Source: https://www.federalregister.gov/documents/2008/10/01/E8-22957/aspergillus-flavus-nrrl-21882-exemption-from-the-requirement-of-a-tolerance
Timestamp: 2017-09-26 15:11:26
Document Index: 196178271

Matched Legal Cases: ['art 178', 'art 180', 'art 178', 'art 178', 'art 178', 'art 2']

This regulation is effective October 1, 2008. Objections and requests for hearings must be received on or before December 1, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
73 FR 56995
EPA-HQ-OPP-2008-0381
FRL-8383-9
E8-22957
https://www.federalregister.gov/d/E8-22957 https://www.federalregister.gov/d/E8-22957
EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2008-0381. All documents in the docket are listed in the docket index available at http://www.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 in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
In addition to accessing electronically available documents at http://www.regulations.gov, you may access this Federal Register document Start Printed Page 56996electronically 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.
Under section 408(g) of FFDCA, 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. 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-2008-0381 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 December 1, 2008.
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-2008-0381, by one of the following methods.
In the Federal Register of June 18, 2008 (72 FR 34734) (FRL-8366-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F7302) by Circle One Global, Inc. (Circle One), P.O. Box 28, Shellman, GA 39886-0028. The petition requested that 40 CFR 180.1254 be amended by expanding the existing exemption from the requirement of a tolerance for residues of Aspergillus flavus NRRL 21882 on corn. A summary of the petition prepared by the petitioner Danny Gay, Acta Group, 1203 Nineteenth St., NW., Suite 300, Washington DC 20036, on behalf of Circle One Global, Inc., was included in the docket at www.regulations.gov (Docket No. EPA-HQ-OPP-2008-0381). On July 9, 2008, Acta Group posted a comment to this docket to clarify that the pending amendment to the current exemption from tolerance for Aspergillus flavus NRRL 21882 is intended to apply to field corn, sweet corn, and pop corn as harvested. The tolerance exemption is being granted for these food commodities on the basis of the toxicology studies which support all food commodities.
A temporary exemption from the requirement of tolerance for Aspergillus flavus NRRL 21882 on corn currently exists at 40 CFR 180.1254(b). That temporary tolerance is connected with Experimental Use Permit No. 75624-EUP-2 and is set to expire on May 2, 2009. The Agency issued this temporary rule on May 16, 2007, after determining that the temporary exemption from the requirement of tolerance was safe (72 FR 27460, May 16, 2007).
Aspergillus flavus NRRL 21882 is a non-aflatoxin-producing fungal active ingredient for use in microbial pesticides. It will be used to displace the ubiquitous Aspergillus flavus group of microbes, many of which can produce aflatoxin, a potent carcinogen. The toxicological profile of this conditionally registered active ingredient has been previously described in the final rule of the Federal Register of June 30, 2004, (69 FR 39341) (FRL-7364-2). On the basis of those studies, the exemption from tolerance of Aspergillus flavus NRRL 21882, a non-aflatoxin-producing strain of Aspergillus flavus, on peanuts was established in 40 CFR 180.1254.
The acute oral toxicology studies provided for peanuts are cited in support of the tolerance exemption for field, pop and sweet corn. Those studies placed Aspergillus flavus NRRL 21882 in Toxicity Category IV for acute oral effects. This active ingredient was not toxic, infective or pathogenic to mammals on the basis of acute oral and pulmonary studies. That database supporting the exemption from tolerance on peanut also supports the proposed exemption of this active ingredient on corn. Even though the active ingredient has demonstrated toxic and infective effects in the acute intraperitoneal studies, there was clearance from all tissues by day 22. The Start Printed Page 56997results of these studies were considered a worse case scenario relevant to issues of occupational exposure for which the agency required appropriate Personal Protective Equipment (PPE) to mitigate risk to workers. In addition, the pesticide is not to be applied to residential areas, but rather to commercial corn fields. Thus, potential non-occupational exposure is not expected. For a summary of the studies and discussions of dietary and non-dietary, non-occupational dermal and inhalation exposures, as well as aggregate and cumulative, exposures, and potential endocrine effects refer to the aforesaid June 30, 2004 final rule (69 FR 39341). All studies met, and continue to meet, the safety standards of the Food Quality Protection Act (FQPA) of 1996. This pesticide has been used for more than a decade in experimental laboratory and field trials without any reports of adverse dermal irritation or hypersensitivity effects.
