[Federal Register Volume 61, Number 35 (Wednesday, February 21, 1996)]
[Rules and Regulations]
[Pages 6550-6551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-3858]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300411; FRL-4995-9]
RIN 2070-AC78


Acrylate Polymers/copolymers; Exemptions From The Requirement of 
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final Rule.

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SUMMARY: This document establishes a generic exemption from the 
requirement of a tolerance for acrylate polymers and copolymers when 
used as inert ingredient in pesticide formulations applied on raw 
agricultural commodities. This tolerance exemption covers the acrylate 
polymers/copolymers which are intrinsically safe and already listed in 
the TSCA inventory or will meet the polymer tolerance exemption from 
requirements of premanufacturing notification. Polymers that are 
exempted can be used as dispensers, resins, fibers, and beads, as long 
as the fibers, beads and resins particle sizes are greater than 10 
microns and insoluble in water. Polymers with high molecular weights 
(3,000 to 100,000 daltons) are generally not readily absorbed through 
the intact skin or intact gastrointestinal (GI) tract. Polymers with 
particle size greater than 10 microns are generally not readily 
absorbed by respiration. Chemicals not absorbed through the skin, GI 
tract, and respiratory system are generally incapable of eliciting a 
toxic response. This exemption pertains to the acrylate polymers/
copolymers used as inert ingredient for sprayable and dispenser 
pesticide formulations that are used on food crops. Any acrylate 
polymers/copolymers used for encapsulating material must be cleared as 
an inert ingredient when used in pesticide formulations that are 
applied on food crops.

EFFECTIVE DATE: This regulation becomes effective February 21, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP OPP-300411], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
document control number and submitted to: Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington , DC 20460. In person, bring copy of objections and hearing 
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202. Fees accompanying objections shall be labeled ``Tolerance 
Petition Fees'' and forwarded to: EPA Headquarters Accounting 
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
PA 15251. An electronic copy of objections and hearing requests filed 
with the Hearing Clerk may be submitted to OPP 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 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [OPP-300411]. 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. Additional 
information on electronic submissions can be found below in this 
document.

FOR FURTHER INFORMATION CONTACT: By mail: Freshteh Toghrol, 
Biopesticides and Pollution Prevention Division (7501W), Office of 
Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location and telephone number: 5th 
Floor, Crystal Station 1, 2800 Crystal Drive, Arlington, VA 22202; 
(703) 308-7014, e- mail:[email protected]

SUPPLEMENTARY INFORMATION: In the November 15, 1995 Federal Register 
(PF-631; FRL-4971-5) EPA issued a notice of filing PP 5E4524 at the 
request of Russel Cook Associates, REDA Bldg., Suit 217, 401 S.E. 
Dewey, Bartlesville, OK 74005, on behalf of Biosys, by establishing an 
generic exemption from the requirement of a food tolerance for acrylate 
polymers and copolymers which fit the Toxic Substances Control Act 
(TSCA) definition of polymers which are intrinsically safe. This 
tolerance exemption covers the acrylate polymers/copolymers that are 
already listed in the TSCA inventory or will meet the polymer tolerance 
exemption under 40 CFR 723.250 as amended on March 29, 1995.

