80 FR 57000 - Draft Compliance Policy Guide Crotalaria spp. Seeds in Grains; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 182 (September 21, 2015)

Page Range		57000-57000
FR Document		2015-23619

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.

Federal Register, Volume 80 Issue 182 (Monday, September 21, 2015)

[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Page 57000]
From the Federal Register Online [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

57000 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices

DEPARTMENT OF HEALTH AND Guide Sec. 100.101 Crotalaria spp. The draft CPG, when finalized, will
HUMAN SERVICES Seeds in Grain.’’ We previously represent our current thinking on
provided guidance on Crotalaria Crotalaria spp. seeds in grains. It does
Food and Drug Administration spectabilis and Crotalaria striata seeds not create or confer any rights for or on
[Docket No. FDA–2015–D–2994] in grains in a CPG entitled ‘‘Compliance any person and does not operate to bind
Policy Guide 7126.15 Crotalaria Seeds FDA or the public. An alternate
Draft Compliance Policy Guide in Grains and Feeds’’ (CPG 7126.15), approach may be used if such approach
Crotalaria spp. Seeds in Grains; which we issued on December 1, 1980. satisfies the requirements of the
Availability We revoked CPG 7126.15 on July 22, applicable statutes and regulations.
1994, because at the time we deemed
AGENCY: Food and Drug Administration, II. Comments
the CPG to be no longer relevant (59 FR
HHS. 37498). However, because Crotalaria Interested persons may submit to the
ACTION: Notice. plants persist in the agricultural Division of Dockets Management (see
environment and still present a ADDRESSES) either electronic or written
SUMMARY: The Food and Drug potential public health risk, we comments regarding the draft CPG. It is
Administration (FDA or we) is continue to monitor grains for the only necessary to send one set of
announcing the availability of a draft presence of Crotalaria spp. seeds. comments. Identify comments with the
Compliance Policy Guide (CPG) entitled We are making available the draft CPG docket number found in brackets in the
‘‘Compliance Policy Guide Sec. 100.101 because the revocation of CPG 7126.15 heading of this document. Received
Crotalaria spp. Seeds in Grains’’ (the in 1994 inadvertently affected comments may be seen in the Division
draft CPG). The draft CPG, when interactions between FDA and the U.S. of Dockets Management between 9 a.m.
finalized, will provide guidance for FDA Department of Agriculture’s (USDA’s) and 4 p.m., Monday through Friday and
staff on our regulatory action guidance Federal Grain Inspection Service (FGIS). may be posted to the docket at http://
criteria for Crotalaria species (spp.) Under a Memorandum of www.regulations.gov.
seeds in grains. Understanding between FDA and USDA
III. Electronic Access
DATES: Although you can comment on (MOU 225–80–2000; http://
any CPG at any time (see 21 CFR www.fda.gov/AboutFDA/ Persons with access to the Internet
10.115(g)(5)), to ensure that we consider PartnershipsCollaborations/ may obtain the draft CPG from FDA’s
your comment on the draft CPG before MemorandaofUnderstandingMOUs/ Office of Regulatory Affairs Compliance
we begin work on the final version of DomesticMOUs/ucm116312.htm), FGIS Policy Guide Revision/Update History
the CPG, submit written or electronic reports to FDA’s district offices the page. It may be accessed at http://
comments on the draft CPG by results of FGIS’s analysis that may be www.fda.gov/ICECI/
November 20, 2015. actionable under the Federal Food, ComplianceManuals/
Drug, and Cosmetic Act (the FD&C Act). CompliancePolicyGuidanceManual/
ADDRESSES: Submit electronic
FGIS has been using the CPG 7126.15 default.htm or http://
comments on the draft CPG to http://
criteria for reporting their analytical www.regulations.gov. Always access an
www.regulations.gov. Submit written
results relating to Crotalaria in grain to FDA guidance document by using
comments on the draft CPG to the
FDA. FDA’s Web site listed previously to find
Division of Dockets Management (HFA–
CPG 7126.25 established a regulatory the most current version of the
305), Food and Drug Administration,
action criterion of ‘‘an average of at least guidance.
5630 Fishers Lane, Rm. 1061, Rockville,
one whole seed of Crotalaria spectabilis Dated: September 15, 2015.
MD 20852. Submit written requests for
and/or Crotalaria striata per pound’’ of Leslie Kux,
single copies of the draft CPG to the
grain. In developing the draft CPG, we
Office of Policy and Risk Management, Associate Commissioner for Policy.
converted the unit of weight from
Office of Regulatory Affairs, Office of [FR Doc. 2015–23619 Filed 9–18–15; 8:45 am]
pounds to kilograms because metric
Global Regulatory Operations and BILLING CODE 4164–01–P
units of measurement (e.g., kilograms)
Policy, Food and Drug Administration, are generally used for scientific
12420 Parklawn Dr., Rockville, MD calculations. The conversion from
20857. Send two self-addressed ‘‘seeds per pound’’ to ‘‘seeds per DEPARTMENT OF HEALTH AND
adhesive labels to assist that office in kilogram’’ resulted in 2.2 seeds per HUMAN SERVICES
processing your request, or fax your kilogram. Because the analytical method
request to 240–632–6861. See the Food and Drug Administration
is based on determining whole seeds,
SUPPLEMENTARY INFORMATION section for [Docket No. FDA–2007–D–0369]
we rounded 2.2 to the nearest number
electronic access to the draft CPG. of whole seeds (i.e., 2 whole seeds). The
FOR FURTHER INFORMATION CONTACT: draft CPG also refers to Crotalaria spp. Product-Specific Bioequivalence
George C. Ziobro, Center for Food Safety seeds in grain instead of Crotalaria Recommendations; Draft and Revised
and Applied Nutrition (HFS–316), Food spectabilis and Crotalaria striata Draft Guidances for Industry;
and Drug Administration, 5100 Paint because it is impracticable to Availability
Branch Pkwy., College Park, MD 20740, distinguish between Crotalaria seeds AGENCY: Food and Drug Administration,
240–402–1700; or Amber M. McCoig, based on species. Thus, the draft CPG HHS.
Center for Veterinary Medicine (HFV– states that FDA may regard grain that ACTION: Notice.
230), Food and Drug Administration, contains more than two whole
rmajette on DSK7SPTVN1PROD with NOTICES

7519 Standish Place, Rockville, MD Crotalaria spp. seeds per one kilogram SUMMARY: The Food and Drug
20855, 240–402–5556. of grain to be adulterated within the Administration (FDA or Agency) is
SUPPLEMENTARY INFORMATION: meaning of section 402(a)(1) of the announcing the availability of
FD&C Act (21 U.S.C. 342(a)(1)). additional draft and revised draft
I. Background The draft CPG is being made available product-specific bioequivalence (BE)
We are announcing the availability of consistent with FDA’s good guidance recommendations. The
a draft CPG entitled ‘‘Compliance Policy practices regulation (21 CFR 10.115). recommendations provide product-

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Document Created: 2015-12-15 09:38:49
Document Modified: 2015-12-15 09:38:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		80 FR 57000

80 FR 57000 - Draft Compliance Policy Guide Crotalaria spp. Seeds in Grains; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 182 (September 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration