Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 11583 

READING AREA’S MOTOR VEHICLE EMISSION BUDGETS FOR THE 1997 ANNUAL PM2.5 NAAQS IN TONS PER YEAR— 

Continued 

Type of control strategy SIP Year PM2.5 NOX Effective date of 

SIP approval 

2025 146 3,719 3/4/15 

PART 81—DESIGNATION OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 1. The authority citation for Part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 2. Section 81.339 is amended by 

revising the 1997 Annual PM2.5 NAAQS 

table entry for the Reading Area to read 

as follows: 

§ 81.339 Pennsylvania. 

* * * * * 

PENNSYLVANIA—1997 ANNUAL PM2.5 NAAQS 

[Primary and secondary] 

Designated Area 

Designation a Classification 

Date 1 Type Date 2 Type 

*******

Reading, PA: 

Berks County ........................................................................... March 4, 2015 .. Attainment.

*******

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is 90 days after January 5, 2005, unless otherwise noted. 

2This date is July 2, 2014, unless otherwise noted. 

* * * * * 

[FR Doc. 2015–04391 Filed 3–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0110; FRL–9921–85] 

Metaldehyde; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of metaldehyde 

in or on multiple commodities which 

are identified and discussed later in this 

document. Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). This 

regulation additionally removes the 

established tolerances in or on fruit, 

citrus group 10 and tomato as the 

tolerances will be superseded by 

tolerances established by this action. 

DATES: This regulation is effective 

March 4, 2015. Objections and requests 

for hearings must be received on or 

before May 4, 2015, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0110 is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

Notices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR site at http://www.ecfr.gov/cgi-bin/ 

text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 


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11584 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 

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–2014–0110 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 May 4, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0110, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of February 

25, 2014 (79 FR 10459) (FRL–9906–77), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 3E8223) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.523 be 

amended by establishing tolerances for 

residues of the molluscicide 

metaldehyde, 2,4,6,8-tetramethyl1,3,5,7-tetroxocane, in or on clover, 

forage at 0.5 parts per million (ppm); 

clover, hay at 0.5 ppm; ginseng at 0.05 

ppm; vegetable legume, edible podded, 

subgroup 6A at 0.8 ppm; pea and bean, 

succulent shelled, subgroup 6B at 0.2 

ppm; vegetable, foliage of legume, 

except soybean, subgroup 7A at 1.5 

ppm; tomato subgroup 8–10A at 0.24 

ppm; and fruit, citrus, group 10–10 at 

0.26 ppm. Clover, forage and clover, hay 

were proposed as tolerances with 

regional registrations. Additionally, the 

petition requested removing the 

established tolerances in or on fruit, 

citrus, group 10 at 0.26 ppm; and tomato 

at 0.24 ppm, upon establishment of the 

proposed tolerances. That document 

referenced a summary of the petition 

prepared by Lonza, Inc., the registrant, 

which is available in the docket, http:// 

www.regulations.gov. Comments were 

received on the notice of filing. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the proposed tolerances for 

clover, forage and clover, hay from 0.5 

ppm to 0.60 ppm. The reason for these 

changes are 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for metaldehyde 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with metaldehyde 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. The principal 

toxic effects for metaldehyde are clinical 

signs of neurotoxicity, as well as 

changes in the liver and testes/prostate 

following repeated oral dosing. The dog 

is the most sensitive species for 

neurotoxic effects. Nervous system 

effects observed in the subchronic and 

chronic oral toxicity studies include: 

Ataxia and tremors; twitching; 

salivation; emesis; rapid respiration in 

dogs and maternal rats; and limb 

paralysis, spinal cord necrosis, and 

hemorrhage in maternal rats. Liver 

effects include increased liver weight, 

increased incidence of liver lesions 

(hepatocellular necrosis, hepatocellular 

hypertrophy and inflammation), and an 

increased incidence of hepatocellular 

adenomas in female rats and in both 

sexes of mice. In dogs, atrophy of the 

testes and prostate was observed 

following subchronic and chronic 

exposure. 

In the rat developmental toxicity 

study, maternal toxicity was observed as 

evidenced by clinical signs including 

ataxia, tremors, and twitching at the 

highest dose tested (HDT) in the absence 

of developmental toxicity. There was no 

observed developmental or maternal 

toxicity in the rabbit developmental 

toxicity study. In the 2-generation rat 

reproductive toxicity study, mortality 

and clinical signs including limb 

paralysis, spinal cord necrosis and 

hemorrhage were observed in the 

maternal animals. Effects on the 

offspring in the rat reproductive toxicity 

study consisted of decreased pup body 

weight and body weight gains; 

reproductive toxicity was not observed. 

In the rat, clinical signs of 

neurotoxicity occurred at high dose 

levels following repeated oral 

exposures. In the 90-day neurotoxicity 

study, bilateral hindlimb paralysis was 

observed in one female rat at the HDT. 

Chronic feeding studies in rats and 

mice indicated that metaldehyde 

produced liver effects characterized by 

liver hypertrophy and liver tumors. The 

chronic mouse toxicity study showed 

that metaldehyde was associated with a 

common tumor in both sexes (liver 

tumors, adenomas), and the rat chronic 


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toxicity study showed that metaldehyde 

was associated with liver adenomas in 

the female. EPA has determined that 

quantification of risk using a nonlinear 

Reference Dose (RfD) approach, using 

the chronic RfD/Population-Adjusted 

Dose (PAD), will adequately account for 

all chronic toxicity, including 

carcinogenicity, that could result from 

exposure to metaldehyde. That 

conclusion is based on the following 

considerations: 

1. Tumors found are commonly seen 

in the mouse; 

2. Liver tumors (adenomas) in both 

species were benign; 

3. Metaldehyde is not mutagenic; 

4. No carcinogenic response was seen 

in the male rat; 

5. Incidence of adenomas at the high 

dose in the female rat was within the 

historical control range of the testing 

lab; and 

6. Both the No Observed Adverse 

Effect Level (NOAEL) and Lowest 

Observed Adverse Effect Level (LOAEL) 

from the chronic rat study on which the 

chronic RfD/PAD was based are well 

below the dose at which adenomas were 

seen. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by metaldehyde as well 

as the no-observed-adverse-effect-level 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Metaldehyde; Human Health Risk 

Assessment for Proposed New Uses on 

Vegetable, Legume, Edible Podded 

[Subgroup 6A], Pea and Bean, Succulent 

Shelled [Subgroup 6B], Vegetable, 

Foliage of Legume, Except Soybean 

[Subgroup 7A], Clover Forage and Hay, 

and Ginseng; and for Amendments to 

Existing Tolerances [Tomato and Crop 

Group 10]’’ in docket ID number EPA– 

HQ–OPP–2014–0110. 

B. Toxicological Points of Departure/

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for metaldehyde used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of November 27, 

2013 (78 FR 70864) (FRL–9399–8). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to metaldehyde, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing metaldehyde tolerances in 40 

CFR 180.523. EPA assessed dietary 

exposures from metaldehyde in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

Such effects were identified for 

metaldehyde. In estimating acute 

dietary exposure, EPA used the Dietary 

Exposure Evaluation Model with the 

Food Commodity Intake Database 

(DEEM–FCID). This software 

incorporates 2003–2008 food 

consumption data from the U.S. 

Department of Agriculture’s National 

Health and Nutrition Examination 

Survey, What We Eat in America, 

(NHANES/WWEIA). As to residue levels 

in food, EPA used tolerance-level 

residues for all commodities and 100 

percent crop treated (PCT) estimates. 

The Agency also assumed processing 

factors to be 1.0 for all commodities 

except for dried tomato, tomato juice, 

cranberry juice, and high fructose corn 

syrup; for these commodities, DEEM 

default processing factors were used. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/

WWEIA. As to residue levels in food, 

EPA used tolerance-level residues for all 

commodities and assumed 100 PCT. 

