This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120]
[Page 260]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec.
120.1 Applicability.
120.3 Definitions.
120.5 Current good manufacturing practice.
120.6 Sanitation standard operating procedures.
120.7 Hazard analysis.
120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
120.9 Legal basis.
120.10 Corrective actions.
120.11 Verification and validation.
120.12 Records.
120.13 Training.
120.14 Application of requirements to imported products.
Subpart B--Pathogen Reduction
120.20 General.
120.24 Process controls.
120.25 Process verification for certain processors.
Authority: 21 U.S.C. 321, 342, 343, 346, 348, 371, 374, 379e, 381,
393; 42 U.S.C. 241, 242l, 264.
Source: 66 FR 6197, Jan. 19, 2001, unless otherwise noted.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.1]
[Page 260-261]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.1 Applicability.
(a) Any juice sold as such or used as an ingredient in beverages
shall be processed in accordance with the requirements of this part.
Juice means the aqueous liquid expressed or extracted from one or more
fruits or
[[Page 261]]
vegetables, purees of the edible portions of one or more fruits or
vegetables, or any concentrates of such liquid or puree. The
requirements of this part shall apply to any juice regardless of whether
the juice, or any of its ingredients, is or has been shipped in
interstate commerce (as defined in section 201(b) of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw agricultural ingredients
of juice are not subject to the requirements of this part. Processors
should apply existing agency guidance to minimize microbial food safety
hazards for fresh fruits and vegetables in handling raw agricultural
products.
(b) The regulations in this part shall be effective January 22,
2002. However, by its terms, this part is not binding on small and very
small businesses until the dates listed in paragraphs (b)(1) and (b)(2)
of this section.
(1) For small businesses employing fewer than 500 persons the
regulations in this part are binding on January 21, 2003.
(2) For very small businesses that have either total annual sales of
less than $500,000, or if their total annual sales are greater than
$500,000 but their total food sales are less than $50,000; or the person
claiming this exemption employed fewer than an average of 100 full-time
equivalent employees and fewer than 100,000 units of juice were sold in
the United States, the regulations are binding on January 20, 2004.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.3]
[Page 261-262]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.3 Definitions.
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act, Sec. 101.9(j)(18)(vi), and part 110 of this chapter
are applicable to such terms when used in this part, except where
redefined in this part. The following definitions shall also apply:
(a) Cleaned means washed with water of adequate sanitary quality.
(b) Control means to prevent, eliminate, or reduce.
(c) Control measure means any action or activity to prevent, reduce
to acceptable levels, or eliminate a hazard.
(d) Critical control point means a point, step, or procedure in a
food process at which a control measure can be applied and at which
control is essential to reduce an identified food hazard to an
acceptable level.
(e) 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 hazard.
(f) Culled means separation of damaged fruit from undamaged fruit.
For processors of citrus juices using treatments to fruit surfaces to
comply with Sec. 120.24, culled means undamaged, tree-picked fruit that
is U.S. Department of Agriculture choice or higher quality.
(g) Food hazard means any biological, chemical, or physical agent
that is reasonably likely to cause illness or injury in the absence of
its control.
(h) Importer means either the U.S. owner or consignee at the time of
entry of a food product 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. The importer is responsible for ensuring that
goods being offered for entry into the United States are in compliance
with all applicable laws. For the purposes of this definition, the
importer is ordinarily not the custom house broker, the freight
forwarder, the carrier, or the steamship representative.
(i) Monitor means to conduct a planned sequence of observations or
measurements to assess whether a process, point, or procedure is under
control and to produce an accurate record for use in verification.
(j)(1) Processing means activities that are directly related to the
production of juice products.
(2) For purposes of this part, processing does not include:
(i) Harvesting, picking, or transporting raw agricultural
ingredients of juice products, without otherwise engaging in processing;
and
(ii) The operation of a retail establishment.
(k) Processor means any person engaged in commercial, custom, or
institutional processing of juice products,
[[Page 262]]
either in the United States or in a foreign country, including any
person engaged in the processing of juice products that are intended for
use in market or consumer tests.
(l) Retail establishment is an operation that provides juice
directly to the consumers and does not include an establishment that
sells or distributes juice to other business entities as well as
directly to consumers. "Provides" includes storing, preparing,
packaging, serving, and vending.
(m) Shall is used to state mandatory requirements.
(n) Shelf-stable product means a product that is hermetically sealed
and, when stored at room temperature, should not demonstrate any
microbial growth.
