VII. Shellfish Federal Regulations
Guide Contents
Part 7 - Enforcement Policy
Subpart A - General Provisions
§ 7.1 Scope.
§ 7.3 Definitions.
§ 7.12 Guaranty.
§ 7.13 Suggested forms of guaranty.
Subpart B - [Reserved]
Subpart C- Recalls
(Including Product Corrections) - Guidelines on Policy,
Procedures, and Industry Responsibilities
§ 7.40 Recall policy.
§ 7.41 Health hazard evaluation and recall classification.
§ 7.42 Recall strategy.
§ 7.45 Food and Drug Administration - requested recall.
§ 7.46 Firm-initiated recall.
§ 7.49 Recall communications.
§ 7.50 Public notification of recall.
§ 7.53 Recall status reports.
§ 7.55 Termination of a recall.
§ 7.59 General industry guidance.
Subpart D - [Reserved]
Subpart E - Criminal Violations
§ 7.84 Opportunity for presentation of views before report of criminal
violation.
§ 7.85 Conduct of a presentation of views before report of criminal violation.
§ 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.
Authority: Secs. 201-903 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321-393); secs. 301, 351, 354-360F, 361 of the
Public Health Service Act (42 U.S.C. 241, 262, 263b-263n, 264).
Source: 42 FR 15567, Mar. 22, 1977, unless otherwise
noted.
Subpart A - General Provisions
§ 7.1 Scope.
This part governs the practices and procedures applicable to regulatory
enforcement actions initiated by the Food and Drug Administration pursuant
to the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) and other
laws that it administers. This part also provides guidelines for manufacturers
and distributors to follow with respect to their voluntary removal or correction
of marketed violative products. This part is promulgated to clarify and
explain the regulatory practices and procedures of the Food and Drug Administration,
enhance public understanding, improve consumer protection, and assure uniform
and consistent application of practices and procedures throughout the agency.
[43 FR 26218, June 16, 1978]
§ 7.3 Definitions.
- (a) Agency means the Food and Drug Administration.
(b) Citation or cite means a document and any attachments
thereto that provide notice to a person against whom criminal prosecution
is contemplated of the opportunity to present views to the agency regarding
an alleged violation.
(c) Respondent means a person named in a notice who presents
views concerning an alleged violation either in person, by designated
representative, or in writing.
(d) Responsible individual includes those in positions of power
or authority to detect, prevent, or correct violations of the Federal
Food, Drug, and Cosmetic Act.
(e) [Reserved]
(f) Product means an article subject to the jurisdiction of the
Food and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, and any item subject to a quarantine regulation under part 1240 of
this chapter. Product does not include an electronic product that emits
radiation and is subject to parts 1003 and 1004 of this chapter.
(g) Recall means a firm§s removal or correction of a marketed
product that the Food and Drug Administration considers to be in violation
of the laws it administers and against which the agency would initiate
legal action, e.g., seizure. Recall does not include a market withdrawal
or a stock recovery.
(h) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a product
without its physical removal to some other location.
(i) Recalling firm means the firm that initiates a recall or,
in the case of a Food and Drug Administration-requested recall, the firm
that has primary responsibility for the manufacture and marketing of the
product to be recalled.
(j) Market withdrawal means a firm's removal or correction of
a distributed product which involves a minor violation that would not
be subject to legal action by the Food and Drug Administration or which
involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
(k) Stock recovery means a firm's removal or correction of a product
that has not been marketed or that has not left the direct control of
the firm, i.e., the product is located on premises owned by, or under
the control of, the firm and no portion of the lot has been released for
sale or use.
(l) Recall strategy means a planned specific course of action
to be taken in conducting a specific recall, which addresses the depth
of recall, need for public warnings, and extent of effectiveness checks
for the recall.
(m) Recall classification means the numerical designation, i.e.,
I, II, or III, assigned by the Food and Drug Administration to a particular
product recall to indicate the relative degree of health hazard presented
by the product being recalled.
- (1) Class I is a situation in which
there is a reasonable probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or death.
(2) Class II is a situation in which
use of, or exposure to, a violative product may cause temporary or medically
reversible adverse health consequences or where the probability of serious
adverse health consequences is remote.
(3) Class III is a situation in which
use of, or exposure to, a violative product is not likely to cause adverse
health consequences.
(n) Consignee means anyone who received, purchased, or used the
product being recalled.
[42 FR 15567, Mar. 22, 1977, as amended at 43 FR
26218, June 16, 1978; 44 FR 12167, Mar. 6, 1979]
§ 7.12 Guaranty.
In case of the giving of a guaranty
or undertaking referred to in section 303(c)(2) or (3) of the act, each person
signing such guaranty or undertaking shall be considered to have given it.
§ 7.13 Suggested forms of guaranty.
- (a) A guaranty or undertaking referred
to in section 303(c)(2) of the act may be:
- (1) Limited to a specific shipment
or other delivery of an article, in which case it may be a part of or attached
to the invoice or bill of sale covering such shipment or delivery, or
(2) General and continuing, in which
case, in its application to any shipment or other delivery of an article, it
shall be considered to have been given at the date such article was shipped
or delivered by the person who gives the guaranty or undertaking.
(b) The following are suggested forms
of guaranty or undertaking under section 303(c)(2) of the act:
- (1) Limited form for use on invoice
or bill of sale. (Name of person giving the guaranty
or undertaking) hereby guarantees that no article listed herein is adulterated
or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act,
or is an article which may not, under the provisions of section 404, 505, or
512 of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or undertaking.)
(2) General and continuing form.
The article comprising each shipment
or other delivery hereafter made by (name of person giving the guaranty or
undertaking) to, or in the order of (name and post-office address of person
to whom the guaranty or undertaking is given) is hereby guaranteed, as of the
date of such shipment or delivery, to be, on such date, not adulterated or
misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act,
and not an article which may not, under the provisions of section 404, 505,
or 512 of the act, be introduced into interstate commerce.
(Signature and post-office address
of person giving the guaranty of undertaking.)
(c) The application of a guaranty or
undertaking referred to in section 303(c)(2) of the act to any shipment or
other delivery of an article shall expire when such article, after shipment
or delivery by the person who gave such guaranty or undertaking, becomes adulterated
or misbranded within the meaning of the act, or becomes an article which may
not, under the provisions of section 404, 505, or 512 of the act, be introduced
into interstate commerce.
(d) A guaranty or undertaking referred
to in section 303(c)(3) of the act shall state that the shipment or other delivery
of the color additive covered thereby was manufactured by a signer thereof.
It may be a part of or attached to the invoice or bill of sale covering such
color. If such shipment or delivery is from a foreign manufacturer, such guaranty
or undertaking shall be signed by such manufacturer and by an agent of such
manufacturer who resides in the United States.
(e) The following are suggested forms
of guaranty or undertaking under section 303(c)(3) of the act:
- (1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees
that all color additives listed herein were manufactured by him, and (where
color additive regulations require certification) are from batches certified
in accordance with the applicable regulations promulgated under the Federal
Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby
severally guarantee that all color additives listed herein were manufactured
by (name of manufacturer), and (where color additive regulations require certification)
are from batches certified in accordance with the applicable regulations promulgated
under the Federal Food, Drug, and Cosmetic Act.
(Signature and post-office address
of manufacturer.)
(Signature and post-office address
of agent.)
(f) For the purpose of a guaranty or
undertak-ing under section 303(c)(3) of the act the manufacturer of a shipment
or other delivery of a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed
by two or more persons, shall state that such persons severally guarantee the
article to which it applies.
(h) No representation or suggestion
that an article is guaranteed under the act shall be made in labeling.
Subpart B - [Reserved]
Subpart C - Recalls (Including Product Corrections) - Guidelines on
Policy, Procedures, and Industry Responsibilities
Source: 43 FR 26218, June 16, 1978, unless otherwise
noted.
§ 7.40 Recall policy.
- (a) Recall is an effective method of removing or correcting consumer
products that are in violation of laws administered by the Food and Drug
Administration. Recall is a voluntary action that takes place because
manufacturers and distributors carry out their responsibility to protect
the public health and well being from products that present a risk of
injury or gross deception or are otherwise defective. This section and
§ 7.41 through 7.59 recognize the voluntary nature of recall by providing
guidelines so that responsible firms may effectively discharge their recall
responsibilities. These sections also recognize that recall is an alternative
to a Food and Drug Administration-initiated court action for removing
or correcting violative, distributed products by setting forth specific
recall procedures for the Food and Drug Administration to monitor recalls
and assess the adequacy of a firm's efforts in recall.
(b) Recall may be undertaken voluntarily
and at any time by manufacturers and distributors, or at the request of the
Food and Drug Administration. A request by the Food and Drug Administration
that a firm recall a product is reserved for urgent situations and is to be
directed to the firm that has primary responsibility for the manufacture and
marketing of the product that is to be recalled.
(c) Recall is generally more appropriate
and affords better protection for consumers than seizure, when many lots of
product have been widely distributed. Seizure, multiple seizure, or other court
action is indicated when a firm refuses to undertake a recall requested by
the Food and Drug Administration, or where the agency has reason to believe
that a recall would not be effective, determines that a recall is ineffective,
or discovers that a violation is continuing.
§ 7.41 Health hazard evaluation and recall
classification.
- (a) An evaluation of the health hazard
presented by a product being recalled or considered for recall will be conducted
by an ad hoc committee of Food and Drug Administration scientists and will
take into account, but need not be limited to, the following factors:
- (1) Whether any disease or injuries
have already occurred from the use of the product.
(2) Whether any existing conditions
could contribute to a clinical situation that could expose humans or animals
to a health hazard. Any conclusion shall be supported as completely as possible
by scientific documentation and/or statements that the conclusion is the opinion
of the individual(s) making the health hazard determination.
(3) Assessment of hazard to various
segments of the population, e.g., children, surgical patients, pets, livestock,
etc., who are expected to be exposed to the product being considered, with
particular attention paid to the hazard to those individuals who may be at greatest
risk.
(4) Assessment of the degree of seriousness
of the health hazard to which the populations at risk would be exposed.
(5) Assessment of the likelihood of
occurrence of the hazard.
(6) Assessment of the consequences
(immediate or long-range) of occurrence of the hazard.
(b) On the basis of this determination,
the Food and Drug Administration will assign the recall a classification, i.e.,
Class I, Class II, or Class III, to indicate the relative degree of health
hazard of the product being recalled or considered for recall.
§ 7.42 Recall strategy.
- (a) General.
- (1) A recall
strategy that takes into account the following factors will be developed by
the agency for a Food and Drug Administration-requested recall and by the recalling
firm for a firm-initiated recall to suit the individual circumstances of the
particular recall:
- (i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product§s
deficiency is obvious to the consumer or user.
(iv) Degree to which the product remains unused in the market place.
(v) Continued availability of essential
products.
(2) The Food and Drug Administration
will review the adequacy of a proposed recall strategy developed by a recalling
firm and recommend changes as appropriate. A recalling firm should conduct
the recall in accordance with an approved recall strategy but need not delay
initiation of a recall pending review of its recall strategy.
(b) Elements of a recall strategy. A recall strategy will address the following elements regarding the conduct of the recall:
- (1) Depth of recall. Depending on the product§s degree of hazard and extent of distribution,
the recall strategy will specify the level in the distribution chain to which
the recall is to extend, as follows:
- (i) Consumer or user level, which may
vary with product, including any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate
wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose
of a public warning is to alert the public that a product being recalled presents
a serious hazard to health. It is reserved for urgent situations where other
means for preventing use of the recalled product appear inadequate. The Food
and Drug Administration in consultation with the recalling firm will ordinarily
issue such publicity. The recalling firm that decides to issue its own public
warning is requested to submit its proposed public warning and plan for distribution
of the warning for review and comment by the Food and Drug Administration.
The recall strategy will specify whether a public warning is needed and whether
it will issue as:
- (i) General public warning through
the general news media, either national or local as appropriate, or
(ii) Public warning through specialized
news media, e.g., professional or trade press, or to specific segments of the
population such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks
is to verify that all consignees at the recall depth specified by
the strategy have received notification about the recall and have
taken appropriate action. The method for contacting consignees may
be accomplished by personal visits, telephone calls, letters, or a
combination thereof. A guide entitled "Methods for Conducting Recall
Effectiveness Checks" that describes the use of these different
methods is available upon request from the Dockets Management Branch
(HFA-30-5), Food and Drug Administration, rm. 1-23, 12420 Parklawn
Dr., Rockville, MD 20857. The recalling firm will ordinarily be responsible
for conducting effectiveness checks, but the Food and Drug Administration
will assist in this task where necessary and appropriate. The recall
strategy will specify the method(s) to be used for and the level of
effectiveness checks that will be conducted, as follows:
- (i) Level A-100 percent of the total
number of consignees to be contacted;
(ii) Level B-Some percentage of the
total number of consignees to be contacted, which percentage is to be determined
on a case-by-case basis, but is greater that 10 percent and less than 100 percent
of the total number of consignees;
(iii) Level C-10 percent of the total
number of consignees to be contacted;
(iv) Level D-2 percent of the total
number of consignees to be contacted; or
(v) Level E-No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR
8455, Jan. 27, 1981]
§ 7.45 Food and Drug Administration requested
recall.
- (a) The Commissioner of Food and Drugs or his designee under §
5.20 of this chapter may request a firm to initiate a recall when the
following determinations have been made:
- (1) That a product that has been distributed
presents a risk of illness or injury or gross consumer deception.
(2) That the firm has not initiated
a recall of the product.
(3) That an agency action is necessary
to protect the public health and welfare.
(b) The Commissioner or his designee will notify the firm of this determination
and of the need to begin immediately a recall of the product. Such notification
will be by letter or telegram to a responsible official of the firm, but may
be preceded by oral communication or by a visit from an authorized representative
of the local Food and Drug Administration district office, with formal,
written confirmation from the Commissioner or his designee afterward.
The notification will specify the violation, the health hazard classification
of the violative product, the recall strategy, and other appropriate instructions
for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to provide
the Food and Drug Administration any or all of the information listed
in § 7.46(a). The firm, upon agreeing to the recall request, may
also provide other information relevant to the agency§s determination
of the need for the recall or how the recall should be conducted.
§ 7.46 Firm-initiated recall.
- (a) A firm may decide of its own volition and under any circumstances
to remove or correct a distributed product. A firm that does so because
it believes the product to be violative is requested to notify immediately
the appropriate Food and Drug Administration district office listed in
§ 5.115 of this chapter. Such removal or correction will be considered
a recall only if the Food and Drug Administration regards the product
as involving a violation that is subject to legal action, e.g., seizure.
In such cases, the firm will be asked to provide the Food and Drug Administration
the following information:
- (1) Identity of the product involved.
(2) Reason for the removal or correction
and the date and circumstances under which the product deficiency or possible
deficiency was discovered.
(3) Evaluation of the risk associated
with the deficiency or possible deficiency.
(4) Total amount of such products produced
and/or the time span of the production.
(5) Total amount of such products estimated
to be in distribution channels.
