Quality Systems Verification Programs, 58969-58974 [05-20310]
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58969
Rules and Regulations
Federal Register
Vol. 70, No. 195
Tuesday, October 11, 2005
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
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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
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
SUMMARY: The Agricultural Marketing
Service (AMS) is establishing a separate
user-fee schedule for the Quality
Systems Verification Programs (QSVP)
and expanding 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 is 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: Effective October 25, 2005.
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,
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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 fiscal year (FY) 2001,
562 assessments in FY 2002, and 715
assessments in FY 2003, and 915
assessments in FY 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.
QSVP user-fees were previously 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,
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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
rule establishes a separate user-fee of
$108 per hour for QSVP services under
a new part 62. Additionally, this rule
expands 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. A new part 62 is
established for QSVP services.
Executive Order 12866
This 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 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
judicial challenge to the provisions of
this rule.
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Regulatory Flexibility Act and
Paperwork Reduction Act
Pursuant to the requirements set forth
in the Regulatory Flexibility Act
(RFA)(5 U.S.C. 601 et seq.), AMS has
considered the economic effect of this
action on small entities and has
determined that this 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. AMS anticipates that
many new applicants for QSVP will be
classified as small entities. The Small
Business Administration (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 $6 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 hourly rate
previously charged by the ARC Branch
for QSVP services did 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. Losses have depleted the
ARC Branch’s operating reserve and
placed the ARC Branch in an unstable
financial position that could adversely
affected its ability to provide QSVP
services.
While existing automated information
management systems for data collection,
retrieval, dissemination, applicant
billing, and disbursement of employee
entitlements, were utilized, the ARC
Branch 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-
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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; 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 action will provide the ARC
Branch with an additional $576,000 for
FY 2006, offsetting the FY 2005
operating losses of $558,000. This fee
increase will help create a 4-month
operating reserve as required by AMS.
The new 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.
The information collection
requirements that appear in this final
rule have been approved by OMB and
assigned OMB Control Number 0581–
0124. Under this rule, applicants are
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
QSVP also requires 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.
AMS’ estimate for recordkeeping
burden reflects 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. AMS estimates the total onetime burden if 50 applicants applied
under this rule to be $24,000.
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Based on its experience, AMS also
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 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
are retained under this rule, the total
annual burden is estimated to be $6,000.
Comments concerning small business
consideration and the information
collection burden or discussed in the
next section of this document.
Comments
AMS published a proposed rule in the
April 7, 2005, Federal Register [66 FR
17611] for public comment. The
comment period ended on May 9, 2005.
The comment period regarding the
information collection requirements that
would result from this proposal ended
on June 6, 2005. The comments have
been posted on AMS’ Web site at
https://www.ams.usda.gov/lsg/arc/
rule.htm.
Discussion of Comments
USDA received 3 comments from
interested persons, which included two
seed trade organizations and one
interested party. While one of the seed
organizations did not oppose the
proposed rule, the second
recommended an alternative program
that would delegate certification
activities to existing organizations. The
comment from the interested party
opposed the QSVP as a new program
that would enhance the federal deficit.
The commenters raised a number of
concerns including establishing
duplicative or conflicting service for the
seed industry and questioning the fee
analysis itself.
The QSVP is an established program
that began providing service in 1995, as
a voluntary, user-fee funded program,
under the authority of the Agricultural
Marketing Act of 1946. As such,
expanding the scope of the QSVP to
include all agricultural products and
services within the responsibility of the
LS Program will not enhance the federal
deficit. Further, with regard to
expanding program service to the seed
industry, the QSVP will facilitate the
global marketing and trade of not only
seeds and seed products, but all
agricultural products and services under
the LS Program. With regard to the
concerns raised about duplicative and
conflicting service for the seed industry,
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we believe that the QSVP has and will
provide a valuable resource for those
businesses and industries that wish to
use a USDA shield or statement. One
commenter noted that some facilities are
already ISO certified and that this
should be taken into account in the
QSVP procedure. To the extent
appropriate, ISO certification will be
taken into account under QSVP.
