Quality Systems Verification Programs, 17611-17616 [05-6957]
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Federal Register / Vol. 70, No. 66 / Thursday, April 7, 2005 / Proposed Rules
7 CFR Parts 54 and 62
FOR FURTHER INFORMATION CONTACT:
James L. Riva, Chief, Audit, Review, and
Compliance (ARC) Branch, telephone
202–720–1124, or e-mail
James.Riva@usda.gov.
[No. LS–02–10]
SUPPLEMENTARY INFORMATION:
RIN #0581–AC12
Background and Discussion
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
Quality Systems Verification Programs
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
SUMMARY: The Agricultural Marketing
Service (AMS) is proposing to establish
a separate user-fee schedule for the
Quality Systems Verification Programs
(QSVP) and expand the scope of the
QSVP to include all agricultural
products and services within the
responsibility of the Livestock and Seed
(LS) Program. A new Part 62 would be
established for QSVP services. QVSP are
a collection of voluntary, audit-based,
user-fee programs authorized under the
Agricultural Marketing Act of 1946.
QSVP facilitate the global marketing and
trade of agricultural products; provide
consumers the opportunity to
distinguish specific characteristics
involved in the production and
processing of agricultural products; and
ensure that product consistently meets
program requirements.
DATES: Written comments must be
received by May 9, 2005. Comments
regarding the information collection
requirements that would result from this
proposal must be received by June 6,
2005.
Send comments concerning
this proposed rule to James L. Riva,
Chief; USDA, AMS, LS, ARC Branch;
STOP 0294, Room 2627–S, 1400
Independence Avenue, SW.,
Washington, DC 20250–0248; by FAX to
202–690–1038; or by e-mail to:
ARCBranch@usda.gov. Comments may
also be submitted electronically through
https://www.regulations.gov. Comments
should reference the date and page
number of this issue of the Federal
Register. Comments will be posted at:
https://www.ams.usda.gov/lsg/
rulemaking.htm and will be made
available for public inspection during
normal business hours at the above
address. Comments concerning the
information collection should be sent to:
Desk Officer for Agriculture, Office of
Information and Regulatory Affairs,
Office of Management and Budget, New
Executive Office Building, 725 17th
Street, NW., Room 725, Washington, DC
20503; or by e-mail to:
OIRA_submissions@OMB.eop.gov.
ADDRESSES:
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The Agricultural Marketing Act of
1946 (AMA), as amended, (7 U.S.C.
1621, et seq.), gives AMS the authority
to provide services so that agricultural
products may be marketed to their best
advantage, that trade may be facilitated,
and that consumers may be able to
ascertain characteristics involved in the
production and processing of products
and obtain the quality of product they
desire. AMA also provides for the
collection of fees from users of these
services that are reasonable and cover
the cost of providing services.
The QSVP were developed in 1995
and have since grown to include several
value-added marketing programs. The
QSVP have grown steadily over the past
few years, with auditors conducting 385
assessments in FY 2001, 562
assessments in FY 2002, and 715
assessments in 2003, and 915
assessments in 2004. Presently, 14 fulltime auditors conduct assessments for
the LS Program.
QSVP are voluntary, audit-based,
user-fee funded programs developed
and conducted at the request of industry
and others as a cost-effective alternative
to conventional product certification.
QSVP use International Organization for
Standardization’s (ISO) Guidelines and
standards as a format for evaluating
program documentation to ensure
consistent assessment practices and
promote international recognition of
assessment results.
Currently, QSVP user-fees are based
on the approved hourly rate established
for meat grading and certification
services provided by the Meat Grading
and Certification (MGC) Branch
pursuant to 7 CFR part 54. Following
the initial program development period,
LS Program management conducted a
detailed cost analysis of QSVP services
and determined that the existing hourly
rate established for meat grading and
certification services did not sufficiently
cover the cost of providing QSVP
services. Due to the complexity of
planning, performing and interpreting
the results of assessments, auditor
positions are classified at the GS–11/12
pay grade, in contrast to the GS–5/7/9
pay grade classifications of most MGC
Branch full-time positions.
Upon considering all QSVP
operational expenses, the LS Program
determined that the actual cost of QSVP
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services, excluding travel costs, to be
$108 per hour. LS Program management
considered employee salaries and
benefits; Agency and LS Program
overhead; total revenue hours available
to the ARC Branch; and included other
anticipated costs such as, federally
mandated pay raises through FY 2005,
rent, communications, utilities,
contractual services, supplies, and
equipment in their analysis.
The LS Program considered
alternatives to creating a separate userfee for QSVP services, but found that
none were sufficient. Maintaining the
same user-fee for QSVP services
currently used for conventional meat
grading and certification services would
not sufficiently cover the cost of
providing QSVP services. Another
option was to terminate all QSVP
services, which would adversely affect
producers, businesses, and consumers
who desire QSVP services and those
entities with already-established
programs.
The QSVP were administered through
the LS Program’s MGC Branch pursuant
to 7 CFR part 54 using the user-fee
schedule established for meat grading
and certification services. In 2001, the
administration of QSVP was moved by
the LS Program to the Audit, Review,
and Compliance (ARC) Branch. This
proposed rule would establish a
separate user-fee of $108 per hour for
QSVP services under a new part 62.
Additionally, this proposed rule would
expand the scope of QSVP services to
include all agricultural products or
services within the responsibility of the
LS Program, such as livestock, meat,
meat products, seed, feedstuffs, as well
as processes involving the production of
these products, agricultural product
data storage, product traceability and
identification. Currently, Part 54 only
provides for services dealing with meat
and meat products. A new Part 62
would be established for QSVP services.
Executive Order 12866
This proposed rule has been
determined to be not significant for
purposes of Executive Order 12866 and,
therefore, has not been reviewed by the
Office of Management and Budget
(OMB).
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. It is not intended to
have retroactive effect and would not
preempt or supersede any State or local
laws, regulations, or policies, unless
they present an irreconcilable conflict.
There are no administrative procedures
that must be exhausted prior to any
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judicial challenge to the provisions of
this rule.
Regulatory Flexibility Act
Pursuant to the requirements set forth
in the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 et seq.), the
Agricultural Marketing Service (AMS)
has considered the economic effect of
this action on small entities and has
determined that this proposed rule will
not have a significant economic impact
on a substantial number of small
entities. The purpose of RFA is to fit
regulatory actions to the scale of
businesses subject to such actions in
order that small businesses will not be
unduly burdened.
AMS, through the LS Program’s ARC
Branch, provides voluntary assessment
services to approximately 415
businesses, including 152 livestock
slaughterers, 72 meat processors, 46
livestock producers feeders, 135 organic
certifying companies, 4 trade
associations, and 4 State and Federal
entities. Seventy-five percent (i.e., 346)
of these businesses are classified as
small entities and generate
approximately 65 percent of the ARC
Branch’s revenue. The Small Business
Administration (SBA) (13 CFR 121.201)
defines small agricultural producers as
those having annual receipts of less than
$750,000; small agricultural service
firms as those whose annual receipts are
less than $5 million; and small meat
packers as those that have less than 500
employees. No entity, small or large, is
obligated to use voluntary QSVP
services provided under the authority of
AMA.
AMS regularly reviews its user-feefinanced programs to determine if the
fees are adequate to cover the cost of the
services provided. The most recent
review determined that the existing
hourly rate that the ARC Branch charges
for QSVP services would not generate
sufficient revenues to recover operating
costs for current and near-term periods
while maintaining a 4-month operating
reserve of $275,000. In FY 2004, the
ARC Branch incurred a $330,000
operating loss; and without a fee
increase, FY 2004 operating losses are
projected to reach $421,000. These
combined losses will deplete the ARC
Branch’s operating reserve and place the
ARC Branch in an unstable financial
position that will adversely affect its
ability to provide QSVP services.
