[Federal Register Volume 74, Number 193 (Wednesday, October 7, 2009)]
[Rules and Regulations]
[Pages 51481-51485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24161]
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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:
[email protected].
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)
* * * * * * *
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[FR Doc. E9-24161 Filed 10-6-09; 8:45 am]
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