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Back-Room Maneuvering Takes the Teeth Out of the Pure Food Law

FDA History 03
by Harvey W. Wiley, M.D., the very first commissioner of the Food and Drug Administration (FDA), then known as the “US Bureau of Chemistry.”

   After the enactment of the food and drugs law the necessary rules and 
regulations for carrying it into effect were prepared. The law provided that a 
period of six months should elapse and that the enforcement of the law should 
begin on the first day of January, 1907. In the preparation of these rules and 
regalations not only were the rights of the public at large to be conserved, but 
also a due regard for the ethical interests in the food and drug industries. The 
committee appointed to formulate these regulations held meetings in Washington, 
New York and Chicago. Extensive advertisements of these meetings were published 
and all interests involved were invited to appear and give their views.
   Secretary Wilson named the Chief of the Bureau of Chemistry as his 
representative on the committee authorized by the law to draft the rules and 
regulations for the enforcement of the new act. The representative of the 
Treasury Department was Mr. James L. Gary; the representative of the Department 
of Commerce and Labor was Mr. S. N. D. North. The Chief of the Bureau of 
Chemistry was named chairman. My colleagues entered most enthusiastically into 
the discharge of the duties assigned to them. First of all they studied the act 
in all of its relations. We sat almost continuously every day, and always with 
cordial collaboration and mutual sympathy in the difficult task set before us.

From left to right: Dr. S.N.D. North, Dept. of Commerce; Dr. H.W. Wiley, Dept. 
of Agriculture; and Mr. James L. Gary, Treasury Dept.
   On the completion of our labors we each undertook to secure the signature of 
our respective secretary. The Secretary of Agriculture promptly signed our 
report; likewise the Secretary of Commerce and Labor. Mr. Gary had some little 
difficulty in securing the signature of the Secretary of the Treasury. He 
thought that the regulations were a little bit too severe upon some of the food 
industries. Finally, however, he affixed his signature without any amendment 
whatever to the rules and regulations as presented.
   During the hearings accorded interested parties there appeared before the 
committee practically the same interests that had been active in opposing the 
enactment of the law. The same arguments with which the chairman of the board 
had been so long familiar were repeated. Pleas for recognition of the use of 
borax under the regulations were made by the fishing interests of Massachusetts; 
the interests engaged in the manufacture of catsup begged for recognition of 
benzoic acid. The manufacturers of syrups pleaded for permission to use sulphur 
dioxide and were joined in this plea by the interests engaged in drying fruits 
in California.
   An interesting incident occurred in this connection. It was while the 
committee was sitting in New York that the advocates for the recognition of 
sulphurous acid and sulphites were heard. A particularly earnest plea was made 
by the representative of the California interests, in which we were told that 
failure to use sulphur dioxide would ruin the dried fruit industry of that 
state. Reporters were constantly present at these hearings and this story of the 
California interests got into the afternoon papers of this city. About seven 
o'clock that evening the card of the California advocate was brought up to my 
room. When he himself appeared he was considerably embarrassed. Finally he 
stated the object of his visit. He said:
     "My wife read an account of my remarks in the afternoon papers. On my 
  return to my apartment she chided me for what I had said. She urged me--almost 
  commanded me--to come to see you in regard to the matter and here I am. My 
  Wife does not allow any sulphur dioxide fruit to come onto our, own table. She 
  is so firmly convinced of the undesirability of this kind of preservative that 
  she will not allow me or any of my family to eat foods preserved with sulphur 
   This confession on the part of the representative of the California interests 
I imparted to my colleagues the next morning before the hearings began.
   It is hardly necessary to say that any regulation for carrying a law into 
effect shall not presume to ignore any function of that law. As it was provided 
in the law that the Bureau of Chemistry alone was to be the judge of what was an 
adulteration and misbranding any decision of that kind under the rules and 
regulations would be illegal.
   The report of the committee after receiving the signature of the three 
cabinet officers authorized to make the rules and regulations was finally 
published on Oct. 17,1906.
   Quite as important as the rules and regulations for carrying out the 
provisions of the law was dependable information respecting the methods of 
judging the quality of foods and drugs by standards which were legal and 
conclusive in their character. About the time of the beginning of the 
experimental work for determining the effect of preservatives and coloring 
matters upon digestion was originated the idea of establishing under proper 
authority standards of foods. Accordingly about 1902 a section was added to the 
appropriation bill of the Department of Agriculture, authorizing the Secretary 
of Agriculture to appoint a committee of this kind. Similar action was taken by 
the Association of Official Agricultural Chemists. When this authority was 
secured the following named representatives of Agricultural Colleges and 
Experiment Stations were selected for this very difficult and important work: 
Mr. M. A. Scovell, Director of the Agricultural Station of Kentucky, Mr. H. A. 
Weber, Professor of Agricultural Chemistry in the College of Agriculture of the 
State University of Ohio, Mr. William Frear, Assistant Director of the 
Agricultural Experiment Station of Pennsylvania, Mr. E. H. Jenkins, Director of 
the Agricultural Experiment Station of Connecticut, at New Haven, and Mr. H. W. 
Wiley, Chief of the Bureau of Chemistry of the Department of Agriculture, at 
Washington, D. C.

Left to Right: Prof. M. A. Scovell, Director, Agricultural Station of Kentucky, 
H. A. Weber, Prof. Agricultural Chemistry, University of Ohio, Dr. William 
Frear, Assistant Director, Agricultural Experiment Station of Pennsylvania, Dr. 
E. H. Jenkins, Director, Agricultural Experiment Station of Connecticut; Dr. H. 
W. Wiley, Chief of the Bureau of Chemistry, Department of Agriculture

   This committee was enlarged subsequently by additional members, but the five 
original members remained as its nucleus and principal actors until the 
Secretary of Agriculture at the instigation of the Solicitor of that Department 
abolished the committee by having the authority for its continuance withdrawn 
from the appropriation bill. This, however, only temporarily prevented its 
activities. Subsequently, after the Chief of the Bureau resigned, it was 
reorganized and is still at work. The value of the contribution made by these 
five original members is almost incalculable. We had frequent meetings lasting 
for days at a time, usually held at the Department of Agriculture, but in many 
cases we met in other cities where it was more convenient for interested parties 
to attend. You may have some idea of the extent of our investigations by seeing 
the official papers piled up on the table before us, as shown in the 
illustration. The results of the deliberations of this committee were published 
from time to time by the Department of Agriculture as official documents. They 
have become the guide and director, not only of the national food law, but also 
they have been approved and adopted by the various states.
   Before this committee also appeared practically the same interests which on 
the enactment of the food law appeared before the committee to establish rules 
and regulations to carry the law into effect. They continually presented their 
claims for indulgences before the Food Standards Committee. The character of 
this opposition has already been definitely illustrated. It was not based on 
ethical grounds but on individual and industrial interests without relation to 
the welfare of the consuming public.
   The result of all these preliminary investigations shows the wisdom and 
timeliness of their inauguration. Had it not been for these fundamental 
investigations the Bureau of Chemistry would have been totally unprepared to 
have organized the machinery which immediately went into effect January 1, 1907.
   It is hardly necessary to add. that all the conferences, indulgences and 
collaborations with vested interests which thereafter were resorted to as a 
means of defeating the purpose of the law have effectively nullified the 
efficiency of the standards originally established.
   The Secretaries of the Treasury and Commerce cannot be blamed for affixing 
their signatures to these documents. They assumed that these decisions were 
intended to carry the provisions of the law into effect. The Secretary of 
Agriculture stood in a different position. He knew the exact purpose of putting 
the decisions of the Remsen Board into effect. He boldly proclaimed that the 
Board was created to protect the manufacturers. Leaving his Solicitor to 
interpret the law, he was firmly convinced that these restrictions were legal 
and binding. He gave himself wholeheartedly to the effective plan of prohibiting 
the Bureau of Chemistry from exercising its duty to enforce the law according to 
its letter and spirit. The food and drugs law became a hopeless paralytic. It 
still breathed but its step was tottering and its hand shaky. The clot on its 
brain has become encysted. There is no hope that it will ever be absorbed. Only 
a capital operation will restore it to health.
   From June 30, 1906, the date the Food and Drugs Act became a law, until 
January 1, 1907, when it went into effect, numerous questions were propounded to 
the Bureau of Chemistry by interested parties respecting the scope and meaning 
of many of its requirements. The Bureau of Chemistry to the best of its ability 
interpreted, as the prospective enforcing unit, the intent of the law. Following 
the usual customs in such cases these opinions were taken to the Secretary of 
Agriculture for signature. The last Food Inspection Decision prior to 1907 was 
No. 48, issued Dec. 13, 1906.
