[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Proposed Rules]
[Pages 1691-1697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00787]
[[Page 1691]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2017-0418; FRL-9970-24]
RIN 2070-ZA16
Fenoxaprop-ethyl, Flufenpyr-ethyl, Imazapyr, Maleic hydrazide,
Pyrazon, Quinclorac, Triflumizole, et al.; Proposed Tolerance and
Tolerance Exemption Actions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to revoke certain tolerances for fenoxaprop-
ethyl, flufenpyr-ethyl, maleic hydrazide, pyrazon, and quinclorac in
follow up to canceled products or where a commodity is no longer a
significant livestock feed item or a tolerance is no longer needed. In
addition, EPA is proposing to establish exemptions from certain
tolerances for maleic hydrazide and to modify certain tolerances for
quinclorac and imazapyr. In accordance with current Agency practice,
EPA also is proposing to update the nomenclature for certain tolerances
for fenoxaprop-ethyl and triflumizole, to remove expired tolerances for
certain pesticide active ingredients, and to conform with rounding
class practices for certain existing tolerances of specific pesticide
active ingredients.
DATES: Comments must be received on or before February 5, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2017-0418, 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 Confidential Business
Information (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.
FOR FURTHER INFORMATION CONTACT: Christina Scheltema, Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (703) 308-2201; 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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
C. What can I do if I wish the Agency to maintain a tolerance that the
Agency proposes to revoke?
This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if
needed. The order would specify data needed and the timeframes for its
submission, and would require that within 90 days some person or
persons notify EPA that they will submit the data. If the data are not
submitted as required in the order, EPA will take appropriate action
under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.
II. Background
A. What action is the Agency taking?
EPA is proposing to revoke or modify specific tolerances, and/or
update the nomenclature for specific tolerances, for the fungicide
triflumizole and the herbicides fenoxaprop-ethyl, flufenpyr-ethyl,
imazapyr, pyrazon, and quinclorac, in or on the commodities specified
in the regulatory text. In addition, EPA is proposing to revoke
tolerances for maleic hydrazide and concomitantly establish tolerance
exemptions to cover the existing food uses for it.
EPA is proposing to revoke certain tolerances because they are no
longer needed, because they are on commodities that EPA no longer
considers to be significant livestock feed items, or because they are
associated with uses that are no longer registered under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) in the United
States (U.S.). EPA is proposing to revoke the tolerance for quinclorac
on grain, aspirated fractions because it is no longer needed, and
proposing to revoke the fenoxaprop-ethyl tolerance on peanut, hulls
because EPA no longer considers the commodity to be a significant
livestock feed item (determination can be found in the June 30, 2008
memorandum titled Revisions of Feedstuffs in Table 1 of OPPTS Test
Guidelines 860.1000 and Guidance on Constructing Maximum Reasonably
Balanced Diets (MRBD), available in docket EPA-HQ-OPPT-2009-0155 at
[[Page 1692]]
https://www.regulations.gov). EPA is proposing to revoke all tolerances
for flufenpyr-ethyl and pyrazon due to cancellation of associated uses
in the United States.
EPA is proposing to remove from 40 CFR part 180, subpart C certain
tolerances for boscalid, cyazofamid, endosulfan, fenoxaprop-ethyl,
fenpyroximate, mandipropamid, methidathion, pendimethalin,
pyraclostrobin, quinclorac, and spiromesifen because those tolerances
have expired. EPA also is proposing to modify tolerance levels to
conform with rounding class practices for certain existing tolerances
of specific pesticide active ingredients.
Detailed explanations for the proposed modifications of tolerances
for imazapyr can be found in the May 24, 2017 memorandum titled
Imazapyr, Isopropylamine Salt: Amendment of Tolerances for Residues on
Livestock Tissues, available in the docket of this proposed rule.
