
[Federal Register: May 21, 2010 (Volume 75, Number 98)]
[Rules and Regulations]               
[Page 28488-28492]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my10-10]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0663; FRL-8824-9]

 
Silver Nitrate; 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 silver nitrate (CAS Reg. No. 7761-88-8) 
when used as an inert ingredient under 40 CFR 180.910 as stabilizer at 
a maximum of 0.06% by weight in pesticide formulations as post-harvest 
treatment for potatoes to control sprouting. Wagner Regulatory 
Associates on behalf of Pimi Agro CleanTech, Ltd. 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 silver nitrate.

DATES: This regulation is effective May 21, 2010. Objections and 
requests for hearings must be received on or before July 20, 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-2009-0663. 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: Alganesh Debesai, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8353; e-mail address: 
debesai.alganesh@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR cite at http://
www.gpoaccess.gov/ecfr

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, and 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-2009-0663 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 [date 
60 days after date of publication in the Federal Register]. 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-2009-0663 by one 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 October 7, 2009 (74 FR 5159) (FRL-8792-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP 9E7584) by 
Wagner Regulatory Associates on behalf of Pimi Agro CleanTech, Ltd., 
P.O.Box. 117, Hutzot Alonim 30049, Israel. The petition requested that 
40 CFR 180.910 be amended establishing an exemption from the 
requirement of a tolerance for residues of silver nitrate (CAS Reg. No. 
7761-88-8) when used as an inert ingredient stabilizer at 0.06% by 
weight in pesticide formulations applied to

[[Page 28489]]

potatoes as a post-harvest treatment to control sprouting. That notice 
referenced a summary of the petition prepared by Wagner Regulatory 
Associates on behalf of Pimi Agro CleanTech, the petitioner, which is 
available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing

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 no 
toxicity; 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 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 silver nitrate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with silver nitrate 
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 silver nitrate are discussed in this 
unit.
    The following provides a brief summary of the risk assessment and 
conclusions for the Agency's review of silver nitrate. The Agency's 
full decision document for this action is available in the Agency's 
electronic docket (regulations.gov) under the docket number EPA-HQ-OPP-
2009-0663.
    Silver nitrate is a water soluble inorganic salt that readily 
dissociates into the silver cation and the nitrate/nitrite anion. 
Nitrate and nitrite are naturally occurring inorganic ions which are 
part of the nitrogen cycle. Nitrate is a natural constituent of soil 
and vegetation. Nitrate is also a normal metabolite in mammals. Nitrate 
in soil, ground water and surface water are derived mainly from 
mineralization of soil organic matter as well as from application of 
mineral fertilizers.
    The EPA IRIS lists an oral RfD for chronic noncarcinogenic health 
effects for nitrate (as nitrate nitrogen) based on early clinical signs 
of methemoglobinemia in excess of 10% (0-3 months old infant's 
formula).
    Silver ions and preparations containing silver in an ionic state 
have been used for over a century for medicinal and bactericidal 
purposes. Because of its bactericidal properties, silver has been used 
as a topical treatment for burns, as a treatment for venereal diseases, 
as an ingredient in cosmetic formulation, in the sanitation of swimming 
pools and hot tubs/spas, and cleansing of hard surfaces in various food 
handling. Silver has also been used in dentistry (as amalgams and as an 
ingredient in mouth washes), in acupuncture, jewelry making, and 
photography. Silver can be found in electroplating as well as in paints 
and in water purification systems.
    The toxicity of silver is well understood based on epidemiological 
data from humans, toxicology data in animals, and documented 
information on the metabolism of silver in mammalian species. These 
studies show that the effect of concern for silver is argyria, a bluish 
discoloration of the skin. Argyria, while a permanent condition, is a 
cosmetic condition. The function of the skin as an organ is not 
compromised and the resulting discoloration is not associated with 
systemic toxicity. Information regarding the toxicity of silver is 
discussed in detail in the recent rulemaking establishing an exemption 
from tolerance for silver used as a surface sanitizing solution in the 
Federal Register published on June 10, 2009 (74 FR 27447; FRL-8412-1).

B. Regulatory Levels

    The EPA's IRIS lists an oral RfD for chronic noncarcinogenic health 
effects for nitrate (as nitrate nitrogen) of 1.6 miligrams/kilogram/day 
(mg/kg/day). This RfD is derived from human epidemiological surveys 
using a no observed adverse effect level (NOAEL) of 10 mg nitrate-
nitrogen/L (equivalent to 1.6 mg/kg/day) and lowest observable adverse 
effect level (LOAEL) of 11-20 mg nitrate-nitrogen/L (equivalent to 1.8-
3.2 mg/kg/day) based on early clinical signs of methemoglobinemia in 
excess of 10% (0-3 months old infant's formula).
     Safe exposure levels for silver have been established by several 
regulatory Agencies including FDA, OSHA and other offices within EPA 
based on the common endpoint argyria and using the same human studies. 
Argyria occurs only after chronic exposure. Both the

[[Page 28490]]

