[Federal Register Volume 66, Number 34 (Tuesday, February 20, 2001)]
[Rules and Regulations]
[Pages 10826-10829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2180]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301096; FRL-6762-1]
RIN 2070-AB78


Dimethylpolysiloxane; Tolerance Exemption

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation amends an existing exemption from the 
requirement of a tolerance for residues of dimethylpolysiloxane; when 
used as an inert ingredient in or on growing crops, and when applied to 
raw agricultural commodities after harvest. Wacker Silicones 
Corporation, submitted a petition to EPA under the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act 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 dimethylpolysiloxane.

DATES:  This regulation is effective February 20, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301096, 
must be received by EPA on or before April 23, 2001.

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-301096 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Indira Gairola, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, 
telephone number; (703) 308-6379 and 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/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301096. 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 September 13, 2000 (65 FR 55240) (FRL-
6738-2), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide petition (PP 5E4430) by Wacker Silicones 
Corporation, 3301 Sutton Road, Adrian, Michigan 49221-9397. 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(c), be amended by 
revising an exemption from the requirement of a tolerance for residues 
of

[[Page 10827]]

dimethylpolysiloxane; CAS Reg. No. 63148-62-9
    Section 408(c)(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(c)(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 an exemption from the 
requirement of 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...'' and specifies 
factors EPA is to consider in establishing an exemption.

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. Risk Assessment and Statutory Findings

    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.
    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. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers that should present minimal or no 
risk. The definition of a polymer is given in 40 CFR 723.250(b). The 
following exclusion criteria for identifying these low risk polymers 
are described in 40 CFR 723.250(d).
    1. The polymer, dimethylpolysiloxane, is not a cationic polymer nor 
is it reasonably anticipated to become a cationic polymer in a natural 
aquatic environment.
    2. Dimethylpolysiloxane does contain as an integral part of its 
composition the atomic elements carbon, hydrogen, and oxygen.
    3. Dimethylpolysiloxane does not contain as an integral part of its 
composition, except as impurities, any element other than those listed 
in 40 CFR 723.250(d)(2)(ii).
    4. Dimethylpolysiloxane is neither designed nor can it be 
reasonably anticipated to substantially degrade, decompose, or 
depolymerize.
    5. Dimethylpolysiloxane is not manufactured or imported from 
monomers and/or reactants that are already included on the TSCA 
Chemical Substance Inventory or manufactured under an applicable TSCA 
section 5 exemption.
    6. Dimethylpolysiloxane is not a water absorbing polymer with a 
number average molecular weight (MW) greater than or equal to 10,000 
daltons.
    Additionally, the polymer, dimethylpolysiloxane, also meets as 
required the following exemption criteria specified in 40 CFR 
723.250(e).
    7. The polymer's number average molecular weight (MW) of 6,800 is 
greater than 1,000 and less than 10,000 daltons. The polymer contains 
less than 10% oligomeric material below MW 500 and less than 25% 
oligomeric material below MW 1,000, and the polymer does not contain 
any reactive functional groups.
    Thus, dimethylpolysiloxane meets all the criteria for a polymer to 
be considered low risk under 40 CFR 723.250. Based on its conformance 
to the above criteria, no mammalian toxicity is anticipated from 
dietary, inhalation, or dermal exposure to dimethylpolysiloxane.

V. Aggregate Exposures

     For the purposes of assessing potential exposure under this 
exemption, EPA considered that dimethylpolysiloxane could be present in 
all raw and processed agricultural commodities and drinking water, and 
that non-occupational non-dietary exposure was possible. The number 
average MW of dimethylpolysiloxane is 6,800 daltons. Generally, a 
polymer of this size would be poorly absorbed through the intact 
gastrointestinal tract or through intact human skin. Since 
dimethylpolysiloxane conforms to the criteria that identify a low risk 
polymer, there are no concerns for risks associated with any potential 
exposure scenarios that are reasonably foreseeable. The Agency has 
determined that a tolerance is not necessary to protect the public 
health.

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 consider ``available information'' concerning the 
cumulative effects of a particular chemical's residues and ``other 
substances that have a common mechanism of toxicity.'' The Agency has 
not made any conclusions as to whether or not dimethylpolysiloxane 
shares a common mechanism of toxicity with any other chemicals. 
However, dimethylpolysiloxane conforms to the criteria that identify a 
low risk polymer. Due to the expected lack of toxicity based on the 
above conformance, the Agency has determined that a cumulative risk 
assessment is not necessary.

VII. Determination of Safety for U.S. Population

    Based on the conformance to the criteria used to identify a low 
risk polymer, EPA concludes that there is a

[[Page 10828]]

reasonable certainty of no harm to the U.S. population from aggregate 
exposure to residues of dimethylpolysiloxane.

VIII. Determination of Safety 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 of safety will be safe for infants and children. Due to the 
expected low toxicity of dimethylpolysiloxane, 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

    There is no available evidence that dimethylpolysiloxane is an 
endocrine disruptor.

B. Existing Exemptions from a Tolerance

     Currently, dimethylpolysiloxane (as defined in 21 CFR 173.340) is 
exempted from the requirement of a tolerance under 40 CFR 180.1001(c).

C. 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.

D. International Tolerances

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

X. Conclusion

    Accordingly, EPA finds that exempting residues of 
dimethylpolysiloxane 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. The 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-301096 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 April 23, 
2001.
    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. M3708, Waterside Mall, 1200 Pennsylvania 
Ave., NW., 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-301096, 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

[[Page 10829]]

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). 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 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); special considerations as required by 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). 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).

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 rule in the Federal Register. This 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: January 8, 2001.

James Jones,
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 371.

    2. In Sec. 180.1001, the table in paragraph (c) is amended by 
revising the following inert ingredient ``Dimethylpolysiloxane'' to 
read as follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (c) * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 *                  *                  *                  *
                   *                  *                  *
Dimethylpolysiloxane minimum      ..................  Defoaming agent
 number average molecular weight
 (in amu) 6,800 (CAS Reg. No.
 63148-62-9)
 *                  *                  *                  *
                   *                  *                  *
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-2180 Filed 2-16-00; 8:45 a.m.]
BILLING CODE 6560-50-S