Appellees Brief — Hillsborough County v. Automated Medical Laboratories, Inc.

NO. 83-1925 AN ed

in the =

Supreme Court

uf the

United States

OCTOBER TERM, 194

HILLSBOROUGH COUNTY, FLORIDA AND

HILLSBOROUGH COUNTY HEALTH DEPARTMENT

1 ppe llants

AUTOMATED MEDICAL LABORATORIES, INC.,

Appellee,

APPELLEE'S BRIEF ON THE MERITS

LARRY A. STUMPI FINLEY, Kl MBLE, WAGNER,

Counse t Record HEINE, UNDERBERG, MANLEY

VICTORIA L. BADEN ~« CASEY

Members, United States ( imset for 1 pp

Supreme Court Bat Suite 1000, Flagship C

ti Brickell] Ave!

Miami, Florida 33131

(305) 371-2600

CHARLES F. JOHNS

On the Brief

QUESTIONS PRESENTED

A. Where the federal legislation and attendant

regulation in a given field is pervasive, what is the

proper test to be applied in determining whether local

legislation in the same field is pre-empted?

B. Does application of the appropriate test for

pre-emption mandate a holding that the subject

Hillsborough County ordinances regulating the

plasmapheresis procedure are pre-empted by federal

regulation of the plasmapheresis procedure under the

Public Health Service Act?

TABLE OF CONTENTS

Zante of Authovtiles ... .....0<cccceuue seen eo

Opinions and Judgments Below................ 1

CUBUIENNED ow 5 ooo é'sé sn ccncunn nee 2

Constitutional and Statutory Provisions 2

ess ..!lUttt—~—

Dtatement of the Case .........cssceusen eee 3

Summary of Argument ....................... 5

Argument:

I. The Decision of the United States Court of

Appeals for the Eleventh Circuit Should be

Summarily Affirmed .................... 13

II. The Court of Appeals Applied the Proper

Legal Standard in Determining that the

Challenged Local Legislation Was Pre-

Pee i4

A. The basic principles of pre-emption

analysis are well settled and free of

re 14

III.

TABLE OF CONTENTS (continued)

Page

B. Contrary to the position advanced by

the National Association of Counties, a

finding of express agency intent to pre-

empt is not a prerequisite to a holding

that the federal regulatory system

governing the plasmapheresis industry

pre-empts the challenged Hillsborough

County ordinances ..................

C. The position advanced by the United

States is contrary to controlling

as cs esas eee.

D. The Court of Appeals applied the proper

legal standard in determining that the

Hillsborough County ordinances are pre-

ee ovina a ceases esse

Proper Application of Well-Settled Principles

of Implied Pre-Emption Analysis Mandates the

Conclusion that the Challenged Ordinances are

Wholly Pre-Empted and Cannot Stand .....

A. Federal regulation of blood piasma

and plasmapheresis is so pervasive

as to leave no room for local

regulationofthearea................

16

18

21

21

TABLE OF CONTENTS (continued)

Page

B. At least in the areas of product purity,

donor safety and adequate plasma supply,

the federal interest is so dominant that

local legislation is precluded .......... 24

IV. Because Enforcement of the Challenged Local

Legislation Would Result in Both an

Irreconcilable Conflict with Federal

Regulations and a Substantial Obstacle to

Full Attainment of Congressionally Mandated

Objects and Purposes, the Local Legislation

) 0 PPP eeerreer er re 29

iin ba Su Da its hog Oe A ee el 32

Certificate of Service ......................0-- 33

i\

TABLE OF AUTHORITIES

Cases: Pages

Automated Medical Laboratories, Inc. v.

Hillsborough County,

722 F.2d 1526 (11th Cir. 1984)............. 2,3, 7

Bethlehem Steel Co. v. New York State Labor

Relations Bd.,

330 U.S. 767, 67 S.Ct. 1026 (1947) ....... 10, 16, 17

Capital Cities Cable, Inc. v. Crisp,

___US. ,1048.Ct. 2694 (1984) ...... 8, 9, 10,

14, 17, 29

City of New Orleans v. Dukes,

427 U.S. 297, 96 S.Ct. 2513 (1976) ............. 9

Edgar v. MITE Corp.,

457 U.S. 624, 102 S.Ct. 2629 (1982) ........... 19

Fidelity Federal Savings & Loan Ass'n. v. de la

Cuesta,

458 U.S. 141, 102 S.Ct. 3014 (1982) ......... 8, 10,

14, 15, 16,

18, 22, 29

Florida Lime & Avocado Growers, Inc. v. Paul,

373 U.S. 132, 83 S.Ct. 1210 (1963) ............ 15

Franklin National Bank of Franklin Square v. New

York,

347 U.S. 373, 74 S.Ct. 550 (1954)............. 17

TABLE OF AUTHORITIES (Continued)

Cases: Pages

Gibbons v. Ogden,

9 Wheat. 1,6 L.Ed. 23 (1824)................ 14

Hines v. Davidowitz,

312 U.S. 52, 61 S.Ct. 399 (1941) .............. 15

Huron Portland Cement Co. v. City of Detroit,

Michigan,

362 U.S. 440, 80 S.Ct. 813 (1960) ............. 28

Jones v. Rath Packing Co.,

430 U.S. 519, 97 S.Ct. 1305 (1977) .... 10, 15, 16, 17

Michigan Canners & Freezers Ass’n., Inc. v.

Agricultural Marketing and Bargaining Board,

___U.S.___., 104 S.Ct. 2518 (1984)....... 10, 15,

Pacific Gas & Electric Co. vu State Energy Resources

Conservation & Dev. Comm’n.,

461 U.S. 190, 103 S.Ct. 1713 (1983) ........... 28

Pennsy!vania v. Nelson,

350 U.S. 497, 76 S.Ct. 477 (1956) ......... 5, 7, 13,

22, 24

Ray wv. Atlantic Richfield Co.,

435 U.S. 151, 98 S.Ct. 988 (1978) ........ 17, 20, 27

vi

TABLE OF AUTHORITIES (Continued)

Cases: Pages

Rice v. Santa Fe Elevator Corp.,

331 U.S. 218, 67 S.Ct. 1146 (1947) ........ 10, 15, 16

Constitution, Statutes, Rules and Regulations:

U.S. Constitution:

Art. VI, cl.2‘Supremacy Clause)........ 2,14, 15

Federal Food, Drug and Cosmetic Act,

rrerr ere 2, 6, 16

Public Health Service Act,

Cg Peerere rere cree 6, 9, 16

Section 351, 42 U.S.C. §262 ............. 2,10, 11

23, 25, 27

Section 361, 42 U.S.C. §264............... 6, 11,

23, 25

Hillsborough County, Fla. Ordinances

(Nov. 26, 1980):

vii

TABLE OF AUTHORITIES (Continued)

