11476 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 

have a significant economic impact on 

a substantial number of small entities as 

that term is defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601 et seq. The 

factual basis is found in the proposed 

rule and is not repeated here. No 

comments were received on the 

certification or the economic impacts of 

this action. As a result, no final 

regulatory flexibility analysis was 

prepared. 

Paperwork Reduction Act 

This final rule contains collection-ofinformation requirements subject to 

review and approval by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (PRA). 

These requirements have been approved 

by OMB (OMB No. 0625–0245; 

Expiration Date: 09/30/2011). Public 

reporting for this collection of 

information is estimated to be less than 

ten minutes per response, including the 

time for reviewing instructions and 

completing and reviewing the collection 

of information. All responses to this 

collection of information are voluntary, 

and will be provided confidentially to 

the extent allowed by law. 

Notwithstanding any other provision 

of law, no person is required to respond 

to, nor shall any person be subject to a 

penalty for failure to comply with a 

collection of information subject to the 

Paperwork Reduction Act unless that 

collection displays a currently valid 

OMB Control Number. 

List of Subjects in 19 CFR Part 360 

Administrative practice and 

procedure, Business and industry, 

Imports, Reporting and recordkeeping 

requirements, Steel. 

Dated: March 13, 2009. 

Michelle O’Neill, 

Acting Under Secretary for International 

Trade. 

■ For reasons discussed in the 

preamble, 19 CFR part 360 is amended 

to read as follows: 

PART 360—STEEL IMPORT 

MONITORING AND ANALYSIS SYSTEM 

■ 1. The authority citation for part 360 

continues to read as follows: 

Authority: 13 U.S.C. 301(a) and 302. 

■ 2. Section 360.105 is revised to read 

as follows: 

§ 360.105 Duration of the steel import 

licensing requirement. 

The licensing program will be in 

effect through March 21, 2013, but may 

be extended upon review and 

notification in the Federal Register 

prior to this expiration date. Licenses 

will be required on all subject imports 

entered during this period, even if the 

entry summary documents are not filed 

until after the expiration of this 

program. The licenses will be valid for 

10 business days after the expiration of 

this program to allow for the final filing 

of required Customs documentation. 

[FR Doc. E9–6013 Filed 3–16–09; 4:15 pm] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 172 

[Docket No. FDA–2005–F–0505] (formerly 

Docket No. 2005F–0138) 

Food Additives Permitted for Direct 

Addition to Food for Human 

Consumption; Silver Nitrate and 

Hydrogen Peroxide 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

food additive regulations to provide for 

the safe use of an aqueous solution of 

silver nitrate and hydrogen peroxide as 

an antimicrobial agent in bottled water. 

This action is in response to a petition 

filed by Kareem I. Batarseh. 

DATES: This final rule is effective March 

18, 2009. Submit written or electronic 

objections and requests for a hearing by 

April 17, 2009. See section VIII of this 

document for information on the filing 

of objections. The Director of the 

Federal Register approves the 

incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51 of certain publications in 21 

CFR 172.167 as of March 18, 2009. 

ADDRESSES: You may submit written or 

electronic objections and requests for a 

hearing identified by Docket No. FDA– 

2005–F–0505 (formerly Docket No. 

2005F–0138) by any of the following 

methods: 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written objections in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

objections, FDA is no longer accepting 

objections submitted to the agency by email. FDA encourages you to continue 

to submit electronic objections by using 

the Federal eRulemaking Portal, as 

described in the Electronic Submissions 

portion of this paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

objections received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

objections received, go to http:// 

www.regulations.gov and insert the 

docket number(s), found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Mical E. Honigfort, Center for Food 

Safety and Applied Nutrition (HFS– 

265), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–1278. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a notice published in the Federal 

Register of April 18, 2005 (70 FR 

20145), FDA announced that a food 

additive petition (FAP 5A4759) had 

been filed by Kareem I. Batarseh, P.O. 

Box 8, College Park, MD 20741–0008. 

