Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 229.
FOOD AND DRUG
Subchapter N. CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
25 TAC §§229.210 - 229.222
The Executive Commissioner of the Health and Human Services
Commission, on behalf of the Department of State Health Services (department),
proposes new §229.210 and amendments to §§229.211 - 229.222,
concerning current good manufacturing and good warehousing practice in manufacturing,
packing, or holding human food.
BACKGROUND AND PURPOSE
The new section and amendments are necessary to update current good manufacturing
and good warehousing practice in manufacturing, packing, or holding human
food in regards food safety during manufacturing and storage and distribution.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 229.211
- 229.222 have been reviewed and the department has determined the reasons
for adopting the sections continue to exist because rules on this subject
are needed.
SECTION-BY-SECTION SUMMARY
A new §229.210, General Provisions, is added to provide clarification
on the facilities subject to this subchapter. Amendments to §229.211
include the addition of new definitions. An amendment to §229.212 clarifies
the reference of the U.S. Code of Federal Regulations. Section 229.213 is
amended to reference employee health. Section 229.214 is amended to clarify
what firms are exempt from these rules. Sections 229.215 and 229.220 reflect
grammatical revisions. Section 229.216 is amended to clarify language on pest
activity, and to include specific language on approved pesticides. Section
229.217 is amended in several subsections to reflect grammatical revisions,
suitable water temperature for hand-washing facilities, and clarification
on waste and food waste operations. Section 229.218 is amended to provide
clarification on the maintenance of instruments. Section 229.219 is amended
in several subsections to include a reference for approved source, update
the current cold holding temperature requirements for potentially hazardous
foods, and to reflect extensive new language on reduced oxygen packaging.
Section 229.221 is amended to add language on approved source, to clarify
language on pest activity, and to update the current cold holding temperature
for potentially hazardous foods. Section 229.222 is amended to clarify enforcement
action on emergency orders and penalties.
FISCAL NOTE
Julie W. Loera, Manager, Foods Group, has determined that for each calendar
year of the first five years the sections are in effect, there will be no
fiscal implications to state or local governments as a result of enforcing
or administering the sections as proposed.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Loera has also determined that there will be no effect on small businesses
or micro-businesses required to comply with the sections as proposed These
entities will not be required to alter their business practices in order to
comply with the sections as proposed. There are no anticipated economic costs
to persons who are required to comply with the sections as proposed. There
is no anticipated negative impact on local employment.
PUBLIC BENEFIT
In addition, Ms. Loera has also determined that for each of the first five
years the sections are in effect, the public will benefit from the adoption
of the sections. The public health benefits anticipated as a result of enforcing
or administering the sections will be a safe food supply from manufacturers
and distributors.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Governmental Code, §2001.0225. " Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed rules do not restrict or
limit an owner's rights to his or her property that would otherwise exist
in the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Julie W. Loera., Manager,
Foods Group, Texas Department of State Health Services, 1100 West 49th Street,
Austin, Texas 78756, (512) 834-6670 or by email to Julie.Loera@dshs.state.tx.us.
Comments will be accepted for 30 days following publication of the proposal
in the
Texas Register
.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the proposed rules have been reviewed by legal counsel and
found to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The proposed new section and amendments are authorized by the Health and
Safety Code, §431.241, which provides the department with the authority
to adopt necessary regulations pursuant to the enforcement of Chapter 431;
and Government Code, §531.0055, and Health and Safety Code, §1001.075,
which authorizes the Executive Commissioner of the Health and Human Services
Commission to adopt rules and policies necessary for the operation and provision
of health and human services by the department and for the administration
of Health and Safety Code, Chapter 1001.
The proposed new section and amendments affect the Health and Safety Code,
Chapters 431 and 1001; and Government Code, Chapter 531; and implements Government
Code, §2001.039.
§229.210.General Provisions.
This subchapter applies to every person engaged in food manufacturing
and/or wholesale food distribution regardless of the license or permit held
under §§229.181 - 229.184, 229.370 - 229.374, and 229.541 - 229.554
of this title, or if the person is exempt from licensure. Retail food establishments,
such as grocery stores and restaurants that are located outside the jurisdiction
of a local health authority, must also comply with the requirements of §§229.161
- 229.171 and 229.173 - 229.175 of this title (Texas Food Establishment Rules)
except for the manufacture or wholesale of food as defined by the Texas Food,
Drug, and Cosmetic Act, Texas Health and Safety Code, §§431.221(2)
and 431.221(3). Retail establishments that are located within the jurisdiction
of a local health authority that permits and inspects retail food establishments
and that are required to license as a food manufacturer under §§229.181
- 229.184 of this title, must also comply with the applicable rules enforced
by the local health authority.
