[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Page 57000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23619]



[[Page 57000]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-2994]


Draft Compliance Policy Guide Crotalaria spp. Seeds in Grains; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft Compliance Policy Guide (CPG) entitled 
``Compliance Policy Guide Sec. 100.101 Crotalaria spp. Seeds in 
Grains'' (the draft CPG). The draft CPG, when finalized, will provide 
guidance for FDA staff on our regulatory action guidance criteria for 
Crotalaria species (spp.) seeds in grains.

DATES: Although you can comment on any CPG at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on the draft CPG 
before we begin work on the final version of the CPG, submit written or 
electronic comments on the draft CPG by November 20, 2015.

ADDRESSES: Submit electronic comments on the draft CPG to http://www.regulations.gov. Submit written comments on the draft CPG to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written 
requests for single copies of the draft CPG to the Office of Policy and 
Risk Management, Office of Regulatory Affairs, Office of Global 
Regulatory Operations and Policy, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857. Send two self-addressed adhesive 
labels to assist that office in processing your request, or fax your 
request to 240-632-6861. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft CPG.

FOR FURTHER INFORMATION CONTACT: George C. Ziobro, Center for Food 
Safety and Applied Nutrition (HFS-316), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1700; or Amber 
M. McCoig, Center for Veterinary Medicine (HFV-230), Food and Drug 
Administration, 7519 Standish Place, Rockville, MD 20855, 240-402-5556.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft CPG entitled 
``Compliance Policy Guide Sec. 100.101 Crotalaria spp. Seeds in 
Grain.'' We previously provided guidance on Crotalaria spectabilis and 
Crotalaria striata seeds in grains in a CPG entitled ``Compliance 
Policy Guide 7126.15 Crotalaria Seeds in Grains and Feeds'' (CPG 
7126.15), which we issued on December 1, 1980. We revoked CPG 7126.15 
on July 22, 1994, because at the time we deemed the CPG to be no longer 
relevant (59 FR 37498). However, because Crotalaria plants persist in 
the agricultural environment and still present a potential public 
health risk, we continue to monitor grains for the presence of 
Crotalaria spp. seeds.
    We are making available the draft CPG because the revocation of CPG 
7126.15 in 1994 inadvertently affected interactions between FDA and the 
U.S. Department of Agriculture's (USDA's) Federal Grain Inspection 
Service (FGIS). Under a Memorandum of Understanding between FDA and 
USDA (MOU 225-80-2000; http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116312.htm), FGIS reports to FDA's district offices the results of 
FGIS's analysis that may be actionable under the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act). FGIS has been using the CPG 7126.15 
criteria for reporting their analytical results relating to Crotalaria 
in grain to FDA.
    CPG 7126.25 established a regulatory action criterion of ``an 
average of at least one whole seed of Crotalaria spectabilis and/or 
Crotalaria striata per pound'' of grain. In developing the draft CPG, 
we converted the unit of weight from pounds to kilograms because metric 
units of measurement (e.g., kilograms) are generally used for 
scientific calculations. The conversion from ``seeds per pound'' to 
``seeds per kilogram'' resulted in 2.2 seeds per kilogram. Because the 
analytical method is based on determining whole seeds, we rounded 2.2 
to the nearest number of whole seeds (i.e., 2 whole seeds). The draft 
CPG also refers to Crotalaria spp. seeds in grain instead of Crotalaria 
spectabilis and Crotalaria striata because it is impracticable to 
distinguish between Crotalaria seeds based on species. Thus, the draft 
CPG states that FDA may regard grain that contains more than two whole 
Crotalaria spp. seeds per one kilogram of grain to be adulterated 
within the meaning of section 402(a)(1) of the FD&C Act (21 U.S.C. 
342(a)(1)).
    The draft CPG is being made available consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft CPG, when 
finalized, will represent our current thinking on Crotalaria spp. seeds 
in grains. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternate approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
draft CPG. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday and may be 
posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft CPG from 
FDA's Office of Regulatory Affairs Compliance Policy Guide Revision/
Update History page. It may be accessed at http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm or http://www.regulations.gov. Always access an FDA guidance document by using 
FDA's Web site listed previously to find the most current version of 
the guidance.

    Dated: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23619 Filed 9-18-15; 8:45 am]
 BILLING CODE 4164-01-P