[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: opp-docket@epa.gov. 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,
gandhi.bipin@epa.gov.
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, tompkins.jim@epa.gov. 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:
opp-docket@epa.gov.
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) * * *
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Inert ingredients Limits Uses
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* * * * * * *
Methacrylic Copolymer (CAS ................ Inert
Reg. No. 63150-03-8),
minimum number average
molecular weight (in amu)
15,000.
* * * * * * *
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* * * * *
(e) * * *
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Inert ingredients Limits Uses
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* * * * * * *
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