While the ARC Branch has utilized
existing automated information
management systems for data collection,
retrieval, dissemination, applicant
billing, and disbursement of employee
entitlements, the ARC Branch has
continued to lose revenue due to the
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cost of providing QSVP services
utilizing auditors classified at the GS–
11/12 pay grade while charging a userfee that is based on a lower GS–5/7/9
pay grade classification.
The ARC Branch operating costs
increased as a result of higher salaries
associated with higher grade employees;
congressionally mandated salary
increases for all Federal Government
employees in 2004 and 2005; ongoing
information system technology upgrades
necessary to remain compatible with
customer and Agency systems; inflation
of non-salary operating expenses; and
office maintenance expenses.
AMS estimates that this proposed
action will provide the ARC Branch
with an additional $420,000 for FY
2005. Of this $420,000, small businesses
would pay an average of $878 more per
year per applicant or a total of $273,000
of the total increase. This proposed fee
increase coupled with a projected
increase in revenue hours would
increase total revenues by $420,000 per
year and offset FY 2004 operating losses
of $330,000. Currently, without a fee
increase, the ARC Branch is projected to
lose $420,000 in FY 2005. The proposed
increase will create a 4-month operating
reserve of $275,000, as required by the
Agency.
The proposed Part 62 includes
sections on definitions; sections related
to providing services, including
availability and how to apply for
services; and suspension, denial, or
cancellation of service and other
sections relating to fees. These sections
are similar to, or the same as, provisions
that currently apply to Quality Systems
Verification Programs.
Paperwork Reduction Act
This proposed rule contains
submission and recordkeeping
requirements subject to public comment
and review by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
Chapter 35).
OMB Number: 0581–0124.
Expiration Date: October 31, 2006.
Type of Request: Revision of currently
approved collection.
Abstract: The QSVP are voluntary,
audit-based programs developed at the
request of the livestock industry and
other interested parties as a costeffective alternative to conventional
product certification. This proposed
rule would permit the LS Program to
carry out independent assessments of
applicant’s programs for any
agricultural product or service within
the scope of the LS Program. This action
is necessary to provide continued,
seamless, and efficient distribution of
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highly differentiated agricultural
products and services to customers who
require production and marketing
process assessments by an authorized
government entity. The information
collection and recordkeeping
requirements in this proposed rule are
essential to maintaining these voluntary
programs. Only authorized
representatives of the USDA, including
AMS, LS Program, ARC Branch staff use
the collected information in the
performance of their official duties.
The AMA, as amended, authorizes the
USDA to provide services that facilitate
the marketing of agricultural products.
Currently, the LS Program provides
QSVP services for livestock, meat, and
meat products, pursuant to 7 CFR part
54. This proposed rule would define
QSVP services to include other
agricultural products within the scope
of the LS Program in a new part, part 62
to Title 7 of the Code of Federal
Regulations.
Applicants may request QSVP
services through submission of the
currently approved form LS–313 to the
ARC Branch. This existing form requires
the minimum information necessary to
effectively carry out the requirements of
the proposed rule including: firm name,
address, telephone number, and other
information necessary to identify the
applicant, and other pertinent
information necessary to determine if
the firm is eligible to apply and receive
QSVP services. Applicants are required
to complete the form only when initially
applying for QSVP service. There is no
annual requirement for resubmission.
The form can be supplied without data
processing equipment or outside
technical expertise. AMS estimates the
one-time burden for submission of Form
LS–313 to average 0.200 hours (12
minutes) per applicant at $20.00 per
hour. The total one-time burden if 50
applicants applied under this proposed
rule is estimated to be $200.00.
Applicants may obtain form LS–313
by (1) Contacting James L. Riva, Chief;
USDA, AMS, LS, ARC Branch; STOP
0294, Room 2627–S; 1400 Independence
Ave., SW., Washington, DC 20250–0294;
(2) downloading a printable version at
the ARC Branch Web site: https://
www.ams.usda.gov/lsg/arc/audit.htm;
or (3) accessing a Web-based version at
the AMS Electronic Forms Web site:
https://151.121.3.189/EManager/
new.htm.
Applicants may submit form LS–313
by (1) mail to: James L. Riva, Chief;
USDA, AMS, LS, ARC Branch; STOP
0294, Room 2627–S, 1400 Independence
Avenue, SW., Washington, DC 20250–
0248; (2) FAX to: (202) 690–1038; or email to: ARCBranch@usda.gov.
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Under this proposed rule, applicants
would be required to submit a cover
letter and a complete copy of the
applicant’s program documentation
when a request for service is made. This
is a one-time requirement per service
request. The PRA also requires the
agency to measure the recordkeeping
burden. The proposed rule would also
require applicants to retain records and
documents necessary to support the
requested service for the period of at
least one calendar year following the
year the record was created and long
enough to assess conformance of the
product though the applicant’s quality
management system. Additionally,
applicants must ensure that such
records and documents are readily
available and easily accessible. The
recordkeeping burden is the amount of
time needed to prepare, store, and
maintain documents.
Based on its experience with QSVP,
AMS understands that applicants
develop and maintain complete
documentation of their programs as a
normal business practice. AMS believes
the cost burden associated with
submission of complete program
documentation to be limited to the time
needed for the applicant to review the
documentation for completeness and
accuracy. AMS estimates this time to
average 24 hours per applicant at $20.00
per hour for a total one-time burden per
applicant of $480.00. The total one-time
burden if 50 applicants applied under
this proposed rule is estimated to be
$24,000.
Based on its experience, AMS
believes that the documents and records
required to be retained are normally
retained by applicants as part of their
normal business practices. However, if
record keepers were compensated for
their time, AMS estimates that the time
required for each applicant to retain
these records and documents in a
manner required in the proposed rule to
average 6 hours per year at $20.00 per
hour for a total annual burden of
$120.00 per applicant. Assuming that 50
applicants were retained under this
proposed rule, the total annual burden
is estimated to be $6,000.
(1) Application for Service form LS–
313.
Estimate of Burden: The proposal to
expand the scope of the QSVP to
include all agricultural products and
services within the responsibility of the
LS Program will increase the approved
burden by 1210 hours. Using the
currently approved form LS–313, the
public reporting burden for this
proposed collection of information is
estimated to average 0.20 hours (12
minutes) per response.
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Respondents: Livestock, meat
industry, and other businesses that
produce, process, or handle agricultural
products or services.
Estimated Number of Respondents:
50.
Estimated Number of Responses per
Respondent: 1.
Estimated Total Number of
Responses: 50.
Estimated Total Annual Burden on
Respondents: 10.00 hours.
Estimated Total Cost: $200.00.
(2) Review and Submission of
Program Documentation.
Estimate of Burden: Public reporting
burden for this proposed collection of
information is estimated to average 24
hours per respondent.
Respondents: Livestock, meat
industry, and other businesses that
produce, process or handle agricultural
products or services.
Estimated Number of Respondents:
50.
Estimated Number of Responses per
Respondent: 1.
Estimated Total Number of
Responses: 50.
Estimated Total Annual Burden on
Respondents: 1200 hours.
Estimated Total Cost: $24,000.
Comments are invited on: (1) Whether
the 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 burden estimate of the
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 through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Comments should reference OMB No.
0581–0124, the QSVP, and be sent to (1)
Desk Officer for Agriculture, Office of
Information and Regulatory Affairs,
Office of Management and Budget, New
Executive Office Building, 725 17th
Street, NW., Room 725, Washington, DC
20503; or by e-mail to:
OIRA_submissions@OMB.eop.gov and
(2) James L. Riva, Chief; USDA, AMS,
LS, ARC Branch; STOP 0294, Room
2627–S, 1400 Independence Avenue,
SW., Washington, DC 20250–0248; or
FAX (202) 690–1038; or e-mail
ARCBranch@usda.gov. A comment to
OMB is best assured of having its full
effect if OMB receives it within 30 days
of publication of this proposed rule.
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All comments will be posted on the
Internet at https://www.ams.usda.gov/
lsg/rulemaking.htm and will be made
available for public inspection in the
above offices during regular business
hours.
