Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Minimal risk active and inert ingredients; tolerance exemptions,

[Federal Register: November 20, 2002 (Volume 67, Number 224)]

[Proposed Rules]

[Page 70036-70042]

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

[DOCID:fr20no02-23]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0280; FRL-7278-3]

Pesticides; Minimal Risk Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes to reorganize certain existing tolerance exemptions. All of these chemical substances were reviewed as part of the tolerance reassessment process required under the Food Quality Protection Act of 1996 (FQPA). As a result of that review, certain chemical substances are now classified as ``minimal risk,'' and are therefore being shifted to the section of 40 CFR part 180 that holds minimal risk chemical substances. The Agency is merely moving certain tolerance exemptions from one section of the CFR to another section: No tolerance exemptions are lost as a result of this action.

DATES: Comments, identified by docket ID number OPP-2002-0280, must be received on or before January 21, 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.

[[Page 70037]]

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:

1. General Information

   1. Does This Action Apply to Me?

      You may be potentially affected by this action if you formulate or market pesticide products or if you market certain pesticides that have been exempted from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pursuant to section 25(b) of FIFRA. Potentially affected categories and entities may include, but are not limited to:

      [sbull] Crop production (NAICS 111)

      [sbull] Animal production (NAICS 112)

      [sbull] Food manufacturing (NAICS 311)

      [sbull] Pesticide manufacturing (NAICS 32532)

      [sbull] 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.

   2. 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-2002-0280. 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 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.

   3. 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

         [[Page 70038]]

         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- 0280. 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-2002-0280. 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-2002-0280.

      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-2002-0280. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.A.1.

   4. 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.

   5. 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 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 your estimate.

      5. Provide specific examples to illustrate your concerns.

      6. Offer alternatives.

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

      8. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.

2. What Action is the Agency Taking?

   In the Federal Register published on May 24, 2002 (67 FR 36534) (FRL-6834-8) EPA established a new Sec. 180.950 to list the pesticide chemical substances that are exempted from the requirement of a tolerance based on the Agency's determination that these chemical substances are of ``minimal risk.'' As the first step in populating this section, the Agency shifted the existing tolerance exemptions for commonly consumed food commodities, animal feed items, and edible fats and oils to this section.

   This proposed rule shifts existing tolerance exemptions for certain inert ingredients that have been classified by the Agency as List 4A, ``minimal risk,'' to 40 CFR 180.950. The decision documents supporting the minimal risk, List 4A-Classification, are in the docket.

   The following tolerance exemptions are being shifted from 40 CFR 180.2: Citric acid, fumaric acid, lime, sodium chloride, and sulfur. The following tolerance exemptions are being shifted from 40 CFR 180.1001(c): Animal glue; bentonite; calcareous shale; calcite; calcium carbonate; calcium citrate; calcium silicate; [alpha]-cellulose; citric acid; coffee grounds; corn dextrin; dextrin; dolomite; graphite; guar gum; gypsum; hydroxyethyl cellulose; hydroxypropyl methylcellulose; iron oxide; kaolinite-type clay; lecithin; licorice root; magnesium carbonate; magnesium-lime; magnesium oxide; magnesium silicate; magnesium sulfate; methylcellulose; mica; montmorillonite-type clay; potassium aluminum silicate; potassium chloride; potassium citrate; potassium sulfate; silica, hydrated; silicon dioxide, fumed, amorphous; sodium acetate; sodium alginate; sodium aluminum silicate; sodium bicarbonate; sodium carboxymethylcellulose; sodium chloride; sodium sulfate; vermiculite; xanthan gum; zeolite (hydrated alkali aluminum silicate); and zinc oxide.

