SCHEDULE 1Amendment of Titles 1 To 15

PART 3Amendment of Title 3: Data sharing and avoidance of unnecessary testing

Chapter 2 of Title 325

1

Article 27 is amended as follows.

2

In paragraph 1, for “a substance has previously been registered less than 12 years earlier” substitute “there is a previous registration of a substance that is less than 12 years old”.

3

For paragraph 2 substitute—

2

Within one month of a request for information being made according to paragraph 1, the owner of the study shall provide proof of the cost of the information to the potential registrant(s) requesting it. The potential and the previous registrant(s) as referred to in paragraph 1 shall make every effort to reach an agreement on the sharing of the information requested by the potential registrant(s) with respect to Article 10(a)(vi) and (vii). Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.

4

In paragraph 4, after “the previous registrant shall” insert “, within two weeks of receipt of payment,”.

5

For paragraph 5 substitute—

5

If the previous registrant as referred to in paragraph 1 refuses to provide either proof of the cost of that study or the study itself to a potential registrant, or there is failure to reach an agreement referred to in paragraph 4, the potential registrant(s) shall inform the Agency and the previous registrant(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the previous registrant(s).