Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Proposed Rules 59973 

PART 73—SPECIAL USE AIRSPACE 

1. The authority citation for part 73 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389. 

§ 73.34 [Amended] 

2. § 73.34 is amended as follows: 

* * * * * 

R–3404—Crane, IN [Revised] 

Boundaries. That airspace within a 1 NM 

radius of lat. 38°49′30′′ N., long. 86°50′08′′ W. 

Designated altitudes. Surface to and 

including 4,100 feet MSL. 

Times of Designation. Sunrise to sunset, 

daily from May 1 through and including 

November 1. Other times by NOTAM 24 

hours in advance. 

Controlling Agency. FAA, Terre Haute 

ATCT. 

Using Agency. U.S. Navy, Crane Division, 

Naval Surface Warfare Center tenant of NSA 

Crane 

* * * * * 

Issued in Washington, DC, October 16, 

2007. 

Paul Gallant, 

Acting Manager, Airspace and Rules Group. 

[FR Doc. E7–20795 Filed 10–22–07; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 15 

[Docket No. 2005P–0450] 

Salt and Sodium; Petition to Revise the 

Regulatory Status of Salt and Establish 

Food Labeling Requirements 

Regarding Salt and Sodium; Public 

Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; notice 

of availability of citizen petition; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing concerning FDA’s 

policies regarding salt (sodium chloride) 

and sodium in food. FDA also is 

announcing the availability for 

comment of a citizen petition, submitted 

by the Center for Science in the Public 

Interest (CSPI), requesting that FDA 

make changes to the regulatory status of 

salt, require limits on salt in processed 

foods, and require health messages 

related to salt and sodium. The purpose 

of the hearing is for FDA to share its 

current framework of policies regarding 

salt and sodium and to solicit 

information and comments from 

interested persons on this current 

framework and on potential future 

approaches, including approaches 

described in the citizen petition. 

DATES: The public hearing will be held 

on November 29, 2007, from 9 a.m. to 

4:30 p.m. Registration begins on October 

22, 2007. See section V of this document 

for other dates associated with 

participation in the hearing. Submit 

written or electronic comments (i.e., 

submissions other than notices of 

participation and written material 

associated with an oral presentation) by 

March 28, 2008. The administrative 

record of the hearing will remain open 

until March 28, 2008. 

ADDRESSES: Public hearing. The public 

hearing will be held at the Harvey W. 

Wiley Federal Building, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, 5100 Paint 

Branch Pkwy., College Park, MD, 

20740–3835 (Metro stop: College Park 

on the Green Line). 

Registration. Submit electronic 

notices of participation for the hearing 

to http://www.cfsan.fda.gov/ 

register.html. We encourage you to use 

this method of registration, if possible. 

Submit written notices of participation 

by mail, fax, or e-mail to Isabelle Howes, 

U.S. Department of Agriculture 

Graduate School, 600 Maryland Ave., 

SW, suite 270, Washington, DC 20024–

2520, FAX: 202–479–6801, or e-mail: 

Isabelle_Howes@grad.usda.gov. You 

may also submit oral notices of 

participation by phone to Isabelle 

Howes, U.S. Department of Agriculture 

Graduate School (see FOR FURTHER

INFORMATION CONTACT). 

Written material associated with an 

oral presentation. Submit written 

material associated with an oral 

presentation by mail, fax or e-mail to 

Isabelle Howes. 

Comments. Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. For 

additional information on submitting 

comments, see section VI in this 

document. 

FOR FURTHER INFORMATION CONTACT: 

For questions about registration or 

written material associated with an 

oral presentation, or to register 

orally: Isabelle Howes, 202–314–

4713. 

For all other questions about the 

hearing or if you need parking or 

special accommodations due to a 

disability: Juanita Yates, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 

301–436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Salt 

1. Salt in the Human Diet 

Salt (sodium chloride) is an essential 

part of the diet. Both the sodium and 

chloride ions are required, for example, 

to maintain extracellular volume and 

serum osmolality (Ref. 1). Salt is found 

naturally in foods such as milk and 

shellfish (Ref. 1). Salt also is added 

intentionally as a food ingredient for 

multiple technical effects in foods, e.g., 

as a seasoning agent and flavor 

enhancer, a preservative and curing 

agent, a formulating and processing aid, 

and a dough conditioner (47 FR 26590, 

June 18, 1982 (the 1982 policy notice)). 

The Dietary Guidelines for 

Americans, 2005 (Dietary Guidelines) 

(Ref. 2), a joint publication of the 

Department of Health and Human 

Services and the U.S. Department of 

Agriculture (USDA), forms the basis for 

the Federal Government’s nutrition 

programs and policies. Chapter 8 of the 

Dietary Guidelines reports that, on 

average, the natural salt content of food 

accounts for only about 10 percent of 

total intake, while discretionary salt use 

(i.e., salt added at the table or while 

cooking) provides another 5 to 10 

percent of total intake. Chapter 8 of the 

Dietary Guidelines also reports that 

approximately 75 percent of total salt 

intake is derived from salt added to 

processed food by manufacturers. 

2. Adverse Health Effects of Salt 

Excessive sodium has been cited by 

the scientific community as a 

contributory factor in the development 

of hypertension and cardiovascular 

disease (47 FR 26580). In general, there 

is a dose-dependent relationship 

between sodium intake and blood 

pressure that has been observed to occur 

throughout the range of levels of sodium 

intake (Ref. 1). Blood pressures among 

individuals in certain populations (e.g., 

persons with hypertension, diabetes, 

kidney disease, older persons, and 

African Americans) are more responsive 

to dietary sodium than blood pressures 

among the general population (Ref. 1). 

The Dietary Guidelines recommend that 

the general population consume no 

more than 2,300 milligrams/day (mg/d) 

and that persons with hypertension, 

blacks, and middle-aged and older 


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adults consume no more than 1,500 mg/ 

d (Ref. 2). 

