Performance audit, State Agricultural Laboratory

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PERFORMANCE AUDIT
B STATE AGRICULTURAL LABORATORY
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Report to the Arizona Legislature
Prepared by Arthur Young & Company
For the Auditor General
October 1984
8
DOUGLAS R. NORTON. CPA
AUDITOR GENERAL
STATE OF ARIZONA
OFFICE OF THE
AUDITOR GENERAL
October 30, 1984
Members of the Arizona Legi sl ature
The Honorable Bruce Babbitt, Governor
Dr. Ivan J. Shields, Director
Arizona Commi ssion of Agri cul ture and Horticul ture
Transmitted herewith i s a report prepared for the Auditor General by
Arthur Young & Company, A Performance Audit of the State Agricultural
Laboratory. An April 27, 1983, resolution of the Joint Legislative
Oversight Committee authorized the Auditor General to conduct the
performance audit as a part of the Sunset Review set forth in A. R. S.
§ § 41- 2351 through 41 - 2379.
This performance audit report is submitted to the Arizona State
Legislature for use i n determining whether to continue the State
Agricul tural Laboratory beyond i t s schedul ed termination date of
July 1, 1986. The report makes recommendations to improve the accuracy of
1 aboratory reports, recommends el iminating the certification of privately
owned 1 aboratories serving agricul ture, and addresses needed changes in
both statutes and agency regulations.
The Arthur Young project staff, my own staff and I will be pleased to
discuss or clarify items in the report.
Respectfully submitted,
~ ouglh! s R. Norton L
Auditor General
Encl osure
1 1 1 WEST MONROE SUITE 600 PHOENIX. ARIZONA - 003 ( 602) 255- 4385
EXECUTIVE SUMMARY
The State Agricultural Laboratory is a division of the Arizona
Commission of Agriculture and Horticulture. It provides the
agricultural identification and testing services which support
regulatory monitoring programs administered by other agencies for
the protection of public health, livestock and the agricultural
economy. The State Agricultural Laboratory administers the
certification of laboratories providing agricultural laboratory
services.
The State Agricultural Laboratory was established by the laws of
1980, Chapter 152, House Bill 2281 and operates under the author-ity
of ARS Title 3, Chapter 1, Article 4.
We believe the State Agricultural Laboratory serves the public
interest and that its operation should be continued. However, the
performance audit identified a number of findings which should
be addressed by the Legislature, the Commission of Agriculture and
Horticulture ( the Commission) and/ or the State Agricultural
Laboratory ( the Agency).
The lack of documented policies and an effective quality
assurance program may be affecting the reliability of test
results in the Analytical Section.
The certification of laboratories providing agricultural
testing services may no longer be necessary.
(*) If the laboratory certification program is continued,
administration should be improved and the program costs
recovered through higher fees.
(*) Regulations have not been published and the draft regula-tions
should be revised before publication if the certi-fication
program is continued.
( * The Agency may not be providing all of the mandated services.
( * The statutes are not clear with regard to the reporting
of test results by private laboratories.
Two Arizona agencies are currently authorized by statute to
provide certification of laboratories to provide agricul-tural
laboratory services.
Following is a brief summary of each finding:
A. The lack of documented policies and an effective quality
assurance program may be affecting the reliability of test
results in the Analytical Section. ( See Finding I, pages
19- 25. )
The lack of written policies and a formal documented quality
assurance program raises questions about the reliability of
testing services provided by the Analytical Section. A review
of 409 official reports disclosed 29 reports with obvious
indications of probable discrepancies. A detailed examination
of these 29 reports resulted in the identification of 16
separate problems which currently exist, including the report-ing
of erroneous or misleading test results. These problems
exist primarily because management policies are not written
and enforced, and a formal documented quality assurance
program is not in place. We recommend that both be accomp-lished.
* All or portions of these findings are irrelevant if the legisla-ture
determines that the laboratory certification program is no
longer necessary.
B. The certification of laboratories providing agricultural
testing services may no longer be necessary. ( See Finding 11,
pages 26- 35.)
Certification offers the opportunity to verify that a labora-tory
is capable of providing the service desired. The issue
is whether or not the provision of this assurance is still
necessary, i. e., ( 1) will harm occur if the laboratory's
ability to perform the service is not certified and ( 2) can
the users properly evaluate the qualifications of those offer-ing
the service?
There are three types of agricultural laboratory- customer
relationships which may require certification:
A private laboratory serving the private sector
A private laboratory serving a government agency
A government laboratory serving another government agency
Under the present circumstances of private agricultural labora-tories
serving the private sector, other programs provide
protection of public health, livestock and the agricultural
economy. These include the U. S. Department of Health Grade A
Pasteurized Milk Ordinance administered by the Dairy Com-missioner
and the Feed, Fertilizer and Pesticide laws adminis-tered
by the State Chemist. Because these laws provide
controls other than certification, we believe that private
enterprise has sufficient incentive to continue appropriate
testing without the laboratory certification program.
In the case of a private laboratory providing services to a
government agency, presumably procurement of these services
would be established by contract. Requirements to demonstrate
proficiency should be included in the provisions of the
contract. Thus, a general certification program is not
necessary unless all agencies must apply uniform rules to
demonstrations of proficiency. The same would be true for
interagency agreements in the case of one government laboratory
serving another government agency. The interagency agreement
takes the place of the contract unless the relationship is
directed by statute.
Therefore, it appears that certification of laboratories
to provide agricultural testing services could be
discontinued and the respective statutes terminated.
C. If the laboratory certification program is continued, admin-istration
should be improved and the program costs recovered
through higher fees. ( See Finding 111, pages 36- 42.)
1. Certification Program Effective Administration
Administration of the certified laboratories program is
minimal and consists primarily of:
Processing the initial application, including an
on- site inspection and demonstration of proficiency.
Processing the annual renewal of certificates.
Handling problems on an exception basis when brought
to the attention of the Assistant Director.
Occasional splitting of samples with a laboratory to
compare results.
Receiving, reviewing and filing of certified aflatoxin
test results from the certified laboratories and check
sample program results.
While this may satisfy the literal statutory requirements,
we do not believe the statutes' intent is satisfied. In
our opinion, the present administration of the certifica-tion
program does not provide reasonable assurance that
the certified laboratories continually provide accurate
and timely results. Without more effective administra-tion,
the program exists in form but lacks substance.
2. Recoverv of Program Costs
All cottonseed products must be tested for aflatoxin by a
certified laboratory. Since private laboratories derive
economic benefit by becoming certified, the certified
laboratories should bear the cost of an effective program.
The statutory fee limits of $ 200 for initial certification
and $ 100 for renewals are insufficient to recover the
costs. The fee proposed by the draft regulation is $ 10.
Our estimate of the annual cost of a more effectively
administered certification program is $ 935 per laboratory.
More effective administration of the laboratory certification
program and increased fees to recover the costs are recommended
if the certification program is continued.
D. Regulations have not been published and the draft regulations
should be revised before publication if the certification
program is continued. ( See Finding IV, pages 43- 49.)
Promulgation of regulations for the laboratory certification
program is the responsibility of the Commission. Regulations
have not been published.
The current draft ( January 1982) regulations are incon-sistent
regarding who has authority to grant or renew a certi-ficate,
i. e., the Commission ( according to the statutes) or the
Assistant Director ( according to the regulations).
Additionally, the draft regulations should be revised to
clarify provisions for application and certification of
samplers and authority for more effective certification
program administration.
We recommend that appropriate revisions be made to the draft
regulations and that publication be aggressively pursued.
E. The Agency may not be providing all of the mandated services.
( See Finding V, pages 50- 57.)
Milk Testing
The definition of agricultural laboratory services pro-vided
in ARS $ 3- 141 appears to include ( the testing of)
milk for residue and nutrient analysis since it is within
the scope of a " raw, processed or manufactured agricul-tural
commodity and product." However, the legislative
intent is not clear. Milk testing is being provided by
the Department of Health Services. We have been advised
by the Agency that they are presently precluded from
providing this service due to resource limitations,
including space, equipment and personnel.
2. Meat Testing
Meat testing is administered by the Agency but the actual
testing is conducted by the U. S. Department of Agriculture
( USDA) laboratory in San Francisco. The USDA funds half
of the cost. However, turnaround time is longer than
would be required locally since the samples are sent to
San Francisco. State Agricultural Laboratory management
has told us they have the capability and have assisted
with meat testing in the past. A study should be con-ducted
to determine the feasibility of performing the meat
testing locally, particularly if the USDA will continue to
fund half of the cost.
3. Laboratory Certification
In accordance with ARS $ 3- 145, all laboratories which
provide agricultural testing services to agencies or
departments of the state require certification by the
Agency. The State Seed Laboratory and the Department of
Health Services laboratory provide such services, but are
not certified by the Agency.
4. Sam~ ler Certification
The Agency has interpreted the statutory authority to
certify laboratories to include the certification of
samplers. It is not clear, however, whether certification
of samplers should be restricted to the private sector
only, which is the present practice, or should include
state agency employees who collect agricultural samples.
We recommend that the above services be evaluated and brought
into compliance with the mandatory provisions of the statutes
or otherwise be clarified.
F. The statutes are not clear with regard to the reporting
of test results by private laboratories. ( See Finding VI
Dage 58. )
ARS $ 3- 145. C states " A certified laboratory shall report test
results only to the party who provided the original sample."
Certified laboratories which currently provide the Agency with
copies of private sector results of aflatoxin tests are
clearly in violation of this particular statute. However, in
an opinion from the Arizona Legislative Council, the labora-tories
may not be in violation of state law by reason of an
apparent conflict among several statutes. Rephrasing of ARS
$ 3- 145. C is recommended.
G. Two Arizona agencies are currently authorized by statute to
provide certification of laboratories to provide agricultural
laboratory services. ( See Finding VII, page 59.)
It appears that both the Commission and the Department of
Health Services ( DHS) have statutory authority to grant
certification to laboratories for agricultural laboratory
services. This leads to confusion for the applicant and gives
rise to potential conflict between the two agencies. We
recommend the legislature consider a revision to the DHS
statutes to remove the authority to certify laboratories for
the provision of agricultural laboratory services.
TABLE OF CONTENTS
INTRODUCTION AND BACKGROUND
SUNSET FACTORS
Page
1
9
FINDING I: THE LACK OF DOCUMENTED POLICIES AND AN
EFFECTIVE QUALITY ASSURANCE PROGRAM MAY BE AFFECTING
THE RELIABILITY OF TEST RESULTS IN THE ANALYTICAL SECTION 21
FINDING 11: THE CERTIFICATION OF LABORATORIES PROVIDING
AGRICULTURAL TESTING SERVICES MAY NO LONGER BE NECESSARY 29
FINDING 111: IF THE LABORATORY CERTIFICATION PROGRAM IS
CONTINUED, ADMINISTRATION SHOULD BE IMPROVED AND THE
PROGRAM COSTS RECOVERED THROUGH HIGHER FEES 39
FINDING IV: REGULATIONS HAVE NOT BEEN PUBLISHED AND THE
DRAFT REGULATIONS SHOULD BE REVISED BEFORE PUBLICATION
IF THE CERTIFICATION PROGRAM IS CONTINUED 47
FINDING V: THE AGENCY MAY NOT BE PROVIDING ALL OF
THE MANDATED SERVICES
FINDING VI: THE STATUTES ARE NOT CLEAR WITH REGARD
TO THE REPORTING OF TEST RESULTS BY PRIVATE LABORATORIES 63
FINDING VII: TWO ARIZONA AGENCIES ARE CURRENTLY
AUTHORIZED BY STATUTE TO PROVIDE CERTIFICATION OF
LABORATORIES TO PROVIDE AGRICULTURAL LABORATORY SERVICES 65
OTHER PERTINENT INFORMATION
AGENCY RESPONSE
APPENDIX
Legislative Council Opinions A- I
TABLE OF CONTENTS
LIST OF TABLES AND EXHIBITS
e
Page
Table 1 - State Agricultural Laboratory Operating Budgets,
Fiscal Years 1980- 1981 through 1984- 1985 6
@
Table 2 - State Agricultural Laboratory Analysis Volumes,
Fiscal Years 1980- 1981 through 1984- 1985 7
Exhibit A - Estimated Annual Cost per Laboratory for
Certification
INTRODUCTION AND BACKGROUND
Arthur Young & Company has completed a performance audit of the
State Agricultural Laboratory for the Office of the Auditor
General. This performance audit was conducted during the period
of May through September 1984. The information, findings and
recommendations presented in this report are based on the program
and operational status at the time of the audit review.
A. The Need for Testing Services
The issue of pesticides and pesticide contamination is
significant. Most have proven harmful to human health.
They are increasing in use and more dangerous ones are being
developed and used; the problem is expanding. The potential
harm to human health and the economy is already proven.
Timely testing is essential both in the identification of
diseases and in preventing their spread. The effect on the
economy or human health could be disastrous. The spread of
a disease in livestock could eradicate the herd. For example,
if brucellosis testing was not performed, the disease would
not be controlled, resulting in a reduction in the calf crop.
Additionally, the disease can be transmitted to humans.
While not usually fatal to humans, it can be debilitating,
resulting in undulating fever, weight loss and other symp-toms.
The disease is controlled through the brucellosis
monitoring program supported by testing.
The potential threats of aflatoxin in milk, brucellosis in
livestock, infestation by the mediterranean fruit fly and the
hazards of EDB are all generally recognized problems in
Arizona which require the support of analytical laboratory
services to control.
B. Background and General Description
The State Agricultural Laboratory ( the Agency) is a division
of the Arizona Commission of Agriculture and Horticulture ( the
Commission). It provides the agricultural identification and
testing services which support regulatory monitoring programs
administered by other agencies for the protection of public
health, livestock and the agricultural economy. The State
Agricultural Laboratory also administers the certification of
laboratories providing agricultural laboratory services.
