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Federal Register / Vol. 86, No. 25 / Tuesday, February 9, 2021 / Rules and Regulations tolerance-level residues for all crops and an assumption of 100 percent crop treated PCT. EPAs aggregate exposure assessment incorporated this assumed dietary exposure, as well as exposure in drinking water and from residential sources, which have not changed since the last assessment. The assessment also considered aggregate risk as a result of the pharmaceutical uses of streptomycin. For a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit IV.B. of the March 15, 2017 rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude that there is reliable data to support the reduction of the Food Quality Protection Act FQPA safety factor. See Unit IV.C.
of the March 15, 2017 rulemaking for a discussion of the Agencys rationale for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose aPAD and chronic PAD cPAD. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate margin of exposure MOE exists. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.
No acute effects were identified in the toxicological studies for streptomycin;
therefore, acute risk is not expected.
Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD: They are 91% of the cPAD for all infants less than 1 year old, the population subgroup with the highest exposure estimate. The short-term MOE
is greater than the Agencys level of concern of 100: It is 260 for adults, the population group of concern.
Intermediate-term or long-term residential exposures are not expected.
Lastly, because the pesticide exposure has no more than a minimal impact on the total dose to a pharmaceutical user, EPA believes that there is a reasonable certainty that the potential dietary pesticide exposure will result in no harm to a user being treated therapeutically with streptomycin.
Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to streptomycin residues.
More detailed information about the
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Agencys analysis can be found at http www.regulations.gov in the document titled Streptomycin. Section 3 Registration for Citrus Fruits Crop Group 1010 in docket ID number EPAHQOPP20160067.
IV. Other Considerations A. Analytical Enforcement Methodology A high-performance liquid chromatography method with tandem mass spectrometry detection LC/MS/
MS is available for tolerance enforcement.
The method may be requested from:
Chief, Analytical Chemistry Branch, Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 207555350;
telephone number: 410 3052905;
email address: residuemethods@
epa.gov.
B. International Residue Limits 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 408b4.
The Codex has not established any MRLs for streptomycin.
C. Revisions to Petitioned-For Tolerances The tolerances proposed by the petitioner for the citrus fruit crop group 1010 0.50 ppm and citrus dried pulp 3.5 ppm are different from those which are being established by this document.
This is primarily because the petitioner input the residue data differently into the calculation procedures for determining the proposed crop group tolerance including all data for the representative crops into a single calculation. As a result, the tolerances are being established at 0.8 ppm for the fruit, citrus, crop group 1010 and 3
ppm for fruit, citrus, group 1010, dried pulp. In addition, the commodity definitions were corrected to reflect the crop group.
As a result of the IR4 petition being withdrawn by the petitioner, EPA is not granting the request to establish the requested tolerances or to increase the tomato tolerance from 0.25 to 0.5 ppm.
EPA is making the editorial changes requested by IR4, however, including modifications to the tolerance expression and tables contained in paragraph a and removal of expired grapefruit tolerances from paragraph b.

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V. Conclusion Therefore, tolerances are established for residues of streptomycin in or on Fruit, citrus, group 1010 at 0.8 ppm and Fruit, citrus, group 1010, dried pulp at 3 ppm. In addition, existing tolerances in 40 CFR 180.245 are amended as follows: 1 Consolidating the subparagraphs and tables in paragraph a into a single paragraph a;
2 removing the time-limited tolerances for grapefruit and grapefruit, dried pulp, as they have expired; and 3 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 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.
VI. Statutory and Executive Order Reviews This action establishes and modifies tolerances under FFDCA section 408d 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, nor is it considered a regulatory action under Executive Order 13771, entitled Reducing Regulations and Controlling Regulatory Costs 82 FR 9339, February 3, 2017. 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 12898, 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
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