Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations 29049 

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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit 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: May 6, 2012. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.670 is added to subpart 

C to read as follows: 

§ 180.670 Sulfoxaflor; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide sulfoxaflor, including its 

metabolites and degradate, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only sulfoxaflor (N- 

[methyloxido[1-[6-(trifluoromethyl)-3- 

pyridinyl]ethyl]-g4- 

sulfanylidene]cyanamide). 

Commodity Parts per 

million 

Almond, hulls ............................ 6.0 

Barley, grain ............................. 0.40 

Barley, hay ................................ 1.0 

Barley, straw ............................. 2.0 

Bean, dry seed ......................... 0.20 

Bean, succulent ........................ 4.0 

Beet, sugar, dried pulp ............. 0.07 

Beet, sugar, molasses .............. 0.25 

Berry, low growing, subgroup 

13–07G ................................. 0.70 

Cattle, fat .................................. 0.10 

Cattle, meat .............................. 0.15 

Cattle, meat byproducts ........... 0.40 

Cauliflower ................................ 0.08 

Citrus, dried pulp ...................... 3.6 

Cotton, gin byproducts ............. 6.0 

Cotton, hulls .............................. 0.35 

Cottonseed subgroup 20C ....... 0.20 

Fruit, citrus, group 10–10 ......... 0.70 

Fruit, pome, group 11–10 ......... 0.50 

Fruit, small, vine climbing, subgroup 13–07F, except fuzzy 

kiwi fruit ................................. 2.0 

Fruit, stone, group 12 ............... 3.0 

Goat, fat .................................... 0.10 

Goat, meat ................................ 0.15 

Goat, meat byproducts ............. 0.40 

Grain, aspirated fractions ......... 20.0 

Grape, raisin ............................. 6.0 

Hog, fat ..................................... 0.01 

Hog, meat ................................. 0.01 

Hog, meat byproducts .............. 0.01 

Horse, fat .................................. 0.10 

Horse, meat .............................. 0.15 

Horse, meat byproducts ........... 0.40 

Leafy greens, subgroup 4A ...... 6.0 

Leafy petiole, subgroup 4B ...... 2.0 

Milk ........................................... 0.15 

Nuts, tree, group 14 ................. 0.015 

Onion, bulb, subgroup 3–07A .. 0.01 

Onion, green, subgroup 3–07B 0.70 

Pistachio ................................... 0.015 

Poultry, eggs ............................. 0.01 

Poultry, fat ................................ 0.01 

Poultry, meat ............................ 0.01 

Poultry, meat byproducts .......... 0.01 

Rapeseed, meal ....................... 0.50 

Rapeseed subgroup 20A .......... 0.40 

Sheep, fat ................................. 0.10 

Sheep, meat ............................. 0.15 

Sheep, meat byproducts .......... 0.40 

Soybean, seed .......................... 0.20 

Tomato, paste ........................... 2.60 

Tomato, puree .......................... 1.20 

Vegetable, brassica, leafy, 

group 5, except cauliflower ... 2.0 

Vegetable, cucurbit, group 9 .... 0.40 

Vegetable, fruiting, group 8–10 0.70 

Vegetable, leaves of root and 

tuber, group 2 ....................... 3.0 

Vegetable, legume, group 7 ..... 3.0 

Vegetable, root and tuber, 

group 1 .................................. 0.05 

Watercress ................................ 6.0 

Wheat, forage ........................... 1.0 

Wheat, grain ............................. 0.08 

Wheat, hay ............................... 1.5 

Wheat, straw ............................. 2.0 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent 

registrations. [Reserved] 

[FR Doc. 2013–11824 Filed 5–16–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0852; FRL–9385–3] 

Streptomycin; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

streptomycin in or on grapefruit and 

grapefruit, 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 on grapefruit. This regulation 

establishes maximum permissible levels 

for residues of streptomycin in or on 

these commodities. The time-limited 

tolerances expire on December 31, 2015. 