   The following tolerance exemptions are being shifted from 40 CFR 180.1001(d): Cellulose acetate; graphite; hydroxypropylcellulose; locust bean gum; paper fiber, deinked or recycled; paper fiber, produced by the kraft (sulfate) or sulfite pulping processes; silicon dioxide, fumed, amorphous; soap bark (quillaja); sodium citrate; and wool fat (anhydrous lanolin). The following tolerance exemptions are being shifted from 40 CFR 180.1001(e): Calcium carbonate; calcium silicate (hydrated calcium silicate); calcium sulfate; castor oil, u.s.p.; [alpha]-cellulose; citric acid; dextrin; graphite; iron oxide; kaolinite-type clay; magnesium carbonate; methylcellulose; montmorillonite-type clay; potassium citrate; silica, amorphous, fumed (crystalline free); silica, hydrated silica; silica aerogel; sodium carboxymethylcellulose, sodium sulfate; sulfur; xanthan gum; and zinc oxide.

   The following tolerance exemptions are also being shifted from: Sec. 180.1036: Hydrogenated castor oil, Sec. 180.1176: Sodium bicarbonate, Sec. 180.1177: Potassium bicarbonate, and Sec. 180.1180: Kaolin. Because this action merely moves certain tolerance exemptions from one section of the CFR to another section, it will have no substantive or procedural effect on the moved tolerance exemptions. No tolerance

   [[Page 70039]]

   exemptions are lost as a result of this action.

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

   This proposed rule is issued under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170). Section 408(e) of FFDCA authorizes EPA to establish, modify, or revoke tolerances, or exemptions from the requirement of a tolerance for residues of pesticide chemical substances in or on raw agricultural commodities and processed foods.

4. What is ``Minimal Risk?''

   The term ``minimal risk'' has been used by EPA for over 10 years, and has generally meant List 4A inert ingredient chemical substances. On April 22, 1987 (52 FR 13305), EPA created a series of four lists as part of an initiative to address the risks potentially posed by inert ingredients in pesticide products. At that time all List 4 inert ingredients were classified as ``inerts of minimal concern.'' The 4A Inert Ingredient List was created on November 22, 1989 (54 FR 48314) by subdividing List 4 into Lists 4A and 4B. List 4B inert ingredients are ``inerts for which EPA has sufficient information to reasonably conclude that the current use pattern in pesticide products will not adversely affect public health or the environment.'' List 4A inert ingredients are ``minimal risk inert ingredients.'' Only substances on List 4A are permitted to be used as inert ingredients in certain pesticides that have been exempted from FIFRA, 7 U.S.C. 136 et seq., pursuant to section 25(b) of FIFRA, 7 U.S.C. 136w(b).

   Minimal risk does not imply no risk under any circumstances. Every substance can present some risk in certain circumstances. Minimal risk is used to indicate a substance for which there is no information to indicate that there is a basis for concern. Many minimal risk or List 4A substances are naturally occurring substances to which some refinement has occurred, such as beeswax, limestone, red cedar chips, salt, and sugar. The determination that a chemical substance is minimal risk would be based on a recognition of the overall safety of the chemical (such as very low toxicity or practically non-toxic) considering the widely available information on the chemical substances known properties, and a history of safe use under reasonable circumstances. Minimal risk (List 4A) chemical substances are recognized as safe for use in all pesticide products subject only to good agricultural practices or good manufacturing practices. Classification as a List 4A, minimal risk, chemical substance is a high standard to meet. As an example, chemical substances of high acute toxicity are usually not considered for classification to List 4A. The critical distinction between List 4A minimal risk chemical substances and other chemical substances, is that the Agency does not define how, where, when or in what manner the chemical substance can be used. Any reasonably foreseeable use of these chemical substances in a pesticide product is not expected to present a risk to humans. Accordingly, there should not be any unreasonable adverse effects from the inclusion of a List 4A chemical substance in a pesticide product to the person applying a pesticide product in and around their home, to a child in a daycare center, or when ingesting a food commodity that has been treated. A List 4A chemical substance used as an inert ingredient, incorporated into a 25(b) product (meeting all the appropriate exemption criteria) is subject to no Federal regulation under FIFRA except as provided in 40 CFR 152.25(g).

   The Agency must give consideration to all routes of exposure to determine that a chemical substance used in a pesticide product can be classified as minimal risk. Several of the chemical substances being shifted to the new section are naturally occurring materials that have been referred to as weathered materials. Weathered materials is the term that the Agency is using to describe a group of substances that could also be referred to as rocks and minerals. Generally, weathered materials are decayed or weathered rocks that are mostly unrefined, i.e., not altered or manufactured by man. When referring to weathered materials as mostly unrefined, the Agency is including the mechanical grinding of larger rocks into smaller pieces that are essentially the same, but not the chemical or physical alteration of the rock into a different substance. Naturally occurring materials such as these can contain impurities such as asbestos or silica which can lead to health effects including pneumoconiosis, silicosis, or kaolinosis. To evaluate these effects, the Agency conducted a screening-level assessment on weathered materials that compared an estimated residential exposure to the OSHA threshold limit value (TLV). A TLV is a limit on inhalation exposure in the workplace. Only those chemical substances that passed this screening level assessment were considered for List 4A status.

5. Nomenclature Changes

   For some of the chemical substances that are being shifted to 40 CFR 180.950, EPA is making minor changes to the chemical substance names that were previously used. Additionally, 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. The lack of a CAS No. will not preclude the Agency from including substances in 40 CFR 180.950. Generally, there will be only one CAS No. per listed substance; however, it is possible that more than one CAS No. may be appropriate for some substances, such as when there is both a hydrated and anhydrous form. EPA has both broadened and consolidated names to account for differing terminologies and current usage status. Also, additional information to better define the impurities in some naturally occurring substances and thus limit the inhalation concerns that can occur with naturally-occurring materials in a respirable form may have been added.

6. Issues for Future Agency Actions

   1. Chemical Substances Being Transferred From List 4A to List 4B

      The proposed rule published in the Federal Register of January 15, 2002 (67 FR 1925) (FRL-6807-8) indicated that several allergen- containing food commodities would be moved from List 4A to List 4B. The Agency has now determined that there are additional chemical substances that no longer meet the criteria of List 4A. These chemical substances are acetic acid, activated charcoal, attapulgite clay, gum arabic, and granite. These chemical substances will be transferred from the Agency's 4A list to the 4B list. Pesticide products containing these inert ingredients will no longer be considered exempt under FIFRA section 25(b) once that transfer is made. Manufacturers of such products will have the option of either reformulating their product, substituting a different List 4A inert ingredient, or of registering the product with the Agency. It is noted that vinegar (maximum of 8% acetic acid in solution), a commonly consumed food commodity, is still classified as List 4A.

   2. Chemical Substances That Have Been Classified as List 4A

      The Agency has classified more chemical substances as List 4A, and is likely to classify additional chemical substances as List 4A. Shifting the

      [[Page 70040]]

      existing tolerance exemptions for all of these chemical substances to 40 CFR 180.950 is a multi-step process that will continue. Additionally, on its own initiative, the Agency will propose to establish tolerance exemptions in 40 CFR 180.950 for some chemical substances that are currently classified as List 4A, but do not have tolerance exemptions. At the conclusion of this multi-step process, all chemical substances classified as List 4A will be included in 40 CFR 180.950 and will thus have tolerance exemptions.

7. Regulatory Assessment Requirements

   This proposed rule merely reorganizes existing exemptions in 40 CFR part 180. This has no substantive effect and hence causes no impact. The Agency is acting on its own initiative under FFDCA section 408 (e) in shifting these existing tolerance exemptions to a new section. Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a ``significant regulatory action'' subject to review by the Office of Management and Budget (OMB). Because the proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).

   This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

   Nor does it require any special considerations under Executive Order 12898 entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994) or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

   Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that these proposed actions will not have significant negative economic impact on a substantial number of small entities. As noted in this unit, this action will have no substantive or procedural effect on the tolerance exemptions affected. However, by grouping tolerance exemptions that have qualified as minimal risk inerts in one location in the CFR, this action will make it easier for small entities to efficiently use EPA's tolerance regulations.

   In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

   For these same reasons, the Agency has determined that this proposed rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.'' This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

   List of Subjects in 40 CFR Part 180

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

   Dated: October 27, 2002. Debra Edwards, Acting Director, Registration Division, Office of Pesticide Programs.

