[Federal Register Volume 67, Number 94 (Wednesday, May 15, 2002)]
[Rules and Regulations]
[Pages 34616-34620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11743]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0031; FRL-6835-5]


Silica, Amorphous, Fumed (Crystalline Free); Exemption from the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of silica, amorphous, fumed (crystalline 
free) (CAS Reg. No. 112945-52-5) also known as silicon dioxide fumed 
amorphous when used as an inert ingredient when applied to animals. 
Cabot Corporation submitted a petition to EPA under the Federal Food, 
Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act (FQPA) of 1996, requesting an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of silica, 
amorphous, fumed (crystalline free). By law, EPA is required to 
reassess 66% or about 6,400 of the tolerances in existence on August 2, 
1996, by August 2002. Upon publication of this final rule, one 
tolerance reassesment for the existing tolerance exemption in 40 CFR 
180.1001(c) for silicon dioxide fumed amorphous will be counted toward 
the August 2002 review deadline of FFDCA section 408(q), as amended by 
FQPA in 1996.

DATES: This regulation is effective May 15, 2002. Objections and 
requests for hearings, identified by docket control number OPP-2002-
0031, must be received on or before July 15, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-2002-0031 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Treva Alston, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8373; 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

[[Page 34617]]

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/. 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.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-2002-0031. 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.

II. Background and Statutory Findings

    In the Federal Register of June 30, 2000 (65 FR 40637) (FRL-6592-
6), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a, as amended by the FQPA Public Law 104-170), announcing the filing 
of a pesticide petition (PP 0E6109) by Cabot Corporation, Route 36W., 
Tuscola, IL 61953. This notice included a summary of the petition 
prepared by the petitioner. There were no comments received in response 
to the notice of filing.
    The petition requested that 40 CFR 180.1001(e) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of silica, amorphous, fumed (crystalline free).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for 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 ploymers 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. Silica, amorphous, fumed (crystalline free) is 
composed of oxygen and silicon, the most abundant and second-most 
abundant elements in the earth's crust, respectively. Silicon almost 
always occurs in combination with oxygen, and a number of naturally-
occurring minerals (such as quartz) are pure, or nearly pure, silicon 
dioxide. Silica can be divided into two types: crystalline and 
amorphous. The major toxicological hazard of crystalline silica is 
through the inhalation route of exposure. Silicosis and/or cancer can 
result from long-term inhalation of the crystalline form (such as 
crystalline quartz). However, exposure to amorphous forms of silica is 
not associated with silicosis or cancer. In fact, IARC (International 
Agency for Research on Cancer) has classified crystalline forms of 
silica when inhaled from occupational exposures as Group I, 
carcinogenic to humans. The IARC has classified amorphous forms of 
silica as Group 3, not classifiable as to its carcinogenicity to 
humans. Silica, amorphous, fumed (crystalline free) is a manufactured 
product. Chemically and physically it is similar to diatomateous earth.
    The petitioner submitted to the Agency four acute toxicity studies 
(acute oral LD50 in the rat, acute inhalation 
LC50 in the rat, primary eye irritation in the rabbit, and 
primary dermal irritation in the rabbit); and four mutagenicity studies 
salmonella typhimurium/mammalian microsome mutagenicity assay (Ames), 
an in vitro unscheduled DNA synthesis (UDS) assay in rat primary 
heptatocytes, an in vitro chromosomal aberation assay in Chinese 
hamster ovary (CHO) Cells; and an in vitro CHO/HGPRT assay). There was 
also an evaluation of oral toxicity of fumed silica which is a 
metabolism and pharmacokinetics study. The results of these studies are 
listed below:
    1. Acute toxicity studies. No mortalities were observed for the 
oral and inhalation studies. For the primary eye irritation study, 
there was no corneal opacity or iridial irritation in

[[Page 34618]]

any of the eyes. For the dermal study, there was no dermal irritation 
at 72 hours. For the acute toxicity study, the oral LD50 is 
>5,000 milligrams/kilograms (mg/kg). For the acute inhalation study, 
the LC50 is >2.08 mg/L. All studies are toxicity category 
IV.
    2. Mutagenic studies. In all four studies there was no indication 
of any mutagenic activity associated with exposure to silica, 
amorphous, fumed (crystalline free).
    3. Oral toxicity of fumed silica. There were no mortalities or 
clinical signs. There was no significant difference between the test 
group and the control group with respect to silica concentration in the 
carcass.

V. Aggregate Exposures

    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.