DATES: This regulation is effective May 

17, 2013. Objections and requests for 

hearings must be received on or before 

July 16, 2013 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–2011–0852, 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), EPA West 

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: 

Andrea Conrath, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9356; email address: 

conrath.andrea@epa.gov. 


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29050 Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations 

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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• 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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&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–2011–0852 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 July 16, 2013. 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– 

2011–0852, 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.htm. 

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, 

5-(2,4-diguanidino-3,5,6-trihydroxycyclohexoxy)-4-[4,5-dihydroxy-6- 

(hydroxymethyl)-3-methylaminotetrahydropyran-2-yl] oxy-3-hydroxy-2- 

methyl-tetrahydrofuran-3-carbaldehyde, 

in or on grapefruit at 0.15 parts per 

million (ppm) and dried grapefruit pulp 

at 0.40 ppm. Streptomycin is an 

antibiotic of the aminoglycoside class 

and is produced by the bacteria 

streptomyces. The active pesticide 

ingredient, streptomycin sulfate, 

dissociates in water to streptomycin, but 

otherwise is relatively stable in crops, 

animals, and humans. Therefore, 

compliance with the tolerance levels is 

determined by measuring the residues 

of streptomycin only and there are no 

toxicologically significant metabolites 

and/or degradates. Streptomycin and 

streptomycin sulfate are considered 

equivalent in this document and both 

are referred to as streptomycin. These 

time-limited tolerances expire on 

December 31, 2015. 

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 

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 Grapefruit and FFDCA 

Tolerances 

The Florida Department of 

Agriculture and Consumer Services 

(FDACS) requested an emergency 

exemption for use of streptomycin on 

up to 54,000 acres of fresh-market 

grapefruit to combat citrus canker, a 

disease caused by the bacteria 

Xanthomonas citri. Citrus canker was 

once limited to localized areas in 

Florida, but several recent severe 

hurricane seasons have spread the 

disease throughout the citrus growing 

areas and widespread treatment to 

control the disease throughout the 

season has become necessary. The 

FDACS requested a maximum of 2 

applications of streptomycin, by ground 

equipment only, at a rate of 0.448 

pounds of active ingredient per acre per 

application, during the hottest part of 

the season when the risk of fruit injury 

from the alternative controls is the 

greatest. After having reviewed the 

submission, EPA determined that an 

emergency condition exists for this 

State, and that the criteria for approval 


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Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations 29051 

of an emergency exemption are met. 

EPA has authorized a specific 

exemption under FIFRA section 18 for 

the use of streptomycin on grapefruit for 

control of citrus canker 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 

grapefruit. In doing so, EPA considered 

the safety standard in FFDCA section 

408(b)(2), and EPA decided that the 

necessary tolerance 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 this tolerance without 

notice and opportunity for public 

comment as provided in FFDCA section 

408(l)(6). Although these time-limited 

tolerances expire on December 31, 2015, 

under FFDCA section 408(l)(5), residues 

of the pesticide not in excess of the 

amounts specified in the tolerances 

remaining in or on grapefruit and 

grapefruit, dried pulp 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 a level that was 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 grapefruit or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

streptomycin by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance by itself 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 

Specific information on the studies 

reviewed and the nature of the adverse 

effects caused by streptomycin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov, under docket ID 

number EPA–HQ–OPP–2011–0852, in 

the document titled ‘‘Streptomycin 

sulfate. Section 18 Petition by the 

Florida Department of Agriculture and 

Consumer Services for use on 

Grapefruit.’’ 

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, the 

aggregate exposures expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

residues of streptomycin in or on 

grapefruit at 0.15 ppm, and grapefruit, 

dried pulp at 0.40 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the timelimited 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 risk posed by human 

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, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates non-threshold risk in terms of 

the probability of an occurrence of the 

adverse effect during a lifetime. For 

more information on the general 

principles EPA uses in risk 

characterization and a complete 

description of the risk assessment 

process, see http://www.epa.gov/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for streptomycin used for 

human risk assessment is shown in the 

Table of this unit. 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR STREPTOMYCIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario Point of departure and 

uncertainty/safety factors 

RfD, PAD, LOC for risk 

assessment Study and toxicological effects 

Acute dietary ..................................

