# FDA National Conference on Indirect Food Additives — Feb 13–14, 1968 — COMPILED RAW MATERIAL

*Assembled 2026-06-10 from the local ToxicDocs SPI / Allied Signal vinyl-chloride collection. This is the
fullest reconstruction of the conference available without the stenographic transcript. Verbatim quotes are
OCR-cleaned (obvious scanner errors only; wording unchanged); provenance is the ToxicDocs file hash + the
Bates stamp + the original Food Chemical News issue/page. Companion analysis: `08_VINYL_CHLORIDE_CAMPAIGN.md` §4.*

**Three headline facts established here:**
1. **A complete verbatim transcript was produced.** Both the printed agenda and the Keller & Heckman cover
   letter say so: stenographic reporting by **Ace-Federal Reporters, Inc., 415 Second Street, N.E.,
   Washington, D.C. 20002**, sold to registrants at 17½¢/page (≈$40–60 total). Copies were ordered by the
   industry. **It is an operator-retrieval target — not yet located** (try Ace-Federal's successor, the FDA
   History Office, NARA RG 88, or the SPI/Keller & Heckman files).
2. **We already hold ~13 printed pages of near-verbatim coverage** — *Food Chemical News*, 19 Feb 1968,
   pp. 3–15 — reproduced in full below, covering every session and speaker.
3. **The conference was convened under congressional pressure** (a House Small Business subcommittee), and the
   industry's parallel ask was an "Industry-Government Advisory Committee" (the 9 Feb 1968 Locke letter, §C).

---

## A. The program (agenda)

*Source: `toxicdocs/1yes__xxxx__AlliedSignal__PolyvinylC__wjga43zZ8kE8x4B61ZvODoqD.txt`, Bates ASI 00000193–194.
The printed conference program (FDA, Bureau of Voluntary Compliance).*

**Note on the program's own promise:** "A summary of the conference will be mailed to all registrants in the
form of abstracts of the formal presentations. **A complete transcript of the conference will also be
available from a stenographic company.**"

- **First Session — Tuesday morning, 13 Feb 1968 — "Chemistry and Migration of Indirect Food Additives."**
  Presiding: **Fred J. Delmore**, Director, Bureau of Voluntary Compliance, FDA.
  - 9:00 Registration
  - 9:15 Welcoming Statement — **James L. Goddard, M.D.**, Commissioner of Food & Drugs
  - "Scientific Aspects of the Migration Problem" — **Mr. John Nair**, Syracuse University Research Corp.
  - 10:25 Presentations by Industry Representatives (ten minutes each): Can Manufacturers Institute; Glass
    Container Manufacturers Institute; American Paper Institute; The Society of the Plastics Industry;
    Rubber Manufacturers Association; American Petroleum Institute; Soap and Detergent Association;
    Adhesives Manufacturers Association of America
  - 11:45 Discussion / Questions and Answers — Speaker Panel; 12:15 Lunch
- **Second Session — Tuesday afternoon, 13 Feb 1968 — "Toxicology of Indirect Food Additives."**
  Presiding: **Dr. N. [Norton] Nelson**, New York University Medical Center.
  - **Dr. J. P. Frawley, Hercules, Inc.**
  - **Dr. Wm. H. Summerson, Bureau of Science, FDA**
  - **Mr. L. L. Ramsey, Bureau of Science, FDA** — "Toxicological Considerations"
  - Break; Discussion; Questions and Answers — Speaker Panel; 5:00 Adjourn
- **Third Session — Wednesday morning, 14 Feb 1968 — "Open Forum."**
  Presiding: **Dr. Wm. H. Summerson**.
  - General discussion for industry to present other problems, including administrative procedures
  - Questions and Comments; Summaries of Sessions by presiding officers; Closing Remarks — Fred J. Delmore;
    12:00 Adjourn

*(So Frawley and Summerson were the two paired toxicology speakers in the same session — the "showdown" was
built into the program, presided by Norton Nelson.)*

---

## B. The verbatim transcript & the abstracts (provenance)

*Source: Keller & Heckman cover letter (Jerome H. Heckman to the SPI Food Packaging Materials Committee),
19 Feb 1968, transmitting the FCN reprint. Bates ASI-PR 0000573–0000574.*

