[Federal Register Volume 67, Number 12 (Thursday, January 17, 2002)]
[Proposed Rules]
[Pages 2393-2397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1247]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301210; FRL-6818-2]
RIN 2070-AC18


Sodium Starch Glycolate; Proposed Exemption From the Requirement 
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish an exemption from the 
requirement of a tolerance for residues of sodium starch glycolate when 
used as an inert ingredient (disintegrant) in granular or tableted 
pesticide products, in or on growing crops, when applied to raw 
agricultural commodities after harvest, or to animals under the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: Comments, identified by docket control number OPP-301210, must 
be received on or before March 18, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPP-301210 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Kathryn Boyle, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703-305-6304; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301210. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-301210 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described in

[[Page 2394]]

this unit. Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding use of special characters and any form of encryption. 
Comments and data will also be accepted on standard disks in 
WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPP-301210. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. 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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

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

II. Background and Statutory Findings

    In a letter to the Agency dated June 28, 1994, Generichem Corp, now 
located at 755 Union Boulevard in Totowa, NJ 07511-0457 requested that 
40 CFR 180.1001(c) and (e), be amended by establishing an exemption 
from the requirement of a tolerance for residues of sodium starch 
glycolate. The action was assigned pesticide petition (PP) number 
5E4433. Neither a Proposed Rule nor a Notice of Filing has been 
previously published for PP 5E4433. After consideration of the 
petition, EPA is proposing to establish an exemption from the 
requirement of a tolerance for residues of sodium starch glycolate.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by sodium 
starch glycolate (CAS Reg. No. 9063-38-1) are discussed in this 
unit.Sodium starch glycolate is manufactured from potato starch. It is 
produced by crossing-linking and carboxymethylation of the potato 
starch. Sodium starch glycolate is a polymer which has a molecular 
weight of approximately 2 million daltons.

A. Medical Uses

    Sodium starch glycolate has been approved for use by the Food and 
Drug Administration (FDA) as a disintegrant in both prescription and 
over-the-counter drug products. In addition to these uses, sodium 
starch glycolate is also often used as a disintegrant in a number of 
dietary supplements. Typically, sodium starch glycolate is incorporated 
into oral dosage forms of drugs (e.g., tablets) at levels up to 8% by 
weight. When the tablet is ingested, the sodium starch glycolate 
readily absorbs many times its weight in water, resulting in swelling 
which leads to the disintegration and enhanced dissolution of the 
tablet.

B. SAR (Structure Activity Relationship) Assessment

    Sodium starch glycolate is an inert ingredient. To the best of the 
Agency's knowledge sodium starch glycolate has no active ingredient 
properties. Toxicity was assessed by a process called structure 
activity relationship (SAR). In this process, the chemical's structural 
similarity to other chemicals (for which data are available) is used to 
determine toxicity. For human health, this process, can be used to 
assess absorption and metabolism, mutagenicity, carcinogenicity, 
developmental and reproductive effects, neurotoxicity, systemic 
effects, immunotoxicity, and

[[Page 2395]]

sensitization and irritation. This is a qualitative assessment using 
terms such as good, not likely, poor, moderate, or high.
    For sodium starch glycolate the SAR assessment determined that the 
chemical was not structurally related to any known carcinogens or 
developmental/reproductive toxicants. The following human exposures 
were examined as part of the analysis: Inhalation, dermal, exposures to 
the eyes, and drinking water. Absorption was expected to be nil for all 
routes of exposure based on the high molecular weight. Digestion in the 
gastrointestinal tract is possible, but the amounts that could be 
absorbed would be extremely small. The only health concern was for 
inhalation of respirable particles (less than 10 microns). Since sodium 
starch glycolate will absorb many times its own weight in water and 
swell (in volume), inhalation of respirable particles can lead to lung 
effects. Thus, there is a moderate concern for inhalation of respirable 
particles only. For all other routes of exposure, concern is low.

