[ Federal Register: December 3, 2002 ( Volume 67, Number 232)] [ Rules and Regulations] [ Page 71847 71861] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr03de02 20]

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002 0278; FRL 6824 2]

Pesticides; Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations ( Food Contact Surface Sanitizing Solutions)

AGENCY: Environmental Protection Agency ( EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final action to add a new section to part 180 which lists the pesticide chemicals that are exempt from the requirement of a tolerance when used in food contact surface sanitizing solutions. The initial list of exempt pesticide chemicals in the new section is duplicated from the Food and Drug Administration's ( FDA) regulations in 21 CFR 178.1010. EPA is also changing FDA's naming [[ Page 71848]]

conventions for some of the chemical substances that were duplicated. Until recently, FDA under the Federal Food, Drug, and Cosmetic Act ( FFDCA) section 409, regulated food contact surface sanitizing solutions. With the amendments to FFDCA by the Food Quality Protection Act ( FQPA) of 1996 and by the Antimicrobial Regulation Technical Corrections Act ( ARTCA) of 1998, these responsibilities have been restructured. Under FFDCA section 408, EPA will now regulate the pesticide uses of these chemical substances and FDA under FFDCA section 409 will continue to regulate any indirect food additive uses of these chemical substances. Registrants of existing food contact surface sanitizing solutions that contain chemical substances other than those listed in this direct final rule should identify these chemical substances and support their claim that the chemical substance is generally recognized as safe ( GRAS), or permitted by FDA prior sanction, or approval, or subject to a letter of no objection in order to remain exempt from the requirement of a FFDCA section 408 tolerance.

DATES: This direct final rule is effective on April 2, 2003 without further notice, unless EPA receives a relevant adverse comment by February 3, 2003. If, however, EPA receives a relevant adverse comment during the comment period, then EPA will publish a timely withdrawal in the Federal Register informing the public that the direct final rule will not take effect. We will also publish a notice of proposed rulemaking in a future issue of the Federal Register. We will address the comments on the direct final rule as part of that notice of proposed rulemaking. Registrants should submit chemical substances not listed in this document and support their claims of GRAS, or prior sanction, or approval, or no objection of these chemical substances on or before June 2, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. Registrants identifying chemical substances not listed in this document and the supporting documentation for their claims of GRAS, or prior sanction, or approval, or no objection of these chemical substances for inclusion in 40 CFR 180.940 should submit the information directly to the person listed under FOR FURTHER INFORMATION. Identification of a chemical substance is not a comment and should be identified as `` Submission of Non designated Prior Approved Chemical Substance.''

FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: ( 703) 305 6304; fax number: ( 703) 305 0599; e mail address: boyle. kathryn@ 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 a food manufacturer, or antimicrobial pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

 Examples of Categories NAICS codes potentially affected entities  Industry 311 Food manufacturing Producers 32561 Antimicrobial pesticides

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP 2002 0278. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html , a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly [[ Page 71849]]

available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. 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. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket , and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP 2002 0278. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP 2002 0278. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001, Attention: Docket ID Number OPP 2002 0278. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2002 0278. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT. E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the rule or collection activity. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

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

This direct final rule is issued under FFDCA section 408, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104 170), and ARTCA ( Public Law 105 324). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Section 408( j)( 2) of FFDCA provides that all regulations issued by FDA under FFDCA section 409 that stated conditions for safe use of substances that are now, post FQPA, considered pesticide chemical residues in or on processed food or that otherwise stated the conditions under which such pesticide chemicals could be safely used, shall be deemed to be regulations issued under FFDCA section 408. Due to the FQPA and ARTCA amedments to FFDCA, those chemical substances originally regulated by FDA under FFDCA section 409 as foodcontact surface sanitizing solutions are now the responsibility of EPA. These pesticide chemicals are now subject to modification or revocation at EPA's initiative under FFDCA section 408( e). This direct final rule duplicates those chemical substances found in 21 CFR 178.1010 which are now pesticide tolerance exemptions to 40 CFR 180.940. EPA's rulemaking activity will have no effect on any of the FDA regulated FFDCA section 409 food additive regulations in 21 CFR 178.1010.

B. Why is EPA Issuing this as a Direct Final Rule?

EPA is issuing this action as a direct final rule without prior proposal because the Agency believes that this action is not controversial and is not likely to result in any adverse comments, inasmuch as this action simply implements amendments to the statutory authority and reflects the statutory transfer of jurisdiction from FDA to EPA. Its primary effect is to substitute EPA's regulatory procedures for those of FDA in approving food contact surface sanitizing solutions under FFDCA. The chemical substances were subject to FDA review under FFDCA section 409 and have food additive clearances codified at 21 CFR 178.1010. This direct final rule duplicates the conditions for use of certain pesticide chemical residues that are currently listed in 21 CFR 178.1010 to 40 CFR 180.940. In addition, this direct final rule changes the process by which pesticide registrants obtain approval of food contact surface sanitizing solutions as well as how those approvals are expressed in the CFR. However, it does not alter the quantity or nature of residues of these food contact surface sanitizing solutions that might lawfully be present in food. The Agency believes that it is important to make this action effective as soon as possible, in order to clarify the jurisdiction between EPA and FDA over these chemical substances. This direct final rule is effective on April 2, 2003 without further notice, unless EPA receives a relevant adverse comment by February 3, 2003. If, however, EPA receives a relevant adverse comment during the comment period, then EPA will publish a timely withdrawal in the Federal Register informing the public that the direct final rule will not take effect. We will also publish a notice of proposed rulemaking in a future issue of the Federal Register. We will address the comments on the direct final rule as part of that notice of proposed rulemaking.

