Federal Register - September 20, 2021
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Source: Federal Register
52080
Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Rules and Regulations
common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to fluazinam and any other substances, and fluazinam does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA
has not assumed that fluazinam has a common mechanism of toxicity with other substances.
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 III.D. of the April 8, 2016 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 points of departure 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.
Acute dietary risks are below the Agencys level of concern of 100% of the aPAD: They are 37% of the aPAD for females 13 to 49 years old, the population subgroup with the highest risk estimate. Chronic dietary risks are below the Agencys level of concern of 100% of the cPAD: they are 88% of the cPAD for all infants, the population subgroup with the highest exposure estimate. The short-term aggregate risk assessments resulted in MOEs that are greater than the Agencys level of concern of 100 and therefore are not of concern. The MOEs are 381 for children 6 to less than 11 years old; 470 for youths 11 to less than 16 years old; and 420 for adults. Intermediate-term and long-term residential exposures are not expected.
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 fluazinam residues. More detailed information about the Agencys analysis can be found at http
www.regulations.gov in the document titled Fluazinam. Human Health Risk Assessment for the Proposed Use on Individual Commodities of Proposed Crop Subgroup 619B; Edible Podded
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Pea Legume Vegetable Subgroup, Crop Subgroup 619D: Succulent Shelled Pea Subgroup, Crop Subgroup 619F: Dried Shelled Pea Subgroup, Crop Subgroup 810A: Tomato Subgroup, Papaya, and Crop Group Conversions. in docket ID
number EPAHQOPP20200245.
IV. Other Considerations A. Analytical Enforcement Methodology For a discussion of the available analytical enforcement method, see Unit IV.A of the April 8, 2016 rulemaking.
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.
No Codex MRLs have been established for fluazinam.
C. Revisions to Petitioned-For Tolerances Most of the proposed commodity definitions have been modified to be consistent with Agency nomenclature.
In addition, EPA adjusted the tolerances for the edible podded bean commodities by removing the trailing zero to be consistent with the OECD Rounding Practice.
V. Conclusion Therefore, tolerances are established for residues of fluazinam in or on Bean, adzuki, dry seed at 0.02 ppm; Bean, American potato, dry seed at 0.02 ppm;
Bean, asparagus, edible podded at 0.1
ppm; Bean, asparagus, dry seed at 0.02
ppm; Bean, black, dry seed at 0.02 ppm;
Bean, broad, dry seed at 0.02 ppm;
Bean, broad, succulent shelled at 0.04
ppm; Bean, catjang, edible podded at 0.1
ppm; Bean, catjang, dry seed at 0.02
ppm; Bean, catjang, succulent shelled at 0.04 ppm; Bean, cranberry, dry seed at 0.02 ppm; Bean, dry, dry seed at 0.02
ppm; Bean, field, dry seed at 0.02 ppm;
Bean, French, dry seed at 0.02 ppm;
Bean, French, edible podded at 0.1 ppm;
Bean, garden, dry seed at 0.02 ppm;
Bean, garden, edible podded at 0.1 ppm;
Bean, goa, dry seed at 0.02 ppm; Bean, goa, edible podded at 0.1 ppm; Bean, goa, succulent shelled at 0.04 ppm;
Bean, great northern, dry seed at 0.02
ppm; Bean, green, dry seed at 0.02 ppm;
Bean, green, edible podded at 0.1 ppm;
Bean, guar, dry seed at 0.02 ppm; Bean, guar, edible podded at 0.1 ppm; Bean, kidney, dry seed at 0.02 ppm; Bean, kidney, edible podded at 0.1 ppm; Bean,
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lablab, dry seed at 0.02 ppm; Bean, lablab, edible podded at 0.1 ppm; Bean, lablab, succulent shelled at 0.04 ppm;
Bean, lima, dry seed at 0.02 ppm; Bean, lima, succulent shelled at 0.04 ppm;
Bean, morama, dry seed at 0.02 ppm;
Bean, moth, dry seed at 0.02 ppm; Bean, moth, edible podded at 0.1 ppm; Bean, moth, succulent shelled at 0.04 ppm;
Bean, mung, dry seed at 0.02 ppm;
Bean, mung, edible podded at 0.1 ppm;
Bean, navy, dry seed at 0.02 ppm; Bean, navy, edible podded at 0.1 ppm; Bean, pink, dry seed at 0.02 ppm; Bean, pinto, dry seed at 0.02 ppm; Bean, red, dry seed at 0.02 ppm; Bean, rice, dry seed at 0.02 ppm; Bean, rice, edible podded at 0.1 ppm; Bean, scarlet runner, dry seed at 0.02 ppm; Bean, scarlet runner, edible podded at 0.1 ppm; Bean, scarlet runner, succulent shelled at 0.04 ppm;
Bean, snap, edible podded at 0.1 ppm;
Bean, sword, dry seed at 0.02 ppm;
Bean, sword, edible podded at 0.1 ppm;
Bean, tepary, dry seed at 0.02 ppm;
Bean, urd, dry seed at 0.02 ppm; Bean, urd, edible podded at 0.1 ppm; Bean, wax, edible podded at 0.1 ppm; Bean, wax, succulent shelled at 0.04 ppm;
Bean, yardlong, dry seed at 0.02 ppm;
Bean, yardlong, edible podded at 0.1
ppm; Bean, yellow, dry seed at 0.02
ppm; Brassica, leafy greens, subgroup 4
16B at 0.01 ppm; Chickpea, dry seed at 0.04 ppm; Chickpea, edible podded at 0.15 ppm; Chickpea, succulent shelled at 0.03 ppm; Cowpea, dry seed at 0.02
ppm; Cowpea, edible podded at 0.1
ppm; Cowpea, succulent shelled at 0.04
ppm; Gram, horse, dry seed at 0.02 ppm;
Grass pea, dry seed at 0.04 ppm; Grass pea, edible podded at 0.15 ppm;
Jackbean, dry seed at 0.02 ppm;
Jackbean, edible podded at 0.1 ppm;
Jackbean, succulent shelled at 0.04 ppm;
Kohlrabi at 0.01 ppm; Lentil, dry seed at 0.04 ppm; Lentil, edible podded at 0.15 ppm; Lentil, succulent shelled at 0.03 ppm; Longbean, Chinese, dry seed at 0.02 ppm; Longbean, Chinese, edible podded at 0.1 ppm; Lupin, Andean, dry seed at 0.02 ppm; Lupin, Andean, succulent shelled at 0.04 ppm; Lupin, blue, dry seed at 0.02 ppm; Lupin, blue, succulent shelled at 0.04 ppm; Lupin, grain, dry seed at 0.02 ppm; Lupin, grain, succulent shelled at 0.04 ppm;
Lupin, sweet white, dry seed at 0.02
ppm; Lupin, sweet white, succulent shelled at 0.04 ppm; Lupin, sweet, dry seed at 0.02 ppm; Lupin, sweet, succulent shelled at 0.04 ppm; Lupin, white, dry seed at 0.02 ppm; Lupin, white, succulent shelled at 0.04 ppm;
Lupin, yellow, dry seed at 0.02 ppm;
Lupin, yellow, succulent shelled at 0.04
ppm; Papaya at 3 ppm; Pea, blackeyed, dry seed at 0.02 ppm; Pea, blackeyed,
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