Pages

Hillsborough County Ordiance 80-12 Rules and

Regulations

tes tion 6 bie Es i ee oe he a 4

21 C.F.R

Pt. 20

Dh ¢ RL chUivewkeeensan Chnaeaeeen 25

Pt. 600

RS aos wid 9 a saw ne ou eeunake 23

Pt. 601

ED osc ccesesvcesswesscesces 23

Pt. 606

SEO ccc ce tcccecvscecevece 23

EE Cus dai erik ee ae Kew eckbewens 3

Pt. 607

ERR ERPS Pee ar 24

Pt. 610

EE SC bbc a wGedan cb hrce tern: coe 24

Pt. 640

Subpt. F—Biologics ...................... 4

Vili

TABLE OF AUTHORITIES (Continued)

Pages

Subpt. G

EE ci cee ey liken nkene eas 23

Miscellaneous:

37 Fed. Reg. (1972):

cn Wi uh hea p.ue6ebs6 eee eek bane es 30

38 Fed. Reg. (1973)

ga IR a Oe eee eer 24

39 Fed. Reg. (1974)

CCC Gulu see ease ces «awe en 19, 25, 26

0 ES eee ee 19, 25, 26

VEL. Ce eee oaks eye ade e as Koo ek> 26

Nag en 26

41 Fed. Reg. (1976)

I a et aS Eines ols ele ede’ 26

rte ee al Bi ite ries at 26

NO. 83-1925

in the

Supreme Court

of the

United States

OCTOBER TERM, 1984

HILLSBOROUGH COUNTY, FLORIDA AND

HILLSBOROUGH COUNTY HEALTH DEPARTMENT

Appellants,

vs.

AUTOMATED MEDICAL LABORATORIES, INC.,

Appellee,

APPELLEE’S BRIEF ON THE MERITS

OPINIONS AND JUDGMENTS BELOW

The opinion (JA 40-46)’ and final judgment (JA 47)

of the United States District Court for the Middle

‘References to the Joint Appendix are indicated by (JA _)},

the Jurisdictional Statement Appendix by (JSA__), and the Transcript

by (TR ).

District of Florida, William J. Castagna, J., are not

reported. The opinion (JA 48-59) of the United States

Court of Appeals for the Eleventh Circuit is reported

at 722 F.2d 1526. The final judgment (JA 60) is not

reported.

JURISDICTION

The judgment of the Court of Appeals was entered

on January 16, 1984 (JSA 21). A petition for rehearing

by panel was denied on February 23, 1984 (JSA 22-26)

and a notice of appeal was filed on April 20, 1984 (JSA

27). This Court noted probable jurisdiction on January

14, 1985. The jurisdiction of this Court rests upon 28

U.S.C. §1254(2).

CONSTITUTIONAL AND STATUTORY PROVISIONS

INVOLVED

1. This Constitution, and the Laws of the

United States which shall be made in Pursuance

thereof; and all Treaties made, or which shall

be made, under the Authority of the United

States, shall be the supreme Law of the Land;

and the Judges in every State shall be bound

thereby, any Thing in the Constitution or

Laws of any State to the Contrary

notwithstanding. United States Constitution,

Article VI, clause 2.

2. Public Health Service Act, Sections 351 &

361, 42 U.S.C. §§262 & 264.

3. Federal Food, Drug and Cosmetic Act, 21

U.S.C. §321, et. seq.

4. 21 C.F.R. §600.3-680.26 (1983).

5. Hillsborough County Ordinances 80-11 and

80-12 and the rules and regulations promulgated

thereunder (JA 21-34).

STATEMENT OF THE CASE

On November 26, 1980, Appellant, HILLSBOROUGH

COUNTY, FLORIDA (“County”), adopted Ordinances

80-11 and 80-12 (JA 21-31), purporting to regulate

plasmapheresis establishments and the eligibility of

donors of blood plasma.’ Ordinance 80-11 (JA 21-23)

imposed a license tax on blood plasma centers, and

required licensees, among other things, to permit

inspection of blood plasma centers by Appellant

HILLSBOROUGH COUNTY HEALTH DEPARTMENT

(“Department”). Ordinance 80-11, in addition, required

blood plasma centers located within Hillsborough County

to provide continuously updated information to the

Department regarding their ownership, employees,

equipment and facilities.

Ordinance 80-12 (JA 24-31), and the rules and

regulations promulgated thereunder (JA 32-34), required

that a blood plasma donor, prior to donating plasma,

undergo a medical examination and obtain a certificate

of good health, and to obtain from the Department an

identification card, which identification card would have

‘Plasmapheresis is a process whereby, during a single procedure,

blood is removed from a human donor, the plasma is removed

from the whole blood, and the red blood cells are returned to the

donor (JA 50; 722 F.2d at 1527-1528; see also, 21 C.F.R. §606.3(e) ).

permitted the potential donor to undergo plasmapheresis

for a period of six months only, and only at a single

specified plasma center within Hillsborough County.

Ordinance 80-12 also required licensee plasma centers

to submit to the Department, on a daily basis, and as to

each procedure performed, detailed information regarding

the donor, reports of testing, and results of the procedure.

Ordinance 80-12 also required licensee plasma centers

to pay to the Department a fee of $1.00 for each procedure

performed.

Appellee, AUTOMATED MEDICAL LABORATO-

RIES, INC. (“AML”), a Florida corporation which, through

a wholly owned subsidiary corporation known as Tampa

Plasma Center, operates a blood plasma center in Tampa,

Hillsborough County, Florida, filed a civil action against

the County and the Department in the United States

District Court for the Middle District of Florida,

challenging the constitutionality of the Ordinances (JA

5-34). AML’s complaint challenged the County regulatory

scheme on the grounds that it was pre-empted by

regulations of the United States Food and Drug

Administration (“FDA”) (21 C.F.R. Subchapter F-Biologics),

that it imposed an undue burden on interstate commerce,

that it denied AML its right to equal protection of the

law, and for other reasons.

After a non-jury trial, the United States District

Court for the Middle District of Florida entered its

opinion (JA 40-46) and final judgment (JA 47), on

November 1, 1982, holding §7 of Ordinance 80-12 and §4

of the rules and regulations (dealing with required

breathalyzer tests) unconstitutional, as impermissibly

burdening interstate commerce, and upholding the

remainder of the County regulatory scheme.

AML appealed to the United States Court of Appeals

for the Eleventh Circuit, and the County cross-appealed

with respect to the portions of the Ordinances invalidated

by the District Court.

The Eleventh Circuit held that Ordinances 80-11

and 80-12 were invalid, because the County regulatory

scheme was wholly pre-empted by federal regulation

of the area, under the tests enunciated in Pennsylvania

v. Nelson, 350 U.S. 497, 76 S.Ct. 477 (1956) (JA 48-59:

722 F.2d 1526 (1984) ). Accordingly, the Eleventh Circuit

did not decide the other questions raised on the appeal.

Hillsborough County petitioned for rehearing by

panel (JSA 22-25). In its petition, the County explicated

its view that the Eleventh Circuit had erred in holding

that federal law pre-empted its Ordinances, had ignored

record evidence and had misapplied the law. The Eleventh

Circuit denied the petition for rehearing (JSA 26).

SUMMARY OF ARGUMENT

Pursuant to the Supremacy Clause of the United

States Constitution, the laws of the United States are

“the supreme Law of the Land.” Accordingly, local

legislation that interferes with, or is contrary to, federal

law is invalid under the doctrine of federal pre-emption.

In interpreting and applying the Supremacy Clause,

and in establishing and defining the doctrine of federal

pre-emption, this Court consistently has held that where

Congress intends, either expressly or impliedly, that a

federal regulatory system covering an area of permissible

federal regulation is the exclusive regulatory system,

local legislation in that area is pre-empted.

It is equally well-settled that, when promulgated

with appropriate legislative authority, federal regulations

have pre-emptive effect equal to that of federal statutes.

The first step, then, in a proper pre-emption analysis

is an examination of the statutory and regulatory

framework. In the case at bar, the system of federal

regulation of the plasmapheresis industry is grounded

upon the Public Health Service Act, 42 U.S.C. §262, et

seq. (and, to a much lesser degree, upon the Federal

Food, Drug and Cosmetic Act, 21 U.S.C. §321, et seg.).°

The relevant portions of the Public Health Service

Act provide that no person shall sell any blood component

or derivative (including blood plasma collected by

plasmapheresis) unless the product was propagated or

manufactured at an establishment holding a valid license

from the Food and Drug Administration (“FDA”). Licenses

for plasmapheresis establishments are, in turn, granted

pursuant to extensive FDA regulations promulgated

to ensure the safety and purity of blood components, to

ensure the safety of the (paid) donors of plasma who

undergo the plasmapheresis procedure, and to ensure

the continued adequate supply of plasma, collected by

the plasmapheresis procedure and subsequently

manufactured into vitally important pharmaceutical

products.

Acting pursuant to the statutory authority of Section

361 of the Public Health Service Act, the FDA has

*The statutory framework for the federal regulation of the

plasmapheresis industry is described at pages 1-4 of the Brief for

the United States, as Amicus Curiae. AML finds that description

to be accurate.

promulgated comprehensive regulations,‘ found by the |

United States Court of Appeals for the Eleventh Circuit

in this case to be pervasive, to be broad in scope and to

“cover virtually every phase of the plasmapheresis

process” (JA 56; 722 F.2d at 1531). There is no dispute

among the parties as to the comprekensiveness of the

regulations.

In its analysis of the doctrine of federal pre-emption

as applied to the facts of the case at bar, the Eleventh

Circuit carefully considered the correct, well-settled

and recently restated principles of pre-emption analysis.

The Eleventh Circuit concluded that, while the statutes

and regulations involved do not expressly pre-empt

local legislation, the federal system of regulation has,

by implication, pre-empted local legislation.

More specifically, the Eleventh Circuit carefully

applied the tests for determining the issue of implied

pre-emption, as articulated in Pennsylvania v. Nelson,

350 U.S. 497, 76 S.Ct. 477 (1956), and concluded that (i)

the federal regujations are comprehensive and fill the

entire field of regulation, (ii) the federal law concerns a

field of dominant federal interest and (iii) enforcement

of the County legislation would present a serious danger

of conflict with the administration of the federal system.

(JA 55-59; 722 F.2d at 1531-1533). Accordingly, the

Eleventh Circuit held the Hillsborough County Ordinances

to be invalid, because local regulation in the field had

been pre-empted.

‘The FDA regulations are found at 21 C.F.R. Parts 600, 601,

606, 607, 610 and 640, Subpart G.

The County’s brief indicates substantial agreement

with AML on the correct principles of pre-emption

analysis applicable to the case at bar. However, without

advancing persuasive reasons in support of their position,

the County argues that the Eleventh Circuit misapplied

the principles of pre-emption analysis.

Amici curiae supporting the County argue that

the Eleventh Circuit applied incorrect principles of

pre-emption analysis in finding that the federal regulatory

system pre-empts local legislation. More specifically,

the National Association of Counties, et al., with misplaced

reliance upon Fidelity Federal Savings & Loan Assn.

v. de la Cuesta, 458 U.S. 141, 102 S.Ct. 3014 (1982) and

Capital Cities Cable, Inc. v. Crisp, ___. U.S. ___, 104

S.Ct. 2694 (1984), argue that, in the absence of explicit

statutory language of pre-emption, a finding of express

agency intent to pre-empt is required before agency

regulations preempt state law. The United States argues

that this Court cannot find implied pre-emption where

the agency initially indicated a lack of intent to pre-

empt local legislation.

The authorities relied upon by the National

Association of Counties, et al. and by the United States

do not, upon proper analysis, stand for the propositions

being urged by the amici curiae supporting the County.

Proper determination of this case does not require a

departure from established principles of pre-emption

analysis.

For the reasons stated above, and fully discussed

in Point II below, the Eleventh Circuit applied the

proper legal standard in concluding that the Hillsborough

County ordinances at issue are pre-empted by the federal

regulatory system authorized by the Public Health

Service Act and effectuated by regulations of the FDA.

For the reasons summarized below and fully

discussed in Part III, application of well-settled principles

of pre-emption analysis mandates a holding that the

conclusion reached by the Eleventh Circuit, that the

challenged ordinances are wholly pre-empted and cannot

stand, was correct.

As recently as June 1984, this Court restated the

three possible bases for a determination that local

legislation has been pre-empted by federal law: (1) in

enacting a federal statute, Congress may explicitly

state that it intends to pre-empt state law (express

pre-emption); (2) in the absence of language expressly

pre-empting state legislation,» Congress may, nevertheless,

indicate its intent to occupy an entire field of regulation,

thereby precluding the states from regulating in that

area (implied pre-emption); and (3) even in the absence

of express or implied congressional intent to displace

state law in its entirety, state law may be pre-empted

to the extent that the state law actually conflicts with

federal law, either when compliance with both state

and federal law is impossible, or when the state law

presents an obstacle to the purposes and objectives of

Congress (obstacle). Capital Cities Cable, Inc. v. Crisp,

supra, ____ U.S. at ___, 104 S.Ct. at 2700-01.