The State Agricultural Laboratory was established by the laws
of 1980, Chapter 152, House Bill 2281 and operates under the
authority of ARS Title 3, Chapter 1, Article 4. The directed
effective date was January 1981. Laboratories of the Agricul-ture
and Horticulture Commission, State Chemist and Livestock
Sanitary Board were combined to create the State Agricultural
Laboratory. The objectives were twofold:
1. To consolidate laboratory activities related to agricul-ture,
and
2. To provide certification to laboratories providing agri-cultural'laboratory
services. ( At that time, a specific
problem existed relative to the accurate analysis of
aflatoxin in cottonseed.)
The State Agricultural Laboratory is basically a service
agency. House Bill 2281 mandated that the Laboratory be
created to provide services to specific agencies:
1. Chief Veterinary Meat Inspector
2. The Board of Pesticide Control
3. The Livestock Sanitary Board
4. The Office of the State Chemist
5. The Commission of Agriculture and Horticulture
The Agency may c o n t r a c t with any o t h e r agency o r p r i v a t e
s e c t o r l a b o r a t o r y t o p r o v i d e l a b o r a t o r y s e r v i c e s f o r t h e
p r o t e c t i o n of t h e a g r i c u l t u r a l community and t h e p u b l i c
h e a l t h . The Agency a l s o has one r e g u l a t o r y f u n c t i o n : I t
recommends c e r t i f i c a t i o n and e n f o r c e s r e g u l a t i o n of a l l
l a b o r a t o r i e s which o f f e r guaranteed a n a l y s i s s e r v i c e s f o r
a g r i c u l t u r a l a c t i v i t i e s .
The S t a t e A g r i c u l t u r a l Laboratory p r o v i d e s s e r v i c e s l a r g e l y t o
t h o s e f i v e a g e n c i e s which are mandated by l a w . S e r v i c e s are
a l s o provided t o t h e S t r u c t u r a l P e s t C o n t r o l Board. More
l i m i t e d a n a l y t i c a l s e r v i c e s are provided t o s e v e r a l o t h e r
s t a t e a g e n c i e s , l o c a l governments and I n d i a n t r i b e s .
The S t a t e A g r i c u l t u r a l Laboratory c e r t i f i e s a l l l a b o r a t o r i e s
which o f f e r guaranteed a n a l y s e s of a g r i c u l t u r a l p r o d u c t s . For
a l l p r a c t i c a l p u r p o s e s , t h i s means l a b o r a t o r i e s o f f e r i n g
a f l a t o x i n t e s t i n g . A f l a t o x i n is a c a r c i n o g e n which o c c u r s i n
c o t t o n s e e d p r o d u c t s . Because a f l a t o x i n has been a problem i n
Arizona, a l l c o t t o n s e e d p r o d u c t s must have a c e r t i f i c a t e
i s s u e d by a c e r t i f i e d l a b o r a t o r y a t t h e t i m e t h e y are s o l d .
The Agency c e r t i f i e s t h e a b i l i t y of t h e s e l a b o r a t o r i e s t o
conduct a c c u r a t e a n a l y s e s f o r a f l a t o x i n .
In a d d i t i o n t o c e r t i f y i n g p r i v a t e l a b o r a t o r i e s , t h e S t a t e
A g r i c u l t u r a l Laboratory a l s o c e r t i f i e s s a m p l e r s . These
samplers a r e p e r s o n s who t a k e samples f o r l a b o r a t o r y a n a l y s i s .
To become a c e r t i f i e d s a m p l e r , o n e must apply t o t h e S t a t e
A g r i c u l t u r a l L a b o r a t o r y , which w i l l t h e n send a s a m p l e r ' s test
and t h e r u l e s and r e g u l a t i o n s on a f l a t o x i n . T h i s is essen-t
i a l l y an open book test, but it is b e l i e v e d t h a t i t a t least
p r o v i d e s some a s s u r a n c e t h a t s a m p l e r s have seen and a r e aware
of t h e r e g u l a t i o n s governing a f l a t o x i n , and t h a t an a p p r o p r i a t e
sample f o r t e s t i n g purposes w i l l b e t a k e n .
C. Organization and Administration
The State Agricultural Laboratory is a division of the Commis-sion
of Agriculture and Horticulture. The Assistant Director
of the Laboratory is the State Chemist. He serves half- time
in this capacity, as does the Executive Secretary. The State
Chemist also has responsibility for regulating the quality of
feed, fertilizers and pesticides. In this role he is a major
user of the agricultural laboratory.
The State Agricultural Labopatopy has two major divisions, the
Analytical Section and the Biological Section.
The Analytical Section does all chemical analyses. These
analyses include formulation testing ( label claim) of
fertilizers, pesticides and animal feeds, and testing for
pesticide and mycotoxin residues including aflatoxin. In this
capacity the State Agricultural Laboratory ensures that
products for agriculture and for consumers are in fact what
they are claimed to be. The section has a total of eight
employees:
One Section Manager ( Chemist)
Two Service Supervisors ( Chemists)
Two Analytical Chemists
Two Laboratory Technicians
One Secretary
The Biological Section conducts testing on plants, entomology
and animal samples. Basically this section identifies
insects, analyzes plant tissues and analyzes samples drawn
from animals, such as blood samples for brucellosis or anti-biotic
content. The section has a total of six employees:
One Section Manager ( Systematic Entomologist)
One Service Manager ( Systematic Entomologist)
Two Laboratory Technicians
One Typist
One Plant Pathologist ( Approved in FY 84- 85 budget)
In addition, the Biological Section has two federally funded
positions in the Animal Disease Laboratory. The Section Manager
also has responsibility for coordinating seed and meat testing.
The laboratory administration ( the State Chemist/ Assistant
Director) and Analytical Section are located at the University of
Arizona experimental farm at Main and Longmore in Mesa. Labora-tory
facilities at this location occupy the west wing of the
main building. The Biological Section is located at the
Agriculture and Horticulture Building in Phoenix at 1688 West
Adams.
D. Operating Budget
The State Agricultural Laboratory operating budget is appro-priated
from the general fund. A five- year summary of the
budget is provided in the following table:
FTEs
Table 1
State Agricultural Laboratory Operating Budget
80- 81 81- 82 82- 83 83- 84 84- 85
Actual Actual Actual Estimate Budget
Personnel Services $ 90,800 $ 292,400 $ 259,200 $ 261,500 $ 300,900 a
Employee Related
Expenses 17,600 63,000 51,100 54,400 71,900
Professional and
Outside 26,400 43,000 78,100'~) 41,200 27,900
Travel: In- State 1,100 3,800 3,800 3,800 9,000
Travel : Out- of- State 1,400 3,100 3,100 3,100 3,100
OOE 22,700 71,800 64,700 64,700 64,300
Equipment 17,700 82,600 61,900 41,600 41,60- 0
Totals $ 177.700 $ 559,700 $ 521.900 $ 470.300 $ 518,70-= 0
( 1) Laboratory began operation in present form in January 1981.
Amounts reflect what was transferred in as of January 8, 1981.
( 2) Breakdown of approved budget provided by A. Spires,
April 19, 1984.
( 3) Addition of full- time Plant Pathologist. These services
were previously provided under contract with the University
of Arizona. a
( 4) Included funding for the State Chemist ( one- half) and secre-tary
( one- half). This funding was subsequently included in
the State Chemist's budget. ( The State Chemist is also
Assistant Director of the Agricultural Laboratory.) a
E. Service Measurements
A five- year summary of the work load volumes for State Agri-cultural
Laboratory services is provided in the following
table:
Table 2
State Agricultural Laboratory Analysis Volumes
80- 81 81- 82 82- 83 83- 84 84- 85
Actual Actual Actual Actual Estimate
Insect
Identifications
Animal Blood Tests( 2)
Seed Tests( 3)
State Meat Tests( 4)
Fertilizer Form-ulation
Analyses
Feed Formulation
Analyses
Pesticide Formula-tion
Analyses
Residue Analyses
Totals
( I) Taken from the 1984- 85 Operating Budget.
( 2) The State Agricultural Laboratory only provides one ( 1)
FTE for this function. Two other FTEs in the Animal
Disease Laboratory are USDA employees.
( 3) The actual testing is performed by Agricultural Seed
Laboratories, Phoenix ( a private laboratory).
( 4) The actual testing is performed by the USDA,
San Francisco, California.
SUNSET FACTORS
In accordance with ARS S41- 2354, the Legislature should con-sider
the following 12 factors in determining whether the State
Agricultural Laboratory within the Arizona Commission of Agricul-ture
and Horticulture should be continued or terminated.
1. Objective and purpose in establishing the State Agricultural
Laboratory.
The State Agricultural Laboratory was established by the laws
of 1980, Chapter 152, House Bill 2281. The objectives of the
legislature in establishing the State Agricultural Laboratory
were twofold:
a. To consolidate the resources providing raw agricultural
products testing services, and
b. To provide certification to laboratories providing
analysis of agricultural products. ( At that time, a
specific problem existed relative to the accurate analy-sis
of aflatoxin in cottonseed.)
The legislature clearly stated this intent in the laws of
1980:
" The purposes of this act are:
1. To establish a state agricultural laboratory as a divi-sion
of the Arizona commission of agriculture and
horticulture to assume the functions of providing labora-tory
services to:
( a) The chief veterinary meat inspector.
( b) The board of pesticide control.
( c) The livestock sanitary board.
( d) The office of the state chemist.
( e) The commission of agriculture and horticulture.
2. To provide laboratory service to agriculture for the
protection of the agricultural community and the public
health.
3. To provide certification to laboratories providing
services and to prescribe criteria for certification."
"$ 3- 144. State agricultural laboratory; maintenance and purpose a
A. The state agricultural laboratory is established and
maintained to carry out this article and for labora-tory
examinations, diagnosis, analysis, testing,
quantifying and identification necessary to perform
the functions and duties assumed or succeeded to
pursuant to $ 3- 142."
The objectives should be reexamined relative to the certifi-cation
of laboratories since the certification program may no
longer be necessary. ( See Finding 11, pages 26- 35.)
2. The effectiveness with which the State Agricultural Laboratory ( I)
has met its objective and purpose and the efficiency with
which the State Agricultural Laboratory has operated.
The State Agricultural Laboratory has generally been effec-tive
in meeting its objectives and purpose. Identification
and testing services are being provided. A laboratory
certification program is being administered. However,
improvements are needed.
The Laboratory does not have written policy guidelines
regarding testing and the recording and reporting of test
results. The Laboratory does not have a documented quality
assurance program. As a result, inaccurate results have been
reported by the Analytical Section and the probability of
this occurring is greater than necessary. ( See Finding I,
pages 19- 25.)
If the laboratory certification program is continued, effec-tive
administration of the program needs to be improved and
administrative costs recovered through higher fees. ( See
Finding 111, pages 36- 42.)
Regulations have not been published by the Commission. ( See
Sunset Factor 4.) The draft regulations need to be improved,
particularly to clarify the authority of the Agency Assistant
Director to effectively administer/ enforce the certification
program. ( See Finding IV, pages 43- 49.)
The Agency may not be providing all of the mandated services.
However, the statutes are not clear with regard to the test-ing
of raw milk. Although certification is the responsibil-ity
of the Commission, not all laboratories which require
mandatory certification pursuant to ARS $ 3- 147 have been
certified, specifically the State Seed Laboratory and
the Department of Health Services laboratory. ( See Finding
V, pages 50- 57.)
The Agency does not have a formal system for measuring its
efficiency or effectiveness beyond counting the number of
tests performed. Lack of work space and expanding needs for
testing services may further impact future efficiency and
effectiveness.
Nevertheless, the Agency has demonstrated the ability to
anticipate and respond to trends such as the recent ban
placed on use of the pesticide EDB. The agencies served by
the State Agricultural Laboratory generally concurred that
the Laboratory has been responsive to their needs.
3. The extent to which the State Agricultural Laboratory has
operated within the public interest.
The State Agricultural Laboratory serves the public interest
by providing testing services in support of regulatory enforce-ment
programs which exist to protect public health and the
agricultural economy. These monitoring and enforcement
programs would be virtually useless without analytical support.
Some of the benefits realized by the general public through
the identification and analytical services provided are:
a. Confidence by the general public of both Arizona and
other states that the products they buy are clean and safe
according to the standards checked.
b. The consumer generally doesn't have to worry about getting
what he/ she is paying for as presented on the label. The
monitoring program supported by testing, provides a
deterrent to the unscrupulous marketer.
c. The agriculture/ agribusiness community has increased
confidence because of expertise available to respond to
problems.
d. Having testing services available helps to stabilize
prices because of ability to react, solve problems and
reach agreements while minimizing economic losses.
Because of rapid pest identification by the Biological labora-tory
and follow- up by Commission field personnel, the state has
had no major outbreak of exotic pests. Arizona has experi-enced
a continued reduction of the incidence of brucellosis
among its livestock due to the detection services of the
agricultural laboratory. Since the organization of the State
Agriculture Laboratory there has been no major public reac-tions
to the fear of pesticide. Rapid identifications of
residues and subsequent information to the public have pre-vented
any outcry. There has been no major problem with
aflatoxin since testing was begun and test methods were
standardized through certification. A number of judgments
have been made in favor of the agencies supported, partially
based on the analytical work done for them.
