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808 No. Collins DEPARTMENT Or HEALTH is. HUMAN SERVICES St. Louis,Mo. 63102 Food and Drug Administration, Region VII FTS 279-4137 (314-425-413

Memorandum August 7 , 193 4 ^

U.S. Food & Drug Adm. yv Charlie D. Bringman, Acting Chief, St. Louis Station

. . . =/V^— Mississippi River Pool #15 Quad Cities, Iowa-I11inois

DAVID A. WAGONER, DIRECTOR, AIR AND WASTE MANAGEMENT DIVISION U.S. ENVIRONMENTAL PROTECTION AGENCY

In response to your memo of 7/18/84, I offer the following information:

Your assumption that FDA has lowered the tolerance of PCBs in fish is correct. The tolerance will be 2.0 ppm as of 8/20/84. I have attached a copy of the Federal Register of 5/22/84 containing the final rule on PCBs in fish.

FDA does consider carp an edible species.

The FDA Pesticides Analytical Manual - Volume 1, General Information Section 141.12 states, under FISH (raw): "Remove and discard heads, scales, tails, fins, guts and inedible bones; do not remove skin ***." it would appear then that the National Academy of Science, your experienced fishermen and FDA's method of analysis are compatible: skins are analyzed.

One of our pesticide analysts confirmed that all fish with scales are analyzed with skin intact. Only catfish skin is discarded prior to analysis.

We have contacted our Chicago, Illinois District. Their District includes the Illinois side of the Mississippi River at Davenport, la. They assure us that they have collected no fish for PCB analysis in at least five years.

We have reviewed our pesticide sampling of fish (includes PCBs) from October 1, 1979 to the present. Fish collected and analytical results are as follows:

Date Collected Species Results

1. 1.2/3/8] Carp Aroclor 1254 - . 508 ppm Fish were from waters of Pool 11 (above lock & dam 11)

2. 12/4/81 Catfish Aroclor 1254 - .922 ppm F i. sh w">re from Pool 16 (above \ 280 bridge)

• 12/4/31 Catfish Aroclor 1254 - .456 ppm Fish were from Pool 14 (3 miles above to 2 miles below Pr i n<-• • l oii , la.)

Page 2 - CDB 8/7/84 memo re Mississippi River Pool #15 Quad Cities, Icwa-I llinois

4. 12/8/81 Buffalo Aroclor 1254 - .363 ppm Fish were from Pool 14 (1 mile above to 1 mile below Camanche, la.)

These samples were from fish markets or commercial fisherman.

Unfortunately, none of our samples are from Pool 15, but these fish samples will give you some idea of PCB levels in fish in this area.

Our pesticide analysis will pick up PCBs as follows: Aroclor 1221, 1232, 1242, 1248, 1254, 1260, 1262, 5442, and 5460.

Investigator Kloud of this office has spoken with Al Van Vooren, Iowa Department of Conservation. His Agency will be fishing Pool #15 in August with fish being submitted to your Kansas City Lab. Mr. David Crawford of your office phoned me on 8/8/84 and said that fish for PCB analysis will be collected by the State of Iowa for PCB analysis in your Lab.

Will you please send us results of your analysis of fish for PCBs from Pool 15?

i l l - - T N -n' < \ }\ tv\U_o •'—J-J. >. ' CHARLIE D. BR^NGMAN Chief (Acting) St. Louis Station

CDB/mc &cm

Encl.: cy FED REG 5/22/84

cc - Kloud cc - St.Louis Station

21514 Federal Register / ? *49, No. 10,, , Tuesday, May 22, 1984 /Wiles and Regulations

American Samoa, we will look at the • laws of the District of Columbia. For a

definition of permanent home, see $ 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 inherit the 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 5 5 404.355-404.359. [FR Doc. 5+-13722 Filed S-ZI-84: 8:45 am] Wtxmo coot 4190-11-44

Food and Drug Administration

21 CFR Part 109 [Docket No.77N-00S0]

PolycMortnatad Btphanyts (PCBs) in Fteh and Sftettfish; Reduction of ToJaraneoa; Final Dadalon AGENCY: Food and Drug Administration. ACTION: Final rule: final decision following a formal evidentiary public hearing.

SUMMARY: The Commissioner of Food and Drugs is issuing a Final Decision following a formal evidentiary hearing 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 20,1984. ADDRESS: 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-305), Rm. 4-02, 5600 Fishers Lane, Rockville, Md.. 20857, from 9 a.m. to 4 p.m., Monday through Friday, FOR FURTHER INFORMATION 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, Md., 20857, 301-443-1587. SUPPLEMENTARY INFORMATION:

I. 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 P(ills in several

classes of food. In relevant part, FDA proposed to lower the 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 persons 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 rule, pending resolution of the issues raised in NFI's objection. In the Federal Register of May 1,1981, FDA announced a formal evidentiary hearing on NFI's objection, on the issue of the "magnitude of the human food loss" from reducing the tolerance to 2 ppm. 46 FR 24551. NFI and FDA's Bureau of Foods ' ("Bureau") were parties at the hearing. In addition to the parties, the National Marine Fisheries Service ("NMFS") of the U.S. Department of Commerce and the Environmental Defense Fund ("EDF") filed notices of participation. EDF subsequently withdrew from participation.

Administrative Law judge ("ALJ") Daniel j. Davidson issued his initial Decision on February 8, 1982. FDA announced the availability of the Initial

Decision in the Federal Register of March 9.1982. 40 FR 10079. NFI and the Bureau filed exceptions to Judge Davidson's Initial Decision under 21 CFR 12.125.

I am issuing this Final Decision under section 400 of the act and 21 CFR 12.130. In taking this action, I have all the powers I would have had in making the Initial Decision. 21 CFR 12.130(a). Section II 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. 46 FR 24553. NFI, the Bureau, NMFS, EDF. the Chemical Manufacturers Association ("CMA"), the General Electric Company ("GE"), the State of Michigan, and others submitted additional information, briefs, or both.

Section III of my Final Decision discusses the scientific issues raised in these submissions and briefs. Section IV deals with several miscellaneous issues. In Section V, I 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.

II. The Evidentiary Hearing Issues

.4. The Initial Decision Judge Davidson made detailed

findings about the human food loss resulting from lowering the tolerances from 5 ppm to 2 ppm:

imports Unviable fisheries................... Related species.. Domestic harvest in violation:

Alewiyes Buffalo fish Carp..

$#43 128

Catfish Trout _ afl Whitefish and chubs jjgj Bluefish Lobster .. .. M Striped bass

63. 4.MI. 2.̂ 34

.IX »

.om ,0» •>*) .«>«) OX) ,.XX) I .Mk)

Total..

Times multiplier of six.. Elasticity effect

13.453 500 00.721,0 JO

8.000.1**)

fur 11 I hr Bureau of^oddR n MOW named the Center

Grand total.