Document 3JvMvZLoBg2z8OmEeN37MMzwa

21514 Federal Register / Vol. 49, No. 100 / Tuesday. May 22. 1984 / Rules and Regulations American Samoa, we will look at the laws of the District of Columbia. For a definition of permanent home, see S 404.303. The State laws we use are the ones the courts would use to decide whether you could inherit a child's share of the insured's personal property if he or she were to die without leaving a wilL If these laws would not permit you to inheritlhe insured's personal property as his or her child, you may still be eligible for child's benefits if you are related to the insured in one of the other ways described in SS 404.355-404.359. [TO Doc. 4-lJra PIM t-23-M: MS *) sajjwo coos eiso.it and Drug Administration 21 CFR Part 109 [Docket NO.77N-00M] Polychlorinated Biphenyta (PCBa) tor Fish and Shellfish; Reduction of Tolerances; Final Decision agency: Food and Drug Administration./ action: Final rule; final decision following a formal evidentiary public^ earing.____________- SUMUtotvUntejCommission^of^ood and Drugs is issuing B FlfiaTuedsion following a formal evidentiary bearing to consider objections to the agency's final rule concerning a tolerance for polychlorinated biphenyls ("PCBs") in fish and shellfish. The Commissioner concludes that the appropriate tolerance, after taking into account public health and human food loss considerations, is 2 parts per million (``ppm'*], as provided for in the final rule. EFFECTIVE DATE August 2a 1984. ADORCSS: The testimony and evidence submitted, the initial decision, and all other documents cited in this decision may be seen in the Dockets . Management Branch (HFA-305J. Rm. 4 62. 5600 Fishers Lane, Rockville, Md, 20857, from 9 us. to 4 pun* Monday through Friday. .. FOR FURTHER NOAMA'nON CONTACT: Allen Heim, Ph. D,, Office of Science Coordination, HF-8, Food and Drug Administration. Department of Health and Human Services. 5600 Fishers Lane, Rockville. MtL, 20857,301-443-1587. SUPPLEMENTARY INFOmSATIOSC L Background This rulemaking proceeding involves the tolerance for unavoidable residues of PCBs in fish and shellfish, 21 CFR 109.30(a)(7). In 1977 the Food and Drug Administration ("FDA") proposed to lower the tolerance for PCBs in several classes of fog^^eelevant part FDA proposed to"low^^he tolerance in fish and shellfish from 5 ppm to 2 ppm. 43 FR 17487 (April 1.1977). In 1979 the agency promulgated a final rule based on the proposal, including lowering the tolerance in fish and shellfish to 2 ppm. 44 FR 38330 (June 29.1979). Section 406 of the Federal Food. Drug, and Cosmetic Act ("the act"), 21 U.S.C. 346. authorizes the establishment of tolerances for poisonous or deleterious substances added to food that cannot be avoided by good manufacturing practice. PCBs are such a substance. Although the agency's paramount concern is protection of the public health, under section 406 the agency must consider, in establishing a tolerance, the extent to which a contaminant is unavoidable. In essence, the agency is permitted to find where the proper balance lies between adequately protecting the public health and avoiding excessive losses of food to American consumers. 44 FR 38330-31. Pursuant to that mandate, the agency examined the amount of commercial fish that would be lost as human food as a result of lowering the tolerance. As required by section 701(e) of the act 21 U.S.C. 371(e), which applies to regulations promulgated under the authority of section 406, FDA provided persons who would be affected adversely by the final rule an ` opportunity to object and request a formal evidentiary hearing. Over 20 persona objected to provisions of the final rule concerning fish and shellfish, but only the National Fisheries Institute. Inc. ("NFI") requested a hearing. .44 FR 57389 (October 5.1979). As provided by section 701(e)(2) of the act that objection and request for hearing automatically stayed the effective date of the final rale, pending resolution of the issues raised in NFTs objection. In the Federal Register of May 1.1981. FDA announced a formal evidentiary hearing ' on NFTs objection, on the issue of the "magnitude of the human food lost" from reducing the tolerance to 2 ppm. 46 FR 24551. NF1 and FDA's Bureau of Foods1 ("Bureau") were parties at the hearing. In addition to die parties, the National Marine Fisheries Service ("NMFS") of the U.S. Department of Commerce end the Environmental Defense Fund ("B)F") filed notices of participation. EDF subsequently withdrew from participation. Administrative Law judge ("AL)") Daniel J. Davidson issued his initial Derision on February 8.1982. FDA announced the availability of the Initial 'The Bunas of Foods is now named the Center far Food Safety and Applied Nutrition. Decision in the Federal Register of March 9.1982. 48 FR 10079. NF1 and the Bureau filed exceptions to Judge Davidson's Initial Decision under 21 CFR 12.125. I am issuing this Final Decision under section 406 of the act and 21 CFR 12.130. In taking this action. I have all the powers 1 would have had in making the Initial Decision. 21 CFR 12.130(a). Section of my Final Decision discusses Judge Davidson's Initial Decision, evidence and testimony introduced during the hearing, the exceptions filed by the Bureau and NFI, and my resolution of the hearing issue. Although the hearing was limited to the issue of the magnitude of human food loss, the agency invited interested persons to submit other relevant materials for possible inclusion in the rulemaking record. Participants could argue in briefs to the Commissioner that a different tolerance should be set 48 FR 24553. NFI, the Bureau, NMFS, EDF, the Chemical Manufacturers Association ("CMA"), the General Electric Company ("GE"), tite State of Michigan, and others submitted additional information, briefs, or both. - Section III of my Final Derision discusses the scientific issues raised in these submissions and briefs. Section IV deals with several miscellaneous issues. In Section V, 1 balance the magnitude of the human food loss that would result from lowering the tolerance to 2 ppm and the public health risks from PCBs. My ultimate conclusion is that a tolerance of 2 ppm for PCBs in fish and shellfish adequately protect the public' health, while not causing excessive loss of food to American consumers. n. The Evidentiary' Hearing Issues A The Initial Decision Judge Davidson mode detailed findings about the human food loss resulting from lowering the tolerances from 5 ppm to 2 ppm: Imports ___ -- Umiabts foheriat. KeittM tpeoet................... . Domestic herrest m violation: r.tE.k Whitefifh and cfanha ,, Tl*l . , ... ___ . 0 fiurnm i?A.nm m_nm 3.684.000 *n-nno U61.000 mimo inm.flm 2.964400 11453JOO , Grand total ....... ......... -- m.?Ti nm 6.000000 8&721.300 wa' Dsoson. cow*. t ItMWW os**. 0754659 TOWOLDMONOQ59638 Federal Register / Vol. 49. No. 100 / Tuesday, May 22. 