Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Acrylic acid terpolymer, partial sodium salts,
[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]
ENVIRONMENTAL PROTECTION AGENCY
[OPP-300704; FRL-6024-1]
RIN 2070-AB78
Acrylic Acid Terpolymer, Partial Sodium Salts; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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 filedwith 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.,
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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 filedwith 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 filedonline 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.
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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.
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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.
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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.
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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.
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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:
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Acrylic acid terpolymer, partial sodium salts are not cationic polymers, nor are they reasonably anticipated to become cationic polymers in a natural aquatic environment.
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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+.
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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).
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Acrylic acid terpolymer, partial sodium salts are not designed, nor are they reasonably anticipated to substantially degrade, decompose, or depolymerize.
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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.
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Acrylic acid terpolymer, partial sodium salts are not water- absorbing polymers.
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The only reactive-functional group the acrylic acid terpolymer, partial sodium salts contain is a carboxylic acid.
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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).
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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.
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Exposures and Risks
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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.
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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.
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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.
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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.
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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.
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Conclusion
Therefore, an exemption from the requirement of a tolerance is established for residues of acrylic acid terpolymer, partial sodium salts.
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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
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filedwith the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filedwith 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.
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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.
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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.
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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.
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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]
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
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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. 98-24151Filed9-8-98; 8:45 am]
BILLING CODE 6560-50-F
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