Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51481 

Inert ingredients Limits Uses 

* * * * * * * 

C10-C18-Alkyl dimethyl amine oxides (CAS Reg. Nos. 1643–20–5, 2571–88–2, 2605–79–0, 3332–27– 

2, 61788–90–7, 68955–55–5, 70592–80–2, 7128–91–8, 85408–48–6, and 85408–49–7) 

15% by weight in pesticide formulation Surfactant 

* * * * * * * 

[FR Doc. E9–24055 Filed 10–06–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0407; FRL–8438–1] 

Ammonium chloride; 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 

chloride (CAS Reg. No. 12125–02–9) 

applied pre-harvest on all raw 

agricultural commodities when applied/ 

used as a carrier/nutrient. SciReg, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting an exemption from 

the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of ammonium chloride. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0407. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Deirdre Sunderland, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 603–0851; e-mail address: 

sunderland.deirdre@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 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–2008–0407 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before December 7, 2009. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2008–0407, 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. Background and Statutory Findings 

In the Federal Register of June 13, 

2008 (73 FR 33814) (FRL–8367–3), EPA 

issued a notice pursuant to section 408 


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51482 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

of FFDCA, 21 U.S.C. 346a, as amended 

by FQPA (Public Law 104–170), 

announcing the filing of a pesticide 

petition (PP 8E7329) by SciReg Inc., 

12733 Director’s Loop, Woodbridge, VA 

22192. The petition requested that 40 

CFR 180.920 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of ammonium chloride when used as an 

inert ingredient in pesticide 

formulations applied pre-harvest. That 

notice included a summary of the 

petition prepared by the petitioner. 

There were no comments received in 

response to the notice of filing. 

Section 408(b)(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 

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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

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 ploymers 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. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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 

nature of the toxic effects caused by 

ammonium chloride are discussed in 

this unit. The following provides a brief 

summary of the risk assessment and 

conclusions for the Agency’s review of 

ammonium chloride. The Agency’s full 

decision document for this action is 

available in the Agency’s electronic 

docket (regulations.gov) under the 

docket ID number EPA–HQ–OPP–2008– 

0407. 

Ammonium and chloride are integral 

components of normal human metabolic 

processes. Ingested ammonium chloride 

is rapidly absorbed from the 

gastrointestinal tract with almost 

complete absorption occurring in 3 to 6 

hours. It is utilized by the liver to form 

amino acids and proteins. 

Acute oral studies on mice and rats 

given ammonium chloride showed LD50

values ranging from 1,220 milligrams/ 

kilogram (mg/kg) to 1,630 mg/kg. No 

acute dermal or inhalation studies are 

available; however, skin irritation and 

eye irritation studies revealed moderate 

transient irritation effects. Skin 

sensitization studies showed that 

ammonium chloride has no sensitizing 

potential. According to the World 

Health Organization (WHO), ‘‘The 

ingestion of ammonium chloride in 

doses of around 500–1,000 mg/kg body 

weight/day (bw/day), for periods 

ranging from 1 to 8 days, has induced 

metabolic acidosis in mice, guinea-pigs, 

rats, rabbits, and dogs. However, one 

study did not report any toxic effects at 

doses of up to 1 gram/kg bw in rats, 

rabbits, guinea-pigs, and cats (50 

animals per group).’’ It is also noted that 

susceptibility to ammonium chloride 

differs among species. 

In one study, male Fisher 344 rats 

given a diet containing 580 mg/kg/day 

for 56 days produced no clinical signs 

of toxicity and no histopathological 

changes were attribute to this chemical. 

Another study administered 684 mg/kg/ 

day of ammonium chloride to male 

Sprague-Dawley rats for 70 days. 

Treated animals showed a reduction in 

urinary pH (6.04 vs. ≥7.56 in controls) 

and an increase in urinary calcium; 

however, no crystals were found in the 

urine. Other urinary parameters were 

not affected by treatment. In addition, 

no histopathological changes were 

noted in the stomach, bladder, or 

kidneys. The no observed adversed 

effect level (NOAEL) for these studies 

are 580 mg/kg/day and 684 mg/kg/day, 

respectively. 