1984 / Rules and Regulations 21515 Judge Davidson's figures are in 1980 dollars-'The loss figures for the individual species are dockside values; except for alewives. they are not now in dispute. Judge Davidson determined the human food loss at 2 ppm by subtracting the loss at 5 ppm from the loss at 2 ppm so as to represent the net loss from reducing the tolerance. He concluded that retail value is the appropriate measure of human food loss and applied a "multiplier" of six to derive retail value from dockside value. B. Exceptions to the Initial Decision NFI excepts to Judge Davidson's figures for imports and unviable fisheries; the Bureau excepts to the figures for alewives and the elasticity effect. Both parties except to the "multiplier" and the grand total. These exceptions, and my resolution of each, are discussed below. 1. Imports Judge Davidson concluded that no human food loss from imports could be found. Initial Decision at 5. He reasoned that the record contains only unsupported claims of loss due to imports. NFI excepts to that finding, and argues that the Judge should have found a human food loss of $31,410,000. NFI Exceptions at 5. NFI's figure was ' derived by assuming that the same percentage of imported fish as domestic fish would exceed a 2 ppm tolerance. Applying those percentages to the value at time of entry into the United States and amount of imported whitefish. freshwater trout, and lobster,**N2FI derived a loss of about $15.7 million, or S31.2 million after the application of a "conservative" multiplier of 2. NFI Exceptions at 6; N-21 at 12. Of the $15.7 million loss, about $400,000 is due to freshwater trout and $500,000 is due to whitefish. The remainder, almost $15 million, is attributed to lobster. See N-21 at 3.11. I conclude that no food loss can be attributed to imports. Although neither Judge Davidson nor NFI considered different imported species separately, I believe that it is useful to do so. First * Uniat* stated otherwise. all dollar figures la my Final Oacition an in 1980 dollan. Conversion from 1974 dollar* to 19S0 dollar* I* bated on use of the (acton In the Initial Decision at page S. note a NFI witness Dr. Strand apparently bawd hi* calculation* on ibe assumption that 2&M of all lobster* would violate a 2 ppm toieranca. See N-21 at 3. However, lodge Devfdton found only.lM of lobtter would violate a 2 ppm tolerance. Initial Decision at 7. Although NFI did sot except to that finding, it continue* to use. without explanation, the 28.8*1 figure in its exception concerning imports. there was specific testimony concerning imported lobsters. Bureau witness Dr. Talhelm testified that no imported lobsters were reported to be violative. G-8 at 16. Dr. Gates testified for the Bureau that imported lobster samples were found to contain no significant levels of PCBs. G-fl at 3.9. NFI did not rebut any of that testimony. Consequently. I conclude that no food loss can be attributed to imported lobster. I agree with Judge Davidson's reasoning as applied to freshwater trout and whitefish. Except for lobster, there was no testimony concerning PCB levels in imported fish. NFI's food loss argument is based on the fact that "[tjhe PCB sample data were, in many instances, drawn from the marketplace." NFI Exceptions at 6. NFI contends that "(tjhere is no evidence that imports contain measurably different PCB levels [than domestic landings]." NFI Exceptions at 6. But that contention is based only on the testimony of Dr. Strand, that the "samples of the FDA . survey may, in fact, have included imported products." N-21 at 9 (Emphasis added.) As authority. Dr. Strand cited only G-5, a 1979 Bureau of Foods memorandum, which stated "(tjhe [NFI] comment assumes that imported species are contaminated to the same extent as corresponding domestic species. It is quite possible they are not however. . . . " G-5 at 1-2.1 acknowledge that FDA samples may have included imports. On the basis of the evidence, however, 1 conclude that any finding concerning a specific human food loss due to imported fish would be speculative. It would not be based on substantial evidence, as required by section 701(e)(3) of the act 2. Unviable Fisheries It is not disputed that as the percentage of fish that exceed the tolerance level may increase due to the tolerance reduction to 2 ppm, tome persons engaged in fishing may cease to operate. Some segments of the fishing industry could possibly cease operations completely. 44 FR 38335. coL 1. What is in dispute is whether a loss due to "unviable" fisheries can be quantified. . NFI asserted during the hearing that there would be a S51.fi million loss due to unviable fisheries. Judge Davidson declined to include a figure for unviable fisheries in his calculation of the total loss, on the basis that NFI did not adequately substantiate its loss figure. Initial Decision at 6. NFI excepts to that conclusion. NFI states that the total loss due to unviable fisheries should be $381.2 million ($51.6 million times a multiplier of 7). NFI Exceptions at 5. I conclude that Judge Davidson was correct. NFI's expert witness Dr. Strand derived the S51.fi million figure by assuming that a fishery would become unviable if the percentage of the catch exceeding a 2 ppm tolerance goes above 25%. N-21 at 8-6. Dr. Strand based his calculation on the following atatement in a "position paper" by the executive director of the Midwest Federated Fisheries Council;4 It should be pointed out that the commercial fisheries of the Crest Lakes are already operating at less than SO percent of the potential annual harvest... 4 25% reduction in the present level ofproduction (implied by the change from 5 ppm to 2 ppm) would put the fishermen who are barely making it. out of business completely. - N-21 at & quoting from N-18 at 4. (Emphasis added.) The position paper (N-18) does not state the basis for its contention or how the 25% figure was derived. There is nothing in the record concerning the qualifications of the position paper's author, so there is no basis on which 1 can conclude that he is a qualified expert on the subject Moreover. Bureau expert Dr. Talhelm testified that Dr. Strand's use of 25% was arbitrary, and that 10% or 30% could have been used just as well. G-8 at 10. Consequently, I conclude that NFI has not substantiated its claimed loss due to unviable fisheries. Even if I were to conclude that the evidence supported the use of a 25% trigger level for unviable fisheries, I would derive a much smaller loss attributed to unviable fisheries.' I base this result on two factors. First the statement quoted above addressed only the Great Lakes fisheries. There is nothing in the record concerning a trigger level for other fisheries. Because Dt. Strand's calculation included two marine species, striped bass and lobster, which are not found in the Great Lakes, see N-2. no loss attributed to these marine species could be included. ' Second NFI states in its exceptions that: in applying the unviable fiahery "trigger," the entire loaa to be expected, not the 'Although NFI oontanda that Dr. Strand relied only "in pari* on this statement. NFI Exception* et 2. Dr. Strand' testimony doe* not Indicate any other taunt tar Us assumption*. See N-21 eta Dr. Strand did not Indicate how he arrived et the SS1S million figure, other than to state that It is bated on catfish freshwater trout, striped best, and lobster. N-21 et a Apparently hit calculation was bated on the total landed value of theee specie*. N- 21 at 4. Table X reduced by the percent loss for each of those ipcdee at 2 ppm. N-21 at 8, Table 3. The reduction i* necessary to avoid any double counting, is the value of the violative fish hat already been taken into account. : 0754660 B TOWOLDMONOQ59639 21516 Federal Register / Vol. 49. No. 100 / Tuesday. May 22. 