What Is SCOGS
What is SCOGS?
SCOGS is the Select Committee on GRAS Substances. It was an expert committee outside FDA that, from the early 1970s, reviewed the safety of food substances already treated in the US as Generally Recognized As Safe (GRAS). It began after a 1969 White House directive from President Nixon. FDA describes the work as done by the Life Sciences Research Office (LSRO), set up by FASEB in 1962, under contract to FDA (FDA, History of the GRAS List and SCOGS Reviews).
What it did
- Size: FDA's SCOGS database page covers 115 reports published between 1972 and 1980, on more than 370 GRAS substances. FDA's history page gives a different figure: 151 detailed reports on over 400 substances by 1982 (FDA, GRAS Substances (SCOGS) Database).
- How FDA used the reports: FDA reviewed them for scientific evidence. It then either proposed rules affirming GRAS status or took other regulatory action.
- Status of the conclusions: FDA states that "The SCOGS Conclusions were made by scientific experts outside of FDA."
The five types of conclusion (FDA's wording, shortened)
- Type 1: No evidence that shows, or gives reasonable grounds to suspect, a hazard at current or reasonably expected future use levels.
- Type 2: No evidence of a hazard at current levels and practices. However, without more data it cannot be determined whether a significant increase in consumption would be a dietary hazard.
- Type 3: No evidence of a hazard at current levels, but "uncertainties exist requiring that additional studies be conducted."
- Type 4: The evidence is insufficient to determine that the reported adverse effects are not harmful at former use levels and practices.
- Type 5: There are almost no biological studies, so the data are insufficient to evaluate safety.
What a record looks like
Each record gives the substance, the report number, the year, the CAS number, the conclusion type and the NTIS accession number:
- Urea: Report 103 (1978), CAS 57-13-6, Type 1 [1]
- Tocopherols: Report 36 (1975), Type 1 [2]
- Sucrose: Report 69 (1976), Type 2 [3]
- Caffeine: Report 89 (1978), CAS 58-08-2, given as Types "3,4" [4]
SCOGS is a historical review programme. It is separate from today's GRAS Notification Program, where FDA's response letters fall into three outcomes: "no questions", "does not provide a basis" for a GRAS conclusion, or evaluation stopped at the notifier's request.
Approach: I searched FDA's SCOGS GRAS substance evaluations dataset and read FDA's SCOGS database and history pages for the committee's background and the conclusion definitions.
I can look up the SCOGS conclusion for any particular substance.
What do its five conclusion types mean?
SCOGS gave every GRAS substance it reviewed one of five conclusion types. They run from Type 1, no reason to suspect a hazard now or at expected future use levels, to Type 5, too few biological studies to judge safety at all. Most substances got Type 1.
FDA's definitions (FDA, GRAS Substances (SCOGS) Database):
| Type | FDA wording | What it means |
|---|---|---|
| 1 | "There is no evidence in the available information on [substance] that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or might reasonably be expected in the future." | This is the cleanest result. It covers current use and reasonably expected future use. |
| 2 | "There is no evidence in the available information on [substance] that demonstrates a hazard to the public when it is used at levels that are now current and in the manner now practiced." | No hazard was shown, but only at current levels and practices. Unlike Type 1, it says nothing about future use. |
| 3 | "While no evidence ... demonstrates a hazard to the public when it is used at levels that are now current and in the manner now practiced, uncertainties exist requiring that additional studies be conducted." | No hazard was shown at current use, but the committee asked for more studies. |
| 4 | "The evidence on [substance] is insufficient to determine that the adverse effects reported are not deleterious to the public health should it be used at former levels and in the manner formerly practiced." | Adverse effects had been reported, and the committee could not rule out harm at former use levels. |
| 5 | "In view of the almost complete lack of biological studies, the Select Committee has insufficient data upon which to evaluate the safety of [substance] as a [intended use]." | There were too few data to make any safety judgement. |
How the types are spread across the records
Of the 374 records with a single type: 272 are Type 1, 69 Type 2, 13 Type 3, 4 Type 4 and 16 Type 5. Some substances were given two types, such as caffeine with "3,4" from the earlier answer, and they are not in these counts. Examples:
- Type 1: zinc gluconate, Report 78 (1978) [5]
- Type 2: zinc sulfate, Report 21 (1973) [6]
- Type 3: starch sodium octenyl succinate, Report 115 (1979) [7]
- Type 4: distarch glycerol, Report 115 (1979) [8]
- Type 5: sodium ferric EDTA, Report 35 (1980) [9]
Approach: I read FDA's SCOGS evaluations records for each substance's type and took the definitions from FDA's SCOGS database page, because the records give only the type number. The Type 2 wording above is as it appeared on that page this time; my earlier answer added a sentence on increased consumption that this reading did not show.
How do I find a substance's SCOGS report?
To find a substance's SCOGS report, look the substance up in the SCOGS evaluations to get its NTIS accession number. Then search that number in NTIS's National Technical Reports Library (NTRL), which holds the full reports. FDA says: "Complete reports containing details of the safety studies that formed the basis of the opinions and conclusions are available from the National Technical Information Service (NTIS)" (FDA, GRAS Substances (SCOGS) Database).
Step 1: Find the substance's record
You can search FDA's online SCOGS database (cfsanappsexternal.fda.gov/scripts/fdcc/?set=SCOGS), or I can look it up for you. Each record gives the substance name, any other names, the report number, the CAS or other ID, the year, the conclusion type and the NTIS accession number. You can search by any of these:
- By name: Caffeine is Report 89 (1978), Types 3,4, NTIS PB283441 [4]
- By CAS number: 57-13-6 gives urea, Report 103 (1978), NTIS PB288673 [1]
- By other name: Waxy maize starch is also listed as "cornstarch, waxy" [10], and milo starch as "grain sorghum starch" [11]
Step 2: Get the full report from NTIS
Search the accession number in the NTRL (ntrl.ntis.gov/NTRL), which gives you the full report.
Some reports cover many substances. Searching by report number shows this: Report 115 (1979) covers 30 starch substances, all under one accession number, PB80128804. Their conclusions range from Type 1 (cornstarch) [12] to Type 5 (sodium hydroxide gelatinized starch) [13]. Likewise, vitamin D2 and D3 share Report 95 (PB293099) [14][15]. So search for the exact substance name, because the report itself may be a group review.
FDA also says its online database gives the 21 CFR citation for substances that have been codified in the CFR. The records I searched do not include that citation.
Approach: I searched FDA's SCOGS GRAS substance evaluations and read FDA's SCOGS database page for how to get the full reports.
If you give me a substance name or CAS number, I can pull its report number and NTIS accession number.