An 8–day dog study administered 200 

mg/kg/day of ammonium chloride. 

Metabolic acidosis occurred in the 

blood and the plasma; however, there 

were no changes in the acid-base system 

in erythrocytes. This study indicates 

that ammonium chloride causes 

substantial acidification of the blood 

and urine but does not affect the acidbase system of erythrocytes. A 330–day 

study which administered 0 or 1.5% 

ammonium chloride in drinking water 

to rats showed the development of 

osteoporosis in test animals due to loss 

of organic bone substance and bone 

minerals. The effect was reversible with 

the supplement of bicarbonate. The 

release of bone mineral by resorption is 

thought to provide additional buffering 

capacity, sparing bicarbonate. 

Renal effects were also observed at 

high doses in some of the studies. One 

study administered 0 or 1.28 g/kg/day of 

ammonium chloride via drinking water 

or gavage to Sprague- Dawley rats for 5 

days. Renal hypertrophy was observed; 

however, no increase in uptake of 

radioactive thymidine was seen, 

implying that no increase in DNA 

synthesis or cell division occurred. 

No evidence of tumors were observed 

in mice and rats administer ammonium 

chloride at doses up to 1% of their diet 

or drinking water for up to 652 days. 

Ammonium chloride is not expected to 

be carcinogenic. Based on available 

mutagencity studies, EPA concludes 

that ammonium chloride is not 

mutagenic. 

No clinical signs of neurotoxicity 

were seen in any of the repeat dose 

studies. Although evidence of 

neurotoxicity was observed in two 

specialized studies at high doses, the 

scenarios presented are not likely to 

occur in a natural setting (i.e. the 

chemical injected directly into the 

brain) and do not include the oral, 

dermal, or inhalation routes of 

exposure. After evaluating the available 

data and the expected exposure from the 

intended use pattern of this inert 

ingredient, the Agency does not feel that 


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a developmental neurotoxicity study is 

needed. 

The primary effect of ammonium 

chloride is related to the subsequent 

metabolic acidosis that occurs as a 

result of ingesting high concentrations 

of the chemical. Fortunately, the body 

has compensatory mechanisms used to 

return it to homeostasis. It is only after 

these buffers are exhausted that adverse 

effects are seen. According to Food and 

Drug Administration in the ‘‘Evaluation 

of the Health Aspects of Certain 

Ammonium Salts as Food Ingredients’’ 

(1974), ‘‘the normal liver so readily 

detoxifies ammonium ion from 

alimentary sources that blood 

concentrations of ammonium salts do 

not rise to the levels necessary to evoke 

toxic response.’’ The FDA has 

designated ammonium chloride as a 

‘‘Generally Recognized as Safe-GRAS’’ 

chemical for use in food products. Many 

of the studies noted that the effects were 

reversible. 

Although no reproduction studies are 

available, ammonium chloride has been 

used medicinally on pregnant women 

and has been classified in Australia 

under Pregnancy Category A meaning 

that it ‘‘has been used for many 

pregnant women and women of 

conceiving age, and that there is no 

proof of increase in the frequency of 

deformation and the frequency of direct 

or indirect detrimental action to the 

embryo.’’ Because ammonium chloride 

is found naturally in the environment 

and is a normal component of the 

human diet, the Agency does not feel 

that there is an increased risk to 

pregnant woman or woman of childbearing age. 

Available studies show that 

ammonium chloride is of low toxicity 

for human health endpoints. Although 

one developmental study did observe 

7% ectrodactyly in the offspring of mice 

that were given 600 mg/kg 4 times a day 

on day 10 of gestation (2.4 g/kg/day), 

another study found no teratogencity in 

the fetuses of rats given almost 4 times 

that dosage (~8.9 mg/kg/day) during 

days 7 to 10 of gestation. Effects of 

treatment were seen in regards to fetal 

weight; however, no fetal malformations 

were observed. 

