[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR115.50]
[Page 262-265]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 115 SHELL EGGS--Table of Contents
Sec. 115.50 Refrigeration of shell eggs held for retail distribution.
(a) For purposes of this section a ``retail establishment'' is an
operation that stores, prepares, packages, serves, vends, or otherwise
provides food for human consumption directly to consumers.
(b) Except as provided in paragraph (c) of this section, all shell
eggs, whether in intrastate or interstate commerce, held for retail
distribution:
(1) Shall promptly be placed under refrigeration as specified in
paragraph (b)(2) of this section upon receipt at a retail establishment,
except that, when short delays are unavoidable, the eggs shall be placed
under refrigeration, as soon as reasonably possible; and
(2) Shall be stored and displayed under refrigeration at an ambient
temperature not greater than 7.2 [deg]C (45 [deg]F) while held at a
retail establishment.
(c) Shell eggs that have been specifically processed to destroy all
viable Salmonella shall be exempt from the requirements of paragraph (b)
of this section.
(d) Under sections 311 and 361 of the Public Health Service Act (PHS
Act), any State or locality that is willing and able to assist the
agency in the enforcement of paragraph (b) of this section, and is
authorized to inspect or regulate retail establishments, may, in its own
jurisdiction, enforce paragraph (b) of this section through inspections
under paragraph (f) of this section and through administrative
enforcement remedies identified in paragraph (e) of this section until
FDA notifies the State or locality in writing that such assistance is no
longer needed. When providing assistance under paragraph (e) of this
section, a State or locality may follow the hearing procedures set out
in paragraphs (e)(2)(iii) through (e)(2)(iv) of this section,
substituting, where necessary, appropriate State or local officials for
designated FDA officials or may utilize State or local hearing
procedures if such procedures satisfy due process.
[[Page 263]]
(e) This section is established under authority of both the Federal
Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under the act,
the agency can enforce the food adulteration provisions under 21 U.S.C.
331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the issuance
of implementing enforcement regulations; therefore, FDA has established
the following administrative enforcement procedures for the diversion or
destruction of shell eggs and for informal hearings under the PHS Act:
(1) Upon finding that any shell eggs have been held in violation of
this section, an authorized FDA representative or a State or local
representative in accordance with paragraph (d) of this section may
order such eggs to be diverted, under the supervision of said
representative, for processing in accordance with the Egg Products
Inspection Act (EPIA) (21 U.S.C. 1031 et seq.) or destroyed by or under
the supervision of an officer or employee of the FDA, or, if applicable,
of the State or locality in accordance with the following procedures:
(i) Order for diversion or destruction. Any district office of FDA
or any State or local agency acting under paragraph (d) of this section,
upon finding shell eggs held in violation of this section, may serve
upon the person in whose possession such eggs are found a written order
that such eggs be diverted, under the supervision of an officer or
employee of the issuing entity, for processing in accordance with the
EPIA (21 U.S.C. 1031 et seq.) or destroyed by or under the supervision
of said district office, within 10-working days from the date of receipt
of the order.
(ii) Issuance of order. The order shall include the following
information:
(A) A statement that the shell eggs identified in the order are
subject to diversion for processing in accordance with the EPIA or
destruction;
(B) A detailed description of the facts that justify the issuance of
the order;
(C) The location of the eggs;
(D) A statement that these eggs shall not be sold, distributed, or
otherwise disposed of or moved except as provided in paragraph (e)(1)(v)
of this section;
(E) Identification or description of the eggs;
(F) The order number;
(G) The date of the order;
(H) The text of this entire section;
(I) A statement that the order may be appealed by written appeal or
by requesting an informal hearing;
(J) The name and phone number of the person issuing the order; and
(K) The location and telephone number of the office or agency and
the name of its director.
(iii) Approval of District Director. An order, before issuance,
shall be approved by the Food and Drug Administration (FDA) District
Director in whose district the shell eggs are located. If prior written
approval is not feasible, prior oral approval shall be obtained and
confirmed by written memorandum as soon as possible.
(iv) Labeling or marking of shell eggs under order. An FDA, State,
or local agency representative issuing an order under paragraph (e)(1)
of this section shall label or mark the shell eggs with official tags
that include the following information:
(A) A statement that the shell eggs are detained in accordance with
regulations issued under section 361(a) of the PHS Act (42 U.S.C.
264(a)).
(B) A statement that the shell eggs shall not be sold, distributed
or otherwise disposed of or moved except, after notifying the issuing
entity in writing, to:
(1) Divert them for processing in accordance with the EPIA or
destroy them; or
(2) Move them to an another location for holding pending appeal.
(C) A statement that the violation of the order or the removal or
alteration of the tag is punishable by fine or imprisonment or both
(section 368 of the PHS Act, 42 U.S.C. 271).
(D) The order number and the date of the order, and the name of the
government representative who issued the order.
(v) Sale or other disposition of shell eggs under order. After
service of the order, the person in possession of the shell eggs that
are the subject of the order shall not sell, distribute, or otherwise
dispose of or move any eggs subject to the order unless and until the
notice is
[[Page 264]]
withdrawn after an appeal except, after notifying FDA's district office
or, if applicable, the State or local agency in writing, to:
(A) Divert or destroy them as specified in paragraph (e)(1)(i) of
this section; or
(B) Move them to another location for holding pending appeal.
