[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Rules and Regulations]
[Pages 13759-13765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04779]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0540; FRL-9957-65]


Streptomycin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of streptomycin in or on fruit, citrus, group 10-10, for both 
fresh fruit and dried pulp. This action is in response to EPA's 
granting of an emergency exemption under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
in citrus production. This regulation establishes maximum permissible 
levels for residues of streptomycin in or on these commodities. The 
time-limited tolerances expire on December 31, 2019.

DATES: This regulation is effective March 15, 2017. Objections and 
requests for hearings must be received on or before May 15, 2017, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0540, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    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:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(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. 
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-
2016-0540 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before May 15, 2017. Addresses for 
mail and hand delivery of objections and hearing requests are provided 
in 40 CFR 178.25(b).
    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 Confidential Business Information (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-2016-0540, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     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. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6), of 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of streptomycin, 
expressed as only streptomycin ((4S,4aR,5S,5aR,6S,12aS)-4-
(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-
hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide), in or on 
fruit, citrus, group 10-10 at 2 parts per million (ppm), and the dried 
pulp of these commodities at 6 ppm. These time-limited tolerances 
expire on December 31, 2019.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA

[[Page 13760]]

section 408 and the safety standard to other tolerances and exemptions. 
Section 408(e) of FFDCA allows EPA to establish a tolerance or an 
exemption from the requirement of a tolerance on its own initiative, 
i.e., without having received any petition from an outside party.
    Section 408(b)(2)(A)(i) 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 
408(b)(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. 
Section 408(b)(2)(C) 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 . . 
.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Streptomycin on Citrus and FFDCA 
Tolerances

    The Florida Department of Agriculture and Consumer Services (FDACS) 
asserted that an emergency situation exists in accordance with the 
criteria for approval of an emergency exemption, and requested the use 
of streptomycin (and oxytetracycline, addressed in a separate document) 
in citrus to suppress the Candidatus Liberibacter asiaticus (CLas) 
bacterium that causes Huanglongbing (HLB) also known as citrus 
greening. HLB is a newly-introduced disease, vectored by the invasive 
insect, the Asian citrus psyllid, and is the most serious disease of 
citrus worldwide. This disease has rapidly spread throughout Florida's 
citrus production area, causing severe losses with an overall decrease 
in production of more than 60% primarily due to HLB. Significant losses 
have occurred, many producers have gone out of business, and FDACS 
asserts that the long-term economic viability of the citrus industry in 
Florida is threatened by this disease. Currently there is no cure. The 
bacteria reside in the phloem (the circulatory system of the tree), 
disrupting circulation of water and nutrients, which ultimately leads 
to death of the tree. FDACS states that use of streptomycin, along with 
other management measures, may suppress HLB symptoms, and prolong the 
productive life of infected trees, allowing citrus producers to remain 
in business while researchers continue to explore and evaluate new 
treatments for the disease.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of streptomycin 
on citrus to suppress the CLas bacterium that causes HLB disease in 
Florida.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of streptomycin 
in or on citrus fruit commodities. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerances under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. Consistent with the 
need to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing these tolerances without notice and 
opportunity for public comment as provided in FFDCA section 408(l)(6). 
Although these time-limited tolerances expire on December 31, 2019, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerances remaining in or on citrus 
fruit commodities after that date will not be unlawful, provided the 
pesticide was applied in a manner that was lawful under FIFRA, and the 
residues do not exceed levels that were authorized by these time-
limited tolerances at the time of that application. EPA will take 
action to revoke these time-limited tolerances earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
streptomycin meets FIFRA's registration requirements for use on citrus 
fruit or whether permanent tolerances for this use would be 
appropriate. Under these circumstances, EPA does not believe that these 
time-limited tolerance decisions serve as bases for registrations of 
streptomycin by a State for special local needs under FIFRA section 
24(c). Nor do these tolerances by themselves serve as the authority for 
persons in any State other than Florida to use this pesticide on the 
applicable crops under FIFRA section 18 absent the issuance of an 
emergency exemption applicable within that State. For additional 
information regarding the emergency exemption for streptomycin, contact 
the Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), 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 expected as a result of this emergency exemption use and the 
time-limited tolerances for residues of streptomycin on fruit, citrus, 
group 10-10 at 2 ppm, and the dried pulp of these commodities at 6 ppm. 
EPA's assessment of exposures and risks associated with establishing 
the time-limited tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risks to humans from exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, EPA assumes that any 
amount of exposure will lead to some degree of risk. Thus, the EPA 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the