A 30-day comment period is provided
for interested persons to comment on
this proposed rule. This comment
period is deemed appropriate in order to
implement this rule, if adopted, as soon
as possible so that program costs are
covered by revenue.
All responses to this proposed rule
will be summarized and included in the
request for OMB approval. All
comments will become a matter of
public record.
List of Subjects
7 CFR Part 54
Meats, Prepared meats, and Meat
products.
7 CFR Part 62
Food grades and standards, Food
labeling, Meat and meat products.
For the reasons set forth in the
preamble, it is proposed that chapter 1
of title 7 of the Code of Federal
Regulations be revised by amending part
54 and adding part 62 to read as follows:
PART 54—[AMENDED]
1. The authority citation for part 54
continues to read as follows:
Authority: 7 U.S.C. 1621–1627.
§ 54.4
[Amended]
2. In § 54.4, paragraph (5) is removed.
3. Part 62 is added to read as follows:
PART 62—LIVESTOCK, MEAT, AND
OTHER AGRICULTURAL
COMMODITIES (QUALITY SYSTEMS
VERIFICATION PROGRAMS)
Subpart A—Quality Systems Verification
Programs
Definitions
Sec.
62.000 Meaning of terms.
Administration
62.100 Administrator.
Service
62.200 Services.
62.201 Availability of service.
62.202 How to apply for service.
62.203 How to withdraw service.
62.204 Authority to request service.
62.205 Conflict of interest.
62.206 Access to program documents and
activities.
62.207 Official assessment.
62.208 Publication of QSVP assessment
status.
62.209 Reassessment.
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62.210 Denial, suspension, or cancellation
of service.
62.211 Appeals.
62.212 Official assessment reports.
62.213 Official identification.
Charges for Service
62.300 Fees and other costs for service.
62.301 Payment of fees and other charges.
Miscellaneous
OMB Control Number
62.400 OMB control number assigned
pursuant to the Paperwork Reduction
Act.
Subpart B—[Reserved]
Authority: 7 U.S.C. Sec. 1621–1627.
Subpart A—Quality Systems
Verification Programs
Definitions
§ 62.000
Meaning of terms.
Words used in this Subpart in the
singular form shall be deemed to impart
the plural, and vice versa, as the case
may demand. For the purposes of such
regulations, unless the context
otherwise requires, the following terms
shall be construed, respectively, to
mean:
Administrator. The Administrator of
the Agricultural Marketing Service
(AMS), or any officer or employee of
AMS to whom authority has heretofore
been delegated or to whom authority
may hereafter be delegated, to act in the
Administrator’s stead.
Agricultural Marketing Service. The
Agricultural Marketing Service of the
U.S. Department of Agriculture.
Applicant. Any individual or business
with financial interest in QSVP services
who has applied for service under this
Part.
Assessment. A systematic review of
the adequacy of program or system
documentation, or the review of the
completeness of implementation of a
documented program or system.
Auditor. Person authorized by the
Livestock and Seed Program to conduct
official assessments.
Branch. The Audit, Review, and
Compliance Branch of the Livestock and
Seed Program.
Chief. The Chief of the ARC Branch,
or any officer or employee of the Branch
to whom authority has heretofore been
delegated, or to whom authority may
hereafter be delegated, to act in the
Chief’s stead.
Conformance. A user’s quality manual
and supporting documentation.
Deputy Administrator. The Deputy
Administrator of the Livestock and Seed
Program, or any officer or employee of
the Livestock and Seed Program to
whom authority has heretofore been
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delegated, or to whom authority may
hereafter be delegated, to act in the
Deputy Administrator’s stead.
Financially interested person. Any
individual, partnership, corporation,
other legal entity, or Government agency
having a financial interest in the
involved product or service.
Livestock. Bovine, ovine, porcine,
caprine, bison or class of Osteichthyes.
Official mark. Official mark or other
official identification means any form of
mark or other identification, used under
the regulations to show the conformance
of products with applicable program
requirements, or to maintain the
identity of products for which service is
provided under the regulations.
Official memoranda or assessment
reports. Official memorandum means
any assessment report of initial or final
record of findings made by an
authorized person of services performed
pursuant to the regulations.
Products. Includes all agricultural
commodities and services within the
scope of the Livestock and Seed
Program This includes livestock, meat,
meat products, seed, feedstuffs, as well
as processes involving the production of
these products, agricultural product
data storage, product traceability and
identification.
QSVP Procedures. Audit rules and
guidelines set forth by the Agricultural
Marketing Service regarding the
development, documentation, and
implementation of QSVP.
Quality Manual. A collection of
documents that describe the applicant’s
quality management system, as it
applies to the requested service.
Quality Systems Verification
Programs (QSVP). A collection of
voluntary, audit-based, user-fee
programs that allow applicants to have
program documentation and program
processes assessed by AMS auditor(s)
and other USDA officials under this
Part.
Regulations. The regulations in this
Part.
USDA. The U.S. Department of
Agriculture.
assess documented processes or
systems.
(a) Assessment services provided
under the regulations shall consist of:
(1) A review of the adequacy of an
applicant’s quality manual against LS
Program QSVP procedures,
internationally recognized guidelines, or
other requirements as approved by the
LS Program;
(2) An onsite assessment of the
applicant’s program to ensure
implementation of provisions within the
quality manual and the applicant’s
conformance with applicable program
requirements and LS Program QSVP
procedures; and
(3) A reassessment of the applicant’s
program to ensure continued
implementation of provisions within the
quality manual and the applicant’s
conformance with program
requirements and applicable LS
Program QSVP procedures;
(b) Developmental assistance in the
form of training to explain LS Program
QSVP procedures is available upon
request.
Administration
§ 62.203
§ 62.100
Administrator.
The LS Program Deputy
Administrator is charged with the
administration of official assessments
conducted according to the regulations
in this Part and approved LS Program
QSVP procedures.
Services.
QSVP, under this regulation, provide
applicants, the ability to have USDA
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Availability of service.
QSVP services under these
regulations are available to international
and domestic government agencies,
private agricultural businesses and any
finically interested person.
§ 62.202
How to apply for service.
Applicants may apply for QSVP
services by submitting the following
information to the ARC Branch
headquarters office at USDA, AMS, LSP,
ARC Branch, 1400 Independence
Avenue, SW., STOP 0294, Room 2627–
S, Washington, DC, 20250–0294; by fax
to: (202) 690–1038, or e-mail to:
ARCBranch@usda.gov.
(a) The original completed form LS–
313, Application for Service;
(b) A letter requesting QSVP services;
and
(c) A complete copy of the applicant’s
program documentation, as described in
the LS Program QSVP procedures.
How to withdraw service.
Service may be withdrawn by the
applicant at any time; provided that, the
applicant notifies the ARC Branch in
writing of his/her desire to withdraw
the application for service and pays any
expenses the Department has incurred
in connection with such application.
§ 62.204
Service
§ 62.200
§ 62.201
Authority to request service.
Any person requesting service may be
required to prove his/her financial
interest in the product or service at the
discretion of the Deputy Administrator.
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Conflict of interest.
No USDA official shall review any
program documentation or determine
conformance of any documented
process or system in which the USDA
official has financial holdings.
§ 62.206 Access to program documents
and activities.
(a) The applicant shall make its
products and program documentation
available and easily accessible for
assessment, with respect to the
requested service. Auditors and other
USDA officials responsible for
maintaining uniformity and accuracy of
service under the regulations shall have
access to all parts of facilities covered
by approved applications for service
under the regulations, during normal
business hours or during periods of
production, for the purpose of
evaluating products or processes. This
includes products in facilities which
have been or are to be examined for
program conformance or which bear any
official marks of conformance. This
further includes any facilities or
operation that is part of an approved
program.
(b) Documentation and records
relating to an applicant’s program must
be retained for at least one calendar year
following the calendar year during
which the record was created.
§ 62.207
Official assessment.
Official assessment of an applicant’s
program shall include:
(a) Documentation assessment.
