This section of the FEDERAL REGISTER

contains documents other than rules or

proposed rules that are applicable to the

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examples of documents appearing in this

section.

Notices Federal Register

58058

Vol. 68, No. 195

Wednesday, October 8, 2003

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

[Doc. No. TM–03–08] 

Request for an Extension of and 

Revision to a Currently Approved 

Information Collection

AGENCY: Agricultural Marketing Service, 

USDA.

ACTION: Notice and request for 

comments. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35), this notice 

announces the Agricultural Marketing 

Service’s intention to request approval 

from the Office of Management and 

Budget, for an extension of and revision 

to the currently approved information 

collection National Organic Program 

Record Keeping Requirements.

DATES: Comments received by December 

8, 2003 will be considered.

ADDITIONAL INFORMATION OR COMMENTS:

Contact Toni Strother, National Organic 

Program, Transportation and Marketing 

Programs, Agricultural Marketing 

Service, U.S. Department of Agriculture, 

1400 Independence Ave., SW., Room 

4008-So., Ag Stop 0268, Washington, 

DC 20250, telephone (202) 720–3252, 

fax (202) 205–7808.

SUPPLEMENTARY INFORMATION: 

Title: National Organic Program. 

OMB Number: 0581–0191. 

Expiration Date Of ApprovaI: January 

31, 2004. 

Type of Request: Extension and 

Revision of a currently approved 

information collection. 

Abstract: The Organic Foods 

Production Act of 1990 (OFPA) as 

amended (7 U.S.C. 6501 et seq.) 

mandates that the Secretary develop a 

National Organic Program (NOP) to 

accredit eligible State program’s 

governing State officials or private 

persons as certifying agents who would 

certify producers or handlers of 

agricultural products that have been 

produced using organic methods as 

provided for in OFPA. This regulation: 

(1) Established national standards 

governing the marketing of certain 

agricultural products as organically 

produced products; (2) assures 

consumers that organically produced 

products meet a consistent standard; 

and (3) facilitates interstate commerce 

in fresh and processed food that is 

organically produced. The NOP requires 

that agricultural products labeled 

‘‘organic’’ be from a production or 

handling operation that is certified by a 

certifying agent who is accredited by the 

U.S. Department of Agriculture (USDA). 

Proposed rules to implement OFPA 

were published in December 1997 and 

March 2000. Both contained 

information collection requirements, an 

estimate of the annual economic burden 

on the organic industry, and a request 

for comments about the burden. The 

Agricultural Marketing Service (AMS) 

addressed these comments in the final 

rule published on December 21, 2000 

(65 FR 80548) to ensure that the least 

amount of the burden is placed on the 

public. 

Reporting and recordkeeping are 

essential to the integrity of the organic 

certification system. They create a paper 

trail that is a critical element in carrying 

out the mandate of OFPA and NOP. 

They serve the AMS mission, program 

objectives, and management needs by 

providing information on the efficiency 

and effectiveness of the program. The 

information affects decisions because it 

is the basis for evaluating compliance 

with OFPA and NOP, for administering 

the program, for management decisions 

and planning, and for establishing the 

cost of the program. It supports 

administrative and regulatory actions in 

response to noncompliance with OFPA 

and NOP. 

In general, the information collected 

is used by USDA, State program 

governing State officials, and certifying 

agents. It is created and submitted by 

State and foreign program officials, peer 

review panel members, accredited 

certifying agents, organic inspectors, 

certified organic producers and 

handlers, those seeking accreditation or 

certification, and parties interested in 

changing the National List. 

Additionally, it necessitates that all of 

these entities have procedures and 

space for recordkeeping. The burden on 

each entity is discussed below. 

USDA. USDA is the accrediting 

authority. USDA accredits domestic and 

foreign certifying agents who certify 

domestic and foreign organic producers 

and handlers, using information from 

the agents documenting their business 

operations and program expertise. 

USDA also permits State program 

governing State officials to establish 

their own organic certification programs 

after the programs are approved by the 

Secretary, using information from the 

States documenting their ability to 

operate such programs and showing that 

such programs meet the requirements of 

OFPA and NOP. 

States. State program governing State 

officials may operate their own organic 

certification programs. State officials 

obtain the Secretary’s approval of their 

programs by submitting information to 

USDA documenting their ability to 

operate such programs and showing that 

such programs meet the requirements of 

OFPA and NOP. To date no State 

organic certification programs have been 

approved by USDA. Upon approval 

State organic certification programs will 

require reporting and recordkeeping 

burdens similar to those required by the 

NOP. The annual burden for each State 

will be an average of 74 hours or if 

calculated at a rate of $27 per hour 

(rounded up to the next dollar) $1,998.