The Agency also assumed processing 

factors to be 1.0 for all commodities 

except for dried tomato, tomato juice, 

cranberry juice, and high fructose corn 

syrup; for these commodities, DEEM 

default processing factors were used. 

iii. Cancer. As discussed in Unit 

III.A., EPA has concluded that a 

nonlinear RfD approach is appropriate 

for assessing cancer risk to 

metaldehyde. Cancer risk was assessed 

using the same exposure estimates as 

discussed in Unit III.C.1.ii. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for metaldehyde. Tolerance-level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for metaldehyde in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

metaldehyde. 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of metaldehyde 

for acute exposures are estimated to be 

205 parts per billion (ppb) for surface 

water and 1,880 ppb for ground water 

and for chronic exposures for noncancer assessments are estimated to be 

136 ppb for surface water and 915 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

For acute dietary risk assessment, the 

water concentration value of 1,880 ppb 

was used to assess the contribution to 

drinking water. 

For chronic dietary risk assessment, 

the water concentration of value 915 

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). 

Metaldehyde is currently registered 

for the following uses that could result 

in residential exposures: Residential 

ornamentals and lawn/turf applications. 


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EPA assessed residential exposure using 

the following assumptions: 

i. Adult handler short-term inhalation 

exposures from loading/applying 

metaldehyde products including liquid 

ready-to-use products (with manuallypressurized hand wands, hose-end 

sprayers, and sprinkler cans) and 

applying granules (via push-type rotary 

spreaders, belly grinders, spoons, cups, 

hands, and shaker cans); and 

ii. Metaldehyde incidental postapplication exposures assessed for 

children, including short-term exposure 

from hand-to-mouth and object-tomouth contact with treated turf, and 

short- and intermediate-term exposures 

from treated soil ingestion. While EPA 

did calculate an acute incidental 

ingestion scenario for toddlers 

accidentally ingesting granules of 

metaldehyde, it is not appropriate to 

aggregate this scenario because it 

represents poisoning incident which is 

not likely to overlap with the typical 

post-application exposure scenario. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

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 metaldehyde to 

share a common mechanism of toxicity 

with any other substances, and 

metaldehyde does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that metaldehyde 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 Web site 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. 

Developmental toxicity was not 

observed in the rat or rabbit 

developmental toxicity studies, and 

maternal toxicity was not observed in 

the rabbit. In the rat, maternal toxicity 

was observed, as evidenced by clinical 

signs (ataxia, tremors, and twitching) at 

the HDT. In the rat reproductive toxicity 

study, mortality and clinical signs (limb 

paralysis, spinal cord necrosis and 

hemorrhage) were observed in the 

maternal animals, and the effects on the 

offspring consisted of decreased pup 

body weight and body weight gains. 

Reproductive toxicity was not observed. 

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 

metaldehyde is complete. 

ii. The toxicity database contains 

indications of neurotoxicity resulting 

from exposure to metaldehyde, 

including: 

a. Clinical signs [ataxia, twitching, 

tremors, prostration, paresis of hind 

legs] in female rats in the developmental 

toxicity study; 

b. Hindlimb paralysis, necrosis and 

hemorrhage in the spinal cord and 

vertebra luxation in F0 dams during 

lactation period in the 2-generation 

reproduction study; 

c. Bilateral hindlimb paralysis 

observed initially on day 10 in one highdose female sacrificed on day 22 due to 

poor condition in the 90-day subchronic 

neurotoxicity study in rats; no 

neuropathology was evident; 

d. Clinical signs [ataxia, tremors, 

twitching, salivation] in the chronic dog 

study, which occurred within the first 

week of exposure and persisted through 

week 19; other signs observed in the 

chronic dog study included lateral 

position, reduced mobility, convulsions, 

and vocalization in one female, and 

agitation in another. 

