[Federal Register Volume 75, Number 178 (Wednesday, September 15, 2010)]
[Rules and Regulations]
[Pages 55991-55997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22976]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0121; FRL-8839-3]
Ammonium Formate; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ammonium formate (CAS Reg. No. 540-69-2)
when used as an inert ingredient (complexing or fixing agent with
copper compounds) in pesticide formulations for certain pre-harvest
uses. Phyton Corporation submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of ammonium formate.
DATES: This regulation is effective September 15, 2010. Objections and
requests for hearings must be received on or before November 15, 2010,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0121. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information
[[Page 55992]]
(CBI) or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Alganesh Debesai, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8353; e-mail address:
[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 Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2006-121 in the subject line on the first page of
your submission. All objections and requests for a hearing must be in
writing, and must be received by the Hearing Clerk on or before
November 15, 2010. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0121, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Exemption
In the Federal Register of April 21, 2006 (71 FR 20671) (FRL-8067-
3), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 6E7028) by
Phyton Corporation, 7449 Cahill Rd., Edina, MN 55439. The petition
requested that 40 CFR 180.920 be amended by establishing an exemption
from the requirement of a tolerance for residues of ammonium formate
(CAS Reg. No. 540-69-2) when used as an inert ingredient (complexing or
fixing agent) with the active ingredient copper in pesticide
formulations applied to growing crops. That notice referenced a summary
of the petition which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
modified the exemption requested to not restrict to use with the active
ingredient copper. No limitations are necessary because no hazard was
identified.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide
[[Page 55993]]
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for ammonium formate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with ammonium formate
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by ammonium formate are discussed in this
unit.
The following provides a brief summary of the risk assessment and
conclusions for the Agency's review of ammonium formate. The Agency's
full decision document for this action can be found at http://www.regulations.gov in the document: Ammonium Formate. Human Health
Risk Assessment and Ecological Effects Summary to Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations Applied Pre-harvest in docket ID
number EPA-HQ-OPP-2006-0121.
Ammonium formate breaks down into ammonium and formate ions.
Ammonium ions are a toxic waste product of the metabolism in animals;
they are ubiquitous in the natural environment and can be considered as
having little toxicity or hazard risk. In fish and aquatic
invertebrates, it is excreted directly into the water. In mammals,
sharks, and amphibians, it is converted in the urea cycle to urea,
because urea is less toxic and can be stored more efficiently. In
birds, reptiles, and terrestrial snails, metabolic ammonium is
converted into uric acid, which is solid, and can therefore be excreted
with minimal water. Formic acid is readily metabolized and eliminated
by the body; it slowly decomposes to carbon monoxide and water.
The toxicological database for ammonium formate is limited. There
is available data on formic acid and related formate compounds (such as
calcium and sodium formate), which can serve as suitable surrogates for
ammonium formate. Studies conducted with methanol are also applicable
to formate compounds, since methanol is metabolized into formic acid.
Acute oral toxicity of ammonium formate in mice is reported to be
moderate via oral route (LD50 2,250 milligrams/kilogram (mg/
kg)). Acute oral toxicity studies have been performed with formic acid,
calcium formate and sodium formate; they all have relatively low
toxicity via this route of exposure.
A subchronic inhalation (13-week) study was performed by the NTP
with formic acid in mice and rats at concentrations of 0.015, 0.030,
0.061, 0.122, or 0.244 milligrams/liter (mg/L) equal to (8, 16, 32, 64,
or 128 parts per million (ppm)) for 13 weeks. Body weight gains were
significantly decreased in mice exposed to 64 and 128 ppm formic acid.
Changes in organ weights in mice were limited largely to increases in
relative weights in animals in the 128 ppm groups. This was primarily a
reflection of the lower body weights of these animals compared to
controls, and of the greater relative weight of organs in smaller
animals. In mice, there were no exposure-related gross lesions;
microscopic changes attributed to toxicity of formic acid were limited
to degeneration of the olfactory epithelium of the nose in a few mice
from the 64 and 128 ppm exposure groups. In rats, hematologic changes
observed were all minimal and, generally, were consistent with
hemoconcentration. Therefore, they were not considered as
toxicologically relevant. Few and slight changes of the biochemical
serum parameters were observed but not considered as adverse. No
unusual gross lesions were observed. In rats, absolute liver weights
were increased in the males of all test groups while the relative liver
weights were increased in the three highest dose groups. Absolute and
relative lung weights were reduced in female rats in all dose groups;
in males, the relative lung weights were reduced in all exposure groups
and absolute lung weights were reduced in the two highest dose groups.
