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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations
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Mail: OPP Docket, Environmental Protection Agency Docket Center EPA/
DC, 28221T, 1200 Pennsylvania Ave.
NW, Washington, DC 204600001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http
www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance In the Federal Register of April 25, 2016 81 FR 24044 FRL994486, EPA issued a document pursuant to FFDCA section 408d3, 21 U.S.C.
346ad3, announcing the filing of a pesticide petition PP 5F8427 by Geo Logic Corporation, P.O. Box 3091, Tequesta, FL 33409. The petition requested that 40 CFR 180.245 be amended by establishing tolerances for residues of streptomycin in or on citrus fruit, crop group 1010 at 0.5 ppm and citrus, dried pulp at 3.5 ppm and by removing the existing tolerances for grapefruit.
In addition, in the Federal Register of September 5, 2014 79 FR 53009 FRL
991498, EPA issued a document pursuant to FFDCA section 408d3, 21
U.S.C. 346ad3, announcing the filing of a pesticide petition PP 4E8236 by Interregional Research Project No. 4
IR4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The petition requested the establishment of tolerances for residues of streptomycin in or on grapefruit at 0.15 ppm, grapefruit, dried pulp at 0.63 ppm, and fruit, pome, group 1110 at 0.25, as well as several amendments to the existing tolerances in 40 CFR 180.245 as follows:
1 Moving the existing tolerances for streptomycin on celery, pepper, and tomato from paragraph a2, and potato from paragraph a3 to the table in paragraph a1; 2 modifying the existing tolerance for tomato from 0.25
ppm to 0.5 ppm; 3 removing the existing time-limited tolerances for grapefruit and grapefruit, dried pulp in paragraph b upon establishment of the permanent tolerances for grapefruit and grapefruit, dried pulp; 4 removing the existing tolerance for fruit, pome, group 11 upon establishment of the tolerance for fruit, pome, group 1110; and 5
modifying the tolerance expression and creating a single paragraph and table under 180.245a to provide that in general tolerances are established for residues of the fungicide streptomycin, including its metabolites and
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degradates, in or on the commodities in the table to the paragraph. Compliance with the tolerance levels specified in the table is to be determined by measuring only streptomycin O-2-Deoxy-2methylamino-a-Lglucopyranosyl-1-2O-5-deoxy-3-Cformyl-a-L-lyxofuranosyl1-4-N,N-bisaminoiminomethyl-Dstreptamine in or on the commodity.
The documents referenced summaries of the petitions prepared by the petitioners, which are available at http www.regulations.gov. in the following dockets: EPAHQOPP
20160067 for PP 5F8427 and EPAHQ
OPP20140134 for PP 4E8236. No comments were received in response to the notice of filing for PP 5F8427;
eighteen comments were submitted in response to the notice of filing for PP
4E8236 although none were relevant to the streptomycin tolerance.
Based upon review of the data supporting the petitions, EPA is establishing the tolerances at different levels than requested. The reasons for these changes are explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety Section 408b2Ai of FFDCA
allows EPA to establish a tolerance the legal limit for a pesticide chemical residue in or on a food only if EPA
determines that the tolerance is safe.
Section 408b2Aii 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. Section 408b2C of FFDCA 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 408b2D, and the factors specified in FFDCA section 408b2D, 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 streptomycin including exposure resulting from the tolerances modified by this action.
EPAs assessment of exposures and risks associated with streptomycin follows.

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In an effort to streamline its publications in the Federal Register, EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary; EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.
EPA has previously published a tolerance rulemaking for streptomycin, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to streptomycin and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
Toxicological Profile. There are no guideline toxicity studies available to assess pesticidal uses of streptomycin.
The toxicity of streptomycin was assessed using the extensive published literature on drug use of streptomycin in humans and in animals, as well as with several toxicity summaries provided by the FDA. Injections of streptomycin as a drug up to a gram, at doses much higher than expected from dietary or residential routes of exposure to pesticidal uses, can cause inner ear toxicity resulting in vestibular problems with loss of balance or equilibrium.
Injections also sometimes cause hearing loss and mild, reversible kidney toxicity. Children born to mothers treated with streptomycin injections have sometimes had hearing loss. No teratogenic effects were noted in a nonguideline rabbit developmental study.
In a non-guideline 2-year rat feeding study, the only adverse effect noted was reduced body weight in males; an increase in treatment-related tumors was not reported. The acute oral toxicity for streptomycin is very low; the LD50
was 9,000 mg/kg in both rats and mice.
Toxicological Points of Departure/
Levels of Concern. For a summary of the Toxicological Points of Departure/
Levels of Concern used for the safety assessment, see Unit IV.A. of the March 15, 2017 rulemaking 82 FR 13759
FRL995765.
Exposure Assessment. EPAs dietary exposure assessments for the permanent tolerances on the citrus fruit crop group 1010 and dried citrus pulp relied on
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