Appendix — Solem v. Courter

Supreme Court brief1996

Ask Donna

What actually matters in this document.

Text

Supreme Court, U.S.

» FILED

95°913 DEC 111%

QERICE OE HE CLERK

In oj he

Supreme Court of the Chhited States

October Term 1995

CHRISTINE SOLEM,

Petitioner,

Vv.

J. CARLTON COURTER, III,

Commissioner of Agriculture

and Consumer Services,

Respondent.

ON PETITION FOR WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

Petitioner’s Appendix

Christine Solem

Pro Se

1836 Polo Grounds Road

Charlottesville, Virginia 22911

(804) 973-6505

THE LEX GROUP ¢ 1205 East Main Street @ Suite 2 East # Richmond, VA 23219

(804) 444-4419 © (800) 856-4419 © Fax: (804) 644-3256

PETITIONER’S APPENDIX

TABLE OF CONTENTS

Opinion of The United States Fourth Circuit Court

of Appeals, entered 8/18/95 ...........cscccscccsscersesrscesees l

Oral Opinion of the Honorable

B. Waugh Crigler In The United States

District Court for the Western District of Virginia,

Charlottesville Division, entered 12/8/94 ................ 4

Order of The United States District Court

for the Western District of Virginia,

Charlottesville Division, entered 12/14/94 ............... 14

Order Denying Petition for Rehearing of The

United States Fourth Circuit Court of Appeals,

I caicteititindcsencsiinenaDacaliniiibipneieviictedes 15

Regulations Governing Grade “A” Milk

(VR 115-05-01); Virginia Department of

Agriculture and Consumer Services, Division

Se Be IE wiht pentctesdiideectenenseninessdattriccrsoess 16

Letter from Allan Ackerman to John S. Coles,

I ns catsbidiinbudies 114

Letter from Dan Rackley to John S. Coles,

UT TIITIEL wcicnsiiiidbbendsisnnkaidaiedtbaiahirtinttebensiianniiasani 115

House Bill No. 1061, offered 1/25/94 00.0.0... eee. 117

Amended Complaint of The United States District

Court for the Western District of Virginia,

Charlottesville Division, filed 11/4/94 00.0... cee. 119

Page Two of Two

Letter from Christine Solem to Dr. Gordon Guyer,

GER SO Ie nisicentensvivsecianisneaciteennecersuaniaianetecs 122

Letter from William E. McCarthy to Christine

SONI, GE SEIT OE sxtcsniccccsenseiicnisviensaeenaaacaciees 123

Letter from Dan Rackley to Christine Solem,

IGG 3 GAINES wrticiseintigintasnecenintainstc tech closeness 125

List of States Adopting the Pasteurized Milk

Ordinance That Nevertheless Permit Sales

OE RT FE wiksitecaneadao aoa 126

UNPUBLISHED

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

Christine Solem,

Plaintiff-Appellant,

v. No. 95-1108

J. Carlton Courter, III,

Commissioner of Agriculture and

Consumer Services,

Defendant-Appellee

Appeal from the United States District Court

for the Western District of Virginia, at Charlottesville

B. Waugh Crigler, Magistrate Judge.

(CA-94-48)

Submitted: July 27, 1995

Decided: August 18, 1995

Entered: August 18, 1995

Before ERVIN, Chief Judge, MOTZ, Circuit Judge,

and PHILLIPS, Senior Circuit Judge.

Affirmed by unpublished per curiam opinion.

COUNSEL

Christine Solem, Appellant Pro Se. John Barry Purcell, Jr.,

OFFICE OF THE ATTORNEY GENERAL OF VIRGINIA,

Richmond, Virginia, for Appellee.

Solem _v. Courter _

Unpublished opinions are not binding precedent in this circuit.

See I.0.P. 36.5 and 36.6,

OPINION

PER CURIAM:

Christine Solem appeals the magistrate judge’s order

dismissing her suit against the Virginia Department of

Agriculture and Consumer Services.* This lawsuit is a

continuation of Solem’s effort to supply unpasteurized goats’

milk to other people notwithstanding Va. Regs. Reg. 115-05-

01, Regulations Governing Grade “A” Milk, which forbids the

sale of such milk. Solem, a goat farmer, contends that the

regulations requiring _ pasteurization are unconstitutional

because they include incidental sales to consumers, and not

just commercial operations. Finding no reversible error, we

affirm the decision of the district court.

Solem is precluded from raising her Fourteenth

Amendment due process claim in federal court. See Migra vy.

Warren City School Dist. Bd of Education, 465 U.S. 75

(1984). Solem has twice litigated pasteurization regulations in

the Virginia Supreme Court, and twice the regulations have

been upheld. See Kenley v. Solem, 375 §.E.2d 532 (Va. 1989);

Carbaugh v. Solem, 302 $.E.2d 33 (Va. 1983). Solem could

have raised her constitutional claims in her prior litigation, as

state courts are always appropriate forums to raise the

constitutionality of the application of a state statute or

regulation. Because it is more important to give full faith and

*The parties consented to the jurisdiction of the

magistrate judge pursuant to 28 U.S.C.A. § 636(c) (West

1993).

S y C

credit to state court judgments than ensure separate forums for

federal and state claims, Solem is precluded from raising

claims that she had ample opportunity to litigate in her state

court proceedings. Migra, 465 U.S. at 84.

We dispense with oral argument because the facts and

legal contentions are adequately presented in the materials

before the court and argument would not aid the decisional

process.

AFFIRMED

IN THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF VIRGINIA

CHARLOTTESVILLE DIVISION

CHRISTINE SOLEM,

Plaintiff

-VS- : CASE NO.: 94-CV-48

J. CARLTON COURTER, ITI,

Commissioner of Agriculture

and Consumer Services,

DECEMBER 8, 1994

HEARD BEFORE:

THE HONORABLE B. WAUGH CRIGLER

23-34

The second thing is with regard to sale, to make that

clear, contracts, | am sorry, to make that clear, I am referring

to sales. A sale is a contract between two people.

THE COURT: Let me preliminarily state on the

Record that this matter is before this Court under authority of

28 USC, Section 636(c), the parties having consented to the

exercise of dispositive jurisdiction by this Court, and is

immediately before the Court on the motion for summary

judgment or motion to dismiss. Based on the virtually

indisputable record that has been generated by both sides in

this case, the Court feels that there really are no material issues

with respect to the legal issues that need to be decided here,

and that is raised by the Defendant, whether or not the

Plaintiff's due process claim, constitutional claim, is barred or

lacks substantiality, or is barred by res judicata, or, as a matter

of law, should be dismissed because it just fails to state any

protected due process right.

Now, what the Defendant essentially argues is that this

is a matter of legislative determination, that the act is

something that regulates the distribution of milk products,

which is within the police power of the state, and they have

the authority to ban, bar, or regulate, depending on how they

see fit under the evidence as presented to the legislature, so

long as they don’t do it in a recognizable, discriminatory way,

based on race, religion, national origin, or those matters.

MS. SOLEM: Could I say something?

THE COURT: I am announcing my decision, but |

will let you say whatever you want to say. Go ahead.

: I think it is not just a question of

material fact. It is also a question of inferences that can be

drawn from that, and I think that - .

THE COURT: Rule 56 deals with that, and that hasn't

escaped the Court, | Promise you.

pertain to a decision in this case is certainly set forth by the

Supreme Court in Carbaugh versus Solem, 225 VA 310, and

Ainies

goat milk.

MS. SOLEM: Is this material to the Case, what has

happened in the past? I don’t think that it is, other than the

question of whether the injunction stil] applies or the question

of res judicata.

THE COURT: Can I ask a favor?

MS. SOLEM: | am sorry.

knowing about it, is found in those Cases.

MS. SOLEM: Oh, I am sorry.

THE COURT: That is all I just said, I hope. If 1 said

anything more, I didn’t mean to infer that that is necessarily

important, but rather than having to recite all of that here, |

just simply cite those cases in case somebody is interested.

Now, what is squarely before the Court is this: One,

whether or not the Plaintiff is barred under principles of res

judicata from even raising the constitutional issue. That is an

issue that is before the Court, and it is the considered opinion

of this court that the actual issues in those prior cases, to the

extent that they are applicable, were not the same issues that

were litigated in this case. So if you look at res judicata in its

purest form, res judicata does not apply, but that raises the

question of whether any form of res judicata applies, and that

is why the Court called the parties’ attention to the Miger

decision, because that decision says this, simply: If the

Plaintiff has litigated State Court cases, and if in those State

Court cases the issues raised in the Federal proceedings could

have been raised in the State proceedings in one form or

another, than she is barred from raising them in Federal Court.

That is what that case says. That is called issue preclusion.

Now this Court has done enough work in the area of

issue preclusion because we do a considerable amount of State

habeas and 1983 cases involving prisoners to know what can

and can’t be raised in State Court litigation. Whether it was or

not, or whether it could be raised at a certain point in those

cases is not the issue that the Court needs to determine. It is

whether or not the constitutional claim that is being asserted

here could have been asserted before the State Judges that

heard these cases initially, and the obvious answer is yes,

legally, they could have. Whether they were or not, whether

the Counsel did it properly or it didn’t do it properly, whether

that was their concern at the time is not what this Court

concerns itself with. It is whether those issues could have

been raised. So, yes, they could have been raised. The State

forum is always an appropriate forum to raise whether or not

the application of the regulation or the statue is constitutional.

Now, it is my considered opinion that issue preclusion

bars the Plaintiff from raising the issues here, but, even if she

is not, I want to address even if you are not, because | think

that is an important thing, what is this claim all about, and |

do believe Ms. Solem articulated what her position is. She

wants the court to determine the propriety of the application of

the statue to her. I mean if anything she has said during this

whole litigation is clear, it is that, and I appreciate that,

because that is exactly what your position is in this case.

Now, what does she want the Court to do, and this is

exactly what she wants the court to do, she wants the Court to

construe the statue in a way that says it does not apply to her,

plain and simple, because if it does not apply to her, where

people come to her for this product under the circumstances

that are set forth in her allegations and in, really, the

indisputable record in this case as to why you want to do and

what you want to do, she wants the Court to say that is okay,

because if it is construed any other way, it is unconstitutional.

If that is not the position that she wants, she just says

simply, “Judge, the Court should construe this as not being

applicable to me.”

Now, that has raised Mr. Purcell’s argument on behalf

of the Defendants because they, basically, take the position

that all she is asking the Court to do is perform a State Court

function of construing the applicability of the statue, Number

One, and, Number Two, if I do anything else, then I am

stepping on the wisdom of the legislature. I am making this a

statue that the legislature did not make.

Now, I don’t care how you say those things, that does

raise whether or not a substantial Federal question has been

raised, and if the only purpose of the litigation is to get the

Court to construe the statute as applied, that is not a

substantial Federal question. That is a State law question.

If there is an out and out challenge to the validity of the

statute under the due process clause because of its application,

that is another matter, and that gets us into the second

argument as to whether or not there is a rational basis for that

application, and the law clearly is that a regulation is

unconstitutional only if there are no grounds that can

conceivably justify it, and this case is packed with grounds.

Based on the history, everything that the parties have

developed in this case, the legislature has, in its wisdom, or

lack thereof, determined that distribution of milk under

conditions, except as set forth by the regulations that it has

permitted, is going to prohibited, and it has permitted the

Agricultural and Consumer Services Board and the State

Health Commissioner to establish those regulations.

It is an exercise of police power.

Now, I will tell you that personally I disagree with this

case, with the decision by the State. If the Court’s personal

judgment controlled in this particular case, I would side with

the Plaintiff, because I do believe there are benefits that should

be recognized by the legislature; that they aren’t though, is not

a constitutional issue. It is simply a disagreement with

legislative wisdom.

I wish that milk, goat milk could be distributed under

those circumstances, personally, but the legislature has chosen

not to allow that. I concede and would agree that this is not of

the stature of marijuana or cocaine or guns or anything like

that. It is different, and there are therapeutic effects that

clearly no one, in my view, could refuse to recognize, but that

doesn’t mean they have to accept them as a sole basis for

determining to grant or deny the right to sell this type of

product, because it has been determined that the sale of any

unpasteurized milk is not going to be allowed, and that is not

an irrational decision in the legal sense, in the legal sense.

Now, in the 13 years I have been on the bench, there

have been two cases where I thought the Government was

absolutely wrong when it dealt with individuals. One was in

the case of Drinkard versus the Secretary of Health and

Human Services, where a man wanted to go out and buy a

$1,000 chair to get himself around in, where the Secretary’s

regulations required him to buy a $10,000 chair. I thought that

was just downright foolish, and this is the other one.

I think it is foolish for the State not to allow her to do

what she is doing, but that is not the test under the exercise of

police powers. It is whether or not there is a rational basis for

it, and if you look at the Supreme Court decisions, particularly

the ones that have come out of the Supreme Court in the last

two years, it is getting harder and harder to find anything

irrational. If you read the decisions of the justices, some of the

most foolish things are determined to be rational, and I think

they would have been better off saying that where there are

matters committed to the exercise of police power to the

legislature and to the regulatory agencies, we are just not

going to mess with it, but they don’t want to quite say that

because they like to mess with the ones they think are foolish

beyond imagination.

Now, it is hard-for me to make this decision because it

is not one that I want to make.

MS. SOLEM: Can I ask a question?

THE COURT: | haven’t finished, and I want you to

understand that it is not one that I like to make, but I think

their defensive position in this case is entirely correct, except

to the extent that they rely on the full force of res judicata,

which | don’t believe applies in the basis they have, but I do

believe that issue preclusion applies. I am going to dismiss

this case, but I do so, I hope, having convinced you that I don’t

like to do what I am doing right now, but the law compels me

to.

MS. SOLEM: Could I still ask a question?

THE COURT: Yes, ma’am.

MS. SOLEM: What about my argument about that it

is unconstitutional as written?

THE COURT: You mean on its face? If that is what

you are - - - I didn’t hear you arguing that, but to the extent

that you argued that, it is absolutely not unconstitutional on its

face because I believe the law is that they could prohibit this

altogether, as a valid exercise of police power based on the

rational basis test, and this does not involve a suspect class.

So, consequently, it is not viewed on a strict scrutiny basis. It

is viewed on a rationality basis, and the law is legend in this

regard, I believe, that supports - - - Now, there is some State

decisions that don’t support that, but the Federal law that I am

aware of would support the ability of the State and the

Commissioner to draw a statute and a regulation that actually

prohibits the distribution of non-pasteurized milk of any form,

and the statute includes goat’s milk, or the regulation does.

MS. SOLEM: But what about the fact that you cannot

buy it?

THE COURT: The answer to that is that you can’t

assert the rights of the purchasers. You can only assert the

rights of the person producing it.

MS. SOLEM: That is exactly the point; they don’t

have access to the court.

THE COURT: Well, but you can’t assert their rights

because you don’t have standing to assert the rights of the

purchaser. You only have standing to assert the rights of the

seller.

MS. SOLEM: How could they assert their rights?

THE COURT: That is not for me to determine in this

case. They can go out and purchase it and be charged with a

violation of it somehow, if that is even a charge.

MS. SOLEM: They can’t ; they are not legal.

THE COURT: They can be charged with contributing

to or accessory to or aider and abettor in.

MS. SOLEM: And, actually, I am a purchaser because

I want to buy it at times.

THE COURT: Well, that is not part of this case.

MS. SOLEM: Can I object?

THE COURT: Here is what you do, just so she knows,

Mr. Purcell, you can file an appeal. I am going to reduce this

to writing, as far as the order is concerned, and if you want a

transcript of this, you need to get a transcript from the Court

Reporter who is right here today, and you have 30 days from

the date that my order is entered to file an appeal to the Fourth

Circuit Court of Appeals in Richmond, okay?

MS. SOLEM: Okay.

THE COURT: If they want to know, I am going to tell

them right now, I hope I am wrong.

MS SOLEM: You probably aren’t.

THE COURT: Personally, I don’t like reaching the

result I did, but I think ¢ is one compelled by the law. So I

hope you will get me reversed.

MS. SOLEM: I will try.

THE COURT: I am sure you will, Thank you. Nice

to see you. Ms. Solem, thank you so much.

(Thereupon, the Proceedings were concluded.)

