This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

46335

Vol. 65, No. 146

Friday, July 28, 2000

DEPARTMENT OF AGRICULTURE

Office of the Secretary

7 CFR Part 1

USDA Freedom of Information Act

Regulations

AGENCY: Department of Agriculture.

ACTION: Final rule.

SUMMARY: The Department of

Agriculture is issuing a final rule

revising its regulations implementing

the Freedom of Information Act (FOIA).

This final rule implements the

Electronic Freedom of Information Act

Amendments of 1996.

EFFECTIVE DATE: August 28, 2000.

FOR FURTHER INFORMATION CONTACT:

Andrea E. Fowler, FOIA Officer, Office

of Communications, at (202) 720–8164.

SUPPLEMENTARY INFORMATION: On May 4,

1998 (63 FR 24467), USDA requested

public comment on proposed revisions

to its regulations at 7 CFR Part 1

implementing the Freedom of

Information Act. This revision is

necessary to implement the Electronic

Freedom of Information Act

Amendments of 1996, Public Law 104–

231 (E–FOIA).

The proposed rule provided for the

expedited processing of certain

categories of requesters; proposed

‘‘multitrack’’ processing requirements;

incorporated new processing deadlines

and appeal rights; implemented the E–

FOIA provisions requiring agencies to

generally provide records in the form or

format requested, extended agency

regulations to the processing of

electronic records, and provides for

frequently requested records as a

category of reading room records.

Analysis of Public Comments and the

Final Rule

USDA received three comment letters

in response to the proposed revisions to

USDA’s FOIA regulations, one from a

trade association representing news

editors and reporters; one from a trade

association representing private

citizens; and one from a natural

resource community group involved in

natural resource issues. The

commenters raised several issues

regarding the proposed rule, generally

seeking clarification of provisions

implementing E–FOIA.

Regarding section 1.4(a)(4), one of the

trade associations requested that USDA

reconsider the provision which allows

USDA agencies to decide on a case-bycase basis whether records that have

already been subject to several requests

should be placed in agency reading

rooms. The commenter would like

USDA to change this section to cover

only records that have not been subject

to subsequent FOIA requests instead of

records that have been subject to several

requests. The regulation tracks the

language of the statute. Therefore,

USDA believes that this section of the

regulation as proposed is appropriate.

Regarding section 1.9(b)(2), the

community group and the association of

news editors and reporters requested

that USDA broaden the circumstances

for expedited processing of FOIA

requests. USDA believes, as a matter of

policy, that expanding the criteria as

embodied in the proposed regulation as

suggested by the commenters would be

counter to even-handed treatment of the

public. In essence, the commenters

desire that self-selected requesters be

placed in line ahead of most members

of the requesting public. One specific

suggestion to USDA was to include the

Department of Justice regulatory

provision allowing expedited treatment

when a request involves the loss of

substantial due process rights. In this

connection, USDA points out that one of

the primary missions of the Department

of Justice is the administration of

criminal justice. USDA does not share

the administration of criminal justice as

one of its primary missions, and

believes that the addition of loss of

substantial due process rights as a

ground for expedited processing is not

necessary.

Regarding section 1.9(2)(c) the

association of news editors and

reporters requested that USDA

incorporate a provision similar to that

adopted by the Department of Justice

and the Federal Deposit Insurance

Corporation in their FOIA regulations

with regard to the formality of

certifications needed to obtain

expedited treatment. More specifically,

and consistently with E–FOIA, the

USDA proposed rule provided that a

requester is entitled to expedited

treatment only where failure to obtain

the records expeditiously could pose an

imminent threat to the life or physical

safety of a person, or where the

requester is a person primarily engaged

in disseminating information and there

is an urgency to inform the public

concerning actual or alleged agency

activity. A requester seeking expedited

processing must submit a certified

statement describing the basis for

requesting expedited treatment. The

Department of Justice and Federal

Deposit Insurance Corporation

regulations, however, provide that the

formality of certification may be waived

as a matter of administrative discretion.

The association of news editors and

reporters requests that USDA

incorporate a similar waiver provision.

The certification required by USDA is

straightforward and, therefore, we do

not expect that it will be burdensome

for eligible requesters to submit a

certification with their initial requests.

The association of news editors and

reporters requested that USDA

incorporate language that the denial of

a request for expedited processing

should be appealable. This language is

already included in proposed section

1.9 of the regulations.

Regarding section 1.5, the community

group requested that USDA remove the

requirement that all requests for records

shall be deemed to have been made

pursuant to FOIA by changing the word

‘‘shall’’ to ‘‘should’’; and change the

requirement that when a requester

wants documents relating to pending

litigation that the requester identify the

court and its location. We believe that

considering all requests for records

under FOIA will confer more rights on

the requester, and therefore we will

keep the word ‘‘shall’’ in the language.

Also, we believe that identifying the

court and its location is part of the

requirement to reasonably describe the

documents requested.

Regarding section 1.6, the community

group requested that USDA remove this

section which pertains to aggregating

requests, asserting that it violates the

due process clause of the constitution.

46336 Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations

We do not concur because aggregation

of requests is specifically permitted by

5 U.S.C. 552(a)(6)(B)(iv).

Regarding section 1.8, the community

group requested that USDA provide a

better description of multitrack

processing and give examples. USDA

does not have a centralized FOIA

process in which requests will be

processed in a central multitracking

process. Each agency within USDA

which decides to have a multitracking

processing system will provide a

description of its system and how it

works in its respective agency

regulations and directives.

Regarding section 1.19, the

community group requested that USDA

better describe the term ‘‘promptly

available’’ as it relates to making records

available to any person submitting a

FOIA request. The group also wants us

to incorporate Attorney General Reno’s

October 4, 1993, memo on discretionary

releases into the regulation. We believe

that the term ‘‘promptly available’’

clearly indicates that FOIA requests

should be processed as soon as

reasonably possible, considering the

nature of the request, and all the facts

and circumstances, including the

volume and location of responsive

records. We also believe that this

section of the USDA regulation reflects

the essence of Attorney General Reno’s

memo to make discretionary releases

under FOIA. However, we emphasize

that this does not reflect a statement of

policy that USDA has specifically

incorporated the Attorney General’s

memorandum of October 4, 1993. USDA

is mindful of its obligation under the

memorandum, but also is aware that the

memorandum, by its terms, specifically

disclaims that it extends enforceable

procedural rights to requesters.

The community group requested that

USDA provide a process for citizens to

file a complaint about officials who

intentionally violate FOIA. We believe

that section 1.14 of the USDA

regulations already provides a process

for citizens to complain if they believe

officials have intentionally violated

FOIA. This section allows citizens to

appeal a denial of a request for records

or denial of a fee waiver to a different

level of the agency. Citizens also have

the right to judicial review of final

appeal denials.

The community group requested that

USDA provide for FOIA requests via

electronic mail over the Internet. USDA

believes that this decision is more

appropriately left to its individual

program agencies and staff offices. This

is so because of decentralization of

FOIA processing within USDA and the

varying electronic capabilities of the

numerous agencies and offices that

would be affected.

Finally, upon review, USDA is

modifying the language of Section 1.8(c)

to accommodate situations where an

agency might have several processing

tracks, so that the requester will have

the opportunity to modify the request to

qualify for a faster track rather than the

‘‘fastest’’ track, as in the proposed

regulation. This approach is more

logical than simply providing for

modification to qualify for the ‘‘fastest

track,’’ where there may be several

tracks to which the request might be

assigned.

Executive Order 12866

Because this rule has been determined

to be not significant, the Office of

Management and Budget (OMB) did not

review it under Executive Order 12866.

This rule will not have any economic

impact. Under these circumstances, the

Secretary has determined that this

action will not have a significant

economic impact on a substantial

number of small entities.

Executive Order 12988

This rule has been reviewed under

Executive Order 12988, Civil Justice

Reform. This rule: (1) Preempts State

and local laws and regulations that are

inconsistent with this rule; (2) has no

retroactive effect; and (3) does not

require administrative proceedings

before parties may file suit in court

challenging this rule. However, the

administrative procedures specified

must be exhausted prior to any judicial

challenge of the application of the

provisions of this rule.

Public Law 96–354, ‘‘Regulatory

Flexibility Act’’ (5 U.S.C. 601)

USDA certifies that this rule is not

subject to the Regulatory Flexibility Act

(5 U.S.C. 601) because it will not have

a significant economic impact on a

substantial number of small entities.

This rule implements the Freedom of

Information Act (5 U.S.C. 552), a statute

concerning the release of Federal

Government records, and does not

economically impact Federal

Government relations with the private

sector.

Public Law 96–511, ‘‘Paperwork

Reduction Act’’ (44 U.S.C. Chapter 35)

USDA certifies that this rule does not

impose any reporting or recordkeeping

requirements under the Paperwork

Reduction Act of 1995.

List of Subjects in 7 CFR Part 1

Administrative practice and

procedure, Freedom of Information,

Privacy.

Accordingly, 7 CFR, part 1, is

amended as follows:

1. The authority citation for 7 CFR,

part 1, continues to read as follows:

Authority: 5 U.S.C. 301, unless otherwise

noted.

2. Part 1 is amended in subpart A by

revising §§ 1.1 through 1.20 and §§ 1.22

through 1.23 and by adding §§ 1.21, 1.24

and 1.25 to read as follows:

PART 1—ADMINISTRATIVE

REGULATIONS

Subpart A—Official Records

Sec.

1.1 Purpose and scope.

1.2 Policy.

1.3 Agency implementing regulations.

1.4 Public access to certain materials.

1.5 Requests for records.

1.6 Aggregating requests.

1.7 Agency response to requests for records.

1.8 Multitrack processing.

1.9 Expedited processing.

1.10 Search services.

1.11 Review services.

1.12 Handling information from a private

business.

1.13 Date of receipt of requests or appeals.

1.14 Appeals.

1.15 General provisions respecting release

of records.

1.16 Extension of administrative deadlines.

1.17 Failure to meet administrative

deadlines.

1.18 Fee schedule.

1.19 Exemptions and discretionary release.

1.20 Annual report.

1.21 Compilation of new records.

1.22 Authentication.

1.23 Records in formal adjudication

proceedings.

1.24 Preservation of records.

1.25 Implementing regulations for the

Office of the Secretary and the Office of

Communications.

Appendix A—Fee Schedule

Subpart A—Official Records

Authority: 5 U.S.C. 301, 552; 7 U.S.C.

3125a; 31 U.S.C. 9701; and 7 CFR

2.28(b)(7)(viii).

§ 1.1 Purpose and scope.

This subpart establishes policy,

procedures, requirements, and

responsibilities for administration and

coordination of the Freedom of

Information Act (‘‘FOIA’’), 5 U.S.C. 552,

pursuant to which any person may

obtain official records. It also provides

rules pertaining to the disclosure of

records pursuant to compulsory process.

This subpart also serves as the

implementing regulations (referred to in

§ 1.3, ‘‘Agency implementing

regulations’’) for the Office of the

Secretary (the immediate offices of the

Secretary, Deputy Secretary, Under

Secretaries and Assistant Secretaries)

and for the Office of Communications.

The Office of Communications has the

Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations 46337

primary responsibility for

implementation of the FOIA in the

Department of Agriculture (‘‘USDA’’ or

‘‘Department’’). The term ‘‘agency’’ or

‘‘agencies’’ is used throughout this

subpart to include both USDA program

agencies and staff offices.

