Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 55991 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Ozone, Volatile organic 

compounds. 

Dated: September 1, 2010. 

Beverly H. Banister, 

Acting Regional Administrator, Region 4. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

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

Subpart S—Kentucky 

■ 2. Section 52.920(c) Table 1 is 

amended by revising the entries for ‘‘401 

KAR 51:001,’’ ‘‘401 KAR 51:017,’’ and 

‘‘401 KAR 51:052’’ to read as follows: 

§ 52.920 Identification of plan. 

* * * * * 

(c) * * * 

TABLE 1—EPA-APPROVED KENTUCKY APPROVED KENTUCKY REGULATIONS

State citation Title/subject State effective date EPA approval date Explanation 

* * * * * **

Chapter 51 Attainment and Maintenance of the National Ambient Air Quality Standards 

401 KAR 51:001 ......... Definitions for 401 

KAR Chapter 51.

2/5/2010 9/15/2010 [Insert citation of publication].Except the phrase ‘‘except ethanol production facilities producing ethanol by natural 

fermentation under the North American 

Industry Classification System (NAICS) 

codes 325193 or 312140,’’ in 401 KAR 

51:001 Section 1 (118)(1)(b)(i) and the 

phrase ‘‘except ethanol production facilities producing ethanol by natural fermentation under NAICS codes 325193 or 

312140,’’ in 401 KAR 51:001 Section 

1(118) (2)(c)(20). 

* * * * * **

401 KAR 51:017 ......... Prevention of significant deterioration 

of air quality.

2/5/2010 9/15/2010 [Insert citation of publication].Except the phrase ‘‘except ethanol production facilities producing ethanol by natural 

fermentation under the North American 

Industry Classification System (NAICS) 

codes 325193 or 312140;’’ in 401 KAR 

51:017 Section 7(1)(c)20. 

401 KAR 51:052 ......... Review of new 

sources in or impacting upon nonattainment areas.

2/5/2010 9/15/2010 [Insert citation of publication].Except the phrase ‘‘except ethanol production facilities producing ethanol by natural 

fermentation under the North American 

Industry Classification System (NAICS) 

codes 325193 or 312140,’’ in 401 KAR 

51:052 Section 2 (3)(t). 

* * * * * **

* * * * * 

[FR Doc. 2010–22856 Filed 9–14–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0121; FRL–8839–3] 

Ammonium Formate; 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 ammonium 

formate (CAS Reg. No. 540–69–2) when 

used as an inert ingredient (complexing 

or fixing agent with copper compounds) 

in pesticide formulations for certain preharvest uses. Phyton Corporation 

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 

ammonium formate. 

DATES: This regulation is effective 

September 15, 2010. Objections and 

requests for hearings must be received 

on or before November 15, 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–2006–0121. 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 

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55992 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 

(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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; e-mail address: 

debesai.alganesh@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: 

• 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 provides 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 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. The EPA procedural 

regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2006–121 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 15, 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 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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0121, 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 Exemption 

In the Federal Register of April 21, 

2006 (71 FR 20671) (FRL–8067–3), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

6E7028) by Phyton Corporation, 7449 

Cahill Rd., Edina, MN 55439. The 

petition requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of ammonium 

formate (CAS Reg. No. 540–69–2) when 

used as an inert ingredient (complexing 

or fixing agent) with the active 

ingredient copper in pesticide 

formulations applied to growing crops. 

That notice referenced a summary of the 

petition 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 

modified the exemption requested to 

not restrict to use with the active 

ingredient copper. No limitations are 

necessary because no hazard was 

identified. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for 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 

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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.’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), 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 ammonium 

formate including exposure resulting 

from the exemption established by this 

action. EPA’s assessment of exposures 

and risks associated with ammonium 

formate follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by ammonium formate are discussed in 

this unit. 

The following provides a brief 

summary of the risk assessment and 

conclusions for the Agency’s review of 

ammonium formate. The Agency’s full 

decision document for this action can be 

found at http://www.regulations.gov in 

the document: Ammonium Formate. 

Human Health Risk Assessment and 

Ecological Effects Summary to Support 

Proposed Exemption from the 

Requirement of a Tolerance When Used 

as an Inert Ingredient in Pesticide 

Formulations Applied Pre-harvest in 

docket ID number EPA–HQ–OPP–2006– 

0121. 