Auditors and other USDA officials shall
review the applicant’s program
documentation and issue finding of the
review to the applicant.
(b) Program assessment. Auditors and
USDA officials shall conduct an onsite
assessment of the applicant’s program to
ensure provisions of the applicant’s
program documentation have been
implemented and conform to LS
Program QSVP procedures.
(c) Program Determination.
Applicant’s determined to meet or not
meet LS Program QSVP procedures or
the applicant’s program requirements
shall be notified of their program’s
approval or disapproval.
(d) Corrective and/or preventative
actions. Applicants may be required to
implement corrective and/or
preventative actions upon completion of
assessment. After implementation of
corrective and/or preventative actions,
the applicant may request another
assessment.
§ 62.208
status.
Publication of QSVP assessment
Approved programs shall be posted
for public reference on the ARC Branch
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Web site: https://www.ams.usda.gov/lsg/
arc/audit.htm. Such postings shall
include:
(a) Program name and contact
information,
(b) Products or services covered under
the scope of approval,
(c) Effective dates of approval, and
(d) Control numbers of official
assessments, as appropriate, and
(e) Any other information deemed
necessary by the Branch Chief.
§ 62.209
Reassessment.
Approved programs are subject to
periodic reassessments to ensure
ongoing conformance with the LS
Program QSVP procedures covered
under the scope of approval. The
frequency of reassessments shall be
based on the LS Program QSVP
procedures, or as determined by the
Deputy Administrator.
§ 62.210 Denial, suspension, or
cancellation of service.
(a) QSVP services may be denied if an
applicant fails to meet its program
requirements, or conform to LS Program
QSVP procedures, such as:
(1) Adequately address any program
requirement resulting in a major nonconformance or an accumulation of
minor non-conformances that result in
the assignment of a major nonconformance for the program.
(2) Demonstrate capability to meet
any program requirement resulting in a
major non-conformance.
(3) Present truthful and accurate
information to any auditor or other
USDA official; or
(4) Allow access to facilities and
records within the scope of the program.
(b) QSVP services may be suspended
if the applicant fails to meet its program
requirements, or conform to LS Program
QSVP procedures; such as failure to:
(1) Adequately address any program
requirement resulting in a major nonconformance;
(2) Demonstrate capability to meet
any program requirement resulting in a
major non-conformance;
(3) Follow and maintain it’s approved
program or QSVP procedures;
(4) Provide corrective actions and
correction as applicable in the
timeframe specified;
(5) Submit significant changes to and
seek approval from the Chief prior to
implementation of significant changes
to an approved program;
(6) Allow access to facilities and
records within the scope of the
approved program;
(7) Accurately represent the eligibility
of agricultural products or services
distributed under an approved program;
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Fmt 4702
Sfmt 4702
(8) Remit payment for QSVP services;
(9) Abstain from any fraudulent or
deceptive practice in connection with
any application or request for service
under the rule; or
(10) Allow any auditor or other USDA
official to perform their duties under the
regulations of this Part.
(c) QSVP services maybe be cancelled,
an application may be rejected, or
program assessment may be terminated
if the Deputy Administrator or his
designee determines that a
nonconformance has remained
uncorrected beyond a reasonable
amount of time.
§ 62.211
Appeals.
Appeals of adverse decisions under
this Part, may be made in writing to the
Livestock and Seed Program Deputy
Administrator at STOP 0249, Room
2092—South, 1400 Independence
Avenue, SW., Washington, DC 20250–
0249. Appeals must be made within 30
days of receipt of adverse decision.
(a) Procedure for Appeals. Actions
under this subparagraph concerning
decision of appeals of the Deputy
Administrator shall be conducted in
accordance with the Rule of Practice
Governing Formal Adjudicatory
Proceedings Instituted by the Secretary
Under Various Statutes set forth at 7
CFR 1.130 through 1.151 and the
Supplemental Rules of Practice in 7 CFR
Part 50.
(b) [Reserved]
§ 62.212
Official assessment reports.
Official QSVP assessment reports
shall be generated by the auditor at the
conclusion of each assessment and a
copy shall be provided to the applicant.
§ 62.213
Official identification.
The following, as shown in figure 1,
constitutes official identification to
show product or services produced
under an approved USDA, Process
Verified Program (PVP):
(a) Products or services produced
under an approved USDA, PVP may use
the ‘‘USDA Process Verified’’ statement
and the ‘‘USDA Process Verified’’
shield, so long as, both the statement
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§ 62.205
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Federal Register / Vol. 70, No. 66 / Thursday, April 7, 2005 / Proposed Rules
and shield are used in direct association
with a clear description of the process
verified points that have been approved
by the Branch.
(b) Use of the ‘‘USDA Process
Verified’’ statement and the ‘‘USDA
Process Verified’’ shield shall be
approved in writing by Chief prior to
use by an applicant.
Charges for Service
§ 62.300
Fees and other costs for service.
Fees and other charges will be levied
based on the following provisions:
(a) Fees for service. Fees for QSVP
services shall be based on the time
required to provide service calculated to
the nearest quarter hour period,
including, but not limited to, official
assessment time, travel time, and time
required to prepare assessment reports.
The hourly fee rate shall be $108 per
hour.
(b) Transportation costs. Applicants
are responsible for paying actual travel
costs incurred to provide QSVP services
including but not limited to: mileage
charges for use of privately owned
vehicles, rental vehicles and gas,
parking, tolls, and public transportation
costs such as airfare, train, and taxi
service.
(c) Per diem costs. The applicant is
responsible for paying per diem costs
incurred to provide QSVP services away
from the auditor’s or USDA officials’
official duty station(s). Per diem costs
shall be calculated in accordance with
existing travel regulations (41 CFR,
subtitle F—Federal Travel Regulation
System, chapter 301).
(d) Other costs. When costs, other
than those costs specified in paragraphs
(a), (b), and (c) of this section, are
involved in providing the QSVP
services, the applicant shall be
responsible for these costs. The amount
of these costs shall be determined
administratively by the Chief. However,
the applicant will be notified of these
costs before the service is rendered.
§ 62.301 Payment of fees and other
charges.
Fees and other charges for QSVP
services shall be paid in accordance
with the following provisions. Upon
receipt of billing for fees and other
charges, the applicant shall remit
payment within 10 business days by
check, electronic funds transfer, draft, or
money order made payable to USDA,
AMS, in accordance with directions on
the billing. Fees and charges shall be
paid in advance if required by the
auditor or other authorized USDA
official.
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Miscellaneous
OMB Control Number
§ 62.400 OMB control number assigned
pursuant to the Paperwork Reduction Act.
The information collection and
recordkeeping requirements of this Part
have been approved by OMB under 44
U.S.C. Chapter 35 and have been
assigned OMB Control Number 0581–
0124.
Subpart B—[Reserved]
Dated: April 4, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 05–6957 Filed 4–6–05; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Rural Business-Cooperative Service
Rural Utilities Service
7 CFR Part 4279
RIN 0570–AA54
Business and Industry Guaranteed
Loan Program
Rural Business-Cooperative
Service, USDA.
ACTION: Proposed rule.
AGENCY:
SUMMARY: The Rural BusinessCooperative Service (RBS) proposes to
amend its regulation for the Business
and Industry (B&I) Guaranteed Loans by
modifying the regulations regarding
personal and corporate guarantors. This
action will standardize the guarantor
process. The Agency will create a
guarantor form which will be used to
obtain the personal or corporate
guarantee of anyone owning greater than
20 percent interest in the borrower. The
effect of this rule is to allow the Agency
to use all remedies available to pursue
collection from guarantors, including
offset under the Debt Collection
Improvement Act.
DATES: Written or e-mail comments
must be received on or before June 6,
2005, to be assured of consideration.
ADDRESSES: You may submit comments
to this rule by any of the following
methods:
• Agency Web site: https://
rdinit.usda.gov/regs/. Follow
instructions for submitting comments
on the Web site.
• E-Mail: comments@usda.gov.
Include RIN No. 0570–AA54 in the
subject line of the message.
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Fmt 4702
Sfmt 4702
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Submit written comments via
the U.S. Postal Service to the Branch
Chief, Regulations and Paperwork
Management Branch, U.S. Department
of Agriculture, STOP 0742, 1400
Independence Avenue, SW.,
Washington, DC 20205–0742.
• Hand Delivery/Courier: Submit
written comments via Federal Express
Mail or other courier service requiring a
street address to the Branch Chief,
Regulations and Paperwork
Management Branch, U.S. Department
of Agriculture, 300 7th Street, SW., 7th
Floor, Washington, DC 20024.
All written comments will be
available for public inspection during
regular work hours at 300 7th Street,
SW., 7th Floor, address listed above.
FOR FURTHER INFORMATION CONTACT:
David Lewis, Business and Industry
Loan Servicing Branch, Rural BusinessCooperative Service, U.S. Department of
Agriculture, STOP 3224, 1400
Independence Avenue, SW.,
Washington, DC 20250–3224, telephone
(202) 690–0797, or by e-mail to
david.lewis@usda.gov.
SUPPLEMENTARY INFORMATION:
Classification
This proposed rule has been reviewed
under Executive Order 12866 and
determined not to be significant and has
not been reviewed by the Office of
Management and Budget (OMB).
Programs Affected
The Catalog of Federal Domestic
Assistance number for the program
impacted by this action is 10.768,
Business and Industry Loans.
Intergovernmental Review
Business and Industry Guaranteed
Loans are subject to the provisions of
Executive Order 12372, which require
intergovernmental consultation with
State and local officials. RBS will
conduct intergovernmental consultation
in the manner delineated in and 7 CFR
part 3015, subpart V,
‘‘Intergovernmental Review of Rural
Development Programs and Activities.’’
Civil Justice Reform
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. In accordance with this
rule, (1) all State and local laws and
regulations that are in conflict with this
rule will be preempted; (2) no
retroactive effect will be given this rule;
and (3) administrative proceedings of
the National Appeals Division (7 CFR
E:\FR\FM\07APP1.SGM
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Agencies
[Federal Register Volume 70, Number 66 (Thursday, April 7, 2005)]
[Proposed Rules]
[Pages 17611-17616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6957]
[[Page 17611]]
=======================================================================
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Parts 54 and 62
[No. LS-02-10]
RIN 0581-AC12
Quality Systems Verification Programs
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Agricultural Marketing Service (AMS) is proposing to
establish a separate user-fee schedule for the Quality Systems
Verification Programs (QSVP) and expand the scope of the QSVP to
include all agricultural products and services within the
responsibility of the Livestock and Seed (LS) Program. A new Part 62
would be established for QSVP services. QVSP are a collection of
voluntary, audit-based, user-fee programs authorized under the
Agricultural Marketing Act of 1946. QSVP facilitate the global
marketing and trade of agricultural products; provide consumers the
opportunity to distinguish specific characteristics involved in the
production and processing of agricultural products; and ensure that
product consistently meets program requirements.
DATES: Written comments must be received by May 9, 2005. Comments
regarding the information collection requirements that would result
from this proposal must be received by June 6, 2005.
ADDRESSES: Send comments concerning this proposed rule to James L.
Riva, Chief; USDA, AMS, LS, ARC Branch; STOP 0294, Room 2627-S, 1400
Independence Avenue, SW., Washington, DC 20250-0248; by FAX to 202-690-
1038; or by e-mail to: ARCBranch@usda.gov. Comments may also be
submitted electronically through https://www.regulations.gov. Comments
should reference the date and page number of this issue of the Federal
Register. Comments will be posted at: https://www.ams.usda.gov/lsg/
rulemaking.htm and will be made available for public inspection during
normal business hours at the above address. Comments concerning the
information collection should be sent to: Desk Officer for Agriculture,
Office of Information and Regulatory Affairs, Office of Management and
Budget, New Executive Office Building, 725 17th Street, NW., Room 725,
Washington, DC 20503; or by e-mail to: OIRA--submissions@OMB.eop.gov.
FOR FURTHER INFORMATION CONTACT: James L. Riva, Chief, Audit, Review,
and Compliance (ARC) Branch, telephone 202-720-1124, or e-mail
James.Riva@usda.gov.
SUPPLEMENTARY INFORMATION:
Background and Discussion
The Agricultural Marketing Act of 1946 (AMA), as amended, (7 U.S.C.
1621, et seq.), gives AMS the authority to provide services so that
agricultural products may be marketed to their best advantage, that
trade may be facilitated, and that consumers may be able to ascertain
characteristics involved in the production and processing of products
and obtain the quality of product they desire. AMA also provides for
the collection of fees from users of these services that are reasonable
and cover the cost of providing services.
The QSVP were developed in 1995 and have since grown to include
several value-added marketing programs. The QSVP have grown steadily
over the past few years, with auditors conducting 385 assessments in FY
2001, 562 assessments in FY 2002, and 715 assessments in 2003, and 915
assessments in 2004. Presently, 14 full-time auditors conduct
assessments for the LS Program.
QSVP are voluntary, audit-based, user-fee funded programs developed
and conducted at the request of industry and others as a cost-effective
alternative to conventional product certification. QSVP use
International Organization for Standardization's (ISO) Guidelines and
standards as a format for evaluating program documentation to ensure
consistent assessment practices and promote international recognition
of assessment results.
Currently, QSVP user-fees are based on the approved hourly rate
established for meat grading and certification services provided by the
Meat Grading and Certification (MGC) Branch pursuant to 7 CFR part 54.
Following the initial program development period, LS Program management
conducted a detailed cost analysis of QSVP services and determined that
the existing hourly rate established for meat grading and certification
services did not sufficiently cover the cost of providing QSVP
services. Due to the complexity of planning, performing and
interpreting the results of assessments, auditor positions are
classified at the GS-11/12 pay grade, in contrast to the GS-5/7/9 pay
grade classifications of most MGC Branch full-time positions.
Upon considering all QSVP operational expenses, the LS Program
determined that the actual cost of QSVP services, excluding travel
costs, to be $108 per hour. LS Program management considered employee
salaries and benefits; Agency and LS Program overhead; total revenue
hours available to the ARC Branch; and included other anticipated costs
such as, federally mandated pay raises through FY 2005, rent,
communications, utilities, contractual services, supplies, and
equipment in their analysis.
The LS Program considered alternatives to creating a separate user-
fee for QSVP services, but found that none were sufficient. Maintaining
the same user-fee for QSVP services currently used for conventional
meat grading and certification services would not sufficiently cover
the cost of providing QSVP services. Another option was to terminate
all QSVP services, which would adversely affect producers, businesses,
and consumers who desire QSVP services and those entities with already-
established programs.
The QSVP were administered through the LS Program's MGC Branch
pursuant to 7 CFR part 54 using the user-fee schedule established for
meat grading and certification services. In 2001, the administration of
QSVP was moved by the LS Program to the Audit, Review, and Compliance
(ARC) Branch. This proposed rule would establish a separate user-fee of
$108 per hour for QSVP services under a new part 62. Additionally, this
proposed rule would expand the scope of QSVP services to include all
agricultural products or services within the responsibility of the LS
Program, such as livestock, meat, meat products, seed, feedstuffs, as
well as processes involving the production of these products,
agricultural product data storage, product traceability and
identification. Currently, Part 54 only provides for services dealing
with meat and meat products. A new Part 62 would be established for
QSVP services.
Executive Order 12866
This proposed rule has been determined to be not significant for
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget (OMB).
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. It is not intended to have retroactive effect and
would not preempt or supersede any State or local laws, regulations, or
policies, unless they present an irreconcilable conflict. There are no
administrative procedures that must be exhausted prior to any
[[Page 17612]]
judicial challenge to the provisions of this rule.
