Document ID: EPA-HQ-OPP-2008-0407-0003
Agency: epa
Document Type: Rule
Title: Ammonium chloride; Exemption from the Requirement of a Tolerance
Posted Date: 2009-10-07T04:00Z

[Federal Register: October 7, 2009 (Volume 74, Number 193)]
[Rules and Regulations]               
[Page 51481-51485]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc09-8]                         

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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.

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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

[[Page 51482]]

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 acid-base 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

[[Page 51483]]

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 child-bearing 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 non-occupational 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

[[Page 51484]]

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 pre-harvest 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

[[Page 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
Ammonium chloride (CAS Reg. No.                        Carrier/nutrient
 12125-02-9)
                              * * * * * * *
------------------------------------------------------------------------

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

BILLING CODE 6560-50-S