48068 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Rules and Regulations 

§ 721.10690 Benzenedicarboxylic acid, 

polymer with substituted alkanediol, 

dodecanedioic acid, 1,2-ethanediol, 

alkanedioic acid, alkanediol,.alpha.-hydro- 

.omega.-hydroxypoly[oxyalkanediyl], 1,3- 

isobenzofurandione, methylene diphenyl 

diisocyanate, 2-oxepanone, 2,2’- 

oxybis[ethanol] and polymethylene 

polyphenylene isocyanate (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as benzenedicarboxylic acid, 

polymer with substituted alkanediol, 

dodecanedioic acid, 1,2-ethanediol, 

alkanedioic acid, alkanediol,.alpha.- 

hydro-.omega.- 

hydroxypoly[oxyalkanediyl], 1,3- 

isobenzofurandione, methylene 

diphenyl diisocyanate, 2-oxepanone, 

2,2’-oxybis[ethanol] and polymethylene 

polyphenylene isocyanate (PMN P–13– 

232) is subject to reporting under this 

section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (o) and (y)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 24. Add § 721.10691 to subpart E to 

read as follows: 

§ 721.10691 Fatty acid amide (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fatty acid amide (PMN P– 

13–267) is subject to reporting under 

this section for the significant new uses 

described in paragraph (a)(2) of this 

section. 

(2) The significant new uses are: 

(i) Release to water. Requirements as 

specified in § 721.90 (a)(4), (b)(4), and 

(c)(4) (N=1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (k) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 25. Add § 721.10692 to subpart E to 

read as follows: 

§ 721.10692 Fluorinated alkyl dianiline 

(generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as fluorinated alkyl dianiline 

(PMN P–13–288) is subject to reporting 

under this section for the significant 

new uses described in paragraph (a)(2) 

of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80(g). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

■ 26. Add § 721.10693 to subpart E to 

read as follows: 

§ 721.10693 Diphenylmethane 

diisocyanate polymer with alkanoic diacid 

and alkanediol (generic). 

(a) Chemical substance and 

significant new uses subject to reporting. 

(1) The chemical substance identified 

generically as diphenylmethane 

diisocyanate polymer with alkanoic 

diacid and alkanediol (PMN P–13–338) 

is subject to reporting under this section 

for the significant new uses described in 

paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Industrial, commercial, and 

consumer activities. Requirements as 

specified in § 721.80 (o) and (y)(1). 

(ii) [Reserved] 

(b) Specific requirements. The 

provisions of subpart A of this part 

apply to this section except as modified 

by this paragraph. 

(1) Recordkeeping. Recordkeeping 

requirements as specified in § 721.125 

(a), (b), (c), and (i) are applicable to 

manufacturers and processors of this 

substance. 

(2) Limitations or revocation of 

certain notification requirements. The 

provisions of § 721.185 apply to this 

section. 

[FR Doc. 2013–18982 Filed 8–6–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0262; FRL–9388–9] 

Topramezone; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of topramezone 

in or on multiple commodities which 

are identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 7, 2013. Objections and requests 

for hearings must be received on or 

before October 7, 2013, 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–2012–0262, 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 


emcdonald on DSK67QTVN1PROD with RULES
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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–2012–0262 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 7, 2013. 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– 

2012–0262, 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.htm. 

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 May 23, 

2012 (77 FR 30481) (FRL–9347–8), 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 2F7997) by BASF 

