Review of Grain Fortification Legislation, Standards, and Monitoring Documents

Kristin J. Marks; Corey L. Luthringer; Laird J. Ruth; Laura A. Rowe; Noor A. Khan; Luz María De-Regil; Ximena López; Helena Pachón

doi:10.9745/GHSP-D-17-00427

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FIGURE 1
Flowchart of Country-Grain Combination^a Exclusions
^a Country-grain combination refers to the unit of analysis; countries that mandate the fortification of multiple cereal grains will contribute more than one country-grain combination (e.g., Philippines-wheat and Philippines-rice).
^b Thirteen Caribbean countries follow the Caribbean Community and Common Market (CARICOM) standard (Caribbean Community Secretariat, 1995): Antigua and Barbuda, Bahamas, Barbados, Dominica, Grenada, Guyana, Haiti, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, and Trinidad and Tobago.
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FIGURE 2
Median Country-Grain Combination Scores^a by Cereal Grain in Countries With Mandatory Cereal-Grain Fortification
Abbreviation: IQR, interquartile range.
^a Country-grain combination refers to the unit of analysis; countries that mandate the fortification of multiple cereal grains will contribute more than one country-grain combination (e.g. Philippines-wheat and Philippines-rice). Scores based on number of checklist items fully documented out of total applicable checklist items.
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FIGURE 3
Median Country-Grain Combination Scores^a by Geographic Region in Countries With Mandatory Cereal-Grain Fortification
Abbreviation: IQR, interquartile range.
^a Country-grain combination refers to the unit of analysis; countries that mandate the fortification of multiple cereal grains will contribute more than one country-grain combination (e.g. Philippines-wheat and Philippines-rice). Scores based on number of checklist items fully documented out of total applicable checklist items.
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FIGURE 4
Median Country-Grain Combination Scores^a by Income Level in Countries With Mandatory Cereal-Grain Fortification
Abbreviation: IQR, interquartile range.
^a Country-grain combination refers to the unit of analysis; countries that mandate the fortification of multiple cereal grains will contribute more than one country-grain combination (e.g. Philippines-wheat and Philippines-rice). Scores based on number of checklist items fully documented out of total applicable checklist items.

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TABLE 1.

Checklist of Key Items^a and All Possible Scoring Options in Fortification Legislation, Standards, and Monitoring Documents

