[Federal Register: September 6, 2007 (Volume 72, Number 172)] [Rules and Regulations] [Page 51180-51187] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06se07-9] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2006-0572; FRL-8146-7] Residues of Quaternary Ammonium Compounds di-n-Alkyl (C8-10) dimethyl Ammonium chloride, Exemption from the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation amends 40 CFR 180.940(a), the exemption from the requirement of a tolerance for residues of Quaternary Ammonium Compounds, di-n-Alkyl (C8-10) dimethyl ammonium chloride, average molecular weight (in amu) 332 to 361 on food contact surfaces when applied/used in public eating places, dairy processing equipment, and food-processing equipment and utensils by increasing the allowable use solution concentrations of quaternary compounds. Lonza Inc. submitted a petition to EPA under the Federal Food, [[Page 51181]] Drug, and Cosmetic Act requesting an increase in the concentrations of quaternary compounds in end-use products eligible for the exemption. As amended, the regulation will exempt solutions from the requirement of a tolerance residues resulting from contact with surfaces treated with solutions where the end use concentration of the specific quaternary compounds does not exceed 240 parts per million (ppm) of active quaternary ammonium compounds, and the end-use concentration of all quaternary chemicals in the solution does not exceed 400 ppm of active quaternary compound. DATES: This regulation is effective September 6, 2007. Objections and requests for hearings must be received on or before November 5, 2007, 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-2006-0572. To access the electronic docket, go to http://www.regulations.gov, select ``Advanced Search,'' then ``Docket Search.'' Insert the docket ID number where indicated and select the ``Submit'' button. Follow the instructions on the regulations.gov web site to view the docket index or access available documents. All documents in the docket are listed in the docket index available in 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 either in the electronic docket at http://www.regulations.gov , or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805. FOR FURTHER INFORMATION CONTACT: Velma Noble, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-6233; e-mail address: noble.velma@epa.gov. SUPPLEMENTARY INFORMATION: I. 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions), paragraph (a). 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 an electronic copy of this Federal Register document through the electronic docket at http://www.regulations.gov , you my 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 pilot e-CFR site at http://www.gpoaccess.gov/ecfr . C. Can I File an Objection or Hearing Request? Under section 408(g) of the FFDCA, as amended by the Food Quality Protection Act (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. 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- 2006-0572 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 November 5, 2007. 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-2006-0572, 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 Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only accepted during the Docket'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 telephone number is (703) 305-5805. II. Background and Statutory Findings In the Federal Register of October 25, 2006 (71 FR 62458) (FRL- 8099-6), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 6F7045) by Lonza, Inc, 90 Boroline Rd, Allendale, NJ 07401. The petition requested that 40 CFR 180.940(a) be amended by increasing concentration limits for aliphatic alkyl quaternary compounds in end-use solutions eligible for the tolerance exemption for Quaternary Ammonium compounds: Di-n-Alkyl (C8- 10) dimethyl ammonium chloride, average molecular weight (in amu) 332 to 361) on food contact surfaces in public eating places, dairy processing equipment, and food [[Page 51182]] processing equipment and utensils from 150 ppm to 240 ppm and the total end use concentration of all quaternary chemicals in solution from 200 ppm to 400 ppm. The notice referenced a summary of the petition prepared by Lonza Inc., 90 Boroline Rd Allendale, NJ 07401, the registrant, which is available to the public in the docket at http://www.regulations.gov, Docket ID Number EPA-HQ-OPP -2006-0572. There were no comments received in response to the notice of filing. Section 408(c)(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(c)(2)(A)(ii) 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. Pursuant to section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C), which 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. III. Toxicological Profile A. Toxic Effects 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 the Aliphatic Alkyl Quaternaries are discussed in this unit. The Aliphatic Alkyl Quaternaries are corrosive, highly irritating to the eye and skin, with moderate acute toxicity by oral, dermal, and inhalation routes of exposure. These chemicals are classified as ``not likely'' to be a human carcinogen based on a negative carcinogenicity study in rats and mice feeding studies using doses above the limit. There is no evidence of these chemicals being associated with increased susceptibility to developmental toxicity or reproductive toxicity based on two developmental toxicity studies and a two-generation reproductive study. Lastly, they are negative for mutagenicity and neurotoxicity. Specific information on