III. Summary of this Action A. Why is There an Overlap of EPA's and FDA's Regulatory Authorities?

Since EPA was created in 1970, EPA and FDA have shared authority under FFDCA over pesticide chemical residues in food. Enactment of FQPA in 1996 amended FFDCA, and shifted to EPA regulatory authority over certain pesticide residues which were previously subject to FDA authority. Prior to 1996, products used to sanitize or disinfect permanent or semi permanent food contact surfaces were regulated by FDA as indirect food additives under FFDCA section 409. Under the FQPA and ARTCA amendments to FFDCA, antimicrobial formulations used on permanent or semi permanent food contact surfaces other than food packaging are now considered `` pesticide chemicals'' and are regulated by EPA under FFDCA section 408. FQPA added a provision to FFDCA to assure an orderly transition to the new regulatory system. Section 408( j)( 2) of FFDCA provides that all food additive regulations issued under FFDCA section 409 prior to the enactment of FQPA for antimicrobial uses that became pesticide chemical uses subsequent to FQPA and that were not affected by ARTCA shall be deemed to be regulations issued under FFDCA section 408. Thus, FQPA converted existing food additive regulations issued by FDA under FFDCA section 409, for chemical substances that post FQPA became pesticide chemicals, into FFDCA section 408 pesticide chemical tolerances or tolerance exemptions. This `` grandfather'' provision of FFDCA section 408( j) assures that pesticide chemical residues conforming to regulations issued under the authority of FFDCA section 409 will not render food adulterated as a result of the jurisdictional shift from FDA to EPA. In 1998, ARTCA amended the definition of `` pesticide chemical'' in FFDCA section 201( q) so as to exclude certain antimicrobial pesticide residues from the authority of FFDCA section 408. Consistent with FFDCA section 408( j)( 4), these residues now fall within the authority of FFDCA section 409. As a result, certain uses of food contact surface sanitizing solutions identified in FDA's regulations at 21 CFR 178.1010 remain subject to FFDCA section 409 regulations just as they did pre FQPA, while other uses are now subject to EPA's jurisdiction under FFDCA section 408.

B. Why are These Tolerance Exemptions not Subject to Tolerance Reassessment at this Time?

Under FFDCA section 408( q), EPA is required to reassess all tolerance exemptions that were in effect on the day before the enactment of the FQPA. The tolerance exemptions for inert ingredients as well as those active ingredients not yet completed will be reassessed in accordance with EPA's schedule for tolerance reassessment published in the Federal Register of August 4, 1997 ( 62 FR 42019) ( FRL 5734 6). The tolerance exemptions in this direct final rule codified in 40 CFR 180.940 already exist as valid FFDCA section 408 regulations. FDA promulgated the food additive regulations in 21 CFR 178.1010 under the authority of FFDCA section 409 prior to the enactment of FQPA. By operation of FFDCA section 408( j)( 2), those portions of 21 CFR 178.1010 that pertain to chemical substances that are pesticide chemicals post FQPA and remain as such post ARTCA were converted to FFDCA section 408 tolerance exemptions. EPA's duplication of these tolerance exemptions is not `` establishing, modifying, or revoking a tolerance'' under FFDCA section 408( b). EPA is, therefore, not required to conduct a full reassessment of these tolerance exemptions at this time.

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C. Why is 40 CFR 180.940 Being Created?

The Agency is duplicating in 40 CFR 180.940 only those portions of the regulations in 21 CFR 178.1010 that pertain to pesticide chemicals. This duplication will have no effect on any of FDA's regulated FFDCA section 409 food additive regulations in 21 CFR 178.1010. In establishing food additive regulations for food contact surface sanitizing solutions in 21 CFR 178.1010, FDA used a formulationspecific approach. Consistent with its authority under FFDCA section 409, FDA issued regulations prescribing the conditions under which food contact surface sanitizing solutions might be safely used. FDA approved the use of each food contact surface sanitizing solution formulation as a whole, rather than regulating each component chemical substance individually. In addition, FDA included a generic exemption for any chemical substance considered to be GRAS, and in some cases, issued letters not objecting to certain additional chemical substances in the formulations. By contrast, FFDCA section 408 authorizes EPA to issue regulations establishing tolerances or exemptions from the requirement of a tolerance. EPA's practice has been to issue these regulations on a chemical specific basis, whereby each ingredient in the product is the subject of a separate tolerance or exemption regulation. Food contact surface sanitizing solutions meet the requirements of FFDCA if each ingredient has an appropriate clearance under FFDCA, either a tolerance or an exemption from the requirement of a tolerance, and any conditions on the clearance are observed. Translating the regulatory decisions made by FDA into a comparable EPA scheme requires considerably greater work on EPA's part than merely copying those portions of the existing regulations in 21 CFR 178.1010 that pertain to pesticide chemicals directly into 40 CFR 180.940. EPA must disaggregate the formulations in 21 CFR 178.1010 that pertain to pesticide chemicals into their component ingredients. EPA must also provide a mechanism to address those ingredients not identified by name in 21 CFR 178.1010 but that were, for example, permitted by prior sanction or approval, not objected to, or generally recognized as safe. This, in fact, places a higher initial demand on EPA resources than would be required to simply copy FDA's approach. However, EPA is convinced that the long term administrative convenience of using a consistent regulatory scheme for all pesticide chemicals subject to FFDCA section 408 outweighs the initial burdens. FDA's formulation specific approach is different from EPA's chemical specific approach. Under EPA's approach, a tolerance exemption would be approved once for each particular pesticide chemical, and would not need to be repeated as new products containing that chemical substance enter the market. EPA's approval process is not complex, will allow for a wide variety of potential products, and fosters innovative formulation approaches. In addition, by listing in one place ( 40 CFR 180.940) all chemical substances exempted from the requirement of a tolerance when used in food contact surface sanitizing solutions, EPA's approach will increase the transparency of its regulatory process. This duplication will not allow any residues beyond those already permitted by 21 CFR 178.1010. EPA believes that the chemical specific approach and FDA's formulation specific approach are equivalent from a risk management perspective, inasmuch as each would result in the same levels of residues from these chemical substances. As part of the duplication, EPA changed the naming conventions ( chemical nomenclature), as well as combining, as appropriate, chemical substances that appear in 21 CFR 178.1010 under two or more names under a single name. The Agency has attempted to identify each of the listed chemical substances using the Chemical Abstracts Service Registry Number ( CAS No.). The CAS No. provides one of the most distinct and universally accepted means of identifying chemical substances. Generally, there will be only one CAS No. per listed chemical substance; however, it is possible that more than one CAS No. may be appropriate for some chemical substances. The lack of a CAS No. will not preclude EPA from including chemical substances in 40 CFR 180.940. The lower concentration limits specified in 21 CFR 178.1010 are not included in 40 CFR 180.940 because of the differences between FDA's approach and EPA's approach. Although EPA establishes tolerance exemptions for use in food contact surface sanitizing solutions under FFDCA, all pesticide products must also meet the criteria for registration under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) before being offered for sale. EPA relies on conditions imposed through the FIFRA registration process to address safety and for antimicrobial formulated products efficacy. Accordingly, the lower limits on concentrations of pesticide chemicals, that appear in 21 CFR 178.1010 will not appear in 40 CFR 180.940. Three types of food contact surface sanitizing solutions are described in 21 CFR 178.1010: [ sbull] Those used on food contact surfaces in public eating places. [ sbull] Those used on dairy processing equipment. [ sbull] Those used on food processing equipment and utensils. According to FDA, food contact surface sanitizing solutions that are acceptable for use on food contact surfaces in public eating places can also be used on dairy processing equipment, and on food processing equipment and utensils. Food contact surface sanitizing solutions that are acceptable for use on dairy equipment can also be used on foodprocessing equipment and utensils. EPA has separated the component ingredients by both chemical and concentration for these three types of food contact surface sanitizing solutions, which will be included in 40 CFR 180.940.

IV. Addition of Non Designated Prior Approved Chemical Substances 21 CFR 178.1010 allows the use of GRAS chemical substances and chemical substances `` permitted by prior sanction or approval,'' that are not expressly identified. These chemical substances were subject to the sanitizer formulation approval under FDA's regulation before these uses became FFDCA section 408 tolerance exemptions under FFDCA section 408( j)( 2). Accordingly, many food contact sanitizing solutions that presently are authorized for use under 21 CFR 178.1010 contain ingredients which are not identified in this direct final rule. As discussed in this unit, EPA is asking registrants to identify these other ingredients that they believe should be included in 40 CFR 180.940. EPA intends to publish a revision to 40 CFR 180.940 adding these chemical substances. In the interim, to preserve the use of foodcontact surface sanitizing solutions that were cleared for use before FQPA's enactment and that contain chemical substances that are not specifically identified in 21 CFR 178.1010, EPA has decided to honor those approvals under 21 CFR 178.1010 until EPA has received and reviewed registrant's claims with respect to unspecified pesticide chemicals, as discussed in this unit. FDA's regulations ( 21 CFR 178.1010( b)) allowed the addition to food contact surface sanitizing solutions [[ Page 71852]]

of GRAS components, and components permitted by prior sanction or approval or subject to a letter of no objection. Much of this information should be in EPA's files. The Agency will access this information. However, EPA may not have ready access to all information on all chemicals in existing food contact surface sanitizing solution formulations which could meet these criteria. Submission of this information to EPA would also reduce the possibility of an existing food contact surface sanitizing solution having a component that lacks a tolerance exemption under 40 CFR 180.940. Therefore, registrants who believe that components of their food contact surface sanitizing solutions are exempted under 21 CFR 178.1010( b) should advise EPA in writing that these chemical substances ( along with the CAS No.) should be included in 40 CFR 180.940. The submission of this information facilitates EPA's process for adding these chemical substances cleared under 21 CFR 178.1010( b), but not specifically listed by name, to 40 CFR 180.940. The EPA will also need any available information documenting the claim that the component is GRAS, prior sanctioned or approved, or subject to a letter of no objection. Claims and supporting documentation should be sent directly to the person listed under FOR FURTHER INFORMATION CONTACT. Claims are not comments on this direct final rule and should be identified on the subject line as `` Submission of Non designated Prior Approved Chemical Substance.'' If you have any questions about the many types of information that could be submitted please consult the person listed under FOR FURTHER INFORMATION CONTACT. The Agency does not anticipate that registrants will be required to submit an excessive amount of information, and, in fact, believes that most registrants will be able to submit the necessary information with minimal effort. EPA will review and evaluate the information provided. Chemical substances identified in claims received not later than June 2, 2003 may be eligible for inclusion in Sec. 180.940 under FFDCA section 408( j)( 2). EPA anticipates publishing a notice of proposed rulemaking identifying those chemical substances shortly after that date.

V. Regulatory Assessment Requirements EPA is taking direct final action to add a new Sec. 180.940 to 40 CFR part 180, subpart D which lists the pesticide chemicals that are exempt from the requirement of a tolerance when used in food contact surface sanitizing solutions. The initial list duplicates pesticide chemicals in 40 CFR 180.940 that are active and inert ingredients listed in 21 CFR 178.1010. Since this direct final rule does not impose any new requirements, it is not subject to review by the Office of Management and Budget ( OMB) under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993), Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997), or Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This direct final rule directly regulates food processors, food handlers, and food retailers, but does not affect States, local, or Tribal governments directly. 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). This action does not have substantial direct effects on State or tribal governments, on the relationship between the Federal government and States or Indian tribes, or on the distribution of power and responsibilities between the Federal government and States or Indian tribes. As a result, this action does not require any action under Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999), or under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Nor does it 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 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 Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights ( 53 FR 8859, March 15, 1988). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards under 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). Under section 605( b) of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.), the Agency hereby certifies that the creation of a new Sec. 180.940 does not have significant negative economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. This direct final rule does not impose any requirements, it establishes exemptions from the requirement for a tolerance. The Agency is, however, also commencing a process whereby EPA will require certain persons to identify chemical substances considered to be GRAS ( which could include self affirmed GRAS chemicals), or permitted by prior sanction or approval in existing food contact surface sanitizing solutions. The information available to the Agency indicates that fewer than 500 companies have approximately 1,300 products that could fall under this category. EPA anticipates the economic burden on small entities to be minor, since the Agency is only asking for confirmation that the chemical substances considered to be GRAS or permitted by prior sanction or approval in existing foodcontact surface sanitizing solutions are in fact part of an existing formulation, and information as to why the chemical is considered to be GRAS, or a copy of an FDA letter not objecting to the use of a chemical substance. By contrast, this direct final rule is beneficial to the regulated community by increasing the number of inert ingredients for use in antimicrobial formulations and by reducing the regulatory burden on persons seeking to market new combinations of ingredients for certain hard surface sanitizing solutions. Additionally, this direct final rule provides a more transparent listing of pesticide chemicals used in food contact surface sanitizing solutions to the public. According to the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after initial display in the preamble of the final rule and in addition to its display on any related collection instrument, are listed in 40 CFR part 9. This direct final rule does not impose any new information collection requirements that would require separate approval by OMB under the PRA. Under 5 CFR 1320.3( h), the request for information discussed in [[ Page 71853]]

Unit VII. is not subject to approval under the PRA, and the information collection activities related to the Agency's tolerance exemption process have already been approved by OMB under OMB control numbers 2070 0024 ( EPA ICR No. 597). The annual `` respondent'' ( petitioner) burden for the pesticide tolerance petitions program is estimated to average 1,726 hours per petition. According to the PRA, `` burden'' means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection, it is the time reading the regulations; planning the necessary data collection activities; conducting tests; analyzing data; generating reports and completing other required paperwork; and storing, filing, and maintaining the data. Send comments regarding this burden estimate or any other aspect of the collection activity, including suggestions for reducing the burden to: Director, Collection Strategies Division, Environmental Protection Agency ( 2822), 1200 Pennsylvania Ave., NW., Washington, DC 20460. Include the OMB control number 2070 0024 in any correspondence about this collection activity, but do not submit the requested information or forms to this address.