Implementation of the laboratory certification program is an
excellent example of serving the public interest in response
to a problem. Development and implementation of test proce-dures
for aflatoxin in cottonseed and the laboratory certifi-cation
program had the effect of improving the quality of
milk and improving the quality and market price for cottonseed
as a commercial feed, both intra- and interstate. The costs
of test services have stabilized through private sector
competition to provide these services. However, it is not
certain that continuation of the laboratory certification
program is in the best public interest. We believe that
private enterprise has sufficient incentive to continue this
service without the regulatory aspects of the laboratory
certification program. ( See Finding 11, pages 26- 35.)
4. The extent to which rules and regulations promulgated by the
State Agricultural Laboratory are consistent with the
legislative mandate.
In accordance with ARS $ 3- 147, rules and regulations: " The
commission shall prescribe reasonable rules and regulations
for..." ( emphasis added). The State Agricultural Laboratory
is clearly not responsible for promulgating the rules and
regulations. Additionally, rules and regulations have not
been published.
Nevertheless, the draft ( January 1982) rules and regulations
were reviewed. They appear to be consistent with legislative
mandate except for who is authorized to grant certification.
The draft regulations identify the Assistant Director as
having this authority. The statutes appear to clearly reserve
this authority for the Commission. ( See Finding IV,
pages 43- 49.)
5. The extent to which the State Agricultural Laboratory has
encouraged input from the public before promulgating its rules
and regulations and the extent to which it has informed the
public as to its actions and their expected impact on the public.
The Commission is responsible for prescribing rules and
regulations.
Pursuant to ARS $ 3- 147. B, an advisory committee was formed to
assist in the formulations of rules and regulations. Appro-priate
public notice was given and a public hearing was held
on October 8, 1981. A review of the minutes of this public
hearing did not disclose any major problems with the proposed
regulations. Adoption of the regulations was ordered by the
Commission at its meeting on February 11, 1982. Nevertheless,
regulations have not been published.
The Commission is considering holding a second public hearing
since some changes have been made and because considerable
time has passed since the first public hearing without the
rules being published.
If the decision is to continue the certification program, we
recommend that the regulatory changes recommended in Finding
IV ( pages 43- 49) be considered and incorporated as appro-priate
before the next public hearing.
6. The extent to which the State Agricultural Laboratory has
been able to investigate and resolve complaints that are
within its jurisdiction.
The State Agricultural Laboratory has adequately investigated
and resolved complaints that are within its jurisdiction,
Actually, most complaints which might arise fall within the
jurisdiction of the Commission or the agency submitting the
sample to the laboratory for identification or analysis.
The few complaints received that are within the agency's
jurisdiction have been related to the accuracy of test results
determined by the Agency or a private certified laboratory.
All were resolved quickly-- and in the case of the Agency, the
findings were upheld.
7. The extent to which the Attorney General or any other applic-able
agency of state government has the authority to prose-cute
actions under enabling legislation.
The Commission, Agency and Attorney General appear to have
adequate authority under the statutes, but their ability to
enforce may be limited because rules and regulations have not
been published.
8. The extent to which the State Agricultural Laboratorv has
addressed deficiencies in the enabling statutes which prevent
it from fulfilling its statutory mandate.
At this time, no deficiencies are known to be present in the
enabling statutes which prevent the Commission or the Agency
from fulfilling its statutory mandste.
9. The extent to which changes are necessary in the laws of
the State Agricultural Laboratory to adequately comply with
the factors listed in the Sunset laws.
If the legislature agrees that the certification of agricul-tural
laboratories is no longer necessary, a major revision of
ARS Title 3, Chapter 1, Article 4 ( ARS § § 3- 141 through 3- 149)
will be necessary. ( See Finding 11, pages 26- 35.)
If the decision is to continue the certification program,
several statutory concerns should be addressed.
It appears that statutory clarification would be appropriate
for ARS $ 3- 145. C which states " A certified laboratory shall
report test results only to the party who provided the origi-nal
sample." Certified laboratories which currently provide
the Agency with copies of the results of aflatoxin tests are
clearly in violation of this statute. However, the labora-tories
may not be in violation of state law by reason of an
apparent conflict among several statutes. ( See Finding VI,
page 58.)
The Department of Health Services ( DHS) also appears to have
statutory authority to grant certifications for agricultural
testing services. This type of dual authority does not appear
to be in the best public interest. We recommend the legisla-ture
consider a revision to the DHS statutes to remove the
authority to certify laboratories for the provision of agri-cultural
testing services. ( See Finding VII, page 59.)
Since the certification program results in a direct economic
benefit to the certified laboratories, we believe the certi-fied
laboratories should bear the cost of a more effectively
administered program. The legislature should consider substan-tially
increasing the fees for initial and renewal certificates a
as set forth in ARS $ 3- 146. ( See Finding 111, pages 36- 42.)
- 16-
10. The extent to which the termination of the State Agricultural
Laboratory would significantly harm the public health, safety
or welfare.
The State Agricultural Laboratory provides agricultural
testing services in the broad areas of environmental and
formulation diagnostic testing. These testing services are
provided specifically to support regulatory programs designed
to safeguard the public health and agricultural economy. The
potential threats of aflatoxin in milk, brucellosis in live-stock,
infestation by the mediterranean fruit fly and the
hazards of EDB and other pesticide residues are all generally
recognized problems in. Arizona which require the support of
analytical services to control.
The major consequences of not having laboratory testing
services would be:
a. Monitoring/ enforcement programs would be virtually useless
without analytical support.
b. The public would not be protected from known health
hazards which would result from such as pesticide residues
or diseases which are carried in the food chain.
c. The economy would suffer as a result of higher losses of
agricultural commodities stemming from infestations of
insects, plant diseases or livestock diseases.
If the State Agricultural Laboratory did not provide these
services, the agencies they serve would have to seek services
elsewhere. However, some of these services are not otherwise
available in Arizona except possibly from the Universities.
11. The extent to which the level of regulation exercised by the
State Agricultural Laboratory is appropriate and whether less
or more stringent levels of regulation would be appropriate.
Regulation of laboratories insofar as the certification program
is concerned could be eliminated. ( See Finding 11, pages 26- 35.) a
If the decision of the legislature is to continue the labora-tory
certification program, then the proposed regulations need
to be strengthened to support effective administration of
the program. ( See Finding IV, pages 43- 49.)
12. The extent to which the State Agricultural Laboratory has
used private contractors in the performance of its duties and
how effective use of private contractors could be accomplished.
The Agency currently uses a private laboratory to do the seed
testing. Private laboratories are also used as " referee"
laboratories when the results of the Agency or another certi-fied
laboratory are challenged. Seven private laboratories
currently provide testing for aflatoxin in cottonseed in
support of the regulatory program under the Commercial Feed
Law. At least two private laboratories have now developed the
capability to test for EDB although they are not currently
doing this in direct support of agency regulatory enforcement
programs.
In areas where there is no profit margin, the private sector
has not developed expertise for the diagnosis. However, there
is expertise available in the private sector for many of the
routine tests performed by the Agency. Therefore, there is
the potential for the Agency to contract for services, thereby
making resources available for expanded services such as milk
or meat testing, providing that space and equipment are
available.
The Agency is concerned that the cost of private sector
testing for regulatory enforcement purposes might be higher
because their results may be subject to litigation. The
private laboratories we talked to did not support this theory.
We believe this concern could be resolved through the competi-tive
bid process for the services. In the specific case of
seed testing, we were advised that development of this capa-bility
within the Agency has been considered. It was deter-mined
that the cost for doing so far outweighs the cost of
contracting with the private sector, primarily because the
volume of tests for enforcement purposes was insufficient.
The Agency is also concerned that if a private laboratory's
results were challenged and a litigation took place, expenses
for appearances at hearings might negate any dollar savings.
However, according to Agency management, no court litigation
involving test results has occurred and appearances at hear-ings
to attest to the results are estimated at not more than
five or six since the Agency was established.
FINDING I
THE LACK OF DOCUMENTED POLICIES AND AN EFFECTIVE QUALITY ASSURANCE
PROGRAM MAY BE AFFECTING THE RELIABILITY OF TEST RESULTS IN THE
ANALYTICAL SECTION.
FINDINGS
The testing services ( analyses and identifications) provided by
the State Agricultural Laboratory appear generally to be accurate.
In the very few instances where test results have been challenged,
split samples have been submitted to reference laboratories such
as other private laboratories, the USDA and the California Depart-ment
of Agriculture. In all instances, Agency management reports
that results were confirmed by the reference laboratory. However,
the reliability and accuracy of the test results may be question-able
because the Agency does not have a formal documented quality
assurance program.
Quality assurance is the concept of maintaining the ability of a
laboratory to furnish reliable information. The Agency does not
have a written policy for quality assurance. The only formal
activity associated with a quality assurance program is the
participation in six ( 6) check sample programs. There are cur-rently
no written procedures to ensure that proper testing pro-cedures
are used or that test results are interpreted and reported
accurately. The Agency has been evaluating the quality assurance
program used by Montana. As of August 1, 1984, no decision has
been made to implement the Montana program or adopt any other
formal program.
To further evaluate the propensity for error due to the lack of
written policy and procedural guidelines, an examination of the
Analytical Section laboratory records was conducted. The records
examined consisted of the Master Log, State Chemist Official
Reports and Laboratory Data Books. The examination consisted of
evaluating the completeness of the records, determining if an
appropriate audit trail existed between them, determining if
reported results accurately reflected the test results, and
whether or not laboratory management policy was being followed.
A total of 409 State Chemist Official Reports were reviewed.
These reports covered the approximate time periods of the first
three months of 1983 and of 1984. From these, a total of 29
reports were selected which appeared to have obvious discrepan-cies.
These 29 reports were then compared to the other labora-tory
records.
Our findings indicate that laboratory procedures and records
require substantial improvement. Following is a summary of the
findings based on review of the 29 reports. Since there is no
written policy, " stated policy" refers to that which was verbally
conveyed to us by laboratory management.
A. There were a number of examples where an Official Report had
been issued and later reissued reflecting different results.
The first reports did not indicate that they were " unofficial"
or " preliminary." The reissued reports did not indicate that
they superceded, amended or revised the first. Therefore, it
would appear that the recipient would be free to act based on
whichever report was most favorable, particularly since no
" date reported" is indicated ( see paragraph L below). It was
noted that for those changed reports indentified in our
sample, if there was a change in the pass or fail result, in
every case the change was from " violation" to " pass."
B. The stated policy is that if only one test is performed
and the results are within the permitted analytical variance
( PAV), the result is considered as a pass. However, if more
than one test is conducted ( policy is then a minimum of 3) the
results shall be averaged in order to determine if it passes
or is a violation, and the deficiency or excess shall be based
on the difference between the average and the guarantee. In
the latter case, the PAV does not apply. What we found in
most instances of more than one test was passlfail determina-tion
being based on the single result which yielded the least
deficiency and would be indicated as a pass if that single
result were within the PAV. This resulted in some samples
being passed which should have been violations.
C. There were several instances in our sample where tests were
run more than three times. In some cases, subsequent tests
were run after the results had been reported. There was no
obvious explanation as to why extra tests were done. There
was also no indication that a supplemental report had been
issued. Justification for running additional tests should be
documented.
D. Many entries in the lab data books, and virtually all entries
in the Aflatoxin Analysis data book, are done in pencil.
Several erasures with changed entries were identified with no
record of the prior entry and no explanation. The standard
practice for laboratory data books is for all entries to be in
ink. Errors should be marked out with a single line through
so they are still legible. A note explaining the reason for
the correcting entry should be entered.
E. Entries in a laboratory data book should not be out of
chronological order as was noted in the Aflatoxin Analysis
data book. At the very least, such an entry should be approved
by appropriate management and so noted in the data book along
with the explanation.
I?. The s t a t e d p o l i c y is t h a t i f t h e r e s u l t of t h e f i r s t test is a
" v i o l a t i o n , " t h e test w i l l a u t o m a t i c a l l y be rerun i n d u p l i c a t e
( two more t i m e s ) . Y e t , i n at least t h r e e of t h e examples
i d e n t i f i e d i n paragraph A above, t h e s i n g l e r e s u l t r e f l e c t e d
on t h e f i r s t r e p o r t i n d i c a t e d t h a t t h e test should have been
rerun before being r e p o r t e d .
G. The s t a t e d p o l i c y is t h a t a l l test r e s u l t s are checked/
reviewed by someone o t h e r than t h e person performing t h e test.
There were many i n s t a n c e s where only one set of i n i t i a l s was
r e f l e c t e d i n t h e l a b d a t a books and on t h e test r e p o r t s .
There were also i n s t a n c e s where r e s u l t s were a p p a r e n t l y
miscopied from t h e l a b d a t a book onto t h e r e p o r t o r t h e
reported r e s u l t did not match any test r e s u l t . This would
suggest t h a t reviewing/ checking is not h a b i t u a l l y performed.
H. In some i n s t a n c e s a test r e s u l t is e n t e r e d on t h e r e p o r t and
then s c r a t c h e d out. The r e s u l t i n d i c a t e s t h a t it w a s an
apparent anomoly and should not be considered i n t h e p a s s / f a i l
determination. In t h e s e i n s t a n c e s , we suggest t h a t t h e r e s u l t
not be recorded on t h e r e p o r t and be s o noted i n t h e lab data
book.
I. Many e n t r i e s i n t h e l a b d a t a d i d not r e f l e c t a d a t e t h e test
w a s performed o r t h e i n i t i a l s of t h e person performing t h e
test. In s e v e r a l books, t h e s e columns have been dropped
e n t i r e l y . The s t a t e d p o l i c y is t h a t a d i f f e r e n t person
perform t h e retests. This was not r e a d i l y e v i d e n t from t h e
l a b d a t a books because of t h e missing i n i t i a l s .
