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OPP ID: [OPP-2005-0240; FRL-7737-5]
SUBJECT CATEGORY: Pesticides; Revisions to Tolerance Exemptions for Polymers
DOCUMENT SUMMARY: EPA is proposing to remove the molecular weight limitations from the tolerance exemption expression for certain polymeric substances codified in 40 CFR 180.960. These exemptions from the requirement of a tolerance were established based on the polymer's meeting the criteria established by the Agency in 40 CFR 723.250, which define a low risk polymer. The Agency is acting on its own initiative.
SUMMARY: Polymers; molecular weight limitations removed,
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at ECFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments, remember to:
i. Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date, and page number).
ii. Follow directions. The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns, and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
II. Background
The rule proposed here would be issued pursuant to section 408(e)
of the Federal Food, Drug, and Comestic Act (FFDCA), as amended by FQPA
(21 U.S.C. 346a(e)). Section 408 of FFDCA authorizes the establishment
of tolerances, exemptions from the requirement of a tolerance,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or tolerance exemption, food
containing pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of FFDCA. If food containing pesticide residues is found to be
[[Page 72759]]
adulterated, the food may not be distributed in interstate commerce (21 U.S.C. 331(a) and 342 (a)).
In the Federal Register of May 24, 2002, (67 FR 36525) (FRL6834 2), EPA issued a direct final rule to add a new section to part 180, subpart D. This section now lists the pesticide chemicals that are polymers subject to exemptions from tolerance requirements, based upon the criteria in 40 CFR 723.250 that identify a lowrisk polymer. Under the Toxic Substances Control Act (TSCA), polymers meeting the criteria of 40 CFR 723.250 are exempt from certain of the premanufacture notice requirements. The Office of Pesticide Programs has used these same criteria to create a streamlined process for establishing a tolerance exemption for a polymeric substance meeting these criteria. In essence, a manufacturer by filing a petition for an exemption from the requirement of a tolerance (which includes the notice of filing) with the Agency's Office of Pesticide Programs is verifying their exemption under section 5(a)(1)(A) of TSCA. In a similar manner, a manufacturer who petitions the Agency for tolerance exemption status by stating that their polymer is described by the chemical nomenclature of a polymer exempted under 40 CFR 180.960 is verifying their exemption under 5(a)(1)(A) of TSCA.
Many of the polymers that were transferred from other sections of the CFR to this new section contained limitations on the molecular weight, usually expressed in a manner similar to the following, ``minimum number average molecular weight (in amu),'' as part of their nomenclature. At the time that these exemptions were established (pre May 2002) including such a limitation assured that polymeric substances that were described by the chemical nomenclature but were of lower molecular weight were not considered to be exempt from the requirement of a tolerance. At the time of the transfer to 40 CFR 180.960, this nomenclature was maintained.
The molecular weight criteria that define a low risk polymer are specified in 40 CFR 723.250(e), and are not limited to the particular molecular weights currently specified in 40 CFR 180.960. In promulgating 40 CFR 180.960, EPA incorporated the criteria of 40 CFR 723.250(e) as a requirement for all polymer exemptions. Because 40 CFR 180.960 through its incorporation of 40 CFR 723.250(e) now imposes a minimum molecular weight to assure safety, chemicalspecific limitations are not needed in 40 CFR 180.960, and EPA proposes to modify the tolerance exemptions accordingly.
This proposed rule removes the chemicalspecific molecular weight limitations codified in the tolerance exemption expressions in 40 CFR 180.960. Since removal of these chemicalspecific molecular weight limitations does not impose any new requirements, it is not subject to review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this proposed rule is not subject to review under Executive Order 12866, this proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 1044). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and LowIncome Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104113, section 12(d) (15 U.S.C. 272 note). Under the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this proposed action will not have significant negative economic impact on a substantial number of small entities. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive Order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This proposed rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this proposed rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive Order to include regulations 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 proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule. List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: November 18, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
[[Page 72760]]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.960 is revised to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance.
Residues resulting from the use of the following substances, that
meet the definition of a polymer and the criteria specified for
defining a lowrisk polymer in 40 CFR 723.250 (which includes the
requirement for a number average molecular weight greater than or equal
to 1000 amu), as an inert ingredient in a pesticide chemical
formulation, including antimicrobial pesticide chemical formulations,
are exempted from the requirement of a tolerance under FFDCA section
408, if such use is in accordance with good agricultural or manufacturing practices.
Polymer CAS No.
