UNITED STATES DEPARTMENT OF AGRICULTURE 


BEFORE THE FOOD SAFETY AND INSPECTION SERVICE 


In re: 

Manuel's Ranch and 

Manuel Coto 

Respondents 

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STIPULATION AND 

CONSENT AGREEMENT 

This administrative action was instituted by the delivery ofa Notice oflneligibility for 

Custom Exempt Status on March 16, 2015, to Manuel's Ranch and Mr. Manuel Coto, hereafter 

"Respondents," notifying them that they were no longer eligible for custom exemption under the 

Federal Meat Inspection Act (FMIA) (21 U.S.C.§601 et seq.), and the Poultry Products Inspection 

Act (PPIA) (21 U.S.C. §451 et~.), and the regulations promulgated thereunder. The Notice of 

Ineligibility that was hand-delivered by FSIS personnel was effective upon receipt, and was 

issued due to Respondents' alleged failure to maintain their facility in a sanitary manner. 

The aforementioned action was instituted by the Food Safety and Inspection Service (FSIS) 

ofthe United States Department ofAgriculture (USDA), hereafter "Complainant," in accordance 

with Section 23(a) ofthe FMIA (21 U.S.C. §623(a)), Part 303 ofthe Federal Meat Inspection 

Regulations Title 9, Code of federal Regulations (9 C.F.R. §303.1 et seq.), Section IS( c) ofthe PPIA 

(21 U.S.C. §464(a)), Part 381.10 ofthe Poultry Products Inspection Regulations, and Part 416 ofthe 

Sanitation Regulations (9 C.F .R. §416 et ~· 

The parties have agreed that this administrative proceeding should be terminated by the 

execution ofthis Stipulation and Consent Agreement, hereafter "Agreement," set forth below and 

have agreed to the following stipulations: 

1. For the purpose ofthis Stipulation and the provisions ofthis Agreement only, 

Respondents admit the jurisdictional allegations ofthe above-mentioned Notice oflneligibility and 
both parties waive: 

(a) any further procedural steps in this proceeding; 

(b) any requirements that the Stipulation and Consent Agreement in this proceeding contains 

findings and conclusions with respect to fact or law, as well as to reason and basis thereof; and 

(c) all rights to seek further judicial review or otherwise challenge or contest the validity of 

this Stipulation and Consent Agreement. 

2. This Stipulation and Consent Agreement is for settlement purposes in this proceeding 

only, and does not otherwise constitute an admission or denial by Respondents that they have 

violated any Federal regulation or statute. 

3. Respondents waive any action against USDA under the Equal Access to Justice Act of 

1980 (5 U.S.C. 504 et seq.) for fees or other expenses incurred .in connection with this proceeding, 

and any other action against the USDA and its employees in connection with this proceeding and the 

facts and events that gave rise to this proceeding. 

FINDINGS OF FACT 

1. Respondent Manuel's Ranch is now, and at all times material herein, located at 13202 NW 

182nd Street, Hialeah, FL 33018. 

2. Respondent Manuel's Ranch is now, and was at all times material herein, a custom exempt 

operation under Section 23(a) ofthe FMIA, Section 15(c) ofthe PPIA at its place ofbusiness in Hialeah, 

Florida. 

3. Respondent Manuel Coto is now, and was at all times material herein, the owner of 

Manuel's Ranch and is responsibly connected to Manuel's Ranch. 

4. Manuel's Ranch and Mr. Manuel Coto operated under the custom exemption eligibility, 

pursuant to Section 23(a) ofthe FMIA, Section 15(c) ofthe PPIA, and applicable federal meat inspection 

(9 C.F.R. Part 303.1), poultry inspection (9 C.F.R. Part 381.10), and sanitation (9 C.F.R. Part 416) 

regulations. 

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5. In a Notice oflneligibility letter delivered on March 16, 2015, Respondents were notified 

that they were no longer eligible to operate under the custom exempt provisions ofthe FMIA and 

PPIA because ofviolations ofsanitation, facility, recordkeeping, and other requirements , as required by 9 

C.F.R. Parts 303.1, 381.10, and Part 416. 

CONCLUSION 

As the Parties have agreed to the provisions set forth in the following Agreement in disposition 

ofthis proceeding, the following Agreement wi11 be issued. 