Detailed explanations for the proposed modifications of tolerances for
quinclorac can be found in the November 6, 2012 Human Health Risk
Assessment for Registration Review and the March 10, 2015 Interim
Registration Review Decision, available in docket EPA-HQ-OPP-2007-1135
at https://www.regulations.gov. Detailed explanations for the proposed
tolerance exemptions for maleic hydrazide can be found in the May 14,
2014 Registration Review Summary of Analytical Chemistry and Residue
Data, the June 18, 2014 Human Health Risk Assessment for Registration
Review, and the September 11, 2015 Interim Registration Review
Decision, available in docket EPA-HQ-OPP-2009-0387 at https://www.regulations.gov.
1. Boscalid. Because the sole tolerance in 40 CFR 180.589(b) for
endive, Belgian expired on December 31, 2013, EPA proposes to remove
the existing paragraph and table, and reserve the section.
2. Cyazofamid. Because the sole tolerance in 40 CFR 180.601(b) for
basil, dried expired on December 31, 2014, EPA proposes to remove the
existing paragraph and table, and reserve the section.
3. Endosulfan. Because the tolerances in 40 CFR 180.182 for
endosulfan residues of concern all expired on various dates from July
31, 2012 through July 31, 2016, EPA proposes to remove that section in
its entirety.
4. Fenoxaprop-ethyl. Because EPA no longer considers peanut hulls
to be a significant livestock feed item, the tolerance on peanut, hulls
is no longer needed, and therefore should be revoked. Consequently, EPA
proposes to revoke the tolerance in 40 CFR 180.430(a) for peanut,
hulls.
Also, because all the tolerances (grass, forage and grass, hay) in
40 CFR 180.430(b) expired on December 31, 2016, EPA proposes to remove
the paragraph and table, and reserve the section.
In order to conform to current Agency practice, EPA proposes in 40
CFR 180.430(a) to revise the commodity terminology for ``soybean'' to
``soybean, seed.''
Also, in accordance with current Agency rounding class practices
for tolerance values, EPA proposes to list the existing tolerance in 40
CFR 180.430(a) for barley, straw at 0.10 ppm.
5. Fenpyroximate. Because the sole tolerance in 40 CFR 180.566(b)
for honey expired on December 31, 2013, EPA proposes to remove the
existing paragraph and table, and reserve the section.
6. Flufenpyr-ethyl. In the Federal Register of July 8, 2015 (80 FR
39100) (FRL-9928-54), EPA announced its receipt of voluntary requests
by registrants to cancel certain pesticide registrations, including
requests to cancel the last flufenpyr-ethyl products registered for use
on food in the U.S. At the time of their voluntary request to cancel,
the flufenpyr-ethyl registrant stated that these products were never
manufactured and there were no existing stocks in the channels of
trade, and therefore no existing stocks provision was requested. In the
Federal Register of September 22, 2015 (80 FR 57179) (FRL-9933-58), EPA
published a cancellation order in follow-up to the July 8, 2015 notice
and granted the requested product cancellations for flufenpyr-ethyl. No
existing stocks provision was requested or needed. Therefore, EPA
proposes to revoke the tolerances in 40 CFR 180.595(a)(1) on corn,
field, grain; soybean, seed; and sugarcane, cane and to revoke the
tolerances in 40 CFR 180.595(a)(2) on corn, field, forage and corn,
field, stover.
7. Imazapyr. Based on the lack of human health endpoints for
imazapyr, EPA determined there are no hazards and no risks of concern
from exposure to residues of imazapyr, and therefore the current U.S.
tolerances in livestock kidneys can be increased to harmonize with the
current Canadian MRLs in livestock kidneys at 0.3 ppm (the
determination is available in the docket of this proposed rule).
Consequently, EPA proposes to increase the tolerances in 40 CFR
180.500(a) in or on cattle, kidney; goat, kidney; horse, kidney; and
sheep, kidney from 0.20 to 0.30 ppm.
Also, in accordance with current Agency rounding class practices
for tolerance values, EPA proposes to list the existing tolerance in 40
CFR 180.500(a) for lentil at 0.20 ppm.