Regulatory Flexibility Act
Pursuant to the requirements set forth in the Regulatory
Flexibility Act (RFA)(5 U.S.C. 601 et seq.), the Agricultural Marketing
Service (AMS) has considered the economic effect of this action on
small entities and has determined that this proposed rule will not have
a significant economic impact on a substantial number of small
entities. The purpose of RFA is to fit regulatory actions to the scale
of businesses subject to such actions in order that small businesses
will not be unduly burdened.
AMS, through the LS Program's ARC Branch, provides voluntary
assessment services to approximately 415 businesses, including 152
livestock slaughterers, 72 meat processors, 46 livestock producers
feeders, 135 organic certifying companies, 4 trade associations, and 4
State and Federal entities. Seventy-five percent (i.e., 346) of these
businesses are classified as small entities and generate approximately
65 percent of the ARC Branch's revenue. The Small Business
Administration (SBA) (13 CFR 121.201) defines small agricultural
producers as those having annual receipts of less than $750,000; small
agricultural service firms as those whose annual receipts are less than
$5 million; and small meat packers as those that have less than 500
employees. No entity, small or large, is obligated to use voluntary
QSVP services provided under the authority of AMA.
AMS regularly reviews its user-fee-financed programs to determine
if the fees are adequate to cover the cost of the services provided.
The most recent review determined that the existing hourly rate that
the ARC Branch charges for QSVP services would not generate sufficient
revenues to recover operating costs for current and near-term periods
while maintaining a 4-month operating reserve of $275,000. In FY 2004,
the ARC Branch incurred a $330,000 operating loss; and without a fee
increase, FY 2004 operating losses are projected to reach $421,000.
These combined losses will deplete the ARC Branch's operating reserve
and place the ARC Branch in an unstable financial position that will
adversely affect its ability to provide QSVP services.
While the ARC Branch has utilized existing automated information
management systems for data collection, retrieval, dissemination,
applicant billing, and disbursement of employee entitlements, the ARC
Branch has continued to lose revenue due to the cost of providing QSVP
services utilizing auditors classified at the GS-11/12 pay grade while
charging a user-fee that is based on a lower GS-5/7/9 pay grade
classification.
The ARC Branch operating costs increased as a result of higher
salaries associated with higher grade employees; congressionally
mandated salary increases for all Federal Government employees in 2004
and 2005; ongoing information system technology upgrades necessary to
remain compatible with customer and Agency systems; inflation of non-
salary operating expenses; and office maintenance expenses.
AMS estimates that this proposed action will provide the ARC Branch
with an additional $420,000 for FY 2005. Of this $420,000, small
businesses would pay an average of $878 more per year per applicant or
a total of $273,000 of the total increase. This proposed fee increase
coupled with a projected increase in revenue hours would increase total
revenues by $420,000 per year and offset FY 2004 operating losses of
$330,000. Currently, without a fee increase, the ARC Branch is
projected to lose $420,000 in FY 2005. The proposed increase will
create a 4-month operating reserve of $275,000, as required by the
Agency.
The proposed Part 62 includes sections on definitions; sections
related to providing services, including availability and how to apply
for services; and suspension, denial, or cancellation of service and
other sections relating to fees. These sections are similar to, or the
same as, provisions that currently apply to Quality Systems
Verification Programs.
Paperwork Reduction Act
This proposed rule contains submission and recordkeeping
requirements subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. Chapter 35).
OMB Number: 0581-0124.
Expiration Date: October 31, 2006.
Type of Request: Revision of currently approved collection.
Abstract: The QSVP are voluntary, audit-based programs developed at
the request of the livestock industry and other interested parties as a
cost-effective alternative to conventional product certification. This
proposed rule would permit the LS Program to carry out independent
assessments of applicant's programs for any agricultural product or
service within the scope of the LS Program. This action is necessary to
provide continued, seamless, and efficient distribution of highly
differentiated agricultural products and services to customers who
require production and marketing process assessments by an authorized
government entity. The information collection and recordkeeping
requirements in this proposed rule are essential to maintaining these
voluntary programs. Only authorized representatives of the USDA,
including AMS, LS Program, ARC Branch staff use the collected
information in the performance of their official duties.
The AMA, as amended, authorizes the USDA to provide services that
facilitate the marketing of agricultural products. Currently, the LS
Program provides QSVP services for livestock, meat, and meat products,
pursuant to 7 CFR part 54. This proposed rule would define QSVP
services to include other agricultural products within the scope of the
LS Program in a new part, part 62 to Title 7 of the Code of Federal
Regulations.
Applicants may request QSVP services through submission of the
currently approved form LS-313 to the ARC Branch. This existing form
requires the minimum information necessary to effectively carry out the
requirements of the proposed rule including: firm name, address,
telephone number, and other information necessary to identify the
applicant, and other pertinent information necessary to determine if
the firm is eligible to apply and receive QSVP services. Applicants are
required to complete the form only when initially applying for QSVP
service. There is no annual requirement for resubmission. The form can
be supplied without data processing equipment or outside technical
expertise. AMS estimates the one-time burden for submission of Form LS-
313 to average 0.200 hours (12 minutes) per applicant at $20.00 per
hour. The total one-time burden if 50 applicants applied under this
proposed rule is estimated to be $200.00.
Applicants may obtain form LS-313 by (1) Contacting James L. Riva,
Chief; USDA, AMS, LS, ARC Branch; STOP 0294, Room 2627-S; 1400
Independence Ave., SW., Washington, DC 20250-0294; (2) downloading a
printable version at the ARC Branch Web site: https://www.ams.usda.gov/
lsg/arc/audit.htm; or (3) accessing a Web-based version at the AMS
Electronic Forms Web site: https://151.121.3.189/EManager/new.htm.
Applicants may submit form LS-313 by (1) mail to: James L. Riva,
Chief; USDA, AMS, LS, ARC Branch; STOP 0294, Room 2627-S, 1400
Independence Avenue, SW., Washington, DC 20250-0248; (2) FAX to: (202)
690-1038; or e-mail to: ARCBranch@usda.gov.
[[Page 17613]]
Under this proposed rule, applicants would be required to submit a
cover letter and a complete copy of the applicant's program
documentation when a request for service is made. This is a one-time
requirement per service request. The PRA also requires the agency to
measure the recordkeeping burden. The proposed rule would also require
applicants to retain records and documents necessary to support the
requested service for the period of at least one calendar year
following the year the record was created and long enough to assess
conformance of the product though the applicant's quality management
system. Additionally, applicants must ensure that such records and
documents are readily available and easily accessible. The
recordkeeping burden is the amount of time needed to prepare, store,
and maintain documents.
Based on its experience with QSVP, AMS understands that applicants
develop and maintain complete documentation of their programs as a
normal business practice. AMS believes the cost burden associated with
submission of complete program documentation to be limited to the time
needed for the applicant to review the documentation for completeness
and accuracy. AMS estimates this time to average 24 hours per applicant
at $20.00 per hour for a total one-time burden per applicant of
$480.00. The total one-time burden if 50 applicants applied under this
proposed rule is estimated to be $24,000.
Based on its experience, AMS believes that the documents and
records required to be retained are normally retained by applicants as
part of their normal business practices. However, if record keepers
were compensated for their time, AMS estimates that the time required
for each applicant to retain these records and documents in a manner
required in the proposed rule to average 6 hours per year at $20.00 per
hour for a total annual burden of $120.00 per applicant. Assuming that
50 applicants were retained under this proposed rule, the total annual
burden is estimated to be $6,000.
(1) Application for Service form LS-313.
Estimate of Burden: The proposal to expand the scope of the QSVP to
include all agricultural products and services within the
responsibility of the LS Program will increase the approved burden by
1210 hours. Using the currently approved form LS-313, the public
reporting burden for this proposed collection of information is
estimated to average 0.20 hours (12 minutes) per response.
Respondents: Livestock, meat industry, and other businesses that
produce, process, or handle agricultural products or services.
Estimated Number of Respondents: 50.
Estimated Number of Responses per Respondent: 1.
Estimated Total Number of Responses: 50.
