Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59853

no longer manufacture any animal feed.

Section 515.30(c) details requirements

for filing a request for a hearing by a

sponsor to give reasons why a

medicated feed mill license application

should not be refused or revoked and

§ 510.305(b) (21 CFR 510.305 (b)),

requires maintenance of approved

labeling for each Type B and/or Type C

medicated feed being manufactured on

the premises of the manufacturing

establishment or the facility where the

feed labels are generated.

Description of Respondents:

Respondents to this collection of

information are individuals or firms that

manufacture medicated animal feed. In

the Federal Register of July 26, 2000 (65

FR 45987), FDA published a 60-day

notice concerning the proposed

extension of this collection of

information and requested comments. In

response to this notice, no comments

were received on the estimated annual

reporting and recordkeeping burden. We

therefore believe that the total burden

estimate of 72 hours for the annual

reporting and recordkeeping burden

should remain unchanged.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

515.10(b) 100 1 100 0.25 25

515.11(b) 25 1 25 0.25 6.25

515.23 50 1 50 0.25 12.25

515.30(c) 0.15 1 0.15 24 3.6

Total burden hours 47.10

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

510.305(b) 100 1 100 .25 25

1There are no capital cost or operating and maintenance cost associated with this collection of information.

The estimate for the number of

respondents is derived from agency

data, i.e. the number of medicated feed

manufacturers entering the market each

year, change in ownership or address,

requests for voluntary revocation of a

medicated feed mill license, revocation

and/or suspension of a license. The

estimate of the time required for the

reporting and recordkeeping

requirements is based on the agency

communication with industry.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25699 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1309]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Suggested

Documentation for Demonstrating

Compliance With the Channels of

Trade Provision

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by November

6, 2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Suggested Documentation for

Demonstrating Compliance With the

Channels of Trade Provision

Description: Under the pesticide

tolerance reassessment process that the

Environmental Protection Agency (EPA)

was mandated to carry out under the

Food Quality Protection Act (FQPA),

EPA has proposed to revoke the

tolerances for the pesticide chemical

methyl parathion on several food

commodities. The FQPA includes a

provision in section 408(l)(5) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 346a(l)(5)), referred

to as the ‘‘channels of trade provision,’’

that addresses the circumstances under

which a food is not unsafe solely due to

the presence of a residue from a

pesticide chemical whose tolerance has

been revoked, suspended, or modified

by EPA. These circumstances are met if

the party responsible for the food can

demonstrate to FDA that the residue in

the food resulted from application of the

pesticide chemical to the food

commodity at a time and in a manner

that was lawful under the Federal

Insecticide Fungicide and Rodenticide

Act (FIFRA).

In general, FDA anticipates that the

party responsible for food found to

contain methyl parathion residues

(within the former tolerance) after the

59854 Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices

tolerance for the pesticide chemical has

been revoked, will be able to

demonstrate that the residue resulted

from a lawful application under FIFRA

by providing appropriate

documentation to the agency showing

that such food was packed or processed

on or prior to December 31, 2000, as

discussed in the draft guidance that was

announced in a notice that FDA

published in the Federal Register of

June 2, 2000 (65 FR 35376) (the June

notice). FDA is not suggesting that firms

maintain a certain set list of documents

where anything less or different would

likely be considered unacceptable.

Rather, the agency is leaving it to each

firm’s discretion to maintain

appropriate documentation to

demonstrate that the food was so packed

or processed.

Examples of documentation that FDA

anticipates will serve this purpose

include but are not limited to packing

codes, batch records, and inventory

records; it is anticipated that most food

processors routinely generate this

documentation as part of their basic

food-production operations.

Description of Respondents: The

likely respondents to this collection of

information are firms in the produce

and food-processing industries who

handle food products that may contain

residues of methyl parathion after the

tolerances for this pesticide chemical in

those foods have been revoked.

In the June notice, the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

67 1 67 3 201

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

No. of Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours Total CapitalCosts

83 1 83 16 1,328 $500

1There are no operating and maintenance costs associated with this collection of information.

Estimates for the annual reporting

burden were determined by using the

maximum number of samples collected

throughout a year that FDA believes

may be found to contain methyl

parathion residues. Because all residues

are expected to have dissipated from

nonfrozen foods by the time FDA

intends to question firms about when a

food product was packed or processed

(i.e., after December 31, 2000), FDA

included only frozen food in its estimate

(i.e., processors of foods stored under

refrigerated and ambient conditions

were excluded). Although residues

within the former tolerance resulting

from legal application of methyl

parathion are not expected to be found

in nonfrozen foods after December 31,

2000, under the channels of trade

provision, firms will have an

opportunity to make a showing that any

such food was packed or processed on

or before this date.

Considering the variation in and

effects of food handling, particularly

with regard to the time between

pesticide application and freezing, FDA

estimated that potentially half of all

frozen food products sampled may

contain methyl parathion residues, and

therefore, the responsible party, under

the approach set forth in this guidance,

would be subject to the reporting

requirement since it would be the

burden of the responsible party to

demonstrate that food found to contain

methyl parathion residues within the

former tolerance was packed or

processed on or before December 31,

2000.

When determining the annual

recordkeeping burden, importers and

domestic processors of frozen food

commodities affected by the revocation

of the pesticide chemical methyl

parathion were considered. FDA

estimated that most firms (at least 90

percent) maintain (or maintain access

to) documentation such as packing

codes, batch records, and inventory

records as part of their basic food

production and/or import operations.

Therefore, the recordkeeping burden

was calculated as the time required for

the 10 percent of firms which may not

currently be maintaining this

documentation, to develop and

maintain (or maintain access to)

documentation such as batch records

and inventory records. It was estimated

that with $500 or less, the necessary

software and/or hard copy filing

systems could be obtained to implement

a system.

Because all residues are expected to

have dissipated from nonfrozen foods

by the time FDA intends to ask for a

showing under section 408(l)(5) of the

act (i.e., after December 31, 2000), FDA

used the number of frozen food

processors when determining the

annual recordkeeping burden. In the

June notice, this burden was originally

determined to be 6,600 hours. However,

due to revisions that FDA will include

in the final guidance document, the

proposed information collection was

refined, and the annual recordkeeping

burden decreased to 1,328 hours. The

‘‘Category II Documentation,’’ which

consisted of documentation relating to

the institution of auditing programs and

supplier verification, will be removed

from the final guidance as suggested

documentation to be provided to

demonstrate compliance with the

channels of trade provision.

As with the annual reporting burden

estimate, although nonfrozen food

processors are entitled to make a

showing under the channels of trade

provision, they were excluded from this

estimate because based upon residue

dissipation estimates provided by EPA,

methyl parathion residues within the

former tolerance resulting from legal

application are not expected to be found

in nonfrozen commodities after

December 31, 2000.

Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59855

1 In its original health claim evaluation, FDA used

the term ‘‘folic acid’’ to describe this B vitamin.

Later, the agency decided that the broader term

‘‘folate’’ was more scientifically accurate because

that term encompasses both synthetic and naturally

occurring forms of the vitamin, whereas folic acid

refers only to the synthetic form (see 58 FR 53254

at 53257–58, and 53280, October 14, 1993).

Accordingly, this notice uses the term ‘‘folate.’’ The

two terms may be used interchangeably in food

labeling.

2Neural tube defects are birth defects of the brain

or spinal cord. Spinabifida and anencephaly are the

most common types of neural tube defects.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25700 Filed 10–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 91N–0101, 91N–0098, 91N–

0103, and 91N–100H]

Food Labeling; Health Claims and

Label Statements for Dietary

Supplements; Update to Strategy for

Implementation of Pearson Court

Decision

AGENCY: Food and Drug Administration,

HHS.

ACTION: :Notice.

SUMMARY: The Food and Drug

Administration (FDA) is updating its

strategy for implementation of the court

of appeals decision in Pearson v.

Shalala (Pearson). The updated

implementation strategy includes an

interim enforcement strategy for dietary

supplement health claims that do not

meet the ‘‘significant scientific

agreement’’ standard of evidence by

which the health claims regulations

require FDA to evaluate the scientific

validity of claims. It also includes

changes in the process that will be used

for reconsidering the four Pearson

health claims and for responding to

future petitions for dietary supplement

health claims. The agency is taking this

action to inform interested persons of

the latest developments in FDA’s plans

for implementation of Pearson.

FOR FURTHER INFORMATION CONTACT:

James E. Hoadley, Center for Food

Safety and Applied Nutrition (HFS–

832), 200 C St. SW., Washington, DC

20204, 202–205–5372.