8. Maleic hydrazide. Based on the low toxicity and lack of human
health endpoints for maleic hydrazide, EPA determined that there are no
risks of concern from exposure to residues of maleic hydrazide. As a
result, EPA concluded that the current tolerances for residues of
maleic hydrazide in 40 CFR 180.175 are no longer needed and should be
revoked, and exemptions from the requirement of a tolerance should be
concomitantly established. Therefore, EPA proposes to revoke the
tolerances in Sec. 180.175(a)(1) in or on onion, bulb and potato; to
revoke the tolerances in Sec. 180.175(a)(2) in or on potato, chips; to
remove Sec. 180.175 in its entirety; and to establish exemptions from
tolerances in 40 CFR part 180, subpart D, for onion, bulb and potato in
newly designated 40 CFR 180.1349(a) and for potato, chips in newly
designated 40 CFR 180.1349(b).
9. Mandipropamid. Because the sole tolerance in 40 CFR 180.637(b)
for basil, dried expired on December 31, 2015, EPA proposes to remove
the existing paragraph and table, and reserve the section.
10. Methidathion. Because the tolerances in 40 CFR 180.298 all
expired on December 31, 2016, EPA proposes to remove that section in
its entirety.
11. Pendimethalin. Because all the tolerances (Bermuda grass,
forage and Bermuda grass, hay) in 40 CFR 180.361(b) expired on December
31, 2010, EPA proposes to remove the existing paragraph and table, and
reserve the section.
12. Pyraclostrobin. Because the sole tolerance in 40 CFR 180.582(b)
for endive, Belgium expired on December 31, 2013, EPA proposes to
remove the existing paragraph and table, and reserve the section.
13. Pyrazon. In the Federal Register of March 12, 2015 (80 FR
12996) (FRL-9923-27), EPA announced its receipt of voluntary requests
by registrants to cancel certain pesticide registrations, including the
last pyrazon products registered for use on food commodities in the
U.S. In the Federal Register of June 3, 2015 (80 FR 31596) (FRL-9926-
88), EPA published a cancellation order in follow-up to the March 12,
2015 notice and granted the requested product cancellations for
pyrazon. EPA permitted the registrant to sell and distribute existing
stocks of the cancelled pyrazon products until June 2, 2016, and
persons other than the registrant to sell, distribute, or use existing
stocks of the cancelled pyrazon products until supplies are exhausted.
[[Page 1693]]
EPA believes that existing stocks in the U.S. are exhausted. However,
in a letter dated February 10, 2015, the pyrazon registrant (BASF)
notified EPA of a need for the pyrazon tolerances for import purposes
through December 31, 2017. Consequently, EPA proposes to revoke the
tolerances in 40 CFR 180.316(a) on beet, garden, roots; beet, garden,
tops; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops;
cattle, fat; cattle, liver; cattle, meat; cattle, meat byproducts,
except liver; goat, fat; goat, liver; goat, meat; goat, meat
byproducts, except liver; horse, fat; horse, liver; horse, meat; horse,
meat byproducts, except liver; milk; sheep, fat; sheep, liver; sheep,
meat; and sheep, meat byproducts, except liver; and in 40 CFR
180.316(d) on corn, field, forage; corn, field, stover; soybean,
forage; soybean, hay; wheat, forage; wheat, hay; and wheat, straw each
with an expiration/revocation date of [DATE 6 MONTHS AFTER DATE OF
PUBLICATION OF THE FINAL RULE] and to add a footnote that there are no
U.S. registrations for them.
Also, in accordance with current Agency rounding class practices
for tolerance values, EPA proposes to list existing tolerances in 40
CFR 180.316(a) for beet, garden, roots at 0.90 ppm and beet, sugar,
roots at 0.20 ppm and to list existing tolerances in 40 CFR 180.316(d)
for corn, field, forage; corn, field, stover; soybean, forage; and
soybean, hay at 0.50 ppm; for wheat, forage at 0.30 ppm; for wheat, hay
at 0.20 ppm; and for wheat, straw at 0.10 ppm.