3. Regulatory Status of Salt (1959–1982) 

The definition of ‘‘food additive’’ in 

section 201(s) of the Federal Food, Drug, 

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

321(s)) is a multistep definition that first 

broadly includes any substance, the 

intended use of which results or may 

reasonably be expected to result, 

directly or indirectly, in its becoming a 

component or otherwise affecting the 

characteristics of food. However, the 

definition then excludes substances that 

are generally recognized, among experts 

qualified by scientific training and 

experience to evaluate their safety as 

having been adequately shown through 

scientific procedures (or, in the case of 

a substance used in food prior to 

January 1, 1958, through either 

scientific procedures or through 

experience based on common use in 

food) to be safe under the conditions of 

their intended use. The definition also 

excludes certain other substances from 

the definition of food additive. In 

particular, under section 201(s)(4) of the 

act, any substance used in accordance 

with a sanction or approval granted 

prior to September 6, 1958, under the 

act, the Poultry Products Inspection Act 

(21 U.S.C. 451 et seq.) or the Federal 

Meat Inspection Act (21 U.S.C. 601 et 

seq.) is excluded from the definition of 

food additive. Under the act, substances 

that are not food additives are not 

subject to the requirements in section 

409 of the act (21 U.S.C. 348) for 

premarket review. Prior-sanctioned 

substances remain subject, however, to 

the general adulteration provisions in 

section 402 of the act (21 U.S.C. 342). 

These provisions prohibit, among other 

things, the use of added deleterious 

substances that ‘‘may render [the food] 

injurious to health.’’

In the Federal Register of November 

20, 1959 (24 FR 9368), FDA clarified the 

regulatory status of a multitude of food 

substances that were used in food prior 

to 1958 and amended its regulations to 

include an initial list of food substances 

that, when used for the purposes 

indicated and in accordance with 

current good manufacturing practice, 

are generally recognized as safe (GRAS). 

This initial list (the ‘‘GRAS list’’) is 

currently published in part 182 (21 CFR 

part 182). Section 182.1(a) provides in 

part: 

‘‘[I]t is impracticable to list all substances 

that are generally recognized as safe for their 

intended use. However, by way of 

illustration, the Commissioner regards such 

common food ingredients as salt, pepper, 

vinegar, baking powder, and monosodium 

glutamate as safe for their intended use.’’

In the early 1970s, FDA announced 

that the agency was conducting a 

comprehensive study of substances 

presumed to be GRAS (35 FR 18623, 

December 8, 1970; and 36 FR 20546; 

October 23, 1971). FDA also issued 

several regulations regarding GRAS 

substances and procedures associated 

with its comprehensive review of GRAS 

substances. These regulations are 

currently in part 170 (21 CFR part 170) 

and include: (1) Criteria that could be 

used to establish whether substances 

presumed to be GRAS should be listed 

as GRAS, become the subject of a food 

additive regulation, or be listed in an 

interim food additive regulation 

pending completion of additional 

studies (§ 170.30) (36 FR 12093, June 25, 

1971); (2) procedures that the agency 

could use, on its own initiative, to 

affirm the GRAS status of substances 

that were the subject of its 

comprehensive review and were found 

to satisfy the established criteria 

(§ 170.35(a) and (b)) (37 FR 25705, 

December 2, 1972); and (3) the general 

process that the agency would use to 

review ingredients included in the 

original GRAS list (§ 170.30(e)) (41 FR 

53600, December 7, 1976). Under 

§ 170.30(e): 

‘‘[f]ood ingredients were listed as GRAS [in 

21 CFR part 182] during 1958–1962 without 

a detailed scientific review of all available 

data and information relating to their safety. 

Beginning in 1969, [FDA] has undertaken a 

systematic review of the status of all 

ingredients used in food on the 

determination that they are GRAS or subject 

to a prior sanction. All determinations of 

GRAS status or food additive status or prior 

sanction status pursuant to this review shall 

be handled pursuant to [21 CFR 170.35, 

170.38, and 180.1] * * *’’

As part of FDA’s approach to the 

comprehensive review of GRAS 

substances, FDA contracted with the 

Federation of American Societies for 

Experimental Biology (FASEB) for a 

committee of scientific experts to 

summarize the available scientific 

literature regarding substances 

presumed to be GRAS, including salt. 

FASEB provided FDA with a tentative 

report containing its findings and 

recommendations, held public hearings 

to provide an opportunity for interested 

persons to submit additional 

information and to express their views 

about the tentative report, and then 

submitted a final report (47 FR 26590). 

In the 1982 policy notice, FDA 

described the uses of salt in food, 

reviewed the statutory framework for 

food ingredients, and described its 

comprehensive review of GRAS 

substances. FDA also discussed the 

findings and conclusions in FASEB’s 

final report on salt. The FASEB report 

recognized that there are many variables 

and uncertainties in determining an 

individual’s healthy salt intake. 

However, the FASEB report also raised 

concerns about salt consumption levels 

and concluded that: 

‘‘The evidence on sodium chloride is 

insufficient to determine that the adverse 

effects reported are not deleterious to the 

health of a significant proportion of the 

public when it is used at levels that are now 

current and in the manner now practiced.’’

The FASEB report recommended the 

development of guidelines for 

restricting the amount of salt in 

processed foods and adequate labeling 

of the salt content of foods. 

In the 1982 policy notice, FDA 

encouraged food manufacturers to 

reduce voluntarily the amount of added 

salt and other sodium-containing 

substances in processed foods and 

requested comment on this approach. 

FDA also announced its tentative 

decision to defer any revision in the 

regulatory status of salt until the agency 

could assess the impact in light of 

proposed sodium labeling regulations 

that would respond to health concerns 

about the levels of use of salt in the food 

supply. We discuss the proposed 

labeling regulations in section I.A.5 of 

this document. 

In the 1982 policy notice, FDA 

described evidence that some uses of 

salt were granted sanction or approval 

prior to September 6, 1958, and 

therefore would be excluded from the 

definition of a food additive under 

section 201(s)(4) of the act (47 FR 

26590). In part, this evidence relates to 

the inclusion of salt as an ingredient in 

several food standards issued before 

September 6, 1958. We discuss food 

standards in section I.A.4 of this 

document. 