Estimated Total Annual Burden on Respondents: 10.00 hours.
Estimated Total Cost: $200.00.
(2) Review and Submission of Program Documentation.
Estimate of Burden: Public reporting burden for this proposed
collection of information is estimated to average 24 hours per
respondent.
Respondents: Livestock, meat industry, and other businesses that
produce, process or handle agricultural products or services.
Estimated Number of Respondents: 50.
Estimated Number of Responses per Respondent: 1.
Estimated Total Number of Responses: 50.
Estimated Total Annual Burden on Respondents: 1200 hours.
Estimated Total Cost: $24,000.
Comments are invited on: (1) Whether the 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 burden estimate of the 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
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology.
Comments should reference OMB No. 0581-0124, the QSVP, and be sent
to (1) Desk Officer for Agriculture, Office of Information and
Regulatory Affairs, Office of Management and Budget, New Executive
Office Building, 725 17th Street, NW., Room 725, Washington, DC 20503;
or by e-mail to: OIRA--submissions@OMB.eop.gov and (2) James L. Riva,
Chief; USDA, AMS, LS, ARC Branch; STOP 0294, Room 2627-S, 1400
Independence Avenue, SW., Washington, DC 20250-0248; or FAX (202) 690-
1038; or e-mail ARCBranch@usda.gov. A comment to OMB is best assured of
having its full effect if OMB receives it within 30 days of publication
of this proposed rule.
All comments will be posted on the Internet at https://
www.ams.usda.gov/lsg/rulemaking.htm and will be made available for
public inspection in the above offices during regular business hours.
A 30-day comment period is provided for interested persons to
comment on this proposed rule. This comment period is deemed
appropriate in order to implement this rule, if adopted, as soon as
possible so that program costs are covered by revenue.
All responses to this proposed rule will be summarized and included
in the request for OMB approval. All comments will become a matter of
public record.
List of Subjects
7 CFR Part 54
Meats, Prepared meats, and Meat products.
7 CFR Part 62
Food grades and standards, Food labeling, Meat and meat products.
For the reasons set forth in the preamble, it is proposed that
chapter 1 of title 7 of the Code of Federal Regulations be revised by
amending part 54 and adding part 62 to read as follows:
PART 54--[AMENDED]
1. The authority citation for part 54 continues to read as follows:
Authority: 7 U.S.C. 1621-1627.
Sec. 54.4 [Amended]
2. In Sec. 54.4, paragraph (5) is removed.
3. Part 62 is added to read as follows:
PART 62--LIVESTOCK, MEAT, AND OTHER AGRICULTURAL COMMODITIES
(QUALITY SYSTEMS VERIFICATION PROGRAMS)
Subpart A--Quality Systems Verification Programs
Definitions
Sec.
62.000 Meaning of terms.
Administration
62.100 Administrator.
Service
62.200 Services.
62.201 Availability of service.
62.202 How to apply for service.
62.203 How to withdraw service.
62.204 Authority to request service.
62.205 Conflict of interest.
62.206 Access to program documents and activities.
62.207 Official assessment.
62.208 Publication of QSVP assessment status.
62.209 Reassessment.
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62.210 Denial, suspension, or cancellation of service.
62.211 Appeals.
62.212 Official assessment reports.
62.213 Official identification.
Charges for Service
62.300 Fees and other costs for service.
62.301 Payment of fees and other charges.
Miscellaneous
OMB Control Number
62.400 OMB control number assigned pursuant to the Paperwork
Reduction Act.
Subpart B--[Reserved]
Authority: 7 U.S.C. Sec. 1621-1627.
Subpart A--Quality Systems Verification Programs
Definitions
Sec. 62.000 Meaning of terms.
Words used in this Subpart in the singular form shall be deemed to
impart the plural, and vice versa, as the case may demand. For the
purposes of such regulations, unless the context otherwise requires,
the following terms shall be construed, respectively, to mean:
Administrator. The Administrator of the Agricultural Marketing
Service (AMS), or any officer or employee of AMS to whom authority has
heretofore been delegated or to whom authority may hereafter be
delegated, to act in the Administrator's stead.
Agricultural Marketing Service. The Agricultural Marketing Service
of the U.S. Department of Agriculture.
Applicant. Any individual or business with financial interest in
QSVP services who has applied for service under this Part.
Assessment. A systematic review of the adequacy of program or
system documentation, or the review of the completeness of
implementation of a documented program or system.
Auditor. Person authorized by the Livestock and Seed Program to
conduct official assessments.
Branch. The Audit, Review, and Compliance Branch of the Livestock
and Seed Program.
Chief. The Chief of the ARC Branch, or any officer or employee of
the Branch to whom authority has heretofore been delegated, or to whom
authority may hereafter be delegated, to act in the Chief's stead.
Conformance. A user's quality manual and supporting documentation.
Deputy Administrator. The Deputy Administrator of the Livestock and
Seed Program, or any officer or employee of the Livestock and Seed
Program to whom authority has heretofore been delegated, or to whom
authority may hereafter be delegated, to act in the Deputy
Administrator's stead.
Financially interested person. Any individual, partnership,
corporation, other legal entity, or Government agency having a
financial interest in the involved product or service.
Livestock. Bovine, ovine, porcine, caprine, bison or class of
Osteichthyes.
Official mark. Official mark or other official identification means
any form of mark or other identification, used under the regulations to
show the conformance of products with applicable program requirements,
or to maintain the identity of products for which service is provided
under the regulations.
Official memoranda or assessment reports. Official memorandum means
any assessment report of initial or final record of findings made by an
authorized person of services performed pursuant to the regulations.
Products. Includes all agricultural commodities and services within
the scope of the Livestock and Seed Program This includes livestock,
meat, meat products, seed, feedstuffs, as well as processes involving
the production of these products, agricultural product data storage,
product traceability and identification.
QSVP Procedures. Audit rules and guidelines set forth by the
Agricultural Marketing Service regarding the development,
documentation, and implementation of QSVP.
Quality Manual. A collection of documents that describe the
applicant's quality management system, as it applies to the requested
service.
Quality Systems Verification Programs (QSVP). A collection of
voluntary, audit-based, user-fee programs that allow applicants to have
program documentation and program processes assessed by AMS auditor(s)
and other USDA officials under this Part.
Regulations. The regulations in this Part.
USDA. The U.S. Department of Agriculture.
Administration
Sec. 62.100 Administrator.
The LS Program Deputy Administrator is charged with the
administration of official assessments conducted according to the
regulations in this Part and approved LS Program QSVP procedures.
Service
Sec. 62.200 Services.
QSVP, under this regulation, provide applicants, the ability to
have USDA assess documented processes or systems.
(a) Assessment services provided under the regulations shall
consist of:
(1) A review of the adequacy of an applicant's quality manual
against LS Program QSVP procedures, internationally recognized
guidelines, or other requirements as approved by the LS Program;
(2) An onsite assessment of the applicant's program to ensure
implementation of provisions within the quality manual and the
applicant's conformance with applicable program requirements and LS
Program QSVP procedures; and
(3) A reassessment of the applicant's program to ensure continued
implementation of provisions within the quality manual and the
applicant's conformance with program requirements and applicable LS
Program QSVP procedures;
(b) Developmental assistance in the form of training to explain LS
Program QSVP procedures is available upon request.
Sec. 62.201 Availability of service.
QSVP services under these regulations are available to
international and domestic government agencies, private agricultural
businesses and any finically interested person.
Sec. 62.202 How to apply for service.
Applicants may apply for QSVP services by submitting the following
information to the ARC Branch headquarters office at USDA, AMS, LSP,
ARC Branch, 1400 Independence Avenue, SW., STOP 0294, Room 2627-S,
Washington, DC, 20250-0294; by fax to: (202) 690-1038, or e-mail to:
ARCBranch@usda.gov.
(a) The original completed form LS-313, Application for Service;
(b) A letter requesting QSVP services; and
(c) A complete copy of the applicant's program documentation, as
described in the LS Program QSVP procedures.
