A. Any person permitted in accordance with Chapter 52 (§ 3.2-5200 et seq.) of Title 3.2 of the Code of Virginia regarding milk, milk products, and dairies shall comply with the provisions of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision."

B. Section 1 of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision", regarding definitions shall be used to determine the meanings of the words or terms used in this chapter or in the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision", unless the context clearly indicates otherwise. If any definition in Section 1 of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision", conflicts with a definition in 2VAC5-490-10, 2VAC5-490-10 shall control to the extent of the conflict.

C. If any provision of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision", conflicts with a provision in 2VAC5-490-10 through 2VAC5-490-140 of this chapter, the provision in 2VAC5-490-10 through 2VAC5-490-140 of this chapter shall control to the extent of the conflict.

D. If any provision of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision", or this chapter conflicts with a regulation pertaining to waterworks or private wells adopted by the State Board of Health pursuant to § 32.1-170 or 32.1-176.4 of the Code of Virginia, the regulation adopted by the State Board of Health shall control to the extent of the conflict.

E. If any provision of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision", or this chapter conflicts with a regulation pertaining to onsite sewage systems adopted by the State Board of Health pursuant to § 32.1-164 of the Code of Virginia, the regulation adopted by the State Board of Health shall control to the extent of the conflict.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Pull date" means the date affixed to a consumer package or container of grade A pasteurized milk or grade A pasteurized milk product that is the date after the day of manufacturing and processing of the package or container and the last day on which the grade A pasteurized milk or grade A pasteurized milk product as determined by the milk plant may be offered for sale to consumers under normal storage.

"State regulatory agency" means the Commissioner of Agriculture and Consumer Services, or his agent, or the State Health Commissioner, or his agent, when such person is carrying out any duty specified in § 3.2-5207 of the Code of Virginia or the State Health Commissioner or his agent when carrying out any duty specified in § 3.2-5208 of the Code of Virginia assigned to such commissioner in Chapter 52 (§ 3.2-5200 et seq.) of Title 3.2 of the Code of Virginia.

"Summarily suspend" means the immediate suspension of a permit issued by the state regulatory agency without the permit holder being granted the opportunity to contest the action prior to the effective date and time of the suspension.

A. The state regulatory agency may impound any condensed milk, condensed milk product, aseptically processed and packaged milk or milk product, retort processed after packaged milk or milk product, dry milk, dry milk product, milk, or milk product if the product is in violation of any requirement of this chapter.

B. The state regulatory agency shall comply with the following administrative procedures when impounding any adulterated or misbranded condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product to prevent movement of these products until such violations of critical processing elements have been corrected:

1. The state regulatory agency shall serve the person with a written impoundment notice. The written impoundment notice shall specify the violations and inform the person of the opportunity to appear before the state regulatory agency in person, by counsel, or by other qualified representative at a fact-finding conference for the informal presentation of factual data, arguments, and proof to contest the written notice of violation.

2. The written impoundment notice shall include:

a. The name of the adulterated or misbranded condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product;

b. The size and number of separate units in the lot being impounded;

c. The product code and sell by date for the lot of product, if each exists; and

d. A statement directing the person to:

(1) Immediately remove from sale the entire lot of adulterated or misbranded condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product;

(2) Isolate and identify as not for sale the entire lot of adulterated or misbranded condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product in the person's storage area in a location separate from any storage accessible from a retail sales area; and

(3) Comply with one of the following options:

(a) If the condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product is adulterated (i) the entire lot shall be destroyed or (ii) the entire lot shall be held and returned to the manufacturer, distributor, or producer; or

(b) If the condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product is misbranded (i) the entire lot shall be destroyed; (ii) the entire lot shall be held and returned to the manufacturer, distributor, or producer; or (iii) the entire lot shall be held and new labels affixed to each container in the lot that comply with all provisions for labeling of condensed milk, condensed milk product, dry milk, dry milk product, milk, or milk product contained in this chapter prior to being offered for sale.