VI. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: November 22, 2002. James Jones, Acting Director, 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. A new Sec. 180.940 is added to subpart D of part 180 to read as follows.

Sec. 180.940 Food contact surface sanitizing solutions; exemptions from the requirement of a tolerance.

Residues of the following chemical substances are exempted from the requirement of a tolerance when used in accordance with good manufacturing practice as ingredients in an antimicrobial pesticide formulation, provided that the chemical substance is applied on a semipermanent or permanent food contact surface ( other than being applied on food packaging) with adequate draining before contact with food. ( a) The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to: Food contact surfaces in public eating places, dairy processing equipment, and foodprocessing equipment and utensils.

 Pesticide chemical CAS No. Limits  Acetic acid 64 19 7 When ready for use, the end use concentration is not to exceed 290 parts per million ( ppm)  [ alpha] Alkyl( C10 C14)[ <] hydroxypoly( oxyethylene) poly ( oxypropylene) average molecular weight ( in amu), 768 to 837  [ alpha] Alkyl( C12 C18)[ <] hydroxypoly( oxyethylene) poly( oxypropylene) average molecular weight ( in amu), 950 to 1,120  Ammonium chloride 12125 02 9 When ready for use, the end use concentration is not to exceed 48 ppm  D& C Blue No. 1 ( methylene blue) 61 73 4 When ready for use, the end use concentration is not to exceed 0.4 ppm  Dextrin 9004 53 9 When ready for use, the end use concentration is not to exceed 16 ppm  Ethanol 64 17 5 None  Ethylenediaminetetraacetic 64 02 8 None acid ( EDTA), tetrasodium salt  Hydrogen peroxide 7722 84 1 When ready for use, the end use concentration is not to exceed 91 ppm  Hypochlorous acid, sodium salt 7681 52 9 When ready for use, the end use concentration is not to exceed 200 ppm determined as total available chlorine  Iodine 7553 56 2 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Magnesium oxide 1309 48 4 None

[[ Page 71854]]

[ alpha]( p Nonylphenyl) None None [< g] hydroxypoly( oxyethylene) average poly( oxyethylene) content 11 moles)  Octadecanoic acid, calcium 1592 23 0 When ready for use, salt the end use concentration is not to exceed 16 ppm  1 Octanesulfonic acid, sodium 5324 84 5 When ready for use, salt the end use concentration is not to exceed 46 ppm of total active fatty acids  Octanoic acid 124 07 2 When ready for use, the end use concentration is not to exceed 52 ppm of total active fatty acids  Oxirane, methyl, polymer with 9003 11 6 None oxirane, minimum molecular weight ( in amu), 1,900  Peroxyacetic acid 79 21 0 When ready for use, the end use concentration is not to exceed 58 ppm  Peroxyoctanoic acid 33734 57 5 When ready for use, the end use concentration is not to exceed 52 ppm  Phosphonic acid, ( 1 2809 21 4 When ready for use, hydroxyethylidene) bis the end use concentration is not to exceed 14 ppm  Phosphoric acid, trisodium 7601 54 9 When ready for use, salt the end use concentration is not to exceed 5,916 ppm  Potassium bromide 7758 02 3 When ready for use, the end use concentration is not to exceed 46 ppm total available halogen  Potassium iodide 7681 11 0 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Potassium permanganate 7722 64 7 When ready for use, the end use concentration is not to exceed 0.7 ppm  2 Propanol ( isopropanol) 67 63 0 None  Quaternary ammonium compounds, None When ready for use, alkyl ( C12 C16) the end use benzyldimethyl, chlorides, concentration is not average molecular weight ( in to exceed 150 ppm of amu), 351 to 380 active quaternary compound  Quaternary ammonium compounds, None When ready for use, alkyl ( C12 C18) the end use benzyldimethyl, chlorides concentration is not to exceed 200 ppm of active quaternary compound in the formulated product  Quaternary ammonium compounds, None When ready for use, n alkyl ( C12 C14) dimethyl the end use ethylbenzyl ammonium concentration is not chloride, average molecular to exceed 200 ppm of weight ( in amu), 377 to 384 active quaternary compound  Quaternary ammonium compounds None When ready for use, n alkyl ( C12 C18) dimethyl the end use ethylbenzyl ammonium chloride concentration is not average molecular weight ( in to exceed 200 ppm of amu), 384 active quaternary compound  Quaternary ammonium compounds None When ready for use, di n alkyl ( C8 C10) dimethyl the end use ammonium chloride, average concentration is not molecular weight ( in amu), to exceed 150 ppm of 332 to 361 active quaternary compound  Sodium bicarbonate 144 55 8 When ready for use, the end use concentration is not to exceed 120 ppm  Starch 9005 25 8 When ready for use, the end use concentration is not to exceed 16 ppm  Sulfuric acid monododecyl 151 21 3 When ready for use, ester, sodium salt ( sodium the end use lauryl sulfate) concentration is not to exceed 3 ppm  1,3,5 Triazine 2,4,6( 1H, 3H, 5H) 2893 78 9 When ready for use, trione, 1,3 dichloro, sodium the end use salt concentration is not to exceed 100 ppm determined as total available chlorine

( b) The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to: Dairyprocessing equipment, and food processing equipment and utensils.

[[ Page 71855]]

