Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Rules and Regulations 66651 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (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 of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VI. 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 25, 2013. 

Lois Rossi, 

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 § 180.641, in the table in 

paragraph (a)(1): 

■ a. Add alphabetically ‘‘corn, sweet, 

kernel plus cob with husks removed’’ 

and ‘‘persimmon’’; and 

■ b. Revise the entries for ‘‘feijoa,’’ 

‘‘papaya,’’ and ‘‘Spanish lime’’. 

The additions and revisions read as 

follows: 

§ 180.641 Spirotetramat; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Corn, sweet, kernel plus cob 

with husks removed ............ 1 .5 

* * * * * 

Feijoa ...................................... 2 .5 

* * * * * 

Papaya .................................... 0 .40 

Commodity Parts per 

million 

* * * * * 

Persimmon .............................. 2 .5 

* * * * * 

Spanish lime ........................... 13 

* * * * * 

* * * * * 

[FR Doc. 2013–26643 Filed 11–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0583; FRL–9401–9] 

Imazapyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of imazapyr in or 

on lentil at 0.2 parts per million (ppm); 

and rapeseed subgroup 20A and 

sunflower subgroup 20B at 0.05 ppm. 

BASF Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

November 6, 2013. Objections and 

requests for hearings must be received 

on or before January 6, 2014, 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–2012–0583, 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), EPA West 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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 

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–2012–0583 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 January 6, 2014. 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 


pmangrum on DSK3VPTVN1PROD with RULES
66652 Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Rules and Regulations 

by docket ID number EPA–HQ–OPP– 

2012–0583, 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 August 22, 

2012 (77 FR 163) (FRL–9358–9), 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 2E8045) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC 27709. The petition 

requested that 40 CFR 180.500 be 

amended by establishing tolerances for 

residues of the herbicide, imazapyr [2- 

[4,5-dihydro-4-methyl-4-(1- 

methylethyl)-5-oxo-1H-imidazol-2-yl]-3- 

pyridinecarboxylic acid], in or on lentil 

at 0.2 ppm; and rapeseed subgroup 20A 

and sunflower subgroup 20B at 0.05 

ppm. That document referenced a 

summary of the petition prepared by 

BASF Corporation, the registrant, which 

is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

EPA has revised the tolerance 

expression to clarify the chemical 

moieties that are covered by the 

tolerances and specify how compliance 

with the tolerance is to be measured. 

The reason for this change is 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 imazapyr 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with imazapyr follows. 

In 2003, EPA quantitatively assessed 

the risk of imazapyr tolerances in 

connection with the final rule published 

in the Federal Register of September 26, 

2003 (68 FR 55475) (FRL–7321–4) 

establishing tolerances for imazapyr in 

or on grass, forage; grass, hay; fish; 

shellfish; fats of cattle, sheep, goats, and 

horses; kidney of cattle, sheep, goats, 

and horses; meat byproducts (except 

kidney) of cattle, sheep, goats, and 

horses; meat of cattle, sheep, goats, and 

horses; and milk. At that time, EPA 

determined that the aggregate risks from 

exposure to imazapyr were minimal. In 

reviewing the current tolerance petition, 

EPA determined that the toxicity 

database for imazapyr is complete and 

no additional studies are needed. EPA 

also determined that the toxicity data 

identified no hazard from imazapyr 

regardless of the route of exposure or 

the species tested. In the absence of 

evidence of neurotoxicity, 

immunotoxicity, genotoxicity, 

carcinogenicity, or other acute or 

chronic toxicity in conjunction with no 

adverse developmental or reproductive 

effects, the Agency concluded that a 

quantitative risk assessment for 

imazapyr was no longer needed and that 

EPA could determine based on a 

qualitative assessment of the imazapyr 

database that the proposed import 

tolerances are safe. This conclusion is 

supported by the findings in the last risk 

assessment, which were based on 

conservative (protective) toxicity 

endpoints showing only negligible 

aggregate exposures and risks identified 

from dietary, residential, and swimming 

and occupational routes. As previously 

indicated, EPA has determined that this 

prior quantitative assessment overstated 

risk because the current toxicology 

database shows no evidence of adverse 

effects from exposure to imazapyr. 

Because EPA is not quantitatively 

assessing the risk of imazapyr based on 

a reliance on the use of safety factors, 

EPA has not retained the additional 

safety factor described in FFDCA 

section 408(b)(2)(C) for the protection of 

infants and children. 

Therefore, based on EPA’s qualitative 

assessment of the imazapyr risk and the 

prior quantitative risk assessment 

discussed in the final rule published in 

the Federal Register of September 26, 

2003 (68 FR 55475) (FRL–7321–4), 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 

imazapyr and its metabolites or 

degradates. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography with tandem 

mass spectrometric detection (LC/MS/

MS)) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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. The Codex has not 

established MRLs for imazapyr on 

rapeseed, sunflower, or lentils. 


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Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Rules and Regulations 66653 

C. Revisions to Petitioned-for Tolerances 

EPA is revising the tolerance 

expressions for plant and livestock 

commodities to clarify the chemical 

moieties that are covered by the 

tolerances and specify how compliance 

with the tolerances is to be measured. 

The revised tolerance expression makes 

clear that the tolerances cover ‘‘residues 

of imazapyr, including its metabolites 

and degradates,’’ as specified in FFDCA 

section 408(a)(3), and that compliance 

with the tolerance levels is to be 

determined by measuring only the 

residues of imazapyr [2-[4,5-dihydro-4- 

methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-3-pyridinecarboxylic 

acid]. EPA has determined that it is 

reasonable to make this change final 

without prior proposal and opportunity 

for comment because public comment is 

not necessary, in that the change has no 

substantive effect on the tolerance, but 

rather incorporates statutory 

requirements and is merely intended to 

clarify the existing tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of imazapyr [2-[4,5-dihydro4-methyl-4-(1-methylethyl)-5-oxo-1Himidazol-2-yl]-3-pyridinecarboxylic 

acid], in or on lentil at 0.2 ppm; 

rapeseed subgroup 20A and sunflower 

subgroup 20B at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule 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 final rule 

has been exempted from review under 

Executive Order 12866, this final 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) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule 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 tolerance 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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

(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 22, 2013. 

Lois Rossi, 

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 § 180.500, paragraph (a) is 

amended by revising the introductory 

text and alphabetically adding the 

following commodities to the table to 

read as follows: 

§ 180.500 Imazapyr; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide, 

imazapyr, including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels is to be determined 

by measuring only the residues of 

imazapyr [2-[4,5-dihydro-4-methyl-4-(1- 

methylethyl)-5-oxo-1H-imidazol-2-yl]-3- 

pyridinecarboxylic acid]. 

Commodity Parts per 

million 

* * * * * 

Lentil 1 ................................... 0.2 

* * * * * 

Rapeseed subgroup 20A1 .... 0.05 

* * * * * 

Sunflower subgroup 20B1 .... 0.05 

1There are no U.S. Registrations. 

* * * * * 

[FR Doc. 2013–26364 Filed 11–5–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Parts 153, 155, 156, 157, and 

158 

[CMS–9964–F3] 

RIN–0938–AR51 

Patient Protection and Affordable Care 

Act; HHS Notice of Benefit and 

Payment Parameters for 2014; 

Correcting Amendment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Correcting amendment. 

SUMMARY: In the March 11, 2013 issue 

of the Federal Register, we published a 


pmangrum on DSK3VPTVN1PROD with RULES