Item	Scoring Options	References
General
1. States that legislation applies to at least one food vehicle fit for human consumption (types/grades to be fortified)	(2) States at least one type fit for human consumption (0) Does not state	^{10, 12, 17, 22}
2. States the public health objective; purpose and scope of legislation	(2) States the public health objective or general purpose of legislation (0) Does not state	^{10, 13, 17, 22}
3. References latest available science or accepted international norms and recommendations, particularly for items that may not be covered in the country's documents	(2) States the documents referenced (0) Does not state	^{12, 17, 21}
4. Provides definitions that include terms that are specific to fortification (e.g., fortified food, premix, fortificant, food vehicle)	(2) States at least one term related to fortification (0) Does not state	^{17, 22}
5. Provides repeals (if there is at least one prior document about fortification)	(2) States repeals (0) Does not state (N/A) No prior documents about fortification	^{12, 17}
6. Provides effective date or gives grace period for when fortification is to begin (e.g., effective 6 months from signing)	(2) States effective date or grace period for when fortification is to begin (e.g., effective 6 months from signing) (0) Does not state	^{12, 17}
Micronutrients/Premix
7. States nutrients required	(2) States nutrients (0) Does not state	^{8, 10, 12, 13, 21}
8. States fortificants (chemical compounds) to be used (including fortificants that are allowable as options)	(2) States fortificants for at least one nutrient (0) Does not state	^{8, 10, 12, 13, 21}
9. States fortification levels	(2) States a range or number with +/- (1) States one number only (0) Does not state	^{8, 10, 13, 21}
10. States consideration of bioavailability/biological activity of fortificants	(2) States some consideration of bioavailability (mentions these or related terms) (0) Does not state any consideration	⁹
11. States consideration of nutrient stability	(2) States consideration of nutrient stability (0) Does not state any consideration	¹¹
Costing
12. States that the cost of fortification is regulated through cost-sharing schemes (between government, industry, consumers) or tax measures (to assist industry)	(2) States consideration of either cost regulation method (0) Does not state any consideration	^{10, 12, 13}
13. States consideration of the financial responsibility (of the government) of monitoring and enforcing fortification (schedule of fees, budget)	(2) Shows consideration that monitoring costs money (0) Does not state any consideration	^{10, 13, 19, 21, 22}
Labeling
14. Includes some sort of statement/label/logo that makes it clear that the product is fortified	(2) Includes a statement, label, or logo (0) Does not include statement, label, or logo	^{8, 10, 12, 13, 18}
15. Provides guidance on health claims that can be made for this product (specific to micronutrients added through fortification)	(2) Provides guidance on health claims specific to micronutrients added through fortification (0) Does not provide	^{12, 15, 20}
Internal Monitoring (Conducted by Industry)
16. States requirement for sampling as part of internal monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing)	(2) States that samples should be taken as part of internal monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process	^{1, 8, 12, 22, 23}
17. States that industry is required to follow quality assurance/quality control in regards to fortification	(2) States requirement of quality assurance/quality control for fortification (0) Does not state requirement	^{1, 8, 12, 22, 23}
18. States applicability of using qualitative testing (e.g., spot tests, iChecks) to determine the presence or absence of a vitamin or mineral	(2) States applicability of spot test to determine presence/absence of vitamin or mineral specific to internal monitoring (1) States applicability of spot test to determine presence/absence of vitamin or mineral generally (0) Does not state	^{11, 21}
External Monitoring (Conducted by Government)
19. States requirement for external monitoring at the production site to assure compliance with standards and regulations	(2) States requirement for external monitoring or the need for audits/inspections (0) Does not state requirement	^{1, 9, 10, 12, 15, 17, 18, 21, 22, 23}
20. Describes protocols and systems for regulatory monitoring	(2) Includes checklists or provides detailed description of regulatory monitoring procedures (1) Does not explicitly describe, but references protocols and systems for regulatory monitoring (0) Does not describe	^{1, 13, 21}
21. If there are two or more government agencies involved in external monitoring, clarifies the roles and responsibilities between different government agencies in external monitoring	(2) Clarifies roles and responsibilities for more than one agency (1) Clarifies roles and responsibilities for one agency (0) Clarifies roles and responsibilities for no agencies (N/A) Only one government agency involved	^{12, 21, 23}
22. Allows for monitoring to be conducted often enough that problems can be identified and addressed on a timely basis; specifies a timeline for inspections (e.g., once every 6 months, increasing to once every 2 months if a discrepancy is found)	(2) Describes frequency and how it is responsive to the needs of industry or the stage of fortification implementation (1) Makes mention of a timeline (0) Does not state	^{1, 16, 18, 23}
23. States requirement for sampling as part of external monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing)	(2) States that samples should be taken as part of external monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process	^{1, 8, 12, 22, 23}
24. States applicability of using qualitative testing (e.g., spot tests, iChecks) to determine the presence or absence of a vitamin or mineral	(2) States applicability of spot test to determine presence/absence of vitamin or mineral specific to external monitoring (1) States applicability of spot test to determine presence/absence of vitamin or mineral generally (0) Does not state	²¹
25. States registration is required in order to use a logo/be licensed to produce fortified foods	(2) Describes some type of registration or licensing (0) Does not state that registration or licensing is required	^{17, 18}
Commercial Monitoring (Conducted by Government)
26. Provides justification for commercial monitoring at retail stores	(2) Provides justification for commercial monitoring (0) Does not provide justification for commercial monitoring	²¹
27. Describes protocols and systems for commercial monitoring	(2) Includes checklists or provides detailed description of commercial monitoring procedures (1) Does not explicitly describe, but references protocols and systems for commercial monitoring (0) Does not describe	^{1, 13, 21}
28. If there are two or more government agencies involved in commercial monitoring, clarifies the roles and responsibilities between different government agencies in commercial monitoring	(2) Clarifies roles and responsibilities for more than one agency (1) Clarifies roles and responsibilities for one agency (0) Clarifies roles and responsibilities for no agencies (N/A) Only one government agency involved	^{12, 21, 23}
29. Allows for monitoring to be conducted often enough that problems at the production site or import companies can be identified and addressed on a timely basis; specifies a timeline for inspections (e.g., once every 6 months) or works with production companies to correct noncompliance	(2) Describes frequency and how it is responsive to the needs of industry or the stage of fortification implementation (1) Makes mention of a timeline (0) Does not state (N/A) No commercial monitoring occurs	^{1, 16, 18, 23}
30. States requirement for sampling as part of commercial monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing)	(2) States that samples should be taken as part of commercial monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process	^{1, 8, 12, 22, 23}
Import Monitoring (Conducted by Government)
31. Provides justification for import monitoring at points of entry	(2) Provides justification for import monitoring (0) Does not provide justification for import monitoring	²¹
32. Describes protocols and systems for import monitoring	(2) Includes checklists or detailed description of import monitoring procedures (1) Does not explicitly state, but references protocols and systems for import monitoring (0) Does not state	^{1, 13, 21}
33. If there are two or more government agencies involved in import monitoring, clarifies the roles and responsibilities between different government agencies in import monitoring	(2) Clarifies roles and responsibilities for more than one agency (1) Clarifies roles and responsibilities for one agency (0) Clarifies roles and responsibilities for no agencies (N/A) Only one government agency involved	^{12, 21, 23}
34. States requirement for sampling as part of import monitoring (e.g., describing number of samples, amount, frequency, individual vs. composite, where samples are taken in the process, and percent considered passing)	(2) States that samples should be taken as part of import monitoring (1) States that samples should be taken (generally) (0) States that samples should not be taken (N/A) Does not describe the sampling process	^{1, 8, 12, 22, 23}
Enforcement/Penalties
35. Indicates roles and responsibilities in enforcing the legislation	(2) States the role and responsibilities of government in enforcement (0) Does not state	^{14, 17, 22}
36. States incentives to start fortification	(2) States any incentives to encourage fortification initiation (e.g., tax incentives for new equipment or premix) (0) Does not state	^{13, 17, 22}
37. States incentives to continue fortification, including ensuring compliance	(2) States any incentives to encourage the continuation of fortification (e.g., transport priority, favorable tax or tariff treatment, or patent rights) (0) Does not state	^{13, 17, 22}
38. States penalties to compel compliance	(2) States any penalties (0) Does not state	^{12, 13, 14, 17, 22}
39. Penalties are objectively defined (e.g., first penalty=$100, second penalty=$300)	(2) Penalties are objectively laid out in the document (e.g., first penalty=$100, second penalty=$300) (0) Penalties are not objectively laid out (N/A) No penalties are stated (answered 0 to previous question)	¹⁰
40. States that enforcement is required to include feedback and support to improve performance and correct noncompliance	(2) Requires any feedback/support to improve performance (0) Does not require	^{1, 10, 17, 18, 21, 23}
Laboratory
41. References required analytical assays for nutrients (e.g., liquid chromatography-mass spectrometry for folic acid, atomic absorption for iron and zinc)	(2) References required assays (0) Does not state requirements	⁸
42. States recognition that laboratory results are subject to several sources of variation and do not provide conclusive evidence of compliance or noncompliance	(2) States recognition that lab results are subject to variation (0) Does not state recognition	²¹
43. Focuses on the quantitative analysis of "marker" micronutrients such as iron	(2) Focuses on quantitative analysis of marker micronutrient such as iron (0) Does not state	^{12, 21, 23}
Reporting
44. States how government monitoring results are shared with stakeholders	(2) States how results are shared with stakeholders (0) Does not state how results are shared	¹⁷