Ammonium formate breaks down into 

ammonium and formate ions. 

Ammonium ions are a toxic waste 

product of the metabolism in animals; 

they are ubiquitous in the natural 

environment and can be considered as 

having little toxicity or hazard risk. In 

fish and aquatic invertebrates, it is 

excreted directly into the water. In 

mammals, sharks, and amphibians, it is 

converted in the urea cycle to urea, 

because urea is less toxic and can be 

stored more efficiently. In birds, 

reptiles, and terrestrial snails, metabolic 

ammonium is converted into uric acid, 

which is solid, and can therefore be 

excreted with minimal water. Formic 

acid is readily metabolized and 

eliminated by the body; it slowly 

decomposes to carbon monoxide and 

water. 

The toxicological database for 

ammonium formate is limited. There is 

available data on formic acid and 

related formate compounds (such as 

calcium and sodium formate), which 

can serve as suitable surrogates for 

ammonium formate. Studies conducted 

with methanol are also applicable to 

formate compounds, since methanol is 

metabolized into formic acid. 

Acute oral toxicity of ammonium 

formate in mice is reported to be 

moderate via oral route (LD50 2,250 

milligrams/kilogram (mg/kg)). Acute 

oral toxicity studies have been 

performed with formic acid, calcium 

formate and sodium formate; they all 

have relatively low toxicity via this 

route of exposure. 

A subchronic inhalation (13–week) 

study was performed by the NTP with 

formic acid in mice and rats at 

concentrations of 0.015, 0.030, 0.061, 

0.122, or 0.244 milligrams/liter (mg/L) 

equal to (8, 16, 32, 64, or 128 parts per 

million (ppm)) for 13 weeks. Body 

weight gains were significantly 

decreased in mice exposed to 64 and 

128 ppm formic acid. Changes in organ 

weights in mice were limited largely to 

increases in relative weights in animals 

in the 128 ppm groups. This was 

primarily a reflection of the lower body 

weights of these animals compared to 

controls, and of the greater relative 

weight of organs in smaller animals. In 

mice, there were no exposure-related 

gross lesions; microscopic changes 

attributed to toxicity of formic acid were 

limited to degeneration of the olfactory 

epithelium of the nose in a few mice 

from the 64 and 128 ppm exposure 

groups. In rats, hematologic changes 

observed were all minimal and, 

generally, were consistent with 

hemoconcentration. Therefore, they 

were not considered as toxicologically 

relevant. Few and slight changes of the 

biochemical serum parameters were 

observed but not considered as adverse. 

No unusual gross lesions were observed. 

In rats, absolute liver weights were 

increased in the males of all test groups 

while the relative liver weights were 

increased in the three highest dose 

groups. Absolute and relative lung 

weights were reduced in female rats in 

all dose groups; in males, the relative 

lung weights were reduced in all 

exposure groups and absolute lung 

weights were reduced in the two highest 

dose groups. However, these changes in 

liver weights and lungs were not 

considered as adverse because they 

seem without histopathological 

correlation. Histopathological changes 

at the respiratory and olfactory nasal 

epithelia were restricted to the highest 

dose groups. The no observed adverse 

effect level (NOAEL) is 0.061 mg/L (32 

ppm) in mice based on a decrease in 

body weight gains seen at the lowest 

observed adverse effect level (LOAEL) of 

0.122 mg/L (64 ppm). The NOAEL in 

rats is 0.122 mg/L equal to (64 ppm) 

based on a decrease in body weight 

gains in mice and histopathological 

changes seen in the respiratory and 

olfactory epithelia at the LOAEL of 

0.244 mg/L (124 ppm). Lifetime and 

repeat dose drinking water studies were 

conducted in rats with calcium formate 

and sodium formate, respectively. 

Toxicity was not observed during either 

study at doses up to 200 mg/kg/day and 

100 mg/kg/day for calcium format and 

sodium formate, respectively. 

In a reproduction study in rats and 

mice with formic acid via inhalation 

route, no effects on sperm motility, 

sperm concentration, testicular and 

epididymal weight or on the duration of 

estrous cycles were observed. In mice, 

formic acid showed no effects on the 

testicular and epididymal weight or on 

the duration of the estrous cycles. In a 

three generation reproduction study in 

rats via drinking water, no treatment 

related effects were observed in the 

parental animals and off springs at 

doses up to 200 mg/kg/day. 

