Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33165 

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: July 1, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.564 is amended in 

paragraph (a) by revising the 

introductory text and by alphabetically 

adding the following commodities to the 

table to read as follows: 

§180.564 Indoxacarb; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of indoxacarb, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only 

indoxacarb, (S)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]

amino]carbonyl]indeno[1,2-e][1,3,4]

[oxadiazine-4a(3H)-carboxylate, and its 

R-enantiomer, (R)-methyl 7-chloro-2,5- 

dihydro-2-[[(methoxycarbonyl)[4- 

(trifluoromethoxy)phenyl]amino]

carbonyl]indeno[1,2- 

e][1,3,4][oxadiazine-4a(3H)-carboxylate. 

Commodity Parts per million 

* * * * * 

Beet, garden, roots .............................................................................................................................................................. 0.30 

Beet, garden, tops ............................................................................................................................................................... 6.0 

Bushberry subgroup 13–07B ............................................................................................................................................... 1.5 

* * * * * 

* * * * * 

[FR Doc. E9–16368 Filed 7–9–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0461; FRL–8422–5] 

Mandipropamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of 

mandipropamid in or on hops, dried 

cones. Syngenta Crop Protection, Inc. 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective July 

10, 2009. Objections and requests for 

hearings must be received on or before 

September 8, 2009, 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–2007–0461. 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: Rose 

Mary Kearns, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5611; e-mail address: 

kearns.rosemary@epa.gov. 


erowe on DSK5CLS3C1PROD with RULES
33166 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 

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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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–2007–0461 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before September 8, 2009. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

HQ–OPP–2007–0461, 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. Petition for Tolerance 

In the Federal Register of June 13, 

2008, (73 FR 33814) (FRL–8367–3), 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 8F7342) by 

Syngenta Crop Protection, Inc., 410 

Swing Road, P.O. Box 18300, 

Greensboro, NC 27419. The petition 

requested that 40 CFR 180.637 be 

amended by establishing tolerances for 

residues of the fungicide 

mandipropamid [4-chloro-N-[2-[3- 

methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)-benzeneacetamide], 

regulated chemical, in or on hops, at 50 

parts per million (ppm). That notice 

referenced a summary of the petition 

prepared by Syngenta Crop Protection, 

Inc, the registrant, which is available to 

the public 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 requested commodity 

‘‘hops’’ to ‘‘hop, dried cones.’’ The 

reason for this change is explained in 

Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue....’’ 

Consistent with 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 the petitioned-for 

tolerances for residues of 

mandipropamid on hop, dried cones at 

50 ppm. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances 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. 

Mandipropamid has low or minimal 

acute toxicity via the oral, dermal, and 

inhalation routes of exposure. It is 

minimally irritating to the eye and nonirritating to the skin. It is also negative 

for skin sensitization. 

Liver toxicity was the primary effect 

and was observed in rats, mice, and 

dogs. In the 24–month rat study, 

nephrotoxicity was observed in males 

only. The lack of liver toxicity in this 

long-term study was probably due to the 

lower doses when compared with the 

90–day study. In a 90–day rat study, 

there was slight hepatotoxicity in both 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33167 

sexes; there was the suggestion of effects 

on the liver in the 90–day mouse study 

in which increased liver weights in both 

sexes and microscopic pathology were 

observed. In the 90–day dog study liver 

effects included increased cholesterol, 

increased liver weights and liver 

enzymes (alkaline phosphatase activity, 

alanine aminotransferase) and increased 

pigment in hepatocytes and Kupffer 

cells in both sexes. Additionally, 

centrilobular hepatocyte vacuolation in 

females was observed. In the combined 

chronic/carcinogenicity rat study, no 

effects on the liver were noted at doses 

up to and including the highest dose 

tested (HDT) of 61/70 mg/kg/day (M/F); 

however, increased nephrotoxicity 

occurred in males. No liver effects were 

observed in the mouse carcinogenicity 

study at doses up to 223/285 mg/kg/day 

(M/F). The following effects on the liver 

were present in the 1–year dog study: 

Increased incidence and severity of 

microscopic pigment in the liver and 

increased alkaline phosphatase activity 

in both sexes, as well as increased 

alanine aminotransferase activity in 

males. Therefore, effects on the liver of 

rats, mice and dogs appear within 90– 

days (also in the 1–year dog study); 

whereas, in the 24–month rat study, 

only nephrotoxicity was observed and, 

in the 18–month mouse study, only 

decreased body weight and food 

utilization was noted. 

