Gambar halaman
PDF
ePub

desirable result would have been more likely to have taken place.

N

ote that we have emphasized "the packaging industry." The absence of direct, industry-initiated dialogue between the packaging industry and FDA has largely characterized the handling of packaging problems. The contacts between FDA and industry have been carried on by the particular industry involved, for example, the canning industry, the pharmaceutical industry, the soft drink bottlers. Yet it remains that many problems have been dealt with or still exist which are fundamentally packaging problems, not problems narrowly related to an individual commodity or group of commodities.

It's true that in the food additive area many petitions have been filed and food additive regulations supported by the manufacturers of packaging materials, but even here the emphasis often tends to be on the needs of one specific customer or group of customers. This is not to say that there is anything dramatically wrong with the present approach; it simply seems that the interests of the packaging industry viewed more broadly might be better represented in everyone's interest were there better direct dialogue between the industry and the involved Federal agencies about packaging, as distinct from commodity, problems.

There is little doubt that FDA could profit in terms of writing better regulations and in doing a generally better job if it had available and would utilize expertise in modern packaging techniques and problems instead of simply trying to acquire specific commodity technology as needed to solve immediate problems.

Interestingly enough, there has been growing congressional recognition of the need for better Government-industry dialogue in the consumer protection field. The Food, Drug, and Cosmetic Act of 1938 did not contain specific provisions for advisory committees, outside boards, or other industry input beyond the perpetuation of the formal hearing as a fact-finding mechanism upon which to base the regulation-making process. However, as early as 1954 the Congress, in amending the Act to provide a more modern approach to pesticide residue problems, included specific authority for the Secretary to draw on an advisory committee of experts either on his own initiative or at the request of an interested party to advise on the establishment of pesticide residue tolerances. The use of an advisory committee, however, was left optional with the Secretary unless an interested party requested referral of a specific tolerance problem to such a body.

With enactment of the Fair Packaging and Labeling Act, however, Congress went so far as to specifically require the Secretary of Commerce to request manufacturers, packers, and distributors to participate in the development of voluntary product standards as one of the prerequisites to Federal action to control the undue proliferation of package sizes-see Sec. 5(d) of the Fair Packaging and Labeling Act.

This legislative pattern of moving toward efforts to assure greater consumer-industry-Government dialogue has found its most recent expression in the Poison Prevention Packaging Act of 1970, enacted last December 30. Here, at Section 6, Congress specifically instructed the Secretary of the Department of Health, Education, and Welfare to "appoint a technical advisory committee," and specified that there shall be no more than 18 members and that the membership shall include, among others, representatives of "consumers," "manufacturers of household substances subject to the Act," and (emphasis added) "manufacturers of packages and closures for household substances."

This requirement that the packaging industry be in effect forced into participation in this problem-solving exercise is in contrast to the corresponding requirement imposed on the Secretary of Commerce in Sec. 5(d) of the Fair Packaging and Labeling Act. Here the participation of "manufacturers, packers, and distributors of the commodity or commodities" is required, but no mention is made of the inclusion of representatives of the packaging industry itself. From this it can be inferred that, in the time between the passage of the two Acts, someone recognized the need to get the packaging industry involved in packaging problems directly related to consumer commodities.

o summarize, FDA has direct, significant impact

[ocr errors]

dustry's many customers in the fields the Agency regulates. Much of the relatively recent important consumer legislation has accentuated this impact. This legislation has also clearly focused attention on the need for a full and effective exchange of information between Government and industry in the public interest. I suggest that

good deal remains to be done by both Government and industry to promote this important exchange. In short, Government must assure industry of its sincere desire for such dialogue and must establish channels through which industry can approach Government in a meaningful way; industry, in turn, must be prepared to deal honestly and frankly in the interest of achieving the goals established by Congress to fully discharge its own responsibility.

[graphic][merged small][merged small]
[graphic][subsumed][subsumed][subsumed][subsumed][merged small][subsumed][subsumed][subsumed][subsumed]
[graphic]
[graphic]

Left top: The unit is electrophorescing. Once the electrodes are attached, five milliamps of current per tube is sent through the gels from the power source Mr. LaTerza operates. At the interface between the two upper layers and the sieving gel, a pH discontinuity occurs and the pore size decreases. The negatively charged protein discs begin migrating toward the positively-charged electrode below and the distance betwe them widens. The pores of the gel inhibit penetration by those proteins wit a large molecular weight, while proteins with a small molecular weight travel quickly down the column. The current will remain on for approximately 30 minutes, until the tracking dye is 1/4 inch from the end of the tube. The tracking dye, in this closeup photo (right top), shows the protein discs have migrated more than halfway down the tubes. The apparatus clearly shows the upper reservoir containing the colored buffer, the tubes in place, and the lower buffer. The columns are removed from the apparatus and placed into ice water, which shrinks the gels from the sides of the tubes. The gels are loosened with a probe-the task is a delicate one, since the column of gel may break. A flexible bulb at one end of the tube forces out the gel by air pressure. The two upper gels have the consistency of jelly and drop off. The lower layer, containing the proteins, is firmer and can be handled (middle). For 30 minutes the clear gels rest in a dye that stains proteins specifically (left bottom). The amount of dye absorbed depends on the molecular weight and structure of the protein. The dye is being poured off (right bottom) by Mr. LaTerza, wearing a protective glove.

[graphic][subsumed]
« SebelumnyaLanjutkan »