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Proposed Rule

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

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Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

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.

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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: boyle.kathryn@epa.gov.

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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:

CategoriesNAICS CodesExamples of Potentially Affected Entities
Industry111Crop production
112Animal production
311Food manufacturing
32532Pesticide 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: opp-docket@epa.gov, or you can submit a computer disk as described in Start Printed Page 2394this 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 Start Printed Page 2395sensitization 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 Start Printed Page 2396will 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 the LC50 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. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). 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. 601 et 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, 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 Start Printed Page 2397that 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.

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List of Subjects in 40 CFR Part 180

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Dated: January 7, 2002.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

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

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PART 180—[AMENDED]

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

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

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

Exemptions from the requirement of a tolerance.
* * * * *

(c) * * *

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

(e) * * *

Inert ingredientsLimitsUses
*   *   *    *   *   *   *
Sodium starch glycolate (CAS Reg. No. 9063-38-1)Granular and tableted products only; not to exceed 8% of the formulated productDisintegrant
*   *   *   *   *   *   *
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[FR Doc. 02-1247 Filed 1-16-02; 8:45 am]

BILLING CODE 6560-50-S