MINISTRY OF H EALTH

SUPREME DECREE No. 707

Published in the Official Gazette, April 3, 2000

 

APPROVES REGULATIONS FOR BROMATOLOGICAL PUBLIC HEALTH LABORATORIES

 

No. 707 – Santiago, November 5, 1999

 

Having had before me:

 

The provisions contained in articles 2, 42, 43, 45, 46, and in Book X of the Health Code, approved by Decree with Force of Law No. 725, of 1967, issued by the Ministry of Health; articles 4, 6, 16, 35, and 37 of Decree-Law No. 2763, of 1979; article 70n of Decree-Law No. 977, of 1996, issued by the Ministry of Health, and bearing in mind the authority granted to me under article 32 No. 8 of the Constitution of the Republic of Chile; and

 

Whereas

 

There is a need to have bromatological laboratories that perform analyses of food consumed in Chile, that are reliable for the health authorities in charge of overseeing and monitoring them within its responsibility of safeguarding the health of the population, as well as analyses of such products intended for export;

 

I hereby decree

 

The following Regulations for Private Public-Health Bromatological Laboratories are hereby approved.

 

TITLE I

GENERAL

 

Article 1 – The Health Agencies will grant recognition as public-health bromatological laboratories for the analysis of the sanitary quality of food for export and internal control  of food factories to private establishments complying with the provisions contained hereunder.

 

Article 2 – For the purposes hereof, the following terms shall have the meaning shown below:

(a)              Quality assurance: set of planned and systematic actions necessary to ensure adequate confidence that a product or service meets established quality requirements.

(b)              Calibration: operation conducted by technical means and procedures to determine by comparison with a template or reference material or by absolute methods the error values of a means or instrument of measurement.

(c)               Sanitary quality of export products: the microbiological and chemico-bromatological conditions required by the purchasing country.

(d)              National reference center: standardizing, evaluating laboratory, supervisor of the network of bromatological public-health laboratories of the Chilean Health Care System and private laboratories; this function is the responsibility of the Chilean Institute for Public Health.

(e)              Sanitary quality control:  verification of compliance with the requirements under the Sanitary Food Regulation by the various food batches,

(f)                 Analytical assay or test: specific technical procedure designed to determine or check that a given food, water, or food additive meets one or more given characteristics.

(g)              Interlab test: evaluation programs on the analytical capability of a given laboratory, by sending blind samples thereto.

(h)               Validation: proof that a given analytical procedure or service complies with the specifications for which  it was defined.

 

Article 3 – A bromatological public-health laboratory is an establishment authorized by a Health Agency to do analytical work in support of public health authorities by analyzing food, food additives, raw materials for food, and table water by standardized, validated analytical  procedures and methods, recognized thereby.

 

Article 4 – Bromatological public-health laboratories shall supply at least one of the following forms of food analysis: microbiological, chemico-bromatological, parasitological, ortoxicological.

 

Article 5 – In performing its function as national reference laboratory, the Institute of Public Health  shall standardize techniques, procedures, and methods used to analyze food and water, and shall assess laboratories yearly by means of the interlab assay program  to determine adherence to standard procedures and techniques, and reliability of the results thereof.  Assay results shall be conveyed to the Health Agency with jurisdiction over the establishment so assessed for information thereof and adoption of necessary measures, as appropriate.

 

Article 6 – Bromatological laboratories governed hereby shall adhere to the provisions hereunder in everything connected with the activity thereof and as regards techniques and methods used for analyses, to the technical standards issued by the Chilean Institute of Public Health for such purpose.

 

Article 7 – Bromatological public-health laboratories shall be managed by a responsible Technical Director, who must be a graduate with at least 8 semesters of professional training in a bromatology-related career.  This fact shall be supported by the appropriate documents.

 

 

 

 

 

 

 

TITLE II

AUTHORIZATION

 

Article 8 – To obtain permission to operate as a public-health bromatological laboratory, the persons concerned shall submit an application to the Health Agency with jurisdiction over the place where such lab is located, supported by the following information:

(a)   Name or company name and address of laboratory

(b)   Identification of owner. If owner is a juristic person, proof of organization and current effect, identification and authority of the representatives thereof.

(c)   Identification of Technical Director and alternate, including professional qualifications

(d)   Drawing or scale sketch of plant and sanitary facilities, showing work areas, equipment location, and flow lines.

(e)   Description of equipment and instruments to be used for analyses, technical characteristics thereof , and calibration and maintenance records.