(o) Should is used to state recommended or advisory procedures or to
identify recommended equipment.
(p) Validation means that element of verification focused on
collecting and evaluating scientific and technical information to
determine whether the HACCP plan, when properly implemented, will
effectively control the identified food hazards.
(q) Verification means those activities, other than monitoring, that
establish the validity of the HACCP plan and that the system is
operating according to the plan.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.5]
[Page 262]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.5 Current good manufacturing practice.
Part 110 of this chapter applies in determining whether the
facilities, methods, practices, and controls used to process juice are
safe, and whether the food has been processed under sanitary conditions.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.6]
[Page 262]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.6 Sanitation standard operating procedures.
(a) Sanitation controls. Each processor shall have and implement a
sanitation standard operating procedure (SSOP) that addresses sanitation
conditions and practices before, during, and after processing. The SSOP
shall address:
(1) Safety of the water that comes into contact with food or food
contact surfaces or that 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 insanitary objects to
food, food packaging material, and other food contact surfaces,
including utensils, gloves, and outer garments, and from raw product to
processed 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.
(b) Monitoring. The 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 appropriate both to the plant and to
the food being processed. Each processor shall correct, in a timely
manner, those conditions and practices that are not met.
(c) Records. Each processor shall maintain SSOP records that, at a
minimum, document the monitoring and corrections prescribed by paragraph
(b) of this section. These records are subject to the recordkeeping
requirements of Sec. 120.12.
(d) Relationship to Hazard Analysis and Critical Control Point
(HACCP) plan. Sanitation standard operating procedure controls may be
included in the HACCP plan required under Sec. 120.8(b). However, to the
extent that they are implemented in accordance with this section, they
need not be included in the HACCP plan.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.7]
[Page 262-263]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.7 Hazard analysis.
(a) Each processor shall develop, or have developed for it, a
written hazard analysis to determine whether there
[[Page 263]]
are food hazards that are reasonably likely to occur for each type of
juice processed by that processor and to identify control measures that
the processor can apply to control those hazards. The written hazard
analysis shall consist of at least the following:
(1) Identification of food hazards;
(2) An evaluation of each food hazard identified to determine if the
hazard is reasonably likely to occur and thus, constitutes a food hazard
that must be addressed in the HACCP plan. A food 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, in the absence of those controls, the food
hazard will occur in the particular type of product being processed.
This evaluation shall include an assessment of the severity of the
illness or injury if the food hazard occurs;
(3) Identification of the control measures that the processor can
apply to control the food hazards identified as reasonably likely to
occur in paragraph (a)(2) of this section;
(4) Review of the current process to determine whether modifications
are necessary; and
(5) Identification of critical control points.
(b) The hazard analysis shall include food hazards that can be
introduced both within and outside the processing plant environment,
including food hazards that can occur before, during, and after harvest.
The hazard analysis shall be developed by an individual or individuals
who have been trained in accordance with Sec. 120.13 and shall be
subject to the recordkeeping requirements of Sec. 120.12.
(c) In evaluating what food hazards are reasonably likely to occur,
consideration should be given, at a minimum, to the following:
(1) Microbiological contamination;
(2) Parasites;
(3) Chemical contamination;
(4) Unlawful pesticides residues;
(5) Decomposition in food where a food hazard has been associated
with decomposition;
(6) Natural toxins;
(7) Unapproved use of food or color additives;
(8) Presence of undeclared ingredients that may be allergens; and
(9) Physical hazards.
(d) Processors should evaluate product ingredients, processing
procedures, packaging, storage, and intended use; facility and equipment
function and design; and plant sanitation, including employee hygiene,
to determine the potential effect of each on the safety of the finished
food for the intended consumer.
(e) HACCP plans for juice need not address the food hazards
associated with microorganisms and microbial toxins that are controlled
by the requirements of part 113 or part 114 of this chapter. A HACCP
plan for such juice shall address any other food hazards that are
reasonably likely to occur.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.8]
[Page 263-264]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.
(a) HACCP plan. Each processor shall have and implement a written
HACCP plan whenever a hazard analysis reveals one or more food hazards
that are reasonably likely to occur during processing, as described in
Sec. 120.7. The HACCP plan shall be developed by an individual or
individuals who have been trained in accordance with Sec. 120.13 and
shall be subject to the recordkeeping requirements of Sec. 120.12. A
HACCP plan shall be specific to:
(1) Each location where juice is processed by that processor; and
(2) Each type of juice processed by the processor. The plan may
group types of juice products together, or group types of production
methods together, if the food hazards, critical control points, critical
limits, and procedures required to be identified and performed by
paragraph (b) of this section are essentially identical, provided that
any required features of the plan that are unique to a specific product
or method are clearly delineated in the plan and are observed in
practice.