§ 1.2 Policy.

(a) Agencies of USDA shall comply

with the time limits set forth in the

FOIA and in this subpart for responding

to and processing requests and appeals

for agency records, unless there are

unusual circumstances within the

meaning of 5 U.S.C. 552(a)(6)(B) and

§ 1.16(b). An agency shall notify a

requester in writing whenever it is

unable to respond to or process a

request or appeal within the time limits

established by the FOIA.

(b) All agencies of the Department

shall comply with the fee schedule

provided as appendix A to this subpart,

with regard to the charging of fees for

providing copies of records and related

services to requesters.

§ 1.3 Agency implementing regulations.

Each agency of the Department shall

promulgate regulations setting forth the

following:

(a) The location and hours of

operation of the agency office or offices

where members of the public may gain

access to those materials required by 5

U.S.C. 552(a)(2) and § 1.4 to be made

available for public inspection and

copying.

(b) Information regarding the

publication and distribution (by sale or

otherwise) of indexes and supplements

to indexes that are maintained in

accordance with the requirements of 5

U.S.C. 552(a)(2) and § 1.4(c);

(c) The title and mailing address of

the official or officials of the agency

authorized to receive requests for

records submitted in accordance with

§ 1.5(a), and to make determinations

regarding whether to grant or deny such

requests. Authority to make such

determinations includes authority to:

(1) Extend the 20 working day

administrative deadline for reply

pursuant to § 1.16;

(2) Make discretionary releases

pursuant to § 1.19(b);

(3) Make determinations regarding the

charging of fees pursuant to appendix A

to this subpart;

(d) The title and mailing address of

the agency official who is authorized to

receive appeals submitted in accordance

with § 1.14 and to make determinations

regarding whether to grant or deny such

appeals. Authority to determine appeals

includes authority to:

(1) Extend the 20 working day

administrative deadline for reply

pursuant to § 1.16 (to the extent the

maximum extension authorized by

§ 1.16(c) was not used with regard to the

initial request;

(2) Make discretionary releases

pursuant to § 1.19(b);

(3) Make determinations regarding the

charging of fees pursuant to appendix A

to this subpart; and

(e) Other information which would be

of concern to a person wishing to

request records from that agency in

accordance with this subpart.

§ 1.4 Public access to certain materials.

(a) In accordance with 5 U.S.C.

552(a)(2), each agency within the

Department shall make the following

materials available for public inspection

and copying (unless they are promptly

published and copies offered for sale):

(1) Final opinions, including

concurring and dissenting opinions, as

well as orders, made in the adjudication

of cases;

(2) Those statements of policy and

interpretation which have been adopted

by the agency and are not published in

the Federal Register;

(3) Administrative staff manuals and

instructions to staff that affect a member

of the public;

(4) Copies of all records, regardless of

form or format, which have been

released pursuant to a FOIA request

under 5 U.S.C. 552(a)(3), and which

because of the nature of their subject

matter, have become or are likely to

become the subject of subsequent

requests for substantially the same

records. Agencies shall decide on a case

by case basis whether records fall into

this category, based on the following

factors:

(i) Previous experience with similar

records;

(ii) The particular characteristics of

the records involved, including their

nature and the type of information

contained in them; and

(iii) The identity and number of

requesters and whether there is

widespread media, historical, academic,

or commercial interest in the records.

(5) A general index of the records

referred to in paragraph (a)(4) of this

section.

(b) Records encompassed within

paragraphs (a)(1) through (a)(5) of this

section created on or after November 1,

1996, shall be made available to the

public by computer telecommunications

or, if computer telecommunications

means have not been established by the

agency, by other electronic means.

(c) Each agency of the Department

shall maintain and make available for

public inspection and copying current

indexes providing identifying

information regarding any matter

issued, adopted or promulgated after

July 4, 1967, and required by paragraph

(a) of this section to be make available

or published. Each agency shall publish

and make available for distribution

copies of such indexes and supplements

to such indexes at least quarterly, unless

it determines by notice published in the

Federal Register that publication would

be unnecessary and impracticable. After

issuance of such notice, each agency

shall provide copies of any index upon

request at a cost not to exceed the direct

cost of duplication.

(d) Each agency is responsible for

preparing reference material or a guide

for requesting records or information

from that agency. This guide shall also

include an index of all major

information systems, and a description

of major information and record locator

systems.

(e) Each agency shall also prepare a

handbook for obtaining information

from that agency. The handbook should

be a short, simple explanation to the

public of what the FOIA is designed to

do, and how a member of the public can

use it to access government records. The

handbook should be available on paper

and through electronic means, and it

should identify how a requester can

access agency Freedom of Information

Act annual reports. Similarly, the

annual reports should refer to the

handbook and how to obtain it.

(f) It is appropriate to make frequently

requested records available in

accordance with paragraph (a)(4) of this

section in situations where public

access in a timely manner is important,

and it is not intended to apply where

there may be a limited number of

requests over a short period of time from

a few requesters. Agencies may remove

a record from this access medium when

the appropriate official determines that

it is unlikely there will be substantial

further requests for that document.

§1.5 Requests for records.

(a) Any person who wishes to inspect

or obtain copies of any record of any

agency of the Department shall submit

a request in writing and address the

request to the official designated in

regulations promulgated by that agency.

The requester may ask for a fee waiver.

All such requests for records shall be

deemed to have been made pursuant to

the Freedom of Information Act,

regardless of whether the request

specifically mentions the Freedom of

Information Act. To facilitate processing

of a request, the requester should place

the phrase ‘‘FOIA REQUEST’’ in capital

letters on the front of the envelope or on

46338 Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations

the cover sheet of the facsimile

transmittal.

(b) A request must reasonably

describe the records to enable agency

personnel to locate them with

reasonable effort. Where possible, a

requester should supply specific

information regarding dates, titles,

names of individuals, names of offices,

and names of agencies or other

organizations that may help identify the

records. If the request relates to a matter

in pending litigation, the requester

should identify the court and its

location.

(c) If an agency determines that a

request does not reasonably describe the

records, the agency shall inform the

requester of this fact and extend the

requester an opportunity to clarify the

request or to confer promptly with

knowledgeable agency personnel to

attempt to identify the records the

requester is seeking. The ‘‘date of

receipt’’ in such instances, for purposes

of § 1.13, shall be the date of receipt of

the amended or clarified request.

(d) If a request for records or a fee

waiver made under this subpart is

denied, the requester shall have the

right to appeal the denial. Requesters

also may appeal agency determinations

of a requester’s status for purposes of fee

levels under sec. 5 of appendix A to this

subpart. All appeals must be in writing

and addressed to the official designated

in regulations promulgated by the

agency which denied the request. To

facilitate processing of an appeal, the

requester should place the phrase

‘‘FOIA APPEAL’’ in capital letters on

the front of the envelope or on the cover

sheet of the fax transmittal.

(e) Requests that are not addressed to

a specific agency in USDA, or which

pertain to more than one USDA agency,

or which are sent to the wrong agency

of USDA, should be forwarded to the

Department’s FOIA Officer in the Office

of Communications, U.S. Department of

Agriculture, Washington, DC 20250.

(f) The Department FOIA Officer will

determine which agency or agencies

should process the request, and, where

necessary, refer the request to the

appropriate agency or agencies. The

Department FOIA Officer will also

notify the requester of the referral and

of the name of each agency to which the

request has been referred.

(g) A request will be properly received

when it is in the possession of the

component agency that has

responsibility for maintaining the

requested records.

(h) Each agency shall develop and

maintain a record of all written requests

and appeals received in that agency.

The record shall include the names of

the requester; a brief summary of the

information requested; whether the

request or appeal was granted, denied,

or partially denied; the exemption from

mandatory disclosure under 5 U.S.C.

552(b) upon which any denial was

based; and the amount of any fees

associated with the request or appeal.

§ 1.6 Aggregating requests.

When an agency reasonably believes

that a requester, or a group of requesters

acting in concert, is attempting to break

a request down into a series of requests

for the purpose of evading the

assessment of fees, the agency may

aggregate any such requests and charge

accordingly. One element that may be

considered in determining whether such

a belief would be reasonable is the

brevity of the time period during which

the requests have been made.

§ 1.7 Agency response to requests for

records.

(a) 5 U.S.C. 552(a)(6)(A)(i) provides

that each agency of the Department to

which a request for records is submitted

in accordance with § 1.5(a) shall inform

the requester of its determination

concerning that request within 20

working days of its date of receipt

(excepting Saturdays, Sundays, and

legal public holidays), plus any

extension authorized under § 1.16. If the

agency determines to grant the request,

it shall inform the requester of any

conditions surrounding the granting of

the request (e.g., payment of fees) and

the approximate date upon which the

agency will provide the requested

records. If the agency grants only a

portion of the request, it shall treat the

portion not granted as a denial, and

make a reasonable effort to estimate the

volume of the records denied and

provide this estimate to the requester,

unless providing such an estimate

would harm an interest protected by an

exemption of the FOIA. If the agency

determines to deny the request in part

or in whole, it shall immediately inform

the requester of that decision and

provide the following:

(1) The reasons for the denial;

(2) The name and title or position of

each person responsible for denial of the

request;

(3) The requester’s right to appeal

such denial and the title and address of

the official to whom such appeal is to

be addressed; and

(4) The requirement that such appeal

be made within 45 days of the date of

the denial.

(b) If the reason for not fulfilling a

request is that the records requested are

in the custody of another agency outside

USDA, other than in the permanent

custody of the National Archives and

Records Administration (‘‘NARA’’), the

agency shall inform the requester of this

fact and shall forward the request to that

agency or Department for processing in

accordance with its regulations. If the

records are in the permanent custody of

NARA, the agency shall so inform the

requester. Information about obtaining

access to records at NARA may be

obtained through the NARA Archival

Information Locator (NAIL) Database at

http://www/nara.gov/nara.nail.html, or

by calling NARA at (301) 713–6800. If

the agency has no knowledge of

requested records or if no records exist,

the agency shall notify the requester of

that fact.

§ 1.8 Multitrack processing.

(a) When an agency has a significant

number of requests, the nature of which

precludes a determination within 20

working days, the requests may be

processed in a multitrack processing

system, based on the date of receipt, the

amount of work and time involved in

processing the request, and whether the

request qualifies for expedited

processing.

(b) Agencies may establish as many

processing tracks as appropriate;

processing within each track shall be

based on a first-in, first-out concept, and

rank-ordered by the date of receipt of

the request.

(c) Agencies may provide a requester

whose request does not qualify for the

fastest track an opportunity to limit the

scope of the request in order to qualify

for a faster track. This multitrack

processing system does not lessen

agency responsibility to exercise due

diligence in processing requests in the

most expeditious manner possible.

(d) Agencies shall process requests in

each track on a ‘‘first-in, first-out’’ basis,

unless there are unusual circumstances

as set forth in § 1.16, or the requester is

entitled to expedited processing as set

forth in § 1.9.

§ 1.9 Expedited processing.