> "As a convenient way of providing those of you who were not in attendance at the above-referenced
> Conference with something of a report on developments, we have obtained permission to reproduce, and are
> herewith enclosing Pages 3 through 15 of this week's issue of Food Chemical News. The Editor of the
> publication, Mr. Louis Rothschild, has indicated to us that he expects to give the sessions some further
> coverage in his next issue…
>
> According to other information we have received, copies of the verbatim transcript of the Conference will
> be available from the reporting company by Tuesday of this week. Those of you who wish to do so may obtain
> copies of the transcript by writing to the reporting company at the following address: **Ace - Federal
> Reporters, Inc., 415 Second Street, N. E., Washington, D. C. 20002**. Incidentally, the cost for the
> transcript will be 17½¢ per page and we understand that the total charges should be somewhere between $40
> and $60…
>
> [T]here is already some impetus for the Food and Drug Administration to take affirmative action, at least
> to the extent of responding to an inter-industry letter forwarded to Dr. Goddard on February 9, 1968."

---

## C. The 9 Feb 1968 inter-industry letter to Goddard (verbatim)

*Source: enclosed with the K&H packet; Bates ASI-PR 0000588–0000589. On American Paper Institute letterhead.*

> "February 9, 1968. Dr. James L. Goddard, Commissioner, Food and Drug Administration…
>
> The industry groups named below welcome your review of the approach to 'indirect food additives'
> (packaging materials, machinery lubricants, etc.) under the Federal Food, Drug and Cosmetic Act and the
> Conference which you have called for February 13 and 14 at which they and others will have an opportunity to
> express views. They have requested and authorized me to write you in their behalf.
>
> They believe you will agree that however valuable the Conference will be, it cannot take the place of round
> table discussion between your scientists and administrators and their industry counterparts.
>
> These organizations, which we believe represent the industries filing most of the indirect additives
> petitions, respectfully suggest that soon after the conclusion of the Conference an 'Industry-Government
> Advisory Committee' be created along the lines envisaged by Executive Order Number 11007 and in accordance
> with that Order. Such a committee would report its findings and recommendations to you.
>
> Sincerely, Edwin A. Locke, Jr. In behalf of: Adhesive Mfrs. Ass'n. of America; American Paper Institute,
> Inc.; American Petroleum Institute; Can Manufacturers Institute; Rubber Manufacturers Association; Soap &
> Detergent Association; Society of the Plastics Industry."

---

## D. *Food Chemical News* conference coverage — 19 Feb 1968, pp. 3–15

*Source: `toxicdocs/1yes__1968__AlliedSignal__PolyvinylC__Kza60dbJNXoEMZbe1v7QM7VxK.txt`, Bates ASI-PR
0000573–0000587. Editors: Louis Rothschild, Jr.; Raymond Galant. (This is a trade-press report, not the
transcript — it quotes the papers and the floor "in part," but at length and quasi-verbatim.)*

### D1. Overview (pp. 3–4) — "FDA Agrees to Consider Frawley Proposal… With Obvious Reluctance; 'Middle Ground' Suggested"

> "Spokesmen for the Food and Drug Administration sharply challenged a proposal by Hercules' Dr. John P.
> Frawley to exempt most packaging materials from food additive administrative procedures at last week's
> indirect additives conference… (See FOOD CHEMICAL NEWS, Jan. 22, Page 21; Feb. 5, Page 16; and Feb. 5,
> Page 18). …Dr. W. H. Summerson, director of FDA's Bureau of Science, said he would not 'dispute directly'
> with Frawley, but said his paper was a 'justification' of FDA's policy. Actually, it was difficult to
> interpret the Summerson presentation as other than a rejection of the Frawley proposal."

On the conference's political origin (p. 4):
> "Industry representatives at the meeting, generally, were aware that the conference had been inspired by
> pressure from a House Small Business subcommittee. The calling of the meeting enabled FDA to tell the
> subcommittee that it was 'doing something' with regard to indirect additives."

### D2. Ramsey's paper — the migration tiers (p. 4)

> "Before beginning the extractability studies for a minor component of a food contact surface, one is well
> advised to make a computation of the amount which might be added to food if it all migrated. If such
> computation showed that no more than 0.01 p.p.m. of the substance could possibly be added to the food, the
> extracts usually need not be tested for such substance…" (L. L. Ramsey)

Summerson's working scheme (p. 4):
> "If the amount expected in any food is equivalent of 0.01 p.p.m. or less, we consider it 'virtual lack of
> migration' and request only an LD50 on the chemical." — between 0.01 and 3 p.p.m., "90-day toxicity studies
> on two species of animals"; over 3 p.p.m., "long-term feeding studies."

