[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Rules and Regulations]
[Pages 8707-8710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02511]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2016-0067; FRL-10017-52]
Streptomycin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
streptomycin in or on the fruit, citrus, group 10-10 and fruit, citrus,
group 10-10, dried pulp. Geo Logic Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective February 9, 2021. Objections and
requests for hearings must be received on or before April 12, 2021, 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-2016-0067, 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.
Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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
Publishing 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-2016-0067 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
April 12, 2021. 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-2016-0067, 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.
[[Page 8708]]
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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
5F8427) by Geo Logic Corporation, P.O. Box 3091, Tequesta, FL 33409.
The petition requested that 40 CFR 180.245 be amended by establishing
tolerances for residues of streptomycin in or on citrus fruit, crop
group 10-10 at 0.5 ppm and citrus, dried pulp at 3.5 ppm and by
removing the existing tolerances for grapefruit.
In addition, in the Federal Register of September 5, 2014 (79 FR
53009) (FRL-9914-98), EPA issued a document pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 4E8236) by Interregional Research Project No. 4 (IR-4),
500 College Road East, Suite 201W, Princeton, NJ 08540. The petition
requested the establishment of tolerances for residues of streptomycin
in or on grapefruit at 0.15 ppm, grapefruit, dried pulp at 0.63 ppm,
and fruit, pome, group 11-10 at 0.25, as well as several amendments to
the existing tolerances in 40 CFR 180.245 as follows: (1) Moving the
existing tolerances for streptomycin on celery, pepper, and tomato from
paragraph (a)(2), and potato from paragraph (a)(3) to the table in
paragraph (a)(1); (2) modifying the existing tolerance for tomato from
0.25 ppm to 0.5 ppm; (3) removing the existing time-limited tolerances
for grapefruit and grapefruit, dried pulp in paragraph (b) upon
establishment of the permanent tolerances for grapefruit and
grapefruit, dried pulp; (4) removing the existing tolerance for fruit,
pome, group 11 upon establishment of the tolerance for fruit, pome,
group 11-10; and (5) modifying the tolerance expression and creating a
single paragraph and table under Sec. 180.245(a) to provide that in
general tolerances are established for residues of the fungicide
streptomycin, including its metabolites and degradates, in or on the
commodities in the table to the paragraph. Compliance with the
tolerance levels specified in the table is to be determined by
measuring only streptomycin (O-2-Deoxy-2-(methylamino)-a-
Lglucopyranosyl-(1-2)-O-5-deoxy-3-Cformyl-a-L-lyxofuranosyl-(1-4)-N,N'-
bis(aminoiminomethyl)-D-streptamine) in or on the commodity.
The documents referenced summaries of the petitions prepared by the
petitioners, which are available at http://www.regulations.gov. in the
following dockets: EPA-HQ-OPP-2016-0067 for PP 5F8427 and EPA-HQ-OPP-
2014-0134 for PP 4E8236. No comments were received in response to the
notice of filing for PP 5F8427; eighteen comments were submitted in
response to the notice of filing for PP 4E8236 although none were
relevant to the streptomycin tolerance.
Based upon review of the data supporting the petitions, EPA is
establishing the tolerances at different levels than requested. The
reasons for these changes are explained 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 streptomycin including exposure
resulting from the tolerances modified by this action. EPA's assessment
of exposures and risks associated with streptomycin follows.
In an effort to streamline its publications in the Federal
Register, EPA is not reprinting sections that repeat what has been
previously published for tolerance rulemakings of the same pesticide
chemical. Where scientific information concerning a particular chemical
remains unchanged, the content of those sections would not vary between
tolerance rulemakings and republishing the same sections is
unnecessary; EPA considers referral back to those sections as
sufficient to provide an explanation of the information EPA considered
in making its safety determination for the new rulemaking.
EPA has previously published a tolerance rulemaking for
streptomycin, in which EPA concluded, based on the available
information, that there is a reasonable certainty that no harm would
result from aggregate exposure to streptomycin and established
tolerances for residues of that chemical. EPA is incorporating
previously published sections from those rulemakings as described
further in this rulemaking, as they remain unchanged.