the studies received and the nature of the toxic effects caused by Di-n-Alkyl (C8-10) dimethyl ammonium chloride, average molecular weight (in amu) 332 to 361) (DDAC) as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov; Docket ID Number EPA-HQ-OPP-2005-0338; Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision (RED) for Didecyl Dimethyl Ammonium Chloride (DDAC). B. Toxic Endpoints For hazards that have a threshold below which there is no appreciable risk, the dose at which no adverse effects are observed (NOAEL) from the toxicology study identified as appropriate for the risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in variations in sensitivity among members of the human population as well as other unknowns. The Agency's level of concern (LOC) for residential Aliphatic Alkyl Quaternaries' inhalation and oral exposures is 100 (i.e., a margin of exposure (MOE) less than 100 exceeds the Agency's level of concern). The level of concern is based on 10x for interspecies extrapolation and 10x for intraspecies extrapolation. However, the uncertainty factor or ``target'' MOE for Aliphatic Alkyl Quaternaries' dermal exposures is 10 for residential scenarios. The target MOE was chosen because the established endpoint is for dermal irritation, not a systemic toxic effect. In addition, dermal irritation is considered a reversible and short-term effect, thus supporting a 10x uncertainty factor (half a log (10.5) or approximately 3x for interspecies extrapolation and half log (10.5) or approximately 3x for intraspecies variation). It should be noted that the determination to reduce the 100x UF to 10X UF for irritation endpoints is made on a case-by-case basis. Aliphatic Alkyl Quaternaries toxicological endpoint summary is listed in the following table. Table 1.--Summary of Toxicological Endpoints for DDAC ---------------------------------------------------------------------------------------------------------------- Target MOE/UF, Special Exposure Scenario Dose Used in Risk FQPA SF for Risk Study and Toxicological Assessment (mg/kg/day) Assessment Effects ---------------------------------------------------------------------------------------------------------------- Acute Dietary (Females 13-50) FQPA SF = 1 Parenatal NOAEL (developmental) = 10 mg/kg/ UF = 100 (10x inter- Developmental day. species Toxicity - Rat MRID extrapolation, 10x 41886701 intra-species LOAEL = 20 mg/kg/day variation). based on increased incidence of skeletal variations.. ---------------------------------------------------------------------------- Acute RfD = 0.1 mg/kg/day (for Females age 13-50) ---------------------------------------------------------------------------------------------------------------- [[Page 51183]] Acute Dietary(general population) An acute dietary endpoint was not identified in the data base. This risk assessment is not required ---------------------------------------------------------------------------------------------------------------- Chronic Dietary (general NOAEL = 10 mg/kg/day FQPA SF = 1 Chronic Toxicity Study - population) UF = 100 (10x inter- Dog MRID 41970401 species LOAEL = 20 mg/kg/day based extrapolation, 10x on increased incidence of intra-species clinical signs in males variation. and females and decreased total cholesterol levels in females ---------------------------------------------------------------------------------------------------------------- Chronic RfD = 0.1 mg/kg/day ---------------------------------------------------------------------------------------------------------------- Incidental Oral (Short-Term) NOAEL (developmental) Target MOE = 100 (10x Prenatal Developmental = 10 mg/kg/day inter-species Toxicity - Rat MRID extrapolation, 10x 41886701 intra-species LOAEL = 20 mg/kg/day based variation) on increased incidence of FQPA SF = 1........... skeletal variations. ---------------------------------------------------------------------------------------------------------------- Incidental Oral (Intermediate-Term) NOAEL = 10 mg/kg/day Target MOE = 100 (10x Chronic Toxicity Study - inter-species Dog MRID 41970401 extrapolation, 10x LOAEL = 20 mg/kg/day based intra-species on increased incidence of variation) clinical signs in males FQPA SF = 1........... and females and decreased total cholesterol levels in females. ---------------------------------------------------------------------------------------------------------------- Dermal, Short-term (formulated No endpoint identified. No dermal or systemic effects identified in the 21- product 0.13% a.i.) day dermal toxicity study (MRID 45656601) up to and including the limit dose of 1,000 mg/kg/day ---------------------------------------------------------------------------------------------------------------- Dermal, Short-term\a\ NOAEL (dermal) = 2 mg/ Target MOE = 10 (3x 90-day Dermal Toxicity - kg/day(8 [mu]g/cm2) inter-species Rat MRID 41305901 extrapolation, 3x LOAEL = 6 mg/kg/day based intra-species on increased clinical and variation) gross findings (erythema, edema, exfoliation, excoriation, and ulceration) ---------------------------------------------------------------------------------------------------------------- Dermal, Intermediate- and Long-term No appropriate endpoint identified ---------------------------------------------------------------------------------------------------------------- Inhalation, Short-Term NOAEL\b\ = 10 mg/kg/ Target MOE = 100 (10x Prenatal Developmental day inter-species Toxicity - Rat MRID extrapolation, 10x 41886701 intra-species LOAEL = 20 mg/kg/day based variation) on increased incidence