In an in vitro incubation in whole 

embryo culture study in rats with formic 

acid, incubations showed significant 

and concentration-dependent reduction 

of yolk sac diameter, crown-rump 

length, head length, somite number, and 

developmental score after 24–hours and 

of crown-rump length, head length, 

somite number and developmental score 

after 48–hours. Embryo lethality was 

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significantly increased in the highest 

concentration after 24–hours and in the 

two highest concentrations after 48– 

hours. Protein and DNA concentrations 

showed significant and concentration 

dependent decreased in both cases. The 

number of anomalies (open anterior and 

posterior neuropores, rotatory defects 

and enlarged maxillary process) showed 

a significant increase only at the highest 

doses after 48–hours. Considering the 

results of in vivo reproduction study in 

mice and rats with formic acid and 3– 

generation reproduction study in rats 

via drinking water at doses up to and 

including 200 mg/kg/day, there is less 

confidence in the results of in vitro 

study. In addition, no developmental 

toxicity was seen in several 

developmental toxicity studies in mice 

and rats with calcium and sodium 

formate described below. 

In developmental toxicity studies 

with calcium and sodium formate in 

rats and mice, respectively, there were 

no statistical differences in organ and 

bone abnormalities and growth of 

treated offspring to controls were 

similar. There was no reduction of 

fertility, maternal toxicity, embryotoxic 

or teratogenic effects observed. The 

NOAEL for the maternal and 

developmental toxicity in rats with 

calcium formate via drinking water was 

200 mg/kg/day (the highest dose tested; 

HDT). The NOAEL for the maternal and 

developmental toxicity in mice with 

sodium formate via gavage was 750 mg/ 

kg/day (HDT). 

In mutagenicity studies with calcium, 

sodium and methyl formate, results of 

the test were negative for all chemicals. 

The weight-of-evidence suggested that 

inorganic formates are not mutagenic. 

In a non-Good Laboratory Practice 

(GLP) lifelong (2–3 years) drinking 

water study with Wistar rats, test 

animals were exposed to calcium 

formate at concentrations of 0.2% and 

0.4% (150–200 mg/kg/day). No 

neoplasias were observed. In a separate 

non-GLP study with Wistar rats, test 

animals were exposed to sodium 

formate at a concentration of 1% (274 

mg/kg/day) for 18 months. No 

neoplasias were observed. Based on lack 

of mutagenicity and no evidence of 

carcinogenicity on surrogate chemicals, 

EPA concluded that the ammonium 

formate is not expected to be 

carcinogenic. 

Ammonium formate breaks down into 

ammonium and formate ions. 

Ammonium ions are ubiquitous in the 

natural environment and can be 

considered as having little toxicity or 

hazard risk. Formate, as noted in the 

above toxicity discussion, is not 

excessively toxic. Formate ions are 

readily converted to carbon dioxide in 

the environment by biodegradation or 

photo oxidation. 

B. Toxicological Points of Departure/ 

Levels of Concern 

No toxicological endpoints of concern 

were identified based on available 

toxicity studies on surrogate chemicals. 

Most of these studies were not 

conducted up to the limit dose. The 

highest dose of 200 mg/kg/day in a 

lifelong study in rats via drinking water 

did not produce any systemic toxicity. 

Therefore, a conservative risk 

assessment was conducted using a 

NOAEL of 200 mg/kg/day for chronic 

dietary and short- and intermediateterm dermal exposure risk estimates. An 

uncertainty/safety factor of 100X (10X 

for interspecies variability and 10X for 

interspecies extrapolation) was used. 

The Food Quality Protection Act 

(FQPA) factor of 10X was reduced to 1X; 

therefore, the chronic Reference Dose 

(cRfD) is equal to chronic Population 

Adjusted Dose (cPAD). A 100% dermal 

absorption is assumed for converting 

oral to dermal equivalent dose in the 

absence of dermal toxicity or dermal 

absorption studies. For short- and 

intermediate-term inhalation exposure, 

the route-specific study was used. The 

NOAEL of 0.62 (32 ppm) was observed 

in a 90–day inhalation toxicity study in 

rats. The uncertainty factor is 100X (10X 

for interspecies variability and 10X for 

interspecies extrapolation). The FQPA 

factor of 10X was reduced to 1X. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to ammonium formate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from 

ammonium formate in food as follows: 

i. Acute exposure. No adverse effect 

attributable to a single exposure of 

ammonium formate was seen in the 

toxicity databases. Therefore, no acute 

risk from exposure to ammonium 

formate is expected and an acute 

exposure assessment is not needed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) (1994–1996 and 1998) 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII). As to 

residue levels in food, no residue data 

were submitted for ammonium formate. 