(6) Distribution information, including the number of direct accounts and, where necessary,
the identity of the direct accounts.
(7) A copy of the firm§s recall communication
if any has issued, or a proposed communication if none has issued.
(8) Proposed strategy for conducting
the recall.
(9) Name and telephone number of the
firm official who should be contacted concerning the recall.
(b) The Food and Drug Administration
will review the information submitted, advise the firm of the assigned recall
classification, recommend any appropriate changes in the firm§s strategy for
the recall, and advise the firm that its recall will be placed in the weekly
FDA Enforcement Report. Pending this review, the firm need not delay initiation
of its product removal or correction.
(c) A firm may decide to recall a product
when informed by the Food and Drug Administration that the agency has determined
that the product in question violates the law, but the agency has not specifically
requested a recall. The firm§s action also is considered a firm-initiated recall
and is subject to paragraphs (a) and (b) of this section.
(d) A firm that initiates a removal
or correction of its product which the firm believes is a market withdrawal
should consult with the appropriate Food and Drug Administration district office
when the reason for the removal or correction is not obvious or clearly understood
but where it is apparent, e.g., because of complaints or adverse reactions
regarding the product, that the product is deficient in some respect. In such
cases, the Food and Drug Administration will assist the firm in determining
the exact nature of the problem.
§ 7.49 Recall communications.
- (a) General. A recalling firm
is responsible for promptly notifying each of its affected direct accounts
about the recall. The format, content, and extent of a recall communication
should be commensurate with the hazard of the product being recalled and the
strategy developed for that recall. In general terms, the purpose of a recall
communication is to convey:
- (1) That the product in question is subject to a recall.
(2) That further distribution or use of any remaining product should cease immediately.
(3) Where appropriate, that the direct account should in turn notify its customers who received the product about the recall.
(4) Instructions regarding what to
do with the product.
(b) Implementation. A recall communication can be accomplished
by telegrams, mailgrams, or first class letters conspicuously marked,
preferably in bold red type, on the letter and the envelope: "drug
[or food, biologic, etc.] recall [or correction]". The letter and the
envelope should be also marked: "urgent" for class I and class II recalls
and, when appropriate, for class III recalls. Telephone calls or other
personal contacts should ordinarily be confirmed by one of the above methods
and/or documented in an appropriate manner.
(c) Contents.
- (1) A recall
communication should be written in accordance with the following guidelines:
- (i) Be brief and to the point;
(ii) Identify clearly the product,
size, lot number(s), code(s) or serial number(s) and any other pertinent descriptive
information to enable accurate and immediate identification of the product;
(iii) Explain concisely the reason for the recall and the hazard involved, if any;
(iv) Provide specific instructions
on what should be done with respect to the recalled products; and
(v) Provide a ready means for the recipient
of the communication to report to the recalling firm whether it has any of
the product, e.g., by sending a postage-paid, self-addressed postcard or by allowing the recipient to place
a collect call to the recalling firm.
(2) The recall communication should
not contain irrelevant qualifications, promotional materials, or any other
statement that may detract from the message. Where necessary, follow-up communications
should be sent to those who fail to respond to the initial recall communication.
(d) Responsibility of recipient.
Consignees that receive a recall communication should immediately carry out
the instructions set forth by the recalling firm and, where necessary, extend
the recall to its consignees in accordance with paragraphs (b) and (c) of this
section.
§ 7.50 Public notification of recall.
The Food and Drug Administration will promptly make available to the public
in the weekly FDA Enforcement Report a descriptive listing of each new recall
according to its classification, whether it was Food and Drug Administration-requested
or firm-initiated, and the specific action being taken by the recalling
firm. The Food and Drug Administration will intentionally delay public notification
of recalls of certain drugs and devices where the agency determines that
public notification may cause unnecessary and harmful anxiety in patients
and that initial consultation between patients and their physicians is essential.
The report will not include a firm§s product removals or corrections
which the agency determines to be market withdrawals or stock recoveries.
The report, which also includes other Food and Drug Administration regulatory
actions, e.g., seizures that were affected and injunctions and prosecutions
that were filed, is available upon request from the Office of Public Affairs
(HFI-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857.
§ 7.53 Recall status reports.
- (a) The recalling firm is requested
to submit periodic recall status reports to the appropriate Food and Drug Administration
district office so that the agency may assess the progress of the recall. The
frequency of such reports will be determined by the relative urgency of the
recall and will be specified by the Food and Drug Administration in each recall
case; generally the reporting interval will be between 2 and 4 weeks.
(b) Unless otherwise specified or inappropriate
in a given recall case, the recall status report should contain the following
information:
- (1) Number of consignees notified of
the recall, and date and method of notification.
(2) Number of consignees responding
to the recall communication and quantity of products on hand at the time it
was received.
(3) Number of consignees that did not
respond (if needed, the identity of nonresponding consignees may be requested
by the Food and Drug Administra-tion).
(4) Number of products returned or
corrected by each consignee contacted and the quantity of products accounted
for.
(5) Number and results of effectiveness
checks that were made.
(6) Estimated time frames for completion
of the recall.
(c) Recall status reports are to be
discontinued when the recall is terminated by the Food and Drug Administration.
§ 7.55 Termination of a recall.
- (a) A recall will be terminated when
the Food and Drug Administration determines that all reasonable efforts have
been made to remove or correct the product in accordance with the recall strategy,
and when it is reasonable to assume that the product subject to the recall
has been removed and proper disposition or correction has been made commensurate
with the degree of hazard of the recalled product. Written notification that
a recall is terminated will be issued by the appropriate Food and Drug Administration
district office to the recalling firm.
(b) A recalling firm may request termination of its recall by submitting
a written request to the appropriate Food and Drug Administration district
office stating that the recall is effective in accordance with the criteria
set forth in paragraph (a) of this section, and by accompanying the request
with the most current recall status report and a description of the disposition
of the recalled product.
§ 7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but there
are several steps a prudent firm can take in advance to minimize this disruptive
effect. Notwithstanding similar specific requirements for certain products
in other parts of this chapter, the following is provided by the Food and
Drug Administration as guidance for a firm's consideration:
- (a) Prepare and maintain a current written contingency plan for use
in initiating and effecting a recall in accordance with §§ 7.40 through
7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated
products to make possible positive lot identification and to facilitate effective
recall of all violative lots.
(c) Maintain such product distribution
records as are necessary to facilitate location of products that are being
recalled. Such records should be maintained for a period of time that exceeds
the shelf life and expected use of the product and is at least the length of
time specified in other applicable regulations concerning records retention.
PART 101 - FOOD LABELING
Subpart A - General Provisions
§ 101.1 Principal display panel of package form food.
§ 101.2 Information panel of package form food.
§ 101.3 Identity labeling of food in packaged form.
§ 101.4 Food; designation of ingredients.
§ 101.5 Food; name and place of business of manufacturer, packer, or distributor.
§ 101.8 Labeling of food with number of servings.
§ 101.9 Nutrition labeling of food.
§ 101.10 Nutrition labeling of restaurant foods.
§ 101.11 Saccharin and its salts; retail establishment notice.
§ 101.12 Reference amounts customarily consumed per eating occasion.
§ 101.13 Nutrient content claims-general principles.
§ 101.14 Health claims: general requirements.
§ 101.15 Food; prominence of required statements.
§ 101.17 Food labeling warning and notice statements.
§ 101.18 Misbranding of food.
Subpart B - Specific Food Labeling Requirements
§ 101.22 Foods; labeling of spices, flavorings, colorings and chemical
preservatives.
§ 101.25 [Removed]
§ 101.29 Labeling of kosher and kosher-style foods.
§ 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
§ 101.33 Label declaration of D-erythro-ascorbic acid when it
is an ingredient of a fabricated food.
§ 101.36 Nutrition labeling of dietary supplements of vitamins and
minerals.
Subpart C - Specific Nutrition Labeling Requirements and Guidelines
§ 101.42 Nutrition labeling of raw fruit, vegetables, and fish.
§ 101.43 Substantial compliance of food retailers with the guidelines
for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
§ 101.44 Identification of the 20 most frequently consumed raw fruit, vegetables, and fish in the United States.
§ 101.45 Guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2,
1993]
Subpart D - Specific Requirements for Nutrient Content Claims
§ 101.54 Nutrient content claims for "good source," "high," and "more."
§ 101.56 Nutrient content claims for "light" or "lite."
§ 101.60 Nutrient content claims for the calorie content of foods.
§ 101.61 Nutrient content claims for the sodium content of foods.
§ 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods.
§ 101.65 Implied nutrient content claims and related label statements.
§ 101.69 Petitions for nutrient content claims.
Subpart E - Specific Requirements for Health Claims
§ 101.70 Petitions for health claims.
§ 101.71 Health claims: claims not authorized.
§ 101.72 Health claims: calcium and osteoporosis.
§ 101.73 Health claims: dietary lipids and cancer.
§ 101.74 Health claims: sodium and hypertension.
§ 101.75 Health claims: dietary saturated fat and cholesterol and risk
of coronary heart disease.
§ 101.76 Health claims: fiber-containing grain products, fruits, and vegetables
and cancer.
§ 101.77 Health claims: fruits, vegetables, and grain products that contain
fiber, particularly soluble fiber, and risk of coronary heart disease.
§ 101.78 Health claims: fruits and vegetables and cancer.
Subpart F - Specific Requirements for Descriptive Claims that are neither Nutrient Content Claims nor Health Claims
§ 101.95 "Fresh," "freshly frozen," "fresh frozen," "frozen fresh."
§ 101.100 Food; exemptions from labeling.
§ 101.103 Petitions requesting exemptions from or special requirements for label declaration of ingredients.
§ 101.105 Declaration of net quantity of contents when exempt.
§ 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments.
Subpart A - General Provisions
§ 101.1 Principal display panel of package form food.
The term "principal display panel" as it applies to food in package form and
as used in this part, means the part of a label that is most likely to be
displayed, presented, shown, or examined under customary conditions of display
for retail sale. The principal display panel shall be large enough to accommodate
all the mandatory label information required to be placed thereon by this
part with clarity and conspicuousness and without obscuring design, vignettes,
or crowding. Where packages bear alternate principal display panels, information
required to be placed on the principal display panel shall be duplicated
on each principal display panel. For the purpose of obtaining uniform type
size in declaring the quantity of contents for all packages of substantially
the same size, the term "area of the principal display panel" means the
area of the side or surface that bears the principal display panel, which
area shall be:
- (a) In the case of a rectangular package where one entire side properly
can be considered to be the principal display panel side, the product
of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical
container, 40 percent of the product of the height of the container times the
circumference;
(c) In the case of any otherwise shaped container,
40 percent of the total surface of the container: Provided, however, that where
such container presents an obvious "principal display panel"such as the
top of a triangular or circular package of cheese, the area shall consist of
the entire top surface. In determining the area of the principal display panel,
exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and
necks of bottles or jars. In the case of cylindrical or nearly cylindrical
containers, information required by this part to appear on the principal display
panel shall appear within that 40 percent of the circumference which is most
likely to be displayed, presented, shown, or examined under customary conditions
of display for retail sale.
§ 101.2 Information panel of package form food.
- (a) The term "information panel"as it applies to packaged food means
that part of the label immediately contiguous and to the right of the
principal display panel as observed by an individual facing the principal
display panel with the following exceptions:
- (1) If the part of the label immediately contiguous and to the right
of the principal display panel is too small to accommodate the necessary
information or is otherwise unusable label space, e.g., folded flaps
or can ends, the panel immediately contiguous and to the right of
this part of the label may be used.
(2) If the package has one or more alternate principal display panels,
the information panel is immediately contiguous and to the right of
any principal display panel.
(3) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package of
food pursuant to §§ 101.4, 101.5, 101.8, 101.9, 101.17, 101.25
and Part 105 of this chapter shall appear either on the principal display
panel or on the information panel, unless otherwise specified by regulations
in this chapter.
(c) All information appearing on the principal display panel or the information
panel pursuant to this section shall appear prominently and conspicuously,
but in no case may the letters and/or numbers be less than one-sixteenth
inch in height unless an exemption pursuant to paragraph (f) of this section
is established. The requirements for conspicuousness and legibility shall
include the specifications of §§ 101.105(h) (1) and (2) and 101.15.
- (1) Packaged foods are exempt from the type size requirements of
this paragraph: Provided, That:
- (i) The package is designed such that it has a surface area
that can bear an information panel and/or an alternate principal
display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in §
101.1 is less than 10 square inches.
(iii) The label information includes:
- (a) Nutrition labeling in accordance with § 101.9.
(b) A full list of ingredients in accordance with regulations
in this part and the policy expressed in § 101.6.
(iv) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label
in accordance with the provisions of this paragraph (c) except
that the type size is not less than three sixty-fourths inch in
height.
(2) Packaged foods are exempt from the type size requirements of this
paragraph: Provided, That:
- (i) The package is designed such that it has a single "obvious
principal display panel"as this term is defined in § 101.1
and has no other available surface area for an information panel
or alternate principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in §
101.1 is less than 12 square inches and bears all labeling appearing
on the package.
(iii) The label information includes:
- (a) Nutrition labeling in accordance with § 101.9.
(b) A full list of ingredients in accordance with regulations
in this part and the policy expressed in § 101.6.
(iv) The information required by paragraph (b) of this section
appears on the single, obvious principal display panel in accordance
with the provisions of this paragraph (c) except that the type
size is not less than one thirty-second inch in height.
(3) Packaged foods are exempt from the type size requirements of this
paragraph: Provided, That:
- (i) The package is designed such that it has a total surface
area available to bear labeling of less than 12 square inches.
(ii) The label information includes:
- (a) Nutrition labeling in accordance with § 101.9.
(b) A full list of ingredients in accordance with regulations
in this part and the policy expressed in § 101.6.
(iii) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label
in accordance with the provisions of this paragraph (c) except
that the type size is not less than one thirty-second inch in
height.
(4)(i) Soft drinks packaged in bottles manufactured before October
31, 1975 shall be exempt from the requirements prescribed by this
section to the extent that information which is blown, lithographed,
or formed onto the surface of the bottle is exempt from the size and
placement requirements of this section.
(ii) Soft drinks packaged in bottles shall be exempt from the size
and placement requirements prescribed by this section if all of the
following conditions are met:
- (a) If the soft drink is packaged in a bottle bearing a paper,
plastic foam jacket, or foil label, or is packaged in a non-reusable
bottle bearing a label lithographed onto the surface of the bottle
or is packaged in metal cans, the product shall not be exempt
from any requirement of this section other than the exemptions
created by § 1.24(a)(5) (ii) and (v) of this chapter and
the label shall bear all required information in the specified
minimum type size, except the label will not be required to bear
the information required by § 101.5 if this information appears
on the bottle closure or on the lid of the can in a type size
not less than one-sixteenth inch in height, or if embossed on
the lid of the can in a type size not less than one-eighth inch
in height.