   Therefore, it is proposed that 40 CFR chapter I be amended as follows:

   PART 180--[AMENDED]

   1. The authority citation for part 180 would continue to read as follows:

      Authority: 21 U.S.C. 321(q), 346(a) and 374.

      Sec. 180.2 [Amended]

   2. In Sec. 180.2, paragraph (a), is amended by removing ``citric acid,'' ``fumaric acid,'' ``lime,'' ``sodium chloride,'' and ``sulfur.''

   3. In Sec. 180.950, paragraph (e) is amended by alphabetically adding the following chemical substances to read as follows:

      Sec. 180.950 Tolerance exemptions for minimal risk active and inert ingredients.

      * * * * *

      (e) * * *

      Chemical substances

      CAS No.

      Acetic acid, sodium salt.......................

      127-09-3 Animal glue....................................

      None Bentonite......................................

      1302-78-9 Bentonite, sodian..............................

      85049-30-5 Calcium oxide silicate (Ca3O(SiO4))............

      12168-85-3 Carbonic acid, calcium salt, (limestone)

      1317-65-3 (marble) (chalk) (mollusc/bivalve shells) (no asbestos and less than 1% crystalline silica). Carbonic acid, calcium salt (calcite) (no

      13397-26-7 asbestos and less than 1% crystalline silica).

      [[Page 70041]]

      Carbonic acid, calcium salt (1:1), (no asbestos

      471-34-1 and less than 1% crystalline silica).......... Carbonic acid, calcium salt (1:1), hexahydrate.

      15634-14-7 Carbonic acid, magnesium salt (1:1) (less than

      546-93-0 1% crystalline silica)........................ Carbonic acid, monopotassium salt..............

      298-14-6 Carbonic acid, monosodium salt.................

      144-55-8 Carob gum (locust bean gum)....................

      9000-40-2 Castor oil.....................................

      8001-79-4 Castor oil, hydrogenated.......................

      8001-78-3 Cellulose......................................

      9004-34-6 Cellulose acetate..............................

      9004-35-7 Cellulose, carboxy methyl ether, sodium salt...

      9004-32-4 Cellulose, 2-hydroxyethyl ether................

      9004-62-0 Cellulose, 2-hydroxypropyl ether...............

      9004-64-2 Cellulose, 2-hydroxypropyl methyl ester........

      9004-65-3 Cellulose, methyl ether........................

      9004-67-5 Cellulose, mixture with cellulose carboxymethyl

      51395-75-6 ether, sodium salt............................ Cellulose, pulp................................

      65996-61-4 Cellulose, regenerated.........................

      68442-85-3 Citric acid....................................

      77-92-9 Citric acid, calcium salt......................

      7693-13-2 Citric acid, calcium salt (2:3)................

      813-94-5 Citric acid, dipotassium salt..................

      3609-96-9 Citric acid, disodium salt.....................

      144-33-2 Citric acid, monohydrate.......................

      5949-29-1 Citric acid, monopotassium salt................

      866-83-1 Citric acid, monosodium salt...................

      18996-35-5 Citric acid, potassium salt....................

      7778-49-6 Citric acid, sodium salt.......................

      994-36-5 Citric acid, tripotassium salt.................

      866-84-2 Citric acid, tripotassium salt monohydrate.....

      6100-05-6 Citric acid, trisodium salt....................

      68-04-2 Citric acid, trisodium salt, dihydrate.........

      6132-04-3 Citric acid, trisodium salt, pentahydrate......

      6858-44-2 Coffee grounds.................................

      68916-18-7 Dextrins.......................................

      9004-53-9 Dolomite (CaMg(CO3)2) (no asbestos and less

      16389-88-1 than 1% crystalline silica)................... Feldspar - group minerals (no asbestos and less

      68476-25-5 than 1% crystalline silica)................... Fuller's earth.................................

      8031-18-3 Fumaric acid...................................

      110-17-8 Graphite (no asbestos and less than 1%

      7782-42-5 crystalline silica)........................... Guar gum.......................................

      9000-30-0 Gypsum (sulfuric acid, calcium salt, dihydrate)

      13397-24-5 (no asbestos and less than 1% crystalline silica)....................................... Iron oxide (FeO)...............................