(a) A requester may apply for

expedited processing at the time of the

initial request for records. Within ten

calendar days of its receipt of a request

for expedited processing, an agency

shall decide whether to grant it, and

shall notify the requester of the

decision. Once the determination has

been made to grant expedited

processing, an agency shall process the

request as soon as practicable. If a

request for expedited processing is

denied, the agency shall act

expeditiously on any appeal of that

decision.

Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations 46339

(b) A request or appeal will be taken

out of order and given expedited

treatment whenever the agency

determines that the requester has

established either of the following

criteria:

(1) Circumstances in which the lack of

expedited treatment could reasonably be

expected to pose an imminent threat to

the life or physical safety of an

individual; or

(2) An urgency to inform the public

about an actual or alleged federal

government activity, if made by an

individual primarily engaged in

disseminating information.

Representatives of the news media

would normally qualify as individuals

primarily engaged in disseminating

information; however, other requesters

must demonstrate that their primary

activity involves publishing or

otherwise disseminating information to

the public as a whole, and not just a

particular segment or group. ‘‘Urgency’’

contemplates that the information has a

particular value that will be lost if not

disseminated quickly. Ordinarily this

means a breaking news story of general

public interest. Information of historical

interest only or information sought for

litigation or commercial activities

would not meet the test of urgency, nor

would a news media publication or

broadcast deadline unrelated to the

news breaking nature of the

information.

(c) A requester who seeks expedited

processing must provide a written

statement that the requester has certified

to be true and correct to the best of the

requester’s knowledge, explaining in

detail the basis for requesting expedited

processing. The agency will not

consider the request to have been

received unless accompanied by a

written, certified statement, and will be

under no obligation to consider the

request for expedited processing until it

receives such a written, certified

statement.

(d) the same procedures apply to

requests for expedited processing of

administrative appeals.

§ 1.10 Search services.

Search services are services of agency

personnel—clerical or professional—

used in trying to find the records, that

are responsive to a request. Search

services includes both manual and

electronic searches and time spent

examining records for the purpose of

finding information that is within the

scope of the request. Search services

also include services to transport

personnel to places of record storage, or

records to the location of personnel for

the purpose of the search, if such

services are reasonably necessary.

§ 1.11 Review services.

(a) Review services are services of

agency personnel—clerical or

professional—in examining records,

both paper and electronic, located in

response to a request that is for a

commercial use (as specified in sec. 6 of

appendix A to this subpart) to

determine whether any portion of any

record located is exempt from

mandatory disclosure.

(b) Review services include

processing any records for disclosure

e.g., doing all that is necessary to redact

exempt portions and otherwise prepare

records for release.

(c) Review services do not include the

time spent resolving general legal or

policy issues regarding the application

of exemptions.

§ 1.12 Handling information from a private

business.

Each USDA agency is responsible for

making the final determination with

regard to the disclosure or

nondisclosure of information in agency

records that has been submitted by a

business. When, in the course of

responding to an FOIA request, an

agency cannot readily determine

whether the information obtained from

a person is privileged or confidential

business information, the policy of

USDA is to obtain and consider the

views of the submitter of the

information and to provide the

submitter an opportunity to object to

any decision to disclose the

information. If a request (including a

subpoena duces tecum as described in

§ 1.215) is received in USDA for

information that has been submitted by

a business, the agency shall:

(a) Provide the business information

submitter with prompt notification of a

request for that information (unless it is

readily determined by the agency that

the information requested should not be

disclosed or, on the other hand, that the

information is not exempt by law from

disclosure). Afford business information

submitter reasonable time in which to

object to the disclosure of any specified

portion of the information. The

submitter must explain fully all grounds

upon which disclosure is opposed. For

example, if the submitter maintains that

disclosure is likely to cause substantial

harm to it competitive position, the

submitter must explain item-by-item

why disclosure would cause such harm.

Information provided by a business

submitter pursuant to this paragraph

may itself be subject to disclosure under

FOIA;

(b) Notify the requester of the need to

inform the submitter of a request for

submitted business information;

(c) Determine whether the requested

records are exempt from disclosure or

must be released;

(d) Provide business information

submitters with notice of any

determination to disclose such records

prior to the disclosure date, in order that

the matter may be considered for

possible judicial intervention; and

(e) Notify business information

submitters promptly of all instances in

which FOIA requesters bring suit

seeking to compel disclosure of

submitted information.

§ 1.13 Date of receipt of requests or

appeals.

The date of receipt of a request or

appeal shall be the date it is received in

the agency and office responsible for the

administrative processing of FOIA

requests or appeals.

§ 1.14 Appeals.

(a) Requesters seeking administrative

appeal of a denial of a request for

records or denial of a fee waiver must

ensure that the appeal is received by the

agency within 45 days of the date of the

denial letter.

(b) Each agency shall provide for

review of appeals by an official different

from the official or officials designated

to make initial denials.

(c) 5 U.S.C. 552(a)(6)(A)(ii) provides

that each agency in the Department to

which an appeal of a denial is submitted

shall inform the requester of its

determination concerning that appeal

within 20 working days (excepting

Saturdays, Sundays, and legal public

holidays), plus any extension

authorized by § 1.16, of its date of

receipt. If the agency determines to

grant the appeal, it shall inform the

requester of any conditions surrounding

the granting of the request (e.g.,

payment of fees) and the approximate

date upon which compliance will be

effected. If the agency grants only a

portion of the appeal, it shall treat the

portion not granted as a denial. If it

determines to deny the appeal either in

part or in whole, it shall inform the

requester of that decision and of the

following:

(1) The reasons for denial;

(2) The name and title or position of

each person responsible for denial of the

appeal; and

(3) The right to judicial review of the

denial in accordance with 5 U.S.C.

552(a)(4).