14. Quinclorac. A tolerance on grain, aspirated fractions exists in
40 CFR 180.463 for residues of quinclorac at 1,200 ppm, a level which
EPA originally determined by calculation in the absence of residue
data. Since that time, residue data on aspirated grain fractions showed
that residues on aspirated grain fractions were no higher than the
individual tolerances set on barley, grain (2.0 ppm), rice, grain (5.0
ppm), and wheat, grain (0.5 ppm). Therefore, a separate tolerance on
grain, aspirated fractions is no longer needed. Consequently, EPA
proposes to revoke the tolerance in 40 CFR 180.463(a)(1) on grain,
aspirated fractions.
Based on the recalculated dietary burdens for livestock, which
demonstrate Maximum Dietary Burdens (MDBs) for poultry at 5.4 ppm and
swine at 6.0 ppm, EPA determined that the existing tolerances in
poultry and hog commodities should be reassessed. Based on quinclorac
data from the available cattle and poultry feeding studies, which
demonstrate that the maximum residues in the commodities are expected
to be <0.05 ppm, EPA determined that the tolerances in poultry, meat
byproducts; hog, fat; and hog, meat byproducts should be set at 0.05
ppm. This will also harmonize the tolerances with the existing Canadian
MRLs at 0.05 ppm. Consequently, EPA proposes to decrease the tolerances
in 40 CFR 180.463(a)(1) for poultry, meat byproducts from 0.1 to 0.05
ppm; hog, fat from 0.7 to 0.05 ppm; and hog, meat byproducts from 1.5
to 0.05 ppm.
Also, in accordance with current Agency rounding class practices
for tolerance values, EPA proposes to list the existing tolerances in
40 CFR 180.463(a)(1) for cattle, fat; goat, fat; horse, fat; and sheep,
fat at 0.70 ppm; for rhubarb; wheat, grain; and wheat, hay at 0.50 ppm;
and for wheat, straw at 0.10 ppm.
In the Federal Register of September 28, 2007 (72 FR 55068) (FRL-
8149-5), a tolerance was established in 40 CFR 180.463 for residues of
quinclorac in or on imported barley, grain. There are no U.S.
registrations for the use of quinclorac on barley. Therefore, EPA will
add a footnote to the tolerance in 40 CFR 180.463(a)(1) on barley,
grain explaining that there are no U.S. registrations as of September
28, 2007.
Because the sole tolerance in 40 CFR 180.463(b) on cranberry
expired on December 31, 2012, EPA proposes to remove the existing
paragraph and table, and reserve the section.
15. Spiromesifen. Because all the tolerances in 40 CFR 180.607(b)
expired on December 31, 2014, EPA proposes to remove the existing
paragraph and table, and reserve the section.
16. Triflumizole. In order to conform to current Agency practice,
EPA proposes in 40 CFR 180.476(a)(l) to revise the commodity
terminology for ``Cilantro, leaves'' to ``Cilantro, fresh leaves.''
B. What is the Agency's authority for taking this action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
authorizes the establishment of tolerances, exemptions from tolerance
requirements, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods. Without a tolerance or exemption, food
containing pesticide residues is considered to be unsafe and therefore
``adulterated'' under FFDCA section 402(a), 21 U.S.C. 342(a). Such food
may not be distributed in interstate commerce, 21 U.S.C. 331(a). For a
food-use pesticide to be sold and distributed, the pesticide must not
only have appropriate tolerances under the FFDCA, but also must be
registered under FIFRA, 7 U.S.C. 136 et seq. Food-use pesticides not
registered in the U.S. must have tolerances in order for commodities
treated with those pesticides to be imported into the United States.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the U.S. of food
containing such pesticide residues. However, when there are no imported
commodities that require these import tolerances, the Agency believes
it is appropriate to revoke tolerances for unregistered pesticides in
order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under FFDCA section 408, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
[[Page 1694]]
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
C. When do these actions become effective?
EPA is proposing that the actions herein become effective 6 months
after the date of publication of the final rule in the Federal
Register. EPA is proposing this effective date for these actions to
allow a reasonable interval for producers in exporting members of the
World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS)
Measures Agreement to adapt to the requirements of a final rule. With
the exception of the proposed revocation of tolerances with expiration
dates for pyrazon, the Agency believes that existing stocks of
pesticide products labeled for the uses associated with the tolerances
proposed for revocation have been completely exhausted and that treated
commodities have cleared the channels of trade. Where EPA is proposing
revocation with expiration dates for pyrazon, the Agency believes that
existing stocks in the U.S. are exhausted and that the proposed date
allow sufficient time for passage of treated commodities through the
channels of trade for import purposes as requested by the manufacturer.