In the absence of specific residue data, 

EPA has developed an approach which 

uses surrogate information to derive 

upper bound exposure estimates for the 

subject inert ingredient. Upper bound 

exposure estimates are based on the 

highest tolerance for a given commodity 

from a list of high-use insecticides, 

herbicides, and fungicides. A complete 

description of the general approach 

taken to assess inert ingredient risks in 

the absence of residue data is contained 

in the memorandum entitled ‘‘Alkyl 

Amines Polyalkoxylates (Cluster 4): 

Acute and Chronic Aggregate (Food and 

Drinking Water) Dietary Exposure and 

Risk Assessments for the Inerts.’’ (DP 

Barcode: 361707, S. Piper, 2/25/2009) 

and can be found at http:// 

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

In the dietary exposure assessment, 

the Agency assumed that the residue 

level of the inert ingredient would be no 

higher than the highest tolerance for a 

given commodity. Implicit in this 

assumption is that there would be 

similar rates of degradation (if any) 

between the active and inert ingredient 

and that the concentration of inert 

ingredient in the scenarios leading to 

these highest of tolerances would be no 

higher than the concentration of the 

active ingredient. 

The Agency believes the assumptions 

used to estimate dietary exposures lead 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. First, 

assuming that the level of residue for an 

inert ingredient is equal to the level of 

residue for the active ingredient will 

overstate exposure. The concentration of 

active ingredient in agricultural 

products is generally at least 50% of the 

product and often can be much higher. 

Further, pesticide products rarely have 

a single inert ingredient; rather there is 

generally a combination of different 

inert ingredients used which 

additionally reduces the concentration 

of any single inert ingredient in the 

pesticide product in relation to that of 

the active ingredient. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume that, for each 

commodity, the active ingredient which 

will serve as a guide to the potential 

level of inert ingredient residues is the 

active ingredient with the highest 

tolerance level. This assumption 

overstates residue values because it 

would be highly unlikely, given the 

high number of inert ingredients, that a 

single inert ingredient or class of 

ingredients would be present at the 

level of the active ingredient in the 

highest tolerance for every commodity. 

Finally, a third compounding 

conservatism is EPA’s assumption that 

all foods contain the inert ingredient at 

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Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 55995 

the highest tolerance level. In other 

words, EPA assumed 100% of all foods 

are treated with the inert ingredient at 

the rate and manner necessary to 

produce the highest residue legally 

possible for an active ingredient. In 

summary, EPA chose a very 

conservative method for estimating 

what level of inert residue could be on 

food, and then used this methodology to 

choose the highest possible residue that 

could be found on food and assumed 

that all food contained this residue. No 

consideration was given to potential 

degradation between harvest and 

consumption even though monitoring 

data show that tolerance level residues 

are typically one to two orders of 

magnitude higher than actual residues 

in food when distributed in commerce. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. 

iii. Cancer. Ammonium formate is not 

expected to be carcinogenic, since there 

was no evidence of carcinogenicity in 

the available studies. The Persistent, 

Bioaccumulative, and Toxic (PBT) 

profiler, a component of the Agency’s 

P2 Framework did not raise any cancer 

concerns. Since the Agency has not 

identified any concerns for 

carcinogenicity relating to ammonium 

formate, a cancer dietary exposure 

assessment is not necessary to assess 

cancer risk. 

2. Dietary exposure from drinking 

water. For the purpose of the screening 

level dietary risk assessment to support 

this request for an exemption from the 

requirement of a tolerance for 

ammonium formate, a conservative 

drinking water concentration value of 

100 parts per billion (ppb) based on 

screening level modeling was used to 

assess the contribution to drinking 

water for the chronic dietary risk 

assessments for parent compound. 

These values were directly entered into 

the dietary exposure model. The Agency 

considers the value of 100 ppb to be a 

high end, conservative assumption that 

is not likely to underestimate drinking 

water risks. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

There are no known or anticipated 

residential uses and therefore, 

residential exposure is not expected. 