[[Page 13761]]

general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for streptomycin used for 
human risk assessment is shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Streptomycin for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/ scenario           and  uncertainty/    RfD, PAD, LOC  for    Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Any population)...  NA..................  NA.................  Toxicity from single dose was not
                                                                               identified.
Chronic dietary (All populations)  NOAEL= 5 mg/kg/day    Chronic RfD =        Two-year feeding study in rats.
                                   UFA = 10............  0.05 mg/kg/day.....  LOAEL = 10 mg/kg/day based on
                                   UFH = 10............  cPAD =.............   reduced body weight in males.
                                   FQPA SF = 1X........  0.05 mg/kg/day.....
Inhalation (All durations).......  NOAEL = 5 mg/kg/day.  LOC <= MOE of 100..  Two-year feeding study in rats.
                                   FQPA SF = 1X........                       LOAEL = 10 mg/kg/day based on
                                                                               reduced body weight in males.
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Cancer...........................  Classification--There is not enough information in line with EPA's guidelines
                                     for toxicological studies of pesticides to classify carcinogenic potential.
                                      The toxicological data requirements have been waived due to the extensive
                                       human database from streptomycin drug use. A 2-year rat carcinogenicity
                                     study, used by FDA and the World Health Organization to set tolerances for
                                       animal drug residues, is available and did not demonstrate evidence of
                                       carcinogenicity. Also, a literature search for streptomycin toxicity in
                                        animals and humans did not result in any data indicating evidence of
                                                                  carcinogenicity.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from
  animal to human (interspecies). UFH = potential variation in sensitivity among the human population
  (intraspecies).

    The complete human risk assessment for this action can be found at 
http://www.regulations.gov in the document ``Streptomycin. Section 18 
Emergency Exemption for Citrus Grown in Florida'' in the docket for ID 
number EPA-HQ-OPP-2016-0450.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to streptomycin, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
streptomycin tolerances in 40 CFR 180.245. EPA assessed dietary 
exposures from streptomycin in food as follows:
    i. Acute exposure. No acute effects were identified in the 
toxicological studies for streptomycin; therefore, a quantitative acute 
dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003-2008 US 
Department of Agriculture (USDA) National Health and Nutrition 
Examination Survey (NHANES). For residue levels in food, EPA assumed 
tolerance level residues for all registered uses plus the new 
tolerances of 2 ppm in citrus fruit and 6 ppm in the dried pulp of 
these commodities. In addition, default processing factors were used 
for all processed commodities, except citrus juice, oil, and tomato 
puree since concentration was not observed in these commodities. One 
hundred percent crop treated (PCT) was assumed for all commodities. 
EPA's exposure assessment included tolerance level residues in 
livestock commodities owing to use of streptomycin as an animal drug as 
well. No anticipated residue or PCT refinements were used.
    iii. Cancer. Based on the data summarized in Unit IV.A., EPA has 
concluded that streptomycin does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for streptomycin. Tolerance level residues and 100% 
CT were assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for streptomycin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of streptomycin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Potential residues resulting in surface water and groundwater were 
modeled based upon registered and new uses. The estimated drinking 
water concentrations (EDWCs) for ground water were higher than for 
surface water, and thus were used for estimating exposure from drinking 
water consumption, as the most conservative (worst case) estimate. 
Based on the Pesticide Root Zone Model, Ground Water, the EDWC in 
groundwater (the highest modeled value) for streptomycin for acute 
exposures is estimated to be 932 parts per billion (ppb), and for 
chronic exposures (non-cancer) is estimated at 760 ppb. No acute 
assessment was required as discussed earlier in this document. The 
modeled estimate of drinking water concentration for chronic exposure 
was directly entered into the dietary exposure model used to estimate 
chronic risks presented by potential residues in food and drinking 
water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control,

[[Page 13762]]