Secondary Maximum Contamination Level (SMCL) reported by the EPA's 
Office of Water and the oral RfD reported under the EPA's IRIS were 
determined based on a human biomonitoring study. For the oral exposure 
route, the Agency is relying on the drinking water SMCL of 0.1 mg/L 
(0.003 mg/kg/day) based on skin discoloration and graying of the whites 
of eyes (argyria) and using a safety factor of 3X. The Agency applied 
an additional 3x uncertainty factor to further address the lack of a 
NOAEL in the study on which this assessment and all regulatory 
advisories are set. Thus, a composite database factor of 10X is being 
applied yielding a chronic RfD of 0.001 mg/kg/day. This composite 
factor of 10X should be sufficient for providing protection from the 
non-toxic effects which may result from chronic oral exposure to 
silver.

Chronic RfD = 0.003 mg/kg/day / 3 = 0.001 mg/kg/day

    A full discussion of the derivation of the RfD is contained in the 
previously-mentioned tolerance exemption action. (June 10, 2009).
    The Agency has concluded that the silver RfD of 0.001 mg/kg/day 
would be protective of both the toxic effects of silver and nitrate 
because the silver SMCL is nearly 1,000X below the RfD calculated for 
nitrate (1.6 mg/kg/day). Therefore, given that silver and nitrate 
exposure would be roughly equivalent, a separate human health risk 
assessment for nitrate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to silver nitrate, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from silver nitrate in food as follows:
    Residue analysis of whole tuber washed potato samples treated with 
silver nitrate showed 0.0085 ppm (equivalent to 0.0085 mg/kg) of 
silver.
    Silver nitrate dietary exposure assessment was conducted using the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCIDTM), Version 2.00. No drinking 
water exposure assessment was included in the DEEM run since no outdoor 
or potable human drinking water system uses for this proposed use of 
silver nitrate. The residues value of 0.0085 ppm (equivalent to 0.0085 
mg/kg/day) of silver nitrate and an empirical processing factor of 6.5 
for dry potatoes were used in this assessment. However, default 
processing factors were used for potato, tuber with or without peel. 
The use of the default processing factors for potato, tuber 
overestimates exposure to these commodities.
    Recently, EPA assessed chronic dietary exposure from the use of 
silver as a food contact sanitizer. (June 10, 2009). The dietary 
assessment was only completed for chronic routes end point of concern 
because the end point of concern that has been identified is based on 
argyria, one that occurs only after chronic exposure. For dietary 
exposures from this product being used on countertops, the Incidental 
Dietary Residential Exposure Assessment Model, (IDREAMTM) 
incorporates consumption data from United State Department of 
Agriculture (USDA) Continuing Surveys of Food Intakes by Individuals 
(CSFII), 1994-1996 and 1998. The 1994-1996, 98 data are based on the 
reported consumption of more than 20,000 individuals over two non-
consecutive survey days.
    2. Dietary exposure from drinking water There are no outdoor or 
potable human drinking water system uses for this proposed use of 
silver. In addition, the uses identified as indoor hard surface 
applications will result in minimal, if any, runoff of silver into the 
surface water. The use of silver as a food contact surface sanitizer 
will result in minimal, if any, runoff of silver into the surface 
water. This use will result in an insignificant contribution to 
drinking water exposures. In addition to sanitization, silver is 
registered as an active ingredient in water filters. The bacteriostatic 
water filters are impregnated with silver and may result in residues in 
the drinking water supply. However, the levels of available residues 
resulting from impregnated water filters are much less when in 
comparison to the amount of residues that will be available for intake 
when silver-containing liquid concentrates are used. As a result, any 
drinking water exposures from the new use of silver are assumed to be 
negligible. Additionally, any drinking water risks from impregnated 
filters are assumed to be represented by the dietary risks resulting 
from hard surface sanitization. The Agency believes that an assessment 
of any potential risks resulting from silver in drinking water is not 
warranted at this time.
    Therefore, based on the proposed uses of silver, the Agency 
believes that risks resulting from silver in drinking water will be 
negligible and as assessment is not warranted at this time.
    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).
    The residential exposure assessment considers all potential non-
occupational pesticide exposure, other than exposure due to residues in 
food or in drinking water. Exposures may occur during and after 
application on hard surfaces (e.g., floors). Each route of exposure 
(incidental oral, dermal, inhalation) is considered where appropriate. 
The risks to handlers are quantitatively assessed based on the nature 
of the chemical. There are no adverse toxicological consequences 
(systemic or irritation) resulting from contact with silver other than 
skin discoloration. Residential exposures are short-term (<30 days) and 
intermediate-term (1-6 months) in nature. As supported in the 
toxicological discussion, however, silver ion produces only cosmetic 
effects and only as a result of chronic exposures. In addition, 
incidental ingestion (hand to mouth behavior of a child on a treated 
floor) as well as dermal exposures resulting from a child contacting a 
freshly cleaned floor is considered short-term in duration.
    Based on the fact that silver will exist in the ionic form, which 
does not volatilize, any post application inhalation exposures to 
vapors are expected to be negligible. Essentially, there are no 
toxicological consequences (systematic or irritation) resulting from 
contact with silver other than discoloration.
    Other non-pesticidal industrial uses of silver include, but are not 
limited to, photography, cosmetics, sunscreens, manufacture of inks and 
dyes, mirror production, and in jewelry. All these uses may result in 
exposures via the dermal route, which over a chronic duration, may 
cause skin discoloration. However, dermal exposures resulting from 
these uses are not appropriate to include in this aggregate exposure 
assessment. Systemic uptake and distribution of silver does not occur 
via the dermal route. The specific uses of silver that were considered 
for this aggregate assessment include the cleansing of hard surfaces in 
various food handling, institutional, medical and residential premises.
    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

