Daily Rules, Proposed Rules, and Notices of the Federal Government
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Dairy Cattle Milk Production (NAICS code 11212).
• Food manufacturing (NAICS code 311).
• Beverage Manufacturing (NAICS code 3121).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 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. 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-2011-0950 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 22, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0950, by one of the following methods:
Section 408(c)(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 exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA 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 FFDCA 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 * * *.”
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for DDACB including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with DDACB follows.
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 DDACB, part of the Aliphatic Alkyl Quaternary group of compounds, are discussed in this unit. In assessing the proposed toxicity, the toxicological endpoints were extracted from the DDAC RED (EPA-HQ-2006-0338).
The Aliphatic Alkyl Quaternaries are corrosive and 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 human carcinogens based on negative carcinogenicity in rat and mouse feeding studies using doses above the limit dose. There is no evidence of these chemicals being associated with increased susceptibility of infants and children based on two developmental toxicity studies and a 2-generation reproductive toxicity study. Lastly, they are negative for mutagenicity and neurotoxicity. Specific information on the studies received and the nature of the toxic effects from the toxicity studies can be found at
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.
A detailed discussion of EPA's conclusions regarding the toxic endpoints for the Aliphatic Alkyl Quaternaries can be found at 73 FR 37852, July 2, 2008.
In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residues in food and all other sources, including drinking water from ground water or surface water and exposure through pesticide use in gardens lawns or buildings (residential and other non-occupational exposures).
Aliphatic alkyl quaternaries are to be used as sanitizers on appliances, beverage bottling, counter tops, food packaging, refrigerators, tables, and utensils. The use of these actives in antimicrobial products for use on food or feed-contact surfaces and in agricultural premises may result in pesticide residues in human food. Residues from treated surfaces, such as appliances, countertops, equipment, and utensils can migrate to food coming into contact with the treated and rinsed surfaces and can be ingested by humans.
The Agency assessed acute and chronic dietary exposures from the use of DACB as a disinfectant and food-contact sanitizer on utensils, countertops, and in food/beverage processing facilities. The assessment calculated the Daily Dietary Dose (DDD) and the Estimated Daily Intake (EDI) using modified Food and Drug Administration (FDA) methodologies for utensils and the Indirect Dietary Residential Exposure Model (IDREAM) for countertops.
The EDI calculations presented in this assessment for treated indirect dietary exposures resulting from sanitizing utensils assumed that food would contact 4,000 cm
There are two levels of refinement for assessing dietary exposure to antimicrobial products used on countertops. The three dimensional approach, Tier 2, was utilized for this assessment. This conservative approach uses food consumption and preparation patterns, food-specific conversion factors that relate the surface area contacting the countertop with the corresponding weight of the food item, transfer efficiency, and likelihood of contact with a countertop. Food ingredients, as presented in the model, are separated into nine categories and reflect a person's daily diet. Based on the structure of the model, available countertop residues are estimated and presented as the amount of residue that is expected to be available for each of the nine food categories. These calculated available residues are then combined with the food consumption rate, as extracted from the USDA Continuing Survey for Food Intake by Individuals (CSFII) consumption data, and a total daily exposure value is provided as the output. This value is then compared to the toxicological endpoint to determine risk to those consuming foods that have come into contact with a freshly sanitized countertop.
For the assessment of 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 DDACB for bottling/packing of food is 0.0033 lbs a.i. per gallon of treatment solution. EDI values were calculated using an approach similar to that used for treated food utensils. Exposure was assumed to occur through the ingestion of three food products that might be packaged with treated material: Beverages (alcoholic and non-alcoholic), egg products, and milk. 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.
The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables). DDACB is currently registered for the following residential non-dietary sites: Homes and day-care nurseries. EPA assessed residential exposure using the following assumptions:
• Residential exposure may occur during the application as well as post application of DDACB to indoor hard surfaces (e.g., mopping, trigger pump sprays, wiping).
• The residential handler scenarios were assessed to determine dermal and inhalation exposures.
• Residential post application scenarios such as children's exposure to treated toys and floors were also assessed to determine dermal and incidental oral exposures.
• Surrogate dermal, inhalation, and incidental oral unit exposure values were estimated using Pesticide Handler Exposure Database (PHED) data and the Chemical Manufactures Association Antimicrobial Exposure Assessment Study (EPA, 1999). 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.
Specific information on the residential exposure assessment for DDACB can be found at
i. The toxicity database for Aliphatic Alkyl Quaternaries is complete except for a 90-day inhalation toxicity study in the rat which was requested in the Aliphatic Alkyl Quaternary Reregistration Eligibility Document. Due to the absence of the 90-day inhalation toxicity study, a FQPA safety factor of 10X has been applied to the oral endpoint to calculate inhalation risks in order to be protective of any uncertainties associated with route-to-route extrapolation.
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
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessment was performed based on 10% transfer rate and tolerance-level residues. Similarly conservative Residential SOPs were used to assess post-application exposure to children as well as incidental oral exposure of toddlers.
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.”
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 Aliphatic Alkyl Quaternary (DDAC) Reregistration Eligibility Decision (RED)) were developed by assuming that a DDAC compound was used on 100% 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 DDACB.
The antimicrobial indirect food use acute and chronic risk estimates from exposure to treated utensils and countertops are below the Agency's LOC. For adult males, the acute and chronic dietary exposure risk estimates are 9.9% for utensils and 0.8% for countertops. The aPAD and cPAD for adult females (13-69) is 11.5% for utensils. The aPAD from countertops for adult females is 0.8% and the cPAD is 0.5%. For children ages 1-2, the most highly exposed population subgroup, the acute and chronic dietary risk estimates are 68.9% for utensils and 2.6% and 1.8%, respectively for acute and chronic dietary risks for countertops. Therefore, dietary exposure estimates are below Agency's LOC for all population subgroups. The antimicrobial indirect food use chronic risk estimates from exposure to treated food packaging and beverage bottles are also below the Agency's LOC.
Specific information on the dietary exposure assessment for DDACB can be found at
Based on the toxicological and exposure data discussed in this preamble, EPA concludes that DDACB will not pose a risk under reasonably foreseeable circumstances. Accordingly, EPA finds that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to DDACB residues.
An analytical method for food is not needed. Food-contact sanitizers are typically regulated by the State health departments to ensure that the food industry is using 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 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 ADBAC and DDACB, then high pressure liquid chromatogram with ultraviolet visible (HPLC-UV) is used to determine the amount of ADBAC. The amount of DDACB is determined by calculating the difference between the total amount of quaternary compounds and ADBAC.
This regulation amends the exemption from the requirement of a tolerance for residues of DDACB under 40 CFR 180.940(a) resulting from an increase in the final use concentration from 240 ppm to 400 ppm on food contact surfaces in public eating establishments, on dairy processing equipment and food processing equipment and utensils.
This final rule establishes 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 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
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
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).
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Aliphatic alkyl quaternaries, Food-contact sanitizers, Pesticides and pests, Quaternary ammonium compounds, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *