This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

14914

Vol. 60, No. 54

Tuesday, March 21, 1995

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 927

[Docket Nos. AO–99–A–6; FV–92–065]

Winter Pears Grown in Oregon,

Washington, and California;

Recommended Decision and

Opportunity to File Written Exceptions

to Proposed Further Amendment of

Marketing Agreement and Order No.

927

AGENCY: Agricultural Marketing Service,

USDA.

ACTION: Proposed rule and opportunity

to file exceptions.

SUMMARY: This recommended decision

invites written exceptions on proposed

amendments to the marketing agreement

and order for winter pears grown in the

States of Oregon, Washington, and

California. The proposed amendments

would redefine ‘‘ship or handle’’ to

include shipments of winter pears

within the production area, update the

definition of ‘‘export market’’ to

recognize that there are now 50 states in

the United States, authorize the Winter

Pear Control Committee (WPCC) to

accept voluntary contributions and how

such funds may be used, and revise the

authority for exempting certain

shipments from regulation. These

proposed amendments are designed to

improve the administration, operation

and functioning of the winter pear

marketing order program.

DATES: Written exceptions must be filed

by April 20, 1995.

ADDRESSES: Written exceptions should

be filed with the Hearing Clerk, U.S.

Department of Agriculture, room 1079–

S, Washington, DC 20250–9200,

Facsimile number (202) 720–9776. Four

copies of all written exceptions should

be submitted and they should reference

the docket numbers and the date and

page number of this issue of the Federal

Register. Exceptions will be made

available for public inspection in the

Office of the Hearing Clerk during

regular business hours.

FOR FURTHER INFORMATION CONTACT:

Kenneth Johnson or Britthany Beadle,

Marketing Specialists, Marketing Order

Administration Branch, Fruit and

Vegetable Division, AMS, USDA, Room

2523–S, Washington, D.C. 20250–0200;

telephone: (202) 720–5127; or Teresa

Hutchinson, Northwest Marketing Field

Office, Marketing Order Administration

Branch, Fruit and Vegetable Division,

AMS, USDA, 1220 S.W. Third Avenue,

Room 369, Portland, Oregon, 97204;

telephone: (503) 326–2725.

SUPPLEMENTARY INFORMATION: Prior

documents in this proceeding: Notice of

Hearing issued on November 16, 1992,

and published in the November 20,

1992, issue of the Federal Register (57

FR 54728).

This administrative action is governed

by the provisions of sections 556 and

557 of Title 5 of the United States Code

and, therefore, is excluded from the

requirements of Executive Order 12866.

The amendments proposed herein

have been reviewed under Executive

Order 12778, Civil Justice Reform. They

are not intended to have retroactive

effect. If adopted, the proposed

amendments would not preempt any

state or local laws, regulations, or

policies, unless they present an

irreconcilable conflict with the

amendments.

The Act provides that administrative

proceedings must be exhausted before

parties may file suit in court. Under

section 608c(15)(A) of the Act, any

handler subject to an order may file

with the Secretary a petition stating that

the order, any provision of the order, or

any obligation imposed in connection

with the order is not in accordance with

law and requesting a modification of the

order or to be exempted therefrom. A

handler is afforded the opportunity for

a hearing on the petition. After the

hearing the Secretary would rule on the

petition. The Act provides that the

district court of the United States in any

district in which the handler is an

inhabitant, or has his or her principal

place of business, has jurisdiction in

equity to review the Secretary’s ruling

on the petition, provided a bill in equity

is filed not later than 20 days after date

of the entry of the ruling.

Preliminary Statement

Notice is hereby given of the filing

with the Hearing Clerk of this

recommended decision with respect to

the proposed further amendment of

Marketing Agreement and Order No.

927, regulating the handling of winter

pears grown in Oregon, Washington,

and California, and the opportunity to

file written exceptions thereto. Copies of

this decision can be obtained from

Kenneth G. Johnson, Britthany Beadle or

Teresa Hutchinson whose addresses are

listed above.

