Title: The Biosafety (Genetically Modified Organisms for Food, Feed, and Processing) Regulations, 2010 (SI NO. 42 OF 2010)

Type: Statutory Instrument

Issuing Agency: Parliament of Zambia

Responsible Agency: National Biosafety Authority

Issuing Date: 11-06-2010

STATUTORY INSTRUMENT NO. 42 OF 2010

The Biosafety Act, 2007

(Act No. 10 of 2007)

The Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010

PART I

PRELIMINARY

1. Title
2. Interpretation

PART II

IMPORTATION OF GENETICALLY MODIFIED ORGANISMS

3. Prohibition of importation of genetically modified organism for food, feed or processing
4. Application for permit to import genetically modified organism for food, feed or processing
5. Consideration for application
6. Referral to other agencies
7. Public consultation
8. Grant of permit
9. Rejection of application
10. Permit conditions
11. Labelling of consignment for importation
12. Approval of genetically modified organisms for direct use to be entered in Register
13. Notice of arrival of shipment
14. Suspension, revocation, or cancellation of permit

PART III

LABELING AND TRACEABILITY

15. Scope of Part
16. Traceability
17. Labelling
18. Exemptions
19. Traceability requirements for food and feed produced from genetically modified organisms
20. Application to place on market food, feed or product derived from genetically modified organisms
21. Unique identifiers
22. Withdrawal of certain genetically modified organisms
23. Risk management measures
24. Inspection and control measures
25. Register
26. Appeal to Tribunal
27. Fees

FIRST SCHEDULE

SECOND SCHEDULE

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IN EXERCISE of the powers contained in section forty-six of the Biosafety Act, 2007, the following Regulations are hereby made:

PART I

1. These Regulations may be cited as the Biosafety (Genetically Modified Organisms for Food, Feed and Processing) Regulations, 2010.
2. In these Regulations, unless the context otherwise requires “Authority has the meaning assigned to it in the Act;

“feed” means any substance, whether processed, semi-processed, or raw, which is intended for animal consumption;

“final consumer” means the ultimate consumer who will not use the product as part of any business operation or activity;

“food” means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance that is used in the manufacture of food, but does not include cosmetics, tobacco or substances used only as drugs;

“genetically modified organism” has the meaning assigned to it in the Act;

“import” has the meaning assigned to it in the Act;

“ingredient” means any substance, including a food or feed additive or a component of a compound ingredient, used in the manufacture or preparation of a foodstuff or feed and present in the final product, whether or not in a modified form;

“label” means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on, or attached to, a container of food or feed;

“operator” means a natural or legal person who places a product on the market or who receives a product that has been placed on the market in Zambia, or from another country, at any stage of the production and distribution chain, but does not include the final consumer;

“placing on the market” has the meaning assigned to it in the Act;

“pre packaged” means packaged or made up in advance in a container, ready for offer to the consumer, or for catering;

“produced from genetically modified organisms” means derived, in whole or in part from genetically modified organisms, but not containing or consisting of genetically modified organisms;

“Register” means the Register established under regulation 24;

“the first stage of the placing on the market of a product” means the initial transaction in the production and distribution chains, where a product is made available to a third party;

“traceability” means the ability to trace genetically modified organisms and products produced from genetically modified organisms at all stages of their placing on the market through the production and distribution chains;

“Tribunal” has the meaning assigned to it in the Act; and

“unique identifier” means a simple numeric or alphanumeric code which serves to identify a genetically modified organism on the basis of the authorized transformation event from which it was developed and providing the means to retrieve specific information pertinent to that genetically modified organism.

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PART II

IMPORTATION OF GENETICALLY MODIFIED ORGANISMS

3. A person shall not import genetically modified organism for direct use as food or feed or processing unless-

1. the importation is duly authorized by the Authority;
2. the genetically modified organism is authorized for commercial distribution as food or feed in the country of origin; and
3. regardless of the intended use, the genetically modified organism poses no significant risks to human or animal health, biological diversity, non genetically modified crop or the environment.

4. An application to import a genetically modified organism for direct use as food or feed or for processing shall be in Form I set out in the First Schedule.
5. (1) The Authority shall, within fourteen days from receipt of an application under regulation 4, examine the application to determine if it meets the requirements of the Act and these Regulations.

(2) The Authority shall, where the application meets the requirements of the Act and these Regulations-

(a)accept the application and inform the applicant in Form II set out in the First Schedule; and

(b)forward a copy of the application to the Scientific Advisory Committee.

(3)The Scientific Advisory Committee shall evaluate an application referred to it under sub regulation (2), particularly the risk assessment studies conducted and actions taken by the relevant regulatory authorities in the country of origin, and submit its report to the Authority within thirty days from its receipt of the application.

(4) The Authority shall, where an application is incomplete or defective, inform the applicant in Form III set out in the First Schedule and give the applicant a period within which to correct the defects in the application.

(5) Where an applicant to whom a notice is sent under sub regulation (4) fails to correct the defect within the period specified by the Authority, the Authority shall reject the application.

(6) An applicant whose application is rejected under sub regulation (5) may re submit the application after the defect is corrected.

(7) The Authority may request an applicant to submit additional information in relation to the application in Form IV set out in the First Schedule.

6. (1) The Authority shall furnish the following agencies with a copy of theapplication for their comments:

1. the Plant Quarantine and Phytosanitary Service, if the genetically modified organism is a raw agricultural commodity intended for direct use as food or processing into food; and
2. the authorized veterinary services, if the genetically modified organism is intended for direct use as feed or for processing into feed.

(2) The agencies referred to under sub regulation (1) shall submit their comments to the Authority within thirty days of receipt of the application.

7. (1) An applicant shall, within fifteen days from the receipt of the acceptance of the application by the Authority, publish a notice, in at least two daily newspapers of general circulation in Zambia, inviting interested parties to send their comments or objections on the proposed importation for direct use as food or feed, or for processing, to the Authority within a period of thirty days from the date of publication of the notice.

(2) An applicant shall submit to the Authority proof of the publication within fifteen days from the date of publication.

8. (1) The Authority shall, within thirty days from the acceptance of an application, approve the application if the use of the genetically modified organism for food or feed, or for processing, does not pose any significant risks to human or animal health, biological diversity, non the genetically modified crops or the environment.

(2) In calculating the thirty day period referred to under sub regulation (1), the period of time during which the Authority awaits further information from an applicant or from any relevant regulatory authority in the country or origin of the genetically modified organism in respect of which an application is made shall not be included.

(3) A permit to import a genetically modified organism for food, feed or processing shall be in Form V set out in the First Schedule.

(4) A permit may be renewed for a further period of five years where the holder shows that the continued importation of the genetically modified organism as food or feed, or for processing, does not pose any risks to human or animal health, biological diversity, non the genetically modified crops or the environment.

9. (1) The Authority shall reject an application-

1. if the genetically modified organism in respect of which the application is made poses risks to human or animal health, biological diversity, non the genetically modified crops or the environment; or
2. if the application does not meet the requirements of the Act or these Regulations.

(2) A notification of a rejection of an application shall be in Form VI set out in the First Schedule.

10. A permit holder shall comply with the following conditions;

1. the genetically modified organism shall be imported solely and exclusively for direct use as food or feed, or for processing into food or feed and not for field testing or propagation;
2. the genetically modified organism shall be maintained and disposed of in such a manner as to prevent any risks to human or animal health, biological diversity, non the genetically modified crop or the environment;
3. all packing materials, shipping containers and all other materials accompanying the genetically modified organism shall be treated or disposed of in such a manner as to prevent any risks to human or animal health, biological diversity, non-genetically modified crop or the environment;
4. the permit holder shall give an inspector access, during regular business hours, to the facility where the genetically modified organism is located and to any records relating to the importation of the genetically modified organism;
5. the genetically modified organism shall be identified with a label showing the permit number, name of the genetically modified organism and the date of importation;
6. the genetically modified organism shall be subject to the application of measures including final disposal, which the Authority considers necessary to prevent its accidental or unauthorized release;
7. the permit holder shall-

1. in the event of any accidental or unauthorized release of the genetically modified organism, report to the Authority verbally, immediately upon discovery, or in writing, within twenty four hours; and
2. notify the Authority in writing, as soon as possible, but not exceeding three working days, if the genetically modified organism or associated host organism is found to have characteristics substantially different from those listed in the application for a permit, or suffers from any excessive mortality or morbidity, unanticipated effect on non target organisms or other unusual occurrence;

8. if new information becomes available indicating that the genetically modified organism could pose significant risks to human or animal health, biological diversity, non-genetically modified crop or the environment, the applicant shall report to the Authority who shall immediately take measures to protect human or animal health, biological diversity, non-genetically modified crop or the environment;
9. the permit holder shall import the genetically modified organism only at the port of entry designated in the permit;
10. the permit holder shall comply with such other conditions as the Authority may consider necessary or desirable to prevent any risks to human or animal health, biological diversity, non-genetically modified crop or the environment; and
11. the permit holder shall comply with such other conditions specified under the Act.

11. A consignment for importation shall be labelled in accordance with the requirements specified under Part III.

12. The Authority shall record in the Register the genetically modified organisms or products of genetically modified organisms that have been approved for importation for direct use as food or feed, or for processing.

13. A holder of a permit for the importation of genetically modified organisms for direct use as food or feed, or for processing shall, within fifteen days from the date of arrival of every shipment of the genetically modified organism, notify the Authority of such arrival in Form VII set out in the First Schedule.

14. (1) A permit shall be revoked if-

1. the permit holder provides false information in the application or declaration relating to any shipment of the genetically modified organisms;
2. the permit holder refuses to allow the inspection of the physical containment facility or intermediate destination of the genetically modified organism;
3. the permit holder violates the relevant phytosanitary and biosafety regulations and measures, or any condition imposed in the permit;
4. the authority to commercially distribute the genetically modified organism in the country of origin is suspended or revoked; or
5. new information becomes available to the Authority indicating that the genetically modified organism, if allowed for its intended use will result in significant risks to human or animal health, biological diversity, non-genetically modified crop or the environment.

(2) The Authority may suspend, for any period, revoke or cancel any permit issued under this Act, if the opinion of the Authority, any genetically modified organism or product of a genetically modified organism to which the permit relates poses any risk to human or animal health, biological diversity, non-genetically modified crop or the environment.

(3) A suspension, revocation or cancellation of a permit shall be in Form VIII set out in the First Schedule.

(4) A suspension, revocation or cancellation of a permit shall be endorsed on the permit.

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PART III

LABELING AND TRACEABILITY

15. This Part applies, at all stages of the placing on the market, to

1. products consisting of, or containing, genetically modified organisms, placed on the market in accordance with the Act; and
2. food and feed produced from genetically modified organisms, placed on the market in accordance with the Act.

16. (1) At the first stage of the placing on the market of a product, including bulk quantities, consisting of, or containing, genetically modified organisms an operator shall transmit the following information in writing to the operator receiving the product:

1. that the product contains or consists of genetically modified organisms; and
2. the unique identifier assigned to the genetically modified organisms in accordance with these Regulations.

(2) An operator shall, at all subsequent stages of the placing on the market of products, ensure that the information received in accordance with sub regulation (1) is transmitted in writing to the operators receiving the products.

(3) In the case of products consisting of or containing mixtures of genetically modified organisms to be used only an directly as food or feed or for processing, the information referred to in sun regulation (1) may be replaced by a declaration of use by the operator, accompanied by a list of the unique identifiers for all the genetically modified organisms that have been used to constitute the mixture.

(4) An operator shall put in place systems and standardized procedures to allow the holding of information specified in sub regulations (1), (2) and (3) and the identification, for a period of five years from each transaction, of the operator by whom, and the operator to whom, the products have been made available.

17. (1) For products consisting of or containing genetically modified organisms, an operator shall ensure that-

1. for pre packaged products consisting of, or containing genetically modified organisms, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ appear on a label; and
2. for non pre packaged products offered to the final consumer, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’ shall appear on, or in connection with, the display of the product.

(2) An operator shall label genetically modified food and feed in a manner that ensures that accurate information is available to operators and consumers to enable them to exercise their freedom of choice in an effective manner and to enable the control and verification of labelling claims.

18. (1) Regulation 5 does not apply-

1. to traces of genetically modified organisms in products in a proportion of less than the 0.9 percent threshold:

Provided that the traces of genetically modified organisms are adventitious or technically unavoidable and the genetically modified organisms have been subject to a scientific risk assessment; and

2. to traces of genetically modified organisms in products intended for direct use as food, feed or for processing in a proportion of less than the 0.9 percent threshold:

intended for direct use as food, feed or for processing in a proportion of less than the .9 percent threshold:

Provided that the traces of genetically modified organisms are adventitious or technically unavoidable.

(2) These Regulations do not apply to food which contains or has genetically modified organisms in a proportion of less than 0.5 percent:

Provided that the presence of such genetically modified organisms is considered technically unavoidable and the organisms have been subjected to a scientific risk assessment and considered to be safe.

19. (1) An operator shall, when placing a product produced from genetically modified organisms on the market, transmit the following information in writing to the operator receiving the product:

a) an indication of each of the food ingredients which is produced from genetically modified organisms;

b) an indication of each of the feed materials or additives which is produced from genetically modified organisms; and

c) in the case of the products for which no list of ingredients exists, an indication that the product is produced from genetically modified organisms.

(2) An operator shall put in place systems and standardized procedures to allow the holding of the information specified in sub regulation (1) and the identification, for a period of five years from each transaction, of the operator by whom, and to whom, the products referred to in sub regulation (1) have been made available.

(3) Sub regulations (1) and (2) do not apply to traces of genetically modified organisms in products for food and feed produced from genetically modified organisms in a proportion of less than 0.9 percent threshold established for those genetically modified organisms, if the traces of genetically modified organisms are adventitious or technically unavoidable.

20. (1)An application for the placing on the market of food and feed and products derived from genetically modified organisms shall be made to the Authority and shall include a unique identifier for each genetically modified organism.

(2) An application under sub-regulation (1) shall be in Form I set out in the First Schedule.

(3) The Authority shall, where the application meets the requirements of these Regulations, accept the application and inform the applicant of such acceptance in Form II set out in the first schedule.

(4) A permit to place on the market food, feed and products derived from genetically modified organisms shall be in Form IX set out in the First Schedule.

21. (1) A producer of a genetically modified organism for food or feed shall develop a unique identifier for each genetically modified organism.

(2) Where consent or authorization is granted under sub regulation (3) of regulation 20, for the placing on the market of a genetically modified organism, the Authority shall communicate the unique identifier for the genetically modified organism in writing, to the Biosafety Clearing House.

(3) The unique identifier for each genetically modified organism shall be recorded in the Register.

22. (1) The Authority shall withdraw a genetically modified product where it has adverse effects on human or animal health, biological diversity, non-genetically modified crops or the environment, including socio economic conditions.

(2) If new information or a re assessment of the existing information reveals that the use of food of genetically modified food approved by theses Regulations endangers human health, or the feed endangers animal health, the Authority shall immediately suspend the sale of such food.

(3) A notice of withdrawal of genetically modified food, feed or products, or suspension of the sale of such food, feed or products shall be in Form X set out in the First Schedule, and such withdrawal or suspension shall be endorsed on the permit.

(4) The Authority shall require the person who submitted the application for the approval to import, store, transport, distribute or sell food or feed withdrawn or suspended under this regulations, as the case may be, to withdraw the product from the market and such person shall immediatelycomply with the requirement.

23. Risk management measures shall be implemented in accordance with the provisions of the Act.

24. An inspector may, subject to the provisions of the Act, conduct inspections, as may be appropriate, to ensure compliance with these Regulations.

25. (1) The Authority shall establish and maintain a Register for purposes of these Regulations.

(2) The Authority shall record in the Register all available sequencing information, reference material for, and any other information relating to, genetically modified organisms that are authorized to be put into circulation in Zambia.

26. Any person aggrieved with the decision of the Authority under these Regulations may appeal to the Tribunal in Form XI set out in the First Schedule.

27. The fees set out in the Second Schedule are payable for the matters set out therein.

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FIRST SCHEDULE

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SECOND SCHEDULE

FEES

 

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Download English: The Biosafety (Genetically Modified Organisms for Food, Feed, and Processing) Regulations, 2010 (SI NO. 42 OF 2010)