Fluridone; Pesticide Tolerances, 72537-72539 [2016-25291]

Download as PDF 72537 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Rules and Regulations Authority: 42 U.S.C. 7401 et seq. PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Review’’ by revising the entry for ‘‘Section 2.0’’ to read as follows: Subpart I—Delaware 2. In § 52.420, the table in paragraph (c) is amended under the heading ‘‘1125 Requirements for Preconstruction ■ 1. The authority citation for part 52 continues to read as follows: ■ § 52.420 * Identification of plan. * * (c) * * * * * EPA-APPROVED REGULATIONS AND STATUTES IN THE DELAWARE SIP State regulation (7 DNREC 1100) * * * 1125 * * Section 2.0 ............................... * * ■ * [FR Doc. 2016–24657 Filed 10–19–16; 8:45 am] asabaliauskas on DSK3SPTVN1PROD with RULES BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2016–0325; FRL–9951–81] Environmental Protection Agency (EPA). 15:55 Oct 19, 2016 Jkt 241001 9/11/2013 10/20/2016 [Insert Federal Register citation]. * Final rule. This regulation establishes a tolerance for residues of fluridone in or on cotton gin byproducts. SePRO Corporation requested the tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective October 20, 2016. Objections and requests for hearings must be received on or before December 19, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2016–0325, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, PO 00000 * * * * * 10/2/12, 77 FR 60053 ............ Added Section 2.2.5, 2.4.3.3 and 2.5.7. SUMMARY: (a) Disapproval. EPA is disapproving Delaware’s October 15, 2013 submittal of revisions to 7 DNREC 1125, sections 2.5.5 and 2.5.6 because it does not meet Clean Air Act (CAA) requirements which establish the criteria under which the owner or operator of a new or modified major stationary source must obtain the required emission offsets for the nonattainment new source review (NSR) preconstruction permitting program and because Delaware exercises authorities that are reserved for EPA under section 107 of the CAA. Delaware’s Federally-approved nonattainment NSR preconstruction program in 7 DNREC 1125, sections 1.0 through 3.16.4, effective in Delaware on February 11, 2012, was fully-approved by EPA on October 2, 2012 and continues to apply. (b) [Reserved] VerDate Sep<11>2014 * 2/11/12 * ACTION: Nonattainment new source AGENCY: * Additional explanation Requirements for Preconstruction Review * Fluridone; Pesticide Tolerances EPA approval date * * Emission Offset Provisions (EOP) including sections 1.0 through 3.16.4. Sections 2.5.5 and 2.5.6 ........ * * * * 3. Add § 52.433 to read as follows: § 52.433 review. State effective date Title/subject Frm 00057 Fmt 4700 Sfmt 4700 Disapproval. See 40 CFR 52.433(a). * * 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/textidx?&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 E:\FR\FM\20OCR1.SGM 20OCR1 72538 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2016–0325 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 December 19, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2016–0325, 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 July 20, 2016 (81 FR 47150) (FRL–9948–45), 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# 6F8451) by SePRO Corporation, 11550 North Meridian Street, Suite 600, Carmel, IN 46032. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the herbicide fluridone in or on cotton, gin byproducts at 0.1 ppm. That document referenced a summary of the petition prepared SePRO, the registrant, which is available in the docket EPA– VerDate Sep<11>2014 15:55 Oct 19, 2016 Jkt 241001 HQ–OPP–2016–0325 at http:// www.regulations.gov. No comments were received in response to the notice of filing. 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), 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 fluridone in or on cotton gin byproducts, consistent with FFDCA section 408(b)(2). In the Federal Register of February 17, 2016 (81 FR 7982) (FRL–9941–69), EPA established a tolerance for residues of fluridone in or on cotton, undelinted seed. EPA is relying upon the risk assessments that supported the findings made in the February 17, 2016 Federal Register document in support of this action. The toxicity profile of fluridone has not changed, and the previous risk assessments that supported the establishment of that tolerance remain valid. For the February 17, 2016 action, the petitioner did not propose a tolerance for residues of fluridone on cotton gin byproducts, however, the Agency determined that a cotton gin byproduct tolerance was needed to cover the cotton raw agricultural commodities (RAC). The commodity ‘‘cotton gin byproducts’’ was