### D3. Summerson's "soundness / middle ground" concessions (pp. 4–5)

> "Under questioning, Summerson said there is a 'soundness of certain portions of Dr. Frawley's thesis,'
> conceding that there is some 'unjustifiable expense' for testing. Asked whether FDA will provide a
> 'documented commentary' on the Frawley proposal, Summerson replied: 'Undoubtedly.' … 'Somewhere in between
> will be a position that both Dr. Frawley and FDA can live with.'"
> Frawley: FDA "is willing to accept 0.01 p.p.m." without toxicological work; his own level is 0.1 p.p.m.; "it
> is just a matter of degree." On FDA requiring only an LD50 at low levels: "doesn't tell you a thing."
> Delmore: FDA and industry views "are [not] too far apart." Heckman (SPI): a "middle ground" is "a good place
> to start."

### D4. Summerson's "Sheer Nonsense" paper (pp. 5–7) — Bates ASI-PR 0000576–0000578

Headline: **"Frawley Proposal Praised for 'Soundness,' Hit as 'Sheer Nonsense.'"** "Summerson's paper, which
dealt almost solely with the Frawley proposal, said, in part:"

> "Unless premarketing clearance is practiced, the only method of detecting harmful effects is retrospective
> with respect to exposure to the suspected agent. The latent or 'incubation' period from the time a chemical
> agent is first applied to the human being until the time that cancer occurs is often 10 years or more. This
> means that one may have to wait a number of years before results of an exposure may even be detected. It is
> obvious, therefore, that after the 10 year period, with changing food habits, additives and packaging, it is
> well nigh impossible to isolate an additive as the original causative agent of a cancer. Thus, if we are to
> give the consumer the protection he expects and demands, we must require premarket testing.
>
> "This seems obvious when we describe it this way, but even today we have offered to us a statement to the
> effect that the proponent feels no food additive clearance is necessary because he has no knowledge of any
> bad effects from his product. … unless a relatively acute poison is involved an effect is not likely to be
> routinely traced to a causative agent in food or packaging."

On the 0.2% / 0.1 ppm generalization and its limits (p. 6):
> "Can we assume that any component of a food container that does not exceed a certain amount, say 0.2%, will
> always give an insignificant amount (less than 0.1 p.p.m.) in the total diet and therefore be safe? If we
> eliminate the pesticides, heavy metals, and carcinogens…, this generalization has considerable appeal and
> some reliability on the basis of 'published' toxicity data.
>
> "This generalization does not take into consideration whole meals in packaged materials, the use of an
> ingredient in more than one class of packaging material, and the additive effect of similar ingredients.
> Nor does it account for the food faddists or other individuals with unusual food preferences… Add to these
> the probability that thick containers, such as plastic bottles, contribute far more to the food than plastic
> coating of a few mils thickness…"

The "biased literature" point and named counter-examples (p. 6):
> "Long-term feeding studies as reported in the literature may not be representative of the total scientific
> knowledge on all possible and useful food packaging chemicals." — some plasticizers extract into fatty foods
> "at 100 p.p.m. or more"; FDA has had requests for **triorthocresyl phosphate**; tight restrictions on
> monomers such as **acrylamide** ("Certainly they are used at safe levels, but without any regulation, would
> this be true?"); objections to sensitizers **toluene diisocyanate** and certain **epoxy curing agents**
> "even at levels below 0.2% of the formulation."

Conclusion (p. 7):
> "…with the ever increasing use of food packaging, more and more segments of our population are exposed to
> greater amounts of packaging chemicals. Some, including babies, may have their entire diet exposed to food
> packaging chemicals. Therefore, I believe… that industry and FDA must know the relative safety of each
> migrant."

