CHEMICAL & ENGINEERING
NEWS VOLUME 38, NUMBER
12 The Chemical World This Week
MARCH
21,
1960
Additives Law Takes Its First Research Victim Research in feed additives weakened as Pfizer transfers experts to new jobs and Eli Lilly shifts to other fields. Pesticides and food additive research continue apprehensively Research on feed additives may be the first casualty of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. Just as the amendment went into full effect early this month, a C&EN survey of the affected industries uncovered these developments: • Chas. Pfizer substantially cut its budget for agricultural research and development. Most of the scientific personnel located at its Terre Haute, Ind., agricultural research center are being transferred to other assignments
in the company. Reason: the difficulties Pfizer experiences in attempting to get FDA clearance for new drugs for veterinary use, particularly those intended for use in animal feeds. • Eli Lilly is shifting its agricultural research efforts away from hormones and thyroxin blockers for feed additive use to household, farm, and industrial pesticides. Reason: in some instances and in some animals, says Lilly, the hormones and thyroxin blockers have caused hyperplasia, an increase in cell growth that is some-
LEAVING THE FARM. Pfizer's 700-acre agricultural research farm at Terre Haute, Ind., is not closed, but most of its
times a forerunner of cancer. A compound causing hyperplasia may come under the ban imposed by the Delaney Clause, which forbids any amount of any carcinogen in animal or human food. • Feed additives manufactures have formed a new trade association, the Feed Additives Council. Its purpose: to deal with agencies that regulate hormones, enzymes, arsenicals, vitamins, antibiotics, and the like used in animal feeds. Feed additives run into difficulty,
scientific personnel have been reassigned. The move points up difficulty in getting new drugs cleared for feed use MARCH
2 1 , 1960
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say Pfizer spokesmen, because the Food Additives Amendment was designed primarily with additives to human food in mind. Its application to drugs for use in feeds is strained and cumbersome. Pfizer says it hopes the situation will be corrected either through changes in FDA's interpretation or by legislative revision. If it is corrected, Pfizer plans to transfer scientific personnel back to agricultural research. The Feed Additives Council expects its executive committee to approve a statement of policy this week that calls for a slight alteration in either the administration or wording of the Delaney Clause to permit protection of the public without cutting off the use of all chemicals in feeds. The practical effect on the feed additives industry of the Delaney Clause and FDA's interpretation of it is that use of newly developed drugs is barred in all but 20 to 30% of today's manufactured feeds. Pfizer says FDA refuses to clear any new drug for incorporation in feeds which contain diethylstilbestrol (DES) or the arsenicals, and about 70 to 80% of all manufactured feeds on the market today contain one or the other of these materials. Furthermore, says Pfizer, the remainder of the feeds contain some other drug or drugs which are exempt from the provisions of the food additives law because of the grandfather clause. To sell a new drug for use in those feeds, the manufacturer must obtain clearance for the new combination under the food additives law. To get clearance for the combination, the firm has to provide safety data on the older drugs as well as the new one, and the potential market cannot justify the cost of obtaining such data. Elsewhere in the chemical industry, the Food Additives Amendment has not so far produced any major cutbacks or shifts in research. Companies that make direct food additives, such as emulsifiers, antioxidants, preservatives, and the like, are either increasing their research or continuing it on the same basis. Hercules, Eastman Chemical Products, Atlas Powder, Dow, and Monsanto are among them. For direct additives, spokesmen say, the effect of the amendment is merely to formalize the testing procedures they had been following all along. Eastman Chemical's Dr. J. E. Magoffin says, for instance: "As far 20
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as we can tell at this time, the new requirements will affect us primarily in the way in which we must report our findings. The actual information required is about the same as that which we provided the Food and Drug Administration under the more informal procedures of past years." Dr. Walter H. C. Rueggeber, director of the chemical research department at Atlas Powder, says, "The provisions of the new law may sometimes make it necessary for us to increase either the number of tests, or the test population, or both to provide additional data on food additives . . . Our current guess is that costs might increase as much as 20% as a result of the amendment. . . . We do not expect to be hampered by the provisions of the new law." Hercules Powder has increased its research budget for food additives and agricultural chemicals by more than $500,000 and has assigned five men to full-time and five men to parttime work on problems associated with the Food Additives Amendment. Says Paul M ay field, Hercules vice president: "How we shall fare in the years ahead depends pretty much on the answers to the following basic questions: Is the use of a chemically produced synthetic substance, as such, inherently more dangerous than substances which appear in nature? Is there a valid distinction between things 'artificial' and 'natural'? If a substance, when consumed in massive amounts, produces a poisonous or carcinogenic effect, should the substance be forever banned no matter how small a quantity used? Is there such a thing as 'balance of nature' and does the use of chemically produced food ingredients upset this balance or is their use a part of it?" But the major bombshell to the chemical industry is not the amendment's effect on direct additives but on substances which are unintentionally added to food. This viewpoint was expressed week before last by John Hogan of Century Chemical before an ACS meeting-in-miniature in New York. Chemicals which were never thought of as additives to food must now be thought of in an entirely new light with the result that research, toxicology, and marketing programs must be revised in accordance with the new amendment. Mr. Hogan mentioned specifically the chemicals that go into making cartons, containers, and packages used by the food