1984 / Rules and Regulations increment between S ppm and 2 ppm. must be "(ajlewives on the east coast of the the most appropriate measure for human considered. Judge Davidson's method brings the ioss for catfish below the "trigger." whereas it is actually above. Compare Doc. N-21. p. S with (Initial Decision atj 10. United States. I believe, are used for human food consumption." G-8 at 5.1 conclude that his statement is sufficient support for the finding that 30% of the food loss. In the short-run fishermen must bear the brunt of loss due to . reducing the tolerance. In the short run. fishermen use their resources to catch NFI Exceptions at 5, n. 4. Specifically, alewife catch is used for human food.* fish without knowing whether the fish the data for catfish indicate a 28.0% loss at a tolerance of 2 ppm. and a 4.7% loss 4. Multiplier will violate the PCB tolerance. If the fish cannot be sold, the fisherman loses at 5 ppm. N-21 at 3. Table 1. Judge Davidson based his calculations on the incremental loss in reducing the tolerance from 5 ppm to 2 ppm (i.e., for catfish, on a net loss of 21.3%. obtained by subtracting 4.7% from 26.0%. Initial Decision at Appendix 1). No one excepted to that method of calculation. The statement by the executive director of the Midwest Federated Fisheries Council quoted above, on which NFI relies, clearly discusses a "reduction in the present level of production (implied by the change from 5 ppm to 2 ppm)." (Emphasis added.) Applying that statement the reduction in the level of catfish production is 21.3%. Because the amount lost is below the 25% trigger level no loss can be attributed to an unviable catfish fishery. Consequently, after elimination of the two marine species and catfish, a loss for unviable fisheries can be calculated only with respect to trout Even if 1 were to include any loss due to unviable fisheries, it would only be $179,000.2* * In the proposal. FDA stated that the processed value of fish is about seven times its landed or dockside value: "processing" includes "cleaning, canning, distributing, retailing, etc." 42 FR17492. col. 2. The preamble to the final rule discussed only landed value. During the hearing,.the Bureau argued that the most appropriate measure of human food loss is the dockside value. Bureau Brief to ALJ at 9-10. In the alternative, the Bureau argued that a "multiplier" of two or three should be used to calculate retail value from dockside value, and in essence disavowed use of the multiplier of seven. Id. at 14. NFI's position was that the agency had developed the multiplier of seven and the Bureau was bound by that figure. NFI Brief to ALJ at 3-4. Against this background Judge Davidson decided that retail value representa human food loss, and found that the appropriate multiplier is six. Initial Decision at 5: Both the Bureau and NFI except to that finding. The what he would have received for the fish but for the tolferance--the landed or dockside value. Persons in the marketing chain such as processors and retailers, and consumers, are not as fixed in the short run. For example, a processor typically has many suppliers of fish. If the processor cannot buy from one source, it probably can make up the difference from alternate sources. Similarly, consumers can react easily by shifting consumption patterns to other species of fish or other foods. Because of this ability to turn to different sources of supply, a lower tolerance level will not have a direct effect on these sectors of the economy and the value that would have been added by processing, distributing, and retailing to the landed value of fish that violate the lower tolerance should not be considered. 5. Elasticity Effect Based on the testimony of Bureau witness Dr. Talhelm. Judge Davidson found that there would be a $6 million 3.Alewives Judge Davidson found that reducing the tolerance from 5 ppm to 2 ppm would result in the annual loss of alewives with a dockside value of $843,900. He arrived at this figure based on testimony that 70% of all alewives caught nationally were taken from the Great Lakes, and that Great Lakes alewives are not used as human food. Therefore, he assumed that the human food loss would, at a maximum, be 30% of the domestic catch (30% of the annual catch of $2413400 (N-21 at 4, Table 2) equals $843400).' Initial Decision at 7. The Bureau excepts to that figure, and asserts that no loss should be attributed to alewives. The Bureau's argument is that the record does not support Judge Davidson's assumption that 30% of the alewife harvest is used for food. Bureau Exceptions at 4. I do not agree with the Bureau. Bureau expert Dr. Talhelm testified that Bureau states that the multiplier should be one or three. Bureau Exceptions at 5. NFI takes the position that the multiplier should be seven. NFI Exceptions at 7. ' I conclude that it ia appropriate to measure human food loss in dockside value, rather than value after processing or retail value. Although the preamble to the proposal and the economic analyses prepared for the proposed and final . rules (G-l and G-2) all discuss both landed and processed value, the preamble to the final rule does not Thus, that preamble reveals that the agency's decision to lower the tolerance to 2 ppm waa based, in the final analysis, on the assumption that the resulting human food loss would have a landed value of $9.8 million ($5.7 million in 1974 dollars). I believe it is appropriate that my decision on the hearing issue provide an answer that can be directly compared with that $9.6 million figure. Having reached this conclusion. I need not decide whether annual cost due to the "elasticity effect." He reasoned that lowering the tolerance would increase the value of the fish remaining on the market by no more than that amount. Initial Decision at 7. The Bureau points out that the Judge misread Dr. Talhelm's testimony. Bureau Exceptions at 3. The Bureau is correct. What Dr. Talhelm actually stated was "I am positive that even under these additional assumptions (the price elasticity of fish], the estimated landed value of the losses would still be less than $8 million per year." G-8 at 18 (Emphasis added.) Because Dr. Talhelm did not provide any estimate of the loss due to the elasticity effect I conclude that a specific dollar loss cannot be attributed to the elasticity effect NFI attempts to bolster Judge Davidson's finding by arguing that it represents (after taking into account a multiplier effect of six) a dockside loss of $1 million, "which is an entirely reasonable estimate." NFI Reply to 'The tncramanul Ion of trout from reducing the tolerance from 5 ppm to 2 ppm ia 30.7X (Initial Judge Davidson's use of a "multiplier" of Exceptions at 2.1 conclude that this six to derive retail value from dockside argument ia without merit as it is Dedtian. Appendix 1). which exceedi the 25* trigger leveL The SI7?.000 figure ie bleed on annuel landing! of trout worth STSWIXW (Table 2. N-21 at 4), reduced by SSOMOO. the value of violative trout at a value was correct Moreover, based on economic principles, 1 believe that landed value is nothing more than an attempted post hoc rationalization without evidentiary support Moreover, it is based on a total 2 ppm tolerance that have already been taken into misreading of the testimony. Since Dr. account (Initial Dedaion. Appendix 2). 'fudge Devidaon implicitly assumed that all alewives would violate a 2 ppm tolerance. See N-21 at 2. S. That assumption is not in dispute. * Approximately 70S of thetl-S. alewife catch comet from the Cruet Lake*: the remaining 90S eomet from the east coast. G~7 at 14-15: eee G-2 el 31. Talhelm testified about "landed" value, the reduction of his estimate by the . "multiplier" to derive dockside value is 0754661 TOWOLDMONOQ59640 Federal Register / Vol. 49. No. 100 / Tuesday. May 22. 1984 / Rules and Regulations 21517 obviously incorrect, as the terms landed . PCBs in fish and shellfish, it is important conclude that that statement continues' and dockside are synonymous. that the agency's decision be based on to be valid today. C. Conclusion 1 have concluded that Judge Davidson correctly found that there would be no quantifiable human food loss due to imports or unviable fisheries, and that he correctly calculated the potential loss due to alewives. 1 have also concluded that human food loss should be stated in terms of dockside or landed value, and that no specific loss can be attributed to the elasticity effect. Therefore. I find that the human food loss in 1980 dollars, from reducing the tolerance from 5 ppm. is S13.4S3.SOO landed value.* Although Judge Davidson also calculated the human food loss for tolerances from 2.5 ppm to 4.5 ppm, those calculations are incomplete due to the lack of date concerning lobster and alewife losses at these intermediate tolerances. See Initial Decision, Appendix 2, note * *. Because these 2 species account for over one-third of the dollar loss at 2 ppm. I conclude that any calculation of the human food loss at intermediate tolerances would be based on speculation rather than substantial evidence. Consequently, I am not making any findings about the human food loss at tolerances between 2 ppm and S ppm. 1 further conclude that Judge Davidson correctly decided all issues not addressed above. III. Scientific Issues In announcing the hearing concerning the magnitude of the human food loss, the agency stated that information not reasonably available during the notice and comment aspect of this rulemaking relating to other aspects of the tolerance, including the toxicity of PCBs. could be submitted for consideration by the Commissioner if the Commissioner all currently known relevant information: Therefore. I conclude that there is good cause for including in the rulemaking record all newly submitted reports and studies that are not presently part of the record. This includes those newly submitted studies that were reasonably available at the time of the notice and comment part of this rulemaking, but that were not then submitted for whatever reason. 1 am aware that none of the additional submissions answer many of the uncertainties that FDA acknowledged in the preamble to the proposal [e.g.. studies involved commercial grade PCB mixtures, rather than the PCB isomers in fish, see 42 FR 17488), cols. 2 and 3). Nevertheless, the submissions are relevant to the toxicity of PCBs and a final decision on the tolerance, so 1 reject NMFS's suggestion that the Bureau's submissions not be included in the rulemaking record. NMFS Reply Brief at 5. The Office of Science Coordination has reviewed all submitted papers. The results of that review are summarized in a report that is available from the Dockets Management Branch. ' ("Report"). I agree with the results of that review, and adopt the Report as part of my Final Decision. That review concluded that the newly submitted data support the conclusions of the Risk Assessment upon which the final rule is based. In their briefs, NFI and GE generally take the position that FDA's concerns about the potential health risks associated with PCBs are overstated. I do not agree with that position. My responses to their specific arguments follow. . NFI and GE contend that PCB levels in fish pose no health problems. NFI Brief at 5; GE Brief at 9-10.1 do not agree. NFI Bnd GE cite a study that investigated potential adverse health effects from human consumption of Lake Michigan fish contaminated with PCB residues. The study was considered in the Risk Assessment and discussed in the preamble to the proposal. 42 FR 17492-03 (Reference 40). Although no adverse health effects or groups of symptoms that were clearly related to PCB exposure could be identified in the exposed group, the investigators reported a highly significant correlation between the quantity of Lake Michigan fish consumed and the concentration of PCBs in the blood of study participants. It is significant that abstinence from Lake Michigan fish consumption for a period of 90 days did notsignificantly change PCB blood levels. Moreover, the study's authors cautioned that the absence of any adverse health effects similar to those effects observed in workers exposed to PCBs does not exclude the possibility that long term effects will occur. NFI states that occupational exposure to PCBs at levels very much higher than would be experienced by those ingesting contaminated fi6h "leads to some health problems but not cancer or chronic health problems." NFI Brief at 5-6. FDA has identified a potential risk of PCBinduced hepatocellular carcinoma and adenoma by use of data from rodent carcinogenesis bioassays. Report at 4. This risk is supported by data in non human primates and man indicating that the liver is a target of PCBs. Report at 5 8. There are also reports that an increased incidence of cancer has been observed in workers exposed to PCBs finds good cause for their late inclusion NFI argues that FDA's concerns are (Brown and (ones (1981)).' Although the in the rulemaking record. 46 FR 24552, unfounded because PCBs are only a incidence is low and a cause-and-effect col. 2. Hearing participants and other cancer promoter, not an initiator. NFI relationship has not been established, interested persons submitted over 100 Brief at S. Presently, there is no these data--coupled with the fact that scientific articles and reports for consensus in the scientific community cancer has a long latent period--support consideration by the Commissioner. regarding the mechanisms of initiation the conclusion that chronic exposure to Some of these articles and reports were and promotion. However,'regardless of PCBs through the diet poses a potential discussed in the agency's risk . whether PCBs are promoters or risk. assessment ("Risk Assessment") supporting the final rule (44 FR 38340, reference 45). some were available at that time but were not discussed, and some were written after the date of this risk assessment . In view of the changing nature of scientific knowledge and the public health importance of a tolerance for* S initiators, I believe the data indicate that PCBs present a significant potential risk to our population. In the preamble to the final rule, FDA stated that "(a)lthough the data do not fully resolve such important questions as the carcinogenicity of PCB's they lead to the conclusion that neither `no-effect* nor `allowable daily intake* levels for PCB's GE argues that because extrapolation of animal data to human experience is difficult and often misleading, priority should be given to valid human data. GE Brief at 3.1 agree. The agency would prefer to base its risk assessment completely on valid human data. 42 FR 17487-88. However, there are rarely enough adequate human data to assess Thi is the Mine figure calculated by Judge Davidson, before application of the multiplier and addition of loss due to the elasticity effect. See page S supra. can be established with any confidence and that from a toxicological point of view, human exposure to PCB's should be reduced." 