EPA has determined that the acute 

and developmental neurotoxicity 

studies are not needed, nor are 

additional uncertainty factors (UFs) 

necessary to account for neurotoxicity. 

There were no indications of neurotoxic 

effects in developing rats or rabbits in 

either the developmental or 

reproductive studies. Although there 

were some effects in adult rats, those 

effects occurred at doses much higher 

than in the dog study. The dog is the 

more sensitive species for neurotoxic 

effects and points of departure (30 mg/ 

kg/day and 10 mg/kg/day) are based on 

the chronic dog oral toxicity study, 

which EPA considers to be protective of 

any neurotoxicity at higher dose levels. 

iii. There is no evidence that 

metaldehyde 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 metaldehyde 

in drinking water. EPA used similarly 

conservative assumptions to assess post 

application exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by metaldehyde. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

metaldehyde will occupy 55% of the 

aPAD for all infants (less than 1 year 

old), the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to metaldehyde 

from food and water will utilize 51% of 

the cPAD for all infants less than 1 year 

old the population group receiving the 

greatest exposure. Chronic exposures to 

metaldehyde are expected for food and 

water only. 


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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). Metaldehyde 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 metaldehyde. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded the combined short-term 

food, water, and residential exposures 

result in aggregate MOEs of 1,400 for 

adults and 590 for children. Because 

EPA’s level of concern for metaldehyde 

is a MOE of 100 or below, these MOEs 

are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Metaldehyde is currently registered for 

uses that could result in intermediateterm residential exposure, and the 

Agency has determined that it is 

appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to metaldehyde. 

Using the exposure assumptions 

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

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 280 for children, 

only. Because EPA’s level of concern for 

metaldehyde is a MOE of 100 or below, 

this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to metaldehyde. Cancer risk 

was assessed using the same cPAD and 

exposure estimates as discussed in Unit 

III.A. and Unit III.C.1.ii. for the chronic 

risk assessment. Based on the results 

discussed in Unit III.E.2., EPA 

concludes that aggregate exposure to 

metaldehyde will 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 metaldehyde 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography with mass 

spectrometry (GC/MS) method (EN–CAS 

Method No. ENC–3/99, Revision 1) is 

available to enforce the tolerance 

expression. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

The Codex has not established a MRL 

for metaldehyde. 

C. Response to Comments 

Six comments were posted in the 

docket for this action. However, the 

comments received were regarding bee 

concerns for a different chemical, 

sulfoxaflor. These comments were 

addressed at the time the Agency 

assessed sulfoxaflor. As a result, the 

only comments received were 

determined to be irrelevant to the 

Agency’s tolerance action on 

metaldehyde. 

D. Revisions to Petitioned-For 

Tolerances 

The Agency has determined that 

tolerances of 0.60 ppm for clover hay 

and forage are appropriate based on 

available residue data and use of the 

OECD tolerance calculation procedures. 

V. Conclusion 

Therefore, tolerances are established 

for residues of metaldehyde in or on the 

following commodities: Vegetable, 

legume, edible podded, subgroup 6A at 

0.80 ppm; pea and bean, succulent 

shelled, subgroup 6B at 0.20 ppm; 

vegetable, foliage of legume, except 

soybean, subgroup 7A at 1.5 ppm; 

tomato subgroup 8–10A at 0.24 ppm; 

fruit, citrus, group 10–10 at 0.26; and 

ginseng at 0.05 ppm; and tolerances 

with regional registrations for clover, 

forage at 0.60 ppm and clover, hay at 

0.60 ppm. The regulation additionally 

removes the tolerances in or on fruit, 

citrus group 10 and tomato. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerances in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 


ebenthall on DSK5SPTVN1PROD with RULES
11588 Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 23, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.523: 

■ a. Revise the entry for ‘‘Fruit, citrus, 

group 10’’ in the table in paragraph (a). 

