Amended in Senate September 3, 2013

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 V. Manuel Pérez)

March 11, 2013

An act to amend Sections 110190 and 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. 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. begin insert Existing law also requires a person requesting an export document to submit specified fees to the department. end insert Under existing law, an export document expires 180 days after its issue date.

This bill would authorize a person requesting an export document to make the request in begin insert certain end insert electronic begin delete format end delete begin insert formats end insert , and would require the department to accept requests submitted by begin delete email end delete begin insert e end insert begin insert -mail end insert or other electronic methods, including electronic copies of labels or advertising. begin insert The bill would require that the fees for requests made by e end insert begin insert -mail, facsimile, or the department’s Internet Web site be submitted within specified time periods. end insert 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 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:

SECTION 1.  

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

110190.  

(a) 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, in hardcopy or begin insert the end insert electronic begin delete format end delete
begin insert formats described in subdivision (c) end insert , all of the following:

(1) All labels, labeling, and advertising affixed to,
accompanying, or relating to the food, drug, device, or cosmetic.
The department shall accept electronic or paper copies of labels,
labeling, or advertising.

(2) If not clearly evident from the materials submitted pursuant
to paragraph (1), the requester shall submit both of the following:

(A) 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.

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

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

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

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

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

begin delete

(7)

end delete

begin insert (b) end insert  The begin insert person making the request shall also submit the end insert 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 delete

(b)

end delete

begin insert (c) end insert  The department shall accept requests for an export document
submitted by begin delete email end delete begin insert e end insert begin insert -mail end insert or other electronic methods.

begin insert

(1) For requests submitted by e-mail or facsimile on or after
January 1, 2014, payment of the fees described in subdivision (b)
shall be provided to, and received by, the department within five
business days after submittal of the request. The department shall
suspend processing of a request if payment is not received within
five business days, and shall resume processing once it receives
the payment.

end insert begin insert

(2) For requests submitted using an electronic document request
submittal process developed by the department and available on
the department’s Internet Web site, payment shall be submitted at
the time of the request.

end insert begin delete

(c)

end delete

begin insert (d) end insert  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.

SEC. 2.  

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.