Exemption from the Requirement of a Tolerance: 1,2-ethanediamine, N,N,N ′,N ′-tetramethyl-, polymer with 1,1′-oxybis[2-chloroethane]
Federal Register: August 19, 2009 (Volume 74, Number 159)
Rules and Regulations
Page 41794-41798
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr19au09-5
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180
EPA-HQ-OPP-2004-0285; FRL-8430-6
1,2-ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'- oxybis[2-chloroethane]; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement of a tolerance under 40 CFR 180.920 for residues of 1,2-ethanediamine,
N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS
Reg. No. 31075-24-8) when used as an inert ingredient in pesticide formulations applied to cotton or wheat crops only. Buckman
Laboratories International, Inc submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 1,2- ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2- chloroethane].
DATES: This regulation is effective August 19, 2009. Objections and requests for hearings must be received on or before October 19, 2009, and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2004-0285. All documents in the docket are listed in the docket index available at http:// www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
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FOR FURTHER INFORMATION CONTACT: Keri Grinstead, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-8373; e-mail address: grinstead.keri@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
A. Does this Action Apply to Me?
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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2004-0285 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 October 19, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2004-0285, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
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Background and Statutory Findings
In the Federal Register of September 17, 2004 (69 FR 56062) (FRL- 7675-9), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by Food Quality Protection Act (FQPA) (Public
Law 104-170), announcing the filing of a pesticide petition (PP 4E6841) by Buckman Laboratories International, Inc., 1256 North McLean Blvd.,
Memphis, TN 38108. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of 1,2-ethanediamine,N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No. 31075-24-8) in or on raw agricultural commodities when used as an inert ingredient in pesticide formulations. That notice included a summary of the petition prepared by the petitioner. There were no substantive comments received in response to the notice of filing. The petitioner subsequently specified that the inert ingredient use of the chemical will be as an adjuvant or water conditioner in pesticide products applied only to cotton and to wheat prior to boot stage.
For ease of reading in this document, 1,2-ethanediamine,N,N,N ',N
'-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] is herein referred to as BCETMD copolymer.
Section 408(b)(2)(A)(i) of 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 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 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 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.
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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
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low toxicity of the individual inert ingredients.
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Toxicological Profile
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 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 1,2- ethanediamine,N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2- chloroethane are discussed in this unit.
The following provides a brief summary of the risk assessment and conclusions from the Agency's review of BCETMD copolymer. The Agency's full risk assessment for this action, ``Inert Ingredient Decision
Document for Pesticide Petition 4E6841: 1,2-ethanediamine, N,N,N ',N '- tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No. 31075-24-8)'', is available in the docket (EPA-HQ-OPP-2004-0285).
Sufficient data were submitted to the Agency in support of this action. In acute toxicity studies, BCETMD copolymer exhibits low to moderate oral toxicity, slight irritation to the rabbit eye and skin, and is not a skin sensitizer in Guinea pigs. A subchronic study in rats had a no observed adverse effect level (NOAEL) of 221 milligrams/ kilogram/day (mk/kg/day) and a lowest observed adverse level (LOAEL) of 752 mg/kg/day due to mineralization of the renal tubules. The following were observed at the two highest dosages: Decreases in body weights and possibly absolute organ weights (heart, liver, kidney and gonads); an equivocal decrease in red blood cell counts; elevated leukocyte counts; non-suppurative inflammation of the choroid plexus of the brain; and death. A chronic study in the dog showed: In males, a NOAEL of 250 mg/ kg/day and a LOAEL of 500 mg/kg/day based on testicular hypoplasia, atrophy/degeneration, aspermia, dysplasia and cellular debris of testicular origin in epididymis; and, in females, a NOAEL of 500 mg/kg/ day and a LOAEL of 1,000 mg/kg/day based on gastrointestinal disturbances, emaciation and neurological signs, bloody stools, weight loss and ataxia. Reproductive/developmental toxicity was only seen at dosage levels at or above those which also caused maternal effects.
BCETMD copolymer was determined not to be mutagenic or carcinogenic. In metabolism studies, most (>86%) of the chemical was excreted in the feces.
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Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational 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.
The primary route of exposure to BCETMD copolymer from its use as an inert ingredient in pesticide products applied to cotton and wheat crops would most likely be through consumption of food to which pesticide products containing it as an inert ingredient have been applied, and possibly through drinking water (from runoff). The use of this chemical is limited to pesticide formulations applied to cotton and wheat crops only, therefore, there are no residential uses of this chemical, and thus no residential (dermal and inhalation) exposures are expected.
No adverse effects attributable to a single exposure of BCETMD copolymer were seen in the toxicity database. Therefore, an acute dietary risk assessment is not required.
