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acrylic acid terpolymer Tolerance Exemption 8/98


[Federal Register: September 9, 1998 (Volume 63, Number 174)]
[Rules and Regulations]               
[Page 48109-48113]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se98-5]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300704; FRL-6024-1]
RIN 2070-AB78

 
Acrylic Acid Terpolymer, Partial Sodium Salts; Tolerance 
Exemption

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 acrylic acid terpolymer, partial sodium 
salts when used as inert ingredients (dispersant) in pesticide 
formulations applied to growing crops, raw agricultural commodities 
after harvest, and animals. BF Goodrich Specialty Chemicals requested 
this exemption from the requirement of a tolerance under the Federal 
Food, Drug and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: This regulation is effective September 9, 1998. Objections and 
requests for hearings must be received by EPA on or before November 9, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300704], 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), 
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-300704], 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.,

[[Page 48110]]

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 also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of 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 objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300704]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of 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. 707A, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703) 308-8380, e-mail: 
gandhi.bipin@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 29, 1998 
(63 FR 23438)(FRL-5783-4), EPA issued a notice pursuant to section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), 
announcing the filing of pesticide petitions (PP 8E4958, 8E4961, and 
8E4962) for tolerance exemptions by BF Goodrich Specialty Chemicals, 
9911 Brecksville Road, Cleveland, OH 44141. This notice included a 
summary of the petitions prepared by BF Goodrich Specialty Chemicals, 
the petitioner. There were no comments received in response to the 
notice of filing.
    The petitions requested that 40 CFR 180.1001(c) and (e) be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of acrylic acid terpolymer, partial sodium salts when used as 
inert ingredients (dispersants) in pesticide formulations applied to 
growing crops, raw agricultural commodities after harvest, and animals.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went 
into effect immediately. Among other things, FQPA amends FFDCA to bring 
all EPA pesticide tolerance-setting activities under a new section 408 
with a new safety standard and new procedures.
    New section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement of a tolerance for a pesticide chemical 
residue on food only if EPA determines that the exemption is ``safe.'' 
Section 408(c)(2)(A)(ii) of FFDCA 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, but does 
not include occupationalc exposure. Section 408(c)(2)(B) of FFDCA 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing an 
exemptionfrom the requirement of 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.

II. 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.

III. 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 ingredient in conjunction with possible exposure to residues of 
the inert ingredient in food, drinking water, and other nonoccupational 
exposures. 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.

IV. Aggregate Risk Assessment and Determination of Safety

    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. EPA has sufficient data to assess the hazards of acrylic 
acid terpolymer, partial sodium salts and to make a determination on 
aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a 
tolerance exemption for residues of acrylic acid terpolymer, partial 
sodium salts on growing crops, raw agricultural commodities after 
harvest and animals. EPA's assessment of the dietary exposures and 
risks associated with establishing these tolerances follows.
    The data submitted in the petitions and other relevant material 
have been evaluated. As part of the EPA policy statement on inert 
ingredients published in the Federal Register of April 22, 1987 (52 FR 
13305), the Agency set forth a list of studies which would generally be 
used to evaluate the risks posed by the presence of an inert ingredient 
in a pesticide formulation. However, where it can be determined without 
that data that the inert ingredient will present minimal or no risk,the 
Agency generally does not require some or all of the listed studies to 
rule on the proposed tolerance or exemption from the requirement of a 
tolerance for an inert ingredient.

A. Toxicological Profile

    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 compared to other chemical substances as well as 
polymers

[[Page 48111]]

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 these criteria will present minimal or 
no risk. Acrylic acid terpolymer, partial sodium salts conform to the 
definition of polymer given in 40 CFR 723.250(b) and meets the 
following criteria that are used to identify low risk polymers:
    1. Acrylic acid terpolymer, partial sodium salts are not cationic 
polymers, nor are they reasonably anticipated to become cationic 
polymers in a natural aquatic environment.
    2. Acrylic acid terpolymer, partial sodium salts contain as an 
integral part of their composition the atomic elements carbon, 
hydrogen, oxygen, sulfur, and nitrogen. They also contain the 
monatomic-counterion Na+.
    3. Acrylic acid terpolymer, partial sodium salts do not contain as 
an integral part of their composition, except as impurities, any 
elements other than those listed in 40 CFR 723.250(d)(2)(ii).
    4. Acrylic acid terpolymer, partial sodium salts are not designed, 
nor are they reasonably anticipated to substantially degrade, 
decompose, or depolymerize.
    5. Acrylic acid terpolymer, partial sodium salts are not 
manufactured or imported from monomers and/or other reactants that are 
not already included on the Toxic Substances Control Act (TSCA) 
Chemical Substance Inventory or manufactured under an applicable TSCA 
section 5 exemption.
    6. Acrylic acid terpolymer, partial sodium salts are not water-
absorbing polymers.
    7. The only reactive-functional group the acrylic acid terpolymer, 
partial sodium salts contain is a carboxylic acid.
    8. Acrylic acid terpolymer, partial sodium salts have a number 
average molecular weight (MW) of 2,440 daltons (and an oligomer content 
less than 10% below MW 500 and less than 25% below MW 1,000).
    9. Acrylic acid terpolymer, partial sodium salts have a number 
average MW of 2,440 daltons. Substances with MW greater than 400 
generally are not absorbed through the intact skin, and substances with 
MW 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.
    Based on the conformance of acrylic acid terpolymer, partial sodium 
salts to the criteria in Unit IV. A. 1-9 of the preamble, no mammalian 
toxicity is anticipated from dietary, inhalation or dermal exposure to 
acrylic acid terpolymer, partial sodium salts.