      1345-25-1 Iron oxide (Fe2O3).............................

      1309-37-1 Iron oxide (Fe2O3), hydrate....................

      12259-21-1 Iron oxide (Fe3O4).............................

      1317-61-9 Kaolin (no asbestos and less than 1%

      1332-58-7 crystalline silica)........................... * * * * * Lanolin........................................

      8006-54-0 Lecithins......................................

      8002-43-5 Lecithins, soya................................

      8030-76-0 Licorice Extract...............................

      68916-91-6 Lime (chemical) dolomitic (magnesium and

      12001-27-3 calcium carbonate) (magnesium-lime)........... Magnesium oxide................................

      1309-48-4 Magnesium silicon oxide (Mg2Si3O8).............

      14987-04-3 Maltodextrin...................................

      9050-36-6 Mica - group minerals (no asbestos and less

      12001-26-2 than 1% crystalline silica)................... Montmorillonite................................

      1318-93-0 Paper..........................................

      None Perlite (no asbestos and less than 1%

      130885-09-5 crystalline silica)........................... Perlite, expanded (no asbestos and less than 1%

      93763-70-3 crystalline silica)........................... Plaster of Paris (sulfuric acid, calcium salt,

      26499-65-0 hemihydrate); (no asbestos and less than 1% crystalline silica)........................... Potassium chloride.............................

      7447-40-7 Silica aerogel................................. Silica, amorphous, diatomaceous earth

      61790-53-2 (Kieselguhr)(less than1% crystalline silica).. Silica, amorphous, fumed (crystalline free)....

      112945-52-5 Silica, amorphous, perlite,.................... Silica, amorphous, precipitated and gel........

      7699-41-4 Silica (crystalline-free forms only)...........

      7631-86-9 Silica gel.....................................

      63231-67-4 Silica gel, precipitated, crystalline-free.....

      112926-00-8 Silica, hydrate................................

      10279-57-9 Silica, vitreous...............................

      60676-86-0 Silicic acid, aluminum potassium salt..........

      1327-44-2 Silicic acid, aluminum salt....................

      1327-36-2 Silicic acid, aluminum salt, hydrate...........

      1335-30-4 Silicic acid, aluminum sodium salt (1:1:1).....

      12003-51-9 Silicic acid, aluminum sodium salt.............

      1344-00-9 Silicic acid, calcium salt.....................

      1344-95-2 Silicic acid, calcium salt, (wollastonite) (no

      13983-17-0 asbestos and less than 1% crystalline silica). Silicic acid, magnesium salt...................

      1343-88-0 Silicic acid, magnesium salt, hydrate..........

      1343-90-4 Silicic acid, magnesium salt (1:1).............

      13776-74-4 Soapbark (Quillaja saponin)....................

      1393-03-9 Sodium alginate................................

      9005-38-3 Sodium chloride (table salt)...................

      7647-14-5 Sulfur.........................................

      7704-34-9

      [[Page 70042]]

      Sulfuric acid, calcium salt (1:1)..............

      7778-18-9 Sulfuric acid, calcium salt, dihydrate (1:1)...

      10101-41-4 Sulfuric acid, calcium salt, hydrate (2:2:1)...

      10034-76-1 Sulfuric acid, magnesium salt, (1:1)...........

      7487-88-9 Sulfuric acid, magnesium salt (1:1)

      10034-99-8 heptahydrate.................................. Sulfuric acid, magnesium salt (1:1) monohydrate

      14168-73-1 Sulfuric acid, monopotassium salt..............

      7646-93-7 Sulfuric acid, dipotassium salt................

      7778-80-5 Sulfuric acid, disodium salt...................

      7757-82-6 Sulfuric acid, disodium salt, decahydrate......

      7727-73-3 Sulfuric acid, disodium salt, heptadydrate.....

      13472-39-4 Vermiculite (no asbestos and less than 1%

      1318-00-9 crystalline silica)........................... Xanthan gum....................................