Toxicological Profile. There are no guideline toxicity studies
available to assess pesticidal uses of streptomycin. The toxicity of
streptomycin was assessed using the extensive published literature on
drug use of streptomycin in humans and in animals, as well as with
several toxicity summaries provided by the FDA. Injections of
streptomycin as a drug (up to a gram), at doses much higher than
expected from dietary or residential routes of exposure to pesticidal
uses, can cause inner ear toxicity resulting in vestibular problems
with loss of balance or equilibrium. Injections also sometimes cause
hearing loss and mild, reversible kidney toxicity. Children born to
mothers treated with streptomycin injections have sometimes had hearing
loss. No teratogenic effects were noted in a non-guideline rabbit
developmental study. In a non-guideline 2-year rat feeding study, the
only adverse effect noted was reduced body weight in males; an increase
in treatment-related tumors was not reported. The acute oral toxicity
for streptomycin is very low; the LD50 was 9,000 mg/kg in
both rats and mice.
Toxicological Points of Departure/Levels of Concern. For a summary
of the Toxicological Points of Departure/Levels of Concern used for the
safety assessment, see Unit IV.A. of the March 15, 2017 rulemaking (82
FR 13759) (FRL-9957-65).
Exposure Assessment. EPA's dietary exposure assessments for the
permanent tolerances on the citrus fruit crop group 10-10 and dried
citrus pulp relied on
[[Page 8709]]
tolerance-level residues for all crops and an assumption of 100 percent
crop treated (PCT). EPA's aggregate exposure assessment incorporated
this assumed dietary exposure, as well as exposure in drinking water
and from residential sources, which have not changed since the last
assessment. The assessment also considered aggregate risk as a result
of the pharmaceutical uses of streptomycin. For a description of the
rest of the EPA approach to and assumptions for the exposure
assessment, see Unit IV.B. of the March 15, 2017 rulemaking.
Safety Factor for Infants and Children. EPA continues to conclude
that there is reliable data to support the reduction of the Food
Quality Protection Act (FQPA) safety factor. See Unit IV.C. of the
March 15, 2017 rulemaking for a discussion of the Agency's rationale
for that determination.
Aggregate Risks and Determination of Safety. EPA determines whether
acute and chronic dietary pesticide exposures are safe by comparing
aggregate exposure estimates to the acute population adjusted dose
(aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate margin of exposure (MOE) exists. For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure.
No acute effects were identified in the toxicological studies for
streptomycin; therefore, acute risk is not expected. Chronic dietary
risks are below the Agency's level of concern of 100% of the cPAD: They
are 91% of the cPAD for all infants less than 1 year old, the
population subgroup with the highest exposure estimate. The short-term
MOE is greater than the Agency's level of concern of 100: It is 260 for
adults, the population group of concern. Intermediate-term or long-term
residential exposures are not expected. Lastly, because the pesticide
exposure has no more than a minimal impact on the total dose to a
pharmaceutical user, EPA believes that there is a reasonable certainty
that the potential dietary pesticide exposure will result in no harm to
a user being treated therapeutically with streptomycin.
Therefore, based on the risk assessments and information described
above, EPA concludes there is a reasonable certainty that no harm will
result to the general population, or to infants and children, from
aggregate exposure to streptomycin residues. More detailed information
about the Agency's analysis can be found at http://www.regulations.gov
in the document titled ``Streptomycin. Section 3 Registration for
Citrus Fruits Crop Group 10-10'' in docket ID number EPA-HQ-OPP-2016-
0067.
IV. Other Considerations
A. Analytical Enforcement Methodology
A high-performance liquid chromatography method with tandem mass
spectrometry detection (LC/MS/MS) is available for tolerance
enforcement.
The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
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 has not established any MRLs for streptomycin.