This action is issued pursuant to the

provisions of the Agricultural Marketing

Agreement Act of 1937, as amended (7

U.S.C. 601 et seq.), hereinafter referred

to as the ‘‘Act,’’ and the applicable rules

of practice and procedure governing the

formulation of marketing agreements

and orders (7 CFR Part 900).

The proposed amendment of

Marketing Agreement and Order No.

927 is based on the record of a public

hearing held in Portland, Oregon, on

December 2, 1992. Notice of this hearing

was published in the Federal Register

on November 20, 1992. The notice of

hearing contained several proposals

submitted by the WPCC, which locally

administers the order.

The proposed amendments would: (1)

Redefine ‘‘ship or handle’’ to include

shipments of winter pears within the

production area; (2) update the

definition of ‘‘export market’’ to

recognize that there are now 50 states in

the United States; (3) authorize the

WPCC to accept voluntary contributions

and how such funds may be used; and

(4) revise the authority for exempting

certain shipments from regulation.

The notice of hearing also included

proposals by the Fruit and Vegetable

Division, Agricultural Marketing Service

(AMS), U.S. Department of Agriculture

(Department), to make such changes as

are necessary to the order, if any or all

of the above amendments are adopted,

so that all of its provisions conform with

the proposed amendment. The

Department also proposed revising the

language in several sections of the order.

Interested persons had until January

15, 1993, to file proposed findings and

conclusions, and written arguments or

briefs based on the evidence received at

the hearing. No such documents were

received.
Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Proposed Rules 14915

Small Business Considerations

In accordance with the provisions of

the Regulatory Flexibility Act (RFA), the

Administrator of the AMS has

determined that this action would not

have a significant economic impact on

a substantial number of small entities.

Small agricultural producers have been

defined by the Small Business

Administration (SBA) (13 CFR 121.601)

as those having annual receipts of less

than $500,000. Small agricultural

service firms, which include handlers

regulated under the order, are defined as

those with annual receipts of less than

$5,000,000.

The purpose of the RFA is to fit

regulatory actions to the scale of

business subject to such actions in order

that small businesses will not be unduly

or disproportionately burdened.

Interested persons were invited to

present evidence at the hearing on the

probable regulatory and informational

impact of the proposed amendments on

small businesses. The record indicates

that handlers would not be unduly

burdened by any additional regulatory

requirements, including those

pertaining to reporting and

recordkeeping, that might result from

this proceeding.

During the 1991–92 crop year, 88

handlers were regulated under

Marketing Order No. 927. In addition,

there were about 1,650 producers of

winter pears in the production area.

Marketing orders and amendments

thereto are unique in that they are

normally brought about through group

action of essentially small entities for

their own benefit. Thus, both the RFA

and the Act are compatible with respect

to small entities.

All of the changes in the amendments

are designed to enhance the

administration and functioning of the

marketing agreement and order which

would benefit the industry. If

implemented, these amendments might

impose some costs on affected handlers

and producers. However, the added

burden on small entities, if present at

all, would not be significant because the

benefits of the proposed amendments

are expected to outweigh the costs.

In accordance with the Paperwork

Reduction Act of 1980 (44 U.S.C. 35),

any change in the reporting and

recordkeeping provisions that may

result from the proposed amendments

would be submitted to the Office of

Management and Budget (OMB). The

provisions would not be effective until

receiving OMB approval.

Material Issues

The material issues of record

addressed in this decision are as

follows: (1) Whether to redefine ‘‘ship or

handle’’ to include shipments of winter

pears within the production area; (2)

whether the definition of ‘‘export

market’’ should be updated to recognize

that there are now 50 states in the

United States; (3) whether the WPCC

should be authorized to accept

voluntary contributions and how such

funds may be used; and (4) whether to

revise authority for exempting certain

shipments from regulation.

Findings and Conclusions

The findings and conclusions on the

material issues, all of which are based

on evidence adduced at the hearing and

the record thereof, are:

(1) Section 927.8, Ship or Handle, of

the winter pear marketing order should

be amended to cover shipments of

winter pears within the production area,

as well as interstate shipments.