AGREEMENT 

Custom exempt livestock and poultry slaughter and meat and poultry processing privileges 

under 9 C.F.R. Part 303.1and 9 C.F.R. Part 381.10 are terminated from Respondents, and its owners, 

officers, directors, partners, successors, affiliates, or assigns, directly or through any corporate device, 

for a period oftwo (2) years. This termination of exemption privileges shall be held in abeyance and 

custom exemption privileges shall be provided to Respondents, pursuant to Section 23 (a) ofthe FMIA, 

Section 15 (c) ofthe PPIA, and 9 C.F.R. Parts 303.1, 381.10, and 416, provided all statutory and 

regulatory requirements and the additional conditions set forth in this Agreement are met. This 

Agreement shall remain in effect for a period oftwo (2) years after the date ofthe "Exempt 

Establishment Review Report," FSIS Form 5930-1, with findings of"acceptable" in every category. 

CONDITIONS 

1. Prior to the reinstatement ofcustom exemption privileges, and subject to verification and 

a satisfactory determination by FSIS, Respondents shall demonstrate compliance with the FSIS 

statutory and regulatory requirements including, but not limited to, 9 C .F.R. Parts 303.1, 381.10, and 

416, upon a facility review by FSIS and examination of(a) Respondents' written operational 

procedures and other programs, and (b) ofthe physical and sanitary conditions ofRespondents' 

facility. 

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2. Prior to the reinstatement of custom exemption privileges, and subject to verification by 

FSIS, Respondents shall address and repair any premises, facility, and or equipment issues identified 

by FSIS at the time of the facility review conducted pursuant to paragraph 1 ofthis Agreement. 

Sanitation Performance Standards (SPS) 

3. Prior to reinstatement of custom exemption privileges, and subject to verification by FSIS, 

Respondents shall: 

(a) develop written procedures for monitoring and identifying noncompliance, corrective and 

prevention actions, and recordkeeping that Respondents will conduct, implement, and retain to operate 

and maintain its premises, facilities, equipment, and outside premises in a manner sufficient to 

prevent the creation of insanitary conditions and practices; and 

(b) comply with the Sanitation Performance Standards (SPS) regulatory requirements specified 

in 9 C.F .R. Parts 416.1 through 416.5, except those addressing water reuse (416.2(g)(2) through (6)), prior 

to resuming custom exempt operations. 

4. Upon reinstatement ofcustom exemption privileges, and subject to verification by FSIS, 


Respondents shall: 


(a) comply with the requirements ofthe SPS regulations (9 C.F .R. Parts 416.1 to 416.5); 

(b) operate and maintain, at all times, the facility, including its premises, facilities, equipment, 

and outside premises, in a manner sufficient to prevent the creation ofinsanitary conditions and practices; 

(c) ensure that meat and poultry and meat and poultry food products are stored, prepared, and 


packaged so as not to become contaminated or adulterated; and 


(d) assess their written SPS procedures to evaluate their effectiveness, and make necessary 

improvements, corrective actions, and repairs to the facility buildings, structures, rooms, and 

compartments to ensure that they are kept in good repair, and are of sufficient size to allow for 

processing, handling, and storage ofproduct in a manner to ensure and maintain sanitary conditions. 

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Sanitation Standard Operating Procedures (SSOP) 

5. Prior to the reinstatement ofcustom exemption privileges, and subject to verification by 


FSIS, Respondents shall: 


(a) develop a written SSOP to describe the monitoring activities, recordkeeping, and other 

procedures that Respondents will conduct , implement, and maintain on a daily and on-going basis before, 

during, and after operations, in accordance with 9 C.F .R. Parts 416.11 to 416.16, to ensure sanitary 

conditions and prevent product adulteration; 

(b) implement and maintain their SSOP system on a daily and on-going basis as required by 9 

C.F.R. Part 416 to ensure sanitary conditions and prevent product adulteration; and 

(c) implement corrective and preventative actions, as required by 9 C.F .R. Part 416.15. 

Planned Improvement Plan (PIP) 

6. Prior to the reinstatement of custom exemption privileges, and subject to verification by 

FSIS, Respondents shall develop a PIP designed to identify and correct noncompliance and to ensure 

that the entire structure ofthe facility, to include its rooms and compartments, is of sound 

construction and that all equipment is maintained in proper working order and kept in good repair. 

7. Upon the reinstatement of custom exemption privileges, and subject to verification by 

FSIS, Respondents shaH implement and maintain their PIP as required in this Agreement and 

document any findings and corrective actions to address structural and mechanical repairs and 

improvements to their facility and make these records available to FSIS for review and copying upon 

request. 