The petition proposed to amend the 

food additive regulations in part 172, 

Food Additives Permitted for Direct 

Addition to Food for Human 

Consumption (21 CFR part 172), to 

provide for the safe use of an aqueous 

solution of silver nitrate and hydrogen 

peroxide as an antimicrobial agent in 

bottled drinking water at a level not to 

exceed 17 micrograms per kilogram (μg/ 

kg) of silver and 23 milligrams per 

kilogram (mg/kg) of hydrogen peroxide 

in the treated bottled water. 

II. Evaluation of Safety 

Under the general safety standard in 

section 409 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

348), a food additive cannot be 

approved for a particular use unless a 

fair evaluation of the data available to 


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Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 11477 

FDA establishes that the additive is safe 

for that use. FDA’s food additive 

regulations (21 CFR 170.3(i)) define safe 

as ‘‘a reasonable certainty in the minds 

of competent scientists that the 

substance is not harmful under the 

intended conditions of use.’’ 

To establish with reasonable certainty 

that a food additive is not harmful 

under its intended conditions of use, 

FDA considers the estimated human 

dietary intake of the additive, the 

additive’s toxicological data, and other 

relevant information (such as published 

literature) available to the agency. FDA 

compares an individual’s estimated 

daily intake (EDI) of the additive to an 

acceptable intake level established by 

toxicological data. The EDI is 

determined by projections based on the 

amount of the additive proposed for use 

in particular foods and on data 

regarding the amount consumed from 

all sources of the additive. The agency 

commonly uses the EDI for the 90th 

percentile consumer of a food additive 

as a measure of high chronic dietary 

intake. 

FDA estimates the EDI of silver from 

the petitioned use in bottled water to be 

26 micrograms per person per day (μg/ 

p/d) for the 90th percentile consumer 

aged 2 years or more (Ref. 1). Currently, 

silver is permitted as a component of an 

antimicrobial agent in water filters (the 

subject of effective food contact 

substance notification number 351 (Ref. 

2)). The EDI from this filter use is 27 μg/ 

p/d for the 90th percentile consumer. 

The petitioner has proposed as a 

condition of safe use that the subject 

additive not be used in bottled water 

that has been or is intended to be 

filtered with a silver-containing water 

filter. Consequently, bottled water 

containing the subject additive will 

generally be consumed as a substitute 

for, rather than in addition to, bottled 

water that has been filtered with a 

silver-containing filter. Thus, the use of 

the subject additive in bottled water will 

not increase consumer exposure to 

silver. Because there is no increase in 

the intake of silver beyond a level that 

has already been established as safe, 

FDA has no concerns regarding the 

petitioned use of silver as a component 

of this additive. 

Regarding exposure to nitrate from 

use of the subject additive, FDA 

estimates that the maximum level of 

nitrate in bottled drinking water treated 

with the subject additive would result 

in a worst-case intake of 15 μg/p/d at the 

90th percentile (Ref. 1), which is 

equivalent to 0.25 micrograms per 

kilogram body weight per day (μg/kgbw/d) in a 60 kg adult. FDA has no 

safety concerns because the intake of 

nitrate in bottled drinking water treated 

with the subject additive is significantly 

lower than the chronic oral reference 

dose of 1,600 μg/kg-bw/d for nitrate that 

was established by the Environmental 

Protection Agency (Ref. 3). 

FDA also has no safety concerns 

regarding the use of hydrogen peroxide 

as a component of this additive as it will 

rapidly break down to water and oxygen 

after addition to the bottled water. 

Consequently, the dietary exposure to 

hydrogen peroxide from the petitioned 

use of the subject additive is essentially 

zero (Ref. 1). 

III. Conclusion 

FDA reviewed data in the petition and 

other available relevant material to 

evaluate the safety of the use of a 

mixture of silver nitrate and hydrogen 

peroxide as an antimicrobial agent in 

bottled water. Based on this 

information, the agency concludes that 

the proposed use of the additive is safe 

and the additive will achieve its 

intended technical effect as an 

antimicrobial agent under the proposed 

conditions of use. Therefore, the 

regulations in part 172 should be 

amended as set forth in this document. 

To ensure that food grade hydrogen 

peroxide is used in food, the additive 

must meet the specifications for 

hydrogen peroxide set forth in this 

regulation. 