Record evidence indicates that the

intent of the proposal is to provide that

shipments of winter pears within the

production area be regulated the same

as shipments marketed outside the

production area. Currently, the order

authorizes grade, size, and quality

regulations and inspection and

reporting requirements for fresh winter

pears. While, no grade, quality or size

requirements have been issued under

the order since the 1979 marketing

season, handlers who ship winter pears

outside the production area are required

to comply with reporting and

recordkeeping requirements and pay

assessments on those shipments.

Handlers who ship winter pears within

the production area are not required to

comply with such requirements. The

WPCC has considered reestablishing

grade and size requirements for winter

pear shipments in order to ensure the

acceptability of such shipments. The

WPCC recommended that winter pear

shipments within the production area

be regulated in the same manner as

interstate shipments in order to improve

the effectiveness of the marketing order.

Regulation of winter pears within the

marketing area will help to enhance the

orderly marketing of winter pears. The

record evidence supports this change in

the definition of the term ‘‘ship or

handle’’ to make shipments of winter

pears within the production area subject

to all order requirements.

In 1985, marketing order No. 927 was

amended to provide for research and

promotion activities, including paid

advertising. Until then, the Oregon,

Washington, California Pear Bureau

(Bureau) represented the northwest

winter pear industry in its market

development and promotion and

advertising programs throughout world

markets. The Bureau’s purpose was to

conduct those activities necessary to

assure the continued success of the

industry.

According to record evidence, the

assessments to conduct these activities

and membership in the Bureau were

voluntary. These voluntary assessments

were paid by handlers on winter pears

marketed both within and outside of the

production area.

The WPCC has the responsibility for

collecting mandatory assessments on

interstate winter pear shipments. The

WPCC provides funds for its research

and promotion activities and is

responsible for oversight of such

projects. Currently, the Bureau manages

the WPCC’s research and promotion

activities. There is a contractual

agreement between the WPCC and the

Bureau for these purposes. The record

indicates that this arrangement has

proven beneficial, and the WPCC

continues to utilize the Bureau which

has over 60 years of experience in trade

relations to conduct its marketing,

promotion and advertising activities.

Other WPCC activities include

collection of various statistical

information, and post- and pre-harvest

research programs to improve cultural

practices. The statistical information

collected is used by the WPCC to target

potential markets to increase sales of

winter pears. Research results to

improve cultural and handling practices

are distributed throughout the winter

pear industry. Handlers pay assessments

only on shipments of winter pears to

destinations outside the production

area, since the order currently provides

no authority for assessments on

shipments of winter pears within the

production area. Currently, handlers of

winter pears shipped within the

production area may benefit from the

WPCC’s activities without absorbing any

of the costs to conduct these programs.

Handlers making shipments of winter

pears within the production area are

currently exempted from paying

assessments.

According to record testimony, it is

appropriate that assessments be paid on

winter pear shipments within the

production area to support production

and marketing research and promotion

projects. Approximately 15 percent

(347,647 cartons out of 2,267,582

cartons for 1991) of the winter pears

marketed within the production area are

sold in the State in which they are

grown.

Record evidence indicates that many

of the pears initially shipped to

intrastate destinations ultimately enter

interstate commerce. According to

record testimony, an estimated 70 to 80
14916 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Proposed Rules

percent of the pears sold at retail in Las

Vegas, Nevada, and Arizona are moved

there from distributors in southern

California either by wholesalers or the

retailer’s own distribution system.

Similar estimates are made for pears

sold at retail in the Reno/Lake Tahoe

area of central Nevada, with service

from the Bay Area and/or Sacramento.

Hawaii is also serviced by wholesalers

in the California seaports. The WPCC

believes and the evidence supports that

many of these shipments originate from

sources in the production area.

Promotions paid for with mandatory

assessments on interstate shipments are

conducted in all of these production

areas.

At the hearing, witnesses for the

WPCC offered a modification of the

proposal as it appeared in the hearing

notice. These witnesses testified that the

term ‘‘handle’’ should not include the

transportation of winter pear shipments

within the production area from the

orchard where grown to a packing

facility located within the production

area for preparation for market. The

intent of this proposal is that winter

pears transported within the production

area for purposes of preparation for

market would not be subject to

assessment or any other order

requirements since they would not yet

have been handled. All other winter

pears placed in interstate commerce or

marketed within the production area

would be subject to regulation, unless

otherwise exempt under other

provisions of the order.