J. Many columns i n t h e l a b d a t a books are incomplete and n o t e s
are e i t h e r u n c l e a r or n o n e x i s t e n t . Every column shoulc! be
completed f o r each test e n t e r e d . Clear, c o n c i s e n o t e s should
be e n t e r e d , e x p l a i n i n g any unusual c o n d i t i o n , which may
c l a r i f y or otherwise a i d i n t e r p r e t a t i o n of t h e test r e s u l t s .
K. The pages of the lab data books should be sequentially page
numbered, preferably with preprinted page numbers. It would
also be helpful if the page number of the previous test run on
a sample was indicated in the notes or in an additional column
for that purpose.
L. Virtually none of the State Chemist Official Report forms
reflect a " date reported" in the space provided in the margin.
Some also were incorrectly marked " pass" when they should have
indicated " violation."
M. Many of the State Chemist Official Report forms do not
include a description of the material being tested. This
would be helpful to the laboratory in those instances where
the brand name is not self explanatory ( e. g., liquid fertilizer,
dry fertilizer, goat feed).
N. The stated policy is to indicate a lot number for the sample,
otherwise insert " none." In 9% of the reports sampled, this
entry was left blank. In 1% of the reports sampled, there was
no entry for lot size.
0. The stated policy is that all test result entries on the
bottom of the State Chemist's Official Report are to be
initialed by the person performing the test. In a sample of
241 reports from 1984, 20 reports ( 8.3%) had initials mis-sing.
( However, the need for these initials on the test
report is questionable.)
P. It was suggested by laboratory management during our review
that laboratory personnel not make the pass/ fail determination
on samples submitted by and reported to the State Chemist on
his Official Report form. The laboratory should only record
the test result. The passlfail determination and amount of
d e f i c i e n c y o r e x c e s s s h o u l d b e determined by t h e S t a t e Chemist's
o f f i c e . We concur, p a r t i c u l a r l y s i n c e t h i s is b a s i c a l l y how
test r e s u l t s f o r o t h e r a g e n c i e s are handled. However, we
b e l i e v e t h a t a d d i t i o n a l i n f o r m a t i o n may be u s e f u l i n judging
t h e test r e s u l t s and should be c o n s i d e r e d f o r i n c l u s i o n with
t h e r e p o r t e d test r e s u l t s t o a l l a g e n c i e s .
1. For t h o s e p r o c e d u r e s where p e r m i t t e d a n a l y t i c a l v a r i a n c e s
have been e s t a b l i s h e d , i n d i c a t e t h e PAV v a l u e i f o n l y one
test is conducted and r e p o r t e d .
2. I n d i c a t e t h e d e t e c t i o n l e v e l f o r t h e p a r t i c u l a r test
p r o c e d u r e , p a r t i c u l a r l y when t h e r e p o r t e d r e s u l t s are
c l o s e ( t o be d e f i n e d ) t o t h e d e t e c t i o n l i m i t , ' t r a c e ' or
' none d e t e c t e d . '
3. I n d i c a t e t h e test p r o c e d u r e used t o d e t e r m i n e t h e r e s u l t s .
I n r e v i e w i n g e a c h o f t h e 29 r e p o r t s and t h e above f i n d i n g s with
management, t h e y concurred t h a t t h e r e were obvious d i s c r e p a n c i e s
o r o t h e r q u e s t i o n s f o r which, i n g e n e r a l , no a p p a r e n t l o g i c a l
e x p l a n a t i o n was a v a i l a b l e from t h e l a b d a t a books o r o t h e r r e c o r d s .
CONCLUSIONS
The l a c k of w r i t t e n p o l i c i e s and a formal documented q u a l i t y
a s s u r a n c e program raises q u e s t i o n s about t h e r e l i a b i l i t y of
t h e t e s t i n g s e r v i c e s . From t h e above f i n d i n g s , one must conclude
t h a t i n a c c u r a t e t e s t r e s u l t s have been r e p o r t e d and t h a t t h e
p r o b a b i l i t y f o r them is above a r e a s o n a b l e l i m i t .
The proposed r e g u l a t i o n s f o r l a b o r a t o r y c e r t i f i c a t i o n ( R3- 1- 205)
r e q u i r e s t h a t each a p p l y i n g l a b o r a t o r y " . . . s ~ b m i t proof t h a t it
h a s a p r e c i s i o n and a c c u r a c y c o n t r o l program f o r each s e r v i c e it
provides. Such a program must be compatible with generally
recognized practices followed by agencies such as ..... the
Arizona State Agricultural Laboratory." Without a formal docu-mented
quality assurance program, the Agency is operating on a
double standard. ( See also Arizona Legislative Council Memo,
Fact Situation E, pages 7 and 8 in the appendix.)
RECOMMENDATIONS
1. State Agricultural Laboratory management policies regarding
testing and documentation procedures should be put in written
form, reviewed with all laboratory personnel and enforced.
2. The State Agricultural Laboratory should develop and implement
a formal quality assurance program.
FINDING I1
THE CERTIFICATION OF LABORATORIES PROVIDING AGRICULTURAL TESTING
SERVICES MAY NO LONGER BE NECESSARY.
FINDINGS
A. Introduction and Background
It appears from our audit findings that three factors
influenced regulation of agricultural laboratory ser-vices,
i. e., establishment of the laboratory certification
program.
1. There existed a high potential for harm to public health.
2. There were economic factors which encouraged government
involvement.
3. Government was influenced to do so by the private sector,
both from business and the general public.
Aflatoxin is a known potent carcinogen. The stimulus for the
certification program was the identification of levels of
aflatoxin in milk which were considered to be above accept-able
limits. This occurred in 1978. From the information
available, the Governor of Arizona determined there was a
potential threat to public health and that the levels of
aflatoxin were above the State established limits. He
therefore ordered the dumping of thousands of gallons of
milk causing a major economic impact on the dairy industry.
Additionally, several states threatened to embargo Arizona
cottonseed, thereby affecting a significant part of the
market. Cottonseed from Arizona would not be permitted in
those states unless it were accompanied by a report certifying
that it was below the FDA limits for aflatoxin.
The possibility of having to dump more milk because of con-taminated
feed posed a threat of further economic losses to
dairying. The agricultural business c~ mmunity, through
various representative organizations, qollaborated with the
State to find a solution. The soluti~ n sought, and sub-sequently
developed and implemented, W@ S the testing of
cottonseed for aflatoxin.
Cottonseed is particularly attractive as a feed for lactating
cattle because of its high protein content, availability and
relatively lower cost when compared torother high- protein feed
products. It was also known to be the- source of the aflatoxin.
Therefore, the agriculture business community wanted assurance
that the cottonseed they bought was below the levels of
aflatoxin contamination which might result in adulteration of
the milk or injury to livestock. The answer was obviously to
have the cottonseed tested before purchase, something for
which they did not have the capability. They also did not
have the means to determine if a laboratory they might select
to do the testing could produce reliable results. They
therefore turned to the State for this assurance.
The private laboratories which could provide the test services
wanted some assurance that all laboratories would require the
same equipment and have to follow the same procedures. This
was to preclude a laboratory from using a less expensive, less
reliable method to an unfair competitive advantage.
B. Current Status
The State and industries involved have established what
appears to be an effective program for controlling aflatoxin
levels in cottonseed and thus in milk. The agricultural
laboratory certification program established by HB 2281 was
initiated in January 1981. Mandatory certication is required
in order to provide agricultural laboratory services to
agencies of the State and for providing guaranteed analysis to
distributors of commercial feed or whole seed for consumption
by livestock.
Approved methods of sampling and testing cottonseed for
aflatoxin are delineated in Department of Health Services
Regulations R9- 17- 311 through R9- 17- 321. Since release of
these regulations in June 1981, the limit of aflatoxin in
cottonseed for use in the rations of non- dairy animals has
been raised from 100 parts per billion to 300 parts per
billion. Approved methods of sampling and testing cottonseed
for aflatoxin are also delineated in the Commercial Feed
Regulations R3- 3- 41 through R3- 3- 56, issued in August 1984.
( Note: DHS is currently revising its regulations on aflatoxin
in cottonseed to eliminate specification of the testing
procedures since the Commercial Feed regulations now include
them. )
Milk is routinely sampled as an end product under the require-ments
of the U. S. Department of Health and Human Services
Grade A Pasteurized Milk Ordinance. This ordinance is incor-porated
by ARS $ 3- 605- The Dairy Commissioner has enforcement
responsibility and sets the sampling and testing frequency if
greater than federally recommended minimums are used. Accord-ing
to the Dairy Commissioner, Arizona currently has the most
stringent milk testing program in the United States. The
permissible level of aflatoxin in milk is established by the
State. Milk which exceeds 0.5 parts per billion aflatoxin is
considered adulterated and cannot be used, blended or other-wise,
in any product for human consumption. In addition, the
United Dairymen of Arizona association imposes fines for milk
which does not conform to established quality standards.
Arizona cottonseed once again has an established interstate
market. This has occurred due to the high quality, competi-tive
price and the fact that each shipment is accompanied by a
laboratory certification of the aflatoxin content.
The only private laboratory agricultural testing service
provided to the private sector requiring mandatory certifica-tion
by the State Agricultural Laboratory at this time is
for aflatoxin in cottonseed. Certification is required by ARS
$ 3- 145. B because it constitutes the provision of guaranteed
laboratory analysis information to distributors of commercial
feed and whole seed for consumption by livestock. However,
this has been interpreted by the Agency to exclude in- house
quality control laboratories operated by a processor/ distributor a
which do not otherwise provide this service to the public.
The program which has been implemented, as far as the private
laboratories are concerned, has been voluntary. The decision
to develop the capability and become certified to test cotton-seed
for aflatoxin has been a profit- motivated business
decision.
C. Criteria for Regulatory Control by Certification
Certification is a form of regulation which grants recognition
to individuals or businesses who have met predetermined
qualifications set by a state agency. Only those who meet the
qualifications may legally use the designated title. Typically,
noncertified businesses may offer similar services to the
public as long as they do not describe themselves as being
" certified." Certification is especially appropriate when the
public needs assistance in identifying competent practitioners,
but where the risks to health and safety are not severe enough
to warrant licensure. ( 1)
In contrast to the typical certification program, the Arizona
program prohibits the offering of services without certifica-tion
if ( 1) those services are provided to a state agency
or ( 2) if it constitutes the provision of guaranteed analysis
to distributors of commercial feed for consumption by livestock.
The specific criteria that were examined to determine if the
certification program is still necessary are:
Whether the unregulated practice of an occupation
poses a serious risk to consumers' life, health, and
safety, or economic well being.
Whether potential users of the occupational service
can be expected to possess the knowledge needed to
properly evaluate the qualifications of those
offering the service.
* Has the least restrictive level of regulation been
applied so as to miminize any harmful regulatory
effects such as a decrease in the availability of
practitioners or higher costs of goods and services.
An equally important criterion is whether or not the market-place
provides a solution. ( 2)
1. It is intended that no profession, occupation, business,
industry or other endeavor be subjected to the State's
regulatory power unless the exercise of such power is
necessary to protect the public health, safety or welfare
from significant and discernable harm or damage.
1. Benjamin Shimberg and Doug Roederer, Occupational Licensing:
Questions a Legislator Should Ask, The Council of State
Governments, Lexington, Kentucky, March 1978, pp 4- 5
2. Jonathan Rose, " Occupational Licensing: A Framework for
Analysis," Arizona State Law Journal, Volume 1979, Number One,
p. 190
In the case of the private laboratory certification
program per se, this cannot be established since other
regulatory controls exist. Specifically, these include
the Grade A Pasteurized Milk Ordinance and the Commercial
Feed Laws. These laws protect public health by requiring
end product testing.
The second consideration is whether consumers of a parti-cular
service are able to make an informed and intelligent
selection of the service providers, free from undue
exploitation by the provider.
The agriculture industry and its vapious associations are
not considered to be uninformed. Their selection of a
service provider in the case of testing for aflatoxin in
cottonseed is assisted by the publication of the proper
methods in the Commercial Feed Regulations and the issuance
of a report of the results which contains an attest a
statement. Should there be a question regarding the
accuracy of results being obtained by a particular labora-tory,
the issue can be brought to the attention of the
State Chemist, who enforces the Commercial Feed Regulations,
for appropriate action. Such actions include making in-a
vestigations, embargoing material and levying fines.
Additionally, other forms of legal redress are available
to the industry.
Testing of cottonseed for aflatoxin as well as any other
testing of raw agricultural products by ( private) labora-tories
should be continued. In the specific case of
aflatoxin testing, purchasers of commercial feed containing a
cottonseed should ensure that the distributor provide a
report which contains signed attest statements by the
sampler and by the laboratory that the sampling and
testing procedures specified in the Commercial Feed
Regulations have been complied with. To make the assump-tion
that harm would result would imply that laboratories
would act irresponsibly and would falsely attest to their
results.
The attest statements which currently appear on the
Aflatoxin Certification Program form are as follows:
Sampler Attest Statement:
" I certify this sample was taken in accordance to
Regulation R3- 3- 53 of the Arizona Commercial Feed Law,
A. R. S. 24- 901 through 24- 917. "
Laboratorv Attest Statement
" I certify this sample was prepared and analyzed in
accordance with procedures stated in Regulation R3- 3- 54
of the Arizona Commercial Feed Law, A. R. S. 24- 901
through 24- 917. "
3. Government should provide only the minimum level of regu-lation.
Certification appears to be the most appropriate form of
regulation for the conditions that existed in 1980 when
House Bill 2281 was passed. Since that time, appropriate
test procedures for aflatoxin have been developed and
implemented and competent practitioners established. The
risks have been reduced and sufficient information has
been disseminated so that users no longer need assistance
in identifying competent practitioners. The Commercial
Feed Laws and the Commercial Feed Regulations issued in
August 1984 provide suitable guidelines for the control of
aflatoxin in commercial feed for livestock.