4. Food standards 

Section 401 of the act (21 U.S.C. 341) 

gives FDA the authority to issue 

regulations fixing and establishing food 

standards, whenever it is the judgment 

of the Secretary of Health and Human 

Services that such action will promote 

honesty and fair dealing in the interest 

of consumers. Food standards are 

established to define the basic nature, 

and describe the essential 

characteristics, of a food consistent with 

consumer beliefs and expectations, and 

to establish its common or usual name. 

The process to amend existing standards 

requires either notice and comment 

rulemaking or formal rulemaking, 

depending on the specific standard. 

Among other things, food standards 

establish the name of the food and the 

ingredients that are mandatory (i.e., 

required ingredients) or permitted (i.e., 


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Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Proposed Rules 59975 

optional ingredients) in the manufacture 

of the food. Foods that are marketed 

under the standardized name must 

conform to all the requirements of the 

relevant standard(s) of identity. 

Conversely, foods that do not meet the 

requirements of the relevant standard(s) 

of identity cannot be marketed under 

the standardized name. Rather, such 

foods must be named using descriptors 

that accurately and adequately describe 

the food and that sufficiently 

distinguish it from the standardized 

food. Examples of foods subject to 

standards of identity include cheeses 

and related cheese products (part 133 

(21 CFR part 133)); bakery products 

(part 136 (21 CFR part 136)); and cereal 

flours and related products (part 137 (21 

CFR part 137)). 

Salt is a required or optional 

ingredient in many standardized foods. 

For example, salt is a required 

ingredient in ‘‘self rising flour’’

(§ 137.180), ‘‘self rising white corn 

meal,’’ (§ 137.270) and ‘‘cheddar 

cheese’’ (§ 133.113). In addition, salt is 

an optional ingredient in bakery 

products such as ‘‘bread, rolls and 

buns’’ (§ 136.110) and ‘‘dry curd cottage 

cheese’’ (§ 133.129). However, such 

standardized foods do not require a 

specific amount of salt and, thus, there 

is flexibility for food companies to 

lower salt concentrations by adjusting 

their formulations regarding the amount 

of salt added in the preparation of these 

standardized foods. The primary 

consideration for lowering salt 

concentrations in standardized foods 

where it is required is to ensure that the 

intended technical effect of the salt 

ingredient is accomplished. 

The provisions in § 130.10 (21 CFR 

130.10) allow standardized foods to 

deviate from certain requirements of a 

standard of identity to make the food 

eligible to bear a FDA-defined nutrient 

content claim. (A ‘‘nutrient content 

claim’’ (defined in section 403(r)(1)(A) 

of the act (21 U.S.C. 343(r)(1)(A))) is a 

claim that characterizes the level of a 

nutrient in a food. We have established 

regulations implementing section 

403(r)(1)(A) of the act with respect to 

nutrient content claims (§ 101.13 (21 

CFR 101.13 and subpart D)).) Under 

§ 130.10, the levels of sodium or salt in 

standardized foods can be altered to 

make the food eligible to bear a FDAdefined sodium- or salt-related claim 

such as ‘‘sodium free,’’ ‘‘low sodium,’’

‘‘reduced sodium,’’ ‘‘salt free,’’ and 

‘‘unsalted’’ (See § 101.61 (21 CFR 

101.61)). For example, although the 

standard of identity for ‘‘self rising 

flour’’ in § 137.180 requires the addition 

of salt in the manufacture of a food 

named ‘‘self rising flour,’’ manufacturers 

may deviate from this requirement for 

the specific purpose of making the food 

eligible for the ‘‘unsalted’’ claim in 

accordance with the provisions of 

§ 101.61(c)(2). Similarly, other 

standardized foods can be modified to 

eliminate or reduce the sodium content 

of the food to manufacture sodium-free 

or lower sodium versions of the 

standardized food, such as ‘‘low sodium 

bread’’ or ‘‘salt free cottage cheese.’’

5. Sodium Labeling 

In 1984, as a followup to the 1982 

policy notice, FDA established in 

§ 101.13 definitions for terms related to 

sodium content, e.g., ‘‘sodium free,’’

‘‘low sodium,’’ and ‘‘no added salt’’ and 

required that information about sodium 

be included with other nutritional 

information wherever it appears on food 

labels (49 FR 15510, April 18, 1984). 

FDA later revised and redesignated 

§ 101.13 as nutrient content regulations 

at §§ 101.56 (21 CFR 101.56) (Nutrient 

content claims for ‘‘light’’ and ‘‘lite’’) 

and 101.61 (Nutrient content claims for 

the sodium content of food) (58 FR 2302 

at 2414 and 2417; January 6, 1993) in 

response to the Nutrition Labeling and 

Education Act of 1990 (NLEA). Section 

101.61 addresses the use of terms such 

as ‘‘sodium free,’’ ‘‘low sodium,’’

‘‘reduced sodium,’’ and ‘‘no added salt’’

(58 FR 2302 at 2417) and § 101.56 

addresses the use of the terms ‘‘light’’

and ‘‘lite,’’ including the use of those 

terms in relation to sodium content (58 

FR 2302 at 2414). 

FDA also published a number of other 

labeling regulations in the January 6, 

1993 Federal Register in response to 

NLEA, which bears on how sodium is 

declared on the label; namely, the 

agency’s revised nutrition labeling 

regulations that required nutrition 

labeling of sodium content on virtually 

all processed food products 

(§ 101.9(c)(4) (21 CFR 101.9(c)(4))) (58 

FR 2079 at 2176) and established a 

reference value or ‘‘Daily Value’’ (DV) 

for sodium (§ 101.9(c)(9)) (58 FR 2206 at 

2227), and the agency’s new regulation 

(§ 101.74 (21 CFR 101.74)) establishing 

a health claim regarding low sodium 

diets and reduced risk of hypertension 

(58 FR 2820). FDA subsequently 

established regulations (§ 101.65 (21 

CFR 101.65)) requiring that foods 

labeled as ‘‘healthy’’ contain less than 

specified amounts of certain food 

components, including sodium (59 FR 

24232, May 10, 1994; amended at 70 FR 

56828, September 29, 2005). 