(Any population) .............................

NA ................................................. NA ................................................. Toxicity from single dose exposure not identified. 

Chronic dietary ...............................

(All populations) .............................

NOAEL= 5 mg/kg/day ...................

UFA = 10 .......................................

UFH = 10 .......................................

FQPA SF = 1X .............................

Chronic RfD = 0.05 mg/kg/day .....

cPAD = 0.05 mg/kg/day ...............

Two-year feeding study in rats. 

LOAEL = 10 mg/kg/day based on 

reduced body weight gain. 

Cancer ........................................... NA—EPA Waived its toxicology data requirements 

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 members 

of the human population (intraspecies). 

The human risk assessment for this 

action can be found at http:// 

www.regulations.gov in the document 

‘‘Streptomycin sulfate. Section 18 

Petition by the Florida Department of 

Agriculture and Consumer Services for 

Use on Grapefruit’’ in the docket for ID 

number EPA-HQ–OPP–2011–0852. 


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29052 Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to streptomycin, EPA 

considered exposure under the timelimited 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 such acute 

adverse 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 food 

consumption information from the U.S. 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, EPA used tolerance level 

residues for all registered commodities, 

and the proposed tolerance levels of 

0.15 ppm for grapefruit and grapefruit 

juice. In addition, default processing 

factors were used for all commodities 

except grapefruit juice. One hundred 

percent crop treated (PCT) was assumed 

for all crops. 

iii. Cancer. No concern for 

carcinogenicity is expected for 

streptomycin based on the weight of 

evidence of available information. 

Streptomycin has been used for decades 

as a human drug at doses much higher 

than those expected from pesticidal 

uses, without findings of an association 

with cancer. Based on this information 

combined with the lack of tumors 

reported in the 2-year rat study assessed 

by FDA, and the properties of the 

molecule (e.g., minimal metabolism and 

large molecular size restricting 

interaction of the chemical with typical 

carcinogenic receptors) EPA has waived 

its toxicological data requirements for 

streptomycin. EPA has concluded that 

streptomycin does not pose a cancer risk 

to humans and a quantitative data 

requirements for streptomycin dietary 

exposure assessment for assessing 

cancer risk was not conducted. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for streptomycin. Tolerance level 

residues and 100 PCT 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 http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST), and Screening 

Concentration in Ground Water (SCI– 

GROW) models, for surface and ground 

water, respectively, the estimated 

drinking water concentrations (EDWCs) 

of streptomycin for ground and surface 

water were calculated as 1.2 parts per 

billion (ppb) and 51.4 ppb, respectively. 

The EDWCs are based on aerial 

application to apple orchards, which is 

the highest rate allowed by the label. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

EDWC value of 51.4 ppb for surface 

water was used to assess the dietary 

exposure contribution from drinking 

water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Streptomycin is currently registered 

for the following uses that could result 

in residential exposures: Use in 

residential areas on trees and shrubs to 

control the same diseases (e.g., blight, 

various rots) for which it is used in 

commercial greenhouse and agricultural 

settings. 

EPA assessed residential nondietary 

exposure using the following 

assumptions: Since streptomycin is not 

significantly absorbed through dermal 

route, only inhalation exposures were 

assessed for residential scenarios of 

homeowner application to fruit trees 

and shrubs using a low pressure 

handwand. Although a quantitative 

residential post-application inhalation 

exposure assessment was not 

performed, an occupational inhalation 

exposure assessment for handlers was 

performed which is representative of a 

higher-end, more intensive inhalation 

exposure. Thus, this assessment is also 

protective for evaluating any potential 

residential post-application inhalation 

exposure. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at: http://www.epa.gov/ 

pesticides/trac/science/trac6a05.pdf. 