Based on available data, the 56–day 

rat study was selected for establishing 

the chronic Reference Dose (cRfD). In 

this study the NOAEL was 580 mg/kg/ 

day (the highest dose tested) where no 

clinical signs of toxicity or 

histopathologic changes were attributed 

to this chemical. With an uncertainty 

factor of 100X for interspecies and 

intraspecies extrapolation and the Food 

Quality Protection Act (FQPA) safety 

factor (SF) reduced to 1X the cRfD is 

equal to the chronic population adjusted 

dose (cPAD). 

V. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

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. 

In order to quantify the anticipated 

dietary exposure, the Agency’s Dietary 

Exposure Evaluation Model (DEEM) was 

employed. In modeling exposure, EPA 

made several very conservative 

assumptions including the assumption 

that the inert ingredient was used in all 

food use pesticide products applied to 

all crops and that 100% of the crop was 

treated. EPA also assumed that the 

residues of ammonium chloride would 

be present in all crops at levels equal to 

or greater than the highest established 

tolerance levels for any pesticide active 

ingredient for pre-harvest use. 

Although EPA used a default value of 

100 parts per billion for the 

concentration of the inert in all sources 

of drinking water, the Agency does not 

anticipate increased exposure to 

ammonium chloride from drinking 

water as a result of the use of 

ammonium chloride as an inert 

ingredient. This conclusion is based on 

the fact that excess ammonium chloride 

is taken up by the plant as a nutrient, 

the rapid disassociation of ammonium 

chloride into its anion/cation parts, and 

the regulation of water treatment plants 

for nutrients in drinking water. 

Furthermore, the unpalatability of the 

amount of ammonium chloride needed 

to induce a toxic response would 

discourage consumption. Due to the 

nature of the chemical, it is unlikely 

that ammonium chloride will volatize 

from water. 

This exposure assessment is 

particularly conservative for several 

reasons. Given the wide spread use of 

ammonium chloride in the food supply 

(both as a direct food additive and 

fertilizer), the amount of ammonium 

chloride contributed by its use as an 

inert ingredient in pesticide products 

will not significantly increase the 

overall exposure to infants and children. 

In addition, based on its high water 

solubility and the use of this product in 

the growing phase of plant life, it is 

expected that the majority of this inert 

ingredient will be washed from the 

plant prior to it reaching the consumer 

market and therefore the residues on the 

plant will be limited. 

VI. Cumulative Effects 

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.’’ 

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

ammonium chloride and any other 

substances, and these chemicals do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

these chemicals 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 the policy statements released by 

EPA’s Office of Pesticide Programs 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://ww.epa.gov/ 

pesticides/cumulative/. 

VII. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408 of FFDCA provides that 

EPA shall apply an additional tenfold 

margin of safety for infants and children 

in the case of threshold effects to 


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account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure 

unless EPA determines that a different 

margin of safety will be safe for infants 

and children. EPA concluded that the 

FQPA SF for ammonium chloride 

should be reduced to 1X. 

The database for ammonium chloride 

is adequate to make a determination of 

safety. Although specific reproduction 

studies have not been presented, the use 

of ammonium chloride as a 

pharmacological agent gives an 

understanding of how the chemical will 

behave. 

Available studies show that 

ammonium chloride is of low toxicity 

for human health endpoints. Although 

one developmental study did observe 

7% ectrodactyly in the offspring of mice 

that were given 600 mg/kg 4 times a day 

(2.4 g/kg/day) on day 10 of gestation, 

another study found no teratogencity in 

the fetuses of rats given almost 4 times 

that dosage (~8.9 mg/kg/day) during 

days 7 to 10 of gestation. Effects of 

treatment were seen in regards to fetal 

weight; however, no fetal malformations 

were observed. Similar results were 

seen when rats were given 0.9% 

(0.17mol/L) ammonium chloride in 

drinking water. The effects seen in these 

studies are believed to be a result of 

maternal acidosis. 

Many of the repeat dose studies and 

human case studies show that the 

effects of ammonium chloride were 

reversible once the exposure was 

removed (in some cases sodium 

bicarbonate was given to reverse the 

acidosis). It was inferred in many of the 

studies that the toxicity was secondary 

to acidosis. 