SUPPLEMENTARY INFORMATION:

I. Background

After the enactment of the Nutrition

Labeling and Education Act of 1990 (the

NLEA) and the Dietary Supplement Act

of 1992, FDA issued regulations

applying the general requirements for

health claims for conventional foods to

dietary supplements (59 FR 395, January

4, 1994). Under these regulations, a

health claim is authorized for use only

if FDA determines that there is

significant scientific agreement, among

experts qualified by scientific training

and experience to evaluate such claims,

that the claim is supported by the

totality of publicly available scientific

evidence, including evidence from welldesigned studies conducted in a manner

that is consistent with generally

recognized scientific procedures and

principles § 101.14 (21 CFR 101.14).

FDA also undertook rulemaking to

consider specific health claims,

including the four health claims at issue

in the Pearson case.

In Pearson, the plaintiffs challenged

FDA’s general health claims regulation

for dietary supplements and FDA’s

decision not to authorize health claims

for four specific substance/disease

relationships: Dietary fiber and cancer,

antioxidant vitamins and cancer, omega3 fatty acids and coronary heart disease,

and the comparative claim that 0.8

milligram of folate1 in dietary

supplement form is more effective in

reducing the risk of neural tube defects2

than a lower amount in conventional

food form. Although the district court

ruled for FDA in all respects (14 F.

Supp. 2d 10 (D.D.C. 1998)), the U.S.

Court of Appeals for the D.C. Circuit

reversed the lower court’s decision (164

F.3d 650 (D.C. Cir. 1999)). The appeals

court held that, on the administrative

record compiled in the challenged

rulemakings, the First Amendment does

not permit FDA to reject health claims

that the agency determines to be

potentially misleading unless the

agency also reasonably determines that

no disclaimer would eliminate the

potential deception. Accordingly, the

court invalidated the regulations

codifying FDA’s decision not to

authorize the four health claims listed

above and directed the agency to

reconsider the four claims. The court

further held that the Administrative

Procedure Act requires FDA to clarify

the ‘‘significant scientific agreement’’

standard for authorizing health claims,

either by issuing a regulatory definition

of significant scientific agreement or by

defining it on a case-by-case basis.

On March 1, 1999, the Government

filed a petition for rehearing en banc

(reconsideration by the full court of

appeals). The U.S. Court of Appeals for

the D.C. Circuit denied the petition for

rehearing on April 2, 1999 (172 F.3d 72

(D.C. Cir. 1999)).

II. Strategy for Implementation of the

Pearson Court Decision

A. The December 1999 Implementation

Strategy Notice

In the Federal Register of December 1,

1999 (64 FR 67289), FDA published a

notice entitled ‘‘Food Labeling: Health

Claims and Label Statements for Dietary

Supplements; Strategy for

Implementation of Pearson Court

Decision’’ to inform the public of the

steps FDA planned to follow to carry

out the Pearson decision. The strategy

included five components: (1) Update

the scientific evidence on the four

claims at issue in Pearson; (2) issue

guidance clarifying the ‘‘significant

scientific agreement’’ standard; (3) hold

a public meeting to solicit input on

what changes to FDA’s general health

claim regulations for dietary

supplements may be warranted in light

of the Pearson decision; (4) conduct a

rulemaking to reconsider the general

health claims regulations for dietary

supplements in light of the Pearson

decision; and (5) conduct rulemakings

on the four Pearson health claims. In

addition, the implementation strategy

notice stated that, until the rulemaking

to reconsider the general health claims

regulations for dietary supplements was

complete, FDA would deny, without

prejudice, any petition for a dietary

supplement health claim that does not

meet the significant scientific agreement

standard in § 101.14(c). The notice

further explained that, once the

rulemaking was complete, the agency

would, on its own initiative, reconsider

any petitions denied during the interim

period.

Since the December 1999 Federal

Register notice was published, FDA has

completed the first three steps in the

implementation strategy. The agency

entered into contracts with two

nongovernment firms to conduct a

literature review for the four claims to

identify relevant scientific information

that became available after the agency’s

initial 1991 to 1993 review of these

claims. FDA also published a notice in

the Federal Register of September 8,

1999 (64 FR 48841), requesting that

interested persons submit any available

scientific data concerning the substancedisease relationships that are the subject

of the four claims.

In December 1999, FDA issued a

guidance clarifying the significant

scientific agreement standard. A notice

of availability of the guidance was

published in the Federal Register of

December 22, 1999 (64 FR 71794). The

guidance is available on the Internet at

http://vm.cfsan.fda.gov/∼dms/

ssaguide.html.