      11138-66-2 Zeolites (excluding erionite; CAS No. 12510-42-

      1318-02-1 8)............................................ Zinc oxide.....................................

      1314-13-2

      Sec. 180.1001 [Amended]

   4. In Sec. 180.1001 the table in paragraph (c) is amended by removing the following entries: ``Animal glue;'' ``Bentonite;'' ``Calcareous shale;'' ``Calcite;'' ``Calcium carbonate;'' ``Calcium citrate;'' ``Calcium silicate;'' ``[alpha]-Cellulose;'' ``Citric acid;'' ``Coffee grounds;'' ``Corn dextrin;'' ``Dextrin;'' ``Dolomite;'' ``Graphite;'' ``Guar gum;'' ``Gypsum;'' ``Hydroxyethyl cellulose;'' ``Hydroxypropyl methylcellulose;'' ``Iron oxide;'' ``Kaolinite-type clay;'' ``Lecithin;'' ``Licorice root;'' ``Magnesium carbonate;'' ``Magnesium-lime;'' ``Magnesium oxide;'' ``Magnesium silicate;'' ``Magnesium sulfate;'' ``Methylcellulose;'' ``Mica;'' ``Montmorillonite-type clay;'' ``Potassium aluminum silicate;'' ``Potassium chloride;'' ``Potassium citrate;'' ``Potassium sulfate;'' ``Silica, hydrated;'' ``Silicon dioxide, fumed, amorphous;'' ``Sodium acetate; ``Sodium alginate;'' ``Sodium aluminum silicate;'' ``Sodium bicarbonate;'' ``Sodium carboxymethylcellulose;'' ``Sodium chloride;'' ``Sodium sulfate;'' ``Vermiculite;'' ``Xanthan Gum;'' ``Zeolite (hydrated alkali aluminum silicate;'' ``Zinc oxide.''

   5. In Sec. 180.1001 the table in paragraph (d) is amended by removing the following inert ingredients: ``Cellulose acetate (CAS Reg. No. 9004-35-7), minimum number average molecular weight, 28,000; ``Graphite;'' ``Hydroxypropyl cellulose;'' ``Locust bean gum;'' ``Paper fiber, deinked or recycled, conforming to 21 CFR 109.30(a)(9) and 21 CFR 176.260;'' ``Paper fiber, produced by the kraft (sulfate) or sulfite pulping processes;'' ``Silicon dioxide, fumed, amorphous;'' ``Soap bark (quillaja);'' ``Sodium citrate;'' ``Wool fat (anhydrous lanolin).''

   6. In Sec. 180.1001 the table in paragraph (e) is amended by removing the following inert ingredients: ``Calcium carbonate;'' Calcium silicate (hydrated calcium silicate);'' Calcium sulfate;'' ``Castor oil, U.S.P.;'' ``[alpha]-Cellulose;'' ``Citric acid;'' ``Dextrin (CAS Reg. No. 9004-53-9);'' ``Graphite;'' ``Iron Oxide (CAS Reg. No. 1309-37-1);'' ``Kaolinite-type clay;'' ``Magnesium carbonate;'' ``Methylcellulose;'' ``Montmorillonite-type clay;'' ``Potassium citrate (CAS Reg. No. 866-84-2);'' ``Silica, amorphous, fumed (crystalline free) (CAS Reg. No. 112945-52-5);'' ``Silica, hydrated silica,;'' ``Silica aerogel (finely powdered microcellular silica foam having a minimum silica content of 89.5%);'' ``Sodium carboxymethylcellulose;'' ``Sodium sulfate;'' ``Sulfur (CAS Reg. No. 7704-34-9);'' ``Xanthan gum;'' ``Zinc oxide.''

      Sec. 180.1036 [Removed]

   7. Section 180.1036 is removed.

      Sec. 180.1176 [Removed]

   8. Section 180.1176 is removed.

      Sec. 180.1177 [Removed]

   9. Section 180.1177 is removed.

      Sec. 180.1180 [Removed]

   10. Section 180.1180 is removed.

       [FR Doc. 02-29172 Filed 11-19-02; 8:45 am]

       BILLING CODE 6560-50-S