GLOBALGAP is an interested party when it comes to FDA's rulemaking on  preventive controls for fresh produce safety. Here is the comment recently submitted to FDA on the federal docket.

Comments on Docket No. FDA-2010-N-0085


Comments to inform the development (1) Safety standards for fresh produce at the farm and packing house (2) strategies and cooperative efforts to ensure compliance.

• Standards for domestic and foreign growers and packers

GLOBALG.A.P believes that domestic and foreign growers and packers should and can comply with the same standards. National interpretation and adaptation to local legislation may need to apply within a pre-defined range.

Since 1996 GLOBALG.A.P has with input from stakeholders and many experts developed global standards for Independent third party certification of GAPs on farm.

This is a cooperative effort driven by the private sector to ensure compliance on farm. Annually 100 000 producers undergo ISO65 controlled verifications in more than 100 countries. It is welcomed by the public sector in many jurisdictions as a complementary food safety effort to National and International legislation. The standards have established a good track record in preventing microbiological and chemical contamination of produce.

The standards are made freely available at under “Standards” and are commended to you for further review. The fourth version of the standards with updates on best practices to prevent microbiological contamination will be published in October 2010.

• Possible Approaches to tailor preventative controls to the scale of an operation so that controls achieve an appropriate level of food safety protection and are feasible for a wide range of large and small operations
• Coordination of produce food safety practices and environmental and/or conservation goals

GLOBALG.A.P certification is carried out in developing countries with export horticulture in mind and includes certification of smallholder farmers. GLOBALG.A.P has developed guidelines to facilitate the implementation of GAPs by small farmers. Some developing countries e.g. Kenya, supported by Government, are adopting a pared down GLOBALG.A.P standard for the national market as an interim step

Compliance and cost efficiency is assisted by the ability for growers to opt for group certification. Groups can provide capacity building and quality management systems to assist in achieving compliance. Further information/resources on Group certification can be found at

The standards have adopted a generic HACCP approach to establishing critical GAPs on farm, which in a holistic way together contribute to the furtherance of food safety, protection of the environment and worker health and safety. The standards also specify practical requirements for safe on farm packing. A research based system of risk assessments and continuous improvement processes help finding new innovative techniques to reduce adverse effects either way.

GLOBALG.A.P also offers an equivalency mechanism whereby other National GAP schemes such as ChinaGAP can be benchmarked and accepted by market participants as meeting the same requirements as the GLOBALG.A.P reference standard.

• Role of the GAPs Guide (Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.
As a document that focuses on minimizing microbial food safety hazards, it is a comprehensive work. The Guide focuses on Microbial contamination, yet it is called the “GAPs Guide”. This may cause confusion in the market regarding the definition of “Good Agricultural Practices”, which for many includes food safety, environmental, economic and social sustainability criteria. It is recommended to rename future work.

• Identification and prioritization of risk factors
GLOBALG.A.P is taking part in the United Fresh GAPs Harmonization Initiative to work on a harmonized standard for fruit and vegetables in the USA, which is globally compatible. It has become clear that risk factors must be identified and prioritized. Real risks need to be separated from perceived risks and farmer education is then necessary to explain the practicality of how to avoid such risks.

• Environmental assessment of hazards and possible ways of contamination
Guidance to help producers to identify environmental hazards that may pose a risk to food safety, operator health as well as scarce resources needs to be developed. GLOBALG.A.P has set basic requirements that should be considered to develop a basic environmental management plan.

• Impact of scale/size of growing operations
As mentioned on page 1, GLOBALG.A.P has experience since its inception in working with smallholders. It has been proven that they can comply with the necessary requirements. This may be facilitated by a step-wise approach to the final level required and also by supplying additional guidelines that explain implementation step-by-step. Also, group certification, has been successful in the smallholder scenario and multi-site certification for the larger operations. GLOBALG.A.P has developed several tools to help producers of all sizes to implement GAP.

• Coordination of produce food safety practices and sustainable and/or organic production methods
Seeing that organic produced food is not necessarily safe food and does not cover all the food safety elements, nor occupational health and safety (OHS) issues, GLOBALG.A.P is working with IFOAM and others on an interpretation guideline for organic GLOBALG.A.P production. This guideline will help to explain which points are not applicable or how an organic producer can comply. Another project under way is the development of add-on modules for food safety ad OHS issues to an organic inspection.

• Coordination of produce food safety practices and Federal, state, local and tribal government statutes and regulations
GLOBALG.A.P requires that producers comply with local legislation at all times. For this reason a US National Interpretation Working Group has been established that firstly looked at the GLOBALG.A.P standards from a “language” perspective. The second task would be to incorporate links to the relevant statutes and regulations to help producers to be able to comply. Where possible, a website which lists all the relevant legislation to primary production would be a great benefit to producers.

• Microbial testing
This is something that should NOT be required to be performed by producers. Implementing and understanding the principles of the guidance document should be sufficient to negate the need for ad-hoc microbial testing of products/hands/facilities on farm. Of course it is a tool that can be used to show corrective action is working.

• Strategies to enhance compliance.
Encouragement to producers from buyers to adopt third party certification is a proven strategy to enhance compliance. Incentives from the public sector such as reduced costs for public inspection, i.e. by offering online access on the certification status to public sector agencies, combined with market recognition would be powerful incentives to drive compliance.

GLOBALG.A.P would be very happy to provide further information and/or receive future FDA consultations
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