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 

Food Quality Protection Act (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 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

In a rabbit developmental toxicity study, 

no teratogenic effects were observed at 

the highest dose tested (10 milligrams/ 

kilogram/day (mg/kg/day) orally). 

However, women receiving clinical 

treatment at doses of approximately 15 

mg/kg/day by intramuscular injection of 

streptomycin during pregnancy have 

been known to give birth to children 

with hearing loss or vestibular 

problems; no other teratogenic effects 

have been attributed to streptomycin 

treatment. Because only about 1% of an 

oral dose of streptomycin is absorbed by 

the body, that intramuscular injection 

corresponds to approximately 1,500 mg/ 

kg/day by the oral route. Thus the 

pharmacological dose at which these 

prenatal effects have been observed is 

about 150 times higher than the no 

observed adverse effect level in the 

rabbit developmental toxicity study, and 


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approximately 30,000 times higher than 

the dose that produced the reduced 

weight gain endpoint used in 

establishing the chronic RfD, EPA is 

confident that the RfD will protect 

against teratogenic effects. 

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 1. That decision is 

based on the following findings: 

i. 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 

(based upon anticipated maximum 

exposures) is based upon a toxicity 

endpoint (decreased weight gain in test 

animals) that occurs at a much lower 

oral dose than the injected dose at 

which prenatal effects occur in humans, 

there are no residual concerns and the 

FQPA safety factor was reduced to 1x. 

ii. There is some indication that 

streptomycin may be neurotoxic at the 

very high doses when injected as a drug. 

Injury to the 8th cranial nerve has been 

noted in some patients receiving 

streptomycin injections. However, this 

injury occurs because streptomycin 

accumulates in the inner ear and is not 

indicative of systemic injury to the 

nervous system. Other rare conditions 

reported in patients treated with 

streptomycin injections at clinical doses 

include neuromuscular blockade 

associated with anesthesia, enlarged 

blind spots of the eye, and paresthesia 

or abnormal sensations. Again, these 

responses are rare and occurred with 

large pharmacological doses at 

approximately 30,000 times higher than 

the RfD for streptomycin. A 

developmental neurotoxicity study is 

therefore not recommended, and there is 

no need for additional UFs to account 

for neurotoxicity. 

iii. There was no evidence that in 

utero rabbits have increased 

susceptibility to streptomycin in the 

prenatal developmental study. A 

reproductive toxicity study has been 

waived and is therefore not available. 

Some children of mothers treated during 

pregnancy with streptomycin have been 

born with hearing deficits, which may 

indicate that the developing fetus is 

more sensitive than the mother to 

streptomycin-induced inner ear toxicity. 

However, these effects occurred after 

treatment with a directly injected 

pharmacological dose which is 

comparable to a dose about 150 times 

higher than the no observed adverse 

effect level in the rabbit developmental 

toxicity study, and approximately 

30,000 times the chronic RfD EPA has 

selected for risk management purposes. 

At the much lower dose that EPA is 

using for risk management, there are no 

residual concerns. Therefore there are 

no concerns for prenatal effects. 

iv. There are no residual uncertainties 

identified in the exposure databases; all 

guideline toxicity data requirements 

were waived because of the extensive 

clinical information available for 

streptomycin from decades of use as a 

drug in humans and animals. The 

dietary food exposure assessments were 

performed based on 100 PCT 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 assess postapplication 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 experiencing 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary adverse effect 

endpoint was identified. Therefore, 

streptomycin is not expected to pose an 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic dietary exposure to 

streptomycin from food and water will 

utilize 13% of the cPAD for children 1– 

2 years old, the population group 

receiving the greatest exposure. Based 

on the explanation in the unit regarding 

residential use patterns, chronic 

residential exposure to residues of 

streptomycin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Streptomycin is 

currently registered for uses that could 

result in short-term residential 

exposure. However, no such effects 

were identified in the studies for 

streptomycin. The Agency has 

determined that the chronic risk 

assessment is adequately protective for 

short-term exposures, and it is 

appropriate to aggregate chronic 

exposure through food and water 

(considered background exposure) with 

short-term residential exposures to 

streptomycin. Using the exposure 

assumptions described in this unit for 

short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

from the highest exposure scenario 

result in an aggregate MOE of 2,100. 