§229.211.Definitions.
The following words and terms, when used in this subchapter, shall
have the following meanings, unless the context clearly indicates otherwise.
Those definitions and interpretations of terms of the
Texas Food, Drug,
and Cosmetic Act, Texas Health and Safety Code, Chapter 431
[
(1)
(No change.)
(2)
Act--
Texas
[
(3) - (14)
(No change.)
(15)
pH--(Potential of Hydrogen) A measure
of the degree of the acidity or the alkalinity of a solution.
(16)
Processing--Including, but not limited,
to the preparing, blending, filtering, preserving, treating, changing into
different market forms, manufacturing, packing, repacking, or labeling of
food ingredients and or products.
(17)
[
(18)
[
(19)
Reduced oxygen packaging--The reduction
of the amount of oxygen in a package by mechanically evacuating the oxygen;
displacing the oxygen with another gas or combination of gases; or otherwise
controlling the oxygen content in a package to a level below that normally
found in the surrounding atmosphere, which is 21% oxygen. The term includes
methods that may be referred to as altered atmosphere, modified atmosphere,
controlled atmosphere, low oxygen, and/or vacuum packing including sous vide.
(20)
[
(21)
[
(22)
[
(23)
[
(24)
[
(25)
[
§229.212.Current Good Manufacturing Practice.
(a)
(No change.)
(b)
Food subject to the requirements of these sections may
also be subject to specific
regulations
[
§229.213.Personnel.
The plant management shall take all reasonable measures and precautions
to ensure the following:
(1)
Disease control
and employee health
. 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.
(2) - (4)
(No change.)
§229.214.Exclusions.
The following operations are not subject to this section: Establishments
engaged solely in the harvesting, storage, or distribution of one or more
raw agricultural commodities which are ordinarily
cleaned and packed
[
§229.215.Plant and Grounds.
(a)
(No change.)
(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
the
[
(2) - (7)
(No change.)
§229.216.Sanitary Operations.
(a) - (c)
(No change.)
(d)
Pest control.
(1)
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.
This exclusion of pests includes:
(A)
no evidence of pest activity in non-food
areas;
(B)
no evidence of pest activity in food storage
or food preparation areas; and
(C)
no evidence of pest activity in or on food
products, food packaging or food preparation utensils, equipment, or devices.
(2)
Only pesticides approved by the Environmental
Protection Agency (EPA) for use in a food processing facility may be used.
Pesticides shall be used only according to label directions. Rodenticides
shall be placed inside enclosed bait boxes or other approved receptacles.
Only a licensed pesticide applicator may apply restricted use pesticides.
(3)
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.
(e) - (f)
(No change.)
§229.217.Sanitary Facilities and Controls.
Each plant shall be equipped with adequate sanitary facilities and
accommodations including, but not limited to:
(1)
Water supply. The water supply shall be sufficient for
the operations intended and shall be derived from an approved source.
(A)
Requirements for approved source. Sources in Texas shall
comply with the following requirements.
(i)
Public water systems. Sources in Texas which are public
water systems shall comply with the Texas Health and Safety Code, Chapter
341, Subchapter C, concerning drinking water standards and rules adopted [
(ii) - (iii)
(No change.)
(B)
(No change.)
(C)
Any water that
is used for hand washing or
contacts
food or food-contact surfaces shall be safe and of sanitary quality for its
intended use.
Hot and cold running
[
(2) - (4)
(No change.)
(5)
Hand-washing facilities. Hand-washing facilities shall
be adequate in number and location and be furnished with
:
[
(A)
running water at a temperature of at least
110 degrees Fahrenheit;
(B)
a supply of hand cleaning liquid, powder,
or bar soap; and
(C)
individual disposable towels, continuous
towel system that supplies a user with a clean towel, or a heated-air hand
drying device.
[
[
[
[
[
[
(6)
Waste
[
(7)
Food waste. Bread, nonmeat pastry products,
and produce that have been completely removed from all packaging may be disposed
of by alternate means according to any applicable requirements of Title 30,
Texas Administrative Code (TAC), Chapters 330, 332, and 335, or Title 4, TAC,
Chapter 55.