B. CSPI’s Prior Challenges to the GRAS 

Status of Salt 

In 1978, CSPI submitted a citizen 

petition requesting that FDA establish 

limits for sodium in processed foods 

and reclassify salt as a food additive. In 

a letter dated August 18, 1982 (Ref. 3), 

FDA denied the petition, stating that the 

agency had decided to leave salt in part 

182. In 1984, CSPI sought review of 

FDA’s actions in the United States 

District Court of the District of 

Columbia. (See Center for Science in the 

Pub. Interest v. Novitch, Food, Drug, 

and Cosm. L. Rep. (CCH) 38,275 (No. 

83–801) (D.D.C. June 11, 1984)). CSPI 

argued that FDA’s denial of its petition 

was arbitrary and capricious because it 

violated FDA’s procedures for reviewing 

substances on the initial GRAS list. 

CSPI also argued that FDA’s decision to 

defer any change to the GRAS status of 

salt constituted unreasonable delay in 

violation of the Administrative 

Procedures Act (5 U.S.C. 706(1)). The 

district court concluded that FDA’s 

decision was consistent with its 

regulations and the act and rejected the 

argument that FDA had unreasonably 

delayed reconsideration of the GRAS 

status of salt. CSPI did not appeal. 

In 2005, CSPI sought a writ of 

mandamus, in the United States Court 

of Appeals for the District of Columbia, 

compelling FDA to publish in the 

Federal Register a proposed rule either 

affirming or denying the GRAS status of 

salt and providing an opportunity for 

comment on the proposal. The court 

dismissed CSPI’s petition for lack of 

jurisdiction, explaining that CSPI had 

not sought a remedy from FDA or 

initiated any proceeding in FDA before 

resorting to the court. (See In re Center 

for Science in the Public Interest, 2005 

U.S. App. (No. 05–1057) (D.C. Cir. 

2005)). 

C. CSPI’s Prior Citizen Petitions 

Regarding Label Requirements for Salt 

The 1978 CSPI citizen petition also 

requested that FDA require sodium 

content labeling on packaged foods and 

require a special symbol on the labels of 

high-sodium foods. FDA denied the 

petition in a letter dated August 18, 

1982 (Ref. 3). In that denial letter, FDA 

considered that mandatory labeling for 

all processed foods was not justified and 

noted that the 1982 sodium labeling 

proposed rule would affect 

approximately one third of all processed 

food at that time. In addition, FDA 

considered a decision regarding special 

symbols for sodium-containing products 

to be premature because FDA was 

researching the utility of such symbols 

and vignettes. 

In 1981, CSPI submitted a citizen 

petition requesting that FDA require 

warning labels on packages of salt 

weighing half an ounce or more. FDA 

denied that petition in a letter dated 


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59976 Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Proposed Rules 

October 7, 1982 (Ref. 4). In that denial 

letter, FDA considered an isolated 

warning appearing on the label of one 

class of food products to be 

inappropriate given that many foods 

contribute to an individual’s sodium 

intake. 

D. Citizen Petition Submitted by CSPI in 

2005 (Docket No. 2005P–0450) 

In a citizen petition dated November 

8, 2005, CSPI requested that the agency 

take certain regulatory actions regarding 

salt. Specifically, CSPI requested that 

FDA initiate rulemaking to revoke the 

GRAS status for salt, amend prior 

sanctions for the use of salt, require food 

manufacturers to reduce the amount of 

sodium in all processed foods, require a 

health message on retail packages of salt 

one-half ounce or larger, and reduce the 

DV for sodium from its current level of 

2,400 mg/d to 1,500 mg/d. CSPI also 

requested that FDA take regulatory 

action to reduce the amount of sodium 

in processed foods sold directly to 

restaurants, e.g., by regulating salt in 

precooked French fries that are 

purchased by restaurants who then add 

more salt. 

In its petition, CSPI acknowledges 

that FDA has implemented several 

labeling requirements related to the 

sodium content of food through the 

NLEA as well as other labeling 

provisions, but asserts that these 

measures have not done enough to 

reduce sodium consumption. 

CSPI summarizes several published 

clinical and population-based studies 

regarding the effect of sodium on blood 

pressure to support its view that the link 

between cardiovascular disease and 

excessive sodium intake has been 

clearly defined in the scientific 

community (Refs. 5 to 8). CSPI discusses 

the potential impact on public health of 

reductions in blood pressure, citing 

published estimates that reductions in 

blood pressure and resultant reductions 

in the incidence of hypertension would 

reduce the risk of stroke and heart 

disease significantly, resulting in fewer 

deaths from cardiovascular disease 

(Refs. 9 to 13). 

CSPI provides a table summarizing 

various estimates of the average 

consumption of sodium collected 

between 1971 and 2000. CSPI argues 

that the data show that per capita 

sodium consumption has increased 

from 2,800 mg/d in the years 1976–1980 

to 3,400 mg/d in the years 1999–2000. 

(CSPI reports that it derived these 

estimates from dietary recall surveys 

conducted by the Centers for Disease 

Control and Prevention (i.e., the 

National Health and Nutrition 

Examination Surveys) and USDA (i.e., 

the Continuing Survey of Food Intakes 

of Individuals)). CSPI also cites a 

clinical study, based on urinary sodium 

excretion, estimating an average sodium 

intake of 4,000 mg/d in the United 

States (Ref. 14). CSPI compares these 

estimates to the current DV for sodium 

(i.e., 2,400 mg/d) and to 

recommendations in the Dietary 

Guidelines (Ref. 2) for the general 

population (i.e., no more than 2,300 mg/ 

d) and for persons with hypertension, 

blacks, and middle-aged and older 

adults (i.e., no more than 1,500 mg/d). 

CSPI concludes that the available data 

demonstrate current intake of sodium is 

significantly higher than the intake 

recommended by governmental and 

scientific organizations around the 

world. 

