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:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
To access the OCSPP test guidelines referenced in this document electronically, please go to
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
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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-1028, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
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 require 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. * * * ” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider” available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity.”
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.
Consistent with FFDCA section 408(b)(2)(D), 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.
EPA established a tolerance exemption for polyoxin D zinc salt in a final rule published in the
As discussed in the
As stated previously in this Unit (III), new toxicity data have been submitted in support of the request by the petitioner to expand the current tolerance exemption to cover all food commodities. These data include:
1. A prenatal developmental toxicity study; and
2. Two mutagenicity studies.
Two new mutagenicity studies were performed for polyoxin D zinc salt to support the expansion of the tolerance exemption. The mutagenicity studies as described herein, along with the mutagenicity studies submitted to support the previous tolerance exemption (73 FR 69561), confirm that polyoxin D zinc salt is not a mutagen and that consumption of food commodities that have been treated with this substance when used as a pesticide is safe and will not result in any harm to human health from dietary exposure.
1. A reverse gene mutation assay in bacteria Master Record Identification Number ((MRID) 48653313) using the technical grade of polyoxin D zinc salt, dissolved in dimethyl sulfoxide (DMSO), with and without metabolic S9 activation, showed no mutagenic effects or evidence of cytotoxicity or insolubility even at the limiting dose of 5,000 ug/plate (See Ref.). Therefore, polyoxin D zinc salt is considered to be non-mutagenic under the conditions of this assay.
Although the submitted
A new developmental study (MRID 48653315) was performed for polyoxin D zinc salt to support the expansion of the tolerance exemption. No treatment-related effects were observed in general appearance, body weight, adjusted for gravid uterine weight, weight gain, or food consumption in maternal rats at the doses tested (0, 100, 300, and 1,000 milligrams/kilograms bodyweight/day (mg/kg bw/day) (See Ref.). Necropsy observations showed that almost all rats (20/24) in the 1,000 mg/kg/day group highest dose tested (HDT) had thickening of the limiting ridge. Therefore, the lowest observed adverse effect level (LOAEL) for maternal toxicity of polyoxin D zinc salt in rats is 1,000 mg/kg bw/day based on gross lesions in the stomach (thickening of the limiting ridge). The no observed adverse effect level (NOAEL) for maternal toxicity is 300 mg/kg bw/day based on no effects observed at this dose. Although an effect of gross lesions in the stomach was found in maternal rats at the limit dose tested (1,000 mg/kg bw/day), there were no reported systemic effects in maternal rats at this dose. The effect in the stomach lining was limited to a localized gastric irritation due to the route of entry (oral gavage) at the limit dose tested (1,000 mg/kg bw/day), which is typical of the nature of the test substance.
For developmental toxicity, no treatment-related effects were observed on developmental parameters including gravid uterine weight, placental weight, mean numbers of corpora lutea and implantation sites, numbers of early and later resorptions (dead or resorbed embryos or fetuses), number of live fetuses per dam, implantation index, viability index, sex ratio, and male and female body weight. The incidence of external, visceral, and skeletal variations and anomalies were not affected by treatment of polyoxin D zinc salt. Based on no effects observed for developmental toxicity at any doses tested, the NOAEL for developmental toxicity is greater than 1,000 mg/kg bw/day HDT. The LOAEL was not identified for developmental toxicity, suggesting that the test animals could have tolerated a higher dose.
Based on the developmental toxicity data submitted for this expansion to the tolerance exemption, and the Tier III 2-generation reproduction study submitted for the previous tolerance exemption (73 FR 69562), which showed no reproductive effects at the limit dose tested, there are sufficient data and information to confirm that polyoxin D zinc salt is not a developmental toxicant, and that consumption of food commodities that have been treated with this substance when used as a pesticide is safe and will not result in any harm to human health from dietary exposure.
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
Dietary risks to humans are considered negligible based on the lack of dietary toxicological endpoints for polyoxin D zinc salt and its non-toxic mode of action as a fungi-specific chitin synthetase inhibitor that passes through mammalian digestive systems. No significant acute, subchronic, mutagenic, immunotoxic, developmental, or chronic dietary toxicity hazards were identified in the studies submitted to support this expansion of the tolerance exemption or the previous tolerance exemption (73 FR 69562). Based on polyoxin D zinc salt's lack of dietary toxicity hazards for mammals, no aggregate dietary exposure concerns are expected.
In addition, a terrestrial exposure model (T-Rex) was performed for the previous tolerance exemption (73 FR 69562), which indicated that it is highly unlikely that there will be adverse effects resulting from the use of polyoxin D zinc salt via the oral route of exposure. EPA's T-Rex calculations delimit aggregate dietary consumption of residues to no more than 40 ppm, a level that is far below the HDT in any of the toxicity testing.
Based on the residue data submitted for this expansion of the tolerance exemption, and the T-Rex residue modeling data from the previous tolerance exemption (73 FR 69562), any residues found are far below any toxicological endpoints identified in this expansion of the tolerance exemption (developmental toxicity NOAEL greater than 1,000 mg/kg bw/day; maternal toxicity NOAEL of 300 mg/kg/day) or in the previous tolerance exemption (73 FR 69561). The previous tolerance exemption showed an acute oral toxicity median lethal dose (LD
In summary, the residue and toxicity data demonstrate a lack of aggregate dietary risk that is sufficient to support this expansion of the tolerance exemption.
No new non-occupational exposure is expected to result from the new food uses of polyoxin D zinc salt. No health risks are expected from any non-occupational exposure to polyoxin D zinc salt based on the data submitted for the previous tolerance exemption (73 FR 69562) and for this expansion of the tolerance exemption.
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 polyoxin D zinc salt to share a common mechanism of toxicity with any other substances, and polyoxin D zinc salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that polyoxin D zinc salt 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 chemicals, see EPA's Web site at
FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of safety will be safe for infants and children. Margins of exposure safety, which are often referred to as uncertainty factors, are incorporated into EPA risk assessments either directly or through the use of a margin of exposure analysis, or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk.
Relevant data and information submitted for the previous tolerance exemption (73 FR 69560) and for this expansion of the tolerance exemption indicate that polyoxin D zinc salt has negligible acute, subchronic, chronic, and developmental toxicity. Moreover, polyoxin D zinc salt is defined by its fungistatic non-toxic mode of action, and demonstrates no significant mammalian effect. Therefore, the
An analytical method is not required for enforcement purposes for the reasons stated above, and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for polyoxin D zinc salt.
EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of polyoxin D zinc salt. Therefore, the existing exemption from the requirement of a tolerance for residues of polyoxin D zinc salt when used as a fungicide on almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes, and strawberries is amended by establishing an exemption from the requirement of a tolerance for residues of polyoxin D zinc salt in or on all food commodities when applied as a fungicide and used in accordance with good agricultural practices.
The reference used in this document is in the OPP docket listed under docket ID EPA-HQ-OPP-2011-1028 and may be seen by accessing the
U.S. EPA. 2011. Memorandum from Manying Xue to Colin Walsh. Polyoxin D zinc salt (EPA Reg. #: 68173-1), Containing 23.8% of Polyoxin D Zinc Salt (Active Ingredient). Science Review of Product Chemistry, Residue Chemistry, Non-Target Organism and Toxicity Data in Support of label Amendment. U.S. Environmental Protection Agency Office of Pesticide Programs. May 11, 2012.
This final rule establishes a 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 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
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance 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
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 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 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) (2 U.S.C. 1501
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) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for the residues of polyoxin D zinc salt in or on all food commodities when applied as a fungicide and used in accordance with good agricultural practices.