FDA notes that bottled water must 

meet the quality standards for bottled 

water in § 165.110(b)(2) through (b)(5) 

(21 CFR 165.110(b)(2) through (b)(5)), 

including the limits specified for total 

silver and nitrate, unless the water bears 

a label statement of substandard quality, 

as provided for under § 165.110(c) (21 

CFR 165.110(c)). Furthermore, bottled 

water containing a substance at a level 

considered injurious to health under 

section 402(a)(1) of the act (21 U.S.C. 

342(a)(1)) is deemed adulterated, 

regardless of whether or not the water 

bears a label statement of substandard 

quality, § 165.110(d) (21 CFR 

165.110(d)). 

IV. Public Disclosure 

In accordance with § 171.1(h) (21 CFR 

171.1(h)), the petition and the 

documents that FDA considered and 

relied upon in reaching its decision to 

approve the petition will be made 

available for inspection at the Center for 

Food Safety and Applied Nutrition by 

appointment with the information 

contact person (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 171.1(h), the agency will delete from 

the documents any materials that are 

not available for public disclosure 

before making the documents available 

for inspection. 

V. Environmental Impact 

The agency has previously considered 

the environmental effects of this rule as 

announced in the notice of filing for 

FAP 5A4759. No new information or 

comments have been received that 

would affect the agency’s previous 

determination that there is no 

significant impact on the human 

environment and that an environmental 

impact statement is not required. 

VI. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VII. Section 301(ll) of the Federal Food, 

Drug, and Cosmetic Act 

FDA’s review of this petition was 

limited to section 409 of the act. This 

final rule is not a statement regarding 

compliance with other sections of the 

act. For example, the Food and Drug 

Administration Amendments Act of 

2007, which was signed into law on 

September 27, 2007, amended the act to, 

among other things, add section 301(ll) 

(21 U.S.C. 301(ll)). Section 301(ll) of the 

act prohibits the introduction or 

delivery for introduction into interstate 

commerce of any food that contains a 

drug approved under section 505 of the 

act (21 U.S.C. 355), a biological product 

licensed under section 351 of the Public 

Health Service Act (42 U.S.C. 262), or a 

drug or biological product for which 

substantial clinical investigations have 

been instituted and their existence has 

been made public, unless one of the 

exceptions in 21 U.S.C. 301(ll)(1) to 

(ll)(4) applies. In our review of this 

petition, FDA did not consider whether 

section 301(ll) or any of its exemptions 

apply to food containing this additive. 

Accordingly, this final rule should not 

be construed to be a statement that a 

food containing this additive, if 

introduced or delivered for introduction 

into interstate commerce, would not 

violate section 301(ll). Furthermore, this 

language is included in all food additive 

final rules and therefore should not be 

construed to be a statement of the 

likelihood that section 301(ll) applies. 

VIII. Objections 

Any person who will be adversely 

affected by this regulation may file with 

the Division of Dockets Management 

(see ADDRESSES) written or electronic 

objections. Each objection shall be 

separately numbered, and each 

numbered objection shall specify with 


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11478 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Rules and Regulations 

particularity the provisions of the 

regulation to which objection is made 

and the grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. Three copies of all documents 

are to be submitted and are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Any objections received in 

response to the regulation may be seen 

in the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

IX. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Memorandum from D. Doell, Division of 

Petition Review, CFSAN, FDA to M. 

Honigfort, Division of Petition Review, 

CFSAN, FDA, June 14, 2005. 

2. FDA, Inventory of Effective Food 

Contact Substance (FCS) Notifications, Food 

Contact Substance Notification Number 351 

(http://www.cfsan.fda.gov/~dms/opafcn.html). 

3. Environmental Protection Agency, 

Integrated Risk Information System: Nitrate 

(CASRN 14797–55–8) (http://www.epa.gov/ 

ncea/iris/subst/0076.htm). (FDA has verified 

the Web site address, but FDA is not 

responsible for any subsequent changes to 

the Web site after this document publishes in 

the Federal Register). 

List of Subjects in 21 CFR Part 172 

Food additives, Incorporation by 

reference, Reporting and recordkeeping 

requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Director, Center for Food Safety and 

Applied Nutrition, 21 CFR part 172 is 

amended as follows: 

PART 172—FOOD ADDITIVES 

PERMITTED FOR DIRECT ADDITION 

TO FOOD FOR HUMAN 

CONSUMPTION 

■ 1. The authority citation for 21 CFR 

part 172 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 348, 

371, 379e. 