However, these changes in liver weights and lungs were not considered
as adverse because they seem without histopathological correlation.
Histopathological changes at the respiratory and olfactory nasal
epithelia were restricted to the highest dose groups. The no observed
adverse effect level (NOAEL) is 0.061 mg/L (32 ppm) in mice based on a
decrease in body weight gains seen at the lowest observed adverse
effect level (LOAEL) of 0.122 mg/L (64 ppm). The NOAEL in rats is 0.122
mg/L equal to (64 ppm) based on a decrease in body weight gains in mice
and histopathological changes seen in the respiratory and olfactory
epithelia at the LOAEL of 0.244 mg/L (124 ppm). Lifetime and repeat
dose drinking water studies were conducted in rats with calcium formate
and sodium formate, respectively. Toxicity was not observed during
either study at doses up to 200 mg/kg/day and 100 mg/kg/day for calcium
format and sodium formate, respectively.
In a reproduction study in rats and mice with formic acid via
inhalation route, no effects on sperm motility, sperm concentration,
testicular and epididymal weight or on the duration of estrous cycles
were observed. In mice, formic acid showed no effects on the testicular
and epididymal weight or on the duration of the estrous cycles. In a
three generation reproduction study in rats via drinking water, no
treatment related effects were observed in the parental animals and off
springs at doses up to 200 mg/kg/day.
In an in vitro incubation in whole embryo culture study in rats
with formic acid, incubations showed significant and concentration-
dependent reduction of yolk sac diameter, crown-rump length, head
length, somite number, and developmental score after 24-hours and of
crown-rump length, head length, somite number and developmental score
after 48-hours. Embryo lethality was
[[Page 55994]]
significantly increased in the highest concentration after 24-hours and
in the two highest concentrations after 48-hours. Protein and DNA
concentrations showed significant and concentration dependent decreased
in both cases. The number of anomalies (open anterior and posterior
neuropores, rotatory defects and enlarged maxillary process) showed a
significant increase only at the highest doses after 48-hours.
Considering the results of in vivo reproduction study in mice and rats
with formic acid and 3-generation reproduction study in rats via
drinking water at doses up to and including 200 mg/kg/day, there is
less confidence in the results of in vitro study. In addition, no
developmental toxicity was seen in several developmental toxicity
studies in mice and rats with calcium and sodium formate described
below.
In developmental toxicity studies with calcium and sodium formate
in rats and mice, respectively, there were no statistical differences
in organ and bone abnormalities and growth of treated offspring to
controls were similar. There was no reduction of fertility, maternal
toxicity, embryotoxic or teratogenic effects observed. The NOAEL for
the maternal and developmental toxicity in rats with calcium formate
via drinking water was 200 mg/kg/day (the highest dose tested; HDT).
The NOAEL for the maternal and developmental toxicity in mice with
sodium formate via gavage was 750 mg/kg/day (HDT).
In mutagenicity studies with calcium, sodium and methyl formate,
results of the test were negative for all chemicals. The weight-of-
evidence suggested that inorganic formates are not mutagenic.
In a non-Good Laboratory Practice (GLP) lifelong (2-3 years)
drinking water study with Wistar rats, test animals were exposed to
calcium formate at concentrations of 0.2% and 0.4% (150-200 mg/kg/day).
No neoplasias were observed. In a separate non-GLP study with Wistar
rats, test animals were exposed to sodium formate at a concentration of
1% (274 mg/kg/day) for 18 months. No neoplasias were observed. Based on
lack of mutagenicity and no evidence of carcinogenicity on surrogate
chemicals, EPA concluded that the ammonium formate is not expected to
be carcinogenic.
Ammonium formate breaks down into ammonium and formate ions.
Ammonium ions are ubiquitous in the natural environment and can be
considered as having little toxicity or hazard risk. Formate, as noted
in the above toxicity discussion, is not excessively toxic. Formate
ions are readily converted to carbon dioxide in the environment by
biodegradation or photo oxidation.