Record testimony also supported

adding the definition of ‘‘consign’’ to

the definition of ‘‘ship or handle’’. The

record indicates that ‘‘consign’’ is

defined as an agreement between a

buyer and seller for the transport of

product to be marketed with no

previous determination of the return of

the product. It is the responsibility of

the buyer to market the product and

return to the seller the proceeds. This

should be included as ‘‘handling’’

because the ‘‘agent’’ or ‘‘handler’’ who

receives the commodity is engaged in

the buying, selling and distributing of

the commodity for market. The record

also indicates that the words ‘‘handle

for shipment’’ should be deleted from

the definition of the term ‘‘ship or

handle’’ because they are redundant and

not necessary.

Section 927.10, Production area,

should be changed from ‘‘area’’ to

‘‘production area’’. This is a conforming

amendment to clarify those areas that

comprise the production area under the

marketing order.

Section 927.41, Assessments, should

be amended to remove any reference to

a specific State. Record testimony

indicates that this is a conforming

amendment to provide the necessary

language to comply with the intent of

the proposal to regulate winter pear

shipments within and outside the

production area. This section should

also be amended to remove the words

‘‘upon billing’’. Record testimony

indicates that current procedures to

collect assessments do not entail billing.

The WPCC does not bill handlers for

assessments due. Rather, handlers pay

their assessments every two weeks

when they submit handler statements of

winter pear shipments to the WPCC.

Section 927.52, Prerequisites to

Control Committee recommendations,

should be amended to provide

conforming language updating the

marketing order. Presently, the

marketing order specifies a basis of one

vote for each 25,000 boxes (except 2,500

boxes for Forelle and Seckel varieties) of

the average quantity of such variety

produced in the particular district and

shipped therefrom during the

immediately preceding three fiscal

periods to destinations outside the State

in which produced. As such, only

interstate shipments of winter pears are

used as a criteria to determine voting

procedures. Record evidence supports

the inclusion of shipments within the

production area in the tonnage vote

during WPCC meetings. This action is

necessary to provide representation

based on all winter pears handled,

consistent with order provisions. The

proposed amendment to the order has

been modified for clarity.

(2) Section 927.12, Export Market,

should be amended to update that

provision of the marketing order. The

marketing order currently provides that

‘‘export market’’ means any destination

which is not within the 48 states, or the

District of Columbia, of the United

States. Record testimony indicates that

this section of the marketing order

should be updated to reflect that the

United States is made up of 50 states.

(3) Section 927.45, Contributions,

should be added to the marketing order

to authorize the WPCC to receive

voluntary contributions. Record

evidence indicates that marketing

promotion and research projects for

winter pears should directly benefit

growers of that commodity and

secondarily benefit other groups and

businesses whose interests are allied

with the production and marketing of

winter pears. These groups frequently

desire to make contributions or

donations to help defray the costs of

such projects. Record testimony

indicates that voluntary contributions

could include money, information or

anything of value. Such contributions

should be received by the WPCC free

from any encumbrances by the donor

and under the complete control of the

WPCC. The WPCC should not receive a

voluntary contribution from any person

if that contribution could represent a

conflict of interest. Handlers under the

order would be allowed to make

voluntary contributions to the WPCC.

Record testimony indicated that the

provision to accept voluntary

contributions as currently provided in

the notice of hearing is too restrictive.

According to the proposal included in

the hearing notice, the WPCC would be

prohibited from accepting funds for any

purposes other than research and

development. However, record

testimony indicates that contributions

might be provided for activities other

than research and promotion projects

including paid advertising. Record

testimony indicates that the WPCC

should be authorized to receive

voluntary contributions for any purpose

authorized under the order.

Witnesses testified at the hearing that

a person making a voluntary

contribution to the WPCC should be

able to specify its use for a particular

authorized activity. However, the WPCC

should be free to receive and use such

contributions, subject to the provisions

of the order, without any encumbrances

upon the donor. The acceptance of

voluntary contributions with

encumbrances by the donor could, at a

minimum, give rise to the appearance of

improprieties. Accordingly, this

recommendation is not included in the

proposed amendment.