CSPI discusses the sources of sodium 

in the food supply, noting that some of 

the salt in the diet occurs naturally as 

an inherent component of foods, such as 

in milk. CSPI acknowledges that one 

reason for the increased consumption of 

sodium by the U.S. population in recent 

years is increased consumption of food 

in general. However, CSPI notes that the 

Dietary Guidelines estimate that 75 

percent of the sodium in the diet is 

derived from processed foods. CSPI 

states that regulatory action to reduce 

the sodium content of the diet should 

therefore focus on these foods. CSPI 

discusses the feasibility of reducing salt 

levels in foods, stating that reductions 

can be made without adversely affecting 

public health or taste. CSPI also 

describes the activities of the British 

government’s Food Standards Agency, 

which has introduced voluntary goals 

for the reduction of sodium in processed 

foods by food category (Ref. 15). 

Based on the health effects of salt 

cited in its petition, CSPI asserts that 

salt should no longer be considered 

‘‘safe.’’ As a result, CSPI argues that salt 

should not be considered as a GRAS 

food ingredient and that prior sanctions 

for certain uses of salt should be 

revoked. 

CSPI also asserts that FDA has 

authority to require the labeling 

requested in its petition under several 

provisions of the act and FDA’s 

regulations in Title 21 of the Code of 

Federal Regulations. These include the 

misbranding provisions of section 

403(a) of the act (together with the 

associated definition in section 201(n) 

of the act and the associated regulation 

in 21 CFR 1.21) and the premarket 

approval provisions of section 409 of 

the act. 

In August 2006, FDA issued a 

tentative response to CSPI’s citizen 

petition, indicating the need for 

additional information before a final 

response could be rendered (Ref. 16). 

II. Purpose and Scope of the Hearing 

The purpose of the hearing is for the 

agency to solicit comment, information 

and discussion from interested persons 

on the regulatory status of salt, and food 

labeling requirements regarding salt and 

sodium, particularly with respect to the 

feasibility and potential effectiveness of 

the regulatory actions requested in 

CSPI’s citizen petition. FDA is aware 

that other organizations are in general 

agreement with some of the 

recommendations in CSPI’s petition. For 

example, at the July 2006 annual 

meeting of the American Medical 

Association (AMA), the AMA 

announced recommendations, in the 

form of a report issued by the AMA’s 

Council on Science and Health, to the 

agency echoing many of the regulatory 

actions suggested by CSPI (Ref. 17). The 

agency is very much interested in 

hearing the views of other interested 

parties, including the AMA. 

The agency also is interested in 

discussions regarding other potential 

approaches for reducing salt intake. 

Because FDA has separate plans to issue 

an advanced notice of proposed 

rulemaking that would address DVs, 

including the DV for sodium (Ref. 18), 

comments regarding the DV for sodium 

are outside the scope of the public 

hearing announced in this document. 

The scope of this hearing is 

determined by this notice. FDA invites 

general comments on the citizen 

petition (other than the requested 

actions regarding DVs) as well as 

comments on the issues and questions 

listed in section III of this document. 

III. Issues and Questions for Discussion 

The following issues and questions 

will be discussed at the public hearing: 

Issue 1: FDA considered revoking the 

GRAS status of salt and declaring it to 

be a food additive in 1982, but rejected 

this approach for several reasons, 

including the following: (1) The agency 

would have to establish a limitation for 

each technical effect for which salt is 

used in each food category, and it would 

be extremely difficult to prescribe and 

enforce ‘‘fair use’’ limitations for salt 

that would be safe and effective for all 

consumers (including those 

hypertensive patients on severe sodium 

restrictions) given the fact that salt has 

numerous technical functions in a wide 

variety of processed foods and may 

often be used for several different 

technical effects in a single food and (2) 

many uses of salt are prior sanctioned 

and the agency would have to show that 

salt in food is a ‘‘poisonous or 


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Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Proposed Rules 59977 

deleterious substance’’ for it to take 

regulatory action against a prior 

sanctioned ingredient. Failing to do this, 

the practical effect of regulating those 

remaining uses of salt not authorized by 

prior sanction might be quite small and 

the issuance and enforcement of 

limitations for uses of salt would 

therefore constitute an extraordinary 

regulatory burden for FDA. These facts 

and the uncertainty about the precise 

role of salt as a basic causative factor in 

essential hypertension left unclear 

whether the use of salt in a particular 

food would render that food uniformly 

injurious to health. Therefore, FDA 

concluded in 1982 that informative 

labeling would be more responsive to 

the health concerns about sodium (47 

FR 26590). FDA is not aware of any 

fundamental changes to these 

considerations since it published the 

1982 policy notice. 

Question 1. Could a food additive 

regulation be constructed to prescribe 

limitations for uses of salt? If so, how 

might the regulation be constructed? 

Question 2. Would reducing the salt 

content of food, even in a modest way, 

impact the safety or quality of various 

foods given the wide variety of technical 

functions for which salt is used in food? 

How feasible would it be to mitigate this 

impact if true? Could it be mitigated by, 

for example, the addition of other 

ingredients? 

Question 3. If you agree with the 

underlying premise of CSPI’s petition 

(i.e., that the sodium content of 

processed foods should be reduced), but 

disagree with one or more of the specific 

actions requested by CSPI, what other 

actions would you recommend? 

Question 4. How could FDA partner 

with interested stakeholders regarding 

the development of appropriate 

recommendations or other information 

to reduce the salt content of processed 

foods? 

Issue 2: Food labeling initiatives 

introduced by FDA during the last 25 

years have been designed to provide 

consumers with more information about 

the sodium content of foods. For 

example, our regulations currently 

require declarative statements on the 

label about the sodium content of 

processed food (§ 101.9(c)(4)), define 

nutrient content claims for foods based 

on their salt content (§§ 101.61 and 

101.56), provide for a health claim 

regarding low sodium diets and reduced 

risk of hypertension (§ 101.74), and 

stipulate maximum sodium 

concentrations for foods that are to be 

labeled as ‘‘healthy’’ (§ 101.65(d)(2)). In 

addition to the goal of providing 

information to consumers, these 

labeling initiatives are also intended to 

encourage food manufacturers to reduce 

the salt content of foods and to provide 

incentives to manufacturers to produce 

lower sodium foods. CSPI argues that 

these measures have not ultimately 

served to reduce salt intake and that 

further, more aggressive regulatory 

action is needed. 