C. Revisions to Petitioned-For Tolerances
The tolerances proposed by the petitioner for the citrus fruit crop
group 10-10 (0.50 ppm) and citrus dried pulp (3.5 ppm) are different
from those which are being established by this document. This is
primarily because the petitioner input the residue data differently
into the calculation procedures for determining the proposed crop group
tolerance (including all data for the representative crops into a
single calculation). As a result, the tolerances are being established
at 0.8 ppm for the fruit, citrus, crop group 10-10 and 3 ppm for fruit,
citrus, group 10-10, dried pulp. In addition, the commodity definitions
were corrected to reflect the crop group.
As a result of the IR-4 petition being withdrawn by the petitioner,
EPA is not granting the request to establish the requested tolerances
or to increase the tomato tolerance from 0.25 to 0.5 ppm. EPA is making
the editorial changes requested by IR-4, however, including
modifications to the tolerance expression and tables contained in
paragraph (a) and removal of expired grapefruit tolerances from
paragraph (b).
V. Conclusion
Therefore, tolerances are established for residues of streptomycin
in or on Fruit, citrus, group 10-10 at 0.8 ppm and Fruit, citrus, group
10-10, dried pulp at 3 ppm. In addition, existing tolerances in 40 CFR
180.245 are amended as follows: (1) Consolidating the subparagraphs and
tables in paragraph (a) into a single paragraph (a); (2) removing the
time-limited tolerances for grapefruit and grapefruit, dried pulp, as
they have expired; and (3) modifying the tolerance expression and
creating a single paragraph and table under Sec. 180.245(a) to provide
that in general tolerances are established for residues of the
fungicide streptomycin, including its metabolites and degradates, in or
on the commodities in the table to the paragraph. Compliance with the
tolerance levels specified in the table is to be determined by
measuring only streptomycin (O-2-Deoxy-2-(methylamino)-a-
Lglucopyranosyl-(1-2)-O-5-deoxy-3-Cformyl-a-L-lyxofuranosyl-(1-4)-N,N'-
bis(aminoiminomethyl)-D-streptamine) in or on the commodity.
VI. Statutory and Executive Order Reviews
This action establishes and modifies 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) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
et seq.), nor does it require any special considerations under
Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition
[[Page 8710]]
under FFDCA section 408(d), 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).
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: January 5, 2021.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. Revise Sec. 180.245 to read as follows:
Sec. 180.245 Streptomycin; tolerances for residues.
(a) General. Tolerances are established for residues of the
fungicide streptomycin, including its metabolites and degradates, in or
on the commodities in Table 1 to this paragraph (a). Compliance with
the tolerance levels specified in Table 1 to this paragraph (a) is to
be determined by measuring only streptomycin (O-2-Deoxy-2-
(methylamino)-a-Lglucopyranosyl-(1-2)-O-5-deoxy-3-Cformyl-a-L-
lyxofuranosyl-(1-4)-N,N'-bis(aminoiminomethyl)-D-streptamine) in or on
the commodity.
Table 1 to Paragraph (a)
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Parts per
Commodity million
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Bean, dry, seed............................................ 0.5
Bean, succulent............................................ 0.5
Celery..................................................... 0.25
Fruit, citrus, group 10-10................................. 0.8
Fruit, citrus, group 10-10, dried pulp..................... 3
Fruit, pome, group 11...................................... 0.25
Pepper..................................................... 0.25
Potato..................................................... 0.25
Tomato..................................................... 0.25
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(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of streptomycin, in or on the agricultural
commodities, as specified in Table 2 to this paragraph (b), resulting
from use of the pesticide pursuant to FIFRA section 18 emergency
exemptions. Compliance with the tolerance levels listed in Table 2 to
this paragraph (b) is to be determined by measuring the levels of
streptomycin only, in or on the commodities listed in this Table 2
paragraph (b). The tolerances expire on the dates specified in Table 2
to this paragraph (b).
Table 2 to Paragraph (b)
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Parts per Expiration
Commodity million date
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Fruit, citrus, group 10-10.................... 2.0 12/31/22
Fruit, citrus, group 10-10, dried pulp........ 6.0 12/31/22
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(c)-(d) [Reserved]
[FR Doc. 2021-02511 Filed 2-8-21; 8:45 am]
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