A. No person may produce, provide, manufacture, sell, offer for sale, or store in the Commonwealth, or bring, send, or receive into the Commonwealth, any milk, milk product, or condensed and dry milk product for use in the commercial preparation of grade A pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort processed after packaging milk or milk product unless the person possesses a grade A permit from the state regulatory agency. Nothing in this chapter shall be deemed to require a person who is a broker, agent, or distributor's representative to have a grade A permit if the person buys condensed and dry milk product for, or sells condensed and dry milk product to, a milk plant that has a valid grade A permit from any state.

B. Only a person who complies with the requirements of this chapter shall be entitled to receive and retain a grade A permit. Permits shall not be transferable with respect to persons or locations. Each person whose name appears on a grade A permit shall be at least 18 years of age. Each person requesting a grade A permit shall provide the state regulatory agency with the following information:

1. The name of the person to whom the permit is to be issued;

2. If the person is requesting a permit for a partnership, corporation, firm, trustee, or institution, the person shall provide the articles of incorporation, partnership agreement, trust document, or other document identifying the names, titles, and mailing addresses of all responsible officials for the partnership, corporation, firm, trustee, or institution;

3. The address of the facility being permitted, including the street and number, city, state, and zip code. Addresses containing post office box designations shall not be permitted;

4. The trade name the permit holder will use if the permit holder will not be trading in the name to which the grade A permit is issued;

5. The name, mailing address, and telephone number for one responsible person designated by the grade A permit holder to receive all sample reports and official correspondence from the state regulatory agency;

6. If the permit application is for a grade A dairy farm, the name of the milk marketing organization or milk marketing cooperative to which the permit holder belongs or the buyer of its milk;

7. The names and phones numbers of responsible persons to contact at the grade A dairy farm or plant;

8. If the permit application is for a grade A dairy farm, the name, address, and telephone number of the owner of the dairy farm;

9. The printed name, signature, and title, and date signed for of each person whose name appears on the permit;

10. The printed name, signature, and title, and date signed by of the most responsible official for the partnership, corporation, firm, trustee, or institution if the permit is to be issued in the name of a partnership, corporation, company, firm, trustee, or institution; and

11. If the permit application is for a grade A plant permit, the plant code embossed or printed on packages of milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product packaged by the plant to identify the plant in lieu of printing the plant's name and address on the packages of milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product, if one has been assigned.

C. Each person who holds a grade A permit and who requests a change in the name on an existing grade A permit shall provide the state regulatory agency with the following information:

1. A written statement by each person whose name appears on the existing grade A permit requesting that the existing grade A permit be canceled that has been signed by each person whose name appears on the existing grade A permit; except that when a person whose name on an existing grade A permit is deceased, the request for cancellation shall be made in writing by the executor or administrator of the permit holder's estate. A copy of the qualification as executor or administrator shall accompany the request for cancellation along with a statement identifying the name of the deceased and the date of death. Each signature shall be made next to or above the person's printed name and shall be dated with the date on which the written statement was signed by the grade A permit holder;

2. If the existing grade A permit is held in the name of a partnership, corporation, company, firm, trustee, or institution, the written statement requesting the existing grade A permit be canceled shall be signed made by a person who is authorized to sign on behalf of the partnership, corporation, company, firm, trustee, or institution. Each signature shall be made next to or above the person's printed name and official title for the partnership, corporation, company, firm, trustee, or institution and shall be dated with the date on which the written statement was signed by the person who is authorized to sign on behalf of the partnership, corporation, company, firm, trustee, or institution.

D. No person may hold a grade A dairy farm permit if any part of his facilities, equipment, storage, or surroundings (except toilet rooms) requiring inspection is accessed through any room used for domestic purposes or part of any room used for domestic purposes. Toilet rooms used for domestic purposes may be approved as complying with the requirements of this chapter only if (i) the toilet room is located within 300 feet of the milkroom and (ii) all labor utilized in the milking parlor, milking barn, and milkroom is provided by members of the permit holder's immediate family.