Question 5. How would you describe 

the effectiveness of the following FDA 

regulations in reducing salt intake by 

the public? (1) Declaration of sodium 

content in the Nutrition Facts panel 

(§ 101.9(c)); (2) sodium content claims 

(§§ 101.61 and 101.56); health claims 

(§ 101.74); and (4) ‘‘healthy’’ claims 

(§ 101.65(d)(2))? How would you change 

these labeling requirements to make 

them more effective? 

Question 6. What, if any, data, such 

as consumer studies, are available 

regarding the potential for label 

statements about the health effects of 

salt to reduce salt intake? 

Question 7. To what extent could 

FDA’s labeling policies provide 

incentives to manufacturers to reduce 

the salt content of processed foods? For 

example, would there be an incentive to 

manufacturers to reduce the salt content 

of processed foods if FDA used 

enforcement discretion to permit a 

claim about a reduction in salt or 

sodium when that claim does not satisfy 

the criteria for a defined nutrient 

content claim? Would there be an 

incentive to manufacturers to reduce the 

salt content of processed foods if FDA 

encouraged the use of health messages 

to identify products with reduced salt? 

How would such incentives differ from 

the incentives provided by currently 

authorized label statements? 

IV. Notice of Hearing Under 21 CFR 

Part 15 

By delegation from the Commissioner 

of Food and Drugs (the Commissioner) 

(Staff Manual Guide 1410.21 paragraph 

1.f.(5)), the Assistant Commissioner for 

Policy finds that it is in the public 

interest to permit persons to present 

information and views at a public 

hearing regarding the regulatory 

framework for salt and sodium, 

particularly with respect to CSPI’s 

petition to revise the regulatory status of 

salt and establish food labeling 

requirements regarding salt and sodium 

and is announcing that the public 

hearing will be held in accordance with 

part 15 (21 CFR part 15). The presiding 

officer will be the Commissioner or his 

designee. The presiding officer will be 

accompanied by a panel of FDA 

employees with relevant expertise. 

Persons who wish to participate in the 

hearing (either by making a presentation 

or as a member of the audience) must 

file a notice of participation (see DATES, 

ADDRESSES, FOR FURTHER INFORMATION

CONTACT, and section V of this 

document). By delegation from the 

Commissioner (Staff Manual Guide 

1410.21 paragraph 1.f.(5)), the Assistant 

Commissioner for Policy has 

determined under § 15.20(c) that 

advance submissions of oral 

presentations are necessary for the panel 

to formulate useful questions to be 

posed at the hearing under § 15.30(e), 

and that the submission of a 

comprehensive outline or summary is 

an acceptable alternative to the 

submission of the full text of the oral 

presentation. For efficiency, we request 

that individuals and organizations with 

common interests consolidate their 

requests for oral presentation and 

request time for a joint presentation 

through a single representative. After 

reviewing the notices of participation 

and accompanying information, we will 

schedule each oral presentation and 

notify each participant of the time 

allotted to the presenter and the 

approximate time that the presentation 

is scheduled to begin. If time permits, 

we may allow interested persons who 

attend the hearing but did not submit a 

notice of participation in advance to 

make an oral presentation at the 

conclusion of the hearing. The hearing 

schedule will be available at the 

hearing. 

After the hearing, the schedule and a 

list of participants will be placed on file 

in the Division of Dockets Management 

(see ADDRESSES) under the docket 

number listed in brackets in the heading 

of this notice. 

To ensure timely handling of any 

mailed notices of participation, written 

material associated with presentations, 

or comments, any outer envelope 

should be clearly marked with the 

docket number listed in brackets in the 

heading of this notice along with the 

statement ‘‘Salt and Sodium; Petition to 

Revise the Regulatory Status of Salt and 

Establish Food Labeling Requirements 

Regarding Salt and Sodium; Public 

Hearing.’’

Under § 15.30(f), the hearing is 

informal, and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. 

Public hearings under part 15 are 

subject to FDA’s policy and procedures 

for electronic media coverage of FDA’s 

public administrative proceedings (part 

10 (21 CFR part 10, subpart C)). Under 

§ 10.205, representatives of the 

electronic media may be permitted, 


rfrederick on PROD1PC67 with PROPOSALS
59978 Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Proposed Rules 

subject to the procedures and 

limitations in § 10.206, to videotape, 

film, or otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b). For additional information 

about transcripts, see section VII in this 

document. 

Any handicapped persons requiring 

special accommodations to attend the 

hearing should direct those needs to the 

appropriate contact person (see FOR

FURTHER INFORMATION CONTACT). 

To the extent that the conditions for 

the hearing, as described in this notice, 

conflict with any provisions set out in 

part 15, this notice acts as a waiver of 

these provisions as specified in §§ 10.19 

and 15.30(h). In particular, § 15.21(a) 

states that the notice of hearing will 

provide persons an opportunity to file a 

written notice of participation with the 

Division of Dockets Management within 

a specified period of time. If the public 

interest requires, e.g., if a hearing is to 

be conducted within a short period of 

time, the notice may name a specific 

FDA employee and telephone number to 

whom an oral notice of participation 

may be given. If the public interest 

requires, the notice may also provide for 

submitting notices of participation at 

the time of the hearing. In this 

document, the conditions for the 

hearing specify that notices of 

participation be submitted 

electronically to an agency Web site, to 

a contact person who will accept notices 

of participation by mail, telephone, fax, 

or e-mail, or in person on the day of the 

hearing (as space permits). In addition, 

the conditions for the hearing specify 

that written material associated with an 

oral presentation be provided to a 

contact person who will accept it by 

mail, fax, or e-mail rather than to the 

Division of Dockets Management. We 

are using these procedures to facilitate 

the exchange of information between 

participants and the agency. By 

delegation from the Commissioner (Staff 

Manual Guide 1410.21 paragraph 

1.f.(5)), the Assistant Commissioner for 

Policy finds under § 10.19 that no 

participant will be prejudiced, the ends 

of justice will thereby be served, and the 

action is in accordance with law if 

notices of participation are submitted by 

any of the procedures listed in this 

notice. 