4. Government intervention to protect consumers is only
necessary when the market fails to perform this function.
Admittedly, this was the case in 1978 with respect to
aflatoxin in cottonseed. However, an effective program
for controlling aflatoxin in cottonseed has been established
in the marketplace. Appropriate sampling and testing
procedures are promulgated by the Commercial Feed Regula-tions.
Regulation of milk poses economic penalties
sufficient to expect that approp~ iate testing would
continue without certification of samplers and laboratories
0
by the State.
If it is desirable to have private laboratories perform com-pliance
testing services in support of a State regulatory
function ( e. g., the State Agricultural Laboratory were to
contract for the provision of specific services by the private
sector), demonstration of the proficiency of the selected
laboratory to provide the specified services should be con-tractually
established on a case- by- case basis. In any event,
the relationship here is private to government rather than
private to private. The underlying purpose is to monitor for
compliance, from which enforcement action may result. There-fore,
performance by the laboratory should be contractually
established between the regulating agency and the private
laboratory, not by a general certification program.
Examination for proficiency could still be provided by the
State Agricultural Laboratory. For example, the Dairy
Commissioner may desire to contract with a private labora-tory
to do the milk testing. The State Agricultural
Laboratory could assist the Dairy Commissioner in assessing
the proficiency of the laboratory ( i. e., certify the
ability of the laboratory to perform the service).
CONCLUSIONS
The agricultural laboratory certification program could be dis-continued
for the following reasons:
A. It cannot be established that deregulation by eliminating the
certification program would result in a serious risk to public
health or to the agricultural economy.
B. Users of the laboratory services are not considered uninformed
and are guided in their selection of a service provider by the
Commercial Feed Regulations.
C. Adequate service providers have been established in the market-place.
D. The combined effects of the Arizona Dairy Laws and regulations
and the Commercial Feed Laws and regulations provide the
necessary regulatory control. They also provide incentive to
continue appropriate testing.
E. Elimination of the certification program does not preclude
laboratories from issuing a report which would contain an
attest statement indicating how their results were derived.
RECOMMENDATIONS
Certification of laboratories desiring to perform agricultural
testing services should be discontinued. However, in the testing
of cottonseed for aflatoxin, private laboratories should continue
providing reports of the test results which contain a statement,
signed by them, attesting that the testing methods ( or for samplers,
the sampling procedures) used comply with the Arizona Commercial
Feed Regulation. The agricultural industry and other state
( non- Arizona) regulatory agencies should be advised that no
cottonseed should be accepted for feed unless accompanied by a
laboratory report which includes the attest statement. A labora-tory
should not accept a sample for which an attested result is
requested unless the sample submitted is accompanied by a signed
attest statement. These requirements could be incorporated
through the commercial feed law and/ or regulations.
Should the certification program be continued by the State,
the effectiveness of its administration should be improved.
Sufficient resources will be necessary to do so, and a fee
sufficient to recover the cost should be charged. ( See Finding
111, pages 36- 42.)
FINDING I11
IF THE LABORATORY CERTIFICATION PROGRAM IS CONTINUED, ADMINIS-TRATION
SHOULD BE IMPROVED AND THE PROGRAM COSTS RECOVERED
THROUGH HIGHER FEES.
FINDINGS
As of August 1, 1984, the Sampling and Laboratory Certification
Regulations R3- 1- 201 through R3- 1- 210 ( January 1982) have not
been approved and published. However, the Assistant Director of
the State Agricultural Laboratory is operating an interim certi-fication
program.
To date, the administration of the interim certification program
has been adequate to the extent that there have not been any major
problems. In May 1984, a laboratory certified to conduct residue
analysis was decertified by the Assistant Director because of a
lack of qualified personnel to perform tests. However, informa-tion
about the lack of qualified personnel was provided by an
outside source, not as a direct result of administering the
program.
The current administrative procedures used by the State Agricul-tural
Laboratory include the following:
Processing of initial applications and renewal applications
for interim certification
Reviewing and verifying the applicants: ( a) precision and
accuracy control program; ( b) methodology program; and
( c) physical, sanitary and safety program.
Inspecting the applicants facilities and equipment, and
evaluating the qualifications of the laboratory personnel
prior to initial certification.
Receiving, reviewing and filing certified aflatoxin test
results.
These procedures are minimal and, at best, are reactive rather
than proactive. An administrative program which is more sub-stantive,
more objective and which more closely satisfies the
statutory intent of such a program is needed. The reason given by
Agency management for not doing so is that they have insufficient
resources.
A. Improve Program Administration
Improved administrative guidelines were developed with
assistance from the State Agricultural Laboratory management.
Following is a listing of the major activities included.
1. Applications will be processed for initial certification
or certification renewal.
2. A review of the applicant's laboratory personnel quali-fications
should be included as part of the requirements
for certification. The qualifications of personnel
performing analytical tests are as important relative to
accurate results as the method and equipment used.
3. Random visits to certified laboratories should be made
at least quarterly to conduct a review and obtain a
portion ( split) of a recent sample tested. Random site
visits are necessary to assure that unreported changes
have not occurred, equipment is maintained, records are in
order and that precision and accuracy controls are main-tained.
4. Conduct analyses on portions ( splits) of samples obtained
from certified laboratories. Check samples sent to a
laboratory for analysis tend to be biased beca~ se the
laboratory knows they are being tested and therefore are
more careful. Samples obtained by random site visits
provide the opportunity to verify that the results of the
certified laboratory are accurate on a continuing basis.
They are more representative of the normal operation.
5. Receive, review and file participant check sample program
test results. A review of the laboratory's performance
trend is an indicator of its precision and accuracy.
6. Receive, review and file all certified test results.
This provides the opportunity to identify undesirable
trends in test results.
7. Collect samples from lots tested by certified laboratories
to evaluate the performance of samplers and laboratories.
8. Evaluate the effect of all changes in certified labora-tories
which may impact their qualification for certifi-cation.
9. Maintain and update certified laboratory and sampler files.
At the time of certification renewal, the Assistant Director
should review the applicants' file. From information placed
in the file, the Assistant Director can objectively make
recommendations to the Commission for certification renewal or
revocation.
Additionally, the following actions should be taken for
clarification or compliance with statutes:
1. The Notice of Certification should stipulate the agri-cultural
service or services as outlined in the regula-tions
and specify appropriate restrictions.
A Notice of Certification issued to a laboratory identifies
the specific services certified, but does not correlate
these services to the laboratory services outlined in the
draft Sampling and Laboratory Certification Regulation
R3- 1- 203. For example, a laboratory conducting analyses
for aflatoxin levels in cottonseed products is issued a
Notice of Certification stating, " This document grants
certification... to ( name of laboratory) for ' Laboratory
Analysis of Cottonseed Products.'" The Notice of Certifi-cation
does not identify which of the agricultural services
outlined in the draft regulations are certified. The
Notice of Certification should read, " This document grants
certification... to ( name of laboratory) in accordance with
regulation R3- 1- 203. A. 10, limited to the laboratory
analysis of aflatoxin levels in cottonseed products."
This administrative change would help clarify ambiguities
that exist between the wording of the certificate and the
regulations.
The Assistant Director should be granted authority to issue
interim certification until such time as the Commission
grants final certification.
Under the current certification program, the Assistant
Director issues a Notice of Certification which is subject
to approval by the Commission. However, these certificates
have not been approved by the Commission. a
ARS § 3- 145. F states, " The commission shall issue a certifi-cate
to an applicant if the assistant director is satisfied
that the applicant has complied with rules and regulations
prescribing standards for certified laboratories." There-fore,
the Commission should grant final approval of the
certification after the Assistant Director has indicated
interim approval. This action should be taken at the next
scheduled Commission meeting after interim approval is granted.
The Commission should authorize the Director to sign the
Notice of Certificate indicating final approval of the Com-mission.
The minutes of the meeting will be the official
record of the Commission's approval.
The certificate should be modified to indicate interim appro-val
by the Assistant Director and a signature block added for
Commission approval by the Director.
B. Recovery of Program Costs
Certification programs are normally considered a form of
industry self regulation. To the extent that the State has
assumed this responsibility, because such a program does not
presently exist for agricultural laboratories, the State has
not been appropriately reimbursed for its services. So far,
no fee has been charged for certification ( because regulations
have not been published) and the proposed fee is only $ 10.
The present statutory limit on such fees is $ 200 for an
initial certification and $ 100 for certification renewal ( ARS
$ 3- 146). These amounts are insufficient to cover the actual
costs of an effectively administered agricultural laboratory
certification program.
The cost of instituting an administrative program such as
outlined above is estimated to be at least $ 935 annually per
certified laboratory. The basis of this estimate is provided
as Exhibit A on the following page. We have been advised by
State Agricultural Laboratory management that private certifi-cation
programs range in cost from $ 1,200 to $ 3,000 annually.
EXHIBIT A
ESTIMATED ANNUAL COST PER LABORATORY FOR CERTIFICATION
Description of Activity
Laboratory Visits
4 visits per year @ 4 hours per visit
times $ 10 per hour ( 1)
Split Sample Analysis ( 2)
4 laboratory samples plus 2 field samples;
6 samples @ $ 100 per sample ( 3)
Review Check Sample Program Test Results
7 tests per year @ .25 hours per test
times $ 10 per hour
Review and File Certified Test Results
.5 hours per week times 52 weeks;
260 hours times $ 10 per hour for 7 labs ( 4)
Evaluate Certified Laboratory Changes
1.5 lab changes @ 4 hours per evaluation
times $ 10 per hour for 7 labs ( 4
Maintain Certified Laboratory Files
1.5 hours per week times 52 weeks
times $ 10 per hour for 7 labs ( 4)
TOTAL ESTIMATED ANNUAL RECURRING COST
PER LABORATORY
Estimated
Annual Cost
( 1) Agency management estimate of average hourly cost including
fringe.
( 2) Based on samples of cottonseed tested for aflatoxin.
( 3) Current agency fee for three aflatoxin tests per sample.
( 4) Agency management estimate based on experience with 7
certified laboratories.
CONCLUSIONS
Current administration of the certification program is minimal and
is not proactive. Administrative procedures can and should be
improved to provide greater assurances of conformance to the
regulations. The cost of instituting a program such as outlined
above is estimated to be at least $ 935 annually per certified
laboratory. According to management, the State Agricultural
Laboratory has been hampered by lack of financial and human
resources to establish an effective administrative program.
RECOMMENDATIONS
If the decision of the legislature is to continue the certification
program, the following actions are recommended:
A. Effective administrative procedures should be developed
and implemented immediately for the certification program.
B. The certificate should be revised and the Commission should
start approving certification as directed by the statutes.
C. The statutory fee limits should be revised and fees sufficient
to recover effective program costs should be imposed.
FINDING IV
REGULATIONS HAVE NOT BEEN PUBLISHED AND THE DRAFT REGULATIONS
SHOULD BE REVISED BEFORE PUBLICATION IF THE CERTIFICATION
PROGRAM IS CONTINUED.
FINDINGS
The State Agricultural Laboratory was created by the laws of 1980,
Chapter 152, HB 2281, to be effective January 1981. Public
hearings were originally conducted on the draft regulations
in October 1981. Adoption of the regulations was ordered by the
Commission at its public meeting on February 11, 1982. Neverthe-less,
regulations have not been published. Due to the time lapse
and subsequent changes to the regulations since the initial public
hearings, the Commission is presently considering holding another
public hearing.
There are currently seven private laboratories that are certi-fied.
Even though the regulations have not been officially
promulgated, regulatory actions have been taken when applicable.
The most recent ( May 1984) was the decertification of a private
laboratory conducting pesticide residue analysis. The reason for
the action was lack of qualified personnel to perform the analy-ses.
However, the laboratory retained its certificate for afla-toxin
testing and guaranteed label analysis of commercial feeds.
Review of the proposed Sampling and Laboratory Certification
regulations R3- 1- 201 through R3- 1- 210 ( January 1982) identified
several improvements which would aid the State Agricultural
Laboratory in effectively controlling and administering the
certification program.
A. The regulations should identify certification application
procedures for sampling.
Proposed regulation R3- 1- 202. A, which deals with whom may
apply for certification states:
" A. Any person who desires t o o p e r a t e a c e r t i f i e d
a g r i c u l t u r a l l a b o r a t o r y s h a l l apply t o t h e Commission
of A g r i c u l t u r e and H o r t i c u l t u r e f o r a c e r t i f i c a t e on
a form f o r t h a t purpose provided by t h e A s s i s t a n t
D i r e c t o r . The a p p l i c a t i o n form s h a l l be prepared and
s i g n e d by both t h e owner of t h e l a b o r a t o r y and t h e person
s u p e r v i s i n g t h e l a b o r a t o r y . "
Proposed r e g u l a t i o n R3- 1- 203. B, which d e a l s w i t h s e r v i c e s f o r
which a c e r t i f i c a t e may be o b t a i n e d , states, " A c e r t i f i c a t e
may b e o b t a i n e d f o r such s e r v i c e s as sampling ..." Although
t h e r e g u l a t i o n s i n d i c a t e a c e r t i f i c a t e may be o b t a i n e d f o r
sampling, t h e y do not s p e c i f y a p p l i c a t i o n p r o c e d u r e s .
( For f u r t h e r i n f o r m a t i o n , see page 3 )
B. The r e g u l a t i o n s should i d e n t i f y procedures f o r g r a n t i n g
c e r t i f i c a t i o n t o s a m p l e r s .