(b) If the soft drink is packaged in a bottle which does not bear
a paper, plastic foam jacket or foil label, or is packaged in
a reusable bottle bearing a label lithographed onto the surface
of the bottle:
- (1) Neither the bottle nor the closure is required to bear
nutrition labeling in compliance with § 101.9, except
that any multiunit retail package in which it is contained
shall bear nutrition labeling if required by § 101.9;
and any vending machine in which it is contained shall bear
nutrition labeling if nutrition labeling is not present on
the bottle or closure, if required by § 101.9.
(2) All other information pursuant to this section shall appear
on the top of the bottle closure prominently and conspicuously
in letters and/or numbers no less than one thirty-second inch
in height, except that if the information required by §
101.5 is placed on the side of the closure in accordance with
§ 1.24(a)(5)(ii) of this chapter, such information shall
appear in letters and/or numbers no less than one-sixteenth
inch in height.
(3) Upon the petition of any interested person demonstrating
that the bottle closure is too small to accommodate this information,
the Commissioner may by regulation establish an alternative
method of disseminating such information. Information appearing
on the closure shall appear in the following priority:
- (i) The warning required by § 100.130 of this chapter.
(ii) The statement of ingredients.
(iii) The name and address of the manufacturer, packer,
or distributor.
(iv) The statement of identity.
(5) Individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, are exempt from type-size requirements
of this paragraph, provided:
- (i) The package has a total area of 3 square inches or less
available to bear labeling;
(ii) There is insufficient area on the package available to print
all required information in a type size of 1/16 inch in
height;
(iii) The label information includes a full list of ingredients
in accordance with regulations in this part and the policy expressed
in § 101.6 of this chapter; and
(iv) The information required by paragraph (b) of this section
appears on the label in accordance with the provisions of this
paragraph, except that the type size is not less than 1/32 inch
in height.
(d)(1) All information required to appear on the principal display panel
or on the information panel pursuant to this section shall appear on the
same panel unless there is insufficient space. In determining the sufficiency
of the available space, any vignettes, design, and other non-mandatory
label information shall not be considered. If there is insufficient space
for all of this information to appear on a single panel, it may be divided
between these two panels except that the information required pursuant
to any given section or part shall all appear on the same panel. A food
whose label is required to bear the ingredient statement on the principal
display panel may bear all other information specified in paragraph (b)
of this section on the information panel.
(2) Any food, not otherwise exempted in this section, if packaged in
a container consisting of a separate lid and body, and bearing nutrition
labeling pursuant to § 101.9, and if the lid qualifies for and
is designed to serve as a principal display panel, shall be exempt from
the placement requirements of this section in the following respects:
- (i) The name and place of business information required by §
101.5 shall not be required on the body of the container if this information
appears on the lid in accordance with this section.
(ii) The nutrition information required by § 101.9 shall not
be required on the lid if this information appears on the container
body in accordance with this section.
(iii) The statement of ingredients required by § 101.4 shall
not be required on the lid if this information appears on the container
body in accordance with this section. Further, the statement of ingredients
is not required on the container body if this information appears
on the lid in accordance with this section.
(e) All information appearing on the information panel pursuant to this
section shall appear in one place without other intervening material.
(f) If the label of any package of food is too small to accommodate all
of the information required by § 101.4, 101.5, 101.8, 101.9, 101.17,
and 101.25, and Part 105 of this chapter, the Commissioner may establish
by regulation an acceptable alternative method of disseminating such information
to the public, e.g., a type size smaller than one-sixteenth inch in height,
or labeling attached to or inserted in the package or available at the
point of purchase. A petition requesting such a regulation, as an amendment
to this paragraph shall be submitted pursuant to Part 10 of this chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977;
44 FR 16006, Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5,
1988]
§ 101.3 Identity labeling of food in packaged
form.
- (a) The principal display panel of a food in package form shall
bear as one of its principal features a statement of the identity of
the commodity.
(b) Such statement of identity shall
be in terms of:
- (1) The name now or hereafter specified
in or required by any applicable Federal law or regulation; or, in the absence
thereof,
(2) The common or usual name of the
food; or, in the absence thereof,
(3) An appropriately descriptive term,
or when the nature of the food is obvious, a fanciful name commonly used by
the public for such food.
(c) Where a food is marketed in various
optional forms (whole, slices, diced, etc.), the particular form shall be considered
to be a necessary part of the statement of identity and shall be declared in
letters of a type size bearing a reasonable relation to the size of the letters
forming the other components of the statement of identity; except that if the
optional form is visible through the container or is depicted by an appropriate
vignette, the particular form need not be included in the statement. This specification
does not affect the required declarations of identity under definitions and
standards for foods promulgated pursuant to section 401 of the act.
(d) This statement of identity shall be presented in bold type on the
principal display panel, shall be in a size reasonably related to the
most prominent printed matter on such panel, and shall be in lines generally
parallel to the base on which the package rests as it is designed to be
displayed.
(e) Under the provisions of section
403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed
to be misbranded if it is an imitation of another food unless its label bears,
in type of uniform size and prominence, the word "imitation"and, immediately
thereafter, the name of the food imitated.
- (1) A food shall be deemed to be an
imitation and thus subject to the requirements of section 403(c) of the act
if it is a substitute for and resembles another food but is nutritionally inferior
to that food.
(2) A food that is a substitute for
and resembles another food shall not be deemed to be an imitation provided
it meets each of the following requirements:
- (i) It is not nutritionally inferior
to the food for which it substitutes and which it resembles.
(ii) Its label bears a common or usual
name that complies with the provisions of § 102.5 of this chapter and that
is not false or misleading, or in the absence of an existing common or usual
name, an appropriately descriptive term that is not false or misleading. The
label may, in addition, bear a fanciful name which is not false or misleading.
(3) A food for which a common or usual
name is established by regulation (e.g., in a standard of identity pursuant
to section 401 of the act, in a common or usual name regulation pursuant to
Part 102 of this chapter, or in a regulation establishing a nutritional quality
guideline pursuant to Part 104 of this chapter), and which complies with all
of the applicable requirements of such regulation(s), shall not be deemed to
be an imitation.
(4) Nutritional inferiority includes:
- (i) Any reduction in the content of an essential nutrient that is present in
a measurable amount, but does not include a reduction in the caloric or fat
content provided the food is labeled pursuant to the provisions of § 101.9,
and provided the labeling with respect to any reduction in caloric content
complies with the provisions applicable to caloric content in Part 105 of this
chapter.
(ii) For the purpose of this section, a measurable
amount of an essential nutrient in a food shall be considered to be 2 percent
or more of the U.S. RDA of protein or any vitamin or mineral listed under § 101.9(c)(7)(iv)
of this chapter per average or usual serving, or where the food is customarily
not consumed directly, per average or usual portion, as established in § 101.9.
(iii) If the Commissioner concludes that a food
is a substitute for and resembles another food but is inferior to the food
imitated for reasons other than those set forth in this paragraph, he may propose
appropriate revisions to this regulation or he may propose a separate regulation
governing the particular food.
(f) A label may be required to bear the percentage(s)
of a characterizing ingredient(s) or information concerning the presence or
absence of an ingredient(s) or the need to add an ingredient(s) as part of
the common or usual name of the food pursuant to Subpart B of Part 102 of this
chapter.
[42 FR 14308, Mar. 15, 1977, as amended at 48 FR
10811, Mar. 15, 1983]
§ 101.4 Food; designation of ingredients.
- (a)(1) Ingredients required to be declared on
the label of a food, including foods that comply with standards of identity
that require labeling in compliance with this Part 101, except those exempted
by § 101.100, shall be listed by common or usual name in descending order of
predominance by weight on either the principal display panel or the information
panel in accordance with the provisions of § 101.2.
(2) The descending order of predominance
requirements of paragraph (a)(1) of this section do not apply to ingredients
present in amounts of 2 percent or less by weight when a listing of these ingredients
is placed at the end of the ingredient statement following an appropriate quantifying
statement, e.g., "Contains ___ percent or less of ___,"or "Less than ___
percent of ___."The blank percentage within the quantifying statement shall
be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent,
1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying
phrase applies may be present in an amount greater than the stated threshold.
(b) The name of an ingredient shall
be a specific name and not a collective (generic) name, except that:
- (1) Spices, flavorings, colorings and
chemical preservatives shall be declared according to the provisions of § 101.22.
(2) An ingredient which itself contains
two or more ingredients and which has an established common or usual name,
conforms to a standard established pursuant to the Meat Inspection or Poultry
Products Inspection Acts by the U.S. Department of Agriculture, or conforms
to a definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement
of ingredients on the label of such food by either of the following alternatives:
- (i) By declaring the established common
or usual name of the ingredient followed by a parenthetical listing of all
ingredients contained therein in descending order of predominance except that,
if the ingredient is a food subject to a definition and standard of identity
established in this Subchapter B, only the ingredients required to be declared
by the definition and standard of identity need be listed; or
(ii) By incorporating into the statement of ingredients in descending
order of predominance in the finished food, the common or usual
name of every component of the ingredient without listing the
ingredient itself.
(3) Skim milk, concentrated skim milk,
reconstituted skim milk, and nonfat dry milk may be declared as "skim milk"or "nonfat milk".
(4) Milk, concentrated milk, reconstituted
milk, and dry whole milk may be declared as "milk".
(5) Bacterial cultures may be declared
by the word "cultured"followed by the name of the substrate, e.g., "made
from cultured skim milk or cultured buttermilk".
(6) Sweet cream buttermilk, concentrated
sweet cream buttermilk, reconstituted sweet cream buttermilk, and dried sweet
cream buttermilk may be declared as "buttermilk".
(7) Whey, concentrated whey, reconstituted
whey, and dried whey may be declared as "whey".
(8) Cream, reconstituted cream, dried
cream, and plastic cream (sometimes known as concentrated milk fat) may be
declared as "cream".
(9) Butter oil and anhydrous butterfat
may be declared as "butterfat".
(10) Dried whole eggs, frozen whole
eggs, and liquid whole eggs may be declared as "eggs".
(11) Dried egg whites, frozen egg whites,
and liquid egg whites may be declared as "egg whites".
(12) Dried egg yolks, frozen egg yolks,
and liquid egg yolks may be declared as "egg yolks".
(13) [Reserved]
(14)
Each individual fat and/or oil ingredient of a food intended for human
consumption shall be declared by its specific common or usual name
(e.g., "beef fat", "cottonseed oil") in its order of predominance in
the food except that blends of fats and/or oils may be designated in
their order of predominance in the foods as "- shortening"or "blend of
- oils", the blank to be filled in with the word "vegetable", "animal",
"marine", with or without the terms "fat"or "oils", or combination of
these, whichever is applicable if, immediately following the term, the
common or usual name of each individual vegetable, animal, or marine
fat or oil is given in parentheses, e.g., "vegetable oil shortening
(soybean and cotton-seed oil)". For products that are blends of fats
and/or oils and for foods in which fats and/or oils constitute the
predominant ingredient, i.e., in which the combined weight of all fat
and/or oil ingredients equals or exceeds the weight of the most
predominant ingredient that is not a fat or oil, the listing of the
common or usual names of such fats and/or oils in parentheses shall be
in descending order of predominance. In all other foods in which a
blend of fats and/or oils is used as an ingredient, the listing of the
common or usual names in parentheses need not be in descending order of
predominance if the manufacturer, because of the use of varying
mixtures, is unable to adhere to a constant pattern of fats and/or oils
in the product. If the fat or oil is completely hydrogenated, the name
shall include the term "hydrogenated", or if partially hydrogenated,
the name shall include the term "partially hydrogenated". If each fat
and/or oil in a blend or the blend is completely hydrogenated, the term
"hydrogenated"may precede the term(s) describing the blend, e.g.,
"hydrogenated vegetable oil (soybean, cottonseed, and palm oils)",
rather than preceding the name of each individual fat and/or oil; if
the blend of fats and/or oils is partially hydrogenated, the term
"partially hydrogenated"may be used in the same manner. Fat and/or oil
ingredients not present in the product may be listed if they may
sometimes be used in the product. Such ingredients shall be identified
by words indicating that they may not be present, such as "or",
"and/or", "contains one or more of the following:", e.g., "vegetable
oil shortening (contains one or more of the following: cottonseed oil,
palm oil, soybean oil)". No fat or oil ingredient shall be listed
unless actually present if the fats and/or oils constitute the
predominant ingredient of the product, as defined in this paragraph
(b)(14).
(15) When all the ingredients
of a wheat flour are declared in an ingredient statement, the principal ingredient
of the flour shall be declared by the name(s) specified in §§ 137.105, 137.200,
137.220 and 137.225 of this chapter, i.e., the first ingredient designated
in the ingredient list of flour, or bromated flour, or enriched flour, or self-rising
flour is "flour", "white flour", "wheat flour", or "plain flour"; the
first ingredient designated in the ingredient list of durum flour is "durum
flour"; the first ingredient designated in the ingredient list of whole wheat
flour, or bromated whole wheat flour is "whole wheat flour", "graham flour",
or "entire wheat flour"; and the first ingredient designated in the ingredient
list of whole durum wheat flour is "whole durum wheat flour".
(16) Ingredients that act as leavening agents
in food may be declared in the ingredient statement by stating the specific
common or usual name of each individual leavening agent in parentheses following
the collective name "leavening", e.g., "leavening (baking soda, monocalcium
phosphate, and calcium carbonate)". The listing of the common or usual name
of each individual leavening agent in parentheses shall be in descending order
of predominance: Except, That if the manufacturer is unable to adhere to a
constant pattern of leavening agents in the product, the listing of individual
leavening agents need not be in descending order of predomi-nance. Leavening
agents not present in the product may be listed if they are sometimes used
in the product. Such ingredients shall be identified by words indicating that
they may not be present, such as "or", "and/or", "contains one or more
of the following:".
(17) Ingredients that act as yeast nutrients
in foods may be declared in the ingredient statement by stating the specific
common or usual name of each individual yeast nutrient in parentheses following
the collective name "yeast nutrients", e.g., "yeast nutrients (calcium sulfate
and ammonium phosphate)". The listing of the common or usual name of each
individual yeast nutrient in parentheses shall be in descending order of predominance:
Except, That if the manufacturer is unable to adhere to a constant pattern
of yeast nutrients in the product, the listing of the common or usual names
of individual yeast nutrients need not be in descending order of predominance.
Yeast nutrients not present in the product may be listed if they are sometimes
used in the product. Such ingredients shall be identified by words indicating
that they may not be present, such as "or", "and/or", or "contains one
or more of the following:".
(18) Ingredients that act as dough conditioners
may be declared in the ingredient statement by stating the specific common
or usual name of each individual dough conditioner in parentheses following
the collective name "dough conditioner", e.g., "dough conditioners (L-cysteine,
ammonium sulfate)". The listing of the common or usual name of each dough
conditioner in parentheses shall be in descending order of predominance: Except,
That if the manufacturer is unable to adhere to a constant pattern of dough
conditioners in the product, the listing of the common or usual names of individual
dough conditioners need not be in descending order of predominance. Dough conditioners
not present in the product may be listed if they are sometimes used in the
product. Such ingredients shall be identified by words indicating that they
may not be present, such as "or", "and/or", or "contains one or more of
the following:".