There was no evidence of 

teratogenicity or indications of 

increased neonatal sensitivity in the 

developmental and reproduction 

toxicity studies. In the rat and rabbit 

developmental toxicity studies, there 

were no treatment-related maternal or 

developmental effects observed up to 

the limit dose of 1,000 mg/kg/day. In the 

2-generation rat reproduction study, the 

only parental/systemic effects were 

decreased body weights, body weight 

gains, food consumption and food 

utilization in males. No effects on 

reproduction were observed at any dose. 

Offspring effects were decreased pup 

body weights in both sexes, but this 

effect occurred at doses which also 

caused effects in parental animals. 

Dermal exposure to mandipropamid 

for 28–days in the rat did not result in 

systemic or dermal toxicity up to the 

limit dose of 1000 mg/kg/day. There 

was no evidence of developmental 

effects, neurotoxicity, mutagenicity or 

carcinogenicity after exposure to 

mandipropamid. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mandipropamid as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in the 

final rule published in the Federal 

Register of January 16, 2008, (73 FR 

2812) (FRL–8346–6). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 

uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 mandipropamid used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of January 16, 

2008. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mandipropamid, EPA 

considered exposure under the 

petitioned-for tolerance as well as all 

existing mandipropamid tolerances in 

(40 CFR 180.637). EPA assessed dietary 

exposures from mandipropamid 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 

mandipropamid; 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 USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

used tolerance level residues and 

assumed 100 percent of all crops are 

treated 100 percent crop treated (PCT). 

iii. Cancer. EPA has determined that 

mandipropamid classified as ‘‘not likely 

to be carcinogenic to humans’’ based on 

the absence of treatment-related 

increases in tumors in rat and mouse 

carcinogenicity studies. Therefore, there 

is no cancer risk associated with the 

proposed use of mandipropamid. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for mandipropamid. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

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. 

EPA did not use PCT information in 

assessing dietary exposure to 

mandipropamid. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for mandipropamid in drinking water. 

These simulation models take into 


erowe on DSK5CLS3C1PROD with RULES
33168 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 

account data on the physical, chemical, 

and fate/transport characteristics of 

mandipropamid. 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. 

The Agency used the FIRST (Version 

1.1.0) model for estimation of surface 

water and the Screening Concentration 

in Ground Water (SCI–GROW, Version 

2.3) model, for estimation of ground 

water to determine estimated drinking 

water concentrations (EDWC) of 

mandipropamid. 

For chronic exposures for non-cancer 

assessment the EDWCs are estimated to 

be 36.5 ppb for surface water and 2.4 

ppb for ground water. 

Modeled estimates of surface water 

drinking water concentrations were 

directly entered into the dietary 

exposure model. 

For chronic dietary risk assessment, 

the water concentration of value 36.5 

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). 

Mandipropamid is not registered for 

any specific use patterns that would 

result in residential exposure. 

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 mandipropamid to 

share a common mechanism of toxicity 

with any other substances, and 

mandipropamid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that mandipropamid 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 safety factor (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. 

There is no evidence (quantitative or 

qualitative) of increased susceptibility 

and no residual uncertainties with 

regard to prenatal toxicity following in 

utero exposure to rats or rabbits 

(developmental studies) and pre and/or 

post-natal exposures to rats 

(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 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

mandipropamid is not complete because 

an immunotoxicity study is required. 

Despite this data gap, EPA has 

concluded that the database is adequate 

to assess the pre- and postnatal toxicity 

of mandipropamid and that there is no 

need for an additional database 

uncertainty factor to account for the 

missing study. 

