Team:ITESM-Guadalajara/Laws

MEXICAN REGULATION LAWS

In our country; Mexico, the Biosecurity Law for Genetically Modified Organisms (GMO) is in charge of the regulation of the activities related with the use, commerce and research of the GMO.

According to this law, our product is catalogued as a derived from a GMO; any product in which production process was involved a GMO input or extract but the final product; which will be commercialized, does not contain it.

Since the process is made by a GMO, it is necessary to make a risk evaluation and to analyze the alternative options that could be performed in order to avoid the use of GMO. The enterprise must consider having the capacity and the regulations to avoid the accidental liberation to the environment of the GMO from the remains of any process in which it had been involved. There are not special requirements since we are not commercializing a GMO.

The GMO use; during the process, it is just for contained use; activities that involved the modification of genetic material and the use of physical, biological or both barriers in order to avoid the contact between the environment and the population. Nevertheless, the following control activities must be done:

• To register the activities in which the OGMs will be involved during the process.
• To implement activities for risk management, final disposure and removal of OGM remains
• To establish an action plan in case of the accidental liberation of GMO to environment.

The “Ley General de Salud” is involved in the sanitary control of the product and the process also; according to this law, since our product will be developed for pharmaceutical use it is considered to be an input for health.

The “Reglamento para insumos de la salud” regulates the activities, sanitary control, services and establishments related with the inputs for health.

The FDA establishes that shrimp-derived chitosan is Generally Recognized as Safe (GRAS) which means that the chitosan does not make reactions on the human body.

Biophrame is looking for the international delivery of chitosan. The Cartagena Protocol establishes the main aspects for the transportation of GMO’s and it does not apply to products derived from genetically modified organisms.

“Ley de Bioseguridad de organismos genéticamente modificados” Cámara de Diputados del H. Congreso de la Unión. 2005.

Bill Proposal of Biophrame.

Mexico is a member of the World Trade Organization (WTO) and it is also an active member of the Cartagena Protocol. Its participation in these organizations should facilitate and enable the transit of living modified organisms (LMO), genetically modified organisms (GMOs) and equipment or samples needed to investigate and / or develop any of the organisms mentioned before. The Secretary of Health and COFEPRIS are responsible for the regulation, information giving, and product verification regarding biological material, such as DNA, bacteria and hormones.

Being the import process of genetic material a time-consuming and ambiguous process, where the final decision of retaining or releasing this material lies in the customs agents; it is proposed to clearly classify products as hormones, bacteria or DNA, and the presentation in which these products are being transported through a guide containing labeling and necessary paperwork specifications to complete the import process without problems.

In case the biological material to be imported does not contain a complete labeling because these products do not contain large specifications on the label, the provider must submit a commitment letter, in which it is ensured that the material being imported into that presentation is risk free and safe. It is also proposed to establish an official standard for labeling, packaging, distribution and transport that specifies:

• Full Product Name and abbreviation
• Classification according to its risk levels in:
  • Health
  • Environment
• Storage and transport conditions

It is proposed the extension and modification of the Official Mexican Standard NOM-087-ECOL-SSA1-2002, about environment protection, environment health, hazardous biological and infectious wastes, classification and handling specifications. If the imported material is destined to Universities or recognized Research Centers in Mexico, agreements, arrangements or an established custom format should be incorporated in order to speed up the process and such material does not persists retained for unnecessary time due to the lack of information. It is proposed attachment to Articles 4 and 6 of the Cartagena Protocol, the provisions of the Agreement on the Application of Sanitary and Phytosanitary Measures, as well as the agreement on Technical Trading Barriers.