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

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is adding a new section to part 180 to list the pesticide chemicals that are exempt from the requirement of a tolerance when used in food-contact surface sanitizing solutions. This list of exempt pesticide chemicals is duplicated from the Food and Drug Administration's (FDA) regulations in 21 CFR 178.1010. For some of these chemical substances, EPA's list will use naming conventions differing from those used by FDA. Additionally, EPA is redesignating/reorganizing § 180.1001. This section of CFR will be split into five separate sections with no changes in text or content.

DATES:

This final rule is effective on April 28, 2004.

ADDRESSES:

EPA has established a docket for this action under Docket ID number OPP-2003-0368 All documents in the docket are listed in the EDOCKET index at http://www.epa.gov/edocket. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805.

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 formulate or market pesticide products. Potentially affected categories and entities may include, but are not limited to:

• Food manufacturing (NAICS 311)
• Antimicrobial pesticides (NAICS 32561)

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 Access Copies Of this Document and Other Related Information?

In addition to using EDOCKET ( http://www.epa.gov/edocket/ , you may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

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

This final rule is issued under the Federal Food, Drug and Cosmetic Act (FFDCA) section 408, 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170), and the Antimicrobial Regulation Technical Correction Act (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. Owing to the FQPA and ARTCA amendments to FFDCA, certain chemical substances originally regulated by FDA under FFDCA section 409 as food-contact surface sanitizing solutions are now subject to EPA's authority under FFDCA section 408. 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.

These pesticide chemical regulations are now subject to modification or revocation at EPA's initiative under FFDCA section 408(e). Today's rule duplicates the substance of FDA's food additive regulations for those chemical substances found in 21 CFR 178.1010 which are now pesticide chemicals, by codifying tolerance exemptions in a format consistent with EPA's authority under section 408 in a new section, 40 CFR 180.940.

Because some solutions described in 21 CFR 178.1010 may still have uses as food additives, FDA is leaving 21 CFR 178.1010 in effect. EPA's rulemaking activity has no effect on any of the FDA-regulated FFDCA section 409 food additive regulations in 21 CFR 178.1010.

III. Impact on Tolerance Reassessment

This rule shifts existing tolerance exemptions from 21 CFR 178.1010 to 40 CFR 180.940. These are duplicated from existing, 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. 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 by FFDCA section 408(j)(2) into FFDCA section 408 tolerance exemptions. Thus, EPA's duplication of these tolerance exemptions is not “establishing, modifying, or revoking a tolerance” under FFDCA section 408(b). EPA is not, therefore, required to conduct a full reassessment of these tolerance exemptions at this time. However, because the tolerance exemptions duplicated from 21 CFR 178.1010 into 40 CFR 180.940 were in effect prior to the enactment of FQPA, they are subject to the tolerance reassessment deadline of August 2, 2006.

IV. Background

In the Federal Register of December 3, 2002 (67 FR 71847) (FRL-6824-2), the Agency published a direct final rule to establish 40 CFR 180.940. Comments were received. In the December 3, 2002 FR final rule, EPA had announced that it would withdraw the direct final rule if it received adverse comment, and proceed with proposed rule as provided by section 553 of the Administrative Procedure Act, 5 U.S.C. 553. Because some of the comments were of a nature that would warrant a response if made on a proposed rule, they were adverse comments that required withdrawal of the direct final rule. EPA withdrew the direct final rule on March 24, 2003 (68 FR 14165)(FRL-7299-4).

In the Federal Register of June 25, 2003 (68 FR 37778) (FRL-7302-2), the Agency issued its proposal to establish 40 CFR 180.940. The comments received as a result of the December 3, 2002, direct final rule were addressed in that proposed rule.

Six comments were received in response to the June 25^th proposed rule. There was also a late comment to the direct final rule.

One commenter requested to increase the concentrations of certain chemical ingredients. At this time, EPA is not proposing to change the upper concentration limits as specified by FDA in 21 CFR 178.1010. The purpose of this final rule action is to duplicate FDA's previous clearances in a format consistent with EPA's authority under section 408. To increase the concentration limitations from those specified by FDA, requires the performance of a risk assessment. At this time EPA is merely duplicating the listing of chemicals in 21 CFR 178.1010 to 40 CFR 180.940, albeit in a different format. EPA is required under section 408(q)(1)(C) to complete tolerance reassessment for all pesticide chemicals by 2006, and will consider the commenter's suggestion during tolerance reassessment.

The same commenter requested that all GRAS ingredients listed under 21 CFR part 184 be included in 180.940. Another commenter requested that all chemical substances designated as GRAS in 21 CFR part 582 be included in 40 CFR 180.940 under a catch-all provision. The Agency understands that 21 CFR 178.1010 allows the inclusion of GRAS chemical substances and chemical substances “permitted by prior sanction or approval,” that are not expressly identified in 21 CFR 178.1010. It is for this reason that the Agency asked registrants of food-contact surface sanitizing solutions to specifically identify all other ingredients that they believe should be included in 40 CFR 180.940. At a later date, EPA intends to publish its proposal to revise 40 CFR 180.940 by adding chemical substances that were not specified by name in 21 CFR 178.1010 but that are included in a registered food-contact surface sanitizing solution. Today's final rule only considers the chemical substances that were specified by name in 21 CFR 178.1010.