EPA began requiring functional 

immunotoxicity testing of all food and 

nonfood use pesticides on December 26, 

2007. This study is not yet available for 

mandipropamid. EPA has evaluated the 

available mandipropamid toxicity 

studies for evidence of potential 

immunotoxicity, including hematology, 

gross organ weights for spleen and 

thymus, clinical chemistry and 

histopathology, to determine if an 

additional database uncertainty factor is 

needed to account for potential 

immunotoxicity. The overall weight of 

evidence suggests that mandipropamid 

does not directly target the immune 

system. Therefore, the Agency does not 

believe that conducting a functional 

immunotoxicity study will result in a 

lower POD than the currently selected 

for overall risk assessment, and 

therefore, a database uncertainty (UFDB) 

is not needed to account for the lack of 

this study. 

ii. There is no indication that 

mandipropamid is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

mandipropamid results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

mandipropamid in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by mandipropamid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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, mandipropamid 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 

mandipropamid from food and water 

will utilize 30% of the cPAD for 

(children 1–2 years of age) the 

population group receiving the greatest 

exposure. There are no residential uses 

for mandipropamid. 

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). 

Mandipropamid is not registered for 

any use patterns that would result in 


erowe on DSK5CLS3C1PROD with RULES
Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 33169 

residential exposure. Therefore, a shortterm aggregate risk assessment was not 

needed. 

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). 

Mandipropamid is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

Therefore, an intermediate-term 

aggregate risk was not needed. 

5. Aggregate cancer risk for U.S. 

population. Based on the absence of 

treatment-related increases in tumors in 

rat and mouse carcinogenicity studies 

with mandipropamid, EPA concludes 

that mandipropamid does not pose a 

cancer risk. 

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 

mandipropamid residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography with tandem 

mass spectrometry (LC/MS/MS)) is 

available to enforce tolerances for 

mandipropamid. 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; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are no specific Codex, 

Canadian, or Mexican maximum residue 

limits (MRLs) for mandipropamid. 

C. Revisions to Petitioned-For 

Tolerances 

EPA changed the requested 

commodity ‘‘hops’’ to ‘‘hop, dried 

cones’’ to harmonize with accepted 

tolerance terminology. 

V. Conclusion 

Therefore, tolerances are established 

for residues of mandipropamid, [4- 

chloro-N-[2-[3-methoxy-4-(2- 

propynyloxy)phenyl]ethyl]-a-(2- 

propynyloxy)-benzeneacetamide in or 

on hop, dried cones at 50 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: June 23, 2009. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.637 is amended by 

alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§180.637 Mandipropamid; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per million 

*****

Hop, dried cones ................................................................................................................................................................. 50 

*****


erowe on DSK5CLS3C1PROD with RULES
33170 Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Rules and Regulations 

* * * * * 

[FR Doc. E9–16369 Filed 7–9–09; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 040205043–4043–01] 

RIN 0648–XO54 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; Snapper– 

grouper Fishery of the South Atlantic; 

Closure of the 2009 Commercial 

Fishery for Golden Tilefish in the 

South Atlantic 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS closes the commercial 

fishery for golden tilefish in the 

exclusive economic zone (EEZ) of the 

South Atlantic. In addition, for a person 

on board a vessel for which a Federal 

commercial or charter vessel/headboat 

permit for the South Atlantic Snapper– 

Grouper Fishery has been issued, the 

provisions of the closure (restriction to 

the bag and possession limits and 

prohibition of sale or purchase) apply 

regardless of whether the golden tilefish 

are harvested in state waters or the 

South Atlantic EEZ. NMFS has 

determined that the quota for the 

commercial fishery for golden tilefish 

will have been reached by July 15, 2009. 

This closure is necessary to protect the 

golden tilefish resource. 

DATES: Closure is effective 12:01 a.m., 

local time, July 15, 2009, through 

December 31, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Catherine Bruger, telephone 727–824– 

5305, fax 727–824–5308, e–mail 

Catherine.Bruger@noaa.gov. 

