53586 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule 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: August 20, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Program. 

■ 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 180.607 is amended by 

alphabetically adding the following 

commodities to the table in paragraph 

(a)(1) and revising paragraphs (a)(1) 

introductory text, (a)(2) introductory 

text, (b) introductory text, and (d) 

introductory text to read as follows: 

§ 180.607 Spiromesifen; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the 

insecticide/miticide spiromesifen, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of spiromesifen [2-oxo-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-4-yl 3,3-dimethylbutanoate] and 4- 

hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one, calculated 

as the stoichiometric equivalent of 

spiromesifen, in or on the following 

primary crop commodities: 

Commodity Parts per million 

* * * * * 

Leaf petiole subgroup 4B ........... 6.0 

* * * * * 

Pea, dry, seed ...... 0.20 

Peppermint, tops .. 45 

Spearmint, tops .... 45 

* * * * * 

(2) Tolerances are established for 

residues of the insecticide/miticide 

spiromesifen, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only the sum of spiromesifen [2-oxo-3- 

(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate] and its metabolites 

containing the 4-hydroxy-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-2-one and 4-hydroxy-3-[4- 

(hydroxymethyl)-2,6-dimethylphenyl]- 

1-oxaspiro[4.4]non-3-en-2-one moieties, 

calculated as the stoichiometric 

equivalent of spiromesifen, in the 

following livestock commodities: 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the insecticide/miticide 

spiromesifen, including its metabolites 

and degradates, in or on the 

commodities listed below. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only the sum of spiromesifen [2-oxo-3- 

(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-4-yl 3,3- 

dimethylbutanoate] and 4-hydroxy-3- 

(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one, calculated 

as the stoichiometric equivalent of 

spiromesifen, in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FIFRA 

section 18 emergency exemptions. The 

tolerances expire and are revoked on the 

date specified in the table. 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

inadvertent or indirect residues of the 

insecticide/miticide spiromesifen, 

including its metabolites and 

degradates, in or on the commodities 

listed below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of spiromesifen [2-oxo-3-(2,4,6- 

trimethylphenyl)-1-oxaspiro[4.4]non-3- 

en-4-yl 3,3-dimethylbutanoate], 4- 

hydroxy-3-(2,4,6-trimethylphenyl)-1- 

oxaspiro[4.4]non-3-en-2-one, and its 

metabolites containing the 4-hydroxy-3- 

[4-(hydroxymethyl)-2,6- 

dimethylphenyl]-1-oxaspiro[4.4]non-3- 

en-2-one moiety, calculated as the 

stoichiometric equivalent of 

spiromesifen, in the following rotational 

crop commodities: 

* * * * * 

[FR Doc. 2010–21686 Filed 8–31–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0890; FRL–8840–9] 

Bifenazate; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of bifenazate in 

or on multiple commodities which are 

identified and discussed later in this 

document. Interregional Research 

Project #4 (IR-4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation additionally deletes the timelimited tolerance for potato, as the 

tolerance expired on December 31, 

2006, and deletes the time-limited 

tolerances for tart cherry, soybean hulls, 

soybean meal, soybean refined oil, and 

soybean seed, as the tolerances expired 

on December 31, 2009. 

DATES: This regulation is effective 

September 1, 2010. Objections and 

requests for hearings must be received 

on or before November 1, 2010, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0890. All documents in the 

docket are listed in the docket index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53587 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

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.gpoaccess.gov/ecfr. 

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–2009–0890 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 November 1, 2010. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0890, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 4, 

2010 (75 FR 5790) (FRL–8807–5), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7642) by 

Interregional Research Project #4 (IR-4), 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.572 be 

amended by establishing tolerances for 

residues of the the insecticide 

bifenazate, (1-methylethyl 2-(4- 

methoxy[1,1′-biphenyl]-3- 

yl)hydrazinecarboxylate) and 

diazinecarboxylic acid, 2-(4-methoxy- 

[1,1′-biphenyl]-3-yl), 1-methylethyl ester 

(expressed as bifenazate), in or on sugar 

apple, cherimoya, atemoya, custard 

apple, ilama, soursop, and biriba at 1.5 

parts per million (ppm); avocado at 7.0 

ppm; fruit, small, vine climbing 

subgroup 13–07F, except fuzzy kiwi 

fruit at 0.75 ppm; and berry, low 

growing, subgroup 13–07G at 1.5 ppm. 