Acetic acid ethenyl ester, polymer with ethenol 137091124 and (alpha)2propenyl(omega)hydroxypoly(oxy
1,2ethanediyl)
Acrylic acid, polymerized, and its ethyl and None methyl esters
Acrylic acidsodium acrylatesodium2 97953258 methylpropanesulfonate copolymer
Acrylic acidstearyl methacrylate copolymer 27756156
Acrylic acid, styrene, alphamethyl styrene 89678900 copolymer, ammonium salt
Acrylic acid terpolymer, partial sodium salt 151006665
Acrylic polymers composed of one or more of the None following monomers: Acrylic acid, methyl
acrylate, ethyl acrylate, butyl acrylate,
hydroxyethyl acrylate, hydroxypropyl acrylate,
hydroxybutyl acrylate, carboxyethyl acrylate,
methacrylic acid, methyl methacrylate, ethyl
methacrylate, butyl methacrylate, isobutyl
methacrylate, hydroxyethyl methacrylate,
hydroxypropyl methacrylate, hydroxybutyl
methacrylate, lauryl methacrylate, and stearyl
methacrylate; with none and/or one or more of
the following monomers: Acrylamide, Nmethyl
acrylamide, N,Ndimethyl acrylamide, N
octylacrylamide, maleic anhydride, maleic
acid, monoethyl maleate, diethyl maleate,
monooctyl maleate, dioctyl maleate; and their
corresponding sodium, potassium, ammonium,
isopropylamine, triethylamine,
monoethanolamine, and/or triethanolamine salts
Acrylonitrilebutadiene copolymer conforming to 9003183 21 CFR 180.22
Acrylonitrilestyrenehydroxypropyl None methacrylate copolymer
Alphaalkyl C12C15)[omega] 68551133 hydroxypoly(oxypropylene)poly(oxyethylene)copo
lymers (where the poly(oxypropylene) content
is 360 moles and the poly(oxyethylene)
content is 580 moles)
Alkyl (C12C20) methacrylatemethacrylic acid None copolymer
1,3 Benzene dicarboxylic acid, 5sulfo,1,3 212842881 dimethyl ester, sodium salt, polymer with 1,3
benzene dicarboxylic acid, 1,4benzene
dicarboxylic acid, dimethyl 1,4benzene
dicarboxylate and 1,2ethanediol
3,5Bis(6isocyanatohexyl)2H1,3,5oxadiazine 87823334 2,4,6(3H,5H)trione, polymer with
diethylenetriamine
Butadienestyrene copolymer None
1,4Butanediolmethylenebis(4phenylisocyanate) 9018046 poly(tetramethylene glycol) copolymer
Butene, homopolymer 9003296
2Butenedioic acid (Z), polymer with ethenol 139871833 and ethenyl acetate, sodium salt
Butyl acrylatevinyl acetateacrylic acid 65405405 copolymer
[alpha]Butylomegahydroxypoly(oxypropylene) None block polymer with poly(oxyethylene)
Castor oil, polyoxyethylated; the None poly(oxyethylene) content averages 554 moles
Chlorinated polyethylene 64754901
Crosslinked nylontype polymer formed by the None reaction of a mixture of sebacoyl chloride and
polymethylene polyphenylisocycanate with a
mixture of ethylenediamine and
diethylenetriamine
Crosslinked polyureatype encapsulating None polymer
Dimethylpolysiloxane 63148629
Dimethyl silicone polymer with silica 67762907
Docosyl methacrylateacrylic acid copolymer, or None docosyl methacrylateoctadecyl methacrylate
acrylic acid copolymer
1,12Dodecanediol dimethacrylate polymer None [[Page 72761]]
1, 2Ethanediamine, polymer with methyl oxirane 26316405 and oxirane
Ethylene glycol dimethyacrylatelauryl None methacrylate copolymer
Ethylene glycol dimethacrylate polymer None
Formaldehyde, polymer with [alpha][bis(1 157291935 phenylethyl)phenyl] hydroxypoly(oxy1,2e
thanediyl)
Fumaric acidisophthalic acidstyreneethylene/ None propylene glycol copolymer
Hexadecyl acrylateacrylic acid copolymer, None hexadecyl acrylatebutyl acrylateacrylic acid
copolymer, or hexadecyl acrylatedodecyl
acrylateacrylic acid copolymer
Hexamethyl disilizane, reaction product with 68909206 silica
1,6Hexanediol dimethyacrylate polymer None
[alpha]Hydroomegahydroxypoly(oxyethylene) 330977009 C8 alkyl ether citrates, poly(oxyethylene)