44 FR 38331, coL 2.1 actual human risk without using data -Citation* in to rafereoce* In Appendix I of the Report 0754662 1 21518 Federal Register / Vol. 49, No. 100 / Tuesday, May 22, 1984 / Rules and Regulations from ncn-human studies. There is associated incidences of hepatoma, Additional Support for this concern is general consensus among scientists that hepatocellular carcinoma or adenoma, provided by the results of a study in properly conducted nimpl studies are or hepatic neoplastic nodules. Report at minks in which PCBs at 2 ppm in the useful in the assessment of human 4. These endpoint histopathologies are diet caused complete reproductive health risks. Here, the results of human generally recognized as indicative of failure (Bleavins el al. (1980)). ~ and animal data show a significant carcinogenic or precarcinogenic GE contends that "no serious effects similarity' of PCB-related effects responses. In addition. Shimada and on reproduction or infant mortality were between animals and human beings. For Sato (1980) reported the finding of a found among 100 nursing mothers in example, a review of the available PCB-moiety that was apparently Michigan." GE Brief at 5. GE*s carcinogenesis data in 1978 compared covalently bound to rat hepatic contention is based on a study that was the responses of man. monkey, and rat to PCBs and concluded that hepatic macromolecules. This finding conducted to measure the levels of PCBs corroborates the animal studies, since it in human milk collected in the state of hypertrophy was one of the responses is generally accepted that the finding of Michigan (Wickizer et al. (1981)). That common to all species (IARC (1978); see intracellular, covalently bound agents is study does not support GE*s contention, Table 9, p. 70). Liver has been found to an important step in the mechanism of because it did not purport to collect data be the predominant target organ in carcinogenesis. Two general statements concerning adverse health consequences rodents and abnormal liver function has can be made. First, there is agreement to any of die donors. The study Is been observed in human beings exposed among scientists that induction of important however, because it to PCBs in the workplace. Report at 5-6. hepatocellular carcinomas early in the demonstrates that PCBs have been * Also, an ahnormal Incidence of liver course of a bioassay is indicative of found in human milk at levels (1-5 0.8 cancer was reported in a population of carcinogenicity under bioassay ppm) almost the same as those levels PCB exposed workers (Brown and Jones conditions. Nagasaki et aL (1972) found in the milk of Rhesus monkeys (1981)). observed hepatocellular carcinoma at 32 whose infants displayed significant I recognize that remaining weeks in mice that were Ted PCBs. signs of toxicity. unanswered questions about the human Second, the occurrence of hepatocellular GE discusses the observation that "in response to PCBs probably will be tumors in more than one species and/or the process of metabolizing PCBs, resolved only by valid human data. more than one sex gives added weight excess amounts of proteins (enzymes) Nevertheless, submitted data not to a finding of carcinogenicity. Here, known as mixed function oxydases (sic) available at the time of the Risk increases in hepatocellular tumors were (MFOs) are produced in occupationally Assessment underscore the agency's observed in both mice and rats fed exposed individuals, principally in the concerns about PCBs and support the PCBs. liver." GE Brief at 10. Contrary to GE'a hypothesis that the human liver is a Although GE correctly points out that assertion. 1 do not believe that these target of PCBs and may be adversely the results of clinical studies with data, together with the results of other affected by exposure to PCBs. Under exposed workers have not proved toxicological experiments, support the section 406 ofthe act, FDA must make a conclusively that PCBs cause adverse conclusion that the observed increase in qualitative Judgment on the basis of liver abnormalities in human beings, GE enzyme activity is of no consequence to available data--however incomplete-- Brief at 8-7, that point is hardly health over the individual's lifetime. The to insure the proper balance between controlling. What is important is that the fact that an increase in enzyme activity adequate public health protection and results of the studies do raise concerns in the human liver was observed excessive loss of food Therefore. I about the response of the human liver to supports the conclusion that the liver is conclude that the extrapolation of the PCBs and indicate that the human liver a target organ of PCBs in KTMan beings animal data is both necessary and . ' is a target of PCBs. FDA is concerned and more generally underscores FDA's proper. about the induction of PCB-associated concerns about the safety of PCB'i to CE suggests that, because PCB- liver abnormalities in human beings as a human health. indiiced morphological changes in the result of long term, low level exposure to GE discusses "Yusho disease." GE gastric mucosa of monkeys ere not PCBs. Brief at 7. The Yusho tragedy helped reported in rodents or other species, and GE contends that PCBs pose no alert the public and this agency to the because there are no clinical findings serious risk of teratogenesis to human dangers of PCB contamination. It is suggesting increased occurrences of beings because animal studies showed discussed in the preamble to the stomach cancer in man, extrapolation negative results or highly questionable from animal models to man is not positive results. GE Brief at 5-6. The appropriate. CE Brief at 4.1 believe GE*s concerns raised in the Risk Assessment proposal, 42 FR17488, coL 1, and In the Risk Assessment However, the Yusho incident involved short-term exposure to suggestion misses the point as.the human liver, not the stomach, is the . principal source of concern. GE contends that animal studies do not clearly indicate that PCBs induce cancer. GE Brief at 6. Although the question of whether PCBs are carcinogenic still has not been fully resolved, results of studies completed since die Risk Assessment support its conclusion that the liver is a target organ for PCBs in the rodent and that hepatocellular carcinoma or adenoma can result from PCB ingestion. Eleven of twelve rodent studies submitted in this proceeding reported significant PCB* about die potential of PCBs to cause reproductive and fetotoxic-effects were based on the results of a