美国豁免抑菌剂1,3-二溴-5,5-二甲基乙内酰脲的最大残留限量

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 1,3-dibromo-5,5-dimethylhydantoin including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with 1,3-dibromo-5,5-dimethylhydantoin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies 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.

Exposures to 1,3-dibromo-5,5-dimethylhydantoin (DBDMH) only occur during the mixing of the treatment solution. These exposures would only be associated with the occupational handling/applying when pouring and mixing with water. When mixed with water, DBDMH rapidly hydrolyzes to 5,5-dimethylhydantion (DMH). DMH is stable in water and is the residue available for dietary exposure.

Most of the toxicology studies submitted to the Agency in support of registration of DBDMH were conducted on DMH (including subchronic oral toxicity in the rat and dog; subchronic dermal toxicity in the rat; chronic toxicity in the dog; combined chronic/oncogenicity in the rat and mouse; oncogenicity in the mouse; developmental toxicity in the rat and rabbit; 2-generation reproductive toxicity in the rat; genotoxicity battery; and general metabolism in the rat). These studies generally show lack of systemic toxicity up to the limit dose. No specific target organs were identified in adult animals tested. No developmental or maternal toxicity was observed. There was no evidence of carcinogenicity. There is also no indication of neurotoxicity or immunotoxicity in the database.

The formation of the bromide ion is also present during the degradation of DBDMH. based on available data, the Agency has previously determined that bromine does not present adverse systemic effects and therefore no endpoints were identified. See Bromine Final Registration Review Decision, Case 4015, which is document number 10 in docket number EPA-HQ-OPP-2009-0167, in www.regulations.gov. based on its previous assessment, which remains valid, the Agency has determined that there are no risks of concern from exposures to bromine.

Specific information on the studies received from the toxicity studies can be found at http://www.regulations.gov in document 1,3-dibromo-5,5-dimethylhydantoin (DBDMH), Human health and ecological risk assessment for the new use as a Fruit and Vegetable Wash and Food Contact Surface Sanitizer in docket ID number EPA-HQ-OPP-2011-1033.

once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a Start Printed Page 57369reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/​pesticides/​factsheets/​riskassess.htm.

The Agency did not identify any toxicological points of departure because the available data indicate a lack of toxicity for DBDMH and its degradates (DMH and the bromide ion).

1. Dietary exposure from food uses and drinking water. based on the use patterns for DBDMH, residues of the degradate DMH may be present in or on food as a result of exposure to the substance in treatment solutions or on treated food contact surfaces. DMH residues are unlikely to be in drinking water because the product is intended to be used in treatment solutions in RAC treatment facilities and on food contact surfaces in public eating places or processing. Nevertheless, because of the lack of toxicological endpoints, quantitative dietary food and drinking water exposure and risk assessments were not conducted.

2. From non-dietary exposure. 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). 1,3-dibromo-5,5-dimethylhydantoin is not registered for use on any sites that would result in residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/​pesticides/​trac/​science/​trac6a05.pdf.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found 1,3-dibromo-5,5-dimethylhydantoin to share a common mechanism of toxicity with any other substances, and 1,3-dibromo-5,5-dimethylhydantoin does not appear to produce a toxic metabolite produced by other substances. based on the lack of toxicity for DBDMH and its metabolites and degradates, therefore, EPA concludes that 1,3-dibromo-5,5-dimethylhydantoin does not 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 chemical, see EPA's Web site at http://www.epa.gov/​pesticides/​cumulative.

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 Food Quality Protection Act (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.

There are adequate pre- and/or post-natal toxicity studies for DMH that show no qualitative or quantitative susceptibility from exposure to DMH. As a result, the Agency has conducted a qualitative assessment in which safety factors were not relevant. Moreover, because of the lack of any threshold effects, the requirement to retain an additional 10X safety factor does not apply.

based on the toxicological profile of DBDMH, EPA concludes that exposures to the antimicrobial 1,3-dibromo-5,5-dimethylhydantoin will not pose a risk under reasonably foreseeable circumstances. In order to use this substance as antimicrobial treatment in process water and as a food contact surface sanitizer, the substance must be mixed with water, necessarily resulting in the conversion of DMDBH into DMH and bromine, for which the Agency has not identified any toxicological endpoints of concern. Therefore, the Agency concludes that reasonably foreseeable uses of this substance are safe. Accordingly, EPA finds that there is a reasonable certainty of no harm will result to the general population, or to infants and children from aggregate exposure to 1,3-dibromo-5,5-dimethylhydantoin residues.

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.

Although the petitioner requested exemptions for residues of 1,3-dibromo-5,5-dimethylhydantoin with limitations on the amount of DBDMH in sanitizing and antimicrobial treatment solutions, EPA is establishing exemptions, without the requested limitations, for residues of 1,3-dibromo-5,5-dimethylhydantoin, because of the lack of toxicity of DMDBH and its metabolites and degradates.

Therefore, exemptions from the requirement of a tolerance are established for residues of 1,3-dibromo-5,5-dimethylhydantoin as follows: When used in food contact surface sanitizing solutions applied to food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils and when used as an antimicrobial treatment in solutions applied to raw agricultural commodities in treatment facilities.

This action establishes exemptions from tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action 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 action 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 Start Printed Page 5737012898, 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).