(19) Ingredients that act as firming agents in
food (e.g., salts of calcium and other safe and suitable salts in canned vegetables)
may be declared in the ingredient statement, in order of predominance appropriate
for the total of all firming agents in the food, by stating the specific common
or usual name of each individual firming agent in descending order of predominance
in parentheses following the collective name "firming agents". If the manufacturer
is unable to adhere to a constant pattern of firming agents in the food, the
listing of the individual firming agents need not be in descending order of
predominance. Firming agents not present in the product may be listed if they
are sometimes used in the product. Such ingredients shall be identified by
words indicating that they may not be present, such as "or", "and/or",
"contains one or more of the following:"
(c) When water is added to reconstitute, completely
or partially, an ingredient permitted by paragraph (b) of this section to be
declared by a class name, the position of the ingredient class name in the
ingredient statement shall be determined by the weight of the unreconstituted
ingredient plus the weight of the quantity of water added to reconstitute that
ingredient, up to the amount of water needed to reconstitute the ingredient
to single strength. Any water added in excess of the amount of water needed
to reconstitute the ingredient to single strength shall be declared as "water"in the ingredient statement.
[42 FR 14308, Mar. 15, 1977, as amended at 43 FR
12858, Mar. 28, 1978; 43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983;
55 FR 17433, Apr. 25, 1990]
§ 101.5 Food; name and place of business of manufacturer,
packer, or distributor.
- (a) The label of a food in packaged form shall
specify conspicuously the name and place of business of the manufacturer, packer,
or distributor.
(b) The requirement for declaration of the name
of the manufacturer, packer, or distributor shall be deemed to be satisfied,
in the case of a corporation, only by the actual corporate name, which may
be preceded or followed by the name of the particular division of the corporation.
In the case of an individual, partnership, or association, the name under which
the business is conducted shall be used.
(c) Where the food is not manufactured by the
person whose name appears on the label, the name shall be qualified by a phrase
that reveals the connection such person has with such food; such as "Manufactured
for -------", "Distributed by -------", or any other wording that expresses
the facts.
(d) The statement of the place of business shall
include the street address, city, State, and ZIP code; however, the street
address may be omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP code shall apply only to
consumer commodity labels developed or revised after the effective date of
this section. In the case of non-consumer packages, the ZIP code shall appear
either on the label or the labeling (including invoice).
(e) If a person manufactures, packs, or distributes
a food at a place other than his principal place of business, the label may
state the principal place of business in lieu of the actual place where such
food was manufactured or packed or is to be distributed, unless such statement
would be misleading.
[Code of Federal Regulations]
[Title 21, Volume 2, Parts 100 to 169]
[Revised as of April 1, 1997]
From the U.S. Government Printing Office via GPO
Access
[CITE: 21CFR109.4]
[Page 192-193]
TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES - CONTINUED
PART 109 - UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL - Table of Contents
Subpart A - General Provisions
Sec. 109.4 Establishment of tolerances, regulatory
limits, and action levels.
- (a) When appropriate under the criteria of
Sec. 109.6, a tolerance for an added poisonous or deleterious substance, which
may be a food additive, may be established by regulation in subpart B of this
part under the provisions of section 406 of the act. A tolerance may prohibit
any detectable amount of the substance in food.
(b) When appropriate under the criteria of
Sec. 109.6, and under section 402(a)(1) of the act, a regulatory limit for
an added poisonous or deleterious substance, which may be a food additive,
may be established by regulation in subpart C of this part under the provisions
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit
any detectable amount of the substance in food. The regulatory limit established
represents the level at which food is adulterated within the meaning of section
402(a)(1) of the act.
(c)(1) When appropriate under the criteria of Sec. 109.6,
an action level for an added poisonous or deleterious substance, which may
be a food additive, may be established to define a level of contamination at
which a food may be regarded as adulterated.
(2) Whenever an action level is established
or changed, a notice shall be published in the Federal Register as soon as
practicable thereafter. The notice shall call attention to the material supporting
the action level which shall be on file with the Dockets Management Branch
before the notice is published. The notice shall invite public comment on the
action level.
(d) A regulation may be established in subpart
D of this part to identify a food containing a naturally occurring poisonous
or deleterious substance which will be deemed to be adulterated under section
402(a)(1) of the act. These regulations do not constitute a complete list of
such foods.
[42 FR 52819, Sept. 30, 1977, as amended at 55
FR 20785, May 21, 1990]
[Code of Federal Regulations]
[Title 21, Volume 2, Parts 100 to 169]
[Revised as of April 1, 1997]
From the U.S. Government Printing Office via GPO
Access
[CITE: 21CFR109.6]
[Page 193-194]
TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES - CONTINUED
PART 109 - UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL - Table of Contents
Subpart A - General Provisions
Sec. 109.6 Added poisonous or deleterious substances.
- (a) Use of an added poisonous or deleterious
substance, other than a pesticide chemical, that is also a food additive, will
be controlled by a regulation issued under section 409 of the act when possible.
When such a use cannot be approved under the criteria of section 409 of the
act, or when the added poisonous or deleterious substance is not a food additive,
a tolerance, regulatory limit, or action level may be established pursuant
to the criteria in paragraphs (b), (c), or (d) of this section. Residues resulting
from the use of an added poisonous or deleterious substance that is also a
pesticide chemical will ordinarily be controlled by a tolerance established
in a regulation issued under sections 406, 408, or 409 of the act by the U.S.
Environmental Protection Agency (EPA). When such a regulation has not been
issued, an action level for an added poisonous or deleterious substance that
is also a pesticide chemical may be established by the Food and Drug Administration.
The Food and Drug Administration will request EPA to recommend such an action
level pursuant to the criteria established in paragraph (d) of this section.
(b) A tolerance for an added poisonous or deleterious
substance in any food may be established when the following criteria are met:
- (1) The substance cannot be avoided by good
manufacturing practice.
(2) The tolerance established is sufficient
for the protection of the public health, taking into account the extent to
which the presence of the substance cannot be avoided and the other ways in
which the consumer may be affected by the same or related poisonous or deleterious
substances.
(3) No technological or other changes are foreseeable
in the near future that might affect the appropriateness of the tolerance established.
Examples of changes that might affect the appropriateness of the tolerance
include anticipated improvements in good manufacturing practice that would
change the extent to which use of the substance is unavoidable and anticipated
studies expected to provide significant new toxicological or use data.
(c) A regulatory limit for an added poisonous or deleterious substance in any food may be established when each of the following
criteria is met:
- (1) The substance cannot be avoided by current
good manufacturing practices.
(2) There is no tolerance established for the
substance in the particular food under sections 406, 408, or 409 of the act.
(3) There is insufficient information by which
a tolerance may be established for the substance under section 406 of the act
or technological changes appear reasonably possible that may affect the appropriateness
of a tolerance. The regulatory limit established represents the level at which
food is adulterated within the meaning of section 402(a)(1) of the act.
(d) An action level for an added poisonous
or deleterious substance in any food may be established when the criteria in
paragraph (b) of this section are met, except that technological or other changes
that might affect the appropriateness of the tolerance are foreseeable in the
near future. An action level for an added poisonous or deleterious substance
in any food may be established at a level at which the Food and Drug Administration
may regard the food as adulterated within the meaning of section 402(a)(1)
of the act, without regard to the criteria in paragraph (b) of this section
or in section 406 of the act. An action level will be withdrawn when a tolerance
or regulatory limit for the same substance and use has been established.
(e) Tolerances will be established under authority
appropriate for action levels (sections 306, 402(a), and 701(a) of the act,
together with section 408 or 409 of the act, if appropriate) as well as under
authority appropriate for tolerances (sections 406 and 701 of the act). In
the event the effectiveness of a tolerance is stayed pursuant to section
701(e)(2) of the act by the filing of an objection,
the order establishing the tolerance shall be deemed to be an order establishing
an action level until final action is taken upon such objection.
[42 FR 52819, Sept. 30, 1977, as amended at 55
FR 20785, May 21, 1990]
PART 110 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTUR-ING, PACKING,
OR HOLDING HUMAN FOOD
Subpart A - General Provisions
§ 110.3 Definitions.
§ 110.5 Current good manufacturing practice.
§ 110.10 Personnel.
§ 110.19 Exclusions.
Subpart B - Buildings and Facilities
§ 110.20 Plant and grounds.
§ 110.35 Sanitary operations.
§ 110.37 Sanitary facilities and controls.
Subpart C - Equipment
§110.40 Equipment and utensils.
Subpart D - [Reserved]
Subpart E - Production and Process Controls
§ 110.80 Processes and controls.
§ 110.93 Warehousing and distribution.
Subpart F - [Reserved]
Subpart G - Defect Action Levels
§ 110.110 Natural and unavoidable defects in food
for human use that present no health hazard.
Authority: Secs. 402, 701, 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health
Service Act (42 U.S.C. 264).
Source: 51 FR 24475, June 19, 1986, unless otherwise
noted.
Subpart A - General Provisions
§ 110.3 Definitions.
The definitions and interpretations
of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act)
are applicable to such terms when used in this part. The following definitions
shall also apply:
- (a) "Acid foods or acidified foods"means foods that
have an equilibrium pH of 4.6 or below.
(b) "Adequate" means that which is needed to accomplish the intended
purpose in keeping with good public health practice.
(c) "Batter" means a semi fluid substance, usually composed of
flour and other ingredients, into which principal components of food are
dipped or with which they are coated, or which may be used directly to
form bakery foods.
(d) "Blanching," except for tree nuts and peanuts, means a prepackaging
heat treatment of foodstuffs for a sufficient time and at a sufficient
temperature to partially or completely inactivate the naturally occurring
enzymes and to effect other physical or biochemical changes in the food.
(e) "Critical control point" means a point in a food process
where there is a high probability that improper control may cause, allow,
or contribute to a hazard or to filth in the final food or decomposition
of the final food.
(f) "Food" means food as defined in section 201(f) of the act
and includes raw materials and ingredients.
(g) "Food-contact surfaces" are those surfaces that contact human
food and those surfaces from which drainage onto the food or onto surfaces
that contact the food ordinarily occurs during the normal course of operations.
"Food-contact surfaces"includes utensils and food-contact surfaces of
equipment.
(h) "Lot" means the food produced during a period of time indicated
by a specific code.
(i) "Microorganisms" means yeasts, molds, bacteria, and viruses
and includes, but is not limited to, species having public health significance.
The term "undesirable microorganisms" includes those microorganisms that
are of public health significance, that subject food to decomposition,
that indicate that food is contaminated with filth, or that otherwise
may cause food to be adulterated within the meaning of the act. Occasionally
in these regulations, FDA used the adjective "microbial"instead of using
an adjectival phrase containing the word microorganism.
(j) "Pest" refers to any objectionable animals or insects including,
but not limited to, birds, rodents, flies, and larvae.
(k) "Plant" means the building or facility or parts thereof,
used for or in connection with the manufacturing, packaging, labeling,
or holding of human food.
(l) "Quality control operation" means a planned and systematic
procedure for taking all actions necessary to prevent food from being
adulterated within the meaning of the act.
(m) "Rework" means clean, unadulterated food that has been removed
from processing for reasons other than unsanitary conditions or that has
been successfully reconditioned by reprocessing and that is suitable for
use as food.
(n) "Safe-moisture level" is a level of moisture low enough to
prevent the growth of undesirable microorganisms in the finished product
under the intended conditions of manufacturing, storage, and distribution.
The maximum safe moisture level for a food is based on its water activity
(aw). An awwill be considered safe for a food if
adequate data are available that demonstrate that the food at or below
the given awwill not support the growth of undesirable microorganisms.
(o) "Sanitize" means to adequately treat food-contact surfaces
by a process that is effective in destroying vegetative cells of microorganisms
of public health significance, and in substantially reducing numbers of
other undesirable microorganisms, but without adversely affecting the
product or its safety for the consumer.
(p) "Shall" is used to state mandatory requirements.
(q) "Should" is used to state recommended or advisory procedures
or identify recommended equipment.
(r) "Water activity"(aw)
is a measure of the free moisture in a food and is the quotient of the water
vapor pressure of the substance divided by the vapor pressure of pure water
at the same temperature.
§ 110.5 Current good manufacturing practice.
- (a) The criteria and definitions
in this part shall apply in determining whether a food is adulterated (1) within
the meaning of section 402(a)(3) of the act in that the food has been manufactured
under such conditions that it is unfit for food; or (2) within the meaning
of section 402(a)(4) of the act in that the food has been prepared, packed,
or held under unsanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to health. The criteria
and definitions in this part also apply in determining whether a food is in
violation of section 361 of the Public Health Service Act (42 U.S.C. 264).
(b) Food covered by specific current good manufacturing practice regulations
also is subject to the requirements of those regulations.
§ 110.10 Personnel.
The plant management shall take all reasonable measures and precautions to ensure the following:
- (a) Disease control. Any person
who, by medical examination or supervisory observation, is shown to have, or
appears to have, an illness, open lesion, including boils, sores, or infected
wounds, or any other abnormal source of microbial contamination by which there
is a reasonable possibility of food, food-contact surfaces, or food-packaging
materials becoming contaminated, shall be excluded from any operations which
may be expected to result in such contamination until the condition is corrected.
Personnel shall be instructed to report such health conditions to their supervisors.
(b) Cleanliness. All persons
working in direct contact with food, food-contact surfaces, and food-packaging
materials shall conform to hygienic practices while on duty to the extent necessary
to protect against contamination of food. The methods for maintaining cleanliness
include, but are not limited to:
- (1) Wearing outer garments suitable
to the operation in a manner that protects against the contamination of food,
food-contact surfaces, or food-packaging materials.
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing
if necessary to protect against contamination with undesirable microorganisms)
in an adequate hand-washing facility before starting work, after each absence
from the work station, and at any other time when the hands may have become
soiled or contaminated.
(4) Removing all unsecured jewelry
and other objects that might fall into food, equipment, or containers, and
removing hand jewelry that cannot be adequately sanitized during periods in
which food is manipulated by hand. If such hand jewelry cannot be removed,
it may be covered by material which can be maintained in an intact, clean,
and sanitary condition and which effectively protects against the contamination
by these objects of the food, food-contact surfaces, or food-packaging materials.
(5) Maintaining gloves, if they are
used in food handling, in an intact, clean, and sanitary condition. The gloves
should be of an impermeable material.
(6) Wearing, where appropriate, in
an effective manner, hairnets, headbands, caps, beard covers, or other effective
hair restraints.
(7) Storing clothing or other personal belongings in areas other than
where food is exposed or where equipment or utensils are washed.
(8) Confining the following to areas
other than where food may be exposed or where equipment or utensils are washed:
eating food, chewing gum, drinking beverages, or using tobacco.
(9) Taking any other necessary precautions
to protect against contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms or foreign substances including, but not limited
to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied
to the skin.
(c) Education and training. Personnel
responsible for identifying sanitation failures or food contamination should
have a background of education or experience, or a combination thereof, to
provide a level of competency necessary for production of clean and safe food.
Food handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be informed
of the danger of poor personal hygiene and unsanitary practices.
(d) Supervision. Responsibility for
assuring compliance by all personnel with all requirements of this part shall
be clearly assigned to competent supervisory personnel.
[51 FR 24475, June 19, 1986, as amended at 54 FR
24892, June 12, 1989]
§ 110.19 Exclusions.
- (a) The following operations are
not subject to this part: Establishments engaged solely in the harvesting,
storage, or distribution of one or more "raw agricultural commodities,"as
defined in section 201(r) of the act, which are ordinarily cleaned, prepared,
treated, or otherwise processed before being marketed to the consuming public.
(b) FDA, however, will issue special
regulations if it is necessary to cover these excluded operations.
Subpart B - Buildings and Facilities
§ 110.20 Plant and grounds.
- (a) Grounds. The grounds
about a food plant under the control of the operator shall be kept in a condition
that will protect against the contamination of food. The methods for adequate
maintenance of grounds include, but are not limited to:
- (1) Properly storing equipment, removing
litter and waste, and cutting weeds or grass within the immediate vicinity
of the plant buildings or structures that may constitute an attractant, breeding
place, or harborage for pests.
(2) Maintaining roads, yards, and parking
lots so that they do not constitute a source of contamination in areas where
food is exposed.
(3) Adequately draining areas that
may contribute contamination to food by seepage, foot-borne filth, or providing
a breeding place for pests.
(4) Operating systems for waste treatment
and disposal in an adequate manner so that they do not constitute a source
of contamination in areas where food is exposed.
If the plant grounds are bordered by grounds not
under the operator§s control and not maintained in the manner described in
paragraph (a) (1) through (3) of this section, care shall be exercised in the
plant by inspection, extermination, or other means to exclude pests, dirt,
and filth that may be a source of food contamination.
(b) Plant construction and design.
Plant buildings and structures shall be suitable in size, construction, and
design to facilitate maintenance and sanitary operations for food-manufacturing
purposes. The plant and facilities shall:
- (1) Provide sufficient space for such
placement of equipment and storage of materials as is necessary for the maintenance
of sanitary operations and the production of safe food.
(2) Permit the taking of proper precautions
to reduce the potential for contamination of food, food-contact surfaces, or
food-packaging materials with microorganisms, chemicals, filth, or other extraneous
material. The potential for contamination may be reduced by adequate food safety
controls and operating practices or effective design, including the separation
of operations in which contamination is likely to occur, by one or more of
the following means: location, time, partition, air flow, enclosed systems,
or other effective means.
(3) Permit the taking of proper precautions
to protect food in outdoor bulk fermentation vessels by any effective means,
including:
- (i) Using protective coverings.
(ii) Controlling areas over and around
the vessels to eliminate harborages for pests.
(iii) Checking on a regular basis for
pests and pest infestation.
(iv) Skimming the fermentation vessels,
as necessary.
(4) Be constructed in such a manner
that floors, walls, and ceilings may be adequately cleaned and kept clean and
kept in good repair; that drip or condensate from fixtures, ducts and pipes
does not contaminate food, food-contact surfaces, or food-packaging materials;
and that aisles or working spaces are provided between equipment and walls
and are adequately unobstructed and of adequate width to permit employees to
perform their duties and to protect against contaminating food or food-contact
surfaces with clothing or personal contact.
(5) Provide adequate lighting in hand-washing
areas, dressing and locker rooms, and toilet rooms and in all areas where food
is examined, processed, or stored and where equipment or utensils are cleaned;
and provide safety-type light bulbs, fixtures, skylights, or other glass suspended
over exposed food in any step of preparation or otherwise protect against food
contamination in case of glass breakage.
(6) Provide adequate ventilation or
control equipment to minimize odors and vapors (including steam and noxious
fumes) in areas where they may contaminate food; and locate and operate fans
and other air-blowing equipment in a manner that minimizes the potential for
contaminating food, food-packaging materials, and food-contact surfaces.
(7) Provide, where necessary, adequate
screening or other protection against pests.
§ 110.35 Sanitary operations.
- (a) General maintenance.
Buildings, fixtures, and other physical facilities of the plant shall be maintained
in a sanitary condition and shall be kept in repair sufficient to prevent food
from becoming adulterated within the meaning of the act. Cleaning and sanitizing
of utensils and equipment shall be conducted in a manner that protects against
contamination of food, food-contact surfaces, or food-packaging materials.
(b) Substances used in cleaning
and sanitizing; storage of toxic materials.
- (1) Cleaning compounds and
sanitizing agents used in cleaning and sanitizing procedures shall be free
from undesirable microorganisms and shall be safe and adequate under the
conditions of use. Compliance with this requirement may be verified by any
effective means including purchase of these substances under a supplier§s
guarantee or certification, or examination of these substances for contamination.
Only the following toxic materials may be used or stored in a plant where
food is processed or exposed:
- (i) Those required to maintain clean
and sanitary conditions;
(ii) Those necessary for use in laboratory
testing procedures;
(iii) Those necessary for plant and
equipment maintenance and operation; and
(iv) Those necessary for use in the
plant§s operations.
(2) Toxic cleaning compounds, sanitizing
agents, and pesticide chemicals shall be identified, held, and stored in a
manner that protects against contamination of food, food-contact surfaces,
or food-packaging materials. All relevant regulations promulgated by other
Federal, State, and local government agencies for the application, use, or
holding of these products should be followed.
(c) Pest control. No pests
shall be allowed in any area of a food plant. Guard or guide dogs may be allowed
in some areas of a plant if the presence of the dogs is unlikely to result
in contamination of food, food-contact surfaces, or food-packaging materials.
Effective measures shall be taken to exclude pests from the processing areas
and to protect against the contamination of food on the premises by pests.
The use of insecticides or rodenticides is permitted only under precautions
and restrictions that will protect against the contamination of food, food-contact
surfaces, and food-packaging materials.
(d) Sanitation of food-contact
surfaces. All food-contact surfaces, including utensils and food-contact
surfaces of equipment, shall be cleaned as frequently as necessary to protect
against contamination of food.
- (1) Food-contact surfaces used for
manufacturing or holding low-moisture food shall be in a dry, sanitary condition
at the time of use. When the surfaces are wet-cleaned, they shall, when necessary,
be sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against
the introduction of microorganisms into food, all food-contact surfaces
shall be cleaned and sanitized before use and after any interruption
during which the food-contact surfaces may have become contaminated.
Where equipment and utensils are used in a continuous production operation,
the utensils and food-contact surfaces of the equipment shall be cleaned
and sanitized as necessary.
(3) Non-food-contact surfaces of equipment
used in the operation of food plants should be cleaned as frequently as necessary
to protect against contamination of food.
(4) Single-service articles (such as
utensils intended for one-time use, paper cups, and paper towels) should be
stored in appropriate containers and shall be handled, dispensed, used, and
disposed of in a manner that protects against contamination of food or food-contact
surfaces.
(5) Sanitizing agents shall be adequate
and safe under conditions of use. Any facility, procedure, or machine is acceptable
for cleaning and sanitizing equipment and utensils if it is established that
the facility, procedure, or machine will routinely render equipment and utensils
clean and provide adequate cleaning and sanitizing treatment.
(e) Storage and handling of cleaned
portable equipment and utensils. Cleaned and sanitized portable equipment with
food-contact surfaces and utensils should be stored in a location and manner
that protects food-contact surfaces from contamination.
[51 FR 24475, June 19, 1986, as amended at 54 FR
24892, June 12, 1989]
§ 110.37 Sanitary facilities and controls.
Each plant shall be equipped with
adequate sanitary facilities and accommodations including, but not limited
to:
- (a) Water supply. The water
supply shall be sufficient for the operations intended and shall be derived
from an adequate source. Any water that contacts food or food-contact surfaces
shall be safe and of adequate sanitary quality. Running water at a suitable
temperature, and under pressure as needed, shall be provided in all areas where
required for the processing of food, for the cleaning of equipment, utensils,
and food-packaging materials, or for employee sanitary facilities.
(b) Plumbing. Plumbing shall
be of adequate size and design and adequately installed and maintained to:
- (1) Carry sufficient quantities of
water to required locations throughout the plant.
(2) Properly convey sewage and liquid
disposable waste from the plant.
(3) Avoid constituting a source of
contamination to food, water supplies, equipment, or utensils or creating an
unsanitary condition.
(4) Provide adequate floor drainage
in all areas where floors are subject to flooding-type cleaning or where normal
operations release or discharge water or other liquid waste on the floor.
(5) Provide that there is not backflow
from, or cross-connection between, piping systems that discharge wastewater
or sewage and piping systems that carry water for food or food manufacturing.
(c) Sewage disposal. Sewage
disposal shall be made into an adequate sewerage system or disposed of through
other adequate means.
(d) Toilet facilities. Each
plant shall provide its employees with adequate, readily accessible toilet
facilities. Compliance with this requirement may be accomplished by:
- (1) Maintaining the facilities in a
sanitary condition.
(2) Keeping the facilities in good
repair at all times.
(3) Providing self-closing doors.
(4) Providing doors that do not open
into areas where food is exposed to airborne contamination, except where alternate
means have been taken to protect against such contamination (such as double
doors or positive airflow systems).
(e) Hand-washing facilities.
Hand-washing facilities shall be adequate and convenient and be furnished with
running water at a suitable temperature. Compliance with this requirement may
be accomplished by providing:
- (1) Hand-washing and, where appropriate,
hand-sanitizing facilities at each location in the plant where good sanitary
practices require employees to wash and/or sanitize their hands.
(2) Effective hand-cleaning and sanitizing
preparations.
(3) Sanitary towel service or suitable
drying devices.
(4) Devices or fixtures, such as water
control valves, so designed and constructed to protect against recontamination
of clean, sanitized hands.
(5) Readily understandable signs directing
employees handling unprotected food, unprotected food-packaging materials,
of food-contact surfaces to wash and, where appropriate, sanitize their hands
before they start work, after each absence from post of duty, and when their
hands may have become soiled or contaminated. These signs may be posted in
the processing room(s) and in all other areas where employees may handle such
food, materials, or surfaces.
(6) Refuse receptacles that are constructed
and maintained in a manner that protects against contamination of food.
(f) Rubbish and offal disposal.
Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize
the development of odor, minimize the potential for the waste becoming an attractant
and harborage or breeding place for pests, and protect against contamination
of food, food-contact surfaces, water supplies, and ground surfaces.
Subpart C - Equipment
§ 110.40 Equipment and utensils.
- (a) All plant equipment and utensils
shall be so designed and of such material and workmanship as to be adequately
cleanable, and shall be properly maintained. The design, construction, and
use of equipment and utensils shall preclude the adulteration of food with
lubricants, fuel, metal fragments, contaminated water, or any other contaminants.
All equipment should be so installed and maintained as to facilitate the cleaning
of the equipment and of all adjacent spaces. Food-contact surfaces shall be
corrosion-resistant when in contact with food. They shall be made of nontoxic
materials and designed to withstand the environment of their intended use and
the action of food, and, if applicable, cleaning compounds and sanitizing agents.
Food-contact surfaces shall be maintained to protect food from being contaminated
by any source, including unlawful indirect food additives.
(b) Seams on food-contact surfaces
shall be smoothly bonded or maintained so as to minimize accumulation of food
particles, dirt, and organic matter and thus minimize the opportunity for growth
of microorganisms.
(c) Equipment that is in the manufacturing
or food-handling area and that does not come into contact with food shall be
so constructed that it can be kept in a clean condition.
(d) Holding, conveying, and manufacturing
systems, including gravimetric, pneumatic, closed, and automated systems, shall
be of a design and construction that enables them to be maintained in an appropriate
sanitary condition.
(e) Each freezer and cold storage compartment
used to store and hold food capable of supporting growth of microorganisms
shall be fitted with an indicating thermometer, temperature-measuring device,
or temperature-recording device so installed as to show the temperature accurately
within the compartment, and should be fitted with an automatic control for
regulating temperature or with an automatic alarm system to indicate a significant
temperature change in a manual open-ration.
(f) Instruments and controls used for
measuring, regulating, or recording temperatures, pH, acidity, water activity,
or other conditions that control or prevent the growth of undesirable microorganisms
in food shall be accurate and adequately maintained, and adequate in number
for their designated uses.
(g) Compressed air or other gases mechanically
introduced into food or used to clean food-contact surfaces or equipment
shall be treated in such a way that food is not contaminated with unlawful
indirect food additives.
Subpart D - [Reserved]
Subpart E - Production and Process Controls
§ 110.80 Processes and controls.
All operations in the receiving,
inspecting, transporting, segregating, preparing, manufacturing, packaging,
and storing of food shall be conducted in accordance with adequate sanitation
principles. Appropriate quality control operations shall be employed to ensure
that food is suitable for human consumption and that food-packaging materials
are safe and suitable. Overall sanitation of the plant shall be under the supervision
of one or more competent individuals assigned responsibility for this function.
All reasonable precautions shall be taken to ensure that production procedures
do not contribute contamination from any source. Chemical, microbial, or extraneous material
testing procedures shall be used where necessary to identify sanitation failures
or possible food contamination. All food that has become contaminated to the
extent that it is adulterated within the meaning of the act shall be rejected,
or if permissible, treated or processed to eliminate the contamination.
- (a) Raw materials and other ingredients.
- (1) Raw materials and other ingredients shall be inspected and segregated
or otherwise handled as necessary to ascertain that they are clean
and suitable for processing into food and shall be stored under conditions
that will protect against contamination and minimize deterioration.
Raw materials shall be washed or cleaned as necessary to remove soil
or other contamination. Water used for washing, rinsing, or conveying
food shall be safe and of adequate sanitary quality. Water may be
reused for washing, rinsing, or conveying food if it does not increase
the level of contamination of the food. Containers and carriers of
raw materials should be inspected on receipt to ensure that their
condition has not contributed to the contamination or deterioration
of food.
(2) Raw materials and other ingredients shall either not contain levels
of microorganisms that may produce food poisoning or other disease
in humans, or they shall be pasteurized or otherwise treated during
manufacturing operations so that they no longer contain levels that
would cause the product to be adulterated within the meaning of the
act. Compliance with this requirement may be verified by any effective
means, including purchasing raw materials and other ingredients under
a supplier§s guarantee or certification.
(3) Raw materials and other ingredients susceptible to contamination
with aflatoxin or other natural toxins shall comply with current Food
and Drug Administration regulations, guidelines, and action levels
for poisonous or deleterious substances before these materials or
ingredients are incorporated into finished food. Compliance with this
requirement may be accomplished by purchasing raw materials and other
ingredients under a supplier§s guarantee or certification, or
may be verified by analyzing these materials and ingredients for aflatoxins
and other natural toxins.
(4) Raw materials, other ingredients, and rework susceptible to contamination
with pests, undesirable microorganisms, or extraneous material shall
comply with applicable Food and Drug Administration regulations, guidelines,
and defect action levels for natural or unavoidable defects if a manufacturer
wishes to use the materials in manufacturing food. Compliance with
this requirement may be verified by any effective means, including
purchasing the materials under a supplier§s guarantee or certification,
or examination of these materials for contamination.
(5) Raw materials, other ingredients, and rework shall be held in
bulk, or in containers designed and constructed so as to protect against
contamination and shall be held at such temperature and relative humidity
and in such a manner as to prevent the food from becoming adulterated
within the meaning of the act. Material scheduled for rework shall
be identified as such.
(6) Frozen raw materials and other ingredients shall be kept frozen.
If thawing is required prior to use, it shall be done in a manner
that prevents the raw materials and other ingredients from becoming
adulterated within the meaning of the act.
(7) Liquid or dry raw materials and other ingredients received and
stored in bulk form shall be held in a manner that protects against
contamination.
(b) Manufacturing operations.
- (1) Equipment and utensils and finished food containers shall be
maintained in an acceptable condition through appropriate cleaning
and sanitizing, as necessary. Insofar as necessary, equipment shall
be taken apart for thorough cleaning.
(2) All food manufacturing, including packaging and storage, shall
be conducted under such conditions and controls as are necessary to
minimize the potential for the growth of microorganisms, or for the
contamination of food. One way to comply with this requirement is
careful monitoring of physical factors such as time, temperature,
humidity, aw, pH, pressure, flow rate, and manufacturing
operations such as freezing, dehydration, heat processing, acidification,
and refrigeration to ensure that mechanical breakdowns, time delays,
temperature fluctuations, and other factors do not contribute to the
decomposition or contamination of food.
(3) Food that can support the rapid growth of undesirable microorganisms,
particularly those of public health significance, shall be held in
a manner that prevents the food from becoming adulterated within the
meaning of the act. Compliance with this requirement may be accomplished
by any effective means, including:
- (i) Maintaining refrigerated foods at 45 °F (7.2 °C)
or below as appropriate for the particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140 °F (60 °C) or above.
(iv) Heat treating acid or acidified foods to destroy mesophilic
microorganisms when those foods are to be held in hermetically
sealed containers at ambient temperatures.
(4) Measures such as sterilizing, irradiating, pasteurizing, freezing,
refrigerating, controlling pH or controlling awthat are
taken to destroy or prevent the growth of undesirable microorganisms,
particularly those of public health significance, shall be adequate
under the conditions of manufacture, handling, and distribution to
prevent food from being adulterated within the meaning of the act.
(5) Work-in-process shall be handled in a manner that protects against
contamination.
(6) Effective measures shall be taken to protect finished food from
contamination by raw materials, other ingredients, or refuse. When
raw materials, other ingredients, or refuse are unprotected, they
shall not be handled simultaneously in a receiving, loading, or shipping
area if that handling could result in contaminated food. Food transported
by conveyor shall be protected against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, or store
raw materials, work-in-process, rework, or food shall be constructed,
handled, and maintained during manufacturing or storage in a manner
that protects against contamination.
(8) Effective measures shall be taken to protect against the inclusion
of metal or other extraneous material in food. Compliance with this
requirement may be accomplished by using sieves, traps, magnets, electronic
metal detectors, or other suitable effective means.
(9) Food, raw materials, and other ingredients that are adulterated
within the meaning of the act shall be disposed of in a manner that
protects against the contamination of other food. If the adulterated
food is capable of being reconditioned, it shall be reonditioned using
a method that has been proven to be effective or it shall be reexamined
and found not to be adulterated within the meaning of the act before
being incorporated into other food.
(10) Mechanical manufacturing steps such as washing, peeling, trimming,
cutting, sorting and inspecting, mashing, dewatering, cooling, shredding,
extruding, drying, whipping, defatting, and forming shall be performed
so as to protect food against contamination. Compliance with this
requirement may be accomplished by providing adequate physical protection
of food from contaminants that may drip, drain, or be drawn into the
food. Protection may be provided by adequate cleaning and sanitizing
of all food-contact surfaces, and by using time and temperature controls
at and between each manufacturing step.
(11) Heat blanching, when required in the preparation of food, should
be effected by heating the food to the required temperature, holding
it at this temperature for the required time, and then either rapidly
cooling the food or passing it to subsequent manufacturing without
delay. Thermophilic growth and contamination in blanchers should be
minimized by the use of adequate operating temperatures and by periodic
cleaning. Where the blanched food is washed prior to filling, water
used shall be safe and of adequate sanitary quality.
(12) Batters, breading, sauces, gravies, dressings, and other similar
preparations shall be treated or maintained in such a manner that
they are protected against contamination. Compliance with this requirement
may be accomplished by any effective means, including one or more
of the following:
- (i) Using ingredients free of contamination.
(ii) Employing adequate heat processes where applicable.
(iii) Using adequate time and temperature controls.
(iv) Providing adequate physical protection of components from
contaminants that may drip, drain, or be drawn into them.
(v) Cooling to an adequate temperature during manufacturing.
(vi) Disposing of batters at appropriate intervals to protect
against the growth of microorganisms.
(13) Filling, assembling, packaging, and other operations shall be
performed in such a way that the food is protected against contamination.
Compliance with this requirement may be accomplished by any effective
means, including:
- (i) Use of a quality control operation in which the critical
control points are identified and controlled during manufacturing.
(ii) Adequate cleaning and sanitizing of all food-contact surfaces
and food containers.
(iii) Using materials for food containers and food-packaging materials
that are safe and suitable, as defined in § 130.3(d) of this
chapter.
(iv) Providing physical protection from contamination, particularly
airborne contamination.
(v) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, intermediate
moisture food, and dehydrated food, that relies on the control of
awfor preventing the growth of undesirable microorganisms
shall be processed to and maintained at a safe moisture level. Compliance
with this requirement may be accomplished by any effective means,
including employment of one or more of the following practices:
- (i) Monitoring the awof food.
(ii) Controlling the soluble solids-water ratio in finished food.
(iii) Protecting finished food from moisture pickup, by use of
a moisture barrier or by other means, so that the awof
the food does not increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified food, that
relies principally on the control of pH for preventing the growth
of undesirable microorganisms shall be monitored and maintained at
a pH of 4.6 or below. Compliance with this requirement may be accomplished
by any effective means, including employment of one or more of the
following practices:
- (i) Monitoring the pH of raw materials, food in process, and
finished food.
(ii) Controlling the amount of acid or acidified food added to
low-acid food.
(16) When ice is used in contact with food, it shall be made from
water that is safe and of adequate sanitary quality, and shall be
used only if it has been manufactured in accordance with current good
manufacturing practice as outlined in this part.
(17) Food-manufacturing areas and equipment used for manufacturing
human food should not be used to manufacture nonhuman food-grade animal
feed or inedible products, unless there is no reasonable possibility
for the contamination of the human food.
§ 110.93 Warehousing and distribution.
Storage and transportation of finished food shall be under conditions that will protect food against physical, chemical,
and microbial contamination as well as against deterioration of the food and
the container.
Subpart F - [Reserved]
Subpart G - Defect Action Levels
§ 110.110 Natural or unavoidable defects in food for human
use that present no health hazard.
- (a) Some foods, even when produced
under current good manufacturing practice, contain natural or unavoidable defects
that at low levels are not hazardous to health. The Food and Drug Administration
establishes maximum levels for these defects in foods produced under current
good manufacturing practice and uses these levels in deciding whether to recommend
regulatory action.
(b) Defect action levels are established
for foods whenever it is necessary and feasible to do so. These levels are
subject to change upon the development of new technology or the availability
of new information.
(c) Compliance with defect action levels
does not excuse violation of the requirement in section 402(a)(4) of the act
that food not be prepared, packed, or held under unsanitary conditions or the
requirements in this part that food manufacturers, distributors, and holders
shall observe current good manufacturing practice. Evidence indicating that
such a violation exists causes the food to be adulterated within the meaning
of the act, even though the amounts of natural or unavoidable defects are lower
than the currently established defect action levels. The manufacturer, distributor,
and holder of food shall at all times utilize quality control operations that
reduce natural or unavoidable defects to the lowest level currently feasible.
(d) The mixing of a food containing
defects above the current defect action level with another lot of food is not
permitted and renders the final food adulterated within the meaning of the
act, regardless of the defect level of the final food.
(e) A compilation of the current defect
action levels for natural or unavoidable defects in food for human use that
present no health hazard may be obtained upon request from the Industry Programs
Branch (HFF-326), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
[Code of Federal Regulations]
[Title 21, Volume 2, Parts 100 to 169]
[Revised as of April 1, 1997]
From the U.S. Government Printing Office via GPO
Access
[CITE: 21CFR123]
[Page 240-248]
TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES - CONTINUEPART 123 - FISH AND FISHERY PRODUCTS
Subpart A - General Provisions
Sec.
123.3 Definitions.
123.5 Current good manufacturing practice.
123.6 Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) plan.
123.7 Corrective actions.
123.8 Verification.
123.9 Records.
123.10 Training.
123.11 Sanitation control procedures.
123.12 Special requirements for imported products.
123.20 General.
123.28 Source controls.
Authority: Secs. 201, 402, 403, 406, 409, 701,
704, 721, 801, 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321,
342, 343, 346, 348, 371, 374, 379e, 381, 393); secs. 301, 307, 361 of the Public
Health Service Act (42 U.S.C. 241, 242l, 264).
Subpart B - Smoked and Smoke-Flavored Fishery Products
123.15 General.
123.16 Process controls.
Subpart C - Raw Molluscan Shellfish
Source: 60 FR 65197, Dec. 18, 1995, unless otherwise
noted.
Effective Date Note: At 60 FR 65197, Dec. 18,
1995, part 123 was added, effective December 18, 1997.
Subpart A - General Provisions
Sec. 123.3 Definitions.
The definitions and interpretations of terms in
section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in part
110 of this chapter are applicable to such terms when used in this part, except
where they are herein redefined. The following definitions shall also apply:
- (a) Certification number means a unique combination
of letters and numbers assigned by a shellfish control authority to a molluscan
shellfish processor.
(b) Critical control point means a point, step,
or procedure in a food process at which control can be applied, and a food
safety hazard can as a result be prevented, eliminated, or reduced to acceptable
levels.
(c) Critical limit means the maximum or minimum
value to which a physical, biological, or chemical parameter must be controlled
at a critical control point to prevent, eliminate, or reduce to an acceptable
level the occurrence of the identified food safety hazard.
(d) Fish means fresh or saltwater finfish,
crustaceans, other forms of aquatic animal life (including, but not limited
to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin
and the roe of such animals) other than birds or mammals, and all mollusks,
where such animal life is intended for human consumption.
(e) Fishery product means any human food product
in which fish is a characterizing ingredient.
(f) Food safety hazard means any biological,
chemical, or physical property that may cause a food to be unsafe for human
consumption.
(g) Importer means either the U.S. owner or
consignee at the time of entry into the United States, or the U.S. agent or
representative of the foreign owner or consignee at the time of entry into
the United States, who is responsible for ensuring that goods being offered
for entry into the United States are in compliance with all laws affecting
the importation. For the purposes of this definition, ordinarily the importer
is not the custom house broker, the freight forwarder, the carrier, or the
steamship representative.
(h) Molluscan shellfish means any edible species
of fresh or frozen oysters, clams, mussels, or scallops, or edible portions
of such species, except when the product consists entirely of the shucked adductor
muscle.
(i) Preventive measure means physical, chemical,
or other factors that can be used to control an identified food safety hazard.
(j) Process-monitoring instrument means an
instrument or device used to indicate conditions during processing at a critical
control point.
(k)(1) Processing means, with respect to fish
or fishery products:
Handling, storing, preparing, heading, eviscerating,
shucking, freezing, changing into different market forms, manufacturing, preserving,
packing, labeling, dockside unloading, or holding.
(2) The regulations in this part do not apply
to:
- (i) Harvesting or transporting fish or fishery
products, without otherwise engaging in processing.
(ii) Practices such as heading, eviscerating,
or freezing intended solely to prepare a fish for holding on board a harvest
vessel.
(iii) The operation of a retail establishment.
(l) Processor means any person engaged in commercial,
custom, or institutional processing of fish or fishery products, either in
the United States or in a foreign country. A processing includes any person
engaged in the production of foods that are to be used in market or consumer
tests.
(m) Scombroid toxin-forming species means tuna,
bluefish, mahi mahi, and other species, whether or not in the family Scombridae,
in which significant levels of histamine may be produced
in the fish flesh by decarboxylation of free histidine as a result of exposure
of the fish after capture to temperatures that permit the growth of mesophilic
bacteria.
(n) Shall is used to state mandatory requirements.
(o) Shellfish control authority means a Federal,
State, or foreign agency, or sovereign tribal government, legally responsible
for the administration of a program that includes activities such as classification
of molluscan shellfish growing areas, enforcement of molluscan shellfish harvesting
controls, and certification of molluscan shellfish processors.
(p) Shellstock means raw, in-shell molluscan
shellfish.
(q) Should is used to state recommended or
advisory procedures or to identify recommended equipment.
(r) Shucked shellfish means molluscan shellfish
that have one or both shells removed.
(s) Smoked or smoke-flavored fishery products
means the finished food prepared by:
- (1) Treating fish with salt (sodium chloride),
and
(2) Subjecting it to the direct action of smoke
from burning wood, sawdust, or similar material and/or imparting to it the
flavor of smoke by a means such as immersing it in a solution of wood smoke.
(t) Tag means a record of harvesting information
attached to a container of shellstock by the harvester or processor.
Sec. 123.5 Current good manufacturing practice.
- (a) Part 110 of this chapter applies in determining
whether the facilities, methods, practices, and controls used to process fish
and fishery products are safe, and whether these products have been processed
under sanitary conditions.
(b) The purpose of this part is to set forth
requirements specific to the processing of fish and fishery products.
Sec. 123.6 Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) plan.
- (a) Hazard analysis. Every processor shall
conduct, or have conducted for it, a hazard analysis to determine whether there
are food safety hazards that are reasonably likely to occur for each kind of
fish and fishery product processed by that processor and to identify the preventive
measures that the processor can apply to control those hazards. Such food safety
hazards can be introduced both within and outside the processing plant environment,
including food safety hazards that can occur before, during, and after harvest.
A food safety hazard that is reasonably likely to occur is one for which a
prudent processor would establish controls because experience, illness data,
scientific reports, or other information provide a basis to conclude that there
is a reasonable possibility that it will occur in the particular type of fish
or fishery product being processed in the absence of those controls.
(b) The HACCP plan. Every processor shall have
and implement a written HACCP plan whenever a hazard analysis reveals one or
more food safety hazards that are reasonably likely to occur, as described
in paragraph (a) of this section. A HACCP plan shall be specific to:
- (1) Each location where fish and fishery products
are processed by that processor; and
(2) Each kind of fish and fishery product processed
by the processor. The plan may group kinds of fish and fishery products together,
or group kinds of production methods together, if the food safety hazards,
critical control points, critical limits, and procedures required to be identified
and performed in paragraph (c) of this section are identical for all fish and
fishery products so grouped or for all production methods so grouped.