of FQPA SF = 1........... skeletal variations. ---------------------------------------------------------------------------------------------------------------- Inhalation, Intermediate- and Long- NOAEL\b\ = 10 mg/kg/ Target MOE = 100 (10x Chronic Toxicity Study - Term day inter-species Dog MRID 41970401 extrapolation, 10x LOAEL = 20 mg/kg/day based intra-species on increased incidence of variation) clinical signs males and FQPA SF = 1........... females and decreased total cholesterol levels in females. ---------------------------------------------------------------------------------------------------------------- UF = uncertainty factor, FQPA SF = special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic), RfD = reference dose, MOE = margin of exposure, LOC = Level of concern, NA = Not Applicable. \a\ Short-term dermal endpoint = (2 mg/kg rat x 0.2 kg rat x 1,000 [mu]g/mg) / 50 cm2 area of rat dosed = 8 [mu]g/cm2. \b\An additional UF of 10x is used for route extrapolation from an oral endpoint to determine if a confirmatory study is warranted. IV. Aggregate Exposures In examining aggregate exposure, FFDCA section 408 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). A. Dietary Exposure Aliphatic Alkyl Quaternaries are used as a sanitizer on counter tops, utensils, appliances, tables, refrigerators, food packaging, and beverage bottling. The use of Aliphatic Alkyl Quaternaries as an antimicrobial product on food or feed contact surfaces, agricultural commodities, and application to food-grade eggs may result in pesticide residues in human food. Residues from treated surfaces, such as utensils, countertops, equipment, and appliances can migrate to food coming into contact with the treated and rinsed surfaces and can be ingested by humans. 1. Food. The Agency assessed acute and chronic dietary exposure from the use of Aliphatic Alkyl Quaternaries as a disinfectant and food contact sanitizer on direct and indirect food-contact surfaces. This assessment calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI) using an FDA model (2003). The FDA model takes into account application rates, residual solution, area of the treated surface which comes into contact with food, pesticide migration fraction, and body weight. The EDI calculations presented in this assessment are based on the assumption that food can contact 2,000 cm2 of treated surface per day (which represents contact with a treated countertop surface area), 4,000 cm2 of treated surface per day (which represents contact with treated silverware, china, and glass used by an individual who regularly eats three meals per day at an institutional or public facility ), or 6,000 cm2 of treated surface per day (which represents treated countertops, silverware, china, [[Page 51184]] and glass by an individual who regularly eats three meals per day at an institutional or public facility). It also assumes that 10% of the pesticide would migrate to food. When assessing the food bottling/packaging use, EPA assumed a 100% transfer rate because the food is potentially in contact with the treated surfaces for very long periods of time. The maximum application rate for Aliphatic Alkyl Quaternaries for bottling/packaging of food is 0.0020 lbs active ingredient (a.i) per gallon of treatment solution. EDI values were calculated using an approach similar to that used for treated food-contact surfaces and food utensils. Exposure was assumed to occur through the ingestion of three food products that might be packaged with treated material: milk, egg products, and beverages (alcoholic and non-alcoholic). A calorie intake modification factor of 0.64 was applied to the EDI for a child to account for the differences between intake values among children and adults. 2. Drinking water exposure. The only Aliphatic Alkyl Quaternaries outdoor uses are an algaecide in decorative/swimming pools, antisapstain wood preservative treatment, once-through cooling tower treatment, and oil field uses. The pond and oil field uses are considered to be contained. The other uses are not expected to significantly contaminate drinking water sources. Therefore, the Aliphatic Alkyl Quaternaries contributions for drinking water exposure are considered to be negligible and are not quantified. It should be noted that the Agency estimated concentrations for exposure to aquatic animals resulting from the antisapstain and cooling tower uses. These levels were not considered appropriate for use in the drinking water assessment due to the very conservative nature of the models used, that the model estimates runoff/point source concentrations and not water body concentrations, and the fact that the models does not account for dilution. Specific information on the dietary and drinking water exposure assessments for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov ; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary Risk Assessment on DDAC and Tier 1 Drinking Water Assessment for Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC); Didecyl Dimethyl Ammonium Chloride (DDAC). B. Other Non-Occupational Exposure The residential exposure assessment considers all potential non- occupational pesticide exposure, other than exposure due to residues in food or in drinking water. Exposures may occur during and after application as a hard surfaces disinfectant (e.g., walls, floors, tables, fixtures), to textiles (e.g., clothing, diapers) to swimming pools and to carpets. Each route of exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a MOE, which is the ratio of estimated exposure to an appropriate NOAEL Residential exposure may occur during the application of Aliphatic Alkyl Quaternaries to indoor hard surfaces (e.g., mopping, wiping, trigger pump sprays), carpets, swimming pools, wood as a preservative, textiles (e.g., diapers treated during washing and clothes treated with fabric spray), and humidifiers. The residential handler scenarios were assessed to determine dermal and inhalation exposures. Surrogate dermal and inhalation unit exposure values were estimated using data from the Pesticide Handler Exposure Database (PHED) and the Chemical Manufactures Association Antimicrobial Exposure Assessment Study (USEPA, 1999), and the SWIMODEL 3.0 was utilized to conduct exposure assessments of pesticides found in swimming pools and spas (Versar, 2003). Note that for this assessment, EPA assumed that residential users complete all elements of an application (mix/load/apply) without the use of personal protective equipment. The duration for most residential exposures is believed to be best represented by the short-term duration (1 to 30 days). The short-term duration was chosen for this assessment because the residential handler and post-application scenarios are assumed to be performed on an episodic, not daily basis. Based on toxicological criteria and the potential for exposure, the Agency has conducted dermal and inhalation exposure assessments for Aliphatic Alkyl Quaternaries residential use. As noted previously, MOEs greater than or equal to 100 for the inhalation route of exposure and 10 for dermal exposure are considered adequately protective for the residential exposure assessment. Specific information on the residential exposure assessment for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov ; Docket ID Number EPA-HQ-OPP-2006-0338; Didecyl Dimethyl Ammonium Chloride (DDAC) Occupational and Residential Exposure Assessment. V. Cumulative Effects Another factor EPA must consider in making a section 408 reasonable certainty of no harm determination is any ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' The Aliphatic Alkyl Quaternaries are a group of structurally similar quaternary ammonium compounds that are characterized by having a positively charged nitrogen covalently bonded to two alkyl group substituents (at least one C8 or longer) and two methyl substituents. In finished form, these quats are salts with the positively charged nitrogen (cation) balanced by a negatively charged molecule (anion). The anion for the quats in this cluster is chloride or bromide. Didecyl dimethyl ammonium chloride, or DDAC, was chosen as the representative chemical for this class in PR notice 88-2. On that basis, the toxicology database for DDAC is accepted as representative of the hazard for this class of quaternary ammonium compounds. However, the toxicologic responses observed from animal toxicity studies with DDAC are generalized responses to treatment and are difficult to attribute to any one mechanism. EPA's risk assessment for the Group I Cluster is based on an assessment of the cumulative exposure to all aliphatic alkyl quaternary compounds. The individual exposure scenarios in the DDAC assessments (as well as the aggregate assessment in the RED) were developed by assuming that a DDAC compound was used on 100 percent of the surfaces authorized on the label that could result in human exposure and summing the percent active ingredients on the labels for all of the aliphatic alkyl quaternary compounds when used in combination. Thus, because the risk assessment for DDAC accounts for exposures to all of the aliphatic alkyl quaternary compounds, there is no need for a separate cumulative risk assessment for those compounds. The Agency has not identified any other substances as sharing a common mode of toxicity with DDAC. VI. Safety Factor for Infants and Children 1. In general. Section 408 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 [[Page 51185]] completeness of the data base 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. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional FQPA safety factor value based on the use of traditional uncertainty/safety factors and/or special FQPA safety factors, as appropriate. 2. Prenatal and postnatal sensitivity. There is no evidence that Aliphatic Alkyl Quaternaries result in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study. 3. Conclusion. EPA has determined that reliable data show that it would be safe for infants and children to reduce the FQPA safety factor to 1X. That decision is based on the following findings: i. The toxicity database for Aliphatic Alkyl Quaternaries is complete for assessing risk to infants and children under the FFDCA. ii. There is no indication that Aliphatic Alkyl Quaternaries are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional uncertainty factors to account for neurotoxicity. iii. There is no evidence that Aliphatic Alkyl Quaternaries result in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the two-generation reproduction study. iv. There are no residual uncertainties identified in the exposure databases. Although EPA may, in the future, refine exposure estimates for Aliphatic Alkyl Quaternaries based on more sophisticated modeling techniques, the current exposure assessment is based on a combination of conservative assumptions that is likely to overstate exposure from food to Aliphatic Alkyl Quaternaries. VII. Aggregate Risks and Determination of Safety Safety is assessed for acute and chronic risks by comparing aggregate 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 LOC by all applicable uncertainty/safety factors. For linear cancer risks, EPA calculates the probability of additional cancer cases given aggregate exposure. Short- , intermediate, and long-term risks are evaluated by comparing aggregate exposure to the LOC to ensure that the MOE called for by the product of all applicable uncertainty/safety factors is not exceeded. 