[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]
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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.
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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:
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 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.
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-2002-0280. 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.
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
[[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.
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 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.
II. 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.
III. 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.
IV. 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.
V. 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.
VI. Issues for Future Agency Actions
A. 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.
B. 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.
VII. 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