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
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-2011-1029 in the subject line on
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 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-2011-1029, 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 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 [a particular pesticide's] * * * 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 1,4-DMN in a Final Rule published in the
As discussed in the
As stated previously in this Unit, new toxicity data have been submitted in support of the request by the petitioner to expand the current tolerance exemption to cover all sprouting root, tuber, and bulb crops. These data include: (1) A prenatal developmental toxicity study and (2) additional data not required by EPA, but used to further support the developmental data and this expansion of the tolerance exemption. All new data, coupled with the data submitted to support the previous tolerance exemption (60 FR 7456), confirm the minimal human health hazard effects, as reported in the original assessment of the tolerance exemption, associated with dietary exposures of 1,4-DMN and fully demonstrate the lack of mammalian toxicity. Summaries of the new toxicological data submitted in support of the expansion of the tolerance exemption follow.
A new developmental study (Master Record Identification (MRID) Number 48590905) was performed for 1,4-DMN to support the expansion of the tolerance exemption. 1,4-DMN was administered by oral gavage to female rabbits at the dose levels of 0, 25, 80, or 250 milligrams/per/day (mg/kg/day) (23 rabbits per test group) over gestation days 6 through 28. No treatment-related clinical signs were noted during the study, and gross necropsy findings were limited to those rabbits that underwent abortion (Ref. 1). The gross necropsy findings consisted of changes in the gastrointestinal tract (dilatation of stomach and/or intestines) and were likely related to the lack of eating prior to and during the abortion. Mean food consumption was significantly reduced in the 250 mg/kg/day treated doses shortly after treatment initiation (over gestation days 6 to 9 and 9 to 12). This reduction in food consumption was likely treatment-related. Corollary reductions in mean body weight gain were observed in the 250 mg/kg/day treated group over gestation days 6 to 9. Alterations in uterus weight were not observed, nor were changes seen in maternal body weight or body weight gain when corrected for uterus weight. As such, the changes seen early on in gestational body weight gain were considered to be solely associated with maternal toxicity. Therefore, the lowest observed adverse effect level (LOAEL) for maternal toxicity of 1,4-DMN in rats is 250 mg/kg/day based on reduced food consumption and reduced body weight gain. The no observed adverse effect level (NOAEL) for maternal toxicity is 80 mg/kg/day based on no effects observed at this dose.
For developmental toxicity, no treatment-related differences in litter viability were detected at any dose level tested. The number of male, female, and total fetuses (sexes combined) were similar across the treatment and control groups and average fetal weights were unaffected. No structural alterations, including gross external, visceral, skeletal, and cephalic, were evident from the fetal examinations; as such, 1,4-DMN did not produce any frank malformations and was not teratogenic. Based on no effects observed for developmental toxicity at any doses tested, the NOAEL for developmental toxicity is greater than 250 mg/kg/day (highest dose tested). 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, which showed no adverse effects at the highest dose tested, 250 mg/kg/day, there are sufficient data and information to confirm that 1,4-DMN is not a developmental toxicant. Therefore, the consumption of food commodities that have been treated with 1,4-DMN when used as a pesticide is safe and will not result in any harm to human health, specifically women of child-bearing age, from dietary exposure.
Additional toxicity data for 1,4-DMN that were not required by EPA to support this expansion of the tolerance exemption were submitted by the petitioner. The additional data include the following: Unscheduled DNA synthesis (mutagenicity),
3. A dermal sensitization test (MRID 48590904) utilizing the Local Lymph Node Assay (LLNA) method showed that 1,4-DMN is not a dermal sensitizer (Ref. 1). The dermal sensitization test utilizing the Buehler method submitted to support the previous tolerance exemption (60 FR 7456) also showed that 1,4-DMN is not a dermal sensitizer.
4. A one-generation reproductive toxicity study (MRID 48590906) was conducted on rats to assess systemic, developmental, and reproductive toxicity. 1,4-DMN was administered in the diet at the dose concentrations of 0, 500, 2,000, and 7,500 ppm with each dose group consisting of 24 males and 24 female rats. The results of the study showed that the NOAEL for systemic toxicity was 2,000 ppm (equivalent to 121 to 207 mg/kg/day in parental male and female rats and 184 to 213 mg/kg/day in F
Based on the reproductive toxicity data submitted for this expansion to the tolerance exemption, which showed no adverse reproductive effects at the highest dose tested, 7,500 ppm (equivalent to 441 to 591 mg/kg/day in parental male and female rats and 776 to 839 mg/kg/day in F
5. A combined chronic toxicity and carcinogenicity study (MRID 48590907) was conducted on rats (65 rats/sex/group for carcinogenicity and 20 rats/sex/group for chronic toxicity) to assess the chronic toxicity and carcinogenicity potential for 1,4-DMN. 1,4-DMN was administered in the diet of rats 7 days/week for a minimum of 52 weeks (chronic toxicity phase) or 104 weeks (carcinogenicity phase), at the dose concentrations of 0, 150, 500, and 3,750 ppm, equivalent to the dose concentrations of 0, 10, 33, and 250 mg/kg/day. For the chronic study, decreased food consumption with concurrent decreases in body weight and body weight gain were noted in the 250 mg/kg/day dose group. Minimal to moderate histologic test material-related effects in the kidney (proteinosis, papillary necrosis and karyomegaly) were noted in male rats at 250 mg/kg/day, while minimal to mild karyomegaly was noted in the kidney of female rats administered 1,4-DMN at dosages of 33 or 250 mg/kg/day. Based on the results of the chronic toxicity study, the NOAEL for chronic toxicity was 33 mg/kg/day for males and 10 mg/kg/day for females. For the carcinogenicity study, no incidences of carcinogenicity were noted in rats in any of the dose concentrations after the 97 weeks and 104 weeks of treatment for female and male rats, respectively.