 Pesticide chemical CAS No. Limits  Acetic acid 64 19 7 When ready for use, the end use concentration is not to exceed 686 ppm  Acetic acid, chloro, sodium 68608 66 2 When ready for use, salt, reaction products with the end use 4,5 dihydro 2 undecyl 1H concentration is not imidazole 1 ethanol and to exceed 42 ppm sodium hydroxide chloroacetic acid  Benzenesulfonic acid, dodecyl 27176 87 0 When ready for use, the end use concentration is not to exceed 5.5 ppm  Butanedioic acid, octenyl 28805 58 5 When ready for use, the end use concentration is not to exceed 156 ppm  Butoxy monoether of mixed None None ( ethylene propylene) polyalkylene glycol, minimum average molecular weight ( in amu), 2400  Calcium chloride 10043 52 4 When ready for use, the end use concentration is not to exceed 17 ppm  n Carboxylic acids ( C6 C12), None When ready for use, consisting of a mixture of the end use not less than 56% octanoic concentration is not acid and not less than 40% to exceed 39 ppm decanoic acid  Citric acid 77 92 9 None  Decanoic acid 334 48 5 When ready for use, the end use concentration is not to exceed 90 ppm total active fatty acids  Ethanesulfonic acid, 2 132 43 4 When ready for use, [ cyclohexyl ( 1 the end use oxohexadecyl) amino], sodium concentration is not salt to exceed 237 ppm  Ethylenediaminetetraacetic 139 33 3 When ready for use, acid ( EDTA), disodium salt the end use concentration is not to exceed 1,400 ppm  FD& C Yellow No. 5 ( Tartrazine) 1934 21 0 None ( conforming to 21 CFR 74.705)  D Gluconic acid, monosodium 527 07 1 When ready for use, salt the end use concentration is not to exceed 760 ppm  Hydriodic acid 10034 85 2 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Hydrogen peroxide 7722 84 1 When ready for use, the end use concentration is not to exceed 465 ppm  Hypochlorous acid 7790 92 3 When ready for use, the end use concentration is not to exceed 200 ppm determined as total available chlorine  Iodine 7553 56 2 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Lactic acid 50 21 5 When ready for use, the end use concentration is not to exceed 138 ppm  [ alpha] Lauroyl[ <] hydroxypoly ( oxyethylene) with an average of 8 9 moles ethylene oxide, average molecular weight ( in amu), 400  Nonanoic acid 112 05 0 When ready for use, the end use concentration is not to exceed 90 ppm  1 Octanamine, N, N dimethyl 7378 99 6 When ready for use, the end use concentration is not to exceed 113 ppm  1,2 Octanedisulfonic acid 113669 58 2 When ready for use, the end use concentration is not to exceed 102 ppm  1 Octanesulfonic acid 3944 72 7 When ready for use, the end use concentration is not to exceed 172 ppm  1 Octanesulfonic acid, sodium 5324 84 5 When ready for use, salt the end use concentration is not to exceed 297 ppm

[[ Page 71856]] 1 Octanesulfonic acid, 2 113652 56 5 When ready for use, sulfino the end use concentration is not to exceed 102 ppm  Octanoic acid 124 07 2 When ready for use, the end use concentration is not to exceed 176 ppm of total active fatty acids  Oxirane, methyl, polymer with 11111 34 5 When ready for use, oxirane, ether with ( 1,2 the end use ethanediyldinitrilo) tetrakis[ concentration is not propanol] ( 4: 1) to exceed 20 ppm in the formulated product  Oxychloro species ( including None When ready for use, chlorine dioxide) generated the end use by acidification of an concentration is not aqueous solution of sodium to exceed 200 ppm of chlorite chlorine dioxide as determined by the method entitled, `` Iodometric Method for the Determination of Available Chlorine Dioxide'' ( 50 250 ppm available chlorine dioxide)  Peroxyacetic acid 79 21 0 When ready for use, the end use concentration is not to exceed 315 ppm  Peroxyoctanoic acid 33734 57 5 When ready for use, the end use concentration is not to exceed 122 ppm  Phosphonic acid, ( 1 2809 21 4 When ready for use, hydroxyethylidene) bis the end use concentration is not to exceed 34 ppm  Phosphoric acid 7664 38 2 None  Phosphoric acid, monosodium 7558 80 7 When ready for use, salt the end use concentration is not to exceed 350 ppm  Potassium iodide 7681 11 0 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Propanoic acid 79 09 4 When ready for use, the end use concentration is not to exceed 297 ppm  2 Propanol ( isopropanol) 67 63 0  2,6 Pyridinedicarboxylic acid 499 83 2 When ready for use, the end use concentration is not to exceed 1.2 ppm  Sodium mono and None When ready for use, didodecylphenoxy the end use benzenedisulfonate concentration is not to exceed 1,920 ppm  Sulfuric acid 7664 93 9 When ready for use, the end use concentration is not to exceed 288 ppm  Sulfuric acid monododecyl 151 21 3 When ready for use, ester, sodium salt ( sodium the end use lauryl sulfate) concentration is not to exceed 350 ppm

( c) The following chemical substances when used as ingredients in an antimicrobial pesticide formulation may be applied to: Foodprocessing equipment and utensils.

 Pesticide chemical CAS No. Limits  Acetic acid 64 19 7 When ready for use, the end use concentration is not to exceed 686 ppm  Acetic acid, chloro, sodium 68608 66 2 When ready for use, salt, reaction products with the end use 4,5 dihydro 2 undecyl 1H concentration is not imidazole 1 ethanol and to exceed 42 ppm sodium hydroxide chloroacetic acid  [ alpha] Alkyl( C10 C14)[ <] hydroxypoly( oxyethylene) poly ( oxypropylene) average molecular weight ( in amu), 768 to 837  [ alpha] Alkyl( C11 C15)[ <] hydroxypoly( oxyethylene) with ethylene oxide content 9 to 13 moles  [ alpha] Alkyl( C12 C15)[ <] hydroxypoly ( oxyethylene) polyoxypropylene, average molecular weight ( in amu), 965

[[ Page 71857]]

[ alpha] Alkyl( C12 C18)[ <] hydroxypoly( oxyethylene) poly( oxypropylene) average molecular weight ( in amu), 950 to 1,120  Alkyl ( C12 C15) monoether of None None mixed ( ethylene propylene) polyalkylene glycol, cloud point of 70 77 [ deg] C in 1% aqueous solution, average molecular weight ( in amu), 807  Ammonium chloride 12125 02 9 When ready for use, the end use concentration is not to exceed 48 ppm  Benzenesulfonamide, N chloro 4 127 65 1 None methyl, sodium salt  Benzenesulfonic acid, dodecyl 27176 87 0 When ready for use, the end use concentration is not to exceed 400 ppm  Benzenesulfonic acid, dodecyl 25155 30 0 When ready for use, , sodium salt the end use concentration is not to exceed 430 ppm  Benzenesulfonic acid, 30260 73 2 When ready for use, oxybis[ dodecyl the end use concentration is not to exceed 474 ppm  [ 1,1' Biphenyl] 2 ol 90 43 7 When ready for use, the end use concentration is not to exceed 400 ppm  Boric acid, sodium salt 7775 19 1  Butanedioic acid, octenyl 28805 58 5 When ready for use, the end use concentration is not to exceed 156 ppm  Butanedioic acid, sulfo, 1,4 1639 66 3 None dioctyl ester, sodium salt  Butoxy monoether of mixed None None ( ethylene propylene) polyalkylene glycol, cloudpoint of 90 100 [ deg] C in 0.5 aqueous solution, average molecular weight ( in amu), 3,300  Butoxy monoether of mixed None None ( ethylene propylene) polyalkylene glycol, minimum average molecular weight ( in amu), 2,400  Calcium bromide 7789 41 5 When ready for use, the end use concentration is not to exceed 200 ppm total available halogen  Calcium chloride 10043 52 4 When ready for use, the end use concentration is not to exceed 17 ppm  n Carboxylic acids ( C6 C12), None When ready for use, consisting of a mixture of the end use not less than 56% octanoic concentration is not acid and not less than 40% to exceed 39 ppm decanoic acid  Citric acid 77 92 9 None  3 Cyclohexene 1 methanol, 98 55 5 None [ alpha],[ alpha], 4 trimethyl  D& C Blue No. 1 ( methylene blue) 61 73 4 When ready for use, the end use concentration is not to exceed 0.4 ppm  1 Decanaminium, N decyl N, N 7173 51 5 When ready for use, dimethyl, chloride the end use concentration is not to exceed 200 ppm of active quaternary compound  Decanoic acid 334 48 5 When ready for use, the end use concentration is not to exceed 234 ppm total active fatty acids  Dextrin 9004 53 9 When ready for use, the end use concentration is not to exceed 16 ppm  Ethanesulfonic acid, 2 132 43 4 When ready for use, [ cyclohexyl ( 1 the end use oxohexadecyl) amino], sodium concentration is not salt to exceed 237 ppm  Ethanol 64 17 5 None  Ethanol, 2 butoxy 111 76 2 None  Ethanol, 2( 2 ethoxyethoxy) 111 90 0 None

