Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Compliance Policy Guide 
Sec. 100.101 Crotalaria spp. Seeds 
in Grains:  Guidance for FDA Staff 
 
Draft Guidance 
 
This guidance is being distributed for comment purposes only. 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that FDA considers your comment on this draft guidance before we begin work on 
the final version of the guidance, submit either electronic or written comments on the 
draft guidance within 60 days of publication in the Federal Register of the notice 
announcing the availability of the draft guidance. Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number listed 
in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document contact the Center for Food Safety and 
Applied Nutrition (CFSAN) at 240-402-1700 or the Center for Veterinary Medicine 
(CVM) at 240-276-9200. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
 Office of Regulatory Affairs 
 
 
September 2015 
 
  1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
Table of Contents 
 
 
  I.  Introduction 
 
 II.  Background 
 
III.  Policy 
 
IV.  Regulatory Action Guidance 
 
 V.  Specimen Charges  
 
 
 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
Compliance Policy Guide 
Sec. 100.101 Crotalaria spp. Seeds in Grains:  
Guidance for FDA Staff 
 
This draft guidance, when finalized, will represent the Food and Drug Administrations 
(FDAs) current thinking on this topic.  It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public.  You can use an alternative 
approach if the approach satisfies the requirements of the applicable statutes and 
regulations. If you want to discuss an alternative approach, contact the FDA staff 
responsible for implementing this guidance.  If you cannot identify the appropriate FDA 
staff, call the telephone number listed on the title page of this guidance. 
 
I. Introduction:  
 
The purpose of this document is to provide guidance for FDA staff on Crotalaria species 
(spp.) seeds in grains.  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
II. Background: 
 
Crotalaria spp. plants present a public health threat for humans and animals due to the 
presence of toxigenic pyrrolizidine alkaloids in the seeds.  Some species of Crotalaria are 
used as a cover crop to improve soil properties, reduce soil erosion, conserve soil water, 
and recycle plant nutrients.  However, if not properly managed, Crotalaria spp. seeds can 
germinate and invade or displace desirable plants in pastures and in fields of grain crops.  
When Crotalaria spp. plants are present in fields of grain crops, the Crotalaria spp. seeds 
may become comingled with the desired grain as the crop is harvested and processed.  
The introduction and growth of Crotalaria spp. in crop fields can be controlled by good 
agricultural practices to reduce or eliminate unwanted plants. 
 
III. Policy: 
 
FDA may regard grain that contains more than two (2 ) whole Crotalaria seeds per one 
(1) kilogram of grain to be adulterated within the meaning of section 402(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(1)).  Under 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)), FDA may refuse admission of 
grain that is offered for import and appears to be adulterated within the meaning of 
section 402(a)(1). 
 
IV. Regulatory Action Guidance: 
 
The following represents criteria for recommending seizure or import refusal of grain that 
may be intended for human food to the Center for Food Safety and Applied Nutrition, 
Office of Compliance, Division of Enforcement (HFS-605) and for recommending 
seizure or import refusal of grain that may be intended for food for animals to the Center 
for Veterinary Medicine, Division of Compliance (HFV-230): 
 
The grain contains more than two (2) whole Crotalaria spp. seeds per one (1) 
kilogram of grain.  
 
Refer to Investigations Operations Manual Sample Schedule 4: Wheat Carload Sampling 
for instructions on sampling grain in railcars, barges, trucks, and other large containers or 
storage vessels. 
 
The United States Department of Agricultures Federal Grain Inspection Service (FGIS) 
reports to the FDA district offices the results of their analysis of grain that contains more 
than two (2) whole Crotalaria spp. seeds per one (1) kilogram of grain.  FDA district 
offices should follow-up as necessary with FGIS regarding the disposition of lots of grain 
sampled by FGIS that are found to meet the actionable level.  (See Memorandum of 
Understanding (MOU 225-80-2000) between FGIS and FDA). 
 
V. Specimen Charges: 
 
Domestic Seizure 
The article of food was adulterated when introduced into interstate commerce or while in 
interstate commerce or  while held for sale after shipment in interstate commerce, within 
the meaning of 21 U.S.C. 342(a)(1), in that it bears or contains an added poisonous or 
deleterious substance, namely Crotalaria spp. seeds, which may render it injurious to 
health. 
 
Import Refusal 
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the 
FD&C Act, in that it appears to be adulterated within the meaning of section 402(a)(1) of 
the FD&C Act in that it bears or contains an added poisonous or deleterious substance, 
namely Crotalaria spp. seeds, which may render it injurious to health. 
 
Issued:  9/21/2015 
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