■ b. Add alphabetically the entries for 

‘‘Ginseng’’; ‘‘Pea and bean, succulent 

shelled, subgroup 6B’’; ‘‘Tomato 

subgroup 8–10A’’; ‘‘Vegetable, foliage of 

legume, except soybean, subgroup 7A’’; 

and ‘‘Vegetable, legume, edible podded 

subgroup 6A’’ to the table in paragraph 

(a). 

■ c. Remove the entry for ‘‘Tomato’’ in 

the table in paragraph (a). 

■ d. Add alphabetically the entries for 

‘‘Clover, forage’’ and ‘‘Clover, hay’’ to 

the table in paragraph (c). 

The amendments read as follows: 

§ 180.523 Metaldehyde; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

*******

Fruit, citrus, group 10–10 .................................................................................................................................................................... 0.26 

Ginseng ................................................................................................................................................................................................ 0.05 

*******

Pea and bean, succulent shelled, subgroup 6B ................................................................................................................................. 0.20 

*******

Tomato subgroup 8–10A ..................................................................................................................................................................... 0.24 

*******

Vegetable, foliage of legume, except soybean, subgroup 7A ............................................................................................................ 1.5 

Vegetable, legume, edible podded subgroup 6A ................................................................................................................................ 0.80 

*******

* * * * * (c) * * * 

Commodity Parts per 

million 

Clover, forage ...................................................................................................................................................................................... 0.60 

Clover, hay ........................................................................................................................................................................................... 0.60 

*******


ebenthall on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 42 / Wednesday, March 4, 2015 / Rules and Regulations 11589 

* * * * * 

[FR Doc. 2015–04277 Filed 3–3–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0601; FRL–9922–29] 

9-Octadecenoic Acid (9Z)-, Sulfonated, 

Oxidized and its Potassium and 

Sodium Salts; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 9-octadecenoic 

acid (9Z)-, sulfonated, oxidized; 9- 

octadecenoic acid (9Z)-, sulfonated, 

oxidized, potassium salts; and 9- 

octadecenoic acid (9Z)-, sulfonated, 

oxidized, sodium salts, when used as an 

inert ingredient in antimicrobial 

pesticide formulations used on food 

contact surfaces in public eating places, 

dairy processing equipment and food 

processing equipment and utensils at a 

maximum end-use concentration not to 

exceed 250 parts per million (ppm). 

Ecolab submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of 9-octadecenoic acid 

(9Z)-, sulfonated, oxidized and its 

potassium and sodium salts. 

DATES: This regulation is effective 

March 4, 2015. Objections and requests 

for hearings must be received on or 

before May 4, 2015, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0601, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Director, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; main 

telephone number: (703) 305–7090; 

email address: RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Publishing 

Office’s e-CFR site at http://

www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2013–0601 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 May 4, 2015. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2013–0601, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Petition for Exemption 

In the Federal Register of September 

12, 2013 (78 FR 56185) (FRL–9399–7), 

EPA issued a document pursuant to 

FFDCA section 408, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP IN–10549) by Ecolab, Inc. 

370 N. Wabasha Street, St. Paul, MN 

55102. The petition requested that 40 

CFR 180.940(a) be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of 9-octadecenoic acid (9Z)-, sulfonated, 

oxidized (CAS Reg. No. 1315321–93–7); 

9-octadecenoic acid (9Z)-, sulfonated, 

oxidized, potassium salts (CAS Reg. No. 

1315321–94–8); and 9-octadecenoic acid 

(9Z)-, sulfonated, oxidized, sodium 

salts, (CAS No. 1315321–95–9) when 

used as an inert ingredient in 

antimicrobial pesticide formulations 

used on food contact surfaces in public 

eating places, dairy processing 

equipment, and food processing 

equipment and utensils at a maximum 

end-use concentration not to exceed 250 

ppm. That document referenced a 

summary of the petition prepared by 

Ecolab Inc, the petitioner, which is 

available in the docket, http://

www.regulations.gov. There were no 


ebenthall on DSK5SPTVN1PROD with RULES