That notice referenced a summary of the 

petition prepared by Chemtura 

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 

changed the tolerances for sugar apple, 

cherimoya, atemoya, custard apple, 

ilama, soursop, and biriba from the 

proposed level of 1.5 ppm to 1.6 ppm 

and for fruit, small, vine climbing 

subgroup 13–07F, except fuzzy kiwi 

tolerance from the proposed level of .75 

ppm to 1.0 ppm. The reason for these 

changes is explained in Unit IV.D. 

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 section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 bifenazate 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with bifenazate 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. 

Bifenazate is not acutely toxic by the 

oral, inhalation, or dermal routes of 

exposure. It is minimally irritating to 

the eye and slightly-irritating to the 

skin. Bifenazate is a dermal sensitizer by 

the Magnusson/Kligman method, but 

not the Buehler method. Subchronic 

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53588 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 

and chronic studies in rats and dogs 

indicate that the liver and 

hematopoietic system (spleen and/or 

bone marrow with associated 

hematological findings) are the primary 

target organs in these species, with 

additional toxicity in the kidney 

(chronic dog) and adrenal gland (male 

rats) also identified. Similarly, the 

hematopoietic system (spleen) was the 

primary target organ in the repeat-dose 

dermal toxicity study. Also associated 

with this toxicity in several studies were 

decreased body weight, body-weight 

gain, and food consumption. No 

evidence of carcinogenicity was seen in 

the rat and mouse studies and the 

Agency has classified bifenazate as ‘‘not 

likely’’ to be a human carcinogen by any 

relevant route of exposure. A full battery 

of mutagenicity studies were negative 

for mutagenic or clastogenic activity. 

The developmental studies in rats and 

rabbits did not demonstrate increased 

sensitivity of fetuses to bifenazate. 

Similarly, increased qualitative or 

quantitative susceptibility to offspring 

were not observed with bifenazate 

during pre- or postnatal development in 

the reproduction study. There was no 

evidence of neurotoxicity (clinical signs 

or neuropathology) in any of the 

toxicology studies conducted with 

bifenazate. Therefore, a bifenazate 

developmental neurotoxicity (DNT) 

study was not required by the Agency. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by bifenazate 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 the document 

titled ‘‘Bifenazate (000586); Petition to 

Add New Uses on: Avocado, Tropical 

Fruits (Sugar Apple, Cherimoya, 

Atemoya, Custard Apple, Ilama, 

Soursop, and Biriba), Small Vine 

Climbing Fruit (Subgroup 13–07F), and 

Low-Growing Berry (Subgroup 13–07G). 

HED Human-Health Risk Assessment,’’ 

pp. 26–27 in docket ID number EPA– 

HQ–OPP–2009–0890. 

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 (LOC) 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 the NOAEL and the 

LOAEL of concern are identified. 

Uncertainty/safety factors (U/SF) are 

used in conjunction with the POD to 

calculate a safe exposure level – 

generally referred to as a populationadjusted 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 bifenazate used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BIFENAZATE 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 

(all populations) 

An acute dietary endpoint was not selected based on the absence of an appropriate endpoint attributed to 

a single dose. 

Chronic dietary 

(All populations) 

NOAEL= 1.0 milligrams/kilogram/ 

day (mg/kg/day) UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.01 mg/kg/day 

cPAD = 0.01 mg/kg/day 

Chronic Toxicity in Dogs 

LOAEL = 8.9/10.4 mg/kg/day 

Male/Female (M/F) based on 

changes in hematological and 

clinical chemistry parameters, 

and histopathology in bone 

marrow, liver, and kidney in 

the 1–year dog feeding study. 

Incidental oral short-term 

(1 to 30 days) 

NOAEL= 10 mg/kg/day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE ≤100 Prenatal Developmental in Rats 

Maternal LOAEL = 100 mg/kg/ 

day based on clinical signs, 

decreased body weight and 

food consumption during the 

dosing period in the rat developmental study. 

Incidental oral intermediate-term 

(1 to 6 months) 

NOAEL= 0.9 mg/kg/day UFA= 10x 

UFH= 10x 

FQPA SF = 1x 

LOC for MOE ≤100 90–Day Oral Toxicity non-Rodents-Dog 

LOAEL = 10.4/10.7 mg/kg/day 

(M/F) based on changes in 

hematologic parameters in the 

90–day subchronic dog study. 

