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OPP ID: [OPP-2005-0115; FRL-7712-1]
SUBJECT CATEGORY:
Two Isopropylamine Salts of Alkyl C
DOCUMENT SUMMARY: This regulation establishes two exemptions from the
requirement of a tolerance for residues of 2propanamine, compound with
[alpha]phosphono [omega] butoxypoly (oxy1,2ethanediyl) (2:1) and
2propanamine, compounds with polyethylene glycol dihydrogen phosphate
C
ethoxyphosphate esters, when used as inert ingredients (emulsifier,
solvent and cosolvent) in pesticide formulations applied only to
growing crops. Rhodia, Inc, CN 7500, Cranbury, NJ 085127500, submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of these two chemicals.
SUMMARY: Two isopropylamine salts of alkyl C4 and alkyl C8- 10 ethoxyphosphate esters,
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.
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 Get Electronic Documents and Other Related Information?
In addition to using EDOCKET at (http://www.epa.gov/edocket/), 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/ .
In the Federal Register of March 17, 1999 (64 FR 13195) (FRL6065 5) EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104170), announcing the filing of pesticide petitions (PP 8E4990 and 8E4956) by Rhodia Inc, CN 7500, Cranbury, NJ 085127500.
The petitions requested that 40 CFR 180.1001(d) newly redesignated
as 40 CFR 180.920 be amended to include exemptions from the requirement
of a tolerance for residues of 2Propanamine, compound with [alpha]
phosphono [omega] butoxypoly (oxy1,2ethanediyl) (2:1) (CAS Reg. No.
43140312) and 2Propanamine, compounds with polyethylene glycol
dihydrogen phosphate C
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of the 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 and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''
EPA performs a number of analyses to determine the risks from aggregate
[[Page 31366]]
exposure to pesticide residues. First, EPA determines the toxicity of
pesticides. Second, EPA examines exposure to the pesticide through
food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
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.
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children. The nature of the toxic effects caused
by these 2 isopropylamine salts of alkyl C
The petitioner has also submitted supporting toxicity information to the Agency which is summarized in Table 1.
The acute toxicity profile is presented in Table 1. Table 1: Acute Toxicity Profile of 2 isopropylamine salts of alkyl C4 and alkyl C8 10 ethoxyphosphate esters Study Result Category Acute oral (Rats) LD50 > 2,000 mg/kg III Acute dermal (Rats) LD50 > 2,000 mg/kg III Eye irritation Slightly irritating III Dermal irritation (Rabbits) Not irritating III Dermal sensitizer (GP) Not a sensitizer NA
The petitioner also submitted the following mutagenicity assays, as described in Table 2:
Table 2: Mutagenicity Assays Conducted Using:
Type of Assay Test Culture Results
Ames S. typhimurium TA 98, TA 100, TA Negative
102, TA 1535, TA 1537 B. Structure Activity Relationship (SAR) Assessment
Toxicity for these 2 isopropylamine salts of alkyl C
The SAR conclusions for these 2 isopropylamine salts of alkyl
C
EPA has reviewed the toxicity data for these 2 isopropylamine salts
of alkyl C
The acute toxicity data demonstrated that these 2 isopropylamine salts of alkyl C
ethoxyphosphate esters exhibited low acute toxicity, Category III,
based on the Agency's rating of toxicity categories I through IV,
highest to lowest. These 2 isopropylamine salts of alkyl C
The SAR indicated that absorption would be poor through the skin,
good through the lungs, and moderate through the GI tract. The SAR also [[Page 31367]]
reflected the typical concerns for lung toxicity and irritation to
mucous membranes if inhaled based on surfactancy. Such concerns are
addressed by use of personal protection equipment as determined by end
product acute inhalation testing, or by limitations on the amount of
surfactant in a formulated pesticide. There are also typical concerns
for neurotoxicity based on the inclusion of an amine salt in the
chemical structure, and for lung toxicity and irritation to mucous
membranes if inhaled based on surfactancy. As a chemical class amine
salts are generally reported to have neurotoxic effects. However, there
is an overall lack of documentation in the public literature to support
a specific concern for neurotoxicity for isopropylamine salts. The SAR
rated these two isopropylamine salts as low to moderate for human
health concerns. This rating reflects the concerns associated with the
irritation to mucous membranes commonly caused by surfactants.
The SAT in OPPT (Office of Pollution Prevention and Toxics) has reviewed information on several surfactants. As a broad class of chemicals surfactants are often corrosive and irritating to mucous membranes. These properties make animal toxicity testing of surfactants difficult, and require interpretation of the test results as to whether the effects are attributed to the corrosive/irritant effects or other mechanisms of toxicity.
Based on the SAR assessment, the review and evaluation of the
submitted data, and given the Agency's understanding of the
toxicological properties of surfactants, EPA concludes that these 2
isopropylamine salts of alkyl C
In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
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 in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. 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.