V. How to Participate in the Hearing 

Registration by submission of a notice 

of participation is necessary to ensure 

participation and will be accepted on a 

first-come, first-served basis. 

Registration begins on October 22, 2007. 

The notice of participation may be 

submitted electronically, orally, or by 

fax, mail, or e-mail (see ADDRESSES and 

FOR FURTHER INFORMATION CONTACT). We 

encourage you to submit your notice of 

participation electronically. A single 

copy of any notice of participation is 

sufficient. 

The notice of participation must 

include your name, title, business 

affiliation (if applicable), address, 

telephone number, fax number (if 

available), and e-mail address (if 

available). If you wish to request an 

opportunity to make an oral 

presentation during the open public 

comment period of the hearing, your 

notice of participation also must include 

the title of your presentation, the 

sponsor of the oral presentation (e.g., 

the organization paying travel expenses 

or fees), if any; and the approximate 

amount of time requested for the 

presentation. Presentations will be 

limited to the questions and subject 

matter identified in section III of this 

document and, depending on the 

number of requests received, we may be 

obliged to limit the time allotted for 

each presentation (e.g., 5 minutes each). 

Under § 15.20(c), if you request an 

opportunity to make an oral 

presentation you must submit your 

presentation (either as the full text of 

the presentation, or as a comprehensive 

outline or summary). You may submit 

your presentation by e-mail, fax, or 

mail. A single copy of your presentation 

is sufficient. See ADDRESSES and FOR

FURTHER INFORMATION CONTACT for 

information on where to send your 

presentation. 

Persons who wish to request an 

opportunity to make an oral 

presentation must submit a notice of 

participation by November 8, 2007, and 

also must submit either the full text of 

the oral presentation, or a 

comprehensive outline or summary of 

the oral presentation, by November 21, 

2007. All other persons wishing to 

attend the hearing must submit a notice 

of participation by November 21, 2007. 

Persons requiring special 

accommodations due to a disability 

must submit a notice of participation by 

November 21, 2007, and should inform 

the contact person of their request (see 

FOR FURTHER INFORMATION CONTACT). 

Persons wishing to park onsite should 

inform the contact person of their 

request by November 26, 2007. 

Individuals who request an opportunity 

to make an oral presentation will be 

notified of the scheduled time for their 

presentation prior to the hearing. 

We will also accept notices of 

participation onsite on a first-come, first 

served basis; however, space is limited 

and registration will be closed when the 

maximum seating capacity is reached. 

Requests for an opportunity to make a 

presentation from individuals or 

organizations that did not make such a 

request in advance may be granted if 

time permits. 

Persons who submit a notice of 

participation in advance of the hearing 

should check in at the onsite 

registration desk between 8 a.m. and 9 

a.m. Persons who wish to submit a 

notice of participation onsite on the day 

of the hearing may do so at the 

registration desk between 8 a.m. and 9 

a.m. We encourage all participants to 

attend the entire hearing. Because the 

hearing will be held in a Federal 

building, hearing participants must 

present photo identification and plan 

adequate time to pass through the 

security system. 

All submissions and comments 

received may be posted without change 

to http://www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. 

VI. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments for consideration at or after 

the hearing in addition to, or in place of, 

a request for an opportunity to make an 

oral presentation (see section V of this 

document). Submit two paper copies of 

any written comments, except that 

individuals may submit one copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VII. Transcripts 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management (see ADDRESSES) 

and on the Internet at http:// 

www.fda.gov/ohrms/dockets 

approximately 30 days after the hearing. 

You may place orders for copies of the 

transcript through the Freedom of 

Information Office (HFI–35), Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857, at 

a cost of 10 cents per page. 

VIII. 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. (FDA has verified Web 

site addresses, but FDA is not 

responsible for any subsequent changes 


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Federal Register / Vol. 72, No. 204 / Tuesday, October 23, 2007 / Proposed Rules 59979 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Dietary Reference Intakes for Water, 

Potassium, Sodium, Chloride, and Sulfate, 

Chapter 6, ‘‘Sodium and Chloride’’ pp. 1, 2, 

43. Food and Nutrition Board, Institute of 

Medicine of the National Academies, The 

National Academies Press, 2004. 

2. Department of Health and Human 

Services and Department of Agriculture, 

Dietary Guidelines for Americans, 2005. 

(Available at http://www.healthierus.gov/ 

dietaryguidelines, accessed and printed on 

June 21, 2007.) 

3. Letter from Joseph P. Hile, Associate 

Commissioner for Regulatory Affairs, FDA to 

Michael F. Jacobson, August 18, 1982. 

4. Letter from Joesph P. Hile, Associate 

Commissioner for Regulatory Affairs, FDA to 

M.F. Jacobson, B. Liebman, B. Silverglade, 

October 7, 1982. 

5. Sacks, F.M., Svetkey L.P., Vollmer W.M., 

et al., ‘‘Effects on Blood Pressure of Reduced 

Dietary Sodium and the Dietary Approaches 

to Stop Hypertension (DASH) Diet,’’ The New 

England Journal of Medicine, 344: 3–10, 

2001. 

6. Whelton, P.K., Appel L.J., Espeland 

M.A., et al. ‘‘Sodium Reduction and Weight 

Loss in the Treatment of Hypertension in 

Older Persons (TONE).’’ The Journal of the 

American Medical Association, 279: 839–

846, 1998. 

7. Kumanyika, S.K., Cook N.R., Cutler J.A., 

et al. ‘‘Sodium Reduction for Hypertension 

Prevention in Overweight Adults: Further 

Results From the Trials of Hypertension 

Prevention Phase II,’’ Journal of Human 

Hypertension, 19: 33–45, 2005. 