study in Rhesus monkeys (Barsotti et at. (1976)). Those concerns continue because a subsequent report of behavioral tests with the infant Rhesus monkeys who survived that study indicated increased errors in five of nine learning tasks at ages eight and 24 months, even though they were no longer nursing. During that period, tissue concentrations of PCBs in those infant monkeys decreased linearly with time (Bowman et al. (1978)). This suggests that PCBs may cause irreversible neurobehavioral abnormalities. high levels of PCBs, while the focus of this proceeding is the long-tom ingestion of low levels of PCBs. Gaffy (1981), in a paper submitted by CMA. stated that "it is doubtful whether any generalization can be made from the (Yusho) incident to lower level environmental or occupational exposures to PCBs." Therefore, 1 will not respond to GE"s specific contenGons concerning Yusho disease. Similarly, dermatological ailments, see GE Brief at 9. are not the focus of FDA's concerns. I have considered the scientific arguments of EDF and the Bureau in making my final decision. Because their 0754663 TOWOLDMONOQ59642 Federal Register / Vol. 49. No. 100 / Tuesday, May 22. 1984 / Rules and Regulations 21519 arguments support the final rule. I will NMFS also argues in its reply brief assumptions and inherently subject to not address them specifically. that FDA should undertake a new risk considerable uncertainty. - IV. Miscellaneous Isssue Several miscellaneous issues were raised in the briefs to the Commissioner and other pleadings. They are addressed in this section of my decision. NFI argues that the agency unlawfully interpreted NFl's objection to the final rule in an overly narrow way, thereby denying it the right to a hearing on some issues. NFI Brief at 8-11. But that contention is not borne out by an examination of NFl's objection. NFI objected "on the grounds that the loss of food which would be caused by the proposed reduction of the tolerance is grossly understated by the agency..." N-l at l. That is precisely the issue on which FDA granted a hearing--"the ' magnitude of the human food loss (in terms of dollars, poundage, percentage of catch, etc.] that would result from lowering the tolerance of PCB's in fish from 5 ppm to 2 ppm." 48 Fed. Reg. 24552. col. 2. NMFS argues in its brief to the Commissioner that FDA should perform a new risk analysis that specifically takes lobster into account NMFS Brief at B. At the time of the Risk Assessment no data concerning PCB levels in lobster were available. In response to that argument a Bureau scientist recalculated the risk estimates, taking residue PCB levels in assessment that takes into account tolerance levels between 2 ppm and 5 I have concluded above that the ' annual dockside human food loss is ppm. NMFS stated that it would work $13.5 million, rather than the $9.6 million with FDA in supporting such an estimate stated in the preamble to the endeavor. NMFS Reply Brief at 14. final rule. 1 have further concluded that As the agency previously stated, it the Risk Assessment supporting the final . must act on the basis of existing rule continues to be valid in light of information, even if incomplete. 44 FR newly submitted scientific information. 38331, col. 1. FDA would not be fulfilling The only question that remains is its obligation to protect the'public health whether a balancing of the unchanged by further delaying the effective date of public health considerations and the the reduced tolerance. I acknowledge increased human food loss yields a NMFS's offer of assistance, and will tolerance greater than 2 ppm. 1 conclude consider it in connection with FDA's on* that the answer is no. I conclude that, going monitoring of PCBs and. if even with an estimated human food loss necessary, future revisions of the of $13.5 million rather than $9.6 million, tolerance. 2 ppm is nevertheless the proper NFI argues that FDA failed to comply balance between public health with the requirements of the Regulatory protection and loss of food. Flexibility Act 5 U.S.C. 601 et seq.. and 1 believe that we should keep in mind Executive Order 12291,48 FR 13192 the fact that total annual domestic (February 19,1981). NFI Brief at 12. That landings of fish are almost $1.6 billion.11 argument is answered by the plain Thus, the total human food loss is less language of that Act and Order. Section than \% of all domestic landings. (l](a)(l) of the Executive Order states that it does not apply to administrative actions governed by 5 U.S.C. 556 and 557, which apply to rulemakings pursuant to section 701(e) of the act The Regulatory Flexibility Act does not apply to rulemaking initiated before its effective date. January 1,1981. Pub. L. 96-354, section 4. NFI contends that FDA should NMF argues that, based on a . balancing of risks to human health and human food loss considerations, the tolerance should be 3.5 ppm. NMFS Brief at 4. Although the risk assessment supporting the final rule included calculations of risk only at 5 ppm, 2 ppm. and 1 ppm. NMFS submitted the results of risk calculations at various levels between 5 ppm and 2 ppm.11 F-32 lobster into account Those calculations conduct a much broader inquiry into the and F-33. show that the overall risk estimates would increase by 1.5% at most The Bureau scientist's report is attached to the Bureau's reply brief to the Commissioner. Because the Bureau's economic costs of the reduced tolerance on the nation. NFI Brief at 11. On the other hand. EDF argues that economic considerations cannot play a significant part in this rulemaking. EDF Brief at 4 I do not agree with NMFS's reasoning. The risk calculations for tolerances between 5 ppm and 2 ppm do not show any sudden decrease in the number of expected cancers below the 3.5 ppm calculations establish that the Risk Assessment results are still valid, no purpose would be served by further 10. As discussed in the preamble to the final rule. 44 FR 38330, coL 3, the agency's paramount consideration in leveLRather, the expected cancer rate drops quickly between 2 ppm and 1 ppm. Those calculations show that the delaying the effective date of the 2 ppm tolerance while a new risk assessment is performed. NFI filed a motion to strike that establishing a tolerance is protection of expected cancer rate is basically an the public health. FDA is authorized by - arithmetic progression at levels between section 408 of the act to consider the 5 ppm and 2 ppm and are consistent unavoidability of substances such as with my final decision that 2 ppm is the recalculation of the Risk Assessment on the basis that the evidentiary record had closed and that NFI would bis prejudiced because it would not have a chance to * rebut the Bureau's recalculations. I am * denying NFl's motion to strike and conclude that it is without merit In its response to the motion to strike, the PCBs. It is in connection with the unavoidability of PCBs that human foods loss, and thus the limited issue of the value of the food loss, are relevent V. Conclusion In promulgating the final rule, the agency concluded that a 2 ppm appropriate tolreance. Moreover; NMFS's argument is based on a comparison of Judge Davidson's total human food loss findings Bt 2 ppm and 3.5 ppm. As I have already