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 ammonium 

formate to share a common mechanism 

of toxicity with any other substances, 

and ammonium formate does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that ammonium formate 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 

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 pre-natal 

and post-natal 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. 

EPA concluded that the FQPA safety 

factor could be removed for ammonium 

formate for the following reasons: 

i. No toxicological studies were 

identified for ammonium formate in the 

publically available databases. However, 

ammonium formate breaks down into 

ammonium and formate ions. 

Ammonium ions are ubiquitous in the 

natural environment and can be 

considered as having little toxicity or 

hazard risk. There is available data on 

formic acid and related formate 

compounds (such as calcium, sodium 

and methyl formate), which can serve as 

suitable surrogates for ammonium 

formate. Studies conducted with 

methanol are also applicable to formate 

compounds, since methanol is 

metabolized into formic acid. Therefore, 

the database is considered adequate for 

FQPA assessment. 

ii. There is no evidence of increased 

susceptibility of infants and children in 

the available reproduction and 

developmental toxicity studies with 

calcium formate and/or sodium formate. 

No developmental or maternal systemic 

toxicity was observed in rats at doses up 

to 200 mg/kg/day when calcium formate 

was administered via drinking water. 

No developmental or maternal toxicity 

was observed in mice at doses up to 750 

mg/kg gavage dose of sodium formate on 

gestation day 8. No evidence of 

increased susceptibility was observed 

following pre- and post-natal exposure 

to calcium formate. In a multigeneration reproduction study (3 to 5 

generations), no parental, reproductive 

or offspring toxicity was observed at 

doses up to 200 mg/kg/day. 

iii. No neurotoxicity studies are 

available in the database. However, 

there is no evidence of clinical signs of 

neurotoxicity in the database, nor 

evidence of susceptibility in the young 

in the database. Therefore, EPA 

concluded that the developmental 

neurotoxicity study is not required. 

There is no evidence of immunotoxicity 

in the available database. 

iv. The dietary food exposure 

assessment utilizes highly conservative 

default assumptions that would not 

underestimate the dietary risk to all 

populations. For the purpose of the 

screening level dietary risk assessment 

to support this request for an exemption 

from the requirement of a tolerance for 

ammonium formate, a value of 100 ppb 

for drinking water based on screening 

level modeling was used for the chronic 

dietary risk assessment. The value of 

100 ppb is considered to be a high end, 

conservative assumption that is not 

likely to underestimate drinking water 

risks. 

Taking into consideration the 

available information, EPA concludes 

the additional 10X FQPA safety factor 

can be reduced to 1X. 

E. Aggregate Risks and Determination of 

Safety 

Determination of safety section. 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 

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55996 Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute aggregate (food and drinking 

water) risk. No adverse effect 

attributable to a single exposure of 

ammonium formate was seen in the 

toxicity databases. Therefore, 

ammonium formate is not expected to 

pose an acute risk. 

2. Chronic aggregate (food and 

drinking water) risk. A chronic aggregate 

risk assessment takes into account 

exposure estimates from chronic dietary 

consumption of food and drinking 

water. Using the exposure assumptions 

discussed in this unit for chronic 

exposure, the chronic dietary exposure 

from food and water to ammonium 

formate is 9.6% of the cPAD for the U.S. 

population and 31.2% of the cPAD for 

children 1–2 years old, the most highly 

exposed population subgroup. The 

chronic dietary exposure estimates for 

food and drinking water are below the 

Agency’s level of concern (<100% 

cPAD) for the U.S. population and all 

population subgroups. There are no 

residential uses known or proposed, and 

therefore, no residential exposure is 

expected. 

3. Aggregate cancer risk for U.S. 

population. The Agency has not 

identified any concerns for 

carcinogenicity relating to ammonium 

formate. 

4. 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 ammonium 

formate residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for nor 

have any CODEX Maximum Residue 

Levels (MRLs) been established for any 

food crops at this time. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for ammonium 

formate (CAS Reg. No. 540–69–2) when 

used as an inert ingredient (complexing 

or fixing agent) in pesticide 

formulations applied to growing crops. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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). 

VIII. 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: September 7, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

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Federal Register / Vol. 75, No. 178 / Wednesday, September 15, 2010 / Rules and Regulations 55997 

Inert ingredients Limits Uses 

*** * *

Ammonium formate (CAS Reg. No. 540–69–2) Complexing or fixing agent 

*** * *

[FR Doc. 2010–22976 Filed 9–14–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2008–0347; FRL–8843–7] 

40 CFR Part 180 

Carbaryl; Order Denying NRDC’s 

Objections and Requests for Hearing 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Order. 