E. No person who holds a grade A permit shall use or allow anyone else to use his facilities and equipment for any purpose other than that for which the grade A permit was issued.

F. Each person who holds a grade A dairy farm permit shall display his permit in the milkroom on his dairy farm.

G. Each person who holds a grade A dairy plant permit shall display his grade A plant permit in his facilities where it is accessible for inspection.

H. No grade A permit holder may transfer any grade A permit to another person or another location.

I. No permit holder who has had his grade A dairy farm permit or dairy plant permit revoked by the state regulatory agency shall be eligible to hold a grade A dairy farm or dairy plant permit at any time after the permit holder's permit is revoked.

J. If multiple grade A dairy farms with separate herds and bulk holding tanks exist at the same physical mailing address or are under different ownership, each facility must have a separate grade A permit.

K. If a dairy farm owner has more than one grade A dairy farm at more than one separate physical mailing address, each facility must have a separate permit.

The state regulatory agency may impound any condensed milk, condensed milk product, aseptically processed and packaged milk or milk product, retort processed after packaged milk or milk product, dry milk, dry milk product, milk, or milk product if it is in violation of any requirement of this chapter.

A. The state regulatory agency shall, except when the production is not on a yearly basis, during each month collect from each milk condensing plant, milk drying plant, whey condensing plant, or whey drying plant holding a grade A permit at least one sample of raw milk for pasteurization, after receipt of the milk by the plant and before pasteurization, and at least one sample of each grade A condensed milk product, grade A dry milk product, grade A condensed whey, and grade A dry whey manufactured. If the production of grade A dry milk products or grade A dry whey is not on a yearly basis, the state regulatory agency shall collect at least five samples within a continuous production period.

B. The state regulatory agency may collect samples of milk and milk products as it deems necessary from retail establishments selling milk or milk products to determine compliance with 2VAC5-490-40 and 2VAC5-490-50. Each person who operates the retail establishment shall furnish the state regulatory agency, upon the request of the state regulatory agency, with the names of all distributors from whom the person has obtained milk or milk products.

C. The state regulatory agency shall provide the remaining portion of the original raw milk sample from each grade A dairy farm that has been screened positive for animal drug residues by a milk plant, receiving station, or transfer station to the grade A dairy farm's milk marketing organization upon request.

D. Each grade A permit holder operating a milk plant within the Commonwealth shall provide to the state regulatory agency laboratory determinations of the quantity of vitamin A and vitamin D present in each of the milk plant's milk and milk products to which vitamin A or vitamin D has been added. Each grade A permit holder who operates a milk plant shall provide these laboratory determinations at least annually from a laboratory certified to determine the amount of vitamin A and vitamin D in milk and milk products under the requirements established in "Evaluation of Milk Laboratories," 2017 2023 revision, available from the Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Field Programs, Division of HACCP, Laboratory Quality Assurance Branch, HFH-450, 6502 South Archer Road, Summit-Argo, Illinois 60501, USA. Each grade A permit holder who operates a milk plant shall pay for the cost of the laboratory determinations.

A. Each grade A permit holder operating a milk plant, receiving station, or transfer station shall:

1. Comply with all regulations set forth in Appendix N of the "Grade "A" Pasteurized Milk Ordinance," 2017 2023 Revision";

2. Retain each sample found to be positive for drug residues for a period of 120 hours after the sample test result is positive for drug residues for the use of the state regulatory agency unless directed otherwise by a representative of the state regulatory agency;

3. Report records of all results of tests on samples of raw milk to the state regulatory agency by the 15th day of each month for the preceding month to include a statement as to whether the test results are positive or negative. If the results are positive, the grade A permit holder shall also record (i) the identity of each producer contributing to the load from which the positive sample of raw milk was taken; (ii) the name of the person notified at the state regulatory agency of the positive test results; (iii) the date and time of day the person at the state regulatory agency was notified of the positive test results; and (iv) the method of notification of the state regulatory agency;