§229.218.Equipment and Utensils.
(a) - (e)
(No change.)
(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 in sufficient quantity for their designated uses. The
instruments shall be operated, maintained, and calibrated according to the
manufacturer's directions.
[
(g)
(No change.)
§229.219.Production and Process Controls.
All operations in the receiving, inspecting, transporting, segregating,
preparing, manufacturing, packaging, and storing of food shall be conducted
in accordance with good public health and 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. Testing procedures shall be used where necessary
to identify sanitation failures or possible food contamination by chemicals,
microbes, or extraneous materials. 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.
(1)
Raw materials and other ingredients.
(A)
Food including raw ingredients and finished
product shall be obtained from an approved source.
(B)
[
(C)
[
(D)
[
(E)
[
(F)
[
(G)
[
(H)
[
(2)
Manufacturing operations.
(A) - (B)
(No change.)
(C)
The internal temperature of potentially
hazardous foods during transport and storage shall be maintained at or below
41 degrees Fahrenheit as appropriate for the food using methods, that include
refrigeration, pre-chilled insulated coolers, dry ice, or storage on ice made
from potable water. The method used must maintain the required temperature
for the entire length of time the food is in transport or storage.
[
[
(i)
[
(ii)
[
(iii)
[
(iv)
[
(v)
[
(D) - (O)
(No change.)
(P)
Reduced oxygen packaging. Manufacturers
performing reduced oxygen packaging:
(i)
shall maintain Standard Operating Procedures
(SOPs) that:
(I)
limit the shelf life of foods to not more
than 14 calendar days from the date the food is packaged to the date the food
is consumed or the original manufacturer's "sell by" or "use by" date, whichever
comes first, except as described in clause (vi) of this subparagraph;
(II)
Describe how the packages shall be prominently
and conspicuously labeled on the principal display panel in bold type on a
contrasting background, with instructions to:
(-a-)
"use by" and provide a date that is within
14 calendar days of packaging or provide a date as allowed by clause (v) of
this subparagraph; and
(-b-)
keep the food refrigerated at 41 degrees
Fahrenheit or below;
(III)
require employees that contact foods
with bare hands to wash hands properly or utilize proper utensils;
(IV)
designate raw food and ready to eat food
areas and place physical barriers or effective methods that minimize the risk
of cross-contamination between raw foods and ready-to-eat foods and restrict
access to the food processing equipment to personnel who are trained to operate
the equipment and understand the risks of cross-contamination;
(V)
describe cleaning and sanitization procedures
for food-contact surfaces; and
(VI)
describe the training program that ensures
that the individual responsible for the reduced oxygen packaging operation
understands the:
(-a-)
concepts required for safe operation;
(-b-)
equipment and facility; and
(-c-)
procedures specified in clauses (i)(II)-(V)
and (iii)-(vii) of this subparagraph;
(ii)
shall maintain records that document employee
training. Records documenting training must be maintained for at least one
year after the employee leaves the company or is moved to other duties that
do not include vacuum packaging. The records must be available at the packaging
facility or corporate offices for review by the regulatory authority;
(iii)
shall maintain food processing records
for at least one year from the time the food is packed. The records must be
available at the facility or corporate offices for review by the regulatory
authority. The records must contain the following information:
(I)
the identity of the food that is packaged;
(II)
the date the food was packaged; and
(III)
the name of the operator performing the
food packaging; and
(iv)
shall limit the types of foods that are
packaged to a food that does not support the growth of
Clostridium botulinum
because it complies with one of the following:
(I)
has a water activity (a
w
) of 0.91 or less;
(II)
has a hydrogen ion concentration (pH)
of 4.6 or less;
(III)
is a meat or poultry product cured at
a food processing plant regulated by the U.S. Department of Agriculture or
the department, and is received in an intact package; or
(IV)
is a food with a high level of competing
organisms such as raw meat or poultry.
(v)
food products, other than those specified
in clause (iv) of this subparagraph may be vacuum packaged if the firm provides
written documentation of product testing such as shelf life studies of the
product under the same storage and packaging conditions or scientific studies
of the product which must be the same species, market form, packaging, and
holding conditions that prove the reduced oxygen packaged product will not
support the growth of
Clostridium botulinum
;
(vi)
the shelf life of a vacuum packaged product
may be extended past the 14 day shelf life limit as specified in clause (i)(I)
of this subparagraph if the firm provides written documentation of product
testing such as shelf life studies of the product under the same storage and
packaging conditions or scientific studies of the product which must be the
same species, market form, packaging, and holding conditions that prove the
extended shelf life of the reduced oxygen packaged product will not support
the growth of
Clostridium botulinum, Listeria, and
Salmonella
;
(vii)
fish shall not be packaged in reduced
oxygen packaging unless the fish is frozen before, during, and after packaging
unless the firm is subject to §§229.121 - 229.129 of this title
(relating to Seafood HACCP).
(Q)
[
(R)
[
(S)
[
§229.220.Natural or Unavoidable Defects in Food for Human Use That Present No Health Hazard.
(a) - (c)
(No change.)
(d)
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
Department of State Health Services
[
§229.221.Good Warehousing Practice.
(a) - (b)
( No change.)
(c)
Sanitary operations.
(1)
(No change.)
(2)
Food storage facilities and transportation vehicles shall
be kept free of rodents, insects, birds, and other pests which may contaminate
food
which includes:
[
(A)
no evidence of pest activity in non-food
areas;
(B)
no evidence of pest activity in food storage
areas; and
(C)
no evidence of pest activity in or on food
products, food packaging or food preparation utensils, equipment or devices.
(3)
(No change.)
(4)
The internal temperature of potentially
hazardous foods during transport and storage shall be maintained at or below
41 degrees Fahrenheit as appropriate for the food using methods that include
refrigeration, pre-chilled insulated coolers, dry ice, or storage on ice made
from potable water. The method used must maintain the required temperature
for the entire length of time the food is in transport or storage.
[
[
(A)
[
(B)
[
(C)
[
(5) - (11)
(No change.)
(d)
Other provisions.
(1)
Distressed foods salvaged by the licensee shall be salvaged
in accordance with
§§229.541-229.554, 229.571-229.584, 229.601-229.614,
and 229.631-229.647
[
(2) - (3)
(No change.)
(e)
Food including raw ingredients and finished
food products shall be obtained from an approved source.
§229.222.Enforcement [
(a) - (b)
(No change.)
(c)
Administrative penalties as provided in Health and Safety
Code §431.054
, §431.055, §431.056, §431.057, §431.058,
and in §229.261 of this title (relating to Assessment of Administrative
[
(d)
Emergency orders as provided in Health
and Safety Code, §431.045, may be issued by the Commissioner or the Commissioner's
designee.
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of
the Secretary of State on February 27, 2006.
TRD-200601024
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: April 9, 2006
For further information, please call: (512) 458-7111 x6972
Chapter 703.
PROJECT CONTRACTS AND GRANTS
25 TAC §§703.3, 703.5, 703.6, 703.10
The Texas Cancer Council proposes amendments to §§703.3,
703.5, 703.6, and 703.10, concerning the scope, project proposal submission,
review process, and funding restrictions.
Sections 703.3, 703.5, and 703.6 are being amended to make the substitution
of "application" for "proposal" consistent throughout the rules to more accurately
reflect the proposal process used for Council grants.
Section 703.10 is being amended to conform to the Uniform Grant Management
Standards, and clarifies the applicability of the restrictions that the Council
previously adopted.
Ms. Sandra K. Balderrama, MPA, BSW, Executive Director of the Texas Cancer
Council, has determined that for the first five-year period the amendments
are in effect there will be no foreseeable implications relating to costs
or revenues for state or local government as a result of enforcing or administering
the amendments as proposed.
Ms. Balderrama also has determined that for each year of the first five
years the amendments are in effect the public benefit anticipated as a result
of enforcing the amendments will be clarification of the policies and procedures
the Council will follow to implement the
Texas Cancer
Plan
. There are no anticipated economic costs to persons who are required
to comply with the amendments.
Ms. Balderrama has determined that the amendments shall not have an effect
on small businesses or on micro businesses.
Comments on the proposed amendments may be submitted to Ms. Sandra Balderrama,
Executive Director, Texas Cancer Council, P.O. Box 12097, Austin, Texas 78711.
The amendments are proposed under the Texas Health and Safety
Code Annotated, §102.002 and §102.009, which provide the Texas Cancer
Council with the authority to develop and implement the
Texas Cancer Plan
, and the Texas Government Code, Annotated, §2001.004.
There is no other statute, article or code that is affected by these proposed
amendments.
§703.3.Scope.
(a)
(No change.)
(b)
Sources.