Corporation, 26 Davis Drive, P.O. Box 

13528, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.612 be amended by 

establishing tolerances for residues of 

the herbicide topramezone ([3-(4,5- 

dihydro-3-isoxazolyl)-2-methyl-4- 

(methylsulfonyl)phenyl](5-hydroxy-1- 

methyl-1H-pyrazol-4-yl)methanone), in 

or on fish and shellfish at 0.05 parts per 

million (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. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed commodity definitions 

and established tolerances for livestock 

meat by-products, which are needed as 

a result of the increased livestock 

dietary burden associated with the 

proposed use for topramezone. 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 topramezone 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with topramezone follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Topramezone is a 

member of the class of herbicides 

known as HPPD inhibitors. Inhibition of 

the enzyme 4-hydroxyphenylpyruvate 

dioxygenase (HPPD) results in 

decreased carotenoid synthesis and 

ultimately bleaching of target plants. In 

mammals, HPPD is involved in the 

catabolism of the amino acid tyrosine, 

and its inhibition causes blood levels of 

tyrosine to rise; a condition known as 

tyrosinemia. Some of the toxicities 

resulting from tyrosinemia in laboratory 

animals include ocular, developmental, 

liver, and kidney effects. Topramezone 

exhibits a mammalian toxicity profile 

that is consistent with HPPD inhibition. 

The primary target organs affected 

following oral administration of 

topramezone in animal toxicity studies 

were the eyes, thyroid, pancreas, and 

liver. The most sensitive species was the 

rat, and in rats and dogs, males were 

more sensitive than females. The effects 

on the eyes in chronic toxicity studies 

consisted of pannus (vascularization) 

and keratitis (cloudiness) of the cornea 

in both sexes. Hypertrophy and 

hyperplasia of the thyroid, hypertrophy 

and focal necrosis in the liver, and 

degeneration of the pancreas were 

among the histopathology findings 

reported across different subchronic and 

chronic studies in rats and dogs. Results 

of chronic toxicity studies in dogs, mice, 

and rats also suggest decrements in 

body weights, body-weight gains, and 

food utilization (dogs only). 

There was evidence for increased 

susceptibility following in utero 

exposure to topramezone in rats and 

rabbits. In rabbits, fetal abnormalities 


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including supernumerary thoracic 

vertebrae and supernumerary 13th rib 

were observed in the presence of 

maternal toxicity in six of eight 

developmental toxicity studies 

conducted in two different strains. In 

rats, developmental effects consisting of 

skeletal variations occurred in the 

presence of maternal toxicity. Increased 

maternal serum levels of tyrosine were 

reported in several developmental 

toxicity studies (several in rabbits and 

one in mice), consistent with the 

proposed mode of action for 

topramezone involving HPPD 

inhibition. In the rat 2-generation 

reproductive toxicity study, there was 

no evidence of increased pre- or postnatal susceptibility; offspring effects 

occurred in the presence of maternal 

effects. The offspring effects consisted of 

decreased pup body weight/bodyweight gain in F2 (both sexes) and 

increased time to preputial separation 

(F1 males). Maternal effects were 

consistent with HPPD inhibition 

(decreased body weights, decreased 

body-weight gains, increased thyroid 

and kidney weights, and microscopic 

findings in the eyes, kidneys, and 

thyroid). No reproductive effects were 

reported. 

Topramezone did not show any 

evidence of neurotoxicity in the acute 

(ACN) or subchronic (SCN) 

neurotoxicity studies, but in a rat 

developmental neurotoxicity (DNT) 

study, where dosing with topramezone 

took place during the prenatal as well as 

postnatal time periods, there was 

evidence for increased qualitative 

susceptibility. In the maternal animals, 

toxicity was limited to corneal opacity, 

whereas effects in the offspring 

included neurobehavioral and 

neuropathological changes. Offspring 

neurobehavioral effects consisted of a 

decreased auditory startle reflex at 

postnatal day 24 in both sexes (20–30%) 

and at postnatal day 60 for males (55%). 

There were also mild decreases in 

offspring absolute brain weights and 

neuropathological effects involving 

decreased brain morphometric 

measurements (e.g., hippocampus, and 

parietal cortex). 

Topramezone is classified as ‘‘not 

likely to be carcinogenic to humans at 

doses that do not alter rat thyroid 

hormone homeostasis.’’ EPA has 

determined that the thyroid tumors arise 

through a non-linear mode of action, 

and the chronic reference dose (cRfD) is 

expected to be protective of alterations 

in hormone homeostasis that may result 

in thyroid tumor formation. 