content is 412 moles
[alpha]Hydroomegahydroxypoly(oxyethylene) 330985585 C10C16alkyl ether citrates,
poly(oxyethylene) content is 412 moles
[alpha]Hydroomegahydroxypoly(oxyethylene) 330985610 C16C18alkyl ether citrates,
poly(oxyethylene) content is 412 moles
[alpha]Hydroomegahydroxypoly(oxyethylene) None
[alpha]Hydroomega None hydroxypoly(oxyethylene)poly (oxypropylene)
poly(oxyethylene) block copolymer; the minimum
poly(oxypropylene) content is 27 moles
[alpha]Hydroomegahydroxypoly(oxypropylene) None
12Hydroxystearic acidpolyethylene glycol 70142346 copolymer
Isodecyl alcohol ethoxylated (28 moles) None polymer with chloromethyl oxirane
Lauryl methacrylate1,6hexanediol None dimethacrylate copolymer
Maleic acidbutadiene copolymer None
Maleic acid monobutyl estervinyl methyl ether 25119680 copolymer
Maleic acid monoethyl estervinyl methyl ether 25087063 copolymer
Maleic acid monoisopropyl estervinyl methyl 31307956 ether copolymer
Maleic anhydridediisobutylene copolymer, 37199818 sodium salt
Maleic anhydridemethylstyrene copolymer sodium 60092151 salt
Maleic anhydridemethyl vinyl ether, copolymer None
Methacrylic acidmethyl methacrylate 100934041 polyethylene glycol methyl ether methacrylate
copolymer
Methacrylic copolymer 63150038
Methyl methacrylatemethacrylic acid 119724548 monomethoxypolyethylene glycol methacrylate
copolymer
Methyl methacrylate2sulfoethyl methacrylate None dimethylaminoethylmethacrylateglycidyl
methacrylatestyrene2ethylhexyl acrylate
graft copolymer
Methyl vinyl ethermaleic acid copolymer 25153406
Methyl vinyl ethermaleic acid copolymer, 62386952 calcium sodium salt
Monophosphate ester of the block copolymer None alphahydroomegahydroxypoly(oxyethylene)
poly(oxypropylene) poly(oxyethylene); the
poly(oxypropylene) content averages 3741
moles
[alpha](pNonylphenylomega None hydroxypoly(oxypropylene) block polymer with
poly(oxyethylene); polyoxypropylene content of
1060 moles; polyoxyethylene content of 1080
moles
[alpha](pNonylphenyl)poly(oxypropylene) block None polymer with poly(oxyethylene); poly
oxyethylene content 30 to 90 moles
Octadecanoic acid, 12hydroxy, homopolymer, 58128226 octadecanoate
[alpha]cis9Octadecenylomega None hydroxypoly(oxyethylene); the octadecenyl
group is derived from oleyl alcohol and the
poly(oxyethylene) content averages 20 moles
[[Page 72762]]
Octadecyl acrylateacrylic acid copolymer, None octadecyl acrylatedodecyl acrylateacrylic
acid copolymer, octadecyl methacrylatebutyl
acrylateacrylic acid copolymer, octadecyl
methacrylatehexyl acrylateacrylic acid
copolymer, octadecyl methacrylatedodecyl
acrylateacrylic acid copolymer, or octadecyl
methacrylatedodecyl methacrylateacrylic acid
copolymer
Oleic acid diester of alphahydroomega None hydroxypoly(oxyethylene); the
poly(oxyethylene)
Oxirane, methyl, polymer with oxirane, mono [2 85637758 (2butoxyethoxy) ethyl] ether
Polyamide polymer derived from sebacic acid, None vegetable oil acids with or without
dimerization, terephthalic acid and/or
ethylenediamine
Polyethylene glycolpolyisobutenyl anhydride 68650282 tall oil fatty acid copolymer
Polyethylene, oxidized None
Polymethylene polyphenylisocyanate, polymer None with ethylene diamine, diethylene triamine and
sebacoyl chloride, crosslinked
Polyoxyethylated primary amine (C14C18); the None fatty amine is derived from an animal source
and contains 3% water; the poly(oxyethylene)
content averages 20 moles
Polyoxyethylated sorbitol fatty acid esters; None the polyoxyethylated sorbitol solution
containing 15% water is reacted with fatty
acids limited to C12, C14, C16, and C18,
containing minor amounts of associated fatty
acids; the poly(oxyethylene) content averages
30 moles.