Because EPA’s level of concern for 

streptomycin is an MOE of 100 or 

below, this MOE is not of concern. 

Although a quantitative residential postapplication inhalation exposure 

assessment was not performed, the 

occupational inhalation exposure 

assessment performed for handlers is 

representative of a worse case inhalation 

exposure and therefore protective of any 

potential post-application inhalation 

exposure in residential scenarios. The 

lowest MOE from the occupational 

assessments was 560, and assumed no 

use of protective equipment such as a 

respirator. Since this is higher than 

EPA’s level of concern of an MOE of 100 

or below it is not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). Streptomycin is not 

registered for any use patterns that 

would result in intermediate-term 

residential exposure and no 

intermediate-term adverse effects have 

been identified. Because there is no 

intermediate-term residential exposure 

or adverse effects identified, and 

chronic dietary exposure has already 

been assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

intermediate-term risk), no further 

assessment of intermediate-term risk is 

necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

streptomycin. 

5. Aggregate cancer risk for U.S. 

population. A quantitative cancer 


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assessment is unnecessary. Available 

data suggest there are no concerns for 

cancer from exposure to streptomycin, 

and EPA has concluded that 

streptomycin is not expected to pose a 

cancer risk to humans. 

6. Antibiotic resistance risk. EPA 

estimated the potential for development 

of antibiotic resistance in pathogenic 

bacteria, in consideration of factors 

recommended by public health experts 

to sustain the effectiveness of antibiotic 

materials. EPA conducted a qualitative 

analysis of this use as outlined in FDA’s 

Guidance for Industry (GFI) #152. FDA’s 

GFI #152 addresses expansion of 

antibiotic uses outside clinical settings 

with respect to potential impact on 

resistance development. Existing 

resistance to streptomycin has 

diminished its use in clinical settings, 

although it is still used as a second line 

treatment for tuberculosis and used for 

several other bacterial diseases. 

However, based upon the limitations of 

the use under an emergency exemption, 

both in terms of rate and geographic 

area, EPA concluded that the use is 

expected to result in low risks of release 

into the environment, and subsequently 

low exposures. Thus, EPA determined 

that the overall rating for risks of 

resistance development from this 

emergency exemption use under an 

emergency exemption is ‘‘low.’’ The 

analysis, ‘‘Review of Florida Department 

of Agriculture/AgroSource’s Analysis of 

Streptomycin’s Safety with Regard to Its 

Microbiological Effect on Bacteria of 

Human Health Concern (FDA/CVM 

Guidance to Industry #152)’’, as well as 

FDA’s GFI #152, may be found at 

http://www.regulations.gov, under 

docket ID number EPA–HQ–OPP–2011– 

0852. 

7. 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 treat a pharmaceutical 

user the same as a non-user, or 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 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 approximately 375,000 times the 

highest dietary exposure estimate of 

0.004 mg/kg/day (the food and water 

exposure estimate for the highestexposed population (children 1–2 years 

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 contribution of 

streptomycin exposure 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 no 

harm will result from the potential 

dietary pesticide exposure of a user 

being treated therapeutically with 

streptomycin. 

8. Determination of safety. Based on 

these risk assessments, EPA concludes 

that 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. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology, ‘‘Confirmation of 

Aminoglycosides by HPCL–MS/MS’’; 

United States Department of 

Agriculture, Food Safety and Inspection 

Service, Office of Public Health Science, 

SOP No: CLG–AMG1.02, using high 

performance liquid chromatography 

with tandem mass spectrometry for 

detection (HPLC–MS/MS), is available 

to enforce the tolerance expression. 