(c) The contents of the HACCP plan. The HACCP
plan shall, at a minimum:
- (1) List the food safety hazards that are reasonably
likely to occur, as identified in accordance with paragraph (a) of this section,
and that thus must be controlled for each fish and fishery product. Consideration
should be given to whether any food safety hazards are reasonably likely to
occur as a result of the following:
- (i) Natural toxins;
(ii) Microbiological contamination;
(iii) Chemical contamination;
(iv) Pesticides;
(v) Drug residues;
(vi) Decomposition in scombroid toxin-forming
species or in any other species where a food safety hazard has been associated
with decomposition;
(vii) Parasites, where the processor has knowledge
or has reason to know that the parasite-containing fish or fishery product
will be consumed without a process sufficient to kill the parasites, or where
the processor represents, labels, or intends for the product to be so consumed;
(viii) Unapproved use of direct or indirect
food or color additives; and
(ix) Physical hazards;
(2) List the critical control points for each
of the identified food safety hazards, including as appropriate:
- (i) Critical control points designed to control
food safety hazards that could be introduced in the processing plant environment;
and
(ii) Critical control points designed to control
food safety hazards introduced outside the processing plant environment, including
food safety hazards that occur before, during, and after harvest;
(3) List the critical limits that must be met
at each of the critical control points;
(4) List the procedures, and frequency thereof,
that will be used to monitor each of the critical control points to ensure
compliance with the critical limits;
(5) Include any corrective action plans that
have been developed in accordance with Sec. 123.7(b), to be followed in response to deviations from critical limits
at critical control points;
(6) List the verification procedures, and frequency
thereof, that the processor will use in accordance with Sec. 123.8(a);
(7) Provide for a recordkeeping system that
documents the monitoring of the critical control points. The records shall
contain the actual values and observations obtained during monitoring.
(d) Signing and dating the HACCP plan.
- (1) The HACCP plan shall be signed and dated,
either by the most responsible individual onsite at the processing facility
or by a higher level official of the processor. This signature shall signify
that the HACCP plan has been accepted for implementation by the firm.
(2) The HACCP plan shall be dated and signed:
- (i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification of the plan in accordance
with Sec. 123.8(a)(1).
(e) Products subject to other regulations.
For fish and fishery products that are subject to the requirements of part
113 or 114 of this chapter, the HACCP plan need not list the food safety hazard
associated with the formation of Clostridium botulinumtoxin in the
finished, hermetically sealed container, nor list the controls to prevent that
food safety hazard. A HACCP plan for such fish and fishery products shall address
any other food safety hazards that are reasonably likely to occur.
(f) Sanitation. Sanitation controls may be
included in the HACCP plan. However, to the extent that they are monitored
in accordance with Sec. 123.11(b) they need not be included in the HACCP plan,
and vice versa.
(g) Legal basis. Failure of a processor to
have and implement a HACCP plan that complies with this section whenever a
HACCP plan is necessary, otherwise operate in accordance with the requirements
of this part, shall render the fish or fishery products of that processor adulterated
under section 402(a)(4) of the act. Whether a processor§s actions are consistent
with ensuring the safety of food will be determined through an evaluation of
the processors overall implementation of its HACCP plan, if one is required.
Sec. 123.7 Corrective actions.
- (a) Whenever a deviation from a critical limit
occurs, a processor shall take corrective action either by:
- (1) Following a corrective action plan that
is appropriate for the particular deviation, or
(2) Following the procedures in paragraph (c)
of this section.
(b) Processors may develop written corrective
action plans, which become part of their HACCP plans in accordance with Sec.
123.6(c)(5), by which they predetermine the corrective actions that they will
take whenever there is a deviation from a critical limit. A corrective action
plan that is appropriate for a particular deviation is one that describes the
steps to be taken and assigns responsibility for taking those steps, to ensure
that:
- (1) No product enters commerce that is either
injurious to health or is otherwise adulterated as a result of the deviation;
and
(2) The cause of the deviation is corrected.
(c) When a deviation from a critical limit
occurs and the processor does not have a corrective action plan that is appropriate
for that deviation, the processor shall:
- (1) Segregate and hold the affected product,
at least until the requirements of paragraphs (c)(2) and (c)(3) of this section
are met;
(2) Perform or obtain a review to determine
the acceptability of the affected product for distribution. The review shall
be performed by an individual or individuals who have adequate training or
experience to perform such a review. Adequate training may or may not include
training in accordance with Sec. 123.10;
(3) Take corrective action, when necessary,
with respect to the affected product to ensure that no product enters commerce
that is either injurious to health or is otherwise adulterated as a result
of the deviation;
(4) Take corrective action, when necessary,
to correct the cause of the deviation;
(5) Perform or obtain timely reassessment by
an individual or individuals who have been trained in accordance with Sec.
123.10, to determine whether the HACCP plan needs to be modified
to reduce the risk of recurrence of the deviation, and modify the HACCP plan
as necessary.
(d) All corrective actions taken in accordance
with this section shall be fully documented in records that are subject to
verification in accordance with Sec. 123.8(a)(3)(ii) and the record keeping
requirements of Sec. 123.9.
Sec. 123.8 Verification.
- (a) Overall verification. Every processor shall
verify that the HACCP plan is adequate to control food safety hazards that
are reasonably likely to occur, and that the plan is being effectively implemented.
Verification shall include, at a minimum:
- (1) Reassessment of the HACCP plan. A reassessment
of the adequacy of the HACCP plan whenever any changes occur that could affect
the hazard analysis or alter the HACCP plan in any way or at least annually.
Such changes may include changes in the following: Raw materials or source
of raw materials, product formulation, processing methods or systems, finished
product distribution systems, or the intended use or consumers of the finished
product. The reassessment shall be performed by an individual or individuals
who have been trained in accordance with Sec. 123.10. The HACCP plan shall
be modified immediately whenever a reassessment reveals that the plan is no
longer adequate to fully meet the requirements of Sec. 123.6(c).
(2) Ongoing verification activities. Ongoing
verification activities including:
- (i) A review of any consumer complaints that
have been received by the processor to determine whether they relate to the
performance of critical control points or reveal the existence of unidentified
critical control points;
(ii) The calibration of process-monitoring instruments;
and,
(iii) At the option of the processor, the performing
of periodic end product or in-process testing.
(3) Records review. A review, including signing
and dating, by an individual who has been trained in accordance with Sec. 123.10,
of the records that document:
- (i) The monitoring of critical control points.
The purpose of this review shall be, at a minimum, to ensure that the records
are complete and to verify that they document values that are within the critical
limits. This review shall occur within 1 week of the day that the records are
made;
(ii) The taking of corrective actions. The
purpose of this review shall be, at a minimum, to ensure that the records are
complete and to verify that appropriate corrective actions were taken in accordance
with Sec. 123.7. This review shall occur within 1 week of the day that the
records are made; and
(iii) The calibrating of any process control
instruments used at critical control points and the performing of any periodic
end-product or in process testing that is part of the processor§s verification
activities. The purpose of these reviews shall be, at a minimum, to ensure
that the records are complete, and that these activities occurred in accordance
with the processor§s written procedures. These reviews shall occur within a
reasonable time after the records are made.
(b) Corrective actions. Processors shall immediately
follow the procedures in Sec. 123.7 whenever any verification procedure, including
the review of a consumer complaint, reveals the need to take a corrective action.
(c) Reassessment of the hazard analysis. Whenever
a processor does not have a HACCP plan because a hazard analysis has revealed
no food safety hazards that are reasonably likely to occur, the processor shall
reassess the adequacy of that hazard analysis whenever there are any changes
that could reasonably affect whether a food safety hazard now exists. Such
changes may include, but are not limited to changes in: Raw materials or source
of raw materials, product formulation, processing methods or systems, finished
product distribution systems, or the intended use or consumers of the finished
product. The reassessment shall be performed by an individual or individuals
who have been trained in accordance with Sec. 123.10.
(d) Record keeping. The calibration of process-monitoring
instruments, and the performing of any periodic end-product and in-process
testing, in accordance with paragraphs (a)(2)(ii) through (iii) of this section
shall be documented in records that are subject to the record
keeping requirements of Sec. 123.9.
Sec. 123.9 Records.
- (a) General requirements. All records required
by this part shall include:
- (1) The name and location of the processor
or importer;
(2) The date and time of the activity that
the record reflects;
(3) The signature or initials of the person
performing the operation; and
(4) Where appropriate, the identity of the
product and the production code, if any. Processing and other information shall
be entered on records at the time that it is observed.
(b) Record retention.
- (1) All records required
by this part shall be retained at the processing facility or importer§s place
of business in the United States for at least 1 year after the date they were
prepared in the case of refrigerated products and for at least 2 years after
the date they were prepared in the case of frozen, preserved, or shelf-stable
products.
(2) Records that relate to the general adequacy
of equipment or processes being used by a processor, including the results
of scientific studies and evaluations, shall be retained at the processing
facility or the importer§s place of business in the United States for at least
2 years after their applicability to the product being produced at the facility.
(3) If the processing facility is closed for
a prolonged period between seasonal packs, or if record storage capacity is
limited on a processing vessel or at a remote processing site, the records
may be transferred to some other reasonably accessible location at the end
of the seasonal pack but shall be immediately returned for official review
upon demand.
(c) Official review. All records required by
this part and all plans and procedures required by this part shall be available
for official review and copying at reasonable times.
(d) Public disclosure.
- (1) Subject to the limitations
in paragraph (d)(2) of this section, all plans and records required by this
part are not available for public disclosure unless they have been previously
disclosed to the public as defined in Sec. 20.81 of this chapter or they relate
to a product or ingredient that has been abandoned and they no longer represent
a trade secret or confidential commercial or financial information as defined
in Sec. 20.61 of this chapter.
(2) However, these records and plans may be
subject to disclosure to the extent that they are otherwise publicly available,
or that disclosure could not reasonably be expected to cause a competitive
hardship, such as generic-type HACCP plans that reflect standard industry practices.
(e) Tags. Tags as defined in Sec. 123.3(t)
are not subject to the requirements of this section unless they are used to
fulfill the requirements of Sec. 123.28(c).
(f) Records maintained on computers. The maintenance
of records on computers is acceptable, provided that appropriate controls are
implemented to ensure the integrity of the electronic data and signatures.
Sec. 123.10 Training.
At a minimum, the following functions shall
be performed by an individual who has successfully completed training in the
application of HACCP principles to fish and fishery product processing at least
equivalent to that received under standardized curriculum recognized as adequate
by the U.S. Food and Drug Administration or who is otherwise qualified through
job experience to perform these functions. Job experience will qualify an individual
to perform these functions if it has provided knowledge at least equivalent
to that provided through the standardized curriculum.
- (a) Developing a HACCP plan, which could include
adapting a model or generic-type HACCP plan, that is appropriate for a specific
processor, in order to meet the requirements of Sec. 123.6(b);
(b) Reassessing and modifying the HACCP plan
in accordance with the corrective action procedures specified in Sec. 123.7(c)(5),
the HACCP plan in accordance with the verification activities specified in
Sec. 123.8(a)(1), and the hazard analysis in accordance with the verification
activities specified in Sec. 123.8(c); and
(c) Performing the record review required by
Sec. 123.8(a)(3); The trained individual need not be an employee of the processor.
Sec. 123.11 Sanitation control procedures.
- (a) Sanitation SOP. Each processor should have
and implement a written sanitation standard operating procedure (herein referred
to as SSOP) or similar document that is specific to each location where fish
and fishery products are produced. The SSOP should specify how the processor
will meet those sanitation conditions and practices that are to be monitored
in accordance with paragraph (b) of this section.
(b) Sanitation monitoring. Each processor shall
monitor the conditions and practices during processing with sufficient frequency
to ensure, at a minimum, conformance with those conditions and practices specified
in part 110 of this chapter that are both appropriate to the plant and the
food being processed and relate to the following:
- (1) Safety of the water that comes into contact
with food or food contact surfaces, or is used in the manufacture of ice;
(2) Condition and cleanliness of food contact
surfaces, including utensils, gloves, and outer garments;
(3) Prevention of cross-contamination from
unsanitary objects to food, food packaging material, and other food contact
surfaces, including utensils, gloves, and outer garments, and from raw product
to cooked product;
(4) Maintenance of hand washing, hand sanitizing,
and toilet facilities;
(5) Protection of food, food packaging material,
and food contact surfaces from adulteration with lubricants, fuel, pesticides,
cleaning compounds, sanitizing agents, condensate, and other chemical, physical,
and biological contaminants;
(6) Proper labeling, storage, and use of toxic
compounds;
(7) Control of employee health conditions that
could result in the microbiological contamination of food, food packaging materials,
and food contact surfaces; and
(8) Exclusion of pests from the food plant. The processor shall correct in a timely manner,
those conditions and practices that are not met.
(c) Sanitation control records. Each processor
shall maintain sanitation control records that, at a minimum, document the
monitoring and corrections prescribed by paragraph (b) of this section. These
records are subject to the requirements of Sec. 123.9.
(d) Relationship to HACCP plan. Sanitation
controls may be included in the HACCP plan, required by Sec. 123.6(b). However,
to the extent that they are monitored in accordance with paragraph (b) of this
section they need not be included in the HACCP plan, and vice versa.
Sec. 123.12 Special requirements for imported
products.
This section sets forth specific requirements
for imported fish and fishery products.
- (a) Importer verification. Every importer of
fish or fishery products shall either:
- (1) Obtain the fish or fishery product from
a country that has an active memorandum of understanding (MOU) or similar agreement
with the Food and Drug Administration, that covers the fish or fishery product
and documents the equivalency or compliance of the inspection system of the
foreign country with the U.S. system, accurately reflects the current situation
between the signing parties, and is functioning and enforceable in its entirety;
or
(2) Have and implement written verification
procedures for ensuring that the fish and fishery products that they offer
for import into the United States were processed in accordance with the requirements
of this part. The procedures shall list at a minimum:
- (i) Product specifications that are designed
to ensure that the product is not adulterated under section 402 of the Federal
Food, Drug and Cosmetic Act because it may be injurious to health or have been
processed under unsanitary conditions, and,
(ii) Affirmative steps that may include any
of the following:
- (A) Obtaining from the foreign processor the
HACCP and sanitation monitoring records required by this part that relate to the specific lot of fish or fishery
products being offered for import;
(B) Obtaining either a continuing or lot-by-lot
certificate from an appropriate foreign government inspection authority or
competent third party certifying that the imported fish or fishery product
is or was processed in accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor§s
facilities to ensure that the imported fish or fishery product is being processed
in accordance with the requirements of this part;
(D) Maintaining on file a copy, in English,
of the foreign processor§s HACCP plan, and a written guarantee from the foreign
processor that the imported fish or fishery product is processed in accordance
with the requirements of the part;
(E) Periodically testing the imported fish
or fishery product, and maintaining on file a copy, in English, of a written
guarantee from the foreign processor that the imported fish or fishery product
is processed in accordance with the requirements of this part or,
(F) Other such verification measures as appropriate
that provide an equivalent level of assurance of compliance with the requirements
of this part.