There are no data provided regarding BCETMD copolymer residues in food or any other nonoccupational exposures to BCETMD copolymer. In the absence of actual residue data for BCETMD copolymer, the Agency performed a chronic dietary (food and drinking water) exposure assessment for BCETMD copolymer when used as an inert ingredient in pesticide formulations applied pre-harvest to cotton and wheat using a series of very conservative assumptions. This exposure assessment was calculated based on the following assumptions: 1. BCETMD copolymer would be used as an inert ingredient in all food use pesticide formulations applied pre-harvest to cotton and wheat crops. 2. A hundred percent of all cotton and wheat crops would be treated with pesticide products containing BCETMD copolymer. 3. BCETMD copolymer residues would be present in all cotton and wheat crops at levels equal to or exceeding the highest established tolerance levels for any pesticide active ingredient. 4. A conservative default value of 1,000 parts per billion (ppb) for the concentration of an inert ingredient in all sources of drinking water was used. This approach is highly conservative as it is extremely unlikely that BCETMD copolymer would have such use as a pesticide product inert ingredient and be present in cotton and wheat food commodities and drinking water at such high levels.
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Cumulative Effects
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.''
Unlike other pesticide ingredients 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 BCETMD copolymer and any other substances and BCETMD copolymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that
BCETMD copolymer has 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/.
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Determination of Safety for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.
EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: 1. The database is considered adequate for FQPA assessment. The studies included in the toxicological database are: 90-day toxicity study in rats via the oral route, 90-day dermal toxicity study in rabbits, chronic toxicity study in dogs, carcinogenicity study in mice, combined chronic/carcinogenicity study in rats, several mutagenicity studies (in vivo and in vitro), metabolism study in rats and dermal penetration study in rats. There are no acute and/or subchronic neurotoxicity studies available in the database. There was no evidence of clinical signs of neurotoxicity in the database except ataxia in the chronic toxicity study in dogs (1,000 mg/kg/day) and convulsions in a carcinogenicity study in mice (1,200 mg/kg/day). These effects are considered due to excessive toxicity and not of a neurologic origin.
Therefore, there is no need for acute and subchronic neurotoxicity studies for this chemical. EPA also concluded that there is no need for a developmental neurotoxicity study for this chemical because there is no evidence in the database of neurotoxicity or increased susceptibility to infants and children. 2. There is no evidence of increased qualitative or quantitative susceptibility in the developmental toxicity study in rats and rabbits and in the two-generation reproduction study in rats. No developmental effects were observed in the rat developmental toxicity study at doses up to 500 mg/kg/day highest dose tested (HDT) in the presence of maternal toxicity. In the rabbit developmental toxicity study, the maternal and developmental NOAELs were 45 mg/kg/day. In this study, skeletal variations (developmental effects) were observed in the presence of equally severe maternal toxicity (abortions). In the 2- generation reproduction study in rats, pup weights were decreased at a dose level higher than the dose that produced maternal toxicity. 3. The highly conservative dietary exposure assessment using default assumptions would not underestimate the risk to infants and children.
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Determination of Safety for U.S. Population
For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. Uncertainty/ safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Residues of concern are not anticipated for dietary exposure (food and drinking water) from the use of BCETMD copolymer as an inert ingredient in pesticide products applied pre-harvest to cotton and wheat and there are no residential uses/exposures from this use. The toxicology data indicate that BCETMD copolymer does not pose an acute risk and, therefore, derivation of an aPAD is unnecessary. Chronic risk was assessed by comparing aggregate exposure to BCETMD copolymer to a cPAD of .45 mg/kg/day (based on a NOAEL of 45 mg/kg/day in the developmental toxicity study in rabbits and a safety/uncertainty factor of 100X (10X for interspecies and 10X for intraspecies variations).
Utilizing the highly conservative aggregate exposure assessment described above, the resulting chronic exposure estimates do not exceed the Agency's level of concern; the chronic dietary estimate for the
U.S. population was 6.7% (non-nursing infants were the most highly exposed population with the chronic exposure estimates occupying 20.0% of the cPAD).
Taking into consideration all available information on BCETMD copolymer and the limitations in the proposed tolerance exemption, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to BCETMD copolymer under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.920 for residues of BCETMD copolymer when used as an inert ingredient in pesticide formulations applied pre-harvest to cotton and wheat only, is safe under section 408 of the FFDCA.
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Other Considerations
A. Analytical Method
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.
B. Existing Exemptions
There are no existing exemptions for BCETMD copolymer.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
BCETMD copolymer nor have any CODEX Maximum Residue Levels been established for any food crops at this time.
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Conclusions
Therefore, an exemption from the requirement of tolerance is established under 40 CFR 180.920 for BCETMD copolymer (CAS Reg. No. 31075-24-8) when used as an inert ingredient (adjuvant or water conditioner) in pesticide formulations applied to cotton or wheat only.
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Statutory and Executive Order Reviews
This final rule establishes an exemption from the requirement of a tolerance under section 408(d) of 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 final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May
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22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of 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.
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not 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 104-4).
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 104-113, section 12(d) (15 U.S.C. 272 note).
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Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report 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: August 6, 2009.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs. 0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. In Sec. 180.920, the table is amended by adding alphabetically the following inert ingredient.
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance.
* * * * *
Inert ingredients
Limits
Uses
* * * * * * * 1,2-ethanediamine,N,N,N ', N '- For use in
Adjuvant or water tetramethyl-, polymer with 1,1'- pesticide
conditioner oxybis[2-chloroethane] (CAS
formulations
Reg. No. 31075-24-8)
applied to cotton or wheat only
* * * * * * *
* * * * *
FR Doc. E9-19762 Filed 8-18-09; 8:45 am
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