(1)
Grants to State of Texas agencies.
(A) - (B)
(No change.)
(C)
State agencies may respond to the request-for-
proposals
[
(2)
Grants to non-state or private organizations. The council
may solicit public and private entities to submit proposals in response to
a request
-
for
-proposals
[
(c)
(No change.)
§703.5.Project Proposal Submission.
(a) - (d)
(No change.)
(e)
Proposals that are late, are grossly incomplete, or substantially
inconsistent with the project components and requirements outlined in the
council's published request
-
for
-proposals
[
§703.6.Review Process.
(a)
Each proposal shall be reviewed by council staff for completeness,
relevance to the published request-for-
proposals
[
(b) - (e)
(No change.)
§703.10.Funding Restrictions.
Contractors will be subject to the following funding restrictions,
unless statute or Council rules require otherwise:
(1) - (2)
(No change.)
(3)
Unallowable
[
(A)
The following is a list of the most common types but not
a comprehensive list of costs which are
unallowed
[
(i) - (x)
(No change.)
(B)
(No change.)
(4)
(No change.)
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on February 23, 2006.
TRD-200600958
Sandra Balderrama
Executive Director
Texas Cancer Council
Proposed date of adoption: May 5, 2006
For further information, please call: (512) 438-3029
Federal
Food, Drug, and Cosmetic Act (the Act), §201
], are also applicable
when used in this subchapter.
Federal
] Food, Drug,
and Cosmetic Act
, Health and Safety Code, Chapter 431
.
(15)
] Quality control operation--A
planned and systematic procedure for taking all actions necessary to prevent
food from being adulterated within the meaning of the Act.
(16)
] Raw agricultural commodity--Any
food in its raw or natural state, including all fruits that are washed, colored,
or otherwise treated in their unpeeled natural form prior to marketing.
(17)
] Rework--Clean, unadulterated
food that has been removed from processing for reasons other than insanitary
conditions or that has been successfully reconditioned by reprocessing and
that is suitable for use as food.
(18)
] Safe-moisture level--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 (a
w
). An (a
w
) will be considered safe for a food if adequate data are available
that demonstrate that the food at or below the given (a
w
) will not support the growth of undesirable microorganisms.
(19)
] Sanitization--The application
of cumulative heat or chemicals on cleaned food-contact surfaces that, when
evaluated for efficacy, yield a reduction of 5 logs, which is equal to a 99.999%
reduction of representative disease microorganisms of public health importance.
(20)
] Shall--Term to state mandatory
requirements.
(21)
] Should--Term to state recommended
or advisory procedures or identify recommended equipment.
(22)
] Water activity (a
w
)--A measure of the free moisture in a food. The quotient of the water
vapor pressure of the substance divided by the vapor pressure of pure water
at the same temperature.
current good manufacturing
practice regulation
] found in
Title 21,
[
the
]
Code of Federal Regulations
(CFR),
or in other sections of this
title (25 Texas Administrative Code).
cleaned, prepared, treated, or otherwise processed
] before
being marketed to the consuming public.
such
] placement of equipment and storage of materials as is necessary for
the maintenance of sanitary operations and the production of safe food;
thereunder
] by the
Texas Commission on Environmental Quality
[
Texas Natural Resource Conservation Commission
], 30 Texas Administrative
Code (TAC), §§290.101 - 290.122 (relating to Drinking Water Standards
Governing Drinking Water Quality and Reporting Requirements for Public Water
Supply Systems), and §§290.38 - 290.47 (relating to Rules and Regulations
for Public Water Systems).
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.
Hot water generation and distribution systems shall be sufficient to meet
peak hot water demands throughout the facility.
running water at a suitable temperature. Compliance with this requirement
may be accomplished by providing:
]
(A)
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;
]
(B)
effective hand-cleaning and sanitizing
preparations;
]
(C)
sanitary towel service or suitable drying
devices;
]
(D)
devices or fixtures, such as water control
valves, so designed and constructed to protect against recontamination of
clean, sanitized hands;
]
(E)
readily understandable signs directing
employees handling unprotected food, unprotected food-packaging materials,
or 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; and
]
(F)
refuse receptacles that are constructed
and maintained in a manner that protects against contamination of food.
]
Rubbish and offal disposal
].
Waste
[
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
, except as allowed in paragraph (7) of this section
.
and properly maintained, and in sufficient
quantity for their designated uses.