indoor pest control, termiticides, and flea and tick control on pets).
    Streptomycin is currently registered for uses on residential 
gardens and trees which could result in residential exposures. EPA 
considered residential exposures from these uses and determined the 
following: Since there is no dermal hazard identified for streptomycin, 
residential dermal exposures were not assessed. Non-dietary incidental 
ingestion and inhalation from post-application residential exposures 
are assumed to be negligible, based upon the use scenarios and chemical 
properties of streptomycin. However, residential handler inhalation 
exposures may occur based on the use sites, equipment, and in 
particular, the lack of personal protective equipment (PPE) 
requirements on certain product labels for residential uses. Risk was 
therefore evaluated from short- and intermediate-term inhalation 
exposures for residential (non-professional) handlers/applicators. 
Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. 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 streptomycin to share a common mechanism of 
toxicity with any other substances, and streptomycin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
streptomycin 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 http://www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 on toxicity 
and exposure unless EPA determines, based on reliable data, that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data are 
available to EPA which support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There were no teratogenic 
effects noted in a rabbit developmental study at the high dose of 10 
mg/kg/day. Although children born to mothers treated with streptomycin 
injections have sometimes had hearing loss, no teratogenic effects have 
been attributed to streptomycin treatment. The injected dose at which 
these effects occurred in humans is equivalent to approximately 150 
times higher than the NOAEL from the rabbit study and approximately 
30,000 times higher than the dose that produced the reduced body weight 
endpoint used in establishing the chronic RfD. Additionally, none of 
the available toxicity data for streptomycin indicate any pre- or post-
natal susceptibility. Therefore there are no residual concerns, EPA is 
confident that the chronic RfD is sufficiently protective for 
teratogenic effects, and the Food Quality Protection Act (FQPA) safety 
factor was reduced to 1X.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for streptomycin is complete. An extensive 
database exists from drug use of streptomycin in humans and animals and 
all guideline toxicity data requirements for streptomycin have been 
waived. The toxicity of streptomycin was assessed using toxicity 
reviews provided by the FDA and from the published literature on drug 
use. Because the dose selected for risk assessment from agricultural 
use is based upon a toxicity endpoint (decreased body weight in test 
animals) that occurs at a much lower oral dose than the injected dose 
at which prenatal hearing effects occurred in humans, there are no 
residual concerns and the FQPA safety factor is reduced to 1X.
    ii. The extensive database in animals and humans does not 
demonstrate any potential for streptomycin to cause either peripheral 
or central nervous system toxicity and there is no need for a 
developmental neurotoxicity study or additional UFs to account for 
neurotoxicity.
    iii. There is no direct evidence of sensitivity/susceptibility in 
the developing or young animal. No teratogenic effects were observed in 
the rabbit. As noted previously, children born to mothers treated with 
streptomycin injections have sometimes had hearing loss but no 
teratogenic effects have been attributed to direct streptomycin 
treatment. Chosen points of departure are expected to be protective of 
any possible hearing loss effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed 
assuming 100% CT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to streptomycin in drinking water. EPA used 
similarly conservative assumptions to consider potential for post-
application exposure of children as well as incidental oral exposure of 
toddlers. These assessments will not underestimate the exposure and 
risks posed by streptomycin.

D. 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 PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. 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 MOE exists.
    1. Acute risk. No adverse effect resulting from a single oral 
exposure was identified and no acute dietary endpoint was selected. 
Therefore, streptomycin is not expected to pose an acute risk.
    2. Chronic risk. Based on the explanation in the unit regarding 
residential use patterns, chronic residential exposures to residues of 
streptomycin are not expected.
    Therefore chronic aggregate risk was assessed considering only 
dietary exposures from potential residues in food and drinking water. 
Using the exposure assumptions described in this unit for chronic 
exposure, EPA has concluded that chronic exposure to streptomycin from 
potential residues in food and drinking water will not result in risks 
of concern (i.e., are <100% of the cPAD) for all population groups

[[Page 13763]]