Pest Management Program 

8. Prior to the reinstatement of custom exemption privileges, and subject to verification by 

FSIS, Respondents shall develop a written pest management program to prevent the harborage and 

breeding ofpests within the facility and on its grounds consistent with 9 C.F.R. Parts 416.2 (a) and 

(b) to ensure that: 

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(a) Respondents review and service the facility and grounds on at least a daily frequency for 

any signs of rodent and insect presence and activity; and 

(b) Respondents provide written reports detailing their findings, corrective actions, and 

recommendations based on their review and service ofthe facility and grounds for any signs of 

rodent and insect presence and activity. 

9. Upon the reinstatement of custom exemption privileges, and subject to verification of 

FSIS, Respondents shall implement and maintain their pest control program in a manner sufficient to 

prevent the creation of insanitary conditions and practices, to prevent the harborage and breeding of 

pests, and to ensure that meat and poultry products are stored, prepared, and packaged so as not to 

become contaminated or adulterated. 

Humane Handling and Slaughter 

I 0. Respondents shall ensure that any cattle, sheep, swine, or goats slaughtered or handled in 

connection with slaughter at their facility complies with the Humane Methods of Slaughter Act 

(HMSA) of August 27, 1958 (7 U.S.C.§§l901-1906), 21 U.S.C. 610(b), 9 C.F.R. Part 313, and any 

Federal, state, or local laws regarding the humane treatment of animals. 

Specified Risk Materials 

11. Prior to the reinstatement ofcustom exemption privileges, and subject to verification by 

FSIS, Respondents shall develop a written specified risk material (SRM) control program for cattle, to 

include daily records sufficient to document procedures for the removal , segregation, and disposition of 

SRM, to ensure the control ofSRM, and to ensure regulatory compliance with 9 C.F .R. §309, 310, and 

31 1. The program shall include procedures indicating the handling and removal ofnon-ambulatory 

disabled cattle (downer) at their facility. 

12. Upon the reinstatement of custom exemption privileges, and subject to verification by FSIS , 

Respondents shall implement and maintain, on a daily and on-going basis, their written SRM control 

program. 

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Sewage and Waste Disposal 

13. Prior to the reinstatement of custom exempt privileges, and subject to verification by 

FSIS, Respondents shall have a sewage waste disposal system in place that properly removes sewage 

and waste materials to prevent the adulteration of food products consistent with 9 C.F.R. Parts 

303.l(a)(2)(i), 381.10(a)(3) and (4), and 416.2(e) and (t). 

14. Upon reinstatement ofcustom exempt privileges, and subject to verification by FSIS, 

Respondents shall maintain the sewage and waste disposal systems to prevent the adulteration of food 

products. When the sewage disposal system is a private system requiring approval by a State or local 

health authority, Respondent must furnish FSIS with a letter ofapproval from that authority upon request 

as required 9 C.F.R. Parts 416.2 (e) and (f). 

Record keeping and Labeling Provisions 

15. Respondents shall properly label and maintain full, complete, and accurate written records of 

all business activities applicable to the FMIA and PPIA, as specified in 9 C.F.R. Parts 303.l(b)(3), 309.3 , 

310.22, 320, and 381 .175. Respondents shall make all such records available for review and copying upon 

request of any authorized representative ofthe Secretary ofAgriculture. Respondents shall maintain such 

records for a period oftwo years after December 31 ofthe year in which the record was made, in 

accordance with 9 C.F.R. Parts 320.3 and 381.177. 

Management and Training

16. Prior to reinstatement ofcustom exemption privileges, and subject to verification by FSIS, 

Respondents shall designate one person and an alternate who shall have overall responsibility for (a) 

implementing, and maintaining the sanitation and other requirements of9 C.F .R. Parts 303, 381.10, and 

416, and (b) compliance with the conditions ofthis Agreement. Respondents may name a new designee or 

alternate only upon written request to, and subject to the written concurrence of, the Director, ELD. 

17. Prior to the reinstatement ofcustom exemption privileges, with prior concurrence and subject 

to verification by FSIS, all ofRespondents' management and employees shall complete training in 

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sanitation and sanitary dressing procedures. 

I8. Prior to the reinstatement of custom exemption privileges, and subject to verification by FSIS, 

Respondents shall train all employees in all programs, procedures, and requirements ofthis Agreement. 

19. Upon reinstatement ofcustom exemption privileges, and subject to verification by FSIS , 

Respondents shall conduct training for new employees, consistent with the requirements of paragraph 17. 