The principles enunciated in Capital Cities are

consistent with, and follow, an established line of decisions

‘Local ordinances are treated as are state statutes for these

purposes. City of New Orleans v. Dukes, 427 U.S. 297, 96 S.Ct.

2513 (1976).

of this Court. See, e.g., Michigan Canners & Freezers

Ass'n. v. Agricultural. Marketing and Bargaining Board.

____ ~-U.S. ___, 104 S.Ct. 2518 (1984); Jones v. Rath

Packing Co., 430 U.S. 519, 97 S.Ct. 1305 (1977); Rice v.

Santa Fe Elevator Corp., 331 U.S. 218, 67 S.Ct. 1146

(1947); Bethlehem Steel Co. v. New York State Labor

Relations Bd., 330 U.S. 767, 67 S.Ct. 1026 (1947). Federal

regulations can have the same pre-emptive effect as do

federal statutes. Fidelity Federal v. de la Cuesta, supra,

___ US. at ___, 102 S.Ct. at 3022; Capital Cities

Cable, Inc. v. Crisp, __. U.S. at ___, 104 S.Ct. at 2700.

The case at bar is not an instance in which Congress

or the FDA has explicitly stated an intent to pre-empt.

Therefore, the first possible basis for a finding of pre-

emption is inapplicable.

In the absence of express pre-emption, an analysis

of whether Congress or the appropriate federal agency

has impliedly pre-empted local law is required. There

are two instances in which implied pre-emption will be

found: (i) where the federal system of regulation is so

pervasive as to fill the field of regulation, or (ii) where

the federal interest in the area regulated is dominant

over any local interest.

The first test for implicit federal pre-emption is

met in the case at bar because the federal system for

regulation of blood and blood products, established

pursuant to Section 35] of the Public Health Service

Act (“the Act”), is so pervasive as to leave no room for

state regulation of the plasmapheresis industry. Section

351 of the Act requires federal licensing of each

10

establishment producing a biological product, federal

licensing of each product to ensure safety, purity and

potency, and federal standards for packing and labeling

of the product. The FDA regulations implementing the

Act contain a section dealing specifically with “Source

Plasma (Human),” as well as more general sections

which apply to the plasmapheresis procedure itself.

The federal regulatory system is so comprehensive

and extensive as to compel the conclusion that Congress

and the FDA have left no room for state regulation in the

field of plasmapheresis.

The second test for implicit pre-emption is met, in

that at least in the areas of product purity, donor

safety and adequate plasma supply, the federal interest

in the plasmapheresis field is so dominant that local

legislation is precluded. Section 351 of the Act prohibits

the sale or transportation of any blood or blood product

which has not been propagated or manufactured and

prepared at a federally licensed establishment. Section

361 of the Act (42 U.S.C. §264) authorizes the FDA to

promulgate such regulations as are necessary to prevent

the introduction, transmission, or spread of blood related

communicable disease from one state to another. This

necessarily requires the FDA to exercise its authority

to regulate a potential disease-causing substance from

the source of its collection through its subsequent

processing (or manufacture) and shipment. The FDA,

in promulgating the regulations concerning biological

products, established a comprehensive National Blood

Policy and employed the full regulatory authorities

vested in the federal government to assure uniform

adherence to the highest attainable standards of practice

in blood banking, including plasmapheresis. The statutory

11

language and the regulatory framework indicate that

Congress intended uniform national standards to promote

product purity, donor safety and an adequate plasma

supply.

The County concedes that the concern of its local

legislation is the source of the blood product, that is,

the donor. The concern for donor safety, then, is shared

by the County and the FDA. However, given the federal

congressional and regulatory intent to establish a uniform,

comprehensive national program in the area, and the

FDA's duty to issue all regulations it deems necessary

to effect that goal, it is apparent that Congress intended

uniform national standards that would foreclose the

imposition of different or more stringent local

requirements.

Because federal regulation of plasma and

plasmapheresis is so pervasive, and because the federal

interest in regulating the field is so dominant as to

preclude enforcement of local laws on the subject, the

federal regulatory system implicitly pre-empts

enforcement of the County’s ordinances.

Even if Congress and the FDA have not implicitly

pre-empted state regulation of the plasmapheresis

industry, enforcement of the challenged local legislation

would result in both an irreconcilable conflict with

federal regulations and a substantial obstacle to the

full attainment of congressional objects and purposes

in regulating blood and blood products. The County

ordinances, including a restrictive donor registration

requirement, a pre-registration hepatitis test, a pre-

donation breath analysis for alcohol content and detailed

recordkeeping and reporting requirements, impose

12

burdensome and expensive requirements in addition to

the extensive federal regulatory system. If enforced,

the County’s legislation would conflict with federal

regulation authorizing the collection of hepatitis plasma

for vaccine manufacture and would frustrate the

congressional goals of ensuring a safe and adequate

blood supply and ensuring a continued supply of healthy

donors.

ARGUMENT

POINT I

THE DECISION OF THE UNITED STATES

COURT OF APPEALS FOR THE ELEVENTH

CIRCUIT SHOULD BE SUMMARILY

AFFIRMED.

AML filed its Motion to Affirm with this Court on

June 27, 1984. For the reasons stated therein, this

Court should now, AML respectfully submits, summarily

affirm the decision of the United States Court of Appeals

for the Eleventh Circuit.

The controlling issues have now been fully briefed

in this Court, and, under the current and well-settled

state of the law of pre-emption, it is abundantly clear,

for the reasons fully discussed in Point II below, that

the Eleventh Circuit applied the appropriate legal

principles in determining that Hillsborough County

Ordinances 80-11 and 80-12 are pre-empted by federal

law. For the reasons fully discussed in Points III and

IV below, the Eleventh Circuit correctly determined,

under the tests set forth in Pennsylvania v. Nelson, 350

U.S. 497, 76 S.Ct. 477 (1956), that the Hillsborough

13

County ordinances were pre-empted by the federal

regulatory system.

POINT I

THE COURT OF APPEALS APPLIED THE

PROPER LEGAL STANDARD IN DETER-

MINING THAT THE CHALLENGED LOCAL

LEGISLATION WAS PRE-EMPTED.

A. The basic principles of pre-emption analysis

are well settled and free of doubt.

It is axiomatic that the doctrine of federal pre-

emption is grounded upon the Supremacy Clause of the

United States Constitution, Article VI, clause 2:

This Constitution, and the Laws of the United

States which shali be made in Pursuance thereof;

... Shall be the supreme Law of the Land; ...

Since as early as 1824, the Supremacy Clause, as

the foundation for the doctrine of federal pre-emption,

has been interpreted and applied to invalidate local

laws that “interfere with, or are contrary to” federal

law. Gibbons v. Ogden, 9 Wheat. 1, 211 (1824).

It is also firmly established that “(federal regulations

have no less pre-emptive effect than federal statutes.”

Fidelity Federal v. de la Cuesta, supra, 458 U.S. at

153-54, 102 S.Ct. at 3022; Capital Cities Cable, Inc. v.

Crisp, __. U.S. at , 104 S.Ct. at 2700:

14

. . . Under the Supremacy Clause, U.S. Const.,

Art. VI, cl. 2, the enforcement of a state

regulation may be pre-empted by federal! law

in several circumstances: first, when Congress,

in enacting a federal statute, has expressed a

clear intent to pre-empt state law, Jones wu.

Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct.

1305, 1309, 51 L.Ed.2d 604 (1977); second, when

it is clear, despite the absence of explicit pre-

emptive language, that Congress has intended

by legislating comprehensively, to occupy an

entire field of regulation and has thereby “left

no room for the States to supplement” federal

law, Rice vu. Santa Fe Elevator Corp., 331 U.S.

218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447

(1947); and, finally, when compliance with both

state and federal law is impossible, Florida

Lime & Avocado Growers, Inc. v. Paul, 373

U.S. 132, 142-143, 83 S.Ct. 1210, 1217-1218, 10

L.Ed.2d 248 (1963), or when the state law “stands

as an obstacle to the accomplishment and

execution of the full purposes and objectives

of Congress.” Hines v. Davidowitz, 312 U.S.

52, 67, 61 S.Ct. 399, 404, 85 L.Ed 581 (1941).

See also Michigan Canners & Freezers Assn.

u Agricultural Marketing and Bargaining Board,

oan : , 104 S.Ct. 2518, ___, 80

L.Ed.2d ___(1984).

And, as we made clear in Fidelity Federal

Savings and Loan Assn. v. De La Cuesta, 458

U.S. 141, 102 S.Ct. 3014, 78 L.Ed.2d 664 (198?).

“Federal regulations have no less pre-

emptive effect than federal statutes

15

The cases cited above flow consistently in a long

stream of cases expressing these now familiar principles.

See, e g.: Bethlehem Steel Co. vu. Allegheny Ludlum

Steel Corp., 330 U.S. 767, 67 S.Ct. 1026, (1947); Rice wv.

Santa Fe Corporation., 331 U.S. 218, 67 S.Ct. 1146

(1947); Jones v. Rath Packing Co., 430 U.S. 519, 97 S.Ct.

1305 (1977); Michigan Canners, supra, _.. U.S. ___.,

104 S.Ct. 2518 (1984).

B. Contrary to the position advanced by the

National Association of Counties, a finding of express

agency intent to pre-empt is not a prerequisite to a

holding that the federal regulatory system governing

the plasmapheresis industry pre-empts the challenged

Hillsborough County ordinances.

Although the principles set forth above would appear

to be certain, the primary substantive disagreements

among the parties (and amici curiae) in this case arise

at this point in the pre-emption analysis.

In the case at bar, the Eleventh Circuit found that

the language of the statutes upon which the

comprehensive FDA regulatory system is based, the

Public Health Service Act and the Federal Food, Drug

and Cosmetic Act, does not support a finding of express

congressional intent to pre-empt (JA 54-55; 722 F.2d at

1530). From that finding, coupled with an unsound analysis

of Fidelity Federal u de la Cuesta, the National Association

of Counties asks this Court to adopt an entirely novel

approach to pre-emption analysis and to depart from

the well settled rules of law expressed above. The

National Association of Counties advances the position

16

that, in the absence of express congressional intent to

pre-empt, a finding of pre-emption by agency regulation

is proper only if the agency has expressly stated its

intent to pre-empt local legislation.’

It hardly merits stating that, in accordance with

modern day concepts of federalism, Congress frequently

provides the statutory basis for federal control over a

given field, and delegates to an agency the task of

promulgating and enforcing the detailed regulatory

system. Bethlehem Steel Co. v. New York State Labor

Relations Bd., 330 U.S. 767, 67 S.Ct. 1026 (1947). This, of

course, is the context of the case at bar, namely, a

congressional enactment stating essential federal

principles and policy, with appropriate authority granted

to the proper agency to enact controlling regulations.

This gives rise to the issue of whether the system of

federal regulation has pre-empted local legislation in

the field.

In such circumstances, this Court has repeatedly

found local regulation to be pre-empted, even without

a finding of express agency intent to pre-empt. Capital

Cities Cable, Inc. v. Crisp ___. U.S. ____, 104 8.Ct. 2694

(1984) (Federal Communications Commission regulations

promulgated under Communications Act of 1934); Jones

v. Rath Packing Co., 430 U.S. 519, 97 S.Ct. 1305 (1977)

(Secretary of Agriculture regulations promulgated under

Federal Meat Inspection Act); Ray v. Atlantic Richfield

Co., 435 U.S. 151, 98 S.Ct. 988 (1978) (Department of

Transportation regulations promulgated under Ports

and Waterways Safety Act of 1972); Franklin National

"Brief of the National Association of Counties, et. al, as Amici

Curiae, p. 16.

17

Bank v. New York, 347 U.S. 373, 74 S.Ct. 550 (1954)

(Federal Reserve Board Regulations promulgated under

Federal Reserve Act).

In short, the National Association of Counties’

position represents a radical departure from the

established precedent of this Court.

In addition, Fidelity Federal v. de la Cuesta simply

does not stand for the proposition advanced —that a

finding of pre-emption “requires a clear expression of

administrative intent to preempt all state efforts, including

non-conflicting laws, to regulate the same subject.”* In

fact, Fidelity Federal v. de la Cuesta restates the classic

principles of pre-emption analysis and explicitly recognizes

that “federai regulations have no less pre-emptive effect

than federal statutes.” ____ U.S. at ___., 102 S.Ct. at

3022. The issue in Fidelity Federal v. de la Cuesta was

whether the agency expressing the intent to pre-empt

did so with proper congressional authority. Fidelity

Federal v. de la Cuesta cannot be construed to stand

for the proposition asserted by the National Association

of Counties.

C. The position advanced by the United States is

contrary to controlling precedent.

The position advanced by the United States appears

to differ from the position of AML in only one, but one

quite substantial, respect. The United States

acknowledges, as indeed it must, that the subject FDA

regulations are “comprehensive” and that:

"Brief of National Association of Counties, et. al, as Amici

Curiae, p. 16.