Polyoxyethylated sorbitol fatty acid esters; None the sorbitol solution containing up to 15%
water is reacted with 2050 moles of ethylene
oxide and aliphatic alkanoic and/or alkenoic
fatty acids C8 through C22 with minor amounts
of associated fatty acids
Poly(oxyethylene/oxypropylene) monoalkyl (C6 102900027 C10) ether sodium fumarate adduct
Polyoxymethylene copolymer None
Poly(oxypropylene) block polymer with None poly(oxyethylene)
Poly(phenylhexylurea), crosslinked None
Polypropylene 9003070
Polystyrene 9003536
Polytetrafluoroethylene 9002840
Polyvinyl acetate, copolymer with maleic None anhydride, partially hydrolyzed, sodium salt
Polyvinylpyrrolidone butylated polymer 26160963
Polyvinyl acetate None
Polyvinyl acetatepolyvinyl alcohol copolymer 25213245
Polyvinyl alcohol 9002895
Polyvinyl chloride None
Polyvinyl chloride 9002862
Poly(vinylpyrrolidone) 9003398
Poly(vinylpyrrolidone1eicosene) 28211189
Poly(vinylpyrrolidone1hexadecene) 63231812
2Propene1sulfonic acid sodium salt, polymer None with ethenol and ethenyl acetate,
2Propenoic acid, polymer with 2propenamide, 25085023 sodium salt
2Propenoic acid, sodium salt, polymer with 2 25987308 propenamide
Silane, dichloromethylreaction product with 68611449 silica
Sodium polyflavinoidsulfonate, consisting None chiefly of the copolymer of catechin and
leucocyanidin
Stearyl methacrylate1,6hexanediol None dimethacrylate copolymer
[[Page 72763]]
Styrene, copolymers with acrylic acid and/or None methacrylic acid, with none and/or one or more
of the following monomers: Acrylamidopropyl
methyl sulfonic acid, methallyl sulfonic acid,
3sulfopropyl acrylate, 3sulfopropyl
methacrylate, hydroxypropyl methacrylate,
hydroxypropyl acrylate, hydroxyethyl
methacrylate, and/or hydroxyethyl acrylate;
and its sodium, potassium, ammonium,
monoethanolamine, and triethanolamine salts
Styrene, 2ethylhexyl acrylate, butyl acrylate 30795234 copolymer
Styrene2ethylhexyl acrylateglycidyl None methacrylate2acrylamido2
methylpropanesulfonic acid graft copolymer
Styrenemaleic anhydride copolymer None
Styrenemaleic anhydride copolymer, ester None derivative
Tetradecyl acrylateacrylic acid copolymer None
Tetraethoxysilane, polymer with 104133097 hexamethyldisiloxane
[alpha][p(1,1,3,3Tetramethylbutyl)phenyl] None poly(oxypropylene) block polymer with
poly(oxyethylene); the poly(oxypropylene)
content averages 25 moles, the
poly(oxyethylene) content averages 40 moles
[alpha][2,4,6Tris[1(phenyl)ethyl]phenyl] None omegahydroxy poly(oxyethylene)
poly(oxypropylene) copolymer, the
poly(oxypropylene) content averages 28 moles,
the poly(oxyethylene) content averages 1630
moles
Ureaformaldehyde copolymer 9011056
Vinyl acetateallyl acetatemonomethyl maleate None copolymer
Vinyl acetateethylene copolymer 24937788
Vinyl acetate polymer with none and/or one or None more of the following monomers: Ethylene,
propylene, Nmethyl acrylamide, acrylamide,
monoethyl maleate, diethyl maleate, monooctyl
maleate, dioctyl maleate, maleic anhydride,
maleic acid, octyl acrylate, butyl acrylate,
ethyl acrylate, methyl acrylate, acrylic acid,
octyl methacrylate, butyl methacrylate, ethyl
methacrylate, methyl methacrylate, methacrylic
acid, carboxyethyl acrylate, and diallyl
phthalate; and their corresponding sodium,
potassium, ammonium, isopropylamine,
triethylamine, monoethanolamine and/or
triethanolamine salts
Vinyl acetatevinyl alcoholalkyl lactone None copolymer
Vinyl alcoholdisodium itaconate copolymer None
Vinyl alcoholvinyl acetate copolymer, None benzaldehydeosodium sulfonate condensate
Vinyl alcoholvinyl acetatemonomethyl maleate, None sodium saltmaleic acid, disodium saltgamma
butyrolactone acetic acid, sodium salt
copolymer
Vinyl chloridevinyl acetate copolymers None
Vinyl pyrrolidoneacrylic acid copolymer 28062444
Vinyl pyrrolidone 30581590 dimethylaminoethylmethacrylate copolymer
Vinyl pyrrolidonestyrene copolymer 25086297 [FR Doc. 0523667 Filed 12605; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 204600001; telephone
number: (703) 3056304; fax number: (703) 3050599; email address:
boyle.kathryn@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 50 CFR Part 679 26 CFR Part 1 40 CFR Part 180 47 CFR Part 73 50 CFR Part 17 33 CFR Part 117 44 CFR Part 67 50 CFR Part 648 14 CFR Part 97 33 CFR Part 100 40 CFR Part 63 26 CFR Part 301 50 CFR Part 622 39 CFR Part 111 40 CFR Part 300 44 CFR Part 65 50 CFR Part 660 40 CFR Part 271 40 CFR Parts 52 and 81 47 CFR Part 64 50 CFR Part 665 49 CFR Part 571 21 CFR Part 522 44 CFR Part 64 14 CFR Part 23 47 CFR Part 76