One commenter suggested that the
QSVP programs be changed to a
program that would delegate
certification activities to existing
organizations. Also, another commenter
was concerned about the QSVP adding
a layer of complexity in connection with
marketing of seed both domestically and
internationally. The existing QSVP
provides services to primarily the
livestock and meat industries. This final
rule will provide the same services in
the expanded program format, which
includes the seed industry. As such, this
does not represent a significant program
change. Further, individual entities are
free to request QSVP services or not, as
the program is voluntary.
Concerns were raised about certain
aspects of the fee analysis. Two
commenters were of the view that the
$20.00 per hour used to estimate the
costs for the applicant was too low. As
part of the Paperwork Reduction Act
burden estimate, a $20.00 per hour cost
was based upon our experience with
QSVP and is reasonable for purposes of
information collection burden estimates.
The $20.00 cost is separate and distinct
from the $108.00 per hour fee. The
commenters also noted that the
methodology concerning the $108.00
per hour fee is sound, but that nonsalary expenses were three times the
expense for salaries. The charge of
$108.00 per hour reflects the rate
necessary to recover the costs of
administering the QSVP. AMS
considered numerous factors in
developing the rate to charge to provide
services. AMS and 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, rent,
communications, utilities, contractual
services, supplies, and equipment in
their analysis.
Finally, one commenter questioned
the salaries of the employees used in the
program. This commenter also disagreed
that the rule will not have a significant
economic impact on small companies.
AMS estimates that this action will
provide an additional $420,000 for FY
2005. Of the $420,000, small businesses
would pay an average of $878.00 more
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per year per applicant. A similar result
is expected for new applicants who
would be considered small businesses.
Further, no entity, small or large, is
obligated to use voluntary QSVP
services provided under the authority of
the AMA. Accordingly, we disagree
with this comment.
Another commenter questioned the
size of businesses with 5,000
employees, noting that such entities
should be considered large businesses.
Under Small Business Administration
criteria, certain entities with less than
500 employees are considered small
businesses.
No changes to the regulation will be
made as a result of the comments
received. However, AMS will continue
to work with the existing trade
organizations and their respective
industries regarding implementation of
this and any future rulemakings.
Pursuant to 5 U.S.C. 533, it is found
and determined that good cause exists
for not postponing the effective date of
this action until 30 days after
publication in the Federal Register. The
fees should be implemented as soon as
possible to avoid further financial losses
for the program. Given the current status
of this program, our effective date of two
weeks after publication in the Federal
Register is reasonable.
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.
I For the reasons set forth in the
preamble, chapter 1 of title 7 of the
Code of Federal Regulations is amended
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:
I
Authority: 7 U.S.C. 1621–1627.
§ 54.4
I
I
[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.
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58971
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.
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.
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
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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.
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§ 62.203
Administration
§ 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
§ 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.
§ 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.
§ 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 2627S, 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.
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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
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.
§ 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.
§ 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
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§ 62.208
status.
Publication of QSVP assessment
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.
§ 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.
§ 62.211
§ 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;
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(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.
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, D.C. 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):
Figure 1.
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
(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
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.
E:\FR\FM\11OCR1.SGM
11OCR1
ER11OC05.174
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.
58973
58974
Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 / Rules and Regulations
§ 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
§ 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.
Dated: October 4, 2005.
Lloyd C. Day,
Administrator, Agricultural Marketing
Service.
[FR Doc. 05–20310 Filed 10–7–05; 8:45 am]
BILLING CODE 3410–02–P
provisions of the Small Business Act
including the Consolidated
Appropriations Act, 2005, specifically,
Subtitle E of Division K entitled the
Small Business Reauthorization and
Manufacturing Assistance Act of 2004.