■ 2. Section 172.167 is added to subpart 

B to read as follows: 

§ 172.167 Silver nitrate and hydrogen 

peroxide solution. 

An aqueous solution containing a 

mixture of silver nitrate and hydrogen 

peroxide may be safely used in 

accordance with the following 

prescribed conditions: 

(a) The additive is used as an 

antimicrobial agent in bottled water. 

(b) Hydrogen peroxide meets the 

specifications of the ‘‘Food Chemicals 

Codex,’’ 6th ed. (2008), pp. 463 and 464, 

which is incorporated by reference. The 

Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may obtain copies 

from the United States Pharmacopeial 

Convention, 12601 Twinbrook Pkwy., 

Rockville, MD 20852 (Internet address 

http://www.usp.org). Copies may be 

examined at the Center for Food Safety 

and Applied Nutrition’s Library, Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2163, or at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

call 202–741–6030 or go to: http://www.

archives.gov/federal_register/code_of_

federal_regulations/ibr_locations.html. 

(c) The amount of silver added will 

not exceed 17 micrograms per kilogram 

in the treated bottled water, and the 

amount of hydrogen peroxide will not 

exceed 23 milligrams per kilogram in 

the treated bottled water. Analyses for 

silver and hydrogen peroxide shall be 

conducted on samples of treated bottled 

water at the site of bottling, using 

samples of the water intended for 

treatment for the blank determination. 

(d)(1) The amount of silver in the 

treated bottled water is determined 

using the method for silver designated 

in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). 

(2) The amount of hydrogen peroxide 

in the treated bottled water is 

determined using a Hydrogen Peroxide 

Test Kit from the HACH Co., or 

equivalent. The manual from the 

Hydrogen Peroxide Test Kit, Model 

HYP–1, Catalog Number 22917–00, 

1991, is incorporated by reference. The 

Director of the Federal Register 

approves this incorporation by reference 

in accordance with 5 U.S.C. 552(a) and 

1 CFR part 51. You may obtain copies 

of the test kit manual from the HACH 

Co., P.O. Box 389, Loveland CO, 80359 

(1–800–227–4224), Model HYP–1, 

Catalog Number 22917–00. Copies may 

be examined at the Center for Food 

Safety and Applied Nutrition’s Library, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740, 301–436–2163, or at the National 

Archives and Records Administration 

(NARA). For information on the 

availability of this material at NARA, 

call 202–741–6030 or go to: http:// 

www.archives.gov/federal_register/ 

code_of_ federal_regulations/ 

ibr_locations.html. 

(e) Substances generally recognized as 

safe in or on food may be used to 

stabilize the additive to ensure that the 

additive will perform its intended 

technical effect. 

(f) The additive may not be added to 

bottled water that has been filtered or is 

intended to be filtered through a silvercontaining water filter. 

(g) Bottled water must meet the 

quality standards for bottled water in 

§ 165.110(b)(2) through (b)(5) of this 

chapter, including the limits specified 

for total silver and nitrate, unless the 

water bears a label statement of 

substandard quality, as provided for 

under § 165.110(c) of this chapter. 

Dated: March 12, 2009. 

Leslye M. Fraser, 

Director, Office of Regulations and Policy, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. E9–5852 Filed 3–17–09; 8:45 am] 

BILLING CODE 4160–01–S 

OFFICE OF THE DIRECTOR OF 

NATIONAL INTELLIGENCE 

32 CFR Part 1702 

Procedures Governing the Acceptance 

of Service of Process Upon the Office 

of the Director of National Intelligence 

and Its Employees in Their Official, 

Individual or Combined Official and 

Individual Capacities 

AGENCY: Office of the Director of 

National Intelligence. 

ACTION: Final rule. 

SUMMARY: This final regulation governs 

the procedures the ODNI will follow for 

the acceptance of service of process 

upon the ODNI and its employees in 

their official, individual or combined 

official and individual capacities. 

DATES: Effective Date: March 18, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Tricia Wellman, 703–275–2527. 


tjames on PRODPC61 with RULES