No clinical signs of neurotoxicity 

were seen in any of the repeat dose 

studies. Although evidence of 

neurotoxicity was observed in two 

specialized studies at high doses, the 

scenarios presented are not likely to 

occur in a natural setting (i.e., the 

chemical injected directly into the 

brain) and do not include the oral, 

dermal, or inhalation routes of 

exposure. After evaluating the available 

data and the expected exposure from the 

intended use pattern of this inert 

ingredient, the Agency does not feel that 

a developmental neurotoxicity study is 

needed. 

Ammonium chloride is a natural part 

of the metabolic process and therefore, 

the body has buffers in place to bring 

the system back to homeostasis when 

levels of ammonium or chloride exceed 

normal values. Because of the low 

toxicity of the chemical, the body’s 

ability to achieve homeostasis, the 

conservative approach taken for 

estimating exposure, the Agency 

concludes there are reliable data 

showing that a reduction of childrens’ 

safety factor from 10X to 1X is safe. 

VIII. Determination of Safety for U.S. 

Population 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and cPAD. The aPAD and cPAD 

represent the highest safe exposures, 

taking into account all appropriate 

uncertainty/safety factors. EPA 

calculates the aPAD and cPAD by 

dividing the point of departure by all 

applicable uncertainty/safety factors. 

As noted in Unit IV., ammonium 

chloride is not expected to pose an 

acute risk. To evaluate chronic risk, EPA 

compared estimated chronic exposure to 

the cPAD of 5.8 mg/kg/day. Utilizing a 

highly conservative aggregate exposure 

assessment, the resulting chronic 

exposure estimates do not exceed the 

Agency’s level of concern (<100% 

cPAD). Children 1 to 2 years old were 

the most highly exposed population 

with the chronic exposure estimate 

occupying 10.8% of the cPAD. In 

addition, this highly conservative 

exposure assessment is protective of any 

possible non-occupational exposures to 

ammonium chloride as it results in 

exposure estimates orders of magnitude 

greater than the high-end exposure 

estimates for residential uses of 

pesticides routinely used by EPA. 

Taking into consideration all available 

information on ammonium chloride, it 

has been determined that there is a 

reasonable certainty that no harm to any 

population subgroup, including infants 

and children, will result from aggregate 

exposure to this chemical. Therefore, 

the exemption from the requirement of 

a tolerance for residues of ammonium 

chloride (CAS Reg. No. 12125–02–9), 

when used as inert ingredient in preharvest applications, under 40 CFR 

180.920 can be considered safe under 

section 408(q) of the FFDCA. 

IX. Other Considerations 

A. Analytical Method 

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. Existing Exemptions 

Ammonium chloride has exemptions 

under 40 CFR 180.910 when used as an 

intensifier with ammonium nitrate as a 

dessicant or defoliant or as a fire 

suppressant in aluminum phosphide 

and magnesium phosphide formulations 

and under 40 CFR 180.940(a) as an 

ingredient in antimicrobial pesticide 

formulation where the end-use 

concentration cannot exceed 48 parts 

per million. 

C. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for 

ammonium chloride nor have any 

CODEX Maximum Residue Levels 

(MRLs) been established for any food 

crops at this time. 

X. Conclusions 

Therefore, a tolerance exemption is 

established for ammonium chloride 

(CAS Reg. No. 12125–02–9) when used 

as an inert ingredient in pesticide 

formulations applied to growing crops 

only. 

XI. 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 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51485 

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). 

XII. 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 29, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. 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. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

Ammonium chloride 

(CAS Reg. No. 

12125–02–9) 

Carrier/ 

nutrient 

* * * * * * * 

[FR Doc. E9–24161 Filed 10–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0518; FRL–8434–3] 

Quinclorac; Pesticide Tolerance for 

Emergency Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

quinclorac in or on cranberry. This 

action is in response to EPA’s granting 

of an emergency exemption under 

section 18 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

cranberries. This regulation establishes 

a maximum permissible level for 

residues of quinclorac in this food 

commodity. The time-limited tolerance 

expires and is revoked on December 31, 

2012. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0518. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Marcel Howard, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6784; e-mail address: 

Howard.Marcel@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 


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