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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53589 

TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BIFENAZATE 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 

Short-, Intermediate- and LongTerm Dermal (1–30 days, 30 

days– 6 months, and 6 months 

to lifetime) 

Dermal study NOAEL = 80 mg/kg/ 

day UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE ≤100 21–Day Dermal Toxicity-Rat 

LOAEL = 400 mg/kg/day based 

on decreased body weight and 

food consumption, hematologic effects, increased spleen 

weight and extramedullary hemapoiesis in the spleen in the 

21–day dermal toxicity study in 

rats. 

Inhalation short-term 

(1 to 30 days) 

Oral study NOAEL= 10 mg/kg/day 

(inhalation absorption rate = 

100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE ≤100 Prenatal Developmental in Rats 

Maternal LOAEL = 100 mg/kg/ 

day based on clinical signs, 

decreased body weight and 

food consumption during the 

dosing period in the rat developmental study. 

Cancer 

(Oral, dermal, inhalation) 

Bifenazate is classified as ‘‘not likely’’ to be a human carcinogen. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to bifenazate, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

bifenazate tolerances in 40 CFR 180.572. 

EPA assessed dietary exposures from 

bifenazate 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. No such effects were 

identified in the toxicological studies 

for bifenazate; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Survey of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA assumed that all 

commodities, except squash, peach, 

tomato and milk, contained tolerancelevel residues. For squash, peach and 

tomato, EPA assumed residues were 

present at average field trial levels. For 

milk, the tolerance level was adjusted 

upward to account for all of the residues 

of concern for risk assessment. Default 

processing factors were assumed for all 

commodities except apple juice, grape 

juice, wine/sherry, tomato paste, and 

tomato puree. The processing factors for 

these commodities were based on data 

from processing studies. The chronic 

analysis also incorporated average 

percent crop treated (PCT) information 

for some registered commodities but 

assumed 100 PCT for the new uses. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that bifenazate does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

Bifenazate contains hydrazine as part 

of its chemical structure. This side 

chain is structurally similar to 

unsymmetrical dimethyl hydrazine 

(UDMH), a category B2 animal 

carcinogen and possible human 

carcinogen. However, EPA has 

concluded that formation of free 

biphenyl hydrazine or other hydrazines 

is unlikely based on the results of 

submitted metabolism studies. The rat, 

livestock, and plant metabolism studies 

indicate that metabolism of bifenazate 

proceeds via oxidation of the hydrazine 

moiety of bifenazate to form D3598 

(diazene). The D3598 is then 

metabolized to D1989 (methoxy 

biphenyl) and to bound residues by 

reaction with natural products. A radish 

metabolism study which specifically 

monitored for the formation of biphenyl 

hydrazine found none. Based on the 

results of the metabolism studies, 

especially the absence of biphenyl 

hydrazine in the radish metabolism 

study or in the excreta of rats in the rat 

metabolism study, EPA concluded that 

the formation of free hydrazines is 

unlikely. This conclusion is further 

supported by the lack of carcinogenic 

effects in the bifenazate carcinogenicity 

studies. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

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• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

Almond 5%; apple 5%; apricot 1%; 

cherry 1%; cucumber 1%; grape 5%; 

nectarine 5%; peach 10%; pear 10%; 

pecan 1%; pepper 1%; pistachio 1%; 

plum 5%; strawberry 30%; tomato 1%; 

walnut 1%; and watermelon 1%. One 

hundred PCT was assumed for all new 

uses and the remaining currently 

registered uses. 

In most cases, EPA uses available data 

from USDA/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which bifenazate may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for bifenazate in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of bifenazate. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

bifenazate for chronic exposures for 

non-cancer assessments are estimated to 

be 11.2 parts per billion (ppb) for 

surface water and 0.044 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 11.2 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). Bifenazate 

is currently registered for the following 

residential non-dietary sites: 

Ornamental plants, including bedding 

plants, flowering plants, foliage plants, 

bulb crops, perennials, trees, and 

shrubs. There is a potential for shortterm dermal and inhalation exposure of 

homeowners applying bifenazate on 

these sites. However, post-application 

exposures of adults and children from 

this use are expected to be negligible. 