↵a As identified in the literature and by content experts.

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TABLE 2.

Percentage of Country-Grain Combinations^a With Documented Items in Fortification Legislation, Standards, and Monitoring Documents (N=72)

Item	Eligible (N)	% (n) Fully Meeting	% (n) Partly Meeting	% (n) Not Meeting
General
1. Food vehicle stated in legislation	72	97% (70)	–	3% (2)
2. Public health objective/purpose	72	69% (50)	–	31% (22)
3. Accepted international norms	72	54% (39)	–	46% (33)
4. Definitions specific to fortification	72	76% (55)	–	24% (17)
5. Repeals of prior documentation^b	59	71% (42)	–	29% (17)
6. Effective date/grace period	72	72% (52)	–	28% (20)
Micronutrients/Premix
7. Nutrients required	72	100% (72)	–	0% (0)
8. Fortificants (chemical compounds)	72	88% (63)	–	13% (9)
9. Fortification levels	72	42% (30)	54% (39)	4% (3)
10. Bioavailability of fortificants	72	31% (22)	–	69% (50)
11. Nutrient stability	72	54% (39)	–	46% (33)
Costing
12. Cost sharing of fortification	72	19% (14)	–	81% (58)
13. Financial responsibility of monitoring and enforcement	72	35% (25)	–	65% (47)
Labeling
14. Labeling required	72	78% (56)	–	22% (16)
15. Guidance on health claims	72	50% (36)	–	50% (36)
Internal Monitoring (conducted by industry during production)
16. Sampling process outlined^b	31	71% (22)	29% (9)	0% (0)
17. Industry QA/QC justified/required	72	64% (46)	–	36% (26)
18. Applicability of qualitative tests	72	29% (21)	1% (1)	69% (50)
External Monitoring (conducted by government at production sites)
19. External monitoring justified	72	64% (46)	–	36% (26)
20. Protocols and systems described	72	33% (24)	28% (20)	39% (28)
21. Roles and responsibilities clarified^b	56	45% (25)	7% (4)	48% (27)
22. Timeline for inspections outlined	72	26% (19)	13% (9)	61% (44)
23. Sampling process outlined^b	45	67% (30)	33% (15)	0% (0)
24. Applicability of qualitative tests	72	19% (14)	1% (1)	79% (57)
25. Registration requirements	72	38% (27)	–	63% (45)
Commercial Monitoring (conducted by government at market or distribution sites)
26. Commercial monitoring justified	72	47% (34)	–	53% (38)
27. Protocols and systems described	72	19% (14)	21% (15)	60% (43)
28. Roles and responsibilities clarified^b	63	32% (20)	0% (0)	68% (43)
29. Timeline for inspections outlined^b	44	14% (6)	25% (11)	61% (27)
30. Sampling process outlined^b	28	71% (20)	29% (8)	0% (0)
Import Monitoring (conducted by government at ports/points of entry)
31. Import monitoring justified	72	64% (46)	–	36% (26)
32. Protocols and systems described	72	35% (25)	26% (19)	39% (28)
33. Roles and responsibilities clarified^b	59	42% (25)	2% (1)	56% (33)
34. Sampling process outlined^b	29	62% (18)	38% (11)	0% (0)
Enforcement/Penalties
35. Enforcement roles and responsibilities clarified	72	69% (50)	–	31% (22)
36. Incentives to start fortification	72	14% (10)	–	86% (62)
37. Incentives to continue fortification	72	10% (7)	–	90% (65)
38. Penalties to compel compliance	72	68% (49)	–	32% (23)
39. Penalties objectively defined^b	49	31% (15)	–	69% (34)
40. Enforcement includes feedback	72	18% (13)	–	82% (59)
Laboratory
41. Analytical methods identified	72	60% (43)	–	40% (29)
42. Recognition of laboratory variation	72	11% (8)	–	89% (64)
43. Quantitative analysis of "marker" micronutrients such as iron	72	36% (26)	–	64% (46)
Reporting
44. Dissemination of monitoring results described	72	31% (22)	–	69% (50)

Abbreviations: QA/QC, quality assurance/quality control.
↵a Country-grain combination refers to the unit of analysis; countries that mandate the fortification of multiple cereal grains will contribute more than one country-grain combination (e.g., Philippines-wheat and Philippines-rice).
↵b The number eligible differs for these items due to a “not applicable” option on the scoring checklist.