[Federal Register Volume 85, Number 156 (Wednesday, August 12, 2020)]
[Rules and Regulations]
[Pages 48651-48654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16456]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0232; FRL-10009-42]


Nitrapyrin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
nitrapyrin in or on sugar beet molasses, sugar beet roots, sugar beet 
tops, rapeseed seed, and the vegetable, tuberous and corm, crop 
subgroup 1C. Dow AgroSciences LLC requested these tolerances under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 12, 2020. Objections and 
requests for hearings must be received on or before October 13, 2020 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0232, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Please note that due to the public health emergency the EPA Docket 
Center (EPA/DC) and Reading Room was closed to public visitors on March

[[Page 48652]]

31, 2020. Our EPA/DC staff will continue to provide customer service 
via email, phone, and webform. For further information on EPA/DC 
services, docket contact information and the current status of the EPA/
DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0232 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing and must be received by the Hearing Clerk on or before 
October 13, 2020. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2019-0232, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 28, 2019 (84 FR 57685) (FRL-
10001-11), EPA issued a document pursuant to FFDCA section 408(d)(3), 
21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8F8723) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 
46268. The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues nitrapyrin in or on beet, sugar, 
roots at 0.30 parts per million (ppm); beet, sugar, molasses at 0.70 
ppm; beet, sugar, tops at 0.70 ppm; canola, seed at 0.30 ppm; canola, 
meal at 0.80 ppm; potato, processed potato waste at 1.50 ppm; and 
vegetable, tuberous and corm, subgroup at 0.60 ppm. That document 
referenced a summary of the petition prepared by Dow AgroSciences, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA is 
establishing some tolerances at different levels than requested and in 
some cases is establishing tolerances for different commodities than 
requested. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for nitrapyrin including exposure 
resulting from the tolerances established by this action.
    On August 27, 2019 EPA published in the Federal Register a final 
rule establishing tolerances for residues of nitrapyrin in or on 
several fruit and vegetable commodities. See 84 FR 44708 (FRL-9996-85). 
That document contains a summary of the toxicological profile, 
assumptions for dietary exposure assessment, cumulative risk, and the 
safety factor for children, which, except for the cancer classification 
of nitrapyrin, have not changed.
    In the analysis supporting the August 27, 2019 rule, EPA had 
concluded that nitrapyrin was appropriately classified as ``suggestive 
evidence of carcinogenic potential'' (See the document ``Nitrapyrin. 
Human Health Risk Assessment for New Uses in/on Vegetable, Bulb, Crop 
Group 3-07; Vegetable Leafy, Crop Group 4-16; Vegetable, Brassica, Head 
and Stem Crop Group 5-16; Fruit, Citrus, Crop Group 10-10; Fruit, 
Citrus, Group 10-10, Dried Pulp; Fruit, Citrus, Group 10-

[[Page 48653]]

10, Oil; and Leaf Petiole Subgroup 22B'' dated July 16, 2019 in docket 
ID EPA-HQ-OPP-2018-0095). The toxicological endpoints table noted that 
the chronic RfD would be protective of any potential cancer risk. Since 
that time, EPA has reassessed the carcinogenic potential of nitrapyrin 
(May 8, 2018 document titled, ``Nitrapyrin: Sixth Report of the Cancer 
Assessment Review Committee''). Based on information submitted by the 
registrant, nitrapyrin is now classified as ``not likely to be 
carcinogenic to humans at doses that do not result in CAR activation as 
indicated by Cyp2b10 expression.'' Quantification of cancer risk using 
a non-linear RfD approach adequately accounts for all chronic toxicity, 
including carcinogenicity that could result from exposure to 
nitrapyrin; therefore, a separate cancer dietary exposure and risk 
assessment was not conducted.
    A summary of the toxicological endpoints for nitrapyrin used for 
human risk assessment can be found in the document titled ``Nitrapyrin. 
Human Health Risk Assessment for New Uses in/on Canola, Tuberous and 
Corm Vegetables (Crop Subgroup 1C), Sugar Beets, and Sorghum'' dated 
May 1, 2020 in docket number EPA-HQ-OPP-2019-0232.
    Further information about EPA's risk assessment and determination 
of safety supporting the tolerances established in the August 27, 2019 
Federal Register action can be found at http://www.regulations.gov in 
the documents titled, ``Nitrapyrin. Human Health Risk Assessment for 
New Uses in/on Vegetable, Bulb, Crop Group 3-07; Vegetable Leafy, Crop 
Group 4-16; Vegetable, Brassica, Head and Stem Crop Group 5-16; Fruit, 
Citrus, Crop Group 10-10; Fruit, Citrus, Group 10-10, Dried Pulp; 
Fruit, Citrus, Group 10-10, Oil; and Leaf Petiole Subgroup 22B'' dated 
July 16, 2019. The document can be found in docket ID EPA-HQ-OPP-2018-
0095.
    The Agency conducted a revised risk assessment to incorporate 
exposure to residues of nitrapyrin from use on canola, tuberous and 
corm vegetables (crop subgroup 1C), and sugar beets. EPA's aggregate 
exposure assessment incorporated this additional dietary exposure, as 
well as exposure in drinking water, although the latter exposure is not 
impacted by the new uses. Acute dietary risks are below the Agency's 
level of concern: 10% of the aPAD for all infants less than one year 
old, the most highly exposed population subgroup. Chronic dietary risks 
are below the Agency's level of concern: 22% of the cPAD for children 
1-2 years old, the most highly exposed population subgroup. There are 
no residential uses for nitrapyrin, so there is no short- or 
intermediate-term residential exposure to aggregate with the chronic 
dietary exposures. Finally, as indicated previously in this document, 
EPA does not expect any cancer risk below doses that do not result in 
CAR activation as indicated by Cyp2b10 expression. Because the chronic 
RfD is below those levels, precluding doses that would result in CAR 
activation, EPA does not expect any cancer risk from aggregate exposure 
to nitrapyrin.
    Therefore, based on the risk assessments and information described 
above, EPA concludes there is a reasonable certainty that no harm will 
result to the general population, or to infants and children from 
aggregate exposure to nitrapyrin residues.
    More detailed information on the subject action to establish a 
tolerance in or on canola, tuberous and corm vegetables (crop subgroup 
1C), and sugar beets can be found in the document titled, ``Nitrapyrin. 
Human Health Risk Assessment for New Uses in/on Canola, Tuberous and 
Corm Vegetables (Crop Subgroup 1C), Sugar Beets, and Sorghum,'' dated 
May 1, 2020 by going to http://www.regulations.gov. The referenced 
document is available in the docket EPA-HQ-OPP-2019-0232.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron 
capture detection) is available to enforce the tolerance expression. 
Seven analytical methods are available in Volume II of the Pesticide 
Analytical Manual (PAM II--Pesticide Reg. Sec. 180.350) for tolerance 
enforcement for nitrapyrin and/or for metabolite 6-CPA.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    Codex has not established any MRLs for residues of nitrapyrin.