Therefore, EPA assessed only short-term 

dermal and inhalation residential 

handler exposures for adults. Handler 

exposures were estimated assuming 

applications would be made using hoseend sprayers, since this application 

method is expected to result in higher 

exposures than other application 

methods, such as pump sprayers or 

similar devices. 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.’’ 

EPA has not found bifenazate to share 

a common mechanism of toxicity with 

any other substances, and bifenazate 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that bifenazate does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

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. 

The prenatal and postnatal toxicology 

database for bifenazate includes rat and 

rabbit developmental toxicity studies 

and a 2–generation reproduction 

toxicity study in rats. There was no 

quantitative or qualitative evidence of 

increased susceptibility of rats or rabbit 

fetuses to in utero exposure in the 

developmental studies, nor of rats 

following prenatal/postnatal exposure 

in the 2–generation reproduction study. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53591 

were reduced to 1X. That decision is 

based on the following findings: 

• There are no residual uncertainties 

in the toxicity database. The bifenazate 

toxicological database is complete with 

the exception of an inhalation study, 

acute and subchronic neurotoxicity 

studies and an immunotoxicity study. 

The immunotoxicity and acute and 

subchronic neurotoxicity studies are 

now required as a part of new data 

requirements in the 40 CFR part 158 for 

conventional pesticide registration and 

a 28–day inhalation study has not been 

submitted. However, the Agency does 

not believe that conducting these 

studies will result in a lower POD than 

that currently used for overall risk 

assessment, and therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for lack of these studies for 

the following reasons: 

i. The toxicology database for 

bifenazate does not indicate that the 

immune system is the primary target 

organ. The observed effects on the 

immune system have been well 

characterized and were seen at dose(s) 

that produce evidence of overt systemic 

toxicity. These effects included 

increased spleen weight in females and 

histopathological changes in the spleen 

in males in a 90–day oral rat toxicity 

study, extramedullary hematopoiesis in 

the both sexes in a 21–day dermal 

toxicity study in rats, and changes in 

hematological parameters, clinical 

chemistry parameters in both sexes and 

histopathological effects in bone 

marrow (compensatory hyperplasia) in 

both sexes in a 1–year chronic toxicity 

study. 

ii. The overall weight of evidence 

suggests that bifenazate does not 

directly target the immune system, and 

these findings may be due to secondary 

effect of overt systemic toxicity. Further, 

there is no evidence of neurotoxicity or 

neuropathology in the bifenazate 

database. 

iii. A 28–day inhalation study is not 

available; however, the EPA has 

determined that the additional FQPA SF 

is not needed. Residential inhalation 

risk was estimated by calculating 

exposure using the Agency’s Residential 

Standard Operational Procedure (SOPs). 

For chemicals with low vapor pressure 

(7.5 x 10–5 mmHg or below for outdoor 

uses at 20–30°C) these standard 

assumptions are expected to 

overestimate the exposure via the 

inhalation route. Bifenazate is such a 

compound and exposure through the 

inhalation route is expected to be 

minimal. Therefore, the risk estimate is 

conservative and is considered 

protective and the additional FQPA SF 

is not needed. 

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. 

• There is no quantitative or 

qualitative evidence of increased 

susceptibility of rats or rabbit fetuses to 

in utero exposure in developmental 

studies, nor following prenatal/ 

postnatal exposure to rats in the 2– 

generation reproduction study. 

• A DNT is not required because there 

is no evidence of neurotoxicity or 

neuropathology in the bifenazate 

database. 

• The dietary food and drinking water 

exposure assessments will not 

underestimate the potential exposures 

for infants and children; and the 

residential use (ornamentals) is not 

expected to result in post-application 

exposure to infants and children. 

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 aPAD and 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. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, bifenazate is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to bifenazate from 

food and water will utilize 81% of the 

cPAD for children 1 to 2 years 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 bifenazate 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). 

Bifenazate is currently registered for 

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 bifenazate. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that 

food, water, and residential exposures 

aggregated result in aggregate MOEs 

greater than or equal to 1,800 for the 

U.S. population. The aggregate MOEs 

for adults take into consideration food 

and drinking water exposures as well as 

dermal and inhalation exposures of 

adults applying bifenazate to 

ornamentals in residential areas. Since 

residential exposure of infants and 

children is not expected, short-term 

aggregate risk for infants and children is 

the sum of the risk from food and water, 

which does not exceed the Agency’s 

LOC. 