The Agency has determined that the previously reviewed acute toxicological studies do support the proposed exemption from tolerance of Aspergillus flavus NRRL 21882 on corn. Summaries of the rationales for this determination may be found in the aforesaid Federal Register final rule of June 30, 2004. No further toxicological data are required for this exemption from the requirement of a tolerance for Aspergillus flavus NRRL 21882 on corn. The applicant must, however, report any incidents of hypersensitivity, or any other adverse effects to comply with the requirements of FIFRA section 6(a)(2).
In evaluating dietary exposure to Aspergillus flavus NRRL 21882, EPA considered exposure under the petitioned-for tolerances as well as the existing Aspergillus flavus NRRL 21882 tolerance for peanuts in (40 CFR 180.1254(a)).
1. Food. Pesticides containing Aspergillus flavus NRRL 21882 are to be applied aerially to corn once per season at the first sign of corn tasseling. Because there is a long period of time between application and harvesting, residues of Aspergillus flavus NRRL 21882 are not expected to be greater than the normal background levels, when the food commodity is harvested. In addition, corn and its byproducts will be subject to several stages of food processing and manufacturing. These stages include washing, threshing, dehulling, dry and wet milling, and fractionation by aspiration and the other food manufacturing and processing technologies which are associated with preparing and marketing corn as a food commodity. Thus, because of the low application rate and food processing steps, this naturally occurring active ingredient is not expected to be present at greater than background levels on consumable corn commodities. Even if it is present, it is not likely to cause harm because it is not toxic, infective or pathogenic as demonstrated in the acute oral toxicity study in rats.
These observations from the acute toxicology tests are also relevant to dietary exposure of human adults, infants and children to peanuts treated with Aspergillus flavus NRRL 21882. The Agency, taking both crops into consideration, concluded that the aggregate exposure to this active ingredient with low toxicity potential will not cause harm if the pesticide is used as labeled.
2. Drinking water exposure. The analysis provided for the tolerance exemption for residues of Aspergillus flavus NRRL 21882 on peanuts also supports the drinking water exposure analysis for corn. As in the case of peanuts, the pesticide is to be applied in drought ridden areas and is not directly applied to crops grown in water. Thus accumulation in drinking water is not expected. Percolation through the soil and municipal treatment of drinking water are expected to preclude exposure of the U.S. population, infants and children to residues of the pesticide. Thus incremental exposure via drinking water is not expected when both corn and peanuts are treated.
Non-occupational dermal and inhalation exposure is expected to be minimal to non-existent when the microbial pesticide containing the active ingredient Aspergillus flavus NRRL 21882 is used as labeled on corn and peanuts. For both crops, the pesticide is to be applied to agricultural sites not in the proximity of residential areas, schools, nursing homes or daycares. While there is a potential for dermal sensitivity to the Aspergillus group of fungi, the specific pesticide at issue here, Aspergillus flavus NRRL 21882, is not intended for residential applications. Instead, it is to be applied once per growing season to commercial agricultural fields. Pesticide drift is not expected to residential areas from the agricultural applications of the granular End-use Product which is applied at a very low rate (approximately 1 gram or 0.002 pound of active ingredient per acre). Thus, non-occupational residential exposure is expected to be minimal to non-existent.
In summary, the Agency considered dietary exposure (including drinking water), as well as non-occupational exposure to treated peanuts and corn, and concluded that aggregate exposure to Aspergillus flavus NRRL 21882 will not cause harm to the U.S. adult, population, infants and children.
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to consider the cumulative effect of exposure to Aspergillus flavus NRRL 21882 and to other substances that have a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Based on tests in mammalian systems, Aspergillus flavus NRRL 21882 does not appear to be toxic to humans via dietary and pulmonary exposure. Therefore, the requirement to consider cumulative effects does not apply.
For the same reasons as stated in the rule issued on June 30, 2004 (69 FR 39341), the Agency has determined that the additional margin of safety is not necessary to protect infants and children, and that not adding any additional margin of safety will be safe for infants and children. As a result, EPA has not used a margin of exposure (safety) approach to assess the safety of Aspergillus flavus NRRL 21882.
In summary, the Agency has determined that, based on available data Start Printed Page 56998and information, there is a reasonable certainty that the use of Aspergillus flavus NRRL 21882 on field, sweet and pop corn will not cause harm to the U.S. adult, children and infant populations via dietary, aggregate and cumulative exposure. Thus, an exemption from the requirement of a tolerance on field, sweet and pop corn is being granted.
2. Section 180.1254 is amended by revising paragraph (b) to read as follows:
[FR Doc. E8-22957 Filed 9-30-08; 8:45 am]