BCH Training Workshop

BCH Training Workshop

Case Study 1

Objective

The objective of this case study is to use the central portal to access information that a user might need to do business.

A Mexican trader wants to move a shipment of cotton seed from the United States (U.S.) to Mexico for food processing. She knows that cotton from the U.S. may be genetically modified and so wants to find out if Mexico will accept a shipment of cotton seed that may contain GM seed.

There are a number of questions to answer:

1. What GM cotton events are used in the U.S. that might be in the shipment?
2. After the oil is extracted from the seed, the seed cake is used for animal feed. What GM cotton events have been approved for food and feed use in Mexico?
3. What is the process to get permission to import the potentially GM cotton seed into Mexico?

Answering question 1 with the help of the BCH:

What GM cotton events are used in the U.S. that might be in the shipment?

Start at the Central Portal for the BCH:

Go to the Decisions and Declarations section.

• AIA decisions are made on LMOs coming into other countries, so skip this area.
• Decisions under Article 11 are made on use of LMOs including food and feed and import. Access this database to see what is approved for use in the United States by clicking on this option.

Select ‘United States of America’ in the first row – ‘Country communicating the decision’; and ‘cotton’ in the 5th row – ‘Recipient common name’

The search results list decisions under Article 11 that the US has logged:

Eight approvals have been logged for use of GM cotton in the US:

Where Country communicating the decision is related to "United States of America" and (Recipient common name is related to "Cotton" orRecipient taxonomic status is related to "Cotton").

Print this list to answer further questions.

To find out what the decision was, select each event in turn:

MON-Ø1445-2 – Monsanto Company

Scrolling down the page, Approved uses of the living modified organism are given as:

Planting, food, and feed

The next four entries also have the same approval:

Planting, food, and feed

Entry MON-ØØ757-7 - Monsanto Company

Scrolling down the page, Approved uses of the living modified organism are given as:

Food, and feed

From the BCH record it would appear that event MON-00757-7 has been approved for food and feed use only; no information is given about planting. However, before the trader can assure herself that this event will not be part of any cotton seed consignment from the USA, she clicks on the link under “Additional information, Relevant documents”. This takes her to the U. S. Regulatory Agency Activity Summary (

where she sees that this event has been approved by USDA

( ) but is not currently registered with EPA. The trader, who doesn’t understand the details of the U.S. regulatory system and doesn’t have time to determine if this event actually is or has been cultivated in the U.S., elects to assume that it may be present in US consignments.

The same decision is given for MON-89924-2 - Monsanto Companyand the trader again finds out that this event was approved by USDA but is not currently registered with the EPA. Again, the trader doesn’t have time to determine if this event actually is cultivated in the U.S. and so elects to assume that it may be present in US consignments.

MON-ØØ531-6 - Monsanto Company has the full ‘Planting, food, and feed’ approval:

In summary, with information from the BCH, the trader finds that the US has clearly approved 6 of the 8 transgenic cotton events for cultivation, food and feed use and the two other events may be present in U.S. consignments.

At this point the trader has a fairly clear idea of what transgenic cotton events might be in the shipment that she is trying to send to Mexico. Now she needs to see what transgenic cotton events have been approved for use in Mexico, i.e. Question 2.

Answering Question 2 with the help of the BCH:

What GM cotton events have been approved for food and feed use in Mexico?

Returning to the BCH Central Portal

the trader selects the Decisions and Declarations, and Decisions under AIAdatabase to find Mexican decisions that have been logged:

Under “Search Decisions on LMOs under Advance Informed Agreement”

AIA decisions are made on LMOs coming into Mexico, but there are currently no records in this database.

The next section, Decisions under Article 11, deals specifically with commodity imports for food, feed and processing.

Access this database to see what is approved for use in Mexico. Select Mexico in the first row – ‘Country communicating the decision’; and cotton in the 5th row – ‘Recipient common name’

The search results list decisions under Article 11 that Mexico has logged with the BCH:

The trader compares the approved Mexican events (9 on this database) with the list of approved events that could be in the US shipment. Here the use of ‘unique identifiers’ is valuable. Not all the entries use these, but where they are used, the comparison of approvals is easier. The trader works through each Mexican approval and matches it to cotton events approved for cultivation in the US.

The first entry in the search results table (DAS-24236-5 - Dow AgroSciences)is for an event that is not included on the BCH as approved in the U.S., and so should not be present in any shipments of cotton seed. However, because this is early days for the BCH the trader is hesitant to assume that all the records have been incorporated. This means the trader will need to clarify whether this event is cultivated in the U.S. and if the cotton seed has been approved for any use in Mexico, or assume that it is not approved and find an alternative source of cottonseed to fulfill the trade request. In the early days of the BCH, it is wise to follow up results where there is uncertainty as there may have been unintended omissions or errors in entries.

The second entry is for an event that has planting, food and feed approval in the US, so could be in any shipments of cotton seed. Selecting the second entry in the searchresults table (MON-ØØ531-6 - Monsanto)gives details of the record.

Scrolling down the record details page shows that the approved use of this living modified organism in Mexico is for food. This means the trader will need to clarify whether the seedcake can be used in feed, or whether the shipment can only be used for oil production. (Details on how to use the BCH to help contact national biosafety regulators are given at the end of this analysis of the identified LMO cotton events. While decisions on specific LMO events may take time to process, most importing countries have a policy on imports from LMO-producing countries that facilitate every day trade.)

The third entry is for an event that has planting, food and feed approval in the US, so could be in any shipments of cotton seed. Selecting the third entry in the search results table (MON-Ø1445-2 - Monsanto)gives details of the record.

Scrolling down the record details page shows that no details of the approved use of this living modified organism are given. This means the trader will need to clarify whether the cotton seed has been approved for any use in Mexico, or assume that it is not approved and find an alternative source of cottonseed to fulfil the trade request. In the early days of the BCH, it is wise to follow up results where there is uncertainty as there may have been unintended omissions or errors in entries.

The fourth entry is for an event that has planting, food and feed approval in the US, so could be in any shipments of cotton seed. Selecting the fourth entry in the search results table (MON-15985-7 - Monsanto) gives details of the record:

Scrolling down the record details page shows that the approved use of this living modified organism in Mexico is for food. This means the trader will need to clarify whether the seedcake can be used in feed, or whether the shipment can only be used for oil production.

The fifth entry is for an event that is not listed as a separate approval in the U.S., where combinations of approved traits can be combined through conventional plant breeding without the need for an additional approval.

So this event has automatic approval in the U.S. and could be in any shipments of cotton seed. Selecting the fifth entry in the search results table (MON-Ø Ø531-6 x MON- Ø1445-2 - Monsanto) gives details of the record.

[eo1]Scrolling down the record details page shows that no details of the approved use of this living modified organism in Mexico are given. This means the trader will need to clarify whether the cotton seed has been approved for any use in Mexico, or assume that it is not approved and find an alternative source of cottonseed to fulfil the trade request. In the early days of the BCH, it is wise to follow up results where there is uncertainty as there may have been unintended omissions or errors in entries.

The sixth entry (DAS-21Ø23-5 x DAS-24236-5 - Dow AgroScience) is for a bred cross between two events for which there is not information on the BCH as to approvals in the U.S. As with event DAS-21023-5, the trader scrolls down the record details page which shows that no details of the approved use of this living modified organism in Mexico are given. This means the trader will need to clarify whether this event is cultivated in the U.S. and if the cotton seed has been approved for any use in Mexico, or assume that it is not approved and find an alternative source of cottonseed to fulfil the trade request.

The seventh entry is for an event that has planting, food and feed approval in the U.S., so could be in any shipments of cotton seed. Selecting the seventh entry in the search results table (Calgene) gives details of the record:

Scrolling down the record details page shows that the approved use of this living modified organism in Mexico is for food. This means the trader will need to clarify whether the seedcake could be used in feed, or whether the shipment can only be used for oil production.

The eighth entry (DAS-21Ø23-5 - Dow AgroScience) is for an event that is not included on the BCH as approved in the U.S., and so should not be present in any shipments of cotton seed. However, because this is early days for the BCH the trader is hesitant to assume that all the records have been incorporated. This means the trader will need to clarify whether this event is cultivated in the U.S. and if the cotton seed has been approved for any use in Mexico, or assume that it is not approved and find an alternative source of cottonseed to fulfil the trade request. In the early days of the BCH, it is wise to follow up results where there is uncertainty as there may have been unintended omissions or errors in entries.

None of the nine events in the U.S. Records for Decisions under Article 11 have been clearly approved for feed use in Mexico. Three of these events have been approved for food use in Mexico: MON-00531-6, MON-15985-7 and Calgene (record ID 11528).

This study leaves the trader with a number of questions for the Mexican biosafety authorities. The fastest way to address these would be to contact the Mexican regulators for specific answers. Contact details for the Mexican biosafety regulators can be obtained from the BCH.

Contacting the national regulators

The trader has two options: she can use the BCH to identify the biosafety focal point for Mexico and ask them specific questions about the approval of the shipment. The focal point will redirect her enquiry to the competent authority. This may take a while. Alternatively, the trader can use the BCH to try to identify the competent authority in Mexico who is directly responsible for these decisions and should be able to give her immediate answers. While decisions on specific LMO events may take a long time, general import decisions are usually available for countries that routinely import agricultural commodities from LMO-producing countries. It may be best for the trader to try both options to see which one produces results faster. A useful, informal translations service is available at help with Spanish entries.

Option 1. Use the BCH to identify the Mexican biosafety focal point.

Returning to the BCH Central Portal

the trader can select the National Contacts database to find the focal point:

Selecting the National Focal Point database will lead the trader to the required contact person:

By selecting Mexico in the first row, ‘Country or Region’, and clicking on ‘Search now ’ the database will identify the Mexican focal point. The search results identify one focal point contact for Mexico:

Dr. Manuel Luis Robert Diaz.

Selecting the name, takes the trader to his contact details:

This gives the trader the information she needs to call for additional clarity on whether she can import the US cotton seed or not.

Option 2. Use the BCH to identify the Mexican biosafety competent authority.

Returning to the BCH Central Portal

the trader can select the National Contacts database to find the competent authorities for Mexico:

Selecting the National Competent Authority database leads the trader to the required search table:

By selecting Mexico in the first row, ‘Country or Region’, and pressing ‘Search now …’ the database identifies the Mexican competent authority. The search results identify three competent authorities for Mexico,

The Secretary of Agriculture, the Secretary of Natural Resources and the Secretary of Health. The trader may be familiar with one of these departments and send a request for clarity to this contact, or the trader may be confused as to which competent authority will deal with the request and decide to call or email all three with the same questions.

The contact details for each authority are obtained by selecting the name of each one in turn and reviewing the entry details page:

By contacting the competent authorities directly or through the focal point the trader will be able to get a broad decision on whether cotton seed that may contain GM seed can be imported from the United States into Mexico. The competent authority will also be able to give the correct procedure for importation and this may prove to be the most direct and fastest solution to the trader’s questions.

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Case Study 1

[eo1]needs to be clarified