18

[t]he purpose of the FDA regulations is to

establish nationwide standards necessary to

provide an adequate supply of safe, pure and

potent blood, blood components, and blood

products, as well, as to protect the health of

blood donors.’

The United States argues, however, that because

a comment made at the time the initial regulations

were proposed indicates a lack of intent to pre-empt,

this Court cannot find implied pre-emption despite the

facts that the regulations are comprehensive in scope,

and concern an area in which the federal interest is

dominant, and the County ordinances have the same

goal as the federal regulations. However, later comments

by the Commissioner indicate that the agency soon

thereafter felt constrained to take steps to ensure that

the plasmaphleresis regulations were uniform,

comprehensive and applicable nationwide. See e.g., 39

Fed. Reg. 18614-15 (1974). The present scope of the

federal regulations should be considered by the Court

in determining if a finding of pre-emption is now

appropriate. Edgar v. MITE Corp., 457 U.S. 624, 633,

102 S.Ct. 2629, 2636 (1982).

AML's position, that a federal regulatory system

impliedly pre-empts the entire field of regulation when

(i) the federal law fills the field by its pervasiveness or

(ii) the federal law regulates a field of dominant federal

interest, is fully supported by the cases cited in Point

II, B above. The fact that the United States concedes

the pervasiveness of the FDA plasmapheresis regulations,

"Brief for the United States, as Amicus Curiae, p. 7 (emphasis

supplied).

19

and the importance of the national interest thusly served,

adds substantial weight to AML’s position that the

Eleventh Circuit's holding of implicit federal pre-emption

of the field of plasmapheresis was sound and should be

affirmed.

Of particular importance is the fact that the United

States admits that the federal regulations have as one

of their purposes the same purpose as the County

ordinances, namely the protection of the health of the

donors. The law is well settled that when local legislation

has the same purpose as a comprehensive federal

regulatory system, local legislation in any area of that

field is pre-empted. Ray v. Atlantic Richfield Company,

435 U.S. 151, 98 S.Ct. 988 (1978).

The facts in Ray are strikingly similar to those in

the case at bar. Pursuant to statutory authority, the

Secretary of Transportation was to promulgate

“comprehensive minimum standards” for the design

and structure of certain cargo carrying vessels. After

promulgating such standards, the Secretary was to

then provide for inspection for compliance with the

minimum requirements, and to issue certificates if the

federal standards were satisfied. The State of Washington

attempted to impose additional and more stringent

requirements to accomplish the same goal as the

Secretary's, namely vessel safety. Applying well

established principles of pre-emption analysis, this Court

held that “[t}he Supremacy Clause dictates that the

federal judgment that a vessel is safe to navigate United

States waters prevails over the contrary state judgment.”

Ray v. Atlantic Richfield Co., 435 U.S. at 165, 98 S.Ct.

at 998. This Court went on to find that to allow the

state to impose additional and more stringent

20

requirements on vessel design and safety would frustrate

the congressional purpose of establishing uniform national

standards, which if met, allow a vessel to operate.

Thus, because Hillsborough County has admittedly

“enacted a regulatory scheme governing [the area covered

by the FDA regulations]’,"” and that scheme imposes

additional and more stringent requirements than those

imposed by federal law, the local legislation is pre-

empted entirely.

D. The Court of Appeals applied the proper legal

standard in determining that the Hillsborough County

ordinances are pre-empted.

Thus, for the reasons stated above, the correct

legal standard was utilized by the Eleventh Circuit in

its analysis of this case. And, as will be demonstrated

in Point III below, application of those well established

pre-emption standards compels the conclusion that the

challenged County ordinances are pre-empted.

POINT Ill

PROPER APPLICATION OF WELL-

SETTLED PRINCIPLES OF IMPLIED PRE-

EMPTION ANALYSIS MANDATES THE

CONCLUSION THAT THE CHALLENGED

ORDINANCES ARE WHOLLY PREEMPTED

AND CANNOT STAND.

The Eleventh Circuit, in determining that the federal

system for regulating blood plasma and plasmapheresis

“Brief for the United States, as Amicus Curiae, p. 7.

implicitly pre-empted the County’s regulation of the

area, applied the tests set forth in Pennsylvania v.

Nelson, 350 U.S. 497, 76 S.Ct. 477 (1956), the identical

tests recently restated by this Court in Fidelity Federal

v. de la Cuesta, supra, 458 U.S. 141, ___, 102 S.Ct.

3014, 3022 (1982): (i) whether the federal scheme is so

pervasive as to make reasonable the inference that

Congress left no room for the states to supplement it,

or (ii) whether the federal system of regulation controls a

field in which the federal interest is so dominant that

the federal system must be assumed to preclude

enforcement of state laws on the same subject.

The Eleventh Circuit was eminently correct in

holding that, based upon the criteria set forth in

Pennsylvania v. Nelson, as restated in Fidelity Federal

v. de la Cuesta, the County regulation of plasma and

plasmapheresis is implicitly pre-empted by the federal

system regulating the area.

A. Federal regulation of blood plasma and

plasmapheresis is so pervasive as to leave no room for

local regulation of the area.

The first test for determining the existence of

implied federal pre-emption is whether federal regulation

of the area is so pervasive as to make reasonable the

inference that Congress left no room for the states to

supplement it. Pennsylvania v. Nelson, 350 U.S. at 502,

76 S.Ct. at 480. In the case at bar, the federal system

for regulation of plasmapheresis is so extensive as to

require such an inference.

As the Eleventh Circuit noted, Section 351 of the

Public Health Service Act (the “Act”) requires federal

licensing of each establishment producing a biological

product, federal licensing of each such product to ensure

safety, purity and potency, and federal standards for

packaging and labeling of the product. 42 U.S.C. §262

(1982). Section 351 and Section 361 (42 U.S.C. §264) of

the Act delegate to the FDA the authority to promulgate

the rules and regulations required to implement the

Act. (JA 56; 722 F.2d at 1531).

The regulations implementing the Act include a

section dealing specifically with “Source Plasma (Human),”

which is defined as the fluid portion of human blood

collected by plasmapheresis and intended as source

material for further manufacturing use. 21 C.F.R.

§640.60-640.76 (1983). Other portions of the regulations

promulgated pursuant to the Act also apply to, and

regulate, virtually every aspect of the plasmapheresis

industry.” Jd.

"The regulations prescribe rules as to consent of a prospective

donor, medical supervision of the procedure, suitability of donors,

method of collection, requirements of the plasmapheresis procedure,

immunization of donors, testing for hepatitis, processing of the

blood, pooling, inspection, labeling, manufacturing responsibility,

records, reporting of fatal donor reactions, modification of source

plasma, alternate procedures, and products stored or shipped at

unacceptable temperatures (JA 56, fn.4; 722 F.2d at 1531, fn.4).

“The subjects included within the remaining regulations are

establishment standards and inspections, 21 C.F.R. §§600.3-22 (1983);

licensing, 21 C.F.R. §§601.1-601.33 (1983); good manufacturing practices

for blood and blood components, 21 C.F.R. §§606.3-606.170 (1983)

(with specific sections relating to personnel, facilities, equipment,

supplies and reagents, standard operating procedures, finished

product and laboratory controls, labeling, records, and reports);

23

Clearly, as found by the Eleventh Circuit, the federal

regulations are broad in their scope and cover virtually

every phase of the plasmapheresis process. The federal

regulatory system is so comprehensive and extensive

that the only reasonable inference that may be drawn

is that Congress and the FDA have left no room for

local regulation in the plasmapheresis field.

B. At least in the areas of product purity, donor

safety and adequate plasma supply, the federal interest

is so dominant that local legislation is precluded.

The second basis for a finding of implicit federal

pre-emption is a finding that the federal regulatory

system covers a field in which the federal interest is so

dominant that the federal system must be assumed to

preclude enforcement of state laws on the same subject.

Pennsylvania v. Nelson, 350 U.S. at 504, 76 S.Ct. at 481.

In the case at bar, the federal interest in ensuring a

safe and adequate supply of blood and blood components,

and in ensuring the safety of the donors, as demonstrated

by congressional act and federal agency regulation,

dominates over any local interest in those areas.

Again, as found by the Eleventh Circuit, Congress

and the FDA have maintained extensive and

comprehensive control over the nation’s blood collection

system since 1946. 38 Fed. Reg. 2966 (1973). The collection

(Footnote 12 Continued)

establishment registration and product listing, 21 C.F.R. §§607.3-607.65

(1983); general biological products standards, 21 C.F.R. §610.65

(1983) (including standards of potency, hepatitis requirements,

dating periods, and labeling standards) (JA 56, fn.5; 722 F.2d at

1531, fn.5).

of blood is an area of nationa! concern, for “{hjuman

blood is a priceless resource.” 39 Fed. Reg. 18614 (1974)

(JA 57; 722 F.2d at 1531).

Section 351 of the Act prohibits the sale or

transportation of any blood or blood product that has

not been propagated (or manufactured) and prepared

at a federally licensed establishment. Pursuant to Section

361 of the Act (42 U.S.C. §264) and under the authority

delegated under 21 C.F.R. §20.21, the FDA is authorized

to promulgate such regulations as are necessary to

prevent the introduction, transmission, or spread of

blood related communicable disease from one state to

another, necessarily requiring the FDA to exercise its

authority to regulate a potential disease-causing substance

from the source of its collection through its subsequent

processing (or manufacture) and shipment. 39 Fed. Reg.

18614 (1974).

In promulgating regulations concerning good

manufacturing practices for blood and blood components,

the Commissioner of Food and Drugs stated that:

The promulgation of standards for these

biological drugs is part of an existing effort to

increase the quality of blood related health

care in this country. Pursuant to the findings

of a special Task Force in Blood Banking, the

Secretary of Health, Education, and Welfare

has established a comprehensive National Blood

‘In 1974, the FDA expressly acknowledged that the inspection

or licensing provisions »nacted by approximately ten states were

inadequate to protect against the spread of hepatitis in blood

products. 39 Fed. Reg. 18614-18615 (1974).

Policy. One of the fundamental methods

prescribed by the Secretary to implement the

policy is to “employ the full regulatory

authorities now vested in the Federal

Government * * * for the purpose of assuring

uniform adherence to the highest attainable

standards of practice in blood banking, including

plasmapheresis and plasma fractionation.”

39 Fed. Reg. 18614 (1974) (emphasis supplied).

The FDA, therefore, has developed a “comprehensive

regulatory program” concerning blood and blood

products. The FDA's express purposes in promulgating

regulations to implement that program are to ensure a

safe and adequate supply of blood and blood products

and to ensure a continuous and healthy donor population.

41 Fed. Reg. 10762-10763 (1976); 39 Fed. Reg. 26161-26162

(1974); 39 Fed. Reg. 18615 (1974).

The United States, in its Brief, acknowledges that,

insofar as those goals are concerned, the federal interest

so dominates as to foreclose local legislation on the

subject.

The federal government has required vendors

nationwide to be subject to the same minimum

product and donor safety standards to further

the two-fold interest in ensuring that the national

supply of safe, pure, and potent blood plasma

remains adequate to meet the nation’s health

care needs and in protecting the health of

“See, supra, fn. 12 and 13.

donors for their own sake and to provide a

healthy donor population. To that extent, the

federal interest in plasmapheresis is dominant

and the states are foreclosed from promoting

a contrary policy.”

The County attempts to create a distinction between

the purposes of the federal regulation and those of the

local ordinances, asserting that the purpose of the local

legislation is to protect the health of the donor of the

plasma, while the purpose of the federal regulations is

to ensure the purity and adequacy of supply of the

product (Appellant’s Brief on the Merits, p. 10). However,

as demonstrated above, the distinction sought to be

made by the County is illusory.

The federal regulatory system aims at ensuring

an adequate supply of blood and blood products,

maintaining product safety and protecting and maintaining

a sufficient supply of healthy donors. Congress, insofar

as those aims are concerned, has entrusted to the FDA

the duty of promulgating all regulations necessary to

meet those ends. Section 351 of the Act, and the attendant

regulatory framework, cleariy demonstrates that

Congress intended uniform national standards in the

areas of product safety and supply and donor protection

that would foreclose the imposition of more stringent

local requirements in those areas. Ray u Atlantic Richfield

Co., 435 U.S. at 164, 98 S.Ct. at 998 (1978).

AML does not, of course, assert that, by reason of

the federal regulatory system, it is free to ignore local

“Brief of the United States, as Amicus Curiae, p. 23.

regulation in areas not covered by the federal regulations,

such as local occupational licensing or general health

and safety requirements. See, e.g., Huron Portland

Cement Co. v. City of Detroit, Michigan, 362 U.S. 440,

80 S.Ct. 813 (1960) (federal approval and licensing of

vessels to ensure seagoing safety did not preclude

enforcement of municipal smoke abatement ordinance);

Pacific Gas & Electric Co. v. State Energy Resources

Conservation & Development Comm'n., 461 U.S. 190,

103 S.Ct. 1713 (1983) (federal regulation of radiological

safety in construction and operation of nuclear power

plants did not preclude state regulation concerning

need, reliability and cost). However, the local ordinances

at issue in this case relate only to the precise areas

encompassed by the federal regulations.

The County attempts to regulate in areas which

have been identified as being of dominant federal concern.

The County is precluded from imposing requirements

which are different from, or more stringent than those

dictated to promote the comprehensive national program

in that area, and, thus the County ordinances, are

impliedly pre-empted by the federal regulatory system.

POINT IV

BECAUSE ENFORCEMENT OF THE

CHALLENGED LOCAL LEGISLATION

WOULD RESULT IN BOTH AN IRRECONCI-

LABLE CONFLICT WITH FEDERAL REGU-

LATIONS AND A SUBSTANTIAL OBSTACLE

TO FULL ATTAINMENT OF CONGRESSION.-

ALLY MANDATED OBJECTS AND

PURPOSES, THE LOCAL LEGISLATION IS

PRE-EMPTED.

Even if the pervasiveness of the federal regulations

(Point iII, A) and the dominance of the federal interest

in the subject matter of those regulations (Point III, B)

were not enough to imply pre-emption of the County

ordinances, enforcement of the ordinances would conflict

with the federal regulations and stand as an obstacle to

the accomplishment and execution of the full purposes

and objectives of Congress in establishing a national

policy with regard to blood and blood products. These

circumstances alone compel a finding that the challenged

legislation is pre-empted. Capital Cities Cable, Inc. v.

Crisp, ___. U.S. at ___, 104 S.Ct. at 2700; Michigan

Canners, supra, ___._ U.S. at ___, 104 S.Ct. at 2523;

Fidelity Federal v. de la Cuesta, supra, ____ US. at

____., 102 3.Ct. at 3022.

The United States recognizes a conflict between

the County ordinances and the federal regulations. If

the County ordinances were to be enforced,

plasmapheresis centers in Hillsborough County would

be prevented from collecting plasma necessary for

&

production of hepatitis vaccine."* This conflict alone

mandates a holding of pre-emption.

More substantially, enforcement of the County

ordinances would stand as a serious obstacle to the

expressly stated federal goal to “insure there is a

continued healthy donor population to serve as a source

of plasma.” 37 Fed. Reg. 17420 (1972). In fact, AML’s

evidence at trial demonstrated that enforcement of the

County ordinances would render the continued existence

of AML’s plasma center in Tampa economically impossible

by substantially increasing costs of plasma production,

while, at the same time, substantially reducing the

donor population.

In particular, enforcement of the County ordinances

would have such a negative effect upon local plasma

centers that the donor population would be significantly

reduced, resulting, obviously, in a diminished supply of

available plasma. The evidence at trial indicated that

enforcement of the County ordinances would result in

an increase in direct costs of plasma production by

$1.50 per litre, and a total increase in production costs

(including both direct and indirect costs) of $7.00 per

litre of plasma, an increase of approximately 15% in

the total cost of production (TR 49-52; AML Trial Exhibit

19). In fact, prior experiences with a virtually identical

set of ordinances indicate that the number of plasma

centers would be reduced, in addition to reducing the

donor population. Similar ordinances have been in effect

in Miami, and since their enactment the number of

plasma centers has been reduced from eleven until

only two currently remain (AML Trial Exhibits 4 and

5).

“Brief of United States, as Amicus Curiae, pp. 29-30.

30

Donor population would be reduced by the complete

elimination of what is known as the “casual donor.” A

casual donor is a donor who does not regularly engage

in a systematic plasmapheresis program, but who does

so only occasionally, usually at times separated over

many months. Casual donors would be effectively excluded

from engaging in plasmapheresis under the County

ordinances because they would need County donor

identification cards, which would be burdensome to

obtain and would be valid for only six months.

Additionally, those donors who participate elsewhere

in a plasmapheresis program on a regular basis, but

who find themselves in Hillsborough County only for a

short period of time, would be effectively excluded

from continuing to participate as plasma donors while

in the County of Hillsborough (TR 54-55).

While it is true that the County has a legitimate

interest in protecting the health and safety of its citizens,

any such protection provided by the subject ordinances

is illusory. None of the features of the County regulations

accomplishes a. purpose that the federal regulatory

system does not accomplish, and none provides protection

to the people of Hillsborough County not afforded by

the comprehensive federal regulations.

Because enforcement of the County ordinances

would, in the above respects, stand as an obstacle to

the accomplishment and execution of the purposes of

Congress in establishing a national blood policy, the

ordinances are pre-empted by the federal regulatory

system.

31

CONCLUSION

The Eleventh Circuit properly determined, based

upon criteria set forth by this Court, that the subject

Ordinances are pre-empted by federal regulation. For

the reasons stated herein, the judgment below should

be affirmed. ‘

Respectfully submitted,

LARRY A. STUMPF

Counsel of Record

VICTORIA L. BADEN

Members, United States

Supreme Court Bar

FINLEY, KUMBLE, WAGNER, HEINE,

UNDERBERG, MANLEY & CASEY

Counsel for Appellee

Suite 1000, Flagship Center

777 Brickell Avenue

Miami, Florida 33131

(305) 371-2600

CHARLES F. JOHNS,

On the Brief

J

CERTIFICATE OF SERVICE

All parties required to be served have been se \ ed

by depositing on this 29th day of March, 1985 three

printed copies of this document in a U.S. Post Office,

with first class postage prepaid, addressed to counsel

of record at his or her post office address as follows:

Joe Horn Mount, Esq.

Hillsborough County Attorney

Counsel for Appellants

P.O. Box 1110

Tampa, Florida 33601

Paul J. Larkin, Jr., Esq.

Counsel for Amicus,

United States Government

Department of Justice

Solicitor General's Office

10th and Constitution Ave.

Room 5634

Washington, D.C. 20004

Joyce Holmes Benjamin, Esq.

Counsel for Amicus,

The Academy for State and

ae Government

tate and Local

Suite 208 Legal Center

444 North Capital Street, N.W.

Washington, D.C. 20001

$3

Landfield, Becker & Green

Counsel for Amicus,

American Blood Resources

Association

1220 Nineteenth Street, N.W.

Washington, D.C. 20036

/3/ Lamy A. Stumpt

LARRY A. STUMPF

Counsel of Record

Member, United States Supreme

Court Bar

FINLEY, KUMBLE, WAGNER, HEINE,

UNDERBERG, MANLEY & CASEY

Counsel for Appellee

Suite 1000, Flagship Center

777 Brickell Avenue

Miami, Florida 33131

(305) 371-2600

w