stated. Judge Davidson's human food loss figures for intermediate tolerances are seriously Bureau stated that it would not oppose tolerance would strike a proper balance 11 According to tbs sccoomic analysis tot the final. the submission of any rebuttal ' between protecting consumers from the rale, domestic lamtioga la 1974 wera B32 million. information by NFL Because NFI did not even attempt to rebut the Bureau's recalculation, it is obvious that NFI has not been prejudiced. Moreover, the risks associated with exposure to PCBs. and the loss of food due to the lowered tolerance. That balancing was based on an estimated annual food loss, in terms C-Z at 3. Expressed in 1980 dofian. that figure becomes Size billion. . " judge Davidson granted the motlona of tha Bureau and EDF to atrike these submissions because they were beyond the scope of the hearing. recalculation was submitted for of landed value, of $9.8 million ($5.7 Older, dated October 16.1BS1. Judge Davidson's consideration by the. Commissioner. It had nothing to do with the hearing issue and was not affected by the closing of million in 1974 dollars). For the reasons discussed in the preamble and supporting economic analysis (G-2). that decision on the motions was correct For the reasons already stated, hossover. page 20 supra, the submissions are part of tha overall rulemaking record and can be considered by the Commissioner- the hearing evidentiary record. estimate was based on a number of In msking a final agency decision. 0754664 TOWOLDMON0059643 21520 . Federal Rogister / Vol. 49. No. 100 / Tuesday, May 22. 1984 / Rules and Regulations **------------'------ incomplete, such that no meaningful comparisons between 2 ppm and higher tolerances ere possible. NFI and GE argue that a balancing of economic costs and public health benefits leads to the result that the tolerance should be S ppm. NFI Brief at 14; GE Brief at 11.1 have already discussed and rejected the arguments that the agency's public health concerns . about PCBs are overstated, and that FDA has not considered the full economic impact of reducing the tolerance. Consequently. I reject the suggestion that the tolerance not be lowered. In rejecting the balancing results urged by NMFS. NFL and GE 1 believe it is important to keep in mind that a decision to set the tolerance at 2 ppm, rather than at some other higher or lower level, is inherently, judgmental in character. As stated in die preamble to the final rule, section 408 of the act does not provide a formula for weighing public health concerns against loss of food. 44 FR 38336, col. 1. In the final analysis, as Commissioner of the agency charged by Congress with protecting the public health in this area, I must make an informed judgment in light of the statutory criteria. My judgment is that 2 ppm is the appropriate tolerance. The foregoing decision in its entirety constitutes my findings of fact and conclusions of law. List of Subjects in 21CFR Part 109 Contaminants. Polychlorinated Biphenyls (PCB's). VI. Final Order , Therefore, on the basis of the foregoing findings of fact and conclusions of law and the record in the above proceeding and under the Federal Food. Drag, and Cosmetic Act (secs. 308. 402(a), 408,701 (a) and (e).52 Stat 1045 1046 as amended, 1055,70 StaL 919 as amended (21 U.S.C 336,342(a), 346,371 (a) and (e))) and under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10): It is ordered that the stay of 21 CFR 109.30(a)(7). as ordered in the Federal Register of October 5.1979 (44 FR 57389), be terminated effective August 20.1984. Dated: May 14.1984. Mark Novitch; f Acting Commissioner ofFoodandDrugs. \ [FR Doc. M-13U8 filed J-17-S* 1030 an) eniMO coot .I ) DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Office of Assistant Secretary for Housing--Federal Housing Commissioner 24 CFR Parts 201.203, and 234 [Docket No. N-S4-1379-.FR-1981] Mortgage Insurance; Changes to Maximum Mortgage Limits for Single Family Residences and Manufactured Homes and Lots AOENCY: Office of Assistant Secretary for Housing--Federal Housing Commissioner, HUD. ACTION: Notice of revisions to FHA ' maximum mortgage limits for high-cost areas. ' summary: This Notice revises the listing of areas eligible for "high-cost" mortgage limits under certain of HUD's insuring authorities under the National Housing Act Mortgage limits are adjusted in an area when the Secretary determines that middle- and moderateincome persons have limited housing opportunities because of high prevailing housing sales prices. EFFECTIVE DATC May 22.1984. FOR FURTHER INFORMATION CONTACT: For single family: John J. Coonts, Director, Single Family Development Division. Room 9270, Telephone (202) 755-8720. For manufactured homes: William L Halpem, Acting Director, Office of Title I Insured Loans, Room 6160, Telephone (202) 755-6680; 451 Seventh Street SW,, Washington, D.C. 20410. (Telephones are not toll-free numbers.] SUPPLEMENTARY INFORMATION:. Background . The National Housing Act (NHA) (12 U.S.C. 1701-1749} authorizes HUD to insure mortgages for single family residences (from one- to four-family structures), condominiums, manufactured homes, manufactured home lots, and combination . manufactured homes and lots. The NHA. as amended by the Housing and Community Development Act of 1980 and the Housing and Community Development Amendments of 1981, permits HUD to increase the maximum mortgage limits under most of these programs to reflect regional differences in the cost of housing. In addition, sections 2(b) and 214 of the NHA provide for special high-cost limits for insured mortgages in Alaska. Guam and Hawaii The Housing and Urban-Rural Recovery Act of 1983 (Pub. L. 98-181. November 30.1983) (the 1983 Act further amended HUD's insuring authority. Of particular interest here are (1) the authorization to insure condominiums in high-cost areas at the same levels as the high-cost limits for one-family residences insured under section 203(b) of the National Housing Act; and (2) the authorization to increase maximum loan limits under the Title 1 loan insurance program for combination manufactured home and lot loans and for individual lot loans in high-cost areas, so long as the percentage increase in the maximum loan limit does not exceed the percentage increase made to a one-family residence in the area authorized under section 203(b) of the NHA. The Department implemented these provisions of the 1983 Act in related documents published in the Federal Register on April 11.1984 (see 49 FR 14332,14335,14336), effective May 22, 1984. These documents amended the Department's rules to codify the procedure of announcing high-cost mortgage limits for single family residences, condominiums, combination manufactured homes and lots and manufactured home lots by notice in the Federal Register (see the April 11,1984 documents, amending 24 CHI 201.1504, 203.18b, 203.29, 234.27, and 234.49). In addition, the documents codified the procedure whereby a party may request an alternative mortgage limit (see the .. same-sections cited above). This Document In this document the Department publishes its entire list of high-cost areas with applicable mortgage limits. The listing is different in several ways from the last complete listing, which was published on December 6.1983 (48 FR 54703). First there is no longer a separate listing for condominium units, since these limits are now the same as those for other one-family residences. Second, (he.listing includes instructions on how to compote the high- cost limits for combination . manufactured homes and lots and - ' individual lots, and specifies the special high-cost amounts for manufactured homes, combination manufactured homes and lots and individual lots insured in Alaska. Cuam and Hawaii Third, it adds the following new high- cost areas, with applicable limits: Lowell. MA-NH PMSA: Lawrence- Haverhill. MA-NH PMSA; Hartford. CT PMSA; Nashua. NH PMSA; Charlotte- Gastonia-Rock Hill NC-SC MSA Raleigh-Durham. NC MSA Jacksonville. 