The proposed r e g u l a t i o n s r e q u i r e t h a t p r i o r t o g r a n t i n g
c e r t i f i c a t i o n :
Each ( l a b o r a t o r y ) a p p l i c a n t s h a l l submit proof t h a t it has
a p r e c i s i o n and a c c u r a c y program f o r each c e r t i f i e d s e r v i c e
it p r o v i d e s ( R3- 1- 205).
A l a b o r a t o r y must i d e n t i f y t e s t i n g methods and p r o c e d u r e s
t o be used ( R3- 1- 206).
A l a b o r a t o r y must p a r t i c i p a t e i n c h e c k s a m p l e programs f o r
each of t h e s e r v i c e s f o r which c e r t i f i c a t i o n is r e q u e s t e d .
The a b i l i t y of t h e l a b o r a t o r y t o perform w i t h a c c u r a c y and
p r e c i s i o n w i l l be e v a l u a t e d u s i n g t h e r e s u l t s o b t a i n e d f o r
each check sample ( R3- 1- 207).
The r e g u l a t i o n s a r e s p e c i f i c i n i d e n t i f y i n g t h e p r o c e d u r e s f o r
g r a n t i n g c e r t i f i c a t i o n t o a l a b o r a t o r y ; however, t h e y d o n o t
s p e c i f y p r o c e d u r e s f o r g r a n t i n g c e r t i f i c a t i o n t o a s a m p l e r .
C. The State Agricultural Laboratory should know the participants1
check sample program tests results.
Check sample programs are conducted in such a manner that the
participants are identified on a published summary of the
results by a code number. This is done to protect the
confidentiality of the participants. Proposed regulation
R3- 1- 207. B states:
" B. Individual laboratory evaluation will be on the
basis of results obtained for each sample in relationship
to results, grouped by methods, received from all labora-tories
participating in that check sample program."
Individual laboratory check sample program code numbers are
not known to the Agency unless voluntarily disclosed by the
laboratory. The proposed regulations do not require disclo-sure.
D. The regulations should provide specific authority for the
State Agricultural Laboratory to administer the certification
program.
In order for any regulatory program to be successful, effec-tive
administration is required. Such administration may
require regulatory authority, i. e., the Agency may require
specific regulatory authority in order to enforce the follow-ing
administrative procedures.
Reviewing a certified laboratory's or sampler's records
Obtaining copies of certified results
Obtaining portions ( splits) of samples tested by the
certified laboratory for comparative analysis by the
State Agricultural Laboratory
Requiring certified laboratories to retain records for
specified periods of time ( i. e., retention schedules)
Evaluating the qualifications of certified laboratory
personnel to perform tests
Inspecting certified laboratory equipment and equipment
servicelmaintenance records
Initiating proceedings to revoke/ suspend certification.
The proposed regulations do not clearly provide the Agency
this specific authority.
E. The regulations should require a certified laboratory to
notify the Assistant Director of any changes within the
laboratory.
The impact of any change in a certified laboratory's per-sonnel,
management, ownership, facilities, test equipment or
test procedures may be significant in terms of its ability to
maintain its qualification for certification. In May 1984, a
laboratory certified to conduct residue analysis was decerti-fied
by the Assistant Director because of a lack of qualified
personnel to perform the tests. Information about the change
in laboratory personnel came from another source. Without
this information, the Assistant Director may not have dis-covered
the change. As a result, the laboratory would have
been in the position to provide potentially unreliable or
inaccurate residue analyses. There is no requirement in the
proposed regulations for a certified laboratory to notify the
Assistant Director of such changes.
F. The regulations should be consistent and should not conflict
with the statutes regarding who has authority to grant
certification.
The proposed regulations R3- 1- 202. C states:
" C. The Assistant Director shall grant or renew or
refuse to grant or to renew a certificate within thirty
( 30) working days of his receipt of the application."
Whereas R3- 1- 209 states:
" The Assistant Director has the responsibility to review
and to screen all certification application forms for the
adequacy of precision and accuracy control programs for
the Commission. If the Assistant Director finds that the
applicant satisfies precision and accuracy requirements,
he shall grant certification subject to approval by
the Commission at its next meeting.. . I1
However A. R. S. 3- 145, paragraph F states:
" F. The commission shall issue a certificate to an
applicant if the assistant director is satisfied that the
applicant has complied with rules and regulations pre-scribing
standards for certified laboratories."
and A. R. S. 3- 148 states:
" The commission may refuse to grant or renew a certifi-cate
or suspend or revoke a certificate..."
Regulation R3- 1- 202. C which indicates the Assistant Director
has the authority to " grant" ( rather than " grant subject to
approval'' or " recommend") certification conflicts with the
intent of the statutes and is not consistent with R3- 1- 209.
G. The regulations should require certified laboratories to
identify official samples received that do not meet
regulatory guidelines.
A certified laboratory may receive a sample from a certified
sampler that may not fall within the guidelines of the Commer-cial
Feed Regulations. These regulations pertaining to the
sampling of whole cottonseed require that:
A gross sample taken from a lot must be a minimum of thirty
( 30) pounds ( R3- 3- 53. C. 1).
A gross sample shall consist of not less than ten ( 10)
probes or stream sample passes ( R3- 3- 53. C. 1).
The sample container shall consist of clean cloth, burlap,
paper or plastic mesh bags ( R3- 3- 53. C. 2).
The sampling and Laboratory Certification Regulations do not
specify what a certified laboratory should do when receiving
certified samples that do not conform to the Commercial Feed
Regulations guidelines. They should provide certified labora-tories
the authority to refuse certified samples that do not
meet the guidelines. An alternative might be to require the
laboratory to " qualify" their test results by noting the
sample deficiency on the test report.
H. Certification of samplers should be restricted to those who
sam~ le cottonseed or cottonseed ~ roducts.
Certification of all samplers of agricultural products may have
far reaching effects, beyond that intended by the statutes or
regulation. ( For discussion on this point, see Finding V,
page 54. )
CONCLUSIONS
The January 1982 draft regulations could be improved in several areas
which would enhance enforcement and clarify requirements.
RECOMMENDATIONS
A. It is recommended the Commission of Agriculture and Horticul-ture
take the following actions to clarify regulatory proce-dures
and the authority of the State Agricultural Laboratory:
1. Identify certification application procedures for samplers.
2. Identify procedures for granting certification to samplers.
3. Authorize the Agency to receive individual certified
laboratory's check sample program test results.
4. Provide the Agency with appropriate authority to administer
the certification program.
5. Require certified laboratories to notify the Assistant
Director of any changes within the laboratory.
6. Clarify who has the authority to grant, renew, refuse to
grant or to renew a certificate.
7. Provide guidelines to certified laboratories for handling
samples that do not meet Commercial Feed Regulations.
8. Limit the requirement for certification of samplers to
only those who sample cottonseed or cottonseed products.
B. The Commission should aggressively pursue publication of the
Sampling and Laboratory Certification Regulations.
FINDING V
THE AGENCY MAY NOT BE PROVIDING ALL OF THE MANDATED SERVICES.
FINDINGS
A. General Organization and Operation
The State Agricultural Laboratory is divided into two sections -
chemical analytical and biological. The Chemical Analytical
Section contains a formulations and a residue laboratory.
The Biological Section contains entomology, animal disease and
plant pathology laboratories. Each section has responsibility
for specific mandated tasks. For example, the Biological
Section is responsible for the identification of insects,
parasites, bacteria and pathogenic organisms. The Chemical
Analytical Section is responsible for residue, nutrient and
formulation analyses.
The State Chemist also serves as the Assistant Director
of the Agency.
B. Description of Mandated Services
1. The Agency is required by ARS $ 3- 142 to provide agri-cultural
laboratory services as defined in ARS S3- 141
which encompass residue and nutrient analysis of:
Raw, processed or manufactured agricultural
products
Soil
Plant or animal tissue
Commercial whole feed including whole seeds and
any feed, mixed or unmixed, that is used in the
feeding of livestock
Fertilizer
Water for irrigation purposes or consumption by
livestock ( residue analysis only)
In a d d i t i o n , t h e Agency is r e q u i r e d t o p r o v i d e :
Q u a n t i t a t i v e a n a l y s i s of i n g r e d i e n t s i n p e s t i c i d e
f o r m u l a t i o n s
Germination and p u r i t y a n a l y s i s of p l a n t i n g
seed
0 I d e n t i f i c a t i o n of i n s e c t s , p a r a s i t e s , b a c t e r i a
and p a t h o g e n i c organisms i n raw, processed o r
manufactured a g r i c u l t u r a l p r o d u c t s and commodi-ties
and i n p l a n t o r animal t i s s u e
S e r v i c e s n e c e s s a r y t o c a r r y out $ 24- 104,
s u b s e c t i o n D ( meat i n s p e c t i o n )
Any o t h e r s e r v i c e s c o m p a t i b l e with o r i n c i d e n t a l
t o t h o s e l a b o r a t o r y s e r v i c e s provided p u r s u a n t to
$$ 3- 142 and 3- 143
By d e f i n i t i o n o f p u r p o s e , t h e Agency is a l s o r e q u i r e d
t o p r o v i d e :
Laboratory s e r v i c e t o a g r i c u l t u r e f o r t h e
p r o t e c t i o n of t h e a g r i c u l t u r a l community and t h e
p u b l i c h e a l t h
C e r t i f i c a t i o n t o l a b o r a t o r i e s p r o v i d i n g s e r v i c e s
and t o p r e s c r i b e c r i t e r i a f o r c e r t i f i c a t i o n
2. The Agency is r e q u i r e d by ARS $ 3- 142 t o p r o v i d e l a b o r a -
t o r y s e r v i c e s s p e c i f i c a l l y f o r f i v e s t a t e a g e n c i e s :
The Chief V e t e r i n a r y Meat I n s p e c t o r
The Board of P e s t i c i d e C o n t r o l
The L i v e s t o c k S a n i t a r y Board
The O f f i c e of t h e S t a t e Chemist
The Commission of A g r i c u l t u r e and H o r t i c u l t u r e
C. E v a l u a t i o n of Mandated L a b o r a t o r y S e r v i c e s
Each of t h e s t a t u t o r i l y s p e c i f i e d u s e r s w a s surveyed t o
d e t e r m i n e t h e e x t e n t t o which t h e y u t i l i z e t h e s e r v i c e s
of t h e S t a t e A g r i c u l t u r a l L a b o r a t o r y . Approximately 90% of
work performed by t h e Chemical A n a l y t i c a l S e c t i o n is f o r t h e
O f f i c e of t h e S t a t e Chemist. A l l o t h e r work, i n c l u d i n g work
f o r o t h e r state a g e n c i e s r e p r e s e n t s 10% of t h e t o t a l
volume. The B i o l o g i c a l S e c t i o n p r i m a r i l y s e r v e s ACAH, t h e
Chief V e t e r i n a r y Meat I n s p e c t o r and L i v e s t o c k S a n i t a r y Board.
Both s e c t i o n s s e r v i c e a g r i c u l t u r e f o r t h e p r o t e c t i o n of
t h e a g r i c u l t u r a l community and p u b l i c h e a l t h .
The Agency c u r r e n t l y u s e s e x t e r n a l s o u r c e s f o r two t e s t i n g
s e r v i c e s . A g r i c u l t u r a l Seed L a b o r a t o r i e s , a p r i v a t e l a b o r a -
t o r y , p r o v i d e s g e r m i n a t i o n and p u r i t y a n a l y s i s of p l a n t i n g
seed. The USDA i n San F r a n c i s c o p r o v i d e s c o n t e n t a n a l y s i s
of meats s o l d t o s t a t e i n s t i t u t i o n s ( e . g . , p r i s o n s , hospi-t
a l s ) . These s e r v i c e s a r e provided f o r t h e state seed
i n s p e c t o r and t h e c h i e f v e t e r i n a r y meat i n s p e c t o r , r e s p e c -
t i v e l y . The Agency is r e s p o n s i b l e f o r paying a l l i n v o i c e s
submitted by t h e two e x t e r n a l s o u r c e s ; however, t h e Agency is
not involved i n t h e s u b m i s s i o n o f samples o r t h e a n a l y s i s of
t h e test r e s u l t s . T h i s f i s c a l r e s p o n s i b i l i t y is performed i n
t h e B i o l o g i c a l S e c t i o n .
1. Milk T e s t i n g
According t o a r e p r e s e n t a t i v e of t h e A g r i c u l t u r a l Com-mittee,
it is t h e l e g i s l a t u r e ' s i n t e n t i o n t o have t h e
Agency p r o v i d e a l l l a b o r a t o r y s e r v i c e s f o r raw a g r i c u l -
t u r a l commodities, i n c l u d i n g milk. The d e f i n i t i o n of
a g r i c u l t u r a l l a b o r a t o r y s e r v i c e s provided i n ARS § 3- 141
a p p e a r s t o i n c l u d e ( t h e t e s t i n g o f ) milk f o r r e s i d u e and
n u t r i e n t a n a l y s i s s i n c e it is w i t h i n t h e scope of a " raw,
processed o r manufactured a g r i c u l t u r a l commodity and
product." However, it is not clear from t h e s t a t u t e s t h a t
milk t e s t i n g is i n c l u d e d as a mandated s e r v i c e . The Dairy
Commissioner is not one of t h e f i v e s p e c i f i c a l l y - l i s t e d
a g e n c i e s . Milk t e s t i n g is p r e s e n t l y being provided by t h e
Department of Health S e r v i c e s .
