or 30-70.

kk. α-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-ω-hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-(1,1,-3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 30-70.

ll. Tridecylpoly(oxyethylene) acetate sodiums salt; where the ethylene oxide content averages 6-7 moles.

5. Section 180.940 is amended as follows:

a. The table in paragraph (a) is amended by removing the following entries:

i. α-Alkyl(C₁₀-C₁₄ )-ω- hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight (in amu), 768 to 837.

ii. α-Alkyl(C₁₂-C₁₈ )-ω hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight (in amu), 950 to 1120.

b. The table in paragraph (b) is amended by removing the following entries:

i. α-Lauroyl-ω-hydroxypoly (oxyethylene) with an average of 8-9 moles ethylene oxide, average molecular weight (in amu), 400.

ii. Oxirane, methyl-, polymer with oxirane, ether with (1,2-ethanediyldinitrilo)tetrakis [propanol] (4:1).

c. The table in paragraph (c) is amended by removing the following entries:

i. α-Alkyl(C₁₀-C₁₄ )-ω-hydroxypoly (oxyethylene) poly (oxypropylene) average molecular weight (in amu), 768 to 837.

ii. α-Alkyl(C₁₁-C₁₅ )-ω-hydroxypoly (oxyethylene) with ethylene oxide content 9 to 13 moles.

iii. α-Alkyl(C₁₂-C₁₅ )-ω-hydroxypoly (oxyethylene) polyoxypropylene, average molecular weight (in amu), 965.

iv. α-Alkyl(C₁₂-C₁₈ )-ω-hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight (in amu), 950 to 1120.

v. α-Lauroyl-ω-hydroxypoly (oxyethylene) with an average of 8-9 moles ethylene oxide, average molecular weight (in amu), 400.

vi. Naphthalene sulfonic acid, sodium salt.

vii. Naphthalene sulfonic acid sodium salt, and its methyl, dimethyl and trimethyl derivatives.

viii. Naphthalene sulfonic acid sodium salt, and its methyl, dimethyl and trimethyl derivatives alkylated at 3% by weight with C₆-C₉ linear olefins.

ix. Oxirane, methyl-, polymer with oxirane, ether with (1,2-ethanediyldinitrilo)tetrakis [propanol] (4:1).

6. In § 180.960, the table is amended by alphabetically adding the following entries: