Amended in Assembly April 15, 2013

California Legislature—2013–14 Regular Session

Assembly Bill No. 1400

Introduced by Committee on Jobs, Economic Development, and the Economy (Medina (Chair), Daly, Fong, Fox, Hueso, and begin delete V. Manuel Pérez) end delete begin insert V. Manuel  end insert begin insert Pérez) end insert

March 11, 2013

An act to amend begin delete Section end delete begin insert Sections 110190 and end insert 110200 of the Health and Safety Code, relating to export documents.

LEGISLATIVE COUNSEL’S DIGEST

AB 1400, as amended, Committee on Jobs, Economic Development, and the Economy. Export documents: expiration.

The Sherman Food, Drug, and Cosmetic Law authorizes a person who ships to another state or country a food, drug, device, or cosmetic manufactured or produced in this state to request that the State Department of Public Health issue an export document to reference the shipment. begin insert Existing law requires that a person requesting an export document submit certain information and documents to the department, including original labels and advertising affixed to, accompanying, or relating to the food, drug, device, or cosmetic, and authorizes the department to accept copies if the submission of the original labels or advertising is impractical. end insert Under existing law, an export document expires 180 days after its issue date.

This bill would begin delete instead end delete begin insert authorize a person requesting an export document to make the request in electronic format, and would require the department to accept requests submitted by email or other electronic methods, including electronic copies of labels or advertising. The bill would require the department to develop procedures to expedite approval of requests for an export document in which the labels and advertising remain unchanged from a previously approved request for an export document for that food, drug, device, or cosmetic. The bill would further end insert require that an export document expire one year after its issue date.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: no.

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1. end insert   

end insert

begin insert Section 110190 of the end insert begin insert Health and Safety Code end insert begin insert is
amended to read: end insert

110190.  

begin insert (a) end insert begin insert   end insert Any person who ships to another state or country
a food, drug, device, or cosmetic manufactured or produced in this
state may request the department to issue an export document to
reference the shipment of the food, drug, device, or cosmetic. The
food, drug, device, or cosmetic shall be manufactured or produced
in this state by a person who has a valid registration, license,
certificate, or permit issued by the department under this part or
the Miscellaneous Food, Food Facility, and Hazardous Substances
Act (Section 27). For each request, the requesting person shall
submit to the department begin insert , in hardcopy or electronic format, end insert all of
the following:

begin delete

(a)

end delete

begin insert (1) end insert  All begin delete original end delete labels, labeling, and advertising affixed to,
accompanying, or relating to the food, drug, device, or cosmetic.
The department begin delete may end delete begin insert shall end insert accept begin insert electronic or paper end insert copies begin delete if
submission of original end delete begin insert of end insert labels, labeling, or advertising begin delete is
impractical end delete .

begin delete

(b)

end delete

begin insert (2) end insert  If not clearly evident from the materials submitted pursuant
to begin delete subdivision (a) end delete begin insert paragraph (1) end insert , the requester shall submit both
of the following:

begin delete

(1)

end delete

begin insert (A) end insert  The name, place of business, and the type and number of
the registration, license, certificate, or permit issued by the
department to the manufacturer or producer of the food, drug,
device, or cosmetic.

begin delete

(2)

end delete

begin insert (B) end insert  The identity of the food, drug, device, or cosmetic being
shipped.

begin delete

(c)

end delete

begin insert (3) end insert  The name of the state or country to which the food, drug,
device, or cosmetic is being shipped.

begin delete

(d)

end delete

begin insert (4) end insert  The approximate date of shipment of the food, drug, device,
or cosmetic.

begin delete

(e)

end delete

begin insert (5) end insert  Additional statements the requesting person wishes to have
incorporated into the export document.

begin delete

(f)

end delete

begin insert (6) end insert  The name and telephone number of the requesting person
to whom the department may refer questions or requests for
additional information.

begin delete

(g)

end delete

begin insert (7) end insert  The one-time fee required by paragraph (1) of subdivision
(a) of Section 110210, if the fee has not yet been paid, and the
minimum charge required by paragraph (2) of subdivision (a) of
Section 110210.

begin insert

(b) The department shall accept requests for an export document
submitted by email or other electronic methods.

end insert begin insert

(c) The department shall develop procedures to expedite
approval of requests for an export document in which the labels,
labeling, and advertising affixed to, accompanying, or relating to
the food, drug, device, or cosmetic remain unchanged from a
previously approved request for an export document for that food,
drug, device, or cosmetic.

end insert

begin delete SECTION 1. end delete
begin insert SEC. 2. end insert   

Section 110200 of the Health and Safety Code is
amended to read:

110200.  

(a)  Each export document issued by the department
shall do all of the following:

(1)  Identify either or both of the following:

(A)  The name and place of business of the manufacturer or
producer of the food, drug, device, or cosmetic.

(B)  The name and place of business of the distributor of the
food, drug, device, or cosmetic.

(2)  Identify the food, drug, device, or cosmetic being shipped.

(3)  Identify the state or country to which the food, drug, device,
or cosmetic is being shipped.

(4)  Identify the approximate date of shipment.

(5)  Describe the department’s authority over the food, drug,
device, or cosmetic to be shipped and its manufacturer or producer.

(6)  State that the department does not object to the sale of the
food, drug, device, or cosmetic in this state or the shipment of the
food, drug, device, or cosmetic to any other state or country.

(b)  Each export document issued by the department may, in
the department’s sole discretion, include additional statements
requested by the person who requested the export document.

(c)  Each export document issued by the department shall be
issued by the Chief of the Food and Drug Branch of the department,
or his or her designee. The chief or his or her designee may issue
an export document prepared by the department or by the
requesting person.

(d)  The export document shall expire one year after its issue
date.