### D5. The floor exchange after the toxicology session (p. 7) — Bates ASI-PR 0000578

- **Survivorship/bias charge:** "Summerson said that Frawley's sources 'bias the data,' since highly-toxic
  substances are not found in two-year studies, because the animals do not survive for two years. He said some
  proposed additives never get to the two-year testing stage. Frawley responded that because of a possible
  bias in the data, he added an additional safety factor of ten."
- **The acrylonitrile counter-example:** "Frawley said he concluded that except for pesticides and heavy
  metals, no packaging materials are toxic at 40 p.p.m. or less. **FDA's Dr. Joseph McLaughlin, Jr.,
  disagreed, pointing to acrylonitrile.**"
- **Summerson:** "FDA cannot set a 'floor' simply because no problem has become apparent."
- **Ramsey:** asked industry to imagine being the regulator — "…how would you exercise control?" — noting "the
  world climate of toxicological opinion is extremely conservative" and concern about "microinsults."
- **The presiding toxicologist's warning:** "Dr. Norton Nelson, of the New York University Medical Center,
  agreed that 'some simplification is required,' but warned against 'over-simplification.' He said 'any single
  set of concentration limits' are not likely to be found. … a cut-off point might work well for
  well-understood classes of materials, but might not be adequate for others."

### D6. Frawley's own presentation (pp. 8–9) — Bates ASI-PR 0000579–0000580

The derivation, verbatim:
> "The Hercules scientist based his proposal on two-year chronic toxicity tests on 245 different substances,
> which he said constituted 90% of all such studies. For all but pesticides and heavy metals, he said, 'every
> compound was without toxic effect in experimental animals when fed for a lifetime at a dietary concentration
> of 40 p.p.m.' Applying a 100-fold safety margin, Frawley found 'every compound which has been studied is safe
> for man at a total dietary concentration of 1 p.p.m.' Because of possible bias in the cross-section of
> studies, Frawley proposed 'that we protect ourselves by adding another factor of ten and adopt 0.1 p.p.m. as
> a level of toxicological insignificance for all materials other than pesticides and heavy metals.'"

> "… a compound which would be toxic to man at 0.1 p.p.m. would have revealed its extremely high toxicity in …
> (industrial) exposures and it would have been rejected as incompatible for the food packaging industry."

The "nonmigratory" expansion announced at the conference:
> "Major components which can be shown by suitable migration studies to contribute no more than 0.1 p.p.m. to
> the diet should be considered nonmigratory." — rosin-size paper: "at a level of 1.0% the maximum dietary
> contribution will be 0.5 p.p.m., and at a level of use of 0.2% an insignificant amount of not more than 0.1
> p.p.m. will be contributed to the diet"; a PVC study with a radioactive plasticizer used at 28% suggested
> "a 0.6% level of an additive in plastics will contribute no more than 0.1 p.p.m. to the diet."

The lobbying frame, in his own mouth:
> "This proposal has received overwhelming support from my profession," the toxicologist said, explaining that
> "24 other toxicologists from universities and industries have supported this proposal in writing to the FDA"
> and "almost as many others have privately supported it." … "Several lawyers have advised me that this
> support from the scientific community of and by itself confirms that these uses are generally recognized as
> safe … and that no action on the part of the FDA is necessary."

### D7. The industry presentations (pp. 9–11)

- **Adhesives Manufacturers Association — Max Goldfrank (Stein-Hall):** endorsed Frawley — "If this doctrine
  is sound for food-contact materials, as I believe it is, then it is even more valid for adhesives components
  where there is substantially no chance of migration."
- **Can Manufacturers Institute — E. W. Erhardt (Mobil Chemical) and Dr. Robert Henry (Continental Can):**
  proposed a 1 p.p.m. cut-off (migration in food or food-simulating solvent). Henry: "The hundreds of
  extractability studies… in the past 15 years have established the level of potential migration that has
  proven to be without hazard," and "none of the substances so cleared has presented any health problems."
- **Society of the Plastics Industry — George W. Ingle (Monsanto):** "what is needed is … to add the explicit
  phrase 'of toxicological significance' to the statutory definition of food additive," with FDA market-basket
  surveys to correlate extraction figures with diet levels.

### D8. The Advisory-Committee debate (pp. 11–13) — Bates ASI-PR 0000583–0000584

- **Summerson** invoked Executive Order 11007's emphasis on "freedom from conflict of interest," recalling
  that at the Army's **Edgewood Arsenal** advisory committees "were never effective because of 'conflict of
  interest.'" An industry-government group advising what the regulation should be is "untenable" — "We couldn't
  get away with it if we wanted to." He allowed a committee on "technical points" only, with consumer
  representation.
- **Heckman (SPI counsel):** argued the "regulatory approaches are so inconsistent, so complex, and so
  virtually incomprehensible… that anything short of an in-depth reevaluation… cannot bring about the type of
  reform so urgently needed," urging "a government-industry cooperative effort employing working committee
  techniques… rather than through ex parte presentations of the type being made here."
- Others on a committee: **William C. Becker** (B. F. Goodrich / Rubber Mfrs. Assn.); **Dr. George W. Fiero**
  (Humble Oil / American Petroleum Institute); **Dr. W. Wayne Stewart** (Sun Oil / API); **Norton Nelson**
  (NYU); **Delmore** offered an "industry liaison committee" through the Bureau of Voluntary Compliance.