B. Toxicological Points of Departure/Levels of Concern
No toxicological endpoints of concern were identified based on
available toxicity studies on surrogate chemicals. Most of these
studies were not conducted up to the limit dose. The highest dose of
200 mg/kg/day in a lifelong study in rats via drinking water did not
produce any systemic toxicity. Therefore, a conservative risk
assessment was conducted using a NOAEL of 200 mg/kg/day for chronic
dietary and short- and intermediate-term dermal exposure risk
estimates. An uncertainty/safety factor of 100X (10X for interspecies
variability and 10X for interspecies extrapolation) was used. The Food
Quality Protection Act (FQPA) factor of 10X was reduced to 1X;
therefore, the chronic Reference Dose (cRfD) is equal to chronic
Population Adjusted Dose (cPAD). A 100% dermal absorption is assumed
for converting oral to dermal equivalent dose in the absence of dermal
toxicity or dermal absorption studies. For short- and intermediate-term
inhalation exposure, the route-specific study was used. The NOAEL of
0.62 (32 ppm) was observed in a 90-day inhalation toxicity study in
rats. The uncertainty factor is 100X (10X for interspecies variability
and 10X for interspecies extrapolation). The FQPA factor of 10X was
reduced to 1X.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ammonium formate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from ammonium formate in food as follows:
i. Acute exposure. No adverse effect attributable to a single
exposure of ammonium formate was seen in the toxicity databases.
Therefore, no acute risk from exposure to ammonium formate is expected
and an acute exposure assessment is not needed.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used food consumption information from the United
States Department of Agriculture (USDA) (1994-1996 and 1998) Nationwide
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue
levels in food, no residue data were submitted for ammonium formate. In
the absence of specific residue data, EPA has developed an approach
which uses surrogate information to derive upper bound exposure
estimates for the subject inert ingredient. Upper bound exposure
estimates are based on the highest tolerance for a given commodity from
a list of high-use insecticides, herbicides, and fungicides. A complete
description of the general approach taken to assess inert ingredient
risks in the absence of residue data is contained in the memorandum
entitled ``Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic
Aggregate (Food and Drinking Water) Dietary Exposure and Risk
Assessments for the Inerts.'' (DP Barcode: 361707, S. Piper, 2/25/2009)
and can be found at http://www.regulations.gov in docket ID number EPA-
HQ-OPP-2008-0738.
In the dietary exposure assessment, the Agency assumed that the
residue level of the inert ingredient would be no higher than the
highest tolerance for a given commodity. Implicit in this assumption is
that there would be similar rates of degradation (if any) between the
active and inert ingredient and that the concentration of inert
ingredient in the scenarios leading to these highest of tolerances
would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary
exposures lead to an extremely conservative assessment of dietary risk
due to a series of compounded conservatisms. First, assuming that the
level of residue for an inert ingredient is equal to the level of
residue for the active ingredient will overstate exposure. The
concentration of active ingredient in agricultural products is
generally at least 50% of the product and often can be much higher.
Further, pesticide products rarely have a single inert ingredient;
rather there is generally a combination of different inert ingredients
used which additionally reduces the concentration of any single inert
ingredient in the pesticide product in relation to that of the active
ingredient.
Second, the conservatism of this methodology is compounded by EPA's
decision to assume that, for each commodity, the active ingredient
which will serve as a guide to the potential level of inert ingredient
residues is the active ingredient with the highest tolerance level.
This assumption overstates residue values because it would be highly
unlikely, given the high number of inert ingredients, that a single
inert ingredient or class of ingredients would be present at the level
of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all
foods contain the inert ingredient at
[[Page 55995]]
the highest tolerance level. In other words, EPA assumed 100% of all
foods are treated with the inert ingredient at the rate and manner
necessary to produce the highest residue legally possible for an active
ingredient. In summary, EPA chose a very conservative method for
estimating what level of inert residue could be on food, and then used
this methodology to choose the highest possible residue that could be
found on food and assumed that all food contained this residue. No
consideration was given to potential degradation between harvest and
consumption even though monitoring data show that tolerance level
residues are typically one to two orders of magnitude higher than
actual residues in food when distributed in commerce.
Accordingly, although sufficient information to quantify actual
residue levels in food is not available, the compounding of these
conservative assumptions will lead to a significant exaggeration of
actual exposures. EPA does not believe that this approach
underestimates exposure in the absence of residue data.
iii. Cancer. Ammonium formate is not expected to be carcinogenic,
since there was no evidence of carcinogenicity in the available
studies. The Persistent, Bioaccumulative, and Toxic (PBT) profiler, a
component of the Agency's P2 Framework did not raise any cancer
concerns. Since the Agency has not identified any concerns for
carcinogenicity relating to ammonium formate, a cancer dietary exposure
assessment is not necessary to assess cancer risk.
