28488 Federal Register / Vol. 75, No. 98 / Friday, May 21, 2010 / Rules and Regulations 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on May 7, 

2010. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2010–11760 Filed 5–20–10; 8:45 am] 

BILLING CODE 4910–13–P 

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. 

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 


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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 


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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 previouslymentioned 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 nonconsecutive 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 nonoccupational, 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 


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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 intraspecies 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. 


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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. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section §180.910, the table is 

amended by adding alphabetically the 

following inert ingredient to read as 

follows: 

§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from 

the requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*****

Silver Nitrate 

(Cas Reg. 

No. 7761– 

88–8) 

For use on 

potatoes as 

post-harvest treatment to 

control 

sprouting at 

no more 

than 0.06% 

by weight 

in pesticide 

formulations 

stabilizer 

*****

[FR Doc. 2010–12116 Filed 5–20–10; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2010–0003; Internal 

Agency Docket No. FEMA–8131] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities, where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP), that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. 

DATES: Effective Dates: The effective 

date of each community’s scheduled 

suspension is the third date (‘‘Susp.’’) 


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