(2) The person on whom the order for diversion or destruction is
served may either comply with the order or appeal the order to the FDA
Regional Food and Drug Director in accordance with the following
procedures:
(i) Appeal of a detention order. Any appeal shall be submitted in
writing to FDA's District Director in whose district the shell eggs are
located within 5-working days of the issuance of the order. If the
appeal includes a request for an informal hearing, the hearing shall be
held within 5-working days after the appeal is filed or, if requested by
the appellant, at a later date, which shall not be later than 20-
calendar days after the issuance of the order. The order may also be
appealed within the same period of 5-working days by any other person
having an ownership or proprietary interest in such shell eggs. The
appellant of an order shall state the ownership or proprietary interest
the appellant has in the shell eggs.
(ii) Summary decision. A request for a hearing may be denied, in
whole or in part and at any time after a request for a hearing has been
submitted, if the FDA Regional Food and Drug Director or his or her
designee determines that no genuine and substantial issue of fact has
been raised by the material submitted in connection with the hearing or
from matters officially noticed. If the FDA Regional Food and Drug
Director determines that a hearing is not justified, written notice of
the determination will be given to the parties explaining the reason for
denial.
(iii) Informal hearing. Appearance by any appellant at the hearing
may be by mail or in person, with or without counsel. The informal
hearing shall be conducted by the FDA Regional Food and Drug Director or
his designee, and a written summary of the proceedings shall be prepared
by the FDA Regional Food and Drug Director.
(A) The FDA Regional Food and Drug Director may direct that the
hearing be conducted in any suitable manner permitted by law and this
section. The FDA Regional Food and Drug Director has the power to take
such actions and make such rulings as are necessary or appropriate to
maintain order and to conduct an informal fair, expeditious, and
impartial hearing, and to enforce the requirements concerning the
conduct of hearings.
(B) Employees of FDA will first give a full and complete statement
of the action which is the subject of the hearing, together with the
information and reasons supporting it, and may present oral or written
information relevant to the hearing. The party requesting the hearing
may then present oral or written information relevant to the hearing.
All parties may conduct reasonable examination of any person (except for
the presiding officer and counsel for the parties) who makes any
statement on the matter at the hearing.
(C) The hearing shall be informal in nature, and the rules of
evidence do not apply. No motions or objections relating to the
admissibility of information and views will be made or considered, but
any party may comment upon or rebut any information and views presented
by another party.
(D) The party requesting the hearing may have the hearing
transcribed, at the party's expense, in which case a copy of the
transcript is to be furnished to FDA. Any transcript of the hearing will
be included with the FDA Regional Food and Drug Director's report of the
hearing.
(E) The FDA Regional Food and Drug Director shall prepare a written
report of the hearing. All written material presented at the hearing
will be attached to the report. Whenever time permits, the FDA Regional
Food and Drug Director may give the parties the opportunity to review
and comment on the report of the hearing.
(F) The FDA Regional Food and Drug Director shall include as part of
the report of the hearing a finding on the credibility of witnesses
(other than expert witnesses) whenever credibility is a material issue,
and shall include a recommended decision, with a statement of reasons.
[[Page 265]]
(iv) Written appeal. If the appellant appeals the detention order
but does not request a hearing, the FDA Regional Food and Drug Director
shall render a decision on the appeal affirming or revoking the
detention within 5-working days after the receipt of the appeal.
(v) Regional Food and Drug Director decision. If, based on the
evidence presented at the hearing or by the appellant in a written
appeal, the Regional Food and Drug Director finds that the shell eggs
were held in violation of this section, he shall affirm the order that
they be diverted, under the supervision of an officer or employee of the
FDA for processing under the EPIA or destroyed by or under the
supervision of an officer or employee of the FDA; otherwise, the
Regional Food and Drug Director shall issue a written notice that the
prior order is withdrawn. If the Regional Food and Drug Director affirms
the order he shall order that the diversion or destruction be
accomplished within 10-working days from the date of the issuance of his
decision. The Regional Food and Drug Director's decision shall be
accompanied by a statement of the reasons for the decision. The decision
of the Regional Food and Drug Director shall constitute final agency
action, reviewable in the courts.
(vi) No appeal. If there is no appeal of the order and the person in
possession of the shell eggs that are subject to the order fails to
divert or destroy them within 10-working days, or if the demand is
affirmed by the Regional Food and Drug Director after an appeal and the
person in possession of such eggs fails to divert or destroy them within
10-working days, FDA's district office or appropriate State or local
agency may designate an officer or employee to divert or destroy such
eggs. It shall be unlawful to prevent or to attempt to prevent such
diversion or destruction of the shell eggs by the designated officer or
employee.
(f) Inspection. Persons engaged in retail distribution of shell eggs
shall permit authorized representatives of FDA to make at any reasonable
time such inspection of the retail establishment in which shell eggs are
being held, including inspection and sampling of such eggs and the
equipment in which shell eggs are held and any records relating to such
equipment or eggs, as may be necessary in the judgement of such
representatives to determine compliance with the provisions of this
section. Inspections may be made with or without notice and will
ordinarily be made during regular business hours.
(g) Preemption. No State or local governing entity shall establish
or continue in effect any law, rule, regulation, or other requirement
allowing refrigeration of unpasteurized shell eggs at retail
establishments at any temperature greater than 7.2 [deg]C (45 [deg]F).
[65 FR 76112, Dec. 5, 2000]
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