Nancy Rodriguez, R.S. and Juan Munguia R.S. Division for Regulatory Services

Department of State Health ServicesFoods Group South

State Offices• Central Offices

based in Austin.

• Regional Office: Public Health Service Region 11, 601 W Sesame Drive, Harlingen, TX 78526

• Numerous field offices across state.

DSHS Commissioner

Division for Regulatory Services

Environmental and Consumer Safety Section

Environmental and Consumer Safety

Section

Policy/Standards/Quality Assurance

Section (PSQA)Inspections Unit Meat Safety

Assurance

Food InspectionsFood & Drug:

• Unannounced inspections.

• No grading system.Investigators issue a Food Letter (Observation Sheet)which note each deficiency they observe.

• Partnership with FDA and USDA.

Meat Safety Assurance:

• IIC’s (Inspectors-in-charge)perform regular inspections while the firm is in operation.

• No grading system. IIC’s issue a NR (Non-compliance Record) which they note the deficiency and regulation violated.

• Partnership with USDA.

Inspections UnitGroups include:• Foods• Drugs & Medical Devices• Milk & Dairy• Seafood & Aquatic Life • Food Establishments (Retail)

Foods GroupThe Foods Group regulates:• Food manufacturers• Wholesale food distributors• Food salvage establishments • Bottled and vended water establishments.• Food Warehouse Operators• Independent Distributors

Foods Group Authority

Regulatory authority has been granted toDSHS, under the…

• Food, Drug, & Cosmetic Act• Food, Drug, & Cosmetic Salvage Act

of the Texas Health and Safety Code, toprevent the unlawful manufacture or distributionof adulterated and misbranded food.

Regulatory Jurisdiction

DSHS has regulatoryjurisdiction and enforcesstate rules and regulations,however, be aware thatlocal agencies have theprerogative to be morestringent and theirrequirements may besomewhat different fromthose of the state of Texas.

Local Ordinances

State Laws

Federal Laws

Food & Drug Inspection Authority

Texas Food, Drug, and Cosmetic Act§ 431.042. Inspection

To enforce this chapter, the commissioner, an authorized agent, or a health authority may, on presenting appropriate credentials to the owner, operator, or agent in charge:

v inspect at reasonable times, within reasonable limits, and in a reasonable manner, the establishment or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of this chapter.

*Note: Inspections are unannounced, we do NOT make appointments.

Authority Texas Food, Drug, and Cosmetic Act

§ 431 Subchapter C. Enforcement§ 431.045 Emergency Order § 431.047 Violation; Injunction § 431.048 Detained or Embargoed Article § 431.0495 Recall Orders § 431.051 Destruction of Article § 431.054 Administrative Penalty

Inspections Performed• Seafood HACCP• Juice HACCP• Low-acid canned foods• Acidified foods• Dietary Supplements• Food Salvage Dealers• Bottled/Vended Water• Vacuum-packed products (Modified Atmosphere

Packaging)• Food Complaints• COOL (Country-of-Origin Labeling-partnership

with USDA)• Tissue Residue investigations • Retail facility inspections after disasters (also

assist local health agencies)• Truck wrecks which involve a food or drug product• Emergency Response Teams (CAT, EOC,)

Pre-licensing Inspections

• Due to the amount of firms in the State of Texas, there are NO pre-licensing food inspections. New firms are given a priority to be inspected within approximately 6 months of initial licensing.

• Other divisions (for example: Seafood Safety & Meat Safety Assurance) DO however, perform pre-licensing inspections.

**It is imperative to research all applicable rules and regulations regarding your food business to ensure compliance.

State Food Inspections

• Present credentials• Meet with most responsible person at

firm• Discuss business information

(Corporate officials/firm management, hours, GAS, etc…)

• Discuss operations of the firm• Review Suppliers (raw materials) and

Customers

State Food Inspections (Con’t)• Evaluate manufacturing process/warehouse operations

– Review firm sanitation– Observe employee practices– Note critical issues in the process that could affect the finished

product

• Review product labeling for:– 4 basic labeling requirements : 1. Manufacturer Information (name,

city, state and zip code 2.) City, State 3.) Zip Code 4.) Ingredients, Net Weight)

– Nutritional Facts/Supplement Facts, if required– Allergen labeling

Documents/Evidence Development

• Records – Invoices, Bills of Lading, Truck Manifests,

etc…– Production records (including HACCP

plans/records and Sanitation Monitoring records)

• Photographs/ Video• Samples

– Environmental– In-Line– Finished Product

Final Discussion

• Observations discussed with firm management.

• Food letter is issued.• Firm responds to Food

Letter– Description of corrective

actions firm plans to take.– Timeframe it will be

accomplished.

What happens after the inspection has been completed?

• The Investigator writes an inspection report detailing information collected.

• Samples (if taken) are submitted to State Lab.

• Inspection report is synced in IDM for review and then it is endorsed by the PSQA division.

PSQA (The Policy Standards QualityAssurance Division)

• Classifies and schedules a follow-up inspection based on the current inspection results.

• Issues a warning letter, if necessary.

• Participates in mediation, court cases, and assessment of penalties.

Who needs a Food License?• Food Manufacturers/Re-packers• Private Label Manufacturers • Food Wholesalers/Distributors• Salvage Food Establishments/Brokers• Water Stores• Ice/Water Vending Machines• Independent Distributors• Produce Wholesalers• Any food item displayed for customer self-

serve.