C. Rat Feeding Study

    This 21-day rat feeding study was conducted using a modified starch 
compound that is very similar to sodium starch glycolate. It was 
performed by the Central Institute for Nutrition and Food Research 
(referred to as TNO) in 1963. The Agency has not reviewed this study. 
Rats were fed diets that contained 60% wheat starch (control), 20%, 
40%, or 60% of the modified starch. The institute summarized the study 
as follows: It ``appears that good growth occurred on rations with 20% 
modified starch, although slight loss of hair was observed; 40% 
modified starch supported good growth, but caused loss of hair and 
slight diarrhea; 60% modified starch caused slight growth retardation, 
moderate diarrhea and loss of hair and distinctly increased water 
intake.''
    In 1993, in correspondence dated July 29, TNO discussed the 1963 
21-day rat feeding study. The reviewer indicated sodium starch 
glycolate would be well-tolerated at a level of 5% which would 
correspond to a daily intake of about 5 g/kg body weight.

D. Information from the Internet

    To ascertain whether additional information on sodium starch 
glycolate were available, the Agency also searched the Tox Net website 
at the National Library of Medicine (http://www.toxnet.nlm.nih.gov). 
The internet site did not contain any information on sodium starch 
glycolate by name or CAS Reg. No.

V. Exposure Assessment

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    For the purposes of assessing potential exposure under this 
exemption, EPA considered that sodium starch glycolate could be present 
in all raw and processed agricultural commodities and drinking water, 
and that non-occupational non-dietary exposure was possible.
    1. Dietary exposure--i. Food. As previously stated, sodium starch 
glycolate is a high molecular weight material that is derived from 
potato starch. It is widely used in pharmaceuticals and dietary 
supplements as a disintegrant. In its 1993 correspondence TNO estimated 
the maximum amount of sodium starch glycolate that would be consumed by 
humans as a result of these FDA-approved uses as 13 mg/kg/day for 
adults and 80 mg/kg/day for children. EPA will regulate only the use of 
sodium starch glycolate as an inert ingredient in pesticide 
formulations. Based on its high molecular weight any sodium starch 
glycolate that may be ingested would not be expected to undergo any 
significant amount of absorption into the body from the 
gastrointestinal (GI) tract. From its proposed use as a disintegrant in 
granular and tableted pesticide products (which should be soil-
directed), any food exposure to sodium starch glycolate as a result of 
its use in a pesticide product as an inert ingredient would be expected 
to be significantly lower than the exposure that currently occurs from 
those uses permitted by FDA.
    ii. Drinking water. Sodium starch glycolate is water-absorbing and 
therefore does not readily dissolve in water. The hydrated form of 
sodium starch glycolate would be practically insoluble in water. Given 
this insolubility, the Agency has determined that exposure for all 
human population groups through drinking water would be extremely low.
    2. Other non-occupational exposure. The term ``residential 
exposure'' is used in this document to refer to non-occupational, non-
dietary exposure (e.g., for lawn and garden pest control, indoor pest 
control, termiticides, and flea and tick control on pets). The Agency 
believes that the potential for the use of sodium starch glycolate in 
and around the home exists. However, given its high molecular weight 
absorption is expected to be nil for dermal exposure. The concern would 
be, as previously stated, for inhalation of respirable particles. This 
concern will be addressed by end-product acute inhalation toxicity 
testing at the time of product registration.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) requires that, when considering whether to 
establish, modify, or revoke a tolerance, the Agency consider 
``available information'' concerning the cumulative effects of a 
particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    Given the low toxicity of sodium starch glycolate, by all routes of 
exposure except inhalation, the Agency does not believe it likely that 
sodium starch glycolate in combination with other substances could 
result in cumulative adverse effects.

