However,

formerly covered by the Caustic Poison Act (21 CFR § 191.109). other labeling changes were required. Unfortunately, not all states have put through similar changes to their caustic poison acts (Example 5, Attachment). (6) "Poisonous pharmaceutical" laws. Here, the state or municipality attempts to regulate the sale or dispensation of poisonous, toxic, or potentially poisonous or toxic products which are commonly sold by retail drug stores but which are not prescription drugs. Typically, the law or regulation will specify a particular labeling which differs from and exceeds the federal standard (Example 6, Attachment).

For all of the above reasons, we strongly support the pre-emption amendment which has been proposed by the Chemical Specialities Manufacturers Association in its statement submitted June 24, 1966. It is especially important that the pre-emption clause not be limited to cases of express conflict between federal and state or local laws and regulations. The pre-emption clause in favor of the federal standard should also apply where the Food and Drug Administration has the power to act but by action or inaction concludes that no hazard is present and does not prescribe labeling. State and local regulators should not be permitted to impose a higher or different standard in these situations. Very truly yours,

J. O. GRAVES,
Director of Marketing,
Consumer Products Division.

ATTACHMENT TO E. I. DU PONT CO. STATEMENT ON H.R. 13886

EXAMPLES OF FEDERAL AND STATE OR LOCAL CONFLICT IN LABELING

Example 1. We know of no substance which is the subject of regulation in more jurisdictions than is methyl alcohol. As with all harmful substances, the likelihood of harm varies with the amount of methyl alcohol to which the human organism is exposed. Thus, a product which is 98% methyl alcohol is much more likely to be harmful than one which is 2% methyl alcohol, all other things being equal. Under federal standards, a mixture containing four per cent (4%) or more by weight of methyl alcohol must be labeled with, among other things, the words "poison" and "danger" and the skull and crossbones symbol (21 CFR § 191.7 (a) (5), (b)(2). However, many state and local laws prescribe different threshold levels. According to the laws of the State of California, for example, any preparation containing more than one per cent (1%) or more methyl alcohol must bear the word "poison" and the skull and crossbones symbol (Deering's California Codes, B. & P.C.A. § 4160, Schedule B(1), § 4161, § 4168). In Massachusetts, on the other hand, the signal word "poison" must be used if a drug or medicine contains any methyl alcohol (Ann. Laws of Mass., c. 94 § 303C). Therefore, a product containing one half of one per cent (2%) methyl alcohol must have the word "poison" if it is to be sold in Massachusetts, but the threshold for such labeling is one per cent (1%) in California and four per cent (4%) under federal law.

Example 2. (a) Under federal standards, products containing five per cent (5%) benzene (benzol) by weight must be labeled with the words "danger", "poison", and "vapor harmful", and the skull and crossbones symbol. Additional labeling is prescribed for products containing ten per cent (10%) or more of benzene. (21 CFR § 191.7(a)(4), (b) (3) (i)). Under Massachusetts law, however, a product which contains any amount of benzene (benzol) must be labeled "danger", "poison", and "vapor harmful", but the skull and crossbones symbol is never required in connection with benzene (Mass. Dept. of Labor and Industries, Div. of Ind. Safety and Dept. of Public Health, Industrial Bulletin No. 11, App. B, p. 7 (1957)).

(b) Under federal standards, preparations containing ten per cent (10%) toluene by weight must be labeled with the signal word "danger" and rather elaborate additional wording must be used, but the skull and crossbones symbol is not required (21 CFR § 191.7 (a) (4), (b) (3) (ii)). Recently, a proposed California law which died in the Assembly would have required the skull and crossbones symbol on any glue or cement containing toluene (Assembly Bill A. 2162, cf. Deering's California Codes, B. & P.C.A. § 4160 Schedule D(a), § 4168).

(c) Under federal standards, a substance is toxic if a single oral dose of more than 50 milligrams but not more than 5 grams per kilogram of body weight kills 50% or more of a given test group of adult white rats. (21 CFR § 191.1 (f) (1)). Under Indiana state administrative standards, however, a substance is toxic if a single oral dose of up to 10 grams per kilogram of body weight kills 50% of a similar test group. The result is that a substance which does not amount to a lethal oral dose in 50% of the test animals unless 8 grams per kilogram of body weight is administered is considered toxic in Indiana but is not considered toxic anywhere else. Thus, many brake fluid labels must bear the legend, "Contains alkyl poly glycol ethers. Do not take internally", or something similar, if the product is offered for sale in Indiana. As a practical matter, the Indiana labeling standard has become the national standard, because of the practical and economic impossibility of adopting a special label just for Indiana (sample label (fig. 1) attached).

Example 3. Under federal standards, products which have flash points of above 20° F. to and include 80° F. when tested by a prescribed method are considered to be flammable and must bear the front panel statement "WarningFlammable" (21 CFR § 191.1 (j) (2)). Products which flash at above 80° F. need not be labeled as flammable. Under New York City Fire Department regulations, products which have flash points of up to 100° F. to 300° F. are said to be combustible (Chap. 19, Administrative Code, City of New York, § C19–2.0, Subdivisions 11 and 22). The signal word "caution" must be used in labeling both classes of products. The result is that household products which flash at 80° F., for example, must bear a front panel notice reading "Warning-Flammable" because of federal requirements, and a back or side panel notice stating Caution-Flammable Mixture" because of New York City's peculiarities. Household products which flash at 120° F., for example, need not bear any front panel warning as to flammability, but must carry the notice "Caution-Combustible Mixture" if they are to be sold in New York City (sample label (fig. 2) attached). Example 4. Current federal flammability standards are based on the determination of flash points by the Tagliabue open cup tester (21 CFR § 191.13). The National Fire Protection Association is currently sponsoring a different method of determining flash points (and thus a different standard for classifying flammable liquids) utilizing the Tagliabue closed cup tester (N.F.P.A. Publication No. 321). The Association also requires the determination of boiling points as a guide to classification. One result would be that a number of products, including gasoline, would be classified as "flammable" under Association standards, while continuing to be classified as "extremely flammable" under federal standards (FDA Publication No. 17, Feb., 1963).