1. Dietary exposure Food. In order to assess dietary exposure
the Agency considered that these two isopropylamine salts could be
present in all raw and processed agricultural commodities. The Agency
has estimated a generic dietary exposure estimate for an inert
ingredient of 0.12 milligrams/kilogram/day (mg/kg/day). To assure that
the exposure is not underestimated, it is assumed that the inert
ingredients are used on all crops and 100% of all crops are ``treated''
with the inert ingredient. The generic dietary exposure estimate is
based on an application rate of 5 pounds per acre. Information from the
petitioner indicates that the anticipated use rate of these 2
isopropylamine salts of alkyl C
2. Drinking water. Based on its biodegradation models, the Agency estimated that the time for complete ultimate biodegradation is weeks to months. There is also strong to very strong sorption to soils and sediments. Due to the strong adherence to soils and sediments, and ready biodegradation the substances would only be minimally available in surface waters. Thus, only low drinking water exposure is expected, and the concern for risk to human health is low.
Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider ``available information'' concerning the cumulative effects of a particular chemical's residues and ``other substances that have a common mechanism of toxicity.''
Unlike other pesticide chemicals for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to these 2
isopropylamine salts of alkyl C
ethoxyphosphate esters do not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that these 2 isopropylamine salts of alkyl C
ethoxyphosphate esters have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .
VII. Safety Factor for the Protection of Infants and Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data unless EPA concludes that a different
margin of safety will be safe for infants and children. For 2
isopropylamine salts of alkyl C
[[Page 31368]]
For the same reasons a tenfold safety factor is unnecessary. VIII. Determination of Safety for U.S. Population
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues of 2 isopropylamine salts of alkyl C
IX. Other Considerations
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect . . .'' EPA has been working with
interested stakeholders to develop a screening and testing program as
well as a priority setting scheme. As the Agency proceeds with
implementation of this program, further testing of these products, 2
isopropylamine salts of alkyl C
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
There are no existing tolerances or tolerance exemptions for these 2 isopropylamine salts of alkyl C
C
The Agency is not aware of any country requiring a tolerance for
these 2 isopropylamine salts of alkyl C
Therefore, an exemption from the requirement for a tolerance is
established for 2Propanamine, compound with [alpha]phosphono
[omega] butoxypoly (oxy1,2ethanediyl) (2:1) (CAS Reg. No. 4314031
2) and 2Propanamine, compounds with polyethylene glycol dihydrogen
phosphate C
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old FFDCA sections 408 and 409 of
the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP20050115 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 1, 2005.
1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 204600001. You may also deliver your request to the Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., Washington, DC 20005. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 5646255.
2. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit XI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in ADDRESSES. Mail your copies, identified by docket ID number OPP20050115, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001. In person or by courier, bring a copy to the location of the PIRIB described in ADDRESSES. You may also send an electronic copy of your request via email to: oppdocket@epa.gov. Please use an ASCII file format and avoid 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 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries. B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40 CFR 178.32).
[[Page 31369]]
This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this 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 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) (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). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 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 final 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 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 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 rule.
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 this final rule in the Federal Register. This final 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: May 20, 2005.
Lois Rossi,
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. 321(q), 346a and 371.
2. In Sec. 180.920, the table is amended by adding alphabetically the following inert ingredients to read as follows:
Sec. 180.920 Inert ingredients used preharvest; exemptions from the requirement of a tolerance.
* * * * *
Inert ingredients Limits Uses * * * * * * *
2Propanamine, compound with Not more than 15% Surfactant [alpha]phosphono [omega] in the formulated
butoxypoly (oxy1,2ethanediyl) product.
(2:1) (CAS Reg. No. 43140312).
2Propanamine, compounds with Not more than 15% Surfactant polyethylene glycol dihydrogen in the formulated
phosphate C8 10 alkyl ether product.
(2:1) (CAS Reg. No. 43106272
5).
* * * * * * *
[[Page 31370]]
* * * * *
[FR Doc. 0510845 Filed 53105; 8:45 am]
BILLING CODE 656050S
FOR FURTHER INFORMATION CONTACT Princess Campbell, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 0001; telephone number: (703) 3088033; email address:
campbell.princess@epa.gov.
14 CFR Part 39 40 CFR Part 52 14 CFR Part 71 33 CFR Part 165 26 CFR Part 1 50 CFR Part 679 40 CFR Part 180 47 CFR Part 73 33 CFR Part 117 50 CFR Part 17 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 50 CFR Part 660 44 CFR Part 65 40 CFR Parts 52 and 81 40 CFR Part 271 47 CFR Part 64 40 CFR Part 300 14 CFR Part 23 14 CFR Part 25 21 CFR Part 522 50 CFR Part 665 47 CFR Part 76 27 CFR Part 9