I. Background

    Inert ingredients are substances, other than the active ingredient, 
which are intentionally included in a pesticide product as defined in 
40 CFR 153.125, and include, but are not limited to, the following 
types of ingredients: solvents such as alcohols and hydrocarbons; 
surfactants such as polyoxyethylene polymers, copolymers, 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'' does not imply lack of toxicity; 
the ingredient may or may not be chemically active.
    For the purposes of this exemption, acrylate polymers/copolymers 
used as inert ingredients in an end-use formulations must meet the 
definition for a polymer as given in 40 CFR 723.250 (b), are not 
automatically excluded by 40 CFR 723.250 (d), and meet the tolerance 
exemption criteria 40 CFR 723.250 (e)(1), 40 CFR 723.250 (e)(2) or 40 
CFR 723.250(e)(3). Therefore, acrylate polymers and copolymers that are 
already listed in the TSCA inventory or will meet the polymer tolerance 
exemption under 40 CFR 723.250 as amended on March 29, 1995 are covered 
by this exemption.
    The Agency believes that the acrylate polymers/copolymers meeting 
the criteria noted above and outlined as follows will present minimal, 
if any risk to human health when used as inert ingredients in pesticide 
formulations applied to growing raw agricultural commodities.
    1. The acrylate polymer/copolymers minimum molecular weight may 
range from 3,000 to greater than 100,000 daltons as are established 
under 40 CFR 180.1112 and 40 CFR 180.1001(c). Substances with high 
molecular weights (greater than 3,000 daltons to 100,000 daltons) are 
generally not readily absorbed through intact skin or intact 
gastrointestinal (GI) tract, respectively. Chemicals not absorbed 
through the skin or GI tract are generally incapable of eliciting a 
toxic response.
    2. These acrylate polymers/copolymers can be used as dispensers, 
fiber, resin, and beads, as long as the fiber, bead and resin sizes are 
well over 10 microns and are insoluble in water. Acrylate polymers/
copolymers of high molecular weight with well over 10 

[[Page 6551]]
micron particle size are generally not absorbed by inhalation.
    3. The acrylate polymers and copolymers that are exempted are not 
cationic or are not anticipated to be converted (by degradation or 
decomposition) to a cationic state.
    4. Acrylate and methacrylate are listed as high-concern reactive 
functional groups. Therefore, to meet the exemption criteria 
Sec. 723.250 (e)(1)(ii)(C) the minimum permissible combined functional 
group equivalent weight is 5,000 daltons, when a number-average 
molecular weight (NAVG MW) of a polymer is greater than 1,000 and lower 
than 10,000 daltons. Additionally, in this range of molecular weight 
(greater than 1,000 and less than 10,000 daltons) the polymer must 
contain less than 10 percent oligomer content of molecular weight below 
500 daltons and less than 25 percent oligomer content of molecular 
weight below 1,000 daltons.
    5. The polymers with NAVG MW equal to or greater than 10,000 
daltons (Sec. 723.250 (e)(2)), the polymer must contain less than 2 
percent oligomer content of molecular weight below 500 daltons and must 
not exceed 5 percent oligomer content of molecular weight below 1,000 
daltons. Water soluble polymers in this molecular weight range are 
excluded from exemption under Sec. 723.250(d), with no restriction 
regarding the functional group.
    6. For a polymer or polyester to meet the exemption criteria 
Sec. 723.250 (e)(3), each feedstock, monomer or reactant in the 
chemical identity of the polymers at greater than 2 percent composition 
must be on the list. Excluded from this exemption would be 
biodegradable polyesters and highly water-absorbing polyester with NAVG 
MW greater than 10,000 daltons.
    7. The acrylate polymers and copolymers must contain as an integral 
part of their composition at least two of the atomic elements carbon, 
hydrogen, nitrogen, oxygen, sulfur, or silicon (40 CFR 
Sec. 723.250(d)(3)). A previous requirement in the 1984 rule stated 
that an eligible polymer contain at least 32 percent carbon. This 
requirement was deleted since cases reviewed to date contain less than 
32 percent carbon, have either received low concern rating, or have 
been excluded for other reasons.
    8. Certain other elements are permitted in the acrylate polymers 
and copolymers as an integral part of the polymers, except if present 
as impurities. The allowed elements (40 CFR Sec. 723.250(d)(3)), in 
addition to the atomic elements carbon, hydrogen, nitrogen, oxygen, 
sulfur, silicon (C, H, N, O, S, Si) are: fluorine, chlorine, bromine, 
and iodine (F, Cl, Br, and I) when covalently bonded to carbon, and 
monoatomic counterions such as chlorine, bromide, and iodide (Cl-,Br-, 
I-), sodium, magnesium, aluminum, potassium, and calcium (Na+, Mg+2, 
Al+3, K+, and Ca+2). Less than 0.2 percent weight total (in any 
combination) of the atomic elements lithium, boron, phosphorus, 
titanium, manganese, iron, nickel, copper, zinc, tin, and zirconium 
(Li, B, P, Ti, Mn, Fe, Ni, Cu, Zn, Sn, and Zr) are permitted. No other 
elements are permitted except as impurities.
    9. The acrylate polymers and copolymers are not biopolymers, they 
are synthetic equivalents of a biopolymer, or derivatives or 
modifications of a biopolymer that is substantially intact. These 
polymers do not contain reactive functional groups that are anticipated 
to be converted to a cationic state.
    10. The acrylate polymers and copolymers are not designated or 
reasonably anticipated to be substantially degraded, decomposed, or 
depolymerized. Based upon the above information and review of its use, 
EPA has found that when used in accordance with good agricultural 
practice, these inert ingredients are useful and a tolerance is not 
necessary to protect public health. Therefore, EPA proposes that the 
exemptions from the requirement of tolerance be established for 
acrylate polymers/copolymers used as inert ingredient for pesticide 
formulations.