   For a few days after January 1, 1907, the Bureau of Chemistry was 
unrestricted in its first steps to carry the law into effect. Although all 
matters relating to adulteration or misbranding were now solely to be 
adjudicated by the Bureau, it was decided to continue to have these opinions, as 
heretofore, signed by the Secretary. The first decision under the new regime was 
signed by the Secretary Jan. 8, 1907. It discussed the time required to render 
decisions. It was prepared because many persons presenting problems were 
complaining of delay.
   An open break in the plan of preparing decisions by the Bureau of Chemistry 
for the Secretary came in the case of F. I. D. 64, signed. by the Secretary 
March 29, 1907. The question was, "What is a sardine?" The Bureau prepared a 
decision that only the genuine sardine prepared on the coasts of Spain, France 
and the Mediterranean Islands was entitled to that name. The Secretary, due to 
protests from the Maine packers, referred this problem to the Fish Commission of 
the Department of Commerce. The Fish Commission, which had no function whatever 
in describing what was a misbranding, made a decision diametrically opposed to 
that reached by the Bureau. It was as follows:
     Commercially the name sardine has come to signify any small, canned 
  clupeoid fish; and the methods of valuation are so various that it is 
  impossible to establish any absolute standard of quality. It appears to this 
  Department that the purposes of the Pure Food law will be carried out and the 
  public fully protected if all sardines bear labels showing the place where 
  produced and the nature of the ingredients used in preserving or flavoring the 
   The Fish Commission, being in the Department of Commerce, would consider any 
commercial process or practice as of more importance than the plain provisions 
of the food law looking to the protection of the public against misbranding. The 
Secretary of Agriculture ignored the protest of the Bureau of Chemistry to this 
decision, placing a trade practice above the plain precepts of the law. The 
Secretary of Agriculture said:
   In harmony with the opinion of the experts of the Bureau of Fisheries, the 
Department of Agriculture holds that the term "sardine" may be applied to any 
small fish described above and that the name "sardine" should be accompanied 
with the name of the country or state in which the fish are taken and prepared 
and with a statement of the nature of the ingredients used in preserving or 
flavoring the fish.
   The Ambassador of France earnestly indicated to me in a personal interview 
his feeling that the sardine packers in France would be subjected to a ruinous 
competition by permitting young sprats and young herrings to be prepared 
according to the manner of the French sardine and thus enter into direct 
competition therewith. I believe also the French Ambassador voiced his objection 
to this decision in a diplomatic way with a protest filed with the Secretary of 
State. Both this protest and the plain provision of the law that the Bureau of 
Chemistry should decide all cases as to whether or not the articles were 
adulterated and mi sbranded failed to have any effect whatever on the Secretary 
of Agriculture. This was the second official departure of the Secretary of 
Agriculture from the plain provisions of the law. His whisky decision, which 
Secretary Bonaparte turned down, was the first.
   Soon after this incident the Board of Food and Drug Inspection was formed in 
the Secretary's office. Theretofore the Chief of the Bureau of Chemistry had not 
affixed his official signature to the Food Inspection Decisions which he had 
prepared and the only signature these decisions carried was that of the 
Secretary of Agriculture. After the organization of the Board of Food and Drug 
Inspection the Secretary required that all the decisions of that Board submitted 
to him for approval should be signed by at least two members of the Board. The 
first decision thus signed was Food Inspection Decision No. 69. The three 
members of the Board affixed their signatures to this and the Secretary of 
Agriculture approved it on May 14, 1907.
   It so happened that when the decisions of this board were deemed of 
extraordinary importance the practice arose of having them approved, not by the 
Secretary of Agriculture alone, but by the three Secretaries authorized by law 
to make rules and regulations for the enforcement of the act. When these 
Secretaries therefore signed a Food Inspection Decision it became a rule and 
regulation. The first decision of this kind thus signed was Food Inspection 
Decision No. 76, concerning dyes, chemicals and preservatives in foods.
   Some time prior to the issuance of this decision, and in fact long before 
there was any hint that the functions of the Bureau of Chemistry would be 
usurped illegally, questionnaires had been sent to three or four hundred 
prominent physiologists and dietitians in the United States as to their attitude 
in regard to the use of preservatives and coloring matters in foods. The 
questions propounded and the number of answers received, both negative and 
affirmative, are as follows:
     1. Are preservatives, other than the condimental preservatives, namely, 
  sugar, salt, alcohol, vinegar, spices and wood smoke, injurious to health? 
  Affirmative, 218; negative, 33.
     2. Does the introduction of any of the preservatives, which you deem 
  injurious to health, render the foods injurious to health? Affirmative, 222; 
  negative, 29.
     3. If a substance added to food is injurious to health, does it become so 
  when a certain quantity is present only, or is it so in any quantity whatever? 
  Affirmative, 169; negative, 79.
     4. If a substance is injurious to health, is there any special limit to the 
  quantity which may be used which may be fixed by regulation of our law? 
  Affirmative, 68; negative, 183.
     5. If foods can be perfectly preserved without the addition of chemical 
  preservatives, is their addition ever advisable? Affirmative, 12; negative, 
   It is readily seen from this tabulation that the opinion of physiologists, 
hygienists, health officers and physicians in the United States to whom these 
questionnaires were sent is overwhemingly against their use. These opinions of 
distinguished experts were obtained before the Remsen Board was ever thought of. 
(Food Inspection Decision No. 76, Pages 5 and 6.)
   Food Inspection Decision No. 87 is signed by the three Secretaries as a rule 
and regulation. It is neither. It was an opinion that the term "corn sirup" is a 
proper label for the substance commonly known as glucose. This opinion repealed 
the opinion of the Bureau of Chemistry, which, after a long argument, was 
endorsed also by the other two members of the Board of Food and Drug Inspection. 
Thus the three Secretaries authorized by law to make rules and. regulations 
usurped the function of the Bureau of Chemistry in regard to what was a proper 
label under the law.
   Food Inspection Decision No. 102 was signed by the three Secretaries, 
legalizing the introduction into the United States of vegetables greened with 
copper. This was clearly another usurpation of the functions of the Bureau of 
   Food Inspection Decision No. 104 legalized the use of benzoate of soda and 
benzoic acid and was signed by the three Secretaries authorized by law to make 
rules and regulations for carrying out its purposes. It was directly contrary to 
the decision of the Bureau of Chemistry that these preservatives were illegal 
under the Act.
   Food Inspection Decision No. 107 is the opinion of the Attorney-General that 
the Referee Board was appointed in a perfectly legal way. In making this 
decision Mr. Wickersham vetoed the decision of Assistant Attorney-General 
Fowler, holding that the Referee Board was illegally appointed. He adopted in 
the main the decision of Solicitor George P. McCabe that it was legally 
appointed. The Referee Board usurped many of the specific functions of the 
Bureau of Chemistry, committted to that Bureau by express wording of the Act.
   Food Inspection Decision No. 113 as to the proper labeling of whisky and its 
mixtures, a function specifically confided to the Bureau of Chemistry by law, 
was signed by the three Secretaries, authorized to make rules and regulations 
for carrying the law into effect. It repealed the decision of the former 
Attorney-General, Mr. Charles J. Bonaparte, and all previous Food Inspection 
Decisions relating thereto.
   Food Inspection Decision No, 118 is an extension of No. 113, just described, 
and of the same character.
   Food Inspection Decision No. 127 is a decision of Attorney-General Wickersham 
in regard to the proper labeling of whiskies sold under distinctive names. It is 
also a complete reversal of the decisions in regard to proper labeling reached 
by the Bureau of Chemistry, and confirmed by many decisions of federal courts.
   Food Inspection Decision No. 135, in regard to saccharin, is a direct 
assumption of authority granted specifically by law to the Bureau of Chemistry. 
It was signed by the three Secretaries authorized to make the rules and 
regulations for carrying the law into effect.
   Food Inspection Decision No. 138 refers to the same subject and is signed by 
the three Secretaries.
   On the publication of the report of the findings of the Moss Committee Mr. 
George P. McCabe retired from the Board of Food and Drug Inspection, and Mr. F. 
L. Dunlap was given an indefinite leave of absence. Mr. R. E. Doolittle was 
appointed in Mr. McCabe's place.
   Food Inspection Decision No. 140, issued Feb. 12, 1912, was signed by H. W. 
Wiley and R. E. Doolittle and approved by James Wilson.
   On Feb. 17, 1912, Mr. Dunlap, having returned from his vacation, signed 
together with H. W. Wiley and R. E. Doolittle Food Inspection Decision No. 141.
   On Feb. 29, 1912, Food Inspection Decision No. 142, in regard to the use of 
saccharin in foods, was signed by two of the Secretaries, namely James Wilson 
and Charles Nagel, but the Secretary of the Treasury dissented. This was a 
function specifically committed to the Bureau of Chemistry by the law.
   The last Food Inspection Decision which I signed was No. 141 as to the proper 
labeling of maraschino cherries. Mr. R. E. Doolittle was appointed as acting 
chief and took my place as Chairman of the Board of Food and Drug Inspection for 
the remainder of its hectic career.
   Mr. F. L. Dunlap resigned from his position as Associate-Chemist at the time 
of the inauguration of President Wilson in his first term as President. Dr. Carl 
L. Alsberg, who had been appointed Chief of the Bureau of Chemistry in the place 
of R. E. Doolittle, became by that office the Chairman of the Food Inspection 
Board and became associated with Dr. W. D. Bigelow and Dr. A. S. Mitchell as the 
new Board of Food and Drug Inspection, the first decision of which was approved 
by James Wilson, Secretary of Agriculture, Jan. 24, 1913.
   On March 15, 1912, having been convinced that it was useless for me to remain 
any longer as a Chief of the Bureau which had been deprived of practically all 
its authority under the law, I resigned.
   Letter of Resignation of Dr. H. W. Wiley March 15, 1912.
     In retiring from this position after so many years of service it seems 
  befitting that I should state briefly the causes which have led me to this 
  step. Without going into detail respecting these causes, I desire to say that 
  the fundamental one is that I believe I can find opportunity for better and 
  more effective service to the work which is nearest my heart, namely, the pure 
  food and drug propaganda, as a private citizen than I could any longer find in 
  my late position.
     In this action I do not intend in any way to reflect upon the position 
  which has been taken by my superior officers in regard to the same problems. I 
  accord to them the same right to act in accordance with their convictions 
  which I claim for myself.
     After a quarter of a century of constant discussion and effort the bill 
  regulating interstate and foreign commerce in foods and drugs was enacted into 
  law. Almost from the very beginning of the enforcement of this act I 
  discovered that my point of view in regard to it was fundamentally different 
  from that of my superiors in office. For nearly six years there has been a 
  growing feeling in my mind that these differences were irreconcilable and I
  have been conscious of an official environment which has been essentially 
  inhospitable. I saw the fundamental principles of the food and drugs act, as 
  they appeared to me, one by one paralyzed or discredited.
     It was the plain provision of the act, and was fully understood at the time 
  of the enactment, as stated in the law itself, that the Bureau of Chemistry 
  was to examine all samples of suspected foods and drugs to determine whether 
  they were adulterated or misbranded and that if this examination disclosed 
  such facts the matter was to be referred to the courts for decision. Interest 
  after interest, engaged in what the Bureau of Chemistry found to be the 
  manufacture of misbranded or adulterated foods and drugs, made an appeal to 
  escape appearing in court to defend their prac tices. Various methods were 
  employed to secure this end, many of which were successful.
     One by one I found that the activities pertaining to the Bureau of 
  Chemistry were restricted and various forms of manipulated food products were 
  withdrawn from its consideration and referred either to other bodies not 
  contemplated by the law or directly relieved from further control. A few of 
  the instances of this kind are well known. Among these may be mentioned the 
  manufacture of so-called whisky from alcohol, colors and flavors; the addition 
  to food products of benzoic acid and its salts, of sulphurous acid and its 
  salts, of sulphate of copper, of saccharin and of alum; the manufacture of 
  so-called wines from pomace, chemicals and colors; the floating of oysters 
  often in polluted waters for the purpose of making them look fatter and larger 
  than they really are for the purposes of sale; the selling of mouldy, 
  fermented, decomposed and misbranded grains; the offering to the people of 
  glucose under the name of "corn sirup," thus taking a name which rightfully 
  belongs to another product made directly from Indian corn stalks.