considered. The population group with the greatest dietary exposure is 
Infants <=1 year old, with 90% of the cPAD occupied by chronic dietary 
exposure. Estimates for chronic dietary exposure contributed by 
residues in food occupy <=32% of the cPAD for all population subgroups, 
indicating that the main contribution to dietary exposure is from 
potential residues in drinking water. The most conservative assumptions 
were made in the drinking water analysis, which likely resulted in 
overestimated exposures. Refinements could be made which would likely 
decrease the EDWCs, thereby further reducing the estimates of exposure 
and risk from potential residues in drinking water. However, assessment 
using these unrefined worst-case exposure scenarios provided chronic 
exposure estimates which would not result in risks of concern (i.e., 
were <100% of the cPAD).
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposures take into account short and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). The dermal route of 
exposure was not assessed because no dermal hazard exists for 
streptomycin. Non-dietary incidental ingestion and inhalation from 
post-application residential exposures are assumed to be negligible, 
based upon the chemical properties and the use scenarios for 
streptomycin. Intermediate-term residential exposure is not expected 
from the residential use patterns registered for streptomycin, and 
therefore was not assessed. However, short-term inhalation exposures 
may occur for residential handlers applying streptomycin, and therefore 
this route of exposure was assessed. For all residential handler 
scenarios considered, the estimated inhalation exposures did not 
present risks of concern (i.e., MOEs >= EPA's LOC of 100). The lowest 
calculated MOE was 86,000 from the highest exposure scenario of the 
handler using hand wand/backpack and no PPE. The adult population group 
with the highest dietary exposure was adults 20 to 49 years old, with 
38% of the cPAD occupied. Therefore, aggregate short- and intermediate-
term exposure included dietary (food and water) and inhalation routes 
from residential handler exposure. Using these two highest-exposure 
scenarios, the short-term exposure estimate resulted in an MOE of 270, 
which does not present a risk of concern (MOE >= LOC of 100). Although 
residential exposures to children may occur through incidental oral and 
inhalation routes during residential application and post-application 
activities, they are assumed to be negligible and thus were not 
quantitatively assessed. Therefore, the child aggregate assessment 
included only contributions from chronic exposure to food and drinking 
water, which was previously presented in this document, and did not 
result in risks of concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in the streptomycin database, no cancer 
risk is expected from streptomycin and a cancer risk assessment was not 
needed.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to streptomycin residues.
    6. Pharmaceutical aggregate risk. Section 408 of the FFDCA requires 
EPA to consider potential sources of exposure to a pesticide and 
related substances in addition to the dietary sources expected to 
result from a pesticide use subject to the tolerance. In order to 
determine whether to maintain a pesticide tolerance, EPA must 
``determine that there is a reasonable certainty of no harm.'' Under 
FFDCA section 505, the Food and Drug Administration reviews human drugs 
for safety and effectiveness and may approve a drug notwithstanding the 
possibility that some users may experience adverse side effects. EPA 
does not believe that, for purposes of the section 408 dietary risk 
assessment, it is compelled to assume that combined exposures to 
pesticide and pharmaceutical residues that lead to a physiological 
effect in the user constitutes ``harm'' under the meaning of section 
408 of the FFDCA.
    Rather, EPA believes the appropriate way to consider the 
pharmaceutical use of streptomycin in its risk assessment is to examine 
the impact that the additional nonoccupational pesticide exposures 
would have to a pharmaceutical user exposed to a related (or, in some 
cases, the same) compound. Where the additional pesticide exposure has 
no more than a minimal impact on the pharmaceutical user, EPA could 
make a reasonable certainty of no harm finding for the pesticide 
tolerances of that compound under section 408 of the FFDCA. If the 
potential impact on the pharmaceutical user as a result of co-exposure 
from pesticide use is more than minimal, then EPA would not be able to 
conclude that dietary residues were safe, and would need to discuss 
with FDA appropriate measures to reduce exposure from one or both 
sources.
    Injected drug doses of streptomycin are approximately 15 mg/kg/day. 
Because the oral absorption of streptomycin is <1%, this corresponds to 
an oral equivalent dose of 1,500 mg/kg/day. This oral equivalent dose 
is over 30,000 times the highest dietary exposure estimate of 0.045 mg/
kg/day, the food and water exposure estimate for the highest-exposed 
population (infants <1 year old). Therefore, dietary exposure from 
pesticide uses of streptomycin is negligible compared to drug exposure 
and would not contribute to drug toxicity, so there are no concerns for 
risks from dietary exposure contribution of streptomycin from pesticide 
use, in patients receiving streptomycin drug injections. 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.

V. Other Considerations

    A. Analytical Enforcement Methodology. An adequate enforcement 
methodology is available to enforce the tolerance expression. The 
method uses high performance liquid chromatography with tandem mass 
spectrometry for detection (HPLC-MS/MS). The method is detailed in 
``Confirmation of Aminoglycosides by HPLC/MS/MS; United States 
Department of Agriculture, Food Safety and Inspection Service, Office 
of Public Health Science SOP No: CLG-AMG1.02,'' which may be requested 
from: Chief, Analytical Chemistry Branch, Environmental Science Center, 
701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-
2905; email address: [email protected].
    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 408(b)(4). The Codex 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

[[Page 13764]]

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 any MRLs for streptomycin in/on citrus fruit commodities.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
streptomycin in or on fruit, citrus, group 10-10, at 2 ppm, and the 
dried pulp of these commodities at 6 ppm. These tolerances expire on 
December 31, 2019.

VII. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA sections 408(e) and 
408(l)(6). 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). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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 et 
seq.) do not apply.
    This action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    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 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA submitted a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 9, 2017.
Michael L. Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.245, add alphabetically the entries ``Fruit, citrus, 
Group 10-10'' and ``Fruit, citrus, Group 10-10, dried pulp'' to the 
table in paragraph (b) to read as follows:


Sec.  [emsp14]180.245  Streptomycin; tolerances for residues.

* * * * *
    (b) * * *

----------------------------------------------------------------------------------------------------------------
                                                     Parts per
                    Commodity                         million                     Expiration date
----------------------------------------------------------------------------------------------------------------
Fruit, citrus, Group 10-10......................             2.0   December 31, 2019.
Fruit, citrus, Group 10-10, dried pulp..........             6.0   December 31, 2019.
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2017-04779 Filed 3-14-17; 8:45 am]
 BILLING CODE 6560-50-P