C. Revisions to Petitioned-For Tolerances

    EPA is establishing a tolerance on ``rapeseed, seed'' rather than 
the requested tolerance on ``canola, seed'' to be consistent with the 
terminology the Agency uses for that commodity. Also, although the 
petitioner requested a separate tolerance for canola, meal, EPA has 
determined that the tolerance established for rapeseed, seed will 
adequately cover residues in canola, meal. Based on the highest average 
field trial (HAFT) value from canola seed raw agricultural commodity 
(RAC) field trials, including combined residues of nitrapyrin and 6-CPA 
(0.151 ppm), and utilizing the processing factor (1.5X), the expected 
residues in meal are lower than the tolerance on rapeseed, seed. 
Therefore, the separate tolerance on canola meal is unnecessary.
    Similarly, although the petitioner requested a tolerance on potato, 
processed potato waste at 1.50 ppm, EPA has determined that the 
tolerance established for tuberous and corm vegetables, subgroup 1C 
will adequately cover residues in processed potato waste. Based on HAFT 
(0.309 ppm) value from potato RAC and the median processing factor in 
potato processed commodities (1.0x), the expected residues in processed 
potato waste are lower than the tolerance for subgroup 1C. Therefore, 
the tolerance for potato, potato processed waste is not needed.
    For beet, sugar, molasses, EPA calculated tolerance value based on 
the HAFT value from sugar beet root RAC for combined residues of 
nitrapyrin and 6-CPA (0.123 ppm) and the processing factor (2.9X); the 
result is expected residues lower than the tolerance requested for 
sugar beet roots. Therefore, the tolerance is being established at 0.5 
ppm rather than as requested at 0.70 ppm.
    Lastly, several of the tolerance values have been corrected to be 
consistent with the Agency's rounding class practice.

V. Conclusion

    Therefore, tolerances are established for residues of nitrapyrin in 
or on beet, sugar, molasses at 0.5 ppm; beet, sugar, roots at 0.3 ppm; 
beet, sugar, tops at 0.7 ppm; rapeseed, seed at 0.3 ppm; and vegetable, 
tuberous and corm, crop subgroup 1C at 0.6 ppm.

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VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under Executive Order 13771, entitled ``Reducing 
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 
2017). This action does not contain any information collections subject 
to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.), nor does it require any special considerations under 
Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 2, 2020.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, the EPA amends 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. In Sec.  180.350, amend paragraph (a) by adding to the table, in 
alphabetical order, the commodities, ``Beet, sugar, molasses'', ``Beet, 
sugar, roots'', ``Beet, sugar, tops'', ``Rapeseed, seed'', and 
``Vegetable, tuberous and corm, crop subgroup 1C'' to read as follows:


Sec.  180.350  Nitrapyrin; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Beet, sugar, molasses.......................................         0.5
Beet, sugar, roots..........................................         0.3
Beet, sugar, tops...........................................         0.7
 
                                * * * * *
Rapeseed, seed..............................................         0.3
 
                                * * * * *
Vegetable, tuberous and corm, crop subgroup 1C..............         0.6
 
                                * * * * *
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[FR Doc. 2020-16456 Filed 8-11-20; 8:45 am]
BILLING CODE 6560-50-P