Section 927.47, Research and

Development, should be changed to

include conforming language that

provides for the acceptance and use of

voluntary contributions. The marketing

order currently provides that research

and development projects shall be paid

from funds collected pursuant to

§ 927.41. This proposed amendment

would allow funds collected from

voluntary contributions pursuant to

§ 927.45 to also pay for such projects.

(4) Section 927.65, Exemption from

regulation, should be amended to

include additional types of winter pear

shipments that may be exempt from

regulation under the marketing order.

Record testimony suggested additional

language should be added to the

proposed order amendments to provide

exemptions to allow the WPCC, with the

approval of the Secretary, to establish

regulations that exempt from any or all

requirements pursuant to this part

quantities of pears or of types of pear

shipments that do not interfere with the

objectives of the order. These proposed
Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Proposed Rules 14917

provisions would be in addition to the

proposed amendments in the notice of

hearing. Record testimony indicates that

the overall intent of this amendatory

action is to enable the exemption of

shipments that do not impact fresh

commercial shipments. Record

testimony indicated further that

§ 927.65, ‘‘Exemptions from regulation’’,

would be reviewed by the WPCC

annually, and that the WPCC would

have the flexibility of including and or

adjusting requirements, subject to the

approval of the Secretary, depending on

the circumstances of any given year.

Rulings on Briefs of Interested Persons

The presiding officer at the hearing

set January 15, 1993, as the final date for

filing briefs with respect to the evidence

presented at the hearing and the

conclusions which should be drawn

therefrom. No briefs were received.

General Findings

(1) The findings hereinafter set forth

are supplementary to the previous

findings and determinations which were

made in connection with the issuance of

the marketing agreement and order and

each previously issued amendment

thereto. Except insofar as such findings

and determinations may be in conflict

with the findings and determinations set

forth herein, all of the said prior

findings and determinations are hereby

ratified and affirmed;

(2) The marketing agreement and

order, as amended, and as hereby

proposed to be further amended, and all

of the terms and conditions thereof, will

tend to effectuate the declared policy of

the Act;

(3) The marketing agreement and

order, as amended, and as hereby

proposed to be further amended,

regulate the handling of winter pears

grown in the production area in the

same manner as, and are applicable only

to, persons in the respective classes of

commercial and industrial activity

specified in the marketing agreement

and order upon which a hearing has

been held;

(4) The marketing agreement and

order, as amended, and as hereby

proposed to be further amended, are

limited in their application to the

smallest regional production area which

is practicable, consistent with carrying

out the declared policy of the Act, and

the issuance of several orders applicable

to subdivision of the production area

would not effectively carry out the

declared policy of the Act; and

(5) All handling of winter pears grown

in the production area as defined in the

marketing agreement and order, as

amended, and as hereby proposed to be

further amended, is in the current of

interstate or foreign commerce or

directly burdens, obstructs, or affects

such commerce.

Recommended Further Amendment of

the Marketing Agreement and Order

The following amendment of the

marketing agreement and order, both as

amended, is recommended as the

detailed means by which the foregoing

conclusions may be carried out:

List of Subjects in 7 CFR Part 927

Marketing agreements, Pears,

Reporting and recordkeeping

requirements.

For the reasons set forth in the

preamble, the following provisions in

Title 7, Part 927, are proposed to be

amended as follows:

PART 927—WINTER PEARS GROWN

IN OREGON, WASHINGTON, AND

CALIFORNIA

1. The authority citation for 7 CFR

Part 927 continues to read as follows:

Authority: 7 U.S.C. 601–674.

2. Section 927.8 is revised to read as

follows:

§ 927.8 Ship or handle.

Ship or handle means to sell, deliver,

consign or transport pears, within the

production area or between the

production area and any point outside

thereof: Provided, That the term

‘‘handle’’ shall not include the

transportation of winter pear shipments

within the production area from the

orchard where grown to a packing

facility located within the production

area for preparation for market.

3. Section 927.10 is revised to read as

follows:

§ 927.10 Production area.