If you have comments regarding existing stocks and whether the
effective date allows sufficient time for treated commodities to clear
the channels of trade, please submit comments as described under
SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this unit, any residues of these pesticides
in or on such food shall not render the food adulterated so long as it
is shown to the satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner, that was lawful under FIFRA,
and
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.
III. 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 U.S. 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 MRLs for pyrazon, fenoxaprop-ethyl,
or flufenpyr-ethyl.
The Codex has not established MRLs for quinclorac in or on grain,
aspirated fractions; hog, fat; hog, meat byproducts; and poultry, meat
products.
The Codex has established MRLs for maleic hydrazide in or on
various commodities including onion, bulb at 15 milligrams per kilogram
(mg/kg) and potato at 50 mg/kg. These MRLs are the same as the current
tolerances for maleic hydrazide in the United States. However, because
the tolerances are not needed, EPA is proposing to revoke the U.S.
tolerances for maleic hydrazide and to establish exemptions from
tolerances in or on onion, bulb; potato; and potato, chips.
The Codex has established MRLs for imazapyr in or on various
commodities including edible offal (mammalian) at 0.2 mg/kg, which is
the same as the current U.S. tolerances, and will be covered by the
proposed U.S. tolerances for imazapyr in or on cattle, kidney; goat,
kidney; horse, kidney; and sheep, kidney at 0.3 ppm, a higher level
than the MRL.
IV. Statutory and Executive Order Reviews
In this proposed rule, EPA is proposing to establish tolerance
exemptions under FFDCA 408(e), and also to modify and revoke specific
tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted these types of actions (e.g.,
establishment of a tolerance/tolerance exemption, modification of a
tolerance, and tolerance revocation for which extraordinary
circumstances do not exist) from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this proposed rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this proposed
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). This proposed rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), or
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.). Nor does it require any special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any other
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This proposed rule 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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether exemptions from
tolerances, raising of tolerance levels, or revocations might
significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
These analyses for tolerance establishments and modifications, and for
tolerance revocations, were published in the Federal Register of May 4,
1981 (46 FR 24950) and December 17, 1997 (62 FR 66020) (FRL-
[[Page 1695]]
5753-1), respectively, and were provided to the Chief Counsel for
Advocacy of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this proposed rule, the Agency hereby certifies that this proposed rule
will not have a significant negative economic impact on a substantial
number of small entities. In a memorandum dated May 25, 2001, EPA
determined that eight conditions must all be satisfied in order for an
import tolerance or tolerance exemption revocation to adversely affect
a significant number of small entity importers, and that there is a
negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. (This Agency
document is available in the docket of this proposed rule).
Furthermore, for the pesticides named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposed rule that would change EPA's previous analysis. Any comments
about the Agency's determination should be submitted to the EPA along
with comments on the proposed rule, and will be addressed prior to
issuing a final rule. In addition, the Agency has determined that this
proposed rule will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This proposed rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This proposed rule does not alter the relationships or
distribution of power and responsibilities established by Congress in
the preemption provisions of FFDCA section 408(n)(4). For these same
reasons, the Agency has determined that this proposed rule does not
have any ``tribal implications'' as described in Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: December 6, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be 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.