Mutagenicity studies conducted on 

technical topramezone and its major 

metabolites did not demonstrate any 

mutagenic potential. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by topramezone as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Topramezone: Human-Health Risk 

Assessment for (1) New Uses in NonCrop Aquatic Sites and (2) Increased 

Maximum Application Rate for 

Currently Registered Terrestrial Uses in 

the Maintenance of Bare Grounds 

(Roadsides, Utility and Railroad Rightsof-Ways, Industrial Sites, and Tank 

Farms),’’ pages 36–39 in docket ID 

number EPA–HQ–OPP–2012–0262. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for topramezone used for 

human risk assessment is shown in the 

Table of this unit. 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOPRAMEZONE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute Dietary (General population including infants and 

children).

LOAEL = 8 mg/kg 

bw.

UF = 100X (for interand intra-species 

extrapolation).

FQPA SF = 10X 

aRfD = 0.008 mg/kg 

bw 

aPAD = 0.008 mg/kg 

bw 

Developmental Neurotoxicity Study in Rats. 

Offspring LOAEL = 8 mg/kg bw based on decreased maximum 

auditory startle reflex response, decreased brain weights, 

and changes in brain morphology. 

Acute Dietary (Females 13–49 

years old).

NOAEL = 0.5 mg/kg/ 

day.

UF = 100X (for interand intra-species 

extrapolation).

FQPA SF = 1X 

aRfD = 0.005 mg/kg/ 

day 

aPAD = 0.005 mg/ 

kg/day 

Developmental Toxicity Study in Rabbits. 

Developmental LOAEL = 5 mg/kg/day based on alterations in 

skeletal ossification sites and increased number of pairs of 

ribs. 


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Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Rules and Regulations 48071 

SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR TOPRAMEZONE FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Chronic Dietary (All populations).NOAEL= 0.4 mg/kg/ 

day.

UF = 100X (for interand intra-species 

extrapolation).

FQPA SF = 1X 

cRfD = 0.004 mg/kg/ 

day 

cPAD = 0.004 mg/ 

kg/day.

Chronic toxicity/Carcinogenicity Study in Rats. 

LOAEL = 3.6 mg/kg/day based on increased incidences of corneal opacity, decreased body weight and body-weight gains 

in males and histopathological evaluations in the eyes, thyroid and pancreas of both sexes. 

Incidental Oral (Short- and Intermediate-Term).NOAEL = 0.4 mg/kg/ 

day.

Residential LOC for 

MOE = 100.

Two-Generation Reproduction Study in Rats. 

Offspring LOAEL = 4.2 mg/kg/day based decreases in body 

weights and body-weight gains in the F2 generation offspring 

and increased time to preputial separation in the F1 male offspring. 

Short- and Intermediate-Term, 

Dermal.

Oral NOAEL = 0.4 

mg/kg/day.

(DAF = 2.6%) 

Residential LOC for 

MOE = 100.

Two-Generation Reproduction Study in Rats. 

Parental LOAEL = 4.2 mg/kg/day based on decreased body 

weight, body-weight gain in males, increased thyroid and kidney weights of both sexes, and microscopic findings in eyes, 

kidney and thyroid of both sexes. 

Short- and Intermediate-Term 

Inhalation.

Oral NOAEL= 0.4 

mg/kg/day (inhalation absorption = 

100%).

Residential LOC for 

MOE = 100.

Two Generation Reproduction Study in Rats. 

Parental LOAEL = 4.2 mg/kg/day based on decreased body 

weight, body-weight gain in males, increased thyroid and kidney weights of both sexes, and microscopic findings in eyes, 

kidney and thyroid of both sexes. 

