Document 6KbeDq4aaRbjwdYMzGwLjmnR

Page 4 August 7, 1967 FOOD CHEMICAL A failure to coordinate more effectively has prevented P'DA from tes ting tiilUSDA method. FDA had asked for more information on the test. However, re. tape delays, and a failure to publish the Banwart findings in a scientific jounun apparently has held up an exchange of information on the subject. FDA's fie, A 1 boratories have been lied up in knots working on Salmonella samples, and an improved method most certainly would cut down the workloac. FDA scientists recently held a workshop designed to aid in the development of dm fluorescent-antibody method of Salmonella detection (See FOOD CKiTlVFCA _ NEVA, Jmic 19, Page 15), ; FDA has apparently concluded.`that this method would not solve its regulatory problems, since it is not foolproof. However, work is expected to continue on the fluorescent-antibody method as an aid to industry in its efforts tp comum. Sal rn o n e 1 i a con la mina lion. FDA recently signed a $G4, 000 contract with the National Academy of Science^ to evaluate Salmonella problems and another for $G0, 000 with the Midwest Research Institute, Kansas City, Mo., to`help develop systems analyses for conuattirg Sa'monella problems. USDAFs screening test, now being tested commercially, the Department said would save laboratory space, labor and shipping delays. USDA requires paswv-izaiicn of all egg products produced under inspection and moving in intersfa: ; commerce. Tests still must be made, however, to check for inefficient past izaiion or post-pasteurization contamination. The areserm commercial test procedure, which is also utilized by FDA, renu 1 a 3 steps, each taking 24 hours or more and totalling from 72 to 96 hours. Banwar.'s test shortens the time considerably, determining samples that are Salmonella negative. Samples showing a positive reaction must be tested further under conventional methods to determine specifically whether Salmonella or ether organisms are present. 1 In a 42-hour period, Banwart tested 225 samples of dried whole egg with the newr method and found 145 without Salmonella. Using the conventional method, it took him 90 hours to find 118 samples without Salmonella. Further testing of the presumptive samples showed 8 actually contained Salmonella organisms. GOODRICH INTERPRETS SCOTUS DECISIONS ON PRE-ENFORCEMENT REVIEW The decision to review or not to review Food and Drug Administration rulemaking actions before they are put into force was left "largely discretionary" by the Supreme Court, according to William W. Goodrich, Health, Education and Welfare Assistant General Counsel for FDA, ASI 00000296 August 7, 1967 Page o FOOD CHEMICAL NEWS Addressing the American Bar Association's Food, Drug, and Cosmetic Division in Honolulu Aug. 2, Goodrich gave his view of the moaning of the recent Supreme Court decisions granting the Toilet Goods Association and the Pharmaceutical Manufacturers Association pre-enforcement judicial review of FDA regulations (See FOOD CHEMICAL NEWS, May 29, Page 3). He concedes only that the 'decisions laid to rest any question of judicial power 1 to entertain suits for pre-enforcement review, "Where SecLion7Q 1(e), the statutory review procedure, applies, " Goodrich explained, "we believe that will continue as the required route for the chalier per, and he cited the ruling of the Court of Appeals in the District of Columbia d^nyi-'g the dietary food supplement appeal by PMA as justification for this belief (See FOOD CHEMICAL NEWS, June 26, Page 10). He continued: "But otherwise it appears that the Courts will entertain a pre-enforcement challenge only when there is a great hardship on private parties in withholding court consider ation and when the cases present essentially legal issues that are ripe for judicial resolution without an evidentiary trial or administrative hearing. " I Goodrich asked what makes an issue fit for judicial decision, and answered: I "First, the interpretive regulations must be issued after notice and an opportunity for comment, as provided in die Administrative Procedure Act, and must carry no hint of informality. This is 'final agency action' within the meaning of the Administrative Procedure Act. Such regulations, if authorized by the Federal Food, Drug, and Cosmetic Act, the Court said have the status of law and violations carry criminal and civil sanctions. Their immediate legal impact makes them reviewable. "Second, they must present a purely legal question of statutory construction in terms of Congressional intent or statutory language, and must not Involve factual matters that require Agency resolution. The Supreme Court said that if, at an evidentiary hearing, the District Court is persuaded that technical questions are raised that require a more concrete getting for proper adjudication, such as would arise in an actual enforcement proceeding, a pre-enforcement order should not issue. " Once the issue is found to be fit, the FDA legal counsel said, the District Court is then to decide the question of hardship which will arise if early judicial relief is denied. t ASI 00000297 Page 6 August 7, 1967 FOOD CHEMICAL NEW "Here, the most important consideration is the impact of the regulation, " he continued, asking: "Does the regulation have an immediate, direct and legally binding impact upon the day-to-day business affairs of the affected industry?" Noting that primary conduct must be affected, Goodrich suggested that the regulation "must cause the industry, for example, to test or substitute ingre dients now - - not perhaps, not in the future - - now. " He noted that the Supreme Court found it particularly relevant that the plaintiffs challenging the interpretive regulations represented nearly all - - 90% -- of the affected industries. "If there is a substantial governmental interest against judicial inquiry in a pre-enforcement setting, " he declared, "that interest is to be protected, " and he added: x f "Relief can be denied on the ground that there is a multiplicity of suits for harrassment purposes. And . those regulated cannot sit idly by with the intent to institute a suit to review the regulation sometime in the future 'in case things get hot. 1 The Court specifically pointed out that the - e'enje laches is available to the Government. "Finally, even if a suit is instituted and the Court decides : lc hear the case, that is not an automatic stay of the i application of the,regulation. The burden is on the appliI caul to allege and establish the necessity for the stay along I the traditional lines. " V v Goodrich concluded that the SCOTUS decisions "do not provide automatic access to the Courts, but they "do grant the District Courts power to review some interpretive regulations Issued as the final action of the FDA. " "informal advisory opinions, even by the Commissioner, as well as rulings of subordinate officials, and tentative regulations, " he stated as his view, "remain non-reviewable as always. " Goodrich told the ABA meeting that the initial food industry reaction to the agency's finalized FPLA regulations indicates that a contest "is not likely. " He said the regulations are subject to objection and public proceedings .on any objection that may be filed, adding that it is possible that their effective dates may be thus delayed. Looking ahead, ie said the drug and cosmetic FPLA mandatory regulations will soon be issued, as well aS the beginning programs on the discretionary regulations, including "regulations making exemptions, regulations for cents- off and other bargain promotions, regulations to prevent non-functional slack filling of containers, regulations for 'large, 1 'small, ' and 'king' size containers, and regulations requiring additional ingredient information in the labeling of drugs and cosmetics. " : , ASI 00000298