(b) The contents of the HACCP plan. The HACCP plan shall, at a
minimum:
(1) List all food hazards that are reasonably likely to occur as
identified in accordance with Sec. 120.7, and that thus
[[Page 264]]
must be controlled for each type of product;
(2) List the critical control points for each of the identified food
hazards that is reasonably likely to occur, including as appropriate:
(i) Critical control points designed to control food hazards that
are reasonably likely to occur and could be introduced inside the
processing plant environment; and
(ii) Critical control points designed to control food hazards
introduced outside the processing plant environment, including food
hazards that occur before, during, and after harvest;
(3) List the critical limits that shall be met at each of the
critical control points;
(4) List the procedures, and the frequency with which they are to be
performed, 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. 120.10(a), and that are to be followed in response
to deviations from critical limits at critical control points;
(6) List the validation and verification procedures, and the
frequency with which they are to be performed, that the processor will
use in accordance with Sec. 120.11; and
(7) Provide for a recordkeeping system that documents the monitoring
of the critical control points in accordance with Sec. 120.12. The
records shall contain the actual values and observations obtained during
monitoring.
(c) Sanitation. Sanitation controls may be included in the HACCP
plan. However, to the extent that they are monitored in accordance with
Sec. 120.6, they are not required to be included in the HACCP plan.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.9]
[Page 264]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.9 Legal basis.
Failure of a processor to have and to implement a Hazard Analysis
and Critical Control Point (HACCP) system that complies with
Secs. 120.6, 120.7, and 120.8, or otherwise to operate in accordance
with the requirements of this part, shall render the juice products of
that processor adulterated under section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act. Whether a processor's actions are consistent
with ensuring the safety of juice will be determined through an
evaluation of the processor's overall implementation of its HACCP
system.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.10]
[Page 264-265]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.10 Corrective actions.
Whenever a deviation from a critical limit occurs, a processor shall
take corrective action by following the procedures set forth in
paragraph (a) or paragraph (b) of this section.
(a) Processors may develop written corrective action plans, which
become part of their HACCP plans in accordance with Sec. 120.8(b)(5), by
which processors 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.
(b) 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 (b)(2) and (b)(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 review;
(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; and
(5) Perform or obtain timely verification in accordance with
Sec. 120.11, by an individual or individuals who
[[Page 265]]
have been trained in accordance with Sec. 120.13, to determine whether
modification of the HACCP plan is required to reduce the risk of
recurrence of the deviation, and to modify the HACCP plan as necessary.
(c) All corrective actions taken in accordance with this section
shall be fully documented in records that are subject to verification in
accordance with Sec. 120.11(a)(1)(iv)(B) and the recordkeeping
requirements of Sec. 120.12.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.11]
[Page 265-266]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.11 Verification and validation.
(a) Verification. Each processor shall verify that the Hazard
Analysis and Critical Control Point (HACCP) system is being implemented
according to design.
(1) Verification activities shall include:
(i) A review of any consumer complaints that have been received by
the processor to determine whether such complaints relate to the
performance of the HACCP plan or reveal previously unidentified critical
control points;
(ii) The calibration of process monitoring instruments;
(iii) At the option of the processor, the performance of periodic
end-product or in-process testing; except that processors of citrus
juice that rely in whole or in part on surface treatment of fruit shall
perform end-product testing in accordance with Sec. 120.25.
(iv) A review, including signing and dating, by an individual who
has been trained in accordance with Sec. 120.13, of the records that
document:
(A) 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 the records document values that are within the
critical limits. This review shall occur within 1 week (7 days) of the
day that the records are made;
(B) 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. 120.10. This review shall occur within 1 week (7 days) of the day
that the records are made; and
(C) The calibrating of any process monitoring instruments used at
critical control points and the performance 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; and
(v) The following of procedures in Sec. 120.10 whenever any
verification procedure, including the review of consumer complaints,
establishes the need to take a corrective action; and
(vi) Additional process verification if required by Sec. 120.25.
(2) Records that document the calibration of process monitoring
instruments, in accordance with paragraph (a)(1)(iv)(B) of this section,
and the performance of any periodic end-product and in-process testing,
in accordance with paragraph (a)(1)(iv)(C) of this section, are subject
to the recordkeeping requirements of Sec. 120.12.