Cancer (Oral, dermal, inhalation).In accordance with the 2005 EPA Guidelines for Carcinogen Risk assessment, topramezone was classified as 

‘‘not likely to be carcinogenic to humans at doses that do not alter rat thyroid hormone homeostasis.’’ EPA has 

determined that the thyroid tumors arise through a non-linear mode of action and that the NOAEL (0.4 mg/kg/ 

day) for deriving the cRfD will be protective of thyroid hormone alterations and thyroid tumor formation. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to topramezone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing topramezone tolerances in 40 

CFR 180.612. EPA assessed dietary 

exposures from topramezone in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. Such effects were identified 

for topramezone. 

In estimating acute dietary exposure 

for both the general U.S. population 

(including infants and children) and for 

females 13–49 years of age, EPA used 

food consumption information from the 

U.S. Department of Agriculture’s 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA assumed 100 

percent crop treated (PCT), Dietary 

Exposure Evaluation Model (DEEM) 

7.81 default processing factors, and 

tolerance-level residues. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the same food consumption 

data and assumptions of tolerance-level 

residues, 100 PCT and DEEM 7.81 

default processing factors. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that topramezone does not 

pose a cancer risk to humans at levels 

that do not alter rat thyroid hormone 

homeostasis, and doses at or below the 

cRfD are not expected to alter thyroid 

homeostasis. Therefore, a dietary 

exposure assessment beyond the 

chronic assessment for the purpose of 

assessing cancer risk is unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for 

topramezone. Tolerance-level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. The highest drinking water 

concentrations are expected to result 

from the direct aquatic applications. 

Estimates of drinking water exposure 

levels were based on label instructions 

(i.e., proposed application rates, 

duration, and water concentration of 

direct aquatic applications at potable 

surface water intakes). For acute and 

chronic dietary risk assessment, the 

water concentration value of 45 parts 

per billion (ppb) was used to assess the 

contribution to drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Topramezone is currently registered for 

turf and golf course uses that could 

result in residential exposures. 

Topramezone is also proposed for use in 

direct aquatic applications that could 

result in exposure during recreational 

swimming activities. EPA assessed 


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48072 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Rules and Regulations 

residential exposure using the following 

assumptions: For adults, short-term 

aggregate assessment considered the 

post-application exposure resulting 

from the physical activities on turf. For 

children, short-term aggregate 

assessment considered combined 

dermal and incidental oral (hand-tomouth) post-application exposures to 

children 1 < 2 years old resulting from 

the registered turf use. These postapplication exposure estimates from the 

turf use are protective of postapplication exposure for older children 

more likely to engage in recreational 

swimming activities. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

Topramezone belongs to a class of 

herbicides that inhibit the liver enzyme 

HPPD, which is involved in the 

catabolism (metabolic breakdown) of 

tyrosine (an amino acid derived from 

proteins in the diet). Inhibition of HPPD 

can result in elevated tyrosine levels in 

the blood, a condition known as 

tyrosinemia. HPPD-inhibiting herbicides 

have been found to cause a number of 

toxicities in laboratory animal studies 

including ocular, developmental, liver, 

and kidney effects. Of these toxicities, 

the ocular effect (corneal opacity) is 

highly correlated with the elevated 

blood tyrosine levels. In fact, rats dosed 

with tyrosine alone show ocular 

opacities similar to those seen with 

HPPD inhibitors. Although the other 

toxicities may be associated with 

chemically induced tyrosinemia, other 

mechanisms may also be involved. 

There are marked differences among 

species in the ocular toxicity associated 

with HPPD inhibition. For example, 

treatments with HPPD inhibitor 

herbicides result in ocular effects in the 

rat, but not the mouse or monkey. The 

explanation of this species-specific 

response is related to the species 

differences in the clearance of tyrosine. 

