[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62489-62494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26343]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0820; FRL-9986-87]


Oxytetracycline; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
oxytetracycline in or on fruit, citrus, crop group 10-10. Geo Logic 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 4, 2018. Objections and 
requests for hearings must be received on or before February 4, 2019 
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-2015-0820, 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 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:
     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 EPA's 
tolerance regulations at 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 FFDCA section 408(g), 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-2015-0820 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 
February 4, 2019. 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-2015-0820, 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. Summary of Petitioned-For Tolerance

    In the Federal Register of March 16, 2016 (81 FR 14030) (FRL-9942-
86), EPA issued a document pursuant to

[[Page 62490]]

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of 
a pesticide petition (PP 5F8415) by Geo Logic Corporation, P.O. Box 
3091, Tequesta, FL 33469. The petition requested that 40 CFR 180.337 be 
amended by establishing tolerances for residues of the bactericide 
oxytetracycline, (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, crop group 
10-10 at 0.01 parts per million (ppm).
    That document referenced a summary of the petition prepared by Geo 
Logic Corporation, the registrant, which is available in the docket, 
http://www.regulations.gov. One comment was received on the notice of 
filing. EPA's response to this comment is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and 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 for oxytetracycline including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with oxytetracycline 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    At high doses, the target organ of tetracycline toxicity is the 
liver. The most common effect in intermediate- or long-term oral 
exposures in rats and mice was a decrease in body weight. In the 
prenatal developmental study in rats, clinical signs included increased 
incidences of respiratory signs and rough hair coat in the dams, in 
addition to increased mortality and a decreased percentage of dams 
found pregnant. Also identified was a decrease in fetal body weight. In 
the mouse prenatal developmental study, there was no toxicity 
identified in the dams or fetuses. In all of the above animal studies, 
adverse effects were seen at doses that exceed the limit dose. There is 
no adequate reproductive toxicity study available in the database, 
however, the data requirement was waived based on the lack of 
reproductive effects reported during the history of use as a drug. No 
evidence of neurotoxicity was observed in any guideline study. A rat 
immunotoxicity study demonstrated immunosuppression at doses lower than 
those for systemic toxicity. Tetracyclines are known to inhibit bone 
growth in developing tissue. When oxytetracycline was administered 
orally as a single dose to two female infant rhesus monkeys, zygomatic 
arch bone (lateral surface of temporal bone) growth was inhibited for 
~12.5 days with no recovery observed by 21 days. Effects on bone growth 
are consistent with oxytetracycline's ability to chelate calcium, and 
so are not unexpected. Bone developmental effects were also observed 
after administration of chlortetracycline and demethylchlortetracycline 
in adult rhesus monkeys highlighting the consistency of tetracycline 
treatment across this class of chemicals.
    The Agency has classified oxytetracycline as ``Group D: Not 
Classifiable as to Human Carcinogenicity''. Oxytetracycline has low 
acute toxicity, being Toxicity Category IV for oral toxicity, the only 
acute lethality study available in the database.
    Specific information on the studies received and the nature of the 
adverse effects caused by oxytetracycline as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Oxytetracycline/Oxytetracycline 
Hydrochloride/Oxytetracycline Calcium: Draft Human Health Risk 
Assessment in Support of Registration Review and Tolerance 
Establishment in/on Citrus Fruit Crop Group 10-10'' in docket ID number 
EPA-HQ-OPP-2015-0820.

B. 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 risk in terms of the probability of an occurrence of 
the adverse effect expected in 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

[[Page 62491]]