B. Exposures and Risks

    1. From food and feed uses, drinking water, and non-dietary 
exposures.  For the purposes of assessing the potential dietary 
exposure, EPA considered that under these tolerance exemptions acrylic 
acid terpolymer, partial sodium salts could be present in all raw and 
processed agricultural commodities and drinking water and that non-
occupational, non-dietary exposure was possible. EPA concluded that, 
based on these chemicals' categorization as polymers conforming to the 
definition of a polymer under 40 CFR 723.250(b) that also meet the 
criteria used to identify low-risk polymers, there are no concerns for 
risks associated with any potential-exposure scenarios that are 
reasonably foreseeable.
    2. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    In the case of acrylic acid terpolymer, partial sodium salts, the 
lack of expected toxicity of these substances based on their 
conformance to the definition of polymers as given in 40 CFR 723.250(b) 
as well as the criteria that identify low-risk polymers results in no 
expected cumulative effects; a cumulative risk assessment is therefore 
not necessary.

C. Aggregate Risks and Determination of Safety for U.S. Population

    Based on these chemicals' conformance to the definition of a 
polymer given in 40 CFR 723.250(b) as well as the criteria that are 
used to identify low-risk polymers, EPA concludes that there is a 
reasonable certainty that no harm to the U.S. population will result 
from aggregate exposure to acrylic acid terpolymer, partial sodium 
salts. EPA believes these compounds present no dietary risk under 
reasonably foreseeable circumstances.

D. Aggregate Risks and Determination of Safety for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional ten-
fold margin of safety for infants and children in the case of threshold 
effects to account for pre-and post-natal toxicity and the completeness 
of the database unless EPA determines that a different margin of safety 
will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. 
Because EPA has concluded that these substances pose minimal or no risk 
it did not use a margin of safety analysis for assessing risk to the 
general population. For the same reason, application of an additional 
margin of safety is unnecessary to protect the safety of infants and 
children. Based on the conclusions in Unit IV. of this preamble, EPA 
concludes that there is a reasonable certainty that no harm to the 
infants and children will result from aggregate exposure to acrylic 
acid terpolymer, partial sodium salts.

V. Other Considerations

    The Agency establishes an exemption from the requirement of a 
tolerance without any numerical limitation; therefore, the Agency has 
concluded that analytical methods are not required for enforcement 
purposes for acrylic acid terpolymer, partial sodium salts.
    There are no Codex Alimentarius Commission (Codex), Canadian or 
Mexican residue limits for acrylic acid terpolymer, partial sodium 
salts.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of acrylic acid terpolymer, partial sodium 
salts.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) 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 govern 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 November 9, 1998, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be

[[Page 48112]]

filed with the Hearing Clerk, at the address given above (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). If a hearing is requested, the objections must 
include a statement of the factual issues on which a hearing is 
requested, the requestor's contentions on such issues, and a summary of 
any evidence relied upon by the requestor (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 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 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 Confidential Business Information (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 rulemaking under docket 
control number [OPP-300704] (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.
    Electronic comments may be sent directly to EPA at:
    opp-docket@epamail.epa.gov.


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. 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) (Pub. L. 104-4). Nor does it require any 
prior consultation as specified 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).
    Executive Order 12875. Under Executive Order 12875, entitled 
Enhancing Intergovernmental Partnerships (58 FR 58093, October 28, 
1993), EPA may not 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 the Office of Management and Budget 
(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.
    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 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.

[[Page 48113]]

    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerances 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 has 
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.

XI. 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 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: August 17, 1998.

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. 346a and 371.

    2. In Sec. 180.1001, the table in paragraph (c) and (e) is 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         
------------------------------------------------------------------------
                                                                        
   *          *          *          *          *          *          *  
Acrylic acid terpolymer,       ................  Dispersant             
 partial sodium salt (CAS                                               
 Reg. No. 151006-66-5),                                                 
 minimum number average                                                 
 molecular weight (in amu)                                              
 2,400.                                                                 
                                                                        
   *          *          *          *          *          *          *  
------------------------------------------------------------------------

    *    *    *    *    *
    (e) *  *  *


------------------------------------------------------------------------
      Inert ingredients             Limits                 Uses         
------------------------------------------------------------------------
                                                                        
   *          *          *          *          *          *          *  
Acrylic acid terpolymer,       ................  Dispersant             
 partial sodium salt (CAS                                               
 Reg. No.151006-66-5),                                                  
 minimum number average                                                 
 molecular weight (in amu)                                              
 2,400.                                                                 
                                                                        
   *          *          *          *          *          *          *  
------------------------------------------------------------------------


[FR Doc. 98-24151 Filed 9-8-98; 8:45 am]
BILLING CODE 6560-50-F