Sec. Sec. 180.175, 180.182, and 180.298 [Removed]
0
2. Remove Sec. Sec. 180.175, 180.182, and 180.298.
0
3. In Sec. 180.316, revise the tables in paragraphs (a) and (d) to
read as follows:
Sec. 180.316 Pyrazon; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Beet, garden, roots \1\.................................... 0.90
Beet, garden, tops \1\..................................... 7.0
Beet, sugar, molasses \1\.................................. 1.5
Beet, sugar, roots \1\..................................... 0.20
Beet, sugar, tops \1\...................................... 3.0
Cattle, fat \1\............................................ 0.10
Cattle, liver \1\.......................................... 0.15
Cattle, meat \1\........................................... 0.10
Cattle, meat byproducts, except liver \1\.................. 0.10
Goat, fat \1\.............................................. 0.10
Goat, liver \1\............................................ 0.15
Goat, meat \1\............................................. 0.10
Goat, meat byproducts, except liver \1\.................... 0.10
Horse, fat \1\............................................. 0.10
Horse, liver \1\........................................... 0.15
Horse, meat \1\............................................ 0.10
Horse, meat byproducts, except liver \1\................... 0.10
Milk \1\................................................... 0.02
Sheep, fat \1\............................................. 0.10
Sheep, liver \1\........................................... 0.15
Sheep, meat \1\............................................ 0.10
Sheep, meat byproducts, except liver \1\................... 0.10
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities; therefore,
these tolerances will expire [DATE 6 MONTHS AFTER DATE OF PUBLICATION
OF THE FINAL RULE].
* * * * *
(d) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Corn, field, forage \1\.................................... 0.50
Corn, field, stover \1\.................................... 0.50
Soybean, forage \1\........................................ 0.50
Soybean, hay \1\........................................... 0.50
Wheat, forage \1\.......................................... 0.30
Wheat, hay \1\............................................. 0.20
Wheat, straw \1\........................................... 0.10
------------------------------------------------------------------------
\1\ There are no U.S. registrations on these commodities.
0
4. In Sec. 180.361, revise paragraph (b) to read as follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
5. In Sec. 180.430, revise the table in paragraph (a) and paragraph
(b) to read as follows:
Sec. 180.430 Fenoxaprop-ethyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain.............................................. 0.05
Barley, straw.............................................. 0.10
Cattle, fat................................................ 0.05
Cattle, meat............................................... 0.05
Cattle, meat byproducts.................................... 0.05
Cotton, undelinted seed.................................... 0.05
Goat, fat.................................................. 0.05
Goat, meat................................................. 0.05
Goat, meat byproducts...................................... 0.05
Hog, fat................................................... 0.05
Hog, meat.................................................. 0.05
Hog, meat byproducts....................................... 0.05
Horse, fat................................................. 0.05
[[Page 1696]]
Horse, meat................................................ 0.05
Horse, meat byproducts..................................... 0.05
Milk....................................................... 0.02
Peanut..................................................... 0.05
Rice, grain................................................ 0.05
Sheep, fat................................................. 0.05
Sheep, meat................................................ 0.05
Sheep, meat byproducts..................................... 0.05
Soybean, seed.............................................. 0.05
Wheat, grain............................................... 0.05
Wheat, straw............................................... 0.50
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
6. In Sec. 180.463, revise the table in paragraph (a)(1) and
paragraph (b) to read as follows:
Sec. 180.463 Quinclorac; tolerances for residues.
(a)(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain \1\.......................................... 2.0
Berry, low growing, except strawberry, subgroup 13-07H..... 1.5
Cattle, fat................................................ 0.70
Cattle, meat............................................... 0.05
Cattle, meat byproducts.................................... 1.5
Egg........................................................ 0.05
Goat, fat.................................................. 0.70
Goat, meat................................................. 0.05
Goat, meat byproducts...................................... 1.5
Grass, forage.............................................. 150
Grass, hay................................................. 130
Hog, fat................................................... 0.05
Hog, meat.................................................. 0.05
Hog, meat byproducts....................................... 0.05
Horse, fat................................................. 0.70
Horse, meat................................................ 0.05
Horse, meat byproducts..................................... 1.5
Milk....................................................... 0.05
Poultry, fat............................................... 0.05
Poultry, meat.............................................. 0.05
Poultry, meat byproducts................................... 0.05
Rhubarb.................................................... 0.50
Rice, bran................................................. 15.0
Rice, grain................................................ 5.0
Sheep, fat................................................. 0.70
Sheep, meat................................................ 0.05
Sheep, meat byproducts..................................... 1.5
Sorghum, grain, forage..................................... 3.0
Sorghum, grain, grain...................................... 6.0
Sorghum, grain, stover..................................... 1.0
Wheat, forage.............................................. 1.0
Wheat, germ................................................ 0.75
Wheat, grain............................................... 0.50
Wheat, hay................................................. 0.50
Wheat, straw............................................... 0.10
------------------------------------------------------------------------
\1\ There are no U.S. registrations for this commodity as of September
28, 2007.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
7. In Sec. 180.476, in the table in paragraph (a)(1), remove the entry
for ``Cilantro, leaves'' and add an entry for ``Cilantro, fresh
leaves'' in its place to read as follows:
Sec. 180.476 Triflumizole; tolerances for residues.