industry. The Packaging Institute has been carrying on a vast educational program in an attempt to prepare the packaging industry for the full effect of the amendment. FDA has granted one-year extensions for a number of the chemicals used in food packaging, but, as one independent researcher remarked, one year will not be sufficient time for testing if some of these chemicals are found to migrate to food and toxicological tests have to be made. Another area of possible trouble is in the chemicals that go into making rubber items used by the food industry—such items as conveyors, hose, gaskets, seals, washers, milking machines, and many others. B. F. Goodrich has a department of industrial hygiene and toxicology that is evaluating its products in terms of the amendment. That company recently introduced a number of products that meet requirements of the law. Among them were conveyor belts, brewery hose, and milling inflations. For the petroleum field, Sonneborn Chemical & Refining has set up a special group to serve as a clearing house for information regarding the law's effect on the use of petroleum products in food manufacturing, packaging, and processing. Other organizations offering education and guidance are the Society of Plastics Engineers, the American Petroleum Institute, the Society of the Plastics Industry, and the Manufacturing Chemists' Association. MCA is now working on a food additives manual. The first section of the manual will be out soon. It will be designed to help manufacturers decide whether or not their products are food additives, as defined in the law. In other areas,. the effects of the Food Additives Amendment are not yet so clear cut. Although pesticides do not come under the Food Additives Amendment and are not subject to the Delaney Clause, they have been dragged into the controversy by Secretary Flemming's public statements in the cranberry episode. Now that his every pronouncement is front-page news, pesticides are also suspect in the mind of the public, even though they have been under tolerance regulations since about 1956. The search for new pesticides and for new uses for older ones continues unabated, despite recent unfavorable publicity. Some companies, notably Frontier Chemical, Stauffer (which
upped its budget 2 6 % ) , and Hercules, are even expanding pesticides research. Holding the line are American Cyanamid, Shell Chemical, Dow, Allied, and Monsanto. There has been some opinion that the Miller Amendment, under which pesticides are regulated, has reduced research in this field. But this is difficult to prove. Experts believe fewer new toxicants have been introduced since 1956, but they admit this may involve factors other than legal ones. The number of formulations registered every year under the Miller Amendment has been going up since 1956. Undoubtedly the Miller Amendment has killed some candidate pesticides because their market potential was not sufficient to justify the expense involved in getting FDA clearance. Even though pesticide research continues, recent events have caused pesticides manufacturers to be apprehensive and watchful. L. S. Hitchner, executive secretary of the National Agricultural Chemicals Association, said recently: ". . . about 25 men in Washington, who may or may not be technically trained in the problems on which they must rule, are today the sole judges of all- research done by private industry, the landgrant colleges, private research institutions, and other government agencies-this insofar as the use of chemicals appearing in or on food. It is something to think about." Pesticide manufacturers are joining with the food additives manufacturers in criticizing the Delaney Clause for its ban on the exercise of scientific judgment in the area of additives that have carcinogenic properties. Shell Chemical, which is a big factor in pesticides, says that if the Delaney Clause is not modified: "It will undoubtedly have a marked effect on our research program. We would be willing to pursue a research program on a particular compound if we knew that any adverse toxicological data would be reviewed in a scientific and objective manner, but we could not commit ourselves to such a longrange program and attendant financial risks knowing that the compound could be banned from use on the basis of an arbitrary decision." A recent editorial in Barrons summed up chemical industry reaction best when it described the current furor as "a triumph of superstition over science."
Capital Outlay Boost Spells Good Year Capital outlays will reach $37 billion this year, up 14% over last year to a new record One indication that business will continue to boom along at a fast clip this year comes from the latest joint survey from the Department of Commerce and the Securities and Exchange Commission on new plant and equipment expenditures. According to the new survey, industry is expected to spend $37 billion on new plants and equipment this year, $4.5 billion or 14% more than last year, and $54 million more than in the record year 1957. Outlays for chemicals and allied products should reach $1.64 billion this year, says the survey. That's 33% more than last year and less than $100 million under the chemical industry's record expansion year in 1957. All major industries expect to spend more in 1960 than in 1959, the survey shows. Manufacturers expect expenditures to increase 25% this year to $15 billion. Durable goods industries expect outlays of $7.7 billion this year - u p 33% over 1959. Nondurable goods industries plan to spend $7.5 billion compared to $6.3 billion last year. In nonmanufacturing, planned increases range from 2% for mining to 10% for railroads. Capital expenditures by nonmanufacturing industries are slated to reach a record rate in the first half of this year. Full Year Spending. Also encouraging are industry's plans to increase its spending throughout the year. With a $37 billion outlay forecast for the full year, an average seasonally adjusted annual rate of $36 billion is predicted for the first half of the year, $38 billion for the second half.
In chemicals and allied products, capital outlays should reach $676 million during the first half of 1960. If the chemical industry reaches its projection of $1.64 billion for all of 1960, predicted for the first half of the year, capital outlays will have to rise to just under $1 billion during the second half of this year. The current survey indicates that capital spending plans are little changed in the past few months. It puts chemical industry outlays, for example, at $363 million for the final three months of 1959 and at $318 million for the current quarter. That's very close to what was predicted in a similar SEC-Commerce report of three months ago. In a survey made last spring, moreover, the government agencies pegged chemical industry outlays for all of 1959 at $1.26 billion, only $27 million more than chemical firms actually spent during the year just past. Last spring's survey also showed that all industries plan to spend $32.56 billion in 1959. Actual spending was only $22 million less than that. What It Covers. The survey, a joint project of the SEC and Commerce Department, is based on industry estimates. Basic data are obtained from reports submitted by companies registered with the SEC, transportation companies under Interstate Commerce Commission jurisdiction, and a large sample of nonregistered companies, unincorporated as well as corporate, reporting to the Commerce Department.
Process Industries Plan Higher Expansion Spending (Millions of Dollars)
Chemicals and allied products Petroleum and coal products Rubber products Paper and allied products Primary nonferrous metals
1957
1958
1959
1960
$1724 3453
$1320 2431
$1235 2491
$1642 2930
200 811 814
134 578 441
190 630 313
254 696 372
Source: Department of Commerce, Securities and Exchange Commission.
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2 1 , 1960
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