Need for Correction
Since publication, SBA has
discovered that this interim rule
inadvertently stated SBA’s intent to
revise § 126.306 (found at 70 FR 51250)
when it should have cited specifically to
§ 126.306(a). SBA intended to revise
only subsection (a) leaving the other
subsections unchanged.
List of Subjects in 13 CFR Part 126
Administrative practice and
procedure, Government procurement,
Small businesses.
I Accordingly, 13 CFR part 126 is
corrected by making the following
correcting amendments:
PART 126—HUBZONE PROGRAM
1. The authority citation for part 126
continues to read as follows:
I
Authority: 15 U.S.C. 632(a), 632(j), 632(p)
and 657a.
2. Revise the first and last sentences
of § 126.306(a) as follows:
I
§ 126.306 How will SBA process this
certification?
SMALL BUSINESS ADMINISTRATION
13 CFR Part 126
RIN 3245–AF31
HUBZone Program; Corrections
Dated: September 30, 2005.
Allegra McCullough,
Associate Deputy Administrator/Office of
Government Contracting and Business
Development.
[FR Doc. 05–20188 Filed 10–7–05; 8:45 am]
U.S. Small Business
Administration (SBA).
ACTION: Correcting amendments.
AGENCY:
SUMMARY: The U.S. Small Business
Administration (SBA) is correcting an
improper citation within the interim
rule that appeared in the Federal
Register on August 30, 2005, which
amends SBA’s HUBZone program
regulations.
DATES: Effective October 11, 2005.
FOR FURTHER INFORMATION CONTACT:
Michael McHale, Associate
Administrator, HUBZone Program, at
(202) 205–6731 or by e-mail at:
michael.mchale@sba.gov.
SUPPLEMENTARY INFORMATION:
BILLING CODE 8025–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 310 and 341
[Docket No. 2004N–0289]
RIN 0910–AF34
Background
On August 30, 2005, at 79 FR 51243,
the SBA published an interim final rule
amending SBA’s HUBZone, 8(a)
Business Development, Government
Contracting and Size Standard
regulations. This rule implemented
VerDate Aug<31>2005
11:46 Oct 07, 2005
Jkt 208001
(a) The AA/HUB or designee is
authorized to approve or decline
certifications. * * * The decision of the
AA/HUB or designee is the final agency
decision.
*
*
*
*
*
Cold, Cough, Allergy, Bronchodilator,
and Antiasthmatic Drug Products for
Over-the-Counter Human Use;
Amendment of Final Monograph for
Over-the-Counter Nasal Decongestant
Drug Products
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
final monograph (FM) for over-thecounter (OTC) nasal decongestant drug
products (drug products used to relieve
nasal congestion due to a cold, hay
fever, or other upper respiratory
allergies) to remove the indication ‘‘for
the temporary relief of nasal congestion
associated with sinusitis’’ and to
prohibit use of the terms ‘‘sinusitis’’ and
‘‘associated with sinusitis’’ elsewhere
on the labeling. This final rule is part of
FDA’s ongoing review of OTC drug
products.
DATES: Effective Date: This regulation is
effective April 11, 2007.
Compliance Dates: The compliance
date for products with annual sales less
than $25,000 is October 11, 2007. The
compliance date for all other products is
April 11, 2007.