EEK ESE ES

IN THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF VIRGINIA

CHARLOTTESVILLE DIVISION

CHRISTINE SOLEM, )Civil Action No. 94-0048-C

Plaintiff, )

Vv JORDER

J. CARLTON COURTER, III)

Commissioner of Agriculture By: B. WAUGH CRIGLER

and Consumer Services, )U.S. MAGISTRATE JUDGE

Defendant, _)

Entered December 14, 1994

For the reasons set forth from the bench on December

8, 1994, it is

ORDERED

that defendant’s motion to dismiss be, and same hereby is

granted, and this action hereby is dismissed from the docket of

the court.’

The clerk of the Court is hereby directed to send a

certified copy of this Order to all counsel of record.

ENTERED: /s/B. Waugh Crigler

Magistrate Judge

December 14, 1994

A TRUE COPY, TESTE:

MORGAN E. SCOTT, JR. CLERK

BY: /s/ Deputy Clerk

' To the extent the court considered evidence offered by both sides outside

the pleadings of the case, the defendant’s motion was treated by the court

as on under Fed. R. Civ. P. 56.

UNITED STATES COURT OF APPEALS

FOR THE FOURTH CIRCUIT

ENTERED

September 25, 1995

No. 95-1108

CA-94-48

CHRISTINE SOLEM

Plaintiff - Appellant

J. CARLTON COURTER, III, Commissioner of Agriculture

and Consumer Services

Defendant - Appellee

On Petition for Rehearing with

Suggestion for Rehearing in Banc

The appellant’s petition for rehearing and suggestion

for rehearing in banc were submitted to this Court. As no

member of this Court or the panel requested a poll on the

suggestion for rehearing in banc, and

As the panel considered the petition for rehearing and

is of the opinion that it should be denied,

IT IS ORDERED that the petition for rehearing and

suggestion for rehearing in banc are denied.

For the Court,

/s/ Bert M. Montague

CLERK

REGULATIONS GOVERNING

GRADE "A" MILK

(VR 115-05-01)

VIRGINIA DEPARTMENT

AGRICULTURE

AND

CONSUMER SERVICES

DIVISION OF DAIRY AND FOODS

RICHMOND, VIRGINIA 23219

VIRGINIA DEPARTMENT OF AGRICULTURE AND

CONSUMER SERVICES

REGULATIONS GOVERNING GRADE "A" MILK

(VR 1115-05-01)

TABLE OF CONTENTS

PAGE

§1. Definitions.

§2. Adulterated or misbranded milk or milk products. 13

§3. Permits. 14

§4. Labeling. 3

§5. Standards for milk or milk products 26

$6. Animal Health. 50

§7. Milk or milk products which may be sold. 5]

§8. Transferring; delivery containers; cooling. 52

SSeS a Sa

ft)

§9. Milk and milk products from points beyond

| the limits of routine inspection. 53

§10. Construction plans for dairy farms and

milk plants. 53

$11. Personnel health.

§12. Procedure when infection is suspected.

§13. Grade A condensed and dry milk products.

and condensed and dry whey. 54

§14. Interpretation and enforcement. 55

Statutory Authority: § 3.1-530.1 through § 3.1-530.9

of the Code of Virginia.

VIRGINIA DEPARTMENT OF

AGRICULTURE AND CONSUMER

SERVICES

REGULATIONS GOVERNING

GRADE "A" MILK

(VR 115-05-01)

§ 1. Definitions and standards of identity.

The following words and terms, when used in this

regulation, shall have the following meaning, unless the

context clearly indicates otherwise:

"Acidified lowfat milk" means "acidified lowfat milk"

as defined in 21 CFR §131.136.

"Acidified milk" means "acidified milk" as defined in

21 CFR §131.111.

"Acidified milk product" means a product with an

acidity of not less than 0.50% expressed as lactic acid,

which product is obtained by the addition of food

grade acids to pasteurized: (i) cream; (ii) half-and-half;

(iii) heavy cream; (iv) light cream; (v) lowfat milk; (vi)

milk; (vii) skim milk; or (viii) sour cream.

"Acidified skim milk" means "acidified skim milk" as

defined in 21 CFR §131.144.

"Acidified sour cream" means "acidified sour cream"

as defined in 21 CFR §131.162.

"Acidified sour half-and-half" means "acidified sour

half-and-half” as defined in 21 CFR §131.187.

"Adulterated milk or milk product" means any milk,

milk product, condensed milk product, or dry milk

product which meets one or more of the conditions

specified in Section 402 of the Federal Food, Drug and

Cosmetic Act, as amended (21 U.S.C. 342).

"Aseptically processed milk" means milk: (i) that is

hermetically sealed in a container and so thermally

processed before or after packaging in conformance

with 21 CFR Part 113 and the provisions of this

regulation so as to render the product free of

microorganisms capable of reproducing in the product

under non-refrigeration conditions of storage and

distribution; and (ii) that is free of viable

microorganisms (including spores) capable of causing

disease in humans.

"Aseptically processed milk product" means any milk

or milk product: (i) that is hermetically sealed in a

container and so thermally processed before or after

packaging in conformance with 21 CFR §113 and the

provisions of this regulation so as to render the product

free of microorganisms capable of reproducing in the

product under normal non-refrigeration conditions of

storage and distribution; and (ii) that is free of viable

microorganisms (including spores) capable of causing

disease in humans.

"Butterfat" means the fat of milk.

"Buttermilk". means the fluid milk product: (i)

remaining after the manufacture of butter from milk or

cream; and (ii) which contains not less than 8.25% of

milk solids not fat.

a nes

"Cancel" means to permanently nullify, void, or delete

a grade A permit issued by the State Regulatory

Authority.

"CFR" means Code of Federal Regulations.

"Coffee cream" means "light cream."

"Concentrated milk" means "concentrated milk" as

defined in 21 CFR §131.115.

"Concentrated milk product" means any of the

following foods: homogenized concentrated milk;

vitamin D concentrated milk; concentrated skim milk;

fortified concentrated skim milk; concentrated lowfat

milk; fortified concentrated lowfat milk; concentrated

flavored milk; concentrated flavored milk product; or

concentrated products made from concentrated milk or

concentrated skim milk; which when combined with

potable water according to the instructions printed on

the food's container, conforms to the definition of the

corresponding milk product in this regulation.

"Condensed and dry milk product" means any of the

following: grade "A" condensed milk, grade "A"

condensed and dry whey, grade "A" dry milk product,

or grade "A" dry milk and whey product.

"Condensed milk" means milk unsterilized and

unsweetened, resulting from the removal of a portion

of water. This definition shall not be deemed to

include:

(A) Any (i) sterilized milk or (ii) milk product,

when the sterilized milk or milk product is

hermetically sealed in a container and

processed, either before or after sealing, so as

to prevent microbial spoilage; or

(B) Any (i) evaporated milk or (ii} sweetened

condensed milk, except when the evaporated

milk or sweetened condensed milk is combined

with other substances in the commercial

preparation of any pasteurized, ultra-

pasteurized, or aseptically processed milk, or

milk product.

"Condensed whey" means the product resulting from

the removal of a portion of water from whey.

"Consumer" means any person who utilizes any grade

"A" milk grade "A" milk product, or milk product.

"Cottage cheese’ means "cottage cheese" as defined in

21 CFR §133.128.

"Cottage cheese dry curd" means "dry curd cottage

cheese."

"Cream" means "cream" as defined in 21 CFR

§131.3(a).

"Cultured half-and-half" means "sour half-and-half."

"Cultured milk" means “cultured milk" as defined in

21 CFR §131.112.

"Cultured lowfat milk" means "cultured lowfat milk"

as defined in 21 CFR §131.138.

"Cultured skim milk" means "cultured skim milk" as

defined in 21 CFR §131.146.

"Cultured sour cream" means “sour cream."

"Dairy farm" means any premises where any cow,

goat, or sheep is kept, from which cow, goat, or sheep

any milk or any milk product is provided, sold, or

offered for sale to a milk plant, transfer station, or

receiving station.

"Deny" means the State Regulatory Authority will not

issue a grade A permit to the applicant.

"Drug" means: (i) articles recognized in the official

United States Pharmacopeia, official Homeopathic

Pharmacopeia of the United States, or official National

Formulary, or any supplement to any of them; (ii)

articles intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in man

or other animals; (iii) articles (other than food)

intended to affect the structure or any function of the

body of man or other animals; and (iv) articles

intended for use as a component of any articles

specified in (i), (ii), or (iii) of this definition, but does

not include devices or their components, parts, or

accessories.

"Dry cream" means "dry cream" as defined in 21 CFR

§131.149.

"Dry curd cottage cheese" means "dry curd cottage

cheese" as defined in 21 CFR §133.129.

"Dry milk product" means a product resulting from the

drying of any milk or milk product and any product

resulting from the combination of a dry milk product

with other safe and suitable dry ingredients.

"Dry whey" means the product resulting from the

drying of whey, while leaving all other constitutents in

the same relative proportions as in whey.

"Dry whole milk" means "dry whole milk" as defined

in 21 CFR §131.147.

"Eggnog" means "eggnog" as defined in 21 CFR

§131.170.

"Eggnog-flavored milk" means a milk product (to

which an emulsifier and a maximum of 0.5% stabilizer

may have been added) consisting of a mixture of: (i) at

least 3.25% butterfat, (ii) at least 0.5% egg yolk solids,

(iii) sweetener, and (iv) flavoring.

"Evaporated milk" means "evaporated milk" as defined

in 21 CFR §131.130.

"Evaporated skimmed milk" means "evaporated

skimmed milk" as defined in 21 CFR §131.132.

"Flavored milk" means milk to which a flavor or

sweetener has been added.

"Flavored milk product" means any milk product to

which a flavor or sweetener has been added.

"Fortified milk" means milk (other than vitamin D

milk), the vitamin or mineral content of which milk

has been increased.

"Fortified milk product" means any milk product

(other than a vitamin D milk product), the vitamin or

mineral content of which milk product has been

increased.

"Frozen milk concentrate" means the frozen milk

product to which, when water is added in accordance

with instructions on the package containing the frozen

milk product, the reconstituted milk product contains

the percent milkfat and the percent milk solids not fat

of milk.

"Goat milk" means the normal lacteal secretion,

practically free of colostrum, obtained by the complete

milking of one or more healthy goats, which lacteal

secretion, when sold in retail packages, contains not

less than 2.5% milkfat and not less than 7.5% milk

solids not fat.

"Grade A condensed and dry whey" means condensed

or dry whey which complies with the provisions of the

“Grade A Condensed and Dry Milk Products and

Condensed and Dry Whey," Supplement I to the Grade

A Pasteurized Milk Ordinance--1978

Recommendations" and this regulation.

"Grade A condensed milk" means condensed milk

which complies with the provisions of the "Grade A

Condensed and Dry Milk Products and Condensed and

Dry Whey," Supplement I to the Grade A Pasteurized

Milk Ordinance--1978 Recommendations" and this

regulation.

"Grade A dry milk product" means any dry milk

product which complies with the provisions of the

"Grade A Condensed and Dry Milk Products and

Condensed and Dry Whey," Supplement I to the

Grade A. Pasteurized Milk Ordinance--1978

Recommendations" and this regulation.

"Grade A dry milk and whey product" means any dry

milk or whey product which: (i) has been produced for

use in any grade A pasteurized, ultra-pasteurized, or

aseptically processed milk product; and (ii) which has

been manufactured under the provisions of the "Grade

A Condensed and Dry Milk Products and Condensed

and Dry Whey", Supplement I to the Grade A

Pasteurized Milk Ordinance--1978

Recommendations"; and this regulation.

"Grade A permit" means the written document issued

by the State Regulatory Authority to the person who

operates a: (i) dairy farm to produce raw milk for

pasteurization, _ultrapasteurization, or aseptic

processing; (ii) milk plant; (ili) receiving station; (iv)

transfer station; (v) milk condensing plant; (vi) milk

drying plant; (vii) whey condensing plant; or (viii)

whey drying plant; after the State Regulatory Authority

has inspected and approved the person's operation

specified in (i) through (viii) of this definition, and

determined the person's compliance with the

provisions specified in this regulation for the

operations specified in (i) through (viii) of this

definition.

"Half-and-half" means "half-and-half" as defined in 2]

CFR §131.180. .

"Heavy cream" means "heavy cream" as defined in 21

CFR §131.150.

“Homogenized" means that: (i) milk or a milk product

has been treated to ensure breakup of the fat globules

in the milk or milk product to such an extent that, after

48 hours of undisturbed Storage at 40°F, no visible

cream separation occurs on the milk or milk product;

and (ii) the fat percentage of the top 100 milliliters of

the milk or milk product in a quart, or of proportionate

volumes in containers of other sizes, does not differ by

more than 10% from the fat percentage of the

remaining milk or milk product as determined after

thorough mixing.

"Lactose-reduced lowfat milk" means the product

resulting from the addition of safe and suitable

enzymes to convert enough lactose to glucose or

galactose so that less than 30% of the lactose remains

in the lowfat milk from which the product is made.

"Lactose-reduced milk" means the product resulting

from the addition of safe and suitable enzymes to

convert enough lactose to glucose or galactose so that

less than 30% of the lactose remains in the milk from

which the product is made.

"Lactose-reduced skim milk" means the product

resulting from the addition of safe and suitable

enzymes to convert enough lactose to glucose or

galactose so that less than 30% of the lactose remains

in the skim milk from which the product is made.

"Light cream" means "light cream" as defined in 21

CFR §131.155.

"Light whipping cream" means "light whipping cream"

as defined in 21 CFR §131.157.

"Lowfat cottage cheese" means "lowfat cottage cheese"

as defined in 21 CFR §133.131.

"Lowfat dry milk" means "lowfat dry milk" as defined

in 21 CFR §131.123.

"Lowfat milk" means "lowfat milk" as defined in 21

CFR §131.135.

"Lowfat yogurt" means "lowfat yogurt" as defined in

21 CFR §131.203.

“Low-sodium lowfat milk" means the milk product

resulting from the treatment of lowfat milk by a

process of passing the lowfat milk through an ion

exchange resin process, or by any other process which

has been recognized by the Food and Drug

Administration that effectively reduces the sodium

content of the product to less than 10 milligrams in 100

milliliters.

"Low-sodium milk" means the milk product resulting

from the treatment of milk by a process of passing the

milk through an ion exchange resin process, or by any

other process which has been recognized by the Food

and Drug Administration that effectively reduces the

sodium content of the product to less than 10

milligrams in 100 milliliters.

"Low-sodium skim milk" means the milk product

resulting from the treatment of skim milk by a process

of passing the skim milk through an ion exchange resin

process, or by any other process which has been

recognized by the Food and Drug Administration that

effectively reduces the sodium content of the product

to less than 10 milligrams in 100 milliliters.

"Market milk" means milk.

"Market milk product" means milk product.

"Milk" means "milk" as defined in 21 CFR §131.110.

Except as otherwise provided in this regulation, and

except where the term "goat milk" is distinguished

from "cow milk" in §3(L) and § 5(A)(3\e) of this

regulation, wherever the term "milk" is used, it shall be

deemed to include "sheep milk" and "goat milk."

"Milk condensing plant" means any plant in which

milk or any milk product is condensed or dried, or in

which milk or any milk product is received, separated,

or otherwise processed for drying and packaging.

"Milk drying plant" means any plant in which milk or

any milk product is condensed or dried, or in which

milk or any milk product is received, separated, or

otherwise processed for drying and packaging.

"Milk distributor" means any person who offers for

sale or sells to another person any milk or milk

product.

"Milkfat" means the fat of milk.

"Milk hauler" means any person who transports any

raw milk or raw milk product to or from a milk plant, a

receiving station, or a transfer station.

"Milkhouse" means the building or room in which

there is conducted on a grade A dairy farm: (i) the

cooling, handling, and storing of milk; and (ii) the

washing, sanitizing, and storing of milk containers and

utensils.

"Milk plant" means any place, premises, or

establishment where any milk or milk product is

collected, handled, processed, stored, pasteurized,

ultra-pasteurized, aseptically processed, condensed,

dried, bottled, or prepared for distribution.

"Milk producer" means any person who operates a

dairy farm and who provides, sells, or offers milk for

sale to a milk plant, receiving station, or transfer

station.

"Milk product" means any of the following foods: (i)

acidified lowfat milk, acidified milk, acidified milk

product, acidified skim milk, acidified sour cream,

acidified sour half-and-half, aseptically processed milk,

aseptically processed milk product, buttermilk, coffee

cream, concentrated milk, concentrated milk product,

cottage cheese, cottage cheese dry curd, cream,

cultured half-and-half, cultured milk, cultured lowfat

milk, cultured skim milk, cultured sour cream, dry curd

cottage cheese, eggnog, eggnog-flavored milk,

flavored milk, flavored milk product, fortified milk,

fortified milk product, frozen milk concentrate, goat

milk, half-and-half, heavy cream, lactose-reduced

lowfat milk, lactose-reduced milk, lactose-reduced

skim milk, light cream, light whipping cream, lowfat

cottage cheese, lowfat milk, lowfat yogurt, low-sodium

lowfat milk, low-sodium milk, lowsodium skim milk,

milk, nonfat milk, nonfat yogurt, recombined milk,

recombined milk product, reconstituted milk,

reconstituted milk product, sheep milk, skim milk, sour

cream, sour half-and-half, table cream, vitamin D milk,

vitamin D milk product, whipped cream, whipped light

cream, whipping cream, or yogurt; (ii) any of the

following foods: milk, lowfat milk, or skim milk with

added safe and suitable microbial organisms; or (iii)

any food made with a food specified in (i) of this

definition by the addition or subtraction of milkfat or

addition of safe and suitable optional ingredients for

protein, vitamin, or mineral fortification.

Nothing in this definition shall be deemed to include

any evaporated milk, evaporated skim milk, condensed

milk (sweetened or unsweetened), infant formula, ice

cream or other dessert, dietary product, dry milk

product (except as defined herein), cained eggnog in a

rigid metal container, or butter or cheese, except when

butter or cheese is combined with other substances to

produce any pasteurized or aseptically processed food

as specified in (i), (ii), or (iii) of this definition.

"Misbranded milk or milk product" means any milk,

milk product, or condensed and dry milk product that:

(i) satisfies any of the conditions specified in §403 of

the Federal Food Drug, and Cosmetic Act, as amended

(21 U.S.C. 343), (ii) does not conform to its definition;

or (ili) is not labeled in accordance with §4 of this

regulation.

"Nonfat dry milk" means "nonfat dry milk" as defined

in 21 CFR §131.125.

"Nonfat dry milk fortified with vitamins A and D"

means "nonfat dry milk fortified with vitamins A and

D" as defined in 21 CFR §131.127.

"Nonfat milk" means "skim milk" as defined in 21

CFR §131.143.

"Nonfat yogurt" means "nonfat yogurt" as defined in

21 CFR §131.206.

"Normal storage" means storage at a temperature of

45°F. or cooler, but shall not be deemed to include

freezing.

"Official laboratory" means a biological, chemical, or

physical laboratory which is operated by the

Commonwealth of Virginia.

"Officially designated laboratory" means: (i) a

commercial laboratory authorized by the State

Regulatory Authority to examine for the State

Regulatory Authority any milk, milk product, or

condensed and dry milk product; or (ii) a milk industry

laboratory authorized by the State Regulatory

Authority to examine: (a) milk producer samples of

raw milk for pasteurization, and (b) for drug residues

and bacterial limits, samples of raw milk commingled

in a tank truck,'

“Optional ingredient" means: (j) only an ingredient

specified as an optional ingredient in the definition of a

milk product; or (ii) in the case in which no optional

ingredient is specified pursuant to (i) of this definition,

grade A condensed milk, grade A dry milk product,

grade A condensed whey, grade A dry whey,

concentrated milk, concentrated milk product, flavor,

Sweetener, stabilizer, emulsifier, acidifier, vitamin.

mineral, or other safe and suitable ingredient.

"Pasteurization" or "pasteurized" means the process of

heating every particle of milk, milk product, or whey

in equipment designed and operated in conformance

with this regulation, to one of the temperatures given in

the following table and held continuously at or above

that temperature for at least the corresponding

specified time:

Temperature Time

145°F.* 30 minutes

161°F.* 15 seconds

191°F. 1 second

194°F. 0.5 second

201°F. 0.1 second

204°F 0.05 second

212°F 0.01 second

*If: (i) the fat content of the milk or milk product is 10

percent or more, (ii) the milk or milk product contains

added sweeteners, (iii) the product is condensed milk,

or (iv) the milk product is a condensed milk product,

then "pasteurization" means increasing the specified

temperature by 5°F. If the milk product is eggnog,

then "pasteurization" means heating to at least the

following temperatures for the corresponding time

specifications:

Temperature Time

155°F. 30 minutes

175°F. 25 seconds

180°F. 15 seconds

Nothing in this definition shall be construed as barring

any other process which has been recognized by the

Food and Drug Administration as being equally

efficacious as pasteurization, so long as that other

process has been approved by the State Regulatory

Authority.

"Person" means any individual, plant operator,

partnership, corporation, company, firm, trustee, or

institution.

"Public" means any person in the Commonwealth.

"Pull date" means the date affixed to a consumer

package or container of grade "A" pasteurized milk or

grade "A" pasteurized milk product which is the date

after the day of manufacturing and processing of the

package or container and the last day on which the

grade "A" pasteurized milk or grade "A" pasteurized

milk product as determined by the milk plant may be

offered for sale to consumers under normal storage.

"Raw milk" means: (i) any milk or any milk product

which has not been pasteurized, ultra-pasteurized, or

aseptically processed; or (ii) any milk or any milk

product which has been pasteurized, ultra-pasteurized,

or aseptically processed, and which has been exposed

to microbiological contamination before, during, or

after packaging.

"Receiving station" means any place, premises, or

establishment where raw milk is: (i) received,

collected, handled, stored, or cooled; and (ii) prepared

for further transporting.

"Recombined milk" means the food which when

combined with potable water according to the

instructions printed on the food's container, conforms

to the milk fat and milk solids not fat requirements for

milk, as specified in the definition of "milk."

"Recombined milk product" means the food which

when combined with potable water according to the

instructions printed on the food's container, conforms

to the milk fat and milk solids not fat requirements for

the milk product designated on the food's container.

"Reconstituted milk" means "recombined milk."

"Reconstituted milk product" means "recombined milk

product.”

"Revoke" means to permanently annul, repeal, rescind,

countermand, or abrogate a grade A permit issued by

the State Regulatory Authority.

"Safe and suitable" means "safe and suitable" as

defined in 21 CFR §130.3(d).

"Sanitization" means the application of any effective

method or substance to a clean surface for the

destruction of pathogens, and of other organisms as far

as is practicable, which method or substance, when

used does not adversely affect: (i) the equipment which

comes in contact with milk, milk product, or

condensed and dry milk product; (ii) the milk, milk

product, or condensed and dry milk product; or (iii) the

health of consumers.

"Septage” means material accumulated in a

pretreatment system or privy.

"Sewage" means water carried and non water carried

human excrement, kitchen, laundry, shower, bath, or

lavatory wastes separately or together with such

underground, surface, storm and other water and liquid

industrial wastes as may be present from residences,

buildings, vehicles, industrial establishments or other

places.

"Sheep milk" means the normal lacteal secretion,

practically free of colostrum, obtained by the complete

milking of one or more healthy sheep.

"Skim milk" means "skim milk" as defined in 21 CFR

§131.143.

"Sour cream" means “sour cream" as defined in 21

CFR §131.160.

"Sour half-and-half" means “sour half-and-half" as

defined in 21 CFR §131.185.

"State Regulatory Authority" means the Commissioner

of Agriculture and Consumer Services or his agent

when carrying out any duty specified in §3.1-530.3 of

the Code of Virginia (1950), as amended, or the State

Health Commissioner or his agent when carrying out

any duty specified in §3.1-530.4 of the Code of

Virginia (1950), as amended.

"Suspend" means to temporarily nullify, void, debar, or

cease for a period of time, a grade A permit issued by

the State Regulatory Authority.

"Sweetened condensed milk" means "sweetened

condensed milk" as defined in 21 CFR §131.120.

"Sweetened condensed skimmed miik" means

“sweetened condensed skimmed milk" as defined in 21

CFR §131.122.

"Table cream" means "light cream" as defined in 21

CFR §131.155.

"Transfer station" means any place, premises, or

establishment where milk or milk products are

transferred directly from one transport tank to another.

"Trim" means to shorten the hair on the udder and tail

of milking cows and goats by clipping, singeing,

cutting, or other means.

"Ultra-pasteurized" means, when used to describe any

milk or milk product that the milk or milk product has

been thermally processed at a temperature of 280°F.

(138°C.) or hotter for at least two seconds, either

before or after packaging, so as to produce a product

that has an extended shelf life under normal storage.

"Vitamin A milk" means milk, the vitamin A content

of which has been increased to at least 2000

International Units per quart.

"Vitamin A milk product" means a milk product, the

vitamin A content of which has been increased to at

least 2000 International Units per quart.

"Vitamin D milk" means milk, the vitamin D content

of which has been increased to at least 400

International Units per quart.

"Vitamin D milk product" means a milk product, the

vitamin D content of which has been increased to at

least 400 International Units per quart.

"Whey" means the liquid substance obtained by

separating the coagulum from milk, cream, or skim

milk during the cheese making procedure and may

have the acidity adjusted by the addition of safe and

suitable | ph-adjusting ingredients prior to

pasteurization.

§ 2.

"Whey condensing plant" means a plant in which whey

is condensed or in which whey is received and

processed for drying and packaging.

"Whey drying plant" means a plant in which whey is

dried, or in which whey is received and processed for

drying and packaging.

"Whipped cream" means “heavy cream" as defined in

21 CFR §131.150 or "light whipping cream" as defined

in 21 CFR §131.157, into which air or gas has been

incorporated.

"Whipped light cream" means "light whipped cream"

as defined in 21 CFR §131.155, into which air or gas

has been incorporated.

"Whipping cream" means "light whipping cream" as

defined in 21 CFR §131.157.

"Yogurt". means "yogurt" as defined in 21 CFR

§131.200.

Adulterated or misbranded milk or milk products.

A. No person may produce, provide, sell,

offer, expose for sale, or possess, any

adulterated milk or milk product, or

any misbranded milk or milk product:

(i) condensed and dry milk product; (ii)

milk; or (iii) milk product.

B. Any person who produces, provides,

sells, offers, exposes for sale, or

possesses, any adulterated or

misbranded: (i) condensed and dry milk

product; (ii) milk; or (iii) milk product;

shall be subject to having the person's

adulterated or misbranded condensed

and dry milk product, milk, or milk

product impounded by the State

Regulatory Authority.

No person may provide, sell, offer, or

expose for sale, any: (i) condensed and

dry milk product; (ii) milk; or (iii) milk

product; to any milk plant for use in any

grade A milk or grade A milk product if

the person does not possess a permit

from the State Regulatory Authority,

unless the Commissioner of Agriculture

and Consumer Services makes a finding

in writing (which the Commissioner of

Agriculture and Consumer Services

may renew for terms not to exceed 90

days per term, without limitation) that:

(i) the supply of grade A raw milk for

pasteurization, ultra-pasteurization, or

aseptic processing is not adequate to

meet the nutritional needs of any person

who secures milk in the

Commonwealth; or (ii) the supply of

pasteurized, _—_ultra-pasteurized, _— or

aseptically processed milk or milk

product at retail is not available for

purchase by any person who secures

milk in the Commonwealth.

No person may produce, provide, sell,

offer, expose for sale, or possess any: (i)

condensed and dry milk product; (ii)

milk; or (iii) milk product; under the

§ 3.

provision of §2(C) unless the milk or

milk product is labeled "ungraded."

Permits.

A. No person may produce in, provide in,

manufacture in, sell in, offer for sale in, store in, bring

into, send into, or receive into, the Commonwealth any

milk, milk product, or condensed and dry milk product

for use in the commercial preparation of grade A

pasteurized, ultra-pasteurized, or aseptically processed

milk or milk product unless the person possesses a

grade A permit from the State Regulatory Authority.

Nothing in this regulation shall apply to any

establishment where milk or milk product is served or

sold at retail, so long as the milk or milk product is not

processed at the establishment. Nothing in this

regulation shall be deemed to require a person who is a

broker, agent, or distributors’ representative to have a

grade A permit if the person buys condensed and dry

milk product for, or sells condensed and dry milk

product to, a milk plant that has a valid grade A permit

from any state.

B. The State Regulatory Authority may cancel,

suspend, or revoke the grade A permit of any person,

or may deny to any person a grade A permit if:

1. The grade A permit holder fails to

engage daily in the business for which the

grade A permit is issued;

2. The grade A permit holder does not

daily produce in, provide in, manufacture in,

sell in, offer for sale in, store in, bring into,

send into, or receive into, the Commonwealth

milk, milk product, or condensed and dry milk

product;

3. The grade A permit holder fails to

provide at no cost to the State Regulatory

Authority samples of milk, milk product, or

condensed and dry milk product in the person's

possession for testing by the State Regulatory

Authority;

4. The grade A permit holder fails to

provide on a daily basis milk, milk product, or

condensed and dry milk product in the person's

possession for sampling and testing by the State

Regulatory Authority;

5. The grade A permit holder fails to

comply with any requirement of this regulation,

or of §§3.1-530.1 through 3.1-530.9, 3.1-420

through 3.1-424, or 3.1-531 through 3.1-545 of

the Code of Virginia (1950), as amended.

6. A public health hazard exists that

affects the grade A permit holder's milk, milk

product, or condensed and dry milk product,

7. The grade A permit holder or any agent

of the grade A permit holder has obstructed or

interfered with the State Regulatory Authority

in the performance of the State Regulatory

Authority's duties.

8. The person supplies false or misleading

information to the State Regulatory Authority:

(i) in the person's application for a grade A

permit, (ii) concerning the identity of the

person who will control the facility that is the

subject of the grade A permit, (iii) concerning

the amount of milk, milk product, or condensed

and dry milk product which the person

produces in, provides in, manufactures in, sells

in, offers for sale in, stores in, brings into,

sends into, or receives into, the Commonwealth

and the distribution of the person's milk, milk

product, or condensed and dry milk product;

(iv) concerning any investigation conducted by

the State Regulatory Authority; or (v)

concerning the location of any part of the

person's operation that is subject to a grade A

permit;

9. The grade A permit holder engages in

fraudulent activity regarding: (i) the amount of

milk, milk product, or condensed and dry milk

product the person offers to sell or sells; or (ii)

the collection of samples of the person's milk,

milk product, or condensed and dry milk

product used to determine compliance with any

provision of this regulation or as a basis for

payment for milk, milk product, or condensed

and dry milk product;

10. Three of the most recent five bacteria

counts, somatic cell counts, or cooling

temperature determinations conducted on the

grade A permit holder's raw milk exceed the

standards specified in this regulation;

11. Three of the most recent five bacteria

counts, coliform determinations, or cooling

temperature determinations conducted on the

grade A permit holder's milk, milk product, or

condensed and dry milk product exceed the

standards specified in this regulation;

12. Two of the most recent cryoscope tests

on the grade A permit holder's milk violate the

standard specified in this regulation and the

most recent violative sample occurred within

two years of the next most recent violative

sample;

13. | The most recent drug residue test on the

grade A permit holder's milk violates the

standards specified in this regulation. In the

event the State Regulatory Authority suspends

the grade A permit the suspension shall be: (i)

for a minimum of two days (except as specified

in §3(B)(13)(b)); (ii) for a minimum of four

days (except as specified in §3(B)(13)(b)) on

the second occurrence of violative drug

residues in the grade A permit holder's milk

within a 12 month period after the grade A

permit holder's first positive test for violative

drug residues; or (iii) for a minimum of four

days (except as specified in §3(B)(13)(b)) on

the third occurrence of violative drug residues

in the grade A permit holder's milk within a 12

month period after the grade A permit holder's

first positive test for violative drug residues and

the grade A permit holder's permit shall be

subject to revocation; and (iv) the grade A

permit holder whose milk test positive for

violative drug residues shall provide and

complete for each separate violation, the "Milk

and Dairy Beef Residue Prevention Protocol”, .

and have a signed quality assurance certificate,

displayed in the grade A permit holder's

milkhouse, within 30 days after the date of

suspension of the grade A permit holder's

permit;

a. The number of days represented

by the grade A permit holder's milk

shipment which tests positive for

violative drug residues shall be

determined by the State Regulatory

Authority using the following factors:

(i) the number of milkings included in

the grade A permit holder's milk

shipment which tests positive for

violative drug residues; and (ii) the

number of times each day the grade A

permit holder milks; and

b. The number of days determined

by the State Regulatory Authority shall

satisfy the same portion of the grade A

permit holder's required suspension

period as the grade A permit holder's

milk shipment represents;

14. The most recent phosphatase test on the

grade A permit holder's milk, milk product, or

condensed and dry milk product violates the

standard specified in this regulation;

15. | The most recent chemical residue test or

pesticide residue test on the grade A permit

holder's milk, milk product, or condensed and

dry milk product exceeds the actionable level,

tolerance level, or safe level for any chemical

residue or pesticide residue specified in: (i) 40

CFR Parts 180, 185, or 186; and (ii) 21 CFR

Parts 70, 71, 73, 74, 80, 82, 130, 131, 133, 170,

172, 173, 174, 175, 176, 177, 178, 189, 556,

564, 570, 573, 589. In the event that no

actionable level, tolerance level, or safe level

for a chemical residue or pesticides residue has

been established in: (i) 40 CFR Parts 180, 185,

or 186; and (ii) 21 CFR Parts 70, 71, 73, 74, 80,

82, 130, 131, 133, 170, 172, 173, 174, 175,

176, 177, 178, 189, 556, 564, 570, 573, 589,

the tolerance level shall be deemed to be zero.

16. The grade A permit holder fails to

correct any deficiency that the State Regulatory

Authority has cited, in a written notice of intent

to suspend the person's grade A permit, as a

violation of this regulation;

17. The grade A permit holder's raw milk

for pasteurization is warmer than 50°F two

hours after the completion of the first milking

or the grade A permit holder's raw milk for

pasteurization is warmer than 50°F during or

after any subsequent milking;

18. The grade A permit holder's equipment

is covered or partially covered by an

accumulation of milk solids, milk fat, or other

residue so that the milk, milk product, or

condensed and dry milk product is adulterated;

19. The grade A permit holder sells or

offers for sale milk, milk products, or

condensed and dry milk product which violate

any requirement of this regulation;

20. The grade A permit holder fails to

complete the "Milk and Dairy Beef Residue

Prevention Protocol,” and have a signed

quality assurance certificate, for display in the

grade A permit holder's milkhouse, within 30

days after the date of the suspension of the

grade A permit holder's permit because of the

grade A permit holder's violation of §3(B)(13)

of this regulation;

21. The authority in another _ state

responsible for issuing grade A permits has

denied, suspended, or revoked the permit of the

person in that state for any act or omission that

would violate this regulation or the statutes

under which this regulation was adopted, had

the act or omission occurred in the

Commonwealth.

Cc. The State Regulatory Authority may summarily

suspend a grade A permit for violation of any of the

following provisions of this regulation: §§3(B)(6),

3(B)(9), 3(B)(10), 3(B)(11), 3(B)(12), 3(B)(13),

3(B)(14), 3(B)(15), 3(B)(16), 3(B)(17), 3(B)(18),

3(B)(19), or 3(B)(20).

D. No grade A permit holder may transfer any

grade A permit to another person or another location.

E. Each grade A permit holder operating a milk

plant within the Commonwealth shall provide to the

State Regulatory Authority laboratory determinations

of the quantity of vitamin A and vitamin D present in

the milk plant's milk, milk product, fortified milk, and

fortified milk product to which vitamin A or vitamin D

has been added. Each grade A permit holder who

operates a milk plant shall provide these laboratory

determinations at least annually from a laboratory

utilizing "Determination of Vitamin D2 and Vitamin

D3 in Foods, Feeds, and Pharmaceuticals, using High

Performance Liquid Chromatography: Comparison of

Three Different Columns*”’ or "HPLC Assays for

Vitamin A and E (HPLC Method 1)* as appropriate for

vitamin A and vitamin D determination, or any other

method approved for such testing by the Food and

Drug Administration. Each grade A permit holder who

operates a milk plant shall pay for the cost of the

laboratory determinations.

F. Inspection of dairy farms, milk plants,

condensing plants, and drying plants.

l. No person who operates a dairy farm,

milk plant, receiving station, transfer station,

condensing plant, or drying plant within the

Commonwealth may hold a grade A permit

until the dairy farm, milk plant, receiving

station, transfer station, condensing plant, or

drying plant has been inspected and approved

by the State Regulatory Authority;

2. The State Regulatory Authority shall

inspect at least once every three months each

dairy farm that holds a grade A permit;

3. The State Regulatory Authority shall

inspect at least every month each milk plant,

transfer station, and receiving station that holds

a grade A permit;

4. The State Regulatory Authority shall

inspect at least once every three months each

condensing plant or drying plant that holds a

grade A permit;

The examination of milk and milk products.

1. The State Regulatory Authority shall

collect during any consecutive six months at

least four samples of raw milk, collected in

separate months, for pasteurization, ultra-

pasteurization, or aseptic processing from each

dairy farm that holds a grade A permit.

2. After receipt of the milk by the milk

plant and prior to pasteurization, ultra-

pasteurization or aseptic processing the State

Regulatory Authority shall collect during any

consecutive six months at least four samples of

raw milk, collected in separate months, for

pasteurization, ultra-pasteurization, or aseptic

processing from each milk plant that holds a

grade A permit.

3. The State Regulatory Authority shall

collect four samples of each pasteurized, ultra-

pasteurized, or aseptically processed milk

product, each sample to be collected in separate

months during any consecutive six month

period, from each milk plant holding a grade A

permit the Production

4. The State Regulatory Authority shall,

except when the production is not on a yearly

basis, during each month collect from each

milk condensing plant, milk drying plant, whey

condensing plant or whey drying plant holding

a grade A permit at least one sample of raw

milk for pasteurization, after receipt of the milk

by the plant and before pasteurization, and at

least one sample of each grade A condensed

milk product, grade A dry milk product, grade

A condensed whey, and grade A dry whey

manufactured. If the production of grade A dry

milk products or grade A dry whey is not on a

yearly basis, the State Regulatory Authority

shall collect at least five samples within a

continuous production period.

5. The State Regulatory Authority shall

collect at least once every three months

samples of milk and milk product from retail

establishments selling milk or milk product to

determine compliance with §§ 2,4,5, and 8 of

this regulation. The person who operates the

retail establishment shall furnish the State

Regulatory Authority, upon the request of the

State Regulatory Authority, with the names of

all distributors from whom the person has

obtained milk or milk product.

6. The State Regulatory Authority shall

provide the remaining portion of the original

raw milk sample from each grade A dairy farm

which has been screened positive for animal

drug residues by a milk plant, receiving station,

or transfer station to the grade A dairy farms’

milk marketing organization upon request.

Drug residue monitoring and farm surveillance.

1. Any grade A permit holder operating a

milk plant, receiving station, or transfer station

shall:

a. Prior to processing any raw milk

from bulk tanks on farms, test for

residues of beta lactam drugs all raw

milk that the milk plant, receiving

station, or transfer station receives for

pasteurization, ultrapasteurization, or

aseptic processing;

b. Test each shipment of bulk tank

raw milk received for pasteurization,

uitrapasteurization, or aseptic

processing by screening tests methods

which have been evaluated by Virginia

Polytechnic Institute and State

University in the study "Evaluation of

Animal Drug Residue Detection

Methods"® and which have been

demonstrated by "Evaluation of Animal

Drug Residue Detection Methods" to

provide positive results for residues of

beta lactam drugs, unless Association of

Official Analytical Chemists(AOAC)-

reviewed and Food and Drug

Administration- (FDA)-accepted

methods are available. In lieu of any test

specified in §3(H)(I)(b) a grade A

permit holder may use AOAC ffirst-

action and AOAC final-action tests

methods. Nothing in §3(H)(1)(b) shall

be deemed to include individual raw

milk samples collected from each grade

A dairy farm included in any shipment

of bulk tank raw milk for pasteurization,

ultra-pasteurization, or aseptic

processing;

c. Implement a random-sampling

program when the Commissioner of the

Food and Drug Administration

determines that a potential problem

exists with animal drug residues or

other contaminants in the milk supply.

Any grade A permit holder operating a

milk plant, receiving station, or transfer

station shall analyze the samples for the

contaminant by a method determined by

FDA to be effective in determining

compliance with actionable levels or

established tolerances. Any grade A

permit holder operating a milk plant,

receiving station, or transfer station

shall continue the random-sampling

program until such time that the

Commissioner of the Food and Drug

Administration is reasonably assured

that the problem has been corrected.

The random sampling program shall

represent and include during any

consecutive six months, at least four

samples collected in at least four

separate months.

d. Retain any sample found to be

positive for drug residues for a period of

120 hours after the sample test result is

positive for drug residues for the use of

the State Regulatory Authority;

e. Abstain from selling or offering

for sale any pasteurized, ultra-

pasteurized, or aseptically processed

milk, milk product, or condensed and

dry milk product processed trom raw

milk for pasteurization, _ultra-

pasteurization, or aseptic processing

before results of drug screening tests are

available and which raw milk later tests

positive for drug residues. Ali of the

grade A permit holders milk

commingled with any raw milk which

tests positive for drug residues shall be

deemed adulterated. Any grade A

permit holder operating a milk plant,

receiving station, or transfer station

shall report to the State Regulatory

Authority instances of adulteration

immediately;

f. (i) Record the results of tests on

samples of raw milk and retain such

records for a period of six months; (ii)

report records of all results of tests on

samples of raw milk to the State

Regulatory Authority by the fifteenth

day of each month for the preceding

month; and (iii) maintain and make

available to the State Regulatory

Authority for inspection and review at

the permitted facility records of results

of tests on samples of raw milk. Any

record of results of tests on samples of

raw milk required by this §3(H)(1)(f)

shall include:

1. The date and time of and place

where the test was performed;

2. The registration identification of

each pickup tanker of bulk raw milk

or raw milk sampled;

3. The test method used;

4. A statement as to whether the

test results were positive or negative.

If the results were positive, the grade

A permit holder shall also record:

a. The identity of each

producer contributing to the load

from which the positive sample

of raw milk was taken;

b. The name of the person

notified at the State Regulatory

Authority of the positive test

results;

Boe ee ee ek Og ae ea at eae ee ooh 2 hl

é. The date and time of day

the person at the State

Regulatory Authority was

notified of the positive test

results; and

d. The method of

notification of the State

Regulatory Authority;

g. Immediately notify the State

Regulatory Authority of any shipment

of bulk tank raw milk for pasteurization,

ultra-pasteurization, or aseptic

processing when the shipment of bulk

rong

tank raw milk is found to be positive for

drug residues. Nothing in §3(H)(I)(g)

shall be deemed to include individual

raw milk samples collected from each

grade A dairy farm included in any

shipment of bulk tank raw milk for

pasteurization, ultra-pasteurization, or

aseptic processing;

h. Test each producer sample of

raw milk to determine the farm of origin

represented by any sample of raw milk

which tests positive for drug residues

and immediately report to the State

Regulatory Authority the result of each

producer sample representing the raw

milk for pasteurization, ultra-

pasteurization, or aseptic processing

found to be positive for drug residues;

i. Immediately discontinue

receiving shipments of raw milk from

the grade A permit holder whose milk

tests positive for drug residue. until

subsequent tests by the Stat. Regulatory

Authority are no longer positive for

drug residues and the producer has

satisfied the requirements of §3(B)(13);

Any grade A permit holder whose milk

tests positive for drug residues shall dispose of

such milk in a manner that removes it from the

human food chain or in any manner approved

by the Food and Drug Administration;

I. Any grade A permit holder who operates a milk

plant, receiving station, or transfer station, and any

person who distributes milk or milk products shall

furnish the State Regulatory Authority, upon request:

l. A true statement of the quantities of

milk and milk products of each grade

purchased or sold by the milk plant, receiving

station, transfer station, or distributor of milk or

milk product; and

2. A list of all sources from which the

milk plant, receiving station, transfer station, or

distributor of milk or milk product, received

milk or milk product;

J. No person holding a grade A permit may

operate a dairy farm that receives on the dairy farm raw

or untreated sewage or septage from any septic tank,

from any private or public sewage system, from any

septic tank pump operator, from any hauler of septic

tank waste or sewage, or from any other source,

K. No person who holds a grade A permit may

place or hold in his milk storage tank: (i) any milk

except that milk which was obtained from cows, sheep,

or goats milked at the grade A permit holder's dairy:

farm; (ii) any milk which did not enter the milk storage

tank through the milking and milk-handling equipment

on the grade A permit holder's dairy farm during the

milking of the grade A permit holder's cows, sheep, or

goats; (iii) any milk which has been held without

refrigeration; or (iv) any milk which has been exposed

to chemical or physical contamination, and

L. No person may produce in, provide in,

manufacture in, sell in, offer for sale in, store in, bring

into, send into, or receive into, the Commonwealth any

milk, milk product, or condensed and dry milk product

for use in the commercial preparation of grade A

pasteurized, ultra-pasteurized, or aseptically processed

milk or milk products, any part of which is a

combination of goat milk and cow milk, sheep milk

and cow milk, or goat milk and sheep milk.

§ 4. Labeling.

A. No person may produce in, provide in,

manufacture in, sell in, offer for sale in, store in, bring

into, send into, or receive into, the Commonwealth any

milk, milk product, or condensed and dry milk product

for use in the commercial preparation of grade A

pasteurized, ultra-pasteurized, or aseptically processed

milk or milk products which are not labeled in

compliance with the following:

1. Except for nutrition labeling, the grade A

permit holder's bottles, containers, and packages

enclosing any milk or milk products shall be labeled in

accordance with the requirements of the Federal Food,

Drug and Cosmetic Act, as amended, the Fair

Packaging and Labeling Act, and _ regulations

developed thereunder;

2. The grade A permit holder shall label or mark all

bottles, containers, and packages enclosing any milk or

milk products with:

a. The name of a defined milk product, if

there is a definition, and if there is no

definition, a name that is not false or

misleading;

b. The word "reconstituted" or

"recombined" if the milk product is made by

reconstitution or recombination;

c. The term "grade A";

d. The identity of the plant where the

grade A permit holder's milk or milk product is

pasteurized, ultra-pasteurized, or aseptically

processed by specifying:

1. The street address, city, state,

and zip code of the plant, or

a The code assigned the plant

under the National Uniform Coding

System for Packaging Identification of

Milk and Milk Product Processing

Plants.”

e. In the case of concentrated milk,

concentrated or concentrated milk products the

volume or proportion of water to be added for

recombining;

f. The name of the milk product that the

concentrated milk product will produce, which

name shall be preceded by the term

“concentrated.” In the case of flavored milk or

flavored reconstituted milk, the grade A permit

holder shall substitute the name of the principal

flavor for the word "flavored";

g. In the case of aseptically processed milk

and milk products the words "keep refrigerated

after opening;"

h. In the case of aseptically processed and

packaged milk or milk products, the term

"UHT" ultra-high-temperature;

i. The term "ultra-pasteurized" if the milk

or milk product has been ultra-pasteurized;

j. The term "goat" preceding the name of

the milk or milk product when the milk or milk

product is goat milk or is made from goat milk;

k. The term "sheep" preceding the name of

the milk or milk product when the milk or milk

product is sheep milk or is made from sheep

milk;

l. The information appearing on the label

of any bottle, container, or package of milk or

milk product shall contain no marks, pictures,

graphics, or words which are misleading;

m. The "pull date" which: (i) shall not

interfere with the legibility of other labeling

required for the milk or milk product; and (ii)

shall be expressed by: (i) the first three letters

in the name of the month, followed by or

preceded by the numeral or numerals

constituting the calendar date after which the

product shall not be sold; or (ii) expressed

numerically by the number of the month

followed by the number of the day. For

example, June 1 shall be expressed "JUN 1", "1

JUN", "06 01", or "06-01"; Nothing in this

regulation pertaining to pull dates shall apply to

grade A pasteurized milk and grade A

pasteurized milk products bottled in glass

containers for home delivery;

n. The grade A permit holder who operates

a milk plant and offers for sale milk or milk

product within the Commonwealth shall file

and certify with the State Regulatory Authority

the maximum number of days after

manufacturing or processing the grade A permit

holder's milk or milk products which will be

used to determine the "pull date". The grade A

permit holder shall establish a "pull date" that

under normal storage the milk or milk product

meets for a minimum of 96 hours after the "pull

date," standards set by this regulation;

0. No person may sell or offer for sale any

grade A pasteurized milk, grade A pasteurized

milk product, or milk product in a package that

does not bear the "pull date;" and

p. Nothing in this regulation shall apply to

containers of grade A pasteurized milk, grade A

milk products, or milk products which are not

to be sold in the Commonwealth.

§ 5. Standards for milk and milk products.

No person may produce in, provide in,

manufacture in, sell in, offer for sale in, store

in, bring into, send into, or receive into, the

Commonwealth any milk, milk product, or

condensed and dry milk product for use in the

commercial preparation of grade A pasteurized,

ultrapasteurized, or aseptically processed milk

or milk products which do not comply with the

following:

1. Grade A raw milk for pasteurization or

ultrapasteurization or aseptic processing and all

grade A _ pasteurized, ultra-pasteurized, or

aseptically processed milk or milk products

shall be produced, processed, and pasteurized

or ultra-pasteurized, or aseptically processed to

conform with the following chemical,

bacteriological, somatic cell, cryoscope, and

temperature standards, and with _ the

requirements of this regulation;

2. No process or manipulation other than:

(i) pasteurization; (ii) ultra-pasteurization; (iii)

aseptic processing; or (iv) processing methods

integral with pasteurization, ultra-

pasteurization, or aseptic processing; and

refrigeration may be applied to milk or milk

products for the purpose of removing or

deactivating microorganisms. Nothing in this

regulation is deemed to prohibit any grade A

permit holder who operates a milk plant from

preparing bulk shipments of cream, skim milk,

or lowfat milk labeled as “heat treated"; if the

raw milk, raw cream, skim milk, or lowfat milk

is heated, one time, to a temperature warmer

than 125°F. but cooler than 161°F. for

separation purposes;

3. Grade A raw milk for pasteurization,

ultrapasteurization, or aseptic processing shall

comply with the following standards:

ia , i

a. Temperature standard: Raw milk

shall be cooled to 40°F. or cooler, but

not frozen, within two hours after

milking and the temperature after the

first or any subsequent milking shall not

be warmer than 50°F;

b. Bacterial limit standard: (i) The

bacteria count of raw milk shall not

exceed 100,000 bacteria per milliliter

prior to commingling with any other

milk; and (ii) the bacteria count of raw

milk that is commingled shall not

exceed 300,000 bacteria per milliliter

prior to pasteurization;

C. Cryoscope standard: Raw milk

shall freeze at or below -0.530° Hortvet;

d. Drugs standard: Raw milk shall

produce no zone greater than or equal to

16 millimeters when tested by the

Bacillus sterothermophilus disc assay

method or other equivalent method and

shall have no positive results of tests for

drug residues by detection methods

reported to the State Regulatory

Authority by milk plants, receiving

stations, or transfer stations;

e. Somatic cell count standard: The

somatic cell count of raw cow's milk or

raw sheep's milk shall not exceed

1,000,000 somatic cells per milliliter

through June 30, 1993. Effective July 1,

1993, raw cow's milk or raw sheep's

milk shall not exceed 750,000 somatic

cells per milliliter. The somatic cell

count of raw goat's milk shall not

exceed 1,000,000 somatic cells per

milliliter; and

f. Chemical residue or pesticide

residue standard: Raw milk shall not

exceed the actionable level, tolerance

level, or safe level for any chemical

residue or pesticide residue specified in:

(i) 40 CFR Parts 180, 185, or 186; and

(ii) 21 CFR Parts 70, 71, 73, 74, 80, 82,

130, 131, 133, 170, 172, 173, 174, 175,

176, 177, 178, 178 §1010, 189, 556,

564, 570, 573, 589. In the event that no

actionable level, tolerance level, or safe

level for a chemical residue or

pesticides residue has been established

in: (i) 40 CFR Parts 180, 185, or 186;

and (ii) 21 CFR Parts 70, 71, 73, 74, 80,

82, 130, 131, 133, 170, 172, 173, 174,

175, 176, 177, 178, 189, 556, 564, 570,

573, 589, the tolerance level shall be

deemed to be zero.

Grade A_ pasteurized or ultra-

pasteurized, milk and milk products shall

comply with the following standards:

a. Temperature standard: Milk and

milk products shall be cooled to 45°F.

or cooler but not frozen and maintained

thereat;

b. Bacterial limit standard®: The

bacteria count for any milk or milk

products shall not exceed 20,000

bacteria per milliliter;

c. Coliform limit standard: Except for

commingled milk shipped in a transport

tank; the coliform count for any milk or

milk products shall not exceed 10

coliform organisms per milliliter.

Commingled milk shipped in a transport

tank shall not exceed 100 coliform

organisms per milliliter;

d. Phosphatase standard’: The

phosphatase test result of any milk or

milk product shall be less than |

microgram per milliliter when tested by

the Scharer Rapid Method or other

equivalent method.

e. Drugs standard: Milk or milk

products shall produce no zone greater

than or equal to 16 millimeters when

tested by the Bacillus sterothermophilus

disc assay method or other equivalent

method;

f. Chemical residue or pesticide residue

standard: Milk or milk products shall

not exceed the actionable level,

tolerance level, or safe level for any

chemical residue or pesticide residue

specified in: (i) 40 CFR Parts 180, 185,

or 186; and (ii) 21 CFR Parts 70, 71, 73,

74, 80, 82, 130, 131, 133, 170, 172,

‘ia |

173, 174, 175, 176, 177, 178, 189, 556,

564, 570, 573, 589. In the event that no

actionable level, tolerance level, or safe

level for a chemical residue or

pesticides residue has been established

in: (i) 40 CFR Parts 180, 185, or 186;

and (ii) 21 CFR Parts 70, 71, 73, 74, 80,

82, 130, 131, 133, 170, 172, 173, 174,

175, 176, 177, 178, 189, 556, 564, 570,

573, 589, the tolerance level shall be

deemed to be zero.

5. Grade A aseptically processed milk and

milk products shall comply with the following

standards:

a. Bacterial limit standard: The

bacteria count of any aseptically

processed milk and mil’ products shall

demonstrate no growth;

b. Drugs. standard: Aseptically

processed milk and milk products shall

produce no zone greater than or equal to

16 millimeters when tested by the

Bacillus sterothermophilus disc assay

method or other equivalent method;

6. Chemical residue or pesticide

residue standard: Aseptically processed

milk and milk products shall not exceed

the actionable level, tolerance level, or

safe level for any chemical residue or

pesticide residue specified in: (i) 40

CFR Parts 180, 185, or 186; and (ii) 21

CFR Parts 70, 71, 73, 74, 80, 82, 130,

131, 133, 170, 172, 173, 174, 175, 176,

177, 178, 189, 556, 564, §70, 573, 589.

In the event that no actionable level,

tolerance level, or safe level for a

chemical residue or pesticides residue

has been established in: (i) 40 CFR

Parts 180, 185, or 186; and (ii) 21 CFR

Parts 70, 71, 73, 74, 80, 82, 130, 131,

133, 170, 172, 173, 174, 175, 176, 177,

178, 189, 556, 564, 570, 573, 589, the

tolerance level shali be deemed to be

zero.

B. Sanitation requirements for grade A raw milk.

1. Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, Or aseptic processing shall comply with:

a. The following administrative

procedures contained in the “Grade A

Pasteurized Milk Ordinance --1989

Recommendations”’: Item Ir, Item 2r, Item 3r,

Item 4r, Item 5r, Item 6r, Item 7r, Item 8r, Item

Or, Item 10r, Item llr, Item 12r, Item 13r, Item

15r, Item 16r.1 through Item 16r.10, Item 17r,

Item 18r, Item 19r.2, Item 20r, Item 21r;

b. The following appendices contained in

the "Grade A Pasteurized Milk Ordinance -- |

1989 Recommendations": Appendixes B.I, IV,

V. VI, C, D, F, and G; and

c. The following requirements:

(1) Item Ir. Abnormal milk.

Any person who holds a grade A permit

to produce raw milk for pasteurization,

ultra-pasteurization, or aseptic

processing shall:

(a) Milk last or with separate equipment

cows, sheep, or goats which show

evidence of the secretion of abnormal

milk in one or more quarters (based

upon bacteriological, chemical, or

physical examination) and discard the

milk obtained from cows, sheep, or

goats which show evidence of the

secretion of abnormal milk in one or

more quarters based upon

bacteriological, chemical, or physical

examination;

(b) Milk last or with separate equipment

cows, sheep, or goats treated with, or

which have consumed, chemical,

medicinal, or radioactive agents which

are capable of being secreted in the milk

and which may be deleterious to human

health; and dispose of in a manner

which will not pollute the environment

or any human food the milk obtained

from cows, sheep, or goats treated with,

or which have consumed, chemical,

medicinal, or radioactive agents which

are capable of being secreted in the milk

and which may be deleterious to human

health;

(2) Item 2r. Milking barn, stable, or

parlor-- construction.

Any person who holds a grade A permit

to produce raw milk for pasteurization,

ultra-pasteurization, or aseptic

processing shall:

(a) Provide on the person's dairy farm a

milking barn, stable, or parlor in which

the milking herd shall be housed during

milking time; and

(b) Provide on the grade A permit

holder's dairy farm a milking barn,

stable, or parlor which, milking barn,

stable, or parlor shall:

(a) Have floors constructed of

concrete or equally impervious

material;

(b) Have walls and ceiling which are

smooth, painted, or finished in an

approved manner, and in good repair

and have a ceiling which is dust

tight;

(i) horses, (ii) calves, and (iii) bulls;

(d) Have natural or artificial light,

well distributed for day or night

milking;

(e) Have sufficient air space and air

circulation to prevent condensation

and excessive odors;

(f) Have dust-tight covered boxes or

bins, or separate storage facilities for

ground, chopped, or concentrated

feed; and

(g) Not be over-crowded;

(3) Item 3r. Milking barn, stable, or parlor--

cleanliness.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Keep the interior of the milking barn, stable,

or parlor clean;

(b) Keep the floors, walls, windows, pipelines,

and equipment in the milking barn, stable, or

parlor free of filth or litter and clean; and

barn, stable, and parlor.

(4) Item 4r. Cow yard, sheep yard, or goat yard.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Provide and maintain the cow yard, sheep

yard, or goat yard, to be graded and drained,

and to have no standing pools of water or

accumulations of organic wastes;

(b) In the cow loafing, goat loafing, sheep

loafing, cattle-housing, sheep-housing, or goat-

housing areas remove cow droppings, sheep

droppings, and goat droppings, and remove

soiled bedding or add clean bedding at

sufficiently frequent intervals to prevent the

soiling of the cow's, sheep's, or goat's udders

and flanks;

in the goat yard, cow yard, sheep yard, cow

loafing, sheep loafing, goat loafing, cattle-

housing, sheep-housing, or goat-housing area;

(d) Maintain any manure packs so as to be

properly drained and so as to provide a

reasonably firm footing; and

(e) Keep swine and fowl out of the cow yard,

sheep yard, goat yard, cow loafing, sheep

loafing, goat loafing, cattle-housing, sheep-

housing, or goat-housing area.

(5) Item 5r. Milkhouse or room--construction

and facilities.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Provide a milkhouse or milkroom of

sufficient size in which the cooling, handling,

and storing of milk and the washing, sanitizing,

and storing of milk containers and utensils shall

be conducted;

(b) Provide a milkhouse with a smooth floor,

constructed of concrete or equally impervious

material graded to drain, and maintained in

good repair;

waste generated in the milkhouse;

(d) Provide one or more floor drains in the

milkhouse, which floor drains shall be: (i)

accessible, and (ii) trapped, if connected to a

sanitary sewer system;

(e) Provide in the milkhouse walls and ceilings

constructed of a smooth material, in good

repair, well painted, or finished in an equally

suitable manner;

(f) Provide adequate natural or artificial light

and ventilation in the milkhouse;

(g) Use the milkhouse for no other purpose than

milkhouse operations;

(h) Provide no direct opening from the

milkhouse into any barn, stable, or into any

room used for domestic purposes, other than a

direct opening between the milkhouse and

milking barn, stable, or parlor provided with a

tight-fitting, self-closing, solid door, which

door has been hinged to be single or double

acting;

(i) Provide in the milkhouse water under

pressure which has been piped into the

milkhouse;

(j) Provide in the milkhouse a two-

compartment wash vat and adequate hot water

heating facilities;

(k) Provide a suitable shelter for the receipt of

milk when the grade A permit holder uses a

transportation tank for the cooling and storage

of milk on the grade A permit holder's dairy

farm, which shelter shall comply with the

following: (i) the shelter shall be adjacent to,

but not a part of, the milkroom; and (ii) the

shelter shall comply with the requirements of

the milkroom with respect to construction,

light, drainage, insect and rodent control, and

general maintenance,

(6) Item 6r. Milkhouse or milkroom--

cleanliness.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Keep clean the floors, walls, ceilings,

windows, tables, shelves, cabinets, wash vats,

non-product contact surfaces of milk

containers, utensils, equipment, and other

milkroom equipment in the milkroom,

(b) Place in the milkroom only those articles

directly related to milkroom activities; and

and fowl.

(7) Item 7r. Toilet.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Provide on the person's grade A dairy farm

one or more toilets, which toilets shall be

conveniently located and properly constructed,

and operated, and maintained in a sanitary

manner;

(b) Prevent the access or flies to the waste

contained in or from the toilet;

toilet. from polluting the soil surface or

contaminating any water supply; and

(d) Assure that there is no direct opening from

the toilet into any milkroom.

(8) Item 8r. Water supply.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Provide water for milkhouse and milking

operations from a water supply properly

located, protected, and operated. The water

supply shall be easily accessible, adequate, and

of a safe, sanitary quality;

(b) Assure that any well casing which is part of

a water supply that provides water for any

milkhouse or milking operation is not located

closer to any source of contamination which

may contaminate the water supply than iS

specified as follows:

(1) No grade A permit holder may

locate a well casing closer than 10 feet

to a pit;

(2) No grade A permit holder may

locate a well casing closer than 10 feet

to any sewer pipe, floor drain, or other

pipe which may back up;

(3) No grade A permit holder may

locate a well casing closer than 50 feet

to any above-ground gas, oil, petroleum,

or chemical storage tank;

(4) No grade A permit holder may

locate a well casing closer than 50 feet

to any accumulated animal manure,

(5) No grade A permit holder may

locate a well casing closer than 50 feet

to any: (i) area to which livestock has

access; or (il) animal-holding area,

feedlot, or loafing area on dirt;

(6) No grade A permit holder may

locate a well casing closer than 50 feet

to any pit not drained to the surface of

the ground. Nothing in this requirement

shall apply to a residential basement,

(7) From and after September 1, 1993

no grade A permit holder may locate a

well casing closer than 100 feet to any

pit privy. Existing well casings located

on grade A dairy farms holding valid

permits issued by the State Regulatory

Authority on September 1, 1993 shall

be exempt from the 100 foot distance

requirement of §5(B)(1)(c)(8)(b)(7) until

the existing permit is canceled or

revoked;

(8) No grade A permit holder may

locate a well casing closer than 100 feet

to any animal-manure disposal area;

(9) No grade A permit holder may

locate a well casing closer than 100 feet

to any cess pool;

(10) No grade A permit holder may

locate a well casing closer than 100 feet

to any dry well;

(11) No grade A permit holder may

locate a well casing closer than 100 feet

to any structure which stores animal

manure;

(12) No grade A permit holder may

locate a well casing closer than 100 feet

to any septic tank or drain field; and

(13) No grade A permit holder may

locate a well casing closer than 100 feet

to any underground or partially-buried

gas, oil, petroleum, or chemical storage

tank;

casing ‘terminates at least two feet above the

highest-known flood plane for the location in

which the water supply is located, and

(D) Construct the water supply so that no

potable water supply pipe attached to the water

supply is located closer than 10 feet measured

horizontally to any sewer pipe, soil pipe, or

drain.

(9) Item 9. Utensils and equipment--

construction.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Provide multiuse containers, equipment, and

utensils for use in the handling, storage, OF

transportation of any milk, which multiuse

containers, equipment, and utensils shall: (i) be

made of smooth, nonabsorbent, corrosion-

resistant, and nontoxic materials; (ii) be so

constructed as to be easily cleaned; and (iii) be

in good repair;

(b) Provide milk pails which are constructed to

be seamless and of the hooded type if the grade

A permit holder does hand milking and

stripping;

material for straining any milk;

(d) Use only single-service articles which have

been manufactured, packaged, transported,

stored, and handled in a sanitary manner and

that comply with the requirements of

§5(C)(I)(c)(11) of this regulations;

(e) Abstain from reusing any article intended

for single-service use; and

(f) Provide farm holding or cooling tanks,

welded sanitary piping, and transportation tanks

which comply with the requirements of

§5(C\I(cK10), and §5(C\I\(c\(ll) of this

regulation on any grade A dairy farm;

(10) Item 1Or. Utensils and equipment--

cleaning.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Clean after each use the product-contact

surfaces of all multiuse containers, multiuse

equipment, and multiuse utensils used in the

handling, storage, or transportation of any milk;

and |

(b) Offer for sale or sell no milk which has

passed through any equipment, if the milk-

contact surfaces of the equipment are no longer

visible, or are covered or partially covered by

an accumulation of milk solids, milk fat,

cleaning compounds or other soils. Any milk

which passes through equipment, the milk-

contact surfaces of which are no longer visible,

——————

or are covered or partially covered by an

accumulation of milk solids, milk fat, cleaning

compounds, or other soils shall be deemed

adulterated;

(11) Item = Ilr. Utensils and equipment--

sanitization.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, OF aseptic processing shall

sanitize before each use the product contact

surfaces of all multiuse containers, equipment,

and utensils used in the handling, storage, OT

transportation of any milk;

(12) Item 12r. Utensils and equipment--storage.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall store

containers, utensils, and equipment used in the

handling, storage, Or transportation of any milk

in a sanitizing solution or store the containers,

utensils, and equipment used in the handling,

storage, OF transportation of any milk to assure

complete drainage, and protected from

contamination prior to use. Nothing in this

requirement shall be deemed to prohibit a grade

A permit holder from storing in a milking barn

or milking parlor a milk pipeline, or the

following pipeline milking equipment: milker

claw, inflation, weigh jar, meter, milk hose,

milk receiver, tubular cooler, plate cooler, or

milk pump; if the milk pipeline or pipeline

milking equipment specified in this §5(B)(12)

is: (i) designed for mechanical cleaning; and

(ii) designed, installed, and operated to protect

the milk product and solution-contact surfaces

from contamination at all times;

(13) Item 13r. Utensils and equipment--

handling.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall

handle all containers, utensils, and equipment

in such a manner so as to prevent the

contamination of any milk-contact surface of

any containers, utensils, or equipment after the

containers, utensils, or equipment have been

sanitized;

(14) Item 14r. Milking--flanks, udders, and

teats.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Milk all cows, sheep, and goats in a milking

barn, stable, or parlor;

(b) Trim the hair from the udder and tail of all

milking cows, sheep, and goats to facilitate

cleaning of the udder and tail;

all milking cows, sheep, and goats free of

visible dirt;

(d) Keep the hair on the udders of all milking

cows, sheep, and goats to a length that the hair

on the udder of any cow, sheep, or goat can not

be incorporated with the teat in the inflation

during milking;

(e) Abstain from milking any cow, sheep, or

goat whose udder or teats is not clean and dry;

(f) Treat with a sanitizing solution, just prior to

milking, the teats of each milking cow, sheep,

and goat, and dry the teats of each milking cow,

sheep, and goat before milking; and

(g) Milk all cows, sheep, and goats with dry

hands;

(15) Item 15r. Milking--surcingles, milk stools,

and antikickers.

Any person who holds a grade! A permit to

produce raw milk for pasteurization, ultra-

pasteurization, Or aseptic processing shall keep

surcingles, milk stools, and antikickers clean

and stored above the floor;

(16) Item 16r. Protection from contamination.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Locate and operate the milking and milk

house operations, equipment, and facilities to

prevent any contamination of the milk,

equipment, containers, or utensils;

(b) Transfer immediately from the milking

barn, stable, or parlor to the milkhouse each

pail or container of milk;

unless it is protected from contamination;

(d) Store all drugs and medicinals in such a

manner that neither the drugs nor the

medicinals can contaminate any milk or the

milk product-contact surface of any equipment,

containers or utensils;

(e) Abstain from using unapproved or

improperly labeled medicinals or drugs to treat

any dairy animals or store unapproved or

improperly labeled medicinals or drugs in the

milkhouse, milking barn, stable or parlor.

Except for topical antiseptics, wound dressings,

(unless intended for direct injection into the

teat) vaccines and other biologics, and dosage

form vitamins and mineral products a drug or

medicinal is properly labeled only if the drug or

medicinal is labeled with the following:

(1) For over-the-counter medicinals or

drugs, the name and address of the

manufacturer or distributor, or for Rx

and extra-label use medicinals or drugs,

the name of the veterinary practitioner

dispensing the product;

(2) Directions for use of the drug or

medicinal and the prescribed holding

time;

(3) Any cautionary statement for the

drug or medicinal, if needed; and

(4) The active ingredient or ingredients

in the drug or medicinal,

(f) Except for topical antiseptics, wound

dressings, (unless intended for direct injection

into the teat) vaccines and other biologics, and

dosage form vitamins and mineral products,

segregate all medicinals and drugs used for

lactating dairy animals from any medicinals

and drugs used for non-lactating dairy animals;

(g) Except for topical antiseptics, wound

dressings, (unless intended for direct injection

into the teat) vaccines and other biologics, and

dosage form vitamins and mineral products,

provide separate shelves in a _ cabinet,

refrigerator, or other storage facility for the

storage of all medicinals and drugs for

treatment of nonlactating dairy animals

separate from those medicinals or drugs used

for lactating dairy animals, and

(h) Store topical antiseptics, wound dressings,

(unless intended for direct injection into the

teat) vaccines and other biologics, and dosage-

form vitamins and mineral products in a

manner that does not contaminate any milk or

the milk-product surfaces of any containers or

utensils;

(17) Item 17r. Personnel--hand-washing

facilities.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall

provide hand-washing facilities that are

convenient to the milkhouse, milking barn,

stable, or parlor, and flush toilet and that

include: (i) separate hot and cold running

water; (ii) soap or detergent; and (iii) individual

sanitary towels;

(18) Item 18r. Personnel--cleanliness.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Wash clean and dry with an individual

sanitary towel the person's hands immediately

before milking, before performing any

milkhouse function, and immediately after the

interruption of milking or performing any

milkhouse function;

(b) Wear clean outer garments while milking or

handling any milk, milk containers, utensils, or

equipment. Milk haulers shall wear clean outer

garments while handling any milk, milk

containers, utensils, or equipment;

(19) Item 19r. Cooling.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) (i) Cool to 40° F. or cooler (but not freeze),

all raw milk for pasteurization, ultra-

pasteurization, OF aseptic processing, within

two hours after the grade A permit holder

completes milking; and (ii) assure that the

temperature of the grade A permit holder's raw

milk is not warmer than 50° F after the first

milking or any subsequent milking. Raw milk

for pasteurization which is warmer than a

temperature of 50°F. after the first milking or

any subsequent milking shall be deemed a

public health hazard and shall not be offered for

sale or sold; and

(b) (i) Agitate all raw milk for pasteurization

for not less than five minutes at least once

every hour; (ii) assure that the milk in the

farm's bulk milk cooling or holding tank covers

the agitator paddle sufficiently to facilitate

proper cooling and sampling after the

completion of the first milking; and (iii) abstain

from selling or offering for sale milk which

does not cover the agitator paddle sufficiently

to faciliatate proper cooling and sampling after

the completion of the first milking;

(20) Item 2Or. Vehicles.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, Or aseptic processing shall:

(a) Transport from the grade A permit

holder's dairy farm to a milk plant or

receiving station all milk in cans, using

vehicles which are constructed and

operated to protect the milk from sun,

freezing, and contamination;

(b) Keep clean the inside and outside of

each vehicle used to transport from the

grade A permit holder's dairy farm to a

milk plant or receiving station any milk

in cans; and

contaminating the milk § when

transporting milk;

(21) Item 2lr. Insect and rodent control.

Any person who holds a grade A permit to

produce raw milk for pasteurization, ultra-

pasteurization, or aseptic processing shall:

(a) Take effective measures to prevent

the contamination of any _ milk,

containers, equipment, and utensils by

insects, rodents, and other animals, and

by chemicals used to control insects,

rodents, and other animals;

(b) Maintain the milkroom free of

insects rodents and other animals; and

milkhouse, milking barn, milking

stable, milking parlor, cattle, sheep, or

goat housing, cattle, sheep, or goat

loafing, water supply, or other facilities

on the grade A permit holder's dairy

farm neat, clean, and free of conditions

which might harbor or be conducive to

the breeding of insects and rodents.

C, Sanitation requirements for grade A

pasteurized, ultrapasteurized, or aseptically processed

milk or milk products.

3 Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized, or

aseptically processed milk or milk products shall

comply with:

a. The following administrative procedures

contained in the "Grade A Pasteurized Milk Ordinance

--1989 Recommendations”: Item Ip, Item 2p, Item 3p,

Item 4p, Item Sp, Item 6p, Item 7p, Item 8p, Item 9p,

Item 10p, Item Ilp.1 through Item Ilp.9, Item 12p.1

through Item 12p.5, Item 12p.7, Item 13p, Item 14p,

Item 15p, Item 16p, Item 17p, Item 18p, Item 19p, Item

20p, Item 21p, and Item 22p.

b. The following appendices contained in the

"Grade A Pasteurized Milk Ordinance --1989

Recommendations": Appendices, C, D, F, G, H, 1, and

J; and

€. The following requirements:

(1) ‘Item Ip. Floors--construction.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Except as _ specified in

§5(C)(I(c)(1)(b), provide floors for all

rooms in which milk or milk products

are processed, handled, or stored, or in

which milk containers, equipment, or

utensils are washed: (i) constructed of

concrete or other equally impervious

and easily cleaned material; and (ii)

which are smooth, properly sloped,

provided with trapped drains, and kept

in good repair;

(b) The floor in any cold-storage room

used for storing milk and milk products

need not be provided with floor drains if

the floors are sloped to drain to one or

more exits from the cold-storage room.

The floor in any storage room used for

storing dry ingredients or packaging

materials need not be provided with

drains and the floor in any storage room

used for storing dry ingredients or

packaging materials may be constructed

of tightly joined wood;

(2) Item 2p. Walls and ceilings--construction.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall provide walls and ceilings of rooms in

which milk or milk products are handled,

processed, or stored, or in which milk

containers, utensils, or equipment are washed,

that have a smooth, washable, light-colored

surface, and that are in good repair;

(3)

(4)

(5)

Item 3p. Doors and windows.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Provide effective means to prevent the

access of flies and rodents to any part of a milk

plant, receiving station, or transfer station; and

(b) Provide solid doors or glazed windows for

all openings to the outside of any milk plant,

receiving station, or transfer station and keep

the doors and windows closed during dusty

weather;

Item 4p. Lighting and ventilation.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall provide rooms in which any milk or milk

products are handled, processed, or stored or in

which any milk containers, equipment, or

utensils are washed, that are well lighted and

well ventilated;

Item 5p. Separate rooms.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Provide separate rooms for: (i) Pasteurizing,

processing, cooling, and packaging milk or

milk products; (ii) cleaning milk cans, bottles,

and cases; (iii) cleaning and sanitizing facilities

for bulk milk transport tanks if the grade A

permit holder receives any milk or milk product

in bulk milk transport tanks; and (iv) receiving

cans of milk and milk products separate from

(i) and (ii) above, unless all of the grade A

permit holder's milk or milk products are

received in bulk milk transport tanks;

(b) Use any room with a direct opening into

any stable or room used for domestic purposes

to: (i) handle, process, or store any milk or milk

products; or (ii) wash or store any milk

containers, utensils, or equipment; and

crowded to: (i) handle, process, or store any

milk or milk products; or (ii) wash or store any

milk containers, utensils, or equipment;

(6) Item 6p. Toilet-sewage disposal facilities.

Any person who holds a grade A permit to

produce grade’A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Provide each milk plant with toilet facilities

conforming with the regulations of the

Commonwealth and the following

requirements: (i) no toilet room may open

directly into any room in which milk or milk

products are processed; (ii) the toilet room shall

(7)

(8)

be completely enclosed and shall have tight-

fitting, self closing doors; (iii) the dressing

room, toilet room, and fixtures shall be kept in

a clean condition, in good repair, and shall be

well ventilated and well lighted; and (iv)

sewage and other liquid wastes from the toilet

room shall be disposed of in a sanitary manner;

Item 7p. Water supply.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Provide water for each milk plant from a

supply which is properly located, protected, and

operated; and

(b) Provide water from a supply which is easily

accessible for inspection by the State

Regulatory Authority, adequate, and of a safe,

sanitary quality;

Item 8p. Hand-washing facilities.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Provide hand-washing facilities, including

separate hot and cold running water, mix valve,

soap, and individual sanitary towels or other

approved hand-drying devices, convenient in:

(i) any area where milk or milk products are

(9)

(10)

handled, processed, or stored, and (ii) any area

where containers, utensils, or equipment, are

washed or stored; and

(b) Keep the hand-washing facilities clean and

in good repair;

Item 9p. Milk plant cleanliness.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Keep clean, neat, and free of any evidence

of animals, insects or rodents, all rooms: (i) in

which milk or milk products are handled,

processed, or stored; or (ii) in which containers,

utensils, or equipment are washed or stored;

(b) Use pesticides safely; and

processing operations or to the handling of

containers, utensils, and equipment, in

pasteurizing, processing, cooling, packaging, or

bulk milk storage rooms;

Item 10p. Sanitary piping.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(11)

(a) Use only sanitary piping, fittings, and

connections consisting of smooth, impervious

corrosion-resistant, nontoxic, easily cleanable

materials that are exposed to any milk or milk

products, or from which liquids may drip,

drain, or be drawn into any milk or milk

products;

(b) Keep all piping in good repair;

use only sanitary piping to transfer any

pasteurized or ultrapasteurized milk or milk

products from one piece of equipment to

another piece of equipment; and

(d) Transport cottage cheese, cheese dressings,

or cheese ingredients by methods which protect

the product from contamination,

Item Ilp. Construction and repair of containers

and equipment.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Use only multiuse containers and equipment

that may come in contact with any milk or milk

products: (i) constructed of smooth,

impervious, corrosion-resistant, and nontoxic

materials; (ii) constructed for ease of cleaning;

and (iii) kept in good repair;

(b) Use only single-service containers, closures,

gaskets, and other articles that may come in

contact with any milk or milk products that: (i)

are nontoxic, and (ii) have been manufactured,

packaged, transported, and handled in a

sanitary manner;

articles intended for single-service use; and

(d) Use only single-service containers, closures,

caps, gaskets, and similar articles

manufactured, packed, transported, and handled

in a manner which complies with the

requirements of "Standards for the Fabrication

of Single-Service Containers and Closures for

Milk and Milk Products--1991 revision,"’”;

(12) Item 12p. Cleaning and sanitizing of containers and

equipment.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Effectively clean and sanitize before each

use the product-contact surfaces of all multiuse

containers and equipment, utensils, and

equipment used in_ the transportation,

processing, handling, and storage of any milk

or milk products; -

(b) Use only multi-use containers for packaging

pasteurized milk and milk products that comply

with the following: (i) the residual bacteria

(13)

count on multi-use containers may not exceed

one per milliliter of capacity when the rinse test

is used, or the residual bacteria count on multi-

use containers may not exceed 50 colonies per

eight square inches (one per square centimeter)

of _product-contact surface, when the swab test

is used; in three-out-of-four samples taken at

random on a given day; and (ii) all multi-use

containers shall be free of coliform organisms;

and

packaging pasteurized milk and milk products

that comply with the following: (i) the residual

bacteria count of single-service containers shall

not exceed 50 per container, when the rinse test

is used, except that in containers less than 100

milliliters, the count shall not exceed 10, or the

residual bacteria count of single-service

containers shall not exceed 50 colonies per

eight square inches (one per square centimeter)

of product contact surface, when the swab test

is used: in three-out-of-four samples taken at

random on a given day; and (ii) all single-

service containers shall be free of coliform

organisms;

Item 13p. Storage of cleaned containers and

equipment.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall after cleaning any multiuse milk or milk

product containers, utensils, or equipment,

transport or store the multiuse milk or milk

(14)

product containers, utensils, or equipment: (i)

in a manner that assures complete drainage; and

(ii) in a manner that protects the multiuse milk

or milk product containers, utensils, or

equipment from contamination before use;

Item 14p. Storage of single-service containers,

utensils, and materials.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Purchase all single-service caps, cap stock,

parchment paper, containers, gaskets, and other

single-service articles for use in contact with

milk or milk products, in sanitary tubes,

wrappings, or cartons;

(b) Store in a clean dry place until used, single-

service caps, cap stock, parchment paper,

containers, gaskets, and other single-service

articles for use in contact with milk or milk

products;

parchment paper, containers, gaskets, and other

single-service articles for use in contact with

milk or milk products in sanitary tubes,

wrappings, or cartons; and

(d) Handle single-service caps, cap stock,

parchment paper, containers, gaskets, and other

single-service articles for use in contact with

milk or milk products in a sanitary manner;

(15)

(16)

Item 15p. Protection from contamination.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Locate the person's equipment and facilities

and conduct milk plant operations to prevent

any contamination of any milk or milk

products, ingredients, equipment, containers, or

utensils;

(b) Discard all milk, milk products, or

ingredients which have been _ spilled,

overflowed, or leaked;

products other than milk and milk products in

the person's milk plant to preclude the

contamination of any milk or milk products;

(d) Store, handle, or use any toxic material to

preclude the contamination of any milk. milk

product, or ingredient, and the milk product-

contact surfaces of all equipment, containers, or

utensils; and

(e) Clean, prior to use, all multi-use cases used

to encase packaged milk or milk product

containers;

Item 16p. Pasteurization and ultra-

pasteurization.