     Table 1--Summary of Toxicological Doses and Endpoints for Oxytetracycline 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 (All populations)..  None selected.......  N/A................  No appropriate endpoint for
                                                                               females age 13-49 or for the
                                                                               general population attributable
                                                                               to a single exposure.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 100 mg/kg/day  Chronic RfD = 1 mg/  WOE from 3 rats and 2 dogs chronic
                                   UFA = 10x...........   kg/day.              studies.
                                   UFH = 10x...........  cPAD = 0.10 mg/kg/   The NOAEL of 100 mg/kg/day was
                                   FQPA SF = 10x.......   day.                 derived from these studies and no
                                                                               specific LOAEL was established.
                                  ------------------------------------------------------------------------------
Cancer...........................         Classified as a Group D carcinogen--not classifiable as to human
                                                                  carcinogenicity.
----------------------------------------------------------------------------------------------------------------
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. RfD = reference dose. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to oxytetracycline, EPA considered exposure under the 
petitioned-for tolerances as well as all existing oxytetracycline 
tolerances in 40 CFR 180.337. EPA assessed dietary exposures from 
oxytetracycline in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. No such effects were 
identified in the toxicological studies for oxytetracycline; therefore, 
a quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA 2003-2008 food consumption data from the USDA's National 
Health and Nutrition Examination Survey/What We Eat in America. As to 
residue levels in food, EPA used tolerance-level residues, default 
processing factors (PFs), and assumed 100 percent crop treated (PCT).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that oxytetracycline 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 PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for oxytetracycline. Tolerance-level residues and/or 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 oxytetracycline in drinking water. These simulation 
models take into account data on the physical, chemical, and fate/
transport characteristics of oxytetracycline. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model version 5.02/Variable Volume 
Water Body Model (VVWM V1.02) and Pesticide Root Zone Model Ground 
Water (PRZM GW), EDWCs of oxytetracycline for chronic exposures for 
non-cancer assessments are estimated to be 2.85 ppb for surface water 
and 0.323 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 2.85 ppb was used to 
assess the contribution to 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, indoor pest control, 
termiticides, and flea and tick control on pets). Oxytetracycline is 
not registered for any specific use patterns that would result in 
residential exposure.
    Tetracycline hydrochloride (97% chemical similarity to 
oxytetracycline) is approved by FDA for use as an oral antibiotic to 
treat certain bacterial and parasitic infections. EPA examined the 
impact that additional pesticide exposures to oxytetracycline would 
have on a person who has been prescribed the antibiotic. EPA determined 
that the additional pesticide exposure would not have more than a 
minimal impact on the total dose to the pharmaceutical patient, and 
thus concludes that there is a reasonable certainty that the additional 
exposure from pesticide uses of oxytetracycline would result in no harm 
finding to a user being treated therapeutically.
    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 assessed the potential for oxytetracycline to share a 
common mechanism of toxicity with any other substances. Based on its 
assessment of the available toxicological data, EPA has determined that 
oxytetracycline does not share a similar toxicological profile with 
other pesticides, and no further cumulative evaluation is necessary for 
oxytetracycline.

D. 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 safety factor when 
reliable

[[Page 62492]]

data available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Considering the toxicity 
database for oxytetracycline, the mouse prenatal development study did 
not identify adverse effects up to the highest dose tested (HDT), 2,100 
mg/kg/day. In addition, the effects seen in the rat prenatal 
development study occurred only at levels above the limit dose. 
Although guideline toxicity studies do not suggest an increased 
lifestage sensitivity/susceptibility (effects above the limit dose or 
no effects at the highest doses tested), data from the literature 
suggests that developing infants and children may be more susceptible 
to oxytetracycline side-effects than adults. When oxytetracycline was 
administered orally, as a single dose, to two female infant rhesus 
monkeys, zygomatic arch bone (lateral surface of temporal bone) growth 
was inhibited for ~12.5 days with no recovery observed by 21 days. The 
delayed bone growth occurs as a result of chelation of calcium, the 
mineral needed for bone growth. When the monkeys are treated with a 
very high dose of oxytetracycline (80 mg/kg), the calcium can be bound 
up for several days, leading to a delay in bone growth during that 
short time frame. However, once the oxytetracycline levels diminish, 
bone growth continues resulting in normal bones at maturity.
    3. Conclusion. The existing database, together with the extensive 
literature and study reports available on oxytetracycline, including 
studies submitted to and reviewed by the EPA, the National Toxicology 
Program, and World Health Organization, the FDA and open literature 
studies, is adequate for characterizing toxicity and quantification of 
risk from the proposed and existing uses of oxytetracycline. EPA is 
retaining the 10X FQPA SF because of the potential for pre-natal 
toxicity. The Agency concludes that this safety factor will be 
protective of potential toxicity to infants and children based on the 
following findings:
    i. The toxicity database for oxytetracycline is complete.
    ii. There is no indication that oxytetracycline is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that oxytetracycline results in increased 
susceptibility in in utero rats in the prenatal developmental studies. 
Within the toxicity database, the mouse prenatal developmental study 
did not identify adverse effects up to the highest does tested (HDT), 
2,100 mg/kg/day. Based on the adverse effects seen in infant rhesus 
monkeys after oral administration of oxytetracycline, the Food Quality 
Protection Act (FQPA) Safety Factor (SF) is being retained at 10X.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary assessment overestimates actual exposures to 
oxytetracycline as it incorporated tolerance-level residues, default 
PFs, assumed that 100% of the proposed and existing crops are treated 
with oxytetracycline, and included high-end ground and surface drinking 
water modeling estimates. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to oxytetracycline in drinking water. These assessments will 
not underestimate the exposure and risks posed by oxytetracycline.