Production area means and includes

the States of Oregon, Washington, and

California.

4. Section 927.12 is revised to read as

follows:

§ 927.12 Export market.

Export market means any destination

which is not within the 50 states, or the

District of Columbia, of the United

States.

5. In § 927.41, paragraph (a) is revised

to read as follows:

§ 927.41 Assessments.

(a) Assessments will be levied only

upon handlers who first handle pears.

Each handler shall pay assessments on

all pears handled by such handler as the

pro rata share of the expenses which the

Secretary finds are reasonable and likely

to be incurred by the Control Committee

during a fiscal period. The payment of

assessments for the maintenance and

functioning of the Control Committee

may be required under this part

throughout the period such assessments

are payable irrespective of whether

particular provisions thereof are

suspended or become inoperative.

* * * * *

6. Section 927.45 is added to read as

follows:

§ 927.45 Contributions.

The Control Committee may accept

voluntary contributions but these shall

only be used to pay expenses incurred

pursuant to § 927.47. Furthermore, such

contributions shall be free from any

encumbrances by the donor and the

Control Committee shall retain complete

control of their use.

7. Section 927.47 is revised to read as

follows:

§ 927.47 Research and development.

The Control Committee, with the

approval of the Secretary, may establish

or provide for the establishment of

production research, or marketing

research and development projects

designed to assist, improve, or promote

the marketing, distribution, and

consumption of pears. Such projects

may provide for any form of marketing

promotion, including paid advertising.

The expense of such projects shall be

paid from funds collected pursuant to

§§ 927.41 and 927.45. Expenditures for

a particular variety of pears shall

approximate the amount of assessments

and voluntary contributions collected

for that variety of pears.

8. In § 927.52, paragraph (b)(1) is

revised to read as follows:

§ 927.52 Prerequisites to Control

Committee recommendations.

* * * * *

(b) * * *

(1) The basis of one vote for each

25,000 boxes (except 2,500 boxes for

Forelle and Seckel varieties) of the

average quantity of such variety

produced in the particular district and

shipped therefrom during the

immediately preceding three fiscal

periods; or

* * * * *

9. In § 927.65, paragraph (b) is revised

to read as follows:

§ 927.65 Exemption from regulation.

* * * * *

(b) The Control Committee may

prescribe rules and regulations, to

become effective upon the approval of

the Secretary, whereby quantities of

pears or types of pear shipments may be
14918 Federal Register / Vol. 60, No. 54 / Tuesday, March 21, 1995 / Proposed Rules

exempted from any or all provisions of

this subpart.

* * * * *

Dated: March 15, 1995.

Lon Hatamiya,

Administrator.

[FR Doc. 95–6909 Filed 3–20–95; 8:45 am]

BILLING CODE 3410–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 101, 111, 170, and 310

[Docket Nos. 91P–0186 and 93P–0306]

Acute Toxicity of Elemental (Reduced,

Metallic Powder) Forms of Iron

Relative to That of Iron Salts; Notice of

a Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop on the acute toxicity of

elemental (reduced, metallic powder)

forms of iron. The purpose of this

workshop is to solicit scientific data and

information from interested persons

about the acute toxicity of elemental

forms of iron with regard to whether

such forms are sufficiently safe in

dietary supplement and drug products

to warrant exemption from the special

packaging and labeling requirements

that FDA has proposed for products

containing iron salts.

DATES: The public workshop will be

held on April 20, 1995, 8:30 a.m. to 5

p.m. Submit written comments by April

20, 1995.

ADDRESSES: The public workshop will

be held at the Parklawn Bldg.,

conference room G, 5600 Fishers Lane,

Rockville, MD 20857. Written comments

regarding the workshop may be

submitted to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John

N. Hathcock, Center for Food Safety and

Applied Nutrition (HFS–465), Food and

Drug Administration, 8301 Muirkirk

Rd., Laurel, MD 20708, 301–594–6006.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 6, 1994 (59

FR 51030), FDA issued a proposal (the

initial proposal) on actions that it

tentatively concluded were necessary to

stem the recent epidemic of pediatric

poisonings from over-consuming ironcontaining products. In the Federal

Register of February 16, 1995 (60 FR

8989), the agency issued a

supplementary proposal to clarify

changes in its legal authority with the

passage of the Dietary Supplement

Health and Education Act (Pub. L. 103–

417).