20. Respondents shall maintain for the duration of the Agreement records documenting the 

completion ofall training as described in paragraphs 17-19 and shall make those records available upon 

any request to any authorized representative ofthe Secretary. 

Custom Exemption Requirements 

21. Respondents shall (a) ensure that product does not become adulterated during process ing, 

handling, storage, loading and unloading, or during transportation; (b) ensure that all slaughtered and 

processed animal carcasses and further processed meat or poultry or meat or poultry food products are 

properly marked, labeled, and packaged, (c) ensure that custom prepared products are plainly marked 

"Not for Sale" , and (d) maintain records as required by 9 C.F.R. Part 303. 

Poultry Exemption Requirements 

22. Res pondent shall en sure that the following poultry exemption require ments in 9 C .F.R. Part 

381. 10 are met: 

(a) Respondents may not engage in the buying and selling ofany poultry products capable of use 

for human food ; 

(b) ensure that the slaughtered poultry is for the personal use ofthe owner ofthe poultry and may 

not be sold or donated; 

(c) ensure that the shipping containers ofcustom slaughtered poultry products bear the owner's 

name, address, and the statement "Exempted-P .L. 90-492"; and 

(d) ensure that only one poultry exemption is c laimed during a calendar year. 

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General Provisions 

23. Respondents shall not (a) commit any felony or fraudulent act; (b) violate any section ofthe 

FMIA, PPIA, Federal, State, or local statue or regulation involving the preparation, sale, transportation, 

distribution or attempted distribution of any adulterated or misbranded meat or poultry product; (c) 

willfully make or cause to be made any false entry into any accounts records or memoranda kept by 

Respondents in compli ance with Federal or State statutes or regulations; fail to make true and correct 

entries in such accounts, records, or memoranda; or fail to keep such accounts that fully disclose all 

transaction s in Re spondent's business; (d) assault, intimidate, impede, or interfere with, or threaten and 

assault, intimidate, impede or interfere with any representative or designee of the Secretary of 

Agriculture. 

24. Respondents shall make all records required to be maintained by the FMIA, PPIA, or 

regulations issued thereunder or this Agreement available to FSIS personnel for review and/or copying 

immediately upon request. 

25. Respondents shall fully and completely cooperate with any USDA or FSIS investigation, 

inquiry, review or examination of Respondents' (a) facility, products, inventory or records, (b) 

compliance with the FMJA, PPJA, or the regulations issued thereunder, or (c) compliance with this 

Agreement. 

26. The Administrator, FSIS, shall have the right to summarily terminate custom exempt 

privileges from Respondents upon a determination by the Director, Enforcement and Litigation Division, 

Office ofInvestigation, Enforcement and Audit, FSIS, or his or her designee, that Respondents have 

failed to comply with 9 C.P.R. Parts 303 . 1, 381.10, and/or 416 or any requirement ofthis 

Agreement. It is acknowledged that Respondents retain the right to request an expedited hearing 

pursuant to the Adopted Rules of Practice, 9 C.F.R. Parts 1.130- 1.151, concerning any violation 

alleged as the basis for a summary termination ofcustom exemption privileges. 

27. The provisions ofthis Agreement shall be applicable for two (2) years, beginning the 

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effective date ofthis Agreement. 

28. This Agreement shall be considered iss ued on the date that is signed by the Administrator, 

FSIS, but shall become effective on the date that an FSIS exempt estabJjsluneot review documents 

findings of"acceptable" in every category, on the "Exempt Establishment Review Report," FSIS Form 

5930-1 , a copy of which will be provided to the Respondent. The exempt establishment review will be 

conducted only after FSIS has verified that all ofthe above provisions stipulating completion " prior to 

reinstatement of custom exemption privileges" have been completed. 

29. Nothjng in this Agreement shall preclude any regulatory or administrative actions or the 

referral of any matter to any agency for possible criminal or civil proceedings, or preclude the 

Administrator, FSIS, from taking other appropriate administrative action under the FMIA, PPIA, or the 

regulations promulgated thereunder. 

Ifany provision ofthis Agreement is declared invalid, such declaration shall not affect the 


validity of any other provision herein . 


on 

Manuel 

(JtY~~ 

behalf 

Coto, 

of him 

Owner 

self and for Manuel 's Ranch 

SQiJJ~ Enforcement and Litigation Division 

Food Safety and Inspection Service 

U.S. Department of Agricu lture 

£1- .() I 

Iss ued this_,_ day of Uctth~f' 2015 

. Almanza, Adminis ato 

ety and Inspection Service 

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