2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for ammonium formate, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. These values were directly entered into the
dietary exposure model. The Agency considers the value of 100 ppb to be
a high end, conservative assumption that is not likely to underestimate
drinking water risks.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
There are no known or anticipated residential uses and therefore,
residential exposure is not expected.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found ammonium formate to share a common mechanism of
toxicity with any other substances, and ammonium formate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
ammonium formate does not have a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for pre-natal and post-natal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
EPA concluded that the FQPA safety factor could be removed for
ammonium formate for the following reasons:
i. No toxicological studies were identified for ammonium formate in
the publically available databases. However, ammonium formate breaks
down into ammonium and formate ions. Ammonium ions are ubiquitous in
the natural environment and can be considered as having little toxicity
or hazard risk. There is available data on formic acid and related
formate compounds (such as calcium, sodium and methyl formate), which
can serve as suitable surrogates for ammonium formate. Studies
conducted with methanol are also applicable to formate compounds, since
methanol is metabolized into formic acid. Therefore, the database is
considered adequate for FQPA assessment.
ii. There is no evidence of increased susceptibility of infants and
children in the available reproduction and developmental toxicity
studies with calcium formate and/or sodium formate. No developmental or
maternal systemic toxicity was observed in rats at doses up to 200 mg/
kg/day when calcium formate was administered via drinking water. No
developmental or maternal toxicity was observed in mice at doses up to
750 mg/kg gavage dose of sodium formate on gestation day 8. No evidence
of increased susceptibility was observed following pre- and post-natal
exposure to calcium formate. In a multi-generation reproduction study
(3 to 5 generations), no parental, reproductive or offspring toxicity
was observed at doses up to 200 mg/kg/day.
iii. No neurotoxicity studies are available in the database.
However, there is no evidence of clinical signs of neurotoxicity in the
database, nor evidence of susceptibility in the young in the database.
Therefore, EPA concluded that the developmental neurotoxicity study is
not required. There is no evidence of immunotoxicity in the available
database.
iv. The dietary food exposure assessment utilizes highly
conservative default assumptions that would not underestimate the
dietary risk to all populations. For the purpose of the screening level
dietary risk assessment to support this request for an exemption from
the requirement of a tolerance for ammonium formate, a value of 100 ppb
for drinking water based on screening level modeling was used for the
chronic dietary risk assessment. The value of 100 ppb is considered to
be a high end, conservative assumption that is not likely to
underestimate drinking water risks.
Taking into consideration the available information, EPA concludes
the additional 10X FQPA safety factor can be reduced to 1X.
E. Aggregate Risks and Determination of Safety
Determination of safety section. EPA determines whether acute and
chronic dietary pesticide exposures are safe by comparing aggregate
exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For
linear cancer risks, EPA calculates the lifetime probability of
acquiring cancer given the estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks are evaluated by comparing the
estimated aggregate food, water, and
[[Page 55996]]
residential exposure to the appropriate PODs to ensure that an adequate
MOE exists.
1. Acute aggregate (food and drinking water) risk. No adverse
effect attributable to a single exposure of ammonium formate was seen
in the toxicity databases. Therefore, ammonium formate is not expected
to pose an acute risk.
2. Chronic aggregate (food and drinking water) risk. A chronic
aggregate risk assessment takes into account exposure estimates from
chronic dietary consumption of food and drinking water. Using the
exposure assumptions discussed in this unit for chronic exposure, the
chronic dietary exposure from food and water to ammonium formate is
9.6% of the cPAD for the U.S. population and 31.2% of the cPAD for
children 1-2 years old, the most highly exposed population subgroup.
The chronic dietary exposure estimates for food and drinking water are
below the Agency's level of concern (<100% cPAD) for the U.S.
population and all population subgroups. There are no residential uses
known or proposed, and therefore, no residential exposure is expected.
3. Aggregate cancer risk for U.S. population. The Agency has not
identified any concerns for carcinogenicity relating to ammonium
formate.
4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to ammonium formate residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
The Agency is not aware of any country requiring a tolerance for
nor have any CODEX Maximum Residue Levels (MRLs) been established for
any food crops at this time.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for ammonium formate (CAS Reg. No.
540-69-2) when used as an inert ingredient (complexing or fixing agent)
in pesticide formulations applied to growing crops.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 7, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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.
* * * * *
[[Page 55997]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
Ammonium formate (CAS Reg. No. Complexing or
540-69-2) fixing agent
* * * * *
------------------------------------------------------------------------
[FR Doc. 2010-22976 Filed 9-14-10; 8:45 am]
BILLING CODE 6560-50-S