VII. Determination of Safety for U.S. Population

    EPA's analysis shows that this derivative of potato starch is 
unlikely to pose any significant toxic potential through dietary 
exposure. Not only can a compound similar to sodium starch glycolate 
serve as a significant portion of the animal diet, but sodium starch 
glycolate cannot be absorbed in the intestinal tract in significant 
amounts. The moderate inhalation toxicity concern with sodium starch 
glycolate

[[Page 2396]]

will be addressed by end-product acute inhalation toxicity testing and 
appropriate label restrictions at the time of product registration. 
Accordingly, the Agency concludes that there is a reasonable certainty 
of no harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of sodium starch glycolate. A tolerance 
is not necessary because sodium starch glycolate residues will pose no 
appreciable risks to human health under reasonably forseeable 
circumstances.

VIII. Additional Safety Factor for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA concludes that a different 
margin safety will be safe for infants and children. Due to the 
expected low toxicity of sodium starch glycolate by the oral and dermal 
pathways of exposure, EPA has not used a safety factor analysis to 
assess the risk. For the same reasons the additional tenfold safety 
factor is unnecessary.

IX. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including all pesticide chemicals (both 
inert and active ingredients), ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect. . . .'' EPA has been working with 
interested stakeholders to develop a screening and testing program as 
well as a priority setting scheme. As the Agency proceeds with 
implementation of this program, further testing of products containing 
sodium starch glycolate for endocrine effects may be required.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

C. Existing Exemptions

    There are no existing exemptions for sodium starch glycolate.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
sodium starch glycolate nor have any CODEX Maximum Residue Levels 
(MRLs) been established for any food crops at this time.

E. Conditions

    Given the moderate concern for sodium starch glycolate inhalation 
toxicity, the Agency would normally require testing of formulated end 
use pesticide products incorporating sodium starch glycolate to 
ascertain theLC50 in the acute inhalation toxicity test 
(OPPTS 870.1300). Since the use of sodium starch glycolate will be 
restricted to granular and tableted products only, it is likely that a 
waiver for the acute inhalation toxicity study would be granted. In 
order to determine the amount of fine particulate materials that could 
form during product transportation and storage, an attrition study will 
be required as part of the registration process for any end use product 
that contains sodium starch glycolate.

X. Conclusions

    Based on the information in this preamble and considering the 
restriction to granular and tableted formulations, EPA concludes that 
there is a reasonable certainty of no harm from aggregate exposure to 
sodium starch glycolate (CAS Reg. No. 9063-38-1). Accordingly, EPA 
finds that exempting sodium starch glycolate from the requirement of a 
tolerance will be safe.

XI. Regulatory Assessment Requirements

    This proposed rule establishes a tolerance under FFDCA section 
408(d) in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this proposed rule has 
been exempted from review under Executive Order 12866 due to its lack 
of significance, this proposed rule is not subject to Executive Order 
13211, Actions Concerning Regulations That Significantly Affect Energy 
Supply, Distribution, or Use (66 FR 28355, May 22, 2001).
    This proposed rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501et 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). Since 
this tolerance exemption would be established on the basis of a 
petition under FFDCA section 408(d), the requirements of the Regulatory 
Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.
    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, 
entitledConsultation 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

[[Page 2397]]

that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.'' This proposed rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: January 7, 2002.
Peter Caulkins,
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 continues to read as 
follows:

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

    2. In Sec. 180.1001, the tables in paragraphs (c) and (e) are 
amended by adding alphabetically the following inert ingredient to read 
as follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (c) *  *  *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
               *      *      *      *      *      *      *
Sodium starch glycolate (CAS      Granular and        Disintegrant
 Reg. No. 9063-38-1)               tableted products
                                   only; not to
                                   exceed 8% of the
                                   formulated
                                   product
               *      *      *      *      *      *      *
------------------------------------------------------------------------

* * * * *
    (e) *  *  *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
               *      *      *      *      *      *      *
Sodium starch glycolate (CAS      Granular and        Disintegrant
 Reg. No. 9063-38-1)               tableted products
                                   only; not to
                                   exceed 8% of the
                                   formulated
                                   product
               *      *      *      *      *      *      *
------------------------------------------------------------------------


[FR Doc. 02-1247 Filed 1-16-02; 8:45 am]
BILLING CODE 6560-50-S