(b) Competent third party. An importer may
hire a competent third party to assist with or perform any or all of the verification
activities specified in paragraph (a)(2) of this section, including writing
the importer§s verification procedures on the importer§s behalf.
(c) Records. The importer shall maintain records,
in English, that document the performance and results of the affirmative steps
specified in paragraph (a)(2)(ii) of this section. These records shall be subject
to the applicable provisions of Sec. 123.9.
(d) Determination of compliance. There must
be evidence that all fish and fishery products offered for entry into the United
States have been processed under conditions that comply with this part. If
assurances do not exist that the imported fish or fishery product has been
processed under conditions that are equivalent to those required of domestic
processors under this part, the product will appear to be adulterated and will
be denied entry.
Subpart B - Smoked and Smoke-Flavored Fishery Products
Sec. 123.15 General.
This subpart augments subpart A of this part
by setting forth specific requirements for processing smoked and smoke-flavored
fishery products.
Sec. 123.16 Process controls.
In order to meet the requirements of subpart A of this part, processors
of smoked and smoke-flavored fishery products, except those subject to the
requirements of part 113 or 114 of this chapter, shall include in their
HACCP plans how they are controlling the food safety hazard associated with
the formation of toxin by Clostridium botulinum for at least as
long as the shelf life of the product under normal and moderate abuse conditions.
Subpart C - Raw Molluscan Shellfish
Sec. 123.20 General.
This subpart augments subpart A of this part
by setting forth specific requirements for processing fresh or frozen molluscan
shellfish, where such processing does not include a treatment that ensures
the destruction of vegetative cells of microorganisms of public health concern.
Sec. 123.28 Source controls.
- (a) In order to meet the requirements of subpart
A of this part as they apply to microbiological contamination, chemical contamination,
natural toxins, and related food safety hazards, processors shall include in
their HACCP plans how they are controlling the origin of the molluscan shellfish
they process to ensure that the conditions of paragraphs (b), (c), and (d)
of this section are met.
(b) Processors shall only process molluscan
shellfish harvested from growing waters approved for harvesting by a shellfish
control authority. In the case of molluscan shellfish harvested from U.S. Federal
waters, the requirements of this paragraph will be met so long
as the shellfish have not been harvested from waters that have been closed
to harvesting by an agency of the Federal government.
(c) To meet the requirements of paragraph (b) of
this section, processors who receive shellstock shall accept only shellstock
from a harvester that is in compliance with such licensor requirements as may
apply to the harvesting of molluscan shellfish or from a processor that is
certified by a shellfish control authority, and that has a tag affixed to each
container of shellstock. The tag shall bear, at a minimum, the information
required in Sec. 1240.60(b) of this chapter. In place of the tag, bulk shellstock
shipments may be accompanied by a bill of lading or similar shipping document
that contains the information required in Sec. 1240.60(b) of this chapter.
Processors shall maintain records that document that all shellstock have met
the requirements of this section. These records shall document:
- (1) The date of harvest;
(2) The location of harvest by State and site;
(3) The quantity and type of shellfish;
(4) The date of receipt by the processor; and
(5) The name of the harvester, the name or
registration number of the harvester§s vessel, or an identification number
issued to the harvester by the shellfish control authority.
(d) To meet the requirements of paragraph (b)
of this section, processors who receive shucked molluscan shellfish shall accept
only containers of shucked molluscan shellfish that bear a label that complies
with Sec. 1240.60(c) of this chapter. Processors shall maintain records that
document that all shucked molluscan shellfish have met the requirements of
this section. These records shall document:
- (1) The date of receipt;
(2) The quantity and type of shellfish; and
(3) The name and certification number of the
packer or repacker of the product.
PART 161 - FISH AND SHELLFISH
Subpart A - General Provisions
161.170 Canned Pacific salmon.
161.173 Canned wet packed shrimp in transparent
or nontransparent containers.
161.175 Frozen raw breaded shrimp.
161.176 Frozen raw lightly breaded shrimp.
161.190 Canned tuna.
161.130 Oysters.
161.30 Declaration of quantity of contents
on labels for canned oysters.
161.136 Olympia oysters.
161.145 Canned oysters
Authority: Secs. 201, 401, 403, 409, 701, 706 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,
376).
Source: 42 FR 14464, Mar. 15, 1977, unless otherwise
noted.
Subpart A - General Provisions
§ 161.30 Declaration of quantity of contents
on labels for canned oysters.
- (a) For many years packers of canned
oysters in the Gulf area of the United States have labeled their output with
a declaration of the drained weight of oysters in the containers. Packers in
other areas have marketed canned oysters with a declaration of the total weight
of the contents of the container. Investigation reveals that under present day
practice consumers generally do not discard the liquid packing medium, but
use it as a part of the food. Section 403(e)(2) of the Federal Food, Drug,
and Cosmetic Act and the regulations there under require food in package form
to bear an accurate label statement of the quantity of food in the container.
(b) It is concluded that compliance with the label declaration of quantity
of contents requirement will be met by an accurate declaration of the
total weight of the contents of the can. The requirements of § 161.145(c),
establishing a standard of fill of container for canned oysters and specifying
the statement of substandard fill
Subpart B - Requirements for Specific Standardized
Fish and Shellfish
§ 161.130 Oysters.
- (a) Oysters, raw oysters, shucked oysters, are the class of foods each
of which is obtained by shucking shell oysters and preparing them in accordance
with the procedure prescribed in paragraph (b) of this section. The name
of each such food is the name specified in the applicable definition and
standard of identity prescribed in § 161.131 to 161.140, inclusive.
(b) If water, or salt water containing
less than 0.75 percent salt, is used in any vessel into which the oysters are
shucked the combined volume of oysters and liquid when such oysters are emptied
from such vessel is not less than four times the volume of such water or salt
water. Any liquid accumulated with the oysters is removed. The oysters are
washed, by blowing or otherwise, in water or salt water, or both. The total
time that the oysters are in contact with water or salt water after leaving
the shucker, including the time of washing, rinsing, and any other contact
with water or salt water is not more than 30 minutes. In computing the time
of contact with water or salt water, the length of time that oysters are in
contact with water or salt water that is agitated by blowing or otherwise,
shall be calculated at twice its actual length. Any period of time that oysters
are in contact with salt water containing not less than 0.75 percent salt before
contact with oysters, shall not be included in computing the time that the
oysters are in contact with water or salt water. Before packing into the containers
for shipment or other delivery for consumption the oysters are thoroughly drained
and are packed without any added substance.
(c) For the purposes of this section:
- (1) "Shell oysters" means live oysters of any of the species, Ostrea
virginica, Ostrea gigas, Ostrea lurida, in
the shell, which, after removal from their beds, have not been floated
or otherwise held under conditions which result in the addition of
water.
(2) "Thoroughly drained" means one of the following:
- (i) The oysters are drained on a strainer
or skimmer which has an area of not less than 300 square inches per gallon
of oysters, drained, and has perforations of at least 1/4 of an inch in diameter
and not more than 1 1/4 inches apart, or perforations of equivalent areas and
distribution. The oysters are distributed evenly over the draining surface
of the skimmer and drained for not less than 5 minutes; or
(ii) The oysters are drained by any
method other than that prescribed by paragraph (c)(2)(i) of this section whereby
liquid from the oysters is removed so that when the oysters are tested within
15 minutes after packing by draining a representative gallon of oysters on
a skimmer of the dimensions and in the manner described in paragraph (c)(2)(i)
of this section for 2 minutes, not more than 5 percent of liquid by weight
is removed by such draining.
§ 161.136 Olympia oysters.
Olympia oysters, raw Olympia oysters,
shucked Olympia oysters, are of the species Ostrea lurida and conform
to the definition and standard of identity prescribed for oysters in § 161.130.
§ 161.145 Canned oysters.
- (a) Identity.
- (1) Canned
oysters is the food prepared from one or any mixture of two or all of the forms
of oysters specified in paragraph (a)(2) of this section, and a packing medium
of water, or the watery liquid draining from oysters before or during processing,
or a mixture of such liquid and water. The food may be seasoned with salt.
It is sealed in containers and so processed by heat as to prevent spoilage.
(2) The forms of oysters referred to
in paragraph (a)(1) of this section are prepared from oysters which have been
removed from their shells and washed and which may be steamed while in the
shell or steamed or blanched or both after removal there from, and are as follows:
- (i) Whole oysters with such broken
pieces of oysters as normally occur in removing oysters from their shells,
washing, and packing.
(ii) Pieces of oysters obtained by
segregating pieces of oysters broken in shucking, washing, or packing whole
oysters.
(iii) Cut oysters obtained by cutting
whole oysters.
(3)(i) When the form of oysters specified
in paragraph (a)(2)(i) of this section is used, the name of the food is "Oysters"or "Cove oysters", if of the species Ostrea virginica; "Oysters"or "Pacific oysters", if of the species Ostrea gigas; "Oysters"or "Olympia oysters", if of the species Ostrea lurida.
(ii) When the form of oysters specified
in paragraph (a)(2)(ii) of this section is used, the name of the food is "Pieces
of ----", the blank being filled in with the name "Oysters"or "Cove oysters",
if of the species Ostrea virginica; "Oysters"or "Pacific oysters",
if of the species Ostrea gigas; "Oysters"or "Olympia oysters",
if of the species Ostrea lurida.
(iii) When the form of oysters specified
in paragraph (a)(2)(iii) of this section is used, the name of the food is "Cut
--", the blank being filled in with the name "Oysters"or "Cove oysters",
if of the species Ostrea virginica; "Oysters"or "Pacific oysters",
if of the species Ostrea gigas; "Oysters"or "Olympia oysters",
if of the species Ostrea lurida.
(iv) In case a mixture of two or all
such forms of oysters is used, the name is a combination of the names specified
in this paragraph (a)(3) of the forms of oysters used, arranged in order of
their predominance by weight.
(4) Label declaration. Each of the
ingredients used in the food shall be declared on the label as required by
the applicable sections of parts 101 and 130 of this chapter.
(b) [Reserved]
(c) Fill of container.
- (1)
The standard of fill of container for canned oysters is a fill such that the
drained weight of oysters taken from each container is not less than 59 percent
of the water capacity of the container.
(2) Water capacity of containers is
determined by the general method provided in § 130.12(a) of this chapter.
(3)
Drained weight is determined by the following method: Keep the
un-opened canned oyster container at a temperature of not less than 68°
or more than 95° Fahrenheit for at least 12 hours immediately preceding
the determination. After opening, tilt the container so as to
distribute its contents evenly over the meshes of a circular sieve
which has been previously weighed. The diameter of the sieve is 8
inches if the quantity of the contents of the container is less than 3
pounds, and 12 inches if such quantity is 3 pounds or more. The bottom
of the sieve is woven-wire cloth that complies with the specifications
for such cloth set forth under "2.38 mm (No. 8)"in "Official Methods of
Analysis of the Association of Official Analytical Chemists,"13th Ed.
(1980), Table 1, "Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),"under the heading "Definitions of Terms and
Explanatory Notes,"which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined
at the Office of the Federal Register, 1100 L St. NW. Washington, DC
20408. Without shifting the material on the sieve, so incline the sieve
as to facilitate drainage. Two minutes from the time drainage begins,
weigh the sieve and the drained oysters. The weight so found, less the
weight of the sieve, shall be considered to be the drained weight of
the oysters.
(4) If canned oysters fall below the
standard of fill of container prescribed in paragraph (a) of this section,
the label shall bear the general statement of substandard fill specified in § 130.14(b)
of this chapter in the manner and form therein specified, followed by the statement,
"A can of this size should contain --- oz. of oysters. This can contains only
--- oz.", the blanks being filled in with the applicable figures.
[42 FR 14464, Mar. 15, 1977, as amended at 47 FR
11832, Mar. 19, 1982; 49 FR 101-02, Mar. 19, 1984; 54 FR 24895, June 12, 1989;
58 FR 2884, Jan 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 6, Parts 500 to 599]
[Revised as of April 1, 1997]
From the U.S. Government Printing Office via GPO
Access
[CITE: 21CFR509.3]
[Page 33]
TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES - (Continued)
PART 509 - UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL - Table of Contents
Subpart A - General Provisions
Sec. 509.3 Definitions and interpretations.
- (a) Act means the Federal Food, Drug, and Cosmetic
Act.
(b) The definitions of terms contained in section
201 of the act are applicable to such terms when used in this part unless modified
in this section.
(c) A naturally occurring poisonous or deleterious
substance is a poisonous or deleterious substance that is an inherent natural
constituent of a food and is not the result of environmental, agricultural,
industrial, or other contamination.
(d) An added poisonous or deleterious substance
is a poisonous or deleterious substance that is not a naturally occurring poisonous
or deleterious substance. When a naturally occurring poisonous or deleterious
substance is increased to abnormal levels through mishandling or other intervening
acts, it is an added poisonous or deleterious substance to the extent of such
increase.
(e) Food includes pet food, animal feed, and
substances migrating to food from food-contact articles.
[Code of Federal Regulations]
[Title 21, Volume 6, Parts 500 to 599]
[Revised as of April 1, 1997]
From the U.S. Government Printing Office via GPO
Access
[CITE: 21CFR509.4]
[Page 33-34]
TITLE 21 - FOOD AND DRUGS
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT
OF HEALTH AND HUMAN SERVICES - (Continued)
PART 509 - UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL - Table of Contents
Subpart A - General Provisions
Sec. 509.4 Establishment of tolerances, regulatory
limits, and action levels.
- (a) When appropriate under the criteria of
Sec. 509.6, a tolerance for an added poisonous or deleterious substance, which
may be a food additive, may be established by regulation in subpart B of this
part under the provisions of section 406 of the act. A tolerance may prohibit
any detectable amount of the substance in food.
(b) When appropriate under the criteria of
Sec. 509.6, and under section 402(a)(1) of the act, a regulatory limit for
an added poisonous or deleterious substance, which may be a food additive,
may be established by regulation in subpart C of this part under the provisions
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit
any detectable amount of the substance in food. The regulatory limit established
represents the level at which food is adulterated within the meaning of section
402(a)(1) of the act.
(c)(1) When appropriate under the criteria
of Sec. 509.6, an action level for an added poisonous or deleterious substance,
which may be a food additive, may be established to define a level of contamination
at which a food may be regarded as adulterated.
(2) Whenever an action level is established
or changed, a notice shall be published in the Federal Register as soon as
practicable thereafter. The notice shall call attention to the material supporting
the action level which shall be on file with the Dockets Management Branch
before the notice is published. The notice shall invite public comment on the
action level.
(d) A regulation may be established in subpart
D of this part to identify a food containing a naturally occurring poisonous
or deleterious substance which will be deemed to be adulterated under section
402(a)(1) of the act. These regulations do not constitute a complete list of
such foods.
[42 FR 52821, Sept. 30, 1977, as amended at 55
FR 20786, May 21, 1990]