(b) Validation of the HACCP plan. Each processor shall validate that
the HACCP plan is adequate to control food hazards that are reasonably
likely to occur; this validation shall occur at least once within 12
months after implementation and at least annually thereafter or whenever
any changes in the process occur that could affect the hazard analysis
or alter the HACCP plan in any way. Such changes may include changes in
the following: Raw materials or source of raw materials; product
formulation; processing methods or systems, including computers and
their software; packaging; finished product distribution systems; or the
intended use or consumers of the finished product. The validation shall
be performed by an individual or individuals who have been trained in
accordance with Sec. 120.13 and shall be subject to the recordkeeping
requirements of Sec. 120.12. The HACCP plan shall be modified
immediately whenever a validation reveals that the plan is no longer
adequate to fully meet the requirements of this part.
(c) Validation of the hazard analysis. Whenever a juice processor
has no HACCP plan because a hazard analysis has revealed no food hazards
that are
[[Page 266]]
reasonably likely to occur, the processor shall reassess the adequacy of
that hazard analysis whenever there are any changes in the process that
could reasonably affect whether a food hazard exists. Such changes may
include changes in the following: Raw materials or source of raw
materials; product formulation; processing methods or systems, including
computers and their software; packaging; finished product distribution
systems; or the intended use or intended consumers of the finished
product. The validation of the hazard analysis shall be performed by an
individual or individuals who have been trained in accordance with
Sec. 120.13, and, records documenting the validation shall be subject to
the recordkeeping requirements of Sec. 120.12.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.12]
[Page 266-267]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.12 Records.
(a) Required records. Each processor shall maintain the following
records documenting the processor's Hazard Analysis and Critical Control
Point (HACCP) system:
(1) Records documenting the implementation of the sanitation
standard operating procedures (SSOP's) (see Sec. 120.6);
(2) The written hazard analysis required by Sec. 120.7;
(3) The written HACCP plan required by Sec. 120.8;
(4) Records documenting the ongoing application of the HACCP plan
that include:
(i) Monitoring of critical control points and their critical limits,
including the recording of actual times, temperatures, or other
measurements, as prescribed in the HACCP plan; and
(ii) Corrective actions, including all actions taken in response to
a deviation; and
(5) Records documenting verification of the HACCP system and
validation of the HACCP plan or hazard analysis, as appropriate.
(b) General requirements. All records required by this part shall
include:
(1) The name of the processor or importer and the location of the
processor or importer, if the processor or importer has more than one
location;
(2) The date and time of the activity that the record reflects,
except that records required by paragraphs (a)(2), (a)(3), and (a)(5) of
this section need not include the time;
(3) The signature or initials of the person performing the operation
or creating the record; 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. The records shall
contain the actual values and observations obtained during monitoring.
(c) Documentation. (1) The records in paragraphs (a)(2) and (a)(3)
of this section shall be signed and dated by the most responsible
individual onsite at the processing facility or by a higher level
official of the processor. These signatures shall signify that these
records have been accepted by the firm.
(2) The records in paragraphs (a)(2) and (a)(3) of this section
shall be signed and dated:
(i) Upon initial acceptance;
(ii) Upon any modification; and
(iii) Upon verification and validation in accordance with
Sec. 120.11.
(d) Record retention. (1) All records required by this part shall be
retained at the processing facility or at the importer's place of
business in the United States for, in the case of perishable or
refrigerated juices, at least 1 year after the date that such products
were prepared, and for, in the case of frozen, preserved, or shelf
stable products, 2 years or the shelf life of the product, whichever is
greater, after the date that the products were prepared.
(2) Offsite storage of processing records required by paragraphs
(a)(1) and (a)(4) of this section is permitted after 6 months following
the date that the monitoring occurred, if such records can be retrieved
and provided onsite within 24 hours of request for official review.
Electronic records are considered to be onsite if they are accessible
from an onsite location and comply with paragraph (g) of this section.
(3) If the processing facility is closed for a prolonged period
between seasonal packs, the records may be transferred to some other
reasonably accessible location at the end of the seasonal pack but shall
be immediately returned to the processing facility for official review
upon request.
[[Page 267]]
(e) Official review. All records required by this part shall be
available for review and copying at reasonable times.
(f) Public disclosure. (1) All 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
unless they relate to a product or ingredient that has been abandoned
and no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61 of this chapter.
(2) Records required to be maintained by this part are 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.