SUMMARY: In this order, the 

Environmental Protection Agency (EPA) 

denies objections, and requests for 

hearing on those objections, to a prior 

order denying a petition requesting that 

EPA revoke all pesticide tolerances for 

carbaryl under section 408(d) of the 

Federal Food, Drug, and Cosmetic Act. 

The objections and hearing requests 

were filed on December 29, 2008, by the 

Natural Resources Defense Council 

(NRDC). The original petition was also 

filed by NRDC. 

FOR FURTHER INFORMATION CONTACT: 

Jacqueline Guerry, Pesticide Reevaluation Division (7508P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (215) 814– 

2184; e-mail address: 

guerry.jacqueline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

In this document, EPA denies 

objections, and requests for hearing on 

those objections, submitted by NRDC in 

response to a prior order denying 

NRDC’s petition requesting that EPA 

revoke all pesticide tolerances for 

carbaryl. In addition to NRDC, and 

others interested in food safety issues 

generally, this action may be of interest 

to agricultural producers, food 

manufacturers, or pesticide 

manufacturers. Potentially affected 

entities may include, but are not limited 

to those engaged in the following 

activities: 

• Crop production (NAICS code 111), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 Copies of this 

Document and Other Related 

Information? 

EPA has established a docket for this 

action under docket identification (ID) 

number EPA–HQ–OPP–2008–0347. 

Publicly available docket materials are 

available either in the electronic docket 

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

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

II. Introduction 

A. What Action Is the Agency Taking? 

In this order, EPA denies objections, 

and requests for a hearing on those 

objections, to an earlier EPA Order, (73 

FR 64229 ), denying a petition to revoke 

all tolerances established for the 

pesticide, carbaryl, under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a, (Refs. 1 and 2). Both the 

objections and hearing requests, as well 

as the petition, were filed with EPA by 

NRDC. 

NRDC’s original petition, dated 

January 10, 2005, submitted to the 

carbaryl public docket during the public 

comment period for the 2004 Amended 

Interim Reregistration Eligibility 

Decision (IRED) for Carbaryl, and filed 

pursuant to FFDCA section 408(d)(1), 

asserted a number of grounds why 

carbaryl tolerances allegedly fail to meet 

the FFDCA’s safety standard. The main 

arguments raised in the petition 

concerned EPA’s drinking water 

assessment and EPA’s decision on the 

statutory safety factor to protect infants 

and children that supported the 2004 

IRED decision. NRDC also petitioned 

the Agency to cancel all carbaryl uses 

pursuant to the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

7 U.S.C. 136(bb) and 136a, and argued 

unreasonable risks on the environment. 

Subsequently, on November 26, 2007, 

NRDC petitioned EPA to cancel all 

carbaryl pet collar uses under FIFRA. 

(Ref. 3). EPA consolidated this latter 

petition with the 2005 FFDCA petition 

because NRDC argued in it that 

exposure to carbaryl pet collars make 

the risks presented by carbaryl unsafe 

within the meaning of FFDCA section 

408. 

On October 29, 2008, EPA responded 

to both the 2005 petition to revoke all 

carbaryl tolerances and the 2007 

petition to cancel all pet collar uses, 

denying them in their entirety. (73 FR 

64229, October 29, 2008) (Ref. 4). 

NRDC then filed objections to EPA’s 

denial of NRDC’s petition to revoke all 

carbaryl tolerances and requested a 

hearing on its objections. These 

objections and hearing requests were 

filed pursuant to the procedures in the 

FFDCA, section 408(g)(2). (21 U.S.C. 

346a(g)(2)). The objections narrowed 

NRDC’s claims to two main topics – that 

EPA lacks reliable data to reduce the 

Food Quality Protection Act (FQPA) 

Children’s Safety Factor and that EPA’s 

exposure assessment for carbaryl is 

flawed and underestimates the exposure 

to children from pet collar uses. After 

carefully reviewing the objections and 

hearing requests, EPA has determined 

that NRDC’s hearing requests do not 

satisfy the regulatory requirements for 

such requests and that its substantive 

objections are without merit. Therefore, 

EPA, in this final order, denies NRDC’s 

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