]
(A)
] 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 sanitary quality for its intended use. 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 contamination
or deterioration of food.
(B)
] 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.
(C)
] 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.
(D)
] Raw materials, other ingredients,
and rework susceptible to contamination with pests, undesirable microorganisms,
or 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.
(E)
] 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 a temperature
and relative humidity and in a manner to prevent the food from becoming adulterated
within the meaning of the Act. Material scheduled for rework shall be identified
as such.
(F)
] Frozen raw materials and other
frozen 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.
(G)
] Liquid or dry raw materials
and other ingredients received and stored in bulk form shall be held in a
manner that protects against contamination.
(C)
The internal temperature of potentially
hazardous foods during transport and storage shall be maintained at 45 degrees
Fahrenheit or lower as appropriate for the food.
]
(i)
After October 5, 2003, the internal temperature
of potentially hazardous foods shall be maintained at 41 degrees Fahrenheit
or lower as appropriate for the food.
]
(ii)
] Frozen foods shall be kept
frozen at all times.
(iii)
] Shell eggs, after initial
packing, must be transported and stored at a temperature of 45 degrees Fahrenheit
or less. If the United States Department of Agriculture and the U.S. Food
and Drug Administration determine by law that a lower temperature must be
maintained, the lower temperature shall prevail.
(iv)
] The temperature of molluscan
shellfish
[
shellstock
] from the harvester through the original
shellfish dealer shall be maintained in accordance with §§241.58
- 241.60 of this title (relating to Molluscan Shellfish). Raw molluscan
shellfish
[
shellstock
] shall be adequately iced or refrigerated
at 45 degrees Fahrenheit or less during all subsequent distribution, storage,
processing, and sale.
(v)
] Hot foods shall be maintained
at
135
[
140
] degrees Fahrenheit (60 degrees Celsius)
or above.
(vi)
] Acid or acidified foods shall
be heat treated to destroy mesophilic microorganisms when those foods are
to be held in hermetically sealed containers at ambient temperatures.
(P)
] Unshelled pecans shall be
thoroughly cleaned to remove foreign matter before cracking. After cleaning,
unshelled pecans shall be sanitized.
(Q)
] 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.
(R)
] 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.
Texas Department of Health, Manufactured Foods Division
],
1100 West 49th Street, Austin, Texas, 78756.
.
]
(4)
The internal temperature of potentially
hazardous foods during transport and storage shall be maintained at 45degrees
Fahrenheit or lower as appropriate for the food.
]
(A)
After October 5, 2003, the internal temperature
of potentially hazardous foods shall be maintained at 41 degrees Fahrenheit
or lower as appropriate for the food.
]
(B)
] Frozen foods shall be kept
frozen at all times.
(C)
] Shell eggs after initial packing,
must be transported and stored at a temperature of 45 degrees Fahrenheit or
less. If the United States Department of Agriculture and the U.S. Food and
Drug Administration determine by law that a lower temperature must be maintained,
the lower temperature shall prevail.
(D)
] The temperature of molluscan
shellfish
[
shellstock
] from the harvester through the original
shellfish dealer shall be maintained in accordance with §§241.58-241.60
of this title (relating to Molluscan Shellfish). Raw molluscan
shellfish
[
shellstock
] shall be adequately iced or refrigerated at
45 degrees Fahrenheit or less during all subsequent distribution, storage,
processing, and sale.
§§229.191 - 229.202
] of this
title (relating to Regulation of Food, Drug, Device, and Cosmetic Salvage
Establishments and Brokers).
Penalties ].
or Civil
] Penalties), may be assessed for violation of these sections.
If the person charged with the violation does not request a hearing, the Commissioner
of the Department of State Health Services (Commissioner) or the Commissioner's
designee may assess a penalty after determining that a violation has occurred
and the amount of the penalty.
Part 11.
TEXAS CANCER COUNCIL
applications
] that will be published from time to time in
the
Texas Register
.
applications
] that
may be published from time to time in the
Texas Register
. The Council may also accept unsolicited proposals from non-state
and private sector applicants.
applications
] will not be accepted and will be returned to the applicant with an
explanation of deficiencies.
application
] adherence to council policies, technical merit, and budget appropriateness.
Staff analyses of each eligible proposal received will be prepared and submitted
to the council before the council makes a funding decision.
Disallowable
] costs.
disallowed
]:
Chapter 704.
TEXANS CONQUER CANCER PROGRAM