One commenter expressed concern that documenting all of FDA's informal clearances could prove to be difficult. They stated that the existence of a registration should be sufficient proof. The Agency agrees. In fact, several registrants of various food-contact surface sanitizing solutions have already supplied the Agency with a list of chemical substances that were not included in the proposed 40 CFR 180.940, but are part of a registered pesticide product. The claims for inclusion of these chemical substances were documented only by reference to an EPA Registration Number. Where EPA's files clearly demonstrate both that the registered pesticide was subject to section 409 and contained the chemical substance before enactment of the FQPA, EPA will include the chemical substance in the upcoming proposal to revise 40 CFR 180.940. So although identifying a registered pesticide as containing a particular chemical substance may be sufficient to support inclusion in 40 CFR 180.940, registrants can maximize the likelihood of inclusion by providing documentation of FDA's prior sanction or approval.

Two commenters requested confirmation on whether or not chemical substances that are included in an existing, registered food-contact surface sanitizing solution, but are not included by name in 21 CFR 178.1010, are considered under this final rule to be FDA-approved substances. Today's final rule does not address such chemical substances. In the preambles to both the direct final rule and the proposed rule, EPA asked registrants of food-contact surface sanitizing solutions to identify to EPA any chemical substances that they claim have been cleared by FDA for use in sanitizing solutions but not expressly identified in 21 CFR 178.1010. As previously stated, at some time in the near future, EPA intends to publish its proposal to revise 40 CFR 180.940 to add chemical substances that were not specified by name in 21 CFR 178.1010. In order to preserve the use of registered food-contact surface sanitizing solutions whose ingredients were cleared by FDA before FQPA's enactment, EPA will treat all of the component chemicals (whether or not they are specifically identified in 21 CFR 178.1010) of registered food-contact surface sanitizing solutions as exempt from the requirement of a tolerance until EPA has completed its review of the registrants' claims with respect to pesticide chemicals not specifically identified in 21 CFR 178.1010.

The same two commenters also stated that EPA should not distinguish between the three categories of food-contact surface sanitizing solutions. They believe that these categories have not been rigidly applied. Today's final rule addresses only those use patterns as specifically described in 21 CFR 178.1010. If a registrant supplies information to the Agency to demonstrate that FDA cleared a solution for uses broader than described in § 178.1010, then EPA can include these changes in its upcoming proposal to revise 40 CFR 180.940. However, today's regulation merely duplicates the substance of the existing FDA regulation.

The late comment (to the direct final rule) requested that all of the quaternary sanitizer solutions currently listed under 21 CFR 178.1010 be approved by EPA for end use at a concentration not to exceed 400 ppm of the active quaternary compound. The rationale for such a change included a statement that FDA had intended to make such a change and a discussion of the concerns of public health officials who advocate for solutions with demonstrated efficacy over a wide range of concentrations. Such a range would provide the user “a reasonable margin of error” while preparing safe and effective sanitizing solutions.

In a similar manner, another commenter indicated its belief that the proposed language for the quaternary ammonium compounds was inconsistent with the existing FDA regulations. According to the commenter FDA had established a total limit of 400 ppm for the quaternary ammonium compounds, while EPA's approach could possibly allow up to 750 ppm. EPA discussed this issue with FDA, and concluded that the comments have merit, not only for the quaternary ammonium compounds, but also for other chemicals that were expressed as total or solution limits. This would include the halogens (chloride-, bromide-, and iodide-producing chemicals) and napthalene sulfonate derivatives. Since the concentration limits for the above chemicals are specified in 21 CFR 178.1010 as total or solution limits, this change has been carried forward to 40 CFR 180.940.

One of the commenters submitted a letter from FDA which seemed to indicate that FDA had raised the maximum at-use concentration of certain chemicals from 200 ppm to 220 ppm. This comment was also discussed with FDA who indicated that while they had “no objection” to 220 ppm as the at-use concentration, they intended that the tolerance for residues in or on food should remain at 200 ppm. FDA would continue to have no objection to use levels as high as 220 as indicated through field testing.

While not in response to a comment, the Agency is making several changes to the list of chemical substances proposed in the June 25^th proposed rule. Several of the chemical substances (citric acid, dextrin, magnesium oxide, sodium bicarbonate, starch and octadecanoic acid, calcium salt) have been recently classified as List 4A minimal risk inert ingredients (see the listings of inert ingredients at http://www.epa.gov/opprd001/inerts/lists.html). Tolerance exemptions for certain of these List 4A substances (citric acid, dextrins, and starch (as a food commodity)) have already been established in 40 CFR 180.950, the section of CFR that holds “Tolerance Exemptions for Minimal Risk Active and Inert Ingredients.” Because chemical substances with a tolerance exemption identified in 40 CFR 180.950 may be used in any pesticide product, including antimicrobial products, without limitation, having tolerance exemptions in both 40 CFR 180.940 and 180.950 would be redundant. Therefore, duplicative entries for citric acid, dextrin, and starch are not created today in 40 CFR 180.940. Additionally, because the Agency intends that all List 4A substances eventually will be transferred to 40 CFR 180.950 without limitations, the Agency is removing the concentration use limitations for sodium bicarbonate, magnesium oxide and octadecanoic acid, calcium salt.