(d) Each agency, upon a

determination that it wishes to deny an

appeal, shall send a copy of the records

46340 Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations

requested and of all correspondence

relating to the request to the Assistant

General Counsel, General Law Division,

Office of the General Counsel

(‘‘Assistant General Counsel’’). When

the volume of records is so large as to

make sending a copy impracticable, the

agency shall enclose an informative

summary of those records. The agency

shall not deny an appeal until it

receives concurrence from the Assistant

General Counsel

(e) The Assistant General Counsel

shall promptly review the matter

(including necessary coordination with

the agency) and render all necessary

assistance to enable the agency to

respond to the appeal within the

administrative deadline or any

extension of the administrative

deadline.

§ 1.15 General provisions respecting

release of records.

(a) When releasing documents,

agencies shall provide the record in any

form or format the requester specifies, if

the record is readily reproducible in that

form of format. Agencies shall make

reasonable efforts to maintain their

records in forms or formats that are

reproducible. In responding to requests

for records, agencies shall make

reasonable efforts to search for records

in electronic form or format, except

when such efforts would significantly

interfere with the operation of an

agency’s automated information system.

Such determinations shall be made on

a case-by-case basis.

(b) In the event a requested record

contains some portions that are exempt

from mandatory disclosure and others

that are not, the official responding to

the request shall ensure that all

reasonably segregable nonexempt

portions are disclosed, and that all

exempt portions are identified

according to the specific exemption or

exemptions which are applicable. The

amount of deleted information shall be

indicated on the released portion of

paper records. Deletions may be marked

by use of brackets or darkened areas

indicating removal of information, or by

any other method that would reasonable

demonstrate the extent of the deletion.

In the case of electronic deletion, or

deletion in audiovisual or microfiche

records, if technically feasible, the

amount of redacted information shall be

indicated at the place in the records, if

technically feasible, the amount of

redacted information shall be indicated

at the place in the record where such

deletion was made. This may be done

by use of brackets, shaded areas, or

some other identifiable technique which

will clearly show the limits of the

deleted information.

(c) If, in connection with a request or

an appeal, a charge is to be made in

accordance with sec. 8 of appendix A to

this subpart, agencies shall inform the

requester of the fee amount and of the

basis for the charge. Each agency, in

accordance with sec. 8 of appendix A to

this subpart, may require payment of the

entire fee, or a portion of the fee, before

it provides the requested records. An

agency shall require full payment of any

delinquent fee owed by the requester

plus any applicable interest prior to

releasing records on a subsequent

request or appeal. If a requester refuses

to remit payment in advance, an agency

may refuse to process the request or

appeal with written notice to that effect

forwarded to the requester. The ‘‘date of

receipt’’ appeal for which advance

payment has been required shall be the

date that payment is received.

(d) In the event compliance with the

request or appeal involves inspection of

records by the requester rather than

providing copies of the records, the

agency response shall include the name,

mailing address, and telephone number

of the person to be contacted to arrange

a mutually convenient time for such

inspection.

(e) Whenever duplication fees, or

search fees for unsuccessful searches

(see sec. 4(f) of appendix A to this

subpart), are anticipated to exceed

$25.00, and the requester has not

indicated, in advance, a willingness to

pay fees as high as those anticipated,

agencies shall notify the requester of the

amount of the anticipated fee. If an

extensive and therefore costly

successful search is anticipated,

agencies also should notify requesters of

the anticipated fees. The notification

shall offer the requester the opportunity

to confer with agency personnel to

reform the request to meet the

requester’s needs at a lower fee. In

appropriate cases, an advance deposit in

accordance with sec. 8 of appendix A to

this subpart may be required.

§ 1.16 Extension of administrative

deadlines.

(a) In unusual circumstances as

specified in this section, when

additional time is needed to respond to

the initial request or to an appeal,

agencies shall acknowledge the request

or the appeal in writing within the 20

working day time period, describe the

unusual circumstances requiring the

delay, and indicate the anticipated date

for a substantive response that may not

exceed 10 additional working days,

except as provided in the following:

(1) In instances in which the agency,

with respect to a particular request, has

extended the response date by 10

additional working days, if the agency

finds that it cannot make a response

determination within the additional 10

working day period, the agency shall

notify the requester and provide the

requester an opportunity to limit the

scope of the request to allow the agency

to process the request within the

extended time limit, or an alternative

time frame for processing the request or

a modified request.

(2) If the requester refuses to

reasonably modify the request or

arrange for an alternative time frame for

processing the request, the FOIA

provides that such refusal shall be

considered as a factor in determining

whether there are exceptional

circumstances that warrant granting

additional time for the agency to

complete its review of the records, as set

forth in 5 U.S.C. 552(a)(6)(C)(iii). The

term ‘‘exceptional circumstances’’ does

not include a delay that results from a

predictable agency backlog, unless the

agency demonstrates reasonable

progress in reducing its backlog of

pending requests.

(b) As used in this section, ‘‘unusual

circumstances’’ that may justify delay

are:

(1) The need to search for and collect

the requested records from field

facilities or other establishments that are

separate from the office processing the

request;

(2) The need to search for, collect, and

appropriately examine a voluminous

amount of separate and distinct records

which are demanded in a single request;

or

(3) The need for consultation, which

shall be conducted with all practicable

speed, with another Department or

agency having a substantial interest in

the determination of the request or

among two or more components of

agency having substantial subject-matter

interest in the request.

Note to paragraph (b): Consultation

regarding policy or legal issues between an

agency and the Office of the General Counsel,

Office of Communications, or the Department

of Justice is not a basis for extension under

this section.

(c) The 10-day extension authorized

by this section may be divided between

the initial and appellate reviews, but in

no event shall the total extension exceed

10 working days.

(d) Nothing in this section shall

preclude the agency and the requester

from agreeing to an extension of time.

Any such agreement should be

confirmed in writing and should specify

clearly the total time agreed upon.

Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations 46341

§ 1.17 Failure to meet administrative

deadlines.

In the event an agency fails to meet

the administrative deadlines set forth in

§§ 1.7 or 1.14, plus any extension

authorized by § 1.16, it shall notify the

requester, state the reasons for the delay,

and the date by which it expects to

dispatch a determination. Although the

requester may be deemed to have

exhausted his or her administrative

remedies under 5 U.S.C. 552(a)(6)(C),

the agency shall continue processing the

request as expeditiously as possible and

dispatch the determination when it is

reached in the same manner and form

as if it had been reached within the

applicable deadline.

§ 1.18 Fee schedule.

Pursuant to § 2.28 of this title, the

Chief Financial Officer is delegated

authority to promulgate regulations

providing for a uniform fee schedule

applicable to all agencies of the

Department regarding requests for

records under this subpart. The

regulations providing for a uniform fee

schedule are found in appendix A to

this subpart.

§ 1.19 Exemptions and discretionary

release.

(a) All agency records, except those

specifically exempted from mandatory

disclosure by one or more provisions of

5 U.S.C. 552(b), shall be made promptly

available to any person submitting a

request under this subpart.

(b) Agencies are authorized, in their

sole discretion, to make discretionary

releases when such release is not

otherwise specifically prohibited by

Executive Order, statute, or regulation.

§ 1.20 Annual report.

(a) Each agency of the Department

shall compile the following Freedom of

Information Act statistics on a fiscal

year basis beginning October 1, 1997,

and report the following information to

the Office of Communications no later

than November 30 following the fiscal

year’s close:

(1) The number of requests for records

received and the number of requests

which were processed;

(2) The number of determinations

made not to comply with initial requests

for records made to it under § 1.5(a), and

the reasons for each such

determinations;

(3) The number of appeals made by

persons under § 1.14(b), the result of

such appeals, and the reason for the

action upon each appeal that results in

a denial of information.

(4) A complete list of all statutes that

the agency relies upon to authorize the

agency to withhold information under 5

U.S.C. 552(b)(3), a description of

whether a court has upheld the decision

of the agency to withhold information

under each such statute, and a concise

description of the scope of any

information withheld;

(5) The number of requests for records

pending before the agency as of

September 30 of the preceding year, and

the median number of days that such

requests had been pending before the

agency as of that date:

(6) The median number of days taken

by the agency to process different types

of requests;

(7) The total amount of fees collected

by the agency for processing requests;

(8) The number of full-time staff of the

agency devoted to processing requests

for records under this section, and the

total amount expended by the agency

for processing such requests.

(b) Each agency shall compile the

information required by paragraph (a) of

this section for the preceding fiscal year

into a report and submit this report to

the Director of Communications, Office

of Communications, no later than

November 30 following the fiscal year’s

close.

(c) The Director of Communications,

Office of Communications, shall

combine the reports from all the

agencies within USDA into a

Departmental report, and shall submit to

the Attorney General on or before

February 1 of each year in accordance

with 5 U.S.C. 552(e).

(d) Each agency shall make the report

available to the public including by

computer telecommunications, or if

computer telecommunications means

have not been established by the agency,

by other electronic means.

§ 1.21 Compilation of new records.

Nothing in 5 U.S.C. 552 or this

subpart requires that any agency create

a new record in order to fulfill a request

for records. However, an agency is

required to provide a record in a form

or format specified by a requester, if the

record is readily reproducible by the

agency in the form or format requested.

Creation of records may be undertaken

voluntarily if the agency determines this

action to be in the public interest or the

interest of USDA.

§ 1.22 Authentication.

When a request is received for an

authenticated copy of a document

which the agency determines to make

available to the requesting party, the

agency shall cause a correct copy to be

prepared and sent to the Office of the

General Counsel which shall certify the

same and cause the seal of the

Department to be affixed, except that the

Hearing Clerk in the Office of

Administrative Law Judges may

authenticate copies of documents in the

records of the Hearing Clerk and that the

Director of the National Appeals

Division may authenticate copies of

documents in the records of the

National Appeals Division.

§ 1.23 Records in formal adjudication

proceedings.

Records in formal adjudication

proceedings are on file in the Hearing

Clerk’s office, Office of Administrative

Law Judges, U.S. Department of

Agriculture, Washington, DC 20250, and

shall be made available to the public.

§ 1.24 Preservation of records.

Agencies shall preserve all

correspondence relating to the requests

it receives under this subpart, and all

records processed pursuant to such

requests, until such time as the

destruction of such correspondence and

records is authorized pursuant to Title

44 of the United States Code, and

appropriate records disposition

authority granted by NARA. Under no

circumstances shall records be sent to a

Federal Records Center, transferred to

the permanent custody of NARA, or

destroyed while they are the subject of

a pending request, appeal, or civil

action under the FOIA.

§ 1.25 Implementing regulations for the

Office of the Secretary and the Office of

Communications.

(a) For the Office of the Secretary and

for the Office of Communications, the

regulations required by § 1.3 are as

follows:

(1) Records available for public

inspection and copying may be obtained

in Room 536–A, Jamie L. Whitten

Federal Building, USDA, Washington,

DC 20250 during the hours of 9 a.m. to

5 p.m. by prior appointment;

(2) Any indexes and supplements

which are maintained in accordance

with the requirements of 5 U.S.C.

552(a)(2) and § 1.5(b) will also be

available in Room 536–A, Jamie L.

