
[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]



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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: 
scheltema.christina@epa.gov.

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

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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.

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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

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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


