Table 4.
Technical feasibility characteristics of NovaSil clay for aflatoxin risk reduction in Africa.
| Category | Criteria | Intervention |
|---|---|---|
| Intervention Characteristics | ||
| Basic product design | Stability | Stable under normal conditions; loss of binding capacity (primary mechanism to reduce aflatoxin bioavailability) if heated ≥ 200° C over 30 minutes (Gilbert 2008) |
| Standardization | Needed for human consumption purposes, to ensure reliable dose whether in capsule form or blended in meal | |
| Safety profile | No significant changes in hematology, liver, kidney function, vitamin A and E levels, and mineral levels. | |
| Mild gastrointestinal symptoms have been observed. Sterilization and standardization necessary. | ||
| Ease of storage / transport | No special requirements for storage. Transportation is needed from other parts of world where clays have shown aflatoxin-binding properties and can be sterilized and standardized. | |
| Supplies | Need for regular supplies | A regular supply is needed in aflatoxin-vulnerable regions, because of daily consumption requirements |
| Equipment | High-technology equipment and infrastructure needed | If imported, no local high-technology equipment is needed. If produced locally, sophisticated manufacturing and packaging equipment is needed. |
| Delivery characteristics | ||
| Facilities | Retail sector and outreach services | Depending on delivery method (capsules, blended into meal, etc.), can be purchased or distributed in food markets or local health centers |
| Human resources | Skill level required for service provision | Staff are needed to distribute NS in the appropriate manner to the general public (e.g., blending the product into meal, selling or providing caplets). If production is done locally, trained scientists are required for manufacture and maintenance of the product. |
| Government capacity requirements | ||
| Regulation/legislation | Need for regulation | May be subject to food additive regulations in target nations |
| Need for monitoring and enforcement | Monitoring needed to prevent potential counterfeiting / inappropriate health claims of untested clay | |
| Management systems | Need for sophisticated management systems | Need for government financing and management to subsidize NS if it is incorporated in major food products, or if distributed for free in capsule form. It is also necessary to manage potential risks of counterfeiting and compliance (Gilbert 2008). |
| Collaborative action | Collaborative efforts within government sectors and between government and other groups | Depending on NS's delivery mechanism, coordination is needed between agricultural, health, pharmaceutical, and food-related governmental sectors. |
| Community volunteers can help government to monitor inappropriate use or the presence of counterfeiting. | ||
| Because this intervention requires continuous action (monetary support), funding from international organizations may be crucial. | ||
| Usage characteristics | ||
| Ease of usage | Need for information/education | In aflatoxin-vulnerable areas, education is needed on when, why, and how often to consume NS. May be difficult for individuals to remember or to desire to take NS capsules with each meal, so alternative delivery mechanisms should be considered (e.g., blending NS into maize or groundnut meal). |
| Pre-existing demand | Need for promotion | Geophagy is common in certain parts of world; however, there is a need to promote NS specifically as distinguished from common clays, and why aflatoxin is an important risk to control. |
| Black-market risk | Need to prevent resale/counterfeiting | Potential risk of counterfeiting with common clays that do not adsorb aflatoxin in the GI tract |