The method 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: 

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 408(b)(4). 

The Codex Alimentarius 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 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 an 

MRL for streptomycin on grapefruit. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of streptomycin, 

in or on grapefruit at 0.15 ppm and 

grapefruit, dried pulp at 0.40 ppm. 

These tolerances expire on December 

31, 2015. 

VII. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule does not 


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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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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 will 

submit 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: May 9, 2013. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.245 is amended by 

adding paragraph (b) to read as follows: 

§ 180.245 Streptomycin; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for residues of streptomycin, in or on 

the agricultural commodities, as 

specified in the following table, 

resulting from use of the pesticide 

pursuant to FIFRA section 18 

emergency exemptions. Compliance 

with the tolerance levels listed in the 

following table is to be determined by 

measuring the levels of streptomycin 

only, in or on the commodities listed in 

the table. The tolerances expire on the 

dates specified in the table. 

Commodity Parts per 

million 

Expiration 

date 

Grapefruit .......... 0.15 12/31/2015 

Grapefruit, dried 

pulp ............... 0.40 12/31/2015 

* * * * * 

[FR Doc. 2013–11858 Filed 5–16–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of Inspector General 

42 CFR Part 1007 

[OIG–1203–F] 

State Medicaid Fraud Control Units; 

Data Mining 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule amends a 

provision in HHS regulations 

prohibiting State Medicaid Fraud 

Control Units (MFCU) from using 

Federal matching funds to identify fraud 

through screening and analyzing State 

Medicaid data, known as data mining. 

To support and modernize MFCU efforts 

to effectively pursue Medicaid provider 

fraud, we finalize proposals to permit 

Federal financial participation (FFP) in 

costs of defined data mining activities 

under specified circumstances. In 

addition, we finalize requirements that 

MFCUs annually report costs and 

results of approved data mining 

activities to OIG. 

DATES: These regulations are effective 

on June 17, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Richard Stern, Department of Health 

and Human Services, Office of Inspector 

General, (202) 619–0480. 

SUPPLEMENTARY INFORMATION: 

I. Background and Statutory Authority 

In 1977, the Medicare-Medicaid AntiFraud and Abuse Amendments (Pub. L. 

95–142) were enacted to strengthen the 

capability of the Government to detect, 

prosecute, and punish fraudulent 

activities under the Medicare and 

Medicaid programs. Section 17(a) of the 

statute amended section 1903(a) of the 

Social Security Act (the Act) to provide 

for Federal participation in the costs 

attributable to establishing and 

operating a MFCU. The requirements for 

operating a MFCU appear at section 

1903(q) of the Act. Promulgated in 1978, 

regulations implementing the MFCU 

authority appear at 42 CFR part 1007. 

Section 1903(a)(6) of the Act requires 

the Secretary of Health and Human 

Services (the Secretary) to pay FFP to a 

State for MFCU costs ‘‘attributable to the 

establishment and operation of a 

MFCU’’ and ‘‘found necessary by the 

Secretary for the elimination of fraud in 

the provision and administration of 

medical assistance provided under the 

State plan.’’ Under the section, States 

receive 90 percent FFP for an initial 3- 

year period for the costs of establishing 

and operating a MFCU, including the 

costs of training, and 75 percent FFP 

thereafter. Currently, all States with 

MFCUs receive FFP at a 75-percent rate. 

In accordance with section 1903(q) of 

the Act, MFCUs must be separate and 

distinct from the State’s Medicaid 

agency. For a State Medicaid agency, 

general administrative costs of operating 

a State Medicaid program are 

reimbursed at a rate of 50 percent, 

although enhanced FFP rates are 

available for certain activities specified 

by statute, including those associated 

with Medicaid management information 

systems (MMIS). 


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