[[ Page 71858]]

Ethylenediaminetetraacetic 139 33 3 When ready for use, acid ( EDTA), disodium salt the end use concentration is not to exceed 1,400 ppm  Ethylenediaminetetraacetic 64 02 8 None acid ( EDTA), tetrasodium salt  Fatty acids, coco, potassium 61789 30 8 None salts  Fatty acids, tall oil, 68309 27 3 When ready for use, sulfonated, sodium salts the end use concentration is not to exceed 66 ppm  FD& C Yellow No. 5 ( Tartrazine) 1934 21 0 None ( conforming to 21 CFR 74.705)  D Gluconic acid, monosodium 527 07 1 When ready for use, salt the end use concentration is not to exceed 760 ppm  Hydriodic acid 10034 85 2 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Hydrogen peroxide 7722 84 1 When ready for use, the end use concentration is not to exceed 1,100 ppm  Hypochlorous acid 7790 92 3 When ready for use, the end use concentration is not to exceed 200 ppm determined as total available chlorine  Hypochlorous acid, calcium 7778 54 3 When ready for use, salt the end use concentration is not to exceed 200 ppm determined as total available chlorine  Hypochlorous acid, lithium 13840 33 0 When ready for use, salt the end use concentration is not to exceed 200 ppm determined as total available chlorine and 30 ppm lithium  Hypochlorous acid, potassium 7778 66 7 When ready for use, salt the end use concentration is not to exceed 200 ppm determined as available chlorine  Hypochlorous acid, sodium salt 7681 52 9 When ready for use, the end use concentration is not to exceed 200 ppm determined as available chlorine  Iodine 7553 56 2 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Lactic acid 50 21 5 None  [ alpha] Lauroyl[ <] hydroxypoly ( oxyethylene) with an average of 8 9 moles ethylene oxide, average molecular weight ( in amu), 400  Magnesium oxide 1309 48 4 None  Naphthalene sulfonic acid, 1321 69 3 When ready for use, sodium salt the end use concentration is not to exceed 332 ppm total naphthalene sulfonates  Naphthalene sulfonic acid None When ready for use, sodium salt, and its methyl, the end use dimethyl and trimethyl concentration is not derivatives to exceed 332 ppm total naphthalene sulfonates  Naphthalene sulfonic acid None When ready for use, sodium salt, and its methyl, the end use dimethyl and trimethyl concentration is not derivatives alkylated at 3% to exceed 332 ppm by weight with C6 C9 linear total naphthalene olefins sulfonates  Neodecanoic acid 26896 20 8 When ready for use, the end use concentration is not to exceed 174 ppm  Nonanoic acid 112 05 0 When ready for use, the end use concentration is not to exceed 90 ppm  [ alpha]( p Nonylphenyl) None None [< g] hydroxypoly( oxyethylene) maximum average molecular weight ( in amu), 748  [ alpha]( p Nonylphenol) None None [< g] hydroxypoly( oxyethylene) average poly( oxyethylene) content 11 moles  [ alpha]( p Nonylphenyl) None None [< g] hydroxypoly( oxyethylene) produced by the condensation of 1 mole p nonylphenol with 9 to12 moles ethylene oxide

[[ Page 71859]]

[ alpha]( p Nonylphenyl) None None [< g] hydroxypoly( oxyethylene), 9 to 13 moles ethylene oxide  Octadecanoic acid, calcium 1592 23 0 When ready for use, salt the end use concentration is not to exceed 16 ppm  9 Octadecenoic acid ( 9Z), 68988 76 1 When ready for use, sulfonated the end use concentration is not to exceed 312 ppm  9 Octadecenoic acid ( 9Z) 68443 05 0 When ready for use, sulfonated, sodium salts the end use concentration is not to exceed 200 ppm  1 Octanamine, N, N dimethyl 7378 99 6 When ready for use, the end use concentration is not to exceed 113 ppm  1,2 Octanedisulfonic acid 113669 58 2 When ready for use, the end use concentration is not to exceed 102 ppm  1 Octanesulfonic acid 3944 72 7 When ready for use, the end use concentration is not to exceed 172 ppm  1 Octanesulfonic acid, sodium 5324 84 5 When ready for use, salt the end use concentration is not to exceed 312 ppm  1 Octanesulfonic acid, 2 113652 56 5 When ready for use, sulfino the end use concentration is not to exceed 102 ppm  Octanoic acid 124 07 2 When ready for use, the end use concentration is not to exceed 234 ppm of total active fatty acids  Oxirane, methyl, polymer with 9003 11 6 None oxirane, minimum molecular weight ( in amu), 1,900  Oxirane, methyl, polymer with 106392 12 5 None oxirane, block, average molecular weight ( in amu), 1,900  Oxirane, methyl, polymer with None None oxirane, block, minimum average molecular weight ( in amu), 2,000  Oxirane, methyl, polymer with None None oxirane, block, 27 to 31 moles of polyoxypropylene, average molecular weight ( in amu) 2,000  Oxirane, methyl, polymer with 11111 34 5 When ready for use, oxirane, ether with ( 1,2 the end use ethanediyldinitrilo) tetrakis[ concentration is not propanol] ( 4: 1) to exceed 20 ppm  Oxychloro species None When ready for use, ( predominantly chlorite, the end use chlorate and chlorine dioxide concentration is not in an equilibrium mixture) to exceed 200 ppm of generated either: By directly chlorine dioxide as metering a concentrated determined by the chlorine dioxide solution method entitled, prepared just prior to use, `` Iodometric Method into potable water, or by for the acidification of an aqueous Determination of alkaline solution of Available Chlorine oxychloro species Dioxide'' ( 50 250 ( predominately chlorite and ppm available chlorate) followed by chlorine dioxide) dilution with potable water  Oxychloro species ( including None When ready for use, chlorine dioxide) generated the end use by acidification of an concentration is not aqueous solution of sodium to exceed 200 ppm of chlorite chlorine dioxide as determined by the method entitled, `` Iodometric Method for the Determination of Available Chlorine Dioxide'' ( 50 250 ppm available chlorine dioxide)  2,4 Pentanediol, 2 methyl 107 41 5 None  Peroxyacetic acid 79 21 0 When ready for use, the end use concentration is not to exceed 315 ppm in the formulated product  Peroxyoctanoic acid 33734 57 5 When ready for use, the end use concentration is not to exceed 122 ppm  Phenol, 4 chloro 2 120 32 1 When ready for use, ( phenylmethyl) the end use concentration is not to exceed 320 ppm  Phenol, 4( 1,1 dimethylpropyl) 80 46 6 When ready for use, the end use concentration is not to exceed 80 ppm