A. Dietary Exposure

    Silica, amorphous, fumed (crystalline free) is composed of oxygen 
and silicon, which are the most abundant and second-most abundant 
elements in the earth's crust respectively. Silicon almost always 
occurs in combination with oxygen, and there are a number of naturally-
occurring forms. For this reason, EPA has considered that silica, 
amorphous, fumed (crystalline free) could be present in all raw and 
processed agricultural commodities and drinking water, and that non-
occupational non-dietary exposure is possible.
    1. Food. Forms of silicon dioxide are considered to be inert when 
ingested. There are currently FDA clearances for the use of silicon 
dioxide as a food additive for direct addition to food for human 
consumption (21 CFR 172.480) at levels up to 2% by weight. It is also 
used as an excipient in pharmaceuticals and in cosmetics. EPA will 
regulate silica, amorphous, fumed (crystalline free) only as an inert 
in pesticide formulations. The amount of silica, amorphous, fumed 
(crystalline free) that can be applied to food as a result of their use 
in pesticide formulations would not significantly increase the amount 
of silica, amorphous, fumed (crystalline free) in the food supply above 
those amounts permitted by FDA. Given the very low toxicity of silica, 
amorphous, fumed (crystalline free), there are no concerns for 
increased exposure.
    2. Drinking water exposure. With various forms of silicon dioxide 
being abundant in nature, increased drinking water exposure from the 
use of silica, amorphous, fumed (crystalline free) in pesticide 
formulations would not be expected.

B. Other Non-Occupational Exposure

    It is highly likely that silica, amorphous, fumed (crystalline 
free) can be used in and around the home. Given its high molecular 
weight (645,000 daltons), it is unlikely that it could be absorbed 
through the skin in sufficient amounts to cause toxicity in a 
residential setting. Given the nature of silica, amorphous, fumed 
(crystalline free) and its anticipated uses, the Agency has examined 
residential inhalation exposures using a screening approach. There are 
no concerns for inhalation exposures typical of those found in a 
residential scenario.

VI. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify or revoke a tolerance or tolerance 
exemption, the Agency considers ``available information'' concerning 
the cumulative effects of a particular chemical's residues and ''other 
substances that have a common mechanism of toxicity.'' Silica, 
amorphous, fumed (crystalline free) has demonstrated a lack of 
toxicity, and thus is unlikely to share a common mechanism of toxicity 
with any other substances.

VII. Children's Safety Factor

    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 of safety will be safe for infants and children. Due to the 
expected low toxicity of silica, amorphous, fumed (crystalline free), 
EPA has not used a safety factor analysis to assess the risk. For the 
same reasons the additional tenfold safety factor is unnecessary.

VIII. Determination of Safety for U.S. Population

    Silica, amorphous, fumed (crystalline free) has a demonstrated lack 
of toxicity. The acute toxicity studies are toxicity category IV. The 
mutagenicity studies are negative. Silica, amorphous, fumed 
(crystalline free) is not classifiable, as to its carcinogenicity 
however, given its amorphous nature, it is not expected to pose a 
carcinogenic risk. Silicas are considered to be inert when ingested, 
and due to the high molecular weight it is unlikely to be absorbed 
through the skin. There should be no concerns for human health, whether 
the exposure is acute, subchronic, or chronic by any route. Thus, based 
on the very low toxicity of silica, amorphous, fumed (crystalline 
free), the Agency has determined that there is a reasonable certainty 
of no harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of silica, amorphous, fumed (crystalline 
free) and that a tolerance is not necessary.

IX. Other Considerations

A. Endocrine Disruptors

    There is no available evidence that silica, amorphous, fumed 
(crystalline free) is an endocrine disruptor.

B. Analytical Method(s)

    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 is an existing exemption from the requirement of a tolerance 
under 40 CFR 180.1001(c) for use as flow control, anticaking, and 
carrier agent.

D. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
silica, amorphous, fumed (crystalline free) nor have any CODEX Maximum 
Residue

[[Page 34619]]

Levels (MRLs) been established for any food crops at this time.

X. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of silica, amorphous, fumed (crystalline free). Accordingly, 
EPA finds that exempting silica, amorphous, fumed (crystalline free) 
from the requirement of a tolerance will be safe.

XI. Objections and Hearing Requests

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

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

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-2002-0031 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before July 15, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-2002-0031, to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. You may also send an 
electronic copy of your request via e-mail to: [email protected]. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

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

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

XII. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency

[[Page 34620]]

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 tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
exemption in this final rule, do not require the issuance of a proposed 
rule, 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 final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). 
For these same reasons, the Agency has determined that this rule does 
not have any ``tribal implications'' as described in Executive Order 
13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications '' is defined in the Executive Order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This rule will not 
have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

XIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule '' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: April 22, 2002.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is 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 374.

    2. In Sec. 180.1001 the table in paragraph (e) is amended by adding 
alphabetically the following inert ingredient to read as follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (e)*      *      *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
         *        *        *        *        *        *        *
Silica, amorphous, fumed            ................  Anti-caking agent,
 (crystalline free) (CAS Reg.No.                       antisettling
 112945-52-5)                                          agent, flow
                                                       control agent,
                                                       carrier agent
         *        *        *        *        *        *        *
------------------------------------------------------------------------

[FR Doc. 02-11743 Filed 5-14-02; 8:45 am]
BILLING CODE 6560-50-S