(17)

(18)

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall perform pasteurization, ultra-

pasteurization, or aseptic processing as defined

in §1 of this regulation;

Item 17p. Cooling of milk.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Maintain all raw milk and milk products at a

temperature of 45° F. or cooler, but not frozen,

until processed;

(b) Immediately cool, except for milk or milk

products to be cultured, all pasteurized or ultra-

pasteurized milk or milk products prior to

filling or packaging in approved cooling

equipment to a temperature of 45° F. or cooler,

but not frozen;

but not frozen, all pasteurized or ultra-

pasteurized milk or milk products; and

(d) Equip with an accurate thermometer each of

the rooms or tanks in which any milk or milk

products are stored;

Item 18p. Bottling and packaging.

(19)

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Bottle or package all milk or milk products

(except for cottage cheese, dry curd cottage

cheese and lowfat cottage cheese) at the place

of pasteurization in the grade A permit holder's

milk plant and in approved mechanical

equipment, and

(b) Transport all cottage cheese, dry curd

cottage cheese, or lowfat cottage cheese not

creamed or packaged in the grade A permit

holder's milk plant; (i) in sealed containers, and

(ii) in a protected, sanitary manner from the

grade A permit holder's milk plant to another

grade A permit holder's milk plant for creaming

or packaging;

Item 19p. Capping.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Cap or close all milk or milk product

containers in a sanitary manner by use of

approved mechanical capping or closing

equipment; and

(b) Use only caps or closures for all milk or

milk products, which protect the pouring lip of

a milk or milk product container to at least its

(20)

largest diameter and, use with respect to fluid

product containers, only caps or closures that

the removal of the cap or closure cannot be

made without detection;

Item 20p. Personnel--cleanliness.

No person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall:

(a) Permit any person in a milk plant to

commence any plant function before the person

has thoroughly washed the person's hands to

remove soil and contamination or to permit any

person in a milk plant to continue any plant

function if the person's hands are not clean;

(b) Permit any person in a milk plant to resume

work after the person has visited the toilet room

before the person has thoroughly washed the

person's hands;

in the processing, pasteurization, handling,

storage, or transportation of any milk, milk

products, containers, equipment or utensils,

unless the person is wearing clean outer

garments;

in the processing of any milk or milk products

unless the person wears adequate hair covering;

and

(d) Permit any person in a milk plant, to engage

in the processing of any milk or milk products

if the person is using tobacco;

(21) Item 21p. Vehicles.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall use vehicles to transport pasteurized and

ultra-pasteurized milk and milk products that

are constructed and operated so that the milk or

milk products are: (i) maintained at a |

temperature of 45° F. or cooler, but not frozen;

and (ii) protected from sunlight, from freezing,

and from contamination;

(22) Item 22p. Surroundings.

Any person who holds a grade A permit to

produce grade A pasteurized, ultra-pasteurized,

or aseptically processed milk, or milk products

shall keep neat, clean, and free from conditions

which might attract or harbor flies, other

insects, rodents, or which otherwise constitute a

nuisance, the area surrounding any milk plant,

(23) Any grade A permit holder's receiving station

shall comply with §5(C\(I(c(l) —‘ through

§5(C)(I(c)(15), inclusive, and §5(C\(I(cM(17), (20),

and (22), except that the partitioning requirement of

§5(C)(1)(c)(5) shall not be deemed to apply;

(24) Any grade A permit holder's transfer station

shall comply with §§5(C)(1)(c)(1), (4), (6), (7), (8),

(9), (10), (11), (12), (14), (15), (20), and (22); and as

- 99

§ 6.

climatic and operating conditions require, the

provisions of §§5(C)(I)(c)(2) and (3); except that each

person shall provide overhead protection for a transfer

station;

(25) Any grade A permit holder's facilities for the

cleaning and sanitizing of bulk tanks which transport

milk and milk products in the grade A permit holder's

milk plant, receiving station, or transfer station shall

comply with §§5(C)(I)(c)(1), (4), (6), (7), (8), (9), (10),

(11), (12), (14), (15), (20), and (22); and as climatic

and operating conditions require, the provisions of

§§5(C)(I(c\(2) and (3); except that each grade A

permit holder shall provide overhead protection for

facilities for the cleaning and sanitizing of bulk tanks

which transport milk and milk products in the grade A

permit holder's milk plant, receiving station, or transfer

station.

Animal health.

No person may produce in, provide in, manufacture in,

sell in, offer for sale in, store in, bring into, send into,

or receive into, the Commonwealth any milk, milk

product, or condensed and dry milk product for use in

the commercial preparation of grade A pasteurized,

ultra-pasteurized, or aseptically processed milk or milk

product unless the person complies with the following

requirements:

A. Milk for pasteurization or ultra-pasteurization

or aseptic processing shall be from a herd that

complies with the "Uniform Methods and Rules;

Bovine Tuberculosis Eradication-- effective February

3, 1989,""' 9 CFR Part 77, and the following:

100

(i) Each herd shall be located in a Modified

Accredited Tuberculosis Area or an Area

Accredited Free of Bovine Tuberculosis as

defined in “Uniform Methods and Rules;

Tuberculosis Eradication--effective February 3,

1989" and certified by the U.S. Department of

Agriculture; or (ii) shall have passed an annual

tuberculosis test;

Milk for pasteurization or ultra-pasteurization

or aseptic processing shall be from a herd that

complies with “Uniform Methods and Rules;

Brucellosis Eradication-- effective May 6, 1992, als

CFR Part 78; and the following:

(1) Each herd shall be located in a Certified

Brucellosis-Free Area or a Modified Certified

Brucellosis Area as defined in "Uniform

Methods and Rules; Brucellosis Eradication--

effective May 6, 1992" and certified by the

United States Department of Agriculture and

enrolled in a testing program for the Certified

Brucellosis-Free Area or the Modified Certified

Brucellosis Area; or

(2) Each herd shall meet the requirements for

an individually certified herd as defined in

"Uniform Methods and Rules; Brucellosis

Eradication-- effective May 6, 1992"; or

(3) Each herd shall participate in a milk ring

testing program meeting the requirements

specified in "Uniform Methods and Rules;

Brucellosis Eradication-- effective May 6,

1992" in an area that conducts a milk ring

testing program at least four times per year at

101

§ 7.

approximately equal intervals, and any herd

with a positive milk ring test result shall be

blood tested within 30 days from the date of the

positive milk ring test; or

(4) Each cow in the herd shall be individually

tested by an "official" blood test as defined in

"Uniform Methods and Rules; Brucellosis

Eradication" for the detection of brucellosis

annually;

C Goat's milk and sheep's milk for pasteurization

or ultrapasteurization or aseptic processing shall be

from a herd or flock which has passed an annual

whole-herd tuberculosis and brucellosis test;

D. For diseases of cows, sheep, or goats which

might affect human health, other than brucellosis and

tuberculosis, the State Regulatory Authority may

require physical, chemical, or bacteriological

examinations or other tests as may be deemed

necessary by a licensed veterinarian or a veterinarian in

the employ of the State Regulatory Authority to

diagnose the disease. Each grade A permit holder shall

dispose of any diseased animal disclosed by testing in

a manner which prevents the spread of the disease to

other animals or humans...

Milk or milk products which may be sold.

A. Except as specified in §7(B) from and after the

date these regulations are effective, a person may sell

in, offer for sale in, or expose for sale in -the

Commonwealth only grade A _ pasteurized, ultra-

pasteurized, or aseptically processed milk or milk

102

§ 8.

products to the final consumer, or to restaurants, soda

fountains, and grocery stores.

B. No person may sell in, offer for sale in, or

expose for sale in the Commonwealth any pasteurized,

ultra-pasteurized, or aseptically processed milk or milk

products which have not been graded or the grade of

which is not known to the final consumer, oF to

restaurants, soda fountains, and grocery stores unless

the Commissioner of Agriculture and Consumer

Services makes a finding in writing (which the

Commissioner of Agriculture and Consumer Services

may renew for terms not to exceed 90 days per term,

without limitation) that: (i) the supply of grade A raw

milk for pasteurization, ultrapasteurization, OF aseptic

processing is not adequate to meet the nutritional needs

of any person who secures milk in Virginia; or (ii) the

supply of pasteurized, ultrapasteurized, or aseptically

processed milk or milk product at retail is not available

for purchase by any person who secures milk in

Virginia.

S. No person may sell in, offer for sale in, expose

for sale in, or possess in the Commonwealth any

pasteurized, ultrapasteurized, or aseptically processed

milk or milk products under the provision of §7(B)

unless the milk or milk product is labeled "ungraded."

Transferring, delivery containers, cooling.

A. No person, except as authorized in these

regulations, may transfer any milk or any milk product

from one container or tank truck to another container

or tank truck in any place except a milk plant,

receiving station, transfer station, or milkhouse

103

especially used for that purpose and no person may dip

or ladle any milk or milk product;

B. No person may sell or serve to the public any

milk or fluid milk product except in the individual,

original container received from the milk distributor, or

from an approved bulk dispenser. Nothing in §8(A) of

this regulation is deemed to prohibit any person from:

(i) transferring milk from one container to another

container for the purpose of mixing drinks, if the

amount of milk required is less than one-half pint of

milk; or (ii) from using an original container of not

more than one-half gallon capacity or an approved bulk

dispenser to serve cream, whipped cream, or half-and-

half, which is to be sold or served to the public;

e No person may sell or serve to the public any

pasteurized or any ultra-pasteurized milk or milk

product which has not been maintained at a

temperature of 45° F. or cooler, but not frozen. No

person may store any pasteurized or ultrapasteurized

containers of milk or milk products in ice unless the

container is properly drained.

§9. Milk and milk products from beyond the limits of

routine inspection.

No person may provide in, sell in, offer for sale in,

store in, bring into, send into, or receive into, the

Commonwealth any milk or milk product from outside

the Commonwealth unless the milk or milk products

are produced and pasteurized, ultrapasteurized, or

aseptically processed under regulations which are

substantially equivalent to these regulations and the

supply of the milk or the milk plant that produced the

milk or milk product has been awarded a milk

104

§10.

$11.

sanitation compliance rating of at least 90 and an

enforcement compliance rating of at least 90, made by

a state milk sanitation rating officer certified by the

United States Public Health Service.

Construction plans for dairy farms and milk plants.

No grade A permit holder may construct, reconstruct,

or modify a milkhouse, milking barn, stable, or parlor,

transfer station, receiving station, or milk plant

regulated under these regulations without submitting to

the State Regulatory Authority written plans for review

and approval before construction work is begun.

Personnel health.

A. No person affected with any disease in a

communicable form, OF while a carrier of a

communicable disease, may work at any dairy farm or

milk plant in any capacity which brings the person into

contact with the production, handling, storage, OF

transportation of milk or milk products, or into contact

with milk or milk product containers, equipment, OF

utensils.

B. No person holding 4 grade A permit may

employ any person having, or suspected of having, any

disease in a communicable form, or of being a carrier

of a communicable disease.

c Any grade A permit holder who produces or

distributes milk or milk products, upon whose dairy

farm, or in whose milk plant any communicable

disease occurs, or who suspects that any employee has

contracted any disease in a communicable form, or has

105

become a carrier of a communicable disease, shall

notify the State Regulatory Authority immediately.

§ 12. Procedure when infection is suspected.

When reasonable cause exists to suspect the possibility

of transmission of infection of a communicable disease from

any person concerned with the handling of milk or milk

products to any other person, the person concerned with the

handling of milk or milk products and the person holding the

grade A permit shall comply with any or all of the following

measures:

A. The immediate exclusion of that person from

milk handling;

B. No grade A permit holder may sell or offer for

sale any milk or milk products that have been handled

by or exposed to a person who is suspected of having a

communicable disease or being a carrier of a

communicable disease;

S Any person who is suspected of having a

communicable disease or being a carrier of a

communicable disease and his associates, at the

discretion of the State Regulatory Authority, shall

submit to medical and bacteriological examination by a

licensed physician in the Commonwealth sufficient to

make a medical diagnosis.

§ 13. Grade A condensed and dry milk products and

condensed and dry whey.

A. No person may produce in, provide in, manufacture

in, sell in, offer for sale in, store in, bring into, send

into, or receive into, the Commonwealth any

106

condensed and dry milk product for use in the

commercial preparation of grade A pasteurized, ultra-

pasteurized, or aseptically processed milk or milk

product if the person does not comply with:

1. The following sections of Part Il of the "Grade A

Condensed and Dry Milk Products and Condensed and

Whey Recommended Sanitation Ordinance for

Condensed and Dry Milk Products and Condensed and

- Supplement I to the Grade A Pasteurized Milk

Ordinance - 1978 Recommendations of the United

States Public Health Service/Food and Drug

Administration, 1978 Edition" 13 and "Supplement I --

1978 Grade A Condensed & Dry Milk Ordinance

(DMO)"*:

Section 2;

Section 4;

Section 7(except that the temperature standard

for grade "A" raw milk for pasteurization shall

be 40°F or cooler, but not frozen);

Section 8;

Section 9;

Section 10;

Section 11; and

2. The following appendices contained in the

"Grade A Condensed and Dry Milk Products and

Condensed and Dry Whey Recommended Sanitation

Ordinance for Condensed and Dry Milk Products and

Condensed and Dry Whey used in Grade A Pasteurized

Milk Products - Supplement I to the Grade A

Pasteurized Milk Ordinance - 1978 Recommendations

of the United States Public Health Service/Food and

107

§14

Drug Administration, 1978 Edition":

Appendices A, B, C, D, E, F, and H.

Interpretation and enforcement.

A. This regulation is based on the "Grade A

Pasteurized Milk Ordinance--1989 recommendations.”

Except as otherwise provided in this regulation, the

provisions of this regulation shall be interpreted in a

manner consistent with interpretations accorded the

"Grade A_ Pasteurized Milk Ordinance--1989

recommendations".

B. The administrative procedures used to conduct

case decisions under this regulation shall be consistent

with the provisions of the Virginia Administrative

Process Act.

tA The State Regulatory Authority shall comply

with the following administrative procedures when

summarily suspending a grade A permit as specified in

§3(C) of this regulation:

l. The State Regulatory Authority shall

serve upon the grade A permit holder a written

notice of suspension. The written notice of

suspension shall specify the violations in

question and inform the grade A permit holder

of the right to appear before the State

Regulatory Authority in person, by counsel, or

by other qualified representative at a fact-

finding conference for the informal presentation

of factual data, arguments, and proof to appeal

this determination of violation;

108

2. Upon receipt of written application

from any person whose grade A permit has

been summarily suspended (within 30 days

after the effective date of the summary

suspension) the State Regulatory Authority

shall within seven days after the date of receipt

by the State Regulatory Authority of a written

application from any person whose grade A

permit has been summarily suspended proceed

to hold an informal fact-finding conference to

ascertain the facts of the violations in question

and upon evidence presented at the informal

fact-finding conference shall affirm, modify, or

rescind the summary suspension,

> The State Regulatory Authority shall,

unless the parties consent, ascertain the fact

basis for their decisions of cases through

informal conference proceedings. Such

cenference proceedings include the rights of

parties to the case: (i) to have reasonable notice

thereof, (ii) to appear in person or by counsel or

other qualified representative before the State

Regulatory Authority for the informal

presentation of factual data, argument, or proof

‘n connection with any case, (iii) to have notice

of any contrary fact basis or information in the

possession of the agency which can be relied

upon in making an adverse decision, (iv) to

receive a prompt decision of any application for

license, benefit, or renewal thereof, and (v) to

be informed, briefly and generally in writing, of

the factual or procedural basis for an adverse

decision in any case,

109

4. No person whose grade A permit has

been summarily suspended may be granted an

informal fact-finding conference by the State

Regulatory Authority unless the State

Regulatory Authority receives the person's

written application within 30 days after the

effective date of the summary suspension;

5. From any adverse decision of an

informal fact-finding conference, the grade A

permit holder may request a formal hearing

under §9-6.14:12 of the Code of Virginia

(1950), as amended, by writing the Director,

Division of Dairy and Foods within 30 days

stating the request and by providing the State

Regulatory Authority with a statement of the

issues in dispute. If the request for a formal.

conference is denied, the State Regulatory

Authority shall notify the grade A permit

holder in writing and further may affirm or

modify the decision of the informal fact-finding

conference; and

6. If a formal fact-finding conference is

denied, the State Regulatory Authority shall

notify the grade A permit holder of the right to

file an appeal in the circuit court.

