[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Rules and Regulations]
[Pages 27182-27185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12248]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300848; FRL-6077-7]
RIN 2070-AB78


Methacrylic Copolymer; 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 the methacrylic copolymer when applied 
to growing crops, to raw agricultural commodities after harvest or to 
animals when applied/used as an inert ingredient in the pesticide 
formulations. Rohm and Haas Company 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 methacrylic 
copolymer.

DATES: This regulation is effective May 19, 1999. Objections and 
requests for hearings must be received by EPA on or before July 19, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300848], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees) and 
forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any 
objections and hearing requests filed with the Hearing Clerk identified 
by the docket control number, [OPP-300848], must also be submitted to: 
Public Information and Records Integrity Branch, Information Resources 
and Services Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
In person, bring a copy of objections and hearing requests to Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of electronic objections and 
hearing requests must be submitted as an ASCII file avoiding 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 5.1/6.1 file format or ASCII file format. All copies of 
electronic objections and hearing requests must be identified by the 
docket number [OPP-300848]. No Confidential Business Information (CBI) 
should be submitted through e-mail. Copies of electronic objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 713J, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-8380, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of November 20, 1998 
(63 FR 64478) (FRL-6042-4), 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 of 1996 (Pub. L. 104-170) 
announcing the filing of a pesticide tolerance petition (PP 8E4952) by 
Rohm and Haas Company, 100 Independence Mall West, Philadelphia, PA 
19106-2399. This notice included a summary of the petition prepared by 
the petitioner Rohm and Haas Company. There were no comments received 
in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of methacrylic copolymer.

I. Background and Statutory Findings

    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 us in residential settings.

II. 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

[[Page 27183]]

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 methacrylic 
copolymer are discussed in this unit:
    In the case of certain chemical substances that are defined as 
``polymers'', the Agency has established a set of criteria which 
identify categories of polymers that present low risk. These criteria 
(described in 40 CFR 723.250) identify polymers that are relatively 
unreactive and stable compounds compared to other chemical substances 
as well as polymers that typically are not readily absorbed. These 
properties generally limit a polymer's ability to cause adverse 
effects. In addition, these criteria exclude polymers about which 
little is known. The Agency believes that polymers meeting the criteria 
noted above will present minimal or no risk. Alkyl (C12-
C20) Methacrylate copolymer conforms to the definition of a 
polymer given in 40 CFR 723.250 (b) and meet the following criteria 
that are used to identify low risk polymers:
    1. Alkyl (C12-C20) Methacrylate copolymer is 
not a cationic polymer, nor is it capable of becoming a cationic 
polymer in the natural aquatic environment.
    2. Alkyl (C12-C20) Methacrylate copolymer 
contains as an integral part of its composition the atomic elements 
carbon, hydrogen, and oxygen.
    3. Alkyl (C12-C20) Methacrylate copolymer 
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)(iii).
    4. Alkyl (C12-C20) Methacrylate copolymer is 
not designed, nor is it reasonably anticipated to substantially 
degrade, decompose or depolymerize.
    5. Alkyl (C12-C20) Methacrylate copolymer is 
not manufactured or imported from monomers and/or other reactants that 
are not already included on the TSCA Chemical Substance Inventory or 
manufactured under an applicable TSCA section 5 exemption.
    6. Alkyl (C12-C20) Methacrylate copolymer is 
not a water absorbing polymer with a number average molecular weight 
greater than or equal to 10,000 daltons.
    7. The minimum number-average molecular weight of Alkyl 
(C12-C20) Methacrylate copolymer is  
15,000 daltons. Substances with molecular weights greater than 400 
generally are not absorbed through the intact skin, and substances with 
molecular weights greater than 1,000 generally are not absorbed through 
the intact gastrointestinal (GI) tract. Chemicals not absorbed through 
the skin or GI tract generally are incapable of eliciting a toxic 
response.
    8. Alkyl (C12-C20) Methacrylate copolymer has 
a minimum number average molecular weight of  15,000 and 
contains less than 2% oligomeric material below molecular weight 500 
and less than 5 percent oligomeric material below 1,000 molecular 
weight.
    9. Alkyl (C12-C20) Methacrylate copolymer 
does contain aliphatic ester groups as reactive functional groups. 
However, these reactive groups are not intended or reasonably 
anticipated to undergo further reactions under usual environmental 
conditions.

III. 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 groundwater or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    1. Food. Alkyl (C12-C20) Methacrylate 
copolymer is not absorbed through the intact gastrointestinal tract and 
is considered incapable of eliciting a toxic response.
    2. Drinking water exposure. Based upon the aqueous insolubility of 
Alkyl (C12-C20) Methacrylate copolymer, there is 
no reason to expect human exposure to residues in drinking water.