Based on the results of the carcinogenicity data submitted for this expansion to the tolerance exemption, which showed that there was no evidence of carcinogenicity at the highest dose tested, 3,750 ppm (equivalent to 250 mg/kg/day), there are sufficient data and information to confirm that 1,4-DMN is not a carcinogen, 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 surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
Dietary risks to humans are considered negligible based on the lack of significant dietary toxicological endpoints for 1,4-DMN, its non-toxic mode of action, and the fact that it is applied to postharvest root, tuber, and bulb crops at the relatively low application rate of 20 ppm up to four applications during the storage season. No significant acute, subchronic, mutagenic, developmental, chronic, or carcinogenicity dietary toxicity hazards were identified in the studies submitted to support this expansion of the tolerance exemption or the previous tolerance exemption (60 FR 7456). The submitted data and information for this expansion of the tolerance exemption show that any residues of 1,4-DMN found in or on the sprouting root, tuber, and bulb crops are far below any toxicological endpoints identified in this expansion of the tolerance exemption or in the previous tolerance exemption (60 FR 7456) and confirm 1,4-DMN's lack of dietary toxicity hazards for mammals (Ref. 2).
Based on the submitted data and information for this expansion of the tolerance exemption, any residues of 1,4-DMN found in or on the sprouting root, tuber, and bulb crops are far below any toxicological endpoints identified in this expansion of the tolerance exemption or in the previous tolerance exemption (60 FR 7456). These toxicological endpoints identified in Unit III of this final rule include: Maternal toxicity NOAEL of 80 mg/kg/day, developmental toxicity NOAEL greater than 250 mg/kg/day, reproductive toxicity NOAEL of 7,500 ppm (equivalent to 441 to 591 mg/kg/day in parental male and female rats and 776 to 839 mg/kg/day in F
No new non-occupational exposure is expected to result from the new food uses of 1,4-DMN. No health risks are expected from any non-occupational exposure to 1,4-DMN based on the data submitted for the previous tolerance exemption (60 FR 7456) 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 1,4-DMN to share a common mechanism of toxicity with any other substances, and 1,4-DMN does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1,4-DMN 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 (60 FR 7456) and for this expansion of the tolerance exemption indicate that 1,4-DMN has negligible acute, subchronic, mutagenic, developmental, chronic, or carcinogenicity toxicity hazards. Moreover, 1,4-DMN has a nontoxic mode of action and naturally occurs in various crops as listed in Unit IV.A.1. Therefore, the Agency 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 the residues of 1,4-DMN. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available on 1,4-DMN do not demonstrate significant toxic potential to mammals. Thus, there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary.
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 1,4-DMN.
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 1,4-DMN. Therefore, the existing exemption from the requirement of a tolerance for residues of the plant growth regulator, 1,4-DMN, when applied postharvest to potatoes is amended by establishing the exemption from the requirement of a tolerance for residues of the plant growth regulator, 1,4-DMN, when applied postharvest to sprouting root, tuber, and bulb crops in accordance with good agricultural practices.
The following references used in this document and the previous Final Rule published in the
1. U.S. EPA. 2012. Memorandum from Gina M. Burnett to Colin Walsh. Science Review of Tolerance Petition 1F7920,
2. U.S. EPA. 2012. Memorandum from Russell S. Jones, Ph.D., to Colin Walsh. Science Review of Registrant's Response to Deficiencies in Tolerance Petition 1F7920, Intended to Expand the Use of 1,4-Dimethylnaphthalene to Include Use on All Root and Tuber Vegetables (Crop Group 01) and Bulb Vegetables (Crop Group 03); Label Amendments for 67727-1, -3 and -4 Upon Tolerance Amendment Approval. U.S. Environmental Protection Agency, Office of Pesticide Programs. June 21, 2012.
This final rule establishes an exemption from the requirement of 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 the plant growth regulator, 1,4-dimethylnaphthalene (1,4-DMN), when applied postharvest to all sprouting root, tuber, and bulb crops in accordance with good agricultural practices.