E. 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. 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 endpoint was selected. Therefore, 
oxytetracycline 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 exposure to 
oxytetracycline from food and water will utilize 33% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential pesticide uses for oxytetracycline.
    3. Short-term risk and Intermediate-term risk. Short-term and 
intermediate-term aggregate exposures take into account short-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level) and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level), respectively. Short and 
intermediate-term adverse effects were identified; however, 
oxytetracycline is not registered for any residential pesticide uses 
that would result in short or intermediate-term residential exposures. 
Short-term risk is assessed based on short-term residential exposure 
plus chronic dietary exposure and intermediate-term risk is assessed 
based on intermediate-term residential exposure plus chronic dietary 
exposure. Because there are no short-term or intermediate-term 
residential exposures 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 short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
oxytetracycline.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in adequate carcinogenicity studies in two 
animals, oxytetracycline is not expected to pose a cancer risk to 
humans and no cancer risk assessment was necessary.
    5. Pharmaceutical aggregate risk for U.S. population. 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 and 
determine that ``there is a reasonable certainty of no harm'' from 
those exposures. Because the Food and Drug Administration (FDA) may 
approve pharmaceutical drugs under FFDCA section 505, notwithstanding 
the possibility that some users may experience adverse side effects. 
EPA examines the impact that the additional pesticide exposures would 
have to a pharmaceutical user exposed to a related (or, in some cases, 
the same) compound in assessing the potential of harm to the 
pharmaceutical user. Where the additional pesticide exposure has no 
more than a minimal impact on the pharmaceutical user, EPA has 
concluded that it can make a reasonable certainty of no harm finding 
for the pesticide tolerances of that compound under section 408 of the 
FFDCA.
    For oxytetracycline, EPA's pesticide exposure assessment has taken 
into consideration the appropriate population, exposure route, and 
exposure duration for comparison with pharmaceutical exposure to 
oxytetracycline. EPA estimates that the pharmaceutical exposure a 
person is expected to receive from a typical therapeutic dose (25 mg/
kg/day for children) is 750 to 2,800 times greater

[[Page 62493]]

than the estimated dietary exposure from the pesticidal sources of 
oxytetracycline (0.0089334 mg/kg/day). Therefore, because the pesticide 
exposure has no more than a minimal impact on the total dose to a 
pharmaceutical user, EPA concludes that there is a reasonable certainty 
that the potential pesticide exposure will result in no harm to a 
person being treated therapeutically with oxytetracycline.
    6. 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 oxytetracycline residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determining 
oxytetracycline residues in/on plant commodities. A high-performance 
liquid chromatography method with tandem mass spectrometry detection 
(LC/MS/MS) has been proposed for tolerance enforcement.
    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: 
[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 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 a MRL for oxytetracycline.

C. Response to Comments

    One comment was received generally opposing the use of any 
pesticides in or on food. The Agency recognizes that some individuals 
oppose the use of pesticides in or on food, but the FFDCA authorizes 
the Agency to establish tolerances for residues of pesticides in or on 
food if the Agency determines that the tolerance is safe. EPA has 
examined all the available data and determined that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue. The commenter has provided no 
information to support a finding that the tolerances would not be safe.

V. Conclusion

    Therefore, tolerances are established for residues of 
oxytetracycline, in or on fruit, citrus, group 10-10 at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001); Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, 
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 
FR 9339, February 3, 2017). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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).

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: November 23, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Program.
    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.  180.337, add alphabetically the entry for ``Fruit, citrus, 
group 10-10'' to the table in paragraph (a) to read as follows:

[[Page 62494]]

Sec.  180.337   Oxytetracycline; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, citrus, group 10-10..............................            0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-26343 Filed 12-3-18; 8:45 am]
 BILLING CODE 6560-50-P