SUPPLEMENTARY INFORMATION: The 

snapper–grouper fishery of the South 

Atlantic is managed under the Fishery 

Management Plan for the Snapper– 

Grouper Fishery of the South Atlantic 

Region (FMP). The FMP was prepared 

by the South Atlantic Fishery 

Management Council and is 

implemented under the authority of the 

Magnuson–Stevens Fishery 

Conservation and Management Act 

(Magnuson–Stevens Act) by regulations 

at 50 CFR part 622. Those regulations, 

found at 50 CFR 622.42(e)(2), set the 

commercial quota for golden tilefish in 

the South Atlantic at 295,000 lb 

(133,810 kg) for the current fishing year, 

January 1 through December 31, 2009. 

Under 50 CFR 622.43(a), NMFS is 

required to close the commercial fishery 

for a species or species group when the 

quota for that species or species group 

is reached, or is projected to be reached, 

by filing a notification to that effect with 

the Office of the Federal Register. Based 

on current statistics, NMFS has 

determined that the available 

commercial quota of 295,000 lb (133,810 

kg) for golden tilefish will be reached on 

or before July 15, 2009. Accordingly, 

NMFS is closing the commercial fishery 

for golden tilefish in the South Atlantic 

EEZ from 12:01 a.m., local time, on July 

15, 2009, through December 31, 2009. 

During the closure, the applicable bag 

and possession limits specified in 50 

CFR 622.39(d)(1)(ii) and (d)(2), 

respectively, apply to all harvest or 

possession of golden tilefish in or from 

the South Atlantic EEZ, and the sale or 

purchase of golden tilefish taken from 

the EEZ is prohibited. In addition, for a 

person on board a vessel for which a 

Federal commercial or charter vessel/ 

headboat permit for the South Atlantic 

Snapper–Grouper Fishery has been 

issued, those provisions of the closure 

for golden tilefish apply regardless of 

whether the fish are harvested in state 

waters or the South Atlantic EEZ. The 

operator of a vessel with golden tilefish 

in excess of the bag or possession limit 

aboard must have landed such golden 

tilefish prior to 12:01 a.m., local time, 

July 15, 2009, and all sale or purchase 

of golden tilefish must occur prior to 

12:01 a.m., local time, July 15, 2009. 

The prohibition on sale or purchase 

does not apply to sale or purchase of 

golden tilefish that were harvested, 

landed ashore, and sold prior to 12:01 

a.m., local time, July 15, 2009, and were 

held in cold storage by a dealer or 

processor. 

Classification 

This action responds to the best 

available information recently obtained 

from the fishery. The Assistant 

Administrator for Fisheries, NOAA, 

(AA), finds good cause to waive the 

requirement to provide prior notice and 

opportunity for public comment 

pursuant to the authority set forth at 5 

U.S.C. 553(b)(B) as such prior notice 

and opportunity for public comment is 

unnecessary and contrary to the public 

interest. Such procedures would be 

unnecessary because the rule itself has 

already been subject to notice and 

comment, and all that remains is to 

notify the public of the closure. 

Allowing prior notice and opportunity 

for public comment is contrary to the 

public interest because of the need to 

immediately implement this action to 

protect the fishery since the capacity of 

the fishing fleet allows for rapid harvest 

of the quota. Prior notice and 

opportunity for public comment would 

require time and would potentially 

result in a harvest well in excess of the 

established quota. 

For the aforementioned reasons, the 

AA also finds good cause to waive the 

30-day delay in the effectiveness of this 

action under 5 U.S.C. 553(d)(3). 

This action is taken under 50 CFR 

622.43(a) and is exempt from review 

under Executive Order 12866. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: July 7, 2009. 

Kristen C. Koch, 

Acting Director, Office of Sustainable 

Fisheries, National Marine Fisheries Service. 

[FR Doc. E9–16378 Filed 7–7–09; 8:45 am] 

BILLING CODE 3510–22–S 


erowe on DSK5CLS3C1PROD with RULES