1. Acute and chronic risk. EPA compares the estimated dietary exposures to an aPAD and a cPAD, 0.1 mg/kg/day, which are the same value for the aliphatic alkyl quaternaries. Generally, a dietary exposure estimate that is less than 100% of the aPAD or cPAD does not exceed the Agency's levels of concern. The antimicrobial indirect food use acute/chronic risk estimates from exposure to treated utensils and countertops are below the Agency's level of concern. For adults, the acute and chronic dietary exposure risk estimates are 3.32% of the aPAD and cPAD for adult females of child bearing age (13 to 50), the highly exposed adult group. For children ages 3 to 5, the most highly exposed population subgroup, the acute and chronic dietary risk estimates are 13.3% of the aPAD and cPAD. Therefore, dietary exposure estimates are below the Agency's level of concern for all population subgroups. The antimicrobial indirect food use acute/chronic risk estimates from exposure to treated food packaging and beverage bottles are below the the Agency's level of concern. Neither the percent aPAD or percent cPAD values exceeded 100% and are not of concern. Specific information on the dietary exposure assessment for Aliphatic Alkyl Quaternaries can be found at http://www.regulations.gov ; Docket ID Number EPA-HQ-OPP-2006-0338; Dietary Risk Assessment on DDAC. 2. Non-occupational risk. Aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Using the exposure assumptions described in this unit for other non-occupational exposures, EPA has concluded that food, water, and residential exposures aggregated result in aggregate MOEs greater than or equal to 100 for the inhalation route of exposure and 10 for dermal exposure; therefore, are not of concern. 3. Aggregate cancer risk for U.S. population. Based on the carcinogenic data, the EPA concludes that there is reasonable certainty that Aliphatic Alkyl Quaternaries doe not pose an aggregate cancer risk to the U. S. population. 4. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to Aliphatic Alkyl Quaternaries residues. VIII. Other Considerations A. Endocrine Disruptors EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) ``may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.'' Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When appropriate screening and/or testing protocols being considered under the Agency's Endocrine Disruption Screening Program (EDSP) have been developed, the Aliphatic Alkyl Quaternaries (DDAC) may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. B. Analytical Method(s) An analytical method for food is not needed. Food contact sanitizers are typically regulated by state health departments to ensure that the food industry is using these products in compliance with the regulations in 40 CFR 180.940. The end use solution that is applied to the food contact surface is analyzed not food items that may come into contact with the treated surface. An analytical method is available to analyze the use dilution that is applied to food contact surfaces. A titration method is used to determine the total amount of quaternary compound. If the use solution is a mixture of DDAC and alkyl dimethyl benzyl ammonium chloride (ADBAC), then High Performance Liquid Chromatography using Ultra [[Page 51186]] Violet Detection (HPLC-UV) is used to determine the amount of ADBAC. The amount of DDAC is determined by calculating the difference between the total amount of quaternary compounds and ADBAC. IX. Statutory and Executive Order Reviews This final rule establishes a tolerance exemption 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 rule has been exempted from review under Executive Order 12866, 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) 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 tolerance 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 6, 2000) do not apply to this rule. In addition, This 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). X. 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, Food contact sanitizers, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: August 29, 2007. Frank Sanders, Director, Antimicrobials 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. Section 180.940 is amended by revising the following entry to the table in paragraph (a): Sec. 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions). * * * * * (a) * * * ------------------------------------------------------------------------ Pesticide Chemical CAS Reg. No. Limits ------------------------------------------------------------------------ * * * * * * * Quaternary Ammonium None When ready for use, the Compounds, Di-n-Alkyl (C8- end-use concentration 10) dimethyl ammonium of these specific in chloride, average molecular quaternary ammonium weight (in amu) 332 to 361 compounds is not to exceed 240 ppm of active quaternary ammonium compound; the end-use concentration of all quaternary chemicals in the solution is not to exceed 400 ppm of active quaternary compound. * * * * * * * ------------------------------------------------------------------------ [[Page 51187]] * * * * * [FR Doc. E7-17634 Filed 9-5-07; 8:45 am] BILLING CODE 6560-50-S
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