In the initial proposal, FDA briefly

described the three basic types of

elemental iron powders that are

marketed for use in foods. The three

types are reduced iron, electrolytic iron,

and carbonyl iron. The term ‘‘carbonyl’’

refers to the production process, not the

composition of the product. The

bioavailability of these various

elemental iron sources is dependent

primarily on their physical

characteristics, which in turn depend on

the manufacturing method. For

example, higher relative

bioavailabilities of elemental iron are

obtained with smaller particle sizes.

Some evidence suggests that carbonyl

iron may be a useful substitute for the

more commonly used chemical

compounds of iron in reducing the risk

of accidental iron poisonings. Data from

studies in animals suggest that carbonyl

iron may be only 1/100th as toxic as

ferrous sulfate in single doses, i.e., the

LD50 (lethal dose for 50 percent of the

test group) of ferrous sulfate is

approximately 0.30 gram ferrous per

kilogram (g Fe/kg) (The Merck Index,

11th ed., p. 635 (1989)), and the LD50 for

carbonyl iron is approximately 30.0 g

Fe/kg body weight. At the same time,

data from human subjects indicate that

the overall bioavailability of carbonyl

iron in supporting the nutritional

functions of iron is about 70 percent

that of ferrous sulfate. Thus, carbonyl

iron, in comparison with ferrous sulfate,

appears to have a much larger margin of

safety between the level that would

provide adequate iron nutrition and the

level that causes acute toxicity.

Consequently, carbonyl iron may be

inherently safer to use, and its use may

help to reduce the risk of iron poisoning

in children, than ferrous sulfate.

In the initial proposal, FDA expressed

interest in receiving data on the

potential of elemental iron to have acute

toxicity in humans, and particularly in

children, and stated that the agency

would carefully consider any

information that it received on this

subject. FDA stated that, if the

information it received was persuasive

in establishing that the use of elemental

iron would substantially decrease the

risk of pediatric poisoning while

allowing for effective dietary iron

supplementation, FDA would consider

exempting iron-containing products that

incorporate elemental iron from any

regulations that result from this

rulemaking.

In response to this request for

information, FDA received several

comments that supplied information on

this topic. Some of the comments

included citations to scientific literature

or copies of scientific articles. The

comments argued that the information

supports an exemption of products

formulated with elemental iron from the

labeling and packaging requirements

applied to products containing iron

salts. These comments have convinced

FDA that the issues and data that they

have presented should be discussed in

a public workshop.

The purpose of the workshop on the

acute toxicity of elemental iron is to:

1. Identify data that objectively

describe the acute toxicity of elemental

iron.

2. Identify the market uses of

elemental iron and any adverse reaction

reporting systems or processes used by

manufacturers and vendors.

3. Identify any data on acute,

accidental exposure of children or

adults to products containing elemental

iron.

4. Discuss a possible conceptual

framework for evaluation of the effects

of elemental forms of iron upon acute

exposure.

5. Discuss the validity, and

limitations, of acute toxicity data in

experimental animals in predicting the

risk in young children.

Specific topics that may be relevant

and on which discussion is invited

include:

1. Physiological factors that influence

acute toxicity of elemental forms of iron,

in comparison with those for iron salts.

2. The quality, results, and relevance

of animal studies on acute toxicity of

elemental iron and iron salts.

3. The quality and results of human

studies for evaluating the effects of

elemental iron.

4. Factors influencing the validity of

extrapolation of experimental animal

data on acute toxicity of various forms

of iron for predicting the risk in young

children.

5. Current uses of elemental iron in

dietary supplements and drugs and the

data available on potential adverse

effects.

Discussion of these topics will be

considered by FDA in the development

of any final rule on the packaging and

labeling of products containing iron

salts. In conjunction with the workshop,

FDA specifically requests comments on

the appropriateness of elemental iron as

a source of iron in drugs and dietary

supplements. The comments should

focus on whether the use of elemental