# John P. Frawley — "A Reasoned Approach to Regulation Based on Toxicologic Considerations"

**The *Frawley side* of the 13 Feb 1968 showdown.** This is the published text of the speech Frawley
delivered at FDA's **National Conference on Indirect Food Additives, Washington D.C., Tuesday, 13 Feb
1968** — the very paper that **Dr. W. H. Summerson** (FDA Bureau of Science) was rebutting when he called
its central device "sheer nonsense" (see the companion file
`Summerson_FDA-BureauOfScience_paper_NationalConf_Feb1968_excerpt.md` and `08_VINYL_CHLORIDE_CAMPAIGN.md`
§4). Together the two excerpts give **both sides** of that exchange from primary text.

**Citation.** John P. Frawley, "A Reasoned Approach to Regulation Based on Toxicologic Considerations,"
*Food Drug Cosmetic Law Journal* **23(5):260–270** (May 1968), Commerce Clearing House / Food and Drug
Law Institute. **Local primary:** `papers/food_drug_1968_v23_n5.pdf` (pp. 260–270); OCR in
`papers/fdclj_1968.txt`. Byline: **"Dr. Frawley Is Chief Toxicologist for Hercules, Incorporated,
Wilmington, Delaware."** All quotes verbatim, kept short; page pinpoints noted.

> **Naming note.** The SPI conference *agenda* (a ToxicDocs doc) listed Frawley's talk as **"Toxicology of
> Indirect Food Additives"**; the published title above is what FDCLJ printed. Same paper, two titles.

---

## The financial driver / conflict of interest, in his own words (p. 261)
> "I personally had spent over a million dollars of my Corporation's money investigating the safety of
> food packaging materials, and from society's point of view it was all wasted, because all were proven to
> be safe. The benefit to the consumer was zero."

He frames the whole problem as wasted effort: essentially all pre-1958-Amendment packaging practices "had
been confirmed as safe and inscribed into a set of regulations too complex for anyone to understand."

## The "de minimis" trichotomy and his three escape routes (pp. 262)
The "ever famous trichotomy": a chemist finds **10 ppb** migrating; the **lawyer** says it is therefore a
food additive needing clearance; the **toxicologist** won't call it safe without studies. Three ways to
"break this vicious circle": (1) the chemist uses a less sensitive method and reports "not there"; (2) the
lawyer invokes **"de minimis non curat lex"**; (3) the toxicologist declares it safe **on the basis of
insignificance.** Frawley puts the duty on toxicologists first, lawyers second — *not* chemists.

## The experience-based derivation of the threshold (pp. 263–265)
Self-questioning ladder: one molecule is accepted as safe (else no new chemical could ever be made); **1
ppb** in diet is accepted daily (chemists are exposed above it); **1 ppm** he answers "emphatically no"
(a few compounds + chemical-warfare agents are toxic there). Then the literature review:

> "I have been able to locate two-year chronic toxicity studies on **245 different substances**… it
> represents between **15 and 20 million dollars** in toxicological research… I now have collected over
> **90%** of all such studies."

Result: for the **"all other"** class (excluding **pesticides and heavy metals**), *every* compound was
without toxic effect at **40 ppm** lifetime feeding; most safe above 100 ppm. Applying the **100-fold FDA
margin of safety** → safe at **1 ppm**; then a further **10×** cushion (his tabulation only "90%
complete") → **0.1 ppm as the level of toxicological insignificance.**

## The container-level rule and the rosin-size experiment (pp. 266–268)
Using **radioactive rosin size in paper** (the most permeable substrate / most-extracted additive — an
"experimental market basket survey," 24 foods) he finds **1.0% use → 0.5 ppm** diet, **0.2% use → ≤0.1
ppm**. Hence the operative rule, formally submitted to FDA:

> "I submitted a formal proposal to the FDA to incorporate this concept in **Regulation 121.2500**, which
> would exempt… 'substances used at a level of no more than **0.2% by weight of the container**… provided
> these substances are not heavy metals… or pesticides.'"

He notes a PVC datum (a "radioactive plasticizer used at **28%** in a polyvinyl chloride film," footnote
4) suggesting ~0.6% in plastics → ≤0.1 ppm, but says the plastics data are "insufficient" to propose a
dividing line yet — confirming paper/rosin as the deliberate worst case. The Delaney Clause is
acknowledged as still applicable.

## The claim of professional / industry consensus (pp. 265, 268) — corroborates the organized campaign
> "**Twenty-four other toxicologists** from universities and industries have supported this proposal in
> writing to the FDA. Almost as many others have privately supported it."

> "two dozen experts have advised the FDA of their endorsement… Several lawyers have advised me that this
> support from the scientific community… confirms that these uses are generally recognized as safe or
> 'gras' and that no action on the part of the FDA is necessary."

*(This public "24 toxicologists wrote to FDA" line is the visible tip of the coordinated SPI / Allied
Signal indirect-additives campaign documented in `08_VINYL_CHLORIDE_CAMPAIGN.md`.)*

## The three proposed categories (Conclusion, pp. 269–270)
1. components used **≤0.2%** → cannot "reasonably be expected" to become food components → **exempt**;
2. components used **>0.2%** but shown by migration studies to contribute **≤0.1 ppm** → **nonmigratory**;
3. components used **>0.2%** that *do* migrate significantly → genuine food additives → tested & regulated.

> "Only by accepting some level of insignificance and recognizing the relative risk to public health from
> different uses can we avoid wasting our resources on predictably unprofitable research."

## Data-base progression across his three airings (analytic note)
Same thesis, growing N of chronic studies: **143** (ACS, 14 Sept 1966) → **220** (BIBRA London / FCT,
25 Jan 1967) → **245** ("$15–20M"; this Feb 1968 conference). The "~18 months ago" backref on p. 265
dates the original 0.1-ppm proposal to the **Sept 1966 ACS** symposium.