Some species (such as the mouse and 

monkey) have a metabolic pathway that 

exists to remove tyrosine from the 

blood. This pathway involves a liver 

enzyme called tyrosine 

aminotransferase (TAT). Unlike rats, 

mice and humans have a highly 

effective metabolic process for handling 

excess tyrosine and are unlikely to 

achieve the levels necessary to produce 

ocular opacities. In fact, HPPD 

inhibitors (e.g. nitisinone) are used as an 

effective therapeutic agent to treat 

human patients suffering from rare 

genetic diseases of tyrosine catabolism. 

The human experience indicates that a 

therapeutic dose (1 mg/kg/day dose) has 

an excellent safety record in infants, 

children, and adults and that serious 

adverse health outcomes have not been 

observed in a population followed for 

approximately a decade. Rarely, ocular 

effects are seen in patients with high 

plasma tyrosine levels; however, these 

effects are transient and can be readily 

reversed upon adherence to a restricted 

protein diet. This indicates that HPPD 

inhibitor in it of itself cannot easily 

overwhelm the tyrosine-clearance 

mechanism in humans. 

Therefore, exposure to environmental 

residues of HPPD-inhibiting herbicides 

are unlikely to result in the high blood 

levels of tyrosine and ocular toxicity in 

humans due to an efficient metabolic 

process to handle excess tyrosine. EPA 

has therefore not conducted cumulative 

risk assessment with other HPPD 

inhibitors for purposes of this 

assessment of topramezone for aquatic 

uses. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA SF. In applying this provision, 

EPA either retains the default value of 

10X, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

In the prenatal developmental toxicity 

study with rats, there was evidence for 

increased qualitative, but not 

quantitative, susceptibility in the 

offspring. Qualitative susceptibility was 

demonstrated by the occurrence of 

decreased fetal body weight and 

increased incidences of skeletal 

variations in the presence of decreased 

body weight gain in the maternal 

animals. 

In six of eight rabbit studies, there 

was evidence for increased qualitative 

susceptibility. In the does, maternal 

toxicity was characterized as decreases 

in body weight, body weight gain, and 

food consumption, all in the presence of 

increased serum levels of tyrosine. In 

the fetuses, developmental toxicity was 

manifested as increased incidences of 

visceral findings (i.e., absent kidney and 

ureter) and/or multiple skeletal 

variations (i.e., delayed ossification, 

supernumerary 13th rib and/or 27th 

presacral vertebrae). In two studies, 

skeletal variations were observed at high 

doses in the absence of any maternal 

toxicity. 

In the 2-generation reproduction 

study with rats, there was no evidence 

of increased susceptibility. Offspring 

toxicity was characterized as decreased 

pup weight and weight gain in F2 male 

and female pups and increased time to 

preputial separation in the F1 males. 

These effects were observed in the 

presence of parental/systemic toxicity 

that included: Decreased body weight, 

decreased body-weight gain in males, 

increased thyroid and kidney weights of 

both sexes, and microscopic findings in 

the eyes, kidney, and thyroid of both 

sexes. 

In the developmental neurotoxicity 

(DNT) study, there was evidence for 

qualitative susceptibility. In the 

maternal animals, toxicity was limited 

to corneal opacity whereas effects in the 

offspring manifested as: 

Neurobehavioral changes (decreased 

auditory startle reflex), decreases in 

absolute brain weight, and decreases in 

brain morphometric measurements (e.g., 

hippocampus, and parietal cortex). 

3. Conclusion. While EPA is retaining 

the 10X FQPA safety factor for the acute 

dietary risk assessment for the U.S. 

general population including infants 

and children, EPA has determined that 

reliable data show the safety of infants 

and children would be adequately 

protected if the FQPA SF were reduced 

to 1X for the acute dietary risk 

assessment for females of child-bearing 

age (i.e., 13–49 years old), the chronic 

dietary risk assessment for the U.S. 

general population, and all non-dietary 

exposure scenarios. That decision is 

based on the following findings: 

i. The toxicity database for 

topramezone is complete, except for an 

immunotoxicity study. A database 

uncertainty factor (UFDB) is not required 

for the lack of an immunotoxicity study 

since the PODs used for overall risk 

assessments are based on effects seen in 

target organs (e.g., eyes, thyroid, and 

liver) consistent with the actions of this 

chemical as an HPPD inhibitor. An 

immunotoxicity study is not likely to 


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yield a lower POD and the preliminary 

results of the retrospective analyses 

provide strong support for not retaining 

the UFDB as no immunotoxicity study 

available thus far has provided sensitive 

endpoints for use in deriving points of 

departure. 

ii. There is some indication that 

topramezone is a neurotoxic chemical 

for developing animals. While there was 

no evidence of neurotoxicity or 

neuropathology to the adult nervous 

system following a single oral 

administration to rats at the limit dose 

in the ACN study or following repeated 

dietary administration to rats in the SCN 

study or in the maternal animals of the 

DNT study, there were neurobehavioral 

as well as neuropathological effects 

observed in the offspring of the DNT 

study as described above. 

The LOAEL of 8 mg/kg/day of the 

DNT study is based on decreased 

auditory startle reflex, decreases in 

brain weight, and brain morphometric 

parameters at the lowest dose tested. A 

NOAEL was not established. 

Nevertheless, the LOAEL (8 mg/kg/day) 

was employed as the point of departure 

in assessing the risk for the general U.S. 

population, including infants and 

children, since the offspring were 

exposed to topramezone both in utero 

and during the lactation period. The 

10X FQPA safety factor is retained as a 

UFL (i.e., use of a LOAEL to extrapolate 

a NOAEL.) 

iii. As discussed in Unit III.D.2., there 

is evidence that topramezone results in 

increased susceptibility in the prenatal 

developmental studies in rats and 

rabbits. But the degree of concern for the 

effects seen in those studies is low 

because there were clear NOAELs for 

the offspring effects and EPA selected 

points of departure that are protective of 

those effects. As explained in Unit 

III.D.3.ii., EPA is retaining the 10X 

FQPA safety factor for the lack of a 

NOAEL in the DNT study and believes 

that doing so will be protective of 

infants and children. 

iv. There are no residual uncertainties 

in the exposure database. The dietary 

and residential exposure analyses are 

conservative in nature. The dietary 

exposure assessment uses tolerancelevel residues and assumes 100 PCT. 

EPA used similarly conservative 

assumptions to assess post-application 

exposure to children/adults. The 

residential exposure assessment uses 

chemical-specific turf transferable 

residue data and the 2012 Residential 

Standard Operating Procedures (SOPs) 

and is considered health-protective. 

These assessments will not 

underestimate the exposure and risks 

posed by topramezone. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Acute aggregate risk is 

made up only of dietary sources; 

therefore, the acute exposure estimates 

provided in the acute dietary exposure 

analysis represent acute aggregate 

exposures. EPA has concluded that 

acute exposure to topramezone from 

food and drinking water will utilize 

98% of the aPAD for the most highly 

exposed population subgroup (all 

infants <1 year old) and 50% of the 

aPAD for females 13–49 years of age. 

The acute dietary assessment did not 

result in exposure estimates above 

EPA’s level of concern. 

2. Chronic risk: Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to topramezone 

from food and water will utilize 62% of 

the cPAD for all infants (<1 year old), 

the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

topramezone is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Topramezone is 

currently registered for residential turf 

uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to topramezone. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 220 for the general U.S. 

population and 120 for children 1–2 

years old (a subgroup predicted to have 

the highest dietary burden as well as the 

highest residential exposure. Because 

EPA’s level of concern for topramezone 

is a MOE of 100 or below, these MOEs 

are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Topramezone is currently registered for 

turf uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to topramezone for children that are 1– 

2 years old that may ingest soil on 

treated turf. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 270. Because 

EPA’s level of concern for topramezone 

is a MOE of 100 or below, this MOE is 

not of concern. 

5. Aggregate cancer risk for U.S. 

population. As noted in Unit III.C.1.iii., 

EPA has concluded that topramezone 

does not pose a cancer risk of concern 

at exposure levels that do not alter 

thyroid hormone homeostasis. The 

chronic aggregate assessment, which 

utilized a cRfD that is protective of 

those effects did not indicate a chronic 

risk above the Agency’s level of 

concern; therefore, topramezone is not 

expected to pose a cancer risk to 

humans. 

6. Determination of safety. Based on 

these risk assessments, 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 topramezone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(BASF method D0104) 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 


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48074 Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Rules and Regulations 

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 are no 

Codex maximum residue limits (MRLs) 

in/on fish/shellfish. 

C. Revisions to Petitioned-For 

Tolerances 

The proposed tolerance definition, 

‘‘fish’’ is being revised to ‘‘fishfreshwater finfish’’ and ‘‘fish-saltwater 

finfish.’’ The proposed tolerance 

definition, ‘‘shellfish’’ is being revised 

to ‘‘fish-shellfish, crustacean’’ and ‘‘fishshellfish, mollusk.’’ EPA is also 

establishing meat byproduct tolerances 

for cattle, goat, horse, sheep (0.80 ppm), 

hog (0.40 ppm), and poultry (0.02 ppm) 

as a result of the additional dietary 

burden resulting from the consumption 

of treated water by livestock since 

consumption of treated water by 

livestock is not restricted on the 

proposed labeling for aquatic uses. With 

the establishment of these tolerances, 

the currently established kidney (cattle, 

goat, horse, and sheep) and liver (cattle, 

goat, horse, and sheep) tolerances are 

being removed as it is now general 

policy to establish meat byproduct 

tolerances rather than separate liver and 

kidney tolerances (Chemistry Science 

Advisory Council (ChemSAC); 

min_494.12-Jan-2011). 

Finally, EPA has revised the tolerance 

expression to clarify that, as provided in 

FFDCA section 408(a)(3), the tolerance 

covers metabolites and degradates of 

topramezone not specifically 

mentioned; and that compliance with 

the specified tolerance levels is to be 

determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of topramezone, including 

its metabolites and degradates, in or on 

fish-freshwater, finfish; fish-saltwater, 

finfish; fish-shellfish, crustacean; and 

fish-shellfish, mollusk at 0.05 ppm. To 

account for additional dietary burden to 

livestock from residues in drinking 

water for the proposed aquatic use, 

tolerances are being established for 

cattle, goat, horse, and sheep meat 

byproducts at 0.80 ppm; hog meat 

byproducts at 0.40 ppm and poultry 

meat byproducts at 0.02 ppm. 

Compliance with the following 

tolerance levels is to be determined by 

measuring only topramezone ([3-(4,5- 

dihydro-3-isoxazolyl)-2-methyl-4- 

(methylsulfonyl)phenyl](5-hydroxy-1- 

methyl-1H-pyrazol-4-yl)methanone) in 

or on the commodities. 

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: July 29, 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. Section 180.612 is revised to read 

as follows: 

§ 180.612 Topramezone; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

topramezone, including its metabolites 

and degradates, in or on the following 

commodities. Compliance with the 

following tolerance levels is to be 

determined by measuring only 

topramezone ([3-(4,5-dihydro-3- 

isoxazolyl)-2-methyl-4- 

(methylsulfonyl)phenyl](5-hydroxy-1- 


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Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Rules and Regulations 48075 

methyl-1H-pyrazol-4-yl)methanone) in 

or on the following commodities: 

Commodity Parts per 

million 

Cattle, meat byproducts ............. 0.80 

Corn, field, forage ....................... 0.05 

Corn, field, grain ......................... 0.01 

Corn, field, stover ....................... 0.05 

Corn, pop, grain .......................... 0.01 

Corn, pop, stover ........................ 0.05 

Corn, sweet, forage .................... 0.05 

Corn, sweet, kernel plus cob 

with husks removed ................ 0.01 

Corn, sweet, stover .................... 0.05 

Fish-freshwater finfish ................ 0.05 

Fish-saltwater finfish ................... 0.05 

Fish-shellfish, crustacean ........... 0.05 

Fish-shellfish, mollusk ................ 0.05 

Goat, meat byproducts ............... 0.80 

Hog, meat byproducts ................ 0.40 

Horse, meat byproducts ............. 0.80 

Poultry, meat byproducts ............ 0.02 

Sheep, meat byproducts ............ 0.80 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2013–18975 Filed 8–6–13; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 665 

[Docket No. 121107617–3628–03] 

RIN 0648–XC351 

Western Pacific Fisheries; 2013 Annual 

Catch Limits and Accountability 

Measures; Correcting Amendment 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final specifications; correcting 

amendment. 

SUMMARY: This document makes a 

technical correction to the final 2013 

annual catch limit specifications for 

western Pacific fisheries that were 

published in the Federal Register on 

March 13, 2013. 

DATES: Effective August 7, 2013 and is 

applicable beginning April 12, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Jarad Makaiau, Sustainable Fisheries, 

NMFS Pacific Islands Region, 808–944– 

2108. 

SUPPLEMENTARY INFORMATION: At its 

155th meeting held from October 29 

through November 1, 2012, the Western 

Pacific Fishery Management Council 

(Council) recommended annual catch 

limits for western Pacific fisheries for 

the 2013 fishing year, including an 

annual catch limit of 140,000 lb for the 

Hawaii non-Deep 7 bottomfish. 

NMFS published the proposed 2013 

specifications and request for public 

comments in the Federal Register on 

January 31, 2013 (78 FR 6798). NMFS 

published the final specifications in the 

Federal Register on March 13, 2013 (78 

FR 15885). Table 4 in each of those 

documents contained a typographical 

error. The limit for Hawaii non-Deep 7 

bottomfish was inadvertently described 

as 145,000 lb, rather than the 140,000 lb 

recommended by the Council. This 

notice corrects the error. 

NMFS assessed the potential 

environmental impacts of specifying an 

annual catch limit of 140,000 lb for 

Hawaii non-Deep 7 bottomfish for the 

2013 fishing year. Consistent with 

National Standard 1 of the MagnusonStevens Fishery Conservation and 

Management Act, NMFS estimated that 

a catch limit of 140,000 lb—which is 

approximately 73% of the estimated 

overfishing limit proxy of 192,000 lb— 

is associated with a 26 percent chance 

of overfishing. National Standard 1 

provides that the probability that 

overfishing will occur cannot exceed 50 

percent, and should be a lower value. 

Accordingly, based on the analyses 

contained in the environmental 

assessment, NMFS determined that 

establishing the catch limit at this level 

would have no significant effect on the 

quality of the human environment. 

NMFS did not receive public 

comments on the catch limit for nonDeep 7 bottomfish. The corrected catch 

limit of 140,000 lb is only 3.5% lower 

than the published limit that contained 

the error. The non-Deep 7 bottomfish 

fishery is not subject to in-season 

closure or other in-season accountability 

measures upon attainment of the annual 

catch limit. Accordingly, in the unlikely 

event that the annual catch limit is 

reached, the Council and NMFS would 

address any overage in the subsequent 

fishing year. For these reasons, NMFS 

does not anticipate that fishermen will 

be adversely affected by the correction. 

Correction 

Accordingly, in the final 

specifications published on March 13, 

2013 (78 FR 15885), on page 15887, in 

Table 4—Hawaii, the entry for NonDeep 7 Bottomfish is revised to read 

140,000 lb (63,503 kg). 

Dated: August 1, 2013. 

Alan D. Risenhoover, 

Director, Office of Sustainable Fisheries, 

performing the functions and duties of the 

Deputy Assistant Administrator for 

Regulatory Programs, National Marine 

Fisheries Service. 

[FR Doc. 2013–19069 Filed 8–6–13; 8:45 am] 

BILLING CODE 3510–22–P 


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