[[ Page 71860]]

Phosphonic acid, ( 1 2809 21 4 When ready for use, hydroxyethylidene) bis the end use concentration is not to exceed 34 ppm  Phosphoric acid 7664 38 2 None  Phosphoric acid, monosodium 7558 80 7 When ready for use, salt the end use concentration is not to exceed 350 ppm  Phosphoric acid, trisodium 7601 54 9 When ready for use, salt the end use concentration is not to exceed 5916 ppm in the formulated product  Poly( oxy 1,2 ethanediyl), None None [ alpha][( 1,1,3,3 tetramethylbutyl) phenyl] [< g] hydroxy, produced with one mole of the phenol and 4 to 14 moles ethylene oxide  Potassium bromide 7758 02 3 When ready for use, the end use concentration is not to exceed 200 ppm total available halogen  Potassium iodide 7681 11 0 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Potassium permanganate 7722 64 7 When ready for use, the end use concentration is not to exceed 0.7 ppm  Propanoic acid 79 09 4 When ready for use, the end use concentration is not to exceed 297 ppm  2 Propanol ( isopropanol) 67 63 0 None  2,6 Pyridinedicarboxylic acid 499 83 2 When ready for use, the end use concentration is not to exceed 1.2 ppm  Quaternary ammonium compounds, 8001 54 5 When ready for use, alkyl ( C12 C16) the end use benzyldimethyl, chlorides, concentration is not to exceed 200 ppm of active quaternary compound  Quaternary ammonium compounds, 8001 54 5 When ready for use, alkyl ( C12 C18) the end use benzyldimethyl, chlorides concentration is not to exceed 200 ppm of active quaternary compound  Quaternary ammonium compounds, None When ready for use, n alkyl ( C12 C14) dimethyl the end use ethylbenzyl ammonium concentration is not chloride, average molecular to exceed 200 ppm of weight ( in amu), 377 to 384 active quaternary compound  Quaternary ammonium compounds, None When ready for use, n alkyl ( C12 C18) dimethyl the end use ethylbenzyl ammonium chloride concentration is not average molecular weight ( in to exceed 200 ppm of amu) 384 active quaternary compound  Quaternary ammonium compounds, None When ready for use, di n Alkyl ( C8 C10) dimethyl the end use ammonium chloride, average concentration is not molecular weight ( in amu), to exceed 240 ppm of 332 to 361 active quaternary compound  Sodium[ alpha] alkyl( C12 C15) None None [< g] hydroxypoly ( oxyethylene) sulfate with the poly( oxyethylene) content averaging one mole  Sodium bicarbonate 144 55 8 When ready for use, the end use concentration is not to exceed 120 ppm  Sodium bromide 7647 15 6 When ready for use, the end use concentration is not to exceed 200 ppm total available halogen  Sodium iodide 7681 82 5 When ready for use, the end use concentration is not to exceed 25 ppm of titratable iodine  Sodium mono and None When ready for use, didodecylphenoxy the end use benzenedisulfonate concentration is not to exceed 1,920 ppm  Starch 9005 25 8 When ready for use, the end use concentration is not to exceed 16 ppm  Sulfuric acid 7664 93 9 When ready for use, the end use concentration is not to exceed 228 ppm  Sulfuric acid monododecyl 151 21 3 None ester, sodium salt ( sodium lauryl sulfate)

[[ Page 71861]]

1,3,5 Triazine 2,4,6( 1H, 3H, 5H) 2782 57 2 When ready for use, trione, 1,3 dichloro the end use concentration is not to exceed 100 ppm determined as total available chlorine  1,3,5 Triazine 2,4,6( 1H, 3H, 5H) 2244 21 5 When ready for use, trione, 1,3 dichloro, the end use potassium salt concentration is not to exceed 100 ppm determined as total available chlorine  1,3,5 Triazine 2,4,6( 1H, 3H, 5H) 2893 78 9 When ready for use, trione, 1,3 dichloro, sodium the end use salt concentration is not to exceed 100 ppm determined as total available chlorine  1,3,5 Triazine 2,4,6( 1H, 3H, 5H) 87 90 1 When ready for use, trione, 1,3,5 trichloro the end use concentration is not to exceed 100 ppm determined as total available chlorine  1,3,5 Triazine, N, N', N'' 7673 09 8 When ready for use, trichloro 2,4,6 triamino the end use concentration is not to exceed 200 ppm as total available chlorine  Xylenesulfonic acid, sodium 1300 72 7 When ready for use, salt the end use concentration is not to exceed 62 ppm  [ FR Doc. 02 30473 Filed 12 2 02; 8: 45 am]

BILLING CODE 6560 50 S


[Federal Register: September 15, 2006 (Volume 71, Number 179)]
[Notices]
[Page 54546-54547]
[DOCID:fr15se06-91]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54414; File No. SR-ISE-2006-49]

 Self-Regulatory Organizations; International Securities
Exchange, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Relating to Fee Changes