Whitten Federal Building, USDA,

Washington, DC 20250 during the hours

of 9 a.m. to 5 p.m.;

(3) The person authorized to receive

Freedom of Information Act requests

and to determine whether to grant or

deny such requests is the FOIA Officer,

Office of Communications, USDA,

Washington, DC 20250;

(4) The official authorized to receive

appeals from denial of FOIA requests

and to determine whether to grant or

deny such appeals is the Director of

Communications, Office of

46342 Federal Register / Vol. 65, No. 146 / Friday, July 28, 2000 / Rules and Regulations

Communications, USDA, Washington,

DC 20250.

(b) The organization and functions of

the Office of the Secretary and the

Office of Communications is as follows:

(1) The Office of the Secretary

provides the overall policy guidance

and direction of the activities of the

Department of Agriculture. Departmentwide policy statements and

announcements are made from this

office.

(2) The Office of the Secretary

consists of the Secretary, Deputy

Secretary, Under Secretaries, Assistant

Secretaries, and other staff members.

(3) In the absence of the Secretary and

the Deputy Secretary, responsibility for

the operation of the Department of

Agriculture is as delegated at part 2,

subpart A, of this title.

(4) The Office of Communications

provides policy direction, review, and

coordination of public information

programs of the Department of

Agriculture. The Office of

Communications has responsibility for

maintaining the flow of information to

the mass communications media,

various constituency groups, and the

general public.

(5) The Office of Communications is

headed by the Director of

Communications. In the Director’s

absence, the Office of Communications

is headed by the Deputy Director.

Appendix A to Subpart A—Fee

Schedule

* * * * *

Dated: July 18, 2000.

Dan Glickman,

Secretary of Agriculture.

[FR Doc. 00–18767 Filed 7–27–00; 8:45 am]

BILLING CODE 3410–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 74

[Docket No. 99C–1455]

Listing of Color Additives for Coloring

Sutures; D&C Violet No. 2

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

color additive regulations to provide for

the safe use of D&C Violet No. 2 as a

color additive in absorbable sutures

prepared from homopolymers of

glycolide for general surgery. The

agency is also revising the nomenclature

‘‘polyglactin 910 (glycolic-lactic acid

polyester)’’ to the generic nomenclature

‘‘copolymers of 90 percent glycolide and

10 percent L-lactide.’’ This action

responds to a petition filed by Genzyme

Surgical Products Corp.

DATES: This rule is effective August 29,

2000; except as to any provisions that

may be stayed by the filing of proper

objections. Submit written objections

and requests for a hearing by August 28,

2000.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3089.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal

Register of June 3, 1999 (64 FR 29871),

FDA announced that a color additive

petition (CAP 9C0266) had been filed by

Genzyme Surgical Products Corp., 600

Airport Rd., Fall River, MA 02720. The

petition proposed to amend the color

additive regulations in § 74.3602 D&C

Violet No. 2 (21 CFR 74.3602) to provide

for the safe use of D&C Violet No. 2 as

a color additive in absorbable sutures

prepared from homopolymers of

glycolide for general surgery. The

petition also proposed that the

nomenclature ‘‘polyglactin 910

(glycolic-lactic acid polyester)’’ be

revised to the generic nomenclature

‘‘copolymers of 90 percent glycolide and

10 percent L-lactide.’’ The petition was

filed under section 721(d)(1) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 379e(d)(1)).

II. Regulatory History

The regulatory history of D&C Violet

No. 2 was summarized in a final rule

published in the Federal Register of

May 7, 1990 (55 FR 18865). Since the

publication of the May 7, 1990, final

rule, other uses of D&C Violet No. 2

have been approved by the agency. For

example, in a final rule published in the

Federal Register of June 18, 1999 (64 FR

32803), FDA amended § 74.3602 to list

D&C Violet No. 2 as a color additive in

absorbable meniscal tacks made from

poly(L-lactic acid).

III. Applicability of the Act

With the passage of the Medical

Device Amendments of 1976 (Public

Law 94–295), Congress mandated the

listing of color additives for use in

medical devices when the color additive

in the device comes into direct contact

with the body for a significant period of

time (section 721(a) of the act). D&C

Violet No. 2 is added to absorbable

sutures prepared from homopolymers of

glycolide in such a way that at least

some of the color additive will come

into contact with the body when the

sutures are in place. In addition, the

sutures are intended to be absorbed by

the body, and during the absorption, the

color additive will be deposited in body

tissue. Thus, the color additive will be

in direct contact with the body for a

significant period of time.

Consequently, the petitioned use of the

color additive is subject to the statutory

listing requirement.

IV. The Color Additive

D&C Violet No. 2 is principally 1-

hydroxy-4-[(4-methylphenyl)amino]-

9,10-anthracenedione (CAS Reg. No. 81–

48–1). It is manufactured by either

condensation of quinizarin with ptoluidine or by condensation of 1-

hydroxy-halogenoanthroquinone with

p-toluidine. Because no chemical

reaction consumes all the starting

materials and yields only the desired

product, both the resulting reaction

mixture and commercial product will

contain residual amounts of the starting

materials, including p-toluidine. This

fact is significant because Weisburger et

al. have demonstrated that p-toluidine is

a carcinogen in the mouse (Ref. 1).

Residual amounts of reactants, such as

p-toluidine, and manufacturing aids are

commonly found as impurities in

chemical products, including color

additives.

V. Determination of Safety

Under the general safety standard of

the act (section 721(b)(4)) for color

additives, a color additive cannot be

approved for a particular use unless a

fair evaluation of the data available to

FDA establishes that the color additive

is safe for that use. FDA’s color additive

regulations (21 CFR 70.3(i)) define

‘‘safe’’ as ‘‘reasonable certainty that no

harm will result from the intended use

of the color additive.’’

The color additives anticancer, or

Delaney, clause of the color additive

amendments (section 721(b)(5)(B) of the

act) provides that no noningested color

additive shall be deemed safe and shall

be listed if, after tests that are

appropriate for evaluating the safety of