Example 5. Sulfamic acid is corrosive under federal standards, but is not among the twelve (12) substances formerly covered by the Federal Caustic Poison Act and now given special treatment under the Federal Hazardous Substances Labeling Act requiring the word "poison" on the label. However, it is used in household bowl cleaners and is substantially as corrosive to the eyes as acetic acid-one of the special twelve (21 CFR § 191.109 (g)). Thus, it is a "caustic acid" under the laws of some states, such as New Jersey (Title 24, Subtitle 1, Chap. 8, N.J. Stat. Ann.). Therefore, under federal law household products containing sulfamic acid are labeled in accordance with the standards for "corrosive" substances, whereas under New Jersey law the word "poison", among other things, must appear on the label of products containing sulfamic acid.

Example 6. Soldering fluxes for home use are likely to contain more than 5 percent (5%) of zinc compounds soluble in water, such as zinc chloride. Under federal law, these products would be labeled with the signal word "danger" and with a warning concerning the hazards of ingestion and skin and eye contact (Notices of Judgment Under the Federal Hazardous Substances Labeling Act, Nos. 12-17, dated August 12, 1963). Under California pharmacy laws, however, such products must be labeled with the word "poison" (Pharmacy Laws of California and Administrative Rules of the Board of Pharmacy, January 1, 1962, p. 59).

Hon. HARLEY O. STAGGERS,

UNION CARBIDE CORP., New York, N.Y., July 6, 1966.

Chairman, Committee on Interstate and Foreign Commerce,
House Office Building, Washington, D.C.

DEAR CONGRESSMAN STAGGERS: We are writing regarding your bill, H.R. 13886, the Child Safety Act of 1966, and more particularly with respect to Title II which would amend the Federal Hazardous Substances Labeling Act in certain respects. We supported the enactment of the Federal Labeling Act in 1960 with hope that it would mean national uniformity for the legal requirements for warning labels on Prestone antifreeze which we make and package at our South Charleston plant, and on other household products which we make and sell. We also supported it because we were in complete accord with all of its objectives, as evidenced by the fact that we had been using strong label warnings on Prestone and on our other products since the 1930's, before there were any statutory requirements, Federal or State.

We now favor and support the enactment of your bill, H.R. 13886, which will broaden the scope of the Federal Labeling Act to include unpackaged substances and will in other ways improve that law in the light of the experience of government and industry since 1960.

We also strongly favor and support the preemption amendment which has been proposed by the Chemical Specialties Manufacturers Association in its statement submitted to your committee on June 24.

This proposed amendment is needed to accomplish a major purpose of the Federal Labeling Act and the express intent of the Congress in passing it. These were to establish uniform standards for warning labels on household products.

The original intent of Congress was clearly stated in Senate Report 1158, 86th Congress, 2d session, at page 3 as follows: "It is desirable that *** the standards and requirements *** be uniform. Thus, Federal legislation on this subject is needed to require uniform labeling of hazardous substances for household use." There was no House Report.

The Senate Report cited certain broad state legislation. Subsequently there has been even more broad state legislative activity.

There are also on the books a substantial mass of aged and obsolete, varying and conflicting labeling requirements for specific products.

One striking example is the mass of state statutes and city ordinances relating to the labeling of products containing methanol (wood alcohol). These laws date back to prohibition days. Our company can testify to the practical impossibility of preparing a single warning label which complies with all of their inconsistent requirements on wording and on type size and on the placement of the warning on the label. The requirements under the Federal Act should be the sole uniform requirements for products containing methanol which move in interstate commerce.

There are other striking instances of the need for uniformity and for a preemption provision in the Federal Act. One city, under an ordinance which dates back some 50 years, enforces its own special rules for the type size and the position of the warning on flammable products which are, of course, numerous and important. Since as a practical matter manufacturers cannot keep special stocks of products, specially labelled for sale there, this one city largely governs the labeling of all flammable products which move in interstate commerce. And states can and do require warnings on the basis of the opinion of a state toxicologist or doctor whose views happen to vary from the consensus of the staff of doctors and toxicologists in the Food and Drug Administration the United States Public Health Service. Again, one State toxicologist or doctor can, and sometimes does, govern the warnings on a specific product for the country as a whole.

This is not a case where there are reasons why Congress should not preempt the subject matter in the interests of uniformity and of simplifying and facilitating the sale of goods in interstate commerce.

First, it is not a case where the "evil" to be remedied varies from state to state or from city to city. The hazards of a particular product are the same in all states and cities and the warnings and their typography and type size and their position on the label can be the same and still fully protect the public everywhere. (In fact, the warnings should be the same, given the tendency of people to move from state to state.)

And, second, as we have noted, this is not a case where a state law or a city ordinance has no extra-territorial effect. On the contrary, the necessities of

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