Peer review panels. The panel assists 

the AMS Administrator in evaluating 

NOP’s adherence to the accreditation 

procedures in subpart F of the 

regulations and International 

Organization for standards/International 

Electro-technical Commission Guide 61, 

General requirements for assessment 

and accreditation of certification/

registration bodies, and NOP’s 

accreditation decisions. The American 

National Standards Institute (ANSI) was 

selected by the NOP to perform the peer 

review assessment. The peer review 

panel consists of three individuals, two 

ANSI provided assessors and one NOP 

technical expert. Estimates: Three 

people participate in the peer review 

panel. The annual burden for each panel 

member is an average of 4 hours or if 

calculated at a rate of $27 per hour 

(rounded up to the next dollar) $108. 

Certifying agents. Certifying agents are 

State program governing State officials, 

private entities, or foreign entities who 

are accredited by USDA to certify 

Federal Register / Vol. 68, No. 195 / Wednesday, October 8, 2003 / Notices 58059

domestic and foreign producers and 

handlers as organic in accordance with 

OFPA and NOP. Each entity wanting to 

be an agent seeks accreditation from 

USDA, submitting information 

documenting its business operations 

and program expertise. Accredited 

agents determine if a producer or 

handler meets organic requirements, 

using detailed information from the 

operation documenting its specific 

practices and on-site inspection reports 

from organic inspectors. Initial 

estimates were based on 59 entities 

applying for accreditation (13 State 

programs, 36 private entities, 10 foreign 

entities). The initial burden for each 

State program was an average of 695 

hours or if calculated at a rate of $27 per 

hour (rounded up to the next dollar) 

$18,765. The initial burden for each 

private or foreign entity was 700 hours 

or if calculated at a rate of $27 per hour 

(rounded up to the next dollar) $18,900. 

To date 87 certifying agents (15 State 

programs, 38 private entities, 34 foreign 

entities) have been accredited. The AMS 

anticipates receiving an estimated 10 

new applications per year. Accredited 

certifying agents submit annual updates 

with an annual burden, for each 

certifying agent, of an average of 3 hours 

or if calculated at a rate of $27 per hour 

(rounded up to the next dollar) $81. 

Administrative costs for reporting, 

disclosure of information, and 

recordkeeping vary among certifying 

agents. Factors affecting costs include 

the number and size of clients, the 

categories of certification provided, and 

the type of systems maintained. 

When an entity applies for 

accreditation as a certifying agent, it 

must provide a copy of its procedures 

for complying with recordkeeping 

requirements (§ 205.504 (b)(3)). Once 

certified, agents have to make their 

records available for inspection and 

copying by authorized representatives of 

the Secretary (§ 205.501 (a)(9)). The 

USDA charges certifying agents for the 

time required to do these document 

reviews. Audits require less time when 

the documents are well organized and 

centrally located. 

Recordkeeping requirements for 

certifying agents are divided into three 

categories of records with varying 

retention periods: (1) Records created by 

certifying agents regarding applicants 

for certification and certified operations, 

maintain 10 years, consistent with 

OFPA’s requirement for maintaining all 

records concerning activities of 

certifying agents; (2) records obtained 

from applicants for certification and 

certified operations, maintain 5 years, 

the same as OFPA’s requirement for the 

retention of records by certified 

operations; and (3) records created or 

received by certifying agents regarding 

accreditation, maintain 5 years, 

consistent with OFPA’s requirement for 

renewal of agent’s accreditation (§ 205.5 

10 (b)). 

Organic inspectors. Inspectors, on 

behalf of certifying agents, conduct onsite inspections of certified operations 

and operations applying for 

certification. They determine whether or 

not certification should continue or be 

granted and report their findings to the 

certifying agent. Inspectors are the 

agents themselves, employees of the 

agents, or individual contractors. We 

estimate that about half are certifying 

agents and their employees and half are 

individual contractors. Individuals who 

apply for positions as inspectors submit 

to the agents information documenting 

their qualifications to conduct such 

inspections. Estimates: 293 inspectors 

(147 certifying agents and their 

employees, 146 individual contractors). 

The annual burden for each inspector is 

an average of 48 hours or if calculated 

at $27 per hour (rounded up to the next 

dollar) $1,296. 

Producers and handlers. Producers 

and handlers, domestic and foreign, 

apply to certifying agents for organic 

certification, submit detailed 

information documenting their specific 

practices, provide annual updates to 

continue their certification, and report 

changes in their practices. Producers 

include farmers, livestock and poultry 

producers, and wild crop harvesters. 

Handlers include those who transport or 

transform food and include millers, bulk 

distributors, food manufacturers, 

processors, repackagers, or packers. 

Some handlers are part of a retail 

operation that processes organic 

products in a location other than the 

premises of the retail outlet.

The OFPA requires certified operators 

to maintain their records for 5 years. 

Initial estimates of: 19,400 total 

operators (14,253 certified and 5,147 

exempt), including 17,150 producers 

(12,176 certified and 4,974 exempt) and 

2,150 handlers (1,977 certified and 173 

exempt) have not changed. The annual 

recordkeeping burden for each certified 

operator is an average of 5 hours or if 

calculated at $24 per hour (rounded up 

to the next dollar) $120. 

The NOP exempts certain operations 

from certification: (1) Producers and 

handlers whose gross agricultural 

income from organic sales totals $5,000 

or less annually; (2) handlers selling 

only agricultural products that contain 

less than 70 percent organic ingredients 

by total weight of the finished product; 

(3) handlers that handle agricultural 

products that contain at least 70 percent 

organic ingredients and choose to use 

the word ‘‘organic’’ only on the 

information panel of a packaged 

product; and (4) handlers that are retail 

food establishments that handle organic 

food but do not process it. The NOP also 

excludes certain operations from 

certification: (1) Handlers selling only 

agricultural products labeled as organic 

or made with organic ingredients that 

are enclosed in a container prior to 

being received, remain in the same 

container, and are not otherwise 

processed while in the control of the 

operation; and (2) handlers that are 

retail food establishments that process 

or prepare, on the premises, raw and 

ready-to-eat food from organic 

agricultural products. 

Administrative costs for reporting and 

recordkeeping vary among certified 

operators. Factors affecting costs 

include the type and size of operation, 

and the type of systems maintained. 

Research studies have indicated that 

operations using product labels 

containing the term ‘‘organic’’ handle an 

average of 19.5 labels annually and that 

there are about 16,000 products with the 

term organic on the label. An estimate 

of the time needed to develop labels for 

products sold, labeled, or represented as 

‘‘100 percent organic,’’ ‘‘organic,’’

‘‘made with organic (specified 

ingredients),’’ or which use the term 

organic to modify an ingredient in the 

ingredients statement is included. Also 

included is the time spent deciding 

about use of the USDA seal, a State 

emblem, or the seal, logo, or other 

identifying marks of a private certifying 

agent (Sec. 205.300–Sec. 205.310). 

Because the labeling requirements are in 

addition to Food and Drug 

Administration and Food Safety and 

Inspection Service requirements, the 

burden measurement does not include 

the hours necessary to develop the 

entire label. For purposes of calculating 

the burden, it is estimated that each 

handler develops 20 labels annually. 

Estimates: 1,977 certified handlers. The 

annual burden for each certified handler 

is an average of 1 hour per product label 

times 20 product labels per handler or 

if calculated at a rate of $27 per hour 

(rounded up to the next dollar) $540. 

Interested parties. Any interested 

party may petition the NOSB for the 

purpose of having a substance evaluated 

for recommendation to the Secretary for 

inclusion on or deletion from the 

National List. Estimates: 25 interested 

parties may petition the NOSB. The 

annual burden for each interested party 

is an average of 104 hours or if 

calculated at $24 per hour (rounded up 

to the next dollar) $2,496. 

58060 Federal Register / Vol. 68, No. 195 / Wednesday, October 8, 2003 / Notices 

Estimate of Burden: Public reporting 

burden for this collection of information 

is estimated to average 1.72 hours per 

response. 

Respondents: Producers, handlers, 

certifying agents, inspectors and State, 

Local or Tribal governments and 

interested parties. 

Estimated Number of Respondents:

19,766. 

Estimated Number of Responses:

345,912. 

Estimated Number of Responses Per 

Respondent: 17.5. 

Estimated Total Annual Burden on 

Respondents: 593,523. 

Comments are invited on: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information will have 

practical utility; (2) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Comments may be sent to: Richard H. 

Mathews, Program Manager, National 

Organic Program, USDA–AMS–TM–

NOP, 1400 Independence Ave., SW., 

Room 4008–S0., Ag Stop 0268, 

Washington, DC 20250 or via the 

Internet at: Paperwork@usda.gov, or by 

fax at: (202) 205–7808. All comments 

received will be available for public 

inspection during regular business 

hours at the same address. Also, all 

comments to this notice will be 

available for viewing on the NOP 

homepage at http://www.ams.usda.gov/

nop.