B. Other Non-Occupational Exposure

    Typical use of Alkyl (C12-C20) Methacrylate 
copolymer is in the oil industry as a wax and viscosity modifier at 
very low use rates. In these uses the primary exposure rate would be 
dermal, however, Alkyl (C12-C20) Methacrylate 
copolymer with a molecular weight significantly greater that 400 is not 
absorbed through the intact skin.

IV. Cumulative Effects

    There is data to support cumulative risk from Alkyl 
(C12-C20) Methacrylate copolymer, since polymers 
with molecular weights greater than 400 generally are not absorbed 
through the intact skin, and substances with molecular weights greater 
than 1,000 generally are not absorbed through the intact 
gastrointestinal (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response. 
Therefore, there is no reasonable expectations of increased risk due to 
cumulative exposure.

V. Determination of Safety for U.S. Population, Infants and 
Children

    1. U.S. population. Alkyl (C12-C20) 
Methacrylate copolymer causes no safety concerns because it conforms to 
the definition of a low risk polymer given in 40 CFR 723.250 (b) and as 
such is considered incapable of eliciting a toxic response. Also, there 
are no additional pathways of exposure (non-occupational, drinking 
water, etc.) where there would be additional risk.
    2. Infants and children. Alkyl (C12-C20) 
Methacrylate copolymer causes no additional concern to infants and 
children because it conforms to the definition of a low risk polymer 
given in 40 CFR 723.250 (b) and as such is considered incapable of 
eliciting a toxic response. Also there are no additional pathways of 
exposure (non-occupational, drinking water, etc.) where infants and 
children would be at additional risk.
    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
methacrylic copolymer residues. Accordingly, EPA finds that exempting 
methacrylic copolymer from the requirement of a tolerance will be safe.

VI. Other Considerations

A. Endocrine Disruptors

    There are no evidence that Alkyl (C12-C20) 
Methacrylate copolymer is an endocrine disrupter, where as substances 
with molecular weights greater than 400 generally are not absorbed 
through the intact skin, and substances with molecular weights greater 
than 1,000 generally are not absorbed through the intact 
gastrointestinal (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response.

B. Analytical Method(s)

    Rohm and Haas has petitioned that Alkyl (C12-
C20) Methacrylate copolymer be exempt from the requirement 
of a tolerance based upon the low risk polymer as per 40 CFR 723.250. 
Therefore, an analytical method to determine residues of Alkyl 
(C12-C20) Methacrylate copolymer in raw 
agricultural commodities has not been proposed.

C. Codex Maximum Residue Level

    The Agency is not aware of any country requiring a tolerance for 
Alkyl (C12-C20) Methacrylate copolymer. Nor have 
been there been any CODEX

[[Page 27184]]

Maximum Residue Levels (MRL's) established for any food crops at this 
time. 

VII. Objections and Hearing Requests

    The new FFDCA 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) and 
as was provided in the old section 408 and in section 409. However, the 
period for filing objections is 60 days, rather than 30 days. EPA 
currently has procedural regulations which governs the submission of 
objections and hearing requests. These regulations will require some 
modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law.
    Any person may, by July 19, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the hearing clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). 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 tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    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). 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). 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.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300848] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:

    [email protected].


    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes an exemption from the tolerance 
requirement under section 408(d) of the FFDCA 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) (Pub. L. 104-4). Nor does it require any 
prior consultation as specficed by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993), or 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 in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, 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. Nevertheless, the Agency previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not

[[Page 27185]]

issue a regulation that is not required by statute and that creates a 
mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

X. 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 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 the 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: April 30, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I, part 180 is amended as follows:

PART 180-[AMENDED]

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

    Authority: 21 U.S.C. 321q, 346a 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
------------------------------------------------------------------------
 
         *        *        *        *        *        *        *
Methacrylic Copolymer (CAS     ................  Inert
 Reg. No. 63150-03-8),
 minimum number average
 molecular weight (in amu)
 15,000.
 
         *        *        *        *        *        *        *
------------------------------------------------------------------------

*    *    *    *    *
    (e) *    *    *

------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses
------------------------------------------------------------------------
 
         *        *        *        *        *        *        *
Methacrylic Copolymer (CAS     ................  Inert
 Reg. No. 63150-03-8),
 minimum number average
 molecular weight (in amu)
 15,000.
 
         *        *        *        *        *        *        *
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[FR Doc. 99-12248 Filed 5-18-99; 8:45 am]
BILLING CODE 6560-50-F