### D9. "FDA-ers Deny Change in Policy on No-Extractive Additives" (pp. 13–15) — Bates ASI-PR 0000585–0000587

On the disputed extraction-test / Petition policy (the issue that had reached the House subcommittee):
> An FDA staff paper to the House Small Business subcommittee had written: "Where FDA's review of the proffered
> extraction studies confirms a lack of potential migration, no regulation is necessary" (cf. FCN Jan. 22, p.
> 21). At the conference, **Ramsey**: if there was a policy change "I am not aware of it." **Summerson**: "food
> manufacturers can decide for themselves that a substance is not a food additive because of its lack of
> migration to food," but "industry has taken the position that they need FDA's concurrence… Eventually
> requests for regulations through the Petition method became the approach of industry for every substance
> which had even a remote possibility of migrating into food."

Heckman asked for "Advisory Opinions which would help build a coherent, understandable, and carefully
rationalized body of law"; Goldfrank recalled the Food Additive Law hearings, where Rep. **Dingell** asked
whether FDA could state that an adhesive "is or is not a food additive" without a Petition, and Deputy
Commissioner **John L. Harvey** answered "we would have authority to give advice of this type and it would be
our intent to do so" — "So far as I know, to this day FDA has consistently refused to use this authority."

---

## E. Adjacent local sources (run-up and aftermath — catalogued, not fully transcribed)

*Mine these next if the scene needs the lead-in or the sequel.*

- **Run-up FCN coverage** — `toxicdocs/2likely__1968__AlliedSignal__PolyvinylC__4aLmvyRNEjKY4MjXxJ87BEkDV.txt`
  (Bates ASI-PR 0000532): "FDA TOPSIDERS WEIGH EASING OF INDIRECT ADDITIVE REQUIREMENTS" — the Frawley
  proposal vs. FDA's own proposal, before the conference (this is the Jan/Feb 1968 coverage the 19 Feb article
  back-references).
- **Conference announcement / FDLI coverage** — `…nka82JKVvGb1jGvMq7NMNwyn6.txt` (ASI-PR 0000605–0000606):
  the 8 Jan 1968 notice of the Feb 13–14 conference; "The Frawley proposal was a major topic at both the
  FDA–Food and Drug Law [Institute]" meeting.
- **Aftermath (1969)** — `…oea1Zq1MeNRb3BV7v094jwO47.txt` (ASI-PR 0000746–0000748) and
  `…e7RBLqa3kqJ7qa9LRJaXwreqp.txt`: "FDA ISSUES INDIRECT ADDITIVE 'DISCUSSION DRAFT' PROPOSAL" — FDA's
  follow-on draft exempting indirect additives used at less than 0.2% by weight of the container; the
  Advisory-Committee push continues.
- **SPI committee minutes** — `…x5DwBD0vXy3xVzQnnmapqOM0m.txt` (large): correspondence with Ramsey, the
  Committee's handling of the proposal, and Frawley's England (BIBRA) trip.

---

## F. Still missing / acquisition targets

1. **The verbatim stenographic transcript** (Ace-Federal Reporters, Inc., Washington D.C.) — the complete
   record of both days. Routes: Ace-Federal's successor firm; the **FDA History Office**; **NARA RG 88**; the
   **SPI / Keller & Heckman** files (a registrant ordered it).
2. **The mailed abstracts** of the formal presentations (promised to registrants in the program).
3. **Goddard's full welcoming statement** and **John Nair's** migration-science paper (only named here).
4. **Summerson's standalone paper** (we have FCN's quotation of it, not the paper).
5. **The full FCN run-up coverage** (Jan. 22 p. 21; Feb. 5 pp. 16, 18) and Rothschild's promised "next issue"
   follow-up — partly in §E; the rest via the *Food Chemical News* archive (National Agricultural Library;
   modern owner Informa/Agra-Net).

*Frawley's own published address — the one piece in true primary form — is `papers/fdclj_1968.txt`
(FDCLJ 23(5):260–270).*