included in the risk assessments that supported the February 17, 2016 Final Rule, but because they were not proposed by the registrant, they could not be established at that time. The registrant has subsequently PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 proposed the cotton gin byproducts tolerance and therefore, the tolerance can now be established. EPA concludes that the aggregate exposure and risk estimates presented in the most recent human health risk assessment document, which were not of concern to the Agency, adequately account for exposures and risk resulting from all fluridone uses including cotton gin byproducts. Therefore, EPA relies upon the findings made in the February 17, 2016, Federal Register document in support of this rule. EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to fluridone residues. For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer to the February 17, 2016, Federal Register document and its supporting documents, available at http://www.regulations.gov in docket ID number EPA–HQ–OPP–2014–0913. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology high performance liquid chromatography (HPLC) method (originally submitted as method AM– AA–CA–RO52–AA–755) is available in the Pesticide Analytical Manual (PAM) Volume II for residues of fluridone in plant commodities. 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. There is no Codex MRL for fluridone residues in or on cotton. V. Conclusion Therefore, a tolerance is established for residues of fluridone, 1-methyl-3- E:\FR\FM\20OCR1.SGM 20OCR1 Federal Register / Vol. 81, No. 203 / Thursday, October 20, 2016 / Rules and Regulations asabaliauskas on DSK3SPTVN1PROD with RULES phenyl-5-(3-(trifluoromethyl)phenyl)4(1H)-pyridinone, in or on cotton, gin byproducts at 0.1 ppm. VI. Statutory and Executive Order Reviews This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). 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 VerDate Sep<11>2014 15:55 Oct 19, 2016 Jkt 241001 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: October 7, 2016. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.420, in paragraph (a)(2) add an entry ‘‘Cotton, gin byproducts’’ in alphabetical order to read as follows: ■ § 180.420 Fluridone; tolerances for residues. (a) * * * (2) * * * Parts per million Commodity * * * Cotton, gin byproducts ......... * * * * * * * * * 0.1 * * * [FR Doc. 2016–25291 Filed 10–19–16; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 72539 SURFACE TRANSPORTATION BOARD 49 CFR Part 1022 [Docket No. EP 716 (Sub-No. 1)] Civil Monetary Penalty Inflation Adjustment Rule Surface Transportation Board. Interim final rule. AGENCY: ACTION: The Surface Transportation Board (Board) is issuing an interim final rule to adjust the Board’s civil monetary penalties for inflation pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. As mandated by that act, the Board is issuing a ‘‘catch-up adjustment’’ for its penalties and will thereafter make annual inflation adjustments according to a specified formula. SUMMARY: This interim final rule is effective on October 20, 2016. DATES: FOR FURTHER INFORMATION CONTACT: Allison Davis: (202) 245–0378. Federal Information Relay Service (FIRS) for the hearing impaired: 1–800–877–8339. SUPPLEMENTARY INFORMATION: I. Background On November 2, 2015, the President signed the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), passed as part of the Bipartisan Budget Act of 2015, Public Law 114–74, 129 Stat. 599. The 2015 Act further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (1990 Act), Public Law 101–410, 104 Stat. 890 (codified as amended at 28 U.S.C. 2461 note), as previously amended by the Debt Collection Improvement Act of 1996 (1996 Act), Public Law 104–134, 110 Stat. 1321, in order to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect.1 The 1996 Act required each federal agency to adopt regulations at least once every four years that adjust for inflation the maximum amount of civil monetary penalties under the statutes administered by the agency. In accordance with the 1996 Act, the Board increased its existing civil monetary penalties, which had not been adjusted for inflation since they were prescribed 1 A ‘‘civil monetary penalty’’ is defined by the 1990 Act as: ‘‘any penalty, fine, or other sanction that—(A)(i) is for a specific monetary amount as provided by Federal law; or (ii) has a maximum amount provided for by Federal law; and (B) is assessed or enforced by an agency pursuant to Federal law; and (C) is assessed or enforced pursuant to an administrative proceeding or a civil action in the Federal courts.’’ See also 49 CFR 1022.2(b). E:\FR\FM\20OCR1.SGM 20OCR1