September 7, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 29, 2006, the International Securities Exchange, Inc.
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the ISE.
The ISE has filed the proposed rule change as one establishing or
changing a due, fee, or other charge imposed by the ISE under Section
19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its Schedule of Fees to establish
fees for transactions in options on 5 Premium Products.\5\ The text of
the proposed rule change is available on the Exchange's Internet Web
site (http://www.iseoptions.com), at the principal office of the ISE,

and at the Commission's Public Reference Room.
---------------------------------------------------------------------------

    \5\ The term ``Premium Products'' is defined in the Schedule of
Fees as the products enumerated therein.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the ISE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The ISE has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is proposing to amend its Schedule of Fees to
establish fees for transactions in options on the following 5 Premium
Products: iShares S&P SmallCap 600 Value Index Fund (``IJS''), iShares
Russell 1000 Growth Index Fund (``IWF''), iShares Russell MidCap Growth
Index Fund (``IWP''), iShares Russell MidCap Value Index Fund
(``IWS''), and iShares Russell 3000 Index Fund (``IWV'').\6\
Specifically, the Exchange is proposing to adopt an execution fee and a
comparison fee for all transactions in options on IJS, IWF, IWP, IWS
and IWV.\7\ The amount of the execution fee and comparison fee for
products covered by this filing shall be $0.15 and $0.03 per contract,
respectively, for all Public Customer Orders \8\ and Firm Proprietary
orders. The amount of the execution fee and comparison fee for all ISE
Market Maker transactions shall be equal to the execution fee and
comparison fee currently charged by the Exchange for ISE Market Maker
transactions in equity options.\9\ Finally, the amount of the execution
fee and comparison fee for all Non-ISE Market Maker transactions shall
be $0.16 and $0.03 per contract, respectively. All of the applicable
fees covered by this filing are identical to fees charged by the
Exchange for all other Premium Products. The Exchange believes the
proposed rule change will further the Exchange's goal of introducing
new products to the marketplace that are competitively priced.
---------------------------------------------------------------------------

    \6\ IJS, IWF, IWP, IWS and IWV constitute ``Fund Shares,'' as
defined by ISE Rule 502(h).
    \7\ These fees will be charged only to Exchange members. Under a
pilot program that is set to expire on July 31, 2007, these fees
will also be charged to Linkage Orders (as defined in ISE Rule
1900). See Securities Exchange Release No. 54204 (July 25, 2006), 71
FR 43548 (August 1, 2006).
    \8\ Public Customer Order is defined in Exchange Rule 100(a)(33)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(32) as a person that is not a broker
or dealer in securities.
    \9\ The execution fee is currently between $.21 and $.12 per
contract side, depending on the Exchange Average Daily Volume and
the comparison fee is currently $.03.
---------------------------------------------------------------------------

    The Exchange has entered into a license agreement with Standard &
Poor's and the Frank Russell Company in connection with the listing and
trading of options on IJS and IWF, IWP, IWS and IWV, respectively. As
with certain other licensed options, the Exchange is adopting a fee of
$0.10 per contract for trading in these options to defray the licensing
costs. The Exchange believes charging the participants that trade this
instrument is the most equitable means of recovering the costs of the
license. However, because of competitive pressures in the industry, the
Exchange proposes to exclude Public Customer Orders from this surcharge
fee. Accordingly, this surcharge fee would be charged only to Exchange
members with respect to Non-Public Customer Orders (e.g., ISE Market
Maker, Non-ISE Market Maker & Firm Proprietary orders) and would apply
to Linkage Orders \10\ under a pilot program that is set to expire on
July 31, 2007. Further, since options on IJS, IWF, IWP, IWS and IWV are
multiply-listed, the Payment for Order Flow fee would also apply.
---------------------------------------------------------------------------

    \10\ See supra note 7.
---------------------------------------------------------------------------

2. Statutory Basis
    The basis for the proposed rule change is the requirement under
Section 6(b)(4) of the Act \11\ that an exchange have an equitable
allocation of reasonable dues, fees, and other charges among its
members and other persons using its facilities.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change establishes or changes a
due, fee, or other charge imposed by the Exchange, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(2) \13\ thereunder. At any time within 60 days of the filing of
the proposed rule change the Commission may summarily abrogate such
proposed rule change if it

appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 19b-4(f)(2).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-ISE-2006-49 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File No. SR-ISE-2006-49. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of the filing
also will be available for inspection and copying at the principal
office of the Exchange. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File No. SR-
ISE-2006-49 and should be submitted on or before October 6, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-15322 Filed 9-14-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 80, Number 26 (Monday, February 9, 2015)]
[Rules and Regulations]
[Pages 6906-6907]
[FR Doc No: 2015-02475]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2015-0050]

Drawbridge Operation Regulation; Willamette River, Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Burlington Northern Santa Fe
Railway Bridge, also known as the St. Johns RR Bridge, across the
Willamette River, mile 6.9, at Portland, OR. The deviation is necessary
to facilitate installation of new rail joints. This deviation allows
the bridge to remain in the closed to navigation position during
maintenance activities.

DATES: This deviation is effective from 7 a.m. on February 12, 2015 to
noon on February 13, 2015.

ADDRESSES: The docket for this deviation, [USCG-2015-0050] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Coast Guard Thirteenth District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Burlington Northern Santa Fe (BNSF) Railway

requested this deviation to facilitate the installation of new rail
joints on the bridge. The bridge, also known as the St. Johns Railway
Bridge, crosses the Willamette River at mile 6.9 and provides 54 feet
of vertical clearance above Columbia River Datum 0.0 while in the
closed position. Under normal operations, this bridge opens on signal
as required by 33 CFR 117.5. The deviation period is from 7 a.m. to
noon on February 12, 2015; from 7 a.m. to noon on February 13, 2015.
This deviation allows the lift span of the BNSF Railway Bridge across
the Willamette River, mile 6.9, to remain in the closed to navigation
position, and need not open for maritime traffic during the periods
listed above. The bridge shall operate in accordance with 33 CFR 117.5
at all other times. BNSF will entertain requests from mariners to
change the above listed schedule for emergent vessel arrivals or
departures that are dependent on water level, given 72 hours advanced
notice. The BNSF contact is Jeff Swanson, who can be reached at (701)
412-6593. Waterway usage on this part of the Willamette River includes
vessels ranging from commercial tug and barge to small pleasure craft.
    Vessels able to pass through the bridge in the closed positions may
do so at any time. The BNSF Railway Bridge will not be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterways
through our Local and Broadcast Notices to Mariners of the change in
operating schedule for the bridge so that vessels can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: January 27, 2015.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2015-02475 Filed 2-6-15; 8:45 am]
BILLING CODE 9110-04-P