"IMS LIST -- Sanitation Compliance and Enforcement

Ratings of Interstate Milk Shippers"; the current

edition of this publication contains the list of officially

designated laboratories and may be obtained from the

U. S. Food and Drug Administration, Milk Safety

Branch, HFF-346, 200 'C' Street, S. W., Washington,

D.C., 20204.

110

"Milk and Dairy Beef Residue Prevention Protocol,”

available from Milk & Dairy Beef Quality Assurance

Center, 801 Shakespeare, Box 497, Stratford, lowa,

50294.

"Determination of Vitamin D2 and Vitamin D3 in

Foods, Feeds, and Pharmaceuticals, Using High

Performance Liquid Chromatography: Comparison of

Three Different Columns," Melina C. Villalobos,

Norman R. Gregory & Martin P. Bueno, Food and

Drug Administration, Center for Food Safety and

Applied Nutrition, Division of Nutrition, HFF-266,

Washington, D.C., 20204.

"HPLC Assays for Vitamin A and E (HPLC Method

1),"_ available from Laboratory Assurance Branch,

HFH-450, Division of Microbiology, Food and Drug

Administration Center for food Safety, 6502 S. Archer

Road, Summit Argo, IL, 60501-1399.

"Evaluation of Animal Drug Residue Detection

Methods,” J. Russell Bishop, Susan E. Duncan, Gerald

M. Jones, and William D. Whittier, available from

Food Science and Technology, Virginia Polytechnic

Institute and State University, Blacksburg, Virginia,

24061.

"IMS List -- Sanitation Compliance and Enforcement

Ratings of Interstate Milk Shippers," specifies the

requirements for the "National Uniform Coding

System for Packaging Identification of Milk and Milk

Product Processing Plants" and list the code for each

milk or milk product processing plant. This document

is available from the U. S. Food and Drug

Administration, Milk Safety Branch, HFF-346,200 "C"

Street, S. W., Washington, D.C., 20204.

111

10.

11.

12.

The bacteria limit standard is not applicable to cultured

milk products.

The phosphatase standard is not applicable to bulk

shipped heat treated milk products.

"Grade A Pasteurized Milk Ordinance --1989

Recommendations" is available from U. S. Food and

Drug Administration, Milk Safety Branch, HFF-346,

200 "C" Street, S. W., Washington, D.C., 20204.

"Standards for the Fabrication of Single-service

Containers and Closures for Milk and Milk Products”,

1991 revision, is available from the U. S. Food and

Drug Administration, Milk Safety Branch, HFF-346,

200 'C' Street, S. W., Washington, D. C. 20204.

"Uniform Methods and Rules; Bovine Tuberculosis

Eradication-- effective February 3, 1989," is available

from Veterinary Services, Animal and Plant Health

Inspection Service, U. S. Department of Agriculture,

Federal Center Building, Hyattville, Maryland, 20782

or Federal Veterinarian in Charge, VS, APHIS, USDA,

Sixth Floor, Washington Building, 1100 Bank Street,

Richmond, Virginia, 23219.

"Uniform Methods and Rules; Brucellosis Eradication-

-effective May 6, 1992" is available from Veterinary

Services, Animal and Plant Health Inspection Service,

U. S. Department of Agriculture, Federal Center

Building, Hyattville, Maryland, 20782 or Federal

Veterinarian in Charge, VS, APHIS, USDA, Sixth

Floor, Washington Building, 1100 Bank Street,

Richmond, Virginia, 23219.

112

13.

14.

"Grade A Condensed and Dry Milk Products and

Condensed and Dry Whey", supplement I to the

"Grade A Pasteurized Milk Ordinance", 1978

recommendations, is available from U. S. Food and

Drug Administration, Milk Safety Branch, HFF-346,

200 "C" Street, S. W., Washington, D.C., 20204.

"Supplement | --1978 Grade A Condensed & Dry Milk

Ordinance (DMO)" was issued December 11, 1992 and

is available from U. 5. Food and Drug Administration,

Milk Safety Branch, HFF-346, 200 "C" Street, S. W.,

Washington, D.C.., 20204.

113

STATE OF NEBRASKA (402) 471-2541

Department of Health

Mark B. Horton, M.D., M.S.P.H.

Director

September 14, 1992

John S. Coles

Route 18, Box 21

Charlottesville, VA 22901

Re: Dairy

Dear Mr. Coles:

Please excuse my delay in answering your letter of July 18,

1992.

The State of Nebraska, Department of Agriculture has adopted

the current issue of the Pasteurized Milk Ordinance (PMO) as

the State Milk Ordinance. With goat milk defined in the PMO

any grade “A” goat dairies would be governed by this code.

At present we have no Grade “A” or Grade “B” goat dairies.

Nebraska has always permitted the sale of raw milk, but only

casual sales direct from the farm and advertising in not

permissible.

Hopefully this answers your questions. If not please contact

me any time.

Sincerely,

(s/Allan Ackerman

Allan Ackerman, R.S.

State Milk Rating Officer

Division of Drinking Water and

Environmental Sanitation AA/tc

114

OKLAHOMA STATE DEPARTMENT OF HEALTH

1000 NE TENTH

OKLAHOMA CITY, OK 73117-1299

Joan K. Leavitt, M.D.

Commissioner

Board of Health

John B. Carmichael, D.D.S. Gordon H. Deckert, M.D.

President Dan H. Fieker, D.O.

Ernest D. Martin, R. Ph. Linda M. Johnson, M.D.

Vice President Walter Scott Mason, III

Burdge F. Green M.D. Lee W. Paden

Secretary- Treasurer

September 28, 1992

Mr. John S. Coles

Virginia State Dairy Goat Association

Route 18, Box 21

Charlottesville, VA 22901

Dear Sir:

Oklahoma centralized their milk regulatory program in July of

1974. The laws regulating Grade A raw milk distribution

were in effect prior to that time.

The Pasteurized Milk Ordinance used by the states to regulate

Grade A milk prohibits interstate shipment of packaged raw

milk, however, it has provisions allowing for incidental sales

of raw milk at the dairy.

I have also enclosed a copy of our most recent raw milk

legislation for your information. The Act passed May 8, 1989

115

allows for unregulated sale of raw goat milk not to exceed 100

gallons per month.

I hope this information is what you needed.

Sincerely,

/s/ Dan Rackley

Dan Rackley, Director

Milk Sanitation Division

Consumer Protection Service

DR:ep

Enclosure

116

1994 SESSION

LD4908486

HOUSE BILL NO. 1061

Offered January 25, 1994

A BILL to exempt certain on-farm sales of goat milk from any

and all regulations governing the production, processing and

sale of grade “A” pasteurized milk; penalty.

Patrons-Way, Bennett, Bloxom, Cantor, Christian, Connally,

Cooper, Crouch, Darner, Dillard, Dudley, Fisher, Forbes,

Giesen, Harris, Hull, Ingram, Katzen, Keating, Marshall,

Martin, Mayer, McDonnell, Miller, Nelms, Plum, Purkey,

Putney, Reid, Reynolds, Robinson, Stump, Van Landingham,

Van Yahres, Wagner, Wardrup, Watkins and Wilkins;

Senators: Bell, Benedetti, Calhoun, Chichester, Gartlan,

Houck, Lambert, Marye, Miller, K.G., Quayle, Robb and

Trumbo

Be it enacted by the General Assembly of Virginia:

1. § J. Incidental sales and delivery of raw goat milk directly

to consumers at the farm where the milk is produced shall be

exempt from any and all regulations governing the production,

processing, and sale of grade “A” pasteurized milk, provided

that there is no advertisement of the milk and the herd is

certified and accredited as free of brucellosis and

tuberculosis. Each container shall be labeled clearly “Raw

Goat Milk, not for resale” and shall identify the farm where

the milk was produced and sold. The label shall also include

the specific wording: “Warning: Raw Goats’ Milk, not

pasteurized, may contain organisms injurious to your health.

Please consult pamphlet which is provided with this container

for information concerning potential health risks, and

instructions on how to pasteurize milk.” The Board of

117

Agriculture and Consumer Services shall promulgate

regulations regarding the form and manner of the label. Each

consumer shall be given a pamphlet, to be developed by the

Department of Agriculture and Consumer Services and the

Department of Health, describing risks associated with

consumption of raw milk and including instructions on how to

pasteurize it. The development of both the label and the

pamphlet shall be completed for use by July 1, 1995. For

purposes of this section, “incidental sales” of goat milk are

those sales where the monthly number of gallons sold does not

exceed 100. Producers shall report on a quarterly basis to the

Department of Agriculture and Consumer Services the number

of gallons sold in the previous quarter. The report shall be

filed with the Department not later than ten days after the end

of the quarter. Any person violating a provision of this section

may be assessed a civil penalty by the Board of Agriculture

and Consumer Services in an amount not to exceed $100 per

violation.

The provisions of this section shall expire on July 1,

1998.

United States District Court For The Western

District of Virginia

Civil Action, File Number 94-0048-C

Filed November 4, 1994

Christine Solem, Plaintiff

Amended

v. Complaint for Declaratory Relief

J. Carlton Courter, III,

Commissioner of Agriculture

and Consumer Services, Defendant

1. Plaintiff is a citizen of the State of Virginia, County

of Albemarle and Defendant represents in an official capacity

the Department of Agriculture and Consumer Services, State

of Virginia. The action arises under the 14th Amendment to

the Constitution of the United States, Section No. 1, the Act of

June 25, 1948, 62 Stat. 930; US.C., Title 28 , §1331, and

involves a state law that is not unclear. Federal Court is being

asked to intervene on behalf of overreaching constitutional

right rather than to interfere with comprehensive state

regulatory scheme.

2. Plaintiff has been engaged in a controversy since

Nov. of 1979 with the Department of Agriculture and

Consumer Services, including, but not limited to, three

appearances in Albemarle Circuit Court and two appearances

in the Virginia Supreme Court concerning sales of ungraded

raw goats’ milk from her farm

3. As a result of this controversy Plaintiff was

enjoined specifically form violating Regulation X of the

——— — ng

4. However, in September of 1993 Regulations

Governing Grade “A” Milk became effective, superseding the

old regulations cited in paragraph No. 3. The injunction

against Plaintiff no longer applies, according to remarks made

by the Judge and Counsel for the Defendant in the Albemarle

Circuit Court on April 25, 1994, which are highlighted in

yellow and attached here as Exhibit “A”.

5. Defendant has stated that if Plaintiff sells any raw

goats’ milk for human consumption that he would ask for the

injunction against her to be amended, (see Exhibit “A”).

Plaintiff wishes to sell ungraded raw goats’ milk in accordance

with the circumstances outlined below, and declares that she

has a constitutional right to do so.

6. Defendant has applied the prohibition against

ungraded raw goats’ milk sales in Regulation VII of the new

Regulations Governing Grade “A” Milk to include the

circumstances in which Plaintiff, producing ungraded raw

goats’ milk on her own farm, is approached by an individual

wishing to buy, on his own initiative, excess ungraded raw

goats’ milk at that farm for that individual’s own

consumption.

7. Plaintiff claims that the above application and

absolute prohibition are unconstitutional, as the circumstances

involved bear no substantial relation to the public health; nor

are such incidental sales to be construed as sales to the public

generally, and any such application and absolute prohibition

under said circumstances, through injunction or otherwise, is

an unreasonable invasion by the Defendant of the Plaintiff's

liberty of contract and personal property rights protected by

120

the 14th amendment, Section 1 of the United States

Constitution.

8. Plaintiff further contends that if Regulation VII was

intended to apply to the circumstances described in paragraph

6 that it should have been worded differently. As it stands,

R ‘on VII, when applied to said circumstances, is

unconstitutional as written. Failure to specify that one cannot

“buy” the product is a violation of due process.

9. The small traditional type of farm, such as the one

owned by the Plaintiff, rather than concentrating solely on

large scale production of one food item as a business with the

intention that that item should move in commerce, has

throughout the history of this country produced a diversity of

food to sustain itself and sold its excess to neighbors and

friends in the community. Plaintiff is engaged in this

inherently safe, time-honored endeavor, which is not hurtful to

the public, but she is being unreasonably denied by the

Defendant the use of her land to sustain herself and make a

living.

10. Wherefore Plaintiff demands that the court

adjudge her constitutional right to sell ungraded raw goats’

milk from her farm under the circumstances described in

paragraph 6.

Christine Solem

Rt. 18, Box 21

Charlottesville, Va. 22901

(804) 973-6505

121

1836 Polo Grounds Rd.

Charlottesville, Va. 22911

October 20, 1995

Dr. Gordon Guyer, Director of Agriculture

Michigan Department of Agriculture

P.O. Box 30017

Lansing, Michigan 48904

Dear Dr. Guyer:

I would really appreciate it if you could answer my

following two questions as soon as possible:

No. 1. How long ago did Michigan adopt the

Pasteurized Milk Ordinance?

No. 2. Does Michigan consider the prohibitory

language of the Pasteurized Milk Ordinance, which states that

only Grade A pasteurized milk, etc , may be sold to the final

consumer, to apply to the unadvertised, incidental, on-farm

sales of a farmer’s excess milk to friends and neighbors?

Many thanks for your time and consideration.

Sincerely,

s/ Christine Sol

Christine Solem

122

STATE OF MICHIGAN

John Engler, Governor

DEPARTMENT OF AGRICULTURE

P.O. BOX 30017, LANSING, MICHIGAN 48909

DR. GORDON GUYER, Director

Commissioner of Agriculture

David Crumbaugh

Douglas E. Darling

Shirley A. Skogman

Jordan B. Tatter

Norman R. Veliquette

October 26, 1995

Ms. Christine Solem

1836 Polo Grounds Road

Charlottesville VA 22911

Dear Ms. Solem:

Your recent letter to Director Gordon Guyer has been

forwarded to our office for a reply.

Michigan adopted the “Pasteurized Milk Ordinance” in 1966

and since that time we have considered all sales of raw milk to

the final consumer to be illegal.

We do recognize that a dairy farmer may wish to provide

employees with raw milk. However, we consider the sale of

raw milk, incidental or not, to be in violation of Michigan's

dairy laws.

We hope this response will answer your concerns. Please feel

free to contact me should you need additional information.

123

Sincerely,

s/ William E. McCart}

William E. McCarthy

Director

Dairy Division

WEM:mad

124

NATIONAL CONFERENCE

ON INTERSTATE MILK SHIPMENTS

10 Tecumseh Trail, Frankfort, KY 40601

Telephone and/or FAX (502) 695-0253

November 6, 1995

Ms. Christine Solem

1836 Polo Grounds Road

Charlottesville, VA 22901

Dear Ms. Solem:

All fifty states have adopted the Pasteurized Milk Ordinance

as of this dates.

Sincerely,

/s/ Dan Rackley

Dan Rackley, Chairman

National Conference

On Interstate Milk Shipments

125

OF THE 50 STATES ADOPTING THE PASTEURIZED

MILK ORDINANCE, THE FOLLOWING NEVERTHELESS

PERMIT SALES OF RAW MILK IF (1) INCIDENTAL

AND/OR (2) LICENSED*

1. States Permitting Incidental Sales of Raw Milk at the Farm:

Arkansas

Illinois

Kansas

Maine

Massachusetts

Minnesota

Nebraska

Oklahoma

Oregon

Rhode Island

South Dakota

Vermont

2. States Permitting Sales of Licensed Grade A Raw Milk

Arizona

California

Connecticut

Idaho

Kentucky

Maine

Massachusetts

Missouri

Montana

New Hampshire

New Mexico

New York

Oklahoma

126

* Information verified as of 1992, Arkansas-1993

127

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.