4. Immediately notify the state regulatory agency and the milk marketing cooperative or broker of any shipment of bulk tank raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging milk and milk products when the shipment of bulk tank raw milk is found to be positive for drug residues. Nothing in this subdivision shall be deemed to include individual raw milk samples collected from each grade A dairy farm included in any shipment of bulk tank raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging milk and milk products; and

5. Provide by facsimile machine or other electronic means to the state regulatory agency copies of load manifests, producer weight tickets, laboratory worksheets where the results of laboratory tests are originally recorded, and records from electronic readers documenting the results for samples tested for all positive loads.

B. Each grade A dairy farm permit holder's milk marketing cooperative or milk marketing agent shall be responsible for the collection and testing of follow-up milk samples for animal drug residues required for permit reinstatement and resumption of milk shipment from the dairy farm each time the grade A dairy farm permit holder's milk test positive for animal drug residues.

C. Each grade A dairy farm permit holder's milk marketing cooperative or milk marketing agent shall comply with the following when following up on a producer's dairy farm after a positive animal drug residue:

1. Only persons who hold valid permits to weigh, sample, and collect milk issued by the state regulatory agency shall collect and deliver follow-up milk samples to laboratories for official testing for the purpose of permit reinstatement and the resumption of milk shipments from the dairy farm; and

2. Reports of laboratory testing shall be provided from officially designated laboratories for each milk sample tested for animal drug residues and shall include the following information:

a. The name of the grade A dairy farm permit holder;

b. The patron number of the grade A dairy farm permit holder;

c. The date, time, and temperature of the milk sample when collected;

d. The name of the person who collected the milk sample;

e. The name of the test method used to test the milk sample; and

f. The test result for the milk sample.

A. Each grade A permit holder operating a dairy plant that receives any milk that could require load confirmation or producer traceback as a result of a positive animal drug residue on a load of milk delivered at the plant shall provide to the state regulatory agency results of animal drug residue tests from an officially designated laboratory. Each officially designated laboratory shall maintain a listing in the IMS List – Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers as an approved milk laboratory certified to test load and producer samples. All laboratory results from officially designated laboratories shall be reported to the state regulatory agency within six hours of the initial presumptive positive result at the plant.

B. Each officially designated laboratory shall comply with the requirements contained in the "Evaluation of Milk Laboratories," 2017 2023 revision", for certification and listing in the "IMS List – Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers."

A. No person may produce, provide, manufacture, sell, offer for sale, or store in the Commonwealth, or bring into, send into, or receive into the Commonwealth any milk, milk product, or condensed and dry milk product for use in the commercial preparation of grade A pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort processed after packaged milk or milk products that are not labeled in compliance with the following:

1. Each grade A permit holder's bottles, containers, and packages enclosing any milk or milk products shall be labeled in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act, as amended; the Nutrition Labeling and Education Act (NLEA) of 1990, and regulations developed thereunder; and the Food Allergen Labeling and Consumer Protection Act of 2004; and the "Grade "A" Pasteurized Milk Ordinance," 2023 Revision;

2. The grade A permit holder shall label or mark all bottles, containers, and packages enclosing any milk or milk products with:

a. The name of a defined milk product, if there is a definition, and if there is no definition, a name that is not false or misleading;

b. The word "reconstituted" or "recombined" if the milk product is made by reconstitution or recombination;

c. The term "grade A" located on the exterior of the package on the principal display panel, the secondary or informational panel, or the cap or cover;

d. The identity of the plant where the grade A permit holder's milk or milk product is pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort processed after packaged by specifying:

(1) The street address, city, state, and zip code of the plant; or

(2) The code assigned the plant under the National Uniform Coding System for Packaging Identification of Milk and Milk Product Processing Plants;

e. In the case of concentrated milk or concentrated milk products the volume or proportion of water to be added for recombining;

f. The name of the milk product that the concentrated milk product will produce, which name shall be preceded by the term "concentrated." In the case of flavored milk or flavored reconstituted milk, the grade A permit holder shall substitute the name of the principal flavor for the word "flavored";

g. In the case of aseptically processed and packaged milk and milk products or retort processed after packaged milk and milk products, the words "keep refrigerated after opening";

h. In the case of aseptically processed and packaged milk or milk products, the term "UHT" ultra-high-temperature;

i. The term "ultra-pasteurized" if the milk or milk product has been ultra-pasteurized;

j. The term "goat" preceding the name of the milk or milk product when the milk or milk product is goat milk or is made from goat milk;

k. The term "sheep" preceding the name of the milk or milk product when the milk or milk product is sheep milk or is made from sheep milk;

l. The term "water buffalo" preceding the name of the milk or milk product when the milk or milk product is water buffalo milk or is made from water buffalo milk;

m. As in the case of cow's milk, goat's milk, sheep's milk, and water buffalo's milk, the common or usual name of the mammal from which the milk was obtained shall precede the name of the milk, milk product, condensed milk, condensed milk product, dry milk, or dry milk product;

n. The information appearing on the label of any bottle, container, or package of milk or milk product shall contain no marks, pictures, graphics, endorsements, or words that are misleading;

o. The "pull date" shall not interfere with the legibility of other labeling required for the milk or milk product and shall be expressed by the first three letters in the name of the month, followed by or preceded by the numeral or numerals constituting the calendar date after which the product shall not be sold or expressed numerically by the number of the month followed by the number of the day. For example, June 1 shall be expressed "JUN 1," "1 JUN," "06 01," or "06-01";

p. B. The grade A permit holder who operates a milk plant and offers for sale milk or milk product within the Commonwealth shall file and certify with the state regulatory agency the maximum number of days after manufacturing or processing the grade A permit holder's milk or milk products that will be used to determine the "pull date." The grade A permit holder shall establish a "pull date" that under normal storage the milk or milk product meets for a minimum of 96 hours after the "pull date," standards set by this chapter;

q. C. No person may sell or offer for sale any packaged grade A pasteurized milk, grade A pasteurized milk product, or milk product after the date of the "pull date" on the package; and

r. D. No person may sell or offer for sale any grade A pasteurized milk, grade A pasteurized milk product, or milk product in a package that does not bear the "pull date";

s. Nothing in this chapter shall apply to containers of grade A pasteurized milk, grade A milk products, or milk products that are not to be sold in the Commonwealth; and.

t. In the case of condensed or dry milk products, the label shall also contain (i) the identity of the state regulatory agency issuing the processing plant's permit; (ii) the identity of the distributor if the condensed or dry milk products are distributed by a party other than the processing plant, the name and address of the distributor shall also be shown by a statement such as "distributed by"; (iii) the code or lot number identifying the contents with a specific date, run, or batch of the product; and (iv) a statement of the quantity of the contents of the container.

A. No person may produce, provide, manufacture, sell, offer for sale, or store in the Commonwealth, or bring, send, or receive into the Commonwealth, grade A raw milk or milk product for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging that does not comply with the following standards:

1. The temperature of the raw milk shall be cooled to 40°F or cooler, but not frozen, within two hours after milking and the temperature after the first or any subsequent milking shall not be warmer than 50°F;

2. The bacteria count of raw cow's milk shall not exceed 50,000 bacteria per milliliter prior to commingling with any other milk; and the bacteria count of raw cow's milk that is commingled shall not exceed 300,000 bacteria per milliliter prior to pasteurization;

3. The bacteria count of raw sheep's milk, raw goat's milk, raw water buffalo's milk, or raw milk from any other hooved mammal shall not exceed 100,000 bacteria per milliliter prior to commingling with any other milk; and the bacteria count of raw sheep's milk, raw goat's milk, raw water buffalo's milk, or raw milk from any other hooved mammal that is commingled shall not exceed 300,000 bacteria per milliliter prior to pasteurization; and

4. The somatic cell count of raw cow's milk shall not exceed 500,000 somatic cells per milliliter. The somatic cell count of raw water buffalo's milk, raw sheep's milk, or raw milk from any other hooved mammal shall not exceed 750,000 somatic cells per milliliter. The somatic cell count of raw goat's milk shall not exceed 1,500,000 somatic cells per milliliter.