(f)     List of analytical services offered and associated validated techniques to be employed for such purpose

(g)   Quality assurance method employed in the laboratory, with documents supporting result validity, service reliability

(h)   System used for storage of hazardous materials and waste disposal.

 

Article 9 – Upon receipt of the application, the Health Agency will assess the stated ability to provide service adequately and reliably.  Such assessment will include inspection of the establishment from the following standpoints:

(a)              organization and administration

(b)              quality assurance

(c)               equipment and instruments to be used

(d)              degree of staff training and expertise

(e)              ability to apply the method to be used in delivering service

(f)                 adequacy of facilities and equipment for proper performance.

 

Article 10 – The application for authorization shall be resolved by the appropriate Health Agency within a period of thirty business days from the date when applicant completes the required information.  All visits, inspections, and other necessary actions or procedures for deciding on acceptance or rejection shall be completed within such term.

            Health Agencies not operating their own bromatological laboratory or not having implemented or validated with the Chilean Institute for Public Health the services proposed by applicant, shall grant the authorizations requested with the advisory services of such Institute.

 

Article 12 – Subsequent applications submitted by laboratories already authorized to perform tests not otherwise covered by the authorization already granted thereto shall be processed as new applications and go through the entire procedure set forth hereunder.

 

Article 13 – The health authority shall draw up and keep an official list of authorized establishments showing the services they can provide, location thereof, name of owner, and Technical Director.  The lists containing such information shall be available to the public.

 

 

TITLE III

LABORATORY FACILITIES

 

Article 14 – Laboratories shall be located in areas distant from unhealthy, dusty, and polluted spots, and the facilities thereof shall be such as to guarantee the fluidity of the process and the quality assurance system.

 

Article 15 – In test areas, floors, walls, and ceilings, together with doors and windows, shall be built of waterproof, non-absorbent, washable, non-toxic materials.

            If activities in neighboring areas are incompatible and affect service quality, effective separation must be ensured.

 

Article 16 – The facilities shall be equipped with water supply, waste water and  (as the case may be) biological waste disposal, gas venting, controlled temperature areas, security or emergency systems, which shall be kept in good operating conditions.

            Locker rooms and toilets shall be available pursuant to provisions contained in the Regulations on Basic Sanitary and Environmental Conditions at the Workplace.

 

 

 

TITLE IV

LABORATORY OPERATION

 

Article 17 – A public-health bromatological laboratory cannot operate in the absence of the technical director thereof, which official, however, may be replaced by an alternate, who shall comply with the same conditions required of the regular director and whose designation shall be communicated to the Health Agency by the laboratory.

 

Article 18 – The responsibilities of the technical director of a public-health bromatology laboratory shall be to

(a)   guarantee the quality of the tests performed at the laboratory, and the accuracy of the reports issued thereon;

(b)   represent the laboratory in technical matters before the Health Agency;

(c)   comply with recommendations and instructions issued by the health authority, and oversee compliance therewith.

 

Article 19 – Public-health bromatology laboratories shall carry a record of all services rendered with numbered entries in a book or computer file, which shall be available to the Health Agency for a period of five years.  Such record shall include, at least the following information:

(a)              Date and time when sample was taken and received

(b)              Nature and quantity of sample

(c)               Name and address of patient and name of sample taker

(d)              Test requested and method used

(e)              Test result

(f)                 Record of calibrations effected both on equipment or instruments, and on the components thereof.

 

Article 20 – Public-health bromatology laboratories shall carry a register of supervision visits, numbered and stamped by the Health Agency, which shall be kept in the custody of the technical director of the lab.  Such book shall include inspection and supervision visits conducted by the competent Health Agency and all events, instructions, objections, or suggestions made in the course thereof.

 

 

 

TITLE XV

SUPERVISION  AND PENALTIES               

 

Article 21 – The Health Agencies with jurisdiction over the territory where public-health bromatology laboratories are located are responsible for supervising application and performance hereof, and applying penalties as appropriate, pursuant to the provisions contained in Book X of the Health Code.

            In particular, and following the relevant summary proceeding, they may terminate authorization to conduct a given form of test if the quality control report issued by the Institute for Public Health states that the minimum acceptable quality level has not been reached, or, as the case may be, suspend such authorization until the defects causing such quality failure have been corrected.

 

To be registered, noted, and published – EDUARDO FREI RUIZ TAGLE, President of the Republic – Alex Figueroa Muρoz, Minister of Health.

            Which I hereby transcribe for your information,  Yours truly, Ernesto Behnke Gutiιrrez , Under Secretary for Health