0754665 TOWOLDMONOQ59644 2488 ^.0\* . ** . . . .. . . . t.- Fadaral Register / Vol 49, No.^J^/^ondayTTSft^^; 1984 / Rules and Regulations : I*; pursuant to Subpart D of Part 284 and 115745 of the Commission's regulations. DEPARTMENT OF HEALTH AND significant effect on this apedesJTlM HUMAN SERVICES . ' . ; amendment to the possessionlimit will V r.n*v J-'o .v continue to allow a total of 8 fiah in . Food and DrugRrtHilMinjaUwt: i>.v, I possession, but 8 of these must be brook p. Statement N is amended bye ^1CFRPartT0;v^ removing the words "for**-rrnrm.1. tn:i;:[.. ' from the end of th'eTtlat sentence in the [Docket No. 77N-0C80] first paragraph.^\ . q. Statemeni0"fa'Miilerid4a by revising Polychlorinated Blphonyts (PCBs), it to read as follows:. \ Fiah and Shellfish; Reduction i Tolerances; Final I ' trout. The other two can be cutthroat , _ (other than greenback cutthroat trout), rainbow or brown trout 10 inches or < more in length. This change will reduce . the take of younger Immature fiahof-.. tbsse latter apedea, allowing' a morely...,.; natural age structure with moniaifirr ' J Statement O--Description of Company Operation*. A description of the company's ection fiah. which should improve the quality of angling. The establishment of special area and diversity of operations Including the In FR Doc. 64*13856 beginning on page management areas where nativetrout following: '; ' 21514 in the issue of Tueaday, May 22. ' have been restored will allow more"rv f- (1) A detailed system map is required only'7 1964, make the. following corrections: flexibility In management actionsju the if significant changes have occored since the 1. On page 21514. second column, status of populations'change. This ' . filing of the last FERC Font No.2. `. i~- .:. -.v-:. third Une,"43 FR"4 should haveread "42 eventually will result In more. ^ ^ (2) A complete raiehistery showing fifing FR". *e e t..-? opportunities for angling of theseV and rate levelsrihe* the banning of the - 2. On page 21517, first column, ., populations as (hey become established.' ""company wlthii'&rteftletienption of eadi *' fifteenth line, "5 ppm." should have read and secure. The number of permanently, filing. Such rate histbrjr'ne&l be filed every "5 ppm to 2 ppm.". . : , V^- - . closed waters will be reduced to two;_:- three year* and any-gefteralTete filing made in the interim'reflect ofily thbse changes since I ....... -tp- hr".- ' . the last complete rate history filhrg:^~> ' ' ;. ; <);*; - ' .* ..it.*:.'--. ..... f..- . (3) A detailed history of each major ' "* VS..' 'DEPARTMENT OF HOUSING AND expansion (new service), and major--' abandonment certificate issuedto the -- URBAN D-E- VELOPMENT"*';?C-TAr EFFECTIVI DATE Jldy 1R1M4L po* nnmm biformation cowTAcn-r:: David R. Stevens, Research Biologiatrrr Rocky Mountain National Paric'Eates' ^'VPark. Colorado 80517, Telephone: (305) company by FERC filing for the last three Qovammont National Morigsge r. i588-23^-,^; years of the company, along with a brief V~. ' r H|ioriitlon"- -- -**3-' SUP---------------------------------------------- description at each certificate.-Such 3 year.-?;-' certificate history need be filed every 3 year* '' -lai^RPartSSO^.. .____ and any general rate filing made inthe `The NatiohdP^.S^^i^^*^^'* ^ interim, reflect onjy those changes since the j. last 3 year rate hiSjtary filing. ;* (4) A detaifd dhseriptibn of how Dm. . . - company designs nd operates Its systems,"' including.designtemperature or tempMAres-.' and tha'afibet of conjunctive billing on design 18Mtiritizadion of Adjuat^WPkyirient - Mortgages - < . . fc,;j ^ Correction^:*---a 1 *; .V. ' in FR Doc. 84-15065 be^^ing oii page with thb U.S. Hah and WQdllfe the Colorado Division of Wildlife attrf'^V the Greenback Hout Recovery. Taonxa-. has made considerable progress toward, restoration of the greenback trout to a" : non-threatened status: liaisonhas alao'f considerstiona.... ;~i~f.zs.vyy.- ..; -23588In the issue of.Wedhesdayi June 8,_. been maintained with Tront Unlimited 1884, make file following correction: v and odterspecial intereat'groups.'ic^jii: 7. Part 154 is amended new 1154.63b to read as by addings followac -i^ri1; ^*:On page.23582, first column.OATES, ; line tiuee, "July 6,1984" shottldsead "August 6,1964^=^-^-: U v. - Research indicatesthat certain waterage j ; can nowbe opened to allaw':j appreciation by the visiting puMic^r-, f 164Mb Cash writing capital v . ' - - thraa^t catobnd-ralease fishing and ^ (a) General rule. Except as provided in paragraphrtitid iljjs sedon. any' * ' ' r^r4^> J?* ; natural gas^rtpedpejoompagy.tiut files / DEPARTMENT OF.MTEinpR an application for a change hi a tariff^ ' .National PiiFSnflM.-'-..^^..^. -. L. `r still give adeqotfe protection to tha t ' populations. This action has baen--5rr. : approved as promoting oonsarvatkm bf ^ the epedes by theJlah and Wildlife S Service thrau^i consultation April.23, under { 154.63 will not receive a cash.. __ ~<r~ : -*fs " * * . 1882, as required by sectioa'7 oftbo-1873 working capital adjustment to itarate.. 3eCFRPrt7-- Endangered SpMiesActTheColmdo base. . . ... . ;*. Diviston.ofJ ` ` " . . (b) xcgpq'ana. If any participant In ar;: rate proceeding onder this ppfM^v-' Colorado; niilkigkagHMOeil^^--*: rati demonstrates with a fuliy*developed ' , ' AOSSCy: ifationAl Park SereSm.^t t >' and reliable lead-lag study met".___j; r Department Of Interior, -i* V- * Three drainages grei revenue receipt lag or a netExpense payment lag ("revenue lead")*.. '. action; Final mla. ' - 4 "; catch-and-relesse fldrfngrThs Big; -ThompsonRiverln Forest Canyon Is a > (1) Any demonstrated net revenue * - summary: Thia final-rule will permit the native popnlstion^very sedzre snd-fT- receipt lag will be credited to rate base; taking of greenback cutthroat trouts \. protected from oveSexploitstion byT ': and - .-v r.v' v > i. threatenedapedes, on a catch-oad-*--^. isolation.The Faylake dndhsgeTyvhich^ (2) Any demonstrated net expense . payment lag will be deducted from rate base. -* . ' " ' --release basit in certain waters where ' secure populations are presast'Studies . and consultation with various groups and agendas indicatsd that this T^ - includes the Caddis Lake pbpulsttoh. -^. w > was rehabilitated and stocked with, i* ' greenback from the Big Thompson tibit population far 1659. Tba Hkidra Valley : rulemaldagwffleshonoetha visitor.' Beaver Ponds, tn wbkb grsenhadctrout i io4a park without - '* . u.. . . were restored in 1973, are aleoprotected 0754666 TOWOLDMONOQ59645