Team:Tec-Monterrey/Humanpractices

1. Introduction
2. Regulations in Mexico related to General Health Law
1. Overview
2. General requirements for labeling importation samples
3. For Biotechnology Labeling
4. Regulations and Requirements
5. Import Procedures
3. Importation manual: a step-by-step guide
1. Document Requirements
2. Step 1
3. Step 2
4. Step 3
5. Step 4
6. Step 5
4. Recommendations

Introduction

This year was the first time that the team Tec-Monterrey participated in iGEM. We are only the third university in Mexico to ever participate in this competition, and one of the few in Latin America. As our ideas slowly began to shape up into a real project, one of the greatest obstacles that we had to overcome, and perhaps one that we had naively not expected, was the Mexican Customs.

We were surprised to discover that our government doesn’t have a defined protocol for the importation of biological material. The Customs Officers freaked out on reading the words “gene”, “DNA” or “bacteria”, and even if the contents were labeled correctly as non-toxic, non-carcinogenic, non-teratogenic, etc… we had several packages delayed or permanently detained. We were constantly sent to different departments, and finally realized that the mandatory permits should have been requested with months in advance and that they naturally required the payment of a considerable fee.

On speaking to researchers in our own and other universities, we learned that we were not alone on this difficulty. Scientists with enough money pay specialized agencies to arrange the importation of their biological material, which may cost more than the material to be imported! Researchers with not such an ample budget simply rely on luck and hope that their package will go unnoticed if undeclared. Clearly, this complication not only slowed down our iGEM project; it delays the progress of science in our country altogether and reflects the lack of understanding of the biological language from our authorities.

Synthetic biology is an emerging science in our country. We know that it is only a short matter of time before more Mexican teams participate in future iGEM competitions, and we believe that we can ease their experience by sharing our own. We have created a quick user manual with the basic instructions needed to fill out the necessary paperwork to receive synthetic DNA donations – such as the iGEM Kit or BioBricks form the Registry.We hope that this information will be valuable not only for future Mexican iGEM teams, but also for any researcher working in the field of synthetic biology in Mexico.

We finally conclude with a list of recommendations that may improve the process of importation of biological material into our country, and that if implemented will greatly facilitate and speed up the progress of science in Mexico. We have submitted this document to our local congresswoman, Brenda Velázquez Valdez, and hope that our leaders will be made aware our views and take them into account for future laws.

Regulations in Mexico related to General Health Law

Overview

The General Health Law assigns the Mexican Ministry of Health (Secretaría de Salud) with the responsibility of issuing regulations related to human health. In the case of importations, the importer must show all the required documentation under implemented regulations by the General Health Law, and must include a health certificate issued by authorities in the country of origin. The Ministry may also randomly sample and inspect imported products to ensure compliance with Mexican requirements. Mexican regulations related to human health are issued through the Ministry of Health’s regulatory agency, by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS); its website www.cofepris.gob.mx.

General requirements for labeling importation samples

There are two options for labeling:

1. The original English container can be used as long as a sticker containing all the labeling requirements in Spanish is attached. Stickers are permitted as long as they remain attached to the container.
2. The product can be packaged for the local Mexican market using Spanish.

Biotechnology labeling

Currently there is not a specific NOM (Mexican Official Norm or standard) for labeling GMO’s or products containing GMO’s. However, the industry has agreed that yellow corn must be identified as such in the package. These products are subject to general labeling requirements.

Regulations and Requirements Based on Public Health Risks (SSA or SALUD)

The Federal Commission for the Sanitary Risk Protection (COFEPRIS) is the regulatory agency in charge of the control and surveillance of food and beverages, food supplements, tobacco, plant nutrients, toxic or dangerous substances, biotechnology products, and pesticides among others types of products.

The Treaty that establishes the classification and codification of products, the importation of which is subject to regulations from the Mexican Ministry of Health SSA, issued on September 27, 2007, and last updated on June 25, 2009, lists the tariff numbers of the products that are subject to SSA regulation. These products require either an import permit “PERMISO Sanitario de Importación” or simply an import notification “AVISO Sanitario de Importación” to COFEPRIS.

The most important thing for the U.S. exporter is to determine the exact tariff classification number. This number will define the regulatory agency and all the documentation necessary to get import approval. In the case of DNA, this classification number (fracción arancelaria) is 29371999 “ácido desoxiribonucleico”. The importer of products subject to SSA regulations must be registered with SALUD and is responsible for securing all the necessary documentation for a successful importation process.

The importer of products subject to SSA regulations must be registered with SALUD and is responsible for securing all the necessary documentation for a well done import process.

Import Procedures

Importation manual: a step-by-step guide

If you are a Mexican team from a public or private university and wish to receive BioBricks from the Registry or synthetic DNA as a donation, then you must begin by obtaining a health permit, three months in advance to avoid setbacks. It is important to know that the regulatory agency for this permission is the COFEPRIS, the Federal Commission for the Protection Against Sanitary Risks in Mexico.

The code for this permission is: COFEPRIS-01-010-E

*It is important that the items be declared as a donation. As a $0.00 price cannot be officially declared, we suggest claiming a cost of $1 or $10 USD.

Document requirements

• Donation letter given and signed by the donor with recent date. This document must be sent on letterhead paper.
• Acceptance letter of the donation given and signed by the responsible of your team in your university. This document must be sent on letterhead paper with recent date and it should contain a statement of no commercialization.
• Copy of professional license of the doctor responsible for the donation.
• Letter that establishes and notifies clearly the use of the product that you want to import.
• Application form named “Solicitudes”.

To get started with this process you must fill out properly the application form “Solicitudes”, which is in the web page: www.cofepris.gob.mx

Particularly you must fill the next numbers in the application form “Solicitudes”:

Step 1

Step 2

Step 3

This section is regarding product information. The fields that must be filled out are: 1, 2, 3, 4, 5, 6, 7, 8, 10,11, 15, 17, 18, 35, 36, 37.

Step 4

This section is regarding import registry.

Step 5

Download the Manual as a PDF here.

Recommendations

We finally conclude with a list of ideas that may improve the process of importation of biological material into our country, and that if implemented will greatly facilitate and speed up the progress of science in Mexico. We have voiced these recommendations to our local congresswoman, Brenda Velázquez Valdez, and hope that our leaders will be made aware our views and take them into account for future laws.

1. Any researcher or university should be able to legally import non-hazardous biological material without necessarily having to hire an agency. An easy step-by-step guide for the correct labeling, and necessary paperwork and proceedings for the importation of biological material should be made available on line and the required forms should be more accessible to the general public.
2. Every Customs Agent should have a minimal understanding of biology and a basic knowledge of scientific terms, such as DNA, gene, synthetic, bacteria, strain, vial, so that these terms don’t immediately suggest a biological hazard or weapon.
3. A scientific committee that reviews the laws governing the importation of biological material and advises on relevant changes should be established. The actual laws need to be modernized in order to encourage scientific research and international collaboration.
4. A new tariff classification for biological products needs to be created. The current classification is very ambiguous. For example, we were once asked to classify our bacterial strain as belonging to either the plant or animal kingdom. This classification should take into account biohazard levels, and each class should be clearly defined and independent.
5. When importing or exporting biological material, a simple declaration form should be initially filled, stating the contents and biohazard level. If there is no potential hazard and the item is correctly labeled, there should be no reason for it to be detained.
6. Donated biological material ($0.00 value) pays no taxes, but we propose to reduce the taxes on biological material imported with investigation or experimental purposes only, especially if it the research is linked to undergraduate or graduate students seeking no monetary gain and usually working with low budgets.
7. Science moves at an extraordinarily fast pace, and it is outrageous that the approval of importation permits in our country can take up to twelve months. Nowadays, requesting these permits from a place other than Mexico City takes an even longer time, because the paperwork needs to be sent the capital city and then back. This time lapse can easily be accelerated if the logistics are improved and state offices are installed.