(a)(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Cilantro, fresh leaves.................................... 35
* * * * *
------------------------------------------------------------------------
* * * * *
0
8. In Sec. 180.500, revise the table in paragraph (a) to read as
follows:
Sec. 180.500 Imazapyr; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.05
Cattle, kidney............................................. 0.30
Cattle, meat............................................... 0.05
Cattle, meat byproducts, except kidney..................... 0.05
Corn, field, forage........................................ 0.05
Corn, field, grain......................................... 0.05
Corn, field, stover........................................ 0.05
Fish....................................................... 1.0
Goat, fat.................................................. 0.05
Goat, kidney............................................... 0.30
Goat, meat................................................. 0.05
Goats, meat byproducts, except kidney...................... 0.05
Grass, forage.............................................. 100
Grass, hay................................................. 30
Horse, fat................................................. 0.05
Horse, kidney.............................................. 0.30
Horse, meat................................................ 0.05
Horse, meat byproducts, except kidney...................... 0.05
Lentil \1\................................................. 0.20
Milk....................................................... 0.01
Rapeseed subgroup 20A \1\.................................. 0.05
Sheep, fat................................................. 0.05
Sheep, kidney.............................................. 0.30
Sheep, meat................................................ 0.05
Sheep, meat byproducts, except kidney...................... 0.05
Shellfish.................................................. 0.10
Soybean, meal \1\.......................................... 4.5
Soybean, seed \1\.......................................... 4.0
Sunflower subgroup 20B \1\................................. 0.05
------------------------------------------------------------------------
\1\ There are no U.S. registrations on these commodities.
* * * * *
0
9. In Sec. 180.566, revise paragraph (b) to read as follows:
Sec. 180.566 Fenpyroximate; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
10. In Sec. 180.582, revise paragraph (b) to read as follows:
Sec. 180.582 Pyraclostrobin; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
11. In Sec. 180.589, revise paragraph (b) to read as follows:
Sec. 180.589 Boscalid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
Sec. 180.595 [Removed]
0
12. Remove Sec. 180.595.
0
13. In Sec. 180.601, revise paragraph (b) to read as follows:
Sec. 180.601 Cyazofamid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
14. In Sec. 180.607, revise paragraph (b) to read as follows:
Sec. 180.607 Spiromesifen; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
15. In Sec. 180.637, revise paragraph (b) to read as follows:
Sec. 180.637 Mandipropamid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
0
16. Add Sec. 180.1349 to subpart D to read as follows:
Sec. 180.1349 Maleic hydrazide; exemption from the requirement of a
tolerance.
(a) An exemption from the requirement of a tolerance is established
for residues of the pesticide maleic hydrazide, including its
metabolites and degradates, when used as a plant growth regulator or
herbicide in or on onion, bulb and potato.
[[Page 1697]]
(b) An exemption from the requirement of a tolerance is established
for residues of the pesticide maleic hydrazide, including its
metabolites and degradates, when present in or on potato, chips as a
result of application of maleic hydrazide to the growing potato plant.
[FR Doc. 2019-00787 Filed 2-4-19; 8:45 am]
BILLING CODE 6560-50-P