B. Each person who holds a grade A permit to produce raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging shall:

1. Offer for sale or sell no milk that has passed through any equipment if the milk-contact surfaces of the equipment are no longer visible or are covered or partially covered by an accumulation of milk solids, milk fat, cleaning compounds, or other soils. Any milk that passes through equipment, the milk-contact surfaces of which are no longer visible or are covered or partially covered by an accumulation of milk solids, milk fat, cleaning compounds, or other soils, shall be deemed adulterated (Item 10r);

2. Provide covered trash containers when individual sanitary towels are used (Item 16r);

3. Cool to 40°F or cooler (but not freeze) all raw milk for pasteurization, ultra-pasteurization, aseptic processing and packaging, or retort processed after packaging within two hours after the grade A permit holder completes milking and ensure that the temperature of the grade A permit holder's raw milk is not warmer than 50°F after the first milking or any subsequent milking. Raw milk for pasteurization that is warmer than a temperature of 50°F after the first milking or any subsequent milking shall be deemed a public health hazard and shall not be offered for sale or sold (Item 18r);

4. Agitate all raw milk for pasteurization for not less than five minutes at least once every hour; assure that the milk in the farm's bulk milk cooling or holding tank covers the agitator paddle sufficiently to facilitate proper cooling and sampling after the completion of the first milking; and abstain from selling or offering for sale milk that does not cover the agitator paddle sufficiently to facilitate proper cooling and sampling after the completion of the first milking (Item 18r); and

5. Equip all farm bulk milk tanks with an approved temperature-recording device (Item 18r); and

6. Maintain the milkroom free of insects, rodents, and other animals (Item 19r).

No person may offer to sell or sell, barter, trade, or accept any goods or services in exchange for unpasteurized milk or unpasteurized milk product if the unpasteurized milk or unpasteurized milk product is intended for human consumption.

Each person operating a milk plant, receiving station, or transfer station and participating in the voluntary HACCP program shall have a minimum of 60 days of HACCP system records prior to a HACCP listing audit. Each milk plant, receiving station, or transfer station shall be inspected and permitted initially by the state regulatory agency and shall be regulated initially under the requirements of this chapter without taking into consideration the provisions of this part until the state regulatory agency conducts an acceptable HACCP listing audit documenting the successful implementation of a fully functioning HACCP system in the person's milk plant, receiving station, or transfer station.

Each person operating a milk plant, receiving station, or transfer station and participating in the voluntary HACCP program shall provide complete, up-to-date process flow diagrams for all grade A milk, milk products, condensed milk, condensed milk products, dry milk, or dry milk products prior to developing the HACCP plan.

Dairy Farm Inspection Report, ODF-DS-102 (rev. 2/2018)

Application for a Dairy Farm Permit, ODF-DS-100 (rev. 4/2018)

Application for Reinstating a Permit (rev. 4/2022)

Grade "A" Fluid Milk Processing Plant Application (rev. 1/2025)

Guide for the Submission of Plans for Milking Operations (rev. 5/2020)

Permit Application for a Dairy Facility (rev. 4/2025)

Evaluation of Milk Laboratories, 2017 Revision, published by the Food and Drug Administration Laboratory Proficiency and Evaluation Team, HFH-450, 6502 South Archer Road, Bedford Park, Illinois 60501

Evaluation of Milk Laboratories, 2023 Revision, U.S. Food and Drug Administration

Grade "A" Pasteurized Milk Ordinance, 2017 Revision, published by the Food and Drug Administration, Milk Safety Branch (HFS-626), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835

Grade "A" Pasteurized Milk Ordinance, 2023 Revision, U.S. Food and Drug Administration