All responses to this notice will be 

summarized and included in the request 

for OMB approval. All comments will 

become a matter of public record.

Authority: 7 U.S.C. 6501–6522.

Dated: October 2, 2003. 

A.J. Yates, 

Administrator, Agricultural Marketing 

Service.

[FR Doc. 03–25459 Filed 10–7–03; 8:45 am] 

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service 

[Docket No. 03–034N] 

Codex Alimentarius Commission: 

Meeting of the Codex Committee on 

Food Import and Export Inspection and 

Certification Systems

AGENCY: Office of the Under Secretary 

for Food Safety, USDA.

ACTION: Notice.

SUMMARY: The Office of the Under 

Secretary for Food Safety, United States 

Department of Agriculture and the 

United States Department of Health and 

Human Services, Food and Drug 

Administration (FDA), are sponsoring 

two public meetings. The first meeting 

will be held on October 22, 2003, to 

review and receive comments in 

preparation to develop draft U.S. 

positions, and the second will be held 

on November 12, 2003, to provide 

information and receive public 

comments on the U.S. Draft positions 

for agenda items that will be discussed 

at the Codex Committee on Food Import 

and Export Inspection and Certification 

Systems (CCFICS), which will be held 

in Brisbane, Australia, December 1–5, 

2003. The Under Secretary and FDA 

recognize the importance of providing 

interested parties with information on 

the Twelfth Session of CCFICS and to 

address items on the Agenda.

DATES: The public meetings are 

scheduled for Wednesday, October 22, 

2003, from 1 p.m. to 4 p.m., and 

Wednesday, November 12, 2003, from 1 

p.m. to 3 p.m.

ADDRESSES: The public meetings will be 

held in Room 1A001 of the Harvey W. 

Wiley Federal Building, 5100 Paint 

Branch Pkwy, College Park, MD (green 

line, College Park Metro stop). 

To receive copies of the documents 

referenced in this notice, contact the 

Food Safety and Inspection Service 

(FSIS) Docket Clerk, U.S. Department of 

Agriculture, FSIS, Room 102, Cotton 

Annex, 300 12th Street, SW., 

Washington, DC 20250–3700. The 

documents will also become available 

via the World Wide Web at the 

following address: http://

codexalimentarius.net/current.asp. If 

you have comments, please send an 

original and two copies to the FSIS 

Docket Clerk and reference Docket #03–

034N. All comments submitted will be 

available for public inspection in the 

Docket Clerk’s Office between 8:30 a.m. 

and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Edith Kennard, Staff Officer, U.S. Codex 

Office, Food Safety and Inspection 

Service, Room 4861, South Agriculture 

Building, 1400 Independence Avenue 

SW., Washington, DC 20250–3700, 

telephone (202) 720–5261, Fax: (202) 

720–3157.

SUPPLEMENTARY INFORMATION: 

Background 

The Codex Alimentarius Commission 

(Codex) was established in 1962 by two 

United Nations organizations, the Food 

and Agriculture Organization (FAO) and 

the World Health Organization (WHO). 

Codex is the major international 

organization for encouraging fair 

international trade in food and 

protecting the health and economic 

interests of consumers. Through 

adoption of food standards, codes of 

practice, and other guidelines 

developed by its committees, and by 

promoting their adoption and 

implementation by governments, Codex 

seeks to ensure that the world’s food 

supply is sound, wholesome, free from 

adulteration, and correctly labeled. In 

the United States, USDA, FDA, and EPA 

manage and carry out U.S. Codex. 

The Codex Committee on Food Import 

and Export Inspection and Certification 

Systems was established to develop 

principles and guidelines for food 

import and export inspection and 

certification systems to facilitate trade 

through harmonization and to supply 

safe and quality foods to consumers. 

The CCFICS develops principles and 

guidelines for the application of 

measures by competent authorities to 

provide assurance that food comply 

with essential requirements. 

Additionally, the CCFICS develops 

guidelines for quality assurance systems 

to ensure that foods conform with 

essential requirements. 

The following issues will be 

discussed during the public meetings: 

1. Proposed Draft Revision to the 

Codex Guidelines for the Exchange of 

Information on Food Control Emergency 

Situations. 

2. Discussion Paper on Traceability/

Product Tracing in the Context of Food 

Import and Export Inspection and 

Certification Systems. 

3. Discussion Paper on the Judgment 

of Equivalence of Technical Regulations 

Associated with Food Inspection and 

Certification Systems. 

Additional Public Notification 

Public involvement in all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that minorities, women, and 

persons with disabilities are aware of 

this notice and informed about the 

mechanism for providing their