(g) Records maintained on computers. The maintenance of computerized
records, in accordance with part 11 of this chapter, is acceptable.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.13]
[Page 267]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.13 Training.
(a) Only an individual who has met the requirements of paragraph (b)
of this section shall be responsible for the following functions:
(1) Developing the hazard analysis, including delineating control
measures, as required by Sec. 120.7.
(2) Developing a Hazard Analysis and Critical Control Point (HACCP)
plan that is appropriate for a specific processor, in order to meet the
requirements of Sec. 120.8;
(3) Verifying and modifying the HACCP plan in accordance with the
corrective action procedures specified in Sec. 120.10(b)(5) and the
validation activities specified in Sec. 120.11(b) and (c); and
Sec. 120.7;
(4) Performing the record review required by Sec. 120.11(a)(1)(iv).
(b) The individual performing the functions listed in paragraph (a)
of this section shall have successfully completed training in the
application of HACCP principles to juice processing at least equivalent
to that received under standardized curriculum recognized as adequate by
the Food and Drug Administration, or shall be otherwise qualified
through job experience to perform these functions. Job experience may
qualify an individual to perform these functions if such experience has
provided knowledge at least equivalent to that provided through the
standardized curriculum. The trained individual need not be an employee
of the processor.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.14]
[Page 267-268]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart A--General Provisions
Sec. 120.14 Application of requirements to imported products.
This section sets forth specific requirements for imported juice.
(a) Importer requirements. Every importer of juice shall either:
(1) Obtain the juice from a country that has an active memorandum of
understanding (MOU) or similar agreement with the Food and Drug
Administration, that covers the food and documents the equivalency or
compliance of the inspection system of the foreign country with the U.S.
system, accurately reflects the relationship between the signing
parties, and is functioning and enforceable in its entirety; or
(2) Have and implement written procedures for ensuring that the
juice that such importer receives for import into the United States was
processed in accordance with the requirements of this part. The
procedures shall provide, at a minimum:
(i) Product specifications that are designed to ensure that the
juice is not adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act because it may be injurious to health or because it may
have been processed under insanitary conditions; and
(ii) Affirmative steps to ensure that the products being offered for
entry were processed under controls that meet the requirements of this
part. These steps may include any of the following:
(A) Obtaining from the foreign processor the Hazard Analysis and
Critical Control Point (HACCP) plan and prerequisite program of the
standard operating procedure records required by this part that relate
to the specific lot of food being offered for import;
(B) Obtaining either a continuing or lot specific certificate from
an appropriate foreign government inspection authority or competent
third party certifying that the imported food has
[[Page 268]]
been processed in accordance with the requirements of this part;
(C) Regularly inspecting the foreign processor's facilities to
ensure that the imported food is being processed in accordance with the
requirements of this part;
(D) Maintaining on file a copy, in English, of the foreign
processor's hazard analysis and HACCP plan, and a written guarantee from
the foreign processor that the imported food is processed in accordance
with the requirements of this part;
(E) Periodically testing the imported food, and maintaining on file
a copy, in English, of a written guarantee from the foreign processor
that the imported food 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. 120.12.
(d) Determination of compliance. The importer shall provide evidence
that all juice offered for entry into the United States has been
processed under conditions that comply with this part. If assurances do
not exist that an imported juice 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.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.20]
[Page 268]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart B--Pathogen Reduction
Sec. 120.20 General.
This subpart augments subpart A of this part by setting forth
specific requirements for process controls.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.24]
[Page 268]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart B--Pathogen Reduction
Sec. 120.24 Process controls.
(a) In order to meet the requirements of subpart A of this part,
processors of juice products shall include in their Hazard Analysis and
Critical Control Point (HACCP) plans control measures that will
consistently produce, at a minimum, a 5 log (i.e., 10\5\) reduction, for
a period at least as long as the shelf life of the product when stored
under normal and moderate abuse conditions, in the pertinent
microorganism. For the purposes of this regulation, the "pertinent
microorganism" is the most resistant microorganism of public health
significance that is likely to occur in the juice. The following juice
processors are exempt from this paragraph:
(1) A juice processor that is subject to the requirements of part
113 or part 114 of this chapter; and
(2) A juice processor using a single thermal processing step
sufficient to achieve shelf-stability of the juice or a thermal
concentration process that includes thermal treatment of all
ingredients, provided that the processor includes a copy of the thermal
process used to achieve shelf-stability or concentration in its written
hazard analysis required by Sec. 120.7.
(b) All juice processors shall meet the requirements of paragraph
(a) of this section through treatments that are applied directly to the
juice, except that citrus juice processors may use treatments to fruit
surfaces, provided that the 5-log reduction process begins after culling
and cleaning as defined in Sec. 120.3(a) and (f) and the reduction is
accomplished within a single production facility.
(c) All juice processors shall meet the requirements of paragraphs
(a) and (b) of this section and perform final product packaging within a
single production facility operating under current good manufacturing
practices. Processors claiming an exemption under paragraph (a)(1) or
(a)(2) of this section shall also process and perform final product
packaging of all juice subject to the claimed exemption within a single
production facility operating under current good manufacturing
practices.
[[Page 269]]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.25]
[Page 269-270]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120--HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of Contents
Subpart B--Pathogen Reduction
Sec. 120.25 Process verification for certain processors.
Each juice processor that relies on treatments that do not come into
direct contact with all parts of the juice to achieve the requirements
of Sec. 120.24 shall analyze the finished product for biotype I
Escherichia coli as follows:
(a) One 20 milliliter (mL) sample (consisting of two 10 mL
subsamples) for each 1,000 gallons of juice produced shall be sampled
each production day. If less than 1,000 gallons of juice is produced per
day, the sample must be taken for each 1,000 gallons produced but not
less than once every 5 working days that the facility is producing that
juice. Each subsample shall be taken by randomly selecting a package of
juice ready for distribution to consumers.
(b) If the facility is producing more than one type of juice covered
by this section, processors shall take subsamples according to paragraph
(a) of this section for each of the covered juice products produced.
(c) Processors shall analyze each subsample for the presence of E.
coli by the method entitled "Analysis for Escherichia coli in Citrus
Juices--Modification of AOAC Official Method 992.30" or another method
that is at least equivalent to this method in terms of accuracy,
precision, and sensitivity in detecting E. coli. This method is designed
to detect the presence or absence of E. coli in a 20 mL sample of juice
(consisting of two 10 mL subsamples). The method is as follows:
(1) Sample size. Total-20 mL of juice; perform analysis using two 10
mL aliquots.
(2) Media. Universal Preenrichment Broth (Difco, Detroit, MI), EC
Broth (various manufacturers).
(3) Method. ColiComplete (AOAC Official Method 992.30--modified).
(4) Procedure. Perform the following procedure two times:
(i) Aseptically inoculate 10 mL of juice into 90 mL of Universal
Preenrichment Broth (Difco) and incubate at 35 deg.C for 18 to 24
hours.
(ii) Next day, transfer 1 mL of preenriched sample into 10 mL of EC
Broth, without durham gas vials. After inoculation, aseptically add a
ColiComplete SSD disc into each tube.
(iii) Incubate at 44.5 deg.C for 18 to 24 hours.
(iv) Examine the tubes under longwave ultra violet light (366 nm).
Fluorescent tubes indicate presence of E. coli.
(v) MUG positive and negative controls should be used as reference
in interpreting fluorescence reactions. Use an E. coli for positive
control and 2 negative controls--a MUG negative strain and an
uninoculated tube media.
(d) If either 10 mL subsample is positive for E. coli, the 20 mL
sample is recorded as positive and the processor shall:
(1) Review monitoring records for the control measures to attain the
5-log reduction standard and correct those conditions and practices that
are not met. In addition, the processor may choose to test the sample
for the presence of pathogens of concern.
(2) If the review of monitoring records or the additional testing
indicates that the 5-log reduction standard was not achieved (e.g., a
sample is found to be positive for the presence of a pathogen or a
deviation in the process or its delivery is identified), the processor
shall take corrective action as set forth in Sec. 120.10.
(e) If two samples in a series of seven tests are positive for E.
coli, the control measures to attain the 5-log reduction standard shall
be deemed to be inadequate and the processor shall immediately:
(1) Until corrective actions are completed, use an alternative
process or processes that achieve the 5-log reduction after the juice
has been expressed;
(2) Perform a review of the monitoring records for control measures
to attain the 5-log reduction standard. The review shall be sufficiently
extensive to determine that there are no trends towards loss of control;
(i) If the conditions and practices are not being met, correct those
that do not conform to the HACCP plan; or
(ii) If the conditions and practices are being met, the processor
shall validate the HACCP plan in relation to the 5-log reduction
standard; and
(3) Take corrective action as set forth in Sec. 120.10. Corrective
actions
[[Page 270]]
shall include ensuring no product enters commerce that is injurious to
health as set forth in Sec. 120.10(a)(1).