8. Khaw, K.T., Bingham S., Welch A., et al., 

‘‘Blood Pressure and Urinary Sodium in Men 

and Women: The Norfolk Cohort of the 

European Prospective Investigation Into 

Cancer (EPIC-Norfolk),’’ The American 

Journal of Clinical Nutrition, 80: 1397–1403, 

2004. 

9. Cook, N.R., Cohen J., Hebert P.R., et al., 

‘‘Implications of Small Reductions in 

Diastolic Blood Pressure for Primary 

Prevention,’’ Archives of Internal Medicine, 

155: 701–709, 1995. 

10. He, F.J. and MacGregor, G.A., ‘‘How Far 

Should Salt Intake be Reduced?’’

Hypertension, 42: 1093–1009, 2003. 

11. Stamler, J., Stamler R., Neaton J.D., 

‘‘Blood Pressure, Systolic and Diastolic, and 

Cardiovascular Risks,’’ Archives of Internal 

Medicine, 153: 598–615, 1993. 

12. Tuomilehto, J., Jousilahti P., Rastenyte 

D., et al., ‘‘Urinary Sodium Excretion and 

Cardiovascular Mortality in Finland: A 

Prospective Study,’’ Lancet 357: 848–51, 

2001. 

13. Havas, S., Roccella E.J., Lenfant C., 

‘‘Reducing the Public Health Burden From 

Elevated Blood Pressure Levels in the United 

States by Lowering Intake of Dietary 

Sodium,’’ American Journal of Public Health, 

94: 19–22, 2004. 

14. Zhou, B.F., Stamler J., Dennis B., et al., 

‘‘Nutrient Intakes of Middle-Aged Men and 

Women in China, Japan, United Kingdom, 

and United States in the Late 1990s: The 

INTERMAP Study,’’ Journal of Human 

Hypertension, 17:623–630, 2003. 

15. ‘‘Salt in Processed Foods’’ Food 

Standards Authority (UK), 2005 (Available at 

http://www.food.gov.uk/healthiereating/salt/ 

saltmodel, accessed and printed on June 21, 

2007.) 

16. Letter from Laura M. Tarantino, 

Director of the Office of Food Additive 

Safety, FDA, to Michael F. Jacobson, June 5, 

2006. 

17. American Medical Association, Report 

10 of the Council on Science and Public 

Health (A–06), Promotion of Healthy 

Lifestyles I: Reducing the Population Burden 

of Cardiovascular Disease by Reducing 

Sodium Intake, Action of the AMA House of 

Delegates 2006 Annual Meeting, 2006. 

18. Food and Drug Administration, Center 

for Food Safety and Applied Nutrition, 

CFSAN FY 2007 Report to Stakeholders, June 

2007, available at http://www.cfsan.fda.gov/ 

~dms/cfsan607.html#fy07pp. 

Dated: October 17, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5216 Filed 10–19–07; 10:35 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF AGRICULTURE 

Forest Service 

36 CFR Part 261 

RIN 0596–AC38 

Amend Certain Paragraphs in 36 CFR 

261.2 and 261.10 To Clarify Issuing a 

Criminal Citation for Unauthorized 

Occupancy and Use of National Forest 

System Lands and Facilities by Mineral 

Operators 

AGENCY: Forest Service, USDA. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: The Forest Service is 

reopening the comment period for an 

additional 30 days and invites written 

comments on this proposed rule. The 

proposed rule was published in the 

Federal Register on May 10, 2007 (72 

FR 26578), and should be referenced 

when preparing responses. This 

proposed rule would allow, if necessary, 

a criminal citation to be issued for 

unauthorized mineral operations on 

National Forest System lands. 

DATES: Comments on this proposed rule 

must be received in writing by 

November 23, 2007. 

ADDRESSES: Send written comments to 

Forest Service, USDA, Attn: Director, 

Minerals and Geology Management 

(MGM) Staff, (2810), at Mail Stop 1126, 

Washington, DC 20250–1126; by 

electronic mail to 36cfr228a@fs.fed.us; 

or by fax to (703) 605–1575; or by the 

electronic process available at the 

Federal e-Rulemaking portal at http:// 

www.regulations.gov. If comments are 

sent by electronic mail or by fax, the 

public is requested not to send 

duplicate written comments via regular 

mail. Please confine written comments 

to issues pertinent to the proposed rule; 

explain the reasons for any 

recommended changes; and, where 

possible, reference the specific wording 

being addressed. All comments, 

including names and addresses when 

provided, will be placed in the record 

and will be available for public 

inspection and copying. The public may 

inspect comments received on this 

proposed rule in the Office of the 

Director, MGM Staff, 5th Floor, Rosslyn 

Plaza Central, 1601 North Kent Street, 

Arlington, Virginia 22209, Monday 

through Friday (except for Federal 

holidays) between the hours of 8:30 a.m. 

and 4 p.m. Those wishing to inspect 

comments are encouraged to call ahead 

at (703) 605–4545 to facilitate entry into 

the building. 

FOR FURTHER INFORMATION CONTACT: 

Janine Clayton, Minerals and Geology 

Management Staff, (703) 605–4788, or 

electronic mail to jclayton01@fs.fed.us. 

Dated: October 16, 2007. 

Gloria Manning, 

Associate Deputy Chief, NFS. 

[FR Doc. E7–20758 Filed 10–22–07; 8:45 am] 

BILLING CODE 3410–11–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Part 17 

Endangered and Threatened Wildlife 

and Plants; 90-Day Finding on a 

Petition To List the Summer-Run 

Kokanee Population in Issaquah 

Creek, WA, as Threatened or 

Endangered 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of 90-day petition 

finding. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce a 

90-day finding on a petition to list the 

summer-run Issaquah Creek kokanee 

(Oncorhynchus nerka) as threatened or 

endangered under the Endangered 

Species Act of 1973, as amended (Act). 

We find that the petition does not 

present substantial scientific or 

commercial information indicating that 

the summer-run Issaquah Creek kokanee 

may represent a distinct population 

segment, and therefore a listable entity, 

under section 3(16) of the Act. 

Therefore, we will not be initiating a 

further status review in response to this 

petition. 


rfrederick on PROD1PC67 with PROPOSALS