How Much Does A Food License Cost?• The cost of a license will depend on the type of operation

and the estimated Gross Annual Sales (GAS) of the firm.

• If just starting a business, you can estimate what the Gross Annual Sales will be for the next year, when figuring what license fee to pay.

• If you underpay the Investigator will update your GAS, and you will be required to pay the appropriate fee.

• Check with the DSHS website for more information.

http://www.dshs.state.tx.us/fdlicense/apps.shtm

Food Manufacturer/ Re-packer

• Produce a food product or component of a food and either package it for customer self service or sell to another business that will serve to customers or resell product. (Includes water and ice)

• Have another firm produce your product, but your company’s name and address is on the label. (Private Label)

• Repack food from bulk into smaller quantities to sell.

Private Label Manufacturer• A person that does NOT directly manufacture

product.

• Another firm (Co-packer) makes the product, but the private label manufacturer labels the product with their own name and address.

• By placing your name and address on the label, you are responsible for the purity and proper labeling of the product.

• Private Label Manufacturer must license as a Food Manufacturer.

Other Licenses

Food Wholesaler/Distributor – A person or business that sells food products to another individual, company, or store.

Salvage Food Establishment/Broker — A person or business that is involved in the reconditioning, sale, or distribution of distressed or salvaged food, drug, medical devices, and/or cosmetics.

Can I manufacture food in my home kitchen?

• The rules do NOT allow any type of manufacturing or holding food for distribution in any areas used as living or sleeping quarters unless it is completely partitioned from your home.

• Individuals that make products in their home, packaging and selling at flea markets, fairs, craft shows, etc… are in violation of the Texas Food, Drug, & Cosmetic Act, of the Texas Health and Safety Code, Chapter 431.

Can I manufacture food in my garage or portable building at my home?

• A garage or a portable building can be an acceptable food facility if:

1. The facility has an outside entrance (you must NOT be able to enter the garage through the house) ---AND---

2. The facility complies with the current (GMP) Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing or Holding Human Food code.

(25 Texas Administrative Code Part 1, Chapter 229, subchapter N).

Cottage Bill Information

http://www.dshs.texas.gov/foodestablishments/cottagefood/default.aspx

Cottage Bill Information• Foods soWhat is a cottage food production operation?

A cottage food production operation is defined as an individual, operating out of the individual’s home, who:

• Produces a baked good, candy, coated and uncoated nuts, unroasted nut butters, fruit butters, a canned jam or jelly, a fruit pie, dehydrated fruit or vegetables, including dried beans, popcorn and popcorn snacks, cereal, including granola, dry mix, vinegar, pickles, mustard, roasted coffee or dry tea, or a dried herb or dried herb mix.

• Has an annual gross income of $50,000 or less from the sale of the described foods.

• Sells the foods produced directly to consumers at the individual’s home, a farmers’ market, a farm stand, or a municipal, county, or nonprofit fair, festival or event; and

• Delivers products to the consumer at the point of sale or another location designated by the consumer.

ld by a cottage food production operation must be packaged and labeled.The food must be packaged in a manner that prevents productcontamination, except for foods that are too large and or bulky forconventional packaging. The labeling information for foods that arenot packaged must be provided to the consumer on an invoice or

• Is a cottage food production operation a food service establishment? No. A cottage food production operation is not a food service establishment.

• What is the definition of a baked good? A baked good is a food item prepared by baking the item in an oven, which includes cookies, cakes, breads, Danishes, donuts, pastries, pies, and other items that are prepared by baking.

Cottage Bill Information

The following are examples of non-potentially hazardous foods that may be prepared and sold at a cottage food production operation

• Breads, rolls, biscuits• Sweet breads, muffins• Cakes (birthday, wedding,

anniversary, etc.• Pastries• Cookies• Candy• Coated and uncoated nuts• Unroasted nut butters• Fruit butters• Canned jams or jellies• Fruit pies

• Dehydrated fruit or vegetables, including dried beans

• Popcorn and popcorn snacks• Cereal, including granola• Dry mixes• Vinegar• Pickles• Mustard• Roasted coffee or dry tea• Dried herbs and dried herb

mixtures

Cottage Bill Food LabelingFoods sold by a cottage food production operation must be

packaged and labeled.The food must be packaged in a manner that prevents productcontamination, except for foods that are too large and or bulkyfor conventional packaging. The labeling information for foodsthat are not packaged must be provided to the consumer on aninvoice or receipt. The label must include:

•The name and address of the cottage food production operation;•The common or usual name of the product, if a food is made with

a major food allergen, such as eggs, nuts, soy, peanuts, milk orwheat that ingredient must be listed on the label; and

•A statement: “This food is made in a home kitchen andis not inspected by the Department of State HealthServices or a local health department."

•The labels must be legible.

Thank youNancy Rodriguez, R.S.

Food Group South

Texas Department of State Health Services

Division of Regulatory Services.

Phone: 512-968-4332

Nancy.rodriguez@dshs.texas.gov

Juan Munguia, R.S.

Food Group South

Texas Department of State Health Services

Division of Regulatory Services.

Phone: 361-215-6329

Juan.munguia@dshs.texas.gov