FOR FURTHER INFORMATION CONTACT:
Michael T. Benson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Silver Spring,
MD 20993, 301–796–2090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 2,
2004 (69 FR 46119), FDA published a
proposed rule to amend the FM for OTC
nasal decongestant drug products to
remove the indication ‘‘for the
temporary relief of nasal congestion
associated with sinusitis’’ and to
prohibit use of the terms ‘‘sinusitis’’ and
‘‘associated with sinusitis’’ elsewhere
on the labeling. Recent publications
(Refs. 1 and 2) indicate that prospective
studies on the role of nasal
decongestants in the treatment of
sinusitis are lacking, and the data on
their use as an adjunct in the treatment
of sinusitis are limited and
controversial. Despite the lack of
evidence for their use, nasal
decongestants are recommended or
prescribed by health care providers as
adjunctive therapy for sinusitis. This
treatment occurs within a physicianpatient relationship and should not be
construed as evidence that consumers
should self-diagnose and self-manage
sinusitis. In addition, there is
preclinical evidence that topical nasal
decongestants may have a negative
effect on the resolution of sinusitis, as
they may increase the degree of sinus
inflammation (Ref. 3). Due to the current
labeling, FDA is concerned that
consumers use OTC nasal decongestant
drug products (both oral and topical) to
treat symptoms associated with
E:\FR\FM\11OCR1.SGM
11OCR1
Agencies
[Federal Register Volume 70, Number 195 (Tuesday, October 11, 2005)]
[Rules and Regulations]
[Pages 58969-58974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20310]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 70, No. 195 / Tuesday, October 11, 2005 /
Rules and Regulations
[[Page 58969]]
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: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Agricultural Marketing Service (AMS) is establishing a
separate user-fee schedule for the Quality Systems Verification
Programs (QSVP) and expanding 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 is 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: Effective October 25, 2005.
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
fiscal year (FY) 2001, 562 assessments in FY 2002, and 715 assessments
in FY 2003, and 915 assessments in FY 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.
QSVP user-fees were previously 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 rule establishes a separate user-fee of $108 per
hour for QSVP services under a new part 62. Additionally, this rule
expands 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. A new part 62 is
established for QSVP services.
Executive Order 12866
This 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 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 judicial
challenge to the provisions of this rule.
[[Page 58970]]
Regulatory Flexibility Act and Paperwork Reduction Act
Pursuant to the requirements set forth in the Regulatory
Flexibility Act (RFA)(5 U.S.C. 601 et seq.), AMS has considered the
economic effect of this action on small entities and has determined
that this 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. AMS anticipates that many new
applicants for QSVP will be classified as small entities. The Small
Business Administration (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
$6 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 hourly rate previously
charged by the ARC Branch for QSVP services did 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. Losses have depleted
the ARC Branch's operating reserve and placed the ARC Branch in an
unstable financial position that could adversely affected its ability
to provide QSVP services.
While existing automated information management systems for data
collection, retrieval, dissemination, applicant billing, and
disbursement of employee entitlements, were utilized, the ARC Branch
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; 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
action will provide the ARC Branch with an additional $576,000 for FY
2006, offsetting the FY 2005 operating losses of $558,000. This fee
increase will help create a 4-month operating reserve as required by
AMS.
The new 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.
The information collection requirements that appear in this final
rule have been approved by OMB and assigned OMB Control Number 0581-
0124. Under this rule, applicants are 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 QSVP also requires 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.
AMS' estimate for recordkeeping burden reflects 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. AMS
estimates the total one-time burden if 50 applicants applied under this
rule to be $24,000.
Based on its experience, AMS also 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 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 are retained under this rule, the total annual burden is
estimated to be $6,000.
Comments concerning small business consideration and the
information collection burden or discussed in the next section of this
document.
Comments
AMS published a proposed rule in the April 7, 2005, Federal
Register [66 FR 17611] for public comment. The comment period ended on
May 9, 2005. The comment period regarding the information collection
requirements that would result from this proposal ended on June 6,
2005. The comments have been posted on AMS' Web site at https://
www.ams.usda.gov/lsg/arc/rule.htm.
Discussion of Comments
USDA received 3 comments from interested persons, which included
two seed trade organizations and one interested party. While one of the
seed organizations did not oppose the proposed rule, the second
recommended an alternative program that would delegate certification
activities to existing organizations. The comment from the interested
party opposed the QSVP as a new program that would enhance the federal
deficit. The commenters raised a number of concerns including
establishing duplicative or conflicting service for the seed industry
and questioning the fee analysis itself.
The QSVP is an established program that began providing service in
1995, as a voluntary, user-fee funded program, under the authority of
the Agricultural Marketing Act of 1946. As such, expanding the scope of
the QSVP to include all agricultural products and services within the
responsibility of the LS Program will not enhance the federal deficit.
Further, with regard to expanding program service to the seed industry,
the QSVP will facilitate the global marketing and trade of not only
seeds and seed products, but all agricultural products and services
under the LS Program. With regard to the concerns raised about
duplicative and conflicting service for the seed industry,
[[Page 58971]]
we believe that the QSVP has and will provide a valuable resource for
those businesses and industries that wish to use a USDA shield or
statement. One commenter noted that some facilities are already ISO
certified and that this should be taken into account in the QSVP
procedure. To the extent appropriate, ISO certification will be taken
into account under QSVP.
One commenter suggested that the QSVP programs be changed to a
program that would delegate certification activities to existing
organizations. Also, another commenter was concerned about the QSVP
adding a layer of complexity in connection with marketing of seed both
domestically and internationally. The existing QSVP provides services
to primarily the livestock and meat industries. This final rule will
provide the same services in the expanded program format, which
includes the seed industry. As such, this does not represent a
significant program change. Further, individual entities are free to
request QSVP services or not, as the program is voluntary.
Concerns were raised about certain aspects of the fee analysis. Two
commenters were of the view that the $20.00 per hour used to estimate
the costs for the applicant was too low. As part of the Paperwork
Reduction Act burden estimate, a $20.00 per hour cost was based upon
our experience with QSVP and is reasonable for purposes of information
collection burden estimates. The $20.00 cost is separate and distinct
from the $108.00 per hour fee. The commenters also noted that the
methodology concerning the $108.00 per hour fee is sound, but that non-
salary expenses were three times the expense for salaries. The charge
of $108.00 per hour reflects the rate necessary to recover the costs of
administering the QSVP. AMS considered numerous factors in developing
the rate to charge to provide services. AMS and 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, rent,
communications, utilities, contractual services, supplies, and
equipment in their analysis.
Finally, one commenter questioned the salaries of the employees
used in the program. This commenter also disagreed that the rule will
not have a significant economic impact on small companies. AMS
estimates that this action will provide an additional $420,000 for FY
2005. Of the $420,000, small businesses would pay an average of $878.00
more per year per applicant. A similar result is expected for new
applicants who would be considered small businesses. Further, no
entity, small or large, is obligated to use voluntary QSVP services
provided under the authority of the AMA. Accordingly, we disagree with
this comment.
Another commenter questioned the size of businesses with 5,000
employees, noting that such entities should be considered large
businesses. Under Small Business Administration criteria, certain
entities with less than 500 employees are considered small businesses.
No changes to the regulation will be made as a result of the
comments received. However, AMS will continue to work with the existing
trade organizations and their respective industries regarding
implementation of this and any future rulemakings.
Pursuant to 5 U.S.C. 533, it is found and determined that good
cause exists for not postponing the effective date of this action until
30 days after publication in the Federal Register. The fees should be
implemented as soon as possible to avoid further financial losses for
the program. Given the current status of this program, our effective
date of two weeks after publication in the Federal Register is
reasonable.
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.
0
For the reasons set forth in the preamble, chapter 1 of title 7 of the
Code of Federal Regulations is amended by amending part 54 and adding
part 62 to read as follows:
PART 54--[AMENDED]
0
1. The authority citation for part 54 continues to read as follows:
Authority: 7 U.S.C. 1621-1627.
Sec. 54.4 [Amended]
0
2. In Sec. 54.4, paragraph (5) is removed.
0
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.
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.
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
[[Page 58972]]
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.
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
[[Page 58973]]
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, D.C.
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 Sec. 1.130 through Sec. 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):
Figure 1.
[GRAPHIC] [TIFF OMITTED] TR11OC05.174
(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 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.
[[Page 58974]]
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.
Dated: October 4, 2005.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. 05-20310 Filed 10-7-05; 8:45 am]
BILLING CODE 3410-02-P