Agencies

[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Rules and Regulations]
[Pages 72537-72539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25291]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0325; FRL-9951-81]


Fluridone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of 
fluridone in or on cotton gin byproducts. SePRO Corporation requested 
the tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 20, 2016. Objections and 
requests for hearings must be received on or before December 19, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0325, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: 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

[[Page 72538]]

and may also request a hearing on those objections. You must file your 
objection or request a hearing on this regulation in accordance with 
the instructions provided in 40 CFR part 178. To ensure proper receipt 
by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0325 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 December 19, 2016. Addresses for mail and 
hand delivery of objections and hearing requests are provided in 40 CFR 
178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0325, 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 July 20, 2016 (81 FR 47150) (FRL-9948-
45), 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# 
6F8451) by SePRO Corporation, 11550 North Meridian Street, Suite 600, 
Carmel, IN 46032. The petition requested that 40 CFR part 180 be 
amended by establishing a tolerance for residues of the herbicide 
fluridone in or on cotton, gin byproducts at 0.1 ppm. That document 
referenced a summary of the petition prepared SePRO, the registrant, 
which is available in the docket EPA-HQ-OPP-2016-0325 at http://www.regulations.gov. No comments were received in response to the 
notice of filing.

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), 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 fluridone in or on 
cotton gin byproducts, consistent with FFDCA section 408(b)(2).
    In the Federal Register of February 17, 2016 (81 FR 7982) (FRL-
9941-69), EPA established a tolerance for residues of fluridone in or 
on cotton, undelinted seed. EPA is relying upon the risk assessments 
that supported the findings made in the February 17, 2016 Federal 
Register document in support of this action. The toxicity profile of 
fluridone has not changed, and the previous risk assessments that 
supported the establishment of that tolerance remain valid.
    For the February 17, 2016 action, the petitioner did not propose a 
tolerance for residues of fluridone on cotton gin byproducts, however, 
the Agency determined that a cotton gin byproduct tolerance was needed 
to cover the cotton raw agricultural commodities (RAC). The commodity 
``cotton gin byproducts'' was included in the risk assessments that 
supported the February 17, 2016 Final Rule, but because they were not 
proposed by the registrant, they could not be established at that time. 
The registrant has subsequently proposed the cotton gin byproducts 
tolerance and therefore, the tolerance can now be established.
    EPA concludes that the aggregate exposure and risk estimates 
presented in the most recent human health risk assessment document, 
which were not of concern to the Agency, adequately account for 
exposures and risk resulting from all fluridone uses including cotton 
gin byproducts.
    Therefore, EPA relies upon the findings made in the February 17, 
2016, Federal Register document in support of this rule. EPA concludes 
that there is a reasonable certainty that no harm will result to the 
general population, or to infants and children from aggregate exposure 
to fluridone residues.
    For a detailed discussion of the aggregate risk assessments and 
determination of safety for these tolerances, please refer to the 
February 17, 2016, Federal Register document and its supporting 
documents, available at http://www.regulations.gov in docket ID number 
EPA-HQ-OPP-2014-0913.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology high performance liquid 
chromatography (HPLC) method (originally submitted as method AM-AA-CA-
RO52-AA-755) is available in the Pesticide Analytical Manual (PAM) 
Volume II for residues of fluridone in plant commodities.

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.
    There is no Codex MRL for fluridone residues in or on cotton.

V. Conclusion

    Therefore, a tolerance is established for residues of fluridone, 1-
methyl-3-

[[Page 72539]]

phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on cotton, 
gin byproducts at 0.1 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in 
response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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: October 7, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


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2. In Sec.  180.420, in paragraph (a)(2) add an entry ``Cotton, gin 
byproducts'' in alphabetical order to read as follows:


Sec.  180.420  Fluridone; tolerances for residues.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cotton, gin byproducts..................................             0.1
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-25291 Filed 10-19-16; 8:45 am]
 BILLING CODE 6560-50-P