II. Filing of Objections

    Any person adversely affected by this regulation may, within 30 
days after publication of this document, file written objections and/or 
request a hearing with the Hearing Clerk and a copy submitted to the 
OPP docket for this rulemaking at the addresses given above.

III. Regulatory Assessment Requirement

A. Executive Order 12866

    The Office of Management and Budget has exempted this notice from 
the requirement of section 3 of Executive Order 12866.

B. Regulatory Flexibility Act

    Pursuant to the requirements of the Regulatory Flexibility Act 
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 
has determined that regulations establishing new tolerances or raising 
tolerance levels or establishing exemptions from tolerance requirements 
do not have a significant economic impact on a substantial number of 
small entities. A certification statement to this effect was published 
in the Federal Register of May 4, 1981 (46 FR 24950).

    Dated: February 7, 1996.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

    Therefore, 40 CFR 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. 346a and 371


    2. By adding new Sec. 180.1162 to subpart D to read as follows:


Sec. 180.1162  Acrylate Polymers and Copolymers; exemption from the 
requirement of a tolerance.

    (a) Acrylate polymers and copolymers are exempt from the 
requirement of a tolerance when used as inert ingredients in pesticidal 
formulations applied to growing, raw agricultural commodities. This 
tolerance exemption covers the acrylate polymers/copolymers that are 
intrinsically safe and already listed in TSCA inventory or will meet 
the polymer tolerance exemption from requirements of premanufacturing 
notification under 40 CFR 723.250. Polymers exempted can be used as 
dispensers, resins, fibers, and beads, as long as the fibers, beads and 
resins particle sizes are greater than 10 microns and insoluble in 
water. This exemption pertains to the acrylate polymers/copolymers used 
as inert ingredients for sprayable and dispenser pesticide formulations 
that are applied on food crops. Any acrylate polymers/copolymers used 
for encapsulating material must be cleared as an inert ingredient when 
used in pesticide formulation applied on food crops.
    (b) For the purposes of this exemption, acrylate polymers/
copolymers used as inert ingredients in an end-use formulation must 
meet the definition for a polymer as given in 40 CFR 723.250(b), are 
not automatically excluded by 40 723.250(d), and meet the tolerance 
exemption criteria in 40 CFR 723.250(e)(1), 40 CFR 723.250 (e)(2) or 40 
CFR 723.250(e)(3). Therefore, acrylate polymers and copolymers that are 
already listed in the TSCA inventory or will meet the polymer tolerance 
exemption under 40 CFR 723.250 as amended on March 29, 1995 are covered 
by this exemption.

[FR Doc. 96-3858 Filed 2-20-96; 8:45]
BILLING CODE 6560-50-F