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). 

An intermediate-term adverse effect 

was identified; however, bifenazate is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary exposure. Because there is no 

intermediate-term residential exposure 

and chronic dietary exposure has 

already been assessed under the 

appropriately protective cPAD (which is 

at least as protective as the POD used to 

assess intermediate-term risk), no 

further assessment of intermediate-term 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

bifenazate. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

bifenazate 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 bifenazate 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

is available to enforce the tolerance 

expression. High-performance liquid 

chromatography (HPLC) Method UCCD2341 is available as a primary 

enforcement method for determination 

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53592 Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 

of the combined residues of bifenazate 

and its metabolite, diazinecarboxylic 

acid, 2-(4-methoxy-[1,1′-biphenyl]-3-yl), 

1-methylethyl ester (expressed as 

bifenazate), in/on crop matrices. The 

method has undergone a successful 

validation and has been forwarded to 

the Food and Drug Administration 

(FDA) for inclusion in the Pesticide 

Analytical Manual (PAM) Volume II. In 

addition, a method utilizing a liquid 

chromatographic system with tandem 

mass spectrometers (LC/MS/MS) was 

recently submitted as a confirmatory 

method (Method NCL ME 245) and has 

been forwarded to FDA. 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. 

There are currently no established 

Codex or Mexican MRLs for bifenazate 

on the commodities included in the 

subject petition; however, Canadian 

MRLs are established for residues of 

bifenazate and its metabolite 

diazinecarboxylic acid, 2-(4-methoxy- 

[1,1′-biphenyl]-3-yl, 1-methylethyl ester 

in or on strawberry at 1.5 ppm, grapes 

at 1.0 ppm and raisins at 1.2 ppm. Thus, 

the tolerance expression is harmonized; 

and the MRL/tolerance levels for 

residues in strawberry, raisins and 

grapes are harmonized. 

C. Revisions to Petitioned-For 

Tolerances 

The residue data for sugar apple were 

entered into the Agency’s tolerance 

spreadsheet using the Guidance for 

Setting Pesticide Tolerances Based on 

Field Trial Data SOP to determine an 

appropriate tolerance level. The results 

of this determination indicate that a 

tolerance level of 1.6 ppm is adequate 

for residues of bifenazate and its 

metabolite (expressed as bifenazate) in/ 

on sugar apple rather than 1.5 ppm as 

originally proposed. This determination 

is translated to cherimoya, atemoya, 

custard apple, ilama, soursop, and 

biriba for tolerance setting purposes. 

V. Conclusion 

Therefore, tolerances are established 

for residues of bifenazate, (1- 

methylethyl 2-(4-methoxy[1,1′- 

biphenyl]-3-yl)hydrazinecarboxylate) 

and diazinecarboxylic acid, 2-(4- 

methoxy-[1,1′-biphenyl]-3-yl), 1- 

methylethyl ester (expressed as 

bifenazate), in or on sugar apple, 

cherimoya, atemoya, custard apple, 

ilama, soursop, and biriba at 1.6 ppm; 

avocado at 7.0 ppm; fruit, small, vine 

climbing subgroup 13–07F, except fuzzy 

kiwi fruit at 1.0 ppm; and berry, low 

growing, subgroup 13–07G at 1.5 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: August 20, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Rules and Regulations 53593 

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 180.572 is amended by: 

■ i. Alphabetically adding commodities 

to the table in paragraph (a)(1), and 

■ ii. Revising the table in paragraph (b), 

so the amendments to paragraphs (a)(1) 

and (b) read as follows: 

§ 180.572 Bifenazate; tolerance for 

residues. 

(a)(1) * * * 

Commodity Parts per million 

*****

Atemoya .......................... 1.6 

Avocado .......................... 7.0 

*****

Berry, low-growing subgroup 13–07G ............. 1.5 

Biriba ............................... 1.6 

*****

Cherimoya ...................... 1.6 

*****

Custard apple ................. 1.6 

Commodity Parts per million 

*****

Fruit, small, vine climbing 

subgroup 13–07F, except fuzzy kiwifruit ....... 1.0 

*****

Ilama ............................... 1.6 

*****

Soursop .......................... 1.6 

*****

Sugar apple .................... 1.6 

*****

(b) * * * 

Commodity Parts per million Expiration/Revocation Date 

Timothy, forage ............................................................................................................................................ 50 12/31/10 