Meat T e s t i n g
Meat t e s t i n g is a d m i n i s t e r e d by t h e Agency b u t t h e a c t u a l
t e s t i n g is conducted by t h e U. S. Department of A g r i c u l t u r e
l a b o r a t o r y i n San F r a n c i s c o . We understand t h a t t h e S t a t e
A g r i c u l t u r a l L a b o r a t o r y has t h e c a p a b i l i t y and, i n f a c t ,
h a s performed some of t h e meat t e s t i n g i n t h e p a s t . The
meat being t e s t e d is s p e c i f i c a l l y d e s i g n a t e d f o r use i n
S t a t e i n s t i t u t i o n s such as t h e p r i s o n s and h o s p i t a l s . I t
would appear t h a t on t h e b a s i s of turnaround t i m e , it
would be more e f f i c i e n t t o have t h e t e s t i n g performed
l o c a l l y , e i t h e r by t h e S t a t e A g r i c u l t u r a l L a b o r a t o r y o r by
c o n t r a c t with a p r i v a t e l a b o r a t o r y . However, t h e USDA
c u r r e n t l y funds h a l f of t h e c o s t of t h e meat t e s t i n g
program. T h e r e f o r e , a s t u d y s h o u l d b e conducted t o
d e t e r m i n e t h e f e a s i b i l i t y of performing t h e meat t e s t i n g
l o c a l l y , e v a l u a t i n g both c o s t and e f f i c i e n c y .
3. P l a n t Pathology
P l a n t pathology s e r v i c e s were p r e v i o u s l y provided p a r t -
t i m e under c o n t r a c t with t h e U n i v e r s i t y o f A r i z o n a .
According t o t h e Commission D i r e c t o r , t h i s arrangement did
not f u l l y s a t i s f y t h e r e q u i r e m e n t s of t h e Agency. S t a r t i n g
i n FY 84- 85, a f u l l - t i m e p o s i t i o n f o r a p l a n t p a t h o l o g i s t
was r e q u e s t e d and approved. However, t h e p o s i t i o n h a s not
been f i l l e d .
D. E v a l u a t i o n of C e r t i f i c a t i o n S e r v i c e s
The s t a t u t e s p l a c e r e s p o n s i b i l i t y f o r promulgating r e g u l a t i o n s
and f o r i s s u i n g c e r t i f i c a t e s on t h e Commission. R e g u l a t i o n s
have not been p u b l i s h e d .
In t h e absence of p u b l i s h e d r e g u l a t i o n s , c e r t i f i c a t e s have
n e v e r t h e l e s s been i s s u e d by t h e A s s i s t a n t D i r e c t o r t o p r i v a t e
l a b o r a t o r i e s .
1. C e r t i f i c a t i o n of L a b o r a t o r i e s
ARS $ 3- 143. D. 2 s a y s t h a t t h e A s s i s t a n t D i r e c t o r s h a l l
" Enforce r u l e s and r e g u l a t i o n s e s t a b l i s h e d p u r s u a n t t o
$ 3- 147 f o r t h e mandatory c e r t i f i c a t i o n of l a b o r a -
t o r i e s . . . i n c l u d i n g t h o s e l a b o r a t o r i e s t h a t are a p a r t of
a state agency o r d e p a r t m e n t o r a p o l i t i c a l s u b d i v i s i o n
of t h e state." ( E m p h a s i s a d d e d . ) The Department of
H e a l t h S e r v i c e s l a b o r a t o r y which c o n d u c t s t h e m i l k
t e s t i n g f o r t h e D a i r y Commissioner h a s n o t been certi-f
i e d by t h e Agency. ( For f u r t h e r d i s c u s s i o n , see
Arizona L e g i s l a t i v e C o u n c i l Memo, F a c t S i t u a t i o n A , pages
1 t o 4 i n t h e Appendix.)
S i n c e t h e A g r i c u l t u r a l Seed L a b o r a t o r y p r o v i d e s l a b o r a -
t o r y s e r v i c e s t o t h e Agency, c e r t i f i c a t i o n is mandatory p e r
ARS $ 3- 145. A. T h i s l a b o r a t o r y h a s n o t been c e r t i f i e d by
t h e Agency. However, t h i s l a b o r a t o r y had p r e v i o u s l y been
d e s i g n a t e d as t h e state s e e d l a b o r a t o r y under t h e
a u t h o r i t y of ARS $ 3- 233 and ACAH r e g u l a t i o n R3- 1- 110/ 111.
C e r t i f i c a t i o n o f S a m p l e r s
The a p p r o p r i a t e n e s s of test r e s u l t s from a sample may
w e l l depend on how t h e sample was o b t a i n e d . T h e r e f o r e ,
r e g u l a t i o n of t h e s a m p l e r a p p e a r s t o be an a p p r o p r i a t e
e x t e n s i o n of t h e c u r r e n t s t a t u t o r y a u t h o r i t y t o c e r t i f y
l a b o r a t o r i e s . C e r t i f i c a t i o n of s a m p l e r s is i n c l u d e d i n
t h e d r a f t Agency r e g u l a t i o n s . I t is n o t clear, however,
whether c e r t i f i c a t i o n of s a m p l e r s s h o u l d be r e s t r i c t e d t o
t h e p r i v a t e s e c t o r o n l y , which is t h e p r e s e n t p r a c t i c e , o r
s h o u l d i n c l u d e s t a t e agency employees who c o l l e c t a g r i -
c u l t u r a l s a m p l e s .
It would be more consistent if agency employees who
conduct sampling were required to be certified since, by
statute, agency laboratories that provide agricultural
laboratory services are required to be certified.
Obviously, this would include all state employees who
collect agricultural samples. Affected personnel would
include all Commission inspectors, inspectors of the State
Chemist and of other agricultural boards and commissions.
Department of Health Services personnel that collect
agricultural samples would also be affected as would dairy
industry truck drivers who collect samples for the Dairy
Commissioner.
E. Other Services Not Mandated
The State Agricultural Laboratory provides testing services
for other state agencies such as the Department of Game and
Fish and the Structural Pest Control Board. However, there
are not any formal interagency agreements and in many
instances, the services provided are not paid for by the
requesting agency. Prior to FY 84- 85, testing services were
provided under contract to the Department of Health Services
( DHS). However, DHS contracted with a private laboratory for
these services for FY 84- 85.
CONCLUSIONS
The Agency appears to be providing most of the mandated services
required by the statutes and by the users to the users' satisfac-tion.
However, certain deficiencies may exist.
A. Plant pathology services are not currently being provided
because the position has not been filled. We understand
that interviews have been conducted and an offer extended.
B. Formal interagency agreements do not exist with agencies
other than those mandated. Therefore, the Agency is not being
properly reimbursed for services provided.
C. Milk testing is not being provided by the Agency. However, it
is not clear whether or not this is a mandated service.
D. Meat testing should be evaluated to determine the feasibility
of performing the testing locally.
E. Not all laboratories which require certification have been
certified, specifically the state seed laboratory and the DHS
laboratory.
F. The requirement to certify samplers of agricultural products
is not clear.
RECOMMENDATIONS
The following actions are recommended:
A. The Commission and the Agency should continue efforts to
procure the services of a qualified plant pathologist.
B. The Commission and the Agency should develop interagency
agreements with those agencies not mandated by statute
that require agricultural laboratory services. An estimate of
the cost of these services should be provided to the request-ing
agency by the State Agricultural Laboratory for inclusion
in their budgets. Such estimates should be based on fore-casts,
provided by the agencies being served, of their antici-pated
volume by type of service.
C. The legislature should clarify its intent with respect to milk
testing. If it is the legislature's intent to have the Agency
provide milk testing then:
1. The Dairy Commissioner should be added to the agencies
specified in ARS $ 3- 142.
2. The legislature should direct that a study be made of the
Department of Health Services to ascertain to what extent
equipment and personnel resources are dedicated to milk
testing.
3. The Commission and the Agency should prepare and submit
the appropriate budgetary request pursuant to establishing
the capability to perform milk testing.
D. The Commission should conduct a study of the present meat
testing program to determine if it would be feasible and
beneficial to have the meat testing done locally.
E. If the certification program is continued, the Commission
should direct the Assistant Director to proceed with the
evaluation of laboratories which require certification and
have not been certified.
F. If the certification program is continued, the Commission
should clarify regulatory requirements for certification
of samplers. Consideration should be given to certifying
only those who sample cottonseed or cottonseed products
whose distribution is intended for livestock.
FINDING VI
THE STATUTES ARE NOT CLEAR WITH REGARD TO THE REPORTING OF TEST
RESULTS BY PRIVATE LABORATORIES.
FINDING
The State Agricultural Laboratory receives a copy of the certified
results of all tests performed for aflatoxin in cottonseed by
certified laboratories. The Aflatoxin Certification Program form
contains a direction at the bottom which says, " Copy to: Arizona
State Agricultural Laboratory, P. O. Box 1586, Mesa, Arizona
85201." There is no requirement in the draft regulations for
copies of any certified results to be provided. Further,
ARS $ 3- 145. C states:
" A certified laboratory shall report test results
only to the party who provided the original sample."
Certified laboratories which currently provide the Agency with
copies of the results of aflatoxin tests are clearly in violation
of this particular statute. However, in an opinion from the
Arizona Legislative Council, the laboratories would not be in
violation of state law by reason of an apparent conflict among
several statutes. ( See Arizona Legislative Council Memo, Fact
Situation C, pages 5 and 6 in the Appendix.)
CONCLUSION
Statutes regarding the reporting of test results to a state agency
by a certified laboratory are in apparent conflict and should be
clarified.
RECOMMENDATION
If the laboratory certification program is continued, we recommend
the legislature consider a revision to ARS $ 3- 145. C which would
clarify the Agency's authority to receive copies of certified
laboratories1 certified services analytical results.
FINDING VII
TWO ARIZONA AGENCIES ARE CURRENTLY AUTHORIZED BY STATUTE TO
PROVIDE CERTIFICATION OF LABORATORIES TO PROVIDE AGRICULTURAL
LABORATORY SERVICES.
According t o Arizona L e g i s l a t i v e Council opinion, t h e Department
of Health S e r v i c e s ( DHS) a l s o has s t a t u t o r y a u t h o r i t y t o g r a n t
c e r t i f i c a t i o n s f o r a g r i c u l t u r a l t e s t i n g s e r v i c e s , s p e c i f i c a l l y t h e
t e s t i n g of arnmoniated cottonseed or c o t t o n s e e d p r o d u c t s , i n c l u d i n g
a u t h o r i t y t o i s s u e r e g u l a t i o n s t o e n f o r c e . ( See Arizona Legisla-t
i v e Council Memo, Fact S i t u a t i o n D, pages 6 and 7 i n t h e Appendix.)
This s i t u a t i o n c l e a r l y provides an option f o r t h e a p p l i c a n t
d e s i r i n g t o test arnrnoniated cottonseed t o apply f o r c e r t i f i c a t i o n
t o e i t h e r t h e Department of Health S e r v i c e s or t h e S t a t e Agricul-t
u r a l Laboratory. If a p p l i c a t i o n were denied or i f c e r t i f i c a t i o n
were revoked by one, c e r t i f i c a t i o n could conceivably be granted
by t h e o t h e r . This type of dual a u t h o r i t y does not appear t o
be i n t h e b e s t p u b l i c i n t e r e s t .
According t o DHS managemen.:, no l a b o r a t o r i e s a r e c e r t i f i e d by them
f o r t h e p r o v i s i o n of a g r i c u l t u r a l l a b o r a t o r y s e r v i c e s , nor has any
l a b o r a t o r y a p p l i e d .
We recommend t h e l e g i s l a t u r e c o n s i d e r a r e v i s i o n t o t h e DHS
s t a t u t e s t o remove t h e a u t h o r i t y t o c e r t i f y l a b o r a t o r i e s f o r t h e
p r o v i s i o n of a g r i c u l t u r a l t e s t i n g s e r v i c e s .
OTHER PERTINENT INFORMATION
A. THE ANALYTICAL SECTION WORK LOAD IS CONTROLLED BY THE STATE
CHEMIST.
The work load of t h e A n a l y t i c a l S e c t i o n is c o n t r o l l e d by t h e
S t a t e Chemist who is a l s o t h e Agency A s s i s t a n t D i r e c t o r . I f a
backlog a c c r u e s , as S t a t e Chemist he d i r e c t s h i s f i e l d i n s p e c t o r s
t o reduce t h e number of samples t h e y c o l l e c t ; i f more work is
needed, t h e i n s p e c t o r s are i n s t r u c t e d t o c o l l e c t more samples.
Because t h e c a p a c i t y of t h e l a b o r a t o r y i n f l u e n c e s t h e number
of samples t a k e n , t h e sampling program may n o t b e as e f f e c t i v e
as it should be.
I t is unknown whether o r not t h e s a m p l i n g c o n d u c t e d by t h e
O f f i c e of t h e S t a t e Chemist is s u f f i c i e n t t o p r o v i d e reason-a
b l e a s s u r a n c e t o t h e p u b l i c t h a t f e e d , f e r t i l i z e r and p e s t i -
c i d e p r o d u c t s a v a i l a b l e on t h e market a r e s a f e , meet l a b e l
claim and o t h e r w i s e conform t o r e g u l a t i o n s .
I t would a p p e a r , n e v e r t h e l e s s , t h a t having t h e same person as
S t a t e Chemist and A s s i s t a n t D i r e c t o r of t h e S t a t e A g r i c u l t u r a l
Laboratory creates t h e p o t e n t i a l f o r c o n f l i c t of i n t e r e s t .
The S t a t e A g r i c u l t u r a l L a b o r a t o r y is d i r e c t e d by s t a t u t e t o
p r o v i d e l a b o r a t o r y s e r v i c e s t o t h e O f f i c e of t h e S t a t e Chemist.
T h e r e f o r e , t h e l a b o r a t o r y work l o a d g e n e r a t e d by t h e S t a t e
Chemist s h o u l d b e accommodated and s h o u l d b e viewed no d i f f e r -
e n t l y t h a n s e r v i c e r e q u i r e m e n t s g e n e r a t e d by t h e o t h e r u s e r
a g e n c i e s .
B. THE STATE AGRICULTURAL LABORATORY FACILITIES ARE CROWDED.
Both the Analytical and Biological Sections of the State
Agricultural Laboratory are extremely crowded. For example,
in the Biological Section, current reports are stored on top
of a refrigerator and historical reports in precious cabinet
space. The Biological Section Manager's office also houses
the reference library, a systematic entomologist and a micro-scope
work station. In the Analytical Section, solvents which
should be isolated due to their hazardous nature are stored in
the laboratory. Sample weighing is done in the same small
storage room where the samples are stored. The Analytical
Section Manager's office is in a store room. We were told by
the Commission Director that the Plant Pathologist, when
hired, will share his office.
Additionally, all of the counter tops in the wet chemistry
section ( formulation laboratory) need to be refinished or
replaced. An obvious conclusion based on a tour of the
facilities is that there is a loss of efficiency which is
directly attributable to the work environment including space
limitations. These conditions also have an obvious negative
impact on the ability of the Agency to provide additional
services.
C. STATE AGRICULTURAL LABORATORY PROFESSIONALS COULD BE USED
AS TRAINERS.
The Biological Section Manager identified several problems
which inhibit the effectiveness of both the laboratory and the
ACAH field inspection personnel. Examples include:
Submittal of specimens which are mislabeled, broken or
damaged, resulting in the return of the specimens without
analysis.
Improper maintenance of field data books.
Submittal of specimens which should have been identified by
the field personnel.
We believe that use of the knowledge and experience of the
professionals in the State Agricultural Laboratory could make
a valuable contribution to the overall effectiveness of ACAH
programs as well as to agriculture by:
1. Developing and providing training programs for field
inspectors and other interested parties in farming and
other agricultural activities.
2. Developing and publishing flyers and brochures which would
aid ACAH field personnel and the agricultural community.
Arizona ( ommission o f
A g r i c u l t u r e dnd H o r t i c u i t u r e
D 1I; SS lAJtST HDAhlS PHOENIX ARIZONA 85007 16321 255 1373
FIELD SERVICES
State : lqriculturnl I, al~ omtorv
B Fr~ lit8i 1. c. qetahlc Stanrinrdization
District Offices
Inspection Stations
Office of State <: liernist
Iloard of I'esticiclc Control
O F F I C E O F T H E D I R E C T O R
October 26, 1984
_ - -- .
, -.
- , ' I . . ! I-,
- L -\
, ..
TO : Douglas R. Norton, Auditor General .' 4
r -
FROM Ivan J. S h i e l d s , D i r e c t o r
SUBJ : S t a t e A g r i c u l t u r a l Laboratory
Sunset Audit
Attached a r e the agency's f i n a l responses i n regard t o the
A g r i c u l t u r a l Laboratory Sunset Audit, due i n your o f f i c e
today.
I JS : AKS : PO
cc: Spires
Performance Audit
Office of the
Auditor General
October 1984
COMMISSION OF AGRICULTURE AND HORTICULTURE
Response from Commission of Agriculture and Horticulture - October 15, 1984
FINDING I
The lack of documented policies and an effective quality assurance program
may be affecting the reliability of test results in the analytical section.
Recommendations
D ( 1) State Agricultural Laboratory management policies regarding testing and
documentation procedures should be put in written form, reviewed with all
laboratory personnel and enforced.
( 2) The State Agricultural Laboratory should develop and implement a formal
quality assurance program.
D
Res~ onse
( 1) The State Agricultural Laboratory operates under the administrative
policies of the Commission of Agriculture and Horticulture. The
Agricultural Laboratory has not issued formal policies to cover Program
needs, but was addressed by written memos to staff to cover testing and
documentation procedures. See attached.
( 2) Our laboratory has been accepted as an EPA Enforcement Laboratory which
requires written quality assurance program for pesticide testing. Test
methods used in the laboratory are AOAC, EPA, and FDA methods which have
been documented as reliable results. Many of these methods have builr- in
quality assurance procedures. In other areas of testing, further docu-mentation
will be developed to support the reliability of results issued
from the laboratory and will be updated to include uniform instructions to
insure accurate documentation.
FINDING TI
The certification of laboratories providing agricultural testing
services may no longer be necessary.
Recommendations
Certification of laboratories desiring to perform agricultural testing
services should be discontinued. However, in the testing of cottonseed
for aflatoxin, private laboratories should continue providing reports
of the test results which contain a statement, signed by them, attesting
that the testing methods ( or for samplers, the sampling procedures) used
comply with the Arizona Commercial Feed Regulation. The agricultural
industry and other state ( non- Arizona) regulatory agencies should be 4
advised that no cottonseed should be accepted for feed unless accompanied
by a laboratory report which includes the attest statement. A laboratory
should not accept a sample for which an attested result is requested
unless the sample submitted is accompanied by a signed attest statement.
These requirements could be incorporated through the commercial feed
law and/ or regulations.
Should the certification program be continued by the State, the effective-ness
of its administration should be improved. Sufficient resources
will be necessary to do so, and a fee sufficient to recover the cost
should be charged. ( See Finding 111, pages 36- 42.)
Response
Arizona agriculture then would not suffer economical setbacks because
this certification procedure would insure acceptance in the market place.
Some modification of the statutes would be necessary through legislation
to allow certification of the other chemicals. * a
It is the agency's opinion that the Certification Program should -(.
Several changes in the Office of Director and in the Assistant Director's
position have caused delays in the full implementation of developing an
effective certification program. A renewed effort to develop resources
and possibly have a cost for services rendered should be implemented if
the certification program is to continue.
not be discontinued. The certification of laboratories did perform
a service when the problem of aflatoxin was being resolved. Following
that accomplishment, a testing procedure was standardized as in the
case of cotton seed for aflatoxin. Private laboratories could continue
to provide the test results, but would need to be audited on a periodic
basis by the Commission. It is the agency's concern that other chemicals
could cause problems of safety to the public's health and welfare, there-fore,
the same procedure should be followed to solve that problem as we
have with aflatoxin.
4
a
FINDING I11
If the laboratory certification program is continued, administration
should be improved and the program costs recovered through higher fees.
Recommendations
If the decision of the legislature is to continue the certification
program, the following actions are recommended:
A. Effective administrative procedures should be developed and
implemented immediately for the certification program.
B. The certificate should be revised and the Commission should start
approving certification as directed by the statutes.
C. The statutory fee limits should be revised and fees sufficient to
recover effective program costs should be imposed.
Response
A. The Commission will need to review its full responsibility of
State Agricultural Laboratory as dictated by statute and thus become
more directly involved in the administration and certification, by
clearly stated rules and regulations.
B. Due to the several findings of the Auditor General's Office, a
revision of the certification rules and regulations has been prepared
and will soon be submitted for approval and public hearing.
C. We concur with your recommendation, if certification is to continue
we will endeavor to make the statutory change.
FINDING TV
Regulations have not been published and the draft regulations should
be revised before publication if the certification program is continued.
Recommendations
It is recommended the Commission of Agriculture and Horticulture take
the following actions to clarify regulatory procedures and the authority
of the State Agricultural Laboratory:
1. Identify certification application procedures for samplers.
2. Identify procedures for granting certification to samplers.
3. Authorize the agency to receive individual certified laboratory's
check sample program test results.
4. Provide the Agency with appropriate authority to administer the
certification program.
5. Require certified laboratories to notify the Assistant Director
of any changes within the laboratory.
6. Clarify who has the authority to grant, renew, refuse to grant or
to renew a certificate.
7. Provide guidelines to certified laboratories for handling samples
that do not meet Commerical Feed Regulations.
8. Limit the requirement for certification of samplers to only those
who sample cottonseed or cottonseed products.
9. The Commission should aggressively pursue publication of the
Sampling and Laboratory Certification Regulations.
Response
The draft, dated January 1982, was signed by the Director of the
Commission of Agriculture and Horticulture and submitted to the Attorney
General's Office in September of 1982.
In the Sunset Auditing process, our attention was drawn to a number of
changes that were necessary to be in full compliance with the statutes.
However, circu~ stances may arise that certification will be necessary
on other commodity areas. A re- draft of those rules and regulations
has been made following the recommendations of the draft copy of the
Sunset findings and this will be resubmitted to the Attorney General's
Office for approval. The Commission agressively intends to pursue the
publication of the sampling and laboratory certification regulations
and plans to hold a hearing in the near future.
FINDING V
The agency may n o t b e providing a l l of the mandated s e r v i c e s .
Recommendations
The following a c t i o n s a r e recommended:
A. The Commission and the Agency should continue e f f o r t s t o procure
the s e r v i c e s of a q u a l i f i e d p l a n t p a t h o l o g i s t .
B. The Commission and the Agency should develop interagency agreements
with those agencies not mandated by s t a t u t e t h a t r e q u i r e a g r i c u l t u r a l
laboratory s e r v i c e s . An estimate of the cost of these s e r v i c e s should
be provided t o the requesting agency by the S t a t e A g r i c u l t u r a l Laboratory
f o r inclusion i n t h e i r budgets. Such estimates should be based on fore-c
a s t s , provided by the agencies being served, of t h e i r a n t i c i p a t e d volume
by type of s e r v i c e s .
C. The l e g i s l a t u r e should c l a r i f y its i n t e n t w i t h r e s p e c t t o milk
t e s t i n g . I f it is the l e g i s l a t u r e ' s i n t e n t t o have the Agency provide
milk t e s t i n g then:
I. The Dairy Conmissioner should be added to the agencies s p e c i f i e d
i n ARS S3- 142.
2. The l e g i s l a t u r e should d i r e c t t h a t a study be made of the
Department of Health Services t o a s c e r t a i n t o what extent equipment
and personnel resources a r e dedicated t o milk t e s t i n g .
3. The Commission and the Agency should prepare and submit the
appropriate budgetary request pursuant t o e s t a b l i s h i n g t h e c a p a b i l i t y
t o perform milk t e s t i n g .
D. The Commission should conduct a study of the present meat t e s t i n g
program t o determine i f it would be f e a s i b l e and b e n e f i c i a l t o have
meat t e s t i n g done l o c a l l y .
E. I f t h e c e r t i f i c a t i o n program is continued, the Commission should
d i r e c t the A s s i s t a n t D i r e c t o r t o proceed with the evaluation of
l a b o r a t o r i e s which r e q u i r e c e r t i f i c a t i o n and have not been c e r t i f i e d .
F. I f the c e r t i f i c a t i o n program is continued, the Commission should
c l a r i f y regulatory requirements f o r c e r t i f i c a t i o n of samplers. Consideration
should be given to c e r t i f y i n g o n l y t h o s e who sample cottonseed or cotton-seed
products whose d i s t r i b u t i o n is intended f o r l i v e s t o c k .
- Re- spo nse
A. The Commission is proceeding i n acquiring the s e r v i c e s of a f u l l -
time q u a l i f i e d P l a n t P a t h o l o g i s t . Presently the S t a t e Personnel Office
is r e a d v e r t i s i n g t h e p o s i t i o n u n t i l such time t h a t a q u a l i f i e d applicant
is acquired.
B. The Commission is in the process of developing interagency agree-ments
for services rendered and will plan to incorporate into these
interagency agreements the estimated costs associated with the
Agricultural Laboratory services which will then be included in other
budgets .
C. The 37th Legislature did address, in part, the use of interagency
agreements between the Commission of Agriculture and Horticulture, the
Dairy Commissioner and Egg Inspector in each of the respective budgets.
The footnote instructs us to develop interagency agreements. This
could be expanded to include milk testing. Budgetary requests have
been made for the past 3 years for additional manpower and funds to
enable the State Agricultural Laboratory to meet its statutory obli-gat
ions.
D. The arrangement of asking an outside agency to conduct meat testing
has been acceptable to meet present needs; however, the question of the
efficiency and turnaround time needs to be looked into and consideration
should be given as to costs and benefits to testing meat samples locally.
This would be contingent upon the standards necessary to receive Federal
endorsement for meat testing.
E. We concur and this needs to be reviewed annually by the Commission.
F. Under the exacting requirements of today's laboratory methodology
it is necessary to sample according to certain recommended practices
and that a set of regulatory requirements be developed for the private
sector and the State employee who will each be taking samples. These
requirements could be made a part of thz certification program.
FINDING VI
The s t a t u t e s a r e not c l e a r with regard t o t h e r e p o r t i n g of tsst
r e s u l t s by p r i v a t e l a b o r a t o r i e s .
Recommendation
I f t h e laboratory c e r t i f i c a t i o n program is continued, we recommend the
l e g i s l a t u r e consider a r e v i s i o n t o ARS S3- 145. C which would c l a r i f y
the Agency's a u t h o r i t y t o receive copies of c e r t i f i e d l a b o r a t o r i e s '
c e r t i f i e d s e r v i c e s ' a n a l y t i c a l r e s u l t s .
Response
We concur although t h e r e needs to be a c e r t a i n amount of c o n f i d e n t i a l i t y
regarding these a n a l y t i c a l r e s u l t s . I n p r a c t i c e , c e r t i f i e d l a b o r a t o r i e s
have given t h i s informat ion v o l u n t a r i l y .
FINDING V I I
Two Arizona agencies a r e c u r r e n t l y authorized by s t a t u t e t o provide
c e r t i f i c a t i o n of l a b o r a t o r i e s to provide a g r i c u l t u r a l l a b o r a t o r y
s e r v i c e s .
Recommendation
We recommend the l e g i s l a t u r e consider a r e v i s i o n to the DHS s t a t u t e s
t o remove the a u t h o r i t y t o c e r t i f y l a b o r a t o r i e s f o r the provi