Sec. 62.203 How to withdraw service.
Service may be withdrawn by the applicant at any time; provided
that, the applicant notifies the ARC Branch in writing of his/her
desire to withdraw the application for service and pays any expenses
the Department has incurred in connection with such application.
Sec. 62.204 Authority to request service.
Any person requesting service may be required to prove his/her
financial interest in the product or service at the discretion of the
Deputy Administrator.
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Sec. 62.205 Conflict of interest.
No USDA official shall review any program documentation or
determine conformance of any documented process or system in which the
USDA official has financial holdings.
Sec. 62.206 Access to program documents and activities.
(a) The applicant shall make its products and program documentation
available and easily accessible for assessment, with respect to the
requested service. Auditors and other USDA officials responsible for
maintaining uniformity and accuracy of service under the regulations
shall have access to all parts of facilities covered by approved
applications for service under the regulations, during normal business
hours or during periods of production, for the purpose of evaluating
products or processes. This includes products in facilities which have
been or are to be examined for program conformance or which bear any
official marks of conformance. This further includes any facilities or
operation that is part of an approved program.
(b) Documentation and records relating to an applicant's program
must be retained for at least one calendar year following the calendar
year during which the record was created.
Sec. 62.207 Official assessment.
Official assessment of an applicant's program shall include:
(a) Documentation assessment. Auditors and other USDA officials
shall review the applicant's program documentation and issue finding of
the review to the applicant.
(b) Program assessment. Auditors and USDA officials shall conduct
an onsite assessment of the applicant's program to ensure provisions of
the applicant's program documentation have been implemented and conform
to LS Program QSVP procedures.
(c) Program Determination. Applicant's determined to meet or not
meet LS Program QSVP procedures or the applicant's program requirements
shall be notified of their program's approval or disapproval.
(d) Corrective and/or preventative actions. Applicants may be
required to implement corrective and/or preventative actions upon
completion of assessment. After implementation of corrective and/or
preventative actions, the applicant may request another assessment.
Sec. 62.208 Publication of QSVP assessment status.
Approved programs shall be posted for public reference on the ARC
Branch Web site: https://www.ams.usda.gov/lsg/arc/audit.htm. Such
postings shall include:
(a) Program name and contact information,
(b) Products or services covered under the scope of approval,
(c) Effective dates of approval, and
(d) Control numbers of official assessments, as appropriate, and
(e) Any other information deemed necessary by the Branch Chief.
Sec. 62.209 Reassessment.
Approved programs are subject to periodic reassessments to ensure
ongoing conformance with the LS Program QSVP procedures covered under
the scope of approval. The frequency of reassessments shall be based on
the LS Program QSVP procedures, or as determined by the Deputy
Administrator.
Sec. 62.210 Denial, suspension, or cancellation of service.
(a) QSVP services may be denied if an applicant fails to meet its
program requirements, or conform to LS Program QSVP procedures, such
as:
(1) Adequately address any program requirement resulting in a major
non-conformance or an accumulation of minor non-conformances that
result in the assignment of a major non-conformance for the program.
(2) Demonstrate capability to meet any program requirement
resulting in a major non-conformance.
(3) Present truthful and accurate information to any auditor or
other USDA official; or
(4) Allow access to facilities and records within the scope of the
program.
(b) QSVP services may be suspended if the applicant fails to meet
its program requirements, or conform to LS Program QSVP procedures;
such as failure to:
(1) Adequately address any program requirement resulting in a major
non-conformance;
(2) Demonstrate capability to meet any program requirement
resulting in a major non-conformance;
(3) Follow and maintain it's approved program or QSVP procedures;
(4) Provide corrective actions and correction as applicable in the
timeframe specified;
(5) Submit significant changes to and seek approval from the Chief
prior to implementation of significant changes to an approved program;
(6) Allow access to facilities and records within the scope of the
approved program;
(7) Accurately represent the eligibility of agricultural products
or services distributed under an approved program;
(8) Remit payment for QSVP services;
(9) Abstain from any fraudulent or deceptive practice in connection
with any application or request for service under the rule; or
(10) Allow any auditor or other USDA official to perform their
duties under the regulations of this Part.
(c) QSVP services maybe be cancelled, an application may be
rejected, or program assessment may be terminated if the Deputy
Administrator or his designee determines that a nonconformance has
remained uncorrected beyond a reasonable amount of time.
Sec. 62.211 Appeals.
Appeals of adverse decisions under this Part, may be made in
writing to the Livestock and Seed Program Deputy Administrator at STOP
0249, Room 2092--South, 1400 Independence Avenue, SW., Washington, DC
20250-0249. Appeals must be made within 30 days of receipt of adverse
decision.
(a) Procedure for Appeals. Actions under this subparagraph
concerning decision of appeals of the Deputy Administrator shall be
conducted in accordance with the Rule of Practice Governing Formal
Adjudicatory Proceedings Instituted by the Secretary Under Various
Statutes set forth at 7 CFR 1.130 through 1.151 and the Supplemental
Rules of Practice in 7 CFR Part 50.
(b) [Reserved]
Sec. 62.212 Official assessment reports.
Official QSVP assessment reports shall be generated by the auditor
at the conclusion of each assessment and a copy shall be provided to
the applicant.
Sec. 62.213 Official identification.
The following, as shown in figure 1, constitutes official
identification to show product or services produced under an approved
USDA, Process Verified Program (PVP):
[GRAPHIC] [TIFF OMITTED] TP07AP05.004
(a) Products or services produced under an approved USDA, PVP may
use the ``USDA Process Verified'' statement and the ``USDA Process
Verified'' shield, so long as, both the statement
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and shield are used in direct association with a clear description of
the process verified points that have been approved by the Branch.
(b) Use of the ``USDA Process Verified'' statement and the ``USDA
Process Verified'' shield shall be approved in writing by Chief prior
to use by an applicant.
Charges for Service
Sec. 62.300 Fees and other costs for service.
Fees and other charges will be levied based on the following
provisions:
(a) Fees for service. Fees for QSVP services shall be based on the
time required to provide service calculated to the nearest quarter hour
period, including, but not limited to, official assessment time, travel
time, and time required to prepare assessment reports. The hourly fee
rate shall be $108 per hour.
(b) Transportation costs. Applicants are responsible for paying
actual travel costs incurred to provide QSVP services including but not
limited to: mileage charges for use of privately owned vehicles, rental
vehicles and gas, parking, tolls, and public transportation costs such
as airfare, train, and taxi service.
(c) Per diem costs. The applicant is responsible for paying per
diem costs incurred to provide QSVP services away from the auditor's or
USDA officials' official duty station(s). Per diem costs shall be
calculated in accordance with existing travel regulations (41 CFR,
subtitle F--Federal Travel Regulation System, chapter 301).
(d) Other costs. When costs, other than those costs specified in
paragraphs (a), (b), and (c) of this section, are involved in providing
the QSVP services, the applicant shall be responsible for these costs.
The amount of these costs shall be determined administratively by the
Chief. However, the applicant will be notified of these costs before
the service is rendered.
Sec. 62.301 Payment of fees and other charges.
Fees and other charges for QSVP services shall be paid in
accordance with the following provisions. Upon receipt of billing for
fees and other charges, the applicant shall remit payment within 10
business days by check, electronic funds transfer, draft, or money
order made payable to USDA, AMS, in accordance with directions on the
billing. Fees and charges shall be paid in advance if required by the
auditor or other authorized USDA official.
Miscellaneous
OMB Control Number
Sec. 62.400 OMB control number assigned pursuant to the Paperwork
Reduction Act.
The information collection and recordkeeping requirements of this
Part have been approved by OMB under 44 U.S.C. Chapter 35 and have been
assigned OMB Control Number 0581-0124.
Subpart B--[Reserved]
Dated: April 4, 2005.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 05-6957 Filed 4-6-05; 8:45 am]
BILLING CODE 3410-02-P