[[Page 28491]]

substances that have a common mechanism of toxicity.''
    EPA has not found silver nitrate to share a common mechanism of 
toxicity with any other substances, and silver nitrate does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
silver nitrate 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

    1. In general. 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 prenatal 
and postnatal 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.
    2. Prenatal and postnatal sensitivity There is extensive data and 
analysis on silver's toxicity in the historical data/literature and 
regulatory advisories established by other Federal Agencies, which do 
not indicate an increased susceptibility of children to the toxic 
effects of silver. A National Toxicology Program (NTP) developmental 
toxicity study concluded that the NOAEL recorded for developmental 
toxicity in rats receiving gavages doses of silver acetate was greater 
than 100 mg/kg/day when the test material was administered on gestation 
day 6 through 19. No increase in susceptibility was apparent in this 
study. Furthermore, silver nitrate has been used for decades to treat 
neonatal conjunctivitis. Finally, there is no reason to believe that 
the effects that are observed following the administration of silver 
would warrant additional safety factors for children. The skin is the 
target organ and deposition of silver should not be age dependent. 
Moreover, because EPA believes that the available biomonitoring studies 
adequately characterize variability in human sensitivity, EPA is not 
applying an intra-species uncertainty factor in deriving the chronic 
RfD for silver.
    3. Conclusion. Although EPA is not applying an inter-species 
uncertainty factor (because of reliance on human data) or an intra-
species uncertainty factor (because human sensitivity has been 
adequately characterized), EPA is retaining the 10X FQPA safety factor 
in assessing oral risk to address the fact that the dose used to 
determine the chronic RfD showed effects from silver (argyria). In 
making its determination regarding the appropriate safety factors for 
evaluating the risk of silver, EPA took into account that argyria is 
not a toxic effect, there is no evidence of increased sensitivity in 
the young from exposure to silver, and the exposure assessment for 
silver is very conservative.

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 population adjusted dose (aPAD) and 
chronic population adjusted dose (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the appropriate point of 
departures (PODs) to ensure that an adequate margin of exposure (MOE) 
exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
silver nitrate is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account exposure estimates from chronic dietary consumption of food and 
from the use of silver as a food contact sanitizer. Using the exposure 
assumptions described in this unit for chronic exposure and the use 
limitations of not more than 0.06% by weight in pesticide formulations, 
the chronic dietary exposure from food to silver nitrate is 20% of the 
cPAD for the U.S. population and 63.8.6% of the cPAD for children 1-2 
years old, the most highly exposed population subgroup.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Because no short-term adverse effect was identified, silver nitrate 
is not expected to pose a short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Because no intermediate-term adverse effect was identified, silver 
nitrate is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. The Agency has not 
identified any concerns for carcinogenicity relating to silver nitrate.
    6. 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 silver nitrate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

     An analytical method is not required for enforcement purposes 
since the Agency is not establishing a numerical tolerance for residue 
of silver nitrate in or on any food commodities. EPA is establishing a 
limitation on the amount of silver nitrate that may be used in 
pesticide formulations. That limitation will be enforced through the 
pesticide registration process under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will 
not register any pesticide for sale or distribution that contains 
greater than 0.06% of silver nitrate by weight in the pesticide 
formulation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.

[[Page 28492]]

    Option 1: If there is NO relevant international standard, use this:

     The Agency is not aware of any country requiring a tolerance for 
silver nitrate 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. 910 for silver nitrate 7761-88-8) when 
used as an inert -ingredient (stabilizer at no more than 0.06% by 
weight) in pesticide formulations applied to potatoes as a post-harvest 
treatment to control sprouting.

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: May 12, 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. Section Sec. 180.910, the table is amended by adding alphabetically 
the following inert ingredient to read as follows:


Sec.  180.910  Inert ingredients used pre-harvest and post-harvest; 
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Silver Nitrate (Cas Reg. No.      For use on          stabilizer
 7761-88-8)                        potatoes as post-
                                   harvest treatment
                                   to control
                                   sprouting at no
                                   more than 0.06%
                                   by weight in
                                   pesticide
                                   formulations
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 2010-12116 Filed 5-20-10; 8:45 am]
BILLING CODE 6560-50-S