     The official toleration and validation of such practices have restricted 
  the activities of the Bureau of Chemistry to a very narrow field. As a result 
  of these restrictions I have been instructed to refrain from stating in any 
  public way my own opinion regarding the effect of these substances upon 
  health, and this restriction has interfered with my academic freedom of speech
  on matters relating directly to the public welfare.
     These restrictions culminated in the summer of 1911 with false charges of 
  misconduct made against me by my colleagues in the Department of Agriculture, 
  which had it not been for the prompt interference on the part of the President 
  of the United States (William Howard Taft), to whom I am profoundly grateful, 
  would have led to my forcible separation from the public service. After the 
  President of the United States and a committee of Congress, as a result of a 
  searching investigation, had completely exonerated me from any wrong doing in 
  this matter, I naturally expected that those who had made these false charges 
  against me would no longer be continued in a position which would make a 
  repetition of such an action possible. The event, however, has not sustained 
  my expectations in this matter. I was still left to come into daily contact 
  with men who secretly plotted my destruction.
     I am now convinced that the freedom which belongs to every private American 
  citizen can be used by me more fruitfully in rallying public opinion to the 
  support of the cause of pure food and drugs than could the limited activity 
  left to me in the position which I have just vacated. I propose to devote the 
  remainder of my life, with such ability as I have at my command and with such 
  opportunities as may arise, to the promotion of the principles of civic 
  righteousness and industrial integrity which underlie the food and drugs act, 
  in the hope that it may be administered in the interest of the people at 
  large, instead of that of a comparatively few mercenary manufacturers and 
     This hope is heightened by my belief that a great majority of manufacturers 
  and dealers in foods and drugs are heartily in sympathy with the views I have 
  held, and that these views are endorsed by an overwhelming majority of the 
  press and of the citizens of the country.
     In severing my official relations with the Secretary of Agriculture I take 
  this opportunity of thanking him for the personal kindness and regard which he 
  has shown me during his long connection with the department. 
   In a supplemental statement to Secretary Wilson Dr. Wiley says:
     In transferring the management of the Bureau of Chemistry to other hands I 
  desire to direct your attention to a few matters in which I think you will be 
     I have always been a believer in the civil service law and have endeavored 
  to carry out both its spirit and its letter. For this reason I have strongly 
  opposed, except in cases of extreme necessity, the appointment of any person 
  in the bureau not secured from the civil service register.
     It is also a matter of extreme gratification to me that in the twenty-nine 
  years which I have been chief of this bureau to my knowledge there has never 
  been a cent wrongfully expended and no officer or employe of this bureau has 
  ever been accused of misappropriation of public funds. 
   Those whose memories carry them back As far as 1912 will recall that the 
resignation of the Chief of the Bureau of Chemistry created quite a commotion. 
Not only were the newspapers and magazines full of references thereto, but the 
caricaturists took up the fight. One of these cartoons in the Rocky Mountain 
News depicted Uncle Sam bidding adieu to the departing Chief of the Bureau. 
Another striking cartoon depicted Uncle Sam measuring the shoes of the departed 
chief. Among the hundreds of editorial comments perhaps the most interesting are 
those made also by the Rocky Mountain News., under the caption "The Borgias of 
     "If the people exhibited the same persistence in looking after their 
  interests that Illegitimate Business displays in looking after its interests, 
  the things of which we complain would soon be brought to an end, and 
  prosperity, like a tidal wave, would flood the land.
     "For twenty years at least, the food poisoners of the country have waged 
  warfare on Dr. Harvey W. Wiley, and since the passage of the Pure Food act in 
  1906 they have trebled efforts to have him discharged. These Borgias of 
  business have won, for the circumstances attending Dr. Wiley's recent 
  resignation make it, in practical effect, a dismissal.
     "Dr. Wiley resigned because the fundamental principles of the Pure Food law 
  have been strangled; because he has been powerless to punish the manufacturers 
  of misbranded and adulterated drugs and foods; and because the powers of his 
  position had been nullified by executive orders. * * *
     "Dr. Wiley was only head of the Bureau of Chemistry, but there is every
  reason to believe that President Taft will find that Dr. Wiley gave the 
  position an importance out of all proportion to its standing."
  --From the Rocky Mountain News, March 21, 1912. 


Dr. Andrew Saul

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