Based on the reasons set forth in the preamble to the proposed rule, and considering the comments received by the Agency in response to the direct final and proposed rules, EPA is creating a new section 40 CFR 180.940.

Redesignation of 40 CFR 180.1001

In the July 1, 2002 edition of title 40 CFR parts 150 to 189, § 180.1001 occupies pages 508 to 537, a large amount of information for one section of CFR. Today's action shifts and splits 40 CFR 180.1001 with no changes to the text or content. See Table 1 for a redesignation of the paragraphs and the new sections.

All references to 40 CFR 180.1001 in other sections of 40 CFR are also being changed to reflect the shift. Additionally two FDA regulations cite to 180.1001: 21 CFR 182.99 and 582.99. FDA is aware that this shift of 40 CFR 180.1001 is occurring.

V. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0368 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 28, 2004. -

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.” -

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit V.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP-2003-0368, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

VI. Statutory and Executive Order Reviews

This final rule reorganizes the existing exemptions in 40 CFR 180.1001, shifting them from one section to another within the same part. The Agency is acting on its own initiative under FFDCA section 408(e) in shifting these existing tolerance exemptions to a new section of part 180. This has no substantive effect, and is not expected to have any adverse impact, or otherwise impose any new requirements.

This final rule also establishes a new section, 40 CFR 180.940, “Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing Solutions).” As discussed in Unit II., this new section merely duplicates that portion of the existing FDA regulation 21 CFR 178.1010 that applies to chemical substances that are now subject to EPA's authority under FFDCA section 408. -

The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). -

Under section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that the proposed action to reorganize 40 CFR 180.1001 will not have significant negative economic impact on a substantial number of small entities. Creation of a new section and the reorganization of 40 CFR 180.1001 does not have a substantive effect and hence causes no impact. 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 final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the Agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and 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 the rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 153, 168, and 180

• Environmental protection
• Administrative practice and procedure
• Advertising
• Agricultual commodities,

Therefore, 40 CFR chapter I is amended as follows:

PART 153—[AMENDED]

1. The authority citation for part 153 continues to read as follows:

Authority: 15 U.S.C. 136 et seq.

2. Sections 153.155 is amended by revising paragraph (c)(1) to read as follows:

(c) * * * 

(1) Sections 180.910, 180.920, and 180.950 if an exemption from the requirement of a tolerance has been established.

PART 168—[AMENDED]

3. The authority citation for part 168 continues to read as follows:

Authority: 15 U.S.C. 136 et seq.

4. Section 168.65 is amended by revising the first sentence of paragraph (b)(1)(iii)(A)( 2)(i), and by revising paragraph (b)(1)(iii)(A)(2)(ii) to read as follows:

(b) * * *

(1) * * *

(iii) * * *

(A) * * *

(2) * * *

(i) The change in color must result only from the addition of a dye included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the dye must not be a List 1 inert. * * *

(ii) The change in fragrance must result only from the addition of a chemical included on the list of the chemicals exempted from the requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the chemical must not be a List 1 inert.

5. Section 168.75 is amended by revising the second and fifth sentences of paragraph (b)(4)(iii) to read as follows:

PART 180—[AMENDED]

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

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

7. Section 180.900 is added to subpart D to read as follows:

8. Section 180.905 is added to subpart D to read as follows:

(a) When applied to growing crops, in accordance with good agricultural practice, the following pesticide chemicals are exempt from the requirement of a tolerance:

(1) [Reserved]

(2) N-Octylbicyclo(2,2,1)-5-heptene-2,3-dicarboximide.

(3) Petroleum oils.

(4) Piperonyl butoxide.

(5) [Reserved]

(6) Pyrethrum and pyrethrins.

(7) Rotenone or derris or cube roots.

(8) Sabadilla.

(b) These pesticides are not exempted from the requirement of a tolerance when applied to a crop at the time of or after harvest.

9. Section 180.910 is added to subpart D to read as follows:

Residues of the following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest:

10. Section 180.920 is added to subpart D to read as follows:

The following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops only:

11. Section 180.930 is added to subpart D to read as follows:

The following materials are exempted from the requirement of a tolerance when used in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to animals:

12. Section 180.940 is added to subpart D to read as follows:

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 substance is applied on a semi-permanent 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 food-processing equipment and utensils.

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

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

13. Section 180.1001 is removed.

14. In § 180.1067, paragraph (b) is revised to read as follows:

(b) This combination is to be impregnated on a carrier (cigarette filter tips (cellulose acetate); cotton strings; fiberboard squares) or mixed with a jel cleared under 40 CFR 180.920 or 180.950.