Timothy, hay ................................................................................................................................................ 150 12/31/10 

[FR Doc. 2010–21719 Filed 8–31–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

Pipeline and Hazardous Materials 

Safety Administration 

49 CFR Parts 107, 171, 172, 173, 176, 

177, 179, and 180 

[Docket No. PHMSA–2010–0195 (HM–244C)] 

RIN 2137–AE61 

Hazardous Materials: Minor Editorial 

Corrections and Clarifications 

AGENCY: Pipeline and Hazardous 

Materials Safety Administration 

(PHMSA), DOT. 

ACTION: Final rule. 

SUMMARY: This final rule corrects 

editorial errors, makes minor regulatory 

changes and, in response to requests for 

clarification, improves the clarity of 

certain provisions in the Hazardous 

Materials Regulations. The intended 

effect of this rule is to enhance the 

accuracy and reduce misunderstandings 

of the regulations. The amendments 

contained in this rule are nonsubstantive changes and do not impose 

new requirements. 

DATES: Effective Date: October 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Boothe, Office of Hazardous 

Materials Standards, 202–366–8553, 

PHMSA, East Building, PHH–10, 1200 

New Jersey Avenue, SE., Washington, 

DC 20590. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Pipeline and Hazardous Materials 

Safety Administration (PHMSA) 

annually reviews the Hazardous 

Materials Regulations (HMR; 49 CFR 

parts 171–180) to identify typographical 

and other errors, outdated addresses or 

other contact information, and similar 

errors. In this final rule, we are 

correcting typographical errors, 

incorrect CFR references and citations, 

inconsistent use of terminology, 

misstatements of certain regulatory 

requirements and inadvertent omissions 

of information. Because these 

amendments do not impose new 

requirements, notice and public 

comment procedures are unnecessary. 

By making these amendments effective 

without the customary 30-day delay 

following publication, the changes will 

appear in the next revision of the 49 

CFR. 

II. Section by Section Review 

The following is a summary by 

section of the minor editorial 

corrections and clarifications made in 

this final rule. The summary does not 

include minor editorial corrections such 

as punctuation errors or similar minor 

revisions. 

Part 107 

Section 107.117 

This section sets forth conditions and 

procedures for emergency processing for 

an application for a special permit. The 

daytime telephone number for the 

Federal Motor Carrier Administration in 

paragraph (d)(3) is no longer correct. 

Accordingly, we are revising this 

contact number. 

Section 107.329 

This section sets forth the maximum 

and minimum civil penalties for 

violations of the Federal hazardous 

material transportation law, 49 U.S.C. 

5101 et seq., and violations of 

regulations issued pursuant to that law. 

Those maximum and minimum 

penalties were most recently adjusted 

on December 29, 2009 (74 FR 68701) to 

consider the effects of inflation since 

reauthorization of the Federal hazardous 

material transportation law in August 

2005. We found that the inflation 

adjustment in the Federal Civil 

Penalties Inflation Adjustment Act (28 

U.S.C. 2461 note) (the Act)—the change 

in the CPI–U over the prescribed 

period—was 12.5%, but that the Act 

limited the adjustment of the maximum 

and minimum civil penalties to 10%. 

These adjusted maximum and minimum 

civil penalties apply to any violation 

occurring on or after January 1, 2010. 

More recently, it has been called to 

our attention that we did not apply the 

‘‘rounding’’ requirement in Section 5 of 

the Act in making adjustments to the 

minimum civil penalty amounts. 

Applying the 12.5% increase in the 

CPI–U to the $450 minimum penalty for 

a violation related to training produces 

an increase of $56.25, which would be 

rounded to $100—except for the 

limitation in the Act that the initial 

adjustment may not exceed 10%. Thus, 

the adjusted minimum penalty of $495 

for a violation related to training was 

correct. However, when the $250 

minimum penalty amount for other 

violations is increased by 12.5%, the 

result would be an increase of $31.25, 

which must be rounded to the nearest 

$100—or $0. Thus, we should have left 

the minimum civil penalty for other 

violations at $250. Accordingly, we are 

correcting this error